Page Range | 42453-42982 | |
FR Document |
Page and Subject | |
---|---|
81 FR 42475 - Airworthiness Directives; General Electric Company Turbofan Engines | |
81 FR 42743 - Sunshine Act Meeting; National Science Board | |
81 FR 42542 - Standards of Performance for New Stationary Sources | |
81 FR 42503 - Civil Monetary Penalty Adjustment and Table | |
81 FR 42759 - Sunshine Act Meeting | |
81 FR 42726 - Sunshine Act Meeting | |
81 FR 42631 - International Standard-Setting Activities | |
81 FR 42648 - Foreign-Trade Zone 158-Tupelo, Mississippi; Notification of Proposed Production Activity; Bauhaus Furniture Group, LLC; H.M. Richards Company, Inc.; Lane Home Furniture; Morgan Fabrics Corporation (Upholstered Furniture) | |
81 FR 42649 - Foreign-Trade Zone 158-Tupelo, Mississippi; Notification of Proposed Production Activity; Southern Motion, Inc.; Subzone 158G (Upholstered Furniture); Pontotoc and Baldwyn, Mississippi | |
81 FR 42650 - Foreign-Trade Zone 18-San Jose, California; Application for Subzone Expansion; Subzone 18E; Space Systems/Loral, LLC; Palo Alto, Menlo Park and Mountain View, California | |
81 FR 42649 - Foreign-Trade Zone (FTZ) 44-Morris County, New Jersey; Notification of Proposed Production Activity; Givaudan Flavors Corporation (Flavor Products); East Hanover, New Jersey | |
81 FR 42649 - Foreign-Trade Zone (FTZ) 230-Piedmont Triad Area, North Carolina; Authorization of Production Activity; United Chemi-Con, Inc. (Aluminum Electrolytic Capacitors); Lansing, North Carolina | |
81 FR 42587 - Approval and Promulgation of Implementation Plans; Oklahoma; Revisions to Major New Source Review Permitting | |
81 FR 42597 - Air Plan Approval; Ohio; Removal of Stage II Gasoline Vapor Recovery Requirements | |
81 FR 42702 - Product Cancellation Order for Certain Pesticide Registrations and Amendments To Terminate Uses | |
81 FR 42704 - Plant-Incorporated Protectants: Proposed Modification of Registration Procedures for Plant-Incorporated Protectants in Breeding Line Intermediates; Notice of Availability | |
81 FR 42543 - Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate); Exemption From the Requirement of a Tolerance | |
81 FR 42784 - Advisory Committee on International Economic Policy; Notice of Open Meeting | |
81 FR 42507 - Safety Zones; Marine Events Held in the Sector Long Island Sound Captain of the Port Zone | |
81 FR 42517 - Safety Zone, Pamlico Sound; Ocracoke, NC | |
81 FR 42629 - Codex Alimentarius Commission: Meeting of the Codex Committee on Processed Fruits and Vegetables | |
81 FR 42666 - National Sea Grant Advisory Board (NSGAB) | |
81 FR 42789 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Examination Questionnaire | |
81 FR 42791 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments | |
81 FR 42706 - FIFRA Scientific Advisory Panel; Notice of Public Meeting | |
81 FR 42798 - Special Medical Advisory Group, Notice of Meeting | |
81 FR 42673 - Revised Non-Foreign Overseas Per Diem Rates | |
81 FR 42743 - North Anna Power Station Independent Spent Fuel Storage Installation | |
81 FR 42528 - Safety Zone; Ohio River Mile 317-318, Ashland, KY | |
81 FR 42530 - Safety Zone; Ohio River Mile 607.5 to 608.6, Indiana | |
81 FR 42524 - Safety Zone; Ohio River mile 307.8-308.8 Huntington, WV | |
81 FR 42552 - Inflation Adjustment of Civil Monetary Penalties | |
81 FR 42569 - Standardizing Phytosanitary Treatment Regulations: Approval of Cold Treatment and Irradiation Facilities; Cold Treatment Schedules; Establishment of Fumigation and Cold Treatment Compliance Agreements | |
81 FR 42705 - Information Collection Request Submitted to OMB for Review and Approval; Comment Request; NSPS for Flexible Vinyl and Urethane Coating and Printing (Renewal) | |
81 FR 42548 - Civil Penalties | |
81 FR 42788 - Agency Information Collection Activities: Information Collection Renewal; Submission for OMB Review; Notice Regarding Unauthorized Access to Customer Information | |
81 FR 42710 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
81 FR 42700 - Haida Energy, Inc.; Notice of Application Accepted For Filing, Soliciting Comments, Motions To Intervene, and Protests | |
81 FR 42697 - Kodiak Electric Association, Inc.; Notice of Application Accepted for Filing, Ready for Environmental Analysis, Soliciting Comments, Motions To Intervene, Protests, Recommendations, Terms and Conditions, and Fishway Prescriptions | |
81 FR 42696 - ISO New England Inc., New England Power Pool Participants Committee; Notice of Designation of Commission Staff as Non-Decisional | |
81 FR 42697 - Saguaro Power Company, a Limited Partnership; Notice of Amendment | |
81 FR 42696 - Transource Wisconsin, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
81 FR 42697 - Xcel Energy Transmission Development Company, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
81 FR 42702 - Xcel Energy Southwest Transmission Company, LLC; Notice of Institution of Proceeding and Refund Effective Date | |
81 FR 42701 - Columbia Gas Transmission, LLC; Notice of Request Under Blanket Authorization | |
81 FR 42700 - Magnum Gas Storage, LLC; Notice of Schedule for Environmental Review of The Magnum Gas Storage Amendment Project | |
81 FR 42698 - Combined Notice of Filings #1 | |
81 FR 42629 - National Wildlife Services Advisory Committee; Reestablishment | |
81 FR 42630 - National Advisory Committee on Meat and Poultry Inspection | |
81 FR 42711 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
81 FR 42756 - Duke Energy Carolinas, LLC and North Carolina Electric Membership Corporation; Acceptance Criteria for Emergency Core Cooling Systems, McGuire Nuclear Station, Units 1 and 2, Catawba Nuclear Station, Units 1 and 2 | |
81 FR 42745 - Vogtle Electric Generating Plant Unit 3; Southern Nuclear Operating Company, Inc.; Georgia Power Company, Oglethorpe Power Corporation, MEAG Power SPVM, LLC., MEAG Power SPVJ, LLC., MEAG Power SPVP, LLC., and the City of Dalton, Georgia | |
81 FR 42784 - Indexing the Annual Operating Revenues of Railroads | |
81 FR 42743 - Omaha Public Power District; Fort Calhoun Station, Unit No. 1 | |
81 FR 42672 - Submission for OMB Review; Comment Request | |
81 FR 42659 - Award Competitions for Hollings Manufacturing Extension Partnership (MEP) Centers in the States of Delaware, Hawaii, Iowa, Kansas, Maine, Mississippi, New Mexico, Nevada, North Dakota, South Carolina and Wyoming | |
81 FR 42742 - Arts Advisory Panel Meetings | |
81 FR 42645 - Notice of Public Meeting of the Alaska State Advisory Committee | |
81 FR 42478 - Civil Penalties Inflation Adjustments | |
81 FR 42794 - Submission for OMB Review; Comment Request | |
81 FR 42784 - Texas Disaster Number TX-00472 | |
81 FR 42783 - Florida Disaster #FL-00117 Declaration of Economic Injury | |
81 FR 42564 - Pipeline Safety: Inflation Adjustment of Maximum Civil Penalties | |
81 FR 42491 - Civil Monetary Penalties Inflation Adjustment | |
81 FR 42641 - Revision of Land and Resource Management Plan for the Santa Fe National Forest; Counties of Los Alamos, Mora, Rio Arriba, Sandoval, San Miguel, Santa Fe, and Taos, New Mexico | |
81 FR 42645 - Deschutes Provinicial Advisory Committee Meeting | |
81 FR 42720 - Current List of HHS-Certified Laboratories and Instrumented Initial Testing Facilities Which Meet Minimum Standards To Engage in Urine Drug Testing for Federal Agencies | |
81 FR 42666 - Submission for OMB Review; Comment Request | |
81 FR 42742 - Proposed Collection; Comment Request | |
81 FR 42798 - Health Services Research and Development Service, Scientific Merit Review Board; Amended Notice of Meetings | |
81 FR 42693 - 36(b)(1) Arms Sales Notification | |
81 FR 42688 - 36(b)(1) Arms Sales Notification | |
81 FR 42671 - 36(b)(1) Arms Sales Notification | |
81 FR 42686 - 36(b)(1) Arms Sales Notification | |
81 FR 42695 - 36(b)(1) Arms Sales Notification | |
81 FR 42684 - 36(b)(1) Arms Sales Notification | |
81 FR 42741 - Maritime Advisory Committee for Occupational Safety and Health | |
81 FR 42731 - Proposed Collection, Comment Request | |
81 FR 42777 - SEC Advisory Committee on Small and Emerging Companies | |
81 FR 42526 - Regulated Navigation Area; Fourth of July, Biscayne Bay, Miami, FL | |
81 FR 42520 - Safety Zone; Fireworks Display; Ohio River Mile 469.6 to 470.2, Newport, KY | |
81 FR 42506 - Madison Regatta, Inc./Madison Regatta, Madison, IN | |
81 FR 42512 - Safety Zone; City of Charleston Independence Celebration, Charleston, WV | |
81 FR 42521 - Safety Zone; Fireworks Display; Ohio River Mile 408 to 409, Maysville, KY | |
81 FR 42517 - Safety Zones; Duluth Fourth Fest, Duluth, MN | |
81 FR 42523 - Safety Zones; Superior Man Triathlon, Duluth, MN | |
81 FR 42510 - Safety Zones; Recurring Events in Captain of the Port Boston Zone | |
81 FR 42779 - Self-Regulatory Organizations; NYSE MKT LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change for a Temporary Suspension of Those Aspects of Rules 36.20-Equities and 36.21-Equities That Would Not Permit Floor Brokers To Use Personal Portable Phone Devices on the Trading Floor Due to the Unavailability of Floor Broker Telephone Services | |
81 FR 42766 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change for a Temporary Suspension of Those Aspects of Rules 36.20 and 36.21 That Would Not Permit Floor Brokers To Use Personal Portable Phone Devices on the Trading Floor Due to the Unavailability of Floor Broker Telephone Services | |
81 FR 42648 - Submission for OMB Review; Comment Request | |
81 FR 42759 - Submission for Review: Reemployment of Annuitants | |
81 FR 42669 - Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Conformity Assessment Body Registration Form | |
81 FR 42646 - Proposed Information Collection; Comment Request; Local Update of Census Addresses Operation | |
81 FR 42625 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Dolphin and Wahoo Fishery Off the Atlantic States; Regulatory Amendment 1 | |
81 FR 42726 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection U.S. Official Order Forms for Schedules I and II Controlled Substances DEA Form 222 | |
81 FR 42727 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of currently approved collection: 2017 School Crime Supplement (SCS) to the National Crime Victimization Survey (NCVS) | |
81 FR 42726 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; OSC Charge Form | |
81 FR 42742 - Advisory Committee for Mathematical and Physical Sciences; Notice of Meeting | |
81 FR 42665 - Judges Panel of the Malcolm Baldrige National Quality Award | |
81 FR 42709 - Meeting of the National Advisory Council for Healthcare Research and Quality | |
81 FR 42654 - Healthcare Business Development Mission to China October 23-28, 2016 | |
81 FR 42657 - Trade Mission to Central America in Conjunction With the Trade Americas-Business Opportunities in Central America Conference, March 26-31, 2017 | |
81 FR 42656 - Information and Communication Technologies and Services Trade Mission to Singapore and Vietnam March 6-10, 2017 | |
81 FR 42651 - Health IT Trade Mission to Brazil September 26-30, 2016 | |
81 FR 42482 - Country-by-Country Reporting | |
81 FR 42654 - Subsea & Onshore Technology Trade Mission to Rio de Janeiro, Brazil October 19-21, 2016; Amendment | |
81 FR 42715 - Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments; Extension of Comment Period | |
81 FR 42650 - Civil Nuclear Trade Advisory Committee: Meeting of the Civil Nuclear Trade Advisory Committee | |
81 FR 42714 - Inorganic Arsenic in Rice Cereals for Infants: Action Level; Draft Guidance for Industry; Supporting Document for Action Level for Inorganic Arsenic in Rice Cereals for Infants; Arsenic in Rice and Rice Products Risk Assessment: Report; Availability; Extension of the Comment Period | |
81 FR 42690 - 36(b)(1) Arms Sales Notification | |
81 FR 42713 - Agency Information Collection Activities; Proposed Collection; Comment Request; Registration of Food Facilities Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002; Extension of Comment Period | |
81 FR 42585 - Society of the Plastics Industry, Inc.; Filing of Food Additive Petition | |
81 FR 42667 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0102, Clearing Exemption for Certain Swaps Entered Into by Cooperatives | |
81 FR 42668 - Agency Information Collection Activities: Notice of Intent To Renew Collection 3038-0005, Rules Relating to the Operations and Activities of Commodity Pool Operators and Commodity Trading Advisors and to Monthly Reporting by Futures Commission Merchants | |
81 FR 42653 - Notice of Final Results of Antidumping Duty Changed Circumstances Review: Circular Welded Non-Alloy Steel Pipe From the Republic of Korea | |
81 FR 42716 - Delegation of Authority | |
81 FR 42716 - Mandatory Guidelines for Federal Workplace Drug Testing Programs | |
81 FR 42730 - Comment Request for Information Collection for Form ETA 9033 Attestation by Employers Using Alien Crewmembers for Longshore Activities in U.S. Ports (OMB Control Number 1205-0309) and Form ETA 9033-A, Attestation by Employers Using Alien Crewmembers for Longshore Activities in the State of Alaska (OMB Control Number 1205-0309) | |
81 FR 42729 - Agency Information Collection Activities; Comment Request; Unemployment Insurance Benefits Operations State Self-Assessment Report of Responses | |
81 FR 42728 - Notice of Reopened Availability of Funds and Funding Opportunity Announcement for the Senior Community Service Employment Program (SCSEP) National Grants for Program Year (PY) 2016 | |
81 FR 42692 - Submission for OMB Review; Comment Request | |
81 FR 42532 - Inspection Service Authority; Civil Monetary Penalty Inflation Adjustment | |
81 FR 42760 - Product Change-Priority Mail and First-Class Package Service Negotiated Service Agreement | |
81 FR 42760 - Product Change-Priority Mail Negotiated Service Agreement | |
81 FR 42760 - Privacy Act of 1974; System of Records | |
81 FR 42548 - Medicare and Medicaid Programs; Fire Safety Requirements for Certain Health Care Facilities; Correction | |
81 FR 42792 - Proposed Collection; Comment Request for Forms 8288 and 8288-A | |
81 FR 42761 - Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940 | |
81 FR 42762 - Self-Regulatory Organizations; New York Stock Exchange LLC; Order Granting Approval of a Proposed Rule Change, as Modified by Amendment Nos. 5 and 6, To Adopt Initial and Continued Listing Standards for the Listing of Equity Investment Tracking Stocks and Adopt Listing Fees Specific to Equity Investment Tracking Stocks | |
81 FR 42781 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change to Temporarily Widen Price Collar Thresholds for the Core Open Auction and Trading Halt Auctions | |
81 FR 42777 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Related to the Acceptance of Pass-Through Letters of Credit as a Form of Margin Asset | |
81 FR 42768 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change to List and Trade the Shares of the VanEck Vectors Long/Flat Commodity ETF | |
81 FR 42792 - Proposed Collection; Comment Request for Form 6478 | |
81 FR 42794 - Art Advisory Panel-Notice of Availability of Report of 2015 Closed Meetings | |
81 FR 42708 - Deletion of Items From Sunshine Act Meeting | |
81 FR 42719 - National Cancer Institute; Notice of Closed Meetings | |
81 FR 42717 - Office of the Director; Notice of Meeting | |
81 FR 42717 - Center For Scientific Review; Notice of Closed Meetings | |
81 FR 42718 - Request for Data and Information on Technologies Used for Identifying Potential Developmental Toxicants | |
81 FR 42719 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
81 FR 42718 - Government-Owned Inventions; Availability for Licensing | |
81 FR 42719 - Government-Owned Inventions; Availability for Licensing | |
81 FR 42512 - Safety Zones; Safety Zones Within the Captain of the Port New Orleans Zone; New Orleans to Baton Rouge, LA | |
81 FR 42506 - Drawbridge Operation Regulation; Chambers Creek, Steilacoom, WA | |
81 FR 42515 - Safety Zone; City of Bayfield Fourth of July Fireworks, Lake Superior, Bayfield, WI | |
81 FR 42566 - Small Entity Size Standards Under the Regulatory Flexibility Act | |
81 FR 42737 - Petitions for Modification of Application of Existing Mandatory Safety Standards | |
81 FR 42736 - Affirmative Decisions on Petitions for Modification Granted in Whole or in Part | |
81 FR 42793 - Proposed Collection; Comment Request for e-Services Registration TIN Matching-Application and Screens for TIN Matching Interactive | |
81 FR 42712 - Agency Information Collection Activities; Proposed Collection; Comment Request; State Annual Long-Term Care Ombudsman Report Amended Data Collection | |
81 FR 42721 - Proclaiming Certain Lands as Reservation for the Port Gamble S'Klallam Tribe of Washington | |
81 FR 42722 - Hannahville Indian Community Liquor Control Code | |
81 FR 42785 - Actions Taken at June 16, 2016, Meeting | |
81 FR 42734 - Proposed Extension of Information Collection; Program To Prevent Smoking in Hazardous Areas (Pertains to Underground Coal Mines) | |
81 FR 42733 - Proposed Extension of Information Collection; Hazardous Conditions Complaints | |
81 FR 42735 - Proposed Extension of Information Collection; Safety Standards for Underground Coal Mine Ventilation-Belt Entry Used as an Intake Air Course To Ventilate Working Sections and Areas Where Mechanized Mining Equipment Is Being Installed or Removed | |
81 FR 42912 - Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record | |
81 FR 42644 - Information Collection; Appeal of Decisions Relating to Occupancy or Use of National Forest System Lands and Resources | |
81 FR 42784 - Culturally Significant Objects Imported for Exhibition Determinations: “The Art of the Qur'an: Treasures From the Museum of Turkish and Islamic Arts” Exhibition | |
81 FR 42577 - Proposed 2020 Census Residence Criteria and Residence Situations | |
81 FR 42786 - Request for Information: Nationally Uniform 911 Data System | |
81 FR 42534 - Ex Parte Communications | |
81 FR 42576 - Draft Environmental Assessment for Notice of Proposed Rulemaking, “Energy Conservation Standards for Manufactured Housing” With Request for Information on Impacts to Indoor Air Quality | |
81 FR 42453 - General Administrative Regulations; Catastrophic Risk Protection Endorsement; Area Risk Protection Insurance Regulations; and the Common Crop Insurance Regulations, Basic Provisions | |
81 FR 42600 - Promulgation of Air Quality Implementation Plans; Arizona; Regional Haze Federal Implementation Plan; Reconsideration | |
81 FR 42609 - Hazardous Materials: Miscellaneous Petitions for Rulemaking (RRR) | |
81 FR 42476 - Adjustment of Civil Monetary Penalty Amounts | |
81 FR 42787 - National Advisory Committee on Travel and Tourism Infrastructure; Solicitation for Committee Member Nominations | |
81 FR 42563 - Defense Federal Acquisition Regulation Supplement: New Designated Country-Ukraine (DFARS Case 2016-D026) | |
81 FR 42608 - Defense Federal Acquisition Regulation Supplement: Administrative Cost To Issue and Administer a Contract (DFARS Case 2016-D020) | |
81 FR 42557 - Defense Federal Acquisition Regulation Supplement: Pilot Program on Acquisition of Military Purpose Nondevelopmental Items (DFARS Case 2016-D014) | |
81 FR 42562 - Defense Federal Acquisition Regulation Supplement: Treatment of Interagency and State and Local Purchases (DFARS Case 2016-D009) | |
81 FR 42559 - Defense Federal Acquisition Regulation Supplement: Defense Contractors Performing Private Security Functions (DFARS Case 2015-D021) | |
81 FR 42607 - Defense Federal Acquisition Regulation Supplement: Contract Financing (DFARS Case 2015-D026) | |
81 FR 42556 - Defense Federal Acquisition Regulation Supplement: Deletion of Supplemental Coverage for the Definition of “Simplified Acquisition Threshold” (DFARS Case 2016-D007) | |
81 FR 42882 - Settlement Intervals and Shortage Pricing in Markets Operated by Regional Transmission Organizations and Independent System Operators | |
81 FR 42802 - Medicare Program; End-Stage Renal Disease Prospective Payment System, Coverage and Payment for Renal Dialysis Services Furnished to Individuals with Acute Kidney Injury, End-Stage Renal Disease Quality Incentive Program, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program Bid Surety Bonds, State Licensure and Appeals Process for Breach of Contract Actions, Durable Medical Equipment, Prosthetics, Orthotics and Supplies Competitive Bidding Program and Fee Schedule Adjustments, Access to Care Issues for Durable Medical Equipment; and the Comprehensive End-Stage Renal Disease Care Model | |
81 FR 42725 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
81 FR 42940 - Clean Energy Incentive Program Design Details | |
81 FR 42576 - Amendment to the Beef Promotion and Research Rules and Regulations; Withdrawal | |
81 FR 42554 - Adjustment of Civil Monetary Penalties To Reflect Inflation |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Federal Crop Insurance Corporation
Food Safety and Inspection Service
Forest Service
Census Bureau
Foreign-Trade Zones Board
International Trade Administration
National Institute of Standards and Technology
National Oceanic and Atmospheric Administration
Defense Acquisition Regulations System
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Aging Administration
Centers for Medicare & Medicaid Services
Children and Families Administration
Community Living Administration
Food and Drug Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Indian Affairs Bureau
National Park Service
Drug Enforcement Administration
Employment and Training Administration
Labor Statistics Bureau
Mine Safety and Health Administration
Occupational Safety and Health Administration
National Endowment for the Arts
Federal Aviation Administration
Maritime Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
Comptroller of the Currency
Financial Crimes Enforcement Network
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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Federal Crop Insurance Corporation, USDA.
Final rule.
The Federal Crop Insurance Corporation (FCIC) finalizes the General Administrative Regulations—Ineligibility for Programs under the Federal Crop Insurance Act, the Catastrophic Risk Protection Endorsement, the Area Risk Protection Insurance Regulations, and the Common Crop Insurance Regulations, Basic Provisions to revise those provisions affected by changes mandated by the Agricultural Act of 2014 (commonly referred to as the 2014 Farm Bill), enacted on February 7, 2014.
This rule is effective June 30, 2016.
Tim Hoffmann, Director, Product Management, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-7730.
This rule finalizes changes to the General Administrative Regulations—Ineligibility for Programs under the Federal Crop Insurance Act, the Catastrophic Risk Protection Endorsement, the Area Risk Protection Insurance Regulations, and the Common Crop Insurance Regulations, Basic Provisions that were published by FCIC on July 1, 2014, as a notice of interim rulemaking in the
A total of 364 comments were received from 74 commenters. The commenters included persons or entities from the following categories: Academic, farmer, financial, insurance company, producer group, trade association, and other.
FCIC received a number of comments regarding sections of the Farm Bill that were not included in the interim rule. The comments received included but are not limited to (1) section 1404 participation of dairy operations in margin protection program; (2) section 11003 supplemental coverage option; (3) section 11017 stacked income protection plan for producers of upland cotton; (4) section 11022 whole farm diversified risk management insurance plan; and (5) section 11023 crop insurance for organic crops. These sections of the Farm Bill were not a part of this regulation. Therefore, FCIC is not publishing these comments in this final rule. FCIC thanks the public for their input.
The public comments received are organized below by the issues identified in this rule and the specific public comments received. The comments received and FCIC's responses are as follows:
The commenter suggested the United States Department of Agriculture (USDA) aggressively promote educational and informational programming, especially initiatives that involve and combine the efforts of public, private and educational entities.
FCIC has published information on its Web site highlighting the major changes to the Federal crop insurance program in response to the 2014 Farm Bill implementation. Also published on the Web site are Fact Sheets, Question and Answers, and brochures regarding each section of the Farm Bill. FCIC has worked closely with approved insurance providers to make system changes and prepare procedural documents. In addition, FCIC participated with approved insurance providers and an insurance trade association to train the trainers, underwriters, loss adjusters, and agents. FCIC will continue to promote and educate on the implementation of the Farm Bill provisions as opportunities arise.
The commenter has long advocated for reforms to make the agricultural safety net more cost-effective, transparent, accountable to taxpayers, and responsive to current market conditions and needs. While the Agricultural Act of 2014 fails to take the necessary steps to achieve this reformed safety net, instead of expanding the role of Washington in agriculture through new business income entitlement programs and increasing spending on federally subsidized crop insurance, there is an opportunity to make progress in the implementation of crop insurance provisions.
The commenter strongly encouraged FCIC to remember that while USDA may consider producers and other agricultural businesses “clients,” it is taxpayers who are footing the bill. Farm Bills are notorious for vastly exceeding their estimated costs—the last two Farm Bills are on pace to exceed by $400 billion their Congressional Budget Office scores at passage. The decisions FCIC makes in developing and administering programs under its jurisdiction play an important role in determining whether taxpayer-funded agricultural programs will continue to be vastly over budget.
The commenter strongly encourages FCIC to implement the Agricultural Act of 2014 while being cognizant of the reality that federal taxpayers are responsible for more than $17 trillion in debt and are facing annual deficits exceeding $500 billion. The commenter suggested FCIC not simply attempt to maximize spending, but follow the will of Congress in prioritizing federal support only where necessary and in a manner that is cost-effective and transparent.
The commenter felt we have gotten very far off-base with government programs. The commenter explained that there are so many people working in government now that don't have any real understanding of how to work land, improve it, etc. They are only there to draw a salary and pretend to know something. Let the real farmers and ranchers control agriculture. Government programs now are really created and maintained for special interest groups, and that creates all kinds of requirements for the real farmers who know what they are doing. The people who farm small operations do not have a chance because there is somebody telling them they must do what the government wants when the government is unfairly operated in favor of takers rather than producers. The further we go into government control of farming, the less productivity we will have, and our food costs will continue to sky-rocket.
The commenter recommended separating the Supplemental Nutrition Assistance Program (SNAP) from farm programs. SNAP is leading the country in the wrong direction—dependency on somebody else to provide for those who will not keep a job, or maybe choose to have children with no intention of making a living for them.
However, while all persons must file a certification of compliance, Form AD-1026, by June 1, 2015, to be eligible for Federal crop insurance premium subsidy for the 2016 reinsurance year (July 1, 2015—June 30, 2016), the 2014 Farm Bill does provide additional time for producers who are subject to the conservation compliance provisions for the first time to develop and comply with a conservation plan or remedy a wetland violation, if needed. Since the conservation provisions are administered by FSA and NRCS, the terms and conditions relating to the additional time frames are specified in 7 CFR part 12. In addition, producers who are subject to the conservation compliance provisions for the first time will receive priority for NRCS technical assistance in developing and applying a conservation plan or in making a wetland determination, if needed.
The commenter added that in order for these provisions to be effective, adequate enforcement of these minimum conservation practices must be prioritized after implementation. Independent analysts including USDA's own Office of Inspector General (OIG) found that from 1991 to 2008, compliance with conservation accountability standards varied from region to region, many farms were out of compliance (up to 20 percent in the 1995 OIG report), and millions in taxpayer dollars could have been saved if subsidies were appropriately withheld for risky production practices (
The commenter also suggested that flexibility should also be built into program regulations so local, on-the-ground knowledge and realities are considered in farms' conservation plans. For instance, if only a small portion of a field is categorized as highly-erodible land, the sensitive acres may require a different conservation plan than the rest of the field. In addition, conservation practices should be evaluated in a holistic view to ensure that those with public benefits greatly outweigh others with potential negative impacts. For instance, installing stream buffers to conserve soil and water could be zeroed out if they are covered in excess agricultural residue left over from flooding or heavy rains. Public benefits of conservation practices may also be reduced when drainage tile is installed on farmland, increasing the rate at which water flows from farmland to nearby waterways. Considering these factors when developing conservation accountability standards will ensure that these provisions not only achieve their stated outcomes but also reduce long-term liabilities of agricultural runoff.
The rule specifically denies the premium subsidy for a compliance violation or failure to file a form AD-1026, and then specifically states that failure by the person to pay the full premium (without the premium subsidy) would result in termination of the policy and all other policies with FCIC. For example, section 6(f) of the CAT Endorsement denies the premium subsidy in the case of a violation and section 6(h) terminates the policy for failure to pay the required premium. The commenter supported the way that compliance has been handled in the rule, and the way it has provided clarity to the way FCIC will be handling it.
However, the commenter also pointed out that form AD-1026, as revised in June 2014 by FSA, can represent a somewhat more complex form for producers that are newly covered by compliance requirements—most of which have been participants in crop insurance, but not other USDA programs that have required compliance for some time. This final rule should provide some greater explanation about the form AD-1026, such as indicating the explanatory purpose of the appendix (as expanded in June of 2014), some description of the boxes to be checked on the form, and the significance of the affiliated person section.
The commenter recommended that the final rule include a specific discussion, perhaps in the background section, that indicates the time allowance for development and compliance with an approved conservation plan. The statute specified that any person newly covered would have five reinsurance years and persons that would have been in violation if they had continued participation in the programs requiring compliance would have two reinsurance years to come into compliance. Some indication of this phase in period would be helpful for those producers that are not familiar with conservation compliance requirements. This is especially important since the rule (and the statute) refer to reinsurance year whereas the form AD-1026 refers to crop year. While the commenter agreed with the time allowance and certain other provisions affecting a decision concerning compliance or a violation being left up to FSA, some greater explanation to that effect and perhaps a link to the FSA rules on HELC and WC would be helpful. Even with the reference to FSA responsibilities, the commenter urged FCIC to provide some clarity on the time allowance the insured has for developing and complying with conservation plans where applicable.
The commenter agreed with the clarity provided by the specific reference in the rule background that the HELC and WC provisions apply only to annually tilled crops.
The interim rule changed the applicable crop insurance Basic Provisions to indicate that producers must have Form AD-1026 on file and they must be in compliance with the conservation compliance provisions of 7 CFR part 12. FSA and NRCS administer the conservation compliance programs and make determinations regarding the additional time frames. Therefore, FSA and NRCS are in the best position to explain the requirements to producers regarding the additional time frames to come into compliance with the conservation compliance provisions. The provisions of 7 CFR part 12 regarding the requirements for conservation compliance and the additional time frames for producers who have never participated in programs for which the conservation compliance provisions were applicable to come into compliance can be found at
Specifically, the commenter asked that USDA clarify that producers must only complete the AD-1026 prior to June 1, 2015, not that a completed compliance check be undertaken. It is also very important that USDA ensure that producers undergoing existing wetland compliance review or appeals are not adversely impacted when seeking crop insurance next year.
The 2014 Farm Bill establishes a new date of February 7, 2014 for wetland conversion related to eligibility for crop insurance premium subsidies and wheat growers suggest a clear distinction be made between reviews to determine eligibility for premium subsidies for crop insurance, and participation in agriculture risk coverage (ARC) or price loss coverage (PLC) and conservation programs. The 2014 Farm Bill also establishes timeframes for producers to come into compliance if they have not been participating in programs covered by conservation compliance. There are wheat growers who may not currently be participating in commodity or conservation programs, and are, therefore, not subject to conservation compliance, so they may need to use the time to come into compliance. USDA must ensure that these producers needing to come into HEL compliance
Technical determinations regarding the conservation compliance provisions, such as whether land is highly erodible or a wetland, are made by NRCS. NRCS is also responsible for approving conservation and mitigation plans, when needed, to ensure land meets the conservation compliance requirements and conducting any compliance reviews and spot-checks. The interim rule did not address the development, approval, or enforcement of the technical requirements for conservation or mitigation plans, as these are not RMA, FCIC, or approved insurance provider responsibilities.
The details regarding the additional time afforded for certain producers to comply with the provisions, how administrative appeals affect a final determination of violation, and the differing dates for determining eligibility for FSA programs and Federal crop insurance premium subsidy due to a wetland conservation violation were not included in the interim rule. The details regarding such provisions and how they apply are contained in an amendment to the regulations at 7 CFR part 12. No change has been made.
(h) Effective for any policies with a sales closing date on or after July 1, 2015:
(1) You will be ineligible for any premium subsidy paid on your behalf by FCIC for any policy issued by us if:
(i) USDA determines you have committed a violation . . .; or
(ii) You fail to file form AD-1026, or a successor form, with FSA by the applicable deadline to be properly identified as in compliance with the applicable conservation provisions specified in section 7(h)(1):
(A) By June 1 after you make application for insurance if you demonstrate you are a beginning farmer or rancher . . . ; or
(B) By June 1 prior to the sales closing date for all others.
(2) To be eligible for premium subsidy paid on your behalf by FCIC, it is your responsibility to assure you meet all the requirements in section 7(h)(1) above.
Another commenter agreed with the requirement of maintaining Conservation Compliance in order to qualify for the insurance premium subsidy and with FCIC's approach of not denying benefits during the year in which a farm is found to be out of compliance. However, the commenter urged FCIC to reconsider the manner in which penalties are imposed in the following year. There is significant time between the start of the reinsurance year and the sales closing date for most crops, especially cotton and other spring-seeded crops. If a producer is found to be out of compliance at the beginning of the reinsurance year, the commenter encouraged FCIC to consider giving producers the opportunity to reinstate their eligibility for premium subsidies if they are able to achieve conservation compliance by the sales closing date.
Another commenter stated the proposed June 1 deadline for filing the AD-1026 form is in the regulation, but not in the statute. The commenter requested that FCIC allow producers who are out of compliance as of June 1 to be able to regain eligibility for premium subsidy if they are determined to be back in compliance before the SCD for any crop on their policy. The commenter assumed that FSA will establish procedures around the ability of producers to become eligible for premium subsidy after June 1 but prior to the SCD for any crop on their policy.
A commenter stated the proposed implementation of the new “Conservation Compliance” provisions for the Federal crop insurance program appears to be fairly straightforward with the exception of the direction FCIC has taken regarding possible penalties for producers who temporarily fall out of compliance during an insurance year. While the commenter supported maintaining producer eligibility for premium assistance during the year that a conservation compliance-related problem is recognized, the commenter believed the automatic exclusion of the producer from participating in the program the following insurance year is overly harsh and inflexible. It fails to recognize that the producer may be able to bring themselves back into compliance prior to the start of the next reinsurance year or by their next applicable sales closing date. For cotton producers in the commenter's service area, there is a nine-month difference between the start of a reinsurance year on July 1 and the applicable sales closing date for cotton of March 15. This is a significant period of time during which a producer can come back into compliance, especially if the issue that made them non-compliant was temporary or short-term in nature and can be remedied prior to the next growing season. The commenter believed FCIC should reevaluate the interim rule and revise so that it recognizes and encourages a producer to get back into compliance as quickly as possible and prior to their next applicable sales closing date in order to prevent any lapse in their ability to participate and receive premium assistance. By allowing this option FCIC will accomplish two important goals. First, it will provide a reasonable incentive to quickly address conservation compliance related issues and further the purpose of the provision to enhance environmental stewardship. Second, it will prevent the unnecessary exclusion of otherwise eligible Federal crop insurance program participants.
An agency does not have to prepare an EIS or EA if the action to be taken falls under a categorical exclusion (CE), which include agency-identified categories of actions that do not individually or cumulatively have a significant effect on the human environment. An EA or EIS must be prepared even for otherwise categorically excluded actions where the action may have the potential to affect the environment.
USDA regulations exempt FCIC from NEPA compliance. However, the commenter notes that actions of excluded agencies, including FCIC, are no longer categorically excluded from the preparation of an EA or EIS if “the agency head determines that an action may have a significant environmental effect.”
Similarly, FSA regulations provide that “major changes in ongoing programs” or “major environmental concerns with ongoing programs” are among the categories of FSA activities “that have or are likely to have significant environment[al] impacts on the human environment.” “Initial NEPA involvement in program categories” that are listed as likely to have significant environmental impacts “shall begin at the time [ ]FSA begins developing proposed legislation, begins the planning stage for implementing a new or changed program or receives notice that an ongoing program may have a significant adverse impact on the quality of the human environment.”
Accordingly, CFS hereby provides notice to FCIC as the joint administrator of the crop insurance program that it must comply with NEPA because the crop insurance provisions of the 2014 Farm Bill implicate conservation programs to which NEPA applies, and may have a significant environmental effect.
The 2014 Farm Bill made two significant changes to existing agricultural programs. First, it tied the federally-funded portion of crop insurance premiums for commodities to conservation compliance. The 2014 Farm Bill requires farmers who purchase subsidized crop insurance to develop conservation plans when they grow crops on land subject to high rates of erosion. The 2014 Farm Bill reattaches soil and wetland conservation requirements to crop insurance premium subsidies, and establishes a Sodsaver provision to protect native grasslands, which prohibits recipients of crop insurance subsidies from draining or filling wetlands unless they mitigate those wetland losses. Now a producer who plows native prairie for crop production in one of the six states covered by the program will receive a 50-percentage-point crop insurance premium subsidy reduction. The prerequisite of implementing an approved conservation plan before producing a commodity on highly erodible land or converting a wetland to crop production has existed since the 1985 Farm Bill and previously affected most USDA farm program benefits, but has excluded crop insurance since 1996. The 2014 Farm Bill again links crop insurance to conservation compliance.
Second, the 2014 Farm Bill merges commodity payments into the crop insurance scheme. The 2014 Farm Bill eliminates direct commodity payments, countercyclical payments in their current form, and the Average Crop Revenue Election (ACRE) program. In place of direct payments, the 2014 Farm Bill revises the counter-cyclical payment program that was established in 2002 and the ACRE program that existed alongside direct payments into the new Price Loss Coverage (PLC) and Agriculture Risk Coverage (ARC) crop insurance options. Thus commodity support is now part of the crop insurance program.
As a result of these two significant changes, NEPA applies to the crop insurance program. First, conservation programs are subject to NEPA under FSA regulations. Because the 2014 Farm Bill explicitly links conservation compliance to the new crop insurance program, NEPA obligations attach to the new crop insurance program.
Second, the changes to the crop insurance program will significantly affect the human environment. In fact, the crop insurance-conservation program is specifically designed to significantly affect the quality of the human environment by protecting sensitive lands and preventing soil loss. Degraded soil quality has a host of serious environmental consequences, while directly undermining the ability of farmers to grow nutritious food and be resilient in the face of disruption. Soil erosion causes water pollution, impacts wildlife habitat, and threatens long-term land productivity. Soil erosion and depletion also affects air quality and climate change: Clearing land converts stored carbon into carbon monoxide, and more than a third of the excess carbon monoxide that has been added to the atmosphere has come from the destruction of soils. Releasing more carbon monoxide into the atmosphere than it can effectively absorb also causes ocean acidification and contributes to the destruction of coral reefs and other marine ecosystems.
Now, farmers who purchase or receive crop insurance will have to develop conservation plans when growing on land subject to high rates of erosion and will be prohibited from draining or filling wetlands without mitigating the losses. Approximately one third of cropland in the United States is highly erodible, meaning that these provisions affect a significant percentage of acreage. The program also limits subsidies to farmers who convert native grasslands to crop production. From 2008 to 2011, more than 23 million acres of grassland, shrub land, and wetlands were destroyed for crop production, destroying habitat that
The new crop insurance program may also significantly, and directly, impact the environment in a negative way. The negative effects of commodity crop subsidies have been thoroughly documented. In short, subsidies—including crop insurance—encourage farmers to grow commodity crops on otherwise fallow or environmentally sensitive land. As just one example, a 2012 study by researchers at Iowa State University utilized field-level yield data up to 2006 and price data over 2005-2008, and found that up to three percent of land under the Federal crop insurance program would not have been converted from grassland if there had been no crop insurance subsidies.
With commodity crop production often comes intensive and environmentally destructive practices such as mono-cropping and heavy pesticide use. Single-crop production is more intensive and requires significantly higher usage of pesticides, herbicides, and fertilizers. Reduced crop diversity significantly increases crop losses due to insects and pathogens and reduced soil organic matter. These problems lead to increased use of pesticides and fertilizers, which in turn can increase pathogen and insect populations. Commodity-crop monoculture reduces habitat for wildlife, including birds, pollinators, and other animals that eat pest insects. In addition to reducing species richness and harming key species, this compounds the need for pesticides. On average organic farms have 30 percent higher biodiversity, including birds, pollinators, and plants, than their mono-cropped industrial counterparts. Subsidies also create higher marginal revenues for inputs (fertilizers, pesticides, herbicides, seeds, and labor), thereby motivating additional input use, by raising prices and reducing price variations in program crops. For example, compared with farmers who do not participate in commodity programs, corn farmers receiving subsidies have reported significantly increased herbicide use in all cropping sequences, “supporting the conventional view that commodity programs directly contribute to greater herbicide use in corn production.” The industrial-scale use of pesticides, herbicides, and fertilizers in turn significantly affects rivers and groundwater, harming aquatic ecosystems and the life forms they support. Over half of synthetic nitrogen fertilizers used on global cereal production (including corn and soy) are lost through groundwater leaching or released as nitrous oxide into the atmosphere. Nitrous oxide is a greenhouse gas 310 times more potent than carbon monoxide, and in the United States three-quarters of it comes from agricultural soil management. The effects of commodity farming as supported by the new crop insurance program are thus serious and significant.
These impacts flow directly from the new crop insurance program—a major Federal action significantly affecting the human environment—triggering FCIC's duty to comply with NEPA in implementing the programs.
For the forgoing reasons, NEPA applies to the new crop insurance program. NEPA requires FCIC to, at a minimum, conduct an EA for the new crop insurance subsidies. FCIC's failure to comply with NEPA in implementing these programs would constitute a blatant violation of NEPA and USDA regulations.
For instance, the Background in the interim rule, in the third column of page 37157, states that “[e]ven if the insured [determined to be non-compliant on June 1, 2015, (2015 reinsurance year)] becomes compliant during the 2016 reinsurance year, the insured will not be eligible for premium subsidy until the 2017 reinsurance year starting on July 1, 2016.” However, when questioned about this matter during a hearing of the House Subcommittee on General Farm Commodities and Risk Management, held July 10, 2014, Undersecretary Michael Scuse stated, “Well, remember, we're asking them to sign up that they will be in compliance on June 15th and then they are given a period of time to come into compliance.” In response to a follow up question of exactly how long the producer would have to come back into compliance, Undersecretary Scuse stated that this would be established “in the rule.”
The commenter agreed with the Undersecretary's point of view that the producer ought to be given time to come back into compliance. However, the interim rule, at least in the Background, appears to take a punitive approach that is inconsistent with the Undersecretary's statement. The commenter respectfully urged that the rule clarify that the producer does, in fact, have time to come back into compliance and what that time period is precisely. The commenter also urged that, beyond the rulemaking, FCIC develop a FAQ document that answers the questions concerning conservation compliance. Only the Department can provide answers that will give producers confidence in the safe harbors provided by the law and regulation.
Since FCIC does not administer the conservation compliance provisions or make determinations of compliance, as stated above, the details regarding the additional time afforded certain producers to comply with the provisions and how administrative appeals affect a final determination of violation are contained in an amendment to the regulations at 7 CFR part 12.
However, the Food Security Act of 1985 and the 2014 Farm Bill provide an exemption for persons who act in good faith and without intent to commit a violation. The exemption allows such persons to remain eligible for Federal crop insurance premium subsidy for a period of time if the person is taking action to remedy the violation. The determination of whether a person acted in good faith and without intent to violate the provisions is part of the administrative appeals process. Therefore, a person who meets the requirements of the good faith exemption would not have a final determination of violation unless they do not take the appropriate steps to remedy the violation within the established time period. The person would not be ineligible for Federal crop insurance premium subsidy until a final determination of violation is made. The details of the good faith exemption are contained in an amendment to the regulations at 7 CFR part 12. No change has been made in this final rule.
Another commenter stated in § 457.8, in section 34 of the CCIP Basic Provisions, the units provision, if a producer elects to insure dry land acreage planted to a specific commodity by enterprise unit, the producer is then also required under the interim rule to insure any irrigated acreage planted to that commodity by enterprise unit. The authority for separate enterprise units by practice, section 11007 of the Farm Bill, provides: “(D) Nonirrigated crops.—Beginning with the 2015 crop year, the Corporation shall make available separate enterprise units for irrigated and nonirrigated acreage of crops in counties.” The purpose of the provision is to require FCIC to make separate enterprise units available to irrigated and dry land acreage planted to a commodity but to allow the producer to elect enterprise units for both or either. As a matter of policy, assuming
If the purpose of section 11007 is fully effectuated, the commenter believed that the risk-reducing intent of enterprise units will be furthered, not diminished. Producers will have a more complete set of options for how best to manage risk, consistent with the goal of the Farm Bill. The commenter respectfully urged that the purpose of section 11007 of the Farm Bill be implemented accordingly.
Another commenter, regarding the proposed implementation of the “Enterprise Unit by Practice” provision, stated they believed that the proposed rule does not provide the degree of flexibility the commenter expected in this provision. The commenter strongly supported the provision based on their understanding that producers would be able to select the enterprise unit structure for a single practice (
Another commenter stated erosion of APH due to consecutive years of disaster is an issue the wheat industry has been fighting for many years. With wheat being grown in some of the most diverse regions of the country, wheat farmers can be devastated with drought, floods or freezes in any given year. This provision would be very beneficial to wheat growers across the country, primarily in areas where they are dealing with multi-year disasters. FCIC announced that this provision will not be available for the 2015 crop year which has left a number of wheat farmers frustrated. The commenter would appreciate FCIC doing everything in its power to make this provision available to our growers for 2015. The commenter is specifically concerned over continued economic injury to those who can least afford it after years of financial stress due to ongoing drought. The commenter believed this provision will go a long way toward their goal of ensuring a producer is paying for coverage that matches his or her production expectation.
Another commenter stated this provision will provide immediate relief to farmers who have suffered from multiple years of extreme weather disasters. The provision is not likely to trigger frequently, but will aid farmers in disaster areas to secure crop insurance coverage that meets average production estimates. A delay in implementation for the APH provision will result in one more year of eroding APH levels for growers across the Southern Plains region who are currently experiencing a record breaking, multiple year drought. The APH provision should be implemented immediately to adequately protect farmers and maintain the strength of the crop insurance program. As several key farm policy leaders have mentioned, if the provision cannot be implemented in 2015 for all areas and all crops, the commenter urged FCIC to target those areas most likely to benefit from the provision.
Another commenter stated they appreciated FCIC's work in making other provisions included in the 2014 Farm Bill applicable for the 2015 insurance year including: The ability to insure at different coverage levels by practice; enterprise unit coverage by practice; and the beginning farmer provisions. One provision that FCIC has indicated will not be available in 2015 is the APH adjustment. This provision is especially important for portions of the Cotton Belt who have recently incurred several years of historic drought conditions. Again, with insurance being the foundation of risk management for cotton producers, the commenter urged FCIC to continue to review every avenue possible for implementation of this important provision.
Another commenter stated concerning the implementation of section 11009 of the 2014 Farm Bill allowing insureds to exclude certain yields, the commenter understood there has been considerable discussion regarding the feasibility of an implementation in time for the 2015 reinsurance year. The commenter also supported the provision and its timely implementation and the commenter offered their expertise and their agent members in assisting to achieve this objective that is so important to producers struck by natural disasters, particularly the drought-stricken producers of recent years.
A commenter stated “Section 11009—The “APH Adjustment” provision is one that is of particular importance to the commenter's membership and is among their top priorities for implementation. Based on previous statements from FCIC, the commenter continues to be concerned that this provision will not be implemented in time for the 2015 insurance year. The commenter appreciated FCIC's willingness to continue to evaluate possible avenues for partial implementation of the provision for those regions of the country that are most impacted by the current drought and for which this provision was intended to provide
The commenters recommended to avoid these potential loopholes, minimize taxpayer liabilities, and maintain Congressional intent, any native sod acreage converted after February 7, 2014, should be subject to sodsaver premium reductions for the first four years of Federally insured crop production. For example, a producer who converted 160 acres of native sod in March 2014 plants alfalfa on that acreage in 2014-2017, and plants Federally insured wheat in 2018 should be subject to four years of sodsaver disincentives beginning in year 2018. This would ensure that the disincentive to convert native sod to cropland is fulfilled as intended by Congress.
A few commenters stated a fact sheet published in June titled “Native Sod Guidelines for Federal Crop Insurance” does not provide any limitation on the types of evidence that may be used to prove that land has been tilled. Instead, the guidance provides seven examples of acceptable documentation. Moreover, the interim rule stated that the absence of tillage will be “determined in accordance with information collected and maintained by an agency of the USDA or other verifiable records that you provide and are acceptable to us[. . .]” The commenters were concerned that this flexibility will result in the use of unreliable evidence of tillage. Therefore, the commenters recommended that if a producer cannot provide FSA, NRCS, or Common Land Unit documentation that demonstrates a cropping history on the land, there must be a body of spatially explicit evidence (
The commenters also stated that functionally, crop insurance agents have access to their own records regarding the cropping history of insured fields. However, that data often does not include the full cropping history of a field. Many fields may have data and history not accessible in insurance files. Often only FSA files have information on cropping history. This would require all crop insurance agents to contact FSA offices to obtain all information. It would simply be easier for FSA to make the determination and to remove the extra step of having the crop insurance agent make the inquiry into FSA.
For many crop insurance agents, selling crop insurance is their livelihood. Placing them in charge of making native sod determinations, what is and is not insurable, stands in a stark conflict of interest. In the free market of crop insurance, if a farmer is not happy with the decision of an agent, they can simply go to another agent. This threat of lost business for upholding the sodsaver provisions could punish crop insurance agents who do the right thing. It is unfair to place that burden on crop insurance agents. Here again, it is better to leave native sod determinations to an independent third party and in particular, to the FSA since they already possess much of the necessary data.
A few commenters stated the FSA and RMA have the ability, expertise and resources to work together to provide independent third-party verifications in a timely and accurate manner.
(1) A Farm Service Agency (FSA)-578 document showing the crop that was previously planted on the requested acreage;
(2) A prior crop year's FSA-578 document showing that the requested acreage is classified as cropland;
(3) A prior crop year's Common Land Unit (CLU) Schema (RMA provides this to approved insurance providers), presented in a map format that contains the farm number, tract number, field number, CLU classification (the cropland classification code is `2'), and calculated acres by field;
(4) Receipts and/or invoices from custom planters or harvesters identifying the fields that were planted or harvested;
(5) A Natural Resources Conservation Service (NRCS) Form CPA-026e identifying the acreage with a “No” in the Sodbust column and a “Yes” in the HEL column;
(6) An NRCS Form CPA-026e identifying the acreage with a “Yes” in the Sodbust column and a determination date on or before February 7, 2014; or
(7) Precision agriculture planting records and/or raw data for previous crop years, provided such records meet the precision farming acreage reporting requirements.
Therefore, agents do not determine the classification of land as native sod but rather the acreage itself and records provided by the producer to the approved insurance providers will be the basis for such determinations. The agent's role in native sod classification is to gather the documents provided by the insured to submit to the approved insurance providers or FCIC. Since agents do not make the determination, approved insurance providers or FCIC acts as a third-party verifier. No change has been made.
The commenters recommended FSA and RMA work together to monitor and provide annual new breakings reports at the county-level to measure the effectiveness of these policies, maintain public transparency, and help inform future policy making decisions. This can be done in a timely and accurate manner without jeopardizing landowner confidentiality. Specifically, the commenters asked USDA to develop and maintain a county-level “data field” of new breakings with no prior cropping history as they update their IT technology infrastructure. A commenter recommended that in order to track the impact of policies on grassland loss and the resulting impacts on wildlife, FSA must produce an annual report that tracks the conversion of native grasslands into row crop production. Another commenter stated information about new land breakings should be made available to the public on an annual basis.
The commenters recommended a cumulative five-acre limit apply to all land that the producer is a property owner, operator, or tenant, similar to current FSA policy for conservation compliance provisions.
The suggested change will also ensure that it conforms to the agency's definition of native sod (which makes no reference to a restriction on acreage being planted for crop year 2014).
If National Appeals Division appeals are precluded, the commenter recommended revising section 2(f)(2)(iv) to read as follows: “You may not commence litigation or arbitration against us, obtain an administrative review in accordance with 7 CFR part 400, subpart J (administrative review), or file an appeal in accordance with 7 CFR part 11 (appeal), with respect to any determination made under section 2(f)(2)(iii)(B) or section 2(f)(2)(iii)(C).”
If National Appeals Division appeals are allowed, the commenter recommended revising section 2(f)(2)(iv) to read as follows: “Determinations made under section 2(f)(2)(iii)(B) or section 2(f)(2)(iii)(C) may only be appealed in accordance with 7 CFR part 11 (appeal). You may not commence litigation or arbitration against us, or obtain an administrative review in accordance with 7 CFR part 400, subpart J (administrative review), with respect to any determination made under section 2(f)(2)(iii)(B) or section 2(f)(2)(iii)(C).”
A commenter stated for the 2015 reinsurance year, FCIC continues to issue Special Provision statement number 01282, which states “In lieu of the second sentence of Section 24(a) of the Basic Provisions, for the purpose of premium amounts owed to us or administrative fees owed to FCIC, interest will start to accrue on the first day of the month following the issuance of the notice by us, provided that a minimum of 30 days have passed from the premium billing date specified in the Special Provisions.” The interim rule does not change the second sentence of 24(a). The commenter did not see a reason why this Special Provision statement could not be incorporated into the interim rule and the Special Provision statement be discontinued. However, the commenter noted that for the February 1 billing date the added provision of a minimum of 30 days does not work as there are only 28 or 29 days in the month of February. FCIC should therefore consider changing this to 28 days.
However, instead of the two changes suggested above by the commenter, ambiguity as to the precise amount of interest owed on unpaid premium billings could be eliminated by replacing the second sentence of 24(a) with the following language, which is modeled on 24(b): “For the purpose of premium amounts owed to us or administrative fees owed to FCIC, interest will start to accrue on the date that notice is issued to you for the collection of the unpaid amount. Amounts found due under this paragraph will not be charged interest if payment is made within 30 days of issuance of the notice by us.” This change not only standardizes basic provision policy language, it is also consistent with revisions to section 6(b) of the CAT Endorsement and ensures premium billing is administered uniformly because interest accrues on a daily basis for all amounts owed.
(3) No later than 30 days from the date of the notice from the FCIC informing the person of ineligibility due to nonpayment of a debt, the ineligible person may request consideration for reinstatement from the Administrator of the Risk Management Agency in accordance with section 2 of the CCIP Basic Provisions (7 CFR 457.8).
You submit a written request for reinstatement of your policy to us no later than 30 days from the date of the notice from the FCIC informing you of your ineligibility due to nonpayment of a debt.
The commenter stated the same comment above about the time limit for these requests that applies to section 2(f)(2)(iii)(C) of the CCIP Basic Provisions. Additionally, it makes no sense to apply the written request requirement to late postmarks that fall within the 7 day transit period. These should just be automatically reinstated by the approved insurance providers. An Appendix III code should be developed so that policies which fit these criteria are tracked, but are never actually terminated and made ineligible in the first instance. As revised, this section would read as follows:
(C) We determine that, in accordance with 7 CFR part 400, subpart U and FCIC issued procedures, one of the following two conditions are met:
(1) You submit a written request for reinstatement of your policy to us in accordance with 7 CFR part 400, subpart U and applicable procedures no later than 30 days after the termination date or the missed payment date of a previously executed written payment agreement, or the due date specified in the notice to you of the amount due, if applicable, in which you demonstrate that:
(i) You made timely payment for the amount of premium owed but you inadvertently omitted some small amount, such as the most recent month's interest or a small administrative fee or the amount of the payment was clearly transposed from the amount that was otherwise due (For example, you owed $832 but you paid $823);
(ii) You remit full payment of the delinquent debt owed to us with your request for reinstatement; and
(iii) There is no evidence of fraud or misrepresentation; or
(2) You sent the full payment to us by mail and the payment was postmarked after the termination date or other applicable due date, but received by us within 7 calendar days after the termination date or other applicable due date.
In addition to the changes described above, FCIC has revised the definition of “approved yield” to clarify the approved yield may have yield exclusions elected under section 5 of the CCIP Basic Provisions. The definition listed exceptions or adjustments that may be made to an
FCIC has also revised the provisions in section 34(a)(5)(i)(A)(
The Administrative Procedure Act (5 U.S.C. 553) provides generally that before rules are issued by Government agencies, the rule is required to be published in the
This rule has been determined to be economically significant for the purposes of Executive Order 12866 and, therefore, it has been reviewed by the Office of Management and Budget (OMB).
A Benefit-Cost Analysis (BCA) has been completed and a summary is shown below; the full analysis may be viewed on
On February 7, 2014, the 2014 Farm Bill was enacted. As a result, FCIC revised those provisions of the General Administrative Regulations—Ineligibility for Programs under the Federal Crop Insurance Act (subpart U), Catastrophic Risk Protection Endorsement (CAT Endorsement), Area Risk Protection Insurance (ARPI) Basic Provisions, and the Common Crop Insurance Provisions (CCIP) Basic Provisions to timely implement program changes identified in Titles II and XI of the 2014 Farm Bill.
On January 2014, the Congressional Budget Office (CBO) issued its estimates for the effects on direct spending and revenues of the 2014 Farm Bill. These estimates were used as a basis for the quantifiable costs and benefits stated in this BCA.
The purpose of this rule is to amend subpart U, the CAT Endorsement, the ARPI Basic Provisions, and the CCIP Basic Provisions to implement the following changes:
Section 2611 requires those enrolled in Federal crop insurance, for certain agriculture commodities, to comply with conservation compliance requirements or forego premium subsidy. For acts or situations of non-compliance, ineligibility for premium subsidy will be applied beginning with the 2016 reinsurance year. Annually, FCIC anticipates a savings of $4.6 million as a result of this change.
Section 11007 makes available insurance coverage by separate enterprise units based on irrigated and non-irrigated acreage of a crop within a county. Annually, FCIC anticipates a cost of $53.3 million as a result of this change.
Section 11009 allows insureds to exclude any recorded or appraised yield for any crop year in which the per planted acre yield in the county is at least 50 percent below the simple average per planted acre yield for the crop in the county for the previous 10 consecutive crop years, and allows insureds in any county contiguous to a county in which an insured is eligible to exclude a recorded or appraised yield to also elect a similar adjustment. Annually, FCIC anticipates a cost of $35.7 million as a result of this change.
Section 11014 applies a reduction of premium subsidy, a reduced insurance guarantee, and eliminates substitute yields in the insurance guarantee during the first four crop years that land is converted from native sod to the production of an annual crop in the States of Iowa, Minnesota, Montana, Nebraska, North Dakota, and South Dakota. Annually, FCIC anticipates a savings of $11.4 million as a result of this change.
Section 11015 allows producers to elect a different level of coverage for an agricultural commodity by irrigated and non-irrigated acreage. Annually, FCIC anticipates a cost of $16.8 million as a result of this change.
Section 11016 establishes crop insurance benefits for beginning farmers and ranchers by increasing the premium subsidy available by ten percentage points, allowing the use of yield history from any previous farm or ranch operation in which they had decision making or physical involvement, and replacing a low yield in their actual production history (APH) with a yield equal to 80 percent of the applicable transitional yield. Annually, FCIC anticipates a cost of $26.1 million as a result of this change.
Section 11019 allows for the correction of errors in information obtained from the producer within a reasonable amount of time and consistent with information provided by the producer to other agencies of the Department of Agriculture subject to certain limitations for maintaining program integrity. This section also provides for the payment of debt after the termination date in accordance with procedures and limitations established by the FCIC, if a producer inadvertently fails to pay a debt and has been determined to be ineligible to participate in the Federal crop insurance program. FCIC does not believe there are any additional cost outlays resulting from this change. Therefore, FCIC believes some insureds will benefit from this change and the benefits are non-quantifiable.
Pursuant to the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the collections of information in this rule have been approved by OMB under control numbers 0563-0085, 0563-0083, and 0563-0053.
FCIC is committed to complying with the E-Government Act of 2002, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. This rule contains no Federal mandates (under the regulatory provisions of title II of the UMRA) for State, local, and tribal governments or the private sector. Therefore, this rule is not subject to the requirements of sections 202 and 205 of UMRA.
It has been determined under section 1(a) of Executive Order 13132, Federalism, that this rule does not have sufficient implications to warrant consultation with the States. The provisions contained in this rule will not have a substantial direct effect on States, or on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.
This rule has been reviewed in accordance with the requirements of Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” Executive Order 13175 requires Federal agencies to consult and coordinate with tribes on a government-to-government basis on policies that have tribal implications, including regulations, legislative comments or proposed legislation, and other policy statements or actions that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes or on the distribution of power and responsibilities between the Federal Government and Indian tribes.
The Federal Crop Insurance Corporation has assessed the impact of this rule on Indian tribes and determined that this rule does not, to our knowledge, have tribal implications that require tribal consultation under E.O. 13175. If a Tribe requests consultation, the Federal Crop Insurance Corporation will work with the Office of Tribal Relations to ensure meaningful consultation is provided where changes, additions and modifications identified herein are not expressly mandated by Congress.
FCIC certifies that this regulation will not have a significant economic impact on a substantial number of small entities. Program requirements for the Federal crop insurance program are the same for all producers regardless of the size of their farming operation. For instance, all producers are required to submit an application and acreage report to establish their insurance guarantees and compute premium amounts, and all producers are required to submit a notice of loss and production information to determine the amount of an indemnity payment in the event of an insured cause of crop loss. Whether a producer has 10 acres or 1000 acres, there is no difference in the kind of information collected. To ensure crop insurance is available to small entities, the Federal Crop Insurance Act (Act) authorizes FCIC to waive collection of administrative fees from beginning farmers or ranchers and limited resource farmers. FCIC believes this waiver helps to ensure that small entities are given the same opportunities as large entities to manage their risks through the use of Federal crop insurance. A Regulatory Flexibility Analysis has not been prepared since this regulation does not have an impact on small entities, and, therefore, this regulation is exempt from the provisions of the Regulatory Flexibility Act (5 U.S.C. 605).
This program is listed in the Catalog of Federal Domestic Assistance under No. 10.450.
This program is not subject to the provisions of Executive Order 12372, which require intergovernmental consultation with State and local officials. See the Notice related to 7 CFR part 3015, subpart V, published at 48 FR 29115, June 24, 1983.
This rule has been reviewed in accordance with Executive Order 12988 on civil justice reform. The provisions of this rule will not have a retroactive effect. The provisions of this rule will preempt State and local laws to the extent such State and local laws are inconsistent herewith. With respect to any direct action taken by FCIC or to require the insurance provider to take specific action under the terms of the crop insurance policy, the administrative appeal provisions published at 7 CFR part 11 must be exhausted before any action against FCIC for judicial review may be brought.
This action is not expected to have a significant economic impact on the quality of the human environment, health, or safety. Therefore, neither an Environmental Assessment nor an Environmental Impact Statement is needed.
Administrative practice and procedure, Crop insurance, Reporting and recordkeeping requirements.
Accordingly, as set forth in the preamble, the Federal Crop Insurance Corporation adopts as final the interim rule amending 7 CFR parts 400, 402, 407, and 457, published at 79 FR 37155 on July 1, 2014, as final with the following changes:
7 U.S.C. 1506(1), 1506(o).
The revision reads as follows:
(g) Has requested the Administrator, Risk Management Agency, for consideration to reinstate their eligibility in accordance with the applicable policy provisions and such request has been denied.
(g) No later than 60 days after the termination date, a missed payment date
7 U.S.C. 1506(l), 1506(o).
The revision reads as follows:
6. Annual Premium and Administrative Fees
(f) * * *
(2) * * *
(i) Notwithstanding section 6(f)(2), if you demonstrate you began farming for the first time after June 1 but prior to the beginning of the reinsurance year (July 1), you may be eligible for premium subsidy the subsequent reinsurance year without having form AD-1026 on file with FSA on or before June 1. For example, if you demonstrate you started farming for the first time on June 15, 2015, you may be eligible for premium subsidy for the 2016 reinsurance year without form AD-1026 on file with FSA.
7 U.S.C. 1506(l), 1506(o).
The revisions read as follows:
1. Definitions
2. Life of Policy, Cancellation, and Termination
(k) * * *
(2) * * *
(iii) Once the policy is terminated, it cannot be reinstated for the current crop year unless:
(A) The termination was in error;
(B) The Administrator of the Risk Management Agency, at his or her sole discretion, determines that the following conditions are met:
(
(
(
(
(
(C) We determine that, in accordance with 7 CFR part 400, subpart U, and FCIC issued procedures, the following are met:
(
(
(
(
(
(
(
(
(iv) A determination made under:
(A) Section 2(k)(2)(iii)(B) may only be appealed to the National Appeals Division in accordance with 7 CFR part 11; and
(B) Section 2(k)(2)(iii)(C) may only be appealed in accordance with section 23.
5. Insurable Acreage
(d) Except as provided in section 5(e), in the states of Iowa, Minnesota, Montana, Nebraska, North Dakota, and South Dakota, during the first four crop years of planting on native sod acreage that has been tilled after February 7, 2014, such acreage may be insured if the requirements of section 5(a) have been met but will:
(1) Notwithstanding the provisions in section 6, receive a liability that is based on 65 percent of the protection factor; and
(2) For additional coverage policies, receive a premium subsidy that is 50 percentage points less than would otherwise be provided on acreage not qualifying as native sod. If the premium subsidy applicable to these acres is less than 50 percent before the reduction, you will receive no premium subsidy.
7. Annual Premium and Administrative Fees
(i) * * *
(2) * * *
(i) Notwithstanding section 7(i)(2), if you demonstrate you began farming for the first time after June 1 but prior to the beginning of the reinsurance year (July 1), you may be eligible for premium subsidy the subsequent reinsurance year without having form AD-1026 on file with FSA on or before June 1. For example, if you demonstrate you started farming for the first time on June 15, 2015, you may be eligible for premium subsidy for the 2016 reinsurance year without form AD-1026 on file with FSA.
7 U.S.C. 1506(1) and 1506(o).
The revisions read as follows:
1. Definitions
2. Life of Policy, Cancellation, and Termination
(f) * * *
(2) * * *
(iii) Once the policy is terminated, it cannot be reinstated for the current crop year unless:
(A) The termination was in error;
(B) The Administrator of the Risk Management Agency, at his or her sole discretion, determines that the following are met:
(
(
(
(
(
(C) We determine that, in accordance with 7 CFR part 400, subpart U, and FCIC issued procedures, the following are met:
(
(
(
(
(
(
(
(
(iv) A determination made under:
(A) Section 2(f)(2)(iii)(B) may only be appealed to the National Appeals Division in accordance with 7 CFR part 11; and
(B) Section 2(f)(2)(iii)(C) may only be appealed in accordance with section 20.
7. Annual Premium and Administrative Fees
(h) * * *
(2) * * *
(i) Notwithstanding section 7(h)(2), if you demonstrate you began farming for the first time after June 1 but prior to the beginning of the reinsurance year (July 1), you may be eligible for premium subsidy the subsequent reinsurance year without having form AD-1026 on file with FSA on or before June 1. For example, if you demonstrate you started farming for the first time on June 15, 2015, you may be eligible for premium subsidy for the 2016 reinsurance year without form AD-1026 on file with FSA.
34. Units
(a) * * *
(5) * * *
(i) * * *
(A) * * *
(
In rule document 2016-14474, beginning on page 41208 in the issue of Friday, June 24, 2016, make the following correction:
On page 41210, in the table titled “Table 1 to Paragraph (e)—HPC Stage 8-10 Spool S/Ns”, the first row of the table should appear as follows:
Federal Trade Commission.
Interim final rule.
Pursuant to the Federal Civil Penalties Inflation Adjustment Act, as amended, the Federal Trade Commission (“FTC” or “Commission”) is increasing the maximum civil penalty amounts within its jurisdiction, as required by the Federal Civil Penalty Inflation Adjustment Act Improvements Act of 2015.
The interim final rule is effective August 1, 2016.
Kenny A. Wright, Attorney, Office of the General Counsel, FTC, 600 Pennsylvania Avenue NW., Washington, DC 20580, (202) 326-2907,
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (“Adjustment Improvements Act” or “Act”)
Commission Rule 1.98 sets forth the maximum civil penalty amounts for violations of laws enforced by the Commission that authorize civil penalties.
When the Commission seeks civil penalties, it is mindful of the statutory criteria courts must apply when determining the amount of the civil penalty: “the degree of culpability, any history of prior such conduct, ability to pay, effect on ability to continue to do business, and such other matters as justice may require.”
As required by the Act, the following adjusted amounts will take effect on August 1, 2016:
• Section 7A(g)(1) of the Clayton Act, 15 U.S.C. 18a(g)(1) (premerger filing notification violations under the Hart-Scott-Rodino (HSR) Improvements Act)—Increase from $16,000 to $40,000;
• Section 11(
• Section 5(
• Section 5(m)(1)(A) of the FTC Act, 15 U.S.C. 45(m)(1)(A) (unfair or deceptive acts or practices)—Increase from $16,000 to $40,000;
• Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. 45(m)(1)(B) (unfair or deceptive acts or practices)—Increase from $16,000 to $40,000;
• Section 10 of the FTC Act, 15 U.S.C. 50 (failure to file required reports)—Increase from $210 to $525;
• Section 5 of the Webb-Pomerene (Export Trade) Act, 15 U.S.C. 65 (failure by associations engaged solely in export trade to file required statements)—Increase from $210 to $525;
• Section 6(b) of the Wool Products Labeling Act, 15 U.S.C. 68d(b) (failure by wool manufacturers to maintain required records)—Increase from $210 to $525;
• Section 3(e) of the Fur Products Labeling Act, 15 U.S.C. 69a(e)(failure to maintain required records regarding fur products)—Increase from $210 to $525;
• Section 8(d)(2) of the Fur Products Labeling Act, 15 U.S.C. 69f(d)(2) (failure to maintain required records regarding fur products)—Increase from $210 to $525;
• Section 333(a) of the Energy Policy and Conservation Act, 42 U.S.C. 6303(a) (knowing violations of EPCA § 332, including labeling violations)—Increase from $210 to $433;
• Section 525(a) of the Energy Policy and Conservation Act, 42 U.S.C. 6395(a) (recycled oil labeling violations)—Increase from $8,500 to $21,250;
• Section 525(b) of the Energy Policy and Conservation Act, 42 U.S.C. 6395(b) (willful violations of recycled oil labeling requirements)—Increase from $16,000 to $40,000;
• Section 621(a)(2) of the Fair Credit Reporting Act, 15 U.S.C. 1681s(a)(2) (knowing violations of the Fair Credit Reporting Act)—Increase from $3,500 to $3,756;
• Section 1115(a) of the Medicare Prescription Drug Improvement and Modernization Act of 2003, Public Law 108-173, 21 U.S.C. 355 note (failure to comply with filing requirements)—Increase from $12,100 to $14,142; and
• Section 814(a) of the Energy Independence and Security Act of 2007, 42 U.S.C. 17304 (violations of prohibitions on market manipulation and provision of false information to federal agencies)—Increase from $1,100,000 to $1,138,330.
The Adjustment Improvements Act directs federal agencies to adjust the civil monetary penalties under their jurisdiction for inflation through an initial “catch-up” cost-of-living adjustment. This catch-up adjustment is defined as the percentage by which the U.S. Department of Labor's Consumer Price Index for all-urban consumers (“CPI-U”) for the month of October 2015 exceeds the CPI-U for the month of October for the year in which the amount of the penalty was last set or adjusted pursuant to law, excluding prior adjustments under FCPIAA.
Agencies do not have discretion over whether to make the initial catch-up adjustment for maximum civil penalty amounts absent a determination that the adjustment will have a negative economic impact or the social costs of the increase outweigh the benefits.
The Adjustment Improvements Act applies to civil penalties assessed after the effective date of the applicable adjustment, including civil penalties whose associated violation predated the effective date.
The Commission finds good cause for adopting this interim final rule without advance public notice or an opportunity for prior public comment. Advance opportunity for notice and comment are not required “when the agency for good cause finds (and incorporates the findings and a brief statement of reasons therefore in the rules issued) that notice and public procedure thereon are impracticable, unnecessary, or contrary to the public interest.” 5 U.S.C. 553(b)(3)(B). The Adjustment Improvements Act directs agencies to promulgate the required inflation adjustments through an interim final rulemaking by no later than July 1, 2016. Pursuant to this Congressional mandate, and because the Commission must adjust its civil penalties according to the statutory formula identified in the Adjustment Improvements Act, the Commission finds that good cause exists to forego prior public notice and comment under the APA.
Administrative practice and procedure, Penalties, Trade practices.
For the reasons set forth in the preamble, the Federal Trade Commission amends Title 16, chapter I, subchapter A, of the Code of Federal Regulations, as follows:
28 U.S.C. 2461 note.
This section makes inflation adjustments in the dollar amounts of civil monetary penalties provided by law within the Commission's jurisdiction. The following maximum civil penalty amounts apply only to penalties assessed after August 1, 2016, including those penalties whose associated violation predated August 1, 2016.
(a) Section 7A(g)(1) of the Clayton Act, 15 U.S.C. 18a(g)(1)—$40,000;
(b) Section 11(
(c) Section 5(
(d) Section 5(m)(1)(A) of the FTC Act, 15 U.S.C. 45(m)(1)(A)—$40,000;
(e) Section 5(m)(1)(B) of the FTC Act, 15 U.S.C. 45(m)(1)(B)—$40,000;
(f) Section 10 of the FTC Act, 15 U.S.C. 50—$525;
(g) Section 5 of the Webb-Pomerene (Export Trade) Act, 15 U.S.C. 65—$525;
(h) Section 6(b) of the Wool Products Labeling Act, 15 U.SC. 68d(b)—$525;
(i) Section 3(e) of the Fur Products Labeling Act, 15 U.S.C. 69a(e)—$525;
(j) Section 8(d)(2) of the Fur Products Labeling Act, 15 U.S.C. 69f(d)(2)—$525;
(k) Section 333(a) of the Energy Policy and Conservation Act, 42 U.S.C. 6303(a)—$433;
(l) Sections 525(a) and (b) of the Energy Policy and Conservation Act, 42 U.S.C. 6395(a) and (b), respectively—$21,250 and $40,000, respectively;
(m) Section 621(a)(2) of the Fair Credit Reporting Act, 15 U.S.C. 1681s(a)(2)—$3,756;
(n) Section 1115(a) of the Medicare Prescription Drug Improvement and Modernization Act of 2003, Public Law 108-173, 21 U.S.C. 355 note—$14,142;
(o) Section 814(a) of the Energy Independence and Security Act of 2007, 42 U.S.C. 17304—$1,138,330; and
(p) Civil monetary penalties authorized by reference to the Federal Trade Commission Act under any other provision of law within the jurisdiction of the Commission—refer to the amounts set forth in paragraphs (c), (d), (e) and (f) of this section, as applicable.
By direction of the Commission.
Bureau of Indian Affairs, Interior.
Interim final rule.
This rule adjusts the level of civil monetary penalties contained in Indian Affairs regulations with an initial “catch-up” adjustment under the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 and Office of Management and Budget (OMB) guidance.
This rule is effective on August 1, 2016. Comments will be accepted until August 29, 2016.
You may submit comments by any of the following methods:
•
•
Elizabeth Appel, Director, Office of Regulatory Affairs and Collaborative Action, Office of the Assistant Secretary—Indian Affairs; telephone (202) 273-4680,
On November 2, 2015, the President signed into law the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (Sec. 701 of Pub. L. 114-74). The Act requires Federal agencies to adjust the level of civil monetary penalties with an initial catch-up adjustment through rulemaking and then make subsequent annual adjustments for inflation. This rule adjusts the level of civil monetary penalties within those parts of Title 25 of the Code of Federal Regulations that fall under Chapter I, the Bureau of Indian Affairs. This rule does not affect criminal penalties, such as those at 25 CFR 273.15. This rule does not affect Chapter V, Bureau of Indian Affairs, and Indian Health Service or Chapter VI, Office of the Assistant Secretary, Indian Affairs, because those chapters contain no civil monetary penalties. This rule does not affect Chapter III, National Indian Gaming Commission, or Chapter IV, Office of Navajo and Hopi Indian Relocation, because those respective offices will determine whether it is necessary to issue separate rulemakings.
The purpose of these adjustments is to maintain the deterrent effect of civil penalties and to further the policy goals of the underlying statutes. This rule adjusts the following civil monetary penalties, as calculated in accordance with the procedures described in Section II, Calculation of Adjustment:
The OMB issued guidance on calculating the catch-up adjustment.
Executive Order (E.O.) 12866 provides that the Office of Information and Regulatory Affairs in the Office of Management and Budget will review all significant rules. The Office of Information and Regulatory Affairs has determined that this rule is not significant.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
The Regulatory Flexibility Act (RFA) requires an agency to prepare a regulatory flexibility analysis for rules unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. The RFA applies only to rules for which an agency is required to first publish a proposed rule.
This rule is not a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. This rule:
(a) Does not have an annual effect on the economy of $100 million or more;
(b) Will not cause a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions;
(c) Does not have significant adverse effects on competition, employment, investment, productivity, innovation, or the ability of U.S.-based enterprises to compete with foreign-based enterprises.
This rule does not impose an unfunded mandate on State, local, or tribal governments or the private sector of more than $100 million per year. The rule does not have a significant or unique effect on State, local, or tribal governments or the private sector. A statement containing the information required by the Unfunded Mandates Reform Act (2 U.S.C. 1531
This rule does not affect a taking of private property or otherwise have taking implications under E.O. 12630. A takings implication assessment is not required.
Under the criteria in section 1 of E.O. 13132, this rule does not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement. A federalism summary impact statement is not required.
This rule complies with the requirements of E.O. 12988. Specifically, this rule:
(a) Meets the criteria of section 3(a) requiring that all regulations be reviewed to eliminate errors and ambiguity and be written to minimize litigation; and
(b) Meets the criteria of section 3(b)(2) requiring that all regulations be written in clear language and contain clear legal standards.
The Department strives to strengthen its government-to-government relationship with Indian tribes through a commitment to consultation with Indian Tribes and recognition of their right to self-governance and tribal sovereignty. We have evaluated this rule under the Department's consultation policy and under the criteria in E.O. 13175 and have determined that is has no substantial direct effects on federally recognized Indian tribes and that consultation under the Department's tribal consultation policy is not required.
This rule does not contain information collection requirements, and a submission to the OMB under the Paperwork Reduction Act (44 U.S.C. 3501
This rule does not constitute a major Federal action significantly affecting the quality of the human environment. A detailed statement under the National Environmental Policy Act of 1969 (NEPA) is not required because the rule is covered by a categorical exclusion. This rule is excluded from the requirement to prepare a detailed statement because it is a regulation of an administrative nature. (For further information, see 43 CFR 46.210(i).) We have also determined that the rule does not involve any of the extraordinary circumstances listed in 43 CFR 46.215 that would require further analysis under NEPA.
This rule is not a significant energy action under the definition in E.O. 13211. A Statement of Energy Effects is not required.
We are required by E.O. 12866 (section 1(b)(12)), and 12988 (section 3(b)(1)(B)), and 13563 (section 1(a)), and by the Presidential Memorandum of June 1, 1998, to write all rules in plain language. This means that each rule we publish must:
(a) Be logically organized;
(b) Use the active voice to address readers directly;
(c) Use common, everyday words and clear language rather than jargon;
(d) Be divided into short sections and sentences; and
(e) Use lists and tables wherever possible.
If you feel that we have not met these requirements, send us comments by one of the methods listed in the
The Act requires agencies to publish interim final rules by July 1, 2016, with an effective date for the adjusted penalties no later than August 1, 2016. To comply with the Act, we are issuing
Business and industry, Indians, Penalties.
Business and industry, Credit, Indians—business and finance, Penalties.
Geothermal energy, Indians—lands, Mineral resources, Mines, Oil and gas exploration, Reporting and recordkeeping requirements.
Indians—lands, Mineral resources, Mines, Oil and gas exploration, Reporting and recordkeeping requirements.
Geothermal energy, Indians—lands, Mineral resources, Mines, Oil and gas exploration, Penalties, Reporting and recordkeeping requirements, Surety bonds.
Indians—lands.
Indians—lands, Mineral resources, Mines, Oil and gas exploration, Reporting and recordkeeping requirements.
Indians, Livestock.
Fishing, Indians.
For the reasons given in the preamble, the Department of the Interior amends Chapter I of title 25 Code of Federal Regulations as follows.
Sec. 5, 19 Stat. 200, sec. 1, 31 Stat. 1066 as amended; 25 U.S.C. 261, 262; 94 Stat. 544, 18 U.S.C. 437; 25 U.S.C. 2 and 9; 5 U.S.C. 301; and Sec. 701, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.
5 U.S.C. 301; 25 U.S.C. 2 and 9; and Sec. 701, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.
Sec. 4, Act of May 11, 1938 (52 Stat. 347); Act of August 1, 1956 (70 Stat. 744); 25 U.S.C. 396a-g; 25 U.S.C. 2 and 9; and Sec. 701, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.
Sec. 2, 35 Stat. 312; sec. 18, 41 Stat. 426; sec. 1, 45 Stat. 495; sec. 1, 47 Stat. 777; 25 U.S.C. 356; and Sec. 701, Pub. L. 114-74, 129 Stat. 599. Interpret or apply secs. 3, 11, 35 Stat. 313, 316; sec. 8, 47 Stat. 779, unless otherwise noted.
25 U.S.C. 2, 9, and 2101-2108; and Sec. 701, Pub. L. 114-74, 129 Stat. 599.
Sec. 3, 34 Stat. 543; secs. 1, 2, 45 Stat. 1478; sec. 3, 52 Stat. 1034, 1035; sec. 2(a), 92 Stat. 1660; and Sec. 701, Pub. L. 114-74, 129 Stat. 599.
Sec. 1, 39 Stat. 519; and Sec. 701, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.
Sec. 12, 50 Stat. 902; 25 U.S.C. 500K; and Sec. 701, Pub. L. 114-74, 129 Stat. 599.
25 U.S.C. 2, and 9; 5 U.S.C. 301; and Sec. 701, Pub. L. 114-74, 129 Stat. 599, unless otherwise noted.
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations that require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group. The final regulations affect United States persons that are the ultimate parent entity of a multinational enterprise group that has annual revenue for the preceding annual accounting period of $850,000,000 or more.
Melinda E. Harvey, (202) 317-6934 (not a toll-free number).
The IRS intends that the information collection requirements in these regulations will be satisfied by submitting a new reporting form, Form 8975,
This document contains amendments to 26 CFR part 1. On December 23, 2015, a notice of proposed rulemaking (REG-109822-15) relating to the furnishing of country-by-country (CbC) reports by certain United States persons (U.S. persons) was published in the
Multiple comments expressed support for the implementation of CbC reporting in the United States. However, one comment recommended that the Treasury Department and the IRS decline to implement CbC reporting because, according to the comment, U.S. multinational enterprise (MNE) groups' direct costs of compliance will exceed the United States Treasury's revenue gains, and there will be high, unanticipated costs from inadvertent disclosures of sensitive information. This recommendation is not adopted. U.S. MNE groups will be subject to CbC filing obligations in other countries in which they do business if the United States does not implement CbC reporting. Thus, a decision by the Treasury Department and the IRS not to implement CbC reporting will result in no compliance cost savings to U.S. MNE groups. In fact, failure to adopt CbC reporting requirements in the United States may increase compliance costs because U.S. MNE groups may be subject to CbC filing obligations in multiple foreign tax jurisdictions. U.S. MNE groups might also be subject to varying CbC filing rules and requirements in different foreign tax jurisdictions, such as requirements to prepare the CbC report using the local currency or language.
In addition, CbC reports filed with the IRS and exchanged pursuant to a competent authority arrangement benefit from the confidentiality requirements, data safeguards, and appropriate use restrictions in the competent authority arrangement. If a foreign tax jurisdiction fails to meet the confidentiality requirements, data safeguards, and appropriate use restrictions set forth in the competent authority arrangement, the United States will pause exchanges of all reports with that tax jurisdiction. Moreover, if such tax jurisdiction has adopted CbC reporting rules that are consistent with the 2015 Final Report for Action 13 (Transfer Pricing Documentation and Country-by-Country Reporting) of the Organisation for Economic Co-operation and Development (OECD) and Group of Twenty (G20) Base Erosion and Profit Shifting (BEPS) Project (Final BEPS Report), the tax jurisdiction will not be able to require any constituent entity of the U.S. MNE group in the tax jurisdiction to file a CbC report. The ability of the United States to pause exchange creates an additional incentive for foreign tax jurisdictions to uphold the confidentiality requirements, data safeguards, and appropriate use restrictions in the competent authority arrangement.
At the time of publication of the proposed regulations, the country-by-country reporting form described in the proposed regulations had not been officially numbered and was referred to in the proposed regulations as Form XXXX,
In the preamble to the proposed regulations, the Treasury Department and the IRS requested comments regarding whether additional guidance was needed for determining which U.S. persons must file Form 8975 or which entities are considered constituent entities of the filer. Specifically, the Treasury Department and the IRS requested comments on whether additional guidance on the definition of a U.S. MNE group was necessary to address situations where U.S. generally accepted accounting principles (GAAP) or U.S. securities regulations permit or require consolidated financial accounting for reasons other than majority ownership, as well as situations, if any, where U.S. GAAP or U.S. securities regulations permit separate financial accounting with respect to majority-owned enterprises.
Multiple comments addressed the inclusion of variable interest entities (VIEs) as constituent entities that are part of the U.S. MNE group. In general, a VIE may be consolidated with another entity for financial accounting purposes, even though that other entity may not control the VIE within the meaning of section 6038(e). Some comments recommended against expanding the definition of a U.S. MNE group to include VIEs and further recommended that, if those entities are nonetheless included, an exception should apply in cases in which the U.S. MNE group is unable to obtain the necessary information from a VIE. Other comments expressed concern that entities like VIEs would be part of the MNE group for purposes of foreign law relating to CbC reporting and, for consistency with such law, recommended that U.S. MNE groups be permitted to include such entities. Still other comments recommended that the definition of constituent entity should not be limited to majority-owned entities and should be expanded to include entities in which the ultimate parent entity owns, directly or indirectly, a 20-percent or greater equity interest.
The final regulations do not modify the definition of constituent entity in the proposed regulations. Because the final regulations are promulgated under the authority of section 6038, the definition of control in section 6038(e) limits the foreign business entities for which U.S. persons can be required to furnish information. Thus, the information described in § 1.6038-4(d)(1) and (2) is not required for foreign corporations or foreign partnerships for which the ultimate parent entity is not required to furnish information under section 6038(a) (determined without regard to §§ 1.6038-2(j) and 1.6038-3(c)) or any permanent establishment of such foreign corporation or foreign partnership.
Under proposed § 1.6038-4(b)(2), a business entity includes a business establishment in a jurisdiction that is treated as a permanent establishment under an income tax convention to which that jurisdiction is a party, or that would be treated as a permanent establishment under the OECD Model Tax Convention on Income and on Capital 2014 (OECD Model Tax Convention), and that prepares financial statements separate from those of its owner for financial reporting, regulatory, tax reporting, or internal management control purposes. One comment recommended that the reference to the OECD Model Tax Convention be revised to account for changes to the definition of permanent establishment that will be incorporated into the OECD Model Tax Convention as a result of work under Action 7 (Preventing the Artificial Avoidance of Permanent Establishment Status) of the BEPS Project.
Upon further consideration, and taking into account the comment received, the Treasury Department and the IRS have determined it would be more appropriate for the final regulations to modify the proposed regulations' reference to a permanent establishment in the definition of business entity for greater clarity and consistency with the intended meaning of the Final BEPS Report. Accordingly, the final regulations provide that the term permanent establishment includes (i) a branch or business establishment of a constituent entity in a tax jurisdiction that is treated as a permanent establishment under an income tax convention to which that tax jurisdiction is a party, (ii) a branch or business establishment of a constituent entity that is liable to tax in the tax jurisdiction in which it is located pursuant to the domestic law of such tax jurisdiction, or (iii) a branch or business establishment of a constituent entity that is treated in the same manner for tax purposes as an entity separate from its owner by the owner's tax jurisdiction of residence. This approach is more consistent with the Final BEPS Report and generally would avoid the need for a U.S. MNE group that has already determined under applicable law whether it has a permanent establishment or a taxable business presence in a particular jurisdiction to make another determination under the OECD Model Tax Convention solely for purposes of completing the CbCR.
Proposed § 1.6038-4(b)(2) defines a business entity as a person, as defined in section 7701(a)(1), that is not an individual. Under this definition, a grantor trust with an individual owner or owners would be a business entity that could be subject to CbC reporting, notwithstanding that the individual owner or owners are generally treated as the owner of the grantor trust's property for federal income tax purposes and would not be subject to CbC reporting if they owned the property directly. Similarly, under the proposed regulations, a decedent's estate would be a business entity that could be subject to CbC reporting, notwithstanding that during the decedent's lifetime, he or she was an individual exempt from CbC reporting. Additionally, under the proposed regulations, an individual's bankruptcy estate would be a business entity that could be subject to CbC reporting, notwithstanding that before entering bankruptcy, the individual debtor would not be subject to CbC reporting. In light of the nature of grantor trusts, decedents' estates, and individuals' bankruptcy estates and their close connection to individual grantors, decedents, and individual debtors, the Treasury Department and the IRS have determined that it is not appropriate to include grantor trusts with only individual owners, decedents' estates, and individuals' bankruptcy estates in the definition of business entity. Accordingly, the final regulations exclude decedents' estates, individuals' bankruptcy estates, and grantor trusts within the meaning of section 671, all the owners of which are individuals, from the definition of business entity.
The proposed regulations define a U.S. business entity as a business entity that is organized, or has its tax jurisdiction of residence, in the United States. One comment requested that the final regulations clarify whether companies that elect to be treated as domestic corporations under section 953(d) will be treated as U.S. business entities resident in the United States. In response to this comment, the final regulations expressly provide that foreign insurance companies that elect to be treated as domestic corporations under section 953(d) are U.S. business entities that have their tax jurisdiction of residence in the United States.
The preamble to the proposed regulations requested comments on the need for a national security exception for reporting CbC information and on procedures for a taxpayer to demonstrate that such an exception is warranted. Multiple comments stated that the information provided on a CbCR does not present a national security concern. Other comments recommended that the final regulations include a national security exception but did not recommend an appropriate scope of the exception or procedures to demonstrate that an exception is warranted in a particular case. One comment recommended that no information should appear on a CbCR with respect to activities performed by a constituent entity of a U.S. MNE group under a U.S. government contract with
The Treasury Department and the IRS have consulted with the Department of Defense regarding the information collected on the CbCR. The Department of Defense concluded that such information reporting generally does not pose a national security concern. Accordingly, the final regulations do not provide a general exception for information that may relate to national security. Nonetheless, the Department of Defense continues to consider the national security implications of the CbCR in particular fact patterns, and future guidance may be issued to provide procedures for taxpayers to consult with the Department of Defense regarding the appropriate presentation of CbC information in such fact patterns.
A business entity that is treated as a partnership in the tax jurisdiction in which it is organized and that does not own or create a permanent establishment in that or another tax jurisdiction generally will have no tax jurisdiction of residence under the definition in proposed § 1.6038-4(b)(6) other than for purposes of determining the ultimate parent entity of a U.S. MNE group. Under the proposed regulations, tax jurisdiction information with respect to constituent entities that do not have a tax jurisdiction of residence, or “stateless entities,” would be aggregated and reported in a separate row of the CbCR. The preamble to the proposed regulations indicates that partners of a partnership that is a stateless entity would report their respective shares of the partnership's items in their respective tax jurisdiction(s) of residence.
A comment requested clarification as to whether the partnership or its partners, or both, should report the partnership's CbC information. In response, the final regulations provide that the tax jurisdiction of residence information with respect to stateless entities is provided on an aggregate basis for all stateless entities in a U.S. MNE group and that each stateless entity-owner's share of the revenue and profit of its stateless entity is also included in the information for the tax jurisdiction of residence of the stateless entity-owner. This rule applies irrespective of whether the stateless entity-owner is liable to tax on its share of the stateless entity's income in the owner's tax jurisdiction of residence. In other words, the stateless entity-owner reports its share of the stateless entity's revenues and profits in the owner's tax jurisdiction of residence even if that jurisdiction treats the stateless entity as a separate entity for tax purposes. In the case in which a partnership creates a permanent establishment for itself or its partners, the CbC information with respect to the permanent establishment is not reported as stateless, but instead is reported as part of the information on the CbCR for the permanent establishment's tax jurisdiction of residence.
A comment requested clarification regarding whether distributions from partnerships and other fiscally transparent entities should be excluded from owners'/partners' reported revenue. In response, the final regulations clarify that distributions from a partnership to a partner are not included in the partner's revenue. Additionally, the final regulations provide that remittances from a permanent establishment to its constituent entity-owner are not included in the constituent entity-owner's revenue.
The preamble to the proposed regulations requested comments on the manner in which the proposed regulations require the reporting of information on taxes paid or accrued by U.S. MNE groups and their constituent entities on taxable income earned in the relevant accounting period. One comment requested that “total accrued tax expense” in proposed § 1.6038-4(d)(2)(v) be revised to read “accrued current tax expense” in order to reflect only operations in the current year and not deferred taxes or provisions for uncertain tax liabilities. The proposed regulations clearly state that the relevant taxes to be reported relate only to the annual accounting period for which the CbCR is provided and exclude deferred taxes and provisions for uncertain tax liabilities. Therefore, the comment is not adopted.
The preamble to the proposed regulations also requested comments on whether the descriptions of any of the other items in § 1.6038-4(d)(2)(i) through (ix) regarding tax jurisdiction of residence information should be further refined or whether additional guidance is needed with respect to how to determine any of these items. One comment requested that the definition for tangible assets be revised to clarify that intangibles and financial assets are excluded consistent with the Final BEPS Report. In response, the final regulations expressly provide that tangible assets do not include intangibles or financial assets.
A comment noted that the term revenue excludes dividends from other constituent entities and recommended that this exclusion be extended to all forms of imputed earnings or deemed dividends. The Treasury Department and the IRS agree that imputed earnings and deemed dividends that are taken into account solely for tax purposes should be treated the same as dividends for purposes of the CbCR. Accordingly, the final regulations incorporate this recommendation.
Multiple comments recommended that the wording “total income tax paid on a cash basis to all jurisdictions” in proposed § 1.6038-4(d)(2)(iv) should be modified to read “total income tax paid on a cash basis to each tax jurisdiction” to avoid misinterpretation of the “all tax jurisdictions” language to require taxes paid by entities that are tax residents of different tax jurisdictions to be aggregated rather than reported on a country-by-country basis as intended. The Treasury Department and the IRS interpret the language of the proposed regulation to require the total income tax paid on a cash basis to any tax jurisdiction by constituent entities that have a tax residence in a particular tax jurisdiction to be reported on an aggregated basis for that particular tax jurisdiction of residence but not the aggregation of taxes paid by constituent entities that have different tax residences. For instance, if a constituent entity pays income tax in its tax jurisdiction of residence on its earnings from operations in that country and is subject to withholding taxes on royalties received from licensees in another country, taxes paid with respect to the income and the taxes withheld with respect to the royalties should be reflected on an aggregated basis on the CbCR in the row for the constituent entity's tax jurisdiction of residence. The Treasury Department and the IRS are concerned that the alternative language proposed in the comments could be misinterpreted to require
Multiple comments also recommended the inclusion of two additional items, deferred taxes and provisions for uncertain tax positions, in the information required to be reported on a tax jurisdiction-by-tax jurisdiction basis. This recommendation has not been adopted in the final regulations because it would impose an additional reporting burden beyond the information described in the Final BEPS Report.
Multiple comments recommended that the final regulations clarify that the information listed in proposed § 1.6038-4(d)(2)(i) through (ix) is reported in the aggregate for all constituent entities resident in each separate tax jurisdiction. Although the language in the proposed regulations does indicate that the information is to be provided with respect to each tax jurisdiction in which one or more constituent entities of the U.S. MNE group are resident and in the form and manner that Form 8975 prescribes, the final regulations provide additional language to clarify that the information is to be presented for each tax jurisdiction as an aggregate of the information for all constituent entities resident in that tax jurisdiction. Multiple comments requested that the final regulations clarify whether the information must be provided for only the constituent entities in each tax jurisdiction or whether the information must also be provided for U.S. MNE group members that are not constituent entities, for instance VIEs. The Treasury Department and the IRS have determined that additional language is unnecessary because § 1.6038-4(d)(1) of the proposed regulations expressly requires reporting of information only with respect to constituent entities of the U.S. MNE group.
The final regulations provide that, for a constituent entity that is an organization exempt from taxation under section 501(a) because it is an organization described in section 501(c), 501(d), or 401(a), a state college or university described in section 511(a)(2)(B), a plan described in section 403(b) or 457(b), an individual retirement plan or annuity as defined in section 7701(a)(37), a qualified tuition program described in section 529, a qualified ABLE program described in section 529A, or a Coverdell education savings account described in section 530, the term revenue includes only revenue that is included in unrelated business taxable income as defined in section 512.
Multiple comments recommended that additional information be included on the CbCR, such as identification of constituent entities as “pass-through” and a legal entity identifier for each constituent entity using a standard international system for identifying individual business entities. The final regulations do not adopt these recommendations because they would impose an additional reporting burden beyond the information described in the Final BEPS Report.
Other countries have adopted CbC reporting requirements for annual accounting periods beginning on or after January 1, 2016, that would require reporting of CbC information by constituent entities of MNE groups with an ultimate parent entity resident in a tax jurisdiction that does not have a CbC reporting requirement for the same annual accounting period. The proposed regulations generally require U.S. MNE groups to file a CbCR for taxable years beginning on or after the date the final regulations are published. Consequently, U.S. MNE groups that use a calendar year as their taxable year generally will not be required to file a CbCR for their taxable year beginning January 1, 2016, and constituent entities of such U.S. MNE groups may be subject to CbC reporting requirements in foreign jurisdictions. Comments expressed concern about this possibility and recommended various approaches for dealing with this issue. Most comments requested that the IRS accept and exchange CbCRs voluntarily filed for taxable years beginning on or after January 1, 2016.
Consistent with the proposed regulations, the final regulations are not applicable for taxable years of ultimate parent entities beginning before June 30, 2016, the date of publication of the final regulations in the
The proposed regulations provide that the CbCR for a taxable year must be filed with the ultimate parent entity's income tax return for the taxable year on or before the due date, including extensions, for filing that person's income tax return. Multiple comments requested that taxpayers be permitted to file a CbCR up to one year from the end of the ultimate parent entity's taxable year or annual accounting period to facilitate the taxpayer's ability to use statutory accounts or tax records of constituent entities to complete the CbCR. After considering the flexibility allowed for sources of information for completing the CbCR, the IRS information technology resources necessary to facilitate a filing separate from the income tax return, and the IRS's concern that CbCRs be linked to an income tax return, the Treasury Department and the IRS have not adopted this recommendation. However, the final regulations do provide that Form 8975 may prescribe an alternative time and manner for filing.
The proposed regulations provide that the CbCR must reflect the number of employees for each tax jurisdiction of residence of the U.S. MNE group. The proposed regulations also provide that independent contractors participating in the ordinary course of business of a constituent entity may be included in the number of full-time equivalent employees. Multiple comments asked for further clarification with respect to the determination of the number of full-time equivalent employees and the treatment of independent contractors, including some recommending that independent contractors not be included as employees. The final regulations do not provide additional guidance with respect to the meaning of full-time equivalent employee or with respect to independent contractor situations and continue to allow for independent contractors that participate in the ordinary operating activities of a
The proposed regulations specify that employees should be reflected on the CbCR in the tax jurisdictions in which the employees performed work for the U.S. MNE group. Comments indicated that this methodology is inconsistent with the Final BEPS Report, which provides that employees of a constituent entity should be reflected in the tax jurisdiction of residence of such constituent entity, and that determining the work location of employees would be burdensome for U.S. MNE groups and would present issues regarding certain employment situations with traveling employees. The comments recommended that the final regulations follow the approach of the Final BEPS Report. In response to these comments, the final regulations do not include the phrase “in the relevant tax jurisdiction” from proposed § 1.6038-4(d)(2)(viii). Accordingly, under the final regulations, employees of a constituent entity are reflected in the tax jurisdiction of residence of such constituent entity.
A comment requested clarification about the tax jurisdiction in which employees of partnerships should be reflected on the CbCR. As discussed in section 5 of this preamble, a partnership may be considered a stateless entity. If the partnership creates a permanent establishment for itself or its partners, then the permanent establishment itself may be a constituent entity of the U.S. MNE group. Employees of the permanent establishment-constituent entity should be reflected in the tax jurisdiction of residence of the permanent establishment. Any other employees of the partnership should be reported on the stateless jurisdiction row under the tax jurisdiction of residence information portion of the CbCR.
The proposed regulations provide that the amounts furnished in the CbCR should be furnished for the annual accounting period with respect to which the ultimate parent entity prepares its applicable financial statements ending with or within the ultimate parent entity's taxable year, or, if the ultimate parent entity does not prepare applicable financial statements, then the information may be based on the applicable financial statements of constituent entities for their accounting period that ends with or within the ultimate parent entity's taxable year. Multiple comments expressed concern that the description of the period covered by the CbCR in the proposed regulations may limit the flexibility of U.S. MNE groups to choose to use consolidated financial statements or separate accounting, regulatory, or tax records prepared for the constituent entities. To mitigate this concern, the final regulations remove the restrictions imposed by the proposed regulations with respect to providing information for the applicable accounting period of the ultimate parent entity or for the applicable accounting period of each constituent entity. The final regulations provide that the reporting period covered by Form 8975 is the period of the ultimate parent entity's annual applicable financial statement that ends with or within the ultimate parent entity's taxable year, or, if the ultimate parent entity does not prepare an annual applicable financial statement, then the ultimate parent entity's taxable year. The final regulations do not limit the constituent entity information to applicable financial statements of the constituent entity but, rather, provide that the source of the tax jurisdiction of residence information on the CbCR must be based on applicable financial statements, books and records, regulatory financial statements, or records used for tax reporting or internal management control purposes for an annual period of each constituent entity ending with or within the reporting period.
The proposed regulations provide that the amounts provided in the CbCR should be based on applicable financial statements, books and records maintained with respect to the constituent entity, or records used for tax reporting purposes. The term “books and records” was intended to be broad enough to include all sources of information that the Final BEPS Report allows. In order to clarify this intent, the final regulations provide that the source of data may also include regulatory financial statements and records used for internal management control purposes.
The proposed regulations state that it is not necessary to have or maintain records that reconcile the amounts provided on the CbCR to the consolidated financial statements of the U.S. MNE group or to the tax returns filed in any particular tax jurisdiction or to make adjustments for differences in accounting principles applied from tax jurisdiction to tax jurisdiction. Multiple comments recommended that reconciliation to tax accounts be required and that ultimate parent entities maintain records of the reconciliation, while other comments supported the approach in the proposed regulations, which does not require reconciliation. The Treasury Department and the IRS considered these comments, and, consistent with the proposed regulations, the final regulations do not require the ultimate parent entity to create and maintain records to reconcile the information reported in the CbCR to consolidated financial statements or to tax returns. This approach provides flexibility for U.S. MNE groups to use the available data for each constituent entity without imposing the potential burden of a need to reconcile information on the CbCR with accounts that may not even be finalized when the CbCR is compiled, and it is consistent with the Final BEPS Report. The affirmative statement in the final regulations that an ultimate parent entity is not required to create and maintain information to support a reconciliation does not, however, affect the requirement to maintain records to support the information provided in the CbCR.
The proposed regulations generally require a U.S. business entity that is an ultimate parent entity of a U.S. MNE group to file a CbCR with respect to business entities that are or would be consolidated with the ultimate parent entity. A CbCR is not required for an MNE group that does not have a U.S. business entity as its ultimate parent entity. Multiple comments requested that reporting be required for any U.S. entity that exercises the “mind and management function” of an MNE group, the foreign parent entity of which is tax resident in a jurisdiction that does not require a report similar to the CbCR, despite the fact that the foreign entities of such MNE group are not controlled foreign corporations. This recommendation, which is not adopted, is beyond the scope of the Final BEPS Report and could not be implemented under the authority provided in section 6038 to collect information on foreign business entities owned by U.S. persons.
One comment recommended that the final regulations allow a foreign-parented MNE group with a U.S. business entity to designate that U.S. business entity as a surrogate parent entity and allow that entity to file a CbCR with the IRS for purposes of satisfying the MNE group's country-by-country reporting obligations in other tax jurisdictions. In light of the IRS resources that would be required to adopt this recommendation, the final regulations do not permit surrogate parent entity filing in the United States by foreign corporations as a general matter. However, the final regulations provide that a U.S. territory ultimate parent entity may designate a U.S. business entity that it controls (as defined in section 6038(e)) to file on the U.S. territory ultimate parent entity's behalf the CbCR that the U.S. territory ultimate parent entity would be required to file if it were a U.S. business entity. A U.S. territory ultimate parent entity is a business entity organized in a U.S. territory or possession of the United States that controls (as defined in section 6038(e)) a U.S. business entity and that is not owned directly or indirectly by another business entity that consolidates the accounts of the U.S. territory ultimate parent entity with its accounts under GAAP in the other business entity's tax jurisdiction of residence, or would be so required if equity interests in the other business entity were traded on a public securities exchange in its tax jurisdiction of residence.
The proposed regulations provide rules for determining the tax jurisdiction of residence of a constituent entity. Under those rules, a business entity is considered a resident in a tax jurisdiction if, under the laws of that tax jurisdiction, the business entity is liable to tax therein based on place of management, place of organization, or another similar criterion. The proposed regulations further provide that “a business entity will not be considered a resident in a tax jurisdiction if such business entity is liable to tax in such tax jurisdiction solely with respect to income from sources in such tax jurisdiction, or capital situated in such tax jurisdiction.” Multiple comments requested that the final regulations clarify that this language in the proposed regulations is not intended to exclude the possibility of a country with a purely territorial tax regime being a tax jurisdiction of residence. The Treasury Department and the IRS did not intend for the proposed regulations to be interpreted to treat all entities in tax jurisdictions with territorial tax regimes as stateless entities. The language in question was intended to indicate that a business entity will not have a tax jurisdiction of residence in a jurisdiction solely by reason of being liable to tax in the jurisdiction on fixed, determinable, annual or periodical income from sources or capital situated in the jurisdiction. For greater clarity, the final regulations provide that “[a] business entity will not be considered a resident in a tax jurisdiction if the business entity is only liable to tax in such tax jurisdiction by reason of a tax imposed by reference to gross amounts of income without any reduction for expenses, provided such tax applies only with respect to income from sources in such tax jurisdiction or capital situated in such tax jurisdiction.”
The proposed regulations provide that a tax jurisdiction is a country or a jurisdiction that is not a country but that has fiscal autonomy. Multiple comments requested that the final regulations address the meaning of fiscal autonomy. In light of the need for consistency of CbC reporting requirements across tax jurisdictions, the Treasury Department and the IRS do not believe it would be helpful to provide a general definition of fiscal autonomy in the final regulations absent international consensus on the meaning of the term. However, the final regulations clarify that a U.S. territory or possession of the United States, defined as American Samoa, Guam, the Northern Mariana Islands, Puerto Rico, or the U.S. Virgin Islands, is considered to have fiscal autonomy for purposes of CbC reporting.
Under the proposed regulations, if a business entity is resident in more than one tax jurisdiction and there is no applicable income tax treaty, the business entity's tax jurisdiction of residence is the tax jurisdiction of the business entity's place of effective management determined in accordance with Article 4 of the OECD Model Tax Convention. One comment noted that the “effective place of management” test under the OECD Model Tax Convention can be uncertain and “subject to second guessing.” The comment recommended that an alternative, bright-line tie-breaker rule be considered to address such situations. The determination of tax jurisdiction of residence in the proposed regulations is based on the Final BEPS Report, and the final regulations do not create a new tie-breaker rule but add that, in addition to the OECD Model Tax Convention, Form 8975 may provide guidance.
Although certain entities may not have a tax jurisdiction of residence, the Treasury Department and the IRS have determined that an entity regarded as a corporation should not be considered stateless merely because it is organized or managed in a jurisdiction that does not impose an income tax on corporations. Accordingly, the final regulations provide that in the case of a tax jurisdiction that does not impose an income tax on corporations, a corporation that is organized or managed in that tax jurisdiction will be treated as resident in that tax jurisdiction, unless such corporation is treated as resident in another tax jurisdiction under another provision of the final regulations.
The revenue threshold at or above which a U.S. MNE group is required to file the CbCR (reporting threshold) is expressed in United States dollars (USD) in proposed § 1.6038-4(h). Foreign jurisdictions that are enacting CbC reporting requirements based on the Final BEPS Report may express the reporting threshold in a foreign currency. Multiple commenters expressed concern that U.S. MNE groups may be required to file a CbC report in a foreign country, even if the USD reporting threshold in § 1.6038-4(h) is not exceeded, because the U.S. MNE group's revenues exceed the local law reporting threshold as expressed in the foreign currency. The comments recommended various approaches to address the possibility of a reporting threshold in the final regulations that is inconsistent with local law reporting thresholds. The reporting threshold of $850,000,000 in the proposed regulation was determined by reference to the USD equivalent of €750,000,000 on January 1, 2015, as provided in the Final BEPS Report. The Treasury Department and the IRS anticipate that other countries will acknowledge that it would be inconsistent with the Final BEPS Report for a country to require local filing by a constituent entity of a U.S. MNE group that has revenue of less than $850,000,000.
Multiple comments requested that the reporting threshold be reduced to the USD equivalent of €40,000,000 in order to subject a greater number of U.S. MNE groups to CbC reporting requirements. Because the reporting threshold in the proposed regulations is based on the Final BEPS Report, it is consistent with the agreed international standard with respect to CbC reporting. The Treasury Department and IRS weighed the potential benefit of obtaining CbC information on a larger number of U.S.
Multiple comments expressed concerns regarding the confidentiality of the CbCR. Some comments recommended public disclosure of CbCRs. These comments requested that the CbCR be treated as a Treasury report, referencing as an example the Treasury Department's Financial Crimes Enforcement Network Report of Foreign Bank and Financial Assets, rather than tax return information, so that the CbCR would not be subject to the confidentiality protections under section 6103. Other comments supported the decision to treat CbCR as return information.
The Treasury Department and the IRS have determined that the information provided on the CbCR is return information subject to the confidentiality protections of section 6103. This approach is consistent with the purpose of CbC reporting as well as the confidentiality standards reflected in the Final BEPS Report. CbC reporting was designed and established as part of an international effort to standardize transfer pricing documentation. This standardized documentation is intended to provide an efficient and effective means for tax administrations to conduct high-level transfer pricing risk assessment. Accordingly, the Treasury Department and the IRS are collecting the CbCR under the authority of sections 6001, 6011, 6012, 6031, and 6038 to assist in the better enforcement of income tax laws. The CbCR is a return, and the information furnished to the Treasury Department and the IRS on the CbCR is return information subject to the confidentiality protections provided under section 6103. In addition, the Final BEPS Report provides that tax administrations should take all reasonable steps to ensure that there is no public disclosure of confidential information in CbC reports and that they be used for tax risk assessment purposes.
The preamble of the proposed regulations indicates that the information reported on the CbCR will be used for high-level transfer pricing risk identification and assessment, and that transfer pricing adjustments will not be made solely on the basis of a CbCR, but that the CbCR may be the basis for further inquiries into transfer pricing practices or other tax matters which may lead to adjustments. Some comments supported the limitations on use of the CbCR information, while other comments expressed concern that a prohibition on disclosure of the CbCR for non-tax law purposes is too restrictive. Consistent with the proposed regulations, the final regulations do not contain specific limitations on the use of CbCR information. However, consistent with the Final BEPS Report, the Treasury Department and the IRS intend to limit the use of the CbCR information and intend to incorporate this limitation into the competent authority arrangements pursuant to which CbCRs are exchanged.
One comment recommended that CbCR information not be provided to state or local jurisdictions and that a statement to that effect be provided in the final regulations. Under section 6103(d), return information may be provided to state agencies, but only for the purposes of, and only to the extent necessary in, the administration of such state's tax laws. The Treasury Department and the IRS believe the circumstances under which this standard would be met for the CbCR are rare, but the final regulations do not preclude the disclosure of CbCRs to state agencies, subject to the restrictions of section 6103 that apply to other returns and return information.
The United States intends to enter into competent authority arrangements for the automatic exchange of CbCRs with jurisdictions with which the United States has an income tax treaty or tax information exchange agreement. Multiple comments expressed concern that review of the confidentiality safeguards and framework of the other jurisdictions would prevent the Treasury Department and IRS from concluding such arrangements on a timely basis. Comments also requested that the Treasury Department and IRS publish a list of jurisdictions with which the United States exchanges CbCRs. The Treasury Department is committed to entering into bilateral competent authority arrangements with respect to CbCRs in a timely manner, taking into consideration the need for appropriate review of systems and confidentiality safeguards in the other jurisdictions. The Treasury Department and the IRS anticipate that information about the existence of competent authority arrangements for CbCRs will be made publicly available, but the manner in which such information would be made publicly available has not yet been determined.
A comment recommended that the final regulations provide a mechanism for reporting suspected violations of the limitations on the use of information by foreign jurisdictions. While the final regulations do not provide procedures for reporting suspected violations, the Treasury Department and the IRS are aware of the concern and intend to establish a procedure to report suspected violations of confidentiality and other misuses of CbCR information.
A comment requested that information transmitted under the competent authority arrangements include the “Additional Information” table in the model CbC report template provided in the Final BEPS Report. It is expected that such information will be collected on Form 8975 and transmitted; however, there may be limits to the amount of information that can be transmitted in any field. Such constraints, if any, will be noted in the Instructions to Form 8975.
One comment requested that penalties with respect to the CbCR be waived for reports filed for the 2016 tax year and that the Treasury Department should advocate that other countries also waive penalties for the 2016 tax year. The final regulations apply to reporting periods of ultimate parent entities that begin on or after the first day of a taxable year of the ultimate parent entity that begins on or after publication of the final regulations in the
Certain IRS regulations, including these, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) and (d) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.
It is hereby certified that this regulation will not have a significant economic impact on a substantial
The principal author of these regulations is Melinda E. Harvey of the Office of Associate Chief Counsel (International). However, other personnel from the IRS and the Treasury Department participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
Section 1.6038-4 also issued under 26 U.S.C. 6001, 6011, 6012, 6031, and 6038.
(a)
(b)
(i) Owns directly or indirectly a sufficient interest in one or more other business entities, at least one of which is organized or tax resident in a tax jurisdiction other than the United States, such that the U.S. business entity is required to consolidate the accounts of the other business entities with its own accounts under U.S. generally accepted accounting principles, or would be so required if equity interests in the U.S. business entity were publicly traded on a U.S. securities exchange; and
(ii) Is not owned directly or indirectly by another business entity that consolidates the accounts of such U.S. business entity with its own accounts under generally accepted accounting principles in the other business entity's tax jurisdiction of residence, or would be so required if equity interests in the other business entity were traded on a public securities exchange in its tax jurisdiction of residence.
(2)
(3)
(i) A branch or business establishment of a constituent entity in a tax jurisdiction that is treated as a permanent establishment under an income tax convention to which that tax jurisdiction is a party;
(ii) A branch or business establishment of a constituent entity that is liable to tax in the tax jurisdiction in which it is located pursuant to the domestic law of such tax jurisdiction; or
(iii) A branch or business establishment of a constituent entity that is treated in the same manner for tax purposes as an entity separate from its owner by the owner's tax jurisdiction of residence.
(4)
(5)
(6)
(7)
(8)
(9)
(10)
(11)
(c)
(d)
(i) The complete legal name of the constituent entity;
(ii) The tax jurisdiction, if any, in which the constituent entity is resident for tax purposes;
(iii) The tax jurisdiction in which the constituent entity is organized or incorporated (if different from the tax jurisdiction of residence);
(iv) The tax identification number, if any, used for the constituent entity by the tax administration of the constituent entity's tax jurisdiction of residence; and
(v) The main business activity or activities of the constituent entity.
(2)
(i) Revenues generated from transactions with other constituent entities;
(ii) Revenues not generated from transactions with other constituent entities;
(iii) Profit or loss before income tax;
(iv) Total income tax paid on a cash basis to all tax jurisdictions, and any taxes withheld on payments received by the constituent entities;
(v) Total accrued tax expense recorded on taxable profits or losses, reflecting only operations in the relevant annual period and excluding deferred taxes or provisions for uncertain tax liabilities;
(vi) Stated capital, except that the stated capital of a permanent establishment must be reported in the tax jurisdiction of residence of the legal entity of which it is a permanent establishment unless there is a defined capital requirement in the permanent establishment tax jurisdiction for regulatory purposes;
(vii) Total accumulated earnings, except that accumulated earnings of a permanent establishment must be reported by the legal entity of which it is a permanent establishment;
(viii) Total number of employees on a full-time equivalent basis; and
(ix) Net book value of tangible assets, which, for purposes of this section, does not include cash or cash equivalents, intangibles, or financial assets.
(3)
(ii)
(iii)
(iv)
(v)
(e)
(2)
(f)
(g)
(h)
(i) [Reserved]
(j)
(k)
Department of Justice.
Interim final rule with request for comments.
In accordance with the provisions of the Bipartisan Budget Act of 2015, the Department of Justice is adjusting for inflation civil monetary penalties assessed or enforced by components of the Department.
To ensure proper handling of comments, please reference “Docket No. OAG 148” on all electronic and written correspondence. The Department encourages all comments be submitted electronically through
Robert Hinchman, Senior Counsel, Office of Legal Policy, U.S. Department of Justice, Room 4252 RFK Building, 950 Pennsylvania Avenue NW., Washington, DC 20530, telephone (202) 514-8059 (not a toll-free number).
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase “CONFIDENTIAL BUSINESS INFORMATION” in the first paragraph of your comment. Personal identifying information and confidential business information identified as set forth above will be placed in the agency's public docket file, but not posted online. If you wish to inspect the agency's public docket file in person by appointment, please see the paragraph above entitled
The Federal Civil Monetary Penalties Inflation Adjustment Act of 1990, Public Law 101-410, 28 U.S.C. 2461 note (2014) (“Inflation Adjustment Act”), provided for the regular evaluation and adjustment for inflation of civil monetary penalties to, among other things, ensure that they continue to maintain their deterrent effect and that penalty amounts due the Federal Government are properly accounted for and collected. Section 31001(s)(1) of the Omnibus Consolidated Rescissions and Appropriations Act of 1996, Public Law 104-134, also known as the Debt Collection Improvement Act of 1996 (“Improvement Act”), amended section 4 of the Inflation Adjustment Act to require the head of each agency to adjust periodically each civil monetary penalty provided by law within the jurisdiction of the Federal agency by regulation and to publish each such regulation in the
The amounts of the adjustments were determined according to a formula set forth in the Inflation Adjustment Act, which used applicable “rounders” (or increments) for calculations based on the amount of the current penalty along with the statutorily defined cost-of-living adjustment.
In compliance with the prior statutory requirements, the Department of Justice published a rule on February 12, 1999 (64 FR 7066-03) adjusting the immigration-related civil monetary penalties assessed or enforced by the Executive Office for Immigration Review's (EOIR) Office of the Chief Administrative Hearing Officer (OCAHO). On August 30, 1999 (64 FR 47099), the Department published a rule adjusting the other civil monetary penalties assessed or enforced by it.
On February 26, 2008 (73 FR 10130-01), the Department of Homeland Security (DHS) and the Department of Justice published a rule adjusting for inflation the immigration-related civil monetary penalties assessed or enforced by those two Departments under sections 274A, 274B, and 274C of the Immigration and Nationality Act (INA).
Section 701 of the Bipartisan Budget Act of 2015, Public Law 114-74 (Nov. 2, 2015), titled the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (“2015 Amendments”), 28 U.S.C. 2461 note, substantially revised the prior provisions of the Inflation Adjustment Act and substituted a different statutory formula for calculating inflation adjustments on an annual basis.
The 2015 Amendments set forth a different method of calculation for the initial adjustment following the 2015 Amendments than for subsequent adjustments. For the initial adjustment, the “cost-of-living adjustment,” which sets the amount by which the maximum civil monetary penalty or the range of minimum and maximum civil monetary penalties, as applicable, would be increased, is defined as “the percentage (if any) for each civil monetary penalty by which the Consumer Price Index for the month of October, 2015 exceeds the Consumer Price Index for the month of October of the calendar year during which the amount of such civil monetary penalty was established or adjusted under a provision of law other than this Act.” Public Law 114-74, sec. 701(b)(2)(B) (amending section 5(b) of the Inflation Adjustment Act). This adjustment is to be applied to “the amount of the civil monetary penalty as it was most recently established or adjusted under a provision of law other than this Act,” and “shall not exceed 150 percent of the amount of that civil monetary penalty on the date of enactment of” the 2015 Amendments.
In short, the 2015 Amendments tie the inflation adjustments for the initial adjustment to an index reflecting the cost of living increases between 2015 and the year in which each civil penalty was established or adjusted by a provision of law other than the Inflation Adjustment Act. For subsequent adjustments, however, the adjustment will be determined by the difference in the Consumer Price Index between the October preceding the new adjustment and the October the year before. In addition, instead of using the larger “rounders” under the old formula, the resulting new civil penalty amounts adjusted under the 2015 Amendments are rounded to the nearest $1.
The 2015 Amendments removed the 10 percent cap on the first-time inflation adjustment for each penalty, and, as noted above, provided that the initial adjustment following the 2015 Amendments “shall not exceed 150 percent of the amount of that civil monetary penalty on the date of enactment of” the 2015 Amendments.
The 2015 Amendments also amended section 6 of the Inflation Adjustment Act to provide that “[a]ny increase under this Act in a civil monetary penalty shall apply only to civil monetary penalties, including those whose associated violation predated such increase, which are assessed after the date the increase takes effect.”
In accordance with the 2015 Amendments, the adjustments made by this rule are based on the Bureau of Labor Statistics' Consumer Price Index for October 2015. The inflation factors used in Table A were provided to all federal agencies in the OMB Memorandum for the Heads of Executive Departments and Agencies M-16-06 (Feb. 24, 2016).
Table A provides the calculations upon which the current inflation adjustments are being made. As summarized above, the key factors for these calculations are (1) the year in which each civil penalty amount was established or adjusted under a provision of law other than the Inflation Adjustment Act; (2) the amount of each civil penalty as so established or adjusted; (3) the inflationary adjustment factor (as determined according to the chart prepared by OMB) for the year of the most recent establishment or adjustment of the amount of the penalty; and (4) the resulting amount of the new adjusted civil penalty. For example, for a civil penalty that was most recently established by law at the amount of $1,000 in the year 1996, applying the inflationary adjustment factor of 1.50245 for that year, the adjusted penalty as determined under this rule is $1,502, as rounded to the nearest $1. The only departures from this straightforward calculation are for those civil penalties whose amount was set decades ago and not previously adjusted; in those few cases, the civil penalty amount is capped at 2.5 times the civil penalty amount currently in effect, as noted by the footnotes in Table A.
Currently, 28 CFR 85.3 provides for inflation adjustments of a number of civil penalties enforced by the Department, pursuant to the former inflation adjustment statutory provisions. This rule revises § 85.3 to provide that the inflation adjustments set forth in that section will continue to apply to violations occurring on or before November 2, 2015, the date of enactment of the 2015 Amendments, as well as to assessments made before August 1, 2016, whose associated violations occurred after November 2, 2015. Other existing Department regulations provide for inflation adjustments of other civil penalties under prior law, such as the civil penalties under certain provisions of the immigration laws in 28 CFR 68.52. Those other existing regulations are also being revised to provide that the existing regulatory inflation adjustments will continue to apply to violations occurring on or before November 2, 2015, as well as to assessments made before August 1, 2016, whose associated violations occurred after November 2, 2015.
A new regulatory provision, § 85.5, includes a comprehensive table setting forth the penalty amounts for civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015. The table in § 85.5 is the same as Table A in this preamble, except that it only includes the first three descriptive columns for each civil penalty provision, and the last two columns setting forth the penalty amounts in effect on November 2, 2015 (the date of enactment of the 2015 Amendments) and the new adjusted civil penalty amounts taking effect for civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015. (The other columns in Table A, which show how the adjusted civil penalty amounts are calculated, are provided for informational purposes in this preamble, but are not being codified in the Code of Federal Regulations.) Those instances where the civil penalty amount for the initial adjustment is capped at 2.5 times the civil penalty amount currently in effect, as provided in the 2015 Amendments, are noted by footnote in the table in § 85.5.
This rule adjusts for inflation civil monetary penalties within the jurisdiction of the Justice Department for purposes of the Inflation Adjustment Act, as amended. Other agencies are responsible for the inflation adjustments of certain other civil monetary penalties that the Department's litigating components bring suit to collect. The reader should consult the regulations of those other agencies for inflation adjustments to those penalties.
In this rule, the adjusted civil penalty amounts are applicable only to civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments. Therefore, violations occurring on or before November 2, 2015, and assessments made prior to August 1, 2016, whose associated violations occurred after November 2, 2015, will continue to be subject to the civil monetary penalty amounts set forth in the Department's existing regulations in 28 CFR parts 20, 22, 36, 68, 71, 76 and 85 (or as set forth by statute if the amount has not yet been adjusted by regulation).
The Attorney General is publishing this rule as an interim final rule, without prior notice and comment, as authorized by the 2015 Amendments. The Department is providing a 60-day period for public comment after publication of this rule and welcomes public comment on the changes made to reflect the revised process for calculating inflation adjustments under the Inflation Adjustment Act, as amended by the 2015 Amendments.
Only those entities that are determined to have violated Federal law and regulations would be affected by the increase in the civil penalty amounts made by this rule. A Regulatory Flexibility Act analysis is not required for this rule because publication of a notice of proposed rulemaking is not required.
This regulation has been drafted and reviewed in accordance with Executive Order 12866, “Regulatory Planning and Review” section 1(b), The Principles of Regulation, and in accordance with Executive Order 13563, “Improving Regulation and Regulatory Review” section 1, General Principles of Regulation.
The Department of Justice has determined that this rule is not a “significant regulatory action” under Executive Order 12866, Regulatory Planning and Review, section 3(f), and accordingly this rule has not been reviewed by the Office of Management and Budget.
Both Executive Orders 12866 and 13563 direct agencies, in certain circumstances, to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). As stated above, the statute authorizes the Department, with the concurrence of the Director of the Office of Management and Budget, to make a determination in certain circumstances to increase a civil penalty by less than the otherwise required amount. However, the Department is not invoking that authority in this rule. The adjustments to existing civil monetary penalties set forth in this rule are calculated pursuant to the statutory formula.
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
This regulation meets the applicable standards set forth in sections 3(a) and 3(b)(2) of Executive Order 12988.
This rule will not result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions
This rule is not a major rule as defined by the Congressional Review Act, 5 U.S.C. 804. It will not result in an annual effect on the economy of $100 million or more; a major increase in costs or prices for consumers, individual industries, Federal, State, or local government agencies, or geographic regions; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and export markets.
Classified information, Crime, Intergovernmental relations, Investigations, Law Enforcement, Penalties, Privacy, Research, and Statistics.
Crime, Juvenile delinquency, Penalties, Privacy, Research, and Statistics.
Administrative practice and procedure, Alcoholism, Americans with disabilities, Buildings and facilities, Business and industry, Civil rights, Consumer protection, Drug abuse, Handicapped, Historic preservation, Individuals with disabilities, Penalties, Reporting and recordkeeping requirements.
Administrative practice and procedure, Aliens, Citizenship and naturalization, Civil rights, Discrimination in employment, Employment, Equal employment opportunity, Immigration, Nationality, Non-discrimination.
Administrative practice and procedure, Claims, Fraud, Organization and function (Government agencies), Penalties.
Administrative practice and procedure, Drug abuse, Drug traffic control, Penalties.
Administrative practice and procedure, Penalties.
Accordingly, for the reasons set forth in the preamble, chapter I of Title 28 of the Code of Federal Regulations is amended as follows:
28 U.S.C. 534; Pub. L. 92-544, 86 Stat. 1115; 42 U.S.C. 3711,
* * * For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, see the civil penalty amount as provided in 28 CFR 85.5. * * *
Secs. 801(a), 812(a), Omnibus Crime Control and Safe Streets Act of 1968, 42 U.S.C. 3701,
* * * For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, see the civil penalty amount as provided in 28 CFR 85.5.
5 U.S.C. 301; 28 U.S.C. 509, 510; 42 U.S.C. 12188(b); Pub. L. 101-410, 104 Stat. 890, as amended by Pub. L. 104-134, 110 Stat. 1321.
(a) * * *
(3) * * *
(i) Not exceeding $50,000 for a first violation occurring before September 29, 1999, and not exceeding $55,000 for a first violation occurring on or after September 29, 1999, and before April 28, 2014, and not exceeding $75,000 for a first violation occurring on or after April 28, 2014, except that, for civil penalties assessed after August 1, 2016, for a first violation occurring after November 2, 2015, the civil penalty shall not exceed the applicable amount set forth in 28 CFR 85.5.
(ii) Not exceeding $100,000 for any subsequent violation occurring before September 29, 1999, and not exceeding $110,000 for any subsequent violation occurring on or after September 29, 1999, and before April 28, 2014, and not exceeding $150,000 for any subsequent violation occurring on or after April 28, 2014, except that, for civil penalties assessed after August 1, 2016, for any subsequent violation occurring after November 2, 2015, the civil penalty shall not exceed the applicable amount set forth in 28 CFR 85.5.
5 U.S.C. 301, 554; 8 U.S.C. 1103, 1324a, 1324b, and 1324c.
(c) * * *
(8)
(d) * * *
(2)
(e) * * *
(3)
5 U.S.C. 301; 28 U.S.C. 509, 510; 31 U.S.C. 3801-3812; Pub. L. 101-410, 104 Stat. 890, as amended by Pub. L. 104-134, 110 Stat. 1321.
(a) Any person shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $5,000 for each claim listed in paragraphs (a)(1) through (a)(4) of this section made before September 29, 1999, and not more than $5,500 for each such claim made on or after September 29, 1999, and not more than the applicable amount as provided in 28 CFR 85.5 for civil penalties assessed after August 1, 2016, for each such claim made after November 2, 2015, if that person makes a claim that the person knows or has reason to know:
(f) Any person shall be subject, in addition to any other remedy that may be prescribed by law, to a civil penalty of not more than $5,000 for each statement listed in paragraphs (f)(1) and (f)(2) of this section made before September 29, 1999, and not more than $5,500 for each such statement made on or after September 29, 1999, and not more than the applicable amount as provided in 28 CFR 85.5 for civil penalties assessed after August 1, 2016 for each such statement made after November 2, 2015, if that person makes a written statement that:
5 U.S.C. 301; 21 U.S.C. 844a, 875, 876; 28 U.S.C. 509, 510; Pub. L. 101-410, 104 Stat. 890, as amended by Pub. L. 104-134, 110 Stat. 1321.
(a) * * * For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, see the civil penalty amount as provided in 28 CFR 85.5.
5 U.S.C. 301, 28 U.S.C. 503; Pub. L. 101-410, 104 Stat. 890, as amended by Pub. L. 104-134, 110 Stat. 1321; Pub. L. 114-74, section 701, 28 U.S.C. 2461 note.
(a) For violations occurring on or before November 2, 2015, and for civil penalties assessed before August 1, 2016, whose associated violations occurred after November 2, 2015, the civil monetary penalties provided by law within the jurisdiction of the Department of Justice and listed in section 85.3 are adjusted as set forth in that section, in accordance with the requirements of the Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 104-410, 104 Stat. 890, in effect prior to November 2, 2015.
(b) For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the civil monetary penalties provided by law within the jurisdiction of the Department of Justice are adjusted as set forth in section 85.5, in accordance with the requirements of the Bipartisan Budget Act of 2015, Public Law 114-74, section 701 (Nov. 2, 2015), 28 U.S.C. 2461 note.
For all violations occurring on or before November 2, 2015, and for assessments made before August 1, 2016, for violations occurring after November 2, 2015, the civil monetary penalties provided by law within the jurisdiction of the respective components of the Department, as set forth in paragraphs (a) through (d) of this section, are adjusted as provided in this section in accordance with the inflation adjustment procedures prescribed in section 5 of the Federal Civil Penalties Inflation Adjustment Act of 1990, Public Law 101-410, as in effect prior to November 2, 2015. The adjusted penalties set forth in paragraphs (a), (c), and (d) of this section are effective for violations occurring on or after September 29, 1999, and on or before November 2, 2015, and for assessments made before August 1, 2016, for violations occurring after November 2, 2015. For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, see the adjusted penalty amounts in section 85.5.
For civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the civil monetary penalties provided by law within the jurisdiction of the Department are adjusted as set forth in the following table.
Financial Crimes Enforcement Network (“FinCEN”), Treasury.
Interim final rule.
FinCEN is amending the regulations under the Bank Secrecy Act to adjust the maximum amount or range, as set by statute, of certain civil monetary penalties within its jurisdiction to account for inflation. This action is being taken to implement the requirements of the Federal Civil Penalties Inflation Adjustment Act of 1990, as further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.
Comments may be submitted, identified by Regulatory
•
•
The FinCEN Resource Center at (800) 767-2825 or email
The Federal Civil Penalties Inflation Adjustment Act of 1990, 28 U.S.C. 2461 note, (“FCPIA Act”), as further amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the “2015 Act”), requires each Federal agency to adjust its civil monetary penalties within its jurisdiction for inflation annually. Specifically, the FCPIA Act now requires agencies to adjust the level of civil monetary penalties with an initial “catch-up” adjustment through an interim final rulemaking, and to make subsequent annual adjustments for inflation. The adjustment is based on the formula described in section 5(b) of the FCPIA Act. Increases are rounded to the nearest multiple of $1.
To calculate the catch-up adjustment, agencies must identify, for each penalty subject to the FCPIA Act, the year and corresponding amount(s) for which the maximum penalty or range of minimum and maximum penalties was established or last adjusted, whichever is later. Agencies will adjust the penalty amount or range of penalty amounts based on the Consumer Price Index for all Urban Consumers (“CPI-U”) for the month of October 2015 using an inflation factor, or multiplier, that reflects the CPI-U increase for the year in which the maximum penalty or range of penalties was established or last adjusted.
Subsequent annual inflation adjustments will be based on any percentage change between the October CPI-U preceding the date of the adjustment, and the prior year's October CPI-U.
FinCEN is authorized to impose civil monetary penalties for violations of the Bank Secrecy Act and its implementing regulations. Several of those penalties, such as the penalty under 31 U.S.C. 5321(a)(2), are not subject to adjustment under the FCPIA Act because they lack a stated dollar amount and are instead written solely as functions of violations. The penalties subject to adjustment under the FCPIA Act are as follows:
• 12 U.S.C. 1829b(j), relating to recordkeeping violations for funds transfers. The $10,000 penalty amount set out in 12 U.S.C. 1929b(j) was last adjusted by statute in 1988. The inflation factor for 1988 is 1.97869. Multiplying the penalty amount of $10,000 by the inflation factor of 1.97869 results in an inflation adjusted maximum penalty amount of $19,787, when rounded to the nearest dollar.
• 12 U.S.C. 1955, relating to willful or grossly negligent recordkeeping violations. The $10,000 penalty amount set out in 12 U.S.C. 1955 was last adjusted by statute in 1988. The inflation factor for 1988 is 1.97869. Multiplying the penalty amount of $10,000 by the inflation factor of 1.97869 results in an inflation adjusted maximum penalty amount of $19,787, when rounded to the nearest dollar.
• 31 U.S.C. 5318(k)(3)(C), relating to failures to terminate correspondent relationships with a foreign bank. The $10,000 penalty amount set out in 31 U.S.C. 5318(k)(3)(C) was last adjusted by statute in 2001. The inflation factor for 2001 is 1.33842. Multiplying the current maximum penalty amount of $10,000 by the inflation factor of 1.33842 results in an inflation-adjusted maximum penalty amount of $13,384, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(1), relating to willful violations of Bank Secrecy Act requirements. The minimum and maximum amounts of $25,000 and $100,000 set out in 31 U.S.C. 5321(a)(1) were last adjusted by statute in 1986. The inflation factor for 1986 is 2.15628. Multiplying the current minimum and maximum penalty amounts of $25,000 and $100,000 by the inflation factor of 2.15628 results in an inflation-adjusted range of minimum and maximum penalty amounts of $53,907 and $215,628, respectively, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(5)(B)(i), relating to non-willful violations of foreign financial agency transactions. The $10,000 amount set out in 31 U.S.C. 5312(a)(5)(B)(i) was last adjusted by statute in 2004. The inflation factor for 2004 is 1.24588. Multiplying the current maximum penalty amount of $10,000 by the inflation factor of 1.24588 results in an inflation-adjusted maximum penalty of $12,459, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(5)(C), relating to willful violations of foreign financial agency transactions. The $100,000 amount set out in 31 U.S.C. 5321(a)(5)(C) was last adjusted by statute in 2004. The inflation factor for 2004 is 1.24588. Multiplying the current maximum penalty amount of $100,000 by the inflation factor of 1.24588 results in an inflation-adjusted maximum penalty amount of $124,588, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(6)(A), relating to negligent violations by a financial institution or non-financial trade or business. The $500 amount set out in 31 U.S.C. 5321(a)(6)(A) was last adjusted by statute in 1986. The inflation factor for 1986 is 2.15628. Multiplying the current maximum penalty amount of $500 by the inflation factor of 2.15628 results in an inflation-adjusted maximum penalty amount of $1,078, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(6)(B), relating to a pattern of negligent activity by a financial institution or non-financial trade or business. The $50,000 penalty amount set out in 31 U.S.C. 5321(a)(6)(B) was last adjusted by statute in 1992. The inflation factor for 1992 is 1.67728. Multiplying the current maximum penalty amount of $50,000 by the inflation factor of 1.67728 results in an inflation-adjusted maximum penalty amount of $83,864, when rounded to the nearest dollar.
• 31 U.S.C. 5321(a)(7), relating to violations of due diligence requirements for private banking accounts or correspondent bank accounts involving foreign persons, the prohibition on correspondent accounts for shell banks, and any special measure. The $1,000,000 amount set out in 31 U.S.C. 5321(a)(7) was last adjusted by statute in 2001. The inflation factor for 2001 is 1.33842. Multiplying the current maximum penalty amount of $1,000,000 by the inflation factor of 1.33842 results in an inflation-adjusted maximum penalty amount of $1,338,420, when rounded to the nearest dollar.
• 31 U.S.C. 5330(e), relating to the failure to register as a money transmitting business. The $5,000 penalty amount set out in 31 U.S.C. 5330(e) was last adjusted by statute in 1994. The inflation factor for 1994 is 1.59089. Multiplying the current penalty amount of $5,000 by the inflation factor of 1.59089 results in an inflation-adjusted penalty amount of $7,954, when rounded to the nearest dollar.
The adjusted civil penalty amounts described in this rule are applicable only to civil penalties assessed after August 1, 2016, whose associated violations occurred after November 2, 2015, the date of enactment of the 2015 Amendments. Therefore, violations occurring on or before November 2, 2015, and assessments made prior to August 1, 2016 whose associated violations occurred after November 2, 2015, will continue to be subject to the civil monetary penalty amounts set forth in FinCEN's existing regulations.
FinCEN invites comment on any and all aspects of the interim final rule.
The FCPIA Act mandates that inflation adjustments to civil monetary penalties be published through an interim final rulemaking to be published by July 1, 2016, and that the inflation-adjusted civil monetary penalties take effect not later than August 1, 2016.
The Regulatory Flexibility Act applies only to rules for which an agency publishes a general notice of proposed rulemaking pursuant to 5 U.S.C. 553(b). See 5 U.S.C. 601(2). Because the FCPIA Act mandates that this rulemaking be an interim final rule, FinCEN is not publishing a general notice of proposed rulemaking. Thus, the Regulatory Flexibility Act does not apply to this interim final rule.
Section 202 of the Unfunded Mandates Reform Act of 1995, Public Law 104-4 (“Unfunded Mandates Act”) requires that an agency prepare a budgetary impact statement before promulgating a rule that includes a Federal mandate that may result in expenditure by state, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any one year. If a budgetary impact statement is required, section 205 of the Unfunded Mandates Act also requires an agency to identify and consider a reasonable number of regulatory alternatives before promulgating a rule. FinCEN has determined that this interim final rule will not result in expenditures by state, local, and tribal governments, or by the private sector, of $100 million or more. Accordingly, FinCEN has not prepared a budgetary impact statement or specifically addressed the regulatory alternatives considered.
Executive Orders 13563 and 12866 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. It has been determined that this is not a significant regulatory action for purposes of Executive Order 12866. Accordingly, a regulatory impact analysis is not required.
The Paperwork Reduction Act does not apply because the interim final rule does not impose information collection requirements that would require the approval of the Office of Management and Budget under 44 U.S.C. 3501
Authority delegations (Government agencies), Banks and banking, Currency, Investigations, Law enforcement, Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, Part 1010 of Chapter X of title 31 of the Code of Federal Regulations is amended as follows:
12 U.S.C. 1829b and 1951-1959; 31 U.S.C. 5311-5314 and 5316-5332; title III, sec. 314, Pub. L. 107-56, 115 Stat. 307; sec. 701. Pub. L. 114-74, 129 Stat. 599.
(i) For penalties that are assessed after August 1, 2016, see § 1010.821 for rules relating to the maximum amount of the penalty.
(a)
(b)
Coast Guard, DHS.
Notice of enforcement of regulations.
The Coast Guard will enforce special local regulations and a safety zone for the Madison Regatta for all waters of the Ohio River, beginning at mile marker 555.0 and ending at mile marker 560.0, Madison, IN. These actions are necessary to protect persons, property, and infrastructure from potential damage and safety hazards associated with a regatta taking place on the Ohio River. During the enforcement period, deviation from the regulations or safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative.
The regulations in 33 CFR 100.801, Table 1, Sector Ohio Valley, No. 16 and 33 CFR 165.801, Table 1, Sector Ohio Valley, No. 52 will be enforced from July 1 through July 3, 2016.
If you have questions on this notice of enforcement, call or email Petty Officer Caloeb Gandy, U.S. Coast Guard; telephone 502-779-5334, Email
The Coast Guard will enforce the special local regulations listed in 33 CFR 100.801, Table 1, Sector Ohio Valley, No. 16, and the safety zone listed in 33 CFR 165.801, Table 1, Sector Ohio Valley, No. 52 during the Madison Regatta as follows:
Under the provisions of 33 CFR part 100 and 33 CFR part 165, a vessel may not enter the regulated area, unless it receives permission from the COTP Ohio Valley or a designated representative. Spectator vessels may safely transit outside the regulated area but may not anchor, block, loiter in, or impede the transit of race participants or official patrol vessels. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
This notice of enforcement is issued under authority of 5 U.S.C. 552 (a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Notice of temporary deviation from regulations; request for comments.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Chambers Creek Burlington Northern Santa Fe railroad vertical lift railroad bridge across Chambers Creek, mile 0.01, near
This deviation is effective from 12:01 on July 1, 2016 to 12:01 on December 27, 2016.
Comments and related material must reach the Coast Guard on or before November 22, 2016.
You may submit comments identified by docket number USCG-2016-0280 using Federal eRulemaking Portal at
See the “Public Participation and Request for Comments” portion of the
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
The Chambers Creek Burlington Northern Santa Fe railroad vertical lift railroad bridge across Chambers Creek, mile 0.01, near Steilacoom in Pierce County, WA has a vertical clearance of 10ft in the closed to navigation position and 50ft of vertical clearance in the open to navigation position (reference plane is MHW elevation of 12.2 feet). The bridge currently operates under 33 CFR 117.5; which requires the bridge to open anytime when a request or signal to open is given.
The bridge owner, Burlington Northern Santa Fe Railroad, has observed minimal to no usage of the drawbridge between 10 p.m. and 6 a.m. and has requested to test this schedule to see if it better balances the needs of marine and rail traffic. The following facts support BNSF's proposal: (1) Over the last 6 years only 2% of the subject bridge lifts have occurred between the hours of 10 p.m. and 6 a.m., which equates to approximately 5 openings a year, (2) from February 2009 to June 2015 there were 1932 total openings of which only 40 occurred between the hours of 10 p.m. and 6 a.m., and (3) the navigation traffic consists primarily of the tenants of Chambers Bay marina (recreational users) that are members of the Chambers Bay Boating Association.
The Coast Guard is publishing this temporary deviation to test the proposed schedule change to determine whether a permanent change to the schedule is appropriate to better balance the needs of marine and rail traffic.
Under this temporary deviation, in effect from 12:01 on July 1, 2016 to 12:01 December 27, 2016, the subject bridge shall open on signal, except from 10 p.m. to 6 a.m. the draw shall open on signal if at least 4 hours notice is given. The bridge will be required to open as soon a possible, no later than 1 hour after notification, for vessels engaged in emergency response.
The Coast Guard will inform the users of the waterways of this temporary deviation through our Local and Broadcast Notices to Mariners and through direct outreach with the Chambers Creek Boating Association so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation. Vessels able to pass underneath the bridge in the closed position may do so at anytime.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
We view public participation as essential to effective rulemaking, and will consider all comments and material received during the comment period. Your comment can help shape the outcome of this rulemaking. If you submit a comment, please include the docket number for this rulemaking, indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation.
We encourage you to submit comments through the Federal eRulemaking Portal at
We accept anonymous comments. All comments received will be posted without change to
Documents mentioned in this notice of temporary deviation, and all public comments, are in our online docket at
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing four temporary safety zones for fireworks displays within the Coast Guard Sector Long Island Sound (LIS) Captain of the Port (COTP) Zone. This temporary final rule is necessary to provide for the safety of life on navigable waters during these events. Entry into, transit through, mooring or anchoring within these regulated areas is prohibited unless authorized by COTP Sector Long Island Sound.
This rule is effective without actual notice from June 30, 2016 through July 7, 2016. For the purposes of enforcement, actual notice will be used from the date the rule was signed, June 15, 2016, through June 30, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, contact Petty Officer Jay TerVeen, Prevention Department, Coast Guard Sector Long Island Sound, telephone (203) 468-4446, email
This rulemaking establishes four safety zones for fireworks displays. Each event and its corresponding regulatory history are discussed below.
The Boys and Girls Club of Bellport-Beach Ball 2016 Fireworks Display is a recurring marine event with regulatory history. A safety zone was established for this event in 2015 via a temporary final rule entitled, “Safety Zones; Marine Events held in the Sector Long Island Sound Captain of the Port Zone.” This rulemaking was published on May 18, 2015 in the
The Arts Project Cherry Grove Fireworks Display is a recurring marine event with regulatory history and is cited in 33 CFR 165.151, Table 1 to § 165.151, section 6.5. This event has been included in this rule due to deviation from the cite date.
The Salute to Veterans Fireworks Display is a recurring marine event with regulatory history and is cited in 33 CFR 165.151, Table 1 to § 165.151, section 6.4. This event has been included in this rule due to deviation from the cite date.
The Clinton Chamber of Commerce Fireworks Display is a recurring marine event with regulatory history. A safety zone was established for this event in 2015 via a temporary final rule entitled, “Safety Zones; Marine Events held in the Sector Long Island Sound Captain of the Port Zone.” This rulemaking was published on August 14, 2015 in the
The Coast Guard is issuing this temporary final rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing an NPRM with respect to this rule because doing so would be impracticable. The event sponsors were late in submitting the marine event applications. These late submissions did not give the Coast Guard enough time to publish an NPRM, take public comments, and issue a final rule before these events take place. For that reason, issuing an NPRM would be impracticable.
Under 5 U.S.C. 553(d)(3), and for the same reasons stated in the preceding paragraph, 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 temporary rule under authority in 33 U.S.C. 1231. The Captain of the Port (COTP) Long Island Sound has determined that the safety zones established by this temporary final rule are necessary to provide for the safety of life on navigable waterways before, during and after these scheduled events.
This rule establishes four safety zones for four fireworks displays. The location of these safety zones are as follows:
This rule prevents vessels from entering, transiting, mooring, or anchoring within the areas specifically designated as a safety zone and restricts vessel movement around the locations of the marine events to reduce the safety risks associated with it during the period of enforcement unless authorized by the COTP or designated representative.
The Coast Guard will notify the public and local mariners of these safety zones 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 these statutes and Executive order 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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
The Coast Guard determined that this rulemaking is not a significant regulatory action for the following reasons: (1) The enforcement of these safety zones will be relatively short in duration; (2) persons or vessels desiring to enter these safety zones may do so with permission from the COTP LIS or a designated representative; (3) these safety zones are designed in a way to limit impacts on vessel traffic, permitting vessels to navigate in other portions of the waterway not designated as a safety zone; and (4) the Coast Guard
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit these regulated areas may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator. Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this proposed 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 Orders 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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969(42 U.S.C. 4321-4370f), and have 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 temporary rule involves the establishment of four temporary safety zones. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and record keeping 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; and Department of Homeland Security Delegation No. 0170.1
(a)
(b)
(c)
(d)
(2) In accordance with the general regulations in § 165.23, entry into or
(3) Any vessel given permission to deviate from these regulations must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.
(4) Any vessel given permission to enter or operate in these safety zones must comply with all directions given to them by the COTP Sector Long Island Sound, or the designated on-scene representative.
(5) Upon being hailed by a U.S. Coast Guard vessel by siren, radio, flashing light or other means, the operator of the vessel shall proceed as directed.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce safety zones in the Captain of the Port Boston Zone on the specified dates and times listed below. This action is necessary to ensure the protection of the maritime public and event participants from the hazards associated with these annual recurring events. Under the provisions of our regulations, no person or vessel, except for the safety vessels assisting with the event may enter the safety zones unless given permission from the COTP or the designated on-scene representative. The Coast Guard may be assisted by other Federal, State, or local law enforcement agencies in enforcing this regulation.
The regulations in 33 CFR 165.118 will be enforced for the safety zones identified in the
If you have questions about this notice of enforcement, call or email Mr. Mark Cutter, Coast Guard Sector Boston Waterways Management Division, telephone 617-223-4000, email
The Coast Guard will enforce the safety zones listed in 33 CFR 165.118 on the specified dates and times as indicated in Table 1 below. This regulation was published in the
This notice of enforcement is issued under authority of 33 CFR 165.118 and 5 U.S.C. 552 (a). In addition to this notice of enforement in the
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce safety zone for the City of Charleston Independence Celebration Fireworks on the Kanawha River from mile marker 58.1 to mile marker 59.1, in Charleston, WV on July 3, 2016. This action is needed to provide for the safety of life on navigable waterways during a fireworks display on or over the waterway. Our regulation for Recurring Marine Events in Captain of the Port Ohio Valley Zone identifies the safety zone for this fireworks display. During the enforcement period, no vessel may transit this regulated area without approval from the Captain of the Port or a designated representative.
The regulations in 33 CFR 165.801, Table 1, Sector Ohio Valley, No. 31 will be enforced from 9:15 p.m. until 10:15 p.m. on July 3, 2016.
If you have questions about this notice of enforcement, call or email MST3 Robert Miller, Marine Safety Unit Huntington, U.S. Coast Guard; telephone 304-733-0198,
The Coast Guard will enforce a safety zone for the annual City of Charleston Independence Celebration Fireworks listed in 33 CFR 165.801, Table 1, Sector Ohio Valley, No. 31, from 9:15 p.m. until 10:15 p.m. on July 3, 2016. This safety zone extends from mile marker 58.1 to mile marker 59.1 on the Kanawha River in Charleston, WV. This action is being taken to provide for the safety of life on navigable waterways during the fireworks display. Entry into this safety zone is prohibited unless authorized by the Captain of the Port Ohio Valley or a designated representative. Persons or vessels desiring to enter into or passage through the zone must request permission from the Captain of the Port Ohio Valley or a designated representative. If permission is granted, all persons and vessels shall comply with the instructions of the Captain of the Port Ohio Valley or designated representative.
This notice of enforcement is issued under authority of 33 CFR 165.801 and 5 U.S.C. 552 (a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing temporary safety zones for multiple locations and dates within the Captain of the Port New Orleans zone. These safety zones are necessary to protect persons and vessels from potential safety hazards associated with fireworks displays on or over federal waterways. Entry into these zones is prohibited unless specifically authorized by the Captain of the Port New Orleans or a designated representative.
This rule is effective without actual notice from June 30, 2016 through September 23, 2016. For the
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this temporary final rule, call or email Lieutenant Commander (LCDR) Howard Vacco, Sector New Orleans, at (504) 365-2281 or
The Coast Guard was notified about several fireworks displays, occurring between June 22 and September 23, 2016 as follows:
(1) The U.S. Travel Association's “IPW” Conference scheduled for one hour in the evening between 6:00 p.m. and 11:00 p.m. on June 22, 2016. The fireworks barge will be positioned adjacent to Mardi Gras World in New Orleans, LA, at approximate mile marker 96.2 above Head of Passes on the Lower Mississippi River. The Coast Guard was notified about this event on April 1, 2016.
(2) The St. John the Baptist Parish Independence Day Celebration scheduled for one hour in the evening between 6:00 p.m. and 11:00 p.m. on June 30, 2016. The fireworks barge will be positioned adjacent to the Parish Courthouse in Edgard, LA, at approximate mile marker 138.0 above Head of Passes on the Lower Mississippi River. The Coast Guard was notified about this event on March 15, 2016. This is an annually recurring event that is published in 33 CFR 165.801, Table 5, line no. 2. This year's occurrence is scheduled for a different date and location than currently listed in the CFR.
(3) The L'Auberge Casino Independence Day Celebration scheduled for one hour in the evening between 6:00 p.m. and 11:00 p.m. on July 4, 2016. The fireworks barge will be positioned adjacent to the L'Auberge Casino in Baton Rouge, LA, at approximate mile marker 216.5 above Head of Passes on the Lower Mississippi River. The Coast Guard was notified about this event on January 27, 2016.
(4) The City of Mandeville Independence Day Celebration scheduled for one hour in the evening between 6:00 p.m. and 11:00 p.m. on July 4, 2016. The fireworks barge will be positioned adjacent to the Mandeville City Lakefront in Mandeville, LA, at approximate position 30° 21.200 N., 90° 04.500 W. The Coast Guard was notified about this event on March 14, 2016.
(5) The American Pyrotechnic Association Convention scheduled for one hour in the evening between 6:00 p.m. and 11:00 p.m. on September 23, 2016. The fireworks barge will be positioned adjacent to Dumaine Street in New Orleans, LA, at approximate mile marker 94.5 above Head of Passes on the Lower Mississippi River. The Coast Guard was notified about this event on February 24, 2016. This event was incorrectly identified as “The American Psychological Association Convention” in the NPRM.
Due to the risks associated with aerial barge-based fireworks displays taking place on and over these sections of navigable waterways, the safety zones are needed to protect persons and property. The Coast Guard will notify the public and maritime community of the safety zones and their respective enforcement periods via broadcast notices to mariners (BNM) and Marine Safety Information Bulletins (MSIB).
In response, on June 3, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Safety Zones; Safety Zones Within the Captain of the Port New Orleans Zone; New Orleans to Baton Rouge, LA (81 FR 35671). There we stated why we issued the NPRM, and invited comments on our proposed regulatory action related to these fireworks displays. During the comment period that ended June 20, 2016, we received no comments.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard will notify the public and maritime community that the safety zone will be in effect and of its enforcement periods via broadcast notices to mariners (BNM).
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The Captain of the Port New Orleans (COTP) has determined that potential hazards associated with the fireworks to be used in upcoming displays will be a safety concern for anyone within one-quarter mile of the fireworks barge for the displays on the Lower Mississippi River and within 600 feet of the fireworks barge for the display in Lake Pontchartrain. The purpose of this rule is to ensure safety of vessels and the navigable waters in the safety zone before, during, and after the scheduled events.
Through this temporary final rule, the Coast Guard is establishing multiple temporary safety zones within the Captain of the Port New Orleans (COTP) Zone on several different dates and in several different locations. While we received no comments to the proposed rule, due to timing of the NPRM publication and cancellation of an event, 2 safety zones are removed and changes to the proposed rule are necessary. We removed the regulatory text for the first safety zone, under paragraph (a)(1) as proposed, which was for a fireworks display on June 15, 2016, from MM 94.0 to MM 95.0 above head of passes on the Lower Mississippi River. We removed the regulatory text for that safety zone because we established it through its own temporary rulemaking before the comment period for the NPRM ended. This allowed the Coast Guard to ensure that the necessary safety measures were in place for the June 15, 2016 display. A copy of that rule is available in the docket as indicated under
These remaining safety zones will be enforced on the respective dates listed above and in the regulatory text as provided at the end of this document.
The COTP New Orleans will inform the public through BNMs of the enforcement period for each safety zone as well as any changes in the planned schedule. Mariners and other members of the public may also contact Coast Guard Sector New Orleans Command Center to inquire about the status of the safety zone by calling (504) 365-2200.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
Four of these safety zones are no greater than 1 river mile in length and would restrict navigation on the Lower Mississippi River for no longer than one hour. The remaining safety zone is limited to a circular area 1200 feet in diameter located along the North Shore of Lake Pontchartrain, in an area with ample room for other traffic to navigate around the safety zone, and would be in effect for no longer than one hour. Due to the limited scope and short duration of each safety zone, the impacts on routine navigation are expected to be minimal. Additionally, the Coast Guard will issue maritime notices widely available to waterway users and deviation from the safety zones may be requested and will be considered on a case-by-case basis.
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 rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have 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 establishes five temporary safety zones within the Captain of the Port New Orleans zone. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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
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)
(1)
(ii)
(2)
(ii)
(3)
(ii)
(4)
(ii)
(5)
(ii)
(b)
(2) Vessels requiring deviation from this rule must request permission from the COTP New Orleans or a COTP New Orleans designated representative. They may be contacted via the U.S. Coast Guard Sector New Orleans Command Center, via VHF-FM Channel 16 or by phone at (504) 365-2200.
(3) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted areas must transit at the slowest safe speed and comply with all lawful directions issued by the COTP New Orleans or the designated representative.
(c)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a safety zone in Lake Superior near Bayfield, WI. This safety zone is intended to restrict vessels from specified waters in Lake Superior during the Bayfield Fourth of July Fireworks Display. This safety zone is necessary to protect spectators from the hazards associated with the fireworks display.
This rule is effective from 9 p.m. through 11 p.m. July 4, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Lieutenant Junior Grade John Mack, Waterways management, MSU Duluth, Coast Guard; telephone 218-725-3818, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it 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 Duluth (COTP) has determined that potential hazards associated with fireworks displays starting at 9:30 p.m. on July 4, 2016 will be a safety concern for anyone within a 420-foot radius of the launch site. The likely combination of recreational vessels, darkness punctuated by bright flashes of light, and fireworks debris falling into the water presents risks of collisions which could result in serious injuries or fatalities. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the fireworks display.
This rule establishes a safety zone from 9 p.m. through 11 p.m. July 4, 2016. The safety zone will cover all navigable waters within an area bounded by a circle with a 420-foot radius of the fireworks display launching site located in Hancock, MI at coordinates 46°48′40″ N., 090°48′32″ W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and Executive order 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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year 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 Keweenaw Waterway in Hancock, MI for 1 hour and during a time of year when commercial vessel traffic is normally low. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to seek permission to enter the zone.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone lasting no more than 2 hours that will prohibit entry within a 420-foot radius from where a fireworks display will be conducted. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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 record keeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(2) This safety zone is closed to all vessel traffic, except as may be permitted by the Captain of the Port Duluth or his designated on-scene representative.
(3) The “on-scene representative” of the Captain of the Port is any Coast Guard commissioned, warrant, or petty officer who has been designated by the Captain of the Port to act on his behalf. The on-scene representative of the Captain of the Port will be aboard either a Coast Guard or Coast Guard Auxiliary vessel. The Captain of the Port or his designated on-scene representative may be contacted via VHF Channel 16.
(4) Vessel operators desiring to enter or operate within the safety zone shall contact the Captain of the Port Duluth or his on-scene representative to obtain permission to do so. Vessel operators given permission to enter or operate in the safety zone must comply with all directions given to them by the Captain of the Port Duluth or his on-scene representative.
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Safety Zone for the Duluth Fourth Fest fireworks display in Duluth, MN July 4, 2016. This action is necessary to protect spectators during the Duluth Fourth Fest Fireworks show. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative.
The regulations in 33 CFR 165.943(b) will be enforced from 9:30 p.m. through 11:30 p.m. on July 4, 2016.
If you have questions about this notice of enforcement, call or email Lieutenant Junior Grade John Mack, Waterways Management Division, Coast Guard; telephone (218) 725-3818, email
The Coast Guard will enforce a safety zone for the annual Duluth Fourth Fest fireworks display in 33 CFR 165.943(a)(3) from 9:30 p.m. until 11:30 p.m. July 4, 2016. This safety zone will include all U.S. navigable waters of the Duluth Harbor Basin Northern Section within a 840 foot radius of position 46°46′14″ N., 092°06′16″ W. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative. The Captain of the Port's designated on-scene representative may be contacted via VHF Channel 16.
This notice of enforcement is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552(a). In addition to this notice of enforcement in the
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Pamlico Sound in Ocracoke, North Carolina within a 500 yard radius of the National Park Service (NPS) Boat Launch. This action is necessary to provide the safety of mariners on navigable waters to protect the life and property of the maritime public and spectators from the hazards posed by Hyde County 4th of July aerial fireworks display. Entry into or movement within the safety zone during the enforcement period is prohibited without approval of the Captain of the Port.
This rule is effective on July 3, 2016, from 9 p.m. through 9:45 p.m.
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 Derek J. Burrill, Waterways Management Division Chief, Sector North Carolina, Coast Guard; telephone (910) 772-2230, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the Coast Guard was awaiting further details on the location of the launch site and also gathering other safety details of the Hyde County July 4th Fireworks display. The Captain of the Port North Carolina is establishing a temporary safety zone on specified waters of Pamlico Sound within a 500 yard radius of the NPS Boat Launch in approximate position 35°07′07″ N., longitude 075°59′16″ W. (NAD 1983) in Ocracoke, NC. This safety zone will be effective and enforced from 9 p.m. to 9:45 p.m. on July 3, 2016. It is impracticable to publish a Notice to Public Rulemaking (NPRM) because we must establish this safety zone by July 3, 2016, and sufficient notice was not given to publish a NPRM due to the Coast Guard awaiting further details on the location of the launch site and continuing to gather other on site safety details associated with the aerial fireworks display.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it 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 North Carolina (COTP) has determined that potential hazards associated with the aerial fireworks on July 3, 2016, will be a safety concern for anyone within a 500 yard radius of the launch site at approximate position 35°07′07″ N., longitude 075°59′16″ W. (NAD 1983). This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone.
This rule establishes a safety zone from 9 p.m. to 9:45 p.m. on July 3, 2016. The safety zone will cover all navigable waters within 500 yards of the NPS Boat Launch at approximate position 35°07′07″ N., longitude 075°59′16″ W. The duration of the zone is intended to protect personnel, vessels, and the marine environment in these navigable waters before, during, and after the aerial fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
The primary impact of these regulations will be on limiting all vessels wishing to transit the affected waterways during enforcement of the safety zone on the waters of Pamlico Sound within a 500 yard radius of the NPS Boat Launch at approximate position 35°07′07″ N., longitude 075°59′16″ W. on July 3, 2016, from 9 p.m. through 9:45 p.m., unless otherwise cancelled by the COTP. Although these regulations prevent traffic from transiting a small portion of Pamlico Sound during this event, that restriction is limited in duration, affects only a limited area, and will be well publicized to allow mariners to make alternative plans for transiting the affected area.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant 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,
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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves the establishment of a safety zone to limit all vessels within a 500 yard radius of the NPS Boat Launch at approximate position 35°07′07″ N., longitude 075°59′16″ W. on July 3, 2016, from 9 p.m. through 9:45 p.m., to protect life and property of mariners from the dangers associated with aerial fireworks. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. We seek any comments or information that may lead to the discovery of a significant environmental impact from this rule.
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) The operator of any vessel granted permission to enter this safety zone must proceed as directed by any commissioned, warrant or petty officer on shore or on board a vessel that is displaying a U.S. Coast Guard Ensign.
(3) The Captain of the Port, North Carolina can be reached through the Sector North Carolina Command Duty Officer at Sector North Carolina in Wilmington, North Carolina at telephone number (910) 343-3882.
(4) The Coast Guard Representatives enforcing the safety zone can be contacted on VHF-FM marine band radio channel 13 (165.65 Mhz) and channel 16 (156.8 Mhz).
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River, surface to bottom, from mile 469.6 to 470.2. This action is necessary to provide for the safety of life on these navigable waters near Newport, KY, during the City of Newport Fireworks Display. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port, Ohio Valley (COTP) or a designated representative.
This rule is effective from 10:00 p.m. to 11:00 p.m. on July 3, 2016.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Petty Officer Caloeb Gandy, Sector Ohio Valley, U.S. Coast Guard; telephone 502-779-5334, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor submitted the event application on June 22, 2016. This late submission did not give the Coast Guard enough time to complete the full NPRM process. This action is necessary to ensure the safety of the life and property during the fireworks display on or over this navigable waterway. It is impracticable to publish an NPRM because we must establish this safety zone by July 3, 2016.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it 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 Ohio Valley (COTP) has determined that potential hazards associated with the fireworks display on July 3, 2016 will be a safety concern for all waters of the Ohio River, surface to bottom, from mile 469.6 to 470.2. The purpose of this rule is to ensure safety of life on the navigable waters in the temporary safety zone before, during, and after the City of Newport Fireworks Display.
This rule establishes a temporary safety zone on July 3, 2016. The temporary safety zone will cover all waters of the Ohio River, surface to bottom, from mile 469.6 to 470.2. Transit into and through this area is prohibited from 10:00 p.m. to 11:00 p.m. on July 3, 2016. The duration of the temporary safety zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled fireworks displays. No vessel or person will be permitted to enter the temporary safety zone without obtaining permission from the COTP or a designated representative. Deviation requests will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7475 or can be reached by VHF-FM channel 16. Public notifications will be made to the local maritime community prior to the event through the Local Notice to Mariners, and Broadcast notice to Mariners.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the temporary safety zone. The temporary safety zone will only be in effect for 60 minutes, during late evening hours and covers an area of the waterway stretching less than one mile. The Coast Guard expects minimum adverse impact to mariners from the temporary safety zone activation as the event has been advertised to the public. Also, mariners may request authorization from the COTP Ohio Valley or a designated representative to transit the temporary 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.
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
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 $165,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting less than two hours that will prohibit entry on all waters of the Ohio River, surface to bottom, extending 500 feet from the Kentucky shoreline, from mile 469.6 to 470.2. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted area must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for
This rule is effective from 10:00 p.m. to 11:00 p.m. on July 4, 2016
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions about this rulemaking, call or email Petty Officer Caloeb Gandy, Sector Ohio Valley, U.S. Coast Guard; telephone 502-779-5334, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because the event sponsor submitted the event application on May 11, 2016. This late submission did not give the Coast Guard enough time to complete the full NPRM process. This action is necessary to ensure the safety of the life and property during the fireworks display on or over this navigable waterway. It is impracticable to publish an NPRM because we must establish this safety zone by July 4, 2016.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it 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 Ohio Valley (COTP) has determined that potential hazards associated with the fireworks display on July 4, 2016 will be a safety concern for all waters of the Ohio River, surface to bottom, extending 500 feet from the Kentucky shoreline, from mile 408 to 409. The purpose of this rule is to ensure safety of life on the navigable waters in the temporary safety zone before, during, and after the City of Maysville Fireworks Display.
This rule establishes a temporary safety zone on July 4, 2016. The temporary safety zone will cover all waters of the Ohio River, surface to bottom, extending 500 feet from the Kentucky shoreline, from mile 408 to 409. Transit into and through this area is prohibited from 10:00 p.m. to 11:00 p.m. on July 4, 2016. The duration of the temporary safety zone is intended to ensure the safety of vessels and these navigable waters before, during, and after the scheduled fireworks displays. No vessel or person will be permitted to enter the temporary safety zone without obtaining permission from the COTP or a designated representative. Deviation requests will be considered and reviewed on a case-by-case basis. The COTP Ohio Valley may be contacted by telephone at 1-800-253-7475 or can be reached by VHF-FM channel 16. Public notifications will be made to the local maritime community prior to the event through the Local Notice to Mariners, and Broadcast notice to Mariners.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-year of the temporary safety zone. The temporary safety zone will only be in effect for 60 minutes and covers an area of the waterway stretching less than one mile and extending 500 feet from the shoreline. The Coast Guard expects minimum adverse impact to mariners from the temporary safety zone activation as the event has been advertised to the public. Also, mariners may request authorization from the COTP Ohio Valley or a designated representative to transit the temporary 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.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman
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 $165,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a temporary safety zone lasting less than two hours that will prohibit entry on all waters of the Ohio River, surface to bottom, extending 500 feet from the Kentucky shoreline, from mile 408 to 409. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted area must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or the designated representative.
(d)
Coast Guard, DHS.
Notice of enforcement of regulation.
The Coast Guard will enforce the Safety Zone for the Superior Man Triathlon in Duluth, MN August 28, 2016. This action is necessary to protect the participants during the event. During the enforcement period, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative.
The regulations in 33 CFR 165.943(b) will be enforced from 5:30 a.m. through 9:30 a.m. on August 28, 2016.
If you have questions about this notice of enforcement, call or email Lieutenant Junior Grade John Mack, Waterways
The Coast Guard will enforce a safety zone for the annual Superior Man Triathlon in Duluth, MN in 33 CFR 165.943(a)(8) from 5:30 a.m. until 9:30 a.m. August 28, 2016. This safety zone will include all U.S. navigable waters of the Duluth Harbor Basin, Northern Section within an imaginary line beginning at point 46°46′36.12″ N. 092°06′06.99″ W., running southeast to 46°46′32.75″ N. 092°06′01.74″ W., running northeast to 46°46′45.92″ N. 092°05′45.18″ W., running northwest to 46°46′49.47″ N. 092°05′49.35″ W. and finally running southwest back to the starting point. Entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Duluth or his designated on-scene representative. The Captain of the Port's designated on-scene representative may be contacted via VHF Channel 16.
This notice of enforcement is issued under authority of 33 CFR 165.943 and 5 U.S.C. 552 (a). 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 all waters of the Ohio River from mile 307.8 to mile 308.8, Huntington, WV. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over the navigable waterway. During the period of enforcement, entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or other designated representative.
This rule is effective from 9:30 to 11:00 p.m. on July 1, 2016.
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 Third Class Robert Miller; telephone (304) 733-0198, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency finds good cause that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because firework displays on or over the navigable waterway pose safety concerns for waterway users. On March 7, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled, “Sector Ohio Valley Annual and Recurring Safety Zones Update” (81 FR 11706). In the NPRM, the Coast Guard proposed to amend and update its list of recurring safety zone regulations that take place in the Coast Guard Sector Ohio Valley area of responsibility (AOR). The public comment period ended on June 6, 2016. The Coast Guard did not receive comments on the NPRM. The Coast Guard issued a final rule on June 14, 2016, finalizing the events proposed in the NPRM, and the rule became effective on June 14, 2016 (see 81 FR 38595).
Before the comment period closed, the Coast Guard received new information regarding the Kindred Communications/Dawg Dazzle event, listed in Table 1 of 33 CFR 165.801, Line 56. For 2016, the event sponsor requested that the event be held on July 1 instead of the July 4, which was the date proposed in the NPRM. Due to the date of the event, it is impracticable to publish an NPRM for this date change because we must establish this safety zone by July 1, 2016. If the event sponsor decides to continue to hold the event annually on July 1, the Coast Guard will publish an NPRM in the
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making the 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 has determined that potential hazards associated with fireworks displays taking place on or over this section of navigable waterway will be a safety concern for anyone within the area designated as the safety zone. This rule is needed to protect personnel, vessels, and the marine environment in the navigable waters within the safety zone during the fireworks display.
This rule establishes a temporary safety zone from 9:30 until 11:00 p.m. on July 1, 2016 for all waters of the Ohio River from mile 307.8 to mile 308.8, for the Dawg Dazzle Fireworks Display in Huntington, WV. This safety zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This temporary final rule establishes a safety zone that will be enforced for a limited time period. During the enforcement period, vessels are prohibited from entering into or remaining within the safety zone unless specifically authorized by the COTP or a designated representative. Based on the location, limited safety zone size, and short duration of the enforcement period, this rule does not pose a significant regulatory impact. Additionally, notice of the safety zone or any changes in the planned schedule will be made via Broadcast Notices to Mariners and Local Notices to Mariners. Deviation from this rule may be requested from the COTP or a designated representative and will be considered on a case-by-case basis.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that the actions are 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 less than two hours that will limit access to a specific area on the Ohio River. This safety zone is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted area must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is temporarily establishing a regulated navigation area on Biscayne Bay in Miami, Florida for the Fourth of July, 2016. This regulation is necessary to protect the public during upcoming Fourth of July events, a period during which a significant concentration of persons and vessels historically operate on the waters of Biscayne Bay. To ensure the public's safety, all vessels within the regulated navigation area are required to transit the regulated navigation area at no more than 15 knots; are subject to control by the Coast Guard officers and petty officers; and are required to follow the instructions of all law enforcement vessels in the area.
This rule is effective on July 4th, 2016, from 7 p.m. until 11:59 p.m.
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 Benjamin Colbert, Sector Miami Waterways Management Branch, U.S. Coast Guard; telephone 305-535-4317, email
Recreational boating traffic on the waters of Biscayne Bay increases significantly during Fourth of July activities. In recent years, recreational vessel speed, especially in crossing navigational channels, contributed to incidents that resulted in severe injury and death. This regulation seeks to increase public safety on the waters of Biscayne Bay during the 4th of July by requiring vessels to travel at a maximum speed of 15 knots. It also subjects recreational vessels to the control by Coast Guard officers and petty officers as well as local law enforcement authorities.
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because publication of an NPRM would be impracticable. During meetings with local law enforcement, only weeks prior to the holiday, it was decided that a regulated navigation area be implemented for the holiday. Local law enforcement expressed opinion that previous implementation of this rule resulted a substantially safer waterway. This late decision makes proposing the rule for comment impracticable.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The legal basis for this proposed rule is the Coast Guard's authority to establish regulated navigation areas and other limited access areas: 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. The District Seven Commander has determined that potential hazards associated with Fourth of July events pose a safety concern for anyone on the waters of Biscayne Bay. The purpose of this rule is to ensure safety of vessels and the navigable waters in Biscayne Bay before, during, and after the July 4th events.
This rule establishes a regulated navigational area from 7 p.m. to 11:59 on July 4th, 2016. This regulated navigation area will encompass certain waters of the Biscayne Bay between Julia Tuttle Causeway Bridge and Cutler Bay, Florida. The duration of the zone is intended to ensure the safety of vessels and these navigable waters before, during, and after Fourth of July events.
All vessels within the proposed regulated navigation area are: (1) Required to transit the regulated navigation area at no more than 15 knots; (2) subject to control by Coast Guard officers and petty officers; and (3) required to follow the instructions of all law enforcement vessels in the area.
We developed this rule after considering numerous statutes and executive orders (E.O.s) related to rulemaking. Below we summarize our analyses based on a number of these
E.O.s 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. E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under E.O. 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, duration, and time-of-day of the safety zone. Although the regulated navigational area covers most of Biscayne Bay, it is only enforced for five hours on a holiday evening. Moreover, the Coast Guard will issue Broadcast Notice to Mariners via VHF-FM marine channel 16 about the zone and the rule allows vessels to enter the regulated navigational area.
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 0 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 regulated navigation area may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under E.O. 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in E.O. 13132.
Also, this rule does not have tribal implications under E.O. 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 Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have 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 is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River from mile 317 to mile 318, Ashland, KY. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over a navigable waterway. During the period of enforcement entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative.
This rule is effective from 9:35 to 10:45 p.m. on July 2, 2016.
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 Third Class Robert Miller; telephone (304) 733-0198, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency finds good cause that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because fireworks displays on or over the navigable waterway poses safety concerns for waterway users. On March 7, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled, “Sector Ohio Valley Annual and Recurring Safety Zones Update” (81 FR 11706). In the NPRM, the Coast Guard proposed to amend and update its list of recurring safety zone regulations that take place in the Coast Guard Sector Ohio Valley area of responsibility (AOR). The public comment period ended on June 6, 2016. The Coast Guard did not receive comments on the NPRM. The Coast Guard issued a final rule on June 14, 2016, finalizing the events proposed in the NPRM, and the rule became effective on June 14, 2016 (see 81 FR 38595).
Before the comment period closed, the Coast Guard received new information regarding the Party in the Park event, listed in Table 1, Line 13 of 33 CFR 165.801. For 2016, the event sponsor requested that the event be held on July 2 instead of July 4, which was the date proposed in the NPRM. Due to the date of the event, it is impracticable to publish an NPRM for this date change because we must establish this safety zone by July 2, 2016. If the event sponsor decides to continue to hold the event annually on July 2, the Coast Guard will publish an NPRM in the
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making the 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 has determined that potential hazards associated with fireworks displays taking place on or over this section of navigable waterway will be a safety concern for anyone within the area designated as the safety zone. This rule is needed to protect personnel, vessels, and the marine environment in
This rule establishes a temporary safety zone from 9:35 until 10:45 p.m. on July 2, 2016 for all waters of the Ohio River from mile 317 to mile 318, for the Party in the Park Fireworks Display in Ashland, KY. This safety zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This temporary final rule establishes a safety zone that will be enforced for a limited time period. During the enforcement period, vessels are prohibited from entering into or remaining within the safety zone unless specifically authorized by the COTP or a designated representative. Based on the location, limited safety zone size, and short duration of the enforcement period, this rule does not pose a significant regulatory impact. Additionally, notice of the safety zone or any changes in the planned schedule will be made via Broadcast Notices to Mariners and Local Notices to Mariners. Deviation from this rule may be requested from the COTP or a designated representative and will be considered on a case-by-case basis.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that the actions are 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 less than two hours that will limit access to a specific area on the Ohio River. This safety zone is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are 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) Persons and vessels permitted to deviate from this safety zone regulation and enter the restricted area must transit at the slowest safe speed and comply with all lawful directions issued by the COTP or a designated representative.
(d)
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone for all waters of the Ohio River from mile 607.5 to mile 608.6. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during a fireworks display on or over the navigable waterway. During the period of enforcement, entry into this safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Ohio Valley or a designated representative.
This rule is effective from 10:30 p.m. until 11:00 p.m. on July 3, 2016.
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 James Robinson, Sector Ohio Valley, U.S. Coast Guard; telephone (502) 779-5347, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency finds good cause that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a notice of proposed rulemaking (NPRM) with respect to this rule because fireworks displays on or over the navigable waterway poses safety concerns for waterway users. On March 7, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) entitled, “Sector Ohio Valley Annual and Recurring Safety Zones Update” (81 FR 11706). In the NPRM, the Coast Guard proposed to amend and update its list of recurring safety zone regulations that take place in the Coast Guard Sector Ohio Valley area of responsibility (AOR). The public comment period ended on June 6, 2016. The Coast Guard did not receive comments on the NPRM. The Coast Guard issued a final rule on June 14, 2016, finalizing the events proposed in the NPRM, and the rule became effective on June 14, 2016 (see 81 FR 38595).
Before the comment period closed, the Coast Guard received new information regarding the Riverfront Independence Festival Fireworks Display, listed in Table 1 of 33 CFR 165.801, Line 21. For 2016, the event sponsor requested that the event be held at Ohio River mile 607.5 to mile 608.6 instead of Ohio River, mile 602.0 to mile 603.5, which is the location listed in the NPRM and current CFR. It is impracticable to publish a NPRM for this location change because we must establish this safety zone by July 3, 2016. If the event sponsor decides to continue to hold the event annually at Ohio River mile 607.5 to mile 608.6, the Coast Guard will publish an NPRM in the
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making the 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 has determined that potential hazards associated with fireworks displays taking place on or over this section of navigable waterway will be a safety concern for anyone within the area designated as the safety zone. This
This rule establishes a temporary safety zone from 10:30 p.m. until 11:00 p.m. on July 03, 2016 for all waters of the Ohio River from mile 607.5 to mile 608.6, for the Riverfront Independence Festival Fireworks Display. This safety zone is intended to protect personnel, vessels, and the marine environment in these navigable waters during the fireworks display. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
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 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This temporary final rule establishes a safety zone that will be enforced for a limited time period. During the enforcement period, vessels are prohibited from entering into or remaining within the safety zone unless specifically authorized by the COTP or other designated representative. Based on the location, limited safety zone size, and short duration of the enforcement period, this rule does not pose a significant regulatory impact. Additionally, notice of the safety zone or any changes in the planned schedule will be made via Broadcast Notices to Mariners and Local Notices to Mariners. Deviation from this rule may be requested from the COTP or other designated representative and will be considered on a case-by-case basis.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A. above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that the actions are 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 less than two hours that will limit access to a specific area on the Ohio River. This safety zone is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination are available in the docket where indicated under
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(c)
(d)
(2) To seek permission to enter, contact the COTP or designated representative via VHF-FM radio channel 16 or phone at 1-800-253-7465.
(3) All persons and vessels shall comply with the instruction of the COTP and designated on-scene personnel.
(e)
Postal Service.
Interim final rule.
This rule updates postal regulations to implement inflation adjustments to civil monetary penalties that may be imposed under consumer protection and mailability provisions enforced by the Postal Service pursuant to the Deceptive Mail Prevention and Enforcement Act and the Postal Accountability and Enhancement Act. These adjustments are required under the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. This notice also includes the statutory civil monetary penalties subject to the 2015 Act.
Steven Sultan, (202) 268-7385.
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act), Public Law 114-74, 129 Stat. 584, amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (1990 Act), Public Law 101-410, 104 Stat. 890 (28 U.S.C. 2461 note), to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. Section 3 of the 1990 Act specifically includes the Postal Service in the definition of “agency” subject to its provisions.
The 2015 Act requires the Postal Service to make two types of adjustments to civil penalties that meet the definition of “civil monetary penalty” under the 1990 Act. The Office of Management and Budget has furnished detailed instructions regarding these adjustments in memorandum M-16-06,
First, the Postal Service must make an initial “catch-up” adjustment to each of its qualifying civil monetary penalties through an interim final rule by July 1, 2016. The catch-up adjustment is based on the Consumer Price Index (CPI-U) and is calculated for each penalty. The amount of the adjustment is calculated by multiplying the current published penalty amount by an adjustment factor provided by the Office of Management and Budget (OMB). The adjustment factor varies depending on the year a penalty was last adjusted. The new penalty amount must be rounded to the nearest dollar.
Second, the Postal Service must make an annual adjustment for inflation and publish the adjustment in the
The 2015 Act allows the interim final rule and annual inflation adjustments to be published without prior public notice or opportunity for public comment.
Civil monetary penalties may be assessed for postal offenses under sections 106 and 108 of the Deceptive Mail Prevention and Enforcement Act, Public Law 106-168, 113 Stat. 1811, 1814 (
Under 39 U.S.C. 3005(a)(1)-(3), the Postal Service may issue administrative orders prohibiting persons from using the mail to obtain money through false representations or lotteries. Persons who evade, attempt to evade, or fail to comply with an order to stop such prohibited practices may be liable to the United States for a civil penalty under 39 U.S.C. 3012(a). This section currently imposes a $50,000 penalty for each mailing less than 50,000 pieces, $100,000 for each mailing 50,000 to 100,000 pieces, and $10,000 for each piece above 100,000 up to a penalty of $2,000,000. These penalties were last adjusted in 2000. Based on the guidance
In lieu of or as part of an order issued under 39 U.S.C. 3005(a)(1)-(3), the Postal Service may assess a civil penalty. Currently, the amount of this penalty, set in 39 U.S.C. 3012(c)(1), is $25,000 for each mailing that is less than 50,000 pieces, $50,000 for each mailing of 50,000 to 100,000 pieces, and an additional $5,000 for every additional 10,000 pieces above 100,000 not to exceed $1,000,000. These penalties were last adjusted in 2000. Based on OMB guidance, an adjustment multiplier of 1.36689 will be used. The new penalties will be $34,172 for each mailing that is less than 50,000 pieces, $68,345 for each mailing of 50,000 to 100,000 pieces, and an additional $6,834 for every additional 10,000 pieces above 100,000 not to exceed $1,366,890.
Persons sending certain deceptive mail matter described in 39 U.S.C. 3001((h)-(k), including:
• Solicitations making false claims of Federal Government connection or approval;
• Certain solicitations for the purchase of a product or service that may be obtained without cost from the Federal Government;
• Solicitations containing improperly prepared “facsimile checks”; and
• Certain solicitations for “skill contests” and “sweepstakes” sent to individuals who, in accordance with 39 U.S.C. 3017(d), have requested that such materials not be mailed to them);
Under 39 U.S.C. 3017(g)(2), the Postal Service may impose a civil penalty against a person who provides information for commercial use about individuals who, in accordance with 39 U.S.C. 3017(d), have elected not to receive certain sweepstakes and contest information. Currently, this civil penalty may not exceed $2,000,000 per violation. The penalty was last adjusted in 2000. Based on OMB guidance, an adjustment multiplier of 1.36689 will be used. The new penalty may not exceed $2,733,780 per violation.
Currently, under 39 U.S.C. 3017(h)(1)(A), any promoter who recklessly mails nonmailable skill contest or sweepstakes matter may be liable to the United States in the amount of $10,000 per violation for each mailing to an individual. The penalty was last adjusted in 2000. Based on OMB guidance, an adjustment multiplier of 1.36689 will be used. The new penalty is $13,669 per violation.
Under 39 U.S.C. 3018(c)(1)(A), the Postal Service may impose a civil penalty payable into the Treasury of the United States on a person who knowingly mails nonmailable hazardous materials or fails to follow postal laws on mailing hazardous materials. Currently, this civil penalty is at least $250, but not more than $100,000 for each violation. The penalty amounts were last adjusted in 2006. Based on OMB guidance, an adjustment multiplier of 1.17858 will be used. The new penalty is at least $295, but not more than $117,858 for each violation.
Administrative practice and procedure, Banks, Banking, Credit, Crime, Infants and children, Law enforcement, Penalties, Privacy, Seizures and forfeitures.
For the reasons set out in this document, the Postal Service amends 39 CFR part 233 as follows:
39 U.S.C. 101, 102, 202, 204, 401, 402, 403, 404, 406, 410, 411, 1003, 3005, 3012, 3017, 3018; 12 U.S.C. 3401-3422; 18 U.S.C. 981, 983, 1956, 1957, 2254, 3061; 21 U.S.C. 881; Pub. L. 101-410, 104 Stat. 890; Pub. L. 104-208, 110 Stat. 3009-378; Pub. L. 106-168, 113 Stat. 1806; Pub. L. 114-74, 129 Stat. 584.
(a)
(b)
(c)
(1) Solicitations making false claims of Federal Government connection or approval;
(2) Certain solicitations for the purchase of a product or service that may be obtained without cost from the Federal Government;
(3) Solicitations containing improperly prepared “facsimile checks”; and
(4) Solicitations for “skill contests” and “sweepstakes” sent to individuals who, in accordance with 39 U.S.C. 3017(d), have requested that such materials not be mailed to them; may be liable to the United States for a civil penalty under 39 U.S.C. 3012(d). As adjusted under Public Law 114-74, this penalty is not to exceed $13,669 for each mailing.
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Postal Regulatory Commission.
Final rule.
The Commission is issuing a set of final rules amending existing Commission rules related to ex parte communications. The final rules are consistent with the recommended approach to agency treatment of ex parte communications. Relative to the proposed rules, some rules were restructured based on comments received, others were modified to alleviate confusion.
David A. Trissell, General Counsel, at 202-789-6820.
81 FR 1931, January 14, 2016.
In this Order, the Commission adopts final rules concerning ex parte communications. The final rules adopted by this Order amend existing Commission rules and remove obsolete rules no longer applicable under the Postal Accountability and Enhancement Act (PAEA), Public Law 109-435, 120 Stat. 3218 (2006). The final rules are located at 39 CFR part 3008. Existing rules located at §§ 3000.735-501, 502, 3001.5(o), and 3001.7 are amended to reflect the revised location of the ex parte communications rules. Existing rules located at 39 CFR part 3000 are renumbered for consistency with
The rules as adopted incorporate suggestions offered by commenters that restructure some rules as proposed, but do not materially affect their substance. The initial approach taken by the Commission was to codify only what were considered mandatory ex parte communications requirements in the Code of Federal Regulations (CFR) applicable to a limited set of Commission docket types. The Commission also proposed to issue a more comprehensive policy document to include ex parte communications requirements for other possible docket types.
The change in structure also is intended to clarify that the Commission in most instances will effectively take a permit-but-disclose approach to ex parte communications, which was suggested by many of the commenters. However, given the opportunities the Commission provides to participants to avoid ex parte communications issues altogether, the rules do not encourage ex parte communications as the norm.
On January 8, 2016, the Commission issued Order No. 3005, introducing a proposed revision and reorganization of its rules concerning ex parte communications.
The existing rules also referred to rate and classification cases under 39 U.S.C. 3624, which were eliminated under the PAEA. Finally, the existing rules lacked guidance for Commission personnel on how to treat ex parte communications falling outside the scope of the specific docket types mentioned.
The operative statute requires the Commission to restrict ex parte communications only in matters where the Commission must provide an opportunity for a hearing on the record pursuant to 5 U.S.C. 556 through 557. Under the PAEA, the Commission is only required to provide an opportunity for a hearing in matters regarding a change in the nature of postal services pursuant to 39 U.S.C. 3633. In addition to nature of service matters, Commission regulations historically have extended restrictions on ex parte communications to post office appeal cases pursuant to 39 U.S.C. 404(d)(5) and (6) and complaint cases pursuant to 39 U.S.C. 3662. The Commission considers the restriction appropriate because of the potential impact ex parte communications might have on participants and their associated rights in those types of proceedings.
In addition to the above three types of proceedings—nature of service, post office closings, and complaints—many other types of proceedings come before the Commission. Accordingly, the Commission attached as a library reference to Order No. 3005 a new proposed internal policy on the treatment of ex parte communications applicable to all cases. For consistency with prevailing principles regarding agency treatment of ex parte
The commenters provide instructive perspectives on the Commission's proposed rules. Notably, the commenters alert the Commission to the confusion caused by proposing both an internal policy applicable to all cases and enforceable only on Commission personnel, and regulations applicable only to specific types of cases and applicable to all persons. This final Order is intended to remedy the confusion surrounding when ex parte restrictions apply, and when and what penalties may be imposed. The changes to the proposed rules reflect the input of the commenters but do not materially change the operation of the proposed rules. The final rules formalize, but do not materially change, the Commission's current practice for handling ex parte communications.
On February 29, 2016, the Commission received comments from the Postal Service,
While the commenters either support the Commission's effort or find it reasonable for the Commission to ensure that its rules concerning ex parte communications promote transparency and fairness,
The Postal Service, MPA, and the Joint Commenters each express concern that the Commission policy treating all case types similarly is more restrictive than is necessary.
The Postal Service proposes several modifications to the proposed rules. The Postal Service recommends that ex parte communications be prohibited only “in `contested proceedings' where there are material issues in dispute.” Postal Service Comments at 10. It also proposes that the Commission's decision to apply the restrictions to a particular proceeding should be based upon specific criteria and that the Commission should give notice when the rules will apply.
In her reply comments, the Public Representative raises concerns about the applicability of the rationale discussed in
The commenters express concern regarding vagueness in when a matter will be considered to be “before the Commission.” MPA states that most agencies do not consider a matter to be before the agency “until it has issued a formal notice of the commencement of the proceeding, an interested person has filed a complaint or formal request that the agency begin the proceeding, or a person has actual knowledge that the proceeding will be noticed.” MPA Comments at 5. MPA states the proposed rules do not adequately define the terms “expected,” “actively preparing,” and “reasonable period of time.”
The Joint Commenters state that Recommendation 2014-4 recommends agencies not impose restrictions on ex parte communications before notice is issued. Joint Comments at 6. The Postal Service criticizes the proposed rules' definition of when a matter is before the Commission, expressing concern that certain docket types involve the filing of periodically required reports, namely the Annual Compliance Report. Postal Service Comments at 16. The Postal Service states that because the scope of the Annual Compliance Report is so broad, the proposed rules would prohibit the Postal Service from ever having an off-the-record discussion about costs, revenues, rates, or quality of service, because of the knowledge that proceeding will be before the Commission annually.
Several commenters note that the Administrative Conference of the United States considers a general prohibition on ex parte communications to be undesirable.
The Postal Service lists the approaches taken by the Department of Justice (DOJ), Federal Communications Commission (FCC), and Federal Energy Regulatory Commission (FERC). Postal Service Comments at 6-7. The Postal Service states the FERC limits ex parte restrictions to “contested on-the-record proceedings,” while the FCC classifies informal rulemakings as “permit-but-disclose” proceedings, and the DOJ permits ex parte communications subject to disclosure.
MPA suggests that the Commission need not go as far as the FERC, identifying a common alternative of permitting ex parte communications but requiring public disclosure of their substance. MPA Comments at 4. Similarly, the Joint Commenters state that “[t]he Commission's proposed rules should be revised, consistent with APA requirements for reasoned decision making, to allow the Commission to permit but disclose any
In its reply comments, the Postal Service suggests that Executive Order 11570, issued by President Nixon shortly after the enactment of the Postal Reorganization Act of 1970, and referenced in the Public Representative's comments, may have “envisioned the `permit-but-disclose' approach” rather than an outright prohibition. Postal Service Reply Comments at 4.
The Public Representative expresses concern about the enforceability of the internal policy on individuals outside the Commission. PR Comments at 5. Although in Order No. 3005 the Commission stated that the policy “will not be binding on persons outside of the Commission,” it is evident from the comments that there is uncertainty and ambiguity regarding the applicability of certain restrictions across both the rules and internal policy.
MPA, in its discussion of the ambiguity of the definition of a matter before the Commission, alludes to the “potentially draconian consequences of an adverse Commission finding.” MPA Comments at 6. The Joint Commenters state that the penalties listed in proposed §§ 3008.7(a) and (b) “may be appropriate in the context of an improper
The Postal Service includes its own proposed rules regarding ex parte communications. Postal Service Comments, Appendix A (Postal Service Proposed Rules). The proposed rules are a “redline” revision of the Commission's proposed rules and include line changes in particular sections.
Postal Service Proposed Rule 3000.735-501(a) changes the description of the Commission's internal policy to read that the policy applies only to interactions “regarding the merits of certain contested proceedings” before the Commission. Postal Service Proposed Rules 3000.735-501(b) and 3000.735-502 remain unchanged from the Commission's proposed rules.
The Postal Service does not propose to change the applicability provisions of proposed §§ 3008.1(a) through (d). However, Postal Service Proposed Rule 3008.1(e) narrows the scope of the Commission's proposed rule. The Postal Service's revision states that:
The Postal Service's proposed revisions to proposed § 3008.2(a), setting forth the definition of ex parte communications, include adding the qualifier that the communication be one “regarding the merits of a matter” before the Commission. Postal Service
Postal Service Proposed Rule 3008.2(b) makes a minor revision to proposed § 3008.2(b)(3) and adds two exceptions to the definition of ex parte communications. Proposed § 3008.2 states the exception for communications made during off-the-record technical conferences where public notice of the event is provided and the event is open to all persons participating in the matter. The Postal Service's proposed change revises the exception to read that the event must be open to all persons participating in the matter before the Commission “as a party, intervenor, or Public Representative.” Postal Service Proposed Rule 3008.2(b)(3).
The Postal Service removes proposed § 3008.2(b)(5), “communications not material to the matter before the Commission,” and adds the following two exceptions, located at §§ 3008.2(b)(5) and (6):
The Postal Service states the Commission's proposed § 3008.2(b)(5) is not well defined and would be unnecessary if ex parte communications were limited to those “regarding the merits.” Postal Service Comments at 14. The Postal Service suggests the sixth exception to allow for general discussions about the postal industry.
The Postal Service proposes that the definition of a matter before the Commission not include matters where the person “has knowledge that a request to initiate a proceeding is expected to be filed.”
Alternatively, the Postal Service suggests amending § 3008.3(c)(4) by adding that “mere knowledge that a periodic report will be filed at regular intervals as required by statute or regulation” does not place a matter before the Commission.
The Postal Service does not propose any revisions to proposed § 3008.4, defining the persons subject to the ex parte communications rules.
The Postal Service proposes to amend the prohibitions set forth in proposed § 3008.5. Postal Service Proposed Rule 3008.5(a) narrows the scope of prohibited communications to only those “regarding the merits of a matter before the Commission.” Postal Service Proposed Rule 3008.5(a).
The Postal Service also proposes to revise proposed § 3008.5(b), regarding the Commission's reliance on information obtained through ex parte communications. Where the Commission's proposed rule prohibits reliance on information obtained through ex parte communications, the Postal Service proposes to allow reliance if certain circumstances are present, most notably the opportunity for rebuttal. Postal Service Comments at 19-20. Postal Service Proposed Rule 3008.5(b) reads as follows:
Commission decision-making personnel
Proposed § 3008.5(c) is unchanged by the Postal Service's proposed revisions.
The Postal Service proposes extensive revisions to proposed § 3008.6. In proposed § 3008.6(a), the Postal Service proposes to change the Commission “will not” to the Commission “may not” consider an ex parte communication. Postal Service Proposed Rule 3008.6(a).
The Postal Services raises concerns about the treatment of sensitive or confidential information submitted in an ex parte communication. Postal Service Comments at 17-18. Postal Service Proposed Rule 3008.6(b) reflects this concern, as the Postal Service includes proposed guidance for the treatment of sensitive information. The Postal Service's adds, in redline, the following:
(b) Commission decision-making personnel who receive, or who make or knowingly cause to be made, ex parte communications prohibited by this part shall
(1) All such written communications;
(2) Memoranda stating the substance of all such oral communications,
. . .
(4)
The Postal Service also adds a requirement upon receipt of communications seeking to explain or clarify the meaning as set forth in Postal Service Proposed Rule 3008.2(b)(5), where the comment ultimately influences the Commission decision. Postal Service Proposed Rule 3008.6(c) reads as follows:
The Postal Service proposes to move the Commission's proposed § 3008.6(c) regarding opportunity for rebuttal to § 3008.6(d) but does not otherwise amend the rule.
The Postal Service does not propose any amendments to proposed § 3008.7 regarding penalties for violations of the ex parte communication rules.
The Public Representative points to Recommendation 2014-4, suggesting that agencies should explain whether social media communications fall within the rules' definition of ex parte communications. PR Comments at 7. The Public Representative also provides background information on the Commission's authority for its existing rules, as well as the Administrative Conference of the United States and its relevant report and recommendation.
The Public Representative suggests conforming the numerical designation of the rules in 39 CFR part 3000 consistent with the
The changes to the proposed rules reflect the Commission's recognition of a key area of concern outlined in the submitted comments. Notably, the proposed rules left uncertainty regarding whether ex parte communications were prohibited in all cases and whether penalties were appropriate for violations in informal rulemaking proceedings.
Although the proposed rules were intended only to strictly prohibit ex parte communications in three particular types of matters (nature of service proceedings, appeals of post office closing and consolidations, and rate or service complaints), the Commission recognizes that proposed § 3008.1(e) left broad discretion to the Commission to apply the rules to any case. Such broad authority coupled with the guidance set forth in the internal policy gave the impression that the Commission could apply the ex parte prohibition and impose penalties for violations in any matter.
Such an interpretation is not the intent of this rulemaking, and therefore clarification and revision are required. The rulemaking is intended to align the Commission's rules with prevailing agency practices and clear the existing rules of redundancy and obsolete references. This rulemaking was not implemented to change, as a practical matter, the status quo for the treatment of ex parte communications. Essentially, this rulemaking was intended to codify the ex parte practices that the Commission has followed for many years.
Several commenters share concern over “draconian” penalties potentially applied in informal rulemakings.
In operation, the final rules create three classes of proceedings before the Commission. The first class includes nature of postal service proceedings (N cases), appeals of postal service decisions to close or consolidate post offices (A cases), and rate or service complaints (C cases). These proceedings will be subject to the ex parte rules, and any ex parte communications occurring in these proceedings will be subject to the penalties set forth in §§ 3008.7(b) and (c).
The second class of proceeding includes public inquiry proceedings (PI cases) and international mail proceedings (IM cases) undertaken pursuant to 39 CFR part 3017. Due to the highly collaborative nature of these proceedings and practical limitations on the ability to disclose each and every communication in these proceedings,
The third class of proceeding includes all other case types before the Commission (Annual Compliance Review (ACR), Competitive Products (CP), Mail Classification (MC), Market Test (MT), Rate (R), Rulemaking (RM), and Tax Computation (T)). The ex parte rules will apply to these proceedings, but ex parte communications received by the Commission will not be subject to the penalties set forth in § 3008.7. Instead, the communication will be disclosed pursuant to § 3008.6(b). In this way, the rules will operate similarly to the “permit-but-disclose” approach suggested by the Postal Service, MPA, and the Joint Commenters.
While the Commission understands and appreciates the benefits of sharing information and promoting a candid dialogue on key issues,
The final rules aim to strike a balance between the Commission's preference for the transparency of on-the-record communication with the Postal Service and interested parties, and the commenters' desire for a permit-but-disclose approach to ex parte communications. While the final rules do not “permit” ex parte communications, in practice the rules will operate quite similarly to the approach proposed by the commenters. Where applicable, an ex parte communication received by the Commission—in cases other than N, A, and C cases—will be subject only to public disclosure and nothing more. Thus, while ex parte communications will not be permitted or encouraged by the Commission, the Commission will treat ex parte communications in a similar manner as the other agencies mentioned by the commenters.
The application of the rules to all cases—other than those exempted by §§ 3008.1(b) through (d)—should alleviate concerns about when the ex parte rules apply. Concerns about “draconian”
By applying the ex parte rules in all case types but only permitting penalties to apply to three specific types of cases, the Commission's final rules aim to eliminate the need for pre-communication evaluation expressed by some commenters of whether a case is a “contested proceeding” or whether a communication “regards the merits” of a case. The ex parte rules' applicability to all case types and communications (aside from those excepted by final §§ 3008.1(b) through (d) and § 3008.2(b)), eliminates uncertainty about the nature of the case and/or communication itself. For example, under the Postal Service's Proposed Rule 3008.2(a), certain terms create uncertainty about the nature of a communication. Specifically, it is unclear how would one determine whether a communication was “intended to affect or influence” or was “capable of affecting or influencing” a Commission decision. The Postal Service's Proposed Rules would also require a determination of what constitutes a “substantive issue in the proceeding.” These necessary determinations would create even more uncertainty than the proposed rules. Accordingly, while the Commission supports the goal of eliminating uncertainty, it declines to adopt the revisions set forth in Postal Service Proposed Rules 3008.1 and 3008.2.
The Postal Service's recommendation that Commission decision-making personnel be permitted to rely on information obtained through ex parte communications is consistent with applicable law. As explained in
Accordingly, the final rules adopt, in part, the suggestions made in Postal Service Proposed Rule 3008.5(b), regarding Commission reliance on information obtained through ex parte communications. This change is consistent with prevailing agency guidance
The Commission acknowledges the comments regarding the definition of when a matter is before the Commission, triggering the application of the ex parte restrictions. The commenters correctly point out that some agencies' ex parte restrictions apply only upon formal notice of commencement of the proceeding. However, as the Public Representative notes, the Commission is differently situated than other administrative agencies, and its current practices go to “considerable effort to accommodate” on-the-record communications.
Under specific circumstances, the APA states that an agency's ex parte communications restrictions may be applied “beginning at such time as the agency may designate,” but the prohibitions must apply in cases where “the person responsible for the communication has knowledge that [the case] will be noticed.” 5 U.S.C. 557(d)(1)(E). If this requirement were to be applied to proceedings involving periodic reports, such as the Annual Compliance Determination (ACD), the Postal Service contends that all communications would be barred because the filing party always will have knowledge that the case will be noticed.
The final rules address this concern by eliminating the prior knowledge provision where the matter before the Commission is a periodic report, such as the ACD, or the Commission's review required by 39 U.S.C. 3622(d)(3) that should commence later this year. The effect of this change is to not consider these types of matters as being before the Commission until the Commission notices the start of proceeding, unless the Commission issues a notice prior to that time specifically restricting ex parte communications. The matter is no longer before the Commission once the Commission issues its final report or review.
The Postal Service expresses concern about the treatment of sensitive or confidential information submitted in ex parte communications. Postal Service Comments at 17-18. The Postal Service suggests revising the proposed rules to require the Commission to advise the disclosing party that the communication must be disclosed and allow an opportunity for an application for non-public treatment to be filed. Postal Service Proposed Rule 3008.6(b).
The Commission's rules located at 39 CFR part 3007 set forth the procedures for the treatment of sensitive material filed on the record in docketed proceedings. Proposed § 3008.6(b) dictates that material submitted not in a docketed proceeding but as part of an ex parte communication must be disclosed in order to be considered by the Commission.
Until disclosure, however, the Commission will treat known sensitive material as confidential, subject to Freedom of Information Act requirements. For example, the Commission may not allow outside persons access to information provided by the Postal Service and identified as exempt from public disclosure.
The definition of an ex parte communication set forth in proposed § 3008.2(a) includes electronic communications. While most social media interactions are made
The Commission agrees with the Public Representative that this rulemaking provides an appropriate opportunity to make the numbering of sections in part 3000 consistent with rest of the Commission's rules. As the Public Representative notes, the recodification is not a substantive change to the rules.
The final rules incorporate many of the suggestions identified in the comments. While the suggestions require the structure of the final rules to change from those initially proposed in Order No. 3005, the substance of the rules and their effect on participants remains the same. Differences between the proposed and final rules are described below.
Proposed § 3008.1 identified the types of Commission matters subject to ex parte restrictions. Listed among those types of matters were nature of postal service proceedings, appeals of post office closings and consolidations, and rate or service complaints. The rule also made applicable, “any other matter in which the Commission, in its discretion, determines that it is appropriate to apply the rules.” Order No. 3005 at 12. In order to address commenters' concerns about vagueness and uncertainty of the rules' applicability, the Commission amends proposed § 3008.1 as follows:
While the proposed rule lists the types of Commission dockets to which the rules apply, the final rules state that the rules of part 3008 apply to all Commission proceedings except for those listed in §§ 3008.1(b) through (d).
The final rule identifies three types of proceedings to which the rules concerning ex parte communication will not apply. Section 3008.1(b) exempts public inquiry (PI) proceedings undertaken to gather information and which are not intended to result in a binding Commission decision. Section 3008.1(c) exempts international mail (IM) proceedings undertaken pursuant to 39 CFR part 3017. Section 3008.1(d) permits the Commission to identify particular proceedings where the rules will not apply.
The final rule removes the prior knowledge provision when the matter before the Commission concern matters such as the ACD or § 3622(d)(3) review. These matters will not be considered before the Commission until noticed, or until the Commission issues a prior notice specifically stating that ex parte rules apply.
Proposed § 3008.5(b) states that “Commission decision-making personnel shall not rely upon any information obtained through ex parte communications.” The final rules amend this section by allowing the Commission to rely on information obtained through ex parte communications where the communications are made part of the record and the Commission provides an opportunity for rebuttal.
The final rule moves proposed §§ 3008.7(a) and (b) to §§ 3008.7(b) and (c), respectively. It replaces § 3008.7(a) with an explanation that the penalties for a violation of the ex parte rules are applicable only to nature of postal service proceedings, appeals of post office closings or consolidations, and rate or service complaints.
In accord with the Public Representative's suggestion of renumbering part 3000, the final rules recodify existing rules in conformance with the
Existing part 3000, subpart A includes: § 3000.735-101 Cross-reference to employee ethical conduct standards and financial disclosure regulations; § 3000.735-102 Counseling and advisory services; § 3000.735-103 Financial interests; and § 3000.735-104 Outside employment. These four provisions are renumbered with the following two-digit extensions, respectively: §§ 3000.05, 3000.10, 3000.15, and 3000.20.
Existing part 3000, subpart B is amended as described in Order No. 3005. Additionally, the two provisions are renumbered. Proposed § 3000.735-501 is renumbered as § 3000.50. Proposed § 3000.735-502 is reserved as § 3000.55.
1. Parts 3000 and 3001 of title 39, Code of Federal Regulations, are revised as set forth below the signature of this order, effective 30 days after publication in the
2. Part 3008 of title 39, Code of Federal Regulations, is adopted as set forth below the signature of this order, effective 30 days after publication in the
3. The Secretary shall arrange for publication of this order in the
Conflicts of interests, Ex parte communications.
Administrative practice and procedure, Confidential business information, Ex parte communications, Freedom of information, Sunshine Act.
Administrative practice and procedure, Ex parte communications.
For the reasons discussed in the preamble, the Commission amends chapter III of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503, 504, 3603; E.O. 12674, 54 FR 15159, 3 CFR,1989 Comp., p. 215, as modified by E.O. 12731, 56 FR 42547, 3 CFR, 1990 Comp., p. 396; 5 CFR parts 2634 and 2635.
(a) The Commission maintains a written employee policy regarding ex
(b) Additional ex parte communications requirements, applicable to specific docket types, are described in part 3008 of this chapter.
39 U.S.C. 404(d); 503; 504; 3661.
39 U.S.C. 404(d)(5); 503; 504; 3661(c); 3662.
(a) The rules in this section are applicable to all Commission proceedings except for the instances identified in paragraphs (b) through (d) of this section.
(b) The rules in this section are not applicable to public inquiry (PI) proceedings, undertaken to gather information and which are not intended to result in a binding Commission decision.
(c) The rules in this section are not applicable to international mail (IM) proceedings undertaken pursuant to part 3017 of this chapter.
(d) The rules in this section are not applicable to specifically identified proceedings upon written directive from the Commission.
(a) Subject to the exceptions specified in paragraph (b) of this section, ex parte communications include all communications, oral or written (including electronic), between Commission decision-making personnel, and the Postal Service or public stakeholders regarding matters before the Commission.
(b) Ex parte communications do not include:
(1) Documents filed using the Commission's docketing system;
(2) Communications during the course of Commission meetings or hearings, or other widely publicized events where the Commission provides advance public notice of the event indicating the matter to be discussed, the event is open to all persons participating in the matter before the Commission, and a summary of the event is provided for the record;
(3) Communications during the course of off-the-record technical conferences associated with a matter before the Commission, or the pre-filing conference for nature of service cases required by § 3001.81 of this chapter, where advance public notice of the event is provided indicating the matter to be discussed, and the event is open to all persons participating in the matter before the Commission;
(4) Questions concerning Commission procedures, the status of a matter before the Commission, or the procedural schedule of a pending matter, where these issues are not contested matters before the Commission; and
(5) Communications not material to the matter before the Commission.
(a) A matter is before the Commission at such time as the Commission may designate, but in no event later than the earlier of the filing of a request to initiate a proceeding or the Commission noticing a proceeding.
(b) A matter is also before the Commission at such time as the person responsible for the communication has knowledge that a request to initiate a proceeding is expected to be filed.
(c) Paragraph (b) of this section does not apply to periodic reviews or reports issued by the Commission, or the 10-year review pursuant to 39 U.S.C. 3622(d)(3).
(d) The following explanations apply:
(1) A matter is no longer before the Commission upon the issuance of the final order or decision in the docketed matter;
(2) A matter is again before the Commission upon the filing of a request for reconsideration. The matter remains before the Commission until resolution of the matter under reconsideration;
(3) A matter is again before the Commission upon the remand of a Commission's final decision or order by an appellate court. The matter remains before the Commission until resolution of the matter under remand; and
(4) The mere potential that a request may be filed does not place a matter before the Commission. An affirmative action announcing, or actively preparing, an actual request with the intent to file within a reasonable period of time must be present.
(a) Commission decision-making personnel include:
(1) The Commissioners and their staffs;
(2) The General Counsel and staff;
(3) The Director of the Office of Accountability and Compliance and staff;
(4) Contractors, consultants, and others hired by the Commission to assist with the Commission's analysis and decision; and
(5) Any other employee who may reasonably be expected to be involved in the decisional process.
(b) The Postal Service includes all Postal Service employees, contractors, consultants, and others with an interest in a matter before the Commission. Any interaction between the Postal Service and Commission decision-making personnel concerning a matter before the Commission expresses an interest in the matter before the Commission.
(c) Public stakeholders include all other persons not previously described, with an interest in a matter before the Commission. This includes the Commission non-decision-making personnel identified in paragraph (d) of this section. Any interaction between a public stakeholder and Commission decision-making personnel concerning a matter before the Commission expresses an interest in the matter before the Commission.
(d) Commission non-decision-making personnel include:
(1) All Commission personnel other than decision-making personnel;
(2) Commission personnel not participating in the decisional process owing to the prohibitions of § 3001.8 of
(3) The Public Representative and other Commission personnel assigned to represent the interests of the general public pursuant to 39 U.S.C. 505 in the specific case or controversy at issue (regardless of normally assigned duties); and
(4) Contractors, consultants, and others hired by the Commission to provide an independent analysis of issues before the Commission (and Commission employees assigned thereto).
(a) Ex parte communications between Commission decision-making personnel, and the Postal Service or public stakeholders is prohibited.
(b) Commission decision-making personnel shall not rely upon any information obtained through ex parte communications unless the communications are made part of the record of the proceeding, where an opportunity for rebuttal has been provided, and reliance on the information will not cause undue delay or prejudice to any party.
(c) Paragraph (a) of this section does not constitute authority to withhold information from Congress.
(a) Commission decision-making personnel who receive ex parte communications relevant to the merits of the proceeding shall decline to listen to such communications and explain that the matter is pending for determination. Any recipient thereof shall advise the communicator that the communication will not be considered, and shall promptly and fully inform the Commission in writing of the substance of and the circumstances attending the communication, so that the Commission will be able to take appropriate action.
(b) Commission decision-making personnel who receive, or who make or knowingly cause to be made, ex parte communications prohibited by this part shall promptly place, or cause to be placed, on the public record of the proceeding:
(1) All such written communications;
(2) Memoranda stating the substance of all such oral communications; and
(3) All written responses, and memoranda stating the substance of all oral responses, to the materials described in paragraphs (b)(1) and (2) of this section.
(c) Requests for an opportunity to rebut, on the record, any facts or contentions contained in an ex parte communication which have been placed on the public record of the proceeding pursuant to paragraph (b) of this section may be filed in writing with the Commission. The Commission will grant such requests only where it determines that the dictates of fairness so require. In lieu of actually receiving rebuttal material, the Commission may in its discretion direct that the alleged factual assertion and the proposed rebuttal be disregarded in arriving at a decision.
(a) The penalties for violation of ex parte communication rules specified in this section are applicable only to:
(1) Nature of postal service proceedings conducted pursuant to 39 U.S.C. 3661(c);
(2) Appeal of Postal Service decisions to close or consolidate any post office conducted pursuant to 39 U.S.C. 404(d)(5); and
(3) Rate or service complaints conducted pursuant to 39 U.S.C. 3662.
(b) Upon notice of a communication knowingly made or knowingly caused to be made by a participant in violation of § 3008.5(a), the Commission or presiding officer may, to the extent consistent with the interests of justice and the policy of the underlying statutes, require the participant to show cause why his/her claim or interest in the proceeding should not be dismissed, denied, disregarded, or otherwise adversely affected on account of such violation.
(c) The Commission may, to the extent consistent with the interests of justice and the policy of the underlying statutes administered by the Commission, consider a violation of § 3008.5(a) sufficient grounds for a decision adverse to a party who has knowingly committed such violation or knowingly caused such violation to occur.
By the Commission.
In Title 40 of the Code of Federal Regulations, Part 60 (§ 60.1 to end of part 60 sections), revised as of July 1, 2015, make the following corrections:
Environmental Protection Agency (EPA).
Final rule.
This regulation establishes exemptions from the requirement of a tolerance for residues of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (CAS Reg. No. 6683-19-8) under 40 CFR 180.910 and 180.930 when used as an inert ingredient (antioxidant/stabilizer) in pesticide formulations applied to growing crops and raw agricultural commodities after harvest at a maximum concentration of 5% by weight in the formulation and applied to animals at a maximum concentration of 3% by weight in the formulation, respectively. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of these exemptions from the requirement of a tolerance. These regulations eliminate the need to establish a maximum permissible level for residues of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) for these uses.
This regulation is effective June 30, 2016. Objections and requests for hearings must be received on or before August 29, 2016, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also Unit I.C. of the
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0183, is available at
Susan Lewis, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site at
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2016-0183 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before August 29, 2016. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing (excluding any Confidential Business Information (CBI)) for inclusion in the public docket. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit the non-CBI copy of your objection or hearing request, identified by docket ID number EPA-HQ-OPP-2016-0183, 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
In the
Inert ingredients are all ingredients that are not active ingredients as defined in 40 CFR 153.125 and include, but are not limited to, the following types of ingredients (except when they have a pesticidal efficacy of their own): Solvents such as alcohols and hydrocarbons; surfactants such as polyoxyethylene polymers and fatty acids; carriers such as clay and diatomaceous earth; thickeners such as carrageenan and modified cellulose; wetting, spreading, and dispersing agents; propellants in aerosol dispensers; microencapsulating agents; and emulsifiers. The term “inert” is not intended to imply nontoxicity; the ingredient may or may not be chemically active. Generally, EPA has exempted inert ingredients from the requirement of a tolerance based on the low toxicity of the individual inert ingredients.
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the 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. . . .”
EPA establishes exemptions from the requirement of a tolerance only in those cases where it can be clearly demonstrated that the risks from aggregate exposure to pesticide chemical residues under reasonably foreseeable circumstances will pose no appreciable risks to human health. In order to determine the risks from aggregate exposure to pesticide inert ingredients, the Agency considers the toxicity of the inert in conjunction with possible exposure to residues of the inert ingredient through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings. If EPA is able to determine that a finite tolerance is not necessary to ensure that there is a reasonable certainty that no harm will result from aggregate exposure to the inert ingredient, an exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) including exposure resulting from the exemption established by this action. EPA's assessment of exposures and risks associated with pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) follows.
EPA has evaluated the available toxicity data and considered their 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. Pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) has low acute toxicity via the oral, dermal, and inhalation routes of exposure. Pentaerythritol tetrakis 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) is not irritating to the eyes and the skin. It is not a dermal sensitizer. In a subchronic study in dogs and a subchronic study in rats, effects were limited to decreases in body weight gain, food consumption, and thyroid weights in rats. No fetal toxicity was reported in developmental toxicity study in the rat. In a developmental toxicity study with mice, incompletely ossified sternebrae in the high-dose group was observed in the absence of maternal toxicity. In a rat 2-generation reproduction study, no adverse effects were observed at doses up to 1,000 milligrams/kilogram/day (mg/kg/day). There was no evidence of carcinogenic potential in a rat chronic toxicity/carcinogenicity study. Specific information on the studies received and the nature of the adverse effects caused by pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) 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
A Proposed Exemption from the Requirement of a Tolerance When Used as an Inert Ingredient” at pages 10-15 in docket ID number EPA-HQ-OPP-2016-018.
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
Based on the results of the available safety studies for pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate, the reference dose (RfD) for repeated oral, dermal, and inhalation exposures to pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate is 1.35 mg/kg/day. The key study for deriving the RfD is the chronic toxicity study in rats. The NOAEL for in this study is 135 mg/kg/day based on decreases in body weight gain, food consumption, and thyroid weights in
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An acute dietary risk assessment was not conducted because no endpoint of concern following a single exposure was identified in the available studies. A chronic dietary exposure assessment was completed and performed using the Dietary Exposure Evaluation Model DEEM-FCID
In the case of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) EPA made specific adjustments to the dietary exposure assessment to account for the use limitations of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) as an inert ingredient in pesticide formulations applied to growing crops and raw agricultural commodities after harvest at a maximum concentration of % by weight in the pesticide formulation and as an inert ingredient in pesticide formulations applied to animals at a maximum concentration of 3% by weight in the pesticide formulation. Preharvest uses.
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EPA has not found pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) to share a common mechanism of toxicity with any other substances, and pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's Web site at
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i. The toxicity database for pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) includes a subchronic toxicity study, two developmental toxicity studies, a reproductive toxicity study, chronic/carcinogenicity studies, and several mutagenicity studies. No parental or offspring effects were observed in a 2-generation reproductive toxicity study in rats at dose levels up to 500 mg/kg/day, the highest dose tested. In a developmental study in mice, no fetal or maternal effects were observed at doses up to 1,000 mg/kg/day. In a developmental toxicity study in rats no maternal effects were observed at 500 mg/kg/day, the highest dose tested, however, fetal effects were observed, albeit only in the high dose test group of 500 mg/kg/day. Since a clear NOAEL (150 mg/kg/day) for fetal effects was established in this study, no effects are observed in the mice developmental and rat reproductive toxicity study, and the selected point of departure for risk assessment purposes is based on dose levels below which effects are seen in the rat developmental toxicity study, there is no need for an additional UF to account for fetal susceptibility.
ii. There is no indication that pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) is a neurotoxic chemical. Although no neurotoxicity studies were available in the database, no clinical signs of neurotoxicity were observed in the available subchronic and chronic studies. Therefore, there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.
iii. There is no indication that pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) is an immunotoxic chemical. Although no immunotoxicity studies were available in the database, no signs of immunotoxicity were observed in the available studies. Therefore, there is no need for an immunotoxicity study or additional UFs to account for immunotoxicity.
iv. The dietary food exposure assessment utilizes 100% crop treated information for all commodities. By using these screening-level assessments, chronic exposures/risks will not be underestimated. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate).
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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An analytical method is not required for enforcement purposes since the Agency is not establishing a numerical tolerance for residues of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) in or on any food commodities. EPA is establishing a limitation on the amount of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) that may be used in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and animals. Those limitations will be
Therefore, exemptions from the requirement of a tolerance are established for residues of pentaerythritol tetrakis (3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (CAS Reg. No. 6683-19-8) when used as an inert ingredient (antioxidant, stabilizer) in pesticide products as follows: under 40 CFR 180.910, at a concentration not to exceed 5% by weight of the formulation in pesticide formulations applied to growing crops and raw agricultural commodities and under 40 CFR 180.930 at a concentration not to exceed 3% by weight of the formulation in pesticide formulations applied to animals.
This action establishes exemptions from the requirement of a tolerance under FFDCA section 408(d) in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled “Regulatory Planning and Review” (58 FR 51735, October 4, 1993). Because this action has been exempted from review under Executive Order 12866, this action is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997). This action does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501
Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408(d), such as the exemptions 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.
Centers for Medicare & Medicaid Services (CMS), HHS.
Final rule; correction.
This document corrects technical errors that appeared in the final rule published in the
This correction is effective July 5, 2016.
Kristin Shifflett, (410) 786-4133.
In FR Doc. 2016-10043 of May 4, 2016 (81 FR 26871), there were technical errors that are identified and corrected in the Correction of Errors section below. The provisions in this correction document are effective as if they had been included in the document published May 4, 2016. Accordingly, the corrections are effective July 5, 2016.
On page 26897, at § 416.44(b)(1), we inadvertently omitted a portion of the sentence. We are correcting this sentence to read, “. . . the ASC must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served[.]”.
On page 26899, at § 482.41(b)(1)(i), we inadvertently omitted a sentence. We are correcting this error by adding a sentence to clarify that outpatient surgical departments must meet the provisions applicable to Ambulatory Health Care Occupancies, regardless of the number of patients served.
On page 26900, at § 483.70(a)(8), we inadvertently specified an incorrect facility type. We are correcting this error to specify the requirements an LTC facility must meet when a sprinkler system is shut down for more than 10 hours.
We ordinarily publish a notice of proposed rulemaking in the
Section 553(d) of the APA ordinarily requires a 30-day delay in effective date of final rules after the date of their publication in the
In FR Doc. 2016-10043 of May 4, 2016 (81 FR 26871), make the following corrections:
Maritime Administration (MARAD), Department of Transportation (DOT).
Interim final rule.
This interim final rule updates the maximum civil penalty amounts for violations of statutes and regulations administered by MARAD pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvement Act of 2015. This interim final rule amends our regulations to reflect the new, adjusted civil penalty amounts MARAD may assess pursuant for violations of procedures related to the American Fisheries Act, certain regulated transactions involving documented vessels, the Automated Mutual Assistance Vessel Rescue
This rule is effective August 1, 2016.
Office of Chief Counsel, MAR 225, Maritime Administration, 1200 New Jersey Avenue SE., West Building, Second Floor, Washington, DC 20590.
T. Mitchell Hudson, Jr., Office of Chief Counsel, MARAD, telephone (202) 366-9373, email to:
On November 2, 2015, the Federal Civil Penalties Inflation Adjustment Act Improvement Act (the 2015 Act), Public Law 114-74, Section 701, was signed into law. The purpose of the 2015 Act is to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The 2015 Act requires agencies to make an initial catch up adjustment to the civil monetary penalties they administer through an interim final rule and then to make subsequent annual adjustments for inflation. The amount of increase of any adjustment to a civil penalty pursuant to the 2015 Act is limited to 150 percent of the current penalty. Agencies are required to issue the interim final rule with the initial catch up adjustment by July 1, 2016.
The method of calculating inflationary adjustments in the 2015 Act differs substantially from the methods used in past inflationary adjustment rulemakings conducted pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990 (the Inflation Adjustment Act), Public Law 101-410. Previously, adjustments to civil penalties were conducted under rules that required significant rounding of figures. For example, a penalty increase that was greater than $1,000, but less than or equal to $10,000, would be rounded to the nearest multiple of $1,000. While this allowed penalties to be kept at round numbers, it meant that penalties would often not be increased at all if the inflation factor was not large enough. Furthermore, increases to penalties were capped at 10 percent. Over time, this formula caused penalties to lose value relative to total inflation.
The 2015 Act has removed these rounding rules; now, penalties are simply rounded to the nearest $1. While this creates penalty values that are no longer round numbers, it does ensure that penalties will be increased each year to a figure commensurate with the actual calculated inflation. Furthermore, the 2015 Act “resets” the inflation calculations by excluding prior inflationary adjustments under the Inflation Adjustment Act, which contributed to a decline in the real value of penalty levels. To do this, the 2015 Act requires agencies to identify, for each penalty, the year and corresponding amount(s) for which the maximum penalty level or range of minimum and maximum penalties was established (
The Director of the Office of Management and Budget (OMB) provided guidance to agencies in a February 24, 2016 memorandum on how to calculate the initial adjustment required by the 2015 Act.
The maximum civil penalties arising under 46 CFR 221.61 have not been updated since they were established, except for inflationary adjustments pursuant to the Inflation Adjustment Act of 1990. The maximum civil penalty for a single violation of any provision under 46 U.S.C. Chapter 313 and all of Subtitle III related MARAD regulations, except section 31329, specified in 31309 of Title 46 of the United States Code was set at $10,000 when the penalty was established by Public Law 100-710, 102 Stat. 4747, enacted in 1988. Likewise, the maximum civil penalty for a single violation of 31329 of Title 46 of the United States Code as it relates to the court sales of documented vessels, specified in 31330 of Title 46 of the United States Code was set at $25,000 when the penalty was established by the same statute, Public Law 100-710, 102 Stat. 4747, enacted in 1988. Lastly, for penalties arising under 46 CFR 221.61, the maximum civil penalty for a single violation of 56101 of Title 46 of the United States Code as it relates to approvals required to transfer a vessel to a noncitizen, specified in 56101(e) of Title 46 United States Code was set at not more than $10,000 when the penalty was established by Public Law 101-225, 103 Stat. 1908, enacted in 1989. Applying the multiplier for the increase in CPI-U for 1988 in Table A of the February 24, 2016 memorandum (1.97869) results in an adjusted civil penalty of $19,787 pursuant to 46 U.S.C. 31309; $49,467 pursuant to 46 U.S.C. 31330. Applying the multiplier for the increase in CPI-U for 1989 (1.89361) results in an adjusted civil penalty of $18,936 pursuant to section 56101(e).
The maximum civil penalty for a single violation of 50113 of Title 46 of the United States Code related to use and performance reports by operators of vessels as specified in 50113(b) of Title 46 of the United States Code was set at $50.00 per day when the penalty was established by Public Law 84-612, 70 Stat. 332, enacted in 1956. This civil penalty has not been updated since it was established. Applying the multiplier for the increase in CPI-U for 1956 in Table A of the February 24,
The maximum civil penalty for a single violation of 4501 of Title 50 of the United States Code, specified in 4513 of Title 50 of the United States Code, at 46 CFR 340.9, was set at not more than $10,000 when the penalty was established by the Defense Production Act, 64 Stat. 799, enacted in 1950. This civil penalty has not been updated since it was established. Applying the multiplier for the increase in CPI-U for 1950 in Table A of the February 24, 2016 memorandum (9.66821) would result in an adjusted civil penalty of $96682.1, which is above the 150 percent limit for inflationary adjustments, so the adjusted civil penalty is $25,000, which is 150 percent of the previous penalty amount not counting updates under the Inflation Adjustment Act.
The maximum civil penalty for a single violation of 12151 of Title 46 of the United States Code for engaging in fishing operations as defined in section 3 of the Magnuson-Stevens Fishery Conservation and Management Act, within the Exclusive Economic Zone, specified in 12151(c) of Title 46 of the United States Code, and at 46 CFR 356.49, was set at $100,000.00 for each day such vessel engaged in fishing when the penalty was established by Public Law 105-277, 112 Stat. 2681-620, enacted in 1998. This civil penalty has not been updated since it was established. Applying the multiplier for the increase in CPI-U for 1998 in Table A of the February 24, 2016 memorandum (1.45023) results in an adjusted civil penalty of $145,023.
MARAD is promulgating this interim final rule to ensure that the amount of civil penalties contained in 46 CFR 221.61, 307.19, 340.9 and 356.49—reflect the statutorily mandated ranges as adjusted for inflation. Pursuant to the 2015 Act, MARAD is required to promulgate a “catch-up adjustment” through an interim final rule. Pursuant to the 2015 Act and 5 U.S.C. 553(b)(3)(B), MARAD finds that good cause exists for immediate implementation of this interim final rule without prior notice and comment because it would be impracticable to delay publication of this rule for notice and comment and because public comment is unnecessary. By operation of the Act, MARAD must publish the catch-up adjustment by interim final rule by July 1, 2016. Additionally, the 2015 Act provides a clear formula for adjustment of the civil penalties, leaving the agency little room for discretion. Furthermore, the increases in MARAD's civil penalty authority authorized by 46 U.S.C. 12151(c), 31309, 31330, 50113(b), 56101(e) and 50 U.S.C. 4513 are already in effect and the amendments merely update the relevant regulations to reflect the new statutory civil penalty. For these reasons, MARAD finds that notice and comment would be impracticable and is unnecessary in this situation.
MARAD has considered the impact of this rulemaking action under Executive Order 12866, Executive Order 13563, and the Department of Transportation's regulatory policies and procedures. This rulemaking document was not reviewed under Executive Order 12866 or Executive Order 13563. This action is limited to the adoption of adjustments of civil penalties under statutes that the agency enforces, and has been determined to be not “significant” under the Department of Transportation's regulatory policies and procedures and the policies of the Office of Management and Budget. Because this rulemaking does not change the number of entities that are subject to civil penalties, the impacts are limited. Furthermore, excluding the penalties in 46 CFR 221.61, 307.19, 340.9 and 356.49 for violating certain long standing procedures, this final rule does not establish civil penalty amounts that MARAD is required to seek.
We also do not expect the increase in the civil penalty amount in any of these regulations to be economically significant. Over the last five years, MARAD has not collected any civil penalties under these regulations. Increasing the current civil penalty amount by 150 percent would not result in an annual effect on the economy of $100 million or more.
We have also considered the impacts of this notice under the Regulatory Flexibility Act. I certify that this rule will not have a significant economic impact on a substantial number of small entities. Since this regulation does not establish a penalty amount that MARAD is required to seek, except for the long standing civil penalties set forth in 46 CFR 221.61, 307.19, 340.9 and 356.49, this rule will not have a significant economic impact on small businesses. Additionally, over the last five years, MARAD has not collected any civil penalties under these regulations. Accordingly, increasingly the civil penalty amount is unlikely to have any economic impact on any small businesses.
In addition, MARAD has determined the RFA does not apply to this rulemaking. The 2015 Inflation Act requires MARAD to publish an interim final rule and does not require MARAD to complete notice and comment procedures under the APA. The Small Business Administration's
If, under the APA or any rule of general applicability governing federal grants to state and local governments, the agency is required to publish a general notice of proposed rulemaking (NPRM), the RFA must be considered [citing 5 U.S.C. 604(a)]. . . . If an NPRM is not required, the RFA does not apply.
Therefore, because the 2015 Inflation Act does not require an NPRM for this rulemaking, the RFA does not apply.
Executive Order 13132 requires MARAD to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” is defined in the Executive Order to include regulations 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.” Under Executive Order 13132, the agency may
This rule will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132. This rule only updates existing penalties, pursuant to statute. MARAD has not collected any civil penalties under these regulations within the last five years and if it were to assess penalties, due to the amounts involved, it would not have a substantial direct effect on a State. Thus, the requirements of Section 6 of the Executive Order do not apply.
The Unfunded Mandates Reform Act of 1995, Public Law 104-4, requires agencies to prepare a written assessment of the cost, benefits and other effects of proposed or final rules that include a Federal mandate likely to result in the expenditure by State, local, or tribal governments, in the aggregate, or by the private sector, of more than $100 million annually. Because this rule will not have a $100 million effect, no Unfunded Mandates assessment will be prepared.
This rule does not have a retroactive or preemptive effect. Judicial review of a rule based on this proposal may be obtained pursuant to 5 U.S.C. 702. That section does not require that a petition for reconsideration be filed prior to seeking judicial review.
In accordance with the Paperwork Reduction Act of 1980, we state that there are no requirements for information collection associated with this rulemaking action.
Please note that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Regulated Transactions Involving Documented Vessels and Other Maritime Interests.
Establishment of Mandatory Position Reporting System for Vessels.
Priority Use and Allocation of Shipping Services, Containers and Chassis, and Port Facilities and Services for National Security and National Defense Related Operations.
Requirements for Vessels of 100 Feet or Greater in Registered Length to Obtain a Fishery Endorsement to the Vessel's Documentation.
In consideration of the foregoing, 46 CFR parts 221, 307, 340, and 356 are amended as set forth below.
46 U.S.C. chs. 301, 313, and 561; Pub. L. 114-74; 49 CFR 1.93.
(a) This subpart describes procedures for the administration of civil penalties that the Maritime Administration may assess under 46 U.S.C. 31309, 31330 and 56101, pursuant to 49 U.S.C. 336.
(b) Pursuant to 46 U.S.C. 31309, a general penalty of not more than $19,787 may be assessed for each violation of chapter 313 or 46 U.S.C. subtitle III administered by the Maritime Administration, and the regulations in this part that are promulgated thereunder, except that a person violating 46 U.S.C. 31329 and the regulations promulgated thereunder is liable for a civil penalty of not more than $49,467 for each violation. A person that charters, sells, transfers or mortgages a vessel, or an interest therein, in violation of 46 U.S.C. 56101(e) is liable for a civil penalty of not more than $18,936 for each violation.
Pub. L. 109-304; 46 U.S.C. 50113; Pub. L. 114-74; 49 CFR 1.93.
The owner or operator of a vessel in the waterborne foreign commerce of the United States is subject to a penalty of $125.00 for each day of failure to file an AMVER report required by this part. Such penalty shall constitute a lien upon the vessel, and such vessel may be libeled in the district court of the United States in which the vessel may be found.
50 U.S.C. 4501
Pursuant 50 U.S.C. 4513 any person who willfully performs any act prohibited, or willfully fails to perform any act required, by the provisions of this regulation shall, upon conviction, be fined not more than $25,000 or imprisoned for not more than one year, or both.
46 U.S.C. 12102; 46 U.S.C. 12151; 46 U.S.C. 31322; Pub. L. 105-277, division C, title II, subtitle I, section 203 (46 U.S.C. 12102 note), section 210(e), and section 213(g), 112 Stat. 2681; Pub. L. 107-20, section 2202, 115 Stat. 168-170; Pub. L. 114-74; 49 CFR 1.93.
(b) A fine of up to $145,023 may be assessed against the vessel owner for each day in which such vessel has engaged in fishing (as such term is defined in section 3 of the Magnuson-Stevens Fishery Conservation and Management Act (16 U.S.C. 1802) within the exclusive economic zone of the United States; and
By Order of the Maritime Administrator.
Federal Maritime Commission.
Interim final rule.
This rule implements the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Act) (Sec. 701 of Pub. L. 11-74). The rule adjusts the maximum amount of each statutory civil penalty subject to Federal Maritime Commission (Commission) jurisdiction for inflation, in accordance with the requirements of that Act. The 2015 Act requires that agencies publish a catch-up adjustment in the penalties in an interim rule by July 1, 2016, and that agencies adjust penalties yearly thereafter.
This rule is effective on August 1, 2016.
Tyler Wood, General Counsel, Federal Maritime Commission, 800 North Capitol Street NW., Room 1018, Washington, DC 20573, (202) 523-5740.
This rule implements the 2015 Act, which became effective on November 2, 2015. The 2015 Act further amends the Federal Civil Penalties Inflation Adjustment Act of 1990 (FCPIAA), Public Law 101-410, 104 Stat. 890 (codified as amended at 28 U.S.C. 2461 note), in order to improve the effectiveness of civil monetary penalties and to maintain their deterrent effect. The Debt Collection Improvement Act of 1996 (DCIA), Public Law 104-134, Title III, 31001(s)(1), 110 Stat. 1321-373, originally amended the FCPIAA and required the head of each executive agency to adopt regulations that adjust the maximum civil monetary penalties (CMPs) assessable under its agency's jurisdiction at least every four years to ensure that they continued to maintain their deterrent value.
The 2015 Act requires that agencies publish a catch-up adjustment in the penalties in an interim rule by July 1, 2016, to become effective no later than August 1, 2016. Following the catch-up adjustment, the 2015 Act requires agencies to adjust CMPs under their jurisdiction annually beginning in 2017 based on changes in the consumer price index using data from October in the previous calendar year.
In order to catch-up CMPs, the 2015 Act requires agencies to identify the year the civil penalty was established or last adjusted by statute or regulation
For example, Section 13 of the Shipping Act of 1984 (1984 Act), 46 U.S.C. 41107, imposes a maximum $45,000 penalty for a knowing and willful violation of the 1984 Act.
The last time the Commission adjusted its CMP
The new formula may result in a lower penalty than the current penalty. The catch-up penalty for 46 U.S.C. 42104 of $8,908, is actually lower than the current penalty of $9,000. This results from two things: (1) the lack of a specific penalty for a violation of 46 U.S.C. 42104 until 1990; and (2) using a multiplier based on the year the penalty was established or modified that excludes adjustments due to the FCPIAA. The later a penalty was established that excludes adjustments due to the FCPIAA, the smaller the multiplier. In this example, the latest penalty amount that excludes adjustments due to the FCPIAA for violating 46 U.S.C. 42104 is $5,000, established in 1990. The $5,000 penalty, therefore, is multiplied by 1.78156 percent to get the adjusted penalty of $8,908.
In contrast, the oldest non-FCPIAA penalty for violating 46 U.S.C. 44103 was established in 1966 in the amount of $5,000. Accordingly, using the required table, such amount is multiplied by 7.22912 percent to get the adjusted penalty of $22,500.
The 2015 Act also requires that agencies round up any increases in civil monetary penalties by a dollar regardless of the amount of the penalty, which differs from the prior rounding system that was based on the amount of a penalty. The penalty in 46 U.S.C. 42104 was between $1,000 and $10,000, and increases were therefore rounded to the nearest $1,000 (often the next highest $1,000), resulting in higher adjusted amounts.
The Commission is also making a number of changes to other sections in part 506 to reflect the amendments made by the 2015 Act, including the frequency and calculation of future increases, how increases are rounded, and when they apply.
This interim final rule is issued without prior public notice or opportunity for public comment. Under the Administrative Procedure Act (APA), 5 U.S.C. 553(b)(B), a final rule may be issued without notice and comment if the agency for good cause finds (and incorporates the finding and a brief statement of reasons therefore in the rules issued) that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest. In this instance, the Commission finds, for good cause, that solicitation of public comment on this final rule is unnecessary and impractical.
Specifically, Congress has mandated that the agency make the catch-up inflation adjustments through an interim final rule, and agencies are not required to conduct notice and comment prior to promulgation. The Commission, under the FCPIAA as amended by the 2015 Act, is required to make the adjustment to the civil monetary penalties according to a formula specified in the statute. The regulation requires ministerial, technical computations that are noncontroversial.
The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801
The rule does not contain any collection of information requirements as defined by the Paperwork Reduction Act of 1995, as amended. Therefore, Office of Management and Budget review is not required.
This regulatory action is not a major rule as defined under 5 U.S.C. 804(2).
Administrative practice and procedure, Penalties.
For the reasons stated in the preamble, Part 506 of title 46 of the Code of Federal Regulations is amended as follows:
28 U.S.C. 2461.
The purpose of this part is to establish a mechanism for the regular adjustment for inflation of monetary penalties and to adjust such penalties in conformity with the Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2641 note) as originally amended by the Debt Collection Improvement Act of 1996, Public Law 104-134, April 26, 1996, and currently amended by the Federal Civil Penalties Inflation Act Adjustment Improvements Act of 2015, Public Law 114-74, in order to maintain the deterrent effect of civil monetary penalties and to promote compliance with the law.
The Commission shall, not later than August 1, 2016, and at least every year thereafter—
(a) The inflation adjustment under § 506.3 will initially be determined by increasing the maximum civil monetary penalty for each civil monetary penalty by the initial cost-of-living adjustment. The inflation adjustment will subsequently be determined by increasing the maximum civil monetary penalty for each civil monetary penalty by the cost-of-living adjustment. Any increase determined under this section shall be rounded to the nearest multiple of $1.
(b)
(c)
(d)
Any adjustment in a civil monetary penalty under this part shall apply only to civil monetary penalties, including those whose associated violation predated such increase, which are assessed after the date the adjustment takes effect.
By the Commission.
Federal Communications Commission.
Final rule.
The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Inflation Adjustment Act) requires the Federal Communications Commission to amend its forfeiture penalty rules for inflation.
This rule is effective August 1, 2016.
Donna Cyrus, Enforcement Bureau, 202-418-7325.
On June 9, 2016, the Enforcement Bureau of the Federal Communications Commission adopted and released an order on delegated authority, DA 16-644, which adjusts the Commission's forfeiture penalties for inflation. On November 2, 2015, the President signed into law the Bipartisan Budget Act of 2015, which included, as Section 701 thereto, the 2015 Inflation Adjustment Act, which amended the Federal Civil Penalties Inflation Adjustment Act of 1990 (Pub. L. 101-410), to improve the effectiveness of civil monetary penalties and maintain their deterrent effect. Under the act, federal agencies, including the Federal Communications Commission, must issue an interim final rulemaking and publish interim final rules by July 1, 2016, which will take effect by August 1, 2016. According to the 2015 Inflation Adjustment Act, the initial inflation adjustment will be the
This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will not send a copy of this Order per the Congressional Review Act,
Administrative practice and procedure, Penalties.
Federal Communications Commission.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 part 1 as follows:
15 U.S.C. 79
(9)
(i) Pursuant to the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (2015 Inflation Adjustment Act), Public Law 114-74 (129 Stat. 599-600), which amends the Federal Civil Monetary Penalty Inflation Adjustment Act of 1990, Public Law 101-410 (104 Stat. 890; 28 U.S.C. 2461 note), the statutory maximum amount of a forfeiture penalty assessed under this section shall be adjusted for inflation with an initial “catch-up” adjustment through an interim final rulemaking and interim final rules published by July 1, 2016, to take effect by August 1, 2016. Subsequent annual adjustments shall be published by January 15 each year. Catch-up adjustments will be based on the `cost-of-living adjustment' (CPI), which is the percentage (if any) by which the CPI for October in the year of the previous adjustment exceeds the CPI for October 2015. Annual inflation adjustments will be based on the percentage (if any) by which the CPI for October preceding the date of the adjustment exceeds the prior year's CPI for October. The Office of Management and Budget has provided “Table A: 2016 Civil Monetary Penalty Catch-Up Adjustment Multiplier by Calendar Year” (Table A) to determine the civil monetary penalty catch-up adjustment multiplier by calendar year. The Catch-up adjustment is determined by
(A) Identifying from Table A, column A the latest year the penalty level or penalty range was established or last adjusted by statute or regulation (other than pursuant to the Inflation Adjustment Act), and from column B, identifying the corresponding multiplier to adjust the penalty level or range for inflation;
(B) Multiplying the corresponding amount from column B by the amount of the maximum penalty level or the range of minimum and maximum penalties as most recently established or adjusted by statute or regulation (other than pursuant to the Inflation Adjustment Act before November 2, 2015);
(C) Rounding to the nearest dollar; and
(D) Comparing the new amount or range of the penalty with the amount or range in the prior year to ensure the maximum increase is not more than 150 percent of the most recent levels.
(ii) The application of the inflation adjustments required by the 2015 Inflation Adjustment Act, 28 U.S.C. 2461 note, results in the following adjusted statutory maximum forfeitures authorized by the Communications Act:
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to delete the supplemental coverage for the definition “simplified acquisition threshold.” Federal Acquisition Regulation (FAR) final rule 2015-020 added to the FAR the simplified acquisition threshold for contracts to be awarded and performed, or purchases to be made, outside the United States in support of a humanitarian or peacekeeping operation.
Defense Acquisition Regulations System, Attn: Ms. Julie Hammond, OUSD (AT&L) DPAP/DARS, Room 3B941, 3060 Defense Pentagon, Washington, DC 20301-3060, telephone 571-372-6174.
DoD is amending the DFARS to delete the supplemental definition for “simplified acquisition threshold” with regard to humanitarian or peacekeeping operations at DFARS part 202. This supplemental definition was included in DFARS when there was no existing coverage in the FAR. The simplified acquisition threshold for humanitarian or peacekeeping operations has been added to the FAR under final rule 2015-020. There is no need to duplicate the definition in the DFARS; therefore, this rule removes the supplemental definition at DFARS part 202.
41 U.S.C. 1707, Publication of Proposed Regulations, is the statute that applies to the publication of the Federal Acquisition Regulation (FAR). Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because the DFARS change to remove a definition that is being elevated to the FAR will not have any cost or administrative impact on contractors or offerors.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant DFARS revision within the meaning of FAR 1.501-1, and 41 U.S.C. 1707 does not require publication for public comment.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the
Government procurement.
Therefore, 48 CFR part 202 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Defense Acquisition Regulations System, Department of Defense (DoD).
Interim rule.
DoD is issuing an interim rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that changes the criteria for the pilot program on acquisition of military purpose nondevelopmental items.
Submit comments identified by DFARS Case 2016-D014, using any of the following methods:
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Comments received generally will be posted without change to
Mr. Dustin Pitsch, telephone 571-372-6090.
This interim rule revises the DFARS to implement section 892 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016 (Pub. L. 114-92). Section 892 amends section 866 of the NDAA for FY 2011 (Pub. L. 111-383) to modify the criteria for use of the pilot program on acquisition of military purpose nondevelopmental items. Section 892 removes the requirements under the program for the use of competitive procedures and for awards to be made to nontraditional defense contractors. Section 892 also increases the threshold for use of the pilot program to contracts up to $100 million.
Section 866 was implemented in DFARS rule 2011-D034, Pilot Program on Acquisition of Military Purpose Nondevelopmental Items (77 FR 2653), which allowed for the creation of the pilot program to test whether the streamlined procedures, similar to those available for commercial items, can serve as an effective incentive for nontraditional defense contractors to channel investment and innovation into areas that are useful to DoD and provide items developed exclusively at private expense to meet validated military requirements. The DFARS changes proposed by this rule will allow for increased opportunities to utilize the pilot program.
This rule amends DFARS subpart 212.71 by—
• Deleting the term “nontraditional defense contractor” and the associated definition;
• Removing the requirement that pilot program contracts be awarded using competitive procedures;
• Increasing the maximum contract award value threshold for use of the pilot program from $53.5 million to $100 million; and
• Revising the prescription for the provision at 252.212-7002 for use only when the pilot program will be used.
Conforming changes are made to DFARS provision 252.212-7002, Pilot Program for Acquisition of Military-Purpose Nondevelopmental Items, to include removal of the requirement at paragraph (c) for offerors to represent by submission of an offer that the firm is a nontraditional contractor.
This rule also makes one editorial change to provide at DFARS 212.7101 the full text of the definitions of “military-purpose nondevelopmental items” and “nondevelopmental items.”
DoD does not intend to apply the requirements of section 892 of the NDAA for FY 2016 to contracts at or below the simplified acquisition threshold (SAT) or for the acquisition of commercial items, including commercially available off-the-shelf (COTS) items.
41 U.S.C. 1905 governs the applicability of laws to contracts or subcontracts in amounts not greater than the simplified acquisition threshold. It is intended to limit the applicability of laws to such contracts or subcontracts. 41 U.S.C. 1905 provides that if a provision of law contains criminal or civil penalties, or if the FAR Council makes a written determination that it is not in the best interest of the Federal Government to exempt contracts or subcontracts at or below the SAT, the law will apply to them. The Director, Defense Procurement and Acquisition Policy (DPAP), is the appropriate authority to make comparable determinations for regulations to be published in the DFARS, which is part of the FAR system of regulations. DoD
41 U.S.C. 1906 governs the applicability of laws to contracts for the acquisition of commercial items, and is intended to limit the applicability of laws to contracts for the acquisition of commercial items. 41 U.S.C. 1906 provides that if a provision of law contains criminal or civil penalties, or if the FAR Council makes a written determination that it is not in the best interest of the Federal Government to exempt commercial item contracts, the provision of law will apply to contracts for the acquisition of commercial items. Likewise, 41 U.S.C. 1907 governs the applicability of laws to COTS items, with the Administrator for Federal Procurement Policy the decision authority to determine that it is in the best interest of the Government to apply a provision of law to acquisitions of COTS items in the FAR. The Director, DPAP, is the appropriate authority to make comparable determinations for regulations to be published in the DFARS, which is part of the FAR system of regulations. DoD did not make that determination. While FAR part 12 commercial procedures may be used to acquire military purpose nondevelopmental items under this pilot program, the rule will not apply to the acquisition of commercial items.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule is necessary to implement section 892 of the National Defense Authorization Act (NDAA) for Fiscal Year (FY) 2016.
The objective of the rule is to modify the criteria for the pilot program at DFARS subpart 212.71, Pilot Program for the Acquisition of Military Purpose Nondevelopmental Items, to increase the opportunities for use of the program. The rule removes the criteria that contracts must be awarded to “nontraditional defense contractors” and awards must be made using competitive procedures. The rule also increases the dollar threshold for the program to allow use on procurements up to $100 million.
The changes to the pilot program will have a positive economic impact on small businesses that did not meet the definition of “nontraditional defense contractors” and have developed products that could be applied to a military purpose. According to data available in the Federal Procurement Data System for FY 2015, 6,514 unique small businesses were awarded a DoD contract in excess of the certified cost and pricing threshold ($750,000) and therefore did not meet the definition of “nontraditional defense contractor.” Prior to the changes made by this rule these small businesses were not eligible for an award under the pilot program. These small businesses will now be able to participate in the pilot program if they are developing a military purpose nondevelopmental item.
This rule does not impose any new reporting, recordkeeping or other compliance requirements. The rule does not duplicate, overlap, or conflict with any other Federal rules. No significant alternatives were identified during the development of this rule.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2016-D014) in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
A determination has been made under the authority of the Secretary of Defense that urgent and compelling reasons exist to promulgate this interim rule without prior opportunity for public comment. This interim rule implements section 892 of the NDAA for FY 2016 (Pub. L. 114-92), which amended section 866 of the NDAA for FY 2011 (Pub. L. 111-383) to—
• Modify criteria for use of the pilot program in order to increase opportunities for use;
• Remove the requirements under the program to use competitive procedures;
• Remove requirements for awards to be made to nontraditional defense contractors; and
• Increase the threshold for use of the program to contracts up to $100 million.
The purpose of the pilot program is to test whether the streamlined procedures, similar to those available for commercial items, can serve as an effective incentive for nontraditional defense contractors to channel investment and innovation into areas that are useful to DoD and provide items developed exclusively at private expense to meet validated military requirements. This action is necessary because the pilot program expires on December 31, 2019, and, in order to realize any of the benefits from the statutory modifications made by this rule prior to the expiration of the pilot program, the changes made by this rule must take effect immediately. However, pursuant to 41 U.S.C. 1707 and FAR 1.501-3(b), DoD will consider public comments received in response to this interim rule in the formation of the final rule.
Government procurement.
Therefore, 48 CFR parts 212 and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
As used in this subpart—
(1) Independent research and development costs or bid and proposal costs, per the definition in FAR 31.205-18, that have been reimbursed directly or indirectly by a Federal agency or have been submitted to a Federal agency for reimbursement; or
(2) Foreign government funding.
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to consolidate all requirements for contractors performing private security functions outside the United States applicable to DoD contracts in the DFARS and make changes regarding applicability and high-level quality assurance standards.
Ms. Julie Hammond, telephone 571-372-6174.
DoD published a proposed rule in the
DoD reviewed the public comments in the development of the final rule. There are no changes from the proposed rule in the final rule. A discussion of the comments is provided as follows:
For consistency in use of terminology in DFARS clause 252.225-7039, in paragraphs (c)(1) and (2), the term “employees of the Contractor” is removed and replaced with “Contractor personnel” in both places.
This rule amends the DFARS to consolidate all requirements for contractors performing private security functions outside the United States applicable to DoD contracts in the DFARS and makes changes regarding applicability and high-level quality assurance standards. DFARS clause 252.225-7039, Defense Contractors Performing Private Security Functions Outside the United States, and its prescription at DFARS 225.302-6 are amended. The revisions, however, do not affect applicability of the clause at or below the simplified acquisition threshold or to commercial item acquisitions.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This final rule amends the Defense Federal Acquisition Regulation Supplement (DFARS) to consolidate all requirements for DoD contractors performing private security functions outside the U.S. from the FAR 25.302 and the clause at FAR 52.225-26, Contractors Performing Private Security Functions Outside the Unites States, in DFARS 225.302 and the clause at DFARS 252.225-7039, Defense Contractors Performing Private Security Functions Outside the United States.
The objectives of this rule are as follows:
• Provide DoD contracting officers and contractors a single clause covering all requirements related to the performance of private security functions outside the United States that may be updated by DoD as policies are issued that affect only defense contractors.
• Identify the international high-quality assurance standard “ISO 18788: Management System for Private Security Operations” as an approved alternative to the American standard “ANSI/ASIS PSC.1-2012” currently required by DFARS clause 252.225-7039.
No comments were received from the public in response to the initial regulatory flexibility analysis.
This final rule will apply to defense contractors performing private security functions outside of the United States in designated operational areas under DoD contracts. According to data available in the Federal Procurement Data System for fiscal year (FY) 2013, DoD awarded 159 contracts that required performance outside the United States, although not necessarily in a designated operation area, and cited the National American Industry Classification System code 561612, Security Guards and Patrol Services, of which 33 contracts (21%) were awarded to small businesses. In FY 2014, DoD awarded 123 such contracts, of which 31 contracts (25%) were to small businesses.
The private security contractors are required to report incidents when: (1) A weapon is discharged by personnel performing private security functions; (2) personnel performing private security functions are attacked, killed, or injured; (3) persons are killed or injured or property is destroyed as a result of conduct by Contractor personnel; (4) a weapon is discharged against personnel performing private security functions or personnel performing such functions believe a weapon was so discharged; or (5) active, non-lethal countermeasures (other than the discharge of a weapon) are employed by personnel performing private security functions in response to a perceived immediate threat. As a regular record keeping requirement, private security contractors are required to keep appropriate records of personnel by registering in the Synchronized Predeployment Operational Tracker the equipment and weapons used by its personnel. The complexity of the work to prepare these records requires the expertise equivalent to that of a GS-11, step 5 with clerical and analytical skills to create the documents.
There are no known significant alternatives to the rule. The impact of this rule on small business is not expected to be significant.
This rule contains information collection requirements under the Paperwork Reduction Act (44 U.S.C. chapter 35). The Office of Management and Budget (OMB) has assigned OMB Control Number 0704-0549, entitled “Defense Federal Acquisition Regulation Supplement (DFARS) part 225, Foreign Acquisition, and Defense Contractors Performing Private Security Functions Outside the United States.”
Government procurement.
Therefore, 48 CFR parts 216, 225, and 252 are amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
The additions and revision read as follows:
(a)
(2) Does not foreclose any contractor rights arising in law, the FAR or the terms of the contract. It does not require—
(i) The contractor to waive its attorney-client privilege or the protections afforded by the attorney work product doctrine; or
(ii) Any officer, director, owner, or employee of the contractor, including a sole proprietor, to waive his or her attorney-client privilege or Fifth Amendment rights; and
(3) Does not restrict the contractor from—
(i) Conducting an internal investigation; or
(ii) Defending a proceeding or dispute arising under the contract or related to a potential or disclosed violation.
(1) Guarding of personnel, facilities, designated sites or property of a Federal agency, the contractor or subcontractor, or a third party.
(2) Any other activity for which personnel are required to carry weapons in the performance of their duties in accordance with the terms of this contract.
(b)
(1) Contingency operations;
(2) Combat operations, as designated by the Secretary of Defense;
(3) Other significant military operations (as defined in 32 CFR part 159), designated by the Secretary of Defense upon agreement of the Secretary of State;
(4) Peace operations, consistent with Joint Publication 3-07.3; or
(5) Other military operations or military exercises, when designated by the Combatant Commander.
(c)
(1) Ensure that all Contractor personnel who are responsible for performing private security functions under this contract comply with 32 CFR part 159 and any orders, directives, or instructions to contractors performing private security functions that are identified in the contract for—
(i) Registering, processing, accounting for, managing, overseeing and keeping appropriate records of personnel performing private security functions;
(ii) Authorizing, accounting for and registering in Synchronized Predeployment and Operational Tracker (SPOT), weapons to be carried by or available to be used by personnel performing private security functions;
(iii) Identifying and registering in SPOT armored vehicles, helicopters and other military vehicles operated by Contractors performing private security functions; and
(iv) In accordance with orders and instructions established by the applicable Combatant Commander, reporting incidents in which—
(A) A weapon is discharged by personnel performing private security functions;
(B) Personnel performing private security functions are attacked, killed, or injured;
(C) Persons are killed or injured or property is destroyed as a result of conduct by Contractor personnel;
(D) A weapon is discharged against personnel performing private security functions or personnel performing such functions believe a weapon was so discharged; or
(E) Active, non-lethal countermeasures (other than the discharge of a weapon) are employed by personnel performing private security functions in response to a perceived immediate threat;
(2) Ensure that Contractor personnel who are responsible for performing private security functions under this contract are briefed on and understand their obligation to comply with—
(i) Qualification, training, screening (including, if applicable, thorough background checks) and security requirements established by 32 CFR part 159;
(ii) Applicable laws and regulations of the United States and the host country and applicable treaties and international agreements regarding performance of private security functions;
(iii) Orders, directives, and instructions issued by the applicable Combatant Commander or relevant Chief of Mission relating to weapons, equipment, force protection, security, health, safety, or relations and interaction with locals; and
(iv) Rules on the use of force issued by the applicable Combatant Commander or relevant Chief of Mission for personnel performing private security functions;
(3) Provide full cooperation with any Government-authorized investigation of incidents reported pursuant to paragraph (c)(1)(iv) of this clause and incidents of alleged misconduct by personnel performing private security functions under this contract by providing—
(i) Access to employees performing private security functions; and
(ii) Relevant information in the possession of the Contractor regarding the incident concerned; and
(4) Comply with ANSI/ASIS PSC.1-2012, American National Standard, Management System for Quality of Private Security Company Operations—Requirements with Guidance or the International Standard ISO 18788, Management System for Private Security Operations—Requirements with Guidance (located at
(d)
(1) The Contracting Officer may direct the Contractor, at its own expense, to remove and replace any Contractor or subcontractor personnel performing private security functions who fail to comply with or violate applicable requirements of this clause or 32 CFR part 159. Such action may be taken at the Government's discretion without prejudice to its rights under any other provision of this contract;
(2) The Contractor's failure to comply with the requirements of this clause will be included in appropriate databases of past performance and considered in any responsibility determination or evaluation of past performance; and
(3) If this is an award-fee contract, the Contractor's failure to comply with the requirements of this clause shall be considered in the evaluation of the Contractor's performance during the relevant evaluation period, and the Contracting Officer may treat such failure to comply as a basis for reducing
(e)
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule amending the Defense Federal Acquisition Regulation Supplement (DFARS) to implement a section of the National Defense Authorization Act for Fiscal Year 2016 that is entitled “Treatment of Interagency and State and Local Purchases.” This section provides that contracts executed by DoD as a result of the transfer of contracts from the General Services Administration or for which DoD serves as an item manager for products on behalf of the General Services Administration shall not be subject to certain domestic source restrictions, to the extent that such contracts are for the purchase of products by other Federal agencies or State or local governments.
Effective June 30, 2016.
Ms. Amy G. Williams, telephone 571-372-6106.
DoD published a proposed rule in the
There are no changes from the proposed rule made in the final rule. The one respondent that submitted a comment fully supported the proposed rule.
This case does not add any new provisions or clauses or impact any existing provisions or clauses.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
A final regulatory flexibility analysis (FRFA) has been prepared consistent with the Regulatory Flexibility Act, 5 U.S.C. 601,
This rule implements section 897 of the National Defense Authorization Act for Fiscal Year 2016. The objective of this rule is to eliminate the domestic source restrictions of 10 U.S.C. chapter 148 when contracts executed by DoD as a result of the transfer of contracts from the General Services Administration or for which DoD serves as an item manager for products on behalf of the General Services Administration, to the extent that such contracts are for the purchase of products by other Federal agencies or State or local governments.
There were no significant issues raised by the public in response to the initial regulatory flexibility analysis.
DoD does not anticipate frequent application of this rule. The rule removes the domestic source restriction for the specified items in the specified circumstances. In the rare instance in which the circumstances of the statute apply, it is possible that an item could be acquired from a foreign source, rather than a domestic source, which could potentially be a small business. It is not possible to estimate the number of small entities that may be affected, because it is unknown the extent to which the given circumstances may occur.
There are no projected reporting, recordkeeping, or other compliance requirements.
DoD has not identified any alternatives that would minimize any economic impact on small entities and still meet the requirements of the statute.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 225 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
(o) Acquisitions that are interagency, State, or local purchases that are executed by DoD as a result of the transfer of contracts from the General Services Administration or for which DoD serves as an item manager for products on behalf of the General Services Administration. According to section 897 of the National Defense
Defense Acquisition Regulations System, Department of Defense (DoD).
Final rule.
DoD is issuing a final rule to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to add Ukraine as a new designated country under the World Trade Organization Government Procurement Agreement.
Effective June 30, 2016.
Mr. Christopher Stiller, telephone 571-372-6176.
On November 11, 2015, the World Trade Organization (WTO) Committee on Government Procurement approved the accession of Ukraine to the WTO Government Procurement Agreement (GPA). Ukraine submitted its instrument of accession to the Secretary General of the WTO on April 18, 2016. The GPA entered into force for Ukraine on May 18, 2016. The United States, which is also a party to the GPA, has agreed to waive discriminatory purchasing requirements for eligible products and suppliers of Ukraine beginning on May 18, 2016. Therefore, this rule adds Ukraine to the list of WTO GPA countries wherever it appears in the DFARS, as part of the definition of “designated country”.
This rule only updates the list of designated countries in the DFARS by adding the newly designated country of Ukraine. The definition of “designated country” is updated in each of the following clauses; however, this revision does not impact the clause prescriptions for use, or applicability at or below the simplified acquisition threshold, or applicability to commercial items. The clauses are: DFARS 252.225-7017, Photovoltaic Devices; DFARS 252.225-7021, Trade Agreements; and DFARS 252.225-7045, Balance of Payments Program—Construction Material Under Trade Agreements.
The statute that applies to the publication of the Federal Acquisition Regulation (FAR) is 41 U.S.C. 1707 entitled “Publication of Proposed Regulations.” Paragraph (a)(1) of the statute requires that a procurement policy, regulation, procedure or form (including an amendment or modification thereof) must be published for public comment if it relates to the expenditure of appropriated funds, and has either a significant effect beyond the internal operating procedures of the agency issuing the policy, regulation, procedure or form, or has a significant cost or administrative impact on contractors or offerors. This final rule is not required to be published for public comment, because it is just updating the lists of designated countries in order to reflect that Ukraine is now a member of the WTO GPA. These requirements affect only the internal operating procedures of the Government.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
The Regulatory Flexibility Act does not apply to this rule because this final rule does not constitute a significant DFARS revision within the meaning of FAR 1.501-1, and 41 U.S.C. 1707 does not require publication for public comment.
This rule affects the information collection requirements in the provisions at DFARS 252.225-7020, Trade Agreements Certificate, and 252.225-7018, Photovoltaic Devices—Certificate, currently approved under OMB Control Number 0704-0229, entitled “Defense Federal Acquisition Regulation Supplement Part 225, Foreign Acquisition, and related clauses,” in accordance with the Paperwork Reduction Act (44 U.S.C. chapter 35). The impact, however, is negligible, because the rule only affects the response of an offeror that is offering a product of Ukraine in an acquisition that exceeds $191,000. In 252.225-7018, the offeror of a product from Ukraine must now check a box at (d)(6)(i) of the provision. However, the offeror no longer needs to list a product from Ukraine under “other end products” at 252.225-7020(c)(2), because Ukraine is now a designated country.
Government procurement.
Therefore, 48 CFR part 252 is amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Interim final rule.
PHMSA is revising references in its regulations to the maximum civil penalties for violations of the Federal Pipeline Safety Laws, or any PHMSA regulation or order issued thereunder. Under the “Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” which further amended the “Federal Civil Penalties Inflation Adjustment Act of 1990,” federal agencies are required to adjust their civil monetary penalties effective August 1, 2016, and then annually thereafter, to account for changes in inflation.
PHMSA finds good cause to amend the regulation related to civil penalties without notice and opportunity for public comment. For the reasons described below, advance public notice is unnecessary.
The effective date of this interim final rule is August 1, 2016.
Aaron Glaser, Attorney-Advisor, Pipeline Safety Division, Office of Chief Counsel, Pipeline and Hazardous Materials Safety Administration, by telephone at 202-366-6318 or by email at
Section 701 of the “Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015” (Pub. L. 114-72) (the 2015 Act) amended the “Federal Civil Penalties Inflation Adjustment Act of 1990” (Pub. L. 101-410) (Inflation Adjustment Act) to require that federal agencies adjust their civil penalties with an initial “catch-up” adjustment through an interim final rulemaking by July 1, 2016, as well as make subsequent annual adjustments for inflation. This interim rule adjusts the maximum civil penalties assessed under 49 U.S.C. 60101,
On February 24, 2016, the Office of Management and Budget (OMB) issued a “Memorandum for the Heads of Executive Departments and Agencies, Implementation of the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015,” M-16-06 (OMB Memorandum M-16-06), providing guidance to federal agencies on how to update their civil penalties pursuant to the 2015 Act. OMB Memorandum M-16-06 directs agencies to use multipliers to adjust their civil monetary penalties, or the minimum and maximum penalties, based on the year the penalty was established or last adjusted by statute or regulation other than under the Inflation Adjustment Act (Base Year). For the catch-up adjustment, the agency must use the multiplier, based on the Consumer Price Index for October 2015, provided in the table of OMB Memorandum M-16-06 and multiply it by the current maximum penalty amount. After making an adjustment, all penalty levels must be rounded to the nearest dollar, but no penalty level may be increased by more than 150 percent of corresponding penalty levels in effect on November 2, 2015.
PHMSA is revising the maximum civil penalty amounts in its regulations, consistent with the process outlined in OMB Memorandum M-16-06. The “Pipeline Safety, Regulatory Certainty, and Job Creation Act of 2011” (the 2011 Act) (Public Law No: 112-90) adjusted the maximum civil penalties for violations under 49 U.S.C. 60101,
The 2015 Act only applies to penalties prospectively and does not retrospectively change any civil penalties previously assessed or enforced.
Starting in January 2017, PHMSA is required to publish in the
The 2015 Act does not alter PHMSA's existing authority to assess penalties levied for violations under 49 U.S.C. 60101,
The Administrative Procedure Act (APA) authorizes agencies to forego providing the opportunity for prior public notice and comment if an agency finds good cause that notice and public procedure are unnecessary.
This rule is published under the authority of the 2015 Act, as well 49 U.S.C. 60101
This rule has been evaluated in accordance with existing DOT policies and procedures and determined to be non-significant under Executive Orders 12866 and 12563. This rule is considered a regulatory action under Section 3(e) of Executive Order 12866, and pursuant to Section 6(a)(3)(D) of Executive Order 12866. Further, this interim final rule is not significant under the Regulatory Policies and Procedures of the Department of Transportation because it is limited to a ministerial act on which the agency has no discretion and the economic impact of this rule is minimal. (44 FR 11034). Accordingly, preparation of a regulatory evaluation is not warranted.
This rule imposes no new costs upon persons conducting operations in compliance with federal pipeline statutes and regulations. Those operators not in compliance with these statutes and regulations may experience an increased cost, based on the penalties levied against them for non-compliance; however, this is an avoidable, variable cost and thus, is not considered in any evaluation of the significance of this regulatory action. The amendments in this rule could provide a deterrent effect that could potentially lead to safety benefits; however, PHMSA does not expect such benefits to be significant. Overall, it is anticipated that costs and benefits from this rule would be minimal in real dollars.
PHMSA has analyzed this rule according to Executive Order 13132 on federalism. The interim final rule does not have a substantial direct effect on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government. The rule neither imposes substantial direct compliance costs on state and local governments nor preempts state law governing intrastate pipelines. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.
This rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 on consultation and coordination with Indian tribal governments. Because the rule does not have tribal implications, does not impose substantial direct compliance costs, and is required by statute, the funding and consultation requirements of Executive Order 13175 do not apply.
This rule is not a “significant energy action” under Executive Order 13211 on actions concerning regulations that significantly affect energy supply, distribution, or use. It is not likely to have a significant adverse effect on supply, distribution, or energy use. Further, the Office of Information and Regulatory Affairs (OIRA) within OMB has not designated this rule as a significant energy action.
The Regulatory Flexibility Act (5 U.S.C. 601-611) requires each agency to analyze proposed regulations and assess their impact on small businesses and
This rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $155,000,000 or more, adjusted for inflation, in any year for either state, local, or tribal governments, in the aggregate, or to the private sector, and is the least-burdensome alternative that achieves the objective of the rule.
This interim final rule imposes no new requirements for recordkeeping or reporting.
The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321-4375), requires federal agencies to consider the consequences of major federal actions and prepare a detailed statement on actions significantly affecting the quality of the human environment. When developing potential regulatory requirements, PHMSA evaluates those requirements to consider the environmental impact of these amendments. Specifically, PHMSA evaluates the risk of release and resulting environmental impact; risk to human safety, including any risk to first responders; if the proposed regulation would be carried out in a defined geographic area; and the resources, especially in environmentally sensitive areas, that could be impacted by any proposed regulations.
This interim final rule would be generally applicable to pipeline operators, and would not be carried out in a defined geographic area. The adjusted, increased civil penalties listed in this interim final rule may act as a deterrent to those violating the Federal Pipeline Safety Laws, or any PHMSA regulation or order issued thereunder. This may result in a positive environmental impact as a result of increased compliance with the Federal Pipeline Safety Laws and any PHMSA regulations or orders issued thereunder. Based on the above discussion, PHMSA concludes there are no significant environmental impacts associated with this interim final rule.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
Sections 3 and 4 of Executive Order 13609 direct an agency to conduct a regulatory analysis and ensure that a proposed rule does not cause unnecessary obstacles to foreign trade. This requirement applies if a rule constitutes a significant regulatory action, or if a regulatory evaluation must be prepared for the rule. This interim final rule is not a significant regulatory action, but a regulatory action under Section 3(e) of Executive Order 12866. PHMSA is not required under Executive Orders 12866 and 13563 to submit a regulatory analysis.
A regulation identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in the spring and fall of each year. The RIN contained in the heading of this document can be used to cross-reference this action in the Unified Agenda.
Administrative practice and procedure, Penalties, Pipeline safety.
In consideration of the foregoing, PHMSA is amending 49 CFR part 190 as follows:
33 U.S.C. 1321(b); 49 U.S.C. 60101
(a) Any person found to have violated a provision of 49 U.S.C. 60101
(b) Any person found to have violated a provision of 33 U.S.C. 1321(j) or any regulation or order issued thereunder is subject to an administrative civil penalty under 33 U.S.C. 1321(b)(6), as adjusted by 40 CFR 19.4.
(c) Any person found to have violated any standard or order under 49 U.S.C. 60103 is subject to an administrative civil penalty not to exceed $75,123, which may be in addition to other penalties to which such person may be subject under paragraph (a) of this section.
(d) Any person who is determined to have violated any standard or order under 49 U.S.C. 60129 is subject to an administrative civil penalty not to exceed $1,194, which may be in addition to other penalties to which such person may be subject under paragraph (a) of this section.
Surface Transportation Board (Board or STB).
Final statement of agency policy.
On July 11, 2013, the Board issued a notice of proposed size standards for purposes of the Regulatory Flexibility Act, along with a request for public comment. This decision discusses the comment received in response to the proposed size standards
This policy statement is effective June 30, 2016.
Amy Ziehm at (202) 245-0391. Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at (800) 877-8339.
The Regulatory Flexibility Act (RFA) requires agencies to consider the impact of their regulations on small entities,
On July 16, 2013, the Board served a notice proposing its own small entity size standards for purposes of the RFA, along with a request for comment. 78 FR 42,484 (July 16, 2013). After consulting with the SBA's Office of Advocacy, the Board proposed to establish a small entity size standard based on its longstanding classification system, which classifies freight railroads as Class I, Class II, or Class III based on annual operating revenues.
The American Short Line and Regional Railroad Association (ASLRRA) submitted a comment on August 5, 2013, opposing the Board's proposal. ASLRRA agrees with the SBA's current definition of small business, which uses the number of employees, rather than revenue, as the relevant metric. It maintains that revenue is an unreliable metric for determining whether a railroad is a small business because railroads are “so capital intensive their revenues must provide a return on that huge investment or they cannot stay in business” and because “small railroad revenues are driven largely by the types of commodities they happen to carry.” (ASLRRA Comment 3) ASLRRA argues that changing the definition would exclude many Class II railroads from the small business designation, and would thus “strip them from the financial impact review that is the right of small entities during the rulemaking process pursuant to the Regulatory Flexibility Act.” (
Despite ASLRRA's objection to the use of our revenue classifications over employee counts to define a small business, we find that it is the more appropriate basis for doing so. Even if, as ASLRRA argues, there is some variation between carriers of similar employment levels due, in part, to the types of commodities being shipped, that alone does not mean that employment level represents the better approach to defining a small business. As the Board explained in the notice, the system of classifying railroads based on revenue is used pervasively by the Board and the railroad industry. The agency has used revenue to classify rail carriers since as early as 1911, and the agency's governing statute, precedent, and regulations often impose different requirements depending on the class of carrier involved. The validity of using revenues to define carrier size has thus been sufficiently demonstrated over time. ASLRRA has not demonstrated that using a size standard based on employment levels is superior to the revenue basis the agency and railroad industry have used for decades.
We now address whether the definition of small business should or should not include Class II carriers. The Board acknowledges ASLRRA's concerns regarding Class II rail carriers and recognizes the differences between Class I, Class II, and Class III railroads. However, the Board does not believe that Class II carriers should be classified as small businesses. Under the Board's governing statutes and regulations, special exceptions are made for Class III carriers, but not Class II carriers.
In addition, the Board also believes there is significant utility in maintaining consistency with the practices of the Federal Railroad Administration, which adopted the same definition of small entity for RFA purposes.
For the reasons set forth above, the Board will define small business for the purpose of Regulatory Flexibility Act analyses to mean those rail carriers classified as Class III rail carriers under 49 CFR 1201.1-1.
1. For the purpose of Regulatory Flexibility Act analyses, the Board adopts the definition of “small business” to mean those rail carriers
2. A copy of this decision will be served upon the Chief Counsel for Advocacy, Office of Advocacy, U.S. Small Business Administration.
3. Notice of this decision will be published in the
4. This decision is effective on June 30, 2016.
Decided: June 22, 2016.
By the Board, Chairman Elliott, Vice Chairman Miller, and Commissioner Begeman. Commissioner Begeman dissented with a separate expression.
COMMISSIONER BEGEMAN, dissenting:
I am a strong proponent of the notice and comment process and find it especially important given the Board's extreme ex parte communication restrictions. So when the only comments received are from the stakeholders most affected, and those stakeholders express strong opposition to a Board proposal, I think we are obligated to carefully consider the concerns expressed and reassess the wisdom of our approach. Upon doing so here, I have concluded this proposal should be withdrawn.
The American Short Line and Regional Railroad Association (ASLRRA), which represents 550 Class II and Class III rail carriers across the country, filed in strong opposition to the Board's July 2013 proposal to alter its small entity definition for Regulatory Flexibility Act (RFA) purposes. ASLRRA argued that the Board's proposal to use revenue rather than number of employees (the measure developed by the Small Business Administration that agencies can use to comply with the RFA) would effectively lump all Class II carriers with Class I carriers for RFA purposes, an unreasonable outcome given the significant differences between those carrier types. ASLRRA further argued that the Board's proposal would be “detrimental to Class II carriers.” I find ASLRRA's concerns alarming.
I am not convinced that the action the Board is taking today is necessary or somehow worth the potential harms described by ASLRRA. After all, the majority's decision does not dispute ASLRRA's claims. It appears the driving factor in this decision is the majority's desire to create “consistency” with the Federal Railroad Administration. While consistency may be fine, it certainly is not a very compelling reason since the two agencies have used different small business definitions for 13 years without issue.
There are a host of stale proceedings piled up at the Board and I am all for the Chairman moving the docket. But if (after three years) the majority was merely going to dismiss the only comment received from representatives of the parties affected, there was no real point in the Board inviting comment in the first place. I dissent.
Animal and Plant Health Inspection Service, USDA.
Proposed rule.
We are proposing to amend the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, would allow us to approve new cold treatment facilities without rulemaking and facilitate the importation of fruit requiring cold treatment while continuing to provide protection against the introduction of pests of concern into the United States. We are also proposing to amend the fruit cutting and inspection requirements in the cold treatment regulations in order to expand cutting and inspection to commodities that have been treated for a wider variety of pests of concern. This action would provide for a greater degree of phytosanitary protection. We are also proposing to add requirements concerning the establishment of compliance agreements for all entities that operate fumigation facilities. Finally, we are proposing to harmonize language concerning State compliance with facility establishment and parameters for the movement of consignments from the port of entry or points of origin in the United States to the treatment facility in the irradiation treatment regulations with proposed language in the cold treatment regulations. These actions would serve to codify and make enforceable existing procedures concerning compliance agreements for these facilities.
We will consider all comments that we receive on or before August 29, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Mr. David B. Lamb, Senior Regulatory Policy Specialist, IRM, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1231; (301) 851-2103.
The phytosanitary treatments regulations in 7 CFR part 305 set out general requirements for certifying or approving treatment facilities and for performing treatments listed in the Plant Protection and Quarantine (PPQ) Treatment Manual
In § 305.6, paragraph (b) allows cold treatment facilities to be located in the area north of 39° latitude and east of 104° longitude. When the cold treatment regulations were established, areas outside of these coordinates were identified as having conditions favorable for the establishment of exotic fruit flies. The location restrictions served as an additional safeguard against the possibility that fruit flies could escape from imported articles prior to treatment and become established in the United States.
Although the regulations initially did not allow cold treatment facilities to be located in Southern and Western States, APHIS periodically received requests for exemptions. In response to these requests, APHIS conducted site-specific evaluations for these locations and determined that regulated articles can be safely transported to, handled in, and treated by specific cold treatment facilities outside of the areas established
In addition to those requests, certain importers of fruits and vegetables have shown considerable interest in locating cold treatment facilities in places that are not currently allowed under the regulations (
In anticipation of future requests to locate additional cold treatment facilities in the Southern and Western States of the United States, we are proposing to establish generic phytosanitary criteria that would replace the current location-specific criteria for cold treatment facilities at the ports mentioned previously and would also apply to new cold treatment facilities in the Southern and Western States of the United States. The proposed criteria are similar to those successfully used for the approval of new irradiation facilities in the Southern United States found in § 305.9 of the regulations, as untreated fruit moving to irradiation facilities in those States presents the same pest risks as untreated fruit moving to cold treatment facilities. We would not require currently approved cold treatment facilities in Southern and Western States to immediately meet the proposed generic criteria since the specific requirements presently in place for each facility would continue to provide adequate phytosanitary protection. Nevertheless, we would require currently approved facilities to meet the new generic requirements as each comes up to renew its required recertification, which takes place at 3 year intervals or at other times as determined by APHIS based on treatments performed, commodities handled, and operations conducted at the facility.
All cold treatment facilities in the Southern and Western States would be required to meet the current criteria for cold treatment facilities north of 39° latitude and east of 104° longitude, in addition to the proposed generic criteria. These generic criteria would be supplemented as necessary by additional measures, which would be described in a compliance agreement (discussed below), based on pests of concern associated with specific regulated articles to be treated at the facility and the location of the specific facility. Facilities that meet these requirements could then be approved for the treatment of regulated articles that are imported, moved interstate from Hawaii or U.S. territories, or moved interstate from areas quarantined for certain pests of concern.
Using APHIS-approved cold treatment facilities located in the United States, rather than those located outside of the United States, to treat imported articles offers the advantage of greater ease of monitoring treatment. Using generic criteria, rather than site by site approval, for future cold treatment facilities located in Southern and Western States would make explicit our criteria for approving these facilities while eliminating the need to undertake rulemaking in order to approve new facilities.
To support this action, we have prepared a treatment evaluation document (TED) entitled “Phytosanitary Criteria for Establishing Locations for Cold Treatment Facilities in Areas of the United States Currently Not Allowed.” Copies of the TED may be obtained from the person listed under
We are therefore proposing to amend the regulations by replacing the current specific criteria for cold treatment facilities at the maritime ports of Wilmington, NC; Seattle, WA; Corpus Christi, TX; and Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; MidAmerica St. Louis Airport, Mascoutah, IL; and Hartsfield-Atlanta International Airport, Atlanta, GA, in § 305.6 with generic phytosanitary criteria for any cold treatment facility in a Southern or Western State. The proposed generic criteria would have to be followed in addition to the current requirements that apply to all cold treatment facilities. The proposed generic criteria for new facilities in the Southern and Western States are based on the current conditions for allowing cold treatment facilities at the maritime ports of Wilmington, NC; Seattle, WA; Corpus Christi, TX; and Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; MidAmerica St. Louis Airport, Mascoutah, IL; and Hartsfield-Atlanta International Airport, Atlanta, GA.
In proposed paragraph (b)(1)(i) of § 305.6, we would require that prospective facility operators submit a detailed layout of the facility site and its location to APHIS. APHIS would evaluate plant health risks based on the proposed location and layout of the facility site before a facility is approved. APHIS would only approve a proposed facility if the Administrator determines that regulated articles can be safely transported to the facility from the port of entry or points of origin in the United States. Proposed paragraph (b)(1)(ii) of § 305.6 provides that the State government of the Southern or Western State in which the facility would be located would also have to concur in writing with the location of the cold treatment facility; if it does not concur, the State government must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, and provides a written explanation of concern based on pest risks, then APHIS and the State would need to agree on a strategy to resolve such risks before APHIS approved the facility. If the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location.
Under this proposal, paragraphs (b)(1)(iii) and (b)(1)(iv) of § 305.6 would provide, respectively, that untreated articles may not be removed from their packaging prior to treatment under any circumstances, and that facilities must have contingency plans, approved by APHIS, for safely destroying or disposing of regulated articles if the facility were unable to properly treat a shipment. Alternatively, facilities could be approved to apply alternative treatments, if available, such as fumigation with methyl bromide or irradiation.
Proposed paragraph (b)(1)(v) of § 305.6 would allow a cold treatment facility to treat only those articles that are approved by APHIS for treatment at that facility. If, during the approval process for regulated articles, APHIS determines that additional safeguards (such as trapping for specific pests using specific lures, inspection for any pests of concern not mitigated by cold treatment or to monitor pest population in the consignment, or applying
Under proposed paragraph (b)(1)(vi) of § 305.6, APHIS, the importer, and the cold treatment facility would need to agree on arrangements for treatment before the departure of a consignment from its country of origin or point of origin in the United States. This would ensure that untreated shipments of regulated articles arriving at the facility would not have to wait for an extended period of time for cold treatment. The expeditious treatment of the articles would minimize the risk of pests of concern maturing in fruits, vegetables, or other articles. In addition, we are proposing that APHIS and the cold treatment facility would have to agree in advance about all parameters, such as time, routing, and conveyance, by which every consignment would move from the port of entry or points of origin in the United States to the cold treatment facility. In most instances, this would be determined by establishing the shortest route between the port of entry or points of origin in the United States and the cold treatment facility that does not include an area that contains host material for pests of concern during the time of year that the host material is most abundant in the region. This route would then be used at all times of the year, since an area that is free of host material during the time of year that it is most abundantly grown, would be unlikely to grow host material at any other time of year. This predetermined route would reduce the amount of time that a shipment would have to wait before undergoing cold treatment and would reduce the risk that any pests of concern in the shipments would come into contact with host material en route to the cold treatment facility. If APHIS and the cold treatment facility cannot reach agreement in advance on all parameters by which consignments would move from the port of entry or points of origin in the United States then no consignments may be moved to that facility until an agreement has been reached.
We are also proposing to require in paragraph (b)(1)(vii) of § 305.6 that the conveyance transporting the regulated article to the cold treatment facility would need to be refrigerated using motorized refrigeration equipment to a temperature that would minimize the mobility of the pests of concern for the article. Fruits and vegetables requiring cold treatment are typically transported in refrigerated conveyances in order to preserve freshness of the commodity and prevent development of toxins that may affect their flavor.
Proposed paragraph (b)(1)(viii) of § 305.6 would stipulate that the cold treatment facility would be required to apply all required post-treatment safeguards as required by the compliance agreement to provide phytosanitary protection (
The current regulations for cold treatment facilities at the maritime ports of Seattle, WA; Corpus Christi, TX; and Gulfport, MS; Seattle-Tacoma International Airport, Seattle, WA; and Hartsfield-Atlanta International Airport, Atlanta, GA, require blacklight or sticky paper to be used within the cold treatment facility and other trapping methods to be used within the 4 square miles surrounding the facility. Proposed paragraph (b)(1)(x) of § 305.6 requires, in addition, that the facility maintain and provide APHIS an updated map identifying places where horticultural or other crops are grown within 4 square miles of the facility. APHIS will use this information to determine if any host material of concern is present. To help prevent establishment of pests in the unlikely event that they escape despite the required precautions, the presence of any host material within 4 square miles of the facility would then necessitate specific trapping or other pest monitoring activities to help prevent establishment of any escaped pests of concern, which would be funded by the facility and described in the compliance agreement. All trapping and pest monitoring activities would need to be approved by APHIS.
The cold treatment facility would also need to have a pest management plan within the facility, which would cover such topics as monitoring for pests in storage and treatment areas and the actions to be taken in the event of the detection of pests within the facility. Cold treatment facilities would also be required to comply with any additional requirements that APHIS might require for a particular facility based on local conditions and any other risk factors of concern. This could include inspection for certain pests for which cold treatment is not an approved treatment, such as mites and scales. Proposed paragraph (b)(1)(xi) of § 305.6 would require that facilities comply with any additional APHIS requirements including, but not limited to, the use of pest-proof packaging and container seals. Such additional requirements would be contained in a compliance agreement. Compliance agreements are required for all facilities in paragraph (f) of § 305.6, which we are proposing to amend as detailed below under the heading “Cold Treatment Facilities in All the United States.”
We also propose to add language specifying the way in which domestically produced fruit would be safeguarded when moving interstate from areas within the United States that are quarantined for fruit flies. In proposed paragraph (b)(2) of § 305.6, we would stipulate that, for articles that are moved interstate from areas quarantined for fruit flies, cold treatment facilities would be permitted to be located within or outside of the quarantined area. If the articles are treated outside the quarantined area, they would have to be accompanied to the facility by a limited permit issued in accordance with 7 CFR 301.32-5(b) of our fruit fly regulations and must be moved in accordance with any safeguards determined appropriate by APHIS. These additions are necessary because the current cold treatment regulations do not address interstate movement and this addition would serve to clarify our requirements.
In paragraph (a) of § 305.6, we are proposing to expand our requirements for initial facility certification and recertification. A prospective facility would only be certified if the Administrator determines that the location of that facility is operationally feasible insofar as the Federal agencies involved in its operation and oversight have adequate resources to conduct the necessary operations at the facility, that the pest risks can be managed at that location, and that the facility meets all criteria for approval. Facility recertification would continue to be required at 3 year intervals or at other times as determined by APHIS based on treatments performed, commodities handled, and operations conducted at the facility.
Currently, as part of the approval process for cold treatment facilities, APHIS considers whether a proposed cold treatment facility is located within the local commuting area for APHIS employees so that they will be able to perform the oversight and monitoring activities required by § 305.6. When imported articles are to be treated at a facility, APHIS also considers whether the facility is located within an area over which the U.S. Department of Homeland Security (DHS)
The regulations in § 305.6(d)(15) currently stipulate that an inspector will sample and cut fruit from consignments that have been cold treated for Mediterranean fruit fly (Medfly) in order to monitor treatment effectiveness. We are proposing to expand the fruit cutting and inspection requirements in order to state that consignments treated for other fruit flies and pests of concern may be subject to sampling and cutting. This would create an extra level of phytosanitary security for cold treated shipments.
If the national plant protection organization cuts and inspects the commodity in the exporting country as part of a biometric sampling protocol that we have approved, however, we are proposing that we may waive this requirement. In such instances, inspection and cutting would be duplicative.
Paragraph (f) of § 305.6 currently requires that cold treatment facilities located in the United States must enter into a compliance agreement with APHIS. These compliance agreements set out requirements for equipment, temperature, circulation, and other operational requirements for performing cold treatment to ensure that treatments are administered properly. They also allow for inspection by APHIS in order to monitor compliance with those requirements. Paragraph (g) contains requirements for facilities located outside the United States, which may only operate under a bilateral workplan. A bilateral workplan may contain some of the same requirements as a domestic compliance agreement, with the potential addition of trust fund agreement information regarding payment of the salaries and expenses of APHIS employees on site. We are proposing to combine these requirements into a single paragraph that would set out the requirements that both domestic and foreign cold treatment facilities and importers would have to meet in order to enter into a compliance agreement with APHIS. We are also proposing to add language regarding compliance agreements required in association with articles moved interstate from Hawaii and the U.S. territories. These requirements are consistent with those required for importers shipping articles to irradiation facilities located in the southern United States and are necessary to ensure that consignments of fruits or vegetables are not diverted to any destination other than an approved treatment facility, to prevent escape of plant pests from the articles to be treated during their transit from the port of first arrival into the United States to the approved cold treatment facility, and to ensure that APHIS is aware of the time, route, and conveyance by which consignments will move to the treatment facility.
We are proposing to add a section to the regulations concerning fumigation treatment found in § 305.5 to provide that both domestic and foreign fumigation treatment facilities and importers enter into a compliance agreement with APHIS, and agree to comply with any requirements deemed necessary by the Administrator. Although we currently enter into compliance agreements with domestic chemical treatment facilities and have done so for more than 20 years, the addition of a requirement for compliance agreements to the fumigation treatment regulations will add a degree of enforceability to the terms of those agreements in addition to codifying our existing practices.
We are also proposing to add a requirement concerning establishment of a compliance agreement, or an equivalent agreement such as a workplan agreement, for those fumigation treatment facilities located outside the United States. Such facilities had not been previously required to sign such an agreement to treat articles imported into the United States under the fumigation treatment regulations. The proposed requirements would be identical to those found in the sections of the treatment regulations concerning cold treatment and heat treatment, and would be added in a new paragraph (c) in § 305.5.
We are proposing to harmonize the language concerning State compliance with irradiation treatment facility establishment and facility agreements found in § 305.9 with the proposed language concerning this compliance in the cold treatment regulations.
Section 305.9(a)(1)(ii) states that the government of the State in which the facility is to be located must concur in writing with the establishment of the facility or, if it does not concur, must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, APHIS and the State will agree on a strategy to resolve the pest risk concerns prior to APHIS approval. We would add that, if the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location.
Section 305.9(a)(1)(vi) states that APHIS and the irradiation treatment facility must agree on all parameters, such as time, routing, and conveyance, by which the consignment will move from the port of entry or points of origin in the United States to the treatment facility. We are proposing to clarify that if APHIS and the facility cannot reach agreement in advance on these parameters then no consignments may be moved to that facility until an agreement has been reached.
We are also proposing to add a definition for “treatment facility” as follows to the regulations in § 305.1: “Any APHIS-certified place, warehouse, or approved enclosure where a treatment is conducted to mitigate a plant pest.” This is intended to provide clarity and guidance in the regulations as the term is included in the proposed additions to the regulations.
Finally, the current regulations in § 305.2, paragraph (b), state that approved treatment schedules are set out in the PPQ Treatment Manual.
We are proposing to remove a cold treatment schedule from the PPQ Treatment Manual. Treatment schedule T107-f was authorized for use on shipments of Ya pears (
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866 and, therefore, has not been reviewed by the Office of Management and Budget.
In accordance with the Regulatory Flexibility Act, we have analyzed the potential economic effects of this action on small entities. The analysis is summarized below. Copies of the full analysis are available on the
We are proposing to establish general criteria for new cold treatment facilities in the Southern and Western United States. These general criteria would be supplemented as necessary by additional measures, which would be described in the facility's compliance agreement, based on pests of concern associated with specific regulated articles to be treated at the facility and the location of the specific facility.
We do not anticipate that the proposed rule would have an economic impact, since it would simply set forth the general criteria, not approve any new facilities.
Under these circumstances, the Administrator of the Animal and Plant Health Inspection Service has determined that this action would not have a significant economic impact on a substantial number of small entities.
This proposed rule has been reviewed under Executive Order 12988, Civil Justice Reform. If this proposed rule is adopted: (1) All State and local laws and regulations that are inconsistent with this rule will be preempted; (2) no retroactive effect will be given to this rule; and (3) administrative proceedings will not be required before parties may file suit in court challenging this rule.
In accordance with section 3507(d) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
APHIS is proposing to amend the phytosanitary treatment regulations to establish generic criteria that would allow for the approval of new cold treatment facilities in the Southern and Western States of the United States. These criteria, if met, would allow APHIS to approve new cold treatment facilities without rulemaking and facilitate the importation of fruit requiring cold treatment while continuing to provide protection against the introduction of pests of concern into the United States. APHIS is also proposing to amend the fruit cutting and inspection requirements in the cold treatment regulations in order to expand cutting and inspection to commodities that have been treated for a wider variety of pests of concern. This action would provide for a greater degree of phytosanitary protection. Finally, APHIS is proposing to add requirements concerning the establishment of compliance agreements for those entities that operate fumigation facilities. This action would serve to codify and make enforceable existing procedures concerning compliance agreements for these facilities.
Implementing this rule will require the completion of compliance agreements, facility certification, detailed layouts of facilities and maps of the surrounding areas, State concurrence letters, limited permits, and contingency plans.
We are soliciting comments from the public (as well as affected agencies) concerning our proposed information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the proposed information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the proposed information collection, 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 information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this proposed rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Irradiation, Phytosanitary treatment, Plant diseases and pests, Quarantine, Reporting and recordkeeping requirements.
Accordingly, we propose to amend 7 CFR part 305 as follows:
7 U.S.C. 7701-7772 and 7781-7786; 21 U.S.C. 136 and 136a; 7 CFR 2.22, 2.80, and 371.3.
The addition reads as follows:
(c)
(1)
(ii)
(2)
(3)
(4)
The additions and revisions read as follows:
(a) * * * A facility will only be certified or recertified if the Administrator determines that the location of the facility is such that those Federal agencies involved in its operation and oversight have adequate resources to conduct the necessary operations at the facility, that the pest risks can be managed at that location, and that the facility meets all criteria for approval. Other agencies that have regulatory oversight and requirements must concur in writing with the establishment of the facility prior to APHIS approval. * * *
(2) Be capable of preventing the escape and spread of pests while regulated articles are at the facility; and
(b)(1)
(i) Prospective facility operators must submit a detailed layout of the facility site and its location to APHIS. APHIS will evaluate plant health risks based on the proposed location and layout of the facility site. APHIS will only approve a proposed facility if the Administrator determines that regulated articles can be safely transported to the facility from the port of entry or points of origin in the United States.
(ii) The government of the State in which the facility is to be located must concur in writing with the location of the facility or, if it does not concur, must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, and provides a written explanation of concern based on pest risks, APHIS and the State must agree on a strategy to resolve the pest risk concerns prior to APHIS approval. If the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location.
(iii) Untreated articles may not be removed from their packaging prior to treatment under any circumstances.
(iv) The facility must have contingency plans, approved by APHIS, for safely destroying or disposing of regulated articles if the facility is unable to properly treat a shipment.
(v) The facility may only treat articles approved by APHIS for treatment at the facility. Approved articles will be listed in the compliance agreement required in paragraph (f) of this section.
(vi) Arrangements for treatment must be made before the departure of a consignment from its port of entry or points of origin in the United States. APHIS and the facility must agree on all parameters, such as time, routing, and conveyance, by which the consignment will move from the port of entry or points of origin in the United States to the treatment facility. If APHIS and the facility cannot reach agreement in advance on these parameters then no consignments may be moved to that facility until an agreement has been reached.
(vii) Regulated articles must be conveyed to the facility in a refrigerated (via motorized refrigeration equipment) conveyance at a temperature that minimizes the mobility of the pests of concern for the article.
(viii) The facility must apply all post-treatment safeguards required for certification under paragraph (a) of this section before releasing the articles.
(ix) The facility must remain locked when not in operation.
(x) The facility must maintain and provide APHIS with an updated map identifying places where horticultural or other crops are grown within 4 square miles of the facility. Proximity of host material to the facility will necessitate trapping or other pest monitoring activities, funded by the facility, to help prevent establishment of any escaped pests of concern, as approved by APHIS; these activities will be listed in the compliance agreement required in paragraph (f) of this section. The treatment facility must have a pest management plan within the facility.
(xi) The facility must comply with any additional requirements including, but not limited to, the use of pest-proof packaging and container seals, that APHIS may require to prevent the escape of plant pests during transport to and from the cold treatment facility itself, for a particular facility based on local conditions, and for any other risk factors of concern. These activities will be listed in the compliance agreement required in paragraph (f) of this section.
(2) For articles that are moved interstate from areas quarantined for fruit flies, cold treatment facilities may be located either within or outside of the quarantined area. If the articles are treated outside the quarantined area, they must be accompanied to the facility by a limited permit issued in accordance with § 301.32-5(b) of this chapter and must be moved in accordance with any safeguards determined to be appropriate by APHIS.
(d) * * *
(15) An inspector will sample and cut fruit from each consignment after it has been cold treated to monitor treatment effectiveness. If a single live pest of concern in any stage of development is found, the consignment will be held until an investigation is completed and appropriate remedial actions have been implemented. If APHIS determines at any time that the safeguards contained in this section do not appear to be effective against the pests of concern, APHIS may suspend the importation of fruits from the originating country and conduct an investigation into the cause of the deficiency. APHIS may waive the sampling and cutting requirement of this paragraph, provided that the national plant protection organization of the exporting country has conducted such sampling and cutting in the exporting country as part of a biometric sampling protocol approved by APHIS.
(e) * * * Facilities must be located within the local commuting area for APHIS employees for inspection purposes. Facilities treating imported articles must also be located within an area over which the U.S. Department of Homeland Security is assigned authority to accept entries of merchandise, to collect duties, and to enforce the provisions of the customs and navigation laws in force.
(f)
(1)
(2)
(3)
The revisions read as follows:
(a) * * *
(1) * * *
(ii) The government of the State in which the facility is to be located must concur in writing with the location of the facility or, if it does not concur, must provide a written explanation of concern based on pest risks. In instances where the State government does not concur with the proposed facility location, and provides a written explanation of concern based on pest risks, APHIS and the State must agree on a strategy to resolve the pest risk concerns prior to APHIS approval. If the State does not provide a written explanation of concern based on pest risks, then State concurrence will not be required before APHIS approves the facility location.
(vi) Arrangements for treatment must be made before the departure of a consignment from its port of entry or points of origin in the United States.
Agricultural Marketing Service, USDA.
Withdrawal of proposed rule.
This document informs the public that the Agricultural Marketing Service (AMS) of the U.S. Department of Agriculture (USDA) is withdrawing the proposed rule published in the
The proposed rule published on March 26, 2016 (81 FR 14022), is withdrawn.
Michael Dinkel, Agricultural Marketing Specialist; Research and Promotion Division, Room 2610-S; Livestock, Poultry, and Seed Program; AMS, USDA, STOP 0249; 1400 Independence Avenue SW., Washington, DC 20250-0249; facsimile 202/720-1125; telephone 301/352-7497, or by email at
The Act authorized the establishment of a national beef promotion and research program. The final Order was published in the
On March 16, 2016, AMS published in the
Following publication, AMS discovered an error in the carcass weight of imported veal carcasses used to determine the assessment rate for imported veal and veal products. The correct weight used to calculate the assessment rate was published as 151 pounds, but the correct weight is 154 pounds. In addition, the industry recently requested the formula for how the assessment rate for imported veal and veal products is calculated. As a result of both the discovered error and the industry request, AMS is withdrawing the proposed rule and will publish a new proposed rule with the corrected carcass weight and formula.
Office of Energy Efficiency and Renewable Energy, U.S. Department of Energy.
Notice of availability; request for public comment, and request for information.
Section 413 of the Energy Independence and Security Act of 2007 (EISA) directs the U.S. Department of Energy (DOE) to establish energy conservation standards for manufactured housing. Section 413 further directs DOE to base its energy conservation standards on the most recent version of the International Energy Conservation Code (IECC) and any supplements to that document, except where DOE finds that the IECC is not cost effective or where a more stringent standard would be more cost effective, based on the impact of the IECC on the purchase price of manufactured housing and on total lifecycle construction and operating costs. On June 17, 2016, DOE published a notice of proposed rulemaking in the
Pursuant to the National Environmental Policy Act (NEPA) of 1969, DOE Office of Energy Efficiency and Renewable Energy (EERE) has prepared a draft environmental assessment (EA) to evaluate the environmental impacts of this proposed action. DOE is seeking public comment on the environmental issues addressed in the EA. In conjunction with issuance of this draft EA for public review and comment, DOE is issuing a request for information that will help it analyze potential impacts on indoor air quality (IAQ) from the proposed energy conservation standards, in particular sealing manufactured homes tighter.
Comments regarding this draft EA and/or information on IAQ must be received on or before August 15, 2016.
Written comments should be sent to Roak Parker at U.S. Department of Energy, 15013 Denver West Parkway, Golden, CO 80401, or by email at
Requests for additional information or copies of the draft environmental assessment should be directed to Roak
DOE has published a notice of proposed rulemaking in the
Bureau of the Census, Department of Commerce.
Proposed criteria and request for comment.
The Bureau of the Census (U.S. Census Bureau) is providing notification and requesting comment on the proposed “2020 Census Residence Rule and Residence Situations.” In addition, this document contains a summary of comments received in response to the May 20, 2015,
To ensure consideration, comments must be received by August 1, 2016.
Direct all written comments regarding the proposed “2020 Census Residence Rule and Residence Situations” to Karen Humes, Chief, Population Division, U.S. Census Bureau, Room 6H174, Washington, DC 20233; or Email [
Population and Housing Programs Branch, U.S. Census Bureau, 6H185, Washington, DC 20233, telephone (301) 763-2381; or Email [
The U.S. Census Bureau is committed to counting every person in the 2020 Census once, only once, and in the right place. The fundamental reason that the decennial census is conducted is to fulfill the Constitutional requirement (Article I, Section 2) to apportion the seats in the U.S. House of Representatives among the states. Thus, for a fair and equitable apportionment, it is crucial that the Census Bureau counts everyone in the right place during the decennial census.
The residence criteria are used to determine where people are counted during each decennial census. Specific residence situations are included with the criteria to illustrate how the criteria are applied.
The Census Act of 1790 established the concept of “usual residence” as the main principle in determining where people were to be counted, and this concept has been followed in all subsequent censuses. “Usual residence” has been defined as the place where a person lives and sleeps most of the time. This place is not necessarily the same as a person's voting residence or legal residence.
Determining usual residence is straightforward for most people. However, given our nation's wide diversity in types of living arrangements, the concept of usual residence has a variety of applications. Some examples include people experiencing homelessness, people with a seasonal/second residence, people in prisons, people in the process of moving, people in hospitals, children in shared custody arrangements, college students, live-in employees, military personnel, and people who live in workers' dormitories.
Applying the usual residence concept to real living situations means that people will not always be counted at the place where they happen to be staying on Census Day (April 1, 2020) or at the time they complete their census questionnaire. For example, some of the ways that the Census Bureau applies the concept of usual residence include the following:
• People who are away from their usual residence while on vacation or on a business trip on Census Day are counted at their usual residence.
• People who live at more than one residence during the week, month, or year are counted at the place where they live most of the time.
• People without a usual residence are counted where they are staying on Census Day.
• People in certain types of group facilities
Every decade, the Census Bureau undertakes a review of the “Residence Rule and Residence Situations” to ensure that the concept of usual residence is interpreted and applied as intended in the decennial census, and that these interpretations are consistent with the intent of the Census Act of 1790, which was authored by a Congress that included many of the framers of the U.S. Constitution and directed that people were to be counted at their usual residence. This review also serves as an opportunity to identify new or changing living situations resulting from societal change, and to create or revise the guidance regarding those situations in a way that is consistent with the concept of usual residence.
This decade, as part of the review, the Census Bureau requested public comment on the “2010 Census Residence Rule and Residence Situations” through the
In addition to the Census Bureau's responses to comments that are described in section B of this document, section C provides a summary of each of the proposed changes to where people would be counted in the 2020 Census compared to the 2010 Census. These proposed changes are based on the consideration of public comments received, as well as an internal review of the criteria and situations.
The Census Bureau is requesting public comment on the proposed “2020 Census Residence Rule and Residence Situations”, as listed in section D of this document. The Census Bureau is requesting public comment on the proposed “2020 Census Residence Rule and Residence Situations,” as listed in section D of this document. The Census Bureau anticipates publishing the final “2020 Census Residence Rule and Residence Situations” by the end of 2016. At that time, the Census Bureau will also respond to the comments received regarding the proposed “2020 Census Residence Rule and Residence Situations.”
On May 20, 2015, the Census Bureau published a document in the
Of the 162 comments pertaining to prisoners, 156 suggested that prisoners should be counted at their home or pre-incarceration address. The rationales included in these comments were as follows:
• Counting prisoners at the prison inaccurately represents the prisoners' home communities, inflates the political power of the area where the prison is located, and deflates the political power in the prisoners' home communities. This distorts the redistricting process.
• Counting prisoners away from their home address goes against the principle of equal representation.
• The current residence criteria for prisoners is inconsistent with some states' laws regarding residency for elections.
• The “usual residence” concept itself should change, as it relates to incarcerated persons, because the tremendous increase in the number of incarcerated people in the last 30 years, and the Supreme Court's support of equal representation, warrants a change in the interpretation of the concept of “usual residence.”
• Prisoners do not interact or participate in the civic life of the community where they are incarcerated, are there involuntarily, and generally do not plan to remain in that community upon their release.
• One comment stated that inmates in local jails who are awaiting trial are presumed innocent, and therefore should not be counted at the jail.
Six comments were in support of the 2010 practice of counting prisoners at the prison, stating that adjusting prisoners' locations would be difficult, expensive, add unneeded complexity, and would be prone to inaccuracy. Of the six comments in support of counting prisoners at the prison, one mentioned a concern that adjusting the prisoners' locations could disenfranchise minorities in rural areas, and four said that changing the current practice could open the door to future census population count adjustments motivated by political gain.
States are responsible for legislative redistricting. The Census Bureau works closely with the states and recognizes that some states have decided, or may decide in the future, to `move' their prisoner population back to the prisoners' pre-incarceration addresses for redistricting and other purposes. Therefore, following the 2020 Census, the Census Bureau plans to offer a product that states can request, in order to assist them in their goals of reallocating their own prisoner population counts. Any state that requests this product will be required to submit a data file (indicating where each prisoner was incarcerated on Census Day, as well as their pre-incarceration address) in a specified format. The Census Bureau will review the submitted file and, if it includes the necessary data, provide a product that contains supplemental information the state can use to construct alternative within-state tabulations for its own purposes. However, the Census Bureau will not use the information in this product to make any changes to the official decennial census counts.
The Census Bureau also plans to provide group quarters data after the 2020 Census sooner than it was provided after the 2010 Census. For the 2010 Census, the Census Bureau released the
Of the 87 comments received pertaining to the military overseas, all suggested that the Census Bureau treat military personnel who are temporarily
In the 2010 Census, the Census Bureau counted all military personnel deployed or stationed overseas in their `home of record' state for apportionment purposes only. Their home of record was provided by the Department of Defense (DOD),
The commenters not only indicated that they want military personnel deployed overseas to be counted at their “usual residence,” “last duty station,” or “home base or port,” (which are inferred to mean the same thing), but also that they want the Census Bureau to collect all decennial census demographic data on these personnel and include them in the local community-level resident population counts, rather than only using a basic population count of them for determining the state-level apportionment counts. For example, many comments referred to the need for counting deployed military in the communities where they usually reside, because doing otherwise “produces flawed data that harms funding and planning in military communities.” Another comment referred to ensuring “communities have the needed resources to support these soldiers and their families.” These and other comments may refer to local-level planning and funding that is normally determined using the Census resident population data (available down to the block level) and not the apportionment counts, which are only available at the state level.
To support the argument for counting deployed military overseas at their usual residence in the United States, one of the 87 commenters compared how the Census Bureau counts U.S. military personnel deployed to a land-based location overseas versus U.S. military personnel on U.S. military vessels with a U.S. homeport. The “2010 Census Residence Rule and Residence Situations” stated that the latter are “counted at the onshore U.S. residence where they live and sleep most of the time. If they have no onshore U.S. residence, they are counted at their vessel's homeport.” The commenter argued that this is inconsistent with how the Census Bureau has counted military personnel who are deployed to a land-based location overseas (while stationed at a location in the United States), and asked that all branches of service be treated the same and counted at their residence or home base/port.
Based on the considerations described in the previous paragraph, for the 2020 Census, the Census Bureau proposes using administrative data from the DOD to count deployed personnel at their usual residence in the United States.
Two comments pertained to group homes for juveniles and two comments to residential treatment centers for juveniles. All four of the comments supported counting the juveniles in these situations at their “household residence.” One of the commenters on the group homes and one of the commenters on the residential treatment centers further stated that the juveniles should only be counted at their household residence if it is in the same state as the facility. If the residence is not in the same state, these two commenters stated that the juvenile should be counted at the facility. All four commenters argued that counting juveniles at the facility inflates the political power of the area where the facility is located and dilutes the representation of the juveniles' home communities.
Based on the considerations described in the previous paragraph, the Census Bureau has determined that the practice of counting people in group homes for juveniles at the facility is consistent with the concept of usual residence. However, for the 2020 Census, the Census Bureau proposes to count people in residential treatment centers for juveniles at the residence where they live and sleep most of the time. If they do not have a usual home elsewhere, they would be counted at the facility.
One of the comments received was related to boarding schools. The commenter suggested applying the current guidance for students attending college to students attending boarding
One letter commented on the specific wording of the residence criteria and four residence situations. The letter focused on people who experience homelessness in nontraditional ways, avoid shelters, and instead stay with family, friends, or acquaintances.
The comment was to add a fourth bullet (in addition to the three bullets that we already use to present the three main principles of the residence criteria, as shown in section D of this document) with language to make it clear where people experiencing homelessness, who are not in a shelter or facility, are counted.
The commenter suggested eliminating the “Visitors on Census Day” residence situation and merging it into the “People Away From Their Usual Residence on Census Day” situation. The commenter was concerned that the way the situation was described in the 2010 documentation implied that that `visitors' had another home to return to, which is not the case for visitors who are experiencing homelessness.
This commenter also suggested changing the 2010 wording for the category title “People Who Live in More Than One Place” to “People With Multiple Residences.” The examples in this category were not intended to address people experiencing homelessness. However, the commenter noted that people experiencing homelessness might stay in a different place from night to night, and therefore could also be interpreted as “People Who Live in More Than One Place.”
The commenter also suggested adding a residence situation for “couch-surfers, youth experiencing homelessness, or other people staying in your residence for short or indefinite periods of time” to the “People Without a Usual Residence” category. The commenter believed that the examples included in this category in 2010 only addressed the more typical conception of homelessness (
Finally, the commenter suggested adding the same new situation, “couch-surfers, youth experiencing homelessness, or other people staying in your residence for short or indefinite periods of time” to the “Nonrelatives of the Householder” category.
Three of the comments received did not address the residence criteria directly, nor did they address any particular residence situation.
One commenter suggested applying and communicating the residence criteria consistently across the country and cited the need for sound training for 2020 Census field workers, clear communication to 2020 Census partners and the public, and a “designated point-of-contact for residence determination.”
One comment requested that the Census Bureau revisit the 2010 Individual Census Report (ICR) questions related to collecting information about where else the respondent might live or stay, and
Most of the provisions regarding where people are counted, which are described in the proposed “2020 Census Residence Rule and Residence Situations” (section D of this document), would remain unchanged from those that were used for the 2010 Census. Therefore, this section C of this document will help the reader by providing a brief description of each of the proposed changes to where people are counted. All other changes to the proposed wording and/or presentation of the residence criteria and residence situations, as compared to how they were written for the 2010 Census, would be made in order to provide more clarity or to document provisions that were not explicitly stated in the past. (In other words, any differences between the 2010 and proposed 2020 Census residence criteria and situations documents that are not explained in section C of this document are only clarifications, rather than actual changes to the residence criteria or to where people would be counted in the decennial census.)
For the 2010 Census, military and civilian employees of the U.S. Government who were deployed or stationed/assigned outside the United States (and their dependents living with them outside the United States) were counted (using administrative data) in their home state for apportionment purposes only. For the 2020 Census, there would be no change to how the Census Bureau counts the military and civilian Federal employees who are stationed or assigned outside the United States. However, there would be a change for deployed personnel, such that military and civilian employees of the U.S. Government who are deployed outside the United States (while stationed or assigned in the United States) would be counted at their usual residence in the United States and included in all 2020 Census data products (rather than only the apportionment counts). This change seeks to count deployed personnel in a way that is more consistent with the concept of usual residence, based on the short duration of most deployments and the fact that the personnel will return to their usual residence where they are stationed or assigned in the United States after their temporary deployment ends. More details about the considerations for this change can be found in section B of this document.
The “2010 Census Residence Rule and Residence Situations” were not clearly consistent regarding whether citizenship was a criterion for being included in the federally affiliated overseas population. The wording of the residence situation for military personnel overseas did not specify any citizenship criteria. However, the wording for Federal civilian employees overseas did specifically refer to U.S. citizens only, and the operational plan for the 2010 Census Federally Affiliated Overseas Count specified that both military and civilian employees of the U.S. Government who were non-citizens were excluded from the overseas counts, despite the fact that non-citizens were included in the stateside population.
After the 2010 Census, the operational assessment report for the Federally Affiliated Overseas Count recommended that the “2020 Census Residence Rule and Residence Situations” should make the guidance regarding citizenship clear and consistent not only across both military and civilian employees overseas, but also across the overseas and stateside populations. When considering such a change, the Census Bureau concluded that the rationales that are used for including the federally affiliated overseas population in the decennial census (
For the 2010 Census, crews of U.S. flag maritime/merchant vessels were counted based on where the vessel was located on Census Day. If the vessel was docked in a U.S. port or sailing from one U.S. port to another U.S. port, then the crewmembers were counted at their onshore usual residence in the United States. (Or if they had no onshore usual residence, they were counted at the vessel's U.S. port of departure.) Otherwise, the crewmembers were not counted in the census if the vessel was sailing from a U.S. port to a foreign port, sailing from a foreign port to a U.S. port, sailing from one foreign port to another foreign port, or docked in a foreign port.
For the 2020 Census, there would be no change to how the Census Bureau counts crews of U.S. flag maritime/merchant vessels that are docked in a U.S. port, sailing from one U.S. port to another U.S. port, sailing from one foreign port to another foreign port, or docked in foreign port. However, there would be a change for crews of U.S. flag maritime/merchant vessels that are sailing from a U.S. port to a foreign port or sailing from a foreign port to a U.S. port, such that the crewmembers of these vessels would be counted at their onshore usual residence in the United States. (Or if they have no onshore usual residence, they would be counted at the U.S. port that the vessel is sailing to or from.) This change seeks to count crews of U.S. flag maritime/merchant vessels in a way that is more consistent with the concept of usual residence, based on the fact that mariners sailing between U.S. and foreign ports typically have the same pattern of usual residence as mariners sailing between two U.S. ports (
For the 2010 Census, all juveniles staying in residential treatment centers for juveniles on Census Day were counted at the facility. For the 2020 Census, juveniles staying in this type of facility would be counted at a usual home elsewhere if they have one (where they live and sleep most of the time around Census Day) and they report a useable address for that usual home elsewhere. If they do not have a usual home elsewhere, then they would be counted at the facility. This change seeks to count juveniles staying in
For the 2010 Census, people staying in religious group quarters were counted at a usual home elsewhere if they had one (where they lived and slept most of the time around Census Day) and they reported a useable address for that usual home elsewhere. If they did not have a usual home elsewhere, then they were counted at the facility. For the 2020 Census, all people staying in religious group quarters on Census Day would be counted at the facility.
The Residence Rule is used to determine where people are counted during the 2020 Census. The Rule says:
• Count people at their usual residence, which is the place where they live and sleep most of the time.
• People in certain types of group facilities on Census Day are counted at the group facility.
• People who do not have a usual residence, or who cannot determine a usual residence, are counted where they are on Census Day.
The following sections describe how the Residence Rule applies to certain living situations for which people commonly request clarification.
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Food and Drug Administration, HHS.
Notice of petition.
The Food and Drug Administration (FDA or we) is announcing that we have filed a petition, submitted by Keller and Heckman LLP on behalf of the Society of the Plastics Industry, Inc. (Petitioner or SPI), requesting that we amend our food additive regulations to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because this use has been abandoned.
The food additive petition was filed on May 11, 2016. Submit either electronic or written comments by August 29, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Thomas C. Zebovitz, Center for Food Safety and Applied Nutrition (HFS-275), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1244.
Under section 409(b)(5) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348(b)(5)), we are giving notice that we have filed a food additive petition (FAP 6B4816) submitted on behalf of the Society of the Plastics Industry, Inc. (Petitioner or SPI) by Keller and Heckman LLP, 1001 G Street NW., Suite 500 West, Washington, DC 20001. The petition proposes that we amend 21 CFR 177.1210 to no longer provide for the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers because the use has been intentionally and permanently abandoned.
Under section 409(i) of the FD&C Act, we “shall by regulation prescribe the procedure by which regulations under the foregoing provisions of this section may be amended or repealed, and such procedure shall conform to the procedure provided in this section for the promulgation of such regulations.” Our regulations specific to administrative actions for food additives provide that the Commissioner, on his own initiative or on the petition of any interested person, under 21 CFR part 10, may propose the issuance of a regulation amending or repealing a regulation pertaining to a food additive or granting or repealing an exception for such additive (21 CFR 171.130(a)). These regulations further provide that any such petition shall include an assertion of facts, supported by data, showing that new information exists with respect to the food additive or that new uses have been developed or old uses abandoned, that new data are available as to toxicity of the chemical, or that experience with the existing regulation or exemption may justify its amendment or repeal. New data must be furnished in the form specified in 21 CFR 171.1 and 171.100 for submitting petitions (21 CFR 171.130(b)). Under these regulations, a petitioner may propose that we amend a food additive regulation if the petitioner can demonstrate that there are “old uses abandoned” for the relevant food additive. Such abandonment must be complete for any intended uses in the U.S. market. While section 409 of the FD&C Act and § 171.130 also provide for amending or revoking a food additive regulation based on safety, an amendment or revocation based on abandonment is not based on safety, but is based on the fact that regulatory authorization is no longer necessary because the use of the food additive has been abandoned.
Abandonment may be based on the abandonment of certain authorized food additive uses for a substance (
The SPI petition includes the following information to support the claim that the use of potassium perchlorate as an additive in closure-sealing gaskets for food containers has been abandoned in the U.S. market. The petition states that three of the four companies that filed the food additive petitions that resulted in the listing for potassium perchlorate in 21 CFR 177.1210 are still operating, and that the fourth company is no longer in business. The Petitioner polled the three companies about their use of potassium perchlorate in closure-sealing gaskets for food containers asking them to verify that they do not: (1) Currently manufacture potassium perchlorate for use as a component of closures with sealing gaskets for food containers in the United States; (2) currently import potassium perchlorate for use as a component of closures with sealing gaskets for food containers in the United States; (3) intend to manufacture or import potassium perchlorate for use as a component of closures with sealing gaskets for food containers in the United States in the future; or (4) currently maintain any inventory of potassium perchlorate for sale or distribution into commerce that is intended to be marketed for use as a component of closures with sealing gaskets for food containers in the United States. The petition includes signed letters from the three companies confirming agreement to these four points.
The petition also includes a signed letter from American Pacific Corporation, Western Electrochemical Company (AMPAC), which the Petitioner states is the sole domestic manufacturer of potassium perchlorate in the United States. The letter states that AMPAC does not manufacture, import, or maintain any inventory of potassium perchlorate for sale or distribution into commerce into the food-contact market for use in closure-sealing gaskets for food containers in the United States.
The petition also asserts that SPI surveyed the member companies that make up SPI's Food, Drug, and Cosmetic Packaging Materials Committee (FDCPMC). According to the petition, no FDCPMC member company responded that it had any knowledge or reason to believe that potassium perchlorate was being manufactured, used, distributed, or imported into the United States for use in the manufacture of closures with sealing gaskets for food-contact applications. The petition also states that SPI has been unable to identify any company with records indicating that potassium perchlorate was actually used as a component of closure-sealing gaskets for food containers.
A supplement to the petition, dated May 16, 2016, asserts that SPI contacted all known U.S.-based manufacturers of gaskets for food-contact applications, which the Petitioner asserts constitute the substantial majority, if not all of such manufacturers. The supplement asserts that each company indicated to SPI that it does not continue to use potassium perchlorate in the manufacture of gaskets for food-contact materials.
We expressly request comments on the Petitioner's request to amend 21 CFR 177.1210 of the food additive regulations to no longer permit the use
We are providing the public with 60 days to submit comments. We anticipate that some interested persons may wish to provide FDA with certain information they consider to be trade secret or confidential commercial information (CCI) that would be exempt under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). Interested persons may claim information that is submitted to FDA as CCI or trade secret by clearly marking both the document and the specific information as “confidential.” Information so marked will not be disclosed except in accordance with the Freedom of Information Act (5 U.S.C. 552) and our disclosure regulations (21 CFR part 20). For electronic submissions to
We are not requesting comments on the safety of the use of potassium perchlorate in closure-sealing gaskets for food containers because such information is not relevant to abandonment, which is the basis of the proposed action. We will not consider any comments addressing the safety of potassium perchlorate or containing safety information on this substance in our evaluation of this petition. In addition to our consideration of this petition, we are considering information on the safety of potassium perchlorate as an additive in closure-sealing gaskets for food containers as part of our consideration of a petition designated for reference as FAP 4B4808 (see 80 FR 13508 (March 16, 2015)). We have determined under 21 CFR 25.32(m) 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.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve severable portions of revisions to the Oklahoma New Source Review (NSR) State Implementation Plan (SIP) submitted by the State of Oklahoma on June 24, 2010; July 16, 2010; December 27, 2010; February 6, 2012; and January 18, 2013. These revisions update the Prevention of Significant Deterioration (PSD) and Nonattainment NSR (NNSR) permit programs to be consistent with federal permitting requirements and make general updates to the Oklahoma SIP to support major NSR permitting. We are proposing this action under section 110, parts C and D of the Clean Air Act (CAA).
Written comments must be received on or before August 1, 2016.
Submit your comments, identified by Docket No. EPA-R06-OAR-2014-0221, at
Ms. Adina Wiley, (214) 665-2115,
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
The CAA at Section 110(a)(2)(C) requires states to develop and submit to the EPA for approval into the SIP, preconstruction review and permitting programs applicable to certain new and modified stationary sources of air pollutants for attainment/unclassifiable and nonattainment areas that cover both major and minor new sources and modifications, collectively referred to as the NSR SIP. The CAA NSR SIP program is composed of three separate programs: PSD, NNSR, and Minor NSR. PSD is established in part C of title I of the CAA and applies in areas that are designated as meeting the National Ambient Air Quality Standards (NAAQS),
On July 16, 2010, the State of Oklahoma submitted revisions to the General Provisions in the Oklahoma SIP that had been adopted by the State and became effective from 2003-2012. Revisions submitted to the EPA for review included updates to the definitions and units, abbreviations, and acronyms used throughout the Oklahoma SIP; provisions establishing the ability to incorporate by reference federal requirements; revisions to the PSD increments regulated under the Oklahoma SIP; and updates to the Emission Inventory provisions.
The State of Oklahoma submitted revisions to the Oklahoma PSD and NNSR Programs on June 24, 2010; July 16, 2010; February 6, 2012; and January 18, 2013. The revisions to the Oklahoma PSD and NNSR programs under review in this action have been submitted to address amendments that the EPA has made to the federal PSD and NNSR regulations as contained in the following final rules:
• NSR Reform Rule (67 FR 800186, December 31, 2002) and (68 FR 63021, November 7, 2003);
• Implementation of the 8-hour Ozone (O
• PSD and NNSR: Reasonable Possibility in Recordkeeping (72 FR 72607, December 21, 2007);
• NSR PM
• PSD for PM
• GHG Tailoring Rule (75 FR 31514, June 3, 2010) (specific to PSD permitting only);
• PSD and NNSR: Reconsideration of Inclusion of Fugitive Rule (76 FR 17548, March 30, 2011).
Some severable provisions submitted by the State of Oklahoma on June 24, 2010; July 16, 2010; February 6, 2012; and January 18, 2013 are not addressed in today's action. In some instances, the EPA has taken separate actions to propose or finalize a decision on these severable provisions. For the remaining provisions, the EPA has severed the submitted provisions from today's rulemaking and will address them at a later date. The Technical Support Document accompanying our rulemaking identifies the provisions that we are not evaluating or proposing in this action.
We have evaluated revisions to the General Provisions for the Oklahoma SIP submitted July 16, 2010; December 27, 2010; February 6, 2012; and January 18, 2013. These revisions, if approved by the EPA, would update the Oklahoma SIP to be consistent with current Oklahoma regulations and support the PSD and NNSR permitting programs in Oklahoma. We find that all of the revisions summarized below are consistent with federal requirements for SIP development under 40 CFR part 51; accordingly, we propose to approve the submitted rules as part of the Oklahoma SIP.
• The revisions to OAC 252:100-1-1, Purpose, and OAC 252:100-1-2, Definitions, effective June 12, 2003 and submitted on July 16, 2010, update the terms, phrases, and statutory definitions used throughout the Oklahoma SIP.
• The revisions to the General Definitions at OAC 252:100-1-3 effective on June 12, 2003; July 1, 2008; July 1, 2009; June 15, 2006; July 1, 2011; and July 1, 2012.
• New provisions at OAC 252:100-1-4 effective on June 12, 2003; July 1, 2009; and July 1, 2011 that establish the units, abbreviations, and acronyms germane to the Oklahoma SIP.
• New provisions at OAC 252:100-2-1, 252:100-2-3, and Appendix Q effective July 1, 2012, to provide the authority to incorporate by reference (IBR) federal requirements and to specifically identify the requirements that are incorporated into the Oklahoma regulations and SIP. The EPA is only proposing to approve the IBR of the identified portions of 40 CFR parts 50 and 51. All remaining portions of Appendix Q as submitted July 16, 2010 and January 18, 2013, were returned to the ODEQ by letters dated March 4, 2016 and May 16, 2016, respectively.
• Revisions to OAC 252:100-3-4 effective June 15, 2005 and July 1, 2011, to maintain consistency with federal requirements and adopt and implement the PSD PM
• New OAC 252:100, Appendix P—Regulated Air Pollutants, effective June 15, 2007, to identify the pollutants regulated under the CAA and EPA regulations.
• Revisions to the regulations at OAC 252:100, Subchapter 5—Registration, Emission Inventory, and Annual Operating Fees on July 16, 2010. These amendments, update the Subchapter 5 Definitions at OAC 252:100-5-1.1 to remove obsolete definitions and promote clarity and revise the Emission Inventory provisions at OAC 252:100-5-1.2 to include non-substantive edits to promote clarity to state Emission Inventory practices.
We evaluated amendments to the Oklahoma PSD and NNSR programs submitted on June 24, 2010; July 16, 2010, February 6, 2012, and January 18, 2013. These submitted revisions update
The EPA promulgated its NSR Reform Program rules on December 31, 2002 (67 FR 80186). On November 7, 2003 (68 FR 63021), the EPA promulgated a final action on its reconsideration of the December 31, 2002, NSR Reform Program rules. Our evaluation of the Oklahoma SIP submittals demonstrates the ODEQ has adopted and submitted revisions to the PSD and NNSR permitting programs that are sufficient for the ODEQ to implement the required elements of NSR Reform.
The rule revisions effective June 15, 2006, submitted as a revision to the Oklahoma SIP on July 16, 2010, include revisions to OAC 252:100 Part 7—Prevention of Significant (PSD) Requirements for Attainment Areas. The submission covers Applicability, PSD requirements, Actuals PALs, and Definitions that implement the NSR Reform revisions to PSD. To be approvable under the SIP, states implementing Part C (PSD permit program in 40 CFR 51.166) must include the EPA's December 31, 2002, changes as minimum PSD program elements. The following summary demonstrates the revisions to the Oklahoma PSD program satisfy the federal PSD program requirements:
• Incorporation of a new method for determining baseline actual emissions; defined in OAC 252:100-8-30 and OAC 252:100-8-31;
• Incorporation of the actual-to-projected-actual methodology for determining whether a major modification has occurred; found in OAC 252:100-8-30; and
• Inclusion of rules that allow major stationary sources to comply with Plantwide Applicability Limits (PALs) to avoid having a significant emissions increase that triggers the requirements of the major NSR program; found OAC 252:100-8-38.
The rule revisions effective June 15, 2006, submitted as a revision to the Oklahoma SIP on July 16, 2010, also include revisions to OAC 252:100 Part 9—Major Sources Affecting Nonattainment Areas. The submission covers Applicability, NNSR requirements, Actuals PALs, and Definitions that implement the NSR Reform revisions to NNSR. To be approvable under the SIP, states implementing Part D (NNSR permit program in 40 CFR 51.165) must include the EPA's December 31, 2002, changes as minimum NNSR program elements. The following summary demonstrates that the revisions to the Oklahoma NNSR program satisfy the federal NNSR program requirements.
• Incorporation of a new method for determining baseline actual emissions; defined in OAC 252:100-8-50 and OAC 252:100-8-51;
• Incorporation of the actual-to-projected-actual methodology for determining whether a major modification has occurred; found in OAC 252:100-8-50; and
• Inclusion of rules that allow major stationary sources to comply with Plantwide Applicability Limits (PALs) to avoid having a significant emissions increase that triggers the requirements of the major NSR program; found OAC 252:100-8-56.
The EPA finalized the O
The revisions to the Oklahoma PSD Program address the required elements of the EPA's final 8-hour ozone NAAQS Phase 2 rule as follows:
• The Oklahoma PSD program contains a revised definition of “major stationary source” at OAC 252:100-8-31, which specifies that a major source that is major for VOC or NO
• The Oklahoma PSD program contains a revised definition of “major modification” at OAC 252:100-8-31, which specifies that any significant increase or net emissions increase at a major stationary source that is significant for VOC or NO
• The Oklahoma PSD program contains a revised definition of “significant” at OAC 252:100-8-31, which specifies that the SER for ozone is 40 TPY of VOC or NO
• The Oklahoma PSD program contains a revised definition of “regulated NSR pollutant” at OAC 252:100-8-31, which specifies that VOC and NO
• The Oklahoma PSD program contains a revised exemption from PSD monitoring at OAC 252:100-8-33(c)(1)(F), which specifies that no de minimis air quality level is provided for ozone.
The EPA's final 8-hour ozone NAAQS Phase 2 Rule also codified requirements added to part D of Title I of the CAA in the 1990 Amendments related to permitting of major stationary sources in areas that are nonattainment for the O
• The Oklahoma NNSR program at OAC 252:100-8-51 incorporates by reference the federal NNSR definition of “major stationary source” at 40 CFR 51.165(a)(1)(iv) as of July 1, 2010.
• The definition of “major modification” at OAC 252:100-8-51 was revised by adding a new paragraph (C) and new OAC 252:100-8-54.1(a) together requiring NO
• The Oklahoma NNSR program at OAC 252:100-8-51 incorporates by reference the federal NNSR definition of “significant” at 40 CFR 51.165(a)(1)(x) as of July 1, 2010.
• New OAC 252:100-8-51.1(b) incorporates by reference the emission offset requirements in 40 CFR 51.165(a)(9) as of July 2, 2007.
• New OAC 252:100-8-54.1(b) makes the PM
The EPA finalized PSD and NNSR: Reasonable Possibility in Recordkeeping on December 21, 2007.
The Oklahoma PSD program does not include the reasonable possibility provisions as promulgated by EPA at 40 CFR 51.166(r)(6)(vi). Instead, in the Oklahoma PSD program, any source using the “projected actual emissions” methodology is required to comply with the recordkeeping requirements at 40 CFR 51.166(r)(6)(i)-(v). Similarly, the revisions to the Oklahoma NNSR program effective June 15, 2006, submitted July 16, 2010, incorporate by reference as of January 2, 2006, the requirements in 40 CFR 51.165(a)(6)(i) through (a)(6)(v), and do not include the reasonable possibility provisions promulgated at 40 CFR 51.165(a)(6)(vi).
The Oklahoma Department of Environmental Quality submitted a letter of interpretation on February 8, 2016, that explained how the Oklahoma PSD program applies the recordkeeping, monitoring and reporting requirements consistent with 40 CFR 51.166(r)(6)(i)-(v) to all sources that use the “projected actual emissions” methodology; not just a subset of sources for which there is a “reasonable possibility” that a project would result in a significant emissions increase of a regulated NSR pollutant. These requirements apply to
The EPA promulgated two rules establishing both required and optional implementation elements for PSD and NNSR permitting programs for PM
Our evaluation of the February 6, 2012, revisions to the Oklahoma PSD permitting program presented below and in our accompanying TSD, demonstrates that the Oklahoma PSD program includes all of the PSD required elements of the NSR PM
• Regulation of Direct PM
• Establish SERs: The revisions to the PSD definition of “significant” at OAC 252:100-8-31 establishes significant emission rates for direct PM
• Condensable PM
Based on the analysis presented below and in our accompanying TSD, the EPA is also proposing to find that the February 6, 2012, revision to the Oklahoma NNSR permitting program includes all of the NNSR requirements
• Regulation of Direct PM
• Establish SERs: The February 6, 2012, submittal incorporates by reference the definition of “significant” at 40 CFR 51.165(a)(1) as it exists on July 1, 2011, and will therefore include significant emission rates for direct PM
• Condensable PM
On January 4, 2013, the U.S. Court of Appeals for the District of Columbia Circuit, in
The 2008 PM
With respect to the nonattainment area requirements in affected rules, including the NNSR requirements of the 2008 PM
In a separate rulemaking process that will follow the April 2014 rule, the EPA is evaluating the requirements of subpart 4 as they pertain to, among other things, nonattainment NSR for PM
Notably, Oklahoma does not have any areas designated as nonattainment under either the 1997 or the 2006 PM
Nonetheless, as discussed above in our evaluation of the NNSR Definitions at OAC 252:100-8-51, the State of Oklahoma submitted a revision to the Oklahoma SIP on February 6, 2012, which included revisions to definitions in the Oklahoma NNSR Permitting Program to address PM
The revisions to Oklahoma's NNSR rule are not required by the statute at this time, nor do the revisions contain all of the necessary elements to satisfy the CAA requirements when evaluated under the subpart 4 provisions; however, the revisions represent an enhancement of the currently SIP-approved Oklahoma NNSR Permitting Program, which does not address PM
The EPA finalized the PSD for PM
With respect to the requirement that revisions to the PSD program must include the increment component of the PSD for PM
With respect to the NNSR Program, the October 20, 2010 final rule also codified the PM
The EPA's October 20, 2010 PSD for PM
On January 22, 2013, the U.S. Court of Appeals for the District of Columbia granted a request from the EPA to vacate and remand to the EPA portions of the federal PSD regulations (40 CFR 51.166(k)(2) and 52.21(k)(2)) setting forth provisions for implementing SILs for PM
Oklahoma has adopted and submitted provisions to establish the PM
The court ruling and the EPA's subsequent good cause final rulemaking only addressed the PSD revisions of the October 20, 2010, final rule; therefore there will be no impact on the submitted revisions to the Oklahoma NNSR program.
On June 3, 2010, the EPA published a final rule, known as the Tailoring Rule, which phased in permitting requirements for greenhouse gas (GHG) emissions from stationary sources under the CAA PSD and title V permitting programs (75 FR 31514). Under its interpretation of the CAA at the time, the EPA believed the Tailoring Rule was necessary to avoid a sudden and unmanageable increase in the number of sources that would be required to obtain PSD and title V permits under the CAA because the sources emitted or had the potential to emit GHGs above the applicable major source and major modification thresholds.
In Step 1 of the Tailoring Rule, which began on January 2, 2011, the EPA limited application of PSD and title V requirements for GHGs to sources that were subject to PSD or title V “anyway” due to their emissions of non-GHG pollutants. These sources are referred to as “anyway sources.” In Step 2 of the Tailoring Rule, which began on July 1, 2011, the EPA applied the PSD and title V permitting requirements under the CAA to sources that were classified as
In response to the
The ODEQ submitted revisions to the Oklahoma SIP addressing the regulation and permitting of GHGs on February 6, 2012 and January 18, 2013. The EPA finds that the provisions for Step 1 permitting submitted on February 6, 2012, at OAC 252:100-8-31, definition of “subject to regulation,” subparagraphs (A), (B), (C), (D), and (F) are consistent with federal requirements for Step 1 GHG Permitting at 40 CFR 51.166(b)(48). Additionally, the February 6, 2012 submittal included revisions to the general definitions at OAC 252:100-1-3 to include new definitions for CO
On May 23, 2016, the EPA promulgated our final disapproval of the provisions for Step 2 permitting submitted on February 6, 2012 and the revisions submitted on January 18, 2013 to implement the GHG Biomass Deferral.
Oklahoma's February 6, 2012, SIP submittal adds automatic rescission provisions to the State's PSD regulations at OAC 252:8-100-36.2, definition of “subject to regulation,” subparagraph (F). The automatic rescission provisions provide that in the event that federal legislation or a federal court determines that a portion of the EPA's tailoring rule, endangerment finding, or light-duty vehicle GHG standard is unenforceable, that provision will be enforceable in the Oklahoma PSD program only to the extent that it is enforceable by the EPA.
The EPA is proposing to approve the Oklahoma automatic rescission provisions. In assessing the approvability of this severability provision, the EPA considers two key factors: (1) Whether the public will be given reasonable notice of any change to the SIP that occurs as a result of the automatic rescission provisions, and (2) whether any future change to the SIP that occurs as a result of the automatic rescission provisions would be consistent with the EPA's interpretation of the effect of the triggering action on federal GHG permitting requirements.
Regarding public notice, CAA section 110(l) provides that any revision to a SIP submitted by a State to EPA for approval “shall be adopted by such State after reasonable notice and public hearing.” In accordance with CAA section 110(l), ODEQ followed applicable notice-and-comment procedures prior to adopting the automatic rescission provisions. Thus, the public is on notice that the automatic rescission provisions in the Oklahoma PSD program will enable the Oklahoma PSD program and the Oklahoma SIP to update automatically to reflect any order by a federal court or any change in federal law that limits or renders ineffective the regulation of GHGs under the CAA's PSD permitting program. In a letter dated April 22, 2016, the ODEQ has stated that it would provide notice to the general public and regulated community of the changes to the Oklahoma PSD program in the event of any change in the federal permitting requirements for GHGs.
The EPA's consideration of whether any SIP change resulting from Oklahoma's automatic rescission provisions would be consistent with our interpretation of the effect of the triggering action on federal GHG permitting requirements is based on 40 CFR 51.105, which states that “[r]evisions of a plan, or any portion thereof, will not be considered part of an applicable plan until such revisions have been approved by the Administrator in accordance with this part.” To be consistent with 40 CFR 51.105, any automatic SIP change resulting from a court order or federal law change must be consistent with the EPA's interpretation of the effect of such order or federal law change on GHG permitting requirements. We interpret this provision to mean that Oklahoma will wait for and follow the EPA's interpretation as to the impact of any federal law change or the D.C. Circuit or the U.S. Supreme Court issues an order before Oklahoma's SIP would be changed. In the event of a court decision or federal law change that triggers (or likely triggers) application of Oklahoma's automatic rescission provisions, the EPA intends to promptly describe the impact of the court decision or federal law change on the enforceability of its GHG permitting regulations. The EPA invites comment,
On December 19, 2008, the EPA issued a final rule revising the requirements of PSD and NNSR program regarding the treatment of fugitive emissions (Fugitive Emissions Rule, 73 FR 77882). The Fugitive Emissions Rule required fugitive emissions to be included in determining whether a physical or operational change results in a major modification only for sources in industries that have been designated through rulemaking under section 302(j) of the CAA. Previously, the EPA rules required that fugitive emissions be included in major modification applicable determinations for all source categories.
On February 17, 2009, the Natural Resources Defense Council (NRDC) submitted a petition for reconsideration of the December 2008 Fugitive Emissions Rule. On April 24, 2009, the EPA responded to the petition by letter indicating we were convening a reconsideration proceeding for the December 2008 Fugitive Emissions Rule and granted a 3-month administrative stay of the rule provisions. The initial 3-month administrative stay of the Fugitive Emissions Rule became effective on September 30, 2009.
Following is a summary of how the Oklahoma PSD program addresses fugitive emissions consistent with the current PSD requirements.
• The Oklahoma PSD program does not include the revisions to “major modification” or “net emissions increase” promulgated by the EPA in the December 2008 Fugitive Emissions Rule at 40 CFR 51.166(b)(2)(v) or 40 CFR 51.166(b)(3)(iii)(
• The Oklahoma PSD program continues to require fugitive emissions to be included in the major modification applicability determinations for all source categories.
• The Oklahoma SIP at OAC 252:100-1-3 includes the definition of “fugitive emissions” consistent with the federal definition at 40 CFR 51.166(b)(20).
• The definition of “projected actual emissions” at OAC 252:100-8-31 in the Oklahoma PSD program has been revised to include fugitive emissions to the extent quantifiable and emissions associated with startups, shutdowns, and malfunctions. This definition has also been revised to allow for the use of the emission unit's potential to emit in TPY consistent with 40 CFR 51.166(b)(40)(ii)(b) and (d).
• The definition of “baseline actual emissions” at OAC 252:100-8-31 in the Oklahoma PSD program has been revised to include fugitive emissions to the extent quantifiable for any existing electric utility steam generating unit (EUSGU) and any existing emissions unit other than an EUSGU consistent with 40 CFR 51.166(b)(47)(i)(a) and (ii)(a). This definition has also been revised to address the requirements for calculating baseline actual emissions for a new emissions unit consistent with 40 CFR 51.166(b)(47)(iii). This definition has also been revised to address the requirements for calculating baseline actual emissions or a PAL consistent with 40 CFR 51.166(b)(47)(iv).
• The Oklahoma SIP at OAC 252:100-8-33(a)(1)(B) includes the exemption at 40 CFR 51.166(i)(1)(ii).
• The source obligation provisions at OAC 252:100-8-36.2(c) for the requirements when using projected actual emissions are consistent with the obligation provisions found at 40 CFR 51.166(r)(6)(i)-(v). Note that the Oklahoma PSD program does not include the reasonable possibility provisions at 40 CFR 51.166(r)(6)(vi). Rather, the Oklahoma PSD program requires all sources using the “projected actual emissions” methodology to maintain records consistent with 40 CFR 51.166(r)(6). This is more stringent than federal requirements and is therefore approvable.
• The Oklahoma PSD program incorporates by reference the PSD PALs provisions at 40 CFR 51.166(w) as of July 2, 2007. However, the definition of “baseline actual emissions” for PALs is not part of this incorporation by reference. Per OAC 252:100-8-31 definition of “baseline actual emissions,” paragraph (E) for a PAL stationary source, the baseline actual emissions for an EUSGU or other existing emissions units other than an EUSGU shall be calculated using the general Oklahoma PSD definition of “baseline actual emissions” at OAC 252:100-8-31 and therefore will include fugitive emissions to the extent quantifiable.
Following is a summary of how the Oklahoma NNSR program addresses fugitive emissions.
• The Oklahoma NNSR program does not include the revisions to “major modification” or “net emissions increase” promulgated by the EPA in the December 2008 Fugitive Emissions Rule at 40 CFR 51.165(a)(1)(v)(G) or 40 CFR 51.165(a)(1)(vi)(C)(3), respectively. As such, the Oklahoma NNSR program does not include the provisions that are indefinitely stayed.
• The Oklahoma NNSR program continues to require fugitive emissions to be included in the major modification applicability determinations for all source categories.
• The Oklahoma NNSR program at OAC 252:100-8-51 incorporates by reference the federal NNSR definitions for “major stationary source,” “fugitive emissions,” and “projected actual emissions” as of July 1, 2010. The Oklahoma NNSR program does not IBR the definition of “baseline actual emissions,” rather the NNSR program relies on the Oklahoma PSD definition at OAC 252:100-8-31 for the definition of “baseline actual emissions.”
• The applicability provisions at OAC 252:100-8-50 have been evaluated elsewhere in this TSD and determined to be consistent with federal requirements for NNSR.
• The Oklahoma NNSR program at OAC 252:100-8-53 incorporates by reference the requirements of 40 CFR 51.165(a)(4) regarding the exemption of fugitive emissions in determining whether a source or modification is major as of July 2, 2007. The Oklahoma NNSR program source obligations at OAC 252:100-8-55 incorporates by reference the requirements of 40 CFR 51.165(a)(6)(i) through (v) as of July 2, 2007. Additionally the Oklahoma NNSR program at OAC 252:100-8-57 incorporates by reference the requirements at 40 CFR 51.165(f) regarding actuals PALs as of July 2, 2007.
Under Section 110(l), the EPA cannot propose to approve a SIP revision that has not been developed with reasonable notice and public hearing. Nor can we propose to approve a revision that will worsen air quality. The submitted revisions to the Oklahoma SIP were developed using the Oklahoma SIP-
For the reasons presented above and in our accompanying TSD, the EPA proposes to approve the severable revisions to the Oklahoma SIP submitted on June 24, 2010; July 16, 2010; December 27, 2010; February 6, 2012; and January 18, 2013. We have made the preliminary determination that the revisions were developed and submitted in accordance with the requirements of the CAA and the EPA's regulations regarding SIP development at 40 CFR part 51. Additionally, we have determined that the submitted revisions to the Oklahoma PSD and NNSR programs are consistent with our major source permitting regulations at 40 CFR 51.160-51.166 and the associated policy and guidance. Therefore, under section 110 and parts C and D of the Act, the EPA proposes to fully approve into the Oklahoma SIP the following revisions:
Upon promulgation of a final approval of the proposed revisions to address the GHG Step 1 permitting requirements, the EPA would also remove the provisions at 40 CFR 52.1929(c), under which the EPA narrowed the applicability of the Oklahoma PSD program to regulate sources consistent with federal requirements. The provisions at 40 CFR 52.1929(c) will no longer be necessary when we finalize approval of the State regulations into the Oklahoma SIP.
The EPA is proposing to find that the February 6, 2012, revisions to the Oklahoma NNSR program address all required NNSR elements for the implementation of the 1997 and 2006 PM
The EPA is also proposing a ministerial correction to 40 CFR 52.1920(c) to remove a duplicate entry for the SIP approval of OAC 252:100-5-1. We propose to remove the first listing of this section, and retain the identical entry in numerical order under OAC, Title 252, Subchapter 5—Registration, Emissions Inventory, and Annual Operating Fees.
The EPA invites the public to make comments on all aspects of our proposed full approval of the revisions to the Oklahoma SIP as presented above and to submit them by the indicated Date. After reviewing the comments received, we will make a final determination of the approvability of the specified revisions to the Oklahoma SIP in the
In this action, we are proposing to include in a final rule regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are proposing to incorporate by reference revisions to the Oklahoma regulations as described in the Proposed Action section above. We have made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Ohio Environmental Protection Agency (Ohio EPA) on July 15, 2015 and February 29, 2016, concerning the state's Stage II vapor recovery (Stage II) program for the Cleveland, Cincinnati, and Dayton ozone areas in Ohio. The revision removes Stage II requirements for the three areas as a component of the Ohio ozone SIP. The submittal also includes a demonstration as required by the Clean Air Act (CAA) that addresses emissions impacts associated with the removal of the program.
Comments must be received on or before August 1, 2016.
Submit your comments, identified by Docket ID No. EPA-R05-OAR-2015-0522 at
Francisco J. Acevedo, Mobile Source Program Manager, Control Strategies Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-6061,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This
I. Background
II. What changes have been made to the Ohio Stage II vapor recovery program?
III. What is EPA's analysis of the state's submittal?
IV. What action is EPA proposing to take?
V. Incorporation by Reference
VI. Statutory and Executive Order Reviews
Stage II and onboard refueling vapor recovery systems (ORVR) are two types of emission control systems that capture fuel vapors from vehicle gas tanks during refueling. Stage II systems are specifically installed at gasoline dispensing facilities (GDF) and capture the refueling fuel vapors at the gasoline pump nozzle. The system carries the vapors back to the underground storage tank at the GDF to prevent the vapors from escaping to the atmosphere. ORVR systems are carbon canisters installed directly on automobiles to capture the fuel vapors evacuated from the gasoline tank before they reach the nozzle. The fuel vapors captured in the carbon canisters are then combusted in the engine when the automobile is in operation. Stage II and vehicle ORVR were initially both required by the 1990 Amendments to the CAA under sections 182(b)(3) and 202(a)(6), respectively. In some areas Stage II has been in place for over 25 years, but Stage II was not widely implemented by the states until the early to mid-1990s as a result of the CAA requirements for moderate, serious, severe, and extreme ozone nonattainment areas, and for states in the Northeast Ozone Transport Region (OTR) under CAA section 184(b)(2).
CAA section 202(a)(6) required EPA to promulgate regulations for ORVR for light-duty vehicles (passenger cars). EPA adopted these requirements in 1994, at which point moderate ozone nonattainment areas were no longer subject to the section 182(b)(3) Stage II requirement. However, some moderate areas retained Stage II requirements to provide a control method to comply with rate-of-progress emission reduction targets. ORVR equipment has been phased in for new passenger vehicles beginning with model year 1998, and starting in 2001 for light-duty trucks and most heavy-duty gasoline-powered vehicles. ORVR equipment has been installed on nearly all new gasoline-powered light-duty vehicles, light-duty trucks and heavy-duty vehicles since 2006.
During the phase-in of ORVR controls, Stage II has provided volatile organic compound (VOC) reductions in ozone nonattainment areas and certain attainment areas of the OTR. Congress recognized that ORVR and Stage II would eventually become largely redundant technologies, and provided authority to EPA to allow states to remove Stage II from their SIPs after EPA finds that ORVR is in widespread use.
Effective May 16, 2012 (77 FR 28772), EPA determined that ORVR is in widespread nationwide use for control of gasoline emissions during refueling of vehicles at GDFs. Currently, more than 75 percent of gasoline refueling nationwide occurs with ORVR-equipped vehicles, so Stage II programs have become largely redundant control
EPA also exercised its authority under CAA section 202(a)(6) to waive certain Federal statutory requirements for Stage II gasoline vapor recovery at GDFs. This decision exempts all new ozone nonattainment areas classified serious or above from the requirement to adopt Stage II control programs. Similarly, any state currently implementing Stage II programs may submit SIP revisions that, once approved by EPA, would allow for the phase out of Stage II control systems. To assist states in the development of SIP revisions to remove Stage II requirements from their SIPs, EPA released its “Guidance on Removing Stage II Gasoline Vapor Control Programs from State Implementation Plans and Assessing Comparable Measures” (EPA-457/B-12-001) on August 7, 2012.
The Ohio EPA originally submitted a SIP revision to EPA on June 7, 1993, to satisfy the requirement of section 182(b)(3) of the CAA. The revision applied to the Cleveland (Ashtabula, Cuyahoga, Geauga, Lake, Lorain, Medina, Portage and Summit counties), Cincinnati (Butler, Clermont, Hamilton and Warren counties), and Dayton (Clark, Greene, Miami and Montgomery counties) ozone nonattainment areas in Ohio. EPA partially approved Ohio's Stage II program on October 20, 1994 (59 FR 52911), including the program's legal authority and administrative requirements found in the Ohio Administrative Code (OAC) rules 3745-21-09 (DDD)(1)-(4).
As a result of EPA's May 16, 2012 determination that ORVR is in widespread nationwide use for control of gasoline emissions during refueling of vehicles at GDFs, Ohio EPA initiated a rulemaking process to revise its SIP to remove Stage II requirements for all facilities in the Cleveland, Cincinnati and Dayton areas. As part of that rulemaking process, an Ohio-specific analysis following EPA's recommended methodology was also completed. The analysis concluded that, starting in calendar year 2017, ORVR would be in widespread use in Ohio and that there would be no remaining emissions reduction benefit from Stage II requirements beyond the benefits from ORVR.
On July 15, 2015, and February 29, 2016, the Ohio EPA submitted a SIP revision requesting EPA approval of amendments to OAC 3745-21-09 (DDD) that removes Stage II requirements from the Ohio ozone SIP and allows GDFs currently implementing Stage II in the Cleveland, Cincinnati and Dayton areas to decommission their systems by 2017. To support the removal of the Stage II requirements, the revision included amended copies of OAC 3745-21-09 (DDD), as adopted on April 29, 2013, and January 17, 2014; a summary of Ohio-specific calculations based on EPA guidance used to calculate program benefits and demonstrate widespread use of ORVR in Ohio; and a section 110(l) demonstration that includes documentation that addresses the period, 2013-2017, when Stage II requirements were waived in Ohio but widespread use of ORVR has not yet occurred.
EPA's primary consideration for determining the approvability of Ohio's request is whether this requested action complies with section 110(l) of the CAA.
Section 110(l) requires that a revision to the SIP not interfere with any applicable requirement concerning attainment and reasonable further progress (as defined in section 171), or any other applicable requirement of the Act. EPA evaluates each section 110(l) noninterference demonstration on a case-by-case basis considering the circumstances of each SIP revision. EPA interprets 110(l) as applying to all national ambient air quality standards (NAAQS) that are in effect, including those that have been promulgated but for which EPA has not yet made designations. The degree of the analysis focused on any particular NAAQS in a noninterference demonstration varies depending on the nature of the emissions associated with the proposed SIP revision.
In its July 15, 2015, and February 29, 2016, SIP revision, the Ohio EPA used EPA's guidance to conduct a series of calculations to determine the potential impact of removing the Stage II program on air quality.
Ohio EPA has calculated that beginning in 2017, ORVR will be in widespread use in all three program areas and the absence of the Ohio Stage II program starting in 2017 would not result in a net VOC emissions increase compared to the continued utilization of this emissions control technology. The emission reduction losses resulting from removing Stage II before 2017 are transitional and relatively small since ORVR-equipped vehicles will continue to phase into the fleet over the coming years. Ohio EPA's calculation indicates a maximum potential loss of 1.858 tons per summer day (tpsd) in Cleveland, 0.914 tpsd in Cincinnati, and 0.655 tpsd in Dayton from 2013 through 2016. In 2013, the year with the highest level of emission increases, these summer day emissions increases are only 0.21 percent to 0.26 percent of the typical summer day VOC emissions rate in the three areas. These emissions increases
To help offset the initial emissions increases during the Stage II phase out period, Ohio EPA is requiring the installation of low permeation hoses at GDFs. Ohio EPA has calculated that low permeation hoses will provide 42.9 tons of VOC emission reductions each year during the ozone seasons (21.4 tons for Cleveland area, 13.6 tons for Cincinnati area, and 7.9 for Dayton area) starting in 2013. Table 1 shows the increase of emissions associated with the phase out of State II systems at facilities in all program areas in Ohio starting in 2013, as well as offset emissions associated with the requirement of low permeation hoses at GDFs.
As illustrated in Table 1, and documented in Ohio's SIP revision, for each year prior to the widespread use of ORVR in Ohio (2017) starting in 2013, the VOC emissions increase associated with the removal of Stage II systems is eventually offset by the VOC emission reductions attributed to ORVR being in widespread use in Ohio and the requirement of low permeation hoses at GDFs.
EPA believes that the removal of the Ohio Stage II program does not interfere with Ohio's ability to demonstrate compliance with the 8-hour ozone NAAQS in all three areas. This is based on the use of permanent, enforceable, contemporaneous, surplus emissions reductions achieved through the requirement of low permeation hoses at GDFs, and the fact that the small emissions increase is both temporary and insignificant with respect to the total summer day emission rates for sectors in these areas.
EPA also examined whether the removal of Stage II program requirements in all three areas will interfere with attainment of other air quality standards. All the counties in the Dayton area are designated attainment for all standards, including sulfur dioxide and nitrogen dioxide. Cincinnati is designated attainment for all standards other than ozone and sulfur dioxide. The Cleveland area is designated attainment for all standards other than ozone, lead (Cuyahoga Co.), sulfur dioxide (Lake Co.) and particulate matter (Cuyahoga and Lorain Counties). Based on Ohio EPA's 110(l) analysis, EPA has no reason to believe that the removal of the Stage II program in Ohio will cause the areas to become nonattainment for any of these pollutants. In addition, EPA believes that removing the Stage II program requirements in Ohio will not interfere with the areas' ability to meet any other CAA requirement.
Based on the above discussion and the state's section 110(l) demonstration, EPA believes that removal of the Stage II program would not interfere with attainment or maintenance of any of the NAAQS in the Cleveland, Cincinnati, and Dayton areas and would not interfere with any other applicable requirement of the CAA, and thus, are approvable under CAA section 110(l).
EPA is proposing to approve the revision to the Ohio ozone SIP submitted by Ohio EPA on July 15, 2015, and February 26, 2016, because we find that the revision meets all applicable requirements and it would not interfere with reasonable further progress or attainment of any of the NAAQS.
In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference Ohio rule 3745-21-09 “Control of emissions of volatile organic
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen oxides, Ozone, Volatile organic compounds.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to revise provisions of the Arizona Regional Haze Federal Implementation Plan (FIP) applicable to the Phoenix Cement Company (PCC) Clarkdale Plant and the CalPortland Cement (CPC) Rillito Plant. In response to requests for reconsideration from the plants' owners, we propose to replace the control technology optimization requirements for nitrogen oxides (NO
Written comments must be submitted on or before August 15, 2016. Requests for a public hearing must be received on or before July 15, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0846 at
Vijay Limaye, U.S. EPA, Region 9, Planning Office, Air Division, AIR-2, 75 Hawthorne Street, San Francisco, CA 94105. Vijay Limaye can be reached at telephone number (415) 972-3086 and via electronic mail at
Throughout this document, “we,” “us,” and “our” refer to the EPA.
For the purpose of this document, we are giving meaning to certain words or initials as follows:
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The proposed action relies on documents, information, and data that are listed in the index on
If anyone contacts the EPA by July 15, 2016 requesting to speak at a public hearing, the EPA will schedule a public hearing and announce the hearing in the
This section provides a brief overview of the requirements of the Clean Air Act (CAA) and the EPA's Regional Haze Rule, as they apply to this particular action. Please refer to our previous rulemakings on the Arizona Regional Haze State Implementation Plan (SIP) for additional background regarding the visibility protection provisions of the CAA and the Regional Haze Rule.
Congress created a program for protecting visibility in the nation's national parks and wilderness areas in section 169A of the 1977 Amendments to the CAA. This section of the CAA establishes as a national goal the “prevention of any future, and the remedying of any existing, impairment of visibility in mandatory Class I Federal areas which impairment results from man-made air pollution.”
The Arizona Department of Environmental Quality (ADEQ) submitted a Regional Haze SIP to the EPA on February 28, 2011. The EPA promulgated two final rules approving in part and disapproving in part the Arizona Regional Haze SIP. The first final rule addressed the State's BART determinations for three power plants (Apache Generating Station, Cholla Power Plant, and Coronado Generating Station).
In a third final rule, the EPA promulgated a FIP addressing the requirements of the Regional Haze Rule and interstate visibility transport for the remainder of the disapproved portions of Arizona's Regional Haze SIP.
PCC and CPC each submitted a petition to the EPA on November 3, 2014, seeking administrative reconsideration and a partial stay of the final FIP under CAA section 307(d)(7)(B) and the Administrative Procedure Act.
The EPA sent letters to PCC and CPC on January 16, 2015 and January 27, 2015, respectively, granting reconsideration of the optimization requirements pursuant to CAA section 307(d)(7)(B).
In light of the objections to the control technology demonstration requirements raised by CPC and PCC, we have re-evaluated the necessity of these requirements for the Rillito and Clarkdale plants. As explained in our September 3, 2014 final rule, the two objectives of the control technology demonstration requirements are to ensure that the NO
The EPA is proposing to remove the control technology demonstration requirements for Kiln 4 (the preheater/precalciner kiln) at the CPC Rillito Plant based on NO
As noted in the response to comments in our September 3, 2014 final rule,
Following promulgation of the final rule on September 3, 2014, the Mojave Plant completed a 270-day demonstration period of its SNCR system.
Given that the SNCR system on the Rillito Kiln 4 can be expected to underperform the Mojave Plant, and that the Mojave demonstration period data resulted in a limit reflecting an SNCR control efficiency of only 40%,
The EPA is also proposing to remove the control technology demonstration requirements for Kiln 4 (the preheater/precalciner kiln) at the PCC Clarkdale Plant based on the NO
As described in III.A above, we no longer consider it necessary for CPC and PCC to comply with the relatively prescriptive and detailed optimization requirements established in our September 4, 2014 final rule. We are therefore proposing to remove the control technology demonstration requirements in the FIP for the Clarkdale and Rillito Plants, and instead are proposing certain revisions to the reporting and recordkeeping requirements that involve documentation and submittal of certain design and optimization activities that are part of a typical SNCR system installation. Specifically, we propose to require PCC and CPC to submit a report of SNCR design prior to commencing construction of the ammonia injection system at Clarkdale Kiln 4 and Rillito Kiln 4 respectively, including information regarding reagent type, locations selected for reagent injection, reagent injection rate, equipment arrangement, and kiln characteristics. In addition, PCC and CPC would be required to submit a report of SNCR debugging and process improvement activities, including a description of each process adjustment performed on the SNCR system, a discussion of whether the adjustment affected the NO
The CAA requires that any revision to an implementation plan shall not be approved by the Administrator if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress or any other applicable requirement of the CAA.
For the reasons described above, the EPA proposes to revise the Arizona Regional Haze FIP to replace the control technology optimization requirements at the PCC Clarkdale Plant and the CPC Rillito Plant with a series of recordkeeping and reporting requirements. Please note that while the proposed regulatory text includes the entirety of 40 CFR 52.145(k), we are only proposing to revise those elements of the regulation related to optimization requirements.
Additional information about these statutes and Executive Orders can be found at
This proposed action is not a “significant regulatory action” under the terms of Executive Order 12866 (58 FR 51735, October 4, 1993) and is therefore not subject to review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). This proposed rule applies to only one facility and is therefore not a rule of general applicability.
This action does not impose an information collection burden under the provisions of the PRA, 44 U.S.C. 3501
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities. For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as: (1) A small business as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. Pursuant to 13 CFR 121.201, footnote 1, a firm is small if it is in NAICS 327310 (cement manufacturing) and the concern and its affiliates have no more than 750 employees. CPC is owned by Taiheiyo Cement Corporation, which has more
This action does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538. This action may significantly or uniquely affect small governments. As a tribal government, SRPMIC is considered a “small government” under UMRA. See 2 U.S.C. 658(11) and (13). The EPA consulted with SRPMIC concerning the regulatory requirements that might significantly or uniquely affect it.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or in the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132.
This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. This proposed action, if finalized, would eliminate the SNCR optimization requirements that currently apply to the PCC Clarkdale Plant. The profits from the Clarkdale Plant are used to provide government services to SRPMIC's members.
The EPA consulted with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it does not change the level of environmental protection for any affected populations.
Pursuant to CAA section 307(d)(1)(B), the EPA proposes to determine that this action is subject to the provisions of section 307(d). Section 307(d) establishes procedural requirements specific to certain rulemaking actions under the CAA. Pursuant to CAA section 307(d)(1)(B), the revision of the provisions of the Arizona Regional Haze FIP that apply to the PCC Clarkdale Plant and the CPC Rillito Plant is subject to the requirements of CAA section 307(d), as it constitutes a revision to a FIP under CAA section 110(c).
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen oxides, Reporting and recordkeeping requirements, Visibility.
42 U.S.C. 7401
Part 52, chapter I, title 40 of the Code of Federal Regulations is proposed to be amended as follows:
42 U.S.C. 7401
The revision reads as follows:
(k)
(2)
(3)
(ii) The owner/operator of kiln 4 of the Rillito Plant, as identified in paragraph (k)(1) of this section, shall not emit or cause to be emitted from kiln 4 NO
(4)
(5)
(ii) If the owner/operator of the Clarkdale Plant chooses to comply with the emission limit of paragraph (k)(4) of this section in lieu of paragraph (k)(3)(i) of this section, the owner/operator shall comply with the NO
(6) [Reserved]
(7)
(B) At all times after the compliance date specified in paragraph (k)(5) of this section, the owner/operator of the unit at the Rillito Plant shall maintain, calibrate, and operate a CEMS, in full compliance with the requirements found at 40 CFR 60.63(f) and (g), to accurately measure concentration by volume of NO
(ii)
(B)(
(
(C) At the end of each kiln operating day, the owner/operator shall calculate and record a new 30-day rolling average emission rate in lb/ton clinker from the arithmetic average of all valid hourly emission rates for the current kiln operating day and the previous 29 successive kiln operating days.
(D) Upon and after the completion of installation of ammonia injection on a unit, the owner/operator shall install, and thereafter maintain and operate, instrumentation to continuously monitor and record levels of ammonia injection for that unit.
(8)
(i)
(ii)
(iii) Upon and after the completion of installation of ammonia injection on the unit, the owner/operator shall install, and thereafter maintain and operate, instrumentation to continuously monitor and record levels of ammonia injection for that unit.
(9)
(i) All CEMS data, including the date, place, and time of sampling or measurement; emissions and parameters sampled or measured; and results.
(ii) All records of clinker production.
(iii) Daily 30-day rolling emission rates of NO
(iv) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records specified by 40 CFR part 60, Appendix F, Procedure 1.
(v) Records of ammonia consumption, as recorded by the instrumentation required in paragraph (k)(7)(ii)(D) of this section.
(vi) Records of all major maintenance activities conducted on emission units, air pollution control equipment, CEMS and clinker production measurement devices.
(vii) Any other records specified by 40 CFR part 60, subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(10)
(i) All CEMS data, including the date, place, and time of sampling or measurement; emissions and parameters sampled or measured; and results.
(ii) Monthly rolling 12-month emission rates of NO
(iii) Records of quality assurance and quality control activities for emissions measuring systems including, but not limited to, any records specified by 40 CFR part 60, Appendix F, Procedure 1.
(iv) Records of ammonia consumption, as recorded by the instrumentation required in paragraph (k)(8)(iii) of this section.
(v) Records of all major maintenance activities conducted on emission units, air pollution control equipment, and CEMS measurement devices.
(vi) Any other records specified by 40 CFR part 60, subpart F, or 40 CFR part 60, Appendix F, Procedure 1.
(11)
(i) Prior to commencing construction of the ammonia injection system, the owner/operator shall submit to EPA a report describing the design of the SNCR system. This report shall include: Reagent type, description of the locations selected for reagent injection, reagent injection rate (expressed as a molar ratio of reagent to exhaust gas), equipment list, equipment arrangement, and a summary of kiln characteristics that were relied upon as the design basis for the SNCR system.
(ii) Within 30 days following the NO
(iii) The owner/operator shall submit a report that lists the daily 30-day rolling emission rates for NO
(iv) The owner/operator shall submit excess emissions reports for NO
(v) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(vi) The owner/operator shall also submit results of any CEMS performance tests specified by 40 CFR part 60, Appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(vii) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the reports required by paragraph (k)(9)(ii) of this section.
(12)
(i) The owner/operator shall submit a report that lists the monthly rolling 12-month emission rates for NO
(ii) The owner/operator shall submit excess emissions reports for NO
(iii) The owner/operator shall submit CEMS performance reports, to include dates and duration of each period during which the CEMS was inoperative (except for zero and span adjustments and calibration checks), reason(s) why the CEMS was inoperative and steps taken to prevent recurrence, and any CEMS repairs or adjustments.
(iv) The owner/operator shall also submit results of any CEMS performance tests specified by 40 CFR part 60, Appendix F, Procedure 1 (Relative Accuracy Test Audits, Relative Accuracy Audits, and Cylinder Gas Audits).
(v) When no excess emissions have occurred or the CEMS has not been inoperative, repaired, or adjusted during the reporting period, the owner/operator shall state such information in the reports required by paragraph (k)(9)(ii) of this section.
(13)
(ii) The owner/operator shall submit semiannual progress reports on construction of any such equipment.
(iii) The owner/operator shall submit notification of initial startup of any such equipment.
(iv) By June 30, 2018, the owner/operator of the Clarkdale Plant shall notify EPA Region 9 by letter whether it will comply with the emission limits in paragraph (k)(3)(i) of this section or whether it will comply with the emission limits in paragraph (k)(4) of this section. In the event that the owner/operator does not submit timely and proper notification by June 30, 2018, the owner/operator of the Clarkdale Plant may not choose to comply with the alternative emission limits in paragraph (k)(4) of this section and shall comply with the emission limits in paragraph (k)(3)(i) of this section.
(14)
(ii) After completion of installation of ammonia injection on a unit, the owner or operator shall inject sufficient ammonia to achieve compliance with NO
(15)
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) regarding the use of customary contact financing, other than loan guarantees and advance payments, on certain fixed-price contracts.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 29, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2015-D026, using any of the following methods:
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Comments received generally will be posted without change to
Mr. Mark Gomersall, telephone 571-372-6099.
DoD is proposing to revise the DFARS regarding the use of customary contract financing, other than loan guarantees and advance payments identified in FAR part 32, on fixed-price contracts with a period of performance in excess of one year that meet the dollar thresholds established in FAR 32.104(d). DoD has determined that the use of such customary contract financing provides improved cash flow as an incentive for commercial companies to do business with DoD, is in DoD's best interest, and requires no further justification of its use.
The proposed rule amends DFARS 232.104 to state that DoD has made the determination that the use of customary contract financing (see FAR 32.113), other than loan guarantees and advance payments, is in DoD's best interest, and further justification of its use is unnecessary on fixed-price contracts that meet the dollar thresholds established in FAR 32.104(d), with a period of performance in excess of a year, and in solicitations expected to result in such contracts.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to state that DoD has made the determination that the use of customary contract financing (see Federal Acquisition Regulation (FAR) 32.113), other than loan guarantees and advance payments, is in DoD's best interest, and further justification of its use is unnecessary on fixed-price contracts that meet the dollar thresholds established in FAR 32.104(d), with a period of performance in excess of a year, and in solicitations expected to result in such contracts.
The objective of the proposed rule is to clarify that the use of certain customary contract financing does not require further justification, as it has been determined to be in DoD's best interest, and the use of the specified contract financing is an incentive for commercial companies to do business with DoD.
This rule will apply to DoD contractors, including small entities, where a fixed-price contract with a period of performance in excess of one year and meeting the thresholds in FAR 32.104(d) is contemplated.
There is no change to reporting or recordkeeping as a result of this rule. This rule changes processes that are internal to the Government and does not have any impact on small entities for reporting or recordkeeping.
The rule does not duplicate, overlap, or conflict with any other Federal rules. There are no known significant alternative approaches to the rule that would meet the requirements.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2015-D026), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 232 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
For fixed-price contracts with a period of performance in excess of a year that meet the dollar thresholds established in FAR 32.104(d), and for solicitations expected to result in such contracts, in lieu of the requirement at FAR 32.104(d)(1)(ii) for the contractor to demonstrate actual financial need or the unavailability of private financing, DoD has determined that—
(1) The use of customary contract financing (see FAR 32.113), other than loan guarantees and advance payments, is in DoD's best interest; and
(2) Further justification of its use in individual acquisitions is unnecessary.
Defense Acquisition Regulations System, Department of Defense (DoD).
Proposed rule.
DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to revise the estimated administrative cost to award and administer a contract, for the purpose of evaluating bids for multiple awards.
Comments on the proposed rule should be submitted in writing to the address shown below on or before August 29, 2016, to be considered in the formation of a final rule.
Submit comments identified by DFARS Case 2016-D020, using any of the following methods:
○
○
○
○
Comments received generally will be posted without change to
Mr. Christopher Stiller, telephone 571-372-6176.
DoD is proposing to revise the DFARS to implement a policy that addresses the Government's cost to award and administer a contract, for the purpose of evaluating bids for multiple awards. The provision at DFARS 252.247-7008, Evaluation of Bids—Basic, and its Alternate I, reflects that $500 is the administrative cost to the Government for issuing and administering contracts. Based on increase in the Consumer Price Index since 1990, an upward adjustment of $500 in the provision to $1,000 would be a realistic reflection of the actual cost to the Government to issue and administer a contract. This increase conforms to an equivalent adjustment proposed under FAR Case 2016-003 published in the
Amendments to DFARS provision 252.247-7008, Evaluation of Bids—Basic, and its Alternate I, are proposed by this rule. A monetary adjustment is proposed to increase, from $500 to $1,000, the administrative cost to the Government for issuing and administering each contract to be awarded under a solicitation for the purpose of evaluating bids for multiple awards.
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This is not a significant regulatory action and, therefore, was not subject to review under section 6(b) of E.O. 12866, Regulatory Planning and Review, dated September 30, 1993. This rule is not a major rule under 5 U.S.C. 804.
DoD does not expect this proposed rule to have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601,
The clause at DFARS 252.247-7008, Evaluation of Bids, reflects that $500 is the administrative cost to the Government for issuing and administering contracts. The rule is necessary to reestablish a more realistic estimate of the cost to award and administer a contract, for the purpose of evaluating bids for multiple awards. The estimated administrative cost to award and administer a contract has not changed since 1990.
The objective of this rule is to revise DFARS 252.247-7008, Evaluation of Bids, to include an inflation adjustment based on increase in the Consumer Price Index since 1990. See
According to the Federal Procurement Data System, in fiscal year 2015, the Federal Government made approximately 2,019 definitive contract awards to small businesses using sealed bidding procedures and 103 indefinite delivery contract awards to small businesses using sealed bidding procedures, 12 of which were multiple awards. Thus, DoD does not expect this rule to have an economic impact on a substantial number of small entities. Additionally, the rule does not place any new requirements on small entities.
The rule does not duplicate, overlap, or conflict with any other Federal rules.
There are no significant alternatives to the rule which accomplish the stated objectives.
DoD invites comments from small business concerns and other interested parties on the expected impact of this rule on small entities.
DoD will also consider comments from small entities concerning the existing regulations in subparts affected by this rule in accordance with 5 U.S.C. 610. Interested parties must submit such comments separately and should cite 5 U.S.C. 610 (DFARS Case 2016-D020), in correspondence.
The rule does not contain any information collection requirements that require the approval of the Office of Management and Budget under the Paperwork Reduction Act (44 U.S.C. chapter 35).
Government procurement.
Therefore, 48 CFR part 252 is proposed to be amended as follows:
41 U.S.C. 1303 and 48 CFR chapter 1.
Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of proposed rulemaking (NPRM).
In response to petitions for rulemaking submitted by the regulated community, PHMSA proposes to amend the Hazardous Materials Regulations (HMR; 49 CFR parts 171 through 180) to update, clarify, or provide relief from miscellaneous regulatory requirements. Specifically, PHMSA is proposing amendments that include, but are not
Comments must be submitted by August 29, 2016. To the extent possible, PHMSA will consider late-filed comments as a final rule is developed.
You may submit comments by identification of the docket number [PHMSA-2015-0102 (HM-219A)] by any of the following methods:
•
•
•
•
Steven Andrews or Matthew Nickels, (202) 366-8553, Office of Hazardous Materials Standards, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
The Administrative Procedure Act (APA) requires Federal agencies to give interested persons the right to petition an agency to issue, amend, or repeal a rule (5 U.S.C. 553(e)). Section 106.95 of the HMR contains the rulemaking procedures for persons to ask PHMSA (also “we” or “us”) to add, amend, or delete a regulation by filing a petition for rulemaking containing adequate support for the requested action. In this NPRM, PHMSA proposes to amend the HMR in response to petitions for rulemaking submitted by shippers, carriers, manufacturers, and industry representatives. These proposed revisions are intended to reduce regulatory burdens while maintaining or enhancing the existing level of safety. We discuss the petitions and proposals in detail in Section II of this NPRM. The following is a brief summary of the proposed regulatory changes:
• Revise approved testing methods for aerosols.
• Revise a table related to cargo tank specifications.
• Update the IBR citation for chlorine tank cars.
• Address inconsistencies between international and domestic labels.
• Revise the vessel requirement to notify the Captain of the Port (COTP) to the presence of limited quantities of hazardous materials.
• Revise testing requirements for packages to allow liquids to be used in place of solid materials.
• Add a shipping description for roadway striping vehicles.
• Extend the service life of tank cars authorized under HM-246 to the full service life of other tanks cars authorized under § 215.203 of the Federal Railroad Administration (FRA) regulations.
• Permit the use of pallets made of non-wood materials for limited quantities.
• Revise requirements for when emergency response numbers are required for excepted quantities.
• Change units for limited quantities of ethyl alcohol to the International System of Units.
• Propose changes concerning valve requirements for cylinders as outlined in “CGA V-9-2012, Compressed Gas Association Standard for Compressed Gas Cylinder Valves, Seventh Edition.”
• Incorporate CGA standard “CGA C-7-2014, Guide to Classification and Labeling of Compressed Gases, Tenth Edition.”
• Remove requirement for the marking of the service pressure on DOT 8 and DOT 8L cylinders.
• Revise recordkeeping requirements for certain cargo tanks certified in accordance with the ASME Code.
• Revise the printing tolerances for label and placard sizes.
• Incorporate Department of Defense (DoD) explosives manual into § 171.7.
• Allow use of electronic manifest.
• Amend the HMR to acknowledge that the marked date of manufacture on a composite Intermediate Bulk Container (IBC) may differ from the marked date of manufacture on the inner receptacle of that IBC.
• Revise the basis weight tolerance provided in § 178.516(b)(7) from ± 5 percent to ± 10 percent from the nominal basis weight reported in the initial design qualification test report for 4G boxes.
In its petition (P-1606), the Council on Safe Transportation of Hazardous Articles (COSTHA) requested that PHMSA allow alternative testing methods, such as those identified in Sections 6.2.4.2.2 and 6.2.4.3 of the United Nations (UN) Model Regulations, to the hot water bath test for aerosols currently found in § 173.306(a)(3)(v) of the HMR. Specifically, COSTHA requested that § 173.306(a)(3) be revised to allow the hot water bath test to be used for aerosols as is allowed in the UN Model Regulations.
On February 22, 2016, PHMSA published a final rule under Docket HM-233F entitled “Adoption of Special Permits” [81 FR 3635] incorporating special permits that allow for alternatives to the hot water bath test similar to those found in the UN Model Regulations. PHMSA believes these alternatives to the hot water bath test satisfy the intent of this petition and it is no longer necessary to propose any new regulatory text at this time.
In its petition (P-1615), The Walker Group requested revisions to the table in § 180.407(g)(1)(iv) to make this section consistent with the applicable packaging specification (
This petition seeks to eliminate confusion by changing the regulations to allow the use of the marked test pressure on the cargo tank nameplate as the requalification test pressure and to amend every test pressure entry in the § 180.407(g)(1)(iv) test pressure table by beginning the entries with the phrase, “The test pressure on the nameplate (specification plate).” PHMSA conducted both a technical and policy review of the petition, and instead of modifying every test pressure entry as suggested by the petitioner, PHMSA is proposing that revisions should only apply to certain cargo tank specifications (DOT 407, MC 304, and MC 307) to harmonize the periodic hydrostatic testing required by part 180 with the initial testing for the applicable packaging specification prescribed in part 178. The revisions should further clarify that test pressures (in case of periodic pneumatic testing required by part 180) are already consistent with the initial testing for the applicable packaging specification prescribed in part 178.
In its petition (P-1619), the Chlorine Institute requested that updates to publications currently listed in § 171.7(l)—specifically § 171.7(l)(1), (2), (5), and (12)—and referenced in various sections of the HMR be incorporated by reference. PHMSA has conducted a review of these publications and found them suitable to propose incorporation into the HMR. Therefore, PHMSA is proposing to include the following updated documents in the referenced material:
• Chlorine Institute Emergency Kit “A” for 100-lb. & 150-lb. Chlorine Cylinders, Edition 12, Revision 2, July 2014.
• Chlorine Institute Emergency Kit “B” for Chlorine Ton Containers, Edition 11, Revision 1, July 2014.
• Pamphlet 57, Emergency Shut-Off Systems for Bulk Transfer of Chlorine, Edition 6, June 2015.
• Pamphlet 168, Guidelines for Dual Valve Systems for Bulk Chlorine Transport, Edition 2, July 2015.
In its petition (P-1620), Labelmaster Services requested revisions to the HMR to address inconsistencies between international and domestic labels and placards. Specifically, the petition requested revisions to §§ 172.519(f) and 172.407(f) of the HMR to allow for the use of labels and placards conforming to the specifications in the UN Recommendations on the Transport of Dangerous Goods, the International Civil Aviation Organization (ICAO) Technical Instructions on the Safe Transport of Dangerous Goods by Air, the International Maritime Dangerous Goods (IMDG) Code, or the Transport Canada Transportation of Dangerous Goods (TDG) Regulations.
After reviewing the petition, PHMSA found that the requested changes are likely to clarify some regulatory requirements and provisions that exist for the transportation of hazardous materials internationally, yet are not likely to be onerous or costly for the regulated community. Therefore, PHMSA is proposing revisions to §§ 172.519(f) and 172.407(f) of the HMR to allow for the use of labels and placards conforming to the specifications in the UN Recommendations, ICAO Technical Instructions, the IMDG Code, or the Transport Canada TDG Regulations.
In its petition (P-1624), Horizon Lines, LLC requested that § 176.415(b) be revised to except limited quantities of “UN1942, Ammonium nitrate” from requiring permission from the Captain of the Port (COTP) before being loaded or unloaded from a vessel at a waterfront facility. This petition for rulemaking is in response to previous changes to the HMR that eliminated the Other Regulated Materials Domestic (ORM-D) classification.
Specifically, Horizon Lines expressed concern that while the change from ORM-D to limited quantities is good for harmonization and the industry overall, the change has had some unintended negative consequences for shippers and vessel operators, including “UN1942, Ammonium nitrate” products shipped as ORM-D having to be reclassified under the limited quantities exception. Currently, the HMR require that “UN1942, Ammonium nitrate, 5.1” be moved under a United States Coast
In its review of the petition, PHMSA found that shipping “UN1942, Ammonium nitrate, 5.1” as a limited quantity instead of ORM-D will put a higher burden of cost on both the shipper and the vessel operator, without increasing safety, because they must continue to abide by the requirements in § 176.415(c)(4) to obtain a permit. Section 176.415(b) already provides exceptions for “UN1942, Ammonium nitrate” when shipped in a rigid packaging with a noncombustible inside packaging and “UN2067, Ammonium nitrate fertilizer” when the nearest COTP is notified at least 24 hours in advance of any loading or unloading in excess of 454 kg (1,000 pounds). Therefore, PHMSA is proposing an exception for “UN1942, Ammonium nitrate” when shipped as a limited quantity to require written notification to the USCG 24 hours prior to loading this type of cargo.
In its petition (P-1625), HAZMATPAC requested the allowance of the shipment of solid materials in a package when that package has been tested with a liquid material. Currently, § 173.24a(b)(3) allows a single or composite non-bulk packaging that is tested and marked for a liquid hazardous material to be filled with a solid hazardous material up to a gross mass in kilograms not exceeding the rated capacity of the packaging in liters, multiplied by the specific gravity of the packaging, or 1.2 if not marked. In addition, paragraphs (i), (ii), and (iii) allow a packaging rated for a liquid Packing Group I to be filled with a solid Packing Group II hazardous material, a packaging rated for a liquid Packing Group I to be filled with a solid Packing Group III hazardous material, and a packaging rated for a liquid Packing Group II to be filled with a solid Packing Group III hazardous material, all with slightly higher allowable gross masses of such solids.
PHMSA conducted both a technical and economic policy review of the HAZMATPAC petition and found it to merit a rulemaking. Therefore, PHMSA is proposing to revise § 173.24a(b)(3) to allow combination packages tested with liquids to transport solid materials.
In its petition (P-1634), 3M Company requested an amendment to the table in § 173.5a(c)(l) to include an additional hazardous material description for transport in roadway striping vehicles. Specifically, 3M requested the addition of UN2735 “Amines, Liquid, Corrosive, n.o.s., 8, III” or “Polyamines, Liquid, Corrosive, n.o.s., 8, III” when used as a catalyst.
The table in § 173.5a(c)(1) currently lists “UN3267, Corrosive liquid basic, organic, n.o.s.” as a catchall for corrosive liquids while at the same time § 172.101(c)(10)(iii) reads, “A mixture or solution not identified in the Table specifically by name, comprised of two or more hazardous materials in the same hazard class, shall be described using an appropriate shipping description (
In its petition (P-1636), the Chlorine Institute requested that PHMSA extend the service life of interim compliant toxic inhalation hazard (TIH) tank cars to the full service life of all other tank cars as allowed in § 215.203 of the FRA regulations. Specifically, the Chlorine Institute requested a revision to paragraph § 173.31(e)(2)(iii), which specifies a 20-year allowable service life for tank cars transporting TIH materials that were built to specifications contemplated in the HM-246 rulemaking because of an expected delay of at least 8 to 10 years before a permanent TIH design standard and specification would be available from the Advanced Tank Car Collaborative Research Program (ATCCRP).
Although the plain language of § 173.31(e)(2)(iii) limits the authorized service life of tank cars meeting the relevant specifications to 20 years from the date of the cars' construction, the final rule in which PHMSA adopted this 20-year service life made clear that tank cars built to these specifications were intended as an interim solution to then-existing market conditions. See [74 FR 1770 (Jan. 13, 2009)]. These interim tank car specifications were intended to make immediate safety improvements in tank car construction and to ensure the ongoing availability of tank cars for the transportation of TIH materials while the Department moved forward with the development and validation of an enhanced performance standard for TIH tank cars and the incorporation of such an enhanced standard into the HMR. With the understanding of the interim nature of these cars, PHMSA intended the 20-year authorized service life to guarantee tank car owners a reasonable service life for the cars, even if the Department were to issue a new tank car standard in the years immediately following the 2009 final rule [74 FR 1770]. The Department is still working towards developing and implementing an enhanced performance standard for TIH materials tank cars. PHMSA's review of the petition found that there is likely economic merit in undertaking a rulemaking as requested. Therefore, PHMSA is proposing to revise § 173.31(e)(2)(iii) to remove the 20-year service life, which will allow continued use of the interim compliant TIH tank cars to the full service life of all other tank cars, as allowed in § 215.203.
In its petition (P-1638), Labelmaster Services requested a revision to the HMR that would allow the use of plastic or metal pallets to transport materials classed and marked as limited quantities. The petition specifically requested that PHMSA revise § 173.156(b)(2)(iii), which specifies these materials be secured to a wooden pallet, to also specify that they could be secured to a plastic or metal pallet.
PHMSA's review of the petition found that there is likely economic merit in undertaking a rulemaking as requested. In addition, a technical review of the petition found there should be no decrease in safety due to the proposed change. The changes suggested by this petition would allow transporters greater flexibility in their choice of pallets, with possible accompanying cost savings. Therefore, PHMSA is proposing to revise § 173.156(b)(2)(iii) to allow for the use of metal, plastic, or composite pallets used to ship limited quantities of hazardous materials.
In its petition (P-1639), Horizon Lines, LLC requested an exception to the requirement in § 172.604(d)(1) to provide an emergency response telephone number in order to no longer require an emergency response telephone number be provided on a shipping paper for excepted quantities
This modification is justified in that excepted quantity weights are less than the already exempted limited quantity weights. In addition, this revision will harmonize the emergency response number requirements with the IMDG Code, which does not require an emergency response telephone number on the dangerous goods documentation (or anywhere else) for any excepted material; however, all hazardous materials, including those in excepted quantities, must comply with Section 5.4.3.2 of the IMDG Code, which requires emergency response information to be communicated in ways other than a phone number, such as a Safety Data Sheet (SDS). PHMSA's review of the petition found that there is likely economic merit in undertaking a rulemaking as requested without any decrease to safety. Therefore, PHMSA is proposing to revise § 172.604(d)(1) to no longer require an emergency response telephone number on a shipping paper be provided for excepted quantities of hazardous materials.
In its petition (P-1640), the Association of HAZMAT Shippers requested that the units of measure included in § 173.150(g) be converted to the International System of Units, as they are expressed elsewhere in the HMR. The International System of Units is typically used in the manufacturing of inner receptacles. PHMSA's review of the petition found that there is likely economic merit in undertaking a rulemaking as requested without any decrease to safety. Therefore, PHMSA is proposing to revise § 173.150(g) to convert measurements to the International System of Units.
In its petition (P-1641), CGA proposed to add new paragraphs § 173.301(a)(11) and (12). The proposed changes concern valve requirements for cylinders as outlined in “CGA V-9-2012, Compressed Gas Association Standard for Compressed Gas Cylinder Valves, Seventh Edition.”
Specifically, CGA requests that cylinder valves and cylinder valve protection caps manufactured on or after May 4, 2015, be required to conform to the requirements in “CGA V-9-2012, Compressed Gas Association Standard for Compressed Cylinder Valves, Seventh Edition.” Justifications for this request include ensuring standardization of cylinder valve designs and providing guidance to users on proper selection of valves. PHMSA's review of the petition found that there is likely economic merit in undertaking a rulemaking as requested without any decrease to safety. Therefore, PHMSA is proposing to add new paragraphs § 173.301(a)(11) and (12) to the HMR to conform to the new standards for cylinder valves and caps as outlined in “CGA V-9-2012, Compressed Gas Association Standard for Compressed Gas Cylinder Valves, Seventh Edition.”
In its petition (P-1644), HAZMAT Resources proposed to add text to § 180.605(l) to address recordkeeping requirements for portable tanks. This revision would harmonize this recordkeeping requirement with § 180.417(a)(3)(ii), which addresses recordkeeping requirements for certain cargo tank motor vehicles constructed and certified in accordance with the ASME Code. The petitioner recommends renaming § 180.605(l) to § 180.605(l)(1) and adding an additional § 180.605(l)(2). This new section would include recordkeeping requirements in line with § 180.417(a)(3)(ii). PHMSA agrees that not harmonizing recordkeeping requirements for portable tanks and cargo tank motor vehicles was an oversight and that this revision as proposed would provide an alternative means of compliance for portable tanks that has already been provided for cargo tanks. PHMSA believes there is likely economic merit in revising this section without a reduction in safety. The inclusion of a similar section in an already published § 180.407(a)(3)(ii) increases the validity of this proposed change. Therefore, PHMSA is proposing to revise § 180.605(l) to allow the owner of a portable tank to contact the National Board for a copy of the manufacture's data report, if the portable tank was registered with the National Board, or copy the information contained on the portable tanks specification plate and ASME Code data plates.
In its petition (P-1650), Labelmaster Services proposed to revise §§ 172.407(c) and 172.519(c) of the HMR to allow for printing tolerances for labels and placards. Labelmaster noted that the printing tolerances specified for the solid-line inner border that is parallel to the edge is extremely difficult to maintain with standard printing processes.
After a policy review of the petition, PHMSA agrees with Labelmaster that the absence of a tolerance will increase printing costs, as well as lead to inconsistent enforcement practices and confusion on the part of businesses attempting to remain compliant, without providing any increase in safety or hazard communication. Therefore, PHMSA is proposing to revise §§ 172.407(c) and 172.519(c) to add the word “approximately” to these sections to allow for printing tolerances with respect to the solid inner border for labels and placards. PHMSA believes that this simple fix and small change in the HMR could reduce costs with no degradation in safety.
In its petition (P-1651), the Department of Defense (DoD) Explosives Safety Board requested that PHMSA amend the citations in § 171.7(o)(1) and (2) to include the latest detailed publications used by the DoD in its examination and classification of explosives. PHMSA reviewed and provided feedback to DoD on the proposed changes to the manuals. Updating this manual is essential to allowing the DoD to safely move explosives in the interest of national security. Therefore, PHMSA is proposing to incorporate these documents into the HMR as requested.
In its petition (P-1655), the Dangerous Goods Trainers Association (DGTA) proposed that PHMSA revise § 171.8 to add definitions for “Basic Description” and “Shipping Description.” The DGTA specifically suggested that adding these definitions to the HMR will provide vital clarification to the meaning of these terms. The DGTA informed PHMSA that its members often receive questions from trainees about the terms “basic description” and “shipping description,” which are used to describe the information required on shipping papers in accordance with part 172, subpart C of the HMR—Shipping Papers. The petition proposes definitions be provided for “basic description” and “shipping description” in § 171.8, along with amendments to the HMR to ensure that these terms are used consistently and appropriately. PHMSA believes there is likely merit in adding these definitions without a reduction in safety. Therefore, PHMSA is proposing definitions for
In its petition (P-1656), Norris Cylinder proposed that PHMSA revise § 178.35(f)(7) to no longer require the marking of the service pressure on DOT 8 and DOT 8L cylinders. After both a technical and policy review of the petition, PHMSA agrees with Norris Cylinder that it was never the intention to require the marking of the service pressure on DOT 8 and DOT 8L cylinders. Therefore, PHMSA is proposing to revise this section as requested by the petitioner.
In its petition (P-1657), CGA proposed to IBR updates to the CGA publication “CGA C-7-2014, Guide to Classification and Labeling of Compressed Gases, Tenth Edition” currently listed in § 171.7(n)(7). This IBR has been updated to meet requirements for the U.S. Occupational Health and Safety Administration (OSHA) and was previously incorporated into OSHA's regulations in 2012. The CGA is requesting that PHMSA permit the use of the 2014 edition of CGA C-7 to keep the DOT current with industry practices that are incorporated into Appendix A of C-7.
PHMSA's review of the petition found that there are some editorial changes to the text of Appendix A in the 2014 edition that were added for clarity but do not impact the use of the required labels. Therefore, PHMSA is proposing the incorporation by reference of “CGA C-7-2014, Guide to Classification and Labeling of Compressed Gases, Tenth Edition” into the HMR.
In its petition (P-1659), COSTHA proposed to revise § 172.205 to permit the use of electronic signatures when completing an EPA form 8700-22 and 8700-22A. PHMSA reviewed and concurred with this proposed change, believing there is likely merit without a reduction in safety. Therefore, PHMSA is proposing to add paragraph (j) to permit the use of electronic signatures when completing an EPA form 8700-22 and 8700-22A.
In its petition (P-1662), Rigid Intermediate Bulk Container Association of North America (RIBCNA) proposed to amend § 178.703(b) to acknowledge that the marked date of manufacture on a composite IBC may differ from the marked date of manufacture on the inner receptacle of that IBC. The RIBCNA petitioned PHMSA to propose the substance of the UN adopted note, “The date of manufacture of the inner receptacle may be different from the marked date of manufacture (see 6.5.2.1), repair (see 6.5.4.5.3) or remanufacture (see 6.5.2.4) of the composite IBC,” as a final sentence in § 178.703(b)(6)(i) to read as follows: “The date of manufacture of the inner receptacle may be different from the marked date of manufacture required by § 178.703(a)(1)(iv) or by § 180.352(d)(1)(iv).”
After a review of the petition, PHMSA found that allowing the inner receptacle and the composite IBC to have different date markings will have no effect on the safety of the use and manufacture of IBCs. Integrating the proposed language into the current HMR will also bring rules governing markings of IBCs more in line with current international standards. Therefore, PHMSA is proposing a change to the HMR to allow the date of manufacture on the inner receptacle to be different than on the composite IBC.
In its petition (P-1663), COSTHA requested PHMSA revise the basis weight tolerance provided in § 178.516(b)(7) from +/−5 percent to +/−10 percent from the nominal basis weight reported in the initial design qualification test report.
PHMSA conducted a review of the petition and found that the requested change is unlikely to affect safety in any way and is largely following industry practices. The realities of paper manufacturing are such that a wide range of basis weights can be found on any large enough sample of fiberboard run on the same line to the same specification. This revision would only modify the percentage threshold for the allowable nominal basis weight for fiberboard boxes and would not result in any fundamental changes to testing, recordkeeping, or approval processes by either PHMSA or the regulated community. Therefore, PHMSA is proposing to revise the basis weight tolerance provided in § 178.516(b)(7) from +/−5 percent to +/−10 percent from the nominal basis weight reported in the initial design qualification test report.
Below is a section-by-section description of the changes being proposed in this NPRM.
Section 171.7 lists all standards incorporated by reference into the HMR that are not specifically set forth in the regulations. This NPRM proposes to incorporate by reference publications by the Chlorine Institute, the DoD, and the CGA.
The Chlorine Institute publications include the following:
1. Chlorine Institute Emergency Kit “A” for 100-lb. & 150-lb. Chlorine Cylinders, Edition 12, Revision 2, July 2014. This publication is freely available on the Chlorine Institute Web site at:
2. Chlorine Institute Emergency Kit “B” for Chlorine Ton Containers, Edition 11, Revision 1, July 2014. This publication is available on the Chlorine Institute Web site at:
3. Pamphlet 57, Emergency Shut-Off Systems for Bulk Transfer of Chlorine, Edition 6, June 2015. This publication is available on the Chlorine Institute Web site at:
4. Pamphlet 168, Guidelines for Dual Valve Systems for Bulk Chlorine
DoD publications include the following:
1. TB 700-2; NAVSEAINST 8020.8C; TO 11A-1-47: DoD Ammunition and Explosives Hazard Classification Procedures, 30 July 2012, into § 173.56. This publication is freely available on the DoD Web site at:
2. DLAR 4145.41/AR 700-143/NAVSUPINST 4030.55D/AFMAN 24-210_IP/MCO 4030.40C: Packaging of Hazardous Materials, 21 April 2015 into § 173.7. This publication is freely available on the DoD Web site at:
CGA publications include the following:
1. “CGA C-7-2014, Guide to Classification and Labeling of Compressed Gases, Tenth Edition. During the open comment period of this NPRM, this publication is freely available on the CGA Web site at:
2. CGA V-9, 2012, Compressed Gas Association Standard for Compressed Gas Cylinder Valves, Seventh Edition. During the open comment period of this NPRM, this publication is freely available on the CGA Web site at:
Section 172.205 describes the requirements for the use of hazardous waste manifest. This NPRM proposes to add paragraph (j) to permit the use of electronic signatures when completing an EPA form 8700-22 and 8700-22A.
Section 172.407 describes the label specifications for packages shipping hazardous materials under the HMR. This NPRM proposes to revise paragraph (c) to allow for size tolerances for the labels by inserting the term “approximately” for the inner border to be 5 mm. This NPRM also proposes to revise paragraph (f) to address inconsistencies between international and domestic labels.
Section 172.519 describes placard specification for shipments of hazardous materials that require placards. This NPRM proposes to revise paragraph (c) to allow for size tolerances for the placards by inserting the term “approximately” for the inner border to be 5 mm.
Section 172.604 describes the requirements to have an emergency response number on shipping papers for shipments of hazardous materials. This NPRM proposes to no longer require an emergency response number for excepted quantities of hazardous materials by revising § 172.604(d).
Section 173.5a outlines the requirements for cargo tank motor vehicles used for roadway striping. This NPRM proposes to add proper shipping names to § 173.5a(c)(1) to the list of authorized materials that can be used under this section.
Section 173.24a outlines the general requirements for non-bulk packages. This NPRM proposes to revise each paragraph in this section to allow for packages tested with a liquid material to be filled with a solid material of the equivalent packing group.
Section 173.31 outlines the specifications for the use of tank cars. Specifically, § 173.31(e) outlines the specifications for tank cars used to transport materials that are poisonous by inhalation. This NPRM proposes to remove the reference to the 20-year service life for these tank cars in § 173.31(e)(2)(iii), thus extending the service life to the standard for all tank cars set forth at § 215.203 of the Federal Railroad Administration (FRA) regulations.
Section 173.150 outlines exceptions for Class 3 flammable and combustible liquids. This NPRM proposes to change the units in § 173.150(g) from imperial units to the International System of Units and to revise all the units in this section to the International System of Units.
Section 173.156 outlines exceptions for limited quantities and ORM-D materials. This NPRM proposes to revise § 173.156(b)(2)(iii) to allow for pallets to be made of metal, plastic, or composite materials in addition to wood.
Section 173.301 outlines the general requirements for the shipment of compressed gases and other hazardous materials in cylinders, UN pressure receptacles, and spherical pressure vessels. This NPRM proposes to revise § 173.301(a) by adding subparagraphs (11) and (12). Paragraph (11) will require all cylinder valves manufactured on or after May 4, 2015, to conform to the requirements in CGA V-9-2012, as well as requiring UN pressure receptacles to conform to the requirements of § 173.301b(c)(1). Paragraph (12) will require that cylinder valve protection caps manufactured on or after May 4, 2015, conform to the
Section 173.306 outlines the requirements for limited quantities of compressed gases. This NPRM proposes to allow alternate test methods to the current hot water bath test in the UN Model Regulations.
Section 176.415 outlines permit requirements for Division 1.5, ammonium nitrates, as well as certain ammonium nitrate fertilizers. This NPRM proposes to no longer require written permission from the COTP to load or unload limited quantities of ammonium nitrates.
Section 178.35 outlines the general requirements for specification cylinders. This NPRM proposes to revise § 178.35 to no longer require the marking of the service pressure for DOT 8 and DOT 8 AL cylinders.
Section 178.337-9 outlines the requirements for pressure relief devices, piping, valves, hoses, and fittings. This NPRM proposes to revise § 178.337-9(b)(8) to add a reference to allow the use of “Sections 4 through 6, Pamphlet 168, Guidelines for Dual Valve Systems for Bulk Chlorine Transport, Edition 1, February 2013” under this section.
Section 178.516 outlines the standards for fiberboard boxes. This NPRM proposes to revise § 178.516(b)(7) to allow for the paper wall basis weights that vary by not more than +/−10 percent from the nominal basis weight reported in the initial design qualification test report.
Section 178.703 outlines the marking requirements for IBCs. This NPRM proposes to revise § 178.703(b)(6)(i) by clarifying that the date of manufacture of the inner receptacle may be different from the marked date of manufacturer required by § 178.703(a)(1)(iv) or § 180.352(d)(1)(iv) provided that the retest and inspection of the IBCs be based on the EARLIEST marked date.
Section 180.407 outlines the requirements for the testing and inspection of specification cargo tanks. This NPRM proposes to revise the table in § 180.407(g)(1)(iv) to put the words “the test pressure on the name plate” in the test pressure column before each test pressure specification.
Section 180.605 outlines the requirements for periodic testing, inspection, and repair of portable tanks. This NPRM proposes to revise § 180.605(l) by adding § 180.605(l)(2) to allow the owner of a portable tank to contact the National Board for a copy of the manufacture's data report, if the portable tank was registered with the National Board, or copy the information contained on the portable tank's specification plate and ASME Code data plates.
This NPRM is published under authority of the Federal Hazardous Materials Transportation Law (Federal Hazmat Law; 49 U.S.C. 5101
This NPRM is not considered a significant regulatory action under Section 3(f) of Executive Order 12866 (“Regulatory Planning and Review”) and, therefore, was not reviewed by the Office of Management and Budget (OMB). The proposed rule is not considered a significant rule under the Regulatory Policies and Procedures order issued by the U.S. Department of Transportation [44 FR 11034].
Executive Orders 12866 (“Regulatory Planning and Review”) and 13563 (“Improving Regulation and Regulatory Review”) require agencies to regulate in the “most cost-effective manner,” to make a “reasoned determination that the benefits of the intended regulation justify its costs,” and to develop regulations that “impose the least burden on society.”
Executive Order 13563 (“Improving Regulation and Regulatory Review”) supplements and reaffirms the principles, structures, and definitions governing regulatory review that were established in Executive Order 12866 of September 30, 1993. In addition, Executive Order 13563 specifically requires agencies to: (1) Involve the public in the regulatory process; (2) promote simplification and harmonization through interagency coordination; (3) identify and consider regulatory approaches that reduce burden and maintain flexibility; (4) ensure the objectivity of any scientific or technological information used to support regulatory action; and (5) consider how to best promote retrospective analysis to modify, streamline, expand, or repeal existing rules that are outmoded, ineffective, insufficient, or excessively burdensome.
Executive Order 13610 (“Identifying and Reducing Regulatory Burdens”), issued May 10, 2012, urges agencies to conduct retrospective analyses of existing rules to examine whether they remain justified and whether they should be modified or streamlined in light of changed circumstances, including the rise of new technologies.
PHMSA has involved the public in the regulatory process in a variety of ways for this proposed rulemaking. Specifically, in this rulemaking PHMSA is responding to 25 petitions that have been submitted by the public in accordance with the Administrative Procedure Act and PHMSA's rulemaking procedure regulations (49 CFR 106.95). Key issues covered by the petitions include requests from the public to revise packaging requirements and incorporate multiple publications by reference.
This NPRM proposes regulatory changes responding to 25 petitions that have been submitted by the public. This NPRM would affect some PHMSA stakeholders, including hazardous materials shippers and carriers by highway, rail, vessel, and aircraft, as well as package manufacturers and testers.
PHMSA anticipates the proposals contained in this rule will have minimal costs. For the purposes of analysis PHMSA grouped the proposed amendments by the type of change they implement. These groupings include Harmonization, Regulatory Clarity/Editorial, Regulatory Flexibility, and Incorporation of Standards. We discuss qualitatively the cost of these groupings below.
While PHMSA anticipates that the proposals contained in this rule will have minimal costs, there are corresponding benefits that exceed those costs. For the purposes of analysis PHMSA grouped the proposed amendments by the type of change they implement. These groupings include Harmonization, Regulatory Clarity/Editorial, Regulatory Flexibility, and Incorporation of Standards. We discuss qualitatively the benefits of these groupings below.
In this NPRM, we propose to amend miscellaneous provisions in the HMR to clarify the provisions and to relax overly burdensome requirements. PHMSA anticipates the proposals contained in this rule will have marginal economic benefits to the regulated community with minimal costs. This NPRM is designed to increase the clarity of the HMR, thereby increasing voluntary compliance while reducing compliance costs.
This proposed rule was analyzed in accordance with the principles and criteria contained in Executive Order 13132 (“Federalism”). This proposed rule would preempt State, local, and Indian tribe requirements but does not propose any regulation that has substantial direct effects on the states, the relationship between the national government and the states, or the distribution of power and responsibilities among the various levels of government. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply.
The Federal Hazardous Materials Transportation Law, 49 U.S.C. 5125(b)(1), contains an express preemption provision (49 U.S.C. 5125(b)) preempting State, local, and Indian tribe requirements on certain covered subjects. Covered subjects are:
(i) The designation, description, and classification of hazardous materials;
(ii) The packing, repacking, handling, labeling, marking, and placarding of hazardous materials;
(iii) The preparation, execution, and use of shipping documents related to hazardous materials and requirements related to the number, content, and placement of those documents;
(iv) The written notification, recording, and reporting of the unintentional release in transportation of hazardous materials; or
(v) The design, manufacture, fabrication, marking, maintenance, reconditioning, repair, or testing of a packaging or container which is represented, marked, certified, or sold as qualified for use in the transport of hazardous materials.
This proposed rule concerns the classification, packaging, marking, labeling, and handling of hazardous materials, among other covered subjects. If adopted, this rule would preempt any State, local, or Indian tribe requirements concerning these subjects unless the non-Federal requirements are “substantively the same” as the Federal requirements. (See 49 CFR 107.202(d).)
The Federal Hazardous Materials Transportation Law provides at 49 U.S.C. 5125(b)(2) that if PHMSA issues a regulation concerning any of the covered subjects, PHMSA must determine and publish in the
This proposed rule has been analyzed in accordance with the principles and criteria contained in Executive Order 13175 (“Consultation and Coordination with Indian Tribal Governments”). Because this proposed rule does not have tribal implications and does not impose substantial direct compliance costs on Indian tribal governments, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.
The Regulatory Flexibility Act (5 U.S.C. 601
The Regulatory Flexibility Act directs agencies to establish exceptions and differing compliance standards for small businesses, where it is possible to do so and still meet the objectives of applicable regulatory statutes. In the case of hazardous materials transportation, it is not possible to establish exceptions or differing standards and still accomplish our safety objectives.
The proposed changes are generally intended to provide relief to shippers, carriers, and packaging manufactures and testers, including small entities. Therefore, this proposed rule will not have a significant economic impact on a substantial number of small entities.
This proposed rule has been developed in accordance with Executive Order 13272 (“Proper Consideration of Small Entities in Agency Rulemaking”) and the DOT's procedures and policies to promote compliance with the Regulatory Flexibility Act to ensure that potential impacts of draft rules on small entities are properly considered.
This proposed rule does not impose any new information collection requirements, and in one instance, marginally decreases the information collection burden on the reregulated community. Specifically, the following information collection requirement is affected by this rulemaking:
PHMSA estimates that no longer requiring the emergency response number for limited quantity shipments by vessel will reduce the number of burden hours by 4,629. PHMSA estimates that no longer requiring the emergency response number on shipping paper will save 10 seconds per shipping paper and affect 1,666,667 shipments per year. PHMSA estimates a savings of $.06 per shipment resulting in cost savings of $95,403.69.
Please direct your requests for a copy of this final information collection to Steven Andrews or T. Glenn Foster, Office of Hazardous Materials Standards (PHH-12), Pipeline and Hazardous Materials Safety Administration, 1200 New Jersey Avenue SE., 2nd Floor, Washington, DC 20590-0001.
A regulatory identifier number (RIN) is assigned to each regulatory action listed in the Unified Agenda of Federal Regulations. The Regulatory Information Service Center publishes the Unified Agenda in April and October of each year. The RIN number contained in the heading of this document can be used to cross-reference this action with the Unified Agenda.
This proposed rule does not impose unfunded mandates under the Unfunded Mandates Reform Act of 1995. It does not result in costs of $141.3 million or more to either State, local, or tribal governments, in the aggregate, or to the private sector, and is the least burdensome alternative that achieves the objective of the rule.
The National Environmental Policy Act, 42 U.S.C. 4321-4375, requires Federal agencies to analyze proposed actions to determine whether the action will have a significant impact on the human environment. The Council on Environmental Quality (CEQ) regulations require Federal agencies to conduct an environmental review considering: (1) The need for the proposed action; (2) alternatives to the proposed action; (3) probable environmental impacts of the proposed action and alternatives; and (4) the agencies and persons consulted during the consideration process.
In response to petitions for rulemaking submitted by the regulated community, PHMSA proposes to amend the Hazardous Materials Regulations (HMR; 49 CFR parts 171-180) to update, clarify, or provide relief from miscellaneous regulatory requirements. Specifically, PHMSA is proposing amendments that include, but are not limited to, the following: Incorporating by Reference (IBR) multiple publications from both the Compressed Gas Association (CGA) and the Chlorine Institute; addressing inconsistencies with domestic and international labels and placards; permitting alternative testing for aerosols; excepting excepted quantities from the emergency response telephone requirement; allowing electronic signatures for Environmental Protection Agency (EPA) manifest forms; and no longer requiring the service pressure to be marked on Department of Transportation (DOT) 8 and 8L cylinders.
These amendments are intended to promote safety, regulatory relief, and clarity. The proposed changes were identified in response to petitions from stakeholders affected by the HMR. These proposed minor changes will clarify the HMR and enhance safety, while offering some net economic benefits.
This action is necessary to: (1) Fulfill our statutory directive to promote transportation safety; (2) fulfill our statutory directive under the Administrative Procedure Act (APA) that requires Federal agencies to give interested persons the right to petition an agency to issue, amend, or repeal a rule (5 U.S.C. 553(e)); (3) support governmental efforts to provide regulatory relief to the regulated community; (4) address safety concerns raised by petitioners and remove identified regulatory ambiguity; and (5) simplify and clarify the regulations in order to promote understanding and compliance.
The intended effect of this action is to enhance the safe transportation of hazardous materials and, in conjunction, clarify, simplify, and relax certain regulatory requirements for carriers, shippers, and other stakeholders. These regulatory revisions will offer more efficient and effective ways of achieving the PHMSA goal of safe and secure transportation, protecting both people and the environment, of hazardous materials in commerce.
In proposing this rulemaking, PHMSA is considering the following alternatives:
If PHMSA chose this alternative, it would not proceed with any rulemaking on this subject and the current regulatory standards would remain in
This alternative is the current proposal as it appears in this NPRM, applying to transport of hazardous materials by highway, rail, vessel, and aircraft. The proposed amendments encompassed in this alternative are more fully addressed in the preamble and regulatory text sections of the NPRM.
When developing potential regulatory requirements, PHMSA evaluates those requirements to consider the environmental impact of each amendment. Specifically, PHMSA evaluates the: Risk of release and resulting environmental impact; risk to human safety, including any risk to first responders; longevity of the packaging; and if the proposed regulation would be carried out in a defined geographic area, the resources, especially any sensitive areas, and how they could be impacted by any proposed regulations. Of the regulatory changes proposed in this rulemaking, most have been determined to be clarification, technology/design updates, harmonization, regulatory flexibility, standard incorporation, or editorial in nature. As such, these amendments have little or no impact on: The risk of release and resulting environmental impact; human safety; or longevity of the packaging. None of these amendments would be carried out in a defined geographic area,
If PHMSA were to select the No Action Alternative, current regulations would remain in place, and no new provisions would be added. However, efficiencies gained through harmonization in updates to transport standards, lists of regulated substances, definitions, packagings, markings requirements, shipper requirements, modal requirements, etc., would not be realized. Foregone efficiencies in the No Action Alternative also include freeing up limited resources to concentrate on hazardous materials transportation issues of potentially much greater environmental impact. Not adopting the proposed environmental and safety requirements in the NPRM under the No Action Alternative would result in a lost opportunity for reducing negative environmental and safety-related impacts. Greenhouse gas emissions would remain the same under the No Action Alternative.
The Preferred Alternative encompasses enhanced and clarified regulatory requirements, which would result in increased compliance and less negative environmental and safety impacts. The table below summarizes possible environmental benefits and any potential negative impacts for the amendments proposed in the NPRM. A detailed discussion on the potential environmental impacts of each type of amendment is included in the complete EA placed in the docket for this rulemaking.
If PHMSA selects the provisions as proposed in this NPRM, we believe that safety and environmental risks would be reduced and that protections to human health and environmental resources would be increased.
This NPRM would affect some PHMSA stakeholders, including hazardous materials shippers and carriers by highway, rail, vessel, and aircraft, as well as package manufacturers and testers. PHMSA sought comment on the environmental assessment contained in the April 26, 2012, NPRM published under Docket PHMSA 2011-0138 [77 FR 24885] (HM-218G); however, PHMSA did not receive any comments on the environmental assessment contained in that rulemaking. In addition, PHMSA sought comment from the following Federal Agencies and modal partners:
PHMSA did not receive any adverse comments on the amendments proposed in this NPRM from these Federal Agencies.
The proposed amendments are intended to update, clarify, or provide relief from certain existing regulatory requirements to promote safer transportation practices; eliminate unnecessary regulatory requirements; facilitate international commerce; and make these requirements easier to understand. These proposed amendments, if adopted, will foster a greater level of compliance with the HMR and thus the net environmental impact of this proposal will be slightly positive.
The provisions of this proposed rule build on current regulatory requirements to enhance the transportation safety and security of shipments of hazardous materials transported by highway, rail, aircraft and vessel, thereby reducing the risks of an accidental or intentional release of hazardous materials and consequent environmental damage. PHMSA believes that there are no non-negligible environmental impacts associated with this proposed rule.
PHMSA welcomes any views, data, or information related to environmental impacts that may result if the proposed requirements are adopted, as well as possible alternatives and their environmental impacts.
Anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the document (or signing the document, if submitted on behalf of an association, business, labor union, etc.). DOT posts these comments, without edit, including any personal information the commenter provides, to
Under Executive Order 13609 (“Promoting International Regulatory Cooperation”), agencies must consider whether the impacts associated with significant variations between domestic and international regulatory approaches are unnecessary or may impair the ability of American business to export and compete internationally. In meeting shared challenges involving health, safety, labor, security, environmental, and other issues, international regulatory cooperation can identify approaches that are at least as protective as those that are or would be adopted in the absence of such cooperation. International regulatory cooperation can also reduce, eliminate, or prevent unnecessary differences in regulatory requirements.
Similarly, the Trade Agreements Act of 1979 (Pub. L. 96-39), as amended by the Uruguay Round Agreements Act (Pub. L. 103-465), prohibits Federal agencies from establishing any standards or engaging in related activities that create unnecessary obstacles to the foreign commerce of the United States. For purposes of these requirements, Federal agencies may participate in the establishment of international standards, so long as the standards have a legitimate domestic objective, such as providing for safety, and do not operate to exclude imports that meet this objective. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards.
PHMSA participates in the establishment of international standards in order to protect the safety of the American public, and we have assessed the effects of the proposed rule to ensure that it does not cause unnecessary obstacles to foreign trade. Accordingly, this rulemaking is consistent with Executive Order 13609 and PHMSA's obligations under the Trade Agreement Act, as amended.
The National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) directs Federal agencies to use voluntary consensus standards in their regulatory activities unless doing so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
Definitions and abbreviations, Exports, Hazardous materials transportation, Hazardous waste, Imports, Incorporation by reference, Reporting and recordkeeping requirements.
Education, Hazardous materials transportation, Hazardous waste, Labeling, Markings, Packaging and containers, Reporting and recordkeeping requirements.
Hazardous materials transportation, Packaging and containers, Reporting and recordkeeping requirements, Training.
Hazardous materials transportation, Maritime carriers, Reporting and recordkeeping requirements.
Hazardous materials transportation, Incorporation by reference, Motor vehicle safety, Packaging and containers, Reporting and recordkeeping requirements.
Hazardous materials transportation, Motor carriers, Motor vehicle safety, Packaging and containers, Railroad safety, Reporting and recordkeeping requirements.
In consideration of the foregoing, we are proposing to amend 49 CFR chapter I as follows:
49 U.S.C. 5101-5128, 44701; Pub. L. 101-410, section 4 (28 U.S.C. 2461 note); Pub. L. 104-121, sections 212-213; Pub. L. 104-134, section 31001; 49 CFR 1.81 and 1.97.
The revisions and additions read as follows:
(l) * * *
(1) Chlorine Institute Emergency Kit “A” for 100-lb. & 150-lb. Chlorine Cylinders (with the exception of repair method using Device 8 for side leaks), Edition 12, January 2013, into § 173.3.
(2) Chlorine Institute Emergency Kit “B” for Chlorine Ton Containers (with the exception of repair method using Device 9 for side leaks), Edition 10, January 2009, into § 173.3.
(5) Section 3, Pamphlet 57, Emergency Shut-Off Systems for Bulk Transfer of Chlorine, Edition 5, Revision 1, March 2009, into § 177.840.
(12) Sections 4 through 6, Pamphlet 168, Guidelines for Dual Valve Systems for Bulk Chlorine Transport, Edition 1, February 2013, into § 178.337-9.
(n) * * *
(7) CGA C-7-2014, Guide to Classification and Labeling of Compressed Gases, Tenth Edition, November 2014, into § 172.400a.
(o)
(1) DOD TB 700-2; NAVSEAINST 8020.8C; TO 11A-1-47: Ammunition and Explosives Hazard Classification Procedures, July 30, 2012, into § 173.56.
(2) DOD DLAR 4145.41/AR 700-143/NAVSUPINST 4030.55D/AFMAN 24-210_IP/MCO 4030.40C: Packaging of Hazardous Material, April 21, 2015, into § 173.7.
49 U.S.C. 5101-5128, 44701; 49 CFR 1.81, 1.96 and 1.97.
(j) Electronic manifests that are obtained, completed, and transmitted in accordance with 40 CFR 262.20(a)(3), and used in accordance with § 262.24 in lieu of EPA Forms 8700-22 and 8700-22A are the legal equivalent of paper manifest forms bearing handwritten signatures, and satisfy for all purposes any requirements in these regulations to obtain, complete, sign, provide, use, or retain a manifest. Electronic signatures in conformance with 40 CFR 262.25 are therefore acceptable in lieu of handwritten signatures required by paragraphs (c) and (d) of this section provided one printed copy of the electronic manifest bearing the electronic signature is provided to the initial transporter as required by 40 CFR 262.24(d).
(c)
(i) If the size of the package so requires, the dimensions of the label and its features may be reduced provided the symbol and other elements of the label remain clearly visible. The solid line forming the inner border must remain approximately 5 mm from the outside edge of the label and the minimum width of the line must remain 2 mm.
(ii) Where dimensions are not specified, all features shall be in approximate proportion to those shown in §§ 172.411 through 172.448 of this subpart, as appropriate.
(iii)
(iv) For domestic transportation, a packaging labeled prior to January 1, 2017 and in conformance with the requirements of this paragraph in effect on December 31, 2014, may continue in service until the end of its useful life.
(2) The CARGO AIRCRAFT ONLY label must be a rectangle measuring at least 110 mm (4.3 inches) in height by 120 mm (4.7 inches) in width. The words “CARGO AIRCRAFT ONLY” must be shown in letters measuring at least 6.3 mm (0.25 inches) in height.
(3) Except as otherwise provided in this subpart, the hazard class number, or division number, as appropriate, must be at least 6.3 mm (0.25 inches) and not greater than 12.7 mm (0.5 inches).
(4) When text indicating a hazard is displayed on a label, the label name must be shown in letters measuring at least 7.6 mm (0.3 inches) in height. For SPONTANEOUSLY COMBUSTIBLE or DANGEROUS WHEN WET labels, the words “Spontaneously” and “When Wet” must be shown in letters measuring at least 5.1 mm (0.2 inches) in height.
(5) The symbol on each label must be proportionate in size to that shown in the appropriate section of this subpart.
(f)
(c)
(i)
(ii) For domestic transportation, a placard manufactured prior to January 1, 2017 in conformance with the requirements of this paragraph in effect on December 31, 2014, may continue in service until the end of its useful life provided the color tolerances are maintained and are in accordance with the display requirements of this chapter.
(2) Except as otherwise provided in this subpart, the hazard class or division number, as appropriate, must be shown in numerals measuring at least 41 mm (1.6 inches) in height.
(3) Except as otherwise provided in this subpart, when text indicating a hazard is displayed on a placard, the printing must be in letters measuring at least 41 mm (1.6 inches) in height.
(f)
(d) The requirements of this section do not apply to—
(1) Hazardous materials that are offered for transportation under the provisions applicable to limited quantities or excepted quantities; or
(2) Materials properly described under the following shipping names:
Battery powered equipment.
Battery powered vehicle.
Carbon dioxide, solid.
Castor bean.
Castor flake.
Castor meal.
Castor pomace.
Consumer commodity.
Dry ice.
Engines, internal combustion.
Fish meal, stabilized.
Fish scrap, stabilized.
Krill Meal, PG III.
Refrigerating machine.
Vehicle, flammable gas powered.
Vehicle, flammable liquid powered.
Wheelchair, electric.
(3) Transportation vehicles or freight containers containing lading that has been fumigated and displaying the FUMIGANT marking (see § 172.302(g)) as required by § 173.9 of this chapter, unless other hazardous materials are present in the cargo transport unit.
49 U.S.C. 5101-5128, 44701; 49 CFR 1.81, 1.96 and 1.97.
(c) * * *
(1)
(b) * * *
(1) A single or composite non-bulk packaging may be filled with a liquid hazardous material only when the specific gravity of the material or gross mass of the package does not exceed that marked on the packaging, or a specific gravity of 1.2 if not marked, except as follows:
(i) A Packing Group I packaging may be used for a Packing Group II material with a specific gravity not exceeding the greater of 1.8, or 1.5 times the specific gravity or gross mass of the package marked on the packaging, provided all the performance criteria can still be met with the higher specific gravity material;
(ii) A Packing Group I packaging may be used for a Packing Group III material with a specific gravity not exceeding the greater of 2.7, or 2.25 times the specific gravity or gross mass of the package marked on the packaging, provided all the performance criteria can still be met with the higher specific gravity material; and
(iii) A Packing Group II packaging may be used for a Packing Group III material with a specific gravity not exceeding the greater of 1.8, or 1.5 times the specific gravity or gross mass of the package marked on the packaging, provided all the performance criteria can still be met with the higher specific gravity material.
(3) A single or composite non-bulk packaging which is tested and marked for liquid hazardous materials may be filled with a solid hazardous material to a gross mass, in kilograms, not exceeding the rated capacity of the packaging in liters, or gross mass of the package, multiplied by the specific gravity or gross mass of the package marked on the packaging, or 1.2 if not marked. In addition:
(i) A single or composite non-bulk packaging which is tested and marked for Packing Group I liquid hazardous materials may be filled with a solid Packing Group II hazardous material to a gross mass, in kilograms, not exceeding the rated capacity of the packaging in liters, or gross mass of the package, multiplied by 1.5, multiplied by the specific gravity or gross mass of the package marked on the packaging, or 1.2 if not marked.
(ii) A single or composite non-bulk packaging which is tested and marked for Packing Group I liquid hazardous materials may be filled with a solid Packing Group III hazardous material to a gross mass, in kilograms, not exceeding the rated capacity of the packaging in liters, or gross mass of the package, multiplied by 2.25, multiplied by the specific gravity or gross mass of the package marked on the packaging, or 1.2 if not marked.
(iii) A single or composite non-bulk packaging which is tested and marked for Packing Group II liquid hazardous materials may be filled with a solid Packing Group III hazardous material to a gross mass, in kilograms, not exceeding the rated capacity of the packaging in liters, or gross mass of the package, multiplied by 1.5, multiplied by the specific gravity or gross mass of the package marked on the packaging, or 1.2 if not marked.
(e)
(2)
(i) A higher test pressure is required if otherwise specified in this chapter; and
(ii) Each tank car constructed on or after March 16, 2009, and used for the transportation of PIH materials must meet the applicable authorized tank car specifications and standards listed in § 173.244(a)(2) or (3) and § 173.314(c) or (d).
(iii) [Reserved]
(iv) A tank car owner retiring or otherwise removing a tank car from service transporting materials poisonous by inhalation, other than because of damage to the car, must retire or remove cars constructed of non-normalized steel in the head or shell before removing any car in service transporting materials poisonous by inhalation constructed of normalized steel meeting the applicable DOT specification.
(g)
(i) For non-glass inner packagings:
(A) The volume does not exceed 16 fluid ounces (473 mL) in capacity for liquids; or
(B) For volumes greater than 16 fluid ounces (473 mL) but not exceeding 1 gallon (5 L) the company name and the words “Contains Ethyl Alcohol” are marked on the package;
(C) Solids containing ethyl alcohol may be packaged in non-glass inner packagings not exceeding 1 pounds (.45 kg) capacity;
(D) For weight greater than 1 pounds (.45 kg) up to 8 pounds (3.6 kg) the company name and the words “Contains Ethyl Alcohol” are marked on the package.
(ii) For glass inner packagings:
(A) The volume does not exceed 8 fluid ounces (236 mL) in capacity; or
(B) For volumes greater than 8 fluid ounces (236 mL) to 16 fluid ounces (473 mL) the company name and the words “Contains Ethyl Alcohol” are marked on the package;
(C) Solids containing ethyl alcohol may be packaged in glass inner packagings not exceeding
(D) For weight greater than
(iii) The net liquid contents of all inner packagings in any single outer packaging may not exceed 192 fluid ounces (5.6 liters). The net solid contents of all inner packagings in any single outer packaging may not exceed 32 pounds (14.5 kg). The gross weight of any single outer package shipped may not exceed 65 pounds (29.4 kg); Inner packagings must be secured and cushioned within the outer package to prevent breakage, leakage, and movement.
(2) Beverages, food, cosmetics and medicines, medical screening solutions, and concentrates sold as retail products containing ethyl alcohol classed as a flammable liquid or flammable solid containing more than 70% ethyl alcohol by volume, by weight for solids are excepted from the HMR provided that:
(i) For inner packagings containing liquids the volume does not exceed 8 fluid ounces (250 mL) in capacity;
(ii) Solids containing ethyl alcohol are not packed in inner packagings exceeding
(iii) The net liquid contents of all inner packagings in any single outer packaging may not exceed 192 fluid ounces (5.6 liters). The net solid contents of all inner packagings in any single outer packaging may not exceed 32 pounds (14.5 kg). The gross weight of any single outer package shipped may not exceed 65 pounds (29.4 kg). Inner packagings must be secured and cushioned within the outer package to prevent breakage, leakage, and movement.
(3) For transportation by passenger or cargo aircraft, no outer package may be transported which contains an inner packaging exceeding:
(i) 16 fluid ounces (473 mL) of flammable liquid; or
(ii) 1 pound (0.45 kg) of solids containing flammable liquid.
(b) Packagings for limited quantity and ORM-D are specified according to hazard class in §§ 173.150 through 173.155, 173.306 and 173.309(b). In addition to exceptions provided for limited quantity and ORM-D materials elsewhere in this part, the following are provided:
(1) Strong outer packagings as specified in this part, marking requirements specified in subpart D of part 172 of this chapter, and the 30 kg (66 pounds) gross weight limitation when—
(i) Unitized in cages, carts, boxes or similar overpacks;
(ii) Offered for transportation or transported by:
(A) Rail;
(B) Private or contract motor carrier; or
(C) Common carrier in a vehicle under exclusive use for such service; and
(iii) Transported to or from a manufacturer, a distribution center, or a retail outlet, or transported to a disposal facility from one offeror.
(2) The 30 kg (66 pounds) gross weight limitation does not apply to packages of limited quantity materials marked in accordance with § 172.315 of this chapter, or, until December 31, 2020, materials classed and marked as ORM-D and described as a Consumer commodity, as defined in § 171.8 of this chapter, when offered for transportation or transported by highway or rail between a manufacturer, a distribution center, and a retail outlet provided—
(i) Inner packagings conform to the quantity limits for inner packagings specified in §§ 173.150(b), 173.152(b), 173.154(b), 173.155(b), 173.306(a) and (b), and 173.309(b), as appropriate;
(ii) The inner packagings are packed into corrugated fiberboard trays to prevent them from moving freely;
(iii) The trays are placed in a fiberboard box which is banded and secured to a metal, plastic, composite, or wooden pallet by metal, fabric, or plastic straps, to form a single palletized unit;
(iv) The package conforms to the general packaging requirements of subpart B of this part; and
(v) The maximum net quantity of hazardous material permitted on one palletized unit is 250 kg (550 pounds).
(a) * * *
(11) Cylinder valves manufactured on or after May 4, 2015, used on cylinders to transport compressed gases must conform to the requirements in CGA V-9-2012. A valve for a UN pressure receptacle must conform to the requirements of § 173.301b(c)(1).
(12) Cylinder valve protection caps manufactured on or after May 4, 2015, must conform to the requirements of CGA V-9-2012. Cylinder valve protection caps used on UN cylinders must conform to the requirements in § 173.301b(c)(2)(ii).
49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.
(b) * * *
(5) Ammonium nitrate, Division 5.1 (oxidizer) UN1942, shipped as a limited quantity, if the nearest COTP is notified at least 24 hours in advance of any loading or unloading in excess of 454 kg (1,000 pounds).
49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.
(f) * * *
(7)
(b) * * *
(8)
(b) * * *
(7) Authorization to manufacture, mark, and sell UN4G combination packagings with outer fiberboard boxes and with inner fiberboard components that have individual containerboard or paper wall basis weights that vary by not more than plus or minus 10% from the nominal basis weight reported in the initial design qualification test report.
(b) * * *
(6) For each composite IBC, the inner receptacle must be marked with at least the following information:
(i) The code number designating the IBC design type, the name and address
(ii) When a composite IBC is designed in such a manner that the outer casing is intended to be dismantled for transport when empty (such as, for the return of the IBC for reuse to the original consignor), each of the parts intended to be detached when so dismantled must be marked with the month and year of manufacture and the name or symbol of the manufacturer.
49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.
(g) * * *
(1) * * *
(iv) Each cargo tank must be tested hydrostatically or pneumatically to the internal pressure specified in the following table. At no time during the pressure test may a cargo tank be subject to pressures that exceed those identified in the following table:
(l)
(2) If the owner does not have the manufacturer's certificate required by the specification and the manufacturer's data report required by the ASME, the owner may contact the National Board for a copy of the manufacturer's data report, if the portable tank was registered with the National Board, or copy the information contained on the portable tanks specification plate and ASME Code data plates.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule; request for comments.
NMFS proposes regulations to implement Regulatory Amendment 1 for the Fishery Management Plan (FMP) for the Dolphin and Wahoo Fishery off the Atlantic States (Regulatory Amendment 1) as prepared and submitted by the South Atlantic Fishery Management Council (Council). If implemented, this proposed rule would establish a commercial trip limit for Atlantic dolphin for vessels with a Federal commercial permit for Atlantic dolphin and wahoo. The purpose of this
Written comments must be received on or before August 1, 2016.
You may submit comments on the proposed rule, identified by “NOAA-NMFS-2016-0033” by either of the following methods:
•
•
Electronic copies of Regulatory Amendment 1, which includes an environmental assessment, an assessment under the Regulatory Flexibility Act, a regulatory impact review, and fishery impact statement, may be obtained from
Karla Gore, NMFS SERO, telephone: 727-551-5753, or email:
The dolphin and wahoo fishery of the Atlantic is managed under the FMP. The FMP was prepared by the Council and implemented through regulations at 50 CFR part 622 under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Steven Act).
The Magnuson-Stevens Act requires NMFS and regional fishery management councils to prevent overfishing and achieve, on a continuing basis, the optimum yield from federally managed fish stocks. These mandates are intended to ensure that fishery resources are managed for the greatest overall benefit to the nation, particularly with respect to providing food production and recreational opportunities, while also protecting marine ecosystems.
In 2015, the commercial sector for Atlantic dolphin was closed on June 30, 2015 (80 FR 36932, June 29, 2015), as a result of the commercial ACL being met, thereby triggering accountability measures (AMs) and closing the sector. This was the first time the dolphin commercial fishing season was closed as a result of AMs in the history of management of Atlantic dolphin under the FMP. Regulatory Amendment 1 and this proposed rule would establish a commercial trip limit for Atlantic dolphin once 75 percent of the commercial ACL is met. The dolphin commercial ACL had already been increased from 1,157,001 lb (524,807 kg), round weight, to 1,534,485 lb (696,031 kg), round weight, by the final rule for Amendment 8 to the FMP (81 FR 3781, January 22, 2016). The Council has determined that this proposed action would reduce the severity of social impacts of an AM closure of the dolphin commercial sector by increasing the likelihood that the commercial sector will remain open throughout the fishing year.
This proposed rule would establish a commercial trip limit for dolphin for vessels that have a Federal commercial permit for Atlantic dolphin and wahoo.
Currently, no commercial trip limit exists for vessels that possess a Federal commercial permit for Atlantic dolphin and wahoo. However, there is a commercial trip limit of 200 lb (91 kg) of dolphin and wahoo, combined, for vessels that do not have a Federal commercial permit for Atlantic dolphin and wahoo but do have a Federal commercial permit in any other fishery, provided that all fishing and landings from that trip occur north of 39° N. lat. (50 CFR 622.278(a)(2)). This proposed rule would establish a commercial trip limit of 4,000 lb (1,814 kg), round weight, for the dolphin commercial sector in the Atlantic, once 75 percent of the commercial ACL is reached. This trip limit would apply to vessels that have a Federal commercial permit for Atlantic dolphin and wahoo, provided that the vessel is not operating a charter vessel or headboat. There would be no applicable trip limit for the dolphin commercial sector in the Atlantic prior to 75 percent of the commercial ACL being reached. The Council determined that establishing this commercial trip limit would reduce the chances of early closures during the fishing year as a result of AMs being triggered, and thereby reduce the severity of any socioeconomic impacts as a result of a commercial sector closure.
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 Regulatory Amendment 1, other provisions of the Magnuson-Stevens Act, and other applicable laws, 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 (SBA) that this rule, if adopted, would not have a significant economic impact on a substantial number of small entities. The factual basis for this determination is as follows:
A description of this proposed rule, why it is being considered, the objectives of, and legal basis for this proposed rule are contained in the preamble and in the
This proposed rule is expected to directly affect federally permitted Atlantic dolphin and wahoo commercial fishermen fishing for dolphin in the South Atlantic and northeastern states (states north of North Carolina) (Atlantic). The Small Business Administration established size criteria for all major industry sectors in the U.S. including fish harvesters. A business involved in fish harvesting is classified as a small business if it is independently owned and operated, is not dominant in its field of operation (including its affiliates), and its combined annual receipts are not in excess of $20.5 million (NAICS code 114111, finfish fishing) for all of its affiliated operations worldwide.
From 2010 through 2014, an average of 531 vessels with the Federal
Because all entities expected to be directly affected by this proposed rule are assumed to be small entities, NMFS determined that this proposed rule would affect a substantial number of small entities. However, the issue of disproportionate effects on small versus large entities does not arise in the present case.
This proposed rule would establish a 4,000 lb (1,814 kg), round weight, commercial trip limit for dolphin for vessels with a Federal commercial permit for Atlantic dolphin and wahoo, once 75 percent of the commercial ACL is reached.
For the first time, the dolphin commercial sector was subject to an in-season closure on June 30, 2015, when the sector's ACL of 1,157,001 lb (524,806 kg), round weight, was reached (80 FR 36249, June 24, 2015, and 80 FR 36932, June 29, 2015). However, the recently implemented final rule for Amendment 8 to the FMP increased the dolphin commercial ACL from 1,157,001 lb (524,807 kg), round weight, to 1,534,485 lb (696,031 kg), round weight (81 FR 3781, January 22, 2016). Using 2015 data for the months open to commercial dolphin harvest during the fishing year and average 2010-2014 data for the months closed to dolphin harvest, NMFS estimated that in the absence of AM closures and commercial trip limits the 2015 commercial landings would have been approximately 1,229,669 lb (557,768 kg), round weight, with a dockside value of $3,725,896 (2014 dollars). Thus, if the increased dolphin commercial allocation had been in effect in 2015, it is likely that no commercial closure would have occurred.
Based on the increased commercial allocation, and assuming effort in 2016 and onwards would remain the same as estimated for the 2015 fishing year, 75 percent of the commercial ACL would be estimated to be reached on August 25 each year, and the proposed trip limit would then apply for the rest of the fishing year. The projected landings under this scenario would be 1,229,669 lb (557,768 kg), round weight, with a dockside value of $3,725,896 (2014 dollars). Thus, the proposed trip limit would not result in any reduction in total landings or revenues.
Although total landings or revenues would not be adversely affected, the proposed trip limit would be expected to have disproportionate impacts on vessels, with high-volume vessels such as those using longline gear more adversely affected than others. However, based on the estimated landings and effort distribution by gear type for 2015, the proposed trip limit would not be expected to adversely affect the trips and landings of any vessel regardless of the gear type they used.
Possibilities exist that the dolphin commercial sector may increase future effort and landings so that the total harvest could reach or exceed the commercial ACL if unrestrained by a trip limit. The harvest closure in 2015, even though it happened before the increase in the commercial ACL took effect, could motivate current participants to increase their effort to take advantage of fishing opportunities before harvest is prohibited. Because the Atlantic dolphin and wahoo commercial permit is an open access permit, new entrants, particularly longliners that fish for highly migratory species, could enter the dolphin and wahoo fishery and increase total effort and harvest. If this occurs, the proposed trip limits could constrain total harvest and prolong the commercial season. Total revenues for a fishing year would be expected to be higher, so long as the higher landings do not substantially depress the dockside price for dolphin. It cannot be determined, however, if higher revenues would translate to higher profits because the trip limit would reduce profit per trip. However, based on available data, NMFS analysis is that the proposed trip limit may be expected to have no adverse effects on vessel revenues, and thus, the proposed trip limit may be considered as a precautionary measure at this time and will not have a significant economic impact on the affected small entities.
No duplicative, overlapping, or conflicting Federal rules have been identified. In addition, no new reporting, recordkeeping, or other compliance requirements are introduced by this proposed rule. Accordingly, this rule does not implicate the Paperwork Reduction Act.
The information provided above supports a determination that this rule would not have a significant economic impact on a substantial number of small entities. Because this rule, if implemented, is not expected to have a significant economic impact on any small entities, an initial regulatory flexibility analysis is not required and none has been prepared.
Commercial, Dolphin, Fisheries, Fishing, Trip limits.
For the reasons stated in the preamble, NMFS proposes to amend 50 CFR part 622 as follows:
16 U.S.C. 1801
(a)
(ii) See § 622.280(b)(1) for the limitations regarding wahoo after the ACL is reached.
(2) The trip limit for a vessel that does not have a Federal commercial vessel permit for Atlantic dolphin and wahoo but has a Federal commercial vessel permit in any other fishery is 200 lb (91 kg) of dolphin and wahoo, combined, provided that all fishing on and landings from that trip are north of 39° N. lat. (A charter vessel/headboat permit is not a commercial vessel permit.)
(3)
(ii) See § 622.280(a)(1) for the limitations regarding dolphin after the ACL is reached.
Animal and Plant Health Inspection Service, USDA.
Notice of intent to reestablish.
Pursuant to the Federal Advisory Committee Act, we are giving notice that the Secretary of Agriculture intends to reestablish the National Wildlife Services Advisory Committee for a 2-year period. The Secretary has determined that the Committee is necessary and in the public interest.
Ms. Carrie Joyce, Designated Federal Officer, Wildlife Services, APHIS, 4700 River Road, Unit 87, Riverdale, MD 20737; (301) 851-3999.
The purpose of the National Wildlife Services Advisory Committee (the Committee) is to advise the Secretary of Agriculture on policies, program issues, and research needed to conduct the Wildlife Services program. The Committee also serves as a public forum enabling those affected by the Wildlife Services program to have a voice in the program's policies.
Office of the Deputy Under Secretary for Food Safety, USDA.
Notice of public meeting and request for comments.
The Office of the Deputy Under Secretary for Food Safety, U.S. Department of Agriculture (USDA), and the Agricultural Marketing Service (AMS), are sponsoring a public meeting on August 1, 2016. The objective of the public meeting is to provide information and receive public comments on agenda items and draft United States (U.S.) positions to be discussed at the 28th Session of the Codex Committee on Processed Fruits and Vegetables (CCPFV) of the Codex Alimentarius Commission (Codex), taking place in Washington, DC, September 12-16, 2016. The Deputy Under Secretary for Food Safety and the AMS recognize the importance of providing interested parties the opportunity to obtain background information on the 28th Session of the CCPFV and to address items on the agenda.
The public meeting is scheduled for Monday, August 1, 2016, from 1:00 p.m.-4:00 p.m.
The public meeting will take place at the USDA, Jamie L. Whitten Building, 1400 Independence Avenue SW., Room 107-A, Washington, DC 20250.
Documents related to the 28th Session of the CCPFV will be accessible via the Internet at the following address:
Dorian LaFond, U.S. Delegate to the 28th Session of the CCPFV, invites U.S. interested parties to submit their comments electronically to the following email address:
If you wish to participate in the public meeting for the 28th Session of the CCPFV by conference call, please use the following call-in-number.
Call-in-Number: 1-888-844-9904
The participant code will be posted on the following Web page:
Attendees may register to attend the public meeting by emailing
Dorian LaFond, Agricultural Marketing Service, Fruits and Vegetables Division, Mail Stop 0235, Room 2086, South Agriculture Building, 1400 Independence Avenue SW., Washington, DC 20250-0235, Telephone: (202) 690-4944, Fax: (202) 720-0016, Email:
Doreen Chen-Moulec, U.S. Codex Office, 1400 Independence Avenue SW., South Agriculture Building, Room 4865, Washington, DC 20250. Telephone: (202) 205-7760, Fax: (202) 720-3157, Email:
Codex was established in 1963 by two United Nations organizations, the Food and Agriculture Organization and the World Health Organization. Through adoption of food standards, codes of practice, and other guidelines developed by its committees, and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers and ensure fair practices in the food trade.
The CCPFV is responsible for elaborating worldwide standards and related texts for all types of processed fruits and vegetables including, but not limited to canned, dried, and frozen products, as well as fruit and vegetable juices and nectars.
The Committee is hosted by the United States.
The following items on the Agenda for the 28th Session of the CCPFV will be discussed during the public meeting:
• Matters referred to the Committee by Codex and its subsidiary bodies;
• Proposed draft Annex on canned pineapples (for inclusion in the Standard for Certain Canned Fruits (CODEX STAN 319-2015) (Step 4);
• Proposed draft Annexes on quick frozen vegetables (for inclusion in the Standard for Quick Frozen Vegetables (CODEX STAN 320-2015) (Step 4) and methods of analysis for quick frozen vegetables (for inclusion in Section 11—Methods of Analysis and Sampling of CODEX STAN 320-2015);
• Discussion paper on standardization of dry and dried produce;
• Food additive provisions in Codex standards for processed fruits and vegetables (canned chestnuts and canned chestnut puree and pickled fruits and vegetables); and
• Status of work on the revision of Codex standards for processed fruits and vegetables.
Each issue listed will be fully described in documents distributed, or to be distributed, by the Secretariat before the Meeting. Members of the public may access or request copies of these documents (see
At the August 1, 2016, public meeting, draft U.S. positions on the agenda items will be described and discussed, and attendees will have the opportunity to pose questions and offer comments. Written comments may be offered at the meeting or sent to the U.S. Delegate for the 28th Session of the CCPFV, Dorian LaFond (see
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Food Safety and Inspection Service, Department of Agriculture.
Notice of the Renewal of the U.S. Department of Agriculture National Advisory Committee on Meat and Poultry Inspection.
The U.S. Department of Agriculture intends to renew the National Advisory Committee on Meat and Poultry Inspection (NACMPI). The purpose of the Committee is to provide advice to the Secretary of Agriculture concerning State and Federal programs with respect to meat, poultry and processed egg products inspection, food safety, and other matters that fall within the scope of the Federal Meat Inspection Act (FMIA), the Poultry Products Inspection Act (PPIA), and the Egg Products Inspection Act (EPIA).
In accordance with the Federal Advisory Committee Act (FACA) (5 U.S.C. App.), notice is hereby given that the Secretary of Agriculture intends to renew the NACMPI for two years. The Committee provides advice and recommendations to the Secretary on meat and poultry inspection programs, pursuant to sections 7(c), 24, 301(a)(3), and 301(c) of the Federal Meat Inspection Act, 21 U.S.C. 607(c), 624, 645, 661(a)(3), and 661(c), and to sections 5(a)(3), 5(c), 8(b), and 11(e) of the Poultry Products Inspection Act, 21 U.S.C. 454(a)(3), 454(c), 457(b), and 460(e).
A copy of the current charter and other information about the committee can be found at
Public awareness of all segments of rulemaking and policy development is
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.), should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Office of Food Safety, USDA.
Notice.
This notice informs the public of the sanitary and phytosanitary standard-setting activities of the Codex Alimentarius Commission (Codex), in accordance with section 491 of the Trade Agreements Act of 1979, as amended, and the Uruguay Round Agreements Act. This notice also provides a list of other standard-setting activities of Codex, including commodity standards, guidelines, codes of practice, and revised texts. This notice, which covers Codex activities during the time periods from June 1, 2015, to May 31, 2016, and June 1, 2016, to May 31, 2017, seeks comments on standards under consideration and recommendations for new standards.
FSIS invites interested persons to submit their comments on this notice. Comments may be submitted by one of the following methods:
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Please state that your comments refer to Codex and, if your comments relate to specific Codex committees, please identify the committee(s) in your comments and submit a copy of your comments to the delegate from that particular committee.
Mary Frances Lowe, United States Manager for Codex Alimentarius, U.S. Department of Agriculture, Office of Food Safety, South Agriculture Building, 1400 Independence Avenue SW., Room 4861, Washington, DC 20250-3700; Telephone: (202) 205-7760; Fax: (202) 720-3157; Email:
For information pertaining to particular committees, contact the delegate of that committee. Documents pertaining to Codex and specific committee agendas are accessible via the Internet at
The World Trade Organization (WTO) was established on January 1, 1995, as the common international institutional framework for the conduct of trade relations among its members in matters related to the Uruguay Round Trade Agreements. The WTO is the successor organization to the General Agreement on Tariffs and Trade (GATT). United States membership in the WTO was approved and the Uruguay Round Agreements Act (Uruguay Round Agreements) was signed into law by the President on December 8, 1994, Public Law 103-465, 108 Stat. 4809. The Uruguay Round Agreements became effective, with respect to the United States, on January 1, 1995. The Uruguay Round Agreements amended the Trade Agreements Act of 1979. Pursuant to section 491 of the Trade Agreements Act of 1979, as amended, the President is required to designate an agency to be “responsible for informing the public of the sanitary and phytosanitary (SPS) standard-setting activities of each international standard-setting organization” (19 U.S.C. 2578). The
Codex was created in 1963 by two United Nations organizations, the Food and Agriculture Organization (FAO) and the World Health Organization (WHO). Codex is the principal international organization for establishing standards for food. Through adoption of food standards, codes of practice, and other guidelines developed by its committees and by promoting their adoption and implementation by governments, Codex seeks to protect the health of consumers, ensure fair practices in the food trade, and promote coordination of food standards work undertaken by international governmental and nongovernmental organizations. In the United States, U.S. Codex activities are managed and carried out by the United States Department of Agriculture (USDA); the Food and Drug Administration (FDA), Department of Health and Human Services (HHS); the National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC); and the Environmental Protection Agency (EPA).
As the agency responsible for informing the public of the SPS standard-setting activities of Codex, the Office of Food Safety publishes this notice in the
1. The SPS standards under consideration or planned for consideration; and
2. For each SPS standard specified:
a. A description of the consideration or planned consideration of the standard;
b. Whether the United States is participating or plans to participate in the consideration of the standard;
c. The agenda for United States participation, if any; and
d. The agency responsible for representing the United States with respect to the standard.
This notice also solicits public comment on standards that are currently under consideration or planned for consideration and recommendations for new standards. The delegate, in conjunction with the responsible agency, will take the comments received into account in participating in the consideration of the standards and in proposing matters to be considered by Codex.
The U.S. delegate will facilitate public participation in the United States Government's activities relating to Codex. The U.S. delegate will maintain a list of individuals, groups, and organizations that have expressed an interest in the activities of the Codex Committees and will disseminate information regarding U.S. delegation activities to interested parties. This information will include the status of each agenda item; the U.S. Government's position or preliminary position on the agenda items; and the time and place of planning meetings and debriefing meetings following the Codex committee sessions. In addition, the U.S. Codex Office makes much of the same information available through its Web page at
The information provided in Attachment 1 describes the status of Codex standard-setting activities by the Codex Committees for the time periods from June 1, 2015, to May 31, 2016, and June 1, 2016, to May 31, 2017. Attachment 2 provides a list of U.S. Codex Officials (including U.S. delegates and alternate delegates). A list of forthcoming Codex sessions may be found at:
Public awareness of all segments of rulemaking and policy development is important. Consequently, FSIS will announce this
FSIS also will make copies of this publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations,
Options range from recalls to export information, regulations, directives, and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.
The Codex Alimentarius Commission will convene for its 39th Session June 27-July 1, 2016, in Rome, Italy. At that time, it will consider proposals for new work as well as proposed standards, codes of practice, and related matters forwarded to the Commission by the general subject committees, commodity committees, and regional coordinating committees for adoption as Codex standards and guidance. The Commission will also consider the relations between FAO and WHO policies, strategies and guidelines and Codex work; Codex work on antimicrobial resistance; FAO/WHO Scientific Support for Codex; and the FAO/WHO Project and Trust Fund for Enhanced Participation in Codex; and financial and budgetary issues.
Before the Commission meeting, the Executive Committee will meet at its 71st Session, June 20-23, 2016. It is composed of the chairperson; vice-chairpersons; seven members elected from the Commission from each of the following geographic regions: Africa, Asia, Europe, Latin America and the Caribbean, Near East, North America, and South-West Pacific; and regional
The Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) determines priorities for the consideration of residues of veterinary drugs in foods and recommends Maximum Residue Limits (MRLs) for veterinary drugs. The Committee also develops codes of practice, as may be required, and considers methods of sampling and analysis for the determination of veterinary drug residues in food. A veterinary drug is defined as any substance applied or administered to any food producing animal, such as meat or milk producing animals, poultry, fish, or bees, whether used for therapeutic, prophylactic or diagnostic purposes, or for modification of physiological functions or behavior.
A Codex Maximum Residue Limit (MRL) for residues of veterinary drugs is the maximum concentration of residue resulting from the use of a veterinary drug (expressed in mg/kg or ug/kg on a fresh weight basis) that is recommended by the Codex Alimentarius Commission to be permitted or recognized as acceptable in or on a food. Residues of a veterinary drug include the parent compounds or their metabolites in any edible portion of the animal product, and include residues of associated impurities of the veterinary drug concerned. An MRL is based on the type and amount of residue considered to be without any toxicological hazard for human health as expressed by the Acceptable Daily Intake (ADI) or on the basis of a temporary ADI that utilizes an additional safety factor. When establishing an MRL, consideration is also given to residues that occur in food of plant origin or the environment. Furthermore, the MRL may be reduced to be consistent with official recommended or authorized usage, approved by national authorities, of the veterinary drugs under practical conditions.
An ADI is an estimate made by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) of the amount of a veterinary drug, expressed on a body weight basis, which can be ingested daily in food over a lifetime without appreciable health risk.
The Committee will convene its 23rd Session in Houston, Texas, October 17-21, 2016. The Committee plans to discuss the following items:
• Matters of Interest arising from FAO/WHO and from the 81st Meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA);
• Report of the World Organisation for Animal Health (OIE) activities, including the harmonization of technical requirements for registration of veterinary medicinal products;
• Proposed draft Risk Management Recommendation (RMR) for gentian violet at Step 3;
• Proposed draft MRLs for ivermectin (cattle muscle) and lasalocid sodium (chicken, turkey, quail and pheasant kidney, liver, muscle, skin + fat) at Step 4;
• Proposed draft MRLs for ivermectin (cattle fat, kidney, muscle), teflubenzuron (salmon fillet, muscle) and zilpaterol hydrocholoride (cattle fat, kidney, liver, muscle) at Step 3;
• Discussion paper on unintended presence of residues of veterinary drugs in food commodities resulting from the carry-over of drug residues into feed;
• Discussion paper on the establishment of a rating system to establish priority for CCRVDF work;
• Global survey to provide information to the CCRVDF to move compounds from the database on countries' needs for MRLs to the JECFA Priority List (Report of EWG);
• Draft priority list of veterinary drugs requiring evaluation or re-evaluation by JECFA; and
• Other Business and Future Work.
The Codex Committee on Contaminants in Foods (CCCF) establishes or endorses permitted maximum levels (MLs) or guideline levels for contaminants and naturally occurring toxicants in food and feed; prepares priority lists of contaminants and naturally occurring toxicants for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives; considers and elaborates methods of analysis and sampling for the determination of contaminants and naturally occurring toxicants in food and feed; considers and elaborates standards or codes of practice for related subjects; and considers other matters assigned to it by the Commission in relation to contaminants and naturally occurring toxicants in food and feed.
The Committee convened for its 10th Session in Rotterdam, The Netherlands, April 4-8, 2016. The relevant document is REP16/CF. The following items are to be considered for adoption by the 39th Session of the Commission in June 2016:
• Draft ML for inorganic arsenic in husked rice; and
• Draft revised Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CAC/RCP 51-2003).
• Proposed draft MLs for lead in fruit juices and nectars ready to drink (inclusion of passion fruit); canned fruits (inclusion of canned berries and other small fruits); canned vegetables (inclusion of canned leafy vegetables and canned legume vegetables); jams, jellies, and marmalades (lower ML and inclusion of marmalades); pickled cucumbers (lower ML); preserved tomatoes (lower ML and note on the application of a concentration factor); and table olives (lower ML); and
• Proposed draft annexes on zearalenone, fumonisins, ochratoxin A, trichothecenes and aflatoxins to the Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CAC/RCP 51-2003).
• Proposed draft annex on ergot and ergot alkaloids in cereal grains (Annex to the Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Cereals (CAC/RCP 51-2003);
• Outstanding issues related to the review of MLs for lead in selected fruits and vegetables (fresh and processed) and other selected food categories;
• Proposed draft Code of Practice for the Prevention and Reduction of Arsenic Contamination in Rice;
• Proposed draft MLs for cadmium in chocolate and cocoa-derived products;
• Proposed draft Code of Practice for the Prevention and Reduction of Mycotoxin Contamination in Spices and its annexes;
• Proposed draft MLs for total aflatoxins in ready to eat peanuts following the JECFA evaluation;
• Discussion paper on MLs for mycotoxins in spices;
• Discussion paper on methylmercury in tuna (fresh/frozen and canned) and in other fish species;
• Discussion paper on non-dioxin like PCBs in the Code of Practice for the Prevention and Reduction of Dioxins and Dioxin like PCB Contamination in Food and Feeds (CAC/RCP 62-2006);
• Pyrrolizidine Alkaloids following the outcome of the JECFA evaluation; and
• Priority list on contaminants and naturally occurring toxicants proposed for evaluation by JECFA.
The Codex Committee on Food Additives (CCFA) establishes or endorses acceptable maximum levels (MLs) for individual food additives; prepares a priority list of food additives for risk assessment by the Joint FAO/WHO Expert Committee on Food Additives (JECFA); assigns functional classes to individual food additives; recommends specifications of identity and purity for food additives for adoption by the Codex Alimentarius Commission; considers methods of analysis for the determination of additives in food; and considers and elaborates standards or codes of practice for related subjects such as the labeling of food additives when sold as such. The 48th Session of the Committee convened in Xi'an, China, March 14-18, 2016. The relevant document is REP16/FA. Immediately prior to the Plenary Session, there was a two-day physical Working Group on the General Standard for Food Additives (GSFA) chaired by the United States.
The following items will be considered by the 39th Session of the Commission in June 2016:
• Amendments to food additive provisions in commodity standards.
• Revised food additives section of the Standards for Cocoa Butter
• Revised food additive provisions of the GSFA related to the alignment of the four commodity standards for chocolate and chocolate products and the commodity standards identified by the Committee on Fish and Fishery Products (CCFFP); and
• Revised the food additive provision of the GSFA for benzoates in water-based flavored drinks in response to a recommendation from JECFA.
• Draft and proposed draft food additive provisions of the GSFA.
• Proposed draft specifications for the identity and purity of food additives;
• Proposed draft amendments to the
• Proposed draft revision of food category 01.1 “Fluid milk and milk products” of the GSFA and consequential changes; and
• Proposed draft revision of Sections 4.1c and 5.1c of the
• Proposed draft food additive provisions of the GSFA (eWG led by the United States);
• Amendments to the INS for food additives; and
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• Alignment of the food additive provisions of commodity standards and relevant provisions of the GSFA (eWG led by Australia and the United States);
• Recommendations on the use of food additives in wine and specific provisions for acidity regulators, stabilizers, and antioxidants (eWG led by France and Australia);
• Discussion paper on the management of CCFA work (China and United States);
• Discussion paper on the use of nitrates and nitrites (Netherlands);
• Proposal for additions and changes to the
• Information document on the GSFA; and
• Information document on food additive provisions in commodity standards.
The Committee also agreed to hold a physical Working Group on the GSFA immediately preceding the 49th Session of CCFA to be chaired by the United States. The group will discuss:
• The recommendations of the eWG on the GSFA on food additive provisions to be circulated for comment.
• The comments submitted in responses to a circular letter requesting information on the use and use levels of adipic acid.
• The new proposals and proposed revisions of food additive provisions in the GSFA.
The Codex Committee on Pesticide Residues (CCPR) is responsible for establishing maximum residue limits (MRLs) for pesticide residues in specific food items or in groups of food; establishing MRLs for pesticide residues in certain animal feeding stuffs moving in international trade where this is justified for reasons of protection of human health; preparing priority lists of pesticides for evaluation by the Joint FAO/WHO Meeting on Pesticide Residues (JMPR); considering methods of sampling and analysis for the determination of pesticide residues in food and feed; considering other matters in relation to the safety of food and feed containing pesticide residues; and establishing maximum limits for environmental and industrial contaminants showing chemical or other similarity to pesticides in specific food items or groups of food.
The 48th Session of the Committee met in Chongqing, China, April 25-30, 2016. The relevant document is REP16/PR. The following items will be considered at the 39th Session of the Codex Alimentarius Commission in June 2016:
1. Group 021—Grasses for sugars or syrup production and;
2. Group 024—Seeds for beverages and sweets.
The Codex Committee on Methods of Analysis and Sampling (CCMAS) defines the criteria appropriate to Codex Methods of Analysis and Sampling; serves as a coordinating body for Codex with other international groups working on methods of analysis and sampling and quality assurance systems for laboratories; specifies, on the basis of final recommendations submitted to it by the bodies referred to above, reference methods of analysis and sampling appropriate to Codex standards which are generally applicable to a number of foods; considers, amends if necessary, and endorses as appropriate, methods of analysis and sampling proposed by Codex commodity committees, except for methods of analysis and sampling for residues of pesticides or veterinary drugs in food, the assessment of microbiological quality and safety in food, and the assessment of specifications for food additives; elaborates sampling plans and procedures, as may be required; considers specific sampling and analysis problems submitted to it by the Commission or any of its Committees; and defines procedures, protocols, guidelines or related texts for the assessment of food laboratory proficiency, as well as quality assurance systems for laboratories.
The 37th Session of the Committee met in Budapest, Hungary, February 22-26, 2016. The relevant document is REP16/MAS. The following items will be considered by the Commission at its 39th Session in June 2016:
• Methods of Analysis and Sampling in Codex Standards; and
• Amendments to the Procedural Manual.
• Guidance on the criteria approach for methods which use a “sum of components”;
• Criteria for endorsement of biological methods to detect chemicals of concern;
• Procedures for determining uncertainty of measurement results (improvements and amendments to CAC/GL-54-2004);
• Review general guidelines on sampling (CAC/GL 50-2004) for potential revision;
• Practical examples on the selection of appropriate sampling plans; and
• Review and update of methods in Codex STAN 234-1999.
• Development of procedures/guidelines for determining equivalency of Type I methods.
The Codex Committee on Food Import and Export Inspection and Certification Systems (CCFICS) is responsible for developing principles and guidelines for food import and export inspection and certification systems, with a view to harmonizing methods and procedures that protect the health of consumers, ensure fair trading practices, and facilitate international trade in foodstuffs; developing principles and guidelines for the application of measures by the competent authorities of exporting and importing countries to provide assurance, where necessary, that foodstuffs comply with requirements, especially statutory health requirements; developing guidelines for the utilization, as and when appropriate, of quality assurance systems to ensure that foodstuffs conform with requirements and promote the recognition of these systems in facilitating trade in food products under bilateral/multilateral arrangements by countries; developing guidelines and criteria with respect to format, declarations, and language of such official certificates as countries may require with a view towards international harmonization; making recommendations for information exchange in relation to food import/export control; consulting as necessary with other international groups working on matters related to food inspection and certification systems; and considering other matters assigned to it by the Commission in relation to food inspection and certification systems.
The 22nd Session of the Committee convened in Melbourne, Australia, February 6-12, 2016. The relevant document is REP16/FICS. There following items will be considered by the Commission at its 39th Session in June 2016:
• Proposed draft Principles and Guidelines for the Exchange of Information Between Importing and Exporting Countries to Support the Trade in Food;
• Proposed draft Revision of the Principles and Guidelines for the Exchange of Information in Food Safety Emergency Situations (CAC/GL 19-1995); and
• Proposed draft Revision of the Guidelines for the Exchange of Information Between Countries on Rejections of Imported Food (CAC/GL 25-1997).
To be considered for adoption at Step 5:
• Proposed draft Guidance for Monitoring the Performance of National Food Control Systems.
The Committee will continue working on:
• Discussion paper on the Use of Electronic Certificates by Competent Authorities and Migration to Paperless Certification;
• Discussion paper on Third Party Certification (with broad parameters);
• Discussion paper on Consideration of Emerging Issues and Future Directions for the Work of the Codex Committee on Food Import and Export Inspection and Certification Systems; and
• Discussion paper on Food Integrity/Food Authenticity As Emerging Issues.
The Codex Committee on Food Labelling (CCFL) drafts provisions on labeling applicable to all foods; considers, amends, and endorses draft specific provisions on labeling prepared by the Codex Committees drafting standards, codes of practice, guidelines; and studies specific labeling problems assigned by the Codex Alimentarius Commission. The Committee also studies problems associated with the advertisement of food with particular reference to claims and misleading descriptions.
The Committee convened for its 43rd Session in Ottawa, Ontario, Canada May 9-13, 2016.
There following items will be considered by the Commission at its 39th Session in June 2016:
To be considered for adoption at Step 5:
• Revision of the General Standard for the Labelling of Prepackaged Foods: Date marking.
The Committee proposed that the Codex Alimentarius Commission identify a more appropriate forum for the revision of the Guidelines for the Production, Processing, Labelling and Marketing of Organically Produced Foods: Organic Aquaculture
The Committee agreed to propose new work on:
• Guidance for the labelling of Non-retail containers
The Committee will continue to work on:
• Front of Pack Labelling;
• Consideration of issues surrounding consumer preference claims; and
• Discussion paper on future work for the Committee.
The Codex Committee on Food Hygiene (CCFH):
• Develops basic provisions on food hygiene applicable to all food or to specific food types;
• Considers and amends or endorses provisions on food hygiene contained in Codex commodity standards and codes of practice developed by other Codex commodity committees;
• Considers specific food hygiene problems assigned to it by the Commission;
• Suggests and prioritizes areas where there is a need for microbiological risk assessment at the international level and develops questions to be addressed by the risk assessors; and
• Considers microbiological risk management matters in relation to food hygiene and in relation to FAO/WHO risk assessments.
The Committee convened for its 47th Session in Boston, Massachusetts, November 9-13, 2015. The relevant document is REP 16/FH. The following items will be considered by the Commission at its 39th Session in June 2016:
• Guidelines for the Control of Non-Typhoidal
• Guidelines on the Application of General Principles of Food Hygiene to the Control of Foodborne Parasites; and
• Proposed draft Annex I “Examples of Microbiological Criteria for Low-Moisture Foods when Deemed Appropriate in accordance with the Principles and Guidelines for the Establishment and Application of Microbiological Criteria Related to Foods (CAC/GL 21-1997)” and Annex II “Guidance for the Establishment of Environmental Monitoring Programs for
• Draft Annex III “Spices and Dried Aromatic Herbs” to the Code of Hygienic Practice for Low-Moisture Foods (CAC/RCP 75-2015)
• Code of Hygienic Practice for Spices and Dried Aromatic Herbs (CAC/RCP 42-1995)
• Compiling all guidance for the control of foodborne parasites into a single document,
• Revision of the General Principles of Food Hygiene (CAC/RCP 1-1969) and its HACCP Annex;
• Revision of the Code of Hygienic Practice for Fresh Fruits and Vegetables (CAC/RCP 53-2003); and
• New work proposals/Forward Work plan.
The Codex Committee on Fresh Fruits and Vegetables (CCFFV) is responsible for elaborating worldwide standards and codes of practice, as may be appropriate for fresh fruits and vegetables; for consulting as necessary, with other international organizations in the standards development process to avoid duplication.
The 19th Session of the Committee met in Ixtapa Zihuatanejo, Guerrero, Mexico October 5-9, 2015. The relevant document is REP 16/FFV. The following items will be considered at the 39th Session of the Codex Alimentarius Commission in June 2016.
To be considered for adoption at Step 5/8:
• Proposed draft Standard for Aubergines.
To be considered for adoption at Step 5:
• Proposed draft Standard for Garlic; and
• Proposed draft Standard for Kiwifruit.
The Committee will continue discussing the following items:
• Proposed draft Standard for Ware Potatoes;
• Proposals for new work for Codex standards for fresh fruits and vegetables;
• Layout for Codex standards for fresh fruits and vegetables;
• Selected provisions in the Layout for Codex/FFV standards pending further consideration by CCFFV; and
• Preparation of a draft Glossary of Terms for Application in the Layout for Codex Standards for Fresh Fruits and Vegetables.
The Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) is responsible for studying nutrition issues referred to it by the Codex Alimentarius Commission. The Committee also drafts general provisions, as appropriate, on nutritional aspects of all foods and develops standards, guidelines, or related texts for foods for special dietary uses in cooperation with other committees where necessary; considers, amends if necessary, and endorses provisions on nutritional aspects proposed for inclusion in Codex standards, guidelines, and related texts.
The Committee convened for its 37th Session in Bad Soden am Taunus, Germany, November 23-27, 2015. The reference document is REP 16/NFSDU. The following items will be considered by the Commission at its 39th Session in June 2016:
To be considered for adoption:
• Draft amendment to the Annex of the Guidelines on Nutrition Labelling (CAC/GL 2-1985) to add a definition for RASBs (
• Draft amendment to Section 10, Methods of analysis in Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants (Codex STAN 72-1981).
To be considered for adoption at Step 5/8:
• Proposed draft
• Proposed draft NRV-R for Vitamin D and the dietary equivalents and conversion factor for Vitamin E);
• Review if the Standard for Follow-Up Formula (CODEX STAN 156-1987) (Section 2.1.1 and 2.2 and essential composition and optional ingredients) (6-12 months);
• Review of the Standard for Follow-Up Formula (CODEX STAN 156-1987);
• Proposed draft Definition for Biofortification;
• Proposed draft NRV-NCD for EPA and DHA long chain omega-3 fatty acids;
• Proposed guideline for Ready-to-Use Foods (RUF);
• Discussion paper on Claim for “Free” of Trans Fatty Acids; and
• Alignment of Food Additive provisions in standards developed by CCNFSDU.
The Fish and Fishery Products Committee (CCFFP) is responsible for elaborating standards for fresh, frozen and otherwise processed fish, crustaceans, and mollusks. The Committee convened for its 34th Session in Alesund, Norway October 19-24, 2015. The relevant document is REP16/FFP.
The following items will be considered by the 39th Session of the Commission in July 2016:
To be considered for approval:
• Sampling plans in the Standard for Live Abalone and for Raw, Fresh Chilled or Frozen Abalone for Direct Consumption or for Further Processing (CODEX STAN 312-2013); Standard for Smoked Fish, Smoked Flavored Fish and Smoke-Dried Fish (CODEX STAN 311-2013); and Standard for Fresh and Quick Frozen Raw Scallop Products (CODEX STAN 315-2014);
• Amendments to Food Additive Provisions in Standards for Fish and Fishery Products;
• Amendments to Section 7.4—Estimation of fish content of the Standard for Quick Frozen Fish Sticks (Fish Fingers), Fish Portions and Fish Fillets—Breaded or in Batter (CODEX STAN 166-1989); and
• Amendment to Section 11—Processing of salted and dried salted fish of the Code of Practice for Fish and Fishery Products (CAC/RCP52-2003).
The following items have recommended for discontinuation:
• Appendices 1-11 to the Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003); and
• Proposal for a standard for fresh chilled pirarucu fillet or whole fish.
The Committee will continue working on:
• New work guidance for histamine control in the Code of Practice for Fish and Fishery Products (CAC/RCP 52-2003) and sampling plans for histamine in standards for fish and fishery products.
The Codex Committee on Fats and Oils (CCFO) is responsible for elaborating worldwide standards for fats and oils of animal, vegetable, and marine origin, including margarine and olive oil. The 25th Session of the Committee will meet in Kuala Lumpur, Malaysia, February 2017. The Committee will consider:
• Proposed draft
• Amendments to Appendix 2 “List of Acceptable Previous Cargoes” of the
• Addition of Palm Oil with High Oleic Acid (OxG);
• Revision of Fatty Acid Composition and Other Quality Factors of Peanut Oil;
• Revision of Limits of Oleic and Linoleic Acids in Sunflower Seed Oils; and
• Inclusion of provisions for Walnut Oil, Almond Oil, Hazelnut Oil, Pistachio Oil, Flaxseed Oil, and Avocado Oil.
The Codex Committee on Processed Fruits and Vegetables (CCPFV) is responsible for elaborating worldwide standards and related texts for all types of processed fruits and vegetables including, but not limited to canned, dried, and frozen products, as well as fruit and vegetable juices and nectars.
The Committee will convene its 28th Session in Washington, DC, September 12-16, 2016.
The committee will continue to discuss the following items:
• Proposed draft Annex on Canned Pineapples; and
• Proposed draft Annexes on Quick Frozen Vegetables. (Including methods of analysis for quick frozen vegetables)
• Amendments to food additive provisions in the standards for canned chestnuts and canned chestnut puree, canned bamboo shoots, canned mushrooms (certain canned vegetables), and pickles fruits and vegetables;
• Amendments to food additive and packing media provisions in Standard for Pickled Fruits and Vegetables;
• Status of work on the review/revision of Codex standards for processed fruits and vegetables; and
• Discussion paper on standardization of dry and dried produce.
The Codex Committee on Sugars (CCS) elaborates worldwide standards for all types of sugars and sugar products.
The Committee has been reactivated electronically to work on a standard for Non-Centrifugated Dehydrated Sugar Cane Juice.
The following item will be considered by the Commission at its 39th Session in July 2016.
• Draft Standard for Non-Centrifugated Dehydrated Sugar Cane Juice at Step 6.
• No additional work is ongoing in this Committee. It will again be adjourned
The Codex Committee on Cereals Pulses & Legumes (CCCPL) elaborates worldwide standards and/or codes of practice as appropriate for cereals, pulses and legumes and their products.
The Committee has been reactivated electronically to draft an international quality standard for Quinoa.
• No additional work is ongoing in this Committee. It will again be adjourned
Several Codex Alimentarius Commodity Committees have adjourned
The FAO/WHO Regional Coordinating Committees define the problems and needs of the regions concerning food standards and food control; promote within the Committee contacts for the mutual exchange of information on proposed regulatory initiatives and problems arising from food control and stimulate the strengthening of food control infrastructures; recommend to the Commission the development of worldwide standards for products of interest to the region, including products considered by the Committees to have an international market potential in the future; develop regional standards for food products moving exclusively or almost exclusively in intra-regional trade; draw the attention of the Commission to any aspects of the Commission's work of particular significance to the region; promote coordination of all regional food standards work undertaken by international governmental and non-governmental organizations within each region; exercise a general coordinating role for the region and such other functions as may be entrusted to it by the Commission; and promote the use of Codex standards and related texts by members.
The Committee (CCAfrica) will convene its 22nd Session January 16-20, 2017.
• Proposed draft regional
• Proposed draft
• Proposed draft
• Proposed draft
The Committee (CCAsia) will convene its 20th Session in New Delhi, India, September 26-30, 2016.
• Key Note Address on Role of Codex in Strengthening National Food Control Systems in the Asian Region—A way forward;
• Food Safety and Quality Situation in the Countries of the Region;
• Prioritization of the Needs of the Region and Possible Approaches to Address Them;
• Use of Codex Standards in the Region: Relevance of Existing Regional Standards and Need for New Standards;
• Matters Arising from the Codex Alimentarius Commission and Other Codex Committees;
• Codex Work Relevant to the Region;
• Monitoring of the Implementation of the Codex Strategic Plan;
• Proposed draft Regional Standard for Laver Products;
• Proposed draft Regional Code of Hygienic Practice for Street-Vended Foods;
• Discussion paper on the Development of a Regional Standard for Makgeolli;
• Discussion paper on the Development of a Regional Standard for Natto; and
• Nomination of the Coordinator.
The Committee (CCEurope) will convene its 30th Session in Astana Kazakhstan, October 3-7, 2016.
The Committee will discuss the following items:
The Coordinating Committee for Latin America and the Caribbean (CCLAC) will convene its 20th Session in Chile, November 21-25, 2016.
The Committee (CCNEA) will convene its 9th Session in Iran, February 20-24, 2017.
• Regional
• Proposed draft
• Proposed draft
• Discussion paper on a
• Draft Strategic Plan for CCNEA 2015-2020.
The Committee (CCNASWP) will convene its 14th Session in Port Vila Vanuatu, September 19-22, 2016.
• Keynote address on the Multi-Sectorial Aspects of Codex and Opportunities for Strengthening Codex as a means to contribute to development of the economic, trade, agriculture, health, and nutrition sectors;
• Food safety and quality situation in the countries of the region;
• Prioritization of the needs of the region and possible approaches to address them;
• Use of Codex standards in the region: relevance of existing regional standards and need for new standards;
• Matters arising from the Codex Alimentarius Commission other Codex Committees;
• Codex work relevant to the region;
• Monitoring of the implementation of the Codex Strategic Plan (Strategic Plan for CCNASWP 2014-2019, Status of implementation);
• Proposed draft Regional Standard for Fermented Noni Juice;
• Discussion paper on the development of a Regional Standard for kava product that can be used as a beverage when mixed with water; and
• Nomination of the Coordinator.
Delegate Note: A member of the Steering Committee heads the
Vacant.
Vacant.
Forest Service, USDA.
Notice of Intent to revise the Santa Fe National Forest Land and Resource Management Plan and to prepare an associated Environmental Impact Statement (EIS).
The Forest Service is revising the Land and Resource Management Plan (hereafter referred to as the forest plan) for the Santa Fe National Forest. This notice describes the documents (assessment report, summaries of public meetings, preliminary needs-to-change statements) currently available for review and how to obtain them; summarizes the needs to change to the existing forest plan; provides information concerning public participation and engagement, including the process for submitting comments; provides an estimated schedule for the planning process, including the time available for comments, and includes the names and addresses of agency contacts who can provide additional information.
Comments concerning the Needs for Change and Proposed Action provided in this notice will be most useful in the development of the revised forest plan and draft EIS if received by August 5, 2016. The agency expects to release a draft revised forest plan and draft EIS by summer, 2017 and a final revised forest plan and final EIS by fall, 2018.
Written correspondence can be sent to: Santa Fe National Forest, Attn: Forest Plan, 11 Forest Lane, Santa Fe, NM 87508, or emailed to
Jennifer Cramer, Forest Planner, Santa Fe National Forest, 11 Forest Lane, Santa Fe, New Mexico 87508. More information on our forest plan revision process can be found on our Web site at
The National Forest Management Act (NFMA) of 1976 requires that every National Forest System (NFS) unit develop a forest plan. On April 9, 2012, the Forest Service finalized its land management planning rule (2012 Planning Rule, 36 CFR 219), which describes requirements for the planning process and the content of the forest plans. Forest plans describe the strategic direction for management of forest resources for ten to fifteen years, and are adaptive and amendable as conditions change over time. Under the 2012 Planning Rule, the assessment of ecological, social, and economic conditions and trends is the first stage of the planning process (36 CFR 219.6). The second stage, formal plan revision, involves the development of our forest plan in conjunction with the preparation of an Environmental Impact Statement under the NEPA. The third stage of the process is monitoring and feedback, which is ongoing over the life of the revised forest plans.
The Santa Fe National Forest has completed its assessment pursuant to 2012 Forest Planning Rule. The assessment was developed with public participation and includes an evaluation of existing information about relevant ecological, economic, cultural and social conditions, trends, and sustainability and their relationship to forest plans within the context of the broader landscape. The intent of the Santa Fe National Forest is that this information builds a common understanding prior to entering formal plan revision. With this notice, the Santa Fe National Forest is initiating formal plan revision and invites other governments, non-governmental parties, and the public to contribute. The intent of public engagement is to inform development of the plan revision. We encourage contributors to share material that may be relevant to the planning process, including desired conditions for the Santa Fe National Forest. As we develop public engagement opportunities to assist with the plan revision phase, public announcements will be made and information will be posted on the Forest's Web site:
The Responsible Official for the revision of the forest plan for the Santa Fe National Forest is Maria T. Garcia, Forest Supervisor, Santa Fe National Forest, 11 Forest Lane, Santa Fe, New Mexico 87508.
The Santa Fe National Forest is proposing to revise the existing forest plan and is preparing an EIS to inform the Forest Supervisor so she can decide which alternative best maintains and restores National Forest System terrestrial and aquatic resources while providing ecosystem services and multiple uses, as required by the National Forest Management Act and the Multiple Use Sustained Yield Act.
The revised forest plan will describe the strategic intent of managing the Santa Fe National Forest for the next 10 to 15 years and will address the identified needs for change to the existing forest plan. The revised forest plan will provide management direction in the form of desired conditions, objectives, standards, guidelines, and suitability of lands. It will identify delineation of new management areas and potentially geographic areas across the Forest; identify the timber sale program quantity; make recommendations to Congress for Wilderness designation; and list rivers and streams eligible for inclusion in the National Wild and Scenic Rivers System. The revised forest plan will also provide a description of the plan area's distinctive roles and contributions within the broader landscape, identify watersheds that are a priority for maintenance or restoration, include a monitoring program, and contain information reflecting expected possible actions over the life of the forest plan.
The revised forest plan will represent decisions that are strategic in nature, but will not make site-specific project decisions and will not dictate day-to-day administrative activities needed to carry on the Forest Service's internal operations. The authorization of project level activities will be based on the guidance/direction contained in the revised forest plan, but will occur through subsequent project specific NEPA analysis and decision-making.
The revised forest plan will provide broad, strategic guidance that is consistent with other laws and regulations. Though strategic guidance will be provided, no decisions will be made regarding the management of individual roads or trails, such as those might be associated with a Travel
According to the National Forest Management Act, forest plans are to be revised every 10 to 15 years. The proposed action is to revise the forest plan to address the identified needs for change to the existing forest plan. Alternatives to the proposed action will be developed to address significant issues identified through scoping.
The purpose and need for revising the current forest plan are to: (1) Update the forest plan which was approved in 1987 and is over 29 years old, (2) reflect changes in economic, social, and ecological conditions, new policies and priorities, and new information based on monitoring and scientific research, and (3) address the preliminary identified needs for change to the existing forest plan, which are summarized below. Extensive public and interdisciplinary team involvement, along with science-based evaluations, have helped to identify these preliminary needs for change to the existing forest plan.
What follows is a summary of the preliminary identified needs for change to the existing forest plan. A more fully developed description of the preliminary needs for change, which has been organized into several resource and management topic sections, is available for review on the plan revision Web site at:
The Santa Fe National Forest has identified twelve focus areas, the first topics presented below, that have the greatest needs for new or different plan direction. Needs for change for additional resources follow and represent additional cases where changes are needed in plan direction. Overall, there is a need for plan direction that is strategic and identifies desired conditions with objectives for how resources should be managed; eliminates redundancies with existing laws, regulations and policy; removes requirements to prepare additional resource plans; and that incorporates the best available scientific information (BASI) into all plan components.
A Notice of initiating the assessment phase of forest plan revision for the Santa Fe National Forest was published in the
Any comments related to the Santa Fe National Forest's assessment report that are received following the publication of this Notice may be considered in the draft and final environmental impact statements.
Written comments received in response to this notice will be analyzed to complete the identification of the needs for change to the existing forest plan, further develop the proposed action, and identify potential significant issues. Significant issues will, in turn, form the basis for developing alternatives to the proposed action. Comments on the preliminary needs for change and proposed action will be most valuable if received by August 17, 2016, and should clearly articulate the reviewer's opinions and concerns. Comments received in response to this notice, including the names and addresses of those who comment, will be part of the public record. Comments submitted anonymously will be accepted and considered in the NEPA process; however, anonymous comments will not provide the Agency with the ability to provide the respondent with subsequent environmental documents. See the below objection process material, particularly the requirements for filing an objection, for how anonymous comments are handled during the objection process. Refer to the Forest's Web site (
Preparation of the revised forest plan for the Santa Fe National Forest began with the publication of a Notice of Assessment Initiation in the
No permits or licenses are needed for the development or revision of a forest plan.
The decision to approve the revised forest plan for the Santa Fe National Forest will be subject to the objection process identified in 36 CFR part 219 Subpart B (219.50 to 219.62). According to 36 CFR 219.53(a), those who may file an objection are individuals and entities who have submitted substantive formal comments related to forest plan revision during the opportunities provided for public comment during the planning process.
The Needs for Change documentation, the Assessment Report, summaries of the public meetings and public meeting materials, and public comments and responses are posted on the Forest's Web site at:
16 U.S.C. 1600-1614; 36 CFR part 219 [77 FR 21260-21273].
Forest Service, USDA.
Notice; requests for comments.
In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments on the renewal of a currently approved information collection.
Comments must be received in writing by August 29, 2016 to be considered.
Comments concerning this notice should be addressed to USDA Forest Service, Deb Beighley, Assistant Director, Appeals and Litigation, Ecosystem Management Coordination staff, 202-205-1277 or by email to
The public may inspect comments received at the Office of Ecosystem Management Coordination, Appeals & Litigation USDA Forest Service, 201 14th Street SW., Mail Stop 1104, Washington, DC 20024-1101, during normal business hours. Visitors are encouraged to call ahead at 202-791-8488 to facilitate entry into the building.
Deb Beighley, Assistant Director, Appeals and Litigation, Ecosystem Management Coordination staff, 202-205-1277. Individuals who use telecommunication devices for the deaf may call the Federal Relay Service at 800 877-8339 twenty
The information collection required for the administrative appeal process in 36 CFR part 214 is approved and assigned OMB Control No. 0596-0231.
All comments received in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the request for OMB approval of the information collection.
Forest Service, USDA.
Notice of meeting.
The Deschutes Provincial Advisory Committee (PAC) will meet in Bend, Oregon. The committee is authorized pursuant to the implementation of E-19 of the Record of Decision and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to provide advice and make recommendations to promote a better integration of forest management activities between Federal and non-Federal entities to ensure that such activities are complementary. PAC information can be found at the following Web site:
The meeting will be held on July 29, 2016, from 9:00 a.m. to 4:00 p.m.
All PAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Deschutes National Forest Headquarters Office, Ponderosa Conference Room, 63095 Deschutes Market Road, Bend, Oregon. The Committee will also be traveling to sites on the Deschutes National Forest.
Written comments may be submitted as described under
Beth Peer, PAC Coordinator, by phone at 541-383-4769 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Hear a presentation on climate change and water;
2. Review restoration thinning and fuels reduction operations on the Forest; and
3. Visit Ryan Ranch wetland restoration project area.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by July 15, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Beth Peer, Deschutes PAC Coordinator, 63095 Deschutes Market Road, Bend, Oregon 97701; by email to
U.S. Commission on Civil Rights.
Announcement of meeting.
Thursday, June 30, 2016. Time: 12:00 p.m.-1:00 p.m. (Alaska Time).
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska State Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Alaska Time) Thursday, June 30, 2016 for the finalizing panels and panelists for the Alaska State Advisory Committee's new project for FY 2016 identifying possible barriers in the election process that may disparately impact limited English proficient (LEP) Alaskan persons based upon the impact of recent settlements regarding voting access, as well as the recent pre-clearance changes to the Voting Rights Act of 1965.
This meeting is available to the public through the following toll-free call-in number: Toll-Free Phone Number: 888-395-3227; when prompted, please provide conference ID number: 2154626.
Any interested member of the public may call this number and listen to the meeting. 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 telephone number.
Persons with hearing impairments may also follow the proceedings by first calling the Federal Relay Service at 1-800-977-8339 and providing the Service with the conference call number and conference ID number. Hearing-impaired persons who will attend the meeting and require the services of a sign language interpreter should contact the Regional Office at least ten (10) working days before the scheduled date of the meeting.
Members of the public are entitled to make comments during the open period at the end of the meeting. Members of the public may also submit written comments within thirty (30) days of the meeting. The comments must be received in the Western Regional Office of the Commission by Friday, July 29, 2016. The address is Western Regional Office, U.S. Commission on Civil Rights, 300 N. Los Angeles Street, Suite 2010, Los Angeles, CA 90012. Persons wishing to email their comments may do so by sending them to Angela French-Bell, Regional Director, Western Regional Office, at
Records and documents discussed during the meeting will be available for public viewing prior to and after the meeting at
This meeting is available to the public through the following toll-free call-in number: Toll-Free Phone Number: 888-395-3227; when prompted, please provide conference ID number: 2154626.
Angela French-Bell, DFO, at (213) 894-3437 or
Exceptional Circumstance: Pursuant to 41 CFR 102-3.150, the notice for this meeting is given less than 15 calendar days prior to the meeting because of the exceptional circumstances of a deadline to complete the project report. Given the exceptional urgency of the events, the agency and advisory committee deem it important for the advisory committee to meet on the date given.
U.S. Census Bureau, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
To ensure consideration, submit written comments on or before August 29, 2016.
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
Direct requests for additional information or copies of the information collection instrument(s) and instructions to Robin A. Pennington, U.S. Census Bureau, 4600 Silver Hill Road, Washington, DC 20233 (or via the Internet at
The U.S. Census Bureau developed the Local Update of Census Addresses (LUCA) Operation prior to the 2000 Census to meet the requirements of the Census Address List Improvement Act of 1994, Public Law 103-430. The Census Bureau will use information collected through LUCA to help develop the housing unit and group quarters (
LUCA will be available to tribal, state, and local governments, the District of Columbia, and Puerto Rico (or their designated representatives) in areas for which the Census Bureau performs a pre-census Address Canvassing Operation. A majority of governments will have some area that will be
The Census Bureau provides an advance notice package to all eligible tribal, state, and local governments. This package contains materials informing the eligible governments of the voluntary operation and provides instructions to update contact information and how to prepare to participate in the operation. This stage occurs between January 2017 and March 2017.
All eligible tribal, state, and local governments receive an invitation package. This package provides information on how to register for the operation and instructions on how to designate a liaison, and allows governments to select the type of materials. Additionally, the invitation package provides information regarding the responsibility for safeguarding and protecting Title 13 materials. The Census Bureau will follow up and send reminder packages to governments that do not respond. This stage occurs between July 2017 and September 2017.
Governments that elect to participate receive materials based on their selection from the invitation package. Governments have a maximum of 120 days from the date of receipt of materials to complete and submit their address and spatial updates to the Census Bureau. The Census Bureau will conduct follow up with letters, postcards, and phone calls to encourage timely submission of address and spatial updates. This stage occurs between February 2018 and May 2018.
The Census Bureau will provide a feedback package to governments that participate in the operation. This package includes detailed information on the results of the address and spatial updates submitted during the operation. This stage occurs between August 2019 and October 2019.
The Census Bureau provides a closeout letter to governments that participated in the operation with notification to destroy or return Title 13 materials. The Census Bureau will also conduct follow up with letters and phone calls to ensure that Title 13 materials are destroyed or returned. This stage occurs between October 2019 and June 2020.
The information on LUCA contacts, certification of agreement to maintain the confidentiality of the Census Bureau address information, physical and information technology security capability, product media preference, shipment inventory, and certification of the destruction or return of materials containing confidential data is collected via the completion of electronic or printed forms.
The information collection on living quarters address additions, corrections, deletions, and address attribute updates, at the participating government's preference, can be submitted in the form of:
1. Digital data files output by the Geographic Update Partnership Software (GUPS), a desktop application supplied free-of-charge to LUCA participants to facilitate the review and update of Census Bureau address and map information;
2. Digital data files formatted to Census Bureau specifications; or
3. Handwritten annotations to printed-paper address listings and address locations on Census block maps (for governments with 6,000 or fewer addresses).
The information collection on living quarters structure point coordinates, roads, and road attribute updates, at the participating government's preference, can be submitted in the form of:
1. Digital data shapefiles output by GUPS;
2. Digital updates to Census Bureau supplied shapefiles; or
3. Handwritten annotations on Census Bureau supplied paper maps.
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;
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 Greater Mississippi Foreign-Trade Zone, Inc., grantee of FTZ 158, submitted a notification of proposed production activity to the FTZ Board on behalf of Bauhaus Furniture Group, LLC (Bauhaus), H.M. Richards Company, Inc. (HMRI), Lane Home Furniture (Lane), and Morgan Fabrics Corporation (Morgan) within FTZ 158 in the greater Tupelo, Mississippi, area. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on June 17, 2016.
Bauhaus, HMRI, Lane, and Morgan currently have authority to conduct cut-and-sew activity using certain foreign micro-denier suede upholstery fabrics to produce upholstered furniture and related parts (upholstery cover sets) on a restricted basis (see B-29-2013, B-21-2013, B-28-2013, 78 FR 49254-49255, August 13, 2013; and, Board Order 1877, 78 FR 5773, January 28, 2013). The companies' authority allows for the production of upholstered furniture (chairs, seats, sofas, sleep sofas, and sectionals) with scopes of authority that only provide FTZ savings on a limited quantity of foreign origin, micro-denier suede upholstery fabric finished with a hot caustic soda solution process (
The current request seeks to add certain polyurethane-type fabrics to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Bauhaus, HMRI, Lane, and Morgan from customs duty payments on the foreign-status fabrics used in export production. On domestic sales, Bauhaus, HMRI, Lane, and Morgan would be able to apply the finished upholstery cover set (
The expanded scope of authority to admit foreign-status fabrics to FTZ 158 in nonprivileged foreign status (19 CFR 146.42) would only involve polyurethane fabrics backed with ground leather (5903.20.2500) and wet coagulation process 100 percent polyurethane coated fabrics (5903.20.2500), as detailed in the notification (duty rate: 7.5%). All other foreign, unauthorized upholstery fabrics used in the companies' production activity would continue to be admitted to the zone in domestic (duty paid) status.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is August 9, 2016.
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 FTZ Board's Web site, which is accessible via
For further information, contact Elizabeth Whiteman at
On February 26, 2016, the Piedmont Triad Partnership, grantee of FTZ 230, submitted a notification of proposed production activity to the FTZ Board on behalf of United Chemi-Con, Inc., within Subzone 230A, in Lansing, North Carolina.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
The State of New Jersey, Department of State, grantee of FTZ 44, submitted a notification of proposed production activity to the FTZ Board on behalf of Givaudan Flavors Corporation (Givaudan), located in East Hanover, New Jersey. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on June 13, 2016.
A separate application for subzone designation at the Givaudan facility was submitted and will be processed under Section 400.31 of the Board's regulations. The facility is used for the production of flavor compounds. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Givaudan from customs duty payments on the foreign-status components used in export production. On its domestic sales, Givaudan would be able to choose the duty rates during customs entry procedures that apply to beverage preparations with alcohol, food articles containing sugar, concentrated orange oil, concentrated lemon oil, concentrated citrus oil, citrus oil blends, flavor preparations for food or drink without alcohol, flavor preparations for food or drink with alcohol, perfume bases and odoriferous substances other than food, drink or perfume bases (duty rate ranges from free to 17 cents/kg + 1.9%) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: benzaldehyde, vanillin, orange oil, concentrated orange oil, lemon oil, and concentrated lemon oil (duty rate ranges from 2.7% to 5.5%).
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 August 9, 2016.
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 Web site, which is accessible via
For further information, contact Kathleen Boyce at
The Greater Mississippi Foreign-Trade Zone, Inc., grantee of FTZ 158, submitted a notification of proposed production activity to the FTZ Board on behalf of Southern Motion, Inc. (SMI), for its facilities in Pontotoc and Baldwyn, Mississippi. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on June 17, 2016.
SMI currently has authority to conduct cut-and-sew activity using certain foreign micro-denier suede upholstery fabrics to produce upholstered furniture and related parts (upholstery cover sets) on a restricted basis (see B-45-2014, 79 FR 64167, October 28, 2014). SMI's authority allows for the production of upholstered furniture (chairs, seats, sofas, sleep sofas, and sectionals) for a five-year period, with a scope of authority that only provided FTZ savings on a limited quantity (6.0 million square yards per year) of foreign origin, micro-denier suede upholstery fabric finished with a hot caustic soda solution process (
The current request seeks to add new foreign-status components and certain polyurethane-type fabrics to the scope of authority. Pursuant to 15 CFR 400.14(b), additional FTZ authority would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt SMI from customs duty payments on the foreign-status fabrics and components used in export production. On its domestic sales, SMI would be able to apply the finished upholstery cover set (
The components sourced from abroad include: Linear actuators and motors; transformers; power adaptors; handset controllers; power cables; and, Y-cables (duty rate ranges from 1.6% to 2.8%). The expanded scope of authority to admit foreign-status fabrics to Subzone 158G would only involve polyurethane fabrics backed with ground leather (5903.20.2500) and wet coagulation process 100 percent polyurethane coated fabrics (5903.20.2500), as detailed in the notification (duty rate: 7.5%). All other foreign, unauthorized upholstery fabrics used in the production activity would continue to be admitted to the zone in domestic (duty paid) status.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is August 9, 2016.
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 FTZ Board's Web site, which is accessible via
For further information, contact Elizabeth Whiteman at
An application has been submitted to the Foreign-Trade Zones (FTZ) Board by the City of San Jose, California, grantee of FTZ 18, requesting to expand Subzone 18E on behalf of Space Systems/Loral, LLC, located in Palo Alto, Menlo Park and Mountain View, California. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the FTZ Board (15 CFR part 400). It was formally docketed on June 22, 2016.
Subzone 18E was approved on June 16, 2006 (71 FR 37041, June 29, 2006) and currently consists of five sites:
In accordance with the FTZ Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to review the application and make recommendations to the Executive Secretary.
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is August 9, 2016. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to August 24, 2016.
A copy of the application 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 FTZ Board's Web site, which is accessible via
For further information, contact Christopher Kemp at
International Trade Administration, U.S. Department of Commerce.
Notice of Federal Advisory Committee Meeting.
This notice sets forth the schedule and proposed agenda for a meeting of the Civil Nuclear Trade Advisory Committee (CINTAC).
The meeting is scheduled for Thursday, August 4, 2016, from 9:00 a.m. to 4:00 p.m. Eastern Daylight Time (EDT). The public session is from 3:00 p.m. to 4:00 p.m.
The meeting will be held in Room 1412, U.S. Department of Commerce, Herbert Clark Hoover Building, 1401 Constitution Ave. NW., Washington, DC 20230.
Mr. Jonathan Chesebro, Office of Energy & Environmental Industries, International Trade Administration, Room 4053, 1401 Constitution Ave. NW., Washington, DC 20230. (Phone: 202-482-1297; Fax: 202-482-5665; email:
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on May 13, 2016, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App. § 10(d)) that the portion of the meeting dealing with matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public
1. Discussion of matters determined to be exempt from the provisions of the Federal Advisory Committee Act relating to public meetings found in 5 U.S.C. App. §§ (10)(a)(1) and 10(a)(3).
1. DOC's Civil Nuclear Trade Initiative (administered by the International Trade Administration (ITA)) Update.
2. Civil Nuclear Trade Promotion Activities Discussion.
3. Public comment period.
The meeting will be disabled-accessible. Public seating is limited and available on a first-come, first-served basis. Members of the public wishing to attend the meeting must notify Mr. Jonathan Chesebro at the contact information above by 5:00 p.m. EDT on Friday, July 29, 2016 in order to pre-register for clearance into the building. Please specify any requests for reasonable accommodation at least five business days in advance of the meeting. Last minute requests will be accepted, but may be impossible to fill.
A limited amount of time will be available for pertinent brief oral comments from members of the public attending the meeting. To accommodate as many speakers as possible, the time for public comments will be limited to two (2) minutes per person, with a total public comment period of 30 minutes. Individuals wishing to reserve speaking time during the meeting must contact Mr. Chesebro and submit a brief statement of the general nature of the comments and the name and address of the proposed participant by 5:00 p.m. EDT on Friday, July 29, 2016. If the number of registrants requesting to make statements is greater than can be reasonably accommodated during the meeting, ITA may conduct a lottery to determine the speakers. Speakers are requested to bring at least 20 copies of their oral comments for distribution to the participants and public at the meeting.
Any member of the public may submit pertinent written comments concerning the CINTAC's affairs at any time before and after the meeting. Comments may be submitted to the Civil Nuclear Trade Advisory Committee, Office of Energy & Environmental Industries, Room 4053, 1401 Constitution Ave. NW., Washington, DC 20230. For consideration during the meeting, and to ensure transmission to the Committee prior to the meeting, comments must be received no later than 5:00 p.m. EDT on Friday, July 29, 2016. Comments received after that date will be distributed to the members but may not be considered at the meeting.
Copies of CINTAC meeting minutes will be available within 90 days of the meeting.
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration (ITA) is organizing the 3rd Annual Health IT Trade Mission to Brazil from September 26-30, 2016. This mission is a continuation of two consecutive Health IT missions to Brazil and part of a sustained effort to help U.S. companies access the Brazilian Health IT market. Further, CS Brazil will work with leading Brazilian health media company, Live Media, and the Brazilian Health Informatics Association (SBIS) to organize an e-Health conference, which will be held in Sao Paulo at the same time as the trade mission. U.S. trade mission delegates will participate in the conference as part of the trade mission.
The purpose of the trade mission is to introduce U.S. firms to Brazil's rapidly expanding market for Health IT products, services and solutions and to assist U.S. companies in the pursuit of export opportunities in this sector. The trade mission to Brazil is designed for U.S. Health IT solution providers, particularly small- and medium-sized enterprises (SMEs), interested in long-term business opportunities in Brazil, as well as the trade associations/organizations that represent them. Target sectors holding high potential for U.S exporters include: Electronic Health Records (EHRs), Enterprise Resource Planning (ERP), Health IT interoperability system integration services, patient security, Health IT architecture design services, cyber security solutions, IoT solution providers, cloud solutions, clinical software, big data, clinical decision support, health analytics, health care transformation consulting, telehealth, smart mobile devices and mobile health applications, M2M connected devices, communication solutions, education of Health IT students and workforce training.
Trade mission delegates will participate in a five-day program, including technical visits to hospitals, roundtables and policy meetings with public health officials in Sao Paulo and Recife. In addition, on September 27, as part of the trade mission, delegates will participate in a one-day technology seminar at the e-Health Conference in Sao Paulo, thus giving the delegation heightened exposure to potential clients and partners from countries around the world. (Note that admission to the e-Health Conference September 27-28 is included in the Trade Mission fee). The delegates will also have networking opportunities to meet face-to-face with potential strategic partners, systems integrators, value added resellers (VAR's), hospital decision makers, planners and public health officials at the federal, state and city levels.
This mission supports President Obama's National Export Initiative (NEI). The mission will help new-to-market companies learn about the Brazilian Health IT market and make initial contacts. It will also support U.S. companies already doing business in Brazil to increase their footprint and deepen their business interests. The mission will also help participating firms and associations/organizations gain market insights, make industry contacts, implement business strategies, and advance specific projects, with the goal of increasing U.S. exports of products and services to Brazil.
• Hospital site and Technology Cluster visits (exclusively for trade mission delegates).
• Roundtable with public and private sector healthcare thought leaders (seminar is open to public).
• Networking reception, Sao Paulo (exclusively for trade mission delegates and invited Brazilian stakeholders).
(All day group bus transportation included).
• U.S. Health IT Business Seminar at e-Health Conference—opportunity for Trade Mission Delegates' Technology Presentations (seminar is open to public).
• Relationship Building dinner with hospitals, policy-makers, regulators and industry thought leaders (exclusively for trade mission delegates and invited Brazilian stakeholders).
(All day group bus transportation included).
• e-Health Conference—Health IT Business and Technology Seminar (seminar is open to public).
• Business networking opportunities and face-to-face meetings with key Health IT industry stakeholders at e-Health Conference for Health IT trade mission delegates exclusive to trade mission delegates.
(All day group bus transportation included).
• Delegation travels to Recife, Pernambuco.
• Health IT Business and Technology Seminar (open to the public).
○ U.S. delegates will participate in panel discussions with the following groups:
• Pernambuco Health Care Hospital Association Members.
• Recife Regional Hospitals.
• State and City Secretariats of Health.
• US Health IT Companies, Brazilian agents, distributors, integrators, VAR's.
○ Lunch and coffee networking breaks.
• Networking reception with key regional healthcare stakeholders (exclusively for trade mission delegates and invited Brazilian stakeholders).
(All day group bus transportation included).
• Hospital site and Technology Cluster visits (exclusively for trade mission delegates).
• Round table with public and private sector healthcare thought leaders (exclusively for trade mission delegates).
(Group bus transportation to official events only, included).
Trade Mission concludes.
All parties interested in participating in the trade mission must complete and submit an application package for consideration by the Department of Commerce (DOC). All applicants will be evaluated, on a rolling basis, on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of six firms and/or trade associations or organizations will be selected to participate in the event from the applicant pool.
After a firm or trade association/organization has been selected to participate in the event, a payment to the Department of Commerce in the form of a participation fee is required. The participation fee for the trade mission will be $2,450 for a small or medium-sized enterprise (SME)
The participation fee for this mission includes admission to the e-Health Conference September 27-28, participation in the technology forum in Recife, September 29 and two airport bus transfers (to the São Paulo international airport and from the Recife airport to the designated hotel), as well as group ground transportation by bus to officially scheduled activities on September 26, 27, 28, 29 and 30.
All interested firms and associations may register via the following link:
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation (except for transportation to and from meetings, and airport transfers during the mission), and air transportation. Participants will, however, be able to take advantage of U.S. Government rates for hotel rooms. Electronic visas are required to participate on the mission, which are easily obtainable online. Applying for and obtaining such visas will be the responsibility of the mission participant. Government fees and processing expenses to obtain such visas are not included in the participation fee. However, the Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Trade mission recruitment will be conducted in an open and public manner, including, posting on the Commerce Department trade mission calendar and other Internet Web sites, email, press releases to general and trade media, notices by industry trade associations and other multiplier groups, and publicity at industry meetings, symposia, conferences, and trade shows.
Recruitment for the trade mission will begin immediately and conclude no later than September 9, 2016. Applications received after September 9, 2016, will be considered only if space and scheduling constraints permit.
The Department of Commerce will review applications and make selection decisions on a rolling basis beginning until the maximum of 20 delegates is selected.
An applicant must sign and submit a completed application and supplemental application materials, including adequate information on the company's products and/or services, primary market objectives, and goals for participation. If an incomplete application form is submitted or the information and material submitted does not demonstrate how the applicant satisfies the participation criteria, the Department of Commerce may reject the application, request additional information, or take the lack of information into account when evaluating the application. Each applicant must also:
• Identify whether the products and services it seeks to export through the mission are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have at least 51% U.S. content. In cases where the U.S. content does not exceed 50%, especially where the applicant intends to pursue investment in major project opportunities, the following factors, may be considered in determining whether the applicant's participation in the Trade Mission is in the U.S. national interest:
○ U.S. materials and equipment content;
○ U.S. labor content;
○ Contribution to the U.S. technology base, including conduct of research and development in the United States;
○ Repatriation of profits to the U.S. economy;
○ Potential for follow-on business that would benefit the U.S. economy;
A trade association/organization applicant must certify to the above for all of the companies it seeks to represent on the mission.
An applicant must also certify that:
• The export of its goods, software, technology, and services would be in compliance with U.S. export control laws and regulations, including those administered by the Department of Commerce's Bureau of Industry and Security;
• It has identified any matter pending before any bureau or office of the Department of Commerce;
• It has identified any pending litigation (including any administrative proceedings) to which it is a party that involves the Department of Commerce;
It and its affiliates (1) have not and will not engage in the bribery of foreign officials in connection with its involvement in this Mission, and (2) maintain and enforce a policy that prohibits the bribery of foreign officials.
U.S. Commercial Service Brazil, Everett Wakai, U.S. Commercial Service, Sao Paulo, Brazil, Tel: + 55 +11-3250-5402, Email:
Jefferson Oliveira, U.S. Commercial Service, Sao Paulo, Brazil, Tel: + 55 +11-3250-5136, Email:
Patricia Marega, U.S. Commercial Service, Sao Paulo, Brazil, Tel: + 55 +11-3250-5482, Email:
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On May 13, 2016, the Department of Commerce (the Department) published the notice of initiation and preliminary results of the changed circumstances review of the antidumping duty order on circular welded non-alloy steel pipe (CWP) from the Republic of Korea.
Effective June 30, 2016.
Joseph Shuler, 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) 482-1293.
On February 24, 2016, Hyundai Steel informed the Department that, effective July 1, 2015, it merged with HYSCO, and requested that the Department conduct an expedited changed circumstances review under section 751(b) of the Act, 19 CFR 351.216(c), and 19 CFR 351.221(c)(3)(ii), to confirm that Hyundai Steel is the successor-in-interest to HYSCO for purposes of determining antidumping duty cash deposits and liabilities. On May 13, 2016, the Department initiated this changed circumstances review and published the notice of preliminary results, determining that Hyundai Steel is the successor-in-interest to HYSCO.
The merchandise subject to the order is circular welded non-alloy steel pipe and tube, of circular cross-section, not more than 406.4 millimeters (16 inches) in outside diameter, regardless of wall thickness, surface finish (black, galvanized, or painted), or end finish (plain end, beveled end, threaded, or threaded and coupled). These pipes and tubes are generally known as standard pipes and tubes and are intended for the low-pressure conveyance of water, steam, natural gas, air, and other liquids and gases in plumbing and heating systems, air-conditioning units, automatic sprinkler systems, and other related uses. Standard pipe may also be used for light load-bearing applications, such as for fence tubing, and as structural pipe tubing used for framing and as support members for reconstruction or load-bearing purposes in the construction, shipbuilding, trucking, farm equipment, and other related industries. Unfinished conduit pipe is also included in the order.
All carbon-steel pipes and tubes within the physical description outlined above are included within the scope of the order except line pipe, oil-country tubular goods, boiler tubing, mechanical tubing, pipe and tube hollows for redraws, finished scaffolding, and finished conduit.
Imports of these products are currently classifiable under the following Harmonized Tariff Schedule of the United States (HTSUS) numbers: 7306.30.1000, 7306.30.5025, 7306.30.5032, 7306.30.5040, 7306.30.5055, 7306.30.5085, and 7306.30.5090. Although the HTSUS numbers are provided for convenience and customs purposes, our written description of the scope of the order is dispositive.
All carbon-steel pipes and tubes within the physical description outlined above are included within the scope of the order except line pipe, oil-country tubular goods, boiler tubing, mechanical tubing, pipe and tube hollows for redraws, finished scaffolding, and finished conduit.
Imports of these products are currently classifiable under the following Harmonized Tariff Schedule
For the reasons stated in the
International Trade Administration, U.S. Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration, is amending the Notice published at 80 FR 76657 (December 10, 2015), regarding the Subsea & Onshore Technology Trade Mission to Rio de Janeiro, Brazil October 19-21, 2016, to modify the selection process of applicants on a rolling basis starting immediately and until at least 10 participants are selected, with a maximum number of 15 participants. Applications received after July 25, 2016, will be considered only if space and scheduling constrains permit and participation fees must be paid by August 9, 2016.
Amendments to revise the selection process.
It has been determined that the selection process of companies interested in participating in the mission will be vetted on a rolling basis. All applications will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria outlined under the conditions of participation clause. Applications for this Mission will be accepted through July 25, 2016 (and after that date if space remains and scheduling constraints permit). Interested U.S. companies and trade associations/organizations providing oil and gas equipment, technology, or services as well as U.S. companies seeking to enter the Brazilian market for the first time are encouraged to apply.
Ethel M. Azueta Glen, International Trade Specialist, Trade Missions, U.S. Department of Commerce, Washington, DC 20230, Tel: 202-482-5388, Fax: 202-482-9000,
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration, is organizing an executive-led Healthcare Business Development Mission to China with an emphasis on the Sector. The mission is proposed at the Deputy Secretary level with participation from U.S. Department of Health and Human Services to ensure adequate access to Chinese government officials.
The purpose of the mission is open access to Chinese government health officials and to introduce U.S. firms and trade associations to the Chinese Healthcare market as well as assist U.S. companies to find business partners and export their products and services to China. The mission is intended to include representatives from U.S. companies and U.S. trade associations with members that provide high end, innovative medical devices (especially imaging), healthcare technology equipment, innovative pharmaceuticals, hospital management or senior care management solutions, and medical education or training, hospital cooperation (
Healthcare is an important issue for both the China. Today, China's annual healthcare spending is about $590.2 billion or 5.7% of its GDP. Commerce and health are not mutually exclusive, as workers become ill and as the cost of healthcare and insurance increases there is a direct impact on business through the loss of worker productivity and skilled workers, and reduced output. With fewer healthy workers earning incomes, businesses will also be harmed by decreased size and purchasing power of consumers. Families and individuals will be burdened with the impact of reduced incomes, increased health costs, and increased likelihood of long term care. As the world's two largest economies, how the two sides approach healthcare in the future has the potential to impact global macro-economic stability and future economic growth.
In recent years China has prioritized the reform of its healthcare system, to ensure citizens have good quality and affordable care, especially given the trends in the population and the increase in various health issues. The aging population, chronic disease and lack of fitness for children create challenges and burdens on establishing an effective healthcare system. Incidence of non-communicable disease (NCDs) such as cardiovascular disease, cancer and diabetes has rapidly increased. Economic growth is also impeded because NCDs hit workers in their prime years of productivity—creating long term chronic conditions, withdrawal from the workforce, diminished family resources and early death. Tackling the prevalence and significance of NCDs is challenging. The causes are rooted in the universal trends of aging and rapid urbanization, demographic factors which will only increase in the future.
Facing similar challenges and possessing common goals to achieve a successful healthcare ecosystem, the United States and China are well positioned to share experiences and find solutions to existing problems through uniting government and private sector forces at the intersection of commerce and healthcare. Areas of mutual collaboration in the healthcare could focus on improving patient access and services delivery, as well as areas of cooperation to benefit the health and lives of the population. As China reforms its' healthcare system and endeavors to create an innovative medical device and pharmaceutical industry it risks the alienation of foreign firms in the market. This trade mission will offer U.S. firms not only the opportunity to market their products and services, but also to explore ways that U.S. industry can support China's efforts to reform their healthcare system through win-win bilateral healthcare cooperation.
The trade mission will include one-on-one business appointments with pre-screened potential buyers, agents, distributors and joint venture partners; meetings with national and regional government officials, chambers of commerce, and business groups; and networking receptions for companies and trade associations representing companies interested in expansion into the Chinese markets. Meetings will be offered with government authorities (such as the National Health and Family Planning Commission, China Food and Drug Administration, Ministry of Human Resources and Social Services, and Ministry of Civil Affairs) that can address questions about policies, tariff rates, incentives, regulations, etc.
Please visit our official mission Web site for more information:
All parties interested in participating in the trade mission must complete and submit an application package for consideration by the DOC. All applicants will be evaluated, on a rolling basis, on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of 12 and maximum of 18 firms and/or trade associations or organizations will be selected to participate in the mission from the applicant pool.
After a trade association/organization has been selected to participate on the mission, a payment to the Department of Commerce in the form of a participation fee is required. The participation fee for the Trade Mission will be $10,500 for a small or medium-sized enterprise (SME);
All interested firms and associations may register via the following link:
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation, except as stated in the proposed timetable, and air transportation from the U.S. to the mission sites and return to the United States. Business visas may be required. Government fees and processing expenses to obtain such visas are also not included in the mission costs. However, the U.S. Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Mission recruitment will be conducted in an open and public manner, including publication in the
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration (ITA) is organizing an Informational and Technologies (ICT) Trade Mission to Singapore and Vietnam from March 6-10th, 2017. The purpose of the mission is to introduce U.S. firms to Singapore and Vietnam's rapidly expanding ICT sector, and to assist U.S. companies in pursuing export opportunities in this sector. The mission is designed for U.S. ICT companies. The mission also will help U.S. companies already doing business in Singapore and Vietnam increase their footprint and deepen their business interests. With the Administration's emphasis on enacting the Trans-Pacific Partnership, medium and long-term opportunities will continue for American companies that strategically position in these markets. The mission will not be an executive-led mission.
This trade mission focus on recruiting U.S. veteran-owned companies
Target sectors holding high potential for U.S exporters include fixed and mobile telephone networks, Internet, satellites, broadcasting, Information Technology (IT) hardware and software, and in any sub-sector related to the telecommunications industry. Mission participants will benefit from country briefings, one-on-one appointments with prospective business contacts, and high-level meetings with government officials and business leaders.
The mission will help participating firms and associations/organizations gain market insights, make industry contacts, solidify business strategies, and advance specific projects, with the goal of increasing U.S. ICT exports. The mission will include market briefings, one-on-one business appointments with pre-screened potential buyers, agents, distributors, industry leaders, and joint venture partners; meetings with host governments; and networking events. Participating in an official U.S. industry delegation, rather than traveling on their own, will enhance the companies' ability to identify opportunities in Vietnam and Singapore.
Please visit our official mission Web site for more information:
All parties interested in participating in the trade mission must complete and submit an application package for consideration by the U.S. Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below. A minimum of ten firms and a maximum of 12 firms, service providers and/or trade associations/organizations will be selected from the applicant pool to participate in the trade mission.
After an applicant has been selected to participate in the mission, a payment to the Department of Commerce in the form of a participation fee is required. Upon notification of acceptance to participate, those selected have 5 business days to submit payment or the acceptance may be revoked.
The participation fee for the trade mission to Singapore and Vietnam alone is $3,200.00 for small or medium-sized enterprises (SME)
All interested firms and associations may register via the following link:
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation (except for transportation to and from meetings, and airport transfers during the mission), and air transportation. Participants will, however, be able to take advantage of U.S. Government rates for hotel rooms. Business or entry visas may be required to participate on the mission. Applying for and obtaining such visas will be the responsibility of the mission participant. Government fees and processing expenses to obtain such visas are not included in the participation fee. However, the Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for this mission will begin immediately and conclude no later than January 8, 2017. The U.S. Department of Commerce will review applications and make selection decisions on rolling basis. Applications received after January 8, 2017 will be considered only if space and scheduling constraints permit.
Ashish Vaid, International Trade Specialist, US & Foreign Commercial Service, 290 Broadway, Suite 1312, New York, NY 10007, t: 646-385-4503,
Dylan Daniels, International Trade Specialist, US & Foreign Commercial Service, 22 N. Front St., Suite 200, Memphis, TN 38103, t: 901-544-0930,
Swee Hoon Chia, Senior Commercial Specialist, U.S. Department of Commerce, U.S. Commercial Service, U.S. Embassy Singapore, Tel: +65 6476-9037, Direct: +65 6476-9403, Fax: + 65 6476-9080, Email:
Stuart Schaag, Senior Commercial Officer, U.S. Department of Commerce, U.S. Commercial Service, U.S. Consulate Embassy Hanoi, Tel: 84-4-3850-5199, Email:
International Trade Administration, Department of Commerce.
Notice.
The United States Department of Commerce, International Trade Administration is organizing a trade mission to Central America that will include the Trade Americas—Business Opportunities in Central America Conference in San Jose, Costa Rica on March 26-28, 2017.
U.S. trade mission participants will arrive in Costa Rica on or before March 26 to attend the opening reception for the Trade Americas—Business Opportunities in Central America Conference, which is also open to U.S. companies not participating in the trade mission. Trade mission participants will attend the Conference on March 27. Following the morning session of the conference, trade mission participants will participate in one-on-one consultations with U.S. and Foreign Commercial Service (US&FCS) Commercial Officers and/or Department of State Economic/Commercial Officers from the following U.S. Embassies in the region: Costa Rica, El Salvador, Honduras, Guatemala, Belize, Nicaragua, and Panama. The following day, March 28, trade mission participants will engage in business-to-business appointments with companies in Costa Rica. A limited number of trade mission participants will then have the option to travel to: El Salvador, Honduras, Guatemala, Belize, Nicaragua or Panama (choosing only one market) for optional additional business-to-business appointments based on recommendations from the US&FCS in those markets. Each business to business appointment will be with a pre-screened potential buyer, agent, distributor or joint-venture partner.
The Department of Commerce's Trade Americas—Business Opportunities in Central America Conference will focus on regional-specific sessions, market entry strategies, legal, logistics, and trade financing resources as well as pre-arranged one-on-one consultations with US&FCS Commercial Officers and/or Department of State Economic/Commercial Officers with expertise in commercial markets throughout the region.
This trade mission is open to U.S. companies from a cross section of industries with growing potential in Central America, but is focused on U.S. companies representing best prospects sectors such as construction equipment/road building machinery, renewable energy, automotive parts and accessories, and safety and security equipment.
The combination of the Trade Americas—Business Opportunities in Central America Conference and this trade mission, including its business-to-business matchmaking opportunities in Costa Rica and one other optional Central American country, will provide participants with access to substantive information on strategies for entering or expanding their business across the Central America region.
All parties interested in participating in the U.S. Department of Commerce Trade Mission to Central America must complete and submit an application package for consideration by the Department of Commerce. All applicants will be evaluated on their ability to meet certain conditions and best satisfy the selection criteria as outlined below.
A minimum of 30 companies and/or trade associations will be selected to participate in the mission from the applicant pool on a first-come, first-served basis. The total number of U.S. companies that may be selected for each country will be limited as follows: 30 companies for Costa Rica, 10 companies for Guatemala, 10 companies for El Salvador; 4 companies for Belize; 12 companies for Honduras; 10 companies for Nicaragua; and 15 companies for Panama.
Additional participants may be accepted based on available space. U.S. companies and/or trade associations already doing business in or seeking business in Costa Rica, El Salvador, Belize, Guatemala, Honduras, Nicaragua and Panama for the first time may apply.
After a company has been selected to participate in the mission, a payment to the Department of Commerce in the form of a participation fee is required.
• For business-to-business meetings in Costa Rica only (not traveling to an additional trade mission country), the participation fee will be $2,100 for a small or medium-sized enterprise (SME)* and $3,300 for a large firm.*
• For business-to-business meetings in Costa Rica and one other market,
* An SME is defined as a firm with 500 or fewer employees or that otherwise qualifies as a small business under SBA regulations. Parent companies, affiliates, and subsidiaries will be considered when determining business size (See
The above trade mission fees include the $450 participation fee for the Trade Americas—Business Opportunities in Central America Conference to be held in San Jose, Costa Rica on March 26-28, 2017.
An additional representative for both SMEs and large firms will require an additional fee of $450.
All interested firms and associations may register via the following link:
The mission fee does not include any personal travel expenses such as lodging, most meals, local ground transportation (except for transportation to and from meetings, and airport transfers during the mission), and air transportation. Participants will, however, be able to take advantage of U.S. Government rates for hotel rooms. Electronic visas are required to participate on the mission, which are easily obtainable online. Applying for and obtaining such visas will be the responsibility of the mission participant. Government fees and processing expenses to obtain such visas are not included in the participation fee. However, the Department of Commerce will provide instructions to each participant on the procedures required to obtain necessary business visas.
Mission recruitment will be conducted in an open and public manner, including publication in the
Recruitment for the mission will begin immediately and conclude no later than January 31, 2017. The U.S. Department of Commerce will review applications and make selection decisions on a rolling basis beginning 14 days after publication of this
• An applicant must submit a completed and signed mission application and supplemental application materials, including adequate information on the company's products and/or services, primary market objectives, and goals for participation. Applicant should specify in their application and supplemental materials which trade mission stops they are interested in participating in. If the Department of Commerce receives an incomplete application, the Department may reject the application, request additional information, or take the lack of information into account when evaluating the applications.
• Each applicant must also certify that the products and services it seeks to export through the mission are either produced in the U.S., or, if not, marketed under the name of a U.S. firm and have at least 51% U.S. content of the value of the finished product or service. In the case of a trade association or trade organization, the applicant must certify that, for each company to be represented by the trade association or trade organization, the products and services the represented company seeks to export are either produced in the United States, or, if not, marketed under the name of a U.S. firm and have at least 51% U.S. content.
The following criteria will be evaluated in selecting participants:
• Suitability of a firm's or service provider's (or in the case of a trade association/organization, represented firm or service provider's) products or services to these markets.
• Firm's or service provider's (or in the case of a trade association/organization, represented firm or service provider's) potential for business in the markets, including likelihood of exports resulting from the mission.
• Consistency of the firm's or service provider's (or in the case of a trade association/organization, represented firm or service provider's) goals and objectives with the stated scope of the mission.
Diversity of company size, sector or subsector, and location may also be considered during the review process.
Referrals from political organizations and any documents containing references to partisan political activities (including political contributions) will be removed from an applicant's submission and not considered during the selection process.
Jessica Gordon, International Trade Specialist, U.S. Export Assistance Center—Jackson, MS,
Diego Gattesco, Director, U.S. Export Assistance Center—Wheeling, WV,
Aileen Nandi, Regional Senior Commercial Officer, U.S. Commercial Service—El Salvador,
Abby Daniell, Commercial Director, U.S. Commercial Service—Costa Rica,
National Institute of Standards and Technology (NIST), United States Department of Commerce (DoC).
Notice of funding availability.
NIST invites applications from eligible organizations in connection with NIST's funding up to eleven (11) separate MEP cooperative agreements for the operation of MEP Centers in the designated States' service areas and in the funding amounts identified in the Funding Availability section of this notice. NIST anticipates awarding one (1) cooperative agreement for each of the identified States. The objective of this announcement by the MEP Program is to provide manufacturing extension services to primarily small and medium-sized manufacturers within the States designated in the Funding Availability section of this notice. The selected organizations will become part of the MEP national system of extension service providers, currently located throughout the United States and Puerto Rico.
Electronic applications must be received no later than 11:59 p.m. Eastern Time on Tuesday, September 27, 2016. Paper applications will not be accepted. Applications received after the deadline will not be reviewed or considered. The approximate start date for awards under this notice and the corresponding FFO is expected to be April 1, 2017.
Applications must be submitted electronically through
Administrative, budget, cost-sharing, and eligibility questions and other programmatic questions should be directed to Diane Henderson at Tel: (301) 975-5105; Email:
15 U.S.C. 278k, as implemented in 15 CFR part 290.
The MEP program is not a Federal research and development program. It is not the intent of the program that awardees will perform systematic research.
To learn more about the MEP program, please go to
Funding Availability: NIST anticipates funding up to eleven (11) MEP Center awards with an initial five-year period of performance in accordance with the multi-year funding policy described below and in Section II.3. of the corresponding FFO. Funding for the awards listed below and in the corresponding FFO is contingent upon the availability of appropriated funds.
The table below lists the eleven (11) States identified for funding as part of this notice and the corresponding FFO and the estimated amount of funding available for each:
Applicants may propose annual Federal funding amounts that are different from the anticipated annual Federal funding amounts set forth in the above table, provided that the total amount of Federal funding being requested by an applicant does not exceed the total amount of Federal funding for the five-year award period as set forth in the above table. For example, if the anticipated annual Federal funding amount for an MEP Center is $500,000 and the total Federal funding amount for the five-year award period is $2,500,000, an applicant may propose Federal funding amounts greater, less than, or equal to $500,000 for any year or years of the award, so long as the total amount of Federal funding being requested by the applicant for the entire five-year award period does not exceed $2,500,000.
Multi-Year Funding Policy. When an application for a multi-year award is approved, funding will usually be provided for only the first year of the project. Recipients will be required to submit detailed budgets and budget narratives prior to the award of any continued funding. Continued funding for the remaining years of the project will be awarded by NIST on a non-competitive basis, and may be adjusted higher or lower from year-to-year of the award, contingent upon satisfactory performance, continued relevance to the mission and priorities of the program, and the availability of funds. Continuation of an award to extend the period of performance and/or to increase or decrease funding is at the sole discretion of NIST.
Potential for Additional 5 Years. Initial awards issued pursuant to this notice and the corresponding FFO are expected to be for up to five (5) years with the possibility for NIST to renew the award, on a non-competitive basis, for an additional 5 years at the end of the initial award period. The review processes described in 15 CFR 290.8 will be used as part of the overall assessment of the recipient, consistent with the potential long-term nature and purpose of the program. In considering renewal for a second five-year, multi-year award term, NIST will evaluate the results of the annual reviews and the results of the 3rd Year peer-based Panel Review findings and recommendations as set forth in 15 CFR 290.8, as well as the Center's progress in addressing findings and recommendations made during the various reviews. The full process is expected to include programmatic, policy, financial, administrative, and responsibility assessments, and the availability of funds, consistent with Department of Commerce and NIST policies and procedures in effect at that time.
Each recipient will be required to attend a kick-off conference, which will be held within 30 days post start date of award, to help ensure that the MEP Center operator has a clear understanding of the program and its components. The kick-off conference will take place at NIST/MEP headquarters in Gaithersburg, MD, during which time NIST will: (1) Orient MEP Center key personnel to the MEP program; (2) explain program and financial reporting requirements and procedures; (3) identify available resources that can enhance the capabilities of the MEP Center; and (4) negotiate and develop a detailed three-year operating plan with the recipient. NIST/MEP anticipates an additional set of site visits at the MEP Center and/or telephonic meetings with the recipient to finalize the three-year operating plan.
The kick-off conference will take up to approximately three days and must be attended by the MEP Center Director, along with up to two additional MEP Center employees. Applicants must include travel and related costs for the kick-off conference as part of the budget for year one (1), and these costs should be reflected in the SF-424A form. (
NIST/MEP typically organizes system-wide meetings approximately four times a year in an effort to share best practices, new and emerging trends, and
Applicants must include travel and related costs for four quarterly MEP system-wide meetings in each of the five (5) project years (4 meetings per year; 20 total meetings over five-year award period). These costs must be reflected in the SF-424A form (
Cost Share or Matching Requirement: Non-Federal cost sharing of at least 50 percent of the total project costs is required for each of the first through the third year of the award, with an increasing minimum non-Federal cost share contribution beginning in year 4 of the award as follows:
Non-Federal cost sharing is that portion of the project costs not borne by the Federal Government. The applicant's share of the MEP Center expenses may include cash, services, and third party in-kind contributions, as described at 2 CFR 200.306, as applicable, and in the MEP program regulations at 15 CFR 290.4(c). No more than 50% of the applicant's total non-Federal cost share for any year of the award may be from third party in-kind contributions of part-time personnel, equipment, software, rental value of centrally located space, and related contributions, per 15 CFR 290.4(c)(5). The source and detailed rationale of the cost share, including cash, full- and part-time personnel, and in-kind donations, must be documented in the budget tables and budget narratives submitted with the application and will be considered as part of the review under the evaluation criterion found in the Evaluation Criteria section of this notice and in Section V.1.c.ii. of the corresponding FFO.
Recipients must meet the minimum non-Federal cost share requirements for each year of the award as identified in the chart above. For purposes of the MEP program, “program income” (as defined in 2 CFR 200.80, as applicable) generated by an MEP Center may be used by a recipient towards the required non-Federal cost share under an MEP award.
As with the Federal share, any proposed costs included as non-Federal cost sharing must be an allowable/eligible cost under this program and under the Federal cost principles set forth in 2 CFR part 200, subpart E. Non-Federal cost sharing incorporated into the budget of an approved MEP cooperative agreement is subject to audit in the same general manner as Federal award funds.
As set forth in Section IV.2.a.(7). of the corresponding FFO, a letter of commitment is required from an authorized representative of the applicant, stating the total amount of cost share to be contributed by the applicant towards the proposed MEP Center. Letters of commitment for all other third-party sources of non-Federal cost sharing identified in a proposal are not required, but are strongly encouraged.
• Incorporates the market analysis described in the criterion set forth in paragraph a.ii.(1) below and Section V.1.a.ii.(1). of the corresponding FFO to inform strategies, products and services;
• defines a strategy for delivering services that balances market penetration with impact and revenue generation, addressing the needs of manufacturers, with an emphasis on the small and medium-sized manufacturers;
• defines the Center's existing and/or proposed roles and relationships with other entities in the State's manufacturing ecosystem, including State, regional, and local agencies, economic development organizations and educational institutions such as universities and community or technical colleges, industry associations, and other appropriate entities;
• plans to engage with other entities in Statewide and/or regional advanced manufacturing initiatives; and
• supports achievements of the MEP mission and objectives while also satisfying the interests of other stakeholders, investors, and partners.
• Segmentation of company size, geography, and industry priorities including some consideration of rural, start-up (a manufacturing establishment that has been in operation for five years or less) and/or very small manufacturers as appropriate to the state;
• alignment with state and/or regional initiatives; and
• other important factors identified by the applicant.
(2) Needs Identification and Product/Service Offerings. Reviewers will assess the quality and extent of the applicant's proposed needs identification and proposed products and services for both sales growth and operational improvement in response to the applicant's market segmentation and understanding assessed by reviewers under paragraph a.ii.(1) above and Section V.1.a.ii.(1) of the corresponding FFO. Of particular interest is how the applicant would leverage new manufacturing technologies, techniques and processes usable by small and medium-sized manufacturers. Reviewers will also consider how an applicant's proposed approach will support a job-driven training agenda with manufacturing clients. (To learn more about the White House job-driven training agenda, please go to:
iii. Business Model. Reviewers will assess the quality, feasibility and potential efficacy and efficiency of the applicant's proposed business model for the Center as provided in the Project Narrative, Qualifications of the Applicant; Key Personnel, Organizational Structure and Management, and the Budget Tables and Budget Narratives sections of its Technical Proposal, submitted under section IV.2.a.(6). of the corresponding FFO, and the likelihood that the proposed business model will result in the Center's ability to successfully execute the strategy evaluated under criterion set forth in paragraph a.1. above and Section V.1.a.i. of the corresponding FFO, based on the market understanding evaluated under criterion set forth in paragraph a.ii. above and Section V.1.a.ii. of the corresponding FFO. The following sub-topics will be evaluated and given equal weight:
(1) Outreach and Service Delivery to the Market. Reviewers will assess the extent to which the proposed Center is organized to:
• Identify, reach and provide proposed services to key market segments and individual manufacturers described above;
• work with a manufacturer's leadership in strategic discussions related to new technologies, new products and new markets; and
• leverage the applicant's past experience in working with small and medium-sized manufacturers as a basis for future programmatic success.
(2) Partnership Leverage and Linkages. Reviewers will assess the extent to which the proposed Center will make effective use of resources or partnerships with third parties such as industry, universities, community/technical colleges, nonprofit economic development organizations, and Federal, State and Local Government Agencies in the Center's business model.
iv. Performance Measurement and Management. Reviewers will assess the extent to which the applicant will use a systematic approach to measuring and managing performance including the:
• Quality and extent of the applicant's stated goals, milestones and outcomes described by operating year (year 1, year 2, etc.);
• applicant's utilization of client-based business results important to stakeholders in understanding program impact; and
• depth of the proposed methodology for program management and internal evaluation likely to ensure effective operations and oversight for meeting program and service delivery objectives.
b. Qualifications of the Applicant; Key Personnel, Organizational Structure and Management; and Oversight Board or Advisory Committee and Governance (30 points; Sub-criteria i and ii will be weighted equally). Reviewers will assess the ability of the key personnel, the applicant's management structure and Oversight Board or Advisory Committee and Governance to deliver the program and services envisioned for the Center. Reviewers will consider the following topics when evaluating the qualifications of the applicant and of program management:
i. Key Personnel, Organizational Structure and Management. Reviewers will assess the extent to which the:
• Proposed key personnel have the appropriate experience and education in manufacturing, outreach, program management and partnership development to support achievements of the MEP mission and objectives;
• proposed management structure and organizational roles are aligned to plan, direct, monitor, organize and control the monetary resources of the proposed center to achieve its business
• proposed organizational structure flows logically from the specified approach to the market and products and service offerings; and
• proposed field staff structure sufficiently supports the geographic concentrations and industry targets for the region.
ii. Oversight Board or Advisory Committee and Governance. Reviewers will assess the extent to which the:
• Proposed Oversight Board or Advisory Committee and its operations are complete, appropriate and will meet the program's objectives at the time of award, or, if such an Oversight Board or Advisory Committee does not exist at the time of application or is not expected to meet these requirements at the time of award, the extent to which the proposed plan for developing and implementing such an Oversight Board or Advisory Committee within 90 days of award start date (expected to be April 1, 2017) is feasible. (Refer to Section I.3. of the corresponding FFO).
• Oversight Board or Advisory Committee and Governance is engaged with overseeing and guiding the Center and supports its own development through a schedule of regular meetings, and processes ensuring Oversight Board or Advisory Committee involvement in strategic planning, recruitment, selection and retention of board members, board assessment practices and board development initiatives (Refer to Section I.3. of the corresponding FFO).
c. Budget and Financial Plan. (30 points; Sub-criteria i and ii will be weighted equally) Reviewers will assess the suitability and focus of the applicant's five (5) year budget. The application will be assessed in the following areas:
i. Budget. Reviewers will assess the extent to which:
• The proposed financial plan is aligned to support the execution of the proposed Center's strategy and business model over the five (5) year project plan;
• the proposed projections for income and expenditures are appropriate for the scale of services that are to be delivered by the proposed Center and the service delivery model envisioned within the context of the overall financial model over the five (5) year project plan;
• a reasonable ramp-up or scale-up scope and budget has the Center fully operational by the 4th year of the project; and
• the proposal's narrative for each of the budgeted items explains the rationale for each of the budgeted items, including assumptions the applicant used in budgeting for the Center.
ii. Quality of the Financial Plan for Meeting the Award's Non-Federal Cost Share Requirements over 5 Years. Reviewers will assess the quality of and extent to which the:
• Applicant clearly describes the total level of cost share and detailed rationale of the cost share, including cash and in-kind, in their proposed budget.
• applicant's funding commitments for cost share are documented by letters of support from the applicant, proposed sub-recipients and any other partners identified and meet the basic matching requirements of the program;
• applicant's cost share meets basic requirements of allowability, allocability and reasonableness under applicable Federal costs principles set forth in 2 CFR 200, subpart E;
• applicant's underlying accounting system is established or will be established to meet applicable Federal costs principles set forth in 2 CFR 200, subpart E; and
• the overall proposed financial plan is sufficiently robust and diversified so as to support the long term sustainability of the Center throughout the five (5) years of the project plan.
Selection Factors: The Selection Factors for this notice as set forth here and in Section V.3. of the corresponding FFO are as follows:
a. The availability of Federal funds;
b. Relevance of the proposed project to MEP program goals and policy objectives;
c. Reviewers' evaluations, including technical comments;
d. The need to assure appropriate distribution of MEP services within the designated State;
e. Whether the project duplicates other projects funded by DoC or by other Federal agencies; and
f. Whether the application complements or supports other Administration priorities, or projects supported by DoC or other Federal agencies, such as but not limited to the National Network for Manufacturing Innovation and the Investing in Manufacturing Communities Partnership.
Proposals, reports, documents and other information related to applications submitted to NIST and/or relating to financial assistance awards issued by NIST will be reviewed and considered by Federal employees, Federal agents and contractors, and/or by non-Federal personnel who enter into nondisclosure agreements covering such information as set forth here and in Section V.2. of the corresponding FFO, which will be used for this competition in lieu of and to the extent they are inconsistent with will supersede the review and selection process provided in the MEP regulations found at 15 CFR part 290, specifically 15 CFR 290.7.
(1) Initial Administrative Review of Applications. An initial review of timely received applications will be conducted to determine eligibility, completeness, and responsiveness to this notice and the corresponding FFO and the scope of the stated program objectives. Applications determined to be ineligible, incomplete, and/or non-responsive may be eliminated from further review. However, NIST, in its sole discretion, may continue the review process for an application that is missing non-substantive information that can easily be rectified or cured.
(2) Full Review of Eligible, Complete, and Responsive Applications. Applications that are determined to be eligible, complete, and responsive will proceed for full reviews in accordance with the review and selection processes below. Eligible, complete and responsive applications will be grouped by the State in which the proposed MEP Center is to be established. The applications in each group will be reviewed by the same reviewers and will be evaluated, reviewed, and selected as described below in separate groups.
(3) Evaluation and Review. Each application will be reviewed by at least three technically qualified individual reviewers who will evaluate each application based on the evaluation criteria (
Applicants whose applications receive an average score of 70 or higher out of 100 will be deemed finalists. If deemed necessary, finalists will be invited to participate with reviewers in a conference call and/or a video conference, and/or finalists will be invited to participate in a site visit that will be conducted by the same reviewers at the applicant's location. In any event, if there are two (2) or more
(4) Ranking and Selection. Based upon an average of the technical reviewers' final scores, an adjectival rating will be assigned to each application in accordance with the following scale:
Fundable, Outstanding (91-100 points);
Fundable, Very Good (81-90 points);
Fundable (70-80 points); or
Unfundable (0-69 points).
For decision-making purposes, applications receiving the same adjectival rating will be considered to have an equivalent ranking, although their technical review scores, while comparable, may not necessarily be the same.
The Selecting Official is the NIST Associate Director for Innovation and Industry Services or designee. The Selecting Official makes the final recommendation to the NIST Grants Officer regarding the funding of applications under this notice and the corresponding FFO. The Selecting Official shall be provided all applications, all the scores and technical assessments of the reviewers, and all information obtained from the applicants during the evaluation, review and negotiation processes.
The Selecting Official will generally select and recommend the most meritorious application for an award based on the adjectival rankings and/or one or more of the six (6) selection factors described in the Selection Factors section of this notice and Section V.3. of the corresponding FFO. The Selecting Official retains the discretion to select and recommend an application out of rank order (
As part of the overall review and selection process, NIST reserves the right to request that applicants provide pre-award clarifications and/or to enter into pre-award negotiations with applicants relative to programmatic, financial or other aspects of an application, such as but not limited to the revision or removal of proposed budget costs, or the modification of proposed MEP Center activities, work plans or program goals and objectives. In this regard, NIST may request that applicants provide supplemental information required by the Agency prior to award. NIST also reserves the right to reject an application where information is uncovered that raises a reasonable doubt as to the responsibility of the applicant. The final approval of selected applications and issuance of awards will be by the NIST Grants Officer. The award decisions of the NIST Grants Officer are final.
Federal Awarding Agency Review of Risk Posed by Applicants. After applications are proposed for funding by the Selecting Official, the NIST Grants Management Division (GMD) performs pre-award risk assessments in accordance with 2 CFR 200.205, which may include a review of the financial stability of an applicant, the quality of the applicant's management systems, the history of performance, and/or the applicant's ability to effectively implement statutory, regulatory, or other requirements imposed on non-Federal entities. In addition, prior to making an award where the total Federal share is expected to exceed the simplified acquisition threshold (currently $150,000), NIST GMD will review and consider the publicly available information about that applicant in the Federal Awardee Performance and Integrity Information System (FAPIIS). An applicant may, at its option, review and comment on information about itself previously entered into FAPIIS by a Federal awarding agency. As part of its review of risk posed by applicants, NIST GMD will consider any comments made by the applicant in FAPIIS in making its determination about the applicant's integrity, business ethics, and record of performance under Federal awards. Upon completion of the pre-award risk assessment, the Grants Officer will make a responsibility determination concerning whether the applicant is qualified to receive the subject award and, if so, whether appropriate special conditions that correspond to the degree of risk posed by the applicant should be applied to an award.
Anticipated Announcement and Award Date. Review, selection, and award processing is expected to be completed in early 2017. The anticipated start date for awards made under this notice and the corresponding FFO is expected to be April 1, 2017.
a. Application Replacement Pages. Applicants may not submit replacement pages and/or missing documents once an application has been submitted. Any revisions must be made by submission of a new application that must be received by NIST by the submission deadline.
b. Notification to Unsuccessful Applicants. Unsuccessful applicants will be notified in writing.
c. Retention of Unsuccessful Applications. An electronic copy of each non-selected application will be retained for three (3) years for record keeping purposes. After three (3) years, it will be destroyed.
The Department of Commerce Pre-Award Notification Requirements: The Department of Commerce will apply the Pre-Award Notification Requirements for Grants and Cooperative Agreements dated December 30, 2014 (79 FR 78390). If the Department of Commerce publishes revised Pre-Award Notification Requirements prior to issuance of awards under this notice and the corresponding FFO, the revised Pre-Award Notification Requirements will apply. Refer to Section VII. of the corresponding FFO, Federal Awarding Agency Contacts, Grant Rules and Regulations for more information.
Unique Entity Identifier and System for Award Management (SAM): Pursuant to 2 CFR part 25, applicants and recipients (as the case may be) are required to: (i) Be registered in SAM before submitting its application; (ii) provide a valid unique entity identifier in its application; and (iii) continue to maintain an active SAM registration with current information at all times during which it has an active Federal award or an application or plan under consideration by a Federal awarding agency, unless otherwise excepted from these requirements pursuant to 2 CFR 25.110. NIST will not make a Federal award to an applicant until the applicant has complied with all applicable unique entity identifier and
Paperwork Reduction Act: The standard forms in the application kit involve a collection of information subject to the Paperwork Reduction Act. The use of Standard Forms 424, 424A, 424B, and SF-LLL have been approved by OMB under the respective Control Numbers 4040-0004, 4040-0006, 4040-0007, and 0348-0046.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.
Certifications Regarding Federal Felony and Federal Criminal Tax Convictions, Unpaid Federal Tax Assessments and Delinquent Federal Tax Returns. In accordance with Federal appropriations law, an authorized representative of the selected applicant(s) may be required to provide certain pre-award certifications regarding Federal felony and Federal criminal tax convictions, unpaid Federal tax assessments, and delinquent Federal tax returns.
Funding Availability and Limitation of Liability: Funding for the program listed in this notice and the corresponding FFO is contingent upon the availability of appropriations. In no event will NIST or DoC be responsible for application preparation costs if this program fails to receive funding or is cancelled because of agency priorities. Publication of this notice and the corresponding FFO does not oblige NIST or DoC to award any specific project or to obligate any available funds.
Other Administrative and National Policy Requirements: Additional administrative and national policy requirements are set forth in Section VI.2. of the corresponding FFO.
Executive Order 13132 (Federalism): It has been determined that this notice does not contain policies with federalism implications as that term is defined in Executive Order 13132.
Executive Order 12372: Proposals under this program are not subject to Executive Order 12372, “Intergovernmental Review of Federal Programs.”
Administrative Procedure Act/Regulatory Flexibility Act: Notice and comment are not required under the Administrative Procedure Act (5 U.S.C. 553) or any other law, for matters relating to public property, loans, grants, benefits or contracts (5 U.S.C. 553(a)). Moreover, because notice and comment are not required under 5 U.S.C. 553, or any other law, for matters relating to public property, loans, grants, benefits or contracts (5 U.S.C. 553(a)), a Regulatory Flexibility Analysis is not required and has not been prepared for this notice, 5 U.S.C. 601
National Institute of Standards and Technology, Department of Commerce.
Notice of closed meeting.
The Judges Panel of the Malcolm Baldrige National Quality Award (Judges Panel) will meet in closed session on Wednesday, August 17, 2016, from 9 a.m. to 3:30 p.m. Eastern time. The purpose of this meeting is to review the results of examiners' scoring of written applications. Panel members will vote on which applicants merit site visits by examiners to verify the accuracy of quality improvements claimed by applicants. The meeting is closed to the public in order to protect the proprietary data to be examined and discussed at the meeting.
The meeting will be held on Wednesday, August 17, 2016, from 9 a.m. to 3:30 p.m. Eastern time. The entire meeting will be closed to the public.
The meeting will be held at the National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899.
Robert Fangmeyer, Director, Baldrige Performance Excellence Program, National Institute of Standards and Technology, 100 Bureau Drive, Mail Stop 1020, Gaithersburg, Maryland 20899-1020, telephone number (301) 975-2360, email
15 U.S.C. 3711a(d)(1) and the Federal Advisory Committee Act, as amended, 5 U.S.C. App.
Pursuant to the Federal Advisory Committee Act, as amended, 5 U.S.C. App., notice is hereby given that the Judges Panel of the Malcolm Baldrige National Quality Award will meet on Wednesday, August 17, 2016, from 9 a.m. to 3:30 p.m. Eastern time. The Judges Panel is composed of twelve members, appointed by the Secretary of Commerce, with a balanced representation from U.S. service, manufacturing, nonprofit, education, and health care industries. Members are selected for their familiarity with quality improvement operations and competitiveness issues of manufacturing companies, service companies, small businesses, health care providers, and educational institutions. Members are also chosen who have broad experience in for-profit and nonprofit areas. The purpose of this meeting is to review the results of examiners' scoring of written applications. Panel members will vote on which applicants merit site visits by examiners to verify the accuracy of quality improvements claimed by applicants. The meeting is closed to the public in order to protect the proprietary data to be examined and discussed.
The Chief Financial Officer and Assistant Secretary for Administration, with the concurrence of the Acting, Assistant General Counsel for Administration, formally determined on May 19, 2016, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended by Section 5(c) of the Government in Sunshine Act, Public Law 94-409, that the meeting of the Judges Panel may be closed to the public in accordance with 5 U.S.C. 552b(c)(4) because the meeting is likely to disclose trade secrets and commercial or financial information obtained from a person which is privileged or confidential and 5 U.S.C. 552b(c)(9)(B) because for a government agency the meeting is likely to disclose information that could significantly frustrate implementation of a proposed agency action. The meeting, which involves examination of current Malcolm Baldrige National Quality Award (Award) applicant data from U.S. organizations and a discussion of these data as compared to the Award criteria
National Oceanic and Atmospheric Administration, Department of Commerce.
Notice of public meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the NSGAB. NSGAB members will discuss and provide advice on the National Sea Grant College Program (NSGCP) in the areas of program evaluation, strategic planning, education and extension, science and technology programs, and other matters as described in the agenda found on the NSGCP Web site at
The announced meeting is scheduled for Friday, August 12, 2016 from 3:00-5:00 p.m. EDT.
The meeting will be held via conference call. Public access is also available at 1315 East-West Highway, Bldg. 3, Room #11817, Silver Spring, MD 20910. In order to attend in person or via conference call, please R.S.V.P to Jennifer Hinden (contact information below) by Friday, July 29, 2016.
The meeting will be open to public participation with a 10-minute public comment period from 4:50-5:00 p.m. EDT. Please check the agenda using link in the Summary section to confirm time.
The NSGAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of three (3) minutes. Written comments should be received by Mrs. Jennifer Hinden by Friday, July 22nd, 2016 to provide sufficient time for NSGAB review. Written comments received after the deadline will be distributed to the NSGAB, but may not be reviewed prior to the meeting date. Seats will be available on a first-come, first-serve basis.
The NSGAB, which consists of a balanced representation from academia, industry, state government and citizens groups, was established in 1976 by Section 209 of the Sea Grant Improvement Act (Pub. L. 94-461, 33 U.S.C. 1128).
The NSGAB advises the Secretary of Commerce and the Director of the NSGCP with respect to operations under the Act, and such other matters as the Secretary refers to them for review and advice.
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).
Average Hours per Response:
Vessel permit application: 45 minutes; vessel permit renewal forms: 30 minutes; initial dealer permit applications: 15 minutes; dealer permit renewal forms: 5 minutes; initial and renewal vessel operator permit applications: 1 hour; obtaining and submitting a dealer or vessel owner email address: 5 minutes; limited access vessel replacement applications: 1.5 hours; and applications for retention of limited access permit history: 1.5 hours.
Installing a VMS unit: 1 hour; confirming VMS connectivity: 5 minutes; VMS certification form: 5 minutes; VMS installation for Canadian herring transport vessels: 1 hour and 20 minutes; email to declare their entrance and departure from U.S. waters: 15 minutes; automatic polling of vessel position using the VMS unit: 0 minutes; area and DAS declarations: 5 minutes; declaration of days-out of the gillnet fishery for monkfish and NE multispecies vessels: 5 minutes; Good Samaritan DAS credit request: 30 minutes; entangled whale DAS credit request: 30 minutes; DAS credit for a canceled trip due to unforeseen circumstances, but have not yet begun fishing: 5 minutes to request via the VMS unit and 10 minutes to request via the paper form; VMS catch reports: 5 minutes; VMS power down exemption: 30 minutes.
Requests for observer coverage are estimated to require either 2 or 10 minutes per request, depending on the program for which observers are requested.
Letter of Authorization (LOA) to participate in any of the exemption programs: 5 minutes; Charter/Party Exemption Certificate for GOM Closed Areas: 5 minutes; limited access sea scallop vessels state waters DAS exemption program or state waters gear exemption program: 2 minutes; withdraw from either state waters exemption program prior to the end of the 7-day designated exemption period requirement: 2 minutes; request for change in permit category designation: 5 minutes; request for transit to another port by a vessel required to remain within the GOM cod trip limit: 2 minutes; gillnet category designation, including initial requests for gillnet tags: 10 minutes; requests for additional tags: 2 minutes; notification of lost tags and requests for replacement tag numbers: 2
Under the Magnuson-Stevens Fishery Conservation and Management Act, the Secretary of Commerce has the responsibility for the conservation and management of marine fishery resources. Much of this responsibility has been delegated to NOAA's National Marine Fisheries Service (NMFS). Under this stewardship role, the Secretary was given certain regulatory authorities to ensure the most beneficial uses of these resources. One of the regulatory steps taken to carry out the conservation and management objectives is to collect information from users of the resources.
The Secretary has enacted rules to issue permits to individuals and organizations participating in federally controlled fisheries. Permits are necessary to: (1) Register fishermen, fishing vessels, fish dealers and processors; (2) list the characteristics of fishing vessels and/or dealer/processor operations; (3) exercise influence over compliance (
This collection also includes the requirement for participants in certain fisheries to use onboard vessel monitoring systems (VMS) and to notify NMFS before fishing trips for the purpose of observer placement. Other permitting in this collection includes the written request to participate in any of the various exemption programs offered in the Greater Atlantic region. Exemption programs may allow a vessel to fish in an area that is limited to vessels of a particular size, using a certain gear type, or fishing for a particular species. This collection also contains paperwork required for vessel owners to request gillnet and lobster trap tags through the Greater Atlantic region permit office.
Lastly, vessel owners that own multiple vessels, but would like to request communication from NMFS be consolidated into one mailing (and not separate mailings for each vessel), may request the single letter vessel owner option to improve efficiency of their business practice.
This information collection request may be viewed at reginfo.gov. Follow the instructions to view Department of Commerce collections currently under review by OMB.
Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection renewal of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before August 29, 2016.
You may submit comments, identified by “Clearing Exemption for Certain Swaps Entered into by Cooperatives,” or OMB Control No. 3038-0102, by any of the following methods:
• The Commission's Web site, at
•
•
•
Please submit your comments using only one method.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
Melissa A. D'Arcy, Special Counsel, Division of Clearing and Risk, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581; (202) 418-5086; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology;
You should submit only information that you wish to make available publicly. If you wish the Commission to consider information that you believe is exempt from disclosure under the Freedom of Information Act, a petition for confidential treatment of the exempt information may be submitted according to the procedures established in § 145.9 of the Commission's regulations.
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
There are no capital costs or operating and maintenance costs associated with this collection.
44 U.S.C. 3501
Commodity Futures Trading Commission.
Notice.
The Commodity Futures Trading Commission (“CFTC” or “Commission”) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (“PRA”), Federal agencies are required to publish notice in the
Comments must be submitted on or before August 29, 2016.
You may submit comments, identified by “Renewal of Collection Relating to the Operations and Activities of Commodity Pool Operators and Commodity Trading Advisors and to Monthly Reporting by Futures Commission Merchants” by any of the following methods:
• The Agency's Web site, at
•
•
•
Please submit your comments using only one method.
Amanda Olear, Associate Director, Division of Swap Dealer and Intermediary Oversight, Commodity Futures Trading Commission, 1155 21st St. NW., Washington, DC 20581, (202) 418-5283; email:
Under the PRA, Federal agencies must obtain approval from the Office of Management and Budget (“OMB”) for each collection of information they conduct or sponsor. “Collection of Information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3 and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA, 44 U.S.C. 3506(c)(2)(A), requires Federal agencies to provide a 60-day notice in the
The disclosure, filing, and recordkeeping requirements within part 4 of the Commission's regulations were established to assist customers, to facilitate the Commission and the National Futures Association (“NFA”) in monitoring compliance with the part 4 rules, and to enable the Commission to better monitor the market risks posed by the Commission's registrants. The information collections are necessary to enable the Commission and NFA to accomplish the purposes of the compliance regime set forth in part 4 enumerated above.
With respect to the collection of information, the CFTC invites comments on:
• Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have a practical use;
• The accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Ways to enhance the quality, usefulness, and clarity of the information to be collected; and
• Ways to minimize the burden of 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;
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of your submission from
44 U.S.C. 3501
Consumer Product Safety Commission.
Notice.
As required by the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Consumer Product Safety Commission (“CPSC” or “Commission”) requests comments on a proposed extension of approval of a collection of information under the requirements pertaining to a third party conformity assessment body registration form, approved previously under OMB Control No. 3041-0143. The Commission will consider all comments received in response to this notice before requesting an extension of this collection of information from the Office of Management and Budget (“OMB”).
Submit written or electronic comments on the collection of information by August 29, 2016.
You may submit comments, identified by Docket No. CPSC-2009-0088, by any of the following methods:
Robert H. Squibb, Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814; (301) 504-7815, or by email to:
CPSC seeks to renew the following currently approved collection of information:
The Consumer Product Safety Improvement Act of 2008 (“CPSIA”) requires third party testing be conducted by a third party conformity assessment body for any children's product, that is subject to a children's product safety rule, before importing for consumption or warehousing or distributing in commerce. The CPSIA allows accreditation of third party conformity assessment bodies to be conducted either by the Commission or by an independent accreditation organization designated by the Commission, and requires that the Commission maintain on its Web site an up-to-date list of entities that have been accredited to assess conformity with children's product safety rules. With the exception of firewalled third party conformity assessment bodies, the Commission has chosen to accept the accreditation of third party conformity assessment bodies that meet accreditation requirements of an independent accreditation organization.
In order to assess a third party conformity assessment body's qualifications for acceptance by CPSC, information related to location, accreditation, and ownership must be collected from third party conformity assessment bodies. The CPSC uses an online collection form, CPSC Form 223, to gather information from third party conformity assessment bodies voluntarily seeking acceptance by CPSC. The information collected relates to location, accreditation, and ownership. The Commission staff uses this information to assess:
• A third party conformity assessment body's status as either an independent third party conformity assessment body, a government-owned or government-controlled conformity assessment body, or a firewalled conformity assessment body;
• Qualifications for acceptance by CPSC to test for compliance to specified children's product safety rules; and
• Eligibility for acceptance on the CPSC Web site.
Part 1112 requires the collection of information in CPSC Form 223:
• Upon initial application by the third party conformity assessment body for acceptance by CPSC;
• Whenever there is a change to accreditation or ownership information; and
• At least every 2 years as part of a regular audit process.
The CPSC estimates the burden of the collection of information in CPSC Form 223 is as follows:
These estimates are based on the following information:
• From March 23, 2015 to March 23, 2016, 39 new third party conformity assessment bodies have registered with the CPSC; 36 registered during the previous 12 months. Therefore, we estimate the number of third party conformity assessment bodies who would register initially each year for the next three years would be 40.
• Under 16 CFR part 1112, third party conformity assessment bodies are required to resubmit CPSC Form 223 every two years. Because all third party conformity assessment bodies have not submitted their first CPSC Form 223s at the same time, only about half would be expected to resubmit a CPSC Form 223 in any one year. As of March 2016, 487 third party conformity assessment bodies have registered with CPSC. Approximately half (243) of these firms would be required to re-register with CPSC each year.
• Under 16 CFR part 1112, third party conformity assessment bodies are required to ensure that the information submitted on CPSC Form 223 is current and must submit a new CPSC Form 223 whenever the information changes. Based on current experience with third party conformity assessment bodies, we estimate that two third party conformity assessment bodies will make revisions per year to update their information. A change in information is a change that does not require review of laboratory accreditation documents, such as scope or test methods. Examples of revised information include changes in the Web site URL, name of the laboratory, and name of point of contact.
The total burden, therefore, is 283.5 hours, which we will round up to 284 hours. We estimate that hourly compensation for the time required for recordkeeping is $32.82 per hour (U.S. Bureau of Labor Statistics, “Employer Costs for Employee Compensation,” Table 9, total compensation for sales, office, and related workers in goods-producing industries, December 2015:
The Commission solicits written comments from all interested persons about the proposed collection of information. The Commission specifically solicits information relevant to the following topics:
• Whether the collection of information described above is necessary for the proper performance of the Commission's functions, including whether the information would have practical utility;
• Whether the estimated burden of the proposed collection of information is accurate;
• Whether the quality, utility, and clarity of the information to be collected could be enhanced; and
• Whether the burden imposed by the collection of information could be minimized by use of automated, electronic or other technological collection techniques, or other forms of information technology.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-17 with attached Policy Justification and Sensitivity of Technology.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Australia requested a possible sale of:
This request also includes the following Non-MDE: MK 13 MOD 0 Vertical Launching System Canisters, operator manuals and technical documentation, U.S. Government and contractor engineering, technical and logistics support services.
The total estimated value of MDE is $216 million. The total overall estimated value is $301 million.
Australia is one of the major political and economic powers in Southeast Asia, a key democratic partner of the United States in ensuring regional peace and stability, a close coalition ally in major/lesser regional contingency operations, and a close cooperative and international exchange agreement partner. It is vital to U.S. national interests that Australia develops and maintains a strong and ready self-defense capability. This sale is consistent with U.S. regional objectives.
The SM-2 Block IIIB missiles proposed in this purchase will be used for anti-air warfare test firings during Combat Systems Ship Qualification Trials for the Royal Australian Navy's three new Air Warfare Destroyers (AWD) currently under construction). The SM-2 Block IIIB missiles, combined with the Aegis combat systems in the AWDs, will provide significantly enhanced area defense capabilities over critical South East Asian air-and-sea-lines of communication. Australia has already integrated the SM-2 Block IIIA into its Perry-class FFGs and recently upgraded its Intermediate-Level Maintenance Depot at Defense Establishment Orchard Hills with new guided missile test equipment capable of maintaining the SM-2 All-Up Round. Australia will have no difficulty absorbing these new missiles.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors will be Raytheon Missile Systems Company, Tucson, Arizona; Raytheon Company, Camden, Arkansas; and BAE of Minneapolis and Aberdeen, South Dakota. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this sale will not require the assignment of any U.S. or contractor representatives to Australia.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii)
1. A completely assembled STANDARD Missile-2 (SM-2) Block IIIB with or without a conventional warhead, whether a tactical, telemetry or inert (training) configuration, is classified CONFIDENTIAL. Missile component hardware includes: Guidance Section (classified CONFIDENTIAL), Target Detection Device (classified CONFIDENTIAL), Warhead (UNCLASSIFIED), Rocket Motor (UNCLASSIFIED), Steering Control Section (UNCLASSIFIED), Safe and Arming Device (UNCLASSIFIED), Autopilot Battery Unit (classified CONFIDENTIAL), and if telemetry missiles, AN/DKT-71 Telemeters (UNCLASSIFIED).
2. SM-2 operator and maintenance documentation is usually CONFIDENTIAL. Shipboard operation/firing guidance is generally CONFIDENTIAL. Pre-firing missile assembly/pedigree information is UNCLASSIFIED.
3. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
4. A determination has been made that Australia can provide substantially the same degree of protection for the sensitive technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
5. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Australia.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by August 1, 2016.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Defense Travel Management Office, DoD.
Notice of Revised Non-Foreign Overseas Per Diem Rates.
The Defense Travel Management Office is publishing Civilian Personnel Per Diem Bulletin Number 304. This bulletin lists revisions in the per diem rates prescribed for U.S. Government employees for official travel in Alaska, Hawaii, Puerto Rico, the Northern Mariana Islands and Possessions of the United States when applicable. AEA changes announced in Bulletin Number 194 remain in effect. Bulletin Number 304 is being published in the
Ms. Sonia Malik, 571-372-1276.
This document gives notice of revisions in per diem rates prescribed by the Defense Travel Management Office for non-foreign areas outside the contiguous United States. It supersedes Civilian Personnel Per Diem Bulletin Number 303. Per Diem Bulletins published periodically in the
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-16 with attached Policy Justification.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Kuwait has requested a possible sale of the following Non-Major Defense Equipment (MDE): Continuation of contractor engineering technical services, contractor maintenance services, Hush House support services, and Liaison Office Support for the Government of Kuwait F/A-18 C/D program. This will include F/A-18 avionics software upgrades, engine component improvements, ground support equipment, engine and aircraft spares and repair parts, publications and technical documentation, Engineering Change Proposals (ECP), U.S. Government and contractor programmatic, financial, and logistics support. Also included are: Maintenance and engineering support, F404 engine and engine test cell support, and Liaison Office support for five (5) Kuwait Liaison Offices. There is no MDE associated with this possible sale. The total overall estimated value is $420 million.
The proposed sale of support services will enable the Kuwait Air Force to ensure the reliability and performance of its F/A-18 C/D aircraft. Kuwait will have no difficulty absorbing this support into its armed forces.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a friendly country that has been, and continues to be, an important force for political stability and economic progress in the Middle East. Kuwait plays a large role in U.S. efforts to advance stability in the Middle East, providing basing, access, and transit for U.S. forces in the region.
The proposed sale of support and services will not alter the basic military balance in the region.
The principal contractors will be Kay and Associates Incorporated in Buffalo Grove, Illinois; The Boeing Company in St. Louis, Missouri; Industrial Acoustics Corporation in Winchester, England; General Electric in Lynn, Massachusetts; and Sigmatech in Huntsville, Alabama. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require two-hundred and seventy-five (275) contractor representatives to travel to Kuwait for a period of three (3) years to provide support.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-08 with attached Policy Justification and Sensitivity of Technology.
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Also included are the following non-MDE items: Training and technical assistance. The estimated cost is $476 million.
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* as defined in Section 47(6) of the Arms Export Control Act.
The United Arab Emirates (UAE) has requested a possible sale of four-thousand (4,000) AGM-114 R/K Hellfire Missiles over the next three (3) years in increments of one-thousand (1,000) to one-thousand five-hundred (1,500) missiles. Also included in this possible sale are training and technical assistance. The total estimated value of MDE is $468 million. The overall total estimated value is $476 million.
This proposed sale will enhance the foreign policy and national security of the United States by helping to improve the security of a partner country, which has been, and continues to be, an important force for political stability and economic progress in the Middle East.
The proposed sale will improve the UAE's capability to meet current and future threats and provide greater security for its critical infrastructure. The UAE will use the enhanced capability to strengthen its homeland defense. UAE will have no difficulty absorbing these Hellfire missiles into its armed forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractor will be Lockheed Martin Missile and Fire Control in Dallas, Texas. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any U.S. Government or contractor representatives to the United Arab Emirates.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii) Sensitivity of Technology
1. The AGM-114 R/K Hellfire Category III Missile is an air-to-ground missile used against heavy and light armored targets, thin-skinned vehicles, urban structures, bunkers, caves, and personnel. The missile is Inertial Measurement Unit-based, with a variable delay fuze, improved safety and reliability. The highest level for release of the AGM-114 R/K Hellfire Missile Semi-Active Laser is SECRET, based upon the software. The highest level of classified information that could be disclosed by a proposed sale or by testing of the end item is SECRET; the highest level that must be disclosed for production, maintenance or training is CONFIDENTIAL. Reverse engineering could reveal CONFIDENTIAL information. Vulnerability data, countermeasures, vulnerability/susceptibility analyses and threat definitions are classified up to SECRET.
2. A determination has been made that the Government of the United Arab Emirates can provide substantially the same degree of protection for the technology being released as the U.S. Government. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification.
3. All defense articles and services listed in this transmittal have been authorized for release and export to the United Arab Emirates.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-20 with attached Policy Justification and Sensitivity of Technology.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Qatar has requested a possible sale of fifty (50) Javelin Guided Missiles (Category I), and ten (10) Command Launch Units (CLUs) with Integrated Day/Thermal Sight (Category III Sensitive) with Container. Also included in this possible sale are: Ten (10) Javelin Missile Simulation Rounds, one (1) Enhanced Basic Skills Trainer (EPBST), and twelve (12) Battery, Non-Rechargeable, six (6) Battery, Storage, Rechargeable, Battery Discharger, Battery Charger for #9, and ten (10) Battery Coolant Units. Also included in this possible sale are U.S. Government Technical Information and Assistance and Life Cycle Contractor support (LCCS) for twenty-four (24) months or until funds are exhausted. This support provides for personnel, services, materials, facilities, equipment, maintenance, supply support, Integrated Support Plan, product assurance, and configuration management. The total estimated value of Major Defense Equipment is $15 million. The overall total estimated value is $20 million.
This proposed sale contributes to the foreign policy and national security of the United States by helping to improve the security of a regional partner. Qatar is an important force for political stability and economic progress in the Persian Gulf region. This proposed sale strengthens U.S. efforts to promote regional stability by enhancing the defense to a key U.S. ally.
The proposed sale will improve Qatar's capability to meet current and future threats and provide greater security for its critical oil and natural gas infrastructure. Qatar will use the enhanced capability to strengthen its homeland defense. Qatar will have no difficulty absorbing these missiles into its armed forces.
The proposed sale will not alter the basic military balance in the region.
The principal contractor will be Lockheed Martin, Troy, AL. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require multiple trips by U.S. Government and contractor representatives to travel to Qatar for up to twenty-four (24) months for equipment de-processing, fielding, system checkout, training, and technical logistics support.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
(vii) Sensitivity of Technology:
1. The Javelin Weapon System is a medium-range, man-portable, shoulder-launched, fire-and-forget, anti-tank system for infantry, scouts, and combat engineers. It may also be mounted on a variety of platforms including vehicles, aircraft and watercraft. The system weighs 49.5 pounds and has a maximum range in excess of 2,500 meters. The system is highly lethal against tanks and other systems with conventional and reactive armors. The system possesses a secondary capability against bunkers.
2. Javelin's key technical feature is the use of fire-and-forget technology which allows the gunner to fire and immediately relocate or take cover. Additional special features are the top attack and/or direct fire modes, an advanced tandem warhead and imaging infrared seeker, target lock-on before launch, and soft launch from enclosures or covered fighting positions. The Javelin missile also has a minimum smoke motor thus decreasing its detection on the battlefield.
3. The Javelin Weapon System comprises two major tactical components, which are a reusable Command Launch Unit (CLU) and a round contained in a disposable launch tube assembly. The CLU incorporates an integrated day-night sight that provides a target engagement capability in adverse weather and countermeasure environments. The CLU may also be used in a stand-alone mode for battlefield surveillance and target detection. The CLU's thermal sight is a second generation Forward-Looking Infrared (FLIR) sensor. To facilitate initial loading and subsequent updating of software, all on-board missile software is uploaded via the CLU after mating and prior to launch.
4. The missile is autonomously guided to the target using an imaging infrared seeker and adaptive correlation tracking algorithms. This allows the gunner to take cover or reload and engage another target after firing a missile. The missile has an advanced tandem warhead and can be used in either the top attack or direct fire modes (for targets undercover). An onboard flight computer guides the missile to the selected target.
5. The Javelin Missile System hardware and the documentation are UNCLASSIFIED. The missile software which resides in the CLU is considered SENSITIVE. The sensitivity is primarily in the software programs which instruct the system how to operate in the presence of countermeasures. The overall hardware is also considered SENSITIVE in that the infrared wavelengths could be useful in attempted countermeasure development. The benefits to be derived from the sale, as outlined in the Policy Justification of the notification, outweigh the potential damage that could result if sensitive technology was revealed to unauthorized persons.
6. If a technologically advanced adversary were to obtain knowledge of the specific hardware or software elements, the information could be used to develop countermeasures that might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities.
7. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Qatar.
Defense Security Cooperation Agency, Department of Defense.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-25 with attached Policy Justification.
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Iraq has requested a possible sale of a five-year sustainment package for its AC/RC-208 fleet that includes: Operational, intermediate, and depot-level maintenance; spare parts; component repair; publication updates; maintenance training; and logistics. Also included in this sale are Contract Logistics Services (CLS), training services, and Contract Engineering Services. There is no MDE associated with this possible sale. The total overall estimated value is $181 million.
The purchase of this sustainment package will allow the Iraqi Air Force (IqAF) to continue to operate its fleet of eight C-208 light attack and Intelligence, Surveillance, and Reconnaissance (ISR) aircraft beyond the June 2016 end of its existing CLS contract. Limited IqAF maintenance capability necessitates continued CLS. Ultimately, the goal is for the IqAF to become self-sufficient in the areas of aircraft maintenance and logistics training. Iraq will have no difficulty absorbing this support.
The proposed sale will contribute to the foreign policy and national security goals of the United States by helping to improve a critical capability of the Iraq Security Forces in defeating the Islamic State of Iraq and the Levant.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The principal contractors will be Orbital ATK in Falls Church, Virginia, and Flight Safety International in Flushing, New York. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will not require the assignment of any additional U.S. Government or contractor representatives to Iraq.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Iraq.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by August 1, 2016.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Stephanie Tatham, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 16-24 with attached Policy Justification and Sensitivity of Technology.
(i)
(ii)
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* as defined in Section 47(6) of the Arms Export Control Act.
The Government of Oman requests follow-on support for its existing F-16 fleet that includes support equipment, communications equipment, personnel training, spare and repair parts, publications, Electronic Combat International Security Assistance Program (ECISAP), Contractor Engineer Technical Services (CETS), Technical Coordination Group (TCG), International Engine Management Program (IEMP), Precision Measurement Equipment Laboratory (PMEL) calibration and technical orders. The estimated value of this possible sale is $260 million.
The proposed sale of support services will enable the Royal Air Force of Oman to ensure the reliability and performance of its F-16 aircraft. Oman will have no difficulty absorbing this support into its armed forces.
This proposed sale contributes to the foreign policy and national security of the United States by helping to improve the security of a friendly country which has been, and continues to be, an important force for political stability and economic progress in the Middle East.
The proposed sale allows the U.S. military to support the Royal Air Force of Oman, further strengthen the U.S.-Omani military-to-military relationship, and ensure continued interoperability of forces and opportunities for bilateral training and exercises with Oman's military forces.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractors for this sale are: Lockheed Martin Aero, Fort Worth, TX; ITT (EXCELIS-Harris), Fort Wayne, IN; BAE Systems, Austin, TX; Honeywell, Clearwater, FL; Northrop Grumman, Linthicum Heights, MD; Marvin Engineering, Inglewood, CA; Lockheed Martin Missile and Fire Control, Orlando, FL; Goodrich Corp, Westford, MA. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale does not require the assignment of any additional U.S. Government or contractor representatives to Oman.
There will be no adverse impact on U.S. defense readiness as a result of this proposed sale.
All defense articles and services have been approved for release to the Government of Oman.
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1. This case involves the sustainment of sensitive technology previously released to Oman in the sales of their F-16C/D aircraft. The F-16C/D Block 50/52 weapon system is UNCLASSIFIED, except as noted below. The aircraft uses the F-16 airframe and features advanced avionics and systems including the Pratt and Whitney F-100-PW-229 or the General Electric F-110-GE-129 engine, AN/APG-68V(9) radar, digital flight control system, external electronic warfare equipment, Advanced Identification Friend or Foe (AIFF), Link-16 datalink, and software computer programs.
2. Sensitive or classified (up to SECRET) elements of the proposed F-16C/D include hardware, accessories, components, and associated software: AN/APG-68V(9) Radar, Have Quick I/II Radios, AN/APX-113 AIFF with Mode IV capability, AN/ALE-47 Countermeasures (Chaff and Flare) set, LINK-16 Advanced Data Link Group A provisions only, Embedded Global Positioning System/Inertial Navigation System, Joint Helmet-Mounted Cueing System (JHMCS), ALQ-211(V)4 Advanced Integrated Defensive Electronic Warfare Suite (AIDEWS) without Digital Radio Frequency Memory, AN/ALQ-211(V)4 Countermeasures Set, Modular Mission Computer, Have Glass I/II without infrared top coat, and Digital Flight Control System. Additional sensitive areas include operating manuals and maintenance technical orders containing performance information, operating and test procedures, and other information related to support operations and repair. The hardware, software, and data identified are classified to protect vulnerabilities, design, and performance parameters and other similar critical information.
3. Software, hardware, and other data, which is classified or sensitive, is reviewed prior to release to protect system vulnerabilities, design data, and performance parameters. Some end-item hardware, software, and other data identified above are classified at the CONFIDENTIAL and SECRET level. Potential compromise of these systems is controlled through management of the basic software programs of highly sensitive systems and software-controlled weapon system on a case-by-case basis.
4. Oman is both willing and able to protect U.S. classified military information. Oman's physical and document security standards are equivalent to U.S. standards.
5. This sale is necessary in furtherance of the U.S. foreign policy and national security objectives outlined in the Policy Justification. Moreover, the benefits to be derived from this sale outweigh the potential damage that could result if the sensitive technology were revealed to unauthorized persons.
6. All defense articles and services listed in this transmittal have been authorized for release and export to the Government of Oman.
Department of Defense, Defense Security Cooperation Agency.
Notice.
The Department of Defense is publishing the unclassified text of a section 36(b)(1) arms sales notification. This is published to fulfill the requirements of section 155 of Public Law 104-164 dated July 21, 1996.
Chandelle K. Parker, DSCA/LMO, (703) 697-9027.
The following is a copy of a letter to the Speaker of the House of Representatives, Transmittal 15-70 with attached Policy Justification and Sensitivity of Technology.
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Non-MDE items also included are containers, spare and repair parts, support and test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor representative technical assistance, engineering and logistics support services, and other related elements of logistics support.
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*as defined in Section 47(6) of the Arms Export Control Act.
The Government of Egypt has requested a possible sale of:
Non-MDE items also included are containers, spare and repair parts, support and test equipment, publications and technical documentation, personnel training and training equipment, U.S. Government and contractor representative technical assistance, engineering and logistics support services, and other related elements of logistics support.
This proposed sale will contribute to the foreign policy and national security of the United States by helping to improve the security of a strategic partner that has been and continues to be an important force for political stability and economic progress in the Middle East.
The proposed sale of these submarine-launched missiles will support the Egyptian Navy's Type 209 submarines, increasing its anti-surface warfare and maritime security capabilities. Egypt already possesses Harpoon Block II missiles and will have no difficulty absorbing these additional weapons.
The proposed sale of this equipment and support will not alter the basic military balance in the region.
The prime contractor will be The Boeing Company in St. Louis, Missouri. There are no known offset agreements proposed in connection with this potential sale.
Implementation of this proposed sale will require annual trips to Egypt involving U.S. Government and contractor representatives for technical reviews, support, and oversight for approximately five years.
There will be no adverse impact on United States defense readiness as a result of this proposed sale.
(vii)
1. The UGM-84L Harpoon Block II Encapsulated missile system is classified CONFIDENTIAL. The Harpoon missile is a conventional tactical weapon system currently in service in the U.S. Navy and in 29 other foreign nations. It provides day, night, and adverse weather, stand-off capability and is an effective Anti-Surface Warfare missile. The UGM-84L incorporates components, software, and technical design information that are considered sensitive. The following components of the proposed sale are classified CONFIDENTIAL:
These elements are essential to the ability of the Harpoon missile to selectively engage hostile targets under a wide range of operations, tactical, and environmental conditions.
2. If a technologically advanced adversary were to obtain knowledge of the specific hardware and software elements, the information could be used to develop countermeasures which might reduce weapon system effectiveness or be used in the development of a system with similar or advanced capabilities. All defense articles and services listed in this transmittal have been authorized for release and export to Egypt.
On June 23, 2016, the Commission issued an order in Docket No. EL16-76-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Transource Wisconsin, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL16-76-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
With respect to the proceeding pending before the Commission in the above-captioned docket, the staff identified below from the Office of
The staff designated as non-decisional is:
On June 23, 2016, the Commission issued an order in Docket No. EL16-75-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Xcel Energy Transmission Development Company, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL16-75-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
Take notice that on June 23 2016, Saguaro Power Company, A Limited Partnership submitted an amendment to its Petition for Waiver filed on June 6, 2016, providing an explanatory statement concerning its legal name in response to the Federal Energy Regulatory Commission's (Commission) staff inquiry.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). 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 Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing motions to intervene and protests, comments, recommendations, terms and conditions, and fishway prescriptions is 60 days from the issuance date of this notice by the Commission; reply comments are due 105 days from the issuance date of this notice by the Commission. The Commission strongly encourages electronic filing. Please file any motion to intervene, protest, comments, and/or recommendations using the Commission's eFiling system at
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On November 16, 2015, Magnum Gas Storage, LLC (Magnum) filed an abbreviated application to amend the Certificate of Public Convenience and Necessity granted by the Federal Energy Regulatory Commission (Commission or FERC) on March 17, 2011 in Docket No. CP10-22-000. Magnum was authorized to construct, own, and operate natural gas storage and transmission facilities in Millard, Juab, and Utah Counties, Utah. To date, construction of the authorized Magnum Gas Storage Project (Magnum Project) has not commenced.
On November 24, 2015, the Commission issued its Notice of Application for the Magnum Gas Storage Amendment Project (Amendment Project). Among other things, that notice alerted agencies issuing federal authorizations of the requirement to complete all necessary reviews and to reach a final decision on a request for a federal authorization within 90 days of the date of issuance of the Commission staff's Environmental Assessment (EA) for the Project. This instant notice identifies the FERC staff's planned schedule for the completion of the EA for the Amendment Project.
If a schedule change becomes necessary, additional notice will be provided so that the relevant agencies are kept informed of the Project's progress.
The Amendment Project would result in the elimination and relocation of facilities within the original footprint of the Magnum Project. Specifically, Magnum would eliminate: Brine evaporation pond 1; monitoring wells DA-1 and DA-2; and monitoring wells, GA-1, GA-2, GA-9, GA-10, and GA-11. Magnum would also relocate: Four natural gas caverns; water wells 1 through 5; compression, dehydration, and pumping facilities; 4-inch gas supply line; maintenance and laydown area; office/warehouse building and substation; and site-wide utilities.
Additionally, Magnum would relocate a 6,252-foot-long segment of the 61.6-mile-long, 36-inch-diameter Header pipeline, 63 feet north of the authorized alignment, west of Jones Road in Millard County, Utah. Magnum is not proposing any changes to the temporary or permanent right-of-way width for this portion of the Header alignment. Therefore, the previously approved temporary and permanent disturbance acreage would not increase.
On January 14, 2016, the Commission issued a
In order to receive notification of the issuance of the EA and to keep track of all formal issuances and submittals in specific dockets, the Commission offers a free service called eSubscription. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Additional information about the Project is available from the Commission's Office of External Affairs at (866) 208-FERC or on the FERC Web site (
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing comments, motions to intervene and protests, is 30 days from the issuance date of this notice. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, and recommendations, using the Commission's eFiling system at
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m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
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Take notice that on June 17, 2016 Columbia Gas Transmission, LLC (Columbia), 5151 San Felipe, Suite 2500, Houston, TX 77056, filed a prior notice request pursuant to sections 157.205 and 157.208(f)(2) of the Commission's regulations under the Natural Gas Act (NGA) Columbia's blanket certificate issued in Docket No. CP83-76-000.
Any questions regarding this application should be directed to Tyler R. Brown, Senior Counsel, Columbia Gas Transmission, LLC, 5151 San Felipe
Any person may, within 60 days after the 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. Any person filing to intervene or the Commission's staff may, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) file 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 protest. If a protest is filed and not withdrawn within 30 days after the time allowed 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 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.
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 commenter's will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenter's will not be required to serve copies of filed documents on all other parties. However, the non-party commentary, will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents 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 via the internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
On June 23, 2016, the Commission issued an order in Docket No. EL16-73-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into whether the formula rate protocols of Xcel Energy Southwest Transmission Company, LLC may be unjust, unreasonable, unduly discriminatory or preferential.
The refund effective date in Docket No. EL16-73-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
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 products listed in Tables 1 and 2 of Unit II., pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). This cancellation order follows a January 5, 2016
The cancellations and amendments are effective June 30, 2016.
Miguel Zavala, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: 703-347-0504; 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-2015-0741, is available at
This notice announces the cancellations and amendments to delete uses, as requested by registrants, of 16 products registered under FIFRA section 3 (7 U.S.C. 136a). These registrations are listed in sequence by registration number in Tables 1 and 2 of this unit.
Table 3 of this unit includes the names and addresses of record for all registrants of the products in Tables 1 and 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 above.
During the public comment period provided, EPA received no comments in response to the January 5, 2016
Pursuant to FIFRA section 6(f) (7 U.S.C. 136d(f)), EPA hereby approves the requested cancellations and amendments to terminate uses of the registrations identified in Tables 1 and 2 of Unit II. Accordingly, the Agency hereby orders that the product registrations identified in Tables 1 and 2 of Unit II. are canceled or amended to terminate the affected uses. The effective date of the cancellations and amendments that are the subject of this notice is June 30, 2016. Any distribution, sale, or use of existing stocks of the products identified in Tables 1 and 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 registrants have indicated to the Agency via written response that there are no existing stocks of these specific products. Therefore, no existing stocks date is necessary. Registrants are prohibited from selling or distributing these specific products listed in Table 1 of Unit II., except for export consistent with FIFRA section 17 (7 U.S.C. 136o) or for proper disposal. Because products 524-523 and 100-1249 were not sold or marketed into the channels of trade, persons other than the registrant do not need an existing stocks period. Regarding products 10163-291 and 10163-292, while the registrant no longer has any inventory, persons other than the registrants may sell, distribute, or use existing stocks of the affected canceled products until existing stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.
The registrants may continue to sell and distribute existing stocks of all other products listed in Table 1 of Unit II. until June 30, 2017, which is 1-year after the publication of the Cancellation Order in the
Persons other than the registrants may sell, distribute, or use existing stocks of the affected canceled products until existing stocks are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the canceled products.
Now that EPA has approved product labels reflecting the requested amendments to delete uses, registrants are permitted to sell or distribute products listed in Table 2 of Unit II. under the previously approved labeling until January 2, 2018, a period of 18 months after publication of the cancellation order in this
Persons other than the registrant may sell, distribute, or use existing stocks of the products whose labels include the terminated uses until supplies are exhausted, provided that such sale, distribution, or use is consistent with the terms of the previously approved labeling on, or that accompanied, the products with the terminated uses.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
EPA is making available for comment a White Paper describing how the Agency is proposing to modify its current approach to plant-incorporated protectants (PIPs) in breeding line intermediates (BLIs) under Section 3, Registration of Pesticides, of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). A PIP is a type of pesticide intended to be produced and used in a living plant, or the produce thereof. A BLI is an intermediate used in plant breeding to bring together, or “stack,” two or more PIPs that have each been individually engineered into different lines of a seed propagated plant. These proposed changes are intended to bring efficiencies to the Agency's approach to PIPs in BLIs while not reducing EPA's ability to ensure that PIPs in BLIs meet the requirements of FIFRA.
Comments must be received on or before August 15, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2016-0310, by one of the following methods:
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Robert McNally, Biopesticides and Pollution Prevention Division (7511P), 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 a person or company involved with agricultural biotechnology that may develop and market plant-incorporated protectants. 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:
• Pesticide and Other Agricultural Chemical Manufacturing (NAICS code 32532)
• Food Processing (NAICS code 311) transforming agricultural products into products for immediate or final consumption;
• Crop Production (NAICS code 111)
• Colleges, Universities and Professional Schools (NAICS code 611310)
• Research and Development in the Physical, Engineering and Life Sciences (NAICS code 54171)
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A copy of the White Paper Concerning Registration of Plant-Incorporated Protectants for Use in Breeding Line Intermediates to Produce Stacked Products is available in the docket under docket identification (ID) number EPA-HQ-OPP-2016-0310.
EPA is making available for comment a White Paper describing a proposed modification of its approach to regulation of plant-incorporated protectants (PIPs) in breeding line intermediates (BLIs) under Section 3, Registration of Pesticides, of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). This modification is proposed in light of the increasing use of BLIs to stack together several different PIPs during seed production.
A plant-incorporated protectant (PIP) is a type of pesticide defined at Title 40 of the Code of Federal Regulations as “intended to be produced and used in a living plant, or the produce thereof, and the genetic material necessary for production of such a pesticidal substance. It also includes any inert ingredient contained in the plant, or the produce thereof.” BLIs are an integral part of the process used to bring together, using conventional breeding in seed production, two or more PIPs that have each been individually engineered into different lines of a seed propagated plant. EPA's proposed modification of its approach to regulation of PIPs in BLIs is a refocusing of the Agency's use of its authority to regulate pesticides, and maintains EPA's ability to ensure that PIPs in BLIs meet the requirements of FIFRA.
The White Paper describes how the Agency proposes to refocus its authority to regulate PIPs in BLIs. Currently, each combination of PIPs in BLIs must have a unique registration before it can be sold or distributed in commerce. Under the proposal described in the White Paper, rather than requiring a unique registration for each BLI combination, EPA would regulate PIPs in BLIs through the terms and conditions imposed on the registrations issued for each PIP to be combined through the use of BLIs in the stacked commercial PIP product. Such registrations would control which PIPs can be used in which BLIs and how the PIPs in BLIs can be used. Under the proposed approach, EPA would continue to assess PIPs in BLIs for potential risk and continue to use its FIFRA authorities to ensure safe use of PIPs in BLIs.
EPA's proposed modifications would introduce changes into its approach to PIPs in BLIs that are intended to reduce administrative costs for both the Agency and for companies using BLIs to stack several PIPs together in a single product. The proposed modification is directed solely at PIPs in BLIs used for the purpose of producing seed and is not intended to change EPA's approach to issuance of unique registrations for PIPs intended for full commercial sale and distribution. A full copy of the White Paper is available in docket EPA-HQ-OPP-2016-0310.
EPA requests comment on the proposal as a whole and on the various aspects of the proposal from both the public and industry, including seed companies, farmers, grain dealers, food processors and grocery manufacturers. EPA is specifically seeking comment from state regulatory officials on how this proposed approach might affect their approach to pesticide regulation. EPA asks comment on the extent to which this type of approach to PIPs in BLIs relieves administrative burden and cost for the regulated community, and how frequently registrants are likely to use such an approach. EPA also requests comment on how the proposed approach would affect efficiency and cost savings, in light of the commercial seed production landscape created by the licensing of intellectual property in the form of PIPs. EPA also asks farmers, grain dealers, food processors and grocery manufacturers whether this proposed change in approach could affect their activities, including possible effects on trade, and if yes, how.
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency has submitted an information collection request (ICR), “NSPS for Flexible Vinyl and Urethane Coating and Printing (40 CFR part 60, subpart FFF) (Renewal)” (EPA ICR No. 1157.11, OMB Control No. 2060-0073), to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (44 U.S.C. 3501
Additional comments may be submitted on or before August 1, 2016.
Submit your comments, referencing Docket ID Number EPA-HQ-OECA-2012-0657, to: (1) EPA online using
EPA's policy is that all comments received will be included in the public docket without change, including any personal information provided, unless the comment includes profanity, threats, information claimed to be Confidential Business Information (CBI), or other information whose disclosure is restricted by statute.
Patrick Yellin, Monitoring, Assistance, and Media Programs Division, Office of Compliance, Mail Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: (202) 564-2970; fax number: (202) 564-0050; email address:
Supporting documents which explain in detail the information that the EPA will be collecting are available in the public docket for this ICR. The docket can be viewed online at
Environmental Protection Agency (EPA).
Notice.
There will be a 2-day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues being considered by the Environmental Protection Agency regarding the human health and ecological risk assessments for SmartStax PRO (MON 89034 x TC1507 x MON 87411 x DAS-59122-7), a plant-incorporated protectant intended to control corn rootworm through ribonucleic acid (RNA) interference.
The meeting will be held on September 27-28, 2016, from approximately 9:00 a.m. to 5:00 p.m.
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Steven Knott, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone number: (202) 564-0103; email address:
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) and FIFRA. Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action.
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You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA-HQ-OPP-2016-0349 in the subject line on the first page of your request.
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The selection of scientists to serve on FIFRA SAP is based on the function of the Panel and the expertise needed to address the Agency's charge to the Panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a federal department or agency, or their employment by a federal department or agency except EPA. Other factors considered during the selection process include availability of the potential Panel member to fully participate in the Panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected to serve on the FIFRA SAP. Numerous qualified candidates are identified for each Panel. Therefore, selection decisions involve carefully weighing a number of factors including the candidates' areas of expertise and professional qualifications and achieving an overall balance of different scientific perspectives on the Panel. The Agency anticipates selecting approximately eight ad hoc scientists to have the collective breadth of experience needed to address the Agency's charge for this meeting.
FIFRA SAP members are subject to the provisions of 5 CFR part 2634—Executive Branch Financial Disclosure, Qualified Trusts, and Certificates of Divestiture, as supplemented by EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidates' employment, stocks, bonds, and where applicable, sources of research support. EPA will evaluate the candidates' financial disclosure forms to assess whether there are financial conflicts of interest, appearance of a lack of impartiality, or any prior involvement with the development of
FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Chemical Safety and Pollution Prevention and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act (5 U.S.C. Appendix). FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA established a Science Review Board (SRB) consisting of at least 60 scientists who are available to FIFRA SAP on an ad hoc basis to assist in reviews conducted by FIFRA SAP. As a scientific peer review mechanism, FIFRA SAP provides comments, evaluations, and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of the FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendations to the Agency.
The use of RNA interference (RNAi) gene silencing technology, particularly RNAi for pesticidal purposes to control macroorganism pests, is a relatively recent innovation. Post-transcriptional silencing of gene function is a very rapid process where double-stranded RNA (dsRNA) directs sequence-specific degradation of a RNA. As EPA anticipated receiving pesticide applications based on RNAi technologies and identified the need to better understand the scientific issues concerning the assessment of the risks to human health and the environment that RNAi technologies pose, it convened a January 28, 2014, Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP). This FIFRA SAP provided EPA with scientific advice regarding the framework for assessing RNAi pesticide products.
On October 29, 2015, EPA registered MON 87411, a corn plant-incorporated protectant (PIP) for seed increase/breeding purposes only and not for commercial release, with a time limitation of 2 years and a per-season acreage cap of 15,000 acres. In addition to Bacillus thuringiensis (Bt) Cry3Bb1 protein, MON 87411 expresses DvSnf7 dsRNA. Upon consumption by corn rootworm (CRW), the insect's RNAi machinery recognizes DvSnf7 dsRNA, resulting in down-regulation of the targeted DvSnf7 gene and leading to CRW mortality. Earlier this year, EPA received applications from Monsanto Company and Dow AgroSciences, LLC, requesting registration of commercial release RNAi PIPs expressing DvSnf7 dsRNA and known by the name SmartStax PRO. SmartStax PRO also expresses several Bt insecticidal Cry proteins.
EPA will present the human health risk assessment conducted for DvSnf7 dsRNA, as expressed in SmartStax PRO, and will consider the fate of ingested dsRNA and the potential for impacts on gene expression and the immune system. The action of a RNA interference construct relies upon some level of sequence homology with the target gene transcript; however, the fidelity of the sequence match may vary in some instances. EPA will discuss the role that bioinformatic analysis may play in understanding and predicting possible off-target effects within the host genome, as well as in predicting nontarget effects as part of the ecological risk assessment.
EPA will also present an ecological risk assessment for DvSnf7 dsRNA, as expressed in SmartStax PRO, and will include descriptions of environmental fate and nontarget exposure, data reviewed in support of the risk assessment, risk characterization and description, and uncertainties. The charge to the panel will request expert opinion on completeness of the data set and uncertainties related to the risk conclusions.
EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (
FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted to the FIFRA SAP Web site or may be obtained from the OPP Docket at
7 U.S.C. 136
The following items have been deleted from the list of items scheduled for consideration at the Friday, June 24, 2016, Open Meeting and previously listed in the Commission's Notice of June 17, 2016. Items 1, 2, 4, 5, 6, and 7 on the consent agenda have been adopted by the Commission.
The Commission will consider the following subjects listed below as a
Agency for Healthcare Research and Quality (AHRQ), HHS.
Notice of public meeting.
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council for Healthcare Research and Quality.
The meeting will be held on Friday, July 22, 2016, from 8:30 a.m. to 2:45 p.m.
The meeting will be held at AHRQ, 5600 Fishers Lane, Rockville, Maryland 20857.
Jaime Zimmerman, Designated Management Official, at the Agency for Healthcare Research and Quality, 5600 Fishers Lane, Mail Stop 06E37A, Rockville, Maryland 20857, (301) 427-1456. For press-related information, please contact Alison Hunt at (301) 427-1244 or
If sign language interpretation or other reasonable accommodation for a disability is needed, please contact the Food and Drug Administration (FDA) Office of Equal Employment Opportunity and Diversity Management on (301) 827-4840, no later than Friday, July 15, 2016. The agenda, roster, and minutes will be available from Ms. Bonnie Campbell, Committee Management Officer, Agency for Healthcare Research and Quality, 5600 Fishers Lane, Rockville, Maryland 20857. Ms. Campbell's phone number is (301) 427-1554.
The National Advisory Council for Healthcare Research and Quality is authorized by Section 941 of the Public Health Service Act, 42 U.S.C. 299c. In accordance with its statutory mandate, the Council is to advise the Secretary of the Department of Health and Human Services and the Director of AHRQ, on matters related to AHRQ's conduct of its mission including providing guidance on (A) priorities for health care research, (B) the field of health care research including training needs and information dissemination on health care quality and (C) the role of the Agency in light of private sector activity and opportunities for public private partnerships. The Council is composed of members of the public, appointed by the Secretary, and Federal ex-officio members specified in the authorizing legislation.
On Friday, July 22, 2016, there will be a subcommittee meeting for the National Healthcare Quality and Disparities Report scheduled to begin at 7:30 a.m. This meeting is open to the public. The Council meeting will convene at 8:30 a.m., with the call to order by the Council Chair and approval of previous Council summary notes. The meeting agenda includes an update on AHRQ's current research, programs, and initiatives, an update on the synthesis of evidence and a presentation on AHRQ's role in quality measurement. The final agenda will be available on the AHRQ Web site at
Centers for Medicare & Medicaid Services.
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 August 29, 2016.
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' Web site 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.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep
1.
For 2017, CMS has a total of nine standardized ANOC/EOC documents: Health Maintenance Organization, Cost, Dual Eligible Special Needs, Medicare Medical Savings Account, Private-Fee-For-Service, Preferred Provider Organizations, Preferred Provider Organization with Prescription Drugs, Health Maintenance Organization with Prescription Drug, and Prescription Drug. These standardized documents will be used by MA organizations and Part D sponsors for the 2018 contract year.
In revising the standardized ANOC/EOCs for contract year 2018, we did not add to or remove any section from the prior contract year ANOC/EOC models. MA organizations and Part D sponsors are still required to use the standardized language in the ANOC/EOC models and to send this document to current members at least 15 days prior to the start of the annual enrollment period or by September 30, 2017 for the 2018 enrollment season, based on 42 CFR 422.111(a) (3) and 423.128(a)(3).
2.
The FDCF is revised for the 2017 and 2018 DV collection periods by changing the scoring of six standards from a binary scale to a five-point Likert-type scale. This change is expected to improve the precision of the data validation scores by increasing overall variation in total scores among the MAOs and PDPs. The revision is not expected to alter resource requirements, since the assessment by DV contractors in scoring standards will continue to be based on the percentage of records that meet the standards.
3.
CMS evaluates the quality and effectiveness of the QIO program as authorized in Part B of Title XI of the Social Security Act. CMS created the Independent Evaluation Center (IEC) to provide CMS and its stakeholders with an independent and objective program evaluation of the 11th SOW. Evaluation activities will focus on analyzing how well the QIO program is achieving the three aims of better care, better health, and lower cost as well as the effectiveness of the new QIO program structure. One of the QIN-QIOs' tasks to achieve these three aims is to support participating nursing homes in their efforts to improve quality of care and health outcomes among residents. According to the 2013 CMS Nursing Home Data Compendium, more than 15,000 nursing homes participated in Medicare and Medicaid programs with more than 1.4 million beneficiaries resided in U.S. nursing homes. These residents and their families rely on nursing homes to provide reliable, safe, high quality care. However, cognitive and functional impairments, pain, incontinence, antipsychotic drug use, and healthcare associated conditions (HAC), such as pressure ulcers and falls, remain areas of concern.
This information collection is to provide data to assess QIN-QIOs efforts aimed at addressing these HACs in nursing homes. QIN-QIOs are responsible for recruiting nursing homes to participate in the program. We will conduct an annual survey of administrators of nursing homes participating in the QIN-QIO program (intervention group) and administrators at nursing homes that are not participating in the QIN-QIO program (comparison group). Our proposed survey assesses progress towards the goals of the QIN-QIO SOW, including activities and strategies to increase mobility among residents, reduce infections, reduce use of inappropriate antipsychotic medication among long-term stay residents.
We plan to conduct qualitative interviews with nursing home administrators. This interview will supplement the Nursing Home Survey and provide more in-depth contextual information about the QIN-QIO program implementation within at nursing homes, including: (i) Their experience with, and perceived success of QIN-QIO collaboratives; (ii) their satisfaction with the QIN-QIO Collaborative and QIO support; (iii) perceived value and impact of QIO program; and (iv) drivers and barriers to QIN-QIO involvement and success.
Information from QIO leadership and/or state/territory task leads will be collected by interviews and focus groups. Interviews with Nursing Home Task leaders at the QIN and QIO will be conducted in-person during site visits and/or over the phone. We will conduct focus groups with QIO-level Directors during the annual CMS Quality conference. The purpose of the interviews and focus groups is to examine: (i) QIO processes for recruiting nursing homes, peer coaches, and beneficiaries to participate in the program; (ii) strengths and challenges of QIN-QIO activities related to nursing homes; (iii) partnership and coordination with other QIN-QIO tasks; and (iv) overall lessons learned. We will also conduct qualitative interviews with nursing home peer coaches.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish a notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site 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.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
2.
Administration for Community Living, Administration on Aging, HHS.
Notice.
The Administration on Community Living, Administration on Aging (ACL/AoA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by August 29, 2016.
Submit electronic comments on the collection of information to:
Submit written comments on the collection of information to: U.S. Department of Health and Human Services: Administration for Community Living 701 Fifth Avenue, Suite 1600 M/S RX-33, Seattle, WA 98104, Attention: Louise Ryan.
Louise Ryan by telephone: (206) 615-2514 or by email:
Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined
Section 1327.21 (conflicts of interest) of the Long-Term Care Ombudsman Program rule requires the State agency and the Ombudsman to identify and take steps to remove or remedy organizational conflicts of interest between the Office and the State agency or other agency carrying out the Ombudsman program. Additionally the rule requires the Ombudsman to identify organizational conflicts of interest in the Ombudsman program and describe steps taken to remove or remedy conflicts within the annual report submitted to the Assistant Secretary through the National Ombudsman Reporting System. The proposed form and instructions are posted on the ACL/AoA Web site at:
AoA estimates the burden of this additional collection of information as follows: Approximately 10 to 30 minutes per respondent, depending on the number of conflicts to report, with 52 state Ombudsman programs responding annually for a range of 8.6 to 26 hours.
Food and Drug Administration, HHS.
Notice; extension of comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for the notice that appeared in the
FDA is extending the comment period on the notice published May 5, 2016 (81 FR 27140). Submit either electronic or written comments by July 12, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In the
From July 1 through July 5, 2016, the Federal eRulemaking Portal,
Food and Drug Administration, HHS.
Notice of availability; extension of the comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for the notice, published in the
Submit either electronic or written comments by July 19, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Philip L. Chao, Center for Food Safety and Applied Nutrition (HFS-24), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2378.
In the
Food and Drug Administration, HHS.
Notice; extension of comment period.
The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled “Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments” that appeared in the
FDA is extending the comment period on the notice published March 4, 2016 (81 FR 11572). Submit either electronic or written comments by July 19, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Jane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Campus Dr., College Park, MD 20740, 240-402-2927.
In the
In early July 2016, the Federal eRulemaking Portal,
Office of the Secretary, Administration for Children and Families, HHS.
Delegation of authority.
Notice is hereby given that I delegate to the Assistant Secretary for the Administration for Children and Families (ACF) the following authorities vested in the Secretary of Health and Human Services under the Trafficking Victims Protection Act of 2000 (TVPA), Public Law 106-386, as amended.
Authority under section 107(b)(1)(B)(i) of the TVPA (22 U.S.C. 7105(b)(1)(B)(i)) to expand benefits and services to victims of severe forms of trafficking in persons in the United States, without regard to immigration status. In the case of non-entitlement programs funded by the Secretary of Health and Human Services, such benefits and services may include services to assist potential victims of trafficking in achieving certification and to assist minor dependent children of victims of severe forms of trafficking in persons or potential victims of trafficking.
Authority under section 107(b)(1)(B)(ii) of the TVPA (22 U.S.C. 7105(b)(1)(B)(ii)) to make grants for a national communication system to assist victims of severe forms of trafficking in persons in communicating with service providers.
Authority under section 107(f) of the TVPA (22 U.S.C. 7105(f)) to establish a program to assist United States citizens and aliens lawfully admitted for permanent residence who are victims of severe forms of trafficking. In addition to the authority to provide such victims with specialized services, the program also has the authority to identify current providers and provide a means to make referrals to programs for which such victims are already eligible. In the course of exercising the authority to conduct activities, personnel in the Administration for Children and Families will consult with the Attorney General, the Secretary of Labor, and non-governmental organizations that provide services to victims of severe forms of trafficking in the United States.
These authorities may be redelegated.
These authorities shall be exercised under the Department's policy on regulations and the existing delegation of authority to approve and issue regulations.
These delegations shall be exercised under financial and administrative requirements applicable to the Administration for Children and Families authorities.
I hereby affirm and ratify any actions taken by the Assistant Secretary for Children and Families, or your subordinates, which involved the exercise of these authorities delegated herein prior to the effective date of this delegation.
This delegation supersedes all existing delegations of these authorities.
This delegation is effective upon signature.
Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services (HHS).
HHS approval of entities that certify Medical Review Officers (MRO).
The current version of the Department of Health and Human Services (HHS) Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines), effective on October 1, 2010, addresses the role and qualifications of Medical Review Officers (MROs) and HHS approval of entities that certify MROs.
HHS approval is effective June 30, 2016.
Jennifer Fan, Pharm.D., J.D., Division of Workplace Programs (DWP), Center for Substance Abuse Prevention (CSAP), Substance Abuse and Mental Health Services Administration (SAMHSA), 5600 Fishers Lane, Room 16N02B, Rockville, MD 20857; Telephone: (240) 276-1759; Email:
Subpart M-Medical Review Officer (MRO), section 13.1(b) of the Mandatory Guidelines, “Who may serve as an MRO?” states as follows: “Nationally recognized entities that certify MROs or subspecialty boards for physicians performing a review of Federal
HHS has completed its review of entities that certify MROs, in accordance with requests submitted by such entities to HHS.
The HHS Secretary approves the following MRO certifying entities that offer MRO certification through examination:
American Association of Medical Review Officers (AAMRO), P.O. Box 12873, Research Triangle Park, NC 27709, Phone: (800) 489-1839, Fax: (919) 490-1010, Email:
Medical Review Officer Certification Council (MROCC), 836 Arlington Heights Road, #327, Elk Grove Village, IL 60007, Phone: (847) 631-0599, Fax: (847) 483-1282, Email:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of a meeting of the NIH Clinical Center Research Hospital Board.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The portions of the meeting devoted to the identification and evaluation of specific candidates for consideration for leadership positions in the Clinical Center will be closed to the public in accordance with the provisions set forth in section 552b(c)(9)(B) and 552b(c)(6), Title 5 U.S.C., as amended. Premature disclosure of potential candidates and their qualifications, as well as the discussions by the committee, could significantly frustrate NIH's ability to recruit these individuals and the consideration of personnel qualifications, performance, and the competence of individuals as candidates would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, Department of Health and Human Services.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive, Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
Technology description follows.
This invention is a platform technology that pertains to the advantages of conjugating therapeutics to Evans Blue thus providing long lasting pharmacokinetic profiles by complexing with albumin. Notably, albumin bound therapeutic- or prodrug-Evans Blue conjugates provide a complex with a total molecular size above 60 kDa thus eliminating the risk for renal clearance. Interestingly, since albumin also crosses the blood-brain barrier and since all circulating Evans Blue is bound to albumin, Evans Blue bound therapeutics or prodrugs can also cross the blood-brain barrier. By way for example but not limitation, Evans Blue can be conjugated to insulin, GLP-1, exendin-4, exendin (9-39), octreotide, bombesin, RGD peptide (arginylglycylaspartic acid), vascular endothelial growth factor (VEGF), interferon (IFN), tumor necrosis factor (TNF), asparaginase, or adenosine deaminase, exenatide, dipeptidyl peptidase-4 inhibitors, neuropilin, epidermal growth factor, islet neogenesis associated protein, alpha-1 antitrypsin, anti-inflammatory agents, glulisine, glucagons, local cytokines, modulators of cytokines, anti-apoptotic molecules, aptamers, asparaginase, adenosine deaminase, interferon α2a, interferon α2b, granulocyte colony stimulating factor, growth hormone receptor antagonists, doxorubicin, paclitaxel, gemcitabine, camptothecin, and temozolomide. Evans Blue conjugates according to this invention can additionally include radionuclides like
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests available data and information on approaches and/or technologies currently used for identifying potential developmental toxicants. Submitted information will be used to assess the state of the science and determine technical needs for non-animal test methods used to evaluate the potential of chemicals to induce adverse effects in offspring.
Data and information should be submitted electronically to
Dr. Warren Casey, Director, NICEATM; email:
Respondents to this request for information should include their name, affiliation (if applicable), mailing address, telephone, email, and sponsoring organization (if any) with their communications. The deadline for receipt of the requested information is August 15, 2016. Responses to this notice will be posted at:
Responses to this request are voluntary. No proprietary, classified, confidential, or sensitive information should be included in responses. This request for information is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to the request. Please note that the U.S. Government will not pay for the preparation of any information submitted or for its use of that information.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development.
Licensing information may be obtained by emailing the indicated licensing contact at the National Heart, Lung, and Blood, Office of Technology Transfer and Development Office of Technology Transfer, 31 Center Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479; telephone: 301-402-5579. A signed Confidential Disclosure Agreement may be required to receive any unpublished information.
Technology description follows.
This invention is a microscopy device and system for multi-photon microscopy utilizing multi-view nonlinear optical imaging. Nonlinear optical imaging remains the premier technique for deep-tissue imaging in which typically a multi photon arrangement may be used to illuminate and excite a sample. However, the penetration depth, signal-to-noise ratio, and resolution of this technique is ultimately limited by scattering. The present system addresses these issues by sequential excitation of a sample through three or more objective lenses oriented at different axes intersecting the sample. Each objective lens is capable of focused sequential excitation that elicits fluorescence emissions from the excited sample, which is then simultaneously detected by each respective objective lens along a respective longitudinal axis. Including multiple lenses will improve the penetration depth and at the same time decrease the loss of detail because of scattering. The system also can overcome losses in spatial resolution because of the scattering of the excitation and emission light.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Substance Abuse and Mental Health Services Administration, HHS
Notice
The Department of Health and Human Services (HHS) notifies federal agencies of the laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the
A notice listing all currently HHS-certified laboratories and IITFs is published in the
If any laboratory or IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter.
This notice is also available on the Internet at
Giselle Hersh, Division of Workplace Programs, SAMHSA/CSAP, 5600 Fishers Lane, Room 16N03A, Rockville, Maryland 20857; 240-276-2600 (voice).
The Mandatory Guidelines were initially developed in accordance with Executive Order 12564 and section 503 of Public Law 100-71. The “Mandatory Guidelines for Federal Workplace Drug Testing Programs,” as amended in the revisions listed above, requires strict standards that laboratories and IITFs must meet in order to conduct drug and specimen validity tests on urine specimens for federal agencies.
To become certified, an applicant laboratory or IITF must undergo three rounds of performance testing plus an on-site inspection. To maintain that certification, a laboratory or IITF must participate in a quarterly performance testing program plus undergo periodic, on-site inspections.
Laboratories and IITFs in the applicant stage of certification are not to be considered as meeting the minimum requirements described in the HHS Mandatory Guidelines. A HHS-certified laboratory or IITF must have its letter of certification from HHS/SAMHSA (formerly: HHS/NIDA), which attests that it has met minimum standards.
In accordance with the Mandatory Guidelines dated November 25, 2008 (73 FR 71858), the following HHS-certified laboratories and IITFs meet the minimum standards to conduct drug and specimen validity tests on urine specimens:
* The Standards Council of Canada (SCC) voted to end its Laboratory Accreditation Program for Substance Abuse (LAPSA) effective May 12, 1998. Laboratories certified through that program were accredited to conduct forensic urine drug testing as required by U.S. Department of Transportation (DOT) regulations. As of that date, the certification of those accredited Canadian laboratories will continue under DOT authority. The responsibility for conducting quarterly performance testing plus periodic on-site inspections of those LAPSA-accredited laboratories was transferred to the U.S. HHS, with the HHS' NLCP contractor continuing to have an active role in the performance testing and laboratory inspection processes. Other Canadian laboratories wishing to be considered for the NLCP may apply directly to the NLCP contractor just as U.S. laboratories do.
Upon finding a Canadian laboratory to be qualified, HHS will recommend that DOT certify the laboratory (
Bureau of Indian Affairs, Interior.
Notice.
This notice informs the public that the Acting Assistant Secretary—Indian Affairs proclaimed approximately 410.50 acres, more or less, an addition to the Reservation of the Port Gamble S'Klallam Tribe of Washington on June 22, 2016.
Ms. Sharlene M. Round Face, Bureau of Indian Affairs, Division of Real Estate Services, 1849 C Street NW., MS-4642-MIB, Washington, DC 20240; telephone: (202) 208-3615.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by part 209 of the Departmental Manual.
A proclamation was issued according to the Act of June 18, 1934, (48 Stat. 984; 25 U.S.C. 467) for the land described below. The land was proclaimed to be part of the Port Gamble S'Klallam Indian Reservation of the Port Gamble S'Klallam Tribe in Kitsap County, Washington.
PARCEL A (Hansville Property North)—The North half of the Northeast quarter and North half of the Southwest quarter of the Northeast quarter, Section 16, Township 27 North, Range 2 East, W.M., Kitsap County, Washington, according to U.S. Government subdivision procedures, shown as Parcel A (North) on that survey recorded October 12, 2004 in Book 62 of Surveys at Pages 63 and 64, under Auditor's File Number 200410120005.
PARCEL B (Hansville Property South)—The South half of the Southwest quarter of the Northeast quarter, the South half of the Northeast quarter of the Southwest quarter; the Northwest quarter of the Southeast quarter; the Southeast quarter of the Southeast quarter; and the Northeast quarter of the Southeast quarter; except the east 495 feet of said Northeast quarter of the Southeast quarter of Section 16, Township 27 North, Range 2 East, W.M., Kitsap County, Washington, according to U.S. Government subdivision procedures, shown as Parcel B (South) on that survey recorded October 12, 2004, in Book 62 of Surveys at Pages 63 and 64, under Auditor's File Number 200410120005; Also excepting therefrom the West 26 feet of the East 521 feet of said Northeast quarter of the Southeast quarter of said Section 16.
PARCEL C (Hansville Property West)—East half of the Northwest quarter; the Southwest quarter of the Northwest quarter; the North half of the Northeast quarter of the Southwest quarter Section 16, Township 27 North, Range 2 East, W.M., Kitsap County,
Lot(s) 1, Record of Survey, recorded in Volume 78, page(s) 23 and 24, of surveys, under Auditor's File No. 201308190235, being a portion of the Southeast Quarter, Section 9, Township 27 North, Range 2 East, W.M. in Kitsap County, Washington.
The above described lands contain a total of 410.50 acres, more or less, which are subject to all valid rights, reservations, rights-of-way, and easements of record.
This proclamation does not affect title to the lands described above, nor does it affect any valid existing easements for public roads, highway, public utilities, railroads, and pipelines or any other valid easements or rights-of-way or reservations of record.
Bureau of Indian Affairs.
Notice.
This notice publishes the amended Hannahville Indian Community Liquor Control Code, title IV, chapter 13. The amended Code regulates and controls the possession, sale, and consumption of liquor in conformity with the laws of the Hannahville Indian Community or applicable laws of the State of Michigan.
This amendment is effective August 1, 2016.
Sherrel LaPointe, Tribal Operations Officer, Midwest Region, Bureau of Indian Affairs, Norman Pointe II, 5600 American Boulevard West, Suite 500, Bloomington, Minnesota 55437, Telephone: (612) 713-4400.
The Hannahville Indian Community duly adopted the amended Code by Resolution Number 0504-2015-A on May 4, 2015. This Code repeals and replaces the previous liquor control code for the Hannahville Indian Community Liquor Control Code, last published in the
Pursuant to the Act of August 15, 1953, Public Law 83-277, 67 Stat. 586, 18 U.S.C. 1161, as interpreted by the Supreme Court in
The Hannahville Indian Community Liquor Control Code, as amended, shall read as follows:
(1) “Alcohol”—the product of distillation of fermented liquid, whether or not rectified or diluted with water, but does not mean ethyl or industrial alcohol, diluted or not, that has been denatured or otherwise rendered unfit for beverage purposes.
(2) “Alcoholic Liquor”—any spirituous, vinous, or fermented liquor, liquids and compounds, whether or not medicated, proprietary, patented, and by whatever name called, containing
(3) “Beer”—any beverage obtained by alcoholic fermentation of an infusion of decoction of barley, malt, hops or other cereal in potable water.
(4) “Brandy”—an alcoholic liquor as defined in 27 CFR 5.22(d) (1980).
(5) “Class C License”—a place licensed to sell at retail beer, wine, mixed spirit drink, and spirits for consumption on the premises.
(6) “Community”—the Hannahville Indian Community.
(7) “Council”—the Tribal Council of the Hannahville Indian Community.
(8) “Licensee”—Any entity or person licensed to sell beverages containing alcohol in accordance with the laws of the Hannahville Indian Community or applicable laws of the State of Michigan. Except where otherwise specifically required by applicable law or regulation, use of the word licensee shall be understood to include the word permittee.
(9) “Mixed Spirit Drink”—a drink produced and packaged or sold by a mixed spirit drink manufacturer or an out of state seller of mixed spirit drink, which contains 10% or less alcohol by volume consisting of distilled spirits mixed with nonalcoholic beverages or flavoring or coloring materials and which may also contain water, fruit juices, fruit adjuncts, sugar, carbon dioxide or preservatives.
(10) “Mixed Wine Drink”—a drink or similar product marketed as a wine cooler and containing less than 7% alcohol by volume, consisting of wine and plain, sparkling or carbonated water and containing 1 or more of the following:
(a) Nonalcoholic Beverages.
(b) Flavoring.
(c) Coloring Materials.
(d) Fruit Juices.
(e) Fruit Adjuncts.
(f) Sugar.
(g) Carbon Dioxide.
(h) Preservative.
(11) “Permittee”—Any entity or person licensed to sell beverages containing alcohol in accordance with the law or regulation of the Hannahville Indian Community or applicable laws or regulations of the State of Michigan. Except where otherwise specifically required by applicable law or regulation, use of the word licensee shall be understood to include the word permittee.
(12) “Sacramental Wine”—wine containing not more than 24% of alcohol by volume which is used for sacramental purposes.
(13) “Seller”—a person who has become at least 18 years of age and who is authorized by a licensee or permittee to sell beverages containing alcohol while acting within the scope of the license or permit that has been issued by the Tribe.
(14) “Spirits”—a beverage that contains alcohol obtained by distillation, mixed with potable water or
(15) “Tribe”—the Hannahville Indian Community.
(16) “Wine”—the product made by the normal alcoholic fermentation of the juice of sound, ripe grapes or any other fruit with the usual cellar treatment, and containing not more than 21% alcohol by volume, including fermented fruit juices other than grapes and mixed wine drinks.
It shall be unlawful to manufacture for sale, sell, offer, serve, trade, or keep for sale, possess, transport or conduct any transaction involving any alcoholic beverage except in compliance with the terms, conditions, limitations and restrictions specified in this Code.
(1) The Tribal Council shall have the sole and exclusive right to authorize, permit, license and control the importation, sale, possession, manufacture, transportation, storage or delivery of alcoholic beverages within the jurisdiction of the Hannahville Indian Community.
(2) Notwithstanding the provision of subsection (1) of this section, a person who has become 21 years of age may purchase alcoholic liquor or may import alcoholic liquor from another jurisdiction for that person's personal use, but not for resale purposes.
Any person who shall sell, serve, trade, transport, keep for sale, manufacture, possess, use, conduct any transaction, aid or abet or conspire to violate any of the terms of this Code within the jurisdiction of the Hannahville Indian Community shall be deemed guilty of an offense and upon conviction shall be dealt with as follows:
(1) If an Indian. The defendant may be sentenced to a period of incarceration not to exceed 1 year or a fine not to exceed $5,000.00, or both such fine and incarceration and court costs. The Tribal Council shall decide whether or not any license previously granted under this Code will be revoked or suspended.
(2) If a Non-Indian. Unless otherwise allowed by law, the defendant shall be liable for a fine not to exceed $5,000.00 and court costs, and shall be subject to the forfeiture and attachment laws of the tribe including prejudgment attachment of personal property in lieu of cash bond to secure judgment and jurisdiction of the tribal court. In the event that criminal jurisdiction as to non-Indians is extended to the Tribe as a matter of federal law then the penalties of section 13.104(1) shall apply. The Tribal Council shall decide whether or not any license previously granted under this Code will be revoked or suspended.
(3) No Pre-Emption. This Code does not pre-empt other civil or criminal codes or provisions of the Hannahville Indian Community Legal Code. Other causes of action and criminal charges that may be brought under other provisions of tribal law are expressly reserved hereunder. Actions required or permitted to be taken pursuant to the employment policies and procedures of the Tribe are also expressly reserved.
(1) Age of Sellers. Sellers of alcoholic beverages must be at least 18 years of age and are only permitted to make sales of beverages containing alcohol by express authorization within the scope of a licensee's or permittee's license or permit and on authorized business premises.
(2) Age of Purchasers. Purchasers of alcoholic beverages must be at least 21 years of age and shall show proper identification and proof of age upon purchase.
(3) Licenses or Permits; Hours of Sale. Hours of sale of alcoholic beverages will be determined upon issuance of the license or special permit, and will be in conformity with the type of license or permit authorized by the Tribal Council in conformity to applicable substantive state law.
(a) Special Event Permits; Conformity to Tribal and Applicable State Law. Permits issued by the Hannahville Indian Community under this Code to any person or entity for special events shall be issued in conformity with applicable substantive provisions of Michigan law or regulation as to times of sales and service, ages of purchasers, and duration of events.
(4) Sales to Obviously Intoxicated Persons. No person may sell, serve, give, furnish, or in any way procure for another, alcoholic beverages for the use of an obviously intoxicated person.
(5) Consumption of Alcohol by Obviously Intoxicated Persons On Premises Prohibited. A licensee or permittee shall not allow a person who is in an obviously intoxicated condition to consume beverages containing alcohol on the licensed or permitted premises.
(6) Adulterated Alcoholic Beverages; Regulation. No person may sell, serve, give, furnish or in any way procure for another any diluted or adulterated alcoholic beverage except as allowed by special license providing for the sale of mixed drinks on the premises of the licensee.
Every licensee or permittee is responsible for the conduct of sellers or servers authorized to participate in transactions related to alcoholic beverages on the premises of the licensee. Provided, however, that if the licensee is a tribally wholly owned enterprise this provision does not constitute a waiver of tribal sovereign immunity as to the enterprise nor as to the Tribe.
Any person who has become 21 years of age, including a tribally owned business entity may apply for an alcoholic beverage license or special permit by submitting an application containing the information required in 13.109, and may be granted a license or special permit for the sale, service, use, possession or transport of alcoholic beverages if the Tribal Council finds, in its sound discretion, on the basis of the facts disclosed by the application and by such additional information as the Council may deem relevant, that such issuance is in the best interest of the Community. Factors which the Tribal Council shall consider in granting, renewing or revoking a license shall include, but not be limited to, information required by section 13.109. Special licenses or permits may be granted to tribal organizations for special events, charitable functions, and special tribal celebrations.
The power to license or permit and to levy taxes under the provisions of this Code is vested exclusively in the Tribal Council.
(1) Applications; Content. An applicant for a license or permit shall provide in the application or demonstrate at a hearing all of the following:
(a) Name. The name of the person or entity seeking a license or permit.
(b) Financial Resources. The existence of adequate financial resources for establishment and operation of the proposed licensed business in proportion to the type and size of the proposed licensed business.
(c) Physical Plant. The existence of an adequate physical plant or plans for an adequate physical plant appropriate for the type and size of the proposed licensed business.
(d) Location. That the location of the proposed business shall adequately service the public.
(e) Permit; Nature of Event. In the case of a permit, a description of the nature of the event and the premises upon which, or within which the event is to occur.
(2) Competing Applications. The Council shall consider the order in which competing application forms are submitted to the Council.
(3) License Renewal; Term of License. Licenses are renewable by action of each new Tribal Council on the anniversary date which occurs at one year from last issuance. Licenses may be granted for any term less than one year but may not be granted for terms of more than three years.
(4) Permits; Term of Permit. Generally, a permit will be granted by the Tribe pursuant to this Code and in accordance with applicable state law or regulation for special events and will be limited to the length of time that the event is to occur.
(5) Notice and Opportunity to be Heard. The Council shall notify the applicant of its decision giving the reason(s) for its decision. In adverse determinations, and upon timely request, which shall occur not more than 5 business days after notice of the adverse action, the Tribal Council shall provide a hearing to the applicant. There is no appeal from the Council's decision.
(1) Licenses and Permits; Content. Each license or permit shall state the name of the license holder and address of the place of business to which it applies; the date of issuance; the date of expiration; the fact that the license or permit is granted by the Hannahville Indian Community Tribal Council; a statement, with the telephone number of the Hannahville Tribal Police Department that violations of the terms of the license or permit or the Liquor Control Code of the Hannahville Indian Community shall be reported to the Hannahville Indian Community Tribal Police who shall report their findings to the Tribal Council.
(2) Posting of Licenses and Permits. Licenses and permits shall be posted in a conspicuous place on the premises of the license holder.
(3) Licenses and Permits; Non-Transferable. Licenses and permits are not transferable to other persons, locations or business entities.
Every licensee or permittee shall have proof of liability insurance or bond as required by applicable state law or regulation.
(1) Violation; Investigation; Procedure. Upon receiving notice of a violation of this Code, the Hannahville Indian Community Tribal Police shall investigate and submit a report to the Tribal Council.
(2) License or Permit; Suspension; Revocation. The Tribal Council may choose to act immediately in response to the alleged violation by suspension or revocation of the license or permit, or may act at any time during or after a prosecution on the complaint. The Council may take any appropriate action in relation to the license, including suspension or revocation and may assess fines civilly against persons responsible for the violation in accord with section 13.104(1) or (2). Such fines may be in addition to any fines, damages or court costs that are assessed pursuant to other provisions of law. The Council may in its deliberations consider any evidence which it considers valuable and relevant.
(3) Notice and Opportunity to be Heard. The Council shall notify the licensee or permittee of its action giving the reason(s) for its decision. Upon timely request, which shall occur not more than 5 business days after notice of the adverse action, the Tribal Council shall provide a hearing to the licensee or permittee. In its discretion, and upon consultation with law enforcement and legal counsel, the Tribal Council may delay a hearing to allow for progress of a court action. There is no appeal from the Council's decision in regard to continued licensure or permitting.
(4) Any appeal from a court action shall be limited to the issues presented and preserved for appeal in the court below.
In addition to compliance with the requirements of section 13.105, class III gaming and other properly licensed tribally owned establishments may sell at retail, and a person may buy, spirits or mixed spirit drinks, including beer and wine or other beverages containing alcohol between the hours of 7:00 a.m. on Sunday and 2:00 a.m. on Monday unless shorter hours of sale have been specified by the Tribal Council pursuant to special license or permit. A person shall not sell at retail, and a person shall not knowingly and willfully buy, alcohol, or liquor of any kind between the hours of 11:59 p.m. on December 24 and 12 noon on December 25.
(1) Violation of Hours of Sale. It shall be a violation of this section, punishable in accordance with section 13.104, for a person to attempt to, or to sell, serve, furnish, purchase, or to procure for another, alcoholic beverages in violation of the hours of sale allowed by this Code.
(2) Time Zones; Clarification. In accordance with Michigan law, times for allowed sales shall be considered to be CST, for any licensee or permittee located in the central time zone. A reference to the time of day includes daylight savings time, when observed.
(3) Amendment Automatic, Substantive State Law. Amendments to this Code to achieve compliance with applicable substantive state law shall occur automatically as Michigan law is further amended.
(4) Notice of Automatic Amendment. If automatic amendment of this Code in accordance with applicable substantive state law occurs, the Tribal Council shall notify all current licensees, permittees, law enforcement, and the general public, of the substance of such amendments in a manner calculated to give actual and adequate notice of the amendments and their effective dates.
(1) Class III Gaming Facility; Purchase and Resale of Alcohol. The Tribe, for resale at its Class III gaming establishment, shall purchase spirits, or mixed spirit drinks, including beer and wine or other alcoholic liquor from distributors licensed or otherwise authorized by the Michigan Liquor Control Commission, at the same price and on the same basis that such beverages are purchased by class C licensees.
(2) Convenience Store; Other Enterprises. The Tribe, for resale at its Island Oasis convenience store and gas
(1) “Adulterated, Misbranded Liquor; Violation.” A licensee who, by himself or herself or by his or her agent or employee, sells, offers for sale, exposes for sale, or possesses alcoholic liquor that is adulterated, misbranded, or in bottles that have been refilled is guilty of a violation of this act.
(2) “Adulterated Liquor; Definition.” For purposes of this section, alcoholic liquor is adulterated if it contains any liquid or other ingredient that was not placed there by the original manufacturer or bottler.
(3) “Misbranded Liquor, Definition.” For purposes of this section, alcoholic liquor is misbranded if it is not plainly labeled, marked, or otherwise designated.
(4) “Refilled Liquor Bottles.” For purposes of this section, alcoholic liquor bottles have been refilled when the bottles contain any liquid or other ingredient not placed in the bottles by the original manufacturer or bottler.
(5) “Beer; Inapplicability.” This section does not apply to beer containers.
This Code may be amended or repealed by a majority vote of the Tribal Council with a quorum present, in regular or special session.
If any portion of this Code, or the application thereof, is found to be invalid the remainder shall be unaffected and shall remain in full force and effect.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before May 28, 2016, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by July 15, 2016.
Comments may be sent via U.S. Postal Service to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before May 28, 2016. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
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.
A request for removal has been received for the following resources:
60.13 of 36 CFR part 60.
United States International Trade Commission.
July 8, 2016 at 11:00 a.m.
Room 101, 500 E Street SW., Washington, DC 20436, Telephone: (202) 205-2000.
Open to the public.
1. Agendas for future meetings: none.
2. Minutes.
3. Ratification List.
4. Vote in Inv. Nos. 701-TA-562 and 731-TA-1329 (Preliminary) (Ammonium Sulfate from China). The Commission is currently scheduled to complete and file its determination on July 11, 2016; views of the Commission are currently scheduled to be completed and filed on July 18, 2016.
5. Vote in Inv. Nos. 731-TA-770-773 and 775 (Third Review) (Stainless Steel Wire Rod from Italy, Japan, Korea, Spain, and Taiwan). The Commission is currently scheduled to complete and file its determinations and views of the Commission on July 25, 2016.
6. Outstanding action jackets: none.
In accordance with Commission policy, subject matter listed above, not disposed of at the scheduled meeting, may be carried over to the agenda of the following meeting.
By order of the Commission.
Drug Enforcement Administration, Department of Justice.
60-Day notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 29, 2016.
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Courtney E. Mallon, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
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:
Overview of this information collection:
1.
2.
3.
4.
Affected public (Primary): Business or other for-profit.
Affected public (Other): Not-for-profit institutions; Federal, State, local, and tribal governments.
Abstract: The Controlled Substances Act (CSA) (21 U.S.C. 801-971) establishes a closed system of distribution for controlled substances. To this end, controlled substances are closely monitored and tightly regulated as they are distributed through the supply chain. One tool that helps to maintain the closed system of distribution is the CSA provision that states it “shall be unlawful for any person to distribute a controlled substance in schedules I or II to another except in pursuance of a written order of the person to whom such substance is distributed, made on a form to be issued by the Attorney General in blank in accordance with subsection (d) of this section..” 21 U.S.C. 828(a).
5.
6.
If additional information is required please contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
Civil Rights Division, Department of Justice.
30-Day notice.
The Department of Justice, Civil Rights Division, Office of Special Counsel for Immigration-Related Unfair Employment Practices, will be submitting the following information collection request to the Office of Management and Budget for review and approval in accordance with the Paperwork Reduction Act of 1995. 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 August 1, 2016.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Alberto Ruisanchez, Deputy Special Counsel, USDOJ-CRT-OSC, 950 Pennsylvania Avenue NW-NYA, Washington, DC 20530. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20503 or sent to
Written comments and/or suggestions are requested from the public and affected agencies concerning the proposed collection of information. Your comments should address one or more of the following four points:
(1) Evaluate whether the collection of information is necessary for the proper performance of the function 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 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, mechanical, or other technological collection techniques or other forms of information technology.
The information collection is listed below:
(1) Type of information collection: Extension of Currently Approved Collection.
(2) The title of the form/collection: Office of Special Counsel for Immigration-Related Unfair Employment Practices Charge Form [OSC Charge Form].
(3) The agency form number and applicable component of the Department sponsoring the collection. Form OSC-1. Office of Special Counsel for Immigration-Related Unfair Employment Practices, Civil Rights Division, U.S. Department of Justice.
(4) Affected public who will be asked to respond, as well as a brief abstract: Primary: The Office of Special Counsel for Immigration-Related Unfair Employment Practices (OSC) enforces the anti-discrimination provision (§ 274B) of the Immigration and Nationality Act (INA), 8 U.S.C. 1324b. The statute prohibits: (1) Citizenship or immigration status discrimination in hiring, firing, or recruitment or referral for a fee, (2) national origin discrimination in hiring, firing, or recruitment or referral for a fee, (3) unfair documentary practices during the employment eligibility verification (Form I-9 and E-Verify) process, and (4) retaliation or intimidation for asserting rights covered by the statute. OSC, within the Department's Civil Rights Division, investigates and, where reasonable cause is found, litigates charges alleging discrimination. OSC also initiates independent investigations, at times based on information developed during individual charge investigations. Independent investigations normally involve alleged discriminatory policies that potentially affect many employees or applicants. These investigations may result in complaints alleging a pattern or practice of discriminatory activity. If the Department lacks jurisdiction over a particular charge but believes another agency with which OSC has a Memorandum of Understanding providing for cross referrals (OSC has over fifty MOU partners) has jurisdiction over the claim, the completed form will be forwarded to the appropriate agency, thus avoiding any duplicative requests for information. OSC will also refer Respondents to non-MOU partner agencies where appropriate.
(5) An estimate of the total number of respondents and the amount of time estimated for an average respondent to respond: 210 respondents per year at 30 minutes per charge form.
(6) An estimate of the total public burden (in hours) associated with the collection: 105 hours annual burden hours associated with this collection.
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Policy and Planning Staff, Justice Management Division, Two Constitution Square, 145 N Street NE., Room 3E.405B, Washington, DC 20530.
Bureau of Justice Statistics, Department of Justice.
60-day notice.
The Department of Justice (DOJ), Office of Justice Programs, Bureau of Justice Statistics, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until August 29, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Rachel Morgan, Statistician, Bureau of Justice Statistics, 810 Seventh Street NW., Washington, DC 20531 (email:
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
—Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Bureau of Justice Statistics, including whether the information will have practical utility;
—Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information,
—Evaluate whether and if so how the quality, utility, and clarity of the information to be collected can be enhanced; and
—Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Overview of this information collection:
(1)
(2)
(3)
(4)
(5)
An estimate of the total number of respondents is 8,889 persons ages 12 to 18. Of the 8,889 SCS respondents, 86% or 7,645 will complete the long SCS interview (entire SCS questionnaire) which will take an estimated 15 minutes to complete. The remaining 14% or 1,244 SCS respondents will complete the short interview (
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Employment and Training Administration, Labor.
Notice of Funding Opportunity Announcement (FOA) re-opening.
The Employment and Training Administration (ETA), U.S. Department of Labor (DOL, the Department, or we), announces a reopening of the availability of approximately $338,520,000 in grant funds authorized by title V of the Older Americans Act (OAA) as amended in 2006, Public Law 109-365 for the Community Service Employment for Older Americans program, commonly referred to as the Senior Community Service Employment Program (SCSEP), for National Grants for Program Year (PY) 2016.
The original
Jeannette Flowers, 200 Constitution Avenue NW., Room N-4716, Washington, DC 20210; Telephone: 202-693-3322.
ETA is reopening the SCSEP FOA open period for 30 days to both new applicants and to applicants who applied for funding under this FOA during the previous open period. This reopening is intended to ensure adequate coverage of the necessary geographic areas and associated participant slots. Details on how to apply for new applicants and for existing applicants which wish to submit a new application are available in the FOA as well as any subsequent amendments to the FOA, which are described in further detail on ETA's Web site at
We anticipate awarding approximately 10-22 grants ranging from $2 million to $50 million each under this FOA. This is a four-year grant, renewable annually for each of those four years based on annual Departmental application requirements and subject to the availability of funds. The grant may be extended for a fifth year at the Department's discretion, contingent upon the grantee meeting or exceeding the minimum negotiated performance measures as required by section 514(a) of the OAA Amendments and 20 CFR 641.700.
Jimmie Curtis is the Grant Officer for the Funding Opportunity Announcement.
Notice.
The Department of Labor (DOL), Employment and Training Administration (ETA) is soliciting comments concerning a proposed extension for the authority to conduct the information collection request (ICR) titled, “Unemployment Insurance Benefits Operations State Self-Assessment Report of Responses.” In 2014, ETA embarked on a major multi-year initiative to reengineer its program accountability processes for state unemployment insurance (UI) benefits operations by integrating peer reviews with new operational review processes that recognizes both Federal and state capacity and ensures that the UI program is administered with a focus on accountability and integrity. Recognizing the need to assess and adequately monitor state UI benefit program operations in the 53 jurisdictions with state UI programs, the ETA has developed a new comprehensive state self-assessment tool, which is a set of questionnaires related to state UI benefits operations. The new collection has two distinct and complimentary purposes: (1) Assisting state UI agencies in making improvements to their UI benefits operations; and (2) assisting ETA in oversight and monitoring of state UI benefit program operations.
This comment request is part of continuing Departmental efforts to reduce paperwork and respondent burden in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
Consideration will be given to all written comments received by August 29, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free by contacting Betty Castillo, Chief of the Division of Unemployment Insurance Operations, by telephone at (202) 693-3029, (this is not a toll-free number), TTY 1-877-889-5627, or by email at
Submit written comments about, or requests for a copy of, this ICR by mail or courier to the U.S. Department of Labor, ETA Office of Unemployment Insurance, FPB Room S-4524, 200 Constitution Ave. NW., Washington, DC 20210; by email:
44 U.S.C. 3506(c)(2)(A).
The DOL, as part of continuing efforts to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies an opportunity to comment on proposed and/or continuing collections of information before submitting them to the Office of Management and Budget (OMB) for final approval. This program helps to ensure requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements can be properly assessed.
The self-assessment report contains responses to a series of in-depth questions on functional and program areas within state UI benefits operations. ETA has developed questionnaires for the following fifteen functional and program areas within UI benefit operations: (1) Adjudications/Benefits Timeliness and Quality Reviews; (2) Benefit Payment Control; (3) Continued Claims and Eligibility Reviews; (4) Data Validation; (5) Disaster Unemployment Assistance; (6) Intake Claims—Unemployment Compensation for Ex-Servicemembers; (7) Intake Claims—Unemployment Compensation for Federal Employees; (8) Intake Initial Claims—Combined Wage Claims; (9) Intake—Initial Claims; (10) Internal Security; (11) Lower Authority Appeals and Higher Authority Appeals; (12) Overarching Operational Matters; (13) Short-Time Compensation; (14) Trade Readjustment Allowances; and (15) Worker Profiling and Reemployment Services and Reemployment Services and Eligibility Assessments. Each functional or program area questionnaire of the self-assessment tool covers nine operational elements (where applicable for the specific functional or program area). The operational elements are: (1) Procedures, Policies and Confidentiality; (2) Training; (3) Workload Analysis and Management Controls; (4) Performance Management; (5) Information Technology; (6) Claimant and Employer Access and Communication; (7) Operational Efficiency and Resource Allocation; (8) Staffing and Merit Staffing; and (9) Fiscal Management. Instructions have also been developed describing the overall use of the tool as well as separate sets of instructions for each functional or program area questionnaire.
As previously noted, the new Unemployment Insurance Benefits Operations State Self-Assessment Report of Responses has two distinct and complimentary purposes: (1) Assisting state UI agencies in making improvements to their UI benefits operations; and (2) assisting ETA in oversight and monitoring state UI benefit program operations.
Section 303(a)(6) of the Social Security Act, 42 U.S.C. 503(a)(6) authorizes this information collection.
This information collection is subject to the Paperwork Reduction Act (PRA). A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to provide comments to the contact shown in the
Submitted comments will also be a matter of public record for this ICR and posted on the Internet, without redaction. The DOL encourages commenters not to include personally identifiable information, confidential business data, or other sensitive statements/information in any comments.
The DOL is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Employment and Training Administration, Labor.
Notice.
The Department of Labor (DOL or Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
Currently, the Employment and Training Administration (ETA) is soliciting comments concerning the collection of data about Form ETA 9033
Written comments must be submitted to the office listed in the addresses section below on or before August 29, 2016.
Submit written comments to Brian Pasternak, National Director of Temporary Programs, Office of Foreign Labor Certification, Employment & Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Suite 12-200, Washington, DC 20210; Telephone: (202) 513-7350 (this is not a toll-free number). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD). Fax: 202-513-7495. Email:
The information collection is required by section 258 of the Immigration and Nationality Act (INA) (8 U.S.C. 1288) and 20 CFR 655 Subpart F. The INA generally prohibits the performance of longshore work by foreign crewmembers in U.S. ports. 8 U.S.C. 1288(a). However,
The information is being collected to ensure compliance with the INA's requirements that employers must make certain attestations as a condition precedent to the employer's use of foreign crewmembers to perform longshore activities in the U.S. The attestations required by section 258 are collected by the Secretary of Labor through his or her designee, the Employment & Training Administration, on Form ETA 9033,
DOL is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• enhance the quality, utility, and clarity of the information to be collected; and
• minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this comment request will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record.
Notice.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Bureau of Labor Statistics (BLS) is soliciting comments concerning the proposed revision of the “The Consumer Expenditure Surveys: The Quarterly Interview and the Diary.” A copy of the proposed information collection request (ICR) can be obtained by contacting the individual listed below in the
Written comments must be submitted to the office listed in the
Send comments to Nora Kincaid, BLS Clearance Officer, Division of Management Systems, Bureau of Labor Statistics, Room 4080, 2 Massachusetts Avenue NE., Washington, DC 20212. Written comments also may be transmitted by fax to 202-691-5111 (this is not a toll free number).
Nora Kincaid, BLS Clearance Officer, at 202-691-7628 (this is not a toll free number). (See
The Consumer Expenditure (CE) Surveys collect data on consumer expenditures, demographic information, and related data needed by the Consumer Price Index (CPI) and other public and private data users. The continuing surveys provide a constant measurement of changes in consumer expenditure patterns for economic analysis and to obtain data for future CPI revisions. The CE Surveys have been ongoing since 1979.
The data from the CE Surveys are used (1) for CPI revisions, (2) to provide a continuous flow of data on income and expenditure patterns for use in economic analysis and policy formulation, and (3) to provide a flexible consumer survey vehicle that is available for use by other Federal Government agencies. Public and private users of price statistics, including Congress and the economic policymaking agencies of the Executive branch, rely on data collected in the CPI in their day-to-day activities. Hence, data users and policymakers widely accept the need to improve the process used for revising the CPI. If the CE Surveys were not conducted on a continuing basis, current information necessary for more timely, as well as more accurate, updating of the CPI would not be available. In addition, data would not be available to respond to the continuing demand from the public and
In the Quarterly Interview Survey, each consumer unit (CU) in the sample is interviewed every three months over four calendar quarters. The sample for each quarter is divided into three panels, with CUs being interviewed every three months in the same panel of every quarter. The Quarterly Interview Survey is designed to collect data on the types of expenditures that respondents can be expected to recall for a period of three months or longer. In general the expenses reported in the Interview Survey are either relatively large, such as property, automobiles, or major appliances, or are expenses which occur on a fairly regular basis, such as rent, utility bills, or insurance premiums.
The Diary (or recordkeeping) Survey is completed at home by the respondent family for two consecutive one-week periods. The primary objective of the Diary Survey is to obtain expenditure data on small, frequently purchased items which normally are difficult to recall over longer periods of time.
Office of Management and Budget clearance is being sought for the proposed revision of the Consumer Expenditure Surveys: The Quarterly Interview and the Diary.
Additionally, as part of an ongoing effort to improve data quality, maintain or increase response rates, and reduce data collection costs, CE is making the below changes.
Three major changes will be implemented in the Diary Survey (CED). First, in an effort to alleviate burden and slow or reverse the decline in response rates, CE has developed an alternative version of the paper diary form. The new version consolidates the four main diary categories onto two, facing, diary pages so that all expenses for a single day can be entered without flipping pages. An effort was also made to reduce the amount of instructions and examples so that respondents are not confused or intimidated.
Second, the earliest placement date and last placement date restrictions for the Diary will be removed allowing Field Representatives to place the diary on any day within the collection month. Data analysis shows that the monthly expenditures cycles that the earliest and last placement dates were put in place to capture are not statistically significant and were most likely the result of normal random fluctuations in the data that are expected in the survey's data rather than actual expenditure cycles.
Third, in order to simplify procedures and reduce costs, all Diaries will be double placed. With this new procedure, Field Representatives (FRs) will have the entire month to place the diaries instead of 7 days. This should drastically reduce the number of diaries CE loses to the non-interview Type A—Placed Too Late outcome code. As a result, the second Field Representative interview to pick up the Week 1 Diary and place the Week 2 Diary will be eliminated. Data analysis shows that double placements do not appear to have any negative effects on the Diary Survey. Approximately 27% of eligible cases and 33% of completed diaries are currently double placed.
Additionally, CE will delete several tax questions that were deleted from CEQ in 2015 as data received from the IRS have enabled CE to calculate this data rather than collect it.
Several changes will also be implemented in CEQ in order to keep the CEQ questionnaire current. These changes include changes to question wording, deletions, additions, and section restructurings. Questions were added for solar panels, internet away from home charges, and alternative fuels such as electrical vehicle charging; health insurance questions were revamped to make them clearer and to align with the structure of the National Health Interview Survey (NHIS); questions were combined and reworded such as streaming videos to be combined with rental of movies and combining book purchases with book club subscriptions; questions were deleted on purchases occurring in the current month and on purchases of apps, games, and ringtones; questions on refinancing of a property and on construction and repair of property were streamlined.
The Bureau of the Census conducts the CE Surveys for the Bureau of Labor Statistics (BLS) in support of the Consumer Price Index (CPI) program. The continuing CE Surveys provide a constant measurement of changes in consumer expenditure patterns for economic analysis, and obtain data for future CPI revisions. The CPI program anticipates the need for CE surveys to collect outlet information to serve as outlet frames for most commodities and services (C&S) items as issues with TPOPS collection have resulted in prohibitively high costs. To support this objective, CE will test the addition of outlet questions in several sections of the CEQ survey instrument. In all sections except vehicles, CE will add these questions to the fourth interview only; because vehicle purchases are not reported often, questions on the purchase location for vehicles will be asked in all four interviews. Finally, the Incentives/Outlets Test study questions will be deleted.
A full list of the proposed changes to the Quarterly Interview Survey and Diary Survey are available upon request.
In addition to the Incentives/Outlets test, the Consumer Expenditure program is planning several tests over the next several years in an effort to improve the CE surveys in the areas of both data quality and respondent burden.
The Bureau of Labor Statistics is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility.
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used.
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they also will become a matter of public record.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Hazardous Conditions Complaints.
All comments must be received on or before August 29, 2016.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
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Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
Under Section 103(g) of the Federal Mine Safety and Health Act of 1977, as amended (Mine Act), a representative of miners, or any individual miner where there is no representative of miners, may submit a written or oral notification of an alleged violation of the Mine Act or a mandatory standard or that an imminent danger exists. The notifier has the right to obtain an immediate inspection by MSHA. A copy of the notice must be provided to the operator, with individual miner names redacted.
MSHA regulations at 30 CFR part 43 implement Section 103(g) of the Mine Act. These regulations provide the procedures for submitting notification of the alleged violation and the actions that MSHA must take after receiving the notice. Although the regulations contain a review procedure (required by section 103(g)(2) of the Mine Act) whereby a miner or a representative of miners may in writing request a review if no citation or order is issued as a result of the original notice, the option is so rarely used that it was not considered in the burden estimates.A30JN3.
MSHA is soliciting comments concerning the proposed information collection related to Hazardous Conditions Complaints. MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The information collection request will be available on
The public may also examine publicly available documents at USDOL—Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Hazardous Conditions Complaints. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Program to Prevent Smoking in Hazardous Areas (Pertains to Underground Coal Mines).
All comments must be received on or before August 29, 2016.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
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•
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Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
Section 317(c) of the Federal Mine Safety and Health Act of 1977 (Mine Act), 30 U.S.C. 877(c), and 30 CFR 75.1702 prohibits persons from smoking or carrying smoking materials underground or in places where there is a fire or explosion hazard. Under the Mine Act, 30 U.S.C. 877(c) and 75.1702, coal mine operators are required to develop programs to prevent persons from carrying smoking materials, matches, or lighters underground and to prevent smoking in hazardous areas, such as in or around oil houses, explosives magazines or other areas where such practice may cause a fire or explosion.
Section 75.1702-1 requires a mine operator to submit a smoking prevention plan to MSHA for approval under § 75.1702 to MSHA for approval. Section 103(h) of the Mine Act, 30 U.S.C. 813, authorizes MSHA to collect information necessary to carry out its duty in protecting the safety and health of miners. These information collection requirements help to ensure that a fire or explosion hazard does not occur.
MSHA is soliciting comments concerning the proposed information collection related to Program to Prevent Smoking in Hazardous Areas (Pertains to Underground Coal Mines). MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The information collection request will be available on
The public may also examine publicly available documents at USDOL—Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Program to Prevent Smoking in Hazardous Areas (Pertains to Underground Coal Mines). MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.
Comments submitted in response to this notice will be summarized and
Mine Safety and Health Administration, Labor.
Request for public comments.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A). This program helps to assure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed.
All comments must be received on or before August 29, 2016.
Comments concerning the information collection requirements of this notice may be sent by any of the methods listed below.
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•
•
Sheila McConnell, Director, Office of Standards, Regulations, and Variances, MSHA, at
MSHA allows operators to use air from a belt air course to ventilate a working section, or an area where mechanized mining equipment is being installed or removed, only under certain conditions. The belt air use must be evaluated and approved by the district manager in the mine ventilation plan and operators must follow a number of other requirements that provide additional protection.
Section 75.350(b) requires that the mine operator must include in a ventilation plan a justification that the use of air from a belt entry would afford at least the same measure of protection as where belt haulage entries are not used. The plan also must include information regarding point feeds and regulators and designated areas for dust and air velocity measurements.
Section 75.351(b)(3) and 75.351(b)(4) require a mine operator to post a map or schematic, at a designated surface location, which shows the locations and type of Atmospheric Monitoring System (AMS) sensors at each location and the intended air flow direction at these locations. This map or schematic must be updated within 24 hours of any change in this information. Contact information for AMS and other appropriate personnel also must be posted at this location.
Section 75.351(j) requires approval of the CO ambient levels, and the means to determine those levels, in the mine ventilation plan.
Section 75.351(m) permits a mine to incorporate time delays into the AMS, or to use other methods for reducing non-fire alerts and alarm levels, provided they are specified and approved in the mine ventilation plan. Permission for such time delays, or other methods of reducing non-fire alerts and alarms, would be granted based on associated documentation that justifies these changes.
Sections 75.351(n)(2) and 75.351(n)(3) require that alarms for AMS be tested every seven days and CO, smoke, or methane sensors be calibrated, every 31 days, respectively.
Section 75.351(o)(1)(i) requires that a record be made if the AMS emits an alert or alarm signal. The record would consist of the date, time, location, and type of sensor, and the reason for its activation.
Section 75.351(o)(1)(ii) requires that, if an AMS malfunctions, a record be made of the date, the extent and cause of the malfunction, and the corrective action taken to return the system to proper operating condition.
Section 75.351(o)(1)(iii) requires that the persons doing the weekly test of alert and alarm signals, the monthly calibration, or maintenance of the system make a record of these tests, calibrations, or maintenance.
Section 75.351(o)(3) requires that all records concerning the AMS be kept in a book or electronically in a computer system that is secure and not susceptible to alteration.
Section 75.351(p) requires the mine operator to keep these records for at least one year at a surface location and to make them available for inspection by authorized representatives of the Secretary and representatives of miners.
Section 75.351(q)(3) requires that a record of annual AMS operator training be kept. The record will include the content of training, the person conducting the training, and the date the training is conducted. The record needs to be maintained at the mine site by the mine operator for at least one year.
Sections 75.352(a), 75.352(b) and 75.352(c) require the designated AMS operator or other appropriate personnel to notify, investigate, or evacuate when malfunction, alert, or alarm signals are received.
Section 75.371(hh) requires reporting within the mine ventilation plan of the “ambient level in parts per million of carbon monoxide, and the method for determining the ambient level, in all areas where carbon monoxide sensors are installed.” This provision is impacted by section 75.351(j).
Section 75.371(kk) requires the locations where air quantities are measured as set forth in section 75.350(b)(6) be included in the mine ventilation plan.
Section 75.371(ll) requires the locations and use of point feed regulators, in accordance with Sections 75.350(c) and 75.350(d)(5), to be in the mine ventilation plan.
Section 75.371(mm) requires the location of any diesel-discriminating
Sections 75.371(nn), 75.371(oo), and 75.371(pp) require modification of the mine ventilation plan to show the length of the time delay or any other method used for reducing the number of non-fire related alert and alarm signals from CO sensors, the lower alert and alarm setting for CO sensors, and the alternate instrument and the alert and alarm levels associated with the instrument, respectively.
MSHA is soliciting comments concerning the proposed information collection related to Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed. MSHA is particularly interested in comments that:
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
• Evaluate the accuracy of MSHA's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Suggest methods to enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
The information collection request will be available on
The public may also examine publicly available documents at USDOL—Mine Safety and Health Administration, 201 12th South, Suite 4E401, Arlington, VA 22202-5452. Sign in at the receptionist's desk on the 4th floor via the East elevator.
Questions about the information collection requirements may be directed to the person listed in the
This request for collection of information contains provisions for Safety Standards for Underground Coal Mine Ventilation—Belt Entry Used as an Intake Air Course to Ventilate Working Sections and Areas Where Mechanized Mining Equipment is Being Installed or Removed. MSHA has updated the data with respect to the number of respondents, responses, burden hours, and burden costs supporting this information collection request.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Mine Safety and Health Administration (MSHA), Labor.
Notice.
Section 101(c) of the Federal Mine Safety and Health Act of 1977 and 30 CFR part 44 govern the application, processing, and disposition of petitions for modification. This
Copies of the final decisions are posted on MSHA's Web site at
Barbara Barron at 202-693-9447 (Voice),
Under section 101 of the Federal Mine Safety and Health Act of 1977, a mine operator may petition and the Secretary of Labor (Secretary) may modify the application of a mandatory safety standard to that mine if the Secretary determines that: (1) An alternative method exists that will guarantee no less protection for the miners affected than that provided by the standard; or (2) the application of the standard will result in a diminution of safety to the affected miners.
MSHA bases the final decision on the petitioner's statements, any comments and information submitted by interested persons, and a field investigation of the conditions at the mine. In some instances, MSHA may approve a petition for modification on the condition that the mine operator complies with other requirements noted in the decision.
On the basis of the findings of MSHA's investigation, and as designee of the Secretary, MSHA has granted or partially granted the following petitions for modification:
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Mine Safety and Health Administration, Labor.
Notice.
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. This notice is a summary of petitions for modification submitted to the Mine Safety and Health Administration (MSHA) by the parties listed below.
All comments on the petitions must be received by the MSHA's Office of Standards, Regulations, and Variances on or before August 1, 2016.
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 (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 determines that:
1. An alternative method of achieving the result of such standard exists which will at all times guarantee no less than the same measure of protection afforded the miners of such mine by such standard; or
2. That the application of such standard to such mine will result in a diminution of safety to the miners in such mine.
In addition, the regulations at 30 CFR 44.10 and 44.11 establish the requirements and procedures for filing petitions for modification.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Viper Mine will maintain a log for electronic surveying equipment. The log will be kept in either a paperbound book or a digital copy. The log will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The log will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used in or inby the last open crosscut will be examined by the person that will operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These checks will include:
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(vi) Recording the results of the inspection in the equipment log.
(4) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment log and will include a description of the work performed.
(5) The non-permissible surveying equipment that will be used in or inby the last open crosscut will not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance.
(6) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment in or inby the last open crosscut, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock-dusted and for the presence of accumulated float coal dust. If the rock-dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment will not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rocked-dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock-dusted prior to energizing the electronic surveying equipment.
(7) Prior to energizing any of the nonpermissible surveying equipment in or inby the last open crosscut, methane tests must be made no more than 8 inches from the roof at the location of the equipment. All hand-held methane detectors will be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(8) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 75.361, an additional examination is not required.
(9) A qualified person as defined in 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment in or inby the last open crosscut. If there are two people in the surveying crew, a second person in the crew will also continuously monitor for methane. That second person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. On completion of the 6-month training period, the second person on the survey crew must become qualified to continue on the survey crew. If the surveying crew consists of one person, that person will monitor for methane with two separate devices. While the equipment is energized in or inby the last open crosscut, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(10) Batteries contained in the surveying equipment must be changed out or charged in intake air outby the last open crosscut. Replacement batteries for the electronic surveying equipment will not be brought in or inby the last open crosscut. Upon each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(11) When using nonpermissible electronic surveying equipment inby the last open crosscut, the surveyor must confirm by measurement or by the air quantity on the section, on that shift, in the last open crosscut or coming to the face is the quantity that is required by the mine's ventilation plan.
(12) Nonpermissible electronic surveying equipment will not be used when active coal extraction is occurring in the section. All active coal extraction in the section will cease prior to use of the equipment in or inby the last open crosscut.
(13) Personnel using the surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(14) All members of the surveying crew will receive specific training on the terms and conditions of this petition before using nonpermissible electronic surveying equipment in or inby the last open crosscut. A record of the training will be kept with the other training records.
(15) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(16) Viper mine will replace or exclude from service any theodolite that was acquired more than 5 years prior to the date that this petition becomes final or any total station acquired more than 10 years prior to the day that the PDO becomes final for use in or inby the last open crosscut. After 5 years, Viper Mine will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than 5 years from date of manufacture and total stations will be no more than 10 years from date of manufacture of use in or inby the last open crosscut.
(17) Viper Mine is responsible for seeing that all surveying contractors hired by Viper Mine are using relatively new electronic equipment,
(18) Nonpermissible equipment will not be used where float coal dust is in suspension.
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.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Viper Mine will maintain a log for electronic surveying equipment. The log will be kept in either a paperbound book or a digital copy. The log will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The log will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used in the return airway will be examined by the person that will operate the equipment prior to taking the equipment underground to ensure the equipment is being maintained in a safe operating condition. These checks will include:
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(vi) Recording the results of the inspection in the equipment log.
(4) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment log and
(5) The nonpermissible surveying equipment used in the return airway will not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance.
(6) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment in the return airway, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock-dusted and for the presence of accumulated float coal dust. If the rock-dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment will not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rocked-dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock-dusted prior to energizing the electronic surveying equipment.
(7) Prior to energizing any of the nonpermissible surveying equipment in the return airway, methane tests must be made no more than 8 inches from the roof at the location of the equipment. All hand-held methane detectors will be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(8) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 75.361, an additional examination is not required.
(9) A qualified person as defined in 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment in the return airway. If there are two people in the surveying crew, a second person in the crew will also continuously monitor for methane. That second person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. On completion of the 6-month training period, the second person on the survey crew must become qualified to continue on the survey crew. If the surveying crew consists of one person, that person will monitor for methane with two separate devices. While the equipment is energized in the return airway, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(10) Batteries contained in the surveying equipment must be changed out or charged in intake air out of a return airway. Replacement batteries for the electronic surveying equipment will not be brought into the return airway. Upon each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(11) When using nonpermissible electronic surveying equipment in the return airway, the surveyor must confirm by measurement or by the air quantity on the section, on that shift, in the return airway is the quantity that is required by the mine's ventilation plan.
(12) Nonpermissible electronic surveying equipment will not be used when active coal extraction is occurring in the section. All active coal extraction in the section will cease prior to use of the equipment in the return airway.
(13) Personnel using the surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(14) All members of the surveying crew will receive specific training on the terms and conditions of this petition before using nonpermissible electronic surveying equipment in the return airway. A record of the training will be kept with the other training records.
(15) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(16) Viper mine will replace or exclude from service any theodolite that was acquired more than 5 years prior to the date that this petition becomes final or any total station acquired more than 10 years prior to the day that the PDO becomes final for use in the return airway. After 5 years, Viper Mine will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than 5 years from date of manufacture and total stations will be no more than 10 years from date of manufacture for use in the return airway.
(17) Viper Mine is responsible for seeing that all surveying contractors hired by Viper Mine are using relatively new electronic equipment,
(18) Nonpermissible equipment will not be used where float coal dust is in suspension.
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.
(1) Nonpermissible electronic surveying equipment will only be used until equivalent permissible electronic surveying equipment is available or if viable new mechanical surveying equipment is not commercially available.
(2) Viper Mine will maintain a log for electronic surveying equipment. The log will be kept in either a paperbound book or a digital copy. The log will contain the date of manufacture and/or purchase of each particular piece of electronic surveying equipment. The log will be made available to MSHA on request.
(3) All nonpermissible electronic surveying equipment to be used within 150 feet of pillar workings be examined by the person that will operate the equipment prior to taking the equipment underground to ensure the
(i) Checking the instrument for any physical damage and the integrity of the case.
(ii) Removing the battery and inspecting for corrosion.
(iii) Inspecting the contact points to ensure a secure connection to the battery.
(iv) Reinserting the battery and powering up and shutting down to ensure proper connections.
(v) Checking the battery compartment cover or battery attachment to ensure that it is securely fastened.
(vi) Recording the results of the inspection in the equipment log.
(4) All nonpermissible electronic surveying equipment will be serviced according to the manufacturer's recommendations. Dates of service will be recorded in the equipment log and will include a description of the work performed.
(5) The nonpermissible surveying equipment that will be used within 150 feet of pillar workings will not be put into service until MSHA has initially inspected the equipment and determined that it is in compliance.
(6) As an additional safety check, prior to setting up and energizing nonpermissible electronic surveying equipment within 150 feet of pillar workings, the surveyor(s) will conduct a visual examination of the immediate area for evidence that the areas appear to be sufficiently rock-dusted and for the presence of accumulated float coal dust. If the rock-dusting appears insufficient or the presence of accumulated coal dust is observed, the equipment will not be energized until sufficient rock dust has been applied and/or the accumulations of coal dust have been cleaned up. If nonpermissible electronic surveying equipment is to be used in an area that is not rocked-dusted within 40 feet of a working face where a continuous miner is used to extract coal, the area will be rock- dusted prior to energizing the electronic surveying equipment.
(7) Prior to energizing any of the nonpermissible surveying equipment within 150 feet of pillar workings, methane tests must be made no more than 8 inches from the roof at the location of the equipment. All hand-held methane detectors will be MSHA-approved and maintained in permissible and proper operating condition as defined by 30 CFR 75.320. All methane detectors must provide visual and audible warnings when methane is detected at or above 1.0 percent.
(8) All areas to be surveyed will be pre-shifted according to 30 CFR 75.360 prior to surveying. If the area was not pre-shifted, a supplemental examination according to 30 CFR 75.361 will be performed before any non-certified person enters the area. If the area has been examined according to 30 CFR 75.360 or 75.361, an additional examination is not required.
(9) A qualified person as defined in 30 CFR 75.151 will continuously monitor for methane immediately before and during the use of nonpermissible surveying equipment within 150 feet of pillar workings. If there are two people in the crew, a second person in the surveying crew will also continuously monitor for methane. That second person will either be a qualified person as defined in 30 CFR 75.151 or will be in the process of being trained to be a qualified person but will not make such tests for a period of 6 months, as required by 30 CFR 75.151. On completion of the 6-month training period, the second person on the survey crew must become qualified to continue on the survey crew. If the surveying crew consists of one person, that person will monitor for methane with two separate devices. While the equipment is energized within 150 feet of pillar workings, one qualified person who is continuously monitoring for methane will remain with the electronic surveying equipment.
(10) Batteries contained in the surveying equipment must be changed out or charged in intake air outside of 150 feet of pillar workings. Replacement batteries for the electronic surveying equipment will not be brought within 150 feet of pillar workings. Upon each entry into the mine, all batteries for the electronic surveying equipment must be fully charged.
(11) When using nonpermissible electronic surveying equipment within 150 feet of pillar workings, the surveyor must confirm by measurement or by the air quantity on the section, on that shift, within 150 feet of pillar workings is the quantity that is required by the mine's ventilation plan.
(12) Nonpermissible electronic surveying equipment will not be used when active coal extraction is occurring in the section. All active coal extraction in the section will cease prior to use of the equipment within 150 feet of pillar workings.
(13) Personnel using the surveying equipment will be properly trained to recognize the hazards and limitations associated with the use of surveying equipment in areas where methane could be present.
(14) All members of the surveying crew will receive specific training on the terms and conditions of this petition before using nonpermissible electronic surveying equipment within 150 feet of pillar workings. A record of the training will be kept with the other training records.
(15) Within 60 days after the Proposed Decision and Order (PDO) becomes final, the petitioner will submit proposed revisions for their approved part 48 training plan to the District Manager. The revisions will specify initial and refresher training regarding the terms and conditions in the PDO. When training is conducted on the terms and conditions stated in the PDO, an MSHA Certificate of Training (Form 5000-23) will be completed. Comments on the certificate of training will indicate surveyor training.
(16) Viper mine will replace or exclude from service any theodolite that was acquired more than 5 years prior to the date that this petition becomes final or any total station acquired more than 10 years prior to the day that the PDO becomes final for use within 150 feet of pillar workings. After 5 years, Viper Mine will maintain a cycle of purchasing new electronic surveying equipment whereby theodolites will be no older than 5 years from date of manufacture and total stations will be no more than 10 years from date of manufacture for use within 150 feet of pillar workings.
(17) Viper Mine is responsible for seeing that all surveying contractors hired by Viper Mine are using relatively new electronic equipment,
(18) Nonpermissible equipment will not be used where float coal dust is in suspension.
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.
Occupational Safety and Health Administration (OSHA), Labor.
Notice of Maritime Advisory Committee for Occupational Safety and Health (MACOSH) meeting.
This
The Committee and workgroups will meet at the U.S. Department of Labor, Frances Perkins Building, 200 Constitution Avenue NW., Washington, DC 20210, in Conference Room S-4215. Meeting attendees must use the visitor's entrance located at 3rd & C Streets NW.
OSHA will place comments and requests to speak, including personal information, in the public docket, which may be available online. Therefore, OSHA cautions interested parties about submitting personal information such as Social Security numbers and birthdates.
Copies of this
All MACOSH committee and workgroup meetings are open to the public. Interested persons may attend the full Committee and its workgroup meetings at the time and place listed above. The Longshoring and Shipyard workgroups will meet from 9 a.m. until approximately 5 p.m. on August 9, 2016, in Conference Rooms S-4215A and S-4215C. The workgroups will discuss protecting workers from toxic preservative coatings, personal protective equipment in shipyards, assessing current provisions of 29 CFR part 1915 subpart E, lashing safety, and mechanic safety.
The full Committee will meet from 9 a.m. until approximately 5 p.m. on August 10, 2016, in Conference Room S-4215. The tentative agenda will include: Updates from OSHA National Office Directorates; updates on maritime enforcement activities from OSHA Regions; and reports from the Longshoring and Shipyard workgroups.
Interested parties also may submit written comments, including data and
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, authorized the preparation of this notice under the authority granted by 29 U.S.C. 655, 656, 5 U.S.C. App. 2, Secretary of Labor's Order No. 1-2012 (77 FR 3912), and 29 CFR part 1912.
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meeting.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 1 meeting of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
All meetings are Eastern time and ending times are approximate:
National Endowment for the Arts, Constitution Center, 400 7th St. SW., Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Kathy Plowitz-Worden, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in confidence to the agency. In accordance with the determination of the Chairman of February 15, 2012, these sessions will be closed to the public pursuant to subsection (c)(6) of section 552b of title 5, United States Code.
Notice.
The National Endowment for the Arts (NEA), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data is provided in the desired format; reporting burden (time and financial resources) is minimized; collection instruments are clearly understood; and the impact of collection requirements on respondents is properly assessed. Currently, the National Endowment for the Arts is soliciting comments concerning the proposed information collection of: Blanket Justification for NEA Funding Application Guidelines and Reporting Requirements. A copy of the current information collection request can be obtained by contacting the office listed below in the address section of this notice.
Written comments must be submitted to the office listed in the address section below within 60 days from the date of this publication in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Can help the agency minimize the burden of the collection of information on those who are to respond, including through the electronic submission of responses.
Send comments to Jillian Miller, Director, Office of Guidelines and Panel Operations, National Endowment for the Arts, at
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation announces the following meeting:
Advisory Committee for Mathematical and Physical Sciences (#66) (Virtual).
July 21, 2016; 1:30 p.m. to 3:30 p.m.
National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. Virtual Meeting.
Open.
Eduardo Misawa, National Science Foundation, 4201 Wilson Boulevard, Suite 505, Arlington, Virginia 22230; Telephone 703-292-8300.
To provide advice, recommendations and counsel on major goals and policies pertaining to mathematical and physical sciences programs and activities.
The National Science Board's Executive Committee, pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business, as follows:
Tuesday, July 5, 2016 from 4:00-5:00 p.m. EDT.
(1) Committee Chair's opening remarks; (2) Approval of Executive Committee minutes of April 2016; (3) Discuss issues and topics for an agenda of the NSB meeting scheduled for August 9-10, 2016; and (4) Committee Chair's closing remarks.
Open.
This meeting will be held by teleconference at the National Science Foundation, 4201 Wilson Blvd., Arlington, VA 22230. A public listening line will be available. Members of the public must contact the Board Office (call 703-292-7000 or send an email message to
Please refer to the National Science Board Web site
Nuclear Regulatory Commission.
License amendment application; withdrawal by applicant.
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Omaha Public Power District to withdraw its application dated September 10, 2015, for a proposed amendment to Facility Operating License No. DPR-40. The proposed amendment would have revised the Updated Safety Analysis Report (USAR) to allow the use of the equipment classification methodology in industry standard American National Standards Institute/American Nuclear Society (ANSI/ANS)-58.14-2011, “Safety and Pressure Integrity Classification Criteria for Light Water Reactors.”
June 30, 2016.
Please refer to Docket ID NRC-2015-0261 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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•
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Carl F. Lyon, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone 301-415-2296, email:
The NRC has granted the request of Omaha Public Power District (the licensee) to withdraw its September 10, 2015, application (ADAMS Accession No. ML15258A680), for proposed amendment to Facility Operating License No. DPR-40 for the Fort Calhoun Station, Unit No. 1, located in Washington County, Nebraska.
The proposed amendment would have revised the USAR to allow the use of the equipment classification methodology in industry standard ANSI/ANS-58.14-2011, “Safety and Pressure Integrity Classification Criteria for Light Water Reactors.”
The licensee's application was previously noticed in the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Environmental assessment and finding of no significant impact; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is considering a license amendment request for the Virginia Electric and Power Company's (Dominion) Special Nuclear Materials (SNM) License SNM-2507 for the operation of North Anna Power Station's (NAPS) independent spent fuel storage installation (ISFSI). The proposed amendment would revise the technical specifications (TSs) to allow the loading and storing of high burnup spent nuclear fuel from NAPS, Units 1 and 2, in a single, modified (and instrumented) TN-32B HBU cask.
The environmental assessment and finding of no significant impact referenced in this document are available on June 30, 2016.
Please refer to Docket ID NRC-2014-0154 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
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•
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Jean Trefethen, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0867, email:
The NRC is considering issuance of a license amendment for Dominion's SNM License SNM-2507 for the NAPS ISFSI located in Louisa County, Virginia (ADAMS Accession No. ML15239B251 and ML15289A189). Dominion is proposing to revise the TSs to allow the loading and storing of high burnup spent nuclear fuel (
The NRC staff has prepared a final environmental assessment (EA) as part of its review of this proposed license amendment in accordance with the requirements in part 51 of title 10 of the
Dominion is requesting to amend its specifically-licensed ISFSI to load and store high burnup spent nuclear fuel from NAPS, Units 1 and 2, in a single, modified (and instrumented) TN-32B HBU cask. Specifically, the TN-32B HBU cask will be modified to insert thermocouples through the cask lid and into the fuel assemblies to monitor fuel temperatures in the cask. The data gathered will support the U.S. Department of Energy and Electric Power Research Institute High Burnup Dry Storage Research Project. Dominion is proposing to revise the TSs that address the functional and operating limits, the limiting condition for operation, and the design features to reflect the use of the TN-32B HBU cask. As part of the High Burnup Dry Storage Research Project, Dominion will monitor the fuel temperature in this cask and collect data to support research on the long-term behavior of high burnup spent nuclear fuel. The information will be used to inform dry cask designs and future ISFSI licensing actions. If the proposed license amendment is approved, Dominion will load the TN-32B HBU cask with high burnup spent nuclear fuel and place it on the single vacant spot in the specifically-licensed ISFSI Pad 1.
The NRC has assessed the potential environmental impacts of the proposed action, and alternatives to the proposed action including the use of the Transnuclear, Inc., Standardized NUHOMS® Cask System under the generally-licensed ISFSI and the no-action alternative. The results of the NRC's environmental review can be found in the final EA (ADAMS Accession No. ML16168A104). The NRC staff performed its environmental review in accordance with the requirements in 10 CFR part 51. In conducting the environmental review, the NRC considered information in the license amendment application (ADAMS Accession No. ML15239B251); information in the responses to the NRC's requests for additional information (ADAMS Accession No. ML16097A213 and ML16097A219); communications and consultation with the Virginia State Historic Preservation Office, the U.S Fish and Wildlife Service (FWS), and the Virginia Department of Health.
Approval of Dominion's proposed license amendment would allow the TN-32B HBU cask to be placed on the specifically-licensed ISFSI Pad 1. Changes to routine operations or maintenance of the NAPS specifically-licensed ISFSI would consist of downloading the data from the data logger on a quarterly basis. Dominion calculated the total dose rate at the site boundary from the placement of this one TN-32B HBU cask and determined that the dose would be 0.937 mrem/year. Adding the total dose rate from the placement of the TN-32B HBU cask to the maximum combined radiation contribution to the nearest permanent resident from the operation of the ISFSI and the NAPS, Units 1 and 2 (5.10 mrem/year), would result in a total combined dose rate of 6.037 mrem/year, which is below the 25 mrem/year regulatory limit in 10 CFR 72.104. In addition, the NRC reviews and oversees casks to ensure these are designed and maintained in accordance with the regulatory limits in 10 CFR parts 20 and 72. Furthermore, Dominion maintains a radiation protection program for NAPS, Units 1 and 2, and the specifically-licensed and generally-licensed ISFSIs
Based on its review of the proposed action, in accordance with the requirements in 10 CFR part 51, the NRC has concluded that the license amendment request for the Dominion's SNM License Number SNM-2507 for the operation of NAPS' ISFSI located in Louisa County, Virginia, will not significantly affect the quality of the human environment. Therefore, the NRC has determined, pursuant to 10 CFR 51.31, that preparation of an environmental impact statement is not required for the proposed action and a finding of no significant impacts is appropriate.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Grant of exemption; approval of alternative.
The U.S. Nuclear Regulatory Commission (NRC) is granting an exemption from the requirements of the Commission's regulations that require a portion of the operating test, which is part of the operator licensing examination, to be administered in a plant walk-through and approving alternative examination criteria in response to a May 27, 2016, request from Southern Nuclear Operating Company (SNC or facility licensee).
This exemption is effective as of June 24, 2016.
Please refer to Docket ID NRC-2008-0252 when contacting the NRC about the availability of information regarding this document. You may obtain publicly available information related to this document using any of the following methods:
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Paul Kallan, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-2809; email:
Southern Nuclear Operating Company, Inc. (SNC or facility licensee); Georgia Power Company; Oglethorpe Power Corporation; MEAG Power SPVM, LLC.; MEAG Power SPVJ, LLC.; MEAG Power SPVP, LLC.; and the City of Dalton, Georgia (together, the “VEGP Owners”); are the holders of Combined License (COL) Nos. NPF-91 and NPF-92, which authorize the construction and operation of VEGP Units 3 and 4, respectively.
VEGP Unit 3 is under construction and most of the plant systems have not been built. The facility licensee requests an exemption from the portion of section 55.45(b) of title 10 of the
As an alternative to the in-plant methods of testing described in NUREG-1021, “Operator Licensing Examination Standards for Power Reactors,” the facility licensee proposed that applicants for operator and senior operator licenses at VEGP Unit 3 be tested using discussion and performance methods in combination with plant layout diagrams, maps, equipment diagrams, pictures, and mock-ups. Approval of proposed alternatives is addressed in NUREG-1021, ES-201, “Initial Operator Licensing Examination Process,” Section B, “Background.” As stated therein,
Facility licensees may propose alternatives to the examination criteria contained here and evaluate how the proposed alternatives provide an acceptable method of complying with the Commission's regulations. The NRC staff will review any proposed alternatives and make a decision regarding their acceptability. The NRC will not approve any alternative that would compromise the agency's statutory responsibility to prescribe uniform conditions for the operator licensing examinations.
The facility licensee also requested an exemption from 10 CFR 55.40(a) and (b), which require, in part, the Commission and facility licensees to prepare the operating tests required by 10 CFR 55.45 in accordance with the criteria in NUREG-1021, because ES-301, Section D.4.a requires in-plant system job performance measures (JPMs) be performed in the plant and Section D.4.b requires that one JPM be performed in the radiologically controlled area (RCA) as part of the walk-through administered to applicants during the operating test. However, the NRC staff determined that no exemption to the requirement to use the examination criteria in NUREG-1021, as stated in 10 CFR 55.40(a) and (b), is necessary because ES-201 allows for the consideration of alternatives. In other words, NUREG-1021 allows alternative testing methods to be used as long as an alternative does not compromise the agency's statutory responsibility to prescribe uniform conditions.
The Commission's regulations in 10 CFR part 55, “Operators' Licenses,” in part establish procedures and criteria for the issuance of licenses to operators and senior operators of utilization facilities licensed under the Atomic Energy Act of 1954, as amended, and 10 CFR part 52, “Licenses, Certifications, and Approvals for Nuclear Power Plants.” Per 10 CFR 55.51, “Issuance of Licenses,” “If the Commission determines that an applicant for an operator license or a senior operator license meets the requirements of the Act and its regulations, it will issue a license in the form and containing any conditions and limitations it considers appropriate and necessary.” Section 55.33(a) states in part that the Commission will approve an initial application for a license if it finds that (1) the applicant's health is sufficient and (2) the applicant has passed the requisite written examination and operating test in accordance with 10 CFR 55.41, “Written Examination: Operators,” or 10 CFR 55.43, “Written Examination: Senior Operators,” and 10 CFR 55.45, “Operating Tests.” These examinations and tests determine whether the applicant for an operator license has learned to operate a facility competently and safely, and additionally, in the case of a senior operator, whether the applicant has learned to direct the licensed activities of licensed operators competently and safely.
The regulations in 10 CFR 55.40(a) require the Commission to use the criteria in NUREG-1021, “Operator Licensing Examination Standards for Power Reactors,” in effect 6 months before the examination date to prepare the written examinations required by 10 CFR 55.41 and 55.43 and the operating tests required by 10 CFR 55.45; 10 CFR 55.40(a) also requires the Commission to use the criteria in NUREG-1021 to evaluate the written examinations and operating tests prepared by power reactor facility licensees pursuant to 10 CFR 55.40(b).
As stated in 10 CFR 55.40(b), power reactor facility licensees may prepare, proctor, and grade the written examinations required by 10 CFR 55.41 and 55.43 and may prepare the operating tests required by 10 CFR 55.45, subject to the following conditions: (1) They shall prepare the required examinations and tests in accordance with the criteria in NUREG-1021 as described in 10 CFR 55.40(a); (2) pursuant to 10 CFR 55.49, they shall establish, implement, and maintain procedures to control examination security and integrity; (3) an authorized representative of the facility licensee shall approve the required examinations and tests before they are submitted to the Commission for review and approval; and (4) they must receive Commission approval of their proposed written examinations and operating tests.
In accordance with 10 CFR 55.45(a), “[t]he operating test, to the extent applicable, requires the applicant to demonstrate an understanding of and the ability to perform the actions necessary to accomplish a representative sample from among . . . 13 [listed] items.” In accordance with 10 CFR 55.45(b):
(1) A simulation facility that the Commission has approved for use after application has been made by the facility licensee under § 55.46(b);
(2) A plant-referenced simulator (§ 55.46(c)); or
(3) The plant, if approved for use in the administration of the operating test by the Commission under § 55.46(b).
NUREG-1021, Revision 10 (December 2014) (ADAMS Accession No. ML14352A297) establishes the policies, procedures, and practices for examining applicants for operator and senior operator licenses and licensees pursuant to 10 CFR part 55; it contains the examination standards that ensure the equitable and consistent administration of operator licensing examinations. NUREG-1021 is organized by topic into chapters designated with “ES,” which stands for “examination standard.” As relevant here, Chapter 2 (ES-2xx) addresses initial pre-examination activities and Chapter 3 (ES-3xx) addresses initial operating tests. Chapter 3 includes ES-301, “Preparing Initial Operating Tests,” and ES-302, “Administering Operating Tests to Initial License Applicants.”
NRC examiners and facility licensees use NUREG-1021 together with the applicable NRC knowledge and abilities (K/A) catalog. NUREG-2103, “Knowledge and Abilities Catalog for Nuclear Power Plant Operators: Westinghouse AP1000 Pressurized-Water Reactors,” was developed specifically to address the passive nature of the Westinghouse AP1000 design. The NRC K/A catalogs provide the basis for the development of content-valid operator licensing examinations. NUREG-1021, Appendix A, “Overview of Generic Examination Concepts,” Section C.1, “Content Validity,” describes that a content-valid examination establishes a link between the examination and the duties that the applicants will perform on the job. Also, this section states,
Test items selected for inclusion in an NRC examination should be based on K/As contained in the appropriate K/A catalog. Testing outside the documented K/As can jeopardize the content validity of the examination. Content validity can also be
Operator licensing examinations developed using the applicable NRC K/A catalog along with the guidance in NUREG-1021 will sample the 13 items listed in 10 CFR 55.45(a) and also ensure that exam topics are associated with K/A statements of significant importance for the safe operation of the plant. Thus, the examinations will be content-valid.
NUREG-1021, Revision 10, ES-301, “Preparing Initial Operating Tests,” Section B, “Background,” describes that the requirements in 10 CFR 55.45 for the operating test are met by administering a simulator test and a walk-through.
The simulator test is typically administered in a team format with up to three applicants in the main control room simulator. It implements Items 1-8 and 11-13 of 10 CFR 55.45(a) and is the most performance-based aspect of the operating test. NRC examiners use the simulator test to evaluate each applicant's ability to safely operate the plant systems under dynamic, integrated conditions.
In contrast, the NRC examiners administer the walk-through to applicants one-on-one. The walk-through consists of two parts: Administrative topics and control room/in-plant systems. The administrative topics part of the walk-through implements Items 9-12 of 10 CFR 55.45(a) and covers K/As associated with administrative control of the plant. The control room/in-plant systems part of the walk-through implements the requirements of Items 3, 4, 7, 8, and 9 of 10 CFR 55.45(a) and encompasses several types of systems, including primary coolant, emergency coolant, decay heat removal, auxiliary, radiation monitoring, and instrumentation and control. ES-301 describes that the control room/in-plant systems part of the walk-through is used to determine whether the applicant has an adequate knowledge of plant system design and is able to safely operate those systems. This part of the walk-through focuses primarily on those systems with which licensed operators are most involved (
To evaluate an applicant's knowledge and abilities relative to control room/in-plant systems and competence in the administrative topics, the NRC examiners administer JPMs and, when necessary, ask specific follow-up questions based on the applicant's performance of the JPM. NUREG-1021 defines a JPM as “[a]n evaluation tool that requires the applicant to perform (or simulate) a task that is applicable to the license level of the examination.”
Tasks are selected for evaluation in accordance with ES-301, Section D.4, “Specific Instructions for the ‘Control Room/In-Plant Systems’ Walk-Through.” This section directs NRC examiners and facility licensees to select plant systems from the nine safety functions listed in the applicable NRC K/A Catalog. Table 1, “Plant Systems by Safety Function,” in NUREG-2103 contains a list of the AP1000 plant systems that are important to each of the nine major safety functions. ES-301, Section D.4.a, directs exam writers to (1) select plant systems from among the nine safety functions and then (2) for each plant system selected, select from either the NRC K/A catalog or the facility licensee's site-specific task list a task for which a JPM exists or can be developed. NUREG-1021, Appendix C, “Job Performance Measure Guidelines,” contains Form ES-C-2, “Job Performance Measure Quality Checklist,” (
Additionally, ES-301, Section E.2.a, “NRC Examiner Review,” directs examiners to independently review each operating test for content, wording, operational validity (
Per 10 CFR 55.45(b), the operating test will be administered in part in a plant walk-through. Further requirements for the plant walk-through (
In addition, ES-301, Section D.4.a states: “Each of the control room systems and evolutions (and separately each of the in-plant systems and evolutions) selected for RO and SRO-I applicants should evaluate a different safety function, and the same system or evolution should not be used to evaluate more than one safety function in each location.”
Also, ES-301, Section D.4.b states, “at least one of the tasks conducted in the plant shall evaluate the applicant's ability to implement actions required during an emergency or abnormal
Taken together, the statements in ES-301, Sections D.4.a and D.4.b show that, for purposes of testing, the control room is separate from the plant. Control room system JPMs are typically performed in the control room simulator. Because plant equipment is not controlled from the simulator, applicants can demonstrate knowledge and abilities by using the simulator to perform the actions necessary to accomplish the task during the JPM. The simulator provides feedback to the applicant about the actions that he or she takes during performance of the task. For example, if the applicant operates a switch to start a pump, the simulator provides indications to the applicant that will allow him or her to determine whether the pump has started.
Typically, each JPM begins with the NRC examiner providing the applicant with a cue sheet, which contains the cue for the applicant to begin to perform the task. The cue sheet also provides the applicant with any initial conditions that he or she should assume have been established. After receiving the cue sheet, the applicant leads the NRC examiner to the location in the plant where the task will be performed. Once the applicant arrives at the correct location in the plant, he or she uses the appropriate plant procedure and the plant equipment in that location as a prop to describe to the NRC examiner exactly how he or she would perform the task. The task is not actually performed because applicants are not permitted to operate plant equipment while performing a JPM; only licensed control room operators can direct the operation of plant equipment (
Consider the following example. An NRC examiner provides the applicant with a cue sheet that directs him or her to start a standby diesel generator from its local control panel, which is located in the plant (
If the applicant correctly locates the equipment in the plant and describes what it takes to perform the task, then the applicant will successfully complete the JPM. If the applicant demonstrates a lack of understanding of the equipment and procedures, then the NRC examiner will ask follow-up questions, as necessary, to confirm whether the applicant is familiar with the design and operation of that plant system.
Additionally, at least one JPM must be performed in the RCA. This provides an opportunity for the applicant to demonstrate knowledge of significant radiation hazards located in radiation and/or contamination areas inside the RCA and the ability to perform procedures to reduce excessive levels of radiation and to guard against personnel exposure.
NUREG-1021, ES-202, Section D.4, “Cold License Eligibility,” states, “[c]old licensing is the process used prior to fuel load that provides a consistent method for operations personnel to acquire the knowledge and experience required for licensed operator duties following fuel load.” The cold licensing process is described in Appendix A, “Cold License Training Plan,” of NEI 06-13A, “Template for an Industry Training Program Description,” Revision 2 (ADAMS Accession No. ML090910554). “Final Safety Evaluation for Topical Report NEI 06-13A, ‘Template for an Industry Training Program Description,’ ” Revision 1, dated December 5, 2008 (ADAMS Accession No. ML082950140), documents the NRC staff's approval of NEI 06-13A for use in combined license applications. The facility licensee incorporated NEI 06-13A, Revision 2, in its entirety into the VEGP Units 3 and 4 Updated Final Safety Analysis Report (UFSAR), Chapter 13, “Conduct of Operation” (ADAMS Accession No. ML15194A468). Section 13.2A.3, “Conduct of On-the-Job Training (OJT),” of the VEGP Units 3 and 4 UFSAR states, “[u]ntil plant construction is completed, acceptable methods for the conduct of on-the-job training include discussion, simulation, and use of mockup equipment and virtual reality technology.” Section 13.2A.6, “Cold Licensing Process Applicability and Termination,” provides additional guidance on the conduct of OJT:
As plant systems, components, and structures are completed, and as integrated plant operations begin, the systematic approach to training process will be used to adjust cold license class training methods . . . The purpose is to optimize student learning using actual in-plant training and experience opportunities as they become available.
Additionally, Section 13.2A.7, “Initial Licensed Operator Examination Schedule,” states, “[a]dministration of [initial] licensed operator examinations begins approximately 18 months prior to fuel load.”
By letter from Ms. Karen Fili, Site Vice President, VEGP Units 3 and 4, to the NRC dated May 27, 2016, “Southern Nuclear Operating Company Vogtle Electric Generating Plant (VEGP) Units 3 and 4 Revised Request for Exemption and RAI Response: Operator Licensing” ND-16-0747 (ADAMS Accession No. ML16148A484) (“May 27 letter”), the facility licensee stated that it seeks to begin operator licensing examinations in July 2016. The May 27 letter superseded the letter from Ms. Karen Fili, Site Vice President, VEGP Units 3 and 4, to the NRC dated April 15, 2016 (ADAMS Accession No. ML16109A013) (
The facility licensee (1) applied for exemptions from the requirements in 10 CFR part 55 that require using a plant walk-through as part of the operating test (
Because VEGP Unit 3 is under construction and most of the plant systems have not yet been built, the facility licensee requests an exemption from the requirement in 10 CFR 55.45(b) to administer a portion of the operating test “in a plant walkthrough.” The facility licensee also requests an exemption from 10 CFR 55.40(a) and (b), which require, in part, the Commission and facility licensees to prepare the operating tests required by 10 CFR 55.45 in accordance with the criteria in NUREG-1021, because ES-301, Section D.4.a and D.4.b require that in-plant system JPMs be performed in the plant (and also that one JPM be performed in the RCA) as part of the walk-through administered to applicants during the operating test. However, with respect to exemptions from 10 CFR 55.40(a) and (b), the Commission determined that none were necessary because the Commission and the facility license would continue to follow NUREG-1021, as required by 10 CFR 55.40(a) and (b), when the Commission and facility licensee used alternative examination criteria pursuant to ES-201, Section B, “Background,” of NUREG-1021. The proposed alternative is discussed below.
The facility licensee proposes an alternative to administering in-plant system JPMs in the plant: It proposes to use “cold license training plan evaluation methods” to administer in-plant system JPMs. Specifically, in Enclosure 1, “Plant Walkthrough Exemptions,” Section 3.1, “Administration of In-Plant JPMs Using Cold License Training Plan Methods,” and Section 3.2, “RCA Mockup Alternative to RCA Entry,” of the May 27 letter, the facility licensee proposes using the following “cold license training plan evaluation methods” in lieu of the plant and plant equipment to administer in-plant system JPMs on an operating test:
• Plant layout diagrams,
• Breaker Lab—VEGP has a breaker lab that contains 6.9kV and 480V breakers that can be operated by applicants.
• Maintenance Flow Loop—contains generic plant equipment, such as pumps, valves, and instruments for demonstrating the fundamental knowledge of operation and monitoring of plant equipment.
• Remote Shutdown Workstation—The VEGP Units 3 & 4 simulation facility includes a Remote Shutdown Workstation that simulates the controls located in the Remote Shutdown Room.
• RCA mock-up—A training environment that allows applicants to demonstrate knowledge of radiation control subjects. Standards for entry into the mock-up RCA are identical to the actual RCA. The mock-up is used to train outage workers at VEGP Units 1 and 2. It contains simulated radiation areas and contaminated areas.
• Discuss method—using the procedure and props such as plant layout drawings, mock-ups, maps and pictures of equipment, the applicant will describe the actions he or she would take to operate equipment and explain how the equipment should respond to these actions. Discussion can cover required personal protective equipment (PPE), actions, system response and location. Location information can include specifics such as building, elevation, and room.
• Perform method—if the JPM is administered in the breaker lab, the flow loop trainer, or the remote shutdown room mock-up, applicants can perform actions during the JPM as well as discuss.
• Plant location drawings and pictures of plant components not directly related to the task that is the subject of the JPM will also be made available to maintain discriminatory value (
The facility licensee requested that the exemption expire after the Commission makes its finding in accordance with 10 CFR 52.103(g) (“The licensee shall not operate the facility until the Commission makes a finding that the acceptance criteria in the combined license are met, except for those acceptance criteria that the Commission found were met under § 52.97(a)(2)”) for VEGP Unit 3.
Pursuant to 10 CFR 55.11, the Commission may, upon application by an interested person, or upon its own initiative, grant exemptions from the requirements of 10 CFR part 55 as it determines are (1) authorized by law and (2) will not endanger life or property and (3) are otherwise in the public interest.
Exemptions are authorized by law where they are not expressly prohibited by statute or regulation. A proposed exemption is implicitly “authorized by law” if all of the conditions listed therein are met (
The regulations in 10 CFR part 55 implement Section 107 of the Atomic Energy Act of 1954, as amended (AEA), which sets requirements upon the Commission concerning operators' licenses and states, in part, that the Commission shall “prescribe uniform conditions for licensing individuals as operators of any of the various classes of . . . utilization facilities licensed” by the NRC. These requirements in the AEA do not expressly prohibit exemptions to the portion of 10 CFR 55.45(b) addressing in-plant JPMs and plant walk-throughs.
Preparing and evaluating operator examinations using the criteria in NUREG-1021 is a means of ensuring the equitable and consistent administration of operator licensing examinations for all applicants and thus helps to ensure uniform conditions exist for the
Upon balancing the overall effect on uniformity and consistency under the exemption, the NRC staff concludes that the uniform conditions will be maintained; the differences in the testing under the exemption will not prevent equitable administration of the operator licensing examinations or challenge the basis for the NRC examiners' licensing decisions. Accordingly, the testing will continue to comply with Section 107 of the AEA. Accordingly, the NRC staff has determined that granting of the facility licensee's proposed exemption will not result in a violation of the AEA, or the Commission's regulations. Therefore, the exemption is authorized by law.
The exemption will not change the fundamental findings needed to issue an operator's or senior operator's license to an applicant. As stated in 10 CFR 55.33 “Disposition of an initial application,”
(a)
. . .
(2)
Competent and safe operators protect against endangerment of life or property. Accordingly, where the tests adequately determine who is competent, those tests are protective of and do not endanger life or property.
The exemption from the requirement in 10 CFR 55.45(b) that the operating test be administered partially “in a plant walkthrough” will not endanger life or property mainly because 10 CFR 55.45(a) will still require the applicant to demonstrate an understanding of and the ability to perform the actions necessary to accomplish a representative sample of tasks. As required by 10 CFR 55.45(a), the content of the operating test will continue to be identified, in part, from learning objectives derived from a systematic analysis of licensed operator or senior operator duties performed by each facility licensee and contained in its training program and from information in the Final Safety Analysis Report, system description manuals and operating procedures, facility license and license amendments, Licensee Event Reports, and other materials requested from the facility licensee by the Commission. Although applicants will not be tested while physically located in front of installed in-plant equipment until the Commission makes its finding in accordance with 52.103(g), the knowledge and abilities applicants must demonstrate to pass the operating test will not change.
Accordingly, there is no endangerment of life or property as a result of the exemption.
The Commission's values guide the NRC in maintaining certain principles as it carries out regulatory activities. These principles focus the NRC on ensuring safety and security while appropriately balancing the interests of the NRC's stakeholders, including the public and licensees. These principles include Independence, Openness, Efficiency, Clarity, and Reliability. Whether granting of an exemption to the requirement to perform in-plant system JPMs in the plant would be in the public interest depends on consideration and balancing of the foregoing factors.
The public and licensees are all entitled to the best possible management and administration of regulatory activities. Regulatory activities should be consistent with the degree of risk reduction they achieve. Where several effective alternatives are available, the option that minimizes the use of resources should be adopted.
The NRC staff considered two options to determine whether one would minimize the use of resources and/or minimize risk: (1) Grant the exemption to the plant walk-through requirement and administer operator licensing examinations prior to completion of VEGP Unit 3, or (2) deny the exemption and wait until the completion of construction to administer the operator licensing examinations. For either option, the same number of NRC examiners will be required to administer the operator licensing examinations at VEGP Unit 3 prior to fuel load. Thus, the use of resources is not minimized by administering exams before the plant is built. Accordingly, the exemption is neutral with respect to the public's interest in efficiency.
Regulations should be coherent, logical, and practical. There should be a clear nexus between regulations and agency goals and objectives whether explicitly or implicitly stated. Here, the goal of the agency is to determine whether applicants for a license have learned to operate a facility competently and safely. Because the applicants must still demonstrate familiarity with the design and operation of systems located outside the main control room using the method proposed by the facility licensee, it is not necessary to perform the in-plant system JPMs within the completed VEGP Unit 3 to achieve this goal. Accordingly, this factor shows that the exemption maintains the public interest in clarity.
Regulations should be based on the best available knowledge from research and operational experience. Systems interactions, technological uncertainties, and the diversity of licensees and regulatory activities must all be taken into account so that risks are maintained at an acceptably low level. Once established, regulation should be perceived to be reliable and not unjustifiably in a state of transition. Regulatory actions should always be fully consistent with written regulations and should be promptly, fairly, and decisively administered so as to lend stability to the nuclear operational and planning processes.
If a sufficient number of applicants do not pass the exams, then the facility licensee may not have a sufficient number of personnel available for fuel load. If exams commenced in June 2018, and fuel load was scheduled for late 2018, then there would only be at most 6 months between the time when licensing decisions would be made and fuel load. As stated in Enclosure 1, Section 6.3, “Otherwise in the Public Interest,” of the May 27 letter, initial license training lasts approximately 24 months; therefore, 6 months is not sufficient to license additional applicants if the needed number of applicants do not pass the examinations. Commencing
With respect to risk reduction, granting of the exemption will not require the NRC examiners or the applicants to enter the RCA, and therefore, the risk of radiation exposure for applicants and NRC examiners will be reduced to zero. Although NRC examiners and applicants typically do not receive any significant exposure to radiation or contamination during the conduct of operating tests administered inside the RCA, the NRC staff concludes that reducing the risk of exposure to zero aligns with the agency's goal of maintaining exposure to ionizing radiation as low as is reasonably achievable (ALARA). Accordingly, this factor shows that the exemption favors the public's interest in reliability.
Nothing but the highest possible standards of ethical performance and professionalism should influence regulation. However, independence does not imply isolation. All available facts and opinions must be sought openly from licensees and other interested members of the public. The many and possibly conflicting public interests involved must be considered. Final decisions must be based on objective, unbiased assessments of all information, and must be documented with reasons explicitly stated.
With the granting of this exemption, the NRC staff will still continue to independently assess whether the applicants at VEGP Unit 3 have the skills, knowledge, and abilities necessary to operate the plant safely and competently. The operator licensing decisions will continue to be based on the NRC examiners' objective, unbiased assessments of each applicant's performance, which will be documented in accordance with NUREG-1021, ES-303, “Documenting and Grading Initial Operating Tests.” Accordingly, this factor shows that the exemption maintains the public interest in independence.
Nuclear regulation is the public's business, and it must be transacted publicly and candidly. The public must be informed about and have the opportunity to participate in the regulatory processes as required by law. Open channels of communication must be maintained with Congress, other government agencies, licensees, and the public, as well as with the international nuclear community.
Granting the exemption allows the portion of the operating test that would otherwise be performed in the plant to be administered in a location other than the plant. The operator licensing examination process described in NUREG-1021 will still be followed using the alternate method proposed by the facility licensee. Therefore, this factor shows that the exemption maintains the public's interest in openness.
Accordingly, the balancing of these factors shows that the exemption is otherwise in the public interest.
The Commission concludes that the exemption is (1) authorized by law and (2) will not endanger life or property and (3) is otherwise in the public interest. Therefore, the Commission grants SNC an exemption from the requirement of 10 CFR 55.45(b) to administer a portion of the operating test “in a plant walkthrough.”
NUREG-1021, ES-201, Section B, “Background,” states,
Facility licensees may propose alternatives to the examination criteria contained here and evaluate how the proposed alternatives provide an acceptable method of complying with the Commission's regulations. The NRC staff will review any proposed alternatives and make a decision regarding their acceptability. The NRC will not approve any alternative that would compromise the agency's statutory responsibility to prescribe uniform conditions for the operator licensing examinations.
As discussed below, the facility licensee's proposed alternatives provide an acceptable method of complying with the Commission's regulations and will not compromise the agency's statutory responsibility to prescribe uniform conditions for the operator licensing examinations.
NUREG-1021, Appendix A, “Overview of Generic Examination Concepts,” Section B, “Background,” discusses internal and external attributes of an examination and their relationship to uniform conditions. The internal attributes of an examination include its level of knowledge (LOK), level of difficulty (LOD), and the use of exam question banks. The external attributes of an examination include the number and types of items, the length of the examination, security procedures, and proctoring instructions. Appendix A states,
If the internal and external attributes of examinations are allowed to vary significantly, the uniform conditions that are required by Section 107 of the Atomic Energy Act of 1954, as amended, and the basis upon which the NRC's licensing decisions rest are challenged. The NRC must reasonably control and structure the examination processes to ensure the integrity of the licenses it issues.
In order to determine whether uniform conditions for licensing individuals as operators and senior operators at VEGP Unit 3 will be maintained using the method proposed by the facility licensee, the NRC staff performed two actions. First, the NRC staff identified the differences between performing in-plant system JPMs in the plant and the facility licensee's proposed method of performing in-plant system JPMs. These are listed in the table below.
Second, the NRC staff evaluated whether the differences could cause the internal and external attributes of the in-plant system JPMs administered to applicants at VEGP Unit 3 prior to the completion of plant construction to vary significantly from those administered to applicants at VEGP Unit 3 after the completion of construction. The evaluation is documented below.
In-plant system JPMs performed in the plant are high LOK test items because they require applicants to recall knowledge such as the location of plant equipment, which was acquired during the initial training program, and also to demonstrate, by walking the NRC examiner to the correct equipment in the plant and by describing the actions that they would take to operate the equipment, an understanding of and familiarity with the design and operation of that equipment. Applicants must also respond to the cues provided by the NRC examiner during the JPM. To successfully complete the JPM, the applicant must be able to analyze the information provided by these cues, apply knowledge of the design and operation of the equipment to determine the appropriate action(s), and then describe the action(s) to the NRC examiner.
The NRC staff determined that the three differences listed in Table 2 do not cause the LOK that an applicant at VEGP Unit 3 must demonstrate during in-plant system JPMs administered prior to the completion of plant construction to vary significantly from the LOK that an applicant must demonstrate during in-plant system JPMs performed after the completion of construction at VEGP Unit 3 for the following reasons.
• As shown in Difference #1 in Table 2, the facility licensee proposes that applicants at VEGP Unit 3 demonstrate knowledge of equipment locations by using plant layout diagrams, equipment diagrams, and/or maps to show the NRC examiner how they would get to the location in the plant where the task would be performed. The facility licensee stated in Enclosure 1, “Plant Walkthrough Exemptions,” Section 5.5, “Conclusion,” of the May 27 letter that the proposed method of performing in-plant system JPMs will “not impact the ability to maintain equitable and consistent testing under uniform conditions because license applicants will be evaluated using the same methods employed during their training.” As described in Section 13.2A.1, “Licensed Operator Experience Requirements Prior To Commercial Operation,” of the VEGP Units 3 and 4 UFSAR, initial license training for all applicants at VEGP Unit 3 includes a site layout course, which is described in NEI 06-13A, Appendix A as a site familiarization course. Therefore, the NRC staff concludes that this method will require applicants at VEGP Unit 3 to recall and demonstrate knowledge of plant equipment location(s), which were addressed in the training program, to successfully complete the JPM even though the JPM will not be performed in the plant.
• As shown in Difference #2 in Table 2, the facility licensee proposes that applicants at VEGP Unit 3 describe how they will operate the equipment and explain how they expect the equipment and systems to respond to their actions using props such as pictures of the equipment or a mock-up equipment in lieu of the actual equipment in the plant. Just as during a JPM in the plant, NRC examiners will need to provide scripted cues to the applicants in response to the actions the applicants say that they would take. The applicants will have to analyze the information provided by these cues, apply knowledge of the design and operation of the equipment to determine the appropriate action(s), and then describe the action(s) to the NRC examiner. Therefore, the NRC staff concludes that this method will require applicants at VEGP Unit 3 to describe the actions that they would take to operate the equipment and analyze information provided by cues to successfully complete the JPM even though the JPM will not be performed in the plant.
• As shown in Difference #3 in Table 2, applicants at VEGP Unit 3 will be required to demonstrate how to enter the RCA. The facility licensee has established a mock-up of the RCA that contains simulated radiation control areas and contaminated areas, and “standards for entry into the mockup RCA are identical to an actual RCA.” Therefore, the NRC staff concludes that this method will require applicants at VEGP Unit 3 to demonstrate knowledge of significant radiation hazards located in radiation and/or contamination areas inside the RCA and the ability to perform procedures to reduce excessive levels of radiation and to guard against personnel exposure even though the JPM will not be performed in the plant.
Accordingly, the NRC staff concludes that the facility licensee's proposed method of performing in-plant system JPMs will not cause the LOK of the in-plant system JPMs administered to applicants at VEGP Unit 3 prior to the completion of plant construction to vary significantly from those administered to applicants at VEGP Unit 3 after the completion of construction.
The NRC staff determined that the three differences listed in Table 2 do not cause the LOD that an applicant at VEGP Unit 3 must demonstrate during in-plant system JPMs administered prior to the completion of plant construction to vary significantly from the LOD that an applicant must demonstrate during in-plant system JPMs performed after the completion of construction at VEGP Unit 3 for the following reasons.
• As shown in Difference #1 in Table 2, the facility licensee proposes that applicants at VEGP Unit 3 demonstrate knowledge of equipment locations by using plant layout diagrams, equipment diagrams, and/or maps to (1) to describe to the NRC examiner how they would get to the location of the plant equipment that is the subject of the JPM and to (2) correctly identify the building, elevation of the building, and room number where the equipment will be located in VEGP Unit 3. Additionally, the facility licensee proposes that “plant layout diagrams and/or pictures of components not directly related to the task will also be made available to the applicant to maintain discriminatory value . . .”
When an in-plant system JPM is performed in the plant, applicants must physically walk the NRC examiner to the correct location in the plant where the task will be performed. Applicants must choose the correct location from among all of the other accessible plant locations. Similarly, applicants at VEGP Unit 3 must choose the correct plant layout diagram(s), equipment diagrams and/or map(s) from a set of diagrams in order to show the NRC examiner how they would locate the equipment in the plant.
If an applicant at an operating reactor has spent a sufficient amount of time in the plant becoming familiar with its layout and the location of plant equipment, then walking the NRC examiner to the correct location during a JPM in the plant will be a relatively easy task. Otherwise, this will be a relatively difficult task, and the applicant may not be able to perform if he or she cannot find the equipment that is the subject of the JPM. Similarly, if an applicant at VEGP Unit 3 has spent a sufficient amount of time becoming familiar with the plant layout diagrams and maps, then using these tools to show the NRC examiner how he or she would access the equipment will be a relatively easy task. Otherwise, this will be a relatively difficult task, and the applicant may not be able to continue with the JPM because he or she will not successfully demonstrate the ability to access the equipment. In both cases, the applicants will either be able to demonstrate knowledge to the NRC examiner, or they will not be able to demonstrate knowledge. The NRC staff concludes that both methods require applicants to select the correct location of plant equipment from among other choices, and therefore the NRC examiners will still be able to discriminate between operators that have this knowledge and those that do not, and thus the LOD of the two methods is comparable.
Also, the NRC staff considered the implications for the testing process of physically walking in the plant to a specific location as compared to using plant layout diagrams and/or maps to show and describe the route that would be taken to find the correct location impacted LOD. Both methods require an applicant to recall and show knowledge of plant locations to the NRC examiner. However, applicants at plants that have been constructed will have spent time becoming familiar with the routes through the plant that they must take to access equipment during the conduct of OJT in the plant. During an in-plant system JPM in the plant, they will likely be able to recall the route(s) they have previously traveled by relying on unique visual clues available in the plant such as signage and various access control points that they must pass through to navigate their path to the equipment that is the subject of the JPM. They may also possibly rely on muscle memory to some extent to locate the equipment that is the subject of the JPM. Additionally, NUREG-1021, Appendix E, “Policies and Guidelines for Taking NRC Examinations,” contains directions that NRC examiners provide to applicants and licensed operators prior to every NRC examination. Appendix E, Section C.3, states,
The operating test is considered “open reference.” The reference materials that are normally available to operators in the facility and control room (including calibration curves, previous log entries, piping and instrumentation diagrams, calculation sheets, and procedures) are also available to you during the operating test.
Unlike applicants at plants that have been constructed, the applicants at VEGP Unit 3 that take operator licensing examinations prior to the completion of plant construction will only use plant layout diagrams and maps to describe the route they would take to access the plant equipment. This method requires applicants to stand in front of a document and trace or identify the route that would be taken. This method is different from actually walking to a location in the plant because (1) visual clues that would be available to applicants in the plant will not be available, and (2) this method requires applicants to use fewer motor skills, and thus it is not likely that applicants will be able to use any muscle memory. This may increase the LOD. However, Section 13.2A.1, “Licensed Operator Experience Requirements Prior To Commercial Operation,” of the VEGP Units 3 and 4 UFSAR states that all applicants at VEGP Unit 3 must complete a site layout course. Also, the facility licensee stated in Enclosure 1, “Plant Walkthrough Exemptions,” Section 5.5, “Conclusion,” of the May 27 letter that the proposed method of performing in-plant system JPMs will “not impact the ability to maintain equitable and consistent testing under uniform conditions because license applicants will be evaluated using the same methods employed during their training.” The NRC staff concludes that any increase in LOD as a result of only using plant layout diagrams and maps to demonstrate knowledge of locations will be offset by the fact that the applicants will have been specifically trained on the locations of plant equipment with these tools.
• As shown in Difference #2 in Table 2, applicants will use pictures of equipment or a mock-up of the equipment as a prop while they describe and simulate how to operate the equipment to perform the task. Instead of pointing to a piece of equipment in the plant and verbally describing how to operate it, the applicant will either point to a diagram or picture of the equipment as a prop while describing how to operate it or use a piece of mock-up equipment to actually perform the task required by the JPM. The facility licensee proposes that diagrams and pictures of components not directly related to the task will also be made available to the applicant so that the applicant must make a choice. The NRC staff determined that the facility
The NRC staff also considered the difference in the quality of the props used in the facility licensee's proposed method of performing in-plant system JPMs compared to the quality of the plant equipment as a prop. Enclosure 2, “Response to NRC Request for Additional Information No.9,” contains Table E2-1, which lists tasks from the VEGP Units 3 and 4 site-specific task list that could be a JPM. The NRC staff reviewed Table E2-1 and determined that the breaker lab, the maintenance flow loop trainer, the RCA mock-up, and the Remote Shutdown Workstation available in the VEGP training facilities could be used as props during some JPMs. These tools are realistic representations of certain pieces of plant equipment and are therefore equivalent to the actual plant equipment.
However, these tools will not be able to be used for every in-plant system JPM that could be developed because the tasks listed in Table E2-1 include tasks unrelated to breaker operation, remote shutdown, or plant components modeled in the flow loop trainer (
• As shown in Difference #3 in Table 2, applicants will have to enter a mock-up of the RCA for at least one in-plant JPM. As stated in the facility licensee's submittal, the “standards for entry into the mockup RCA are identical to an actual RCA.” Therefore, the NRC staff concludes that this difference has no impact on the LOD of the in-plant system JPMs because there is no difference between demonstrating the ability to enter the actual RCA and demonstrating the ability to enter a mock-up of the RCA.
Accordingly, the NRC staff concludes that the facility licensee's proposed method of performing in-plant system JPMs will not cause the LOD of the in-plant system JPMs administered to applicants at VEGP Unit 3 prior to the completion of plant construction to vary significantly from those administered to applicants at VEGP Unit 3 after the completion of construction.
In summary, the NRC staff concludes that the facility licensee's proposed method of performing in-plant system JPMs does not significantly impact the internal attributes of the in-plant system JPMs that will be administered to applicants at VEGP Unit 3 prior to the completion of plant construction as compared to the in-plant system JPMs administered to applicants at plants that have been constructed.
The external attributes of an examination include the number and types of items (
In summary, the NRC staff concludes that the facility licensee's proposed method of performing in-plant system JPMs does not cause the internal and external attributes of the in-plant system JPMs administered to applicants at VEGP Unit 3 prior to the completion of plant construction to vary significantly from those administered to applicants at VEGP Unit 3 after the completion of construction. Because in-plant system JPMs are a portion of the operator licensing examination, the NRC staff also concludes that the facility licensee's proposed method does not cause the internal or external attributes of the operator licensing examinations that will be administered to applicants at VEGP Unit 3 prior to the completion of plant construction to vary significantly from those administered to applicants at VEGP Unit 3 after the completion of construction.
In Enclosure 2, “Response to NRC Request for Additional Information No. 9” of the May 27 letter, the facility licensee stated that some in-plant tasks on the site-specific task list that have an importance rating of 2.5 or higher cannot be used to develop a JPM at this time. Because not all plant systems have been constructed or turned over to the facility licensee from the vendor, some procedures are not available at this time. A JPM cannot be performed without a procedure. If the pool of in-plant tasks that could be used to develop a JPM is limited, then it is possible that important K/As could be omitted from the operating test, which would reduce the content validity of the exam.
In Enclosure 2 of the May 27 letter, the facility licensee provided Table E2-1. Of the tasks that the facility licensee included in Table E2-1, the NRC staff found that 101 of 109 possible tasks have procedures available at this time and therefore can be used to develop an in-plant system JPM; only eight tasks do not have procedures available at this time and thus cannot be used to develop an in-plant system JPM. Of these eight tasks, the NRC staff compared the safety functions listed for each of the eight tasks with the safety functions listed in Table 1, “Plant Systems by Safety Function,” in NUREG-2103. The NRC staff found that of the eight tasks, two are associated with plant systems
The NRC staff reviewed the 101 tasks that do have procedures available at this time and found that multiple tasks associated with the plant systems related to these safety functions as well as the other safety functions listed in Table 1 in NUREG-2103 can be used at this time to develop an in-plant system JPM. Thus, although these eight tasks may be excluded from the sample at this time, there is still a diverse set of other tasks that can be used to test an applicant's knowledge and abilities related to the operation of plant systems associated with each of the nine safety functions. Additionally, because the plant systems associated with Safety Functions #4, 6, and 8 are primarily operated from the main control room, the criteria in NUREG-1021, ES-301, Section D.4.a, which states that “each of the control room systems and evolutions (and separately each of the in-plant systems and evolutions) selected . . . should evaluate a different safety function . . .,” will still be followed, thus ensuring that the content of each operating test sufficiently samples the safety functions and K/As. Thus, the NRC staff concludes that the elimination of these eight tasks from the possible pool of in-plant system JPMs at this time does not result in any omission of K/As from the operator licensing examinations administered to applicants at VEGP Unit 3 at this time. Therefore, the examinations administered to applicants at VEGP Unit 3 at this time will be content-valid examinations.
The NRC staff has assurance that all applicants who become licensed at VEGP Unit 3 will be trained and tested on new procedures and tasks as they become available. This is because all licensed operators are subject to the requalification requirements of 10 CFR 55.59. These requirements include additional operating tests as follows:
(a)
(1) Successfully complete a requalification program developed by the facility licensee that has been approved by the Commission. This program shall be conducted for a continuous period not to exceed 24 months in duration.
(2) Pass a comprehensive requalification written examination and an annual operating test.
(i) The written examination will sample the items specified in §§ 55.41 and 55.43 of this part, to the extent applicable to the facility, the licensee, and any limitation of the license under § 55.53(c) of this part.
(ii) The operating test will require the operator or senior operator to demonstrate an understanding of and the ability to perform the actions necessary to accomplish a comprehensive sample of items specified in § 55.45(a) (2) through (13) inclusive to the extent applicable to the facility.
NUREG-1021 provides guidance for applicants transitioning from the initial license program to the requalification program: ES-605, Section C.1.b, states, “Newly licensed operators must enter the requalification training and examination program promptly upon receiving their licenses.” Also, ES-204 states that the region may administer a license examination to an applicant who has not satisfied the applicable training or experience requirements at the time of the examination, but is expected to complete them shortly thereafter. These requirements in NUREG-1021 help to ensure that the period of time between completing all of the requirements to be licensed, which includes completing the initial license training program and passing the operator licensing examination, and entering a requalification program that meets the requirements of 10 CFR 55.59 is minimized so that applicants (1) receive refresher training on topics learned in the initial training program, which ensures knowledge retention of operationally-important topics, and (2) receive training on new operationally-important topics as they become available (
In Enclosure 1, “Plant Walkthrough Exemptions,” Section 6.3, “Otherwise in the Public Interest,” of the May 27 letter, the facility licensee stated that applicants “enrolled in an initial license training (ILT) program are training as a full-time job and cannot participate in completing the required 6 months of meaningful work experience.” As described in NEI 06-13A, Appendix A, applicants in the cold licensing process must complete at least 6 months of “practical and meaningful work experience” as part of the experience requirements for an operator's license. Applicants that do not complete any of a portion of the 6 months of practical and meaningful work assignments prior to enrolling in the ILT program will have to do so before the NRC issues a license. Therefore, some applicants at VEGP Unit 3 may not complete the requirements to be licensed “shortly” after taking the operator licensing examination. Because these applicants would not yet be licensed, under NRC regulations they would not be required to be enrolled in a training program that meets the requirements of 10 CFR 55.59, “Requalification.”
Although these applicants will be participating in practical and meaningful work assignments to gain experience with the AP1000 design, these assignments do not necessarily ensure that these applicants will receive refresher training on topics learned in the ILT program or receive training on new topics as they become available. In accordance with 10 CFR 55.51,
If the Commission determines that an applicant for an operator license or a senior operator license meets the requirements of the Act and its regulations, it will issue a license in the form and containing any conditions and limitations it considers appropriate and necessary.
In summary, as allowed by NUREG-1021, ES-201, Section B, “Background,” with its exemption request, the facility licensee proposed alternatives to the examination criteria contained in NUREG-1021 with respect to the in-plant/plant walk-through portions of the operating test. The NRC staff reviewed the proposed method of administering in-plant system JPMs described in Enclosure 1 of the May 27 letter. For the reasons described above, the NRC staff concluded that the proposed alternatives provide an acceptable method of complying with the Commission's regulations, as exempted.
If, in the future, the facility licensee desires to implement an approach that differs from the alternative described in the May 27 letter, then it should seek approval from the NRC.
The facility licensee requested the exemption from the regulation that requires the operating test to be administered in a plant walk-through because of the incomplete construction of the plant. As construction of different sections of the facility becomes substantially complete and in-plant systems, components, and structures (SSCs) near completion, usage of this exemption will become unnecessary for those areas and SSCs. Accordingly, on a case-by-case basis, for those tasks that are selected to be part of an operating task in accordance with NUREG-1021, ES-301, Section D.4.a and Section D.4.b, where it is possible to both perform on-the-job training in the plant and administer part of an operating test in a plant walk-through, as determined by the NRC examiners, this exemption may not be used. Furthermore, this exemption will finally expire and may no longer be used upon the Commission's finding for VEGP Unit 3 in accordance with 10 CFR 52.103(g) (“The licensee shall not operate the facility until the Commission makes a finding that the acceptance criteria in the combined license are met, except for those acceptance criteria that the Commission found were met under § 52.97(a)(2).”).
This exemption allows one, two, or three of the required in-plant system JPMs to be performed using discussion and performance methods in combination with plant layout diagrams, maps, equipment diagrams, pictures, and mock-ups in lieu of plant equipment. The NRC staff evaluated whether there would be significant environmental impacts associated with the issuance of the requested exemptions. The NRC staff determined the proposed action fits a category of actions that do not require an environmental assessment or environmental impact statement.
For the following reasons, this exemption meets the eligibility criteria of 10 CFR 51.22(c)(25) for a categorical exclusion. There is no significant hazards consideration related to this exemption. The NRC staff has also determined that the exemption involves no significant increase in the amounts, and no significant change in the types, of any effluents that may be released offsite; that there is no significant increase in individual or cumulative public or occupational radiation exposure; that there is no significant construction impact; and that there is no significant increase in the potential for or consequences from radiological accidents. Finally, the requirements to which the exemption applies involve qualification requirements. Accordingly, the exemption meets the eligibility criteria for categorical exclusion set forth in 10 CFR 51.22(c)(25). Pursuant to 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared in connection with the issuance of the exemption.
Accordingly, the Commission has determined that, pursuant to 10 CFR 55.11, issuing this exemption from the requirement in 55.45(b) to administer a portion of the operating test in a plant walk-through is authorized by law and will not endanger life or property and is otherwise in the public interest. The Commission also has approved the facility licensee's proposed alternative to the examination criteria in NUREG-1021, ES-301, Section D.4.a and Section D.4.b and therefore will allow one, two, or three of the required in-plant system JPMs to be performed using discussion and performance methods in combination with plant layout diagrams, maps, equipment diagrams, pictures, and mock-ups in lieu of plant equipment until the Commission makes a finding for VEGP Unit 3 that acceptance criteria in the combined license are met in accordance with 10 CFR 52.103(g).
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to a license amendment request and exemption request dated August 20, 2015, from Duke Energy Carolinas, LLC (Duke Energy or the licensee) from portions of the regulations to support the use of fuel that is clad in Optimized ZIRLO
Please refer to Docket ID NRC-2016-0128 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
•
•
•
G. Edward Miller, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-2481, email
Duke Energy is the holder of Facility Operating License Nos. NPF-9, NPF-17, NPF-35, and NPF-52, which authorize operation of the McGuire Nuclear Station (MNS), Units 1 and 2, and Catawba Nuclear Station (CNS), Units 1 and 2. The licenses provide, among other things, that each facility is subject to all rules, regulations, and orders of the NRC now or hereafter in effect.
The MNS and CNS units are pressurized-water reactor located in Mecklenburg County, North Carolina, and York County, South Carolina, respectively.
Pursuant to section 50.12 of title 10 of the
Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR part 50, when the exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security. However, § 50.12(a)(2) states that the Commission will not consider granting an exemption unless special circumstances are present as set forth in § 50.12(a)(2). Under 10 CFR 50.12(a)(2)(ii), special circumstances are present when application of the regulation in the particular circumstances would not serve, or is not necessary to achieve, the underlying purpose of the rule.
Special circumstances, in accordance with 10 CFR 50.12(a)(2)(ii), are present whenever application of the regulation in the particular circumstances is not necessary to achieve the underlying purpose of the rule. The underlying purpose of 10 CFR 50.46 and appendix K to 10 CFR part 50 is to establish acceptance criteria for ECCS performance to provide reassurance of safety in the event of a loss-of-coolant (LOCA) accident. Although the wording of the regulations in 10 CFR 50.46 and appendix K is not expressly applicable to Optimized ZIRLO
This exemption would allow the use of fuel rods clad with Optimized ZIRLO
The provisions of 10 CFR 50.46 establish acceptance criteria for ECCS performance. Westinghouse topical reports WCAP-12610-P-A and CENPD-404-P-A, Addendum 1-A, “Optimized ZIRLO
Ring compression tests performed by Westinghouse on Optimized ZIRLO
The provisions of 10 CFR part 50, appendix K, paragraph I.A.5, “Metal-Water Reaction Rate,” serve to ensure that cladding oxidation and hydrogen generation are limited appropriately during a loss-of-coolant accident (LOCA) and conservatively accounted for in the ECCS evaluation model. That regulation requires that the Baker-Just equation be used in the ECCS evaluation model to determine the rate of energy release, cladding oxidation, and hydrogen generation. Since the use of the Baker-Just equation presumes the use of zircaloy-clad fuel, strict application of the rule would not permit use of the equation for Optimized ZIRLO
The NRC-approved topical reports have demonstrated that predicted chemical, thermal, and mechanical characteristics of the Optimized ZIRLO
Based on the above, no new accident precursors are created by using Optimized ZIRLO
The proposed exemption would allow the use of Optimized ZIRLO
The NRC staff determined that the exemption discussed herein meets the eligibility criteria for the categorical exclusion set forth in 10 CFR 51.22(c)(9) because it is related to a requirement concerning the installation or use of a facility component located within the restricted area, as defined in 10 CFR part 20, and issuance of this exemption involves: (i) No significant hazards consideration, (ii) no significant change in the types or a significant increase in the amounts of any effluents that may be released offsite, and (iii) no significant increase in individual or cumulative occupational radiation exposure. Therefore, in accordance with 10 CFR 51.22(b), no environmental impact statement or environmental assessment need be prepared in connection with the NRC's consideration of this exemption request. The basis for the NRC staff's determination is discussed as follows with an evaluation against each of the requirements in 10 CFR 51.22(c)(9)(i)-(iii).
The NRC staff evaluated whether the exemption involves no significant hazards consideration using the standards described in 10 CFR 50.92(c), as presented below:
1. Does the proposed exemption involve a significant increase in the probability or consequences of an accident previously evaluated?
The proposed TS changes add flexibility in the selection of fuel rod cladding materials for use at CNS and MNS. The proposed change of adding a cladding material does not result in an increase to the probability or consequences of an accident previously evaluated. TS 4.2.1 addresses the fuel assembly design, and currently specifies that, “Each assembly shall consist of a matrix of either ZIRLO® or Zircaloy fuel rods . . .” The proposed change will add Optimized ZIRLO
The NRC has previously approved use of Optimized ZIRLO
Therefore, the proposed change does not involve a significant increase in the probability or consequences of an accident previously evaluated.
2. Does the proposed exemption create the possibility of a new or different kind of accident from any accident previously evaluated?
The proposed TS changes add flexibility in the selection of fuel rod cladding materials for use at CNS and MNS. Optimized ZIRLO
3. Does the proposed exemption involve a significant reduction in a margin of safety?
The proposed change will not involve a significant reduction in the margin of safety because it has been demonstrated that the material properties of the Optimized ZIRLO
Based on the above, the NRC staff concludes that the proposed exemption involves no significant hazards consideration. Accordingly, the requirements of 10 CFR 51.22(c)(9)(i) are met.
The proposed exemption would allow the use of Optimized ZIRLO
The proposed exemption would allow the use of Optimized ZIRLO
Accordingly, the Commission has determined that pursuant to 10 CFR 50.12(a), the exemption is authorized by law, will not present an undue risk to the public health and safety, is consistent with the common defense and security, and that special circumstances are present to warrant issuance of the exemption. Therefore, the Commission hereby grants Duke Energy an exemption from the requirements of 10 CFR 50.46 and Appendix K, paragraph I.A.5 to 10 CFR part 50, to allow the application of these criteria to, and the use of, Optimized ZIRLO
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
June 28, 2016.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public.
9:55 a.m. Affirmation Session (Public Meeting) (Tentative)
Strata Energy Inc. (Ross in Situ Uranium Recovery Project)—Joint Intervenors' Petition for Review of Initial Decision, LBP-15-3, and Related Interlocutory Decisions. (Tentative)
By a vote of 4-0 on June 27, 2016, the Commission determined pursuant to U.S.C. 552b(e) and 9.107(a) of the Commission's rules that the item in the above referenced Affirmation Session be held with less than one week notice to the public. The meeting is scheduled on June 29, 2016.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Denise McGovern at 301-415-0681 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
U.S. Office of Personnel Management.
30-Day Notice and request for comments.
As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), the Retirement Services, Office of Personnel Management (OPM) offers the general public and other federal agencies the opportunity to comment on an existing information collection request (ICR) 3206-0211, Reemployment of Annuitants. Notice of the information collection was previously published in the
Comments are encouraged and will be accepted until August 1, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW.,
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of 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 CFR 837.103, Reemployment of Annuitants, requires agencies to collect information from retirees who become employed in Government positions. Agencies need to collect timely information regarding the type and amount of annuity being received so the correct rate of pay can be determined. Agencies provide this information to OPM so a determination can be made whether the reemployed retiree's annuity must be terminated.
U.S. Office of Personnel Management.
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 A. 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 June 24, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. 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 June 24, 2016, it filed with the Postal Regulatory Commission a
Postal Service
Notice of modification to existing systems of records.
The United States Postal Service® (Postal Service) is proposing to modify two Customer Privacy Act Systems of Records (SOR). These changes are being made to support the automatic and seamless update of National Change of Address (NCOA) information, voluntarily provided by customers, in related customer databases that require the same NCOA information.
These revisions will become effective without further notice on August 1, 2016 unless comments received on or before that date result in a contrary determination.
Comments may be mailed or delivered to the Privacy and Records Office, United States Postal Service, 475 L'Enfant Plaza SW., Room 1P830, Washington, DC 20260-0004. Copies of all written comments will be available at this address for public inspection and photocopying between 8 a.m. and 4 p.m., Monday through Friday.
Janine Castorina, Chief Privacy Officer/A, Privacy and Records Office, 202-268-3089 or
This notice is in accordance with the Privacy Act requirement that agencies publish their systems of records in the
The Postal Service currently collects and stores information provided voluntarily by customers for the purpose of updating their address when
Privacy Act System of Records 800.000, Address Change, Mail Forwarding, and Related Services and 810.100,
Also, due to organizational changes, the Postal Service is adding a System Manager and Address to SOR 800.000.
Pursuant to 5 U.S.C. 552a(e)(11), interested persons are invited to submit written data, views, or arguments on this proposal. A report of the proposed modifications has been sent to Congress and to the Office of Management and Budget for their evaluations. The Postal Service does not expect these amended systems of records to have any adverse effect on individual privacy rights. The affected systems are as follows:
Address Change, Mail Forwarding, and Related Services
6. To provide automatic updates to USPS customer systems using mail forwarding and change-of-address services.
7. To facilitate communication between USPS customers and the Postal Service with regard to change-of-address and address correction services.
Vice President, Retail and Customer Service Operations, United States Postal Service, 475 L'Enfant Plaza SW., Washington, DC 20260.
3. To maintain current and up-to-date address information to assure accurate and reliable delivery and fulfillment of postal products, services, and other material.
The following is a notice of applications for deregistration under section 8(f) of the Investment Company Act of 1940 for the month of June 2016. A copy of each application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
The Commission: Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Hae-Sung Lee, Attorney-Adviser, at (202) 551-7345 or Chief Counsel's Office at (202) 551-6821; SEC, Division of Investment Management, Chief Counsel's Office, 100 F Street NE., Washington, DC 20549-8010.
For the Commission, by the Division of Investment Management, pursuant to delegated authority.
On April 7, 2016, the New York Stock Exchange LLC (“NYSE” or the “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposed to adopt initial and continued listing standards for the listing of Equity Investment Tracking Stocks. Proposed new Section 102.07 of the NYSE Listed Company Manual (“Manual”) defines an Equity Investment Tracking Stock as a class of common equity securities that tracks on an unleveraged basis the performance of an investment by the issuer in the common equity securities of a single other company listed on the Exchange. An Equity Investment Tracking Stock may track multiple classes of common equity securities of a single issuer, so long as all of those classes have identical economic rights and at least one of those classes is listed on the Exchange.
In order to qualify for initial listing under proposed Section 102.07, an Equity Investment Tracking Stock will be required to meet the distribution and public float requirements currently applicable to companies listing in connection with an initial public offering set forth in Sections 102.01A and 102.01B of the Manual, respectively, and the Global Market Capitalization Test set forth in Section 102.01C. Thus, at the time of initial listing an Equity Investment Tracking Stock will be required to: (i) Have at least 400 holders of 100 shares or more and 1,100,000 publicly held shares available for trading, as required under Section 102.01A; and (ii) have an aggregate market value of publicly-held shares of $40,000,000 and a price per share of $4 at the time of initial listing, as required under Section 102.01B.
Pursuant to proposed Section 102.07, the Exchange will not list an Equity Investment Tracking Stock if, at the time of the proposed listing, the issuer of the equity tracked by the Equity Investment Tracking Stock has been deemed below compliance with the Exchange's listing standards. In addition, the issuer of the Equity Investment Tracking Stock must own (directly or indirectly) at least 50% of both the economic interest and voting power of all of the outstanding classes of common equity securities of the issuer whose equity is tracked by the Equity Investment Tracking Stock.
Proposed Section 102.07 provides that prior to the commencement of trading of any Equity Investment Tracking Stock, the Exchange will distribute an Information Memorandum to its Members and Member Organizations that includes (i) any special characteristics and risks of trading the Equity Investment Tracking Stock, and (ii) the Exchange Rules that will apply to the Equity Investment Tracking Stock including Exchange Rules that require Member Organizations: (a) To use reasonable diligence in regard to the opening and maintenance of every account, to know (and retain) the essential facts concerning every customer and concerning the authority of each person acting on behalf of such customer; and (b) in recommending transactions in the Equity Investment Tracking Stock to have a reasonable basis to believe that (1) the recommendation is suitable for a customer given reasonable inquiry concerning the customer's investment objectives, financial situation, needs, and any other information known by such Member Organization, and (2) the customer can evaluate the special characteristics, and is able to bear the financial risks, of an investment in the Equity Investment Tracking Stock.
The Exchange proposed to subject Equity Investment Tracking Stocks to the same continued listing standards under Sections 802.01A and 802.01B of the Manual as are applicable to other common stock listed on the Exchange. Thus, an Equity Investment Tracking Stock will be considered to be below compliance with Section 802.01A if: (i) The number of total stockholders is less than 400; or (ii) the number of total stockholders is less than 1,200 and the average monthly trading volume is less than 100,000 shares (for the most recent 12 months); or (iii) the number of publicly-held shares is less than 600,000.
In addition, the Exchange has proposed to review the continued listing status of an Equity Investment Tracking Stock if: (i) The listed equity security or securities whose value is tracked by the Equity Investment Tracking Stock ceases or cease to be listed on the Exchange; (ii) the issuer of the Equity Investment Tracking Stock owns
The Exchange proposed to amend Section 202.06(B) of the Manual to provide that, in the event that the issuer of a common equity security tracked by an Equity Investment Tracking Stock intends to issue a material news release during the trading day and the Exchange determines to halt trading of such security under Section 202.06 pending dissemination of the news, or the Exchange implements any other required regulatory trading halt in a common equity security tracked by an Equity Investment Tracking Stock, the Exchange will also halt trading in the Equity Investment Tracking Stock that tracks the performance of such security. In such a case, the Exchange will halt trading of the Equity Investment Tracking Stock simultaneously with the halt in the common equity security being tracked and will also recommence trading in the two securities at the same time.
The Exchange has represented that it will monitor activity in Equity Investment Tracking Stocks to identify and deter any potential improper trading activity in such securities and will adopt enhanced surveillance procedures to enable it to monitor Equity Investment Tracking Stocks alongside the common equity securities whose value is tracked by such stocks.
The Exchange has represented that it will conduct a review of compliance with continued listing standards of Equity Investment Tracking Stocks and their issuers and the trading characteristics of Equity Investment Tracking Stocks over the initial two year period that the proposed listing standard is in operation.
The Exchange proposed to amend Sections 902.02 and 902.03 of the Manual to adopt fees relating to Equity Investment Tracking Stocks. Specifically, the Exchange proposed to establish a fixed initial listing fee of $100,000 (inclusive of the one-time special charge of $50,000)
The Exchange further proposed to amend Section 907.00 of the Manual, which sets forth certain complimentary products and services that are offered to certain currently and newly listed issuers. Specifically, proposed Section 907.00 provides that the issuer of an Equity Investment Tracking Stock that is that issuer's only class of common equity securities listed on the Exchange will not receive the products and services provided for under Section 907.00, with the exception that such issuers will receive the complimentary products and services and access to discounted third-party products and services through the NYSE Market Access Center available to all listed issuers, as described on the Exchange's Web site. The Exchange stated that issuers of Equity Investment Tracking
After careful review, the Commission finds that the proposed rule change, as amended, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange.
The development, implementation, and enforcement of standards governing the initial and continued listing of securities on an exchange are activities of critical importance to financial markets and the investing public. Listing standards, among other things, serve as a means for an exchange to screen issuers and to provide listed status only to bona fide companies that have or, in the case of an initial public offering, will have sufficient public float, investor base, and trading interest to provide the depth and liquidity necessary to promote fair and orderly markets. Once a security has been approved for initial listing, maintenance criteria allow an exchange to monitor the status and trading characteristics of that issue to ensure that fair and orderly markets can be maintained.
The Commission believes that the proposed quantitative and qualitative initial and continued listing standards for Equity Investment Tracking Stocks are consistent with the Act. These standards, which require issuers of Equity Investment Tracking Stocks to meet the quantitative and qualitative listing standards applicable to other common stock listed on the Exchange, should ensure that only substantial companies that are capable of meeting their financial obligations and have adopted robust corporate governance procedures can issue Equity Investment Tracking Stocks.
The listing and trading of Equity Investment Tracking Stocks on the Exchange present unique issues by virtue of the fact that they are designed to track the performance of another publicly traded company. As a result, investors may expect that the trading price of an Equity Investment Tracking Stock will be related to the trading price of the tracked company and, as such, affected by news and information disclosed by such company. To address these issues, the Exchange has proposed to adopt additional requirements for the initial and continued listing of Equity Investment Tracking Stocks that are not applicable to other common stock listed on the Exchange.
These proposed listing standards require, among other things, that for the initial and continued listing of an Equity Investment Tracking Stock, the issuer of the equity security tracked by the Equity Investment Tracking Stock (the “tracked stock”) must be listed on the Exchange and in good standing. Similarly, the proposed rules provide that whenever trading in the tracked stock is subject to a regulatory halt, or the tracked stock is suspended or delisting proceedings are commenced, trading in the Equity Investment Tracking Stock will also be halted, or the Equity Investment Tracking Stock will be suspended or delisting proceedings will be commenced, respectively.
The Commission believes that these additional requirements should protect investors and the public interest by assuring that pricing and other information with respect to the tracked stock is publicly available whenever the Equity Investment Tracking Stock is being traded. In addition, these requirements should help assure that the tracked stock is subject to comparable quantitative and qualitative requirements as the Equity Investment Tracking Stock, and that the Exchange has a listing relationship with, and direct access to information from, the issuer of the tracked stock.
In addition, the proposal requires that for initial and continued listing on the Exchange an issuer of an Equity Investment Tracking Stock must own, directly or indirectly, at least 50% of the economic interest and voting power of all of the outstanding classes of common equity securities of the issuer of the tracked stock. By effectively allowing only a single Equity Investment Tracking Stock to be issued for any tracked stock, and by requiring the issuer to be the controlling shareholder of the tracked stock, the Commission believes the proposal is reasonably designed to address concerns that the proliferation of tracking stocks could lead to undue market complexity or investor confusion.
Further, the Exchange has proposed to distribute an Information Memorandum prior to the commencement of trading apprising member firms of the special characteristics and risks of the Equity Investment Tracking Stock, as well as the Exchange's know-your-customer, suitability, and other rules applicable thereto.
The Exchange also has represented that it will monitor activity in Equity Investment Tracking Stocks to identify and deter any potential improper trading activity in such securities and will adopt enhanced surveillance procedures to enable it to monitor Equity Investment Tracking Stocks together with the related tracked stocks. In addition, the Exchange has agreed to conduct a review both of compliance with continued listing standards and the trading characteristics of Equity Investment Tracking Stocks, provide certain reports to the Commission, and make any appropriate recommendations for enhancements to its listing standards for Equity Investment Tracking Stocks based on this review. The Commission believes these measures should reduce the risks of manipulative or other
With respect to the proposed fees, the Commission believes it is consistent with the Act for the Exchange to exclude issuers whose only common equity security listed on the Exchange is an Equity Investment Tracking Stock from receiving the complimentary products and services provided for under Section 907.00 of the Manual. The Exchange stated that most of the services provided under Section 907.00 would be of limited value and appeal to issuers of Equity Investment Tracking Stocks.
Finally, the Commission believes that the proposed listing and annual fees for Equity Investment Tracking Stocks are an equitable allocation of reasonable fees. The Exchange stated that it is appropriate to charge lower fees to issuers whose only common equity security listed on the Exchange is an Equity Investment Tracking Stock because there are regulatory efficiencies for the Exchange when the issuer of an Equity Investment Tracking Stock and the issuer of the tracked stock are both listed on the Exchange. The Exchange represented that it does not believe that the proposed fees would negatively affect its ability to continue to adequately fund its regulatory program or the services the Exchange provides to issuers. According to the Exchange, these lower fees also reflect the fact that issuers whose only listed security is an Equity Investment Tracking Stock will not receive the complimentary products and services that other listed issuers of equity securities are eligible for under Section 907.00 of the Manual.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes a temporary suspension of those aspects of Rules 36.20 and 36.21 that would not permit Floor brokers to use personal portable phone devices on the Trading Floor due to the unavailability of Floor broker telephone services on June 24, 2016. The proposed rule change is available on the Exchange's Web site 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 temporarily suspend those aspects of Rules 36.20 and 36.21 that would not permit Floor brokers to use personal portable phone devices on the Trading Floor.
On June 24, 2016, the third-party carrier that provides service for the wired phone lines for Floor brokers experienced an issue that affected the availability of those phone lines. This suspension of service only impacted the service for telephone service for Floor brokers and did not impact phone service for Designated Market Makers. The Exchange is working closely with the third-party carrier to restore such phone service.
Rules 36.20 and 36.21 govern the type of telephone communications that are approved for Floor brokers. Pursuant to Rule 36.20, Floor brokers may maintain a telephone line on the Trading Floor and use Exchange authorized and provided portable phones while on the Trading Floor. The use of such Exchange authorized and provided portable phones is governed by Rule 36.21. Because of the issues with the third-party carrier, Floor brokers are unable to reach their customers via their third-party carrier wired telephone lines. While Exchange-provided portable phones are operating, not all Floor brokers have Exchange-provided and authorized portable phones. However, the personal cell phones of Floor brokers are operational on the Trading Floor. The Exchange believes that because communications with customers is a vital part of a Floor broker's role as agent and therefore contributes to maintaining a fair and orderly market, during the period when the phone lines are non-operational, Floor brokers who do not have Exchange authorized and provided portable phones should be permitted to
The Exchange therefore proposes to temporarily suspend the limitations in Rules 36.20 and 36.21 that permit Floor brokers to use only Exchange authorized and provided portable phones so that Floor brokers who do not have an Exchange authorized and portable phone may use personal cell phones on the Trading Floor. The Exchange proposes that pursuant to this temporary suspension, Floor brokers must provide the Exchange with the names of all Floor-based personnel who used personal portable phones during this temporary suspension period, together with the phone number and applicable carrier for each number. Floor broker member organizations must maintain in their books and records all cell phone records that show both incoming and outgoing calls that were made during the period that a personal portable phone was used on the Trading Floor. To the extent the records are unavailable from the third-party carrier, the Floor brokers must maintain contemporaneous records of all calls made or received on a personal portable phone while on the Trading Floor. As with all member organization records, such cell phone records must be provided to Exchange regulatory staff on request.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
In particular, because of issues experienced by a third-party phone carrier, wired phone lines are not functional. The Exchange believes that the proposed temporary suspensions from those aspects of Rule 36 that restrict Floor broker's use of personal portable phones on the Trading Floor removes impediments to and perfects the mechanism of a free and open market and national market system because the proposed relief will enable Floor brokers who do not have an Exchange authorized and provided portable phone to conduct their regular business, notwithstanding the ongoing issues with telephone service. The Exchange further believes that without the requested relief, Floor brokers would be compromised in their ability to conduct their regular course of business on the Trading Floor. In particular, for Floor brokers, because they operate as agents for customers, their inability to communicate with customers could compromise their ability to represent public orders on the Trading Floor.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on competition because the proposed change only impacts Floor brokers and has no change in operations for other market participants or other market centers. To the contrary, the Exchange believes that without the proposed relief, Floor brokers would be compromised in their ability to conduct their regular course of business on the Trading Floor, thereby placing a burden on the Floor brokers' ability to compete.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to list and trade the shares of the VanEck Vectors Long/Flat Commodity ETF (the “Fund”), a series of VanEck Vectors ETF Trust (“Trust”), under Nasdaq Rule 5735 (“Managed Fund Shares”). The shares of the Fund are collectively referred to herein as the “Shares.”
The text of the proposed rule change is available at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to list and trade the Shares of the Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares
Van Eck Absolute Return Advisers Corporation will be the investment adviser (“Adviser”) and the
Paragraph (g) of Rule 5735 provides that if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company portfolio.
Rule 5735(g) is similar to Nasdaq Rule 5705(b)(5)(A)(i); however, paragraph (g) operates in connection with the establishment of a “fire wall” between the investment adviser and the broker-dealer reflects the applicable open-end fund's portfolio, not an underlying benchmark index, as is the case with index-based funds.
The Adviser is not a broker-dealer, although it is affiliated with the Distributor, a broker-dealer. The Adviser has implemented a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the Fund's (including the Subsidiary's) portfolio.
In the event (a) the Adviser becomes newly affiliated with a broker-dealer or registers as a broker-dealer, or (b) any new adviser or sub-adviser to the Fund is a registered broker-dealer or becomes affiliated with a broker-dealer, it will implement a fire wall with respect to its relevant personnel and/or such broker-dealer affiliate, if applicable, regarding access to information concerning the composition and/or changes to the portfolio and will be subject to procedures designed to prevent the use and dissemination of material non-public information regarding such portfolio. The Fund does not currently intend to use a sub-adviser.
The Fund's investment objective will be to seek long-term capital appreciation while seeking to manage volatility and reduce downside risk during sustained market declines.
The Fund will be an actively managed ETF that seeks to achieve its investment objective by investing, under normal circumstances, in exchange-traded commodity futures contracts and, under certain limited circumstances, other commodity-linked instruments (“Other Commodity Instruments”
The Fund will invest in Commodities Instruments primarily through a wholly-owned subsidiary of the Fund organized under the laws of the Cayman Islands (“Subsidiary”). The Subsidiary will be advised by the Adviser.
With respect to the exchange-traded commodity futures contracts and options on futures contracts (if applicable) held, not more than 10% of the weight
The Fund (directly or indirectly through the Subsidiary) will normally invest in exchange-traded commodity futures contracts that are components of the Morningstar® Long/Flat Commodity Index
The Subsidiary will be an exempted company operating under Cayman Islands law. It will be wholly-owned and controlled by the Fund and will be advised by the Adviser. The Fund's investment in the Subsidiary may not exceed 25% of the value of the Fund's total assets at each quarter-end of the Fund's fiscal year. The Fund's investment in the Subsidiary is expected to provide the Fund with exposure to Commodities Instruments within the limits of the federal tax laws, which limit the ability of investment companies like the Fund to invest directly in such instruments. The Subsidiary will have the same investment objective as the Fund and will follow the same general investment policies and restrictions, except that unlike the Fund, it may invest without limit in Commodities Instruments.
The Fund (and the Subsidiary, as applicable) expects to invest its remaining assets in any one or more of the following: U.S. government securities,
The Fund also may invest directly in ETFs, exchange-traded closed end funds (to the extent permitted by the 1940 Act, and certain exemptive relief therefrom), and exchange-traded notes (“ETNs”) that provide exposure to commodities.
As previously noted, the Subsidiary will be advised by the Adviser.
As U.S.
The Fund currently intends to invest first in exchange-traded commodity futures contracts. Thereafter, if the Fund reaches the position limits applicable to one or more Index Commodity Contracts or a Futures Exchange imposes limitations on the Fund's ability to maintain or increase its positions in an exchange-traded commodity futures contract after reaching accountability levels or a price limit is in effect on an exchange-traded commodity futures contract during the last 30 minutes of its regular trading session, the Fund's intention is to invest first in Cleared Swaps to the extent permitted under the position limits applicable to Cleared Swaps and appropriate in light of the liquidity in the Cleared Swaps market, and then, using its commercially reasonable judgment, in Other Commodity Instruments.
The Fund may also invest in commodity-related foreign and domestic equity securities.
The Commodity Futures Trading Commission (“CFTC”) has recently adopted substantial amendments to CFTC Rule 4.5 relating to the permissible exemptions and conditions for reliance on exemptions from registration as a commodity pool operator.
The Fund
The Fund may not borrow money, except as permitted under the 1940 Act, and as interpreted or modified by regulation from time to time. The Fund also may not issue senior securities, except as permitted under the 1940 Act, and as interpreted or modified by regulation from time to time.
The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment).
The Fund may not purchase any security if, as a result of that purchase, 25% or more of its total assets would be invested in securities of issuers having their principal business activities in the same industry. This limit does not apply to securities issued or guaranteed by the U.S. Government, its agencies or instrumentalities, or securities of other investment companies.
The net asset value (“NAV”) per Share for the Fund will be computed by dividing the value of the net assets of the Fund (
The values of the Fund's portfolio securities will be valued in accordance with the Trust's valuation policies and procedures which may be amended from time to time. Included herein is a description of how various types of securities and instruments will be valued based on the current valuation policies and procedures for the Trust. ETFs, exchange-traded closed-end funds, ETNs, and commodity-related foreign and domestic equity securities, will be based on the securities' closing prices on local markets, when available. Due to the time differences between the United States and certain countries, securities on these non-U.S. exchanges may not trade at times when Shares of the Fund will trade. In the absence of a last reported sales price, or if no sales were reported, and for other assets for which market quotes are not readily available, values may be based on quotes obtained from a quotation reporting system, established market makers or by an outside independent pricing service using data reflecting the earlier closing of the principal markets for those securities. U.S. government securities, treasury inflation-protected securities and sovereign debt obligations of non-U.S. countries will normally be valued on the basis of quotes from brokers or dealers, established market makers or an outside independent pricing service. Short-term investments purchased with a remaining maturity of 60 days or less, including repurchase agreements and cash equivalents, will be valued on the basis of quotes from broker dealers, established major market makers, an independent pricing service or at amortized cost. Money market funds will be valued at their reported closing NAV. Futures contracts and options on futures contracts, which are traded on exchanges, will be valued at the current settle price for like contracts acquired on the day on which the futures contract will be valued as of the close of such exchanges.
Other Commodity Instruments not traded on exchanges will generally be valued daily based upon quotations from market makers or by a pricing service and in accordance with the Trust's valuation policies and procedures. Prices obtained by an
The Fund may also use fair value pricing in a variety of circumstances, including but not limited to, situations when the value of a security or instrument in the Fund's portfolio has been materially affected by events occurring after the close of the market on which the security or instrument is principally traded (such as a corporate action or other news that may materially affect the price of a security) or trading in a security or instrument has been suspended or halted.
In addition, the Fund expects that it will fair value certain of the foreign equity securities held by the Fund each day it calculates its NAV, except those securities principally traded on exchanges that close at the same time the Fund calculates its NAV. Accordingly, the Fund's NAV may reflect certain portfolio securities' or instruments' fair values rather than their market prices at the time the exchanges on which they principally trade close. Fair value pricing involves subjective judgments and it is possible that a fair value determination for a security or instrument will be materially different than the value that could be realized upon the sale of the security or instrument. With respect to securities or instruments that are principally traded on foreign exchanges, the value of the Fund's portfolio securities or instruments may change on days when you will not be able to purchase or sell your Shares.
The Trust will issue and sell Shares of the Fund only to authorized participants (“Authorized Participants”) and only in aggregations of 50,000 Shares (each, a “Creation Unit”), on a continuous basis through the Distributor, without an initial sales load, at their NAV next determined after receipt, on any Business Day,
The consideration for a purchase of Creation Units will generally consist of cash and/or the in-kind deposit of a designated portfolio of securities (“Deposit Securities”) and an amount of cash computed as described below (“Cash Component”). The Cash Component together with the Deposit Securities, as applicable, will be referred to as the “Fund Deposit,” which represents the minimum initial and subsequent investment amount for Shares. The Cash Component will represent the difference between the NAV of a Creation Unit and the market value of Deposit Securities and may include a Dividend Equivalent Payment. The “Dividend Equivalent Payment” will enable the Fund to make a complete distribution of dividends on the next dividend payment date, and will be an amount equal, on a per Creation Unit basis, to the dividends on all the securities held by the Fund (“Fund Securities”) with ex-dividend dates within the accumulation period for such distribution (the “Accumulation Period”), net of expenses and liabilities for such period, as if all of the Fund Securities had been held by the Trust for the entire Accumulation Period. The Accumulation Period will begin on the ex-dividend date for the Fund and will end on the next ex-dividend date.
The Administrator, through the NSCC, will make available on each Business Day, immediately prior to the opening of business on the Exchange (currently 9:30 a.m. Eastern Time), the list of the names and the required number of shares of each Deposit Security to be included in the current Fund Deposit (based on information at the end of the previous Business Day) as well as the Cash Component for the Fund. Such Fund Deposit will be applicable, subject to any adjustments as described below, in order to effect creations of Creation Units of the Fund until such time as the next-announced Fund Deposit composition is made available.
The identity and number of shares of the Deposit Securities required for the Fund Deposit for the Fund may change as rebalancing adjustments and corporate action events occur from time to time. In addition, the Trust will reserve the right to accept a basket of securities or cash that differs from Deposit Securities or to permit or require the substitution of an amount of cash (
In light of the foregoing, in order to seek to replicate the in-kind creation order process, the Trust expects to purchase the Deposit Securities represented by the cash in lieu amount in the secondary market (“Market Purchases”). In such cases where the Trust makes Market Purchases because a Deposit Security may not be permitted to be re-registered in the name of the Trust as a result of an in-kind creation order pursuant to local law or market convention, or for other reasons, the Authorized Participant will reimburse the Trust for, among other things, any difference between the market value at which the securities were purchased by the Trust and the cash in lieu amount (which amount, at the Adviser's discretion, may be capped), applicable registration fees and taxes.
Brokerage commissions incurred in connection with the Trust's acquisition of Deposit Securities will be at the expense of the Fund and will affect the value of all Shares of the Fund; but the Adviser may adjust the transaction fee to the extent the composition of the Deposit Securities changes or cash in lieu is added to the Cash Component to protect ongoing shareholders. The adjustments described above will reflect changes, known to the Adviser on the date of announcement to be in effect by the time of delivery of the Fund Deposit, resulting from stock splits and other corporate actions.
In addition to the list of names and numbers of securities constituting the current Deposit Securities of the Fund Deposit, the Administrator, through the NSCC, will also make available (i) on each Business Day, the Dividend Equivalent Payment, if any, and the estimated Cash Component effective through and including the previous Business Day, per outstanding Shares of the Fund, and (ii) on a continuous basis throughout the day, the Indicative Optimized Portfolio Value (“IOPV”).
To be eligible to place orders with the Distributor to create and redeem
All orders to create Creation Units must be received by the Distributor no later than the closing time of the regular trading session on Nasdaq (“Closing Time”) (ordinarily 4:00 p.m., Eastern Time) on the date such order is placed in order for creation of Creation Units to be effected based on the NAV of the Fund as determined on such date.
Shares may be redeemed only in Creation Units at their NAV next determined after receipt of a redemption request in proper form by the Distributor, only on a Business Day and only through a Participating Party or DTC Participant who has executed a Participant Agreement. In order to redeem Creation Units, an Authorized Participant must submit an order to redeem for one or more Creation Units. All such orders must be received by the Distributor in proper form no later than Closing Time in order to receive the day's closing NAV per share.
To the extent the Fund's redemptions are effected in-kind, the Administrator, through NSCC, makes available immediately prior to the opening of business on the Exchange (currently, 9:30 a.m., Eastern Time) on each day that the Nasdaq is open for business, the Fund Securities that will be applicable (subject to possible amendment or correction) to redemption requests received in proper form (as defined below) on that day.
Unless cash redemptions are permitted or required for the Fund, the redemption proceeds for a Creation Unit generally consist of Fund Securities as announced by the Administrator on the Business Day of the request for redemption, plus cash in an amount equal to the difference between the NAV of the Shares being redeemed, as next determined after a receipt of a request in proper form, and the value of the Fund Securities, less the redemption transaction fee and applicable variable fees. Should the Fund Securities have a value greater than the NAV of the Shares being redeemed, a compensating cash payment to the Trust equal to the differential plus the applicable redemption transaction fee will be required to be arranged for by or on behalf of the redeeming shareholder. The Fund reserves the right to honor a redemption request by delivering a basket of securities or cash that differs from the Fund Securities.
The Fund's Web site (
On a daily basis, the Fund will disclose on the Fund's Web site the following information regarding each portfolio holding, as applicable to the type of holding: Ticker symbol, CUSIP number or other identifier, if any; a description of the holding (including the type of holding), the identity of the security or other asset or instrument underlying the holding, if any; for options, the option strike price; quantity held (as measured by, for example, par value, notional value or number of shares, contracts or units); maturity date, if any; coupon rate, if any; effective date, if any; market value of the holding; and percentage weighting of the holding in the Fund's portfolio. The Web site information will be publicly available at no charge.
In addition, a basket composition file, which includes the security names and quantities required to be delivered in exchange for the Fund's Shares, together with estimates and actual cash components, will be publicly disseminated daily prior to the opening of the Exchange via NSCC. The basket represents one Creation Unit of the Fund.
Also, for the Fund, an IOPV,
The dissemination of the Intraday Indicative Value, together with the Disclosed Portfolio, will allow investors to determine the value of the underlying portfolio of the Fund on a daily basis and will provide a close estimate of that value throughout the trading day.
Intra-day, executable price quotations on the exchange-traded assets held by the Fund and the Subsidiary, including futures contracts, options on futures contracts, ETFs, ETNs, closed-end funds and foreign and domestic equity securities are expected to be available on the exchange on which they are traded. Intra-day, executable price quotations on swaps, money market funds, forward contracts, U.S. government securities, cash and other cash equivalents, treasury inflation-
Investors will also be able to obtain the Fund's Statement of Additional Information (“SAI”), the Fund's Shareholder Reports, and its Form N-CSR and Form N-SAR, filed twice a year. The Fund's SAI and Shareholder Reports will be available free upon request from the Fund, and those documents and the Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from the Commission's Web site at
Information on the Morningstar Long/Flat Commodity Index
The Shares will be subject to Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares. The Exchange represents that, for initial and/or continued listing, the Fund and the Subsidiary must be in compliance with Rule 10A-3
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund. Nasdaq will halt trading in the Shares under the conditions specified in Nasdaq Rules 4120 and 4121, including the trading pauses under Nasdaq Rules 4120(a)(11) and (12). Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and other assets constituting the Disclosed Portfolio of the Fund and the Subsidiary; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Rule 5735(d)(2)(D), which sets forth circumstances under which Shares of the Fund may be halted.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. Nasdaq will allow trading in the Shares from 4:00 a.m. until 8:00 p.m. Eastern Time. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in Nasdaq Rule 5735(b)(3), the minimum price variation for quoting and entry of orders in Managed Fund Shares traded on the Exchange is $0.01.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows, and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
FINRA, on behalf of the Exchange, will communicate as needed regarding trading information it can obtain relating to the Shares, other exchange-traded securities and other assets held by the Fund and the Subsidiary, which include exchange-traded commodity-related equity securities, exchange-traded futures contracts, exchange-traded options on futures contracts, ETNs, ETFs and exchange-traded closed-end funds, with other markets and other entities that are members of the ISG
In addition, with respect to the exchange-traded futures contracts and options on futures contracts held, not more than 10% of the weight
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (3) how and by whom the information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (5) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information.
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Fund. Members purchasing Shares from the Fund for resale to investors will deliver a prospectus to such investors. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
Additionally, the Information Circular will reference that the Fund is subject to various fees and expenses. The Information Circular will also disclose the trading hours of the Shares of the Fund and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares of the Fund will be publicly available on the Fund's Web site.
All statements and representations made in this filing regarding (a) the description of the portfolio, (b) limitations on portfolio holdings or reference assets, or (c) the applicability of Exchange rules and surveillance procedures shall constitute continued listing requirements for listing the Shares on the Exchange. In addition, the issuer has represented to the Exchange that it will advise the Exchange of any failure by the Fund to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under the Nasdaq 5800 Series.
Nasdaq believes that the proposal is consistent with Section 6(b) of the Act in general and Section 6(b)(5) of the Act in particular in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and in general, to protect investors and the public interest.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in Nasdaq Rule 5735. The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws. The Adviser is affiliated with a broker-dealer and has implemented a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the Fund's portfolio. In addition, paragraph (g) of Nasdaq Rule 5735 further requires that personnel who make decisions on the open-end fund's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material, non-public information regarding the open-end fund's portfolio.
The Fund's and the Subsidiary's investments will be consistent with the Fund's investment objective and although certain investments will have a leveraging effect on the Fund, the Fund will not seek leveraged returns. FINRA may obtain information via ISG from other exchanges that are members of ISG.
In addition, the Exchange may obtain information regarding trading in the Shares, other exchange-traded securities and other assets held by the Fund and the Subsidiary from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement.
Moreover, FINRA, on behalf of the Exchange, will be able to access, as needed, trade information for certain fixed income securities held by the Fund reported to FINRA's TRACE. With respect to the futures contracts held, not more than 10% of the weight
The Fund will invest up to 25% of its total assets in the Subsidiary as measured at each quarter-end of the Fund's fiscal year end. The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid securities (calculated at the time of investment). The Fund will use the fixed-income securities as investments and to collateralize the Fund's or the Subsidiary's commodity exposure on a day-to-day basis. The Fund may also invest directly in ETFs and exchange-traded closed-end funds, that provide exposure to commodities, equity securities and fixed income securities to the extent permitted under the 1940 Act.
The proposed rule change is designed to promote just and equitable principles
In addition, a large amount of information will be publicly available regarding the Fund and the Shares, thereby promoting market transparency. Moreover, the Intraday Indicative Value, available on the NASDAQ OMX Information LLC proprietary index data service will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Regular Market Session. On each business day, before commencement of trading in Shares in the Regular Market Session on the Exchange, the Fund will disclose on its Web site the Disclosed Portfolio of the Fund and the Subsidiary that will form the basis for the Fund's calculation of NAV at the end of the business day.
Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services, and quotation and last sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges and the Consolidated Tape Association plans for the Shares. Intra-day price information will be available through subscription services, such as Bloomberg and Reuters.
The Fund's Web site will include a form of the prospectus for the Fund and additional data relating to NAV and other applicable quantitative information. Trading in Shares of the Fund will be halted under the conditions specified in Nasdaq Rules 4120 and 4121 or because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable, and trading in the Shares will be subject to Nasdaq Rule 5735(d)(2)(D), which sets forth circumstances under which Shares of the Fund may be halted. In addition, as noted above, investors will have ready access to information regarding the Fund's holdings, the Intraday Indicative Value, the Disclosed Portfolio, and quotation and last sale information for the Shares.
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of actively-managed exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace.
As noted above, FINRA, on behalf of the Exchange, will communicate as needed regarding trading information it can obtain relating to the Shares, other exchange-traded securities and other assets held by the Fund and the Subsidiary with other markets and other entities that are members of the ISG and FINRA may obtain trading information regarding trading in the Shares, other exchange-traded securities and other assets held by the Fund and the Subsidiary from such markets and other entities.
In addition, the Exchange may obtain information regarding trading in the Shares, other exchange-traded securities and other assets held by the Fund and the Subsidiary from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement.
Additionally, FINRA's TRACE will be a source of price information for certain fixed income securities held by the Fund. Furthermore, as noted above, investors will have ready access to information regarding the Fund's holdings, the Intraday Indicative Value, the Disclosed Portfolio, and quotation and last sale information for the Shares. For the above reasons, Nasdaq believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change will facilitate the listing and trading of an additional type of actively-managed exchange-traded fund that will enhance competition among market participants, to the benefit of investors and the marketplace.
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
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.
Securities and Exchange Commission.
Notice of meeting.
The Securities and Exchange Commission Advisory Committee on Small and Emerging Companies is providing notice that it will hold a public meeting on Tuesday, July 19, 2016, in Multi-Purpose Room LL-006 at the Commission's headquarters, 100 F Street NE., Washington, DC. The meeting will begin at 9:30 a.m. (EDT) and will be open to the public. The meeting will be webcast on the Commission's Web site at
The public meeting will be held on Tuesday, July 19, 2016. Written statements should be received on or before July 15, 2016.
The meeting will be held at the Commission's headquarters, 100 F Street NE., Washington, DC. Written statements may be submitted by any of the following methods:
• Use the Commission's Internet submission form (
• Send an email message to
• Send paper statements to Brent J. Fields, Federal Advisory Committee Management Officer, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Statements also will be available for Web site viewing and printing in the Commission's Public Reference Room, 100 F Street NE., Washington, DC 20549, on official business days between the hours of 10:00 a.m. and 3:00 p.m. All statements received will be posted without change; we do not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
Julie Z. Davis, Senior Special Counsel, at (202) 551-3460, Office of Small Business Policy, Division of Corporation Finance, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-3628.
In accordance with Section 10(a) of the Federal Advisory Committee Act, 5 U.S.C.-App. 1, and the regulations thereunder, Keith Higgins, Designated Federal Officer of the Committee, has ordered publication of this notice.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The proposed rule change by OCC would amend OCC Rule 604 to permit pass-through letters of credit (“Pass-Through Letters of Credit”) as a form of margin asset to satisfy margin obligations for futures, futures options, and commodity options positions (collectively referred to as “futures positions”) held in segregated futures accounts and segregated futures professional accounts (collectively referred to as “segregated futures accounts”) that are not eligible to hold positions in security futures.
In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The purpose of the proposed rule change is to amend OCC Rule 604 to permit Pass-Through Letters of Credit as a form of margin asset to satisfy margin
Recently, certain futures market participants have inquired about using Pass-Through Letters of Credit as a form of margin asset at OCC. Pass-Through Letters of Credit are letters of credit issued on behalf of a third party (in this case, a customer of a Clearing Member) with a joint beneficiary structure that would allow the Clearing Member, as a joint beneficiary, to “pass through” the letter of credit directly to the clearinghouse, as joint beneficiary, and avoid the need for the Clearing Member to write its own letter of credit to the clearinghouse or to deposit cash margin on behalf of the customer. Pass-Through Letters of Credit are standard collateral vehicles accepted by other futures clearinghouses, particularly clearinghouses that provide clearance and settlement services for energy futures products. In order to provide OCC's futures commission merchant (“FCM”) Clearing Members with the ability to deposit similar forms of collateral for segregated futures accounts as they could deposit at other futures clearinghouses, OCC proposes to add new Interpretation and Policy .10 to Rule 604 to permit its FCM Clearing Members to deposit Pass-Through Letters of Credit as margin assets to satisfy margin requirements for their futures customers. Pass-Through Letters of Credit would be permitted only to satisfy margin obligations for positions held in segregated futures accounts and would not be available as a form of margin asset to satisfy margin obligations for securities products.
Pass-Through Letters of Credit would be subject to the same requirements and risk controls of Rule 604 as the currently accepted two party letters of credit. Pass-Through Letters of Credit deposited as margin assets would be based on the industry standard
In addition, existing Interpretations and Policies .10-.16 to Rule 604 would be renumbered but otherwise remain unchanged.
OCC believes that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act,
In addition to the restrictions and safeguards under Rule 604, the terms of the Pass-Through Letters of Credit would require that they effectively operate similarly to the two party letters of credit currently on deposit as margin assets at OCC. For example, OCC must be notified of (and in certain cases must affirmatively accept) any changes to the terms of the letter of credit, the issuing bank would be required to inform OCC in the case that the Clearing Member beneficiary wished to draw on the letter of credit, and all potential draws on the letter of credit, regardless of who initiates them, would be deposited
For the reasons stated above, OCC believes that the proposed rule change is designed to assure the safeguarding of securities and funds which are in the custody or control of OCC or for which it is responsible in accordance with Section 17A(b)(3)(F) of the Act
OCC does not believe that the proposed rule change would have any impact or impose any burden on competition
Written comments on the proposed rule change were not and are not intended to be solicited with respect to the proposed rule change and none have been received.
The foregoing rule change has become effective upon filing
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; the Commission does not edit personal identifying information from submissions. You should submit only information that you wish to make available publicly.
All submissions should refer to File Number SR-OCC-2016-003 and should be submitted on or before July 21, 2016.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes a temporary suspension of those aspects of Rules 36.20—Equities and 36.21—Equities that would not permit Floor brokers to use personal portable phone devices on the Trading Floor due to the unavailability of Floor broker telephone services on June 24, 2016. The proposed rule change is available on the Exchange's Web site 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 temporarily suspend those aspects of Rules 36.20—Equities (“Rule 36.20”) and 36.21—Equities (“Rule 36.21”) that would not permit Floor brokers to use personal portable phone devices on the Trading Floor.
On June 24, 2016, the third-party carrier that provides service for the wired phone lines for Floor brokers experienced an issue that affected the availability of those phone lines. This suspension of service only impacted the service for telephone service for Floor brokers and did not impact phone service for Designated Market Makers. The Exchange is working closely with the third-party carrier to restore such phone service.
Rules 36.20 and 36.21 govern the type of telephone communications that are approved for Floor brokers. Pursuant to Rule 36.20, Floor brokers may maintain a telephone line on the Trading Floor and use Exchange authorized and provided portable phones while on the Trading Floor. The use of such Exchange authorized and provided portable phones is governed by Rule 36.21. Because of the issues with the third-party carrier, Floor brokers are unable to reach their customers via their third-party carrier wired telephone lines. While Exchange-provided portable phones are operating, not all Floor brokers have Exchange-provided and authorized portable phones. However, the personal cell phones of Floor brokers are operational on the Trading Floor. The Exchange believes that because communications with customers is a vital part of a Floor broker's role as agent and therefore contributes to maintaining a fair and orderly market, during the period when the phone lines are non-operational, Floor brokers who do not have Exchange authorized and provided portable phones should be permitted to use personal cell phone devices in lieu of the non-operational wired phone lines.
The Exchange therefore proposes to temporarily suspend the limitations in Rules 36.20 and 36.21 that permit Floor brokers to use only Exchange authorized and provided portable phones so that Floor brokers who do not have an Exchange authorized and portable phone may use personal cell phones on the Trading Floor. The Exchange proposes that pursuant to this temporary suspension, Floor brokers must provide the Exchange with the names of all Floor-based personnel who used personal portable phones during this temporary suspension period, together with the phone number and applicable carrier for each number. Floor broker member organizations must maintain in their books and records all cell phone records that show both incoming and outgoing calls that were made during the period that a personal portable phone was used on the Trading Floor. To the extent the records are unavailable from the third-party carrier, the Floor brokers must maintain contemporaneous records of all calls made or received on a personal portable phone while on the Trading Floor. As with all member organization records, such cell phone records must be provided to Exchange regulatory staff on request.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
In particular, because of issues experienced by a third-party phone carrier, wired phone lines are not functional. The Exchange believes that the proposed temporary suspensions from those aspects of Rule 36 that restrict Floor broker's use of personal portable phones on the Trading Floor removes impediments to and perfects the mechanism of a free and open market and national market system because the proposed relief will enable Floor brokers who do not have an Exchange authorized and provided portable phone to conduct their regular business, notwithstanding the ongoing issues with telephone service. The Exchange further believes that without the requested relief, Floor brokers would be compromised in their ability to conduct their regular course of business on the Trading Floor. In particular, for Floor brokers, because they operate as agents for customers, their inability to communicate with customers could compromise their ability to represent public orders on the Trading Floor.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange does not believe that the proposed rule change will impose any burden on competition because the proposed change only impacts Floor brokers and has no change in operations for other market participants or other market centers. To the contrary, the Exchange believes that without the proposed relief, Floor brokers would be compromised in their ability to conduct their regular course of business on the Trading Floor, thereby placing a burden on the Floor brokers' ability to compete.
No written comments were solicited or received with respect to the proposed rule change.
The Exchange has filed the proposed rule change pursuant to Section 19(b)(3)(A)(iii) of the Act
A proposed rule change filed under Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to temporarily widen price collar thresholds for the Core Open Auction and Trading Halt Auctions, which would be operative on June 24, 2016 only. The proposed rule change is available on the Exchange's Web site 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 temporarily widen price collar thresholds for the Core Open Auction and Trading Halt Auctions, which would be operative for June 24, 2016 only.
On June 23, 2016, the United Kingdom (“UK”) held a referendum vote to decide whether the UK should leave or remain in the European Union. The results of this vote were not made public until after the U.S. markets closed on June 23, 2016. Based on this referendum, the UK has voted to leave the European Union. As expected, this vote has resulted in an extraordinary level of global market activity on June 24, 2016, as the markets assess what the impact of the UK leaving the European Union will mean. This spike in market volatility has also impacted the U.S. equities markets, including pricing of Exchange Traded Products (“ETP”), the majority of which are listed on the Exchange.
Because of the extraordinary level of market volatility following the UK referendum vote, including in the U.S. ETP market, the Exchange believes that widening the Auction Collars for the Core Open Auction and Trading Halt Auctions for June 24, 2016 only would assist the Exchange in conducting fair and orderly auctions.
As set forth in Rule 7.35P(a)(10), the price collar thresholds for the Core Open Auction and Trading Halt Auctions are currently set at 10% for securities with an Auction Reference Price of $25.00 or less, 5% for securities with an Auction Reference Price greater than $25.00 but less than or equal to $50.00, and 3% for securities with an Auction Reference Price greater than $50.00.
The Exchange proposes to apply Auction Collars of 10% for all Auction-Eligible Securities,
The proposed rule change is consistent with Section 6(b) of the Act,
In particular, the Exchange believes that the impact of the UK vote to leave the European Union has resulted in extraordinary global market volatility, not seen in scale since August 24, 2015, and the U.S. ETP market is not immune. In response to this extraordinary market volatility, the Exchange believes that it would promote the protection of investors and the public interest to temporarily widen the price collar thresholds for the Core Open Auction and Trading Halt Auctions on June 24, 2016 only because it would promote fair and orderly auctions. The Exchange further believes that widening the price collar thresholds would remove impediments to and perfect the mechanism of a national market system because it is designed to allow for greater price movement, while at the same time preventing auction trades from occurring at prices significantly away from the applicable Auction Reference Price. Accordingly, investors would be protected from executions significantly away from the last sale in a security or other applicable reference price, but natural price fluctuations resulting from the market volatility would be permitted. In addition, the Exchange believes that widening the Auction Collars could reduce the possibility of securities triggering multiple trading pauses under the Regulation NMS Plan to Address Market Volatility.
The Exchange does not believe that the proposed rule change would impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change is not designed to address any competitive issues but rather is designed to ensure a fair and orderly market by temporarily widening the price collar thresholds for the Core Open Auction and Trading Halt Auctions on a trading day with extraordinary market volatility due to the UK vote to leave the European Union, In addition, the proposed rule change is intended to be in effect for June 24, 2016 only to respond to unique events relating to UK referendum and therefore will not create a burden on competition.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of Florida, dated 06/23/2016.
Submit completed loan applications to: U.S. Small Business Administration Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's EIDL declaration, applications for economic injury disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for economic injury is 14748
The States which received an EIDL Declaration # are Florida.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Texas (FEMA-4272-DR), dated 06/11/2016.
Submit completed loan applications to: U.S. Small Business Administration Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Texas, dated 06/11/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
The Advisory Committee on International Economic Policy (ACIEP) will meet from 2:00 until 5:00 p.m. on Wednesday, July 27 in Washington, DC at the State Department, 2201 C Street NW. in conference Room 7516. The meeting will be hosted by the Assistant Secretary of State for Economic and Business Affairs, Charles H. Rivkin, and Committee Chair Paul R. Charron. The ACIEP serves the U.S. Government in a solely advisory capacity, and provides advice concerning topics in international economic policy. It is expected that during this meeting, the ACIEP subcommittees on sanctions policy and the Stakeholder Advisory Board will provide updates on their recent work.
This meeting is open to the public, though seating is limited. Entry to the building is controlled. To obtain pre-clearance for entry, members of the public planning to attend should
For additional information, contact Alan Krill, Bureau of Economic and Business Affairs, at (202) 647-2231, or
Notice is hereby given of the following determinations: 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,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
The Surface Transportation Board (STB) is publishing the annual inflation-adjusted index factors for 2015. These factors are used by the railroads to adjust their gross annual operating revenues for classification purposes. This indexing methodology ensures that railroads are classified based on real business expansion and not from the effects of inflation. Classification is important because it determines the extent to which individual railroads must comply with STB reporting requirements.
The STB's annual inflation-adjusted factors are based on the annual average Railroad's Freight Price Index which is developed by the Bureau of Labor Statistics (BLS). The STB's deflator factor is used to deflate revenues for comparison with established revenue thresholds.
The base year for railroads is 1991. The inflation index factors are presented as follows:
By the Board, William F. Huneke, Director, Office of Economics.
Susquehanna River Basin Commission.
Notice.
As part of its regular business meeting held on June 16, 2016, in Lancaster, Pennsylvania, the Commission took the following actions: (1) Approved or tabled the applications of certain water resources projects; (2) accepted a settlement in lieu of penalty from New Enterprise Stone & Lime Co., Inc.; and (3) took additional actions, as set forth in the
June 16, 2016.
Susquehanna River Basin Commission, 4423 N. Front Street, Harrisburg, PA 17110-1788.
Jason E. Oyler, General Counsel, telephone: (717) 238-0423, ext. 1312; fax: (717) 238-2436; email:
In addition to the actions taken on projects identified in the summary above and the listings below, the following items were also presented or acted upon at the business meeting: (1) Election of the member from the State of Maryland as Chair of the Commission and the member from the Federal Government as the Vice Chair of the Commission for the period of July 1, 2016, to June 30, 2017; (2) adoption of the FY2017-2018 Water Resources Program; (3) adoption of amendment of the
The Commission approved a settlement in lieu of civil penalty for the following project:
1. New Enterprise Stone & Lime Co., Inc., Valley Quarries, Inc.—Shippensburg Quarry, Shippensburg Borough, Cumberland County, Pa.—$30,000.
The Commission approved the following project applications:
1. Project Sponsor and Facility: Black Bear Waters, LLC (Lycoming Creek), Lewis Township, Lycoming County, Pa. Renewal of surface water withdrawal of up to 0.900 mgd (peak day) (Docket No. 20120303).
2. Project Sponsor and Facility: Blossburg Municipal Authority, Bloss Township, Tioga County, Pa. Renewal of groundwater withdrawal of up to 0.288 mgd (30-day average) from Route 15 Well (Docket No. 20120304).
3. Project Sponsor and Facility: Cabot Oil & Gas Corporation (Martins Creek), Harford Township, Susquehanna County, Pa. Surface water withdrawal of up to 0.500 mgd (peak day).
4. Project Sponsor and Facility: Todd and Gemma Campbell (Susquehanna River), Athens Township, Bradford County, Pa. Renewal of surface water withdrawal of up to 0.999 mgd (peak day) (Docket No. 20120609).
5. Project Sponsor and Facility: Mount Joy Borough Authority, East Donegal Township, Lancaster County, Pa. Modification to increase withdrawal limit from Well 1 by an additional 0.073 mgd (30-day average), for a total Well 1 withdrawal limit of 1.300 mgd (30-day average) (Docket No. 20110617).
6. Project Sponsor: New Enterprise Stone & Lime Co., Inc. Project Facility: Burkholder Quarry, Earl Township, Lancaster County, Pa. Groundwater withdrawal of up to 0.005 mgd (30-day average) from Sump 4.
7. Project Sponsor: New Enterprise Stone & Lime Co., Inc. Project Facility: Burkholder Quarry, Earl and Ephrata Townships, Lancaster County, Pa. Modification to increase consumptive water use by an additional 0.07 mgd (peak day), for a total consumptive water use of up to 0.220 mgd (peak day) and to add an additional new source (Sump 4) (Docket No. 20040307).
8. Project Sponsor and Facility: Renovo Energy Center LLC (West Branch Susquehanna River), Renovo Borough, Clinton County, Pa. Surface water withdrawal of up to 0.612 mgd (peak day).
9. Project Sponsor and Facility: Renovo Energy Center LLC, Renovo Borough, Clinton County, Pa. Consumptive water use of up to 0.217 mgd (peak day).
10. Project Sponsor: SUEZ Water Pennsylvania Inc. Project Facility: Newberry System, Newberry Township, York County, Pa. Groundwater withdrawal of up to 0.108 mgd (30-day average) from the Coppersmith Well.
11. Project Sponsor: SUEZ Water Pennsylvania Inc. Project Facility: Newberry System, Newberry Township, York County, Pa. Groundwater withdrawal of up to 0.200 mgd (30-day average) from Conley 1 Well.
12. Project Sponsor and Facility: Sugar Hollow Trout Park and Hatchery, Eaton Township, Wyoming County, Pa. Renewal of groundwater withdrawal of up to 0.864 mgd (30-day average) from Wells 1, 2, and 3 (the Hatchery Wellfield) (Docket No. 20100913).
13. Project Sponsor and Facility: Tioga Downs Racetrack, LLC, Town of Nichols, Tioga County, N.Y. Groundwater withdrawal of up to 0.099 mgd (30-day average) from the Racetrack Well.
14. Project Sponsor and Facility: Tioga Downs Racetrack, LLC, Town of Nichols, Tioga County, N.Y. Consumptive water use of up to 0.099 mgd (peak day).
The Commission tabled action on the following project applications:
1. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.201 mgd (30-day average) from Well 1.
2. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.106 mgd (30-day average) from Well 3.
3. Project Sponsor and Facility: Elizabethtown Area Water Authority, Elizabethtown Borough, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.130 mgd (30-day average) from Well 4.
4. Project Sponsor and Facility: Elizabethtown Area Water Authority, Mount Joy Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.187 mgd (30-day average) from Well 8.
5. Project Sponsor and Facility: Elizabethtown Area Water Authority, Mount Joy Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 0.216 mgd (30-day average) from Well 9.
6. Project Sponsor: Exelon Generation Company, LLC. Project Facility: Muddy Run Pumped Storage Project, Drumore and Martic Townships, Lancaster County, Pa. Application for an existing hydroelectric facility.
7. Project Sponsor and Facility: Manbel Devco I, LP, Manheim Township, Lancaster County, Pa. Application for groundwater withdrawal of up to 4.320 mgd (30-day average) from the Belmont Quarry.
The following project sponsor withdrew its project application:
1. Project Sponsor and Facility: EQT Production Company (Pine Creek), Porter Township, Lycoming County, Pa. Application for surface water withdrawal of up to 1.000 mgd (peak day).
Public Law 91-575, 84 Stat. 1509
National Highway Traffic Safety Administration (NHTSA), U.S. Department of Transportation (DOT).
Notice; request for information.
The development of a nationally uniform 911 data system, containing uniform data elements for all Computer Aided Dispatch (CAD) data, data associated with the operation of local and State 911 systems, and Extensible Markup Language (XML) schema (or technical equivalent) that would enable the collection, analysis and sharing of standardized administrative data, operational data, cost data and all Computer Aided Dispatch (CAD) data received, collected, processed, and transmitted during 911 calls; that would be developed and made available to all 911 Public Safety Answering Points (PSAPs) and 911 Authorities at the state and local levels. This nationally uniform 911 data system, once developed, would provide essential information to assist strategic planning, governance decisions, and improvements to the 911 system and its operation at all levels of government. These data would also be useful to private sector companies providing support services to local and state 911 agencies.
It is requested that comments on this announcement be submitted by September 28, 2016.
You may submit comments [identified by Docket No. NHTSA-2016-0069] through one of the following methods:
•
•
Laurie Flaherty, National Highway Traffic Safety Administration, Office of Emergency Medical Services, (202) 366-2705,
DOT/NHTSA, on behalf of the National 911 Program, is seeking comments from all sources (public, private, governmental, academic, professional, associations, public interest groups, and other interested parties) on the idea of establishing a nationally uniform data system, to document PSAP 911 call data and the data related to the operation of 911 systems at all levels of government within the 911 community. A nationally uniform 911 data system was identified as a need by the Federal Communication Commission's (FCC's) Task Force on Optimal PSAP Architecture (TFOPA), in its final report, released January 29, 2016: “A National system enabling the collection and analysis of standardized administrative data, operational data, cost data and CAD data should be developed and made available to PSAPS and 911 Authorities, to provide essential information to substantiate planning decisions and improvements to assist in the migration towards NG911.” Models for a nationally uniform data system exist in other disciplines, for example, the National Fire Operations Reporting System (N-FORS),
The purpose of this notice is to solicit comments and ideas on all aspects of the development, implementation and operation of a nationally uniform 911 data system from the broad 911 stakeholder community, including CAD vendors, CAD interface developers, PSAP managers, local and State 911 authorities and agencies, national
In January 2016, in partnership with the PSAP community, national professional 911 associations, all levels of government, and the private sector, the Task Force on Optimal PSAP Architecture (TFOPA) delivered its final report to the FCC. This document contains a collaborative vision for the future of optimal PSAPs and 911 systems in the United States. The document includes a section (5.9.2) entitled, “Findings and Considerations” recommending that, “a National system enabling the collection and analysis of standardized administrative data, operational data, cost data and CAD data should be developed and made available to PSAPS and 911 Authorities, to provide essential information to substantiate planning decisions and improvements to assist in the migration towards NG911.”
This RFI request directly relates to this recommendation by seeking comment on specific potential components of a nationally uniform 911 data system that would be implemented and operated to bridge this identified gap, and the process that would be used to develop, implement and operate this data system.
Responses to the following questions are requested to help plan the development and creation of a nationally uniform 911 data system that would enable the collection and analysis of standardized PSAP data and operational 911 system data. Please provide references as appropriate.
1. What significant changes have occurred in 911 and PSAP related data systems at the national, State and local levels during the last ten years?
2. As a 911 stakeholder, how might the implementation of a nationally uniform 911 data system be most useful to you (
3. What are the most critical issues facing current use and future interconnection of PSAP CAD systems that could be addressed in the development of the nationally uniform 911 data system? Please be as specific as possible.
4. What CAD and/or PSAP and/or 911 system data do you presently collect and what additional data would be beneficial to assist with staffing, budgeting, testing, contract compliance, performance metrics, planning, governance, or quality improvement activities?
5. What kind of data elements would you consider as essential data related to information handled by telecommunicators and by CAD systems, in receiving and processing 911 calls, and transmitting information to emergency responders? Please be as specific as possible in listing examples.
6. What kind of data elements would you consider as essential data related to the administration and operation of a PSAP? Please be as specific as possible in listing examples.
7. What kind of data elements would you consider as essential data related to the administration and operation of a local/state 911 system? Please be as specific as possible in listing examples.
8. How could a nationally uniform 911 data system enhance collaboration among CAD/Records Management Systems (RMS), 911 authorities, the first responder community, and others?
9. How could the proposed data system promote community preparedness and resilience?
10. How could this proposed data system contribute to improved coordination at the local, regional, state and national levels?
11. What are your suggestions for the process that should be used in developing, implementing and/or operating a nationally uniform 911 data collection system? Please be as specific as possible.
12. What specific agencies/organizations/entities are essential to involve, as part of a collaborative group that develops, implements, and/or operates this data system?
13. In your opinion, what are the challenges that would have to be overcome, in implementing a nationally uniform 911 data system?
14. In your opinion, how would the existence of a nationally uniform 911 data system be beneficial in implementing Next Generation 911? Please be as specific as possible in providing examples.
15. Do you have any additional comments regarding this subject?
Department of Transportation.
Notice.
The Department of Transportation seeks member nomination for our National Advisory Committee on Travel and Tourism Infrastructure (NACTTI).
All nominations for NACTTI membership must be received on or before July 13, 2016.
All nomination material should be emailed to the Office of the Secretary at:
Any person requiring accessibility accommodations should contact the Office of the Secretary at (202) 366-5903 or email the NACTTI Designated Federal Official at
NACTTI Designated Federal Official, at
Pursuant to Section 1431 of the Fixing America's Surface Transportation (FAST) Act, the Secretary of Transportation established NACTTI on June 1, 2016, to provide information, advice, and recommendations to the Secretary on matters relating to the role of intermodal transportation in facilitating mobility related to travel and tourism activities. NACTTI will—
a. Advise the Secretary on current and emerging priorities, issues, projects, and funding needs related to the use of the intermodal transportation network of the United States to facilitate travel and tourism, taking into consideration existing data and recommendations on the U.S. transportation network including, but not limited, to DOT's 30-year Beyond Traffic framework.
b. Serve as a forum for discussion for travel and tourism stakeholders on transportation issues affecting interstate and interregional mobility of passengers;
c. Promote the sharing of information between the private and public sectors on transportation issues impacting travel and tourism;
d. Gather information, develop technical advice, and make recommendations to the Secretary on policies that improve the condition and performance of an integrated national transportation system that—
• Is safe, economical, and efficient; and
• maximizes the benefits to the United States generated through the travel and tourism industry;
e. Identify critical transportation facilities and corridors that facilitate and support the interstate and interregional transportation of passengers for tourism, commercial, and recreational activities;
f. Provide for development of measures of condition, safety, and performance for transportation related to travel and tourism;
g. Provide for development of transportation investment, data, and planning tools to assist Federal, State, and local officials in making investment decisions relating to transportation projects that improve travel and tourism; and
h. Address other issues of transportation policy and programs impacting the movement of travelers for tourism and recreational purposes, including by making legislative recommendations.
NACTTI shall be composed of no more than 25 members, each of whom shall be appointed by the Secretary of Transportation for a 2-year term. The membership shall include public and private sector stakeholders involved in the transportation and travel and tourism industries including, but not limited to:
• The travel and tourism industry, product and service providers;
• Travel and tourism-related associations;
• Travel, tourism, and destination marketing organizations;
• The travel and tourism-related workforce;
• State tourism offices;
• State departments of transportation;
• Regional and metropolitan planning organizations;
• Local governments;
• Organizations with expertise in intermodal connectivity for travel and tourism; and
• Entities with expertise in public-private-partnerships (P3).
The Department shall establish a Chair and Vice Chair of the Advisory Committee from among those selected representatives.
A selection team comprised of representatives from several DOT operating administrations will review nomination packages. The selection team will make recommendations regarding membership to the Secretary of Transportation based on criteria including, but not limited to:
• Professional or academic expertise, experience, and knowledge;
• Stakeholder representation;
• Availability and willingness to serve; and
• Experience and skills working collaboratively on committees and advisory panels.
Additional factors which will be considered in the selection of NACTTI members include candidates' proven experience in the strategic development and management of travel, tourism, transportation-related or other service-related organizations; or the candidate's proven experience in promoting, developing, and implementing advertising, marketing, or financial programs for travel, tourism or transportation-related industries.
Priority may be given to a Chief Executive Officer, Executive Director, or President (or comparable level of responsibility) of a U.S. company, U.S. organization, or U.S. entity in the travel, tourism, or transportation sectors.
Each NACTTI member shall serve as the representative of a U.S. entity engaged in any of the above-listed activities.
Members shall serve in a representative capacity, representing the views and interests of their particular industry subsector. NACTTI members are not Special Government Employees, and will receive no compensation for their participation in NACTTI activities. Members participating in NACTTI meetings and events will be responsible for their travel, living and other personal expenses. Meetings will be held regularly and, to the extent practical, not less than twice annually, usually in Washington, DC.
For immediate consideration for membership, please provide the following information by the Wednesday, July 13, 2016, deadline to the address listed in the
1. Name, title, and relevant contact information (including phone, fax, and email address) of the individual under consideration;
2. The company's, organization's, or entity's size, product or service line, and major markets in which the company, organization, or entity operates.
3. A letter of support or recommendation letter, on letterhead, from a company, union, trade or membership association, or non-profit organization containing a brief description of why the nominee should be considered for membership;
4. A one-page cover letter summarizing the applicant's unique experiences and qualifications, any professional and academic credentials, and the reason(s) why he or she would like to join NACTTI.
5. A resume for the individual under consideration.
Please do not send company, trade association, organization brochures or any other promotional information. Materials submitted should total five pages or less and must be in 12-point font, formatted in Microsoft Word or PDF. Should more information be needed, DOT staff will contact the nominee, obtain information from the nominee's past affiliations, or obtain information from publicly available sources, such as the Internet.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
In accordance with the requirements of the PRA, the OCC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently
The OCC is soliciting comment concerning the renewal of its information collection titled, “Notice Regarding Unauthorized Access to Customer Information.” The OCC also is giving notice that it has sent the collection to OMB for review.
Comments must be submitted on or before August 1, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0227, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0227, U.S. Office of Management and Budget, 725 17th Street NW., #10235, Washington, DC 20503, or by email to:
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219.
The OCC is proposing to extend the approval of the following information collection:
The Interagency Guidelines Establishing Information Security Standards, 12 CFR Part 30, Appendix B and Part 170, Appendix B (collectively, Security Guidelines), which implement section 501(b), require each entity supervised by the OCC (supervised institution) to consider and adopt a response program, as appropriate, that specifies actions to be taken when the supervised institution suspects or detects that unauthorized individuals have gained access to customer information.
The Interagency Guidance on Response Programs for Unauthorized Customer Information and Customer Notice (Breach Notice Guidance),
(1) Assessing the nature and scope of an incident and identifying what customer information systems and types of customer information have been accessed or misused;
(2) Notifying its primary Federal regulator as soon as possible when the supervised institution becomes aware of an incident involving unauthorized access to, or use of, sensitive customer information;
(3) Consistent with the OCC's Suspicious Activity Report regulations, notifying appropriate law enforcement authorities and filing a timely SAR in situations in which a Federal criminal violation requires immediate attention, such as when a reportable violation is ongoing;
(4) Taking appropriate steps to contain and control the incident in an effort to prevent further unauthorized access to, or use of, customer information, for example, by monitoring, freezing, or closing affected accounts, while preserving records and other evidence; and
(5) Notifying customers, as warranted.
This collection of information covers the notice provisions in the Breach Notice Guidance.
On April 12, 2016, the OCC issued a notice for 60 days regarding this collection, 81 FR 21666. No comments were received. Comments continue to be invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the information collection;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the renewal of an information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information
The OCC is soliciting comment concerning renewal of its information collection titled, “Examination Questionnaire.” The OCC also is giving notice that it has sent the collection to OMB for review.
Comments must be submitted by August 1, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0199, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0199, U.S. Office of Management and Budget, 725 17th Street NW., #10235, Washington, DC 20503, or by email to:
Shaquita Merritt, Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Washington, DC 20219.
The OCC is proposing to extend OMB approval for the following information collection:
The OCC provides each national bank or Federal savings association with an Examination Survey at the end of its supervisory cycle (12- or 18-month period). This information collection permits banks to assess the OCC's bank supervisory activities, including the:
• Effectiveness of OCC communications with the bank;
• Reasonableness of OCC requests for data and information;
• Quality of OCC decisionmaking during the exam process;
• Professionalism of OCC examining staff; and
• Responsiveness of OCC examiners.
The OCC developed the survey at the suggestion of the banking industry. Banking industry members expressed a desire to provide examination-related feedback to the OCC. The Comptroller of the Currency and OCC supervisory staff considered that suggestion and concurred. Further, the Comptroller of the Currency and OCC supervisory staff find this information collection to be an important tool for measuring OCC examination performance, designing more efficient and effective examinations, and targeting examiner training.
This information collection continues to formalize and promote a long-standing OCC program. The OCC always has given the institutions it supervises the opportunity to provide input regarding the examination process.
The Post Exit Survey is no longer being used and has been deleted from this collection.
The commenter stated that the collection has no practical utility and is not necessary for the proper performance of the functions of the OCC because it does not generate objective assessments of the OCC's performance. The commenter suggested that the OCC should discuss why the potential for retaliation does not bias the results of the questionnaire and limit its usefulness.
The commenter believed that the practical utility of the questionnaire would be improved if the OCC explained why the questionnaire is not offered to the general public, bank customers, or other stakeholders and why it believes that banks provide a more accurate assessment of OCC effectiveness and quality.
The commenter believed that burden could be minimized by eliminating the questionnaire and instead soliciting feedback from bankers through regular outreach activities and called on the OCC to discuss in its final issuance why it has not been eliminated.
The commenter stated that the OCC improves the quality, utility, and clarity of the information when it attentively responds to all significant public comments before finalizing rules. The commenter also believed that when the OCC leaves unclear whether it considered comments, the public record is incomplete and the OCC creates the perception that it makes final decisions on rules without considering the data, views, and arguments of others.
The questionnaire attempts to receive feedback from bankers on supervision areas they find most valuable and areas that could be improved. The feedback is not meant to be an objective method of collection because it will be based on individual bank's experiences with the OCC staff and processes. The collection is voluntary, and the OCC's Ombudsman oversees the data and maintains confidentiality of individual bank responses to prevent retaliation.
Bankers are best equipped to respond to the survey given the objective of the questionnaire to measure OCC's performance and progress in improving the supervisory experience and agency communications. Bankers are direct stakeholders in the OCC's supervisory process and have ongoing contact with the OCC's staff and processes to assess the agency's performance. The general public, bank customers, and other stakeholders do not have direct interaction with the OCC's supervisory process to assess the agency's performance.
The questionnaire is administered in combination with feedback solicited directly from bankers through regular outreach activities. The questionnaire provides bankers the ability to provide candid feedback on the entire supervisory process while preserving their identity from the OCC staff that directly supervises the institutions.
Comments continue to be invited on:
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the information collection burden;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information.
Office of the Comptroller of the Currency (OCC), Treasury.
Notice and request for comment.
The OCC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on a continuing information collection, as required by the Paperwork Reduction Act of 1995 (PRA).
An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number.
The OCC is soliciting comment concerning its information collection titled, “Community and Economic Development Entities, Community Development Projects, and Other Public Welfare Investments.” The OCC also is giving notice that it has sent the collection to OMB for review.
Comments must be submitted on or before August 1, 2016.
Because paper mail in the Washington, DC area and at the OCC is subject to delay, commenters are encouraged to submit comments by email, if possible. Comments may be sent to: Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, Attention: 1557-0194, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219. In addition, comments may be sent by fax to (571) 465-4326 or by electronic mail to
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not include any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
Additionally, please send a copy of your comments by mail to: OCC Desk Officer, 1557-0194, U.S. Office of Management and Budget, 725 17th Street NW., #10235, Washington, DC 20503, or by email to:
Shaquita Merritt, OCC Clearance Officer, (202) 649-5490 or, for persons who are deaf or hard of hearing, TTY, (202) 649-5597, Legislative and Regulatory Activities Division, Office of the Comptroller of the Currency, 400 7th Street SW., Suite 3E-218, Mail Stop 9W-11, Washington, DC 20219.
The OCC is proposing to extend OMB approval of the following information collection:
Section 24.5(a) provides that an eligible national bank may make an investment without prior notification to, or approval by, the OCC if the bank submits an after-the-fact notification of an investment within 10 days of making the investment.
Section 24.4(a) provides that a national bank may submit a written request or letter to the OCC to exceed the five percent limit for its aggregate, outstanding investments. The OCC may grant permission to the bank to make subsequent public welfare investments without prior notification to, or approval by the OCC, using the after-the-fact notification process consistent with Section 24.5(a).
Section 24.5(a)(5) provides that a national bank that is not an eligible bank, but that is at least adequately capitalized and has a composite rating of at least 3 with improving trends under the Uniform Financial Institutions Rating System, may submit a letter to the OCC requesting authority to submit after-the-fact notices of its investments.
Section 24.5(b) provides that if a national bank does not meet the requirements for after-the-fact notification, including if the bank's aggregate outstanding investments exceed the five percent limit, unless previously approved by the OCC for subsequent public welfare investments, the bank must submit an investment proposal to the OCC seeking permission to make the public welfare investment.
(a) Whether the collection of information is necessary for the proper performance of the functions of the OCC, including whether the information has practical utility;
(b) The accuracy of the OCC's estimate of the burden of the collection of information;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of the collection on respondents, including through the use of automated collection techniques or other forms of information technology; and
(e) Estimates of capital or startup costs and costs of operation, maintenance, and purchase of services to provide information.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 8288, U.S. Withholding Tax Return for Disposition by Foreign Persons of U.S. Real Property Interests, and Form 8288-A, Statement of Withholding on Dispositions by Foreign Persons of U.S. Real Property Interests.
Written comments should be received on or before August 29, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to Kerry Dennis at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet, at
Form 8288:
Form 8288A:
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning Form 6478, Biofuel Producer Credit.
Written comments should be received on or before August 29, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to LaNita Van Dyke at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the Internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103.
Internal Revenue Service (IRS), Treasury.
Notice and request for comments.
The Department of the Treasury, 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, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)). Currently, the IRS is soliciting comments concerning e-Services registration TIN matching—application and screens for TIN matching interactive.
Written comments should be received on or before August 29, 2016 to be assured of consideration.
Direct all written comments to Tuawana Pinkston, Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224.
Requests for additional information or copies of the form and instructions should be directed to LaNita Van Dyke, at Internal Revenue Service, Room 6526, 1111 Constitution Avenue NW., Washington, DC 20224, or through the internet at
The following paragraph applies to all of the collections of information covered by this notice:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless the collection of information displays a valid OMB control number. Books or records relating to a collection of information must be retained as long as their contents may become material in the administration of any internal revenue law. Generally, tax returns and tax return information are confidential, as required by 26 U.S.C. 6103
Internal Revenue Service, Treasury.
Notice.
Pursuant to 5 U.S.C. App. 2, section 10(d), of the Federal Advisory Committee Act, and 5 U.S.C. 552b, of the Government in the Sunshine Act, a report summarizing the closed meeting activities of the Art Advisory Panel during Fiscal Year 2015 has been prepared. A copy of this report has been filed with the Assistant Secretary for Management of the Department of the Treasury.
The report is available for public inspection and requests for copies should be addressed to: Internal Revenue Service, Freedom of Information Reading Room, Room 1621, 1111 Constitution Avenue NW., Washington, DC 20224, Telephone number (202) 622-5164 (not a toll free number). The report is also available at
Maricarmen R. Cuello, AP:SO:AAS, Internal Revenue Service/Appeals, 51 SW., 1st Avenue, Room 1014, Miami, FL 33130, Telephone number (305) 982-5364 (not a toll free number).
It has been determined that this document is not a major rule as defined in Executive Order 12291 and that a regulatory impact analysis is, therefore, not required. Additionally, this document does not constitute a rule subject to the Regulatory Flexibility Act (5 U.S.C. Chapter 6).
The Department of the Treasury will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, Public Law 104-13, on or after the date of publication of this notice.
Comments should be received on or before August 1, 2016 to be assured of consideration.
Send comments regarding the burden estimates, or any other aspect of the information collection, including suggestions for reducing the burden, to (1) Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for Treasury, New Executive Office Building, Room 10235, Washington, DC 20503, or email at
Copies of the submission may be obtained by emailing
The Pension Benefit Guaranty Corporation (PBGC), the Department of Labor (DOL), and the Internal Revenue Service (IRS) work together to produce Form 5500 Annual Return/Report for Employee Benefit Plan and Form 5500-SF Short Form Annual Return/Report for Small Employee Benefit Plan (Form 5500 Series), through which the regulated public can satisfy the combined reporting/filing requirements applicable to employee benefit plans. The IRS produces Form 5500-SUP, a paper-only form, that is used by certain sponsors and administrators of retirement plans to satisfy certain of the reporting requirements of section 6058 of the Internal Revenue Code. Form 5500-SUP should be used only if certain IRS compliance questions are not answered electronically on the Form 5500 or Form 5500-SF.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Special Medical Advisory Group will meet on September 1, 2016, at the Department of Veterans Affairs Central Office, 810 Vermont Ave. NW., Conference Room 830, Washington, DC 20420 from 8:00 a.m. to 4:00 p.m. ET. The meeting is open to the public.
The purpose of the Group is to advise the Secretary of Veterans Affairs and the Under Secretary for Health on the care and treatment of Veterans, and other matters pertinent to the Department's Veterans Health Administration (VHA).
The agenda for the meeting will include a review of MyVA Access, the Center for Compassionate Innovation/Fellowship Program, Strategic Partnerships and Rebuilding Relationships.
Thirty (30) minutes will be allocated for receiving oral presentations from the public. Members of the public may submit written statements for review by the Committee to Donna Wells-Taylor, Department of Veterans Affairs, Office of Specialty Care Services (10P4), Veterans Health Administration, 810 Vermont Avenue NW., Washington, DC 20420, or by email at
Because the meeting is being held in a VA Central Office, a photo I.D. is required at the entrance as a part of the clearance process. Therefore, you should plan to arrive 15 minutes before the meeting begins to allow time for the clearance process. Any member of the public wishing to attend the meeting or seeking additional information should contact Ms. Donna Wells-Taylor at (202) 461-1025 or by email.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Health Services Research and Development Service Scientific Merit Review Board will conduct in-person and teleconference meetings of its seven Health Services Research (HSR) subcommittees on the dates below from 8:00 a.m. to approximately 5:00 p.m. (unless otherwise listed) at the Hilton Crystal City, 2399 Jefferson Davis Highway, Crystal City, VA 22202 (unless otherwise listed):
• HSR 1—Health Care and Clinical Management on August 23-24, 2016;
• HSR 2—Behavioral, Social, and Cultural Determinants of Health and Care on August 23-24, 2016;
• HSR 3—Healthcare Informatics on August 24-25, 2016;
• HSR 4—Mental and Behavioral Health on August 23-24, 2016;
• HSR 5—Health Care System Organization and Delivery on August 24-25, 2016;
• HSR 6—Post-acute and Long-term Care on August 23, 2016;
• HSR 8—Randomized Program Evaluations from 8:00 a.m. to 12:00 p.m. on August 25, 2016; HSR 0—Precision Mental Health from 1:00 p.m. to 5:00 p.m. on August 25, 2016;
• CDA—Career Development Award Meeting on August 25-26, 2016; and
• NRI—Nursing Research Initiative from 1:00 p.m. to 5:00 p.m. on August 26, 2016.
** This notice is amended to reflect changes in one or more of the meetings (
The purpose of the Board is to review health services research and development applications involving: The measurement and evaluation of health care services; the testing of new methods of health care delivery and management; and nursing research. Applications are reviewed for scientific and technical merit, mission relevance, and the protection of human and animal subjects. Recommendations regarding funding are submitted to the Chief Research and Development Officer.
Each subcommittee meeting of the Board will be open to the public the first day for approximately one half-hour at the start of the meeting on August 23 (HSR 6), August 23-24 (HSR 1, 2, 4), August 24-25 (HSR 3, 5), August 25 (HSR 0, 6, 8), August 25-26 (CDA), and August 26 (NRI) to cover administrative matters and to discuss the general status of the program. Members of the public who wish to attend the open portion of the subcommittee meetings may dial 1-800-767-1750, participant code 10443#.
The remaining portion of each subcommittee meeting will be closed for the discussion, examination, reference to, and oral review of the intramural research proposals and critiques. During the closed portion of each subcommittee meeting, discussion and recommendations will include qualifications of the personnel conducting the studies (the disclosure of which would constitute a clearly unwarranted invasion of personal privacy), as well as research information (the premature disclosure of which would likely compromise significantly the implementation of proposed agency action regarding such research projects). As provided by subsection 10(d) of Public Law 92-463, as amended by Public Law 94-409, closing the meeting is in accordance with 5 U.S.C. 552b(c)(6) and (9)(B).
No oral or written comments will be accepted from the public for either portion of the meetings. Those who plan to participate during the open portion of a subcommittee meeting should contact Ms. Liza Catucci, Administrative Officer, Department of Veterans Affairs,
Centers for Medicare & Medicaid Services (CMS), HHS.
Proposed rule.
This rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) for calendar year 2017 as well as proposing to implement policies for coverage and payment for renal dialysis services furnished by an ESRD facility to individuals with acute kidney injury. This rule also proposes to set forth requirements for the ESRD Quality Incentive Program, and proposes to establish and revise requirements for quality reporting and measurement, including the inclusion of new quality measures for payment year (PY) 2020 and beyond and updates to programmatic policies for the PY 2018 and PY 2019 ESRD QIP. This rule also proposes to implement statutory requirements for bid surety bonds and state licensure for the Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) Competitive Bidding Program (CBP). This rule also proposes to expand suppliers' appeal rights in the event of a breach of contract action by CMS. In particular, this rule proposes a revision to current regulations to provide that the appeals process is applicable to all breach of contract actions taken by CMS, rather than just for the termination of a competitive bidding contract. It also proposes changes to the methodologies for adjusting fee schedule amounts for DMEPOS using information from Competitive Bidding Programs and for submitting bids and establishing single payment amounts under the Competitive Bidding Programs for certain groupings of similar items with different features. Changes are also proposed to the methodology for establishing bid limits for items under the DMEPOS Competitive Bidding Programs. In addition, this rule also solicits comments on the impacts of coordinating Medicare and Medicaid Durable Medical Equipment for dually eligible beneficiaries. Finally, this rule announces a request for information related to the Comprehensive ESRD Care Model and future payment models affecting renal care.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on August 23, 2016.
In commenting, please refer to file code CMS-1651-P. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (please choose only one of the ways listed):
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2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a. For delivery in Washington, DC—
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
For information on viewing public comments, see the beginning of the
Janae James, (410) 786-0801 or Michelle Cruse, (410) 786-7540, for issues related to the ESRD PPS, and coverage and payment for renal dialysis services furnished to individuals with AKI.
Tamyra Garcia, (410) 786-0856, for issues related to the ESRD QIP.
Julia Howard, (410) 786-8645, for issues related to DMEPOS CBP and bid surety bonds, state licensure, and the appeals process for breach of DMEPOS CBP contract actions.
Anita Greenberg, (410) 786-4601, or Hafsa Vahora, (410) 786-7899, for issues related to competitive bidding and payment for similar DMEPOS items with different features and bid limits.
Kristen Zycherman, for issues related to DME access issues.
Tom Duvall, (410) 786-8887 or email
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
This
To assist readers in referencing sections contained in this preamble, we are providing a Table of Contents. Some of the issues discussed in this preamble affect the payment policies, but do not require changes to the regulations in the Code of Federal Regulations (CFR).
Because of the many terms to which we refer by acronym in this proposed rule, we are listing the acronyms used and their corresponding meanings in alphabetical order below:
On January 1, 2011, we implemented the ESRD PPS, a case-mix adjusted, bundled prospective payment system for renal dialysis services furnished by ESRD facilities. This rule proposes to update and make revisions to the End-Stage Renal Disease (ESRD) prospective payment system (PPS) for calendar year (CY) 2017. Section 1881(b)(14) of the Social Security Act (the Act), as added by section 153(b) of the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA) (Pub. L. 110-275), and section 1881(b)(14)(F) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act Pub. L. 111-148), established that beginning CY 2012, and each subsequent year, the Secretary shall annually increase payment amounts by an ESRD market basket increase factor, reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act.
On June 29, 2015, the President signed the Trade Preferences Extension Act of 2015 (TPEA) (Pub. L. 114-27). Section 808(a) of TPEA amended section 1861(s)(2)(F) of the Act to provide coverage for renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or a provider of services paid under section 1881(b)(14) to an individual with AKI. Section 808(b) of TPEA amended section 1834 of the Act by adding a new paragraph (r) of the Act that provides for payment for renal dialysis services furnished by renal dialysis facilities or providers of services paid under section 1881(b)(14) to individuals with AKI at the ESRD PPS base rate beginning January 1, 2017.
This rule also proposes to set forth requirements for the ESRD QIP, including for payment years (PYs) 2018, 2019, and 2020. The program is authorized under section 1881(h) of the Social Security Act (the Act). The ESRD QIP is the most recent step in fostering improved patient outcomes by establishing incentives for dialysis facilities to meet or exceed performance standards established by CMS.
This rule proposes to implement statutory requirements for Bid Surety Bonds and State Licensure. This rule also proposes to expand suppliers' appeal rights in the event of a breach of contract determination to allow suppliers to appeal any breach of contract action CMS takes, rather than just a termination action. To effect this policy change, we propose revisions to the regulations to provide that the appeals process applies to all breach of contract actions that CMS may take.
This rule proposes to adjust the methodology for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from DMEPOS competitive bidding programs (CBPs), submitting bids and determining single payment amounts for certain groupings of similar items with different features under the DMEPOS CBPs, and establishing bid limits for individual items under the DMEPOS CBP.
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We are implementing the TPEA amendments to sections 1834(r) and 1861(s)(2)(F) by proposing to cover renal dialysis services furnished by renal dialysis facilities paid under section 1881(b)(14) of the Act to individuals with acute kidney injury. We are also proposing to pay ESRD facilities for renal dialysis services furnished to individuals with acute kidney injury at the amount of the ESRD PPS base rate, as adjusted by the ESRD PPS wage index. In addition, drugs, biologicals, and laboratory services that ESRD facilities are certified to furnish, but that are not renal dialysis services, may be paid for separately when furnished by ESRD facilities to individuals with AKI. In addition, because AKI patients are often under the care of a hospital, physician, or other practitioner, these providers could continue to bill Medicare for services outside of the ESRD PPS payment rate.
This rule proposes to set forth requirements for the ESRD QIP, including for payment years (PYs) 2018, 2019 and 2020.
Specifically, for PY 2019 we are proposing to assign 15 percent of a facility's TPS to the proposed Safety Measure Domain, 75 percent of the TPS to the Clinical Measure Domain and 10 percent to the Reporting Measure Domain. To accommodate the removal of the Safety Subdomain from the Clinical Measure Domain, we are proposing to adjust individual measure weights for the measures that remain in the Clinical Measure Domain. For PY 2020, we are proposing to reduce the weight of the Safety Measure Domain to 10 percent of a facility's Total Performance Score. This modification, in combination with the proposed addition of the SHR measure necessitates further adjustments to individual measure weights in the Clinical Measure Domain.
For PY 2019, we are also proposing to increase the size of the NHSN BSI Data Validation study. Specifically, we propose to randomly select 35 facilities to participate in an NHSN dialysis event validation study for two quarters of data reported in CY 2017. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period, as well as randomly selected patient records. Each facility selected will be required to submit 10 records total to the validation contractor. The CMS contractor will utilize a methodology for reviewing and validating the candidate events and will analyze those records to determine whether the facility reported dialysis events for those patients in accordance with the NHSN Dialysis Event Protocol. Information from the validation study may be used to develop a methodology to score facilities based on the accuracy of their reporting of the NHSN BSI measure.
This proposed rule proposes to implement statutory requirements for the DMEPOS CBP for bid surety bonds and state licensure. In addition, we are proposing to define the term “bidding entity” for purposes of the DMEPOS CBP. We also propose to expand suppliers' appeal rights in the event of a breach of contract determination to allow suppliers to appeal any breach of contract action CMS takes, rather than just a termination action. We propose revisions to the regulations to extend the appeals process to all competitive bidding breach of contract actions.
• A bidding entity must obtain a bid surety bond from an authorized surety on the Department of the Treasury's Listing of Certified Companies, submit proof of the surety bond by the deadline for bid submission, and the bond must meet certain specifications. We are proposing to define the term “bidding entity” to mean the entity whose legal business name is identified in the “Form A: Business Organization Information” section of the bid.
• If the bidding entity is offered a contract for any product category for a competitive acquisition area (herein referred to as a “Competitive Bidding Area” or “CBA”), and its composite bid for such product category and area is at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category/CBA combination (herein also referred to as “competition”), and the entity does not accept the contract offered, the entity's bid surety bond for the applicable CBA will be forfeited and CMS will collect on the bid surety bond via Electronic Funds Transfer from the respective authorized surety. If the forfeiture conditions are not met, the bond liability will be returned to the bidding entity. Bidding entities that provide a falsified bid surety bond will be prohibited from participation in the DMEPOS CBP for the current round of the CBP in which they submitted a bid and also from bidding in the next round of the CBP. Bidding entities that provide a falsified bid surety bond will also be referred to the Office of Inspector General and Department of Justice for further investigation.
• We propose to conform the language of our regulation at 42 CFR 414.414(b)(3) to the language of section 1847(b)(2)(A)(v) of the Act, as added by section 522 of MACRA, which requires bidding entities to meet applicable State licensure requirements in order to be eligible for a DMEPOS CBP contract. We note, however, that this does not reflect a change in policy as CMS already has a regulation in place to require suppliers to meet applicable State licensure requirements.
• Appeals process for breach of DMEPOS CBP contract actions would extend the appeals process, specified in § 414.423, that currently only applies to contract terminations to all breach of contract actions taken by CMS and specified in § 414.422(g)(2). We propose to revise § 414.422(g)(2) to eliminate certain breach of contract actions for the reasons explained below. We also propose to revise 414.423(l) to describe the effects of certain breach of contract actions CMS may take.
This rule proposes to set forth requirements for the CBP and Fee Schedule Adjustments.
• Methodologies for Adjusting DMEPOS Fee Schedule Amounts for Certain Groupings of Similar Items with Different Features using Information from Competitive Bidding Programs: Within the Healthcare Common Procedure Coding System (HCPCS), there are many instances where there are multiple codes for an item that are distinguished by the addition of a feature (for example, non-powered versus powered mattress, Group 1 versus Group 2 power wheelchair, pump without alarm versus pump with alarm, walker without wheels versus walker with wheels, etc.) Under CBPs, the code with the higher utilization (typically the item with additional features and higher fee schedule amounts) receives a higher weight and the bid for this item has a greater impact on the supplier's composite bid than the bids for the less frequently used codes. This is resulting in price inversions where the single payment amounts (SPAs) for the item without the feature are higher than the SPAs for the item with the feature. This could lead to a program vulnerability by shifting beneficiaries from products with features to less appropriate products without the features because the latter receives higher payment under competitive bidding. We are proposing to limit SPAs for items without a feature to the weighted average of the SPAs for the items both with and without the feature prior to using the SPAs in adjusting the fee schedule amounts for certain groupings of similar items specified below. The item weights would be the same weights used in calculating the composite bids under the CBP.
• Submitting Bids and Determining Single Payment Amounts for Certain Groupings of Similar Items with Different Features under the DMEPOS CBP: This proposal addresses the price inversions under competitive bidding to prevent situations where beneficiaries receive items with fewer features at a higher price than items with more features. In addition to affecting the appropriateness of items supplied to beneficiaries, these price inversions also undermine the CBP and diminish the savings intended from implementation of the program. We are proposing to revise the provisions of § 414.408 to add a lead item bidding methodology where all of the HCPCS codes for similar items with different features would be
• Bid Limits for Individual Items under the DMEPOS CBP: Current regulations require that bids submitted by suppliers under the CBP be lower than the amount that would otherwise apply (that is, the fee schedule amount). This ensures that total payments expected to be made to contract suppliers in a CBA are less than the total amounts that would otherwise be paid, which is a condition mandated by the section 1847(b) of the Act for awarding contracts under the program in an area. Beginning in 2016, the fee schedule amounts for DMEPOS items and services are adjusted based on information from the CBPs. We indicated in the final rule (79 FR 66232), which was published in the
In section XVI.A of this proposed rule, we set forth a detailed analysis of the impacts that the proposed changes would have on affected entities and beneficiaries. The impacts include the following:
The impact chart in section XVI.B.1 of this proposed rule displays the estimated change in payments to ESRD facilities in CY 2017 compared to estimated payments in CY 2016. The overall impact of the CY 2017 changes is projected to be a 0.5 percent increase in payments. Hospital-based ESRD facilities have an estimated 0.7 percent increase in payments compared with freestanding facilities with an estimated 0.5 percent increase.
We estimate that the aggregate ESRD PPS expenditures would increase by approximately $50 million from CY 2016 to CY 2017. This reflects a $30 million increase from the payment rate update and a $20 million increase due to the updates to the outlier threshold amounts. As a result of the projected 0.5 percent overall payment increase, we estimate that there will be an increase in beneficiary co-insurance payments of 0.5 percent in CY 2017, which translates to approximately $10 million.
We anticipate an estimated $2.0 million being redirected from hospital outpatient departments to ESRD facilities in CY 2017 as a result of some AKI patients receiving renal dialysis services in the ESRD facility at the lower ESRD PPS base rate versus continuing to receive those services in the hospital outpatient setting.
We estimate that the overall economic impact of the ESRD QIP will be approximately $15.5 million in PY 2019 and $113 million in PY 2020. The $15.5 million figure for PY 2019 includes costs associated with the collection of information requirements, which we estimate will be approximately $21 thousand.
The ESRD QIP will continue to incentivize facilities to provide high-quality care to beneficiaries.
The DMEPOS CBP bidding entities will be impacted by the bid surety bond requirement as they will be required to purchase a bid surety bond for each CBA in which they are submitting a bid. The state licensure requirement will have no new impact on the supplier community because this is already a Medicare DMEPOS supplier requirement and the appeals process for a breach of a DMEPOS CBP contract action(s) is expected to have a beneficial, positive impact on suppliers.
Overall, the bid surety bond requirement may have a positive financial impact on the program as CMS anticipates that the requirement will encourage all bidding entities to submit substantiated bids. However, there will be an administrative burden for implementation of the bid surety bond requirement for CMS. The state licensure and appeals process for breach of DMEPOS CBP contract actions proposals will have minimal administrative costs.
We do not anticipate that the proposed DMEPOS CBP regulations for bid surety bonds, state licensure, and the appeals process for breach of DMEPOS CBP contract actions will have an impact on Medicare beneficiaries.
The overall economic impact for the proposed changes to the DMEPOS CBPs and Fee Schedule Adjustments would be about $20 million dollars in savings to the Part B Trust Fund over five years beginning January 1, 2017. The savings is a result of avoiding price inversions. This proposal should have a minor impact on the suppliers of CBAs and in the non-competitive bidding areas (non-CBAs). Beneficiaries would have lower coinsurance payments and receive the most appropriate items as a result of this proposal.
On January 1, 2011, we implemented the End-Stage Renal Disease (ESRD) Prospective Payment System (PPS), a case-mix adjusted bundled PPS for renal dialysis services furnished by ESRD
Section 632 of the American Taxpayer Relief Act of 2012 (ATRA) (Pub. L. 112-240) included several provisions that apply to the ESRD PPS. Section 632(a) of ATRA added section 1881(b)(14)(I) to the Act, which required the Secretary, by comparing per patient utilization data from 2007 with such data from 2012, to reduce the single payment for renal dialysis services furnished on or after January 1, 2014 to reflect the Secretary's estimate of the change in the utilization of ESRD-related drugs and biologicals (excluding oral-only ESRD-related drugs). Consistent with this requirement, in the CY 2014 ESRD PPS final rule we finalized $29.93 as the total drug utilization reduction and finalized a policy to implement the amount over a 3- to 4-year transition period (78 FR 72161 through 72170).
Section 632(b) of ATRA prohibited the Secretary from paying for oral-only ESRD-related drugs and biologicals under the ESRD PPS prior to January 1, 2016. And section 632(c) of ATRA required the Secretary, by no later than January 1, 2016, to analyze the case-mix payment adjustments under section 1881(b)(14)(D)(i) of the Act and make appropriate revisions to those adjustments.
On April 1, 2014, Congress enacted the Protecting Access to Medicare Act of 2014 (PAMA) (Pub. L. 113-93). Section 217 of PAMA included several provisions that apply to the ESRD PPS. Specifically, sections 217(b)(1) and (2) of PAMA amended sections 1881(b)(14)(F) and (I) of the Act and replaced the drug utilization adjustment that was finalized in the CY 2014 ESRD PPS final rule (78 FR 72161 through 72170) with specific provisions that dictated the market basket update for CY 2015 (0.0 percent) and how the market basket should be reduced in CYs 2016 through CY 2018.
Section 217(a)(1) of PAMA amended section 632(b)(1) of ATRA to provide that the Secretary may not pay for oral-only ESRD-related drugs under the ESRD PPS prior to January 1, 2024. Section 217(a)(2) further amended section 632(b)(1) of ATRA by requiring that in establishing payment for oral-only drugs under the ESRD PPS, the Secretary must use data from the most recent year available. Section 217(c) of PAMA provided that as part of the CY 2016 ESRD PPS rulemaking, the Secretary shall establish a process for (1) determining when a product is no longer an oral-only drug; and (2) including new injectable and intravenous products into the ESRD PPS bundled payment.
Finally, on December 19, 2014, the President signed the Stephen Beck, Jr., Achieving a Better Life Experience Act of 2014 (ABLE) (Pub. L. 113-295). Section 204 of ABLE amended section 632(b)(1) of ATRA, as amended by section 217(a)(1) of PAMA, to provide that payment for oral-only renal dialysis services cannot be made under the ESRD PPS bundled payment prior to January 1, 2025.
Under the ESRD PPS, a single, per-treatment payment is made to an ESRD facility for all of the renal dialysis services defined in section 1881(b)(14)(B) of the Act and furnished to individuals for the treatment of ESRD in the ESRD facility or in a patient's home. We have codified our definitions of renal dialysis services at 42 CFR 413.171 and our other payment policies are included in regulations in subpart H of 42 CFR part 413. The ESRD PPS base rate is adjusted for characteristics of both adult and pediatric patients and accounts for patient case-mix variability. The adult case-mix adjusters include five categories of age, body surface area (BSA), low body mass index (BMI), onset of dialysis, four co-morbidity categories, and pediatric patient-level adjusters consisting of two age categories and two dialysis modalities (42 CFR 413.235(a) and(b)).
In addition, the ESRD PPS provides for three facility-level adjustments. The first payment adjustment accounts for ESRD facilities furnishing a low volume of dialysis treatments (42 CFR 413.232). The second adjustment reflects differences in area wage levels developed from Core Based Statistical Areas (CBSAs) (42 CFR 413.231). The third payment adjustment accounts for ESRD facilities furnishing renal dialysis services in a rural area (42 CFR 413.233).
The ESRD PPS allows for a training add-on for home and self-dialysis modalities (42 CFR 413.235(c)). Lastly, the ESRD PPS provides additional payment for high cost outliers due to unusual variations in the type or amount of medically necessary care when applicable (42 CFR 413.237).
Policy changes to the ESRD PPS are proposed and finalized annually in the
On November 6, 2015, we published in the
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Since the composite rate payment system was implemented in the 1980s, we have reimbursed ESRD facilities for up to three hemodialysis (HD) treatments per week and only paid for weekly dialysis treatments beyond this limit when those treatments were medically justified due to the presence of specific comorbid diagnoses that necessitate additional dialysis treatments (see paragraph (d) of this section). When we implemented the ESRD PPS in 2011, we adopted a per treatment unit of payment (75 FR 49064). This per treatment unit of payment is the same base rate that is paid for all dialysis treatment modalities furnished by an ESRD facility (HD and the various forms of peritoneal dialysis (PD)) (75 FR 49115). Consistent with our policy since the composite rate payment system was implemented in the 1980s, we also adopted the 3-times weekly payment limit for HD under the ESRD PPS (74 FR 49931). When a beneficiary's plan of care requires more than 3 weekly dialysis treatments, whether HD or daily PD, we apply payment edits to ensure that Medicare payment on the monthly claim is consistent with the 3-times weekly dialysis treatment payment limit. Thus, for a 30-day month, payment is limited to 13 treatments, and for a 31-day month payment is limited to 14 treatments.
Because PD is typically furnished more frequently than HD, we calculate HD-equivalent payment rates for PD that are based on the ESRD PPS base rate per treatment. To do this, we adjust the base rate by any applicable patient- or facility-level adjustments, and then multiply the adjusted base rate by 3 (the weekly treatment limit), and divide this number by 7. This approach creates a per treatment amount that is paid for each day of PD treatment and that complies with the monthly treatment payment limit. With regard to HD, because we do not have a payment mechanism for the ESRD facility to bill and be paid for every treatment furnished when more than 3 treatments are furnished per week (for example, how they bill daily for PD), we apply edits to the monthly claim so that in total for the month (as described above) Medicare does not make payment for more than 3 weekly HD treatments. In the situation where an ESRD facility bills for more than 3 weekly HD treatments (or more than 13 or 14 for the month, depending on the days in the month) without medical justification, we deny payment for the additional HD treatments. We calculate HD-equivalent payments for PD so that the amount we pay for dialysis is modality-neutral. As we explained in the CY 2011 ESRD PPS final rule (75 FR 49115), we chose not to use dialysis modality as a payment variable when we developed the ESRD PPS because utilizing one dialysis-neutral payment resulted in a slightly higher payment for PD than a modality-specific payment, which we believed would encourage home dialysis, which is typically PD.
In recent years, ESRD facilities have increasingly begun to offer HD where the standard treatment regimen exceeds 3 treatments per week. At the same time, we observed variation in how MACs processed claims for HD treatments exceeding three treatments per week, resulting in payment of more than 13 or 14 treatments per month. As a result, in the CY 2015 ESRD PPS final rule (79 FR 66145 through 66147), we reminded ESRD facilities and MACs that the Medicare ESRD benefit allows for the payment of 3 weekly dialysis treatments, and that additional weekly dialysis treatments may be paid only if there is documented medical justification. Additional conventional HD treatments are reimbursed at the full ESRD PPS payment if the facility's Medicare Administrative Contractor (MAC) determines the treatments are medically justified based on a patient condition, such as congestive heart failure or pregnancy. MACs have developed local coverage determinations and automated processes to pay for all the treatments reported on the claim if the ESRD facility reports diagnoses determined by the MAC to medically justify treatments beyond 3 times per week.
The option to furnish more than 3 HD treatments per week is the result of evolving technology. We believe that use of this treatment option provides a level of toxin clearance on a weekly basis similar to that achieved through 3-times weekly conventional in-center HD. However, HD treatments exceeding three times per week are generally shorter and afford patients greater flexibility in managing their ESRD and other activities. As stated above, under the ESRD PPS, we currently do not have a payment mechanism that could apply a 3 treatments-per week equivalency to claims for patients with prescriptions for more than 3 HD treatments per week that do not have medical justification (see paragraph (d) of this section). As a result, the additional payments for treatments beyond 3 per week are
ESRD facilities have expressed concern that due to the monthly payment limit of 13 or 14 treatments, they are unable to report all dialysis treatments on their monthly claim, and therefore, they are not appropriately paid for each treatment furnished. We understand ESRD facilities' concerns and also would like to ensure that facilities are able to accurately report all of the treatments they furnish. Therefore, we analyzed 2015 ESRD facility claims data and found that there is a discrepancy between treatments furnished and treatments billed and paid for HD patients. The data indicate that HD patients are receiving HD treatments in excess of 3 per week, but facilities are usually only being paid for 3 treatments per week. The creation of an equivalency payment mechanism serves multiple purposes. First, it allows for payment for situations in which more than 3 HD treatments are furnished in a week that complies with the 3 treatment per week payment limit. Second, it encourages facilities to report all treatments furnished. This, in turn, would provide us with the information necessary to determine exactly how many treatments are being furnished. Finally, it would allocate the total amount of payment based on 3 HD sessions per week in accordance with the number of treatments actually furnished. For these reasons, we are proposing a payment equivalency for HD treatment regimens when more than 3 treatments are furnished per week, similar to the HD-equivalency payment that has been used for PD since the composite rate payment system was implemented in 1983. As discussed in paragraph (d) of this section, while the policy would be effective January 1, 2017, we are proposing not to implement the HD equivalency payments until July 1, 2017. We believe it is necessary to delay implementation of this policy until July 1, 2017 to allow time to make operational changes to accommodate this new payment mechanism. We would expect that, for dates of service between January 1, 2017 and July 1, 2017, facilities would continue to submit claims under the current claims submission parameters. Once the operational elements are implemented on July 1, 2017, facilities will be expected to have the appropriate billing systems in place to accommodate claims submission changes. Educational materials will be distributed to stakeholders as the claims processing changes are implemented.
For CY 2017, for adult patients, we propose to calculate a per treatment payment amount that would be based upon the number of treatments prescribed by the physician and would be composed of the ESRD PPS base rate as adjusted by applicable patient and facility-level adjustments, the home dialysis training add-on (if applicable), and the outlier payment adjustment (if applicable). As discussed above, the policy would be effective on January 1, 2017, but the operational elements would be implemented no later than July 1, 2017 to give interested parties time to operationalize the changes. For dates of service from January 1, 2017 through June 30, 2017, facilities would submit claims consistent with current payment limits. On July 1, 2017, the operational changes will be implemented and facilities would be expected to submit claims in compliance with the new policy where more than 3 HD treatments can be billed for a week and paid using the HD equivalency payment. To calculate the equivalency payment where more than 3 HD treatments are furnished per week, we would first adjust the ESRD PPS base rate by the applicable patient-level adjustments (patient age, body surface area, low body mass index, comorbidities—acute and chronic, and onset of dialysis) and facility-level adjustments (wage index, rural facility, and low-volume facility). Second, we would multiply the adjusted ESRD PPS base rate by 3 to develop the weekly treatment amount and then we would divide this number by the number of treatments prescribed to determine the per treatment amount. Third, we would multiply the calculated outlier payment amount by 3 and divide this number by the number of treatments prescribed to determine the per treatment outlier amount. Finally, we would add the per-treatment ESRD PPS base rate and the per treatment outlier amount together to determine the final per treatment payment amount. For example, a beneficiary whose prescription indicates 5 treatments per week would be paid as follows: (Adjusted Base Rate *
While we are proposing an equivalency payment based on 3 HD treatments per week, ESRD facilities submit bills monthly and, as a result, the monthly maximums presented below are the treatment limits that would be applied to 30-day and 31-day months:
In order to accommodate this proposed policy change, we would establish new claim processing guidelines and edits that would allow facilities to report the prescribed number of HD treatments for each patient. There would be individual claims processing system identifiers established for treatments provided 4 times per week, 5 times per week, 6 times per week, and 7 times per week. These identifiers would allow the claims processing system to adjust the payment calculation and allow the appropriate payment for each treatment.
We are proposing that this policy change would be effective on January 1, 2017 but implemented on July 1, 2017, in order to allow sufficient time for CMS and ESRD facilities to implement necessary operational and systems changes. We recognize that this is a substantial change for the ESRD facility's billing systems and for the MACs and we want to allow ample time for changes to be implemented.
While the majority of ESRD patients are prescribed conventional 3-times-per-week HD, we have always recognized that some patient conditions benefit from more than 3 HD sessions per week and as such, we developed a policy for payment of medically necessary dialysis treatments beyond the 3-treatments-per-week payment limit. Under this policy, the MACs determine whether additional treatments furnished during a month are medically necessary and when the MACs determine that the additional treatments are medically justified, we pay the full base rate for the additional treatments. While Medicare does not define specific patient conditions that meet the requirements of medical necessity, the MACs consider appropriate patient conditions that would result in a patient's medical need for additional dialysis treatments (for example, excess fluid). When such patient conditions are indicated on the claim, we instruct MACs to consider medical justification and the appropriateness of payment for the additional sessions.
Extra treatments that are medically justifiable would be for conditions such as congestive heart failure. The medical necessity for additional dialysis sessions must be documented in the patient's medical record at the dialysis facility and available for review upon request. The documentation should include the physician's progress notes, the dialysis records and the results of pertinent laboratory tests. The submitted medical record must support the use of the diagnosis code(s) reported on the claim and the medical record documentation must support the medical necessity of the services. This documentation would need to be available to the contractor upon request.
In section 50.A of the Medicare Benefit Policy Manual (Pub. 100-02), we explain our policy regarding payment for HD-equivalent PD and payment for more than 3 dialysis treatments per week under the ESRD PPS. This proposal does not affect our policy to pay the full ESRD PPS base rate for medically justified treatments beyond 3 treatments per week. Rather, the intent of this proposal is to provide a mechanism for payment for evolving technologies that provide for a different schedule of treatments that accommodate a patient's preference and thereby improve that patient's quality of life. In the event that a beneficiary receives traditional HD treatments in excess of 3 per week without medical justification for the additional treatments, these additional treatments will not be paid.
Beneficiary training is crucial for the long-term efficacy of home dialysis. Under our current policy for PD training, we pay the full ESRD PPS base rate, not the daily HD-equivalent payment amount, for each PD training treatment a beneficiary receives up to the limit of 15 training treatments for PD. As we stated in the CY 2011 ESRD PPS final rule (75 FR 49056) we pay the full ESRD PPS base rate during training because it is the base rate that accounts for the costs involved in furnishing the treatment and the add-on accounts for the additional staffing costs that are incurred. As we discuss in section II.B.2, we are investigating payments and costs related to training and plan to refine training payments in the future. Until that time, we believe that paying the full base rate during training continues to support home dialysis modalities. When training accompanies HD treatments exceeding 3 per week, the training would continue to be limited to 25 sessions, in accordance with our policy for training for conventional HD.
Because the home dialysis training add-on under the ESRD PPS (described in more detail in section II.B.2 of this proposed rule) is applied to each treatment on training claims up to the applicable limits for HD or PD, we anticipate that ESRD facilities will appreciate the ability to receive payment for each training treatment when more than 3 HD treatments are furnished per week and training is furnished with each of those treatments. We believe this effect of our proposed policy would be beneficial to facilities and beneficiaries receiving HD treatment more than 3 times per week because, as mentioned above, under our current policy, our claim edits only allow payment for 13 or 14 HD treatments in a monthly billing cycle. This means that ESRD facilities can only bill for 13 or 14 treatments for the month and may not receive the full number of home dialysis training add-on for the treatments that would otherwise be billable because of these payment limits. We believe that permitting facilities to bill for training treatments that are furnished to beneficiaries receiving more than 3 HD treatments per week will allow these facilities to receive payment for training more consistently with how they are furnishing these treatments. We expect ESRD facilities to engage patients in the decision making process for determining the best candidates for additional weekly hemodialysis beyond 3 treatments per week and thoroughly discuss with the patient the potential benefits and adverse effects associated with more frequent dialysis. For example, while there could be potential quality of life and physiological benefits there is also risk of a possible increase in vascular access procedures and the potential for hypotension during dialysis.
We believe this proposed payment mechanism, if finalized, would provide several benefits. Facilities would be able to bill for treatments accurately and be paid appropriately for the treatments they furnish. This policy would provide clarity for the MACs and providers on billing and payment for HD regimens that exceed 3 treatments per week and assist MACs in determining which HD treatments should be paid at the equivalency payment rate and which HD treatments should be paid at the full base rate because the facility has provided adequate evidence of medical justification. Beneficiaries and facilities would have more flexibility to request and furnish patient-centered treatment options. Finally, the proposal would increase the accuracy of payments and data and would provide CMS the ability to monitor outcomes for beneficiaries utilizing various treatment frequencies.
In 2014, Medicare paid approximately $30 million to ESRD facilities for home and self-dialysis training claims, $6 million of which is in the form of home dialysis training add-on payments. These payments accounted for 115,593 dialysis training treatments (77,481 peritoneal dialysis (PD) training treatments and 38,112 hemodialysis (HD) training treatments) for 12,829 PD beneficiaries and 2,443 HD beneficiaries. Hereinafter, we will refer to this training as home dialysis training. Under the ESRD PPS, there are three components to payment for home dialysis training: The base rate, a wage-
When the ESRD PPS was implemented in 2011, we proposed that the cost for all home dialysis services would be included in the bundled payment (74 FR 49930), and therefore, the computation of the base rate included home dialysis training add-on payments made to facilities as well as all composite rate payments, which account for facility costs associated with equipment, supplies, and staffing. In response to public comments, in the CY 2011 ESRD PPS final rule, we noted that although we were continuing to include training payments in computing the ESRD PPS base rate, we agreed with commenters that we should treat training as an adjustment under the ESRD PPS. Accordingly, we finalized the home dialysis training add-on amount of $33.44 per treatment as an additional payment made under the ESRD PPS when one-on-one home dialysis training is furnished by a nurse for either HD or PD training or retraining (75 FR 49063). In addition, we continued the policy of paying the home dialysis training add-on payment for 15 training treatments for PD and 25 training treatments for HD. In 2011, the amount we finalized for the home dialysis training add-on was $33.44, which was updated from the previous adjustment amount of $20. This updated amount of $33.44 per treatment was based on the national average hourly wage for nurses from the Bureau of Labor Statistics data updated to 2011 (75 FR 49063), and reflects 1 hour of training time by a registered nurse (RN) for both HD and PD. Section 494.100(a)(2) of the Conditions for Coverage for ESRD Facilities stipulates that the RN must conduct the home dialysis training, but in the ESRD Program Interpretive Guidance published October 3, 2008 (
The $33.44 amount of the home dialysis training add-on was based on the national mean hourly wage for Registered Nurses as published by the Occupational Employment Statistics (OES) data compiled by the Bureau of Labor Statistics (BLS). This mean hourly wage was then inflated to 2011 by the ESRD wages and salaries proxy used in the 2008-based ESRD bundled market basket. In the calendar year (CY) 2014 ESRD PPS final rule (78 FR 72185), CMS further increased this amount from $33.44 to $50.16 to reflect 1.5 hours of training time by an RN in response to stakeholder concerns that the training add-on was insufficient. The $50.16 training add-on amount was consistent with average costs based on an analysis of pre-PPS cost report data.
In response to the CY 2016 ESRD PPS proposed rule, we received a significant number of stakeholder comments concerning the adequacy of the home dialysis training add-on for HD. Because we did not make any proposals regarding the home dialysis training add-on in the CY 2016 ESRD PPS proposed rule, we made no changes to the home dialysis training add-on for CY 2016 but we did provide a history of the home dialysis training add-on and stated our intention to conduct further analysis of the adjustment.
While some commenters, primarily patients on home HD and a manufacturer of home HD machines, requested that we increase the home dialysis training add-on payment adjustment so that more ESRD patients could receive the benefit of home HD, we also heard from large dialysis organizations (LDOs) that the current home dialysis training add-on amount is sufficient. In addition to these differing viewpoints, we received public comments indicating a wide variance in training hours per treatment and the number of training sessions provided. As we indicated in the CY 2016 ESRD PPS final rule (80 FR 69004), patients who have been trained for home HD and their caregivers have stated that the RN training time per session spanned from 2 to 6 hours per training treatment and the number of training sessions ranged from 6 to 25 sessions. Home HD patients also acknowledged that the training they received took place in a group setting, indicating perhaps that the amount of hands-on RN training time gradually decreased over the course of training so that by the end of training, the patient was able to perform home dialysis independently.
In order to incentivize the use of PD when medically appropriate, Medicare pays the same home dialysis training add-on for all home dialysis training treatments for both PD and HD, even though PD training takes fewer hours per training treatment. It has never been our intention that the training add-on payment adjustment would reimburse a facility for all of its costs associated with home dialysis training treatments. Rather, for each home dialysis training treatment, Medicare pays the ESRD PPS base rate, all applicable case-mix and facility-level adjustments, and outlier payments plus a training add-on payment of $50.16 to account for RN time devoted to training. The home dialysis training add-on payment provides ESRD facilities with payment in addition to the ESRD PPS payment amount. Therefore, the ESRD PPS payment amount plus the $50.16 training add-on payment should be considered the Medicare payment for each home dialysis training treatment and not the home dialysis training add-on payment alone.
As we indicated in the CY 2016 ESRD PPS final rule, we committed to analyzing the home dialysis training add-on to determine whether an increase in the amount of the adjustment is appropriate. To begin an analysis of the home dialysis training add-on payment adjustment, we looked at the information on 2014 ESRD facility claims and cost reports.
We analyzed the ESRD facility claims data to evaluate if the information currently reported provides a clear representation of the utilization of training. We note that after an initial home dialysis training program is completed, ESRD facilities may bill for the retraining of patients who continue to be good candidates for home dialysis. Retraining is allowed for certain reasons as specified in the Medicare Claims Processing Manual (Pub 100-4, Chapter 8, section 50.8): the patient changes from one dialysis modality to another (for example, from PD to HD); the patient's home dialysis equipment changes; the patient's dialysis setting changes; the patient's dialysis partner changes; or the patient's medical condition changes (for example, temporary memory loss due to stroke, physical impairment). Currently, we are not able to differentiate training treatments from retraining treatments. That is, all training claims are billed with condition code 73, which is what an ESRD facility would use for both training and retraining treatments. Under the current claims processing systems, there is no mechanism that limits the allowable training treatments to, 25 for HD and 15 for PD. Therefore, we are unable to clearly tell when the patient is still training on the modality versus when they have completed the initial training and need retraining for one of these reasons provided in the
In addition, ESRD facilities have indicated they are unable to report all treatments furnished on the monthly claim. For this reason, we believe the number of training treatments currently reported on claims may be inaccurate. As discussed in detail in section II.B.1.a of this proposed rule, there are claims processing edits in place that prevent reporting of HD treatments, including both training and maintenance treatments, that exceed the number of treatments typically furnished for conventional HD, that is, 3 per week, unless the additional treatments are medically justified. This is because of the longstanding Medicare payment policy of basing payment on 3 HD treatments per week, which, for claims processing purposes is 13 to 14 treatments per month. As we discuss in detail in section II.B.1.a of this proposed rule, for PD, which is furnished multiple times each day, ESRD facilities report a treatment every day of the month and MACs pay for these treatments by applying an HD-equivalent daily rate. We are proposing a similar payment approach for HD treatments furnished more than 3 times per week, which would allow facilities to report all HD treatments furnished, but payment would be made based on a 3 treatments per week daily rate. Implementation of the proposed HD payment equivalency would allow facilities to bill accurately for all the HD treatments furnished during home dialysis training, which would better align Medicare payments for training to when facilities are incurring the cost for training.
Further, we believe that finalizing the proposed HD payment equivalency and establishing coding for retraining will greatly improve the accuracy of the reporting of training treatments. We solicit comments on this approach for improving reporting on ESRD facility claims.
In the CY 2016 Final Rule (80 FR 60093), we incorrectly cited the payment amount to facilities for HD training as $1,881 based on a total of 37.5 hours of training. The amount we should have cited is $1,254. This is the result of a multiplication error.
CMS has evaluated 2014 ESRD cost report data in an effort to identify the nature of the specific costs reported by ESRD facilities associated with home dialysis training treatments. We found that there is a significant disparity among facilities with regard to their reported average cost per home dialysis training treatment particular to HD training, ranging from under $100 per treatment to as high as several thousand dollars per treatment. Because of this substantial variation, we believe that the cost report data we currently collect cannot be used to accurately gauge the adequacy of the current $50.16 amount of the per treatment training add-on and that additional cost reporting instructions are necessary. We believe that the cost difference between training treatment costs and maintenance treatment costs is primarily the additional staff time required for training and inconsistencies in how to report related costs. All other training costs, that is, equipment, supplies, and support staff are accounted for in the ESRD PPS base rate. Based on this understanding, extreme variations in staff time should not occur as the number of hours required should fluctuate only slightly for some patients depending on modality or other factors. However, one patient needing a total nursing time of 1-2 hours compared to another patient needing 50 hours for the same modality indicates a lack of precision in the data. In response to these findings and in an effort to obtain a greater understanding of costs for dialysis facilities, CMS is considering a 3-pronged approach to improve the quality and the value of the cost report data and to enable us to use the average cost per home dialysis training treatment reported by ESRD facilities to set the amount of the training add-on payment adjustment in the future.
First, CMS would complete an in-depth analysis of cost report data elements. The analysis would assist CMS in determining what areas of the cost report are being incorrectly populated by ESRD facilities, what fields are left blank, and which ESRD facilities are deviating from the instructions for the proper completion of various fields within the report. Once we identify facilities that are deviating from proper reporting procedures, we would further evaluate the specific nature of how other ESRD facilities' cost reports were completed to see if there is a systemic problem that may be the result of imprecise instructions. If so, we would update the instructions appropriately to fix the common error. If we believe the instructions are clear but facilities are not following the guidance, we would work through the MACs to correct errors. We anticipate the result of our analysis will be greater uniformity in reporting methods and in turn, heightened data quality in future years.
Second, in accordance with section 217(e) of PAMA, CMS is currently performing comprehensive audits of ESRD facility cost reports. We anticipate the audits will result in greater uniformity in reporting methods and in turn, heightened data quality in future years.
Third, we are considering an update to the independent ESRD facility cost report (CMS-265-11) to include new fields and to rework several worksheets in an effort to obtain more granularity in data on home dialysis training. Also, we are considering a locking mechanism that would prevent a facility from submitting a cost report if certain key fields have not been completed, such as those in Worksheet S, allowing CMS to capture the needed information to appropriately pay home dialysis training by an RN.
Based on our analysis of ESRD facility claims and cost reports which we describe above, we are pursuing changes which we believe will enable us to use the data to set the home dialysis training add-on payment adjustment in the future. Although we have already begun the process to implement changes to the cost report and claims, it will take several years for the changes to be implemented and yield data we could use as the basis for a change in the home training add-on payment adjustment. However, each year since implementation of the ESRD PPS in 2011, we have received public
Under the ESRD PPS, and in accordance with section 1881(b)(14)(A)(i) of the Act, we implemented a single base rate that applies to all treatments, even though PD costs facilities less than HD in terms of staff time, equipment, and supplies. To be consistent with this payment approach for routine maintenance dialysis treatments, we implemented a single home dialysis training add-on for both PD and HD, even though home dialysis training for PD takes half the time per training treatment on average than HD.
In order to maintain this payment approach and provide an increase in the payment for home dialysis training treatments, we are proposing an increase in the single home dialysis training add-on amount for PD and HD, based on the average treatment time for PD and HD and the percentage of total training treatments for each modality as a proxy for nurse training time. We have received industry feedback that our training payment amount is not adequate. In addition, as KDOQI guidelines specify an average HD time of 4 hours and an average PD time of 2 hours, this tells us our payment should reflect a number of hours somewhere in this range. Because our current payment reflects 1.5 hours, we propose increasing the number of hours using the weighted average formula described below, until such time as we have data that concretely indicates what an adequate payment should be.
For wages, we would use the latest Occupational Employment Statistics (
As we did in CY 2014 when we last increased the training add-on payment, we are proposing that the proposed increase in the training add-on payment would be made in a budget neutral manner by applying a budget neutrality adjustment to the ESRD PPS base rate. The proposed increase would result in a budget neutrality adjustment of 0.999729.
In accordance with section 1881(b)(14)(F)(i) of the Act, as added by section 153(b) of MIPPA and amended by section 3401(h) of the Affordable Care Act, beginning in 2012, the ESRD PPS payment amounts are required to be annually increased by an ESRD market basket increase factor and reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. The application of the productivity adjustment may result in the increase factor being less than 0.0 for a year and may result in payment rates for a year being less than the payment rates for the preceding year. The statute also provides that the market basket increase factor should reflect the changes over time in the prices of an appropriate mix of goods and services used to furnish renal dialysis services.
Section 1881(b)(14)(F)(i)(I) of the Act, as added by section 217(b)(2)(A) of PAMA, provides that in order to accomplish the purposes of subparagraph (I) with respect to 2016, 2017, and 2018, after determining the market basket percentage increase factor for each of 2016, 2017, and 2018, the Secretary shall reduce such increase factor by 1.25 percentage points for each of 2016 and 2017 and by 1.0 percentage point for 2018. Accordingly, for CY 2017, we will reduce the proposed amount of the market basket percentage increase factor by 1.25 percent as required by section 1881(b)(14)(F)(i)(I) of the Act, and will further reduce it by the productivity adjustment.
As required under section 1881(b)(14)(F)(i) of the Act, CMS developed an all-inclusive ESRDB input price index (75 FR 49151 through 49162) and subsequently revised and rebased the ESRDB input price index in the CY 2015 ESRD final rule (79 FR 66129 through 66136). Although “market basket” technically describes the mix of goods and services used for ESRD treatment, this term is also commonly used to denote the input price index (that is, cost categories, their respective weights, and price proxies combined) derived from a market basket. Accordingly, the term “ESRDB market basket,” as used in this document, refers to the ESRDB input price index.
We propose to use the CY 2012-based ESRDB market basket as finalized and described in the CY 2015 ESRD PPS final rule (79 FR 66129 through 66136) to compute the CY 2017 ESRDB market basket increase factor and labor-related share based on the best available data. Consistent with historical practice, we estimate the ESRDB market basket update based on IHS Global Insight (IGI), Inc.'s forecast using the most recently available data. IGI is a nationally recognized economic and financial forecasting firm that contracts
Using this methodology and the IGI forecast for the first quarter of 2016 of the CY 2012-based ESRDB market basket (with historical data through the fourth quarter of 2015), and consistent with our historical practice of estimating market basket increases based on the best available data, the proposed CY 2017 ESRDB market basket increase factor is 2.1 percent. As required by section 1881(b)(14)(F)(I)(i) of the Act as amended by section 217(b)(2) of PAMA, we must reduce the amount of the market basket increase factor by 1.25 percent, resulting in a proposed CY 2017 ESRDB market basket percentage increase factor of 0.85 percent.
Under section 1881(b)(14)(F)(i) of the Act, as amended by section 3401(h) of the Affordable Care Act, for CY 2012 and each subsequent year, the ESRD market basket percentage increase factor shall be reduced by the productivity adjustment described in section 1886(b)(3)(B)(xi)(II) of the Act. MFP is derived by subtracting the contribution of labor and capital input growth from output growth, the detailed methodology for deriving the MFP projection was finalized in the CY 2012 ESRD PPS final rule (76 FR 40503 through 40504). The most up-to-date MFP projection methodology is available on the CMS Web site at
Using IGI's first quarter 2016 forecast, the MFP adjustment for CY 2017 (the 10-year moving average of MFP for the period ending CY 2017) is projected to be 0.5 percent.
For the CY 2017 ESRD payment update, we propose to continue using a labor-related share of 50.673 percent for the ESRD PPS payment, which was finalized in the CY 2015 ESRD final rule (79 FR 66136).
Under section 1881(b)(14)(F) of the Act, beginning in CY 2012, ESRD PPS payment amounts shall be annually increased by an ESRD market basket percentage increase factor reduced by the productivity adjustment. For CY 2017, section 1881(b)(14)(F)(i)(I) of the Act, as amended by section 217(b)(2)(A)(ii) of PAMA, requires the Secretary to implement a 1.25 percentage point reduction to the ESRDB market basket increase factor in addition to the productivity adjustment.
As a result of these provisions, the proposed CY 2017 ESRD market basket increase is 0.35 percent. This market basket increase is calculated by starting with the proposed CY 2017 ESRDB market basket percentage increase factor of 2.1 percent, reducing it by the mandated legislative adjustment of 1.25 percent (required by section 1881(b)(14)(F)(I)(i)), and reducing it further by the MFP adjustment (the 10-year moving average of MFP for the period ending CY 2017) of 0.5 percent. As is our general practice, if more recent data are subsequently available (for example, a more recent estimate of the market basket or MFP adjustment), we will use such data to determine the CY 2017 market basket update and MFP adjustment in the CY 2017 ESRD PPS final rule.
Section 1881(b)(14)(D)(iv)(II) of the Act provides that the ESRD PPS may include a geographic wage index payment adjustment, such as the index referred to in section 1881(b)(12)(D) of the Act, as the Secretary determines to be appropriate. In the CY 2011 ESRD PPS final rule (75 FR 49117), we finalized the use of the Office of Management and Budget's (OMB) Core-Based Statistical Areas (CBSAs)-based geographic area designations to define urban and rural areas and their corresponding wage index values. OMB publishes bulletins regarding CBSA changes, including changes to CBSA numbers and titles. The latest bulletin, as well as subsequent bulletins, is available online at
For CY 2017, we would continue to use the same methodology as finalized in the CY 2011 ESRD PPS final rule (75 FR 49117) for determining the wage indices for ESRD facilities. Specifically, we are updating the wage indices for CY 2017 to account for updated wage levels in areas in which ESRD facilities are located. We use the most recent pre-floor, pre-reclassified hospital wage data collected annually under the inpatient prospective payment system. The ESRD PPS wage index values are calculated without regard to geographic reclassifications authorized under section 1886(d)(8) and (d)(10) of the Act and utilize pre-floor hospital data that are unadjusted for occupational mix. The proposed CY 2017 wage index values for urban areas are listed in Addendum A (Wage Indices for Urban Areas) and the proposed CY 2017 wage index values for rural areas are listed in Addendum B (Wage Indices for Rural Areas). Addenda A and B are located on the CMS Web site at
In the CY 2011 and CY 2012 ESRD PPS final rules (75 FR 49116 through 49117 and 76 FR 70239 through 70241, respectively), we also discussed and finalized the methodologies we use to calculate wage index values for ESRD facilities that are located in urban and rural areas where there is no hospital data. For urban areas with no hospital data, we compute the average wage index value of all urban areas within the State and use that value as the wage index. For rural areas with no hospital data, we compute the wage index using the average wage index values from all contiguous CBSAs to represent a reasonable proxy for that rural area.
We apply the wage index for Guam as established in the CY 2014 ESRD PPS final rule (78 FR 72172) (0.9611) to American Samoa and the Northern Mariana Islands. We apply the statewide urban average based on the average of all urban areas within the state (78 FR 72173) (0.8637) to Hinesville-Fort Stewart, Georgia. We note that if hospital data becomes available for these areas, we will use that data for the appropriate CBSAs instead of the proxy.
A wage index floor value has been used in lieu of the calculated wage index values below the floor in making payment for renal dialysis services under the ESRD PPS. In the CY 2011 ESRD PPS final rule (75 FR 49116 through 49117), we finalized that we would continue to reduce the wage index floor by 0.05 for each of the remaining years of the ESRD PPS transition. In the CY 2012 ESRD PPS final rule (76 FR 70241), we finalized the 0.05 reduction to the wage index floor for CYs 2012 and 2013, resulting in a wage index floor of 0.5500 and 0.5000, respectively. We continued to apply and to reduce the wage index floor by 0.05 in the CY 2013 ESRD PPS final rule (77 FR 67459 through 67461). Although our intention initially was to provide a wage index floor only through the 4-year transition to 100 percent implementation of the ESRD PPS (75 FR 49116 through 49117; 76 FR 70240 through 70241), in the CY 2014 ESRD PPS final rule (78 FR 72173), we continued to apply the wage index floor and continued to reduce the floor by 0.05 per year for CY 2014 and for CY 2015.
In the CY 2016 ESRD PPS final rule (80 FR 69006 through 69008), we
For the CY 2017 proposed rule, we analyzed ESRD facility cost report and claims data submitted by facilities located in Puerto Rico and compared them to mainland facilities. Specifically, we analyzed CY 2013 claims and cost report data for 37 freestanding Puerto Rico facilities and compared it to 5,024 non-Puerto Rico freestanding facilities. We found that the freestanding facilities in Puerto Rico are bigger than facilities elsewhere in the United States. The Puerto Rico facilities produce roughly twice the number of treatments as other facilities and this larger size likely results in higher labor productivity. Finally, dialysis patients in Puerto Rico are much more likely to be non-Medicare. We discuss the findings below in detail.
In addition to this analysis, we researched staffing requirements for ESRD facilities located in Puerto Rico and confirmed that under Puerto Rico law, ESRD facilities cannot hire technicians and must only hire RNs. This requirement supports the data findings above, specifically, that Puerto Rico facilities employ a richer mix of staffing, as reflected in more than double the RNs per treatment in Puerto Rico than elsewhere.
We believe that this information provides evidence that in furnishing renal dialysis services, Puerto Rico could potentially have an economic disadvantage that the rest of the country may not be experiencing. Although we have this information available, we still believe that we need to engage the industry for input on potential changes and to assist us in assessing the appropriateness of discontinuing the wage index floor. Therefore, we are proposing to continue to apply a wage index floor of 0.4000 to areas with wage index values below the floor for CY 2017 and soliciting comments on the use of a wage index floor for Puerto Rico going forward. Our review of the wage indices show that CBSAs in Puerto Rico continue to be the only areas with wage index values that would benefit from a wage index floor because they are so low. Because the wage index floor is only applicable to a small number of CBSAs, the impact to the base rate through the wage index budget neutrality factor would be insignificant. To the extent other geographical areas fall below the floor in CY 2017 or beyond, we believe they should have the benefit of the 0.4000 wage index floor as well.
For CY 2017, we are soliciting public comments on the wage index for CBSAs in Puerto Rico as part of our continuing effort to determine an appropriate course of action. We are not proposing to change the wage index floor for CBSAs in Puerto Rico, but we are requesting public comments in which stakeholders can provide useful input for consideration in future decision-making. Specifically, we are soliciting comment on the useful suggestions that were submitted in last year's final rule (80 FR 69007) and reiterated above. Along with comments we will continue to review wage index values and the appropriateness of a wage index floor in the future.
A facility's wage index is applied to the labor-related share of the ESRD PPS base rate. In the CY 2015 ESRD PPS final rule (79 FR 66136), we finalized a new labor-related share of 50.673 percent, which was based on the 2012-based ESRDB market basket finalized in that rule, and transitioned the new labor-related share over a 2-year period. Thus, for CY 2017, the labor-related share to which a facility's wage index would be applied is 50.673 percent.
Section 1881(b)(14)(D)(ii) of the Act requires that the ESRD PPS include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variability in the amount of erythropoiesis stimulating agents (ESAs) necessary for anemia management. Some examples of the patient conditions that may be reflective of higher facility costs when furnishing dialysis care would be frailty, obesity, and comorbidities such as cancer. The ESRD PPS recognizes high cost patients, and we have codified the outlier policy in our regulations at 42 CFR 413.237. The policy provides the following ESRD outlier items and services are included in the ESRD PPS bundle: (i) ESRD-related drugs and biologicals that were or would have been, prior to January 1, 2011, separately billable under Medicare Part B; (ii) ESRD-related laboratory tests that were or would have been, prior to January 1, 2011,
In the CY 2011 ESRD PPS final rule (75 FR 49142), we stated that for purposes of determining whether an ESRD facility would be eligible for an outlier payment, it would be necessary for the facility to identify the actual ESRD outlier services furnished to the patient by line item (that is, date of service) on the monthly claim. Renal dialysis drugs, laboratory tests, and medical/surgical supplies that are recognized as outlier services were originally specified in Attachment 3 of Change Request 7064, Transmittal 2033 issued August 20, 2010, rescinded and replaced by Transmittal 2094, dated November 17, 2010. Transmittal 2094 identified additional drugs and laboratory tests that may also be eligible for ESRD outlier payment. Transmittal 2094 was rescinded and replaced by Transmittal 2134, dated January 14, 2011, which was issued to correct the subject on the Transmittal page and made no other changes.
Furthermore, we use administrative issuances and guidance to continually update the renal dialysis service items available for outlier payment via our quarterly update CMS Change Requests, when applicable. We use this separate guidance to identify renal dialysis service drugs which were or would have been covered under Part D for outlier eligibility purposes and in order to provide unit prices for calculating imputed outlier services. In addition, we also identify through our monitoring efforts items and services that are either incorrectly being identified as eligible outlier services or any new items and services that may require an update to the list of renal dialysis items and services that qualify as outlier services, which are made through administrative issuances.
Our regulations at 42 CFR 413.237 specify the methodology used to calculate outlier payments. An ESRD facility is eligible for an outlier payment if its actual or imputed MAP amount per treatment for ESRD outlier services exceeds a threshold. The MAP amount represents the average incurred amount per treatment for services that were or would have been considered separately billable services prior to January 1, 2011. The threshold is equal to the ESRD facility's predicted ESRD outlier services MAP amount per treatment (which is case-mix adjusted) plus the fixed-dollar loss amount. In accordance with section 413.237(c) of our regulations, facilities are paid 80 percent of the per treatment amount by which the imputed MAP amount for outlier services (that is, the actual incurred amount) exceeds this threshold. ESRD facilities are eligible to receive outlier payments for treating both adult and pediatric dialysis patients.
In the CY 2011 ESRD PPS final rule, using 2007 data, we established the outlier percentage at 1.0 percent of total payments (75 FR 49142 through 49143). We also established the fixed-dollar loss amounts that are added to the predicted outlier services MAP amounts. The outlier services MAP amounts and fixed-dollar loss amounts are different for adult and pediatric patients due to differences in the utilization of separately billable services among adult and pediatric patients (75 FR 49140). As we explained in the CY 2011 ESRD PPS final rule (75 FR 49138 through 49139), the predicted outlier services MAP amounts for a patient are determined by multiplying the adjusted average outlier services MAP amount by the product of the patient-specific case-mix adjusters applicable using the outlier services payment multipliers developed from the regression analysis to compute the payment adjustments.
For the CY 2017 outlier policy, we would use the existing methodology for determining outlier payments by applying outlier services payment multipliers that were developed for the CY 2016 ESRD PPS final rule (80 FR 68993-68994, 69002). We used these outlier services payment multipliers to calculate the predicted outlier service MAP amounts and projected outlier payments for CY 2017.
For CY 2017, we propose that the outlier services MAP amounts and fixed-dollar loss amounts would be derived from claims data from CY 2015. Because we believe that any adjustments made to the MAP amounts under the ESRD PPS should be based upon the most recent data year available in order to best predict any future outlier payments, we propose the outlier thresholds for CY 2017 would be based on utilization of renal dialysis items and services furnished under the ESRD PPS in CY 2015. We recognize that the utilization of ESAs and other outlier services have continued to decline under the ESRD PPS, and that we have lowered the MAP amounts and fixed-dollar loss amounts every year under the ESRD PPS. We continue to believe that since the implementation of the ESRD PPS, data for CY 2015 are reflective of relatively stable ESA use, in contrast with the relatively large initial declines in the use of both EPO and darbepoetin in the first 2 years of the ESRD PPS. In 2015, there were both decreases in the use of EPO and increases in the use of darbepoetin based on estimates of average ESA utilization per session, suggesting a relative shift towards the use of darbepoetin between 2014 and 2015.
For CY 2017, we are not proposing any change to the methodology used to compute the MAP or fixed-dollar loss amounts. Rather, we will continue to update the outlier services MAP amounts and fixed-dollar loss amounts to reflect the utilization of outlier services reported on 2015 claims. For this proposed rule, the outlier services MAP amounts and fixed dollar loss amounts were updated using 2015 claims data. The impact of this update is shown in Table 1, which compares the outlier services MAP amounts and fixed-dollar loss amounts used for the outlier policy in CY 2016 with the updated proposed estimates for this rule. The estimates for the proposed CY 2017 outlier policy, which are included in Column II of Table 1, were inflation adjusted to reflect projected 2017 prices for outlier services.
As demonstrated in Table 1, the estimated fixed-dollar loss amount per treatment that determines the CY 2017 outlier threshold amount for adults (Column II; $83.00) is lower than that used for the CY 2016 outlier policy (Column I; $86.97). The lower threshold is accompanied by a decline in the adjusted average MAP for outlier services from $50.81 to $47.26. For pediatric patients, there is an increase in the fixed dollar loss amount from $62.19 to $67.44. Unlike the adult patients, there was a slight increase in the adjusted average MAP for outlier services among pediatric patients, from $39.20 to $39.92.
We estimate that the percentage of patient months qualifying for outlier payments in CY 2017 will be 6.7 percent for adult patients and 4.5 percent for pediatric patients, based on the 2015 claims data. The pediatric outlier MAP and fixed-dollar loss amounts continue to be lower for pediatric patients than adults due to the continued lower use of outlier services (primarily reflecting lower use of ESAs and other injectable drugs).
In the CY 2011 ESRD PPS final rule (75 FR 49081), in accordance with 42 CFR 413.220(b)(4), we reduced the per treatment base rate by 1 percent to account for the proportion of the estimated total payments under the ESRD PPS that are outlier payments. Based on the 2015 claims, outlier payments represented approximately 0.9 percent of total payments, slightly below the 1 percent target due to small overall declines in the use of outlier services. Recalibration of the thresholds using 2015 data is expected to result in aggregate outlier payments close to the 1 percent target in CY 2017. We believe the update to the outlier MAP and fixed-dollar loss amounts for CY 2017 will increase payments for ESRD beneficiaries requiring higher resource utilization and move us closer to meeting our 1 percent outlier policy. We note that recalibration of the fixed-dollar loss amounts in this proposed rule would result in no change in payments to ESRD facilities for beneficiaries with renal dialysis items and services that are not eligible for outlier payments, but would increase payments to ESRD facilities for beneficiaries with renal dialysis items and services that are eligible for outlier payments. Therefore, beneficiary co-insurance obligations would also increase for renal dialysis services eligible for outlier payments.
We note that many industry stakeholder associations and renal facilities have expressed concern that the outlier target percentage has not been achieved under the ESRD PPS and have asked that CMS eliminate the outlier policy. With regard to the suggestion that we eliminate the outlier adjustment altogether, we note that, under section 1881(b)(14)(D)(ii) of the Act, the ESRD PPS must include a payment adjustment for high cost outliers due to unusual variations in the type or amount of medically necessary care, including variations in the amount of erythropoiesis stimulating agents necessary for anemia management. We believe that the ESRD PPS is required to include an outlier adjustment in order to comply with section 1881(b)(14)(D)(ii) of the Act.
In addition, while we believe that the ESRD PPS base rate and other payment adjustments capture the cost for the average renal patient having certain characteristics, there may continue to be certain individual patients or certain subgroups of patients, such as patients with bacterial pneumonia or monoclonal gammopathy, which were eliminated as payment adjustments factors for CY2016, who receive more ESAs or other outlier services than the average patient. We believe that the inclusion of the 1 percent outlier policy helps to protect patient access to care by providing additional payment for patients requiring higher use of outlier services not otherwise captured in the payment adjustments made under the ESRD PPS.
We understand the industry's concern that payments under the outlier policy have not reached 1 percent of total ESRD PPS payments since the implementation of the payment system. As we explained in the CY 2015 ESRD PPS final rule (78 FR 72165), each year we simulate payments under the ESRD PPS in order to set the outlier fixed-dollar loss and MAP amounts for adult and pediatric patients to try to achieve the 1 percent outlier policy. As we stated above, based on the 2015 claims, outlier payments represented approximately 0.9 percent of total payments, slightly below the 1 percent target, which could indicate that ESRD facilities are getting better at reporting outlier services. We note that we would not increase the base rate to account for years where outlier payments were less than 1 percent of total ESRD PPS payments, nor would we reduce the base rate if the outlier payments exceed 1 percent of total ESRD PPS payments.
In the CY 2011 ESRD PPS final rule (75 FR 49071 through 49083), we discussed the development of the ESRD PPS per treatment base rate that is codified in the Medicare regulations at § 413.220 and § 413.230. The CY 2011 ESRD PPS final rule also provides a detailed discussion of the methodology used to calculate the ESRD PPS base rate and the computation of factors used to adjust the ESRD PPS base rate for projected outlier payments and budget neutrality in accordance with sections
We are proposing an ESRD PPS base rate for CY 2017 of $231.04. This update reflects several factors, described in more detail below.
In summary, we are proposing a CY 2017 ESRD PPS base rate of $231.04. This amount reflects a market basket increase of 0.35 percent, the CY 2017 wage index budget-neutrality adjustment factor of 0.999552, and the home dialysis training add-on payment adjustment budget-neutrality adjustment of 0.999729.
On June 29, 2015, the Trade Protection Extension Act of 2015 (TPEA) (Pub. L. 114-27) was enacted. In the TPEA, the Congress amended the Act to include coverage and provide for payment for dialysis furnished by an ESRD facility to an individual with AKI. Specifically, section 808(a) of the TPEA amended section 1861(s)(2)(F) of the Act by including coverage for renal dialysis services furnished on or after January 1, 2017 by a renal dialysis facility or provider of services currently paid under section 1881(b)(14) of the Act to an individual with AKI. In addition, section 808(b) of TPEA amended section 1834 of the Act by adding a new subsection (r). Subsection (r)(1) of section 1834 of the Act provides that in the case of renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or a provider of services paid under such section during a year (beginning with 2017) to an individual with acute kidney injury, the amount of payment under Part B for such services shall be the base rate for renal dialysis services determined for such year under such section, as adjusted by any applicable geographic adjustment applied under subparagraph (D)(iv)(II) of such section and may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r) of the Act) by any other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act. Section 1834(r)(2) defines “individual with acute kidney injury” to mean an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under section 1881(b)(14). In this rule, we are proposing payment and billing requirements as discussed below.
Consistent with section 1834(r)(2) of the Act, we propose to define an individual with AKI as an individual who has acute loss of renal function and does not receive renal dialysis services for which payment is made under section 1881(b)(14). Section 1881(b)(14) of the Act contains all of the provisions related to the ESRD PPS. We interpret the reference to section 1881(b)(14) of the Act to mean that we would pay renal dialysis facilities for renal dialysis services furnished to individuals with acute loss of kidney function when the services furnished to those individuals are not payable under section 1881(b)(14) because the individuals do not have ESRD. We propose to codify the statutory definition of individual with acute kidney injury at 42 CFR 413.371 and we solicit comments on this definition.
Section 1834(r)(1) of the Act, as added by section 808(b) of TPEA, provides that the amount of payment for AKI services shall be the base rate for renal dialysis services determined for a year under section 1881(b)(14). We propose to interpret this provision to mean the ESRD PPS per treatment base rate as set forth in 42 CFR 413.220, which is updated annually by the market basket less the productivity adjustment as set forth in 42 CFR 413.196(d)(1), and adjusted by any other adjustment factor applied to the ESRD PPS base rate. This amount would be established on an annual basis through rulemaking and finalized in the CY ESRD PPS final rule. We recognize that there could be rulemaking years in which legislation or policy decisions could directly impact the ESRD PPS base rate because of changes to ESRD PPS policy that may not relate to the services furnished for
Section 1834(r)(1) of the Act further provides that the amount of payment for AKI dialysis services shall be the base rate for renal dialysis services determined for a year under section 1881(b)(14), as adjusted by any applicable geographic adjustment factor applied under section 1881(b)(14)(D)(iv)(II). We interpret the reference to “any applicable geographic adjustment factor applied under section (D)(iv)(II)” of such section to mean the geographic adjustment factor that is actually applied to the ESRD PPS base rate for a particular facility. Accordingly, we propose to apply the same wage index that is used under the ESRD PPS, that is, the most recent pre-floor, pre-reclassified hospital wage data collected annually under the inpatient prospective payment system that are unadjusted for occupational mix. The ESRD PPS wage index policy was finalized in the CY 2011 ESRD PPS final rule (75 FR 49117) and codified at 42 CFR 413.231. The AKI dialysis payment rate would be adjusted for wage index for a particular facility in the same way that the ESRD PPS base rate is adjusted for wage index for that facility. Specifically, we would apply the wage index to the labor-related share of the ESRD PPS base rate that we will utilize for AKI dialysis to compute the wage-adjusted per-treatment AKI dialysis payment rate. We propose that for CY 2017, the AKI dialysis payment rate would be the CY 2017 ESRD PPS base rate (established in the CY 2017 ESRD PPS final rule), adjusted by the ESRD facility's wage index. In proposed 42 CFR 413.372(a), we refer to the ESRD PPS wage index regulation at 42 CFR 413.231 as an adjustment we will apply to the ESRD PPS base rate.
Section 1834(r)(1) also provides that the payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r)) by any other adjustment factor under subparagraph (D) of section 1881(b)(14). For purposes of payment for AKI dialysis, we are not proposing to adjust the AKI payment rate by any other adjustments at this time. Therefore, for at least the first year of implementation of the AKI payment rate, we are not proposing to apply any of the optional payment adjustments under subparagraph (D) of section 1881(b)(14). We propose to codify our authority to adjust the AKI payment rate by any of the adjustments under section 1881(b)(14)(D) in our regulations at 42 CFR 413.373.
Section 1834(r)(1) provides that the AKI payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14)) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14). We propose that drugs, biologicals, laboratory services, and supplies that are considered to be renal dialysis services under the ESRD PPS as defined in 42 CFR 413.171, would be considered to be renal dialysis services for patients with AKI. As such, no separate payment would be made for renal dialysis drugs, biologicals, laboratory services, and supplies that are included in the ESRD PPS base rate when they are furnished by an ESRD facility to an individual with AKI. We propose to codify this policy in the regulations at 42 CFR 413.374(a).
However, we recognize that the utilization of items and services for beneficiaries with AKI receiving dialysis may differ from the utilization of these same services by ESRD beneficiaries. This is because we expect that individuals with AKI will only need dialysis for a finite number of days while they recover from kidney injury, while ESRD beneficiaries require dialysis indefinitely unless they receive a kidney transplant. We recognize that the intent of dialysis for patients with AKI is curative; therefore, we are proposing that we will pay for all hemodialysis treatments furnished to beneficiaries with AKI in a week, even if the number of treatments exceeds the three times-weekly limitation we apply to HD treatments furnished to beneficiaries with ESRD.
Other items and services furnished to beneficiaries with AKI that are not considered to be renal dialysis services as defined in 42 CFR 413.171, but that are related to their dialysis treatment as a result of their AKI and that an ESRD facility might furnish to a beneficiary with AKI, would be separately payable. In particular, an ESRD facility could seek separate payment for drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting. Therefore, we are proposing to pay for these items and services separately when they are furnished to beneficiaries with AKI receiving dialysis in ESRD facilities. We propose to codify this policy at 42 CFR 413.374(b).
Generally, we would pay for only one treatment per day across all settings. However, similar to the policy applied under the ESRD PPS for treatments for patients with ESRD, in the interest of fairness and in accordance with Chapter 8, section 10.2 of the Medicare Claims Processing Manual, if a dialysis treatment is started, that is, a patient is connected to the machine and a dialyzer and blood lines are used, but the treatment is not completed for some unforeseen, but valid reason, for example, a medical emergency when the patient must be rushed to an emergency room, both the ESRD facility and the hospital would be paid. We consider this to be a rare occurrence that must be fully documented to the A/B MAC's satisfaction.
We do not expect that beneficiaries with AKI will receive dialysis in their homes due to the duration of treatment and the unique needs of AKI. Specifically, it is our understanding that these patients require supervision by qualified staff during their dialysis and close monitoring through laboratory tests to ensure that they are receiving the necessary care to improve their condition and get off of dialysis. Therefore, we are proposing not to extend the home dialysis benefit to beneficiaries with AKI.
Section 1881(b)(14)(B) of the Act specifically excludes vaccines covered under section 1861(s)(10) of the Act from the ESRD PPS. However, ESRD facilities are identified as an entity that can bill Medicare for vaccines and their administration. Therefore, we propose to allow ESRD facilities to furnish vaccines to beneficiaries with AKI and bill Medicare in accordance with billing requirements in Pub. 100-04, Chapter 18 Preventive and Screening Services, section 10.2 which is located on the CMS Web site:
Because we are aware of the unique acute medical needs of the AKI population, we plan to closely monitor utilization of dialysis and all separately billable items and services furnished to individuals with AKI by ESRD facilities. For example, stakeholders have stated that beneficiaries with AKI will require frequent labs to monitor renal function or they will be at risk for developing chronic renal failure. Another recurrent concern is the flexibility necessary in providing dialysis sessions to beneficiaries with AKI. Stakeholders have told us that these patients may need frequent dialysis, but will also require days with no dialysis to test for kidney recovery. Consequently, we will closely monitor utilization of dialysis treatments and the drugs, labs and services provided to these beneficiaries.
We have met with both physician and provider associations with regard to the care of patients with AKI. Both have expressed concerns that physician oversight will be limited for these beneficiaries, based on current operational models used by ESRD facilities. They have encouraged CMS to support close monitoring of this patient population—particularly with regard to lab values—in the interest of preventing these patients from becoming ESRD patients. A close patient-physician relationship is critical for the successful outcome of the AKI patient.
The ESRD Conditions for Coverage (CfCs) at 42 CFR part 494 are health and safety standards that all Medicare-participating dialysis facilities must meet. These standards set baseline requirements for patient safety, infection control, care planning, staff qualifications, record keeping, and other matters to ensure that all ESRD patients receive safe and appropriate care.
We propose a technical change to 42 CFR 494.1(a), statutory basis, to incorporate the changes to ESRD facilities and treatment of AKI in the Act as enacted by section 808 of the Trade Protection Extension Act of 2015 (Pub. L. 114-27, June 29, 2015) (TPEA).
While the substance of the ESRD CfCs (comprehensively updated in 2008) does not directly address treatment of patients with AKI, we believe that the current ESRD facility requirements are sufficient to ensure that such patients are dialyzed safely. For example, infection control protocols would be the same for an ESRD patient receiving maintenance dialysis and an AKI patient. For the areas in which care and care planning may differ, such as frequency of certain patient assessments, we note that the CfCs set baseline standards and do not limit additional or more frequent services that may be necessary for AKI patients receiving temporary dialysis to restore kidney function.
Accordingly, we are not proposing changes to the CfCs specific to AKI at this time. However, we are soliciting comment from the dialysis community as to whether revisions to the CfCs might be appropriate for addressing treatment of AKI in ESRD facilities. Some of our specific questions include: Should we address AKI care directly in the ESRD CfCs? Should care planning for AKI patients be addressed differently than care planning for ESRD patients? Are there other areas, such as medical records, that might be appropriate for AKI-related revisions? We do not intend to respond to comments related to potential CfC revisions for AKI in the final rule, but will consider them in future rulemaking.
For payment purposes, claims for beneficiaries with AKI would be identified through a specific condition code, an AKI diagnosis, an appropriate revenue code, and an appropriate Common Procedural Terminology code. These billing requirements would serve to verify that a patient has AKI and differentiate claims for AKI from claims for patients with ESRD. ESRD facilities are expected to report all items and services furnished to individuals with AKI and include comorbidity diagnoses on their claims for monitoring purposes. We anticipate that with exceptions for separately billable items and services, most of the claims policies laid out in Chapter 8 of the Medicare Claims Processing Manual will also apply to claims for dialysis furnished to AKI beneficiaries. All billing requirements will be implemented and furnished through sub-regulatory guidance.
In future years, we anticipate announcing the AKI payment rate in the annual ESRD PPS rule or in a
Section 1881(h) of the Act requires the Secretary to establish an End-stage renal disease (ESRD) quality incentive program (QIP) by (1) selecting measures; (2) establishing the performance standards that apply to the individual measures; (3) specifying a performance period with respect to a year; (4) developing a methodology for assessing the total performance of each facility based on the performance standards with respect to the measures for a performance period; and (5) applying an appropriate payment reduction to facilities that do not meet or exceed the established Total Performance Score (TPS). This proposed rule discusses
In the CY 2016 ESRD PPS Final Rule, we revised the calculation of the Small Facility Adjuster (SFA) (80 FR 69039). We are proposing to correct our description of the SFA for payment year (PY) 2017 and future years. Our original proposal pegged the SFA to the national mean, such that small facilities scoring below the national mean would receive an adjustment, but small facilities scoring above the national mean would not. Several commenters supported the overall objectives of the proposed SFA modification but were concerned that too few facilities would receive an adjustment under our proposed methodology. They recommended that rather than pegging the SFA to the national mean, we peg the SFA to the benchmark, which is the 90th percentile of national facility performance on a measure, such that facilities scoring below the benchmark would receive an adjustment, but those scoring above the benchmark would not. In the process of updating the finalized policy to reflect public comment, we inadvertently neglected to update this sentence from our statement of finalized policy: “For the standardized ratio measures, such as the Standardized Readmission Ratio (SRR) and Standardized Transfusion Ratio (STrR) clinical measures, the national mean measure rate (that is,
We seek comments on this proposal.
During the measure maintenance process at National Quality Forum (NQF), two substantive changes were made to the Hypercalcemia clinical measure. First, plasma was added as an acceptable substrate in addition to serum calcium. Second, the denominator definition changed such that it now includes patients regardless of whether any serum calcium values were reported at the facility during the 3-month study period. Functionally, this means that a greater number of patient-months will be included in this measure, because patient-months will not be excluded from the measure calculations solely because a facility reports no calcium data for that patient during the entire three month study period.
We are proposing to update the measure's technical specifications for PY 2018 and future years to include these two substantive changes to the Hypercalcemia clinical measure included in the ESRD QIP. These changes will positively impact data completeness in the ESRD QIP because facilities' blood tests typically use plasma calcium rather than serum calcium. Including patients with unreported calcium values in the measure calculations will encourage more complete reporting of this data. Additionally, these changes will ensure that the measure aligns with the NQF-endorsed measure and can continue to satisfy the requirements of the Protecting Access to Medicare Act (PAMA), which requires that the ESRD QIP include in its measure set measures (outcomes-based, to the extent feasible), that are specific to the conditions treated with oral-only drugs.
We seek comments on this proposal.
We first adopted the National Healthcare Safety Network (NHSN) Dialysis Event Reporting Measure for the PY 2014 ESRD QIP. For that program year, we required facilities to (1) enroll in the NHSN and complete any training required by the CDC; and (2) submit three or more consecutive months of dialysis event data to the NHSN (76 FR 70268 through 69). For PY 2015, we retained the requirement for facilities to enroll in the NHSN and complete any training required by the CDC, but expanded the reporting period to require facilities to report a full 12 months of dialysis event data (77 FR 67481 through 84). Beginning with PY 2016, we replaced the NHSN Dialysis Event Reporting Measure with the clinical version of the measure (78 FR 72204 through 07). As a result, facilities were scored for purposes of the ESRD QIP based on how many dialysis events they reported to the NHSN in accordance with the NHSN protocol. We introduced the clinical version of the measure because we believed that the measure would hold facilities accountable for monitoring and preventing infections in the ESRD population. We continue to believe it is vitally important to hold facilities accountable for their actual clinical performance on this measure.
Since we introduced the NHSN Bloodstream Infection (BSI) Clinical Measure into the ESRD QIP, some stakeholders have expressed significant concerns about two distinct types of accidental or intentional under-reporting. First, these stakeholders believe that many facilities do not consistently report monthly dialysis event data for the full 12-month performance period. Second, these stakeholders believe that even with respect to the facilities that report monthly dialysis event data, many of those facilities do not consistently report all of the dialysis events that they should be reporting. (80 FR 69048). These public comments, as well as our thorough review of data reported for the PY 2015 NHSN Dialysis Event Reporting Measure and results from the PY 2014 NHSN data validation feasibility study, suggest that as many as 60-80 percent of dialysis events are under-reported.
We believe that there are delicate tradeoffs associated with incentivizing facilities to both report monthly dialysis event data and to accurately report such data. On the one hand, if we incentivize facilities to report monthly dialysis event data but do not hold them accountable for their performance, we believe that facilities will be more likely to accurately report all dialysis events.
In light of these considerations, we believe that the best way to strike the proper balance between these competing interests is to propose to reintroduce the expanded NHSN Dialysis Event Reporting Measure, beginning with PY 2019, and to include both this measure and the NHSN BSI Clinical Measure in the ESRD QIP measure set.
In combination with other programmatic features described more fully below (see sections IV.C.2. and IV.C.8.), we believe this reporting measure will bolster incentives for facilities to report complete and accurate data to NHSN, while the clinical measure will preserve incentives to reduce the number of dialysis events. We believe that including both of these measures in the ESRD QIP measure set will ensure that we hold facilities accountable for the frequency with which they report data to the NHSN and will address validation concerns related to the two distinct types of under-reporting of data, described above.
, we propose that beginning with PY 2019, facilities must enroll in NHSN and complete any training required by the CDC related to reporting dialysis events via NHSN, and that they must report monthly dialysis event data on a quarterly basis to the NHSN. We also propose that each quarter's data would be due 3 months after the end of the quarter. For example, data from January 1 through March 31, 2017 would need to be submitted to NHSN by June 30, 2017; data from April 1 through June 30, 2017 would need to be submitted by September 30, 2017; data from July 1 through September 30, 2017 would need to be submitted by December 31, 2017; and data from October 1 through December 31, 2017 would need to be submitted by March 31, 2018. For further information regarding NHSN's dialysis event reporting protocols, please see
Section 1881(h)(2)(B)(i) of the Act requires that, unless the exception set forth in section 1881(h)(2)(B)(ii) of the Act applies, the measures specified for the ESRD QIP under section 1881(h)(2)(A)(iii) of the Act must have been endorsed by the entity with a contract under section 1890(a) of the Act (which is currently NQF). Under the exception set forth in 1881(h)(2)(B)(ii) of the Act, in the case of a specified area or medical topic determined appropriate by the Secretary for which a feasible and practical measure has not been endorsed by the entity with a contract under section 1890(a) of the Act, the Secretary may specify a measure that is not so endorsed so long as due consideration is given to measures that have been endorsed or adopted by a consensus organization identified by the Secretary. The proposed NHSN Dialysis Event Reporting Measure is not endorsed by the NQF, but for the reasons explained above, we believe that it is appropriate to assess facilities solely based on whether they actually report full and accurate monthly dialysis event data to the NHSN. Although we recognize that the NHSN BSI Clinical Measure is currently included in the ESRD QIP measure set and that this measure and the proposed NHSN Dialysis Event Reporting Measure would be calculated using the same set of data, the two measures assess different outcomes. We believe that including both of these measures in the ESRD QIP measure set will collectively support our efforts to ensure that facilities report, and are scored based on, complete and accurate dialysis event data.
For the reasons stated above, we propose to reintroduce the NHSN Dialysis Event Reporting Measure to the ESRD QIP beginning with PY 2019.
We seek comments on this proposal.
With respect to the proposed NHSN Dialysis Event Reporting measure, we are proposing to score facilities with a CCN Open Date on or before January 1, 2017. Using the methodology described below, we propose to assign the following scores for reporting different quantities of data:
We selected these scores for the following reasons: First, due to the seasonal variability of bloodstream infection rates, we want to incentivize facilities to report the full 12 months of data and reward reporting consistency over the course of the entire performance period. We therefore propose that facilities will receive 10 points for submitting twelve months of data. We recognize, however, that from the perspective of national prevention strategies and internal quality improvement initiatives, there is still some value in collecting fewer than 12 months of data from facilities. We also need at least 6 months of data in order to calculate reliable scores on the NHSN BSI Clinical Measure. For these reasons, we propose that facilities will receive 2 points for reporting between 6 and 11 months of dialysis event data. Finally, in consultation with the CDC, we have determined that NHSN BSI Clinical Measure rates are not reliable when they are calculated using fewer than six months of data. For that reason, we propose that a facility will receive 0 points on the proposed NHSN Dialysis Event Reporting Measure if it reports fewer than six months of data.
The proposed scoring methodology for the proposed NHSN Dialysis Event Reporting Measure differs slightly from what we finalized for PY 2015. For that year of the program, facilities were awarded 0 points for reporting fewer than 6 months of data, 5 points for reporting 6 consecutive months, and 10 points for reporting all 12 months of data. We believe that it is appropriate to reduce the number of points facilities receive for reporting 6-11 months of data from 5 to 2 because by PY 2019, facilities will have had 3 more years of experience reporting data to NHSN than they had for PY 2015.
For PY 2019 and future years of the program, we are proposing to create a new NHSN BSI Measure Topic. We propose that this measure topic consist of the following two measures:
We believe it is appropriate to combine these two measures into one measure topic, because data from the reporting measure will be used to score both that measure and the clinical measure, and combining both measures under the same measure topic will better enable us to precisely calibrate incentives for complete and accurate reporting and high clinical performance. The NHSN BSI Clinical Measure and the NHSN Dialysis Event Reporting Measure are mutually reinforcing because one measure encourages accurate reporting while the other uses the reported data to assess facility performance on preventing BSIs in their patients. Therefore, combining the reporting and clinical measures under the same measure topic will simplify the process of weighting each of the two measures, such that incentives from one measure can be simply reallocated to the other if new evidence suggests that the incentives are not properly balanced to optimize both reporting and prevention.
We seek comments on this proposal.
We currently use two domains in the ESRD QIP for purposes of scoring. The first of these domains, termed the Clinical Measure Domain, is defined as an aggregated metric of facility performance on the clinical measures and measure topics in the ESRD QIP, and we use subdomains within the Clinical Measure Domain for the purposes of calculating the Clinical Measure Domain score (79 FR 66213). We also have a Reporting Measure Domain, in which scores on reporting measures are weighted equally (79 FR 66218 through 66219).
In section IV.C.2 above, we describe the proposed NHSN BSI Measure Topic. We believe that this measure topic, consisting of both the proposed NHSN Dialysis Event Reporting Measure and the NHSN BSI Clinical Measure, is fundamentally different from the other measures and measure topics included in the ESRD QIP's measure set. The two measures included in this measure topic are inextricably linked because data from the reporting measure is used to calculate the clinical measure. No other reporting measures currently included in the ESRD QIP's measure set are used for this purpose. As mentioned above, placing these two measures together in a single measure topic that is given a single measure topic score, creates the important linkage between the two measures and balances out the competing incentives involved: Incentivizing complete and accurate reporting of data to NHSN while also incentivizing facilities to achieve high clinical scores on the clinical measure. Without complete and accurate data, the clinical measure will not produce meaningful results. The measure topic is also different from others included in the ESRD QIP's measure set because it is comprised of both a clinical measure and a reporting measure. It therefore does not appropriately belong in either the Reporting Measure Domain or the Clinical Measure Domain.
Because of these fundamental differences, we propose to remove the Safety Subdomain from the Clinical Measure Domain for PY 2019 and future payment years. We propose that the Safety Subdomain will instead be a new, third Domain, separate from and in addition to the existing Clinical and Reporting Measure Domains. Additionally, we propose that facilities will receive a Safety Measure Domain score in addition to their Reporting Measure Domain and Clinical Measure Domain scores. We describe our proposed scoring methodology more fully below in section IV.C.6, but we propose that these three Domain scores will be combined and weighted to produce a Total Performance Score (TPS) for each facility.
We seek comments on these proposals.
In light of the concerns we have discussed above, including the accidental or intentional underreporting of dialysis event data, we are proposing to assign significant weight to the proposed NHSN Dialysis Event Reporting Measure in the overall NHSN BSI Measure Topic score. However, our proposed weighting scheme also reflects our goal to incentivize strong performance on the clinical measure. For these reasons, we propose that the NHSN Dialysis Event Reporting Measure be weighted at 40 percent of the measure topic score and the NHSN BSI Clinical Measure be weighted at 60 percent of the measure topic score. The formula below depicts how the NHSN BSI Measure Topic would be scored.
We seek comment on this proposal.
In the calendar year (CY) 2016 ESRD PPS final rule, we finalized that for PY 2019, the performance standards, achievement thresholds, and benchmarks for the clinical measures would be set at the 50th, 15th and 90th percentile, respectively, of national performance in CY 2015, because this will give us enough time to calculate and assign numerical values to the proposed performance standards for the PY 2019 program prior to the beginning of the performance period. (80 FR 69060). At this time, we do not have the necessary data to assign numerical values to the proposed performance standards, achievement thresholds, and benchmarks because we do not yet have complete data from CY 2015. Nevertheless, we are able to estimate these numerical values based on the most recent data available. For the Vascular Access Type, Hypercalcemia, NHSN BSI and ICH CAHPS clinical measures, this data comes from the period of January through December 2015. For the SRR and STrR clinical measures, this data comes from the period of January through December 2014. In Table 2, we have provided the estimated numerical values for all of the finalized PY 2019 ESRD QIP clinical measures. We will publish updated values for the clinical measures, using data from the first part of CY 2016, in the CY 2017 ESRD PPS final rule.
In previous rulemaking, we have finalized policies to the effect that if final numerical values for the performance standard, achievement threshold, and/or benchmark were worse than they were for that measure in the previous year of the ESRD QIP, then we would substitute the previous year's performance standard, achievement threshold, and/or benchmark for that measure. We finalized this policy because we believe that the ESRD QIP should not have lower performance standards than in previous years. In light of recent discussions with CDC, we have determined that in certain cases it may be appropriate to re-baseline the NHSN BSI Clinical Measure, such that expected infection rates are calculated on the basis of a more recent year's data. In such cases, numerical values assigned to performance standards may appear to decline, even though they represent higher standards for infection prevention. For this reason, with the exception of the NHSN BSI Clinical Measure, we propose to substitute the PY 2018 performance standard, achievement threshold, and/or benchmark for any measure that has a final numerical value for a performance standard, achievement threshold, and/or benchmark that is worse than it was for that measure in the PY 2018 ESRD QIP. We also propose that the performance standards for the NHSN BSI Clinical Measure for PY 2019 will be used irrespective of what values were assigned to the performance standards for PY 2018.
We seek comments on this proposal.
As discussed in Section IV.C.3 above, we are proposing to remove the Safety Subdomain from the Clinical Measure Domain and establish it as a third domain alongside the Clinical Measure and Reporting Measure Domains for the purposes of scoring facilities and determining Total Performance Scores.
In light of stakeholder comments we have received about the prevalence of under-reporting for the NHSN BSI Clinical Measure, as well as the tradeoffs (discussed more fully in section IV.C.1.a. above) between our desire to maintain strong incentives for facilities to report bloodstream infections and to prevent those infections, and because the Safety Domain is comprised of a single measure topic, we believe it is necessary to reduce the weight of the Safety Measure Domain as a percentage of the TPS. However, we believe it is important to maintain as much consistency as possible in the ESRD QIP scoring methodology. Therefore, we are proposing to gradually reduce the weight of the Safety Measure Domain to 15 percent of the TPS in PY 2019, and then reduce it further in PY 2020, as proposed below. We further propose that the Clinical Measure Domain will be weighted at 75 percent of the TPS, and the Reporting Measure Domain will continue to be weighted at 10 percent of the TPS because we do not want to diminish the incentives to report data on the reporting measures.
In the CY 2015 ESRD PPS final rule, we finalized the criteria we will use to assign weights to measures in a facility's Clinical Measure Domain score (79 FR 66214 through 66216). Under these criteria, we take into consideration: (1) the number of measures and measure topics in a subdomain; (2) how much experience facilities have had with the measures; and (3) how well the measures align with CMS' highest priorities for quality improvement for patients with ESRD.
With respect to criterion 3, one of our top priorities for improving the quality of care furnished to ESRD patients includes increasing the number and significance of both outcome and patient experience of care measures because these measures track important patient outcomes, instead of focusing on the implementation and achievement of clinical processes that may not result in improved health for patients.
In light of the proposed addition of the Safety Measure Domain as well as the policy priorities discussed above, we are proposing to change the Clinical Measure Domain weighting for the PY 2019 ESRD QIP. Specifically, we are proposing to increase the weight of the
For the reasons discussed above, we propose to use the following weighting system in Table 3 below, for calculating a facility's Clinical Measure Domain score for PY 2019. For comparison, in Table 4, we have also provided the Measure Weights we originally finalized for PY 2019 in the CY 2016 ESRD PPS Final Rule (80 FR 69063).
In the CY 2016 ESRD PPS Final Rule, we finalized a requirement that, to be eligible to receive a TPS, a facility had to be eligible for at least one reporting measure and at least one clinical measure (80 FR 69064). With the proposed addition of the Safety Measure Domain for PY 2019, we are proposing a change to this policy. Specifically, for PY 2019, we propose that to be eligible to receive a TPS, a facility must be eligible for at least one measure in the Clinical Measure Domain and at least one measure in the Reporting Measure Domain. As such, facilities do not need to receive a score on a measure in the Safety Measure Domain in order to be eligible to receive a TPS. The NHSN BSI Clinical Measure and the NHSN Dialysis Event Reporting Measure have the same eligibility requirements (specifically they require that a facility treated at least 11 eligible patients during the performance period). We are proposing this change in policy to avoid a situation in which a facility is eligible to receive a TPS when they only receive a score for a single measure topic. We are not proposing any changes to the policy that a facility's TPS will be rounded to the nearest integer, with half of an integer being rounded up.
We seek comments on these proposals.
In this section, we provide an example to illustrate the proposed scoring methodology for PY 2019. Figures 1 through 4 illustrate how to calculate the Clinical Measure Domain score, the Reporting Measure Domain score, the Safety Measure Domain score, and the TPS. Figure 5 illustrates the full proposed scoring methodology for PY 2019. Note that for this example,
Figure 1 illustrates the methodology used to calculate the Clinical Measure Domain score for Facility A.
Figure 2 illustrates the general methodology for calculating the Reporting Measure Domain score for Facility A.
Figure 3 illustrates the methodology used for calculating the Safety Measure Domain score for Facility A.
Figure 4 illustrates the methodology used to calculate the TPS for Facility A.
Figure 5 illustrates the full scoring methodology for PY 2019.
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to ensure that the application of the ESRD QIP scoring methodology results in an appropriate distribution of payment reductions across facilities, such that facilities achieving the lowest TPSs receive the largest payment reductions. In the CY 2016 ESRD PPS final rule, we finalized our proposal for calculating the minimum TPS for PY 2019 and future payment years (80 FR 69067). Under our current policy, a facility will not receive a payment reduction if it achieves a minimum TPS that is equal to or greater than the total of the points it would have received if: (i) It performs at the performance standard for each clinical measure; and (ii) it receives the number of points for each reporting measure that corresponds to the 50th percentile of facility performance on each of the PY 2017 reporting measures (80 FR 69067).
We were unable to calculate a minimum TPS for PY 2019 in the CY 2016 ESRD PPS final rule because we were not yet able to calculate the performance standards for each of the clinical measures. We therefore stated that we would publish the minimum TPS for the PY 2019 ESRD QIP in the CY 2017 ESRD PPS final rule (80 FR 69068).
Based on the estimated performance standards listed above, we estimate that a facility must meet or exceed a minimum TPS of 59 for PY 2019. For all of the clinical measures except the SRR and STrR, these data come from CY 2015. The data for the SRR and STrR clinical measures come from CY 2014 Medicare claims. For the ICH CAHPS clinical measure, we set the performance standard to zero for the purposes of determining this minimum TPS, because we are not able to establish a numerical value for the performance standard through the rulemaking process before the beginning of the PY 2019 performance period. We are proposing that a facility failing to meet the minimum TPS, as established in the CY 2017 ESRD PPS final rule, will receive a payment reduction based on the estimated TPS ranges indicated in Table 5 below.
We seek comments on these proposals.
One of the critical elements of the ESRD QIP's success is ensuring that the
In the CY 2015 ESRD PPS final rule, we also finalized that there will be a feasibility study for validating data reported to the Centers for Disease Control and Prevention (CDC's) National Healthcare Safety Network (NHSN) Dialysis Event Module for the NHSN BSI Clinical Measure. Healthcare-Acquired Infections (HAI) are relatively rare, and we finalized that the feasibility study would target records with a higher probability of including a dialysis event, because this would enrich the validation sample while reducing the burden on facilities. This methodology resembles the methodology we use in the Hospital Inpatient Quality Reporting Program to validate the central line-associated bloodstream infection measure, the catheter-associated urinary tract infection measure, and the surgical site infection measure (77 FR 53539 through 53553).
For the PY 2019 ESRD QIP, we propose to randomly select 35 facilities to participate in an NHSN dialysis event validation study by submitting 10 patient records covering two quarters of data reported in CY 2017. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period;
We recognize that facilities have previously had 60 days to respond to these requests. However, in the process of implementing the pilot validation study for CY 2015 data, we recognized that the validation contractor did not have enough time to initiate requests, receive responses, validate data reported to NHSN, and generate a comprehensive validation report before the end of the contract cycle. Although facilities will have less time, the 30-day response requirement is consistent with validation studies conducted in the Hospital IQR Program, and we believe that 30 days is a reasonable amount of time for facilities to obtain and transmit the requisite medical records.
We seek comments on this proposal.
We consider a quality measure for removal or replacement if: (1) Measure performance among the majority of ESRD facilities is so high and unvarying that meaningful distinctions in improvements or performance can no longer be made (in other words, the measure is topped-out); (2) performance or improvement on a measure does not result in better or the intended patient outcomes; (3) a measure no longer aligns with current clinical guidelines or practice; (4) a more broadly applicable (across settings, populations, or conditions) measure for the topic becomes available; (5) a measure that is more proximal in time to desired patient outcomes for the particular topic becomes available; (6) a measure that is more strongly associated with desired patient outcomes for the particular topic becomes available; or (7) collection or public reporting of a measure leads to negative or unintended consequences (77 FR 67475). In the CY 2015 ESRD PPS final rule, we adopted statistical criteria for determining whether a clinical measure is topped out, and also adopted a policy under which we could retain an otherwise topped-out measure if we determined that its continued inclusion in the ESRD QIP measure would address the unique needs of a specific subset of the ESRD population (79 FR 66174).
Subsequent to the publication of the CY 2016 ESRD PPS final rule, we evaluated the finalized PY 2019 ESRD QIP measures that would be continued in PY 2020 against all of these criteria. We determined that none of these measures met criterion (1), (2), (3), (4), (5) or (6). As part of this evaluation for criterion one, we performed a statistical analysis of the PY 2019 measures to determine whether any measures were “topped out.” The full results of this analysis can be found at
As the information in Table 6 indicates, none of these clinical measures are currently topped-out in the ESRD QIP. Accordingly, we are not proposing to remove any of these measures from the ESRD QIP for PY 2020 because they are topped out.
We consider the data sources we use to calculate our measures based on the reliability of the data, and we also try to use CROWNWeb data whenever possible. The Mineral Metabolism measure currently in the ESRD QIP measure set uses CROWNWeb data to determine how frequently facilities report serum phosphorus data, but it also uses Medicare claims data to exclude patients when they were treated at a facility fewer than seven times in a month. There is no evidence to suggest that the Mineral Metabolism reporting measure is leading to negative or unintended clinical consequences. However, we do not think it is optimal to use claims data to calculate the measure because that is inconsistent with our intention to increasingly use CROWNWeb as the data source for calculating measures in the ESRD QIP. There is also another available measure that can be calculated using only CROWNWeb data and that we believe is as reliable as the Mineral Metabolism Reporting Measure. The measure also excludes patients using criteria consistent with that used by other ESRD QIP measures. For these reasons, we are proposing to remove the Mineral Metabolism Reporting Measure from the ESRD QIP measure set beginning with the PY 2020 program and to replace that measure with the proposed Serum Phosphorus Reporting measure, the specifications for which are described below in section IV.D.2.c.i.
We seek comments on this proposal.
We previously finalized 12 measures in the CY 2016 ESRD PPS final rule for the PY 2019 ESRD QIP, and these measures are summarized in Table 7 below. In accordance with our policy to continue using measures unless we propose to remove or replace them, (77 FR 67477), we will continue to use 11 of these measures in the PY 2020 ESRD QIP. As noted above, we are proposing to replace the Mineral Metabolism
Hospitalization rates are an important indicator of patient morbidity and quality of life. On average, dialysis patients are admitted to the hospital nearly twice a year and spend an average of 11.2 days in the hospital per year.
At the end of 2013 there were 661,648 patients being dialyzed, of which 117,162 were new (incident) ESRD patients.
Hospitalization measures have been in use in the Dialysis Facility Reports (formerly Unit-Specific Reports) since 1995. The Dialysis Facility Reports are used by the dialysis facilities and ESRD Networks for quality improvement, and by ESRD state surveyors for monitoring and surveillance. In particular, the Standardized Hospitalization Ratio (SHR) for Admissions is used in the CMS ESRD Core Survey Process, in conjunction with other standard criteria for prioritizing and selecting facilities to survey. In addition, the SHR has been found to be predictive of dialysis facility deficiency citations in the past (ESRD State Outcomes List). The SHR is also a measure that has been publicly reported since January 2013 on the Centers for Medicare and Medicaid Services (CMS) Dialysis Facility Compare Web site.
The SHR measure is an NQF-endorsed all-cause, risk-standardized rate of hospitalizations during a 1-year observation window. The Measures Application Partnership supports the direction of this measure for inclusion in the ESRD QIP.
We are proposing to adopt a modified version of the SHR currently endorsed by NQF (NQF #1463). We have submitted this modified measure to NQF for endorsement consideration as part of the standard maintenance process for NQF #1463. When we previously proposed the SHR for implementation in the QIP, we received public comments urging us to not rely solely on CMS Medical Evidence Form 2728 as the only source of patient comorbidity data in the risk-adjustment calculations for the SHR measure. These comments correctly stated that incident comorbidity data are collected for all ESRD patients on CMS Form 2728 when patients first become eligible to receive Medicare ESRD benefits, regardless of payer. Although CMS Form 2728 is intended to inform both facilities and us whether one or more comorbid conditions are present at the start of ESRD, “there is currently no mechanism for either correcting or updating patient comorbidity data on CMS' Medical Evidence Reporting Form 2728” (76 FR 70267). Commenters were concerned that risk-adjusting the SHR solely on the basis of comorbidity data from CMS Form 2728 would create access to care problems for patients, because patients typically develop additional comorbidities after they begin chronic dialysis, and facilities would have a disincentive to treat these patients if recent comorbidities were not included in the risk-adjustment calculations (77 FR 67495 through 67496).
In the CY 2013 ESRD PPS proposed rule, we noted that updated comorbidity data could be captured on the ESRD 72x claims form. Some public comments stated that, “reporting comorbidities on the 72x claim could be a huge administrative burden for facilities, including time associated with validating that the data they submit on these claims is valid” (77 FR 67496). In response to these comments, we stated that we would “continue to assess the best means available for risk-adjustment for both the SHR and Standardized Mortality Ratio (SMR) measures, taking both the benefits of the information and the burden to facilities into account, should we propose to adopt these measures in future rulemaking” (77 FR 67496). We proposed to adopt a Comorbidity Reporting Measure for the PY 2016 ESRD QIP. This measure would have allowed us to collect and analyze the updated comorbidity data “to develop risk adjustment methodologies for possible use in calculating the SHR and SMR measures” (78 FR 72208). We chose not to finalize the comorbidity measure “as a result of the significant concerns expressed by commenters (78 FR 72209).
In response to the comments on the SHR when originally proposed, and subsequently the proposed comorbidity reporting measure, we have made revisions to the SHR specifications. The modified SHR that we are currently proposing to adopt beginning with the PY 2020 ESRD QIP includes a risk adjustment for 210 prevalent comorbidities in addition to the incident comorbidities from the CMS Medical Evidence Form 2728. The 210 prevalent comorbidities were identified through review by a Technical Expert Panel (TEP) first convened in late 2015. The details of how the 210 comorbidities were identified are described below. We propose to identify these prevalent comorbidities for purposes of risk adjusting the measure using available Medicare claims data. We believe this approach allows us to address commenters' concerns about increased reporting burden, while also resulting in a more robust risk-adjustment methodology.
Our understanding is that the NQF evaluates measures on the basis of four criteria: importance, scientific acceptability, feasibility, and usability. The validity and reliability of a measure's risk-adjustment calculations fall under the “scientific acceptability” criterion, and Measure Evaluation Criterion 2b4 specifies NQF's preferred approach for risk-adjusting outcome measures (
Reflecting these criteria, the TEP evaluated a list of prevalent comorbidities derived through the following process. First, the ESRD Hierarchical Comorbidity Conditions (ESRD-HCCs) were used as a starting point to identify ICD-9 diagnosis codes that could be used for risk adjustment. Those individual ICD-9 conditions that comprised the respective ESRD HCCs, with a prevalence of at least 0.1 percent in the patient population, were then selected for analysis to determine their statistical relationship to mortality or hospitalization. This step resulted in 555 diagnoses for comorbidities (out of over 3000 ICD-9 diagnosis codes in the ESRD-HCCs). Next, an adaptive lasso variable selection method was applied to these 555 diagnoses to identify those with a statistically significant relationship to mortality and/or hospitalization (p<0.05). This process identified 242 diagnoses. The TEP members then scored each of these diagnoses as follows:
1. Very likely the result of dialysis facility care.
2. Likely the result of dialysis facility care.
3. May or may not be the result of dialysis facility care.
4. Unlikely to be the result of dialysis facility care.
5. Very likely not the result of dialysis facility care.
This scoring exercise aimed at identifying a set of prevalent comorbidities are not likely the result of facility care and therefore potentially are risk adjusters for SHR and SMR. The TEP concluded that comorbidities scored as “unlikely” or “very unlikely the result of facility care” by at least half of TEP members (simple majority) were appropriate for inclusion as risk-adjusters. This process resulted in 210 conditions as risk adjustors. The TEP recommended incorporation of these adjustors in the risk model for the SHR, and CMS concurred.
Section 1881(h)(2)(B)(i) of the Act requires that, unless the exception set forth in section 1881(h)(2)(B)(ii) of the Act applies, the measures specified for the ESRD QIP under section 1881(h)(2)(A)(iv) of the Act must have been endorsed by the entity with a contract under section 1890(a) of the Act (that entity currently is NQF).
We have analyzed the measure's reliability, the results of which are provided below and in greater detail in the SHR Measure Methodology report, available at:
Overall, we found that IURs for the 1-year SHRs have a range of 0.70 through 0.72 across the years 2010, 2011, 2012 and 2013, which indicates that two-thirds of the variation in the 1-year SHR can be attributed to the between-facility differences and one-third to within-facility variation.
In addition, SHR is negatively correlated in each of the 4-years with the measure assessing percentage of patients in the facility with an AV Fistula (Spearman's rho= −0.12, −0.15, −0.12, −0.13). Thus higher values of SHR are associated with lower usage of AV Fistulas. Further, SHR is positively correlated with catheter use >= 90 days (Spearman's rho=0.21, 0.21, 0.18, 0.16), indicating that higher values of SHR are associated with increased use of catheters. These correlations are all highly significant (p<0.001). For each year of 2010 through 2013, the SHR is also found to be negatively correlated with the percent of hemodialysis patients with Kt/V>=1.2, again in the direction expected (Spearman's rho= −0.11, −0.13, −0.10,−0.11; p<0.0001). Lower SHRs are associated with a higher percentage of patients receiving adequate dialysis dose.
Data are derived from an extensive national ESRD patient database, which is largely derived from the CMS Consolidated Renal Operations in a Web-enabled Network (CROWN), which includes Renal Management Information System (REMIS), and the Standard Information Management System database, the Enrollment Database, Medicare dialysis and hospital payment records, the CMS Medical Evidence Form (Form CMS-2728), transplant data from the Organ Procurement and Transplant Network, the Death Notification Form (Form CMS-2746), the Nursing Home Minimum Dataset, the Dialysis Facility Compare and the Social Security Death Master File. The database is comprehensive for Medicare Parts A and B patients. Non-Medicare patients are included in all sources except for the Medicare payment records. Standard Information Management System/CROWNWeb provides tracking by dialysis provider and treatment modality for non-Medicare patients. Information on hospitalizations and patient comorbidities are obtained from Medicare Inpatient Claims Standard Analysis Files.
The outcome for this measure is the number of inpatient hospital admissions among eligible chronic dialysis patients under the care of the dialysis facility during the 1-year reporting period.
The measure eligible population includes adult and pediatric Medicare ESRD patients who have reached day 91 of ESRD treatment and who received dialysis within the 1-year period.
Patients are included in the measure after the first 90 days of treatment. For each patient, we identify the dialysis provider at each point in time. Starting with day 91 of ESRD treatment, we attribute patients to facilities according to the following rules. A patient is attributed to a facility once the patient has been treated there for 60 days. When a patient transfers from one facility to another, the patient continues to be attributed to the original facility for 60 days and then is attributed to the destination facility. In particular, a patient is attributed to his or her current facility on day 91 of ESRD treatment if that facility had treated him or her for at least 60 days. If on day 91, the facility had treated a patient for fewer than 60 days, we wait until the patient reaches day 60 of treatment at that facility before
The SHR measure estimates expected hospitalizations calculated from a Cox model that adjusts for patient risk factors and demographic characteristics. This model accounts for clustering of patients in particular facilities and allows for an estimate of the performance of each individual facility, while applying the risk adjustment model to obtain the expected number of hospitalizations for each facility. The model does not adjust for sociodemographic status. We understand the important role that sociodemographic status plays in the care of patients. However, we continue to have concerns about holding dialysis facilities to different standards for the outcomes of their patients of diverse sociodemographic status because we do not want to mask potential disparities or minimize incentives to improve the outcomes of disadvantaged populations. We routinely monitor the impact of sociodemographic status on facilities' results on our measures.
NQF is currently undertaking a 2-year trial period in which new measures and measures undergoing maintenance review will be assessed to determine if risk-adjusting for sociodemographic factors is appropriate. For 2-years, NQF will conduct a trial of a temporary policy change that will allow inclusion of sociodemographic factors in the risk-adjustment approach for some performance measures. At the conclusion of the trial, NQF will determine whether to make this policy change permanent. Measure developers must submit information such as analyses and interpretations as well as performance scores with and without sociodemographic factors in the risk adjustment model.
Furthermore, the Office of the Assistant Secretary for Planning and Evaluation is conducting research to examine the impact of sociodemographic status on quality measures, resource use, and other measures under the Medicare program as directed by the Improving Medicare Post-Acute Care Transformation Act. We will closely examine the findings of the Assistant Secretary for Planning and Evaluation reports and related Secretarial recommendations and consider how they apply to our quality programs at such time as they are available.
The SHR measure is calculated as the ratio of the number of observed hospitalizations to the number of expected hospitalizations. A ratio greater than one means that facilities have more hospitalizations than would be expected for an average facility with a similar patient-mix; a ratio less than one means the facility has fewer hospitalizations than would be expected for an average facility with a similar patient-mix.
The SHR uses expected hospital admissions calculated from a Cox model as extended to handle repeated events, with piecewise constant baseline rates. The model is fit in two stages. The stage 1 model is first fitted to the national data with piecewise constant baseline rates applied to each facility. Hospitalization rates are adjusted for patient age, sex, diabetes, duration of ESRD, nursing home status, BMI at incidence, comorbidity index at incidence, and calendar year. This model allows the baseline hospitalization rates to vary between facilities then applies the regression coefficients equally to all facilities. This approach is robust to possible differences between facilities in the patient mix being treated. The second stage then uses a risk adjustment factor from the first stage as an offset. The stage 2 model then calculates the national baseline hospitalization rate. The predicted value from stage 1 and the baseline rate from stage 2 are then used to calculate the expected number of hospital days for each patient over the period during which the patient is seen to be at risk.
The SHR is a point estimate—the best estimate of a facility's hospitalization rate based on the facility's patient- mix. For more detailed information on the calculation methodology please refer to our Web site at:
We seek comments on our proposal to adopt the SHR measure for the ESRD QIP beginning with PY 2020.
As mentioned above, for PY 2020 we are proposing to adopt a new Proposed Serum Phosphorus Reporting Measure. Section 1881(h)(2)(A)(iii) of the Act states that the measures specified for the ESRD QIP shall include other measures as the Secretary specifies, including, to the extent feasible, measures of bone mineral metabolism. Abnormalities of bone mineral metabolism are exceedingly common and contribute significantly to morbidity and mortality in patients with advanced Chronic Kidney Disease (CKD). Numerous studies have associated disorders of mineral metabolism with morbidity, including fractures, cardiovascular disease, and mortality. Overt symptoms of these abnormalities often manifest in only the most extreme states of calcium-phosphorus dysregulation, which is why we believe that routine blood testing of calcium and phosphorus is necessary to detect abnormalities.
The proposed Serum Phosphorus Reporting Measure is based on a serum phosphorus measure that is endorsed by the NQF (NQF #0255), which evaluates the extent to which facilities monitor and report patient phosphorus levels. In addition, and as explained above, the proposed Serum Phosphorus Reporting Measure is collected using CROWNWeb data and excludes patients using criteria consistent with other ESRD QIP measures. The Measure Applications Partnership expressed full support for this measure.
For PY 2020 and future payment years, we propose that facilities must report serum or plasma phosphorus data to CROWNWeb at least once per month for each qualifying patient. Qualifying patients for this proposed measure are defined as patients 18 years of age or older, who have a completed CMS Medical Evidence Form 2728, who have not received a transplant with a functioning graft, and who are assigned to the same facility for at least the full calendar month (for example, if a patient is admitted to a facility during the middle of the month, the facility will not be required to report for that patient for that month). We further propose that facilities will be granted a one-month period following the calendar month to enter this data. For example, we would require a facility to report Serum Phosphorus rates for January 2018 on or before February 28, 2018. Facilities would be scored on whether they successfully report the required data within the timeframe
We seek comments on this proposal.
The ultrafiltration rate measures the rapidity with which fluid (ml) is removed during dialysis per unit (kg) of body weight in unit (hour) time. A patient's ultrafiltration rate is under the control of the dialysis facility and is monitored throughout a patient's hemodialysis session. Studies suggest that higher ultrafiltration rates are associated with higher mortality and higher odds of an “unstable” dialysis session,
We have given due consideration to endorsed measures, as well as those adopted by a consensus organization. Because no NQF-endorsed measures or measures adopted by a consensus organization that require reporting of relevant ultrafiltration data currently exist, we are proposing to adopt the Ultrafiltration Rate reporting measure under the authority of section 1881(h)(2)(B)(ii) of the Act.
The proposed Ultrafiltration Rate reporting measure is based upon the NQF-endorsed Avoidance of Utilization of High Ultrafiltration Rate (>/= 13 ml/kg/hr) (NQF #2701). This measure assesses the percentage of patient-months for patients with an ultrafiltration rate greater than or equal to 13 ml/kg/hr. The Measure Applications Partnership expressed full support for this measure.
For PY 2020 and future payment years, we propose that facilities must report the following data to CROWNWeb for all hemodialysis sessions during the week of the monthly Kt/V draw submitted to CROWNWeb for that clinical month, for each qualifying patient (defined below):
We seek comments on this proposal.
We are proposing to establish CY 2018 as the performance period for the PY 2020 ESRD QIP for all but the NHSN Healthcare Personnel Influenza Vaccination reporting measure because it is consistent with the performance periods we have historically used for these measures and accounts for seasonal variations that might affect a facility's measure score.
We are proposing that the performance period for the NHSN Healthcare Personnel Influenza Vaccination reporting measure will be from October 1, 2016 through March 31, 2017, because this period spans the length of the 2016-2017 influenza season.
We seek comments on these proposals.
Section 1881(h)(4)(A) of the Act provides that “the Secretary shall establish performance standards with respect to measures selected . . . for a performance period with respect to a year.” Section 1881(h)(4)(B) of the Act further provides that the “performance standards . . . shall include levels of achievement and improvement, as determined appropriate by the Secretary.” We use the performance standards to establish the minimum score a facility must achieve to avoid a Medicare payment reduction. We use achievement thresholds and benchmarks to calculate scores on the clinical measures.
For the same reasons stated in the CY 2013 ESRD PPS final rule (77 FR 67500 through 76502), we are proposing for PY 2020 to set the performance standards, achievement thresholds, and benchmarks for the clinical measures at the 50th, 15th, and 90th percentile, respectively, of national performance in CY 2016, because this will give us enough time to calculate and assign numerical values to the proposed performance standards for the PY 2020 program prior to the beginning of the performance period. We continue to believe these standards will provide an incentive for facilities to continuously improve their performance, while not reducing incentives to facilities that score at or above the national performance rate for the clinical measures. We seek comments on these proposals.
At this time, we do not have the necessary data to assign numerical values to the proposed performance standards for the clinical measures, because we do not yet have data from CY 2016 or the first portion of CY 2017. We will publish values for the clinical measures, using data from CY 2016 and the first portion of CY 2017, in the CY 2018 ESRD PPS final rule.
In the CY 2014 ESRD PPS final rule, we finalized performance standards for the Anemia Management and Mineral Metabolism reporting measures (78 FR
In the CY 2016 ESRD PPS final rule, we finalized performance standards for the Screening for Clinical Depression and Follow-Up, Pain Assessment and Follow-Up, and NHSN Healthcare Provider Influenza Vaccination reporting measures (79 FR 66209). We are not proposing any changes to these policies.
For the proposed Ultrafiltration Rate Reporting Measure, we propose to set the performance standard as successfully reporting the following data to CROWNWeb for all hemodialysis sessions during the week of the monthly Kt/V draw for that clinical month, for each qualifying patient (1) HD Kt/V Date; (2) Post-Dialysis Weight; (3) Pre-Dialysis Weight; (4) Delivered Minutes of BUN Hemodialysis; and (5) Number of sessions of dialysis delivered by the dialysis unit to the patient in the reporting month. This information must be submitted for each qualifying patient in CROWNWeb on a monthly basis, for each month of the reporting period.
For the proposed Serum Phosphorus Reporting measure, we propose to set the performance standard as successfully reporting a serum phosphorus value for each qualifying patient in CROWNWeb on a monthly basis, for each month of the reporting period.
For the proposed NHSN Dialysis Event Reporting measure, we propose to set the performance standard as successfully reporting 12 months of data from CY 2018.
We seek comments on these proposals.
In the CY 2014 ESRD PPS Final Rule, we finalized a policy for scoring performance on clinical measures based on achievement (78 FR 72215). Under this methodology, facilities receive points along an achievement range based on their performance during the performance period for each measure, which we define as a scale between the achievement threshold and the benchmark. In determining a facility's achievement score for each clinical measure under the PY 2020 ESRD QIP, we propose to continue using this methodology for all clinical measures except the ICH CAHPS clinical measure. The facility's achievement score would be calculated by comparing its performance on the measure during CY 2018 (the proposed performance period) to the achievement threshold and benchmark (the 15th and 90th percentiles of national performance on the measure in CY 2016).
We seek comment on this proposal.
In the CY 2014 ESRD PPS Final Rule, we finalized a policy for scoring performance on clinical measures based on improvement (78 FR 72215 through 72216). In determining a facility's improvement score for each measure under the PY 2020 ESRD QIP, we propose to continue using this methodology for all clinical measures except the ICH CAHPS clinical measure. Under this methodology, facilities receive points along an improvement range, defined as a scale running between the improvement threshold and the benchmark. We propose to define the improvement threshold as the facility's performance on the measure during CY 2017. The facility's improvement score would be calculated by comparing its performance on the measure during CY 2018 (the proposed performance period) to the improvement threshold and benchmark.
We seek comment on this proposal.
In the CY 2015 ESRD PPS final rule, we finalized a policy for scoring performance on the ICH CAHPS clinical measure based on both achievement and improvement (79 FR 66209 through 66210). We are not proposing any changes to this policy. Under this methodology, facilities will receive an achievement score and an improvement score for each of the three composite measures and three global ratings in the ICH CAHPS survey instrument. A facility's ICH CAHPS score will be based on the higher of the facility's achievement or improvement score for each of the composite measures and global ratings, and the resulting scores on each of the composite measures and global ratings will be averaged together to yield an overall score on the ICH CAHPS clinical measure. For PY 2020, the facility's achievement score would be calculated by comparing where its performance on each of the three composite measures and three global ratings during CY 2018 falls relative to the achievement threshold and benchmark for that measure and rating based on CY 2016 data. The facility's improvement score would be calculated by comparing its performance on each of the three composite measures and three global ratings during CY 2018 to its performance rates on these items during CY 2017.
We seek comments on this proposal.
In the CY 2013 ESRD PPS final rule, we finalized policies for scoring performance on the Anemia Management and Mineral Metabolism reporting measures in the ESRD QIP (77 FR 67506). We are not proposing any changes to these policies for the PY 2020 ESRD QIP.
In the CY 2015 ESRD PPS final rule, we finalized policies for scoring performance on the Clinical Depression Screening and Follow-Up, Pain Assessment and Follow-Up, and NHSN Healthcare Provider Influenza Vaccination reporting measures (79 FR 66210 through 66211). We are not proposing any changes to these policies.
With respect to the proposed Ultrafiltration Rate and Serum Phosphorus reporting measures, we are proposing to score facilities with a CMS Certification Number (CCN) Open Date before July 1, 2018 using the same formula previously finalized for the Mineral Metabolism and Anemia Management reporting measures (77 FR 67506):
We seek comments on these proposals.
In light of the proposed removal of the Safety Subdomain from the Clinical Measure Domain, our policy priorities for quality improvement for patients with ESRD discussed in Section IV.C.6 above, and the criteria finalized in the CY 2015 ESRD PPS Final Rule used to assign weights to measures in a facility's Clinical Measure Domain score (79 FR 66214 through 66216), we propose to weight the following measures in the following subdomains of the proposed clinical measure domain as follows (see Table 10, below):
Specifically, we are proposing to reduce the weight of the Safety Measure Domain in light of validation concerns discussed above in the context of the proposal to reintroduce the NHSN Dialysis Event Reporting Measure (see Section (IV)(1)(a) above). For PY 2020 we are proposing to reduce the weight of the Safety Measure Domain from 15 percent to 10 percent. In future years of the program, we may consider increasing the weight of the NHSN BSI Clinical Measure and/or the NHSN BSI Measure Topic once we see that facilities are completely and accurately reporting to NHSN and once we have analyzed the data from the proposed increased NHSN Data Validation Study. In order to accommodate the reduction of the weight of the Safety Measure Domain, we are proposing to increase the weight of the Clinical Measure Domain to 80 percent, and to keep the weight of the Reporting Measure Domain at 10 percent.
We are also proposing to weight the proposed SHR Clinical Measure at 11 percent of a facility's Clinical Measure Domain score. Facilities have had significant experience with SHR via public reporting on Dialysis Facility Compare, and reducing hospitalizations is a top policy goal for CMS. Further, increasing the emphasis on outcome measures is an additional policy goal of CMS, for reasons discussed above. For these reasons, we believe it is appropriate to weight the proposed SHR Clinical Measure at 11 percent of a facility's Clinical Measure Domain score.
Next, we are proposing to decrease the weight of the Hypercalcemia clinical measure within the Clinical Care Subdomain to 2 percent of a facility's clinical domain score. We are proposing to do so at this time to accommodate the weight assigned to the proposed SHR measure. The Hypercalcemia clinical measure was recently re-endorsed at NQF with a reserved status because there was very little room for improvement and facility scores on the measure are very high overall. Although this is true, the Hypercalcemia clinical measure does not meet the criterion for being topped out in the ESRD QIP (as described in Section IV.D.1. above). Therefore, despite its limited value for assessing facility performance, we decided not to propose to remove the Hypercalcemia clinical measure from the ESRD QIP measure set, but rather to significantly reduce its weight in the clinical subdomain because it provides some indication of the quality of care furnished to patients by facilities.
Finally, to accommodate the proposed addition of the SHR Clinical Measure beginning in PY 2020 and the proposed reduction in weight of the Hypercalcemia measure, we are proposing to reduce the weights of the following measures by 1 percentage point each from what we have proposed for PY 2019, within the Clinical Measure Domain: ICH CAHPS, SRR, STrR, Dialysis Adequacy, and Vascular Access Type. As illustrated in Table 10, these minor reductions in the weights of these measures in the Clinical Measure Domain would be counterbalanced by the increase in the overall percent of the TPS that we are proposing to make to the Clinical Measure Domain, such that the proposed weights for these measures as a percentage of the TPS will remain as constant as possible from PY 2019 to PY 2020. Accordingly, this proposal would generally maintain the percentage of the TPS assigned to these measures.
We seek comments on these proposals.
We continue to believe that while the reporting measures are valuable, the clinical measures evaluate actual patient care and therefore justify a higher combined weight (78 FR 72217). We are proposing to reduce the weight of the Safety Measure Domain from 15 percent of a facility's TPS for PY 2019 to 10 percent of a facility's TPS for PY 2020. As noted in Section IV.C.1.a. above, we are gradually reducing the weight of this Safety Measure Domain over the course of 2 years because we believe it is important to reduce the weight of the Domain in light validation concerns, but it is important to maintain as much
For the same reasons discussed above, in Section IV.C.6., we propose that for PY 2020, to be eligible to receive a TPS, a facility must be eligible to be scored on at least one measure in the Clinical Measure Domain and at least one measure in the Reporting Measure Domain.
We seek comments on these proposals.
In this section, we provide an example to illustrate the proposed scoring methodology for PY 2020. Figures 6-9 illustrate how to calculate the Clinical Measure Domain score, the Reporting Measure Domain score, the Safety Measure Domain score, and the TPS. Figure 10 illustrates the full proposed scoring methodology for PY 2020. Note that for this example, Facility A, a hypothetical facility, has performed very well. Figure 6 illustrates the methodology used to calculate the Clinical Measure Domain score for Facility A.
Figure 7 illustrates the general methodology for calculating the Reporting Measure Domain score for Facility A.
Figure 8 illustrates the methodology used for calculating the Safety Measure Domain score for Facility A.
Figure 9 illustrates the methodology to calculate the TPS for Facility A.
Our policy is to score facilities on clinical and reporting measures for which they have a minimum number of qualifying patients during the performance period. With the exception of the Standardized Readmission Ratio, Standardized Hospitalization Ratio, Standardized Transfusion Ratio, and ICH CAHPS clinical measures, a facility must treat at least 11 qualifying cases during the performance period in order to be scored on a clinical or reporting measure. A facility must have at least 11 index discharges to be eligible to receive a score on the SRR clinical measure, 10 patient-years at risk to be eligible to receive a score on the STrR clinical measure, and 5 patient-years at risk to be eligible to receive a score on the SHR clinical measure. In order to receive a score on the ICH CAHPS clinical measure, a facility must have treated at least 30 survey-eligible patients during the eligibility period and receive 30 completed surveys during the performance period. We are not proposing to change these minimum data policies for the measures that we have proposed to continue including in the PY 2019 ESRD QIP measure set.
For the proposed Ultrafiltration Rate and Serum Phosphorus Reporting Measures, we also propose that facilities with at least 11 qualifying patients will receive a score on the measure. We believe that setting the case minimum at 11 for these reporting measures strikes the appropriate balance between the need to maximize data collection and the need to not unduly burden or penalize small facilities. We further believe that setting the case minimum at 11 is appropriate because this aligns with case minimum policy for the vast majority of the reporting measures in the ESRD QIP.
Under our current policy, we begin counting the number of months for which a facility is open on the first day of the month after the facility's CMS Certification Number (CCN) Open Date. Only facilities with a CCN Open Date before July 1, 2018 would be eligible to be scored on the Anemia Management, Mineral Metabolism, Pain Assessment and Follow-Up, Clinical Depression Screening and Follow-Up reporting measures, and only facilities with a CCN Open Date before January 1, 2018 would be eligible to be scored on the NHSN Bloodstream Infection Clinical Measure, ICH CAHPS Clinical Measure, and NHSN Healthcare Personnel Influenza Vaccination reporting measure. We further propose that, consistent with our CCN Open Date policy for other reporting measures, facilities with a CCN Open Date after July 1, 2018, would not be eligible to receive a score on the Ultrafiltration Rate Reporting Measure because of the difficulties these facilities may face in meeting the requirements of this measure due to the short period of time left in the performance period.
We seek comments on these proposals.
Table 11 displays the proposed patient minimum requirements for each of the measures, as well as the proposed CCN Open Dates after which a facility would not be eligible to receive a score on a reporting measure.
Section 1881(h)(3)(A)(ii) of the Act requires the Secretary to ensure that the application of the scoring methodology results in an appropriate distribution of payment reductions across facilities, such that facilities achieving the lowest TPSs receive the largest payment reductions. We propose that, for the PY 2020 ESRD QIP, a facility will not receive a payment reduction if it achieves a minimum TPS that is equal to or greater than the total of the points it would have received if:
• It performed at the performance standard for each clinical measure; and
• It received the number of points for each reporting measure that corresponds to the 50th percentile of facility performance on each of the PY 2018 reporting measures.
We recognize that we are not proposing a policy regarding the inclusion of measures for which we are not able to establish a numerical value for the performance standard through the rulemaking process before the beginning of the performance period in the PY 2019 minimum TPS. We have not proposed such a policy because no measures in the proposed PY 2020 measure set meet this criterion. However, should we choose to adopt a clinical measure in future rulemaking without the baseline data required to calculate a performance standard before the beginning of the performance period, we will propose a criterion accounting for that measure in the minimum TPS for the applicable payment year at that time.
The PY 2018 program is the most recent year for which we will have calculated final measure scores before the beginning of the proposed performance period for PY 2020 (that is, CY 2018). Because we have not yet calculated final measure scores, we are unable to determine the 50th percentile of facility performance on the PY 2018 reporting measures. We will publish that value in the CY 2018 ESRD PPS final rule once we have calculated final measure scores for the PY 2018 program.
Section 1881(h)(3)(A)(ii) of the Act requires that facilities achieving the lowest TPSs receive the largest payment reductions. In the CY 2014 ESRD PPS final rule (78 FR 72223 through 72224), we finalized a payment reduction scale for PY 2016 and future payment years: for every 10 points a facility falls below the minimum TPS, the facility would receive an additional 0.5 percent reduction on its ESRD PPS payments for PY 2016 and future payment years, with a maximum reduction of 2.0 percent. We are not proposing any changes to this policy for the PY 2020 ESRD QIP.
Because we are not yet able to calculate the performance standards for each of the clinical measures, we are also not able to calculate a proposed minimum TPS at this time. We will publish the minimum TPS, based on data from CY 2016 and the first part of CY 2017, in the CY 2018 ESRD PPS final rule.
We seek comments on this proposal.
As we continue to refine the ESRD QIP's policies and measures, we are evaluating different methods of ensuring that facilities strive for continuous improvement in their delivery of care to patients with ESRD. We also seek to refine our scoring methodology in an effort to make it easier for facilities and the ESRD community to understand. For future rulemaking, we are considering several policies and measures, and we are seeking comments on each of these policies and measures.
As discussed in Section III.D.3.a.i above, we are proposing to adopt the Standardized Hospitalization Ratio (SHR) Clinical measure and calculate performance rates for that measure in
In PY 2019, we proposed to adopt a patient-level influenza immunization reporting measure that could be used to calculate a future clinical measure based on either “ESRD Vaccination—Full-Season Influenza Vaccination” (MAP #XDEFM) or NQF #0226: “Influenza Immunization in the ESRD Population (Facility Level).” We continue to believe that it is important to include a clinical measure on patient-level influenza vaccination in the ESRD QIP. However, at this time we are not proposing to add a patient-level influenza immunization reporting measure into the ESRD QIP. Nevertheless, data elements were recently amended in CROWNWeb to support data collection for either of the two potential clinical measures on patient-level influenza (that is, MAP # XDEFM and NQF #0226). We will continue to collect these data and conduct detailed analyses to determine whether either of these clinical measures would be appropriate for future inclusion in the ESRD QIP. We are seeking comments on these issues, including whether data for a patient-level influenza immunization clinical measure should be collected through CROWNWeb or through NHSN.
As part of our effort to continuously improve the ESRD QIP, we are also working on developing additional, robust measures that provide valid assessments of the quality of care furnished to ESRD patients by ESRD facilities. Some measures we are considering developing for future inclusion in the ESRD QIP measure set include a Standardized Mortality Ratio (SMR) measure, a measure examining utilization of hospital Emergency Departments, a measure examining medication reconciliation efforts, and a measure examining kidney transplants in patients with ESRD.
We seek comments on these measures and policies that we are considering for adoption in the ESRD QIP in the future.
Section 1847(a) of the Act, as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary to establish and implement the CBP in CBAs throughout the United States for contract award purposes for the furnishing of certain competitively priced DMEPOS items and services. The programs, mandated by section 1847(a) of the Act, are collectively referred to as the “Medicare DMEPOS Competitive Bidding Program.” The 2007 DMEPOS competitive bidding final rule (Medicare Program; Competitive Acquisition for Certain DMEPOS and Other Issues published in the April 10, 2007
Section 1847(a)(1)(G) of the Act, added by section 522(a) of the Medicare Access and CHIP Reauthorization Act of 2015 (Pub. L. 114-10) (MACRA), now requires a bid surety bond for bidding entities.
Section 1847(a)(1)(G) of the Act, as added by section 522(a) of MACRA, provides that, with respect to rounds of competitions under section 1847 beginning not earlier than January 1, 2017 and not later than January 1, 2019, a bidding entity may not submit a bid for a CBA unless, as of the deadline for bid submission, the entity has (1) obtained a bid surety bond, in the range of $50,000 to $100,000 in a form specified by the Secretary consistent with subparagraph (H) of section 1847(a)(1), and (2) provided the Secretary with proof of having obtained the bid surety bond for each CBA in which the entity submits its bid(s). Section 1847(a)(1)(H)(i) provides that in the event that a bidding entity is offered a contract for any product category for a CBA, and its composite bid for such product category and area was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amount(s) for the product category and CBA, and the entity does not accept the contract offered, the bid surety bond(s) for the applicable CBAs will be forfeited and CMS will collect on the bid surety bond(s). In instances where a bidding entity does not meet the bid forfeiture conditions for any product category for a CBA as specified in section 1847(a)(1)(H)(i) of the Act, then the bid surety bond liability submitted by the entity for the CBA will be returned to the bidding entity within 90 days of the public announcement of the contract suppliers for such area.
Section 522 of MACRA further amended Section 1847(b)(2)(A) of the Act by adding clause (v) to the conditions that a bidding entity must meet in order for the Secretary to award a contract to any entity under a competition conducted in a CBA to furnish items and services. New clause (v) of section 1847(b)(2)(A) of the Act adds the requirement that the bidding entity must meet applicable State licensure requirements in order to be eligible for a DMEPOS CBP contract award. We note, however, that this does not reflect a change in policy as CMS already requires contract suppliers to meet applicable State licensure requirements in order to be eligible for a contract award.
This rule proposes to extend our current appeals process for contract terminations to all breach of contract actions that CMS might take. We propose to effectuate this change by expanding the breach of contract actions to which our current appeals process at § 414.423 applies to include all of the breach of contract actions specified in § 414.422(g)(2) and not just § 414.422(g)(2)(iii), which currently describes CMS' ability to terminate a supplier's contract. Any deviation from contract requirements, including a failure to comply with governmental agency or licensing organization requirements, constitutes a breach of contract under our regulations at § 414.422(g)(1). Pursuant to
At § 414.402, we propose adding a definition for “bidding entity” to mean the entity whose legal business name is identified in the “Form A: Business Organization Information” section of the bid.
At § 414.412, “Submission of bids under a competitive bidding program,” we propose to add a new paragraph (h) that would allow CMS to implement section 1847(a)(1)(G) of the Act, as amended by section 522(a) of MACRA, to state that an entity may not submit a bid for a CBA unless, as of the deadline for bid submission, the entity has obtained a bid surety bond for the CBA. Proposed § 414.412(h)(1) would specify that the bond must be obtained from an authorized surety. An authorized surety is a surety that has been issued a Certificate of Authority by the U.S. Department of the Treasury as an acceptable surety on Federal bonds and the certificate has neither expired nor been revoked.
At proposed § 414.412(h)(2) “Bid Surety Bond requirements,” we propose a bid surety bond contain the following information: (1) the name of the bidding entity as the principal/obligor; (2) The name and National Association of Insurance Commissioners number of the authorized surety; (3) CMS as the named obligee; (4) The conditions of the bond as specified in this proposed rule at (h)(3); (5) The CBA covered by the bond; (6) The bond number; (7) The date of issuance; and (8) The bid bond value of $100,000.
Section 1847(a)(1)(G) of the Act permits CMS to determine the amount of the bond within a range of $50,000 to $100,000. Given the importance of this provision, we have determined that it is appropriate to require bidding entities to obtain bid surety bonds in an amount of $100,000 for each CBA in which they submit a bid. This requirement is intended to ensure that bidding entities accept a contract offer(s) when their composite bid(s) is at or below the median composite bid rate used in the calculation of the single payment amounts. We also believe that setting the bid surety bond amount at $100,000 will provide an additional level of assurance that all bidding entities submit substantiated bids. The CBP has historically had a contract acceptance rate exceeding 90 percent, and we believe that this acceptance rate will increase with the promulgation of this regulation. We are considering whether a lower bid surety bond amount would be appropriate for a particular subset of suppliers, for example, small suppliers as defined by § 414.402, and are specifically soliciting comments on whether to establish a lower bid surety bond amount for certain types of suppliers.
Proposed 414.412(h)(3) specifies conditions for forfeiture of the bid surety bond and return of the bond liability. Pursuant to section 1847(a)(1)(H) of the Act, when (1) a bidding entity is offered a contract for any product category in a CBA, (2) the entity's composite bid is at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category and CBA, and (3) the entity does not accept the contract offer, then the entity's bid surety bond for that CBA will be forfeited and CMS will collect on it. When the bidding entity does not meet these forfeiture conditions, the bid bond liability will be returned within 90 days of the public announcement of the contract suppliers for the CBA. The proposed provision requires CMS to notify a bidding entity when it does not meet the bid forfeiture conditions and as a result CMS will not collect on the bid surety bond.
We propose that bidding entities that provide a falsified bid surety bond would be prohibited from participation in the current round of the CBP in which they submitted a bid and from bidding in the next round of the CBP. Additionally, offending suppliers would be referred to the Office of Inspector General and Department of Justice for further investigation. We also propose that if we find that a bidding entity has accepted a contract offer and then breached the contract in order to avoid bid surety bond forfeiture, the breach would result in a termination of the contract and preclusion from the next round of competition in the CBP. These proposed penalties would be included in our regulations at § 414.412(h)(4).
We propose to revise § 414.414(b)(3), “Conditions for awarding contracts,” to align with 1847(b)(2)(A) of the Act as amended by section 522(b) of MACRA. The amendment to the Act states that “[t]he Secretary may not award a contract to any entity under the competition conducted in an [
We believe suppliers should have the option to appeal all breach of contract actions. As a result, we propose to revise § 414.423, Appeals Process for Termination of Competitive Bidding Contract, to expand the appeals process for suppliers who have been sent a notice of a breach of contract stating that CMS intends to take one or more of the actions described in § 414.422(g)(2) as a result of the breach. While we recognize that we have the authority to take one or more breach of contract actions specified in § 414.422(g)(2), we currently only have an appeals process for one of those actions, specifically, contract termination. Therefore, the
Proposed revisions are made throughout § 414.423 to extend the appeals process to any breach of contract actions described in § 414.422(g)(2) that we might take as a result of the breach, rather than just contract termination actions. We are also proposing to remove the references to termination throughout 414.423 and instead to cross-reference all of the breach of contract actions in § 414.422(g)(2).
In revisions to § 414.423(a), we are proposing to delete the language indicating that termination decisions made under this section are final and binding as this reference is not inclusive of all breach of contract actions, and the finality of a decision is correctly addressed in paragraph (k)(4) of this section.
In the revisions to § 414.423(b)(1), we propose to delete the phrase “either in part or in whole” because 414.422(g)(1) specifies that any deviation from contract requirements constitutes a breach of contract. In addition, we propose to remove the requirement that the breach of contract notice to the supplier be delivered by certified mail from § 414.423(b)(1) to allow CMS the flexibility to use other secure methods for notifying suppliers. We are also proposing changes to § 414.423 (b)(2)(i) and (b)(2)(ii). The revised § 414.423(b)(2)(i) states that the notice of breach of contract will include the details of the breach of contract, while § 414.423(b)(2)(ii) requires CMS to include the action(s) that it is taking as a result of the breach of contract and the timeframes associated with the each breach of contract action in the notice. For example, when a notice of breach of contract includes preclusion, the effective date of the preclusion will be the date specified in the letter and the timeframe of the preclusion will specify the round of the CBP from which the supplier is precluded. We have also added language to (b)(2)(vi) to specify that the effective date of the action(s) that CMS is taking is the date specified by CMS in the notice of breach of contract, or 45 days from the date of the notice of breach of contract unless a timely hearing request has been filed or a CAP has been submitted within 30 days of the date of the notice of breach of contract where CMS allows a supplier to submit a CAP.
We are proposing to revise § 414.423(c)(2)(ii) to specify that the subsequent notice of breach of contract may, at CMS' discretion, allow the supplier to submit another written CAP pursuant to § 414.423(c)(1)(i). Section 414.423(e)(3) will be revised to clarify that CMS retains the option to offer the supplier an opportunity to submit another CAP, if CMS deems appropriate, in situations where CMS has already accepted a prior CAP.
Proposed revisions to § 414.423(f)(5) explain that in the event the supplier fails to timely request a hearing, the breach of contract action(s) specified in the notice of breach of contract will take effect 45 days from the date of the notice of breach of contract. Proposed revisions to § 414.423(g)(3) will be made to clarify that the scheduling notice must be sent to all parties, not just the supplier.
We are proposing to revise § 414.423(j) to clarify that the hearing officer will issue separate recommendations for each breach of contract action in situations where there is more than one breach of contract action presented at the hearing.
In § 414.423(k), we are proposing to specify that CMS will make separate decisions for each recommendation when the hearing officer issues multiple recommendations. In addition, we are proposing revisions to this paragraph to expand CMS' final determination process, clarifying that the notice of CMS' decision will be sent to the supplier and the hearing officer and will indicate whether any breach of contract actions included in the notice of breach of contract still apply and will be effectuated, and will indicate the effective date of the breach of contract action, if applicable. We propose to expand on § 414.423(l), effect of breach of contract action(s), to specify effects of all contract actions described in § 414.422(g)(2). We propose to add § 414.423(l)(1), effect of contract suspension, to outline the supplier's requirements regarding furnishing items and reimbursement for the duration of the contract suspension, as well as the details regarding the supplier's obligation to notify beneficiaries. We are also proposing to add § 414.423(l)(3), effect of preclusion, to specify that a supplier who is precluded will not be allowed to participate in a specific round of the CBP, which will be identified in the original notice of breach of contract. Additionally, we propose to add § 414.423(l)(4), effect of other remedies allowed by law, to state if CMS decides to impose other remedies under § 414.422(g)(2)(iv), the details of the remedies will be included in the notice of breach of contract. Proposed § 414.423(l) also specifies the steps suppliers must take to notify beneficiaries after CMS takes the contract action(s) described in § 414.422(g)(2). Lastly, we have removed language from § 414.423(l)(2), effect of contract termination, to avoid confusion as to which supplier is providing notice to the beneficiary.
Section 1834(a) of the Act governs payment for durable medical equipment (DME) covered under Part B and under Part A for a home health agency and provides for the implementation of a fee schedule payment methodology for DME furnished on or after January 1, 1989. Sections 1834(a)(2) through (a)(7) of the Act set forth separate payment categories of DME and describe how the fee schedule for each of the following categories is established:
• Inexpensive or other routinely purchased items;
• Items requiring frequent and substantial servicing;
• Customized items;
• Oxygen and oxygen equipment;
• Other covered items (other than DME); and
• Other items of DME (capped rental items).
Section 1834(h) of the Act governs payment for prosthetic devices, prosthetics, and orthotics (P&O) and sets
Section 1847(a) of the Act, as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary to establish and implement CBPs in competitive bidding areas (CBAs) throughout the United States for contract award purposes for the furnishing of certain competitively priced DMEPOS items and services. The programs mandated by section 1847(a) of the Act are collectively referred to as the “Medicare DMEPOS Competitive Bidding Program.” Section 1847(a)(2) of the Act provides that the items and services to which competitive bidding applies are:
• Off-the-shelf (OTS) orthotics for which payment would otherwise be made under section 1834(h) of the Act;
• Enteral nutrients, equipment and supplies described in section 1842(s)(2)(D) of the Act; and
• Certain DME and medical supplies, which are covered items (as defined in section 1834(a)(13) of the Act) for which payment would otherwise be made under section 1834(a) of the Act.
The DME and medical supplies category includes items used in infusion and drugs (other than inhalation drugs) and supplies used in conjunction with DME, but excludes class III devices under the Federal Food, Drug, and Cosmetics Act and Group 3 or higher complex rehabilitative power wheelchairs and related accessories when furnished with such wheelchairs. Sections 1847(a) and (b) of the Act specify certain requirements and conditions for implementation of the Medicare DMEPOS CBP.
Below is a summary of the three general methodologies used in adjusting payment amounts for DMEPOS items in areas that are not CBAs for the items using information from the DMEPOS CBP. Also summarized are the processes for updating adjusted fee schedule amounts and for addressing the impact of unbalanced bidding on SPAs when adjusting payment amounts using information from the DMEPOS CBPs. We issued a final rule (Medicare Program; End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies; Final Rule) on November 6, 2014 (hereinafter, the CY 2015 final rule) in which we adopted these methodologies (79 FR 66223-66233). We also issued program instructions on these methodologies in Transmittal #3350, (Change Request # 9239), issued on September 11, 2015 and Transmittal #3416, (Change Request # 9431) issued on November 23, 2015. The CBP product categories, HCPCS codes and single payment amounts (SPAs) included in the CBPs are available on the Competitive Bidding Implementation Contractor (CBIC) Web site:
Section 1834(a)(1)(F)(ii) of the Act provides the Secretary with the authority to use information from the DMEPOS CBPs to adjust the DME payment amounts for covered items furnished on or after January 1, 2011, in areas where competitive bidding is not implemented for the items. Similar authority exists at section 1834(h)(1)(H)(ii) of the Act for OTS orthotics. Also, Section 1842(s)(3)(B) of the Act provides authority for making adjustments to the fee schedule amounts for enteral nutrients, equipment, and supplies (enteral nutrition) based on information from CBPs. Section 1834(a)(1)(F)(ii) also requires adjustments to the payment amounts for all DME items subject to competitive bidding furnished in areas where CBPs have not been implemented on or after January 1, 2016.
For items furnished on or after January 1, 2016, section 1834(a)(1)(F)(iii) requires us to continue to make such adjustments to DME payment amounts where CBPs have not been implemented as additional covered items are phased in or information is updated as contracts are re-competed. Section 1834(a)(1)(G) of the Act requires that the methodology used to adjust payment amounts for DME and OTS orthotics using information from the CBPs be promulgated through notice and comment rulemaking. Also, Section 1834(a)(1)(G) of the Act requires that we consider the “costs of items and services in areas in which such provisions [sections 1834(a)(1)(F)(ii) and 1834(h)(1)(H)(ii)] would be applied compared to the payment rates for such items and services in competitive acquisition [competitive bidding] areas.”
Pursuant to § 414.210(g)(1), CMS determines a regional price for DME items or services for each state in the contiguous United States and the District of Columbia equal to the un-weighted average of the single payment amounts (SPAs) for an item or service for CBAs that are fully or partially located in the same region that contains the state or the District of Columbia. CMS uses the regional prices to determine a national average price equal to the un-weighted average of the regional prices. The regional SPAs (RSPAs) cannot be greater than 110 percent of the national average price (national ceiling) or less than 90 percent of the national average price (national floor). This methodology applies to enteral nutrition and most DME items furnished in the contiguous United States (that is, items that are included in more than 10 CBAs).
The fee schedule amounts for areas defined as rural areas for the purposes of the CBP are adjusted to 110 percent of the national average price described above. The regulations at § 414.202 define a rural area to mean, for the purpose of implementing § 414.210(g), a geographic area represented by a postal zip code if at least 50 percent of the total geographic area of the area included in the zip code is estimated to be outside any metropolitan area (MSA). A rural area also includes a geographic area represented by a postal zip code that is a low population density area excluded from a CBA in accordance with the authority provided by section 1847(a)(3)(A) of the Act at the time the rules at § 414.210(g) are applied.
Pursuant to § 414.210(g)(2), in areas outside the contiguous United States
Pursuant to § 414.210(g)(3), for DME items included in ten or fewer CBAs, the fee schedule amounts for the items are reduced to 110 percent of the un-weighted average of the SPAs from the ten or fewer CBAs. This methodology applies to all areas within and outside the contiguous United States.
Section 1834(a)(1)(F)(ii) of the Act requires the Secretary to use information from the CBP to adjust the DMEPOS payment amounts for items furnished on or after January 1, 2016, and section 1834(a)(1)(F)(iii) requires the Secretary to continue to make such adjustments as additional covered items are phased in or information is updated as competitive bidding contracts are recompeted. In accordance with § 414.210(g)(8), the adjusted fee schedule amounts are revised when an SPA for an item or service is updated following one or more new competitions and as other items are added to CBPs. DMEPOS schedule amounts that are adjusted using SPAs will not be subject to the annual DMEPOS covered item update and will only be updated when SPAs from the CBP are updated. Updates to the SPAs may occur at the end of a contract period as contracts are recompeted, as additional items are added to the CBP, or as new CBAs are added. In cases where adjustments to the fee schedule amounts are made using any of the methodologies described above, and the adjustments are based solely on the SPAs from CBPs that are no longer in effect, the SPAs are updated before being used to adjust the fee schedule amounts. The SPAs are adjusted based on the percentage change in the Consumer Price Index for all Urban Consumers (CPI-U) over the course of time described in § 414.210(g)(4). For example, if the adjustments were to be effective January 1, 2017, the SPAs from CBPs no longer in effect would be updated based on the percentage change in the CPI-U from the mid-point of the last year the SPAs were in effect to June 30, 2016, the month ending 6 months prior to the date the initial fee schedule reductions go into effect. Following the initial adjustment, if the adjustments continue to be based solely on the SPAs that are no longer in effect, the SPAs will be updated every 12 months using the CPI-U for the 12-month period ending 6 months prior to the date the updated payment adjustments would go into effect.
In our CY 2015 final rule (79 FR 66263), we adopted a methodology to address unbalanced bidding, which is a situation that results in price inversions under CBPs. We added § 414.210(g)(6) for certain limited situations where bidding for similar but different enteral infusion pumps and standard power wheelchairs resulted in the SPAs for higher utilized items with additional features (for example, an enteral infusion pump with an alarm or a Group 2 power wheelchair) being less than the SPAs for lower utilized items without those additional features (for example, an enteral infusion pump without an alarm or Group 1 power wheelchair). A Group 2 power wheelchair is faster, travels further, and climbs higher obstacles than a Group 1 power wheelchair. Under CBPs, when similar items with different features are included in the same product category, the code with higher utilization at the time of the competition receives a higher weight and the bid for this item has a greater impact on the supplier's composite bid as well as the competitiveness of the supplier's overall bid for the product category (PC) within the CBP as compared to the bid for the less frequently utilized item. If, at the time the competition takes place under the CBP, the item with the additional features is priced higher and over time is utilized more than the other similar items without these features, it could result in unbalanced bidding, which in turn causes the item without the additional features to receive a higher single payment amount under the CBP than the item with the additional features. This situation results in a price inversion, where the higher weighted and higher priced item at the time of the competition becomes the lower priced item in the CBP following the competition. Unbalanced bidding can occur when a bidder has a higher incentive to submit a lower bid for one item than another due to the fact that the item has a higher weight and therefore a greater effect on the supplier's composite bid for the product category than the other item. Our current regulation at § 414.210(g)(6) for adjusting DMEPOS fee schedule amounts paid in non-CBAs using information from CBPs includes methodologies to address price inversions for power wheelchairs and enteral infusion pumps only. This rule limits SPAs for items without additional features (for example, an enteral infusion pump without an alarm) to the SPAs for items with the additional features (for example, an enteral infusion pump with an alarm) prior to using these SPAs to adjust fee schedule amounts.
For example, if most of the utilization or allowed services for standard power wheelchairs are for higher paying Group 2 wheelchairs than Group 1 wheelchairs at the time the competition occurs, the bids for the Group 2 wheelchairs have a greater impact on the supplier's composite bid and chances of being offered a contract. Therefore the supplier has a much greater incentive to make a lower bid for the Group 2 wheelchairs relative to the fee schedule payment than they do for the Group 1 wheelchairs. If, for example, Medicare is paying $450 per month for a Group 2 wheelchair at the time of the competition and a Group 2 wheelchair has a high weight, while Medicare is paying $350 per month for the Group 1 version of the same wheelchair at the time of the competition and the Group 1 wheelchair has a very low weight, the bids for the two items could be unbalanced or inverted whereby the bid submitted for the Group 2 wheelchair is $250 (44 percent below the fee schedule amount for the item) while the bid submitted for the Group 1 wheelchair is $300 (14 percent below the fee schedule amount for the item). A price inversion therefore results where Medicare previously paid $450 for one item and now pays $250, and previously paid $350 for another item for which it now pays $300. The item weight under the CBP results in Medicare paying more for a Group 1 power wheelchair than a higher-performing Group 2 power wheelchair.
In the CY 2015 proposed rule published on July 11, 2014 in the
We performed a review of all HCPCS codes in the CBPs in order to comply with our commitment to consider whether to apply the regulation at § 414.210(g)(6) to other cases of price inversion that resulted from unbalanced bidding that were not identified or addressed in the CY 2015 final rule (79 FR 66231). We found a significant number of price inversions resulting from the 2016 DMEPOS CBP Round 2 Recompete for contract periods beginning July 1, 2016. The items affected included transcutaneous electrical nerve stimulation (TENS) devices, walkers, hospital beds, power wheelchairs, group 2 support surfaces (mattresses and overlays), enteral infusion pumps, and seat lift mechanisms. As a result of our review, we are proposing a rule that will expand the provisions of § 414.210(g)(6) to address these and other price inversions.
To perform our review, we examined instances within the HCPCS where there are multiple codes for an item (for example, a walker) that are distinguished by the addition of features (for example, folding walker versus rigid walker or wheels versus no wheels) which may experience price inversions. Our review included all groupings of similar items with different features within each of the product categories. We have included the HCPCS codes describing groupings of similar items that would be subject to this proposed rule and the features associated with each code below:
As shown in Table 12 below, under the 2015 DMEPOS fee schedule, Medicare pays more for walkers with wheels than walkers without wheels. The same is true for walkers that fold as compared to walkers that do not fold. Walkers that are rigid and do not fold are very rarely used and have extremely low utilization, and a walker that folds and has wheels is used much more frequently than a walker that folds but does not have wheels.
Under the DMEPOS CBP, because the folding walker without wheels (E0135) is used more frequently than the rigid walker without wheels (E0130), code E0135 receives a higher weight than code E0130. In addition, under the 2015 fee schedule, Medicare pays more for code E0135 than code E0130. Weights are assigned to individual items (HCPCS codes) within a product category (for example, standard mobility equipment) under the DMEPOS CBP for the purpose of calculating a composite bid for each supplier submitting bids for that product category in a CBA. The weights are based on the beneficiary utilization rate using national data when compared to other items in the same product category. The beneficiary utilization rate of an item captures the total allowed services for the item from Medicare claims submitted for the item on a national basis. A supplier's bid for each item in the product category is multiplied by the weight assigned to the item, and the sum of these calculations equals the supplier's composite bid. Contracts are offered to eligible suppliers with the lowest composite bids. Therefore, the higher the weight for an item in a product category, the more the bid for that item will affect the supplier's composite bid and chances of being offered a contract for that product category. Conversely, the lower the weight for an item in a product category, the less the bid for that item will affect the supplier's composite bid and chances of being offered a contract for that product category.
Similarly, because the folding walker with wheels (E0143) is used more frequently than the rigid walker with wheels (E0141), and more frequently than the walkers without wheels (E0130 and E0135), it receives a higher weight under the DMEPOS CBP than all three codes for the less expensive, less frequently utilized codes with fewer features: E0130, E0135, and E0141. Under the 2015 fee schedule, Medicare pays more for code E0143 than codes E0130 (rigid walkers without wheels), E0135 (folding walkers without wheels) or E0141 (rigid walkers with wheels). Under the Round 2 Recompete, the fact that code E0143 (folding walkers with wheels) received a far greater weight than the other walkers that either did not fold, did not have wheels, or had neither feature resulted in price inversions as illustrated in Table 13 below. The first price inversion involves a rigid walker without wheels (E0130). A rigid walker without wheels has lower fee schedule amounts on average and a lower weight than a folding walker without wheels (E0135), yet under competitive bidding, it has a greater SPA than the folding walker. The second price inversion involves a rigid walker with wheels (E0141), which has lower fee schedule amounts on average and a lower weight than a folding walker with wheels (E0143), but has a greater SPA than the folding walker with wheels under competitive bidding. The third price inversion involves a rigid walker without wheels (E0130), which has a greater SPA than a folding walker with wheels despite having lower fee schedule amounts on average and a lower weight than the folding walker with wheels (E0143).
In all cases, Medicare pays higher payment for walkers with wheels than walkers without wheels under the fee schedule. This differential in payment amounts is significant because it reflects the fact that the walker with wheels has a feature that likely resulted in higher fee schedule amounts for this item, making it more costly than the same type of walker without the addition of wheels. Rather than defining the ability of a walker to fold or the presence of wheels as a “hierarchal” feature, it can simply be noted that under the fee schedule, Medicare pays more for walkers with the ability to fold than walkers without the ability to fold and that Medicare pays more for walkers
The first methodology we considered for addressing price inversions (method 1) uses the methodologies at 42 CFR 414.210(g)(6) and limits the SPA for the code without the feature to the SPA for the code with the feature before the SPA is used to adjust the fee schedule amounts for the item. For example, under the Round 2 Recompete, the SPA for code E0141 for the South Haven-Olive Branch, MS CBA is $106.52. Code E0143 describes the same type of walker, but code E0143 walkers fold, while code E0141 walkers are rigid and do not fold. However, under the Round 2 Recompete, the SPA for code E0143 (wheeled walkers that fold) for the South Haven-Olive Branch, MS CBA is $44.00, or $62.52 less than the SPA for E0141 (wheeled walkers that do not fold). The average of the 2015 fee schedule amounts for codes E0141 and E0143 are $107.89 and $111.69, respectively. Altogether, since (a) one walker in a product category includes a feature that another, similar walker in the same product category does not have (in this situation, the ability to fold); (b) the average of the 2015 fee schedule amounts for the folding walker (E0143) is higher than the average of the 2015 fee schedule amounts for the rigid walker (EO141); and (c) the SPA for the folding walker ($44.50) is lower than the SPA for the rigid walker ($106.52), these items would meet the proposed definition of a price inversion under the DMEPOS CBP. Under method 1, the SPA of $106.52 for code E0141 in this CBA would be adjusted to the SPA of $44.00 for code E0143 in this CBA, so that $44.00, rather than $106.52, would be used for this CBA in computing the regional price for code E0141 described in § 414.210(g)(1)(i) under the methodology used to adjust the fee schedule amounts for code E0141. To further illustrate how method 1 would work, the 2016 SPAs for codes E0130, E0135, E0141, and E0143 for the Akron, Ohio CBA, and the amounts they would be adjusted to before applying the fee schedule adjustment methodologies are listed in Table 14 below.
The method 1 approach is currently used for enteral infusion pumps and standard power wheelchairs at § 414.210(g)(6), and each price inversion correction is made for a set of two items, as described in the regulation. For example, § 414.210(g)(6)(ii) states: “In situations where a single payment amount in a CBA for a Group 1, standard, sling/solid seat and back power wheelchair is greater than the single payment amount in the same CBA for a Group 2, standard, sling/solid seat and back power wheelchair, the single payment amount for the Group 1, standard, sling/solid seat and back power wheelchair is adjusted to be equal to the single payment amount for the Group 2, standard, sling/solid seat and back power wheelchair prior to applying the payment adjustment methodologies in this section.” If method 1 is finalized, we would indicate that additional price inversions involving additional sets of two items to which this rule would be applied would be identified in a table in the preamble of the final rule. An example of such a table is provided below in Table 15 using codes for walkers, seat lift mechanisms, and TENS devices:
The second methodology we considered and are proposing (method 2) would limit the SPAs in situations where price inversions occur so that the SPAs for all of the similar items, both with and without certain features, are limited to the weighted average of the SPAs for the items based on the item weights assigned under competitive bidding. This approach would factor in the supplier bids for the lower volume and higher volume items. This would establish one payment for similar types of items that incorporates the volume and weights for items furnished prior to the unbalanced bidding and resulting price inversions. To illustrate how method 2 would work, the 2016 SPAs for codes E0130, E0135, E0141, and E0143 for the Vancouver, WA CBA, and the amounts they would be adjusted to before applying the fee schedule adjustment methodologies using the weights from Round 2 Recompete are listed in Table 16 below.
The item weights from the Round 2 Recompete for the four walker codes in this subcategory of walkers in the table above are 0.1 percent for E0130, 4.8 percent for E0135, 0.5 percent for E0141, and 94.6 percent for E0143. The weighted average of the SPA for the four walker codes would be $45.53 ($51.62 × 0.001 + $47.65 × 0.048 + $81.62 × 0.005 + $45.22 × 0.946). This weighted average SPA would be used to adjust the fee schedule amounts for these four codes rather than simply limiting the SPAs for E0135 and E0143 in Table 16 above. This method uses item weights in a product category to adjust the SPA before making adjustments to the fee schedule amount. In accordance with the proposed definition of a price inversion, (a) E0135 and E0143 include features that other, similar walkers in the same product category do not (the ability to fold); (b) the average of the 2015 fee schedule amounts for the folding walkers (E0135 & E0143) are higher than the average of the 2015 fee schedule amounts for the rigid walkers (E0130 & E0141); and (c) the 2016 SPAs for the folding walkers were less than the SPAs for the respective rigid walkers. Therefore, the SPA for code E0130 is higher than the SPA for code E0135, the SPAs for codes E0141 and E0143 were inverted such that the SPA for code E0141 is higher than the SPA for code E0143, and the SPAs for codes E0135 and E0143 were inverted such that the SPA for code E0135 is higher than the SPA for code E0143. Under proposed method 2, these three price inversions would be addressed so that the SPAs for all of the similar items described by codes E0130, E0135, E0141, and E0143 in this CBA would be adjusted to the weighted average of the SPAs for these codes for similar items in this CBA. As a result, the adjusted SPA of $45.53 rather than $51.62, $47.65, $81.62, and $45.22, would be used to compute the regional price for codes E0130, E0135, E0141, and E0143, respectively, using method 2 to adjust the fee schedule amounts for these items and in accordance with § 414.210(g)(1)(i).
Although we believe that both method 1 and method 2 would correct inverted SPAs, method 1 simply limits the amount paid for the item without a feature(s) to the item with the feature(s), while method 2 factors in the SPAs for all of the items. Therefore, if the cost of an item without a feature was actually more than the cost of an item with a feature (for example, for volume discounts for the item with the feature drives the price down below the price for the item without the feature), method 1 would not allow the higher cost of the item without the feature to be factored into the payment made to the suppliers of the items. Therefore, we are proposing to use method 2 because it takes into account the supplier bids for all of the similar items into account in establishing the payment amounts used to adjust fees; and therefore, factors in contemporary information relative to bids and supplier information for various items with different features and costs. The SPAs established based on supplier bids for all of the similar items are used to calculate the weighted average. If, for some reason, the market costs for an item without a feature are actually higher than the market costs for an item with the feature, due to economies of scale, supply and demand, or other economic factors, these costs are accounted for in the weighted average of the SPAs established for each of the similar items. Under method 1, the SPA for the lower weight item without a feature is limited to the SPA for the higher weight item with the feature, and so potential cost inversions driven by market forces or supplier costs are not accounted for in establishing the adjusted payment amounts. However, we are soliciting comments on both method 2, which we are proposing, and method 1, which we are considering.
Other examples of price inversions resulting from the Round 2 Recompete are listed in Table 17 below. This is not an exhaustive list of price inversions that have resulted under the CBPs and to which the proposed rule would apply.
In summary, we propose to expand use of the methodology at § 414.210(g)(6) to other situations where price inversions occur under CBPs. First, we propose to revise 42 CFR 414.402 to add the definition of price inversion as any situation where the following occurs:
• One item (HCPCS code) in a grouping of similar items (for example, walkers, enteral infusion pumps or power wheelchairs) in a product category includes a feature that another, similar item in the same product category does not have (for example, wheels, alarm, or Group 2 performance);
• The average of the 2015 fee schedule amounts (or initial, unadjusted fee schedule amounts for subsequent years for new items) for the code with the feature is higher than the average of the 2015 fee schedule amounts for the code without the feature; and
• The SPA in any year after and including 2016 for the code with the feature is lower than the SPA for the code without that feature.
Second, we propose to revise § 414.210(g)(6) to specify that, in situations where price inversions occur under a CBP, the SPAs for the items would be adjusted before applying the fee schedule adjustment methodologies under § 414.210(g). We are proposing that the adjustments to the SPAs would be made using method 2 described above. We are proposing changes to the regulation text at 414.210(g)(6) to reflect use of method 2 to adjust the SPAs for all of the similar items where price inversions have occurred, both with and without certain features, so that they are limited to the weighted average of the SPAs for the items in the product category in the CBA before applying the fee schedule adjustment methodologies under § 414.210(g). We propose to apply this rule to price inversions as defined in this proposed rule for the groupings of similar items listed in the Table 18 below. For the purpose of calculating the weighted average at proposed § 414.210(g)(6)(iii), we are proposing to add a definition of “total nationwide allowed services” at § 414.202, to mean the total number of services allowed for an item furnished in all states, territories, and the District of Columbia where Medicare beneficiaries reside and can receive covered DMEPOS items and services. We are proposing to define the weight for each code in a grouping of similar items at § 414.210(g)(6)(iii) for purposes of calculating the weighted average as the proportion of the total nationwide allowed services for the code for claims with dates of service in calendar year 2012 relative to the total nationwide allowed services for each of the other codes in the grouping of similar items for claims with dates of service in calendar year 2012. We are proposing to use data from calendar year 2012 because this is the most recent calendar year that includes data for items furnished before implementation of Round 2 of the CBP and the beginning of the price inversions. The weights reflect the frequency that covered items in a grouping of similar items were furnished in calendar year 2012 on a national basis relative to other items in the grouping.
We are soliciting comments on this section.
Medicare pays for most DMEPOS furnished after January 1, 1989, pursuant to fee schedule methodologies set forth in sections 1834 and 1842 of the Social Security Act (the Act). Specifically, subsections (a) and (h) of section 1834 and subsection (s) of section 1842 of the Act provide that Medicare payment for these items is equal to 80 percent of the lesser of the actual charge for the item or a fee schedule amount for the item. The regulations implementing these provisions are located at 42 CFR part 414, subparts C and D.
Section 1847(a) of the Act, as amended by section 302(b)(1) of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173), requires the Secretary to establish and implement CBPs in competitive bidding areas (CBAs) throughout the United States for contract award purposes for the furnishing of certain competitively priced DMEPOS items and services. Section 1847(b)(5) of the Act directs the Secretary to base the single payment amount (SPA) for each item or service in each CBA on the bids submitted and accepted in the CBP. For competitively bid items, the SPAs have replaced the fee schedule payment methodology. Section 1847(b)(5) of the Act provides that Medicare payment for these competitively bid items and services is made on an assignment-related basis and is equal to 80 percent of the applicable SPA, less any unmet Part B deductible described in section 1833(b) of the Act. Section 1847(b)(2)(A)(iii) of the Act prohibits the Secretary from awarding a contract to an entity in a CBA unless the Secretary finds that the total amounts to be paid to contractors in a CBA are expected to be less than the total amounts that would otherwise be paid. This requirement guarantees savings to both the Medicare program and its beneficiaries.
We implemented CBPs in 9 Round 1 metropolitan statistical areas on January 1, 2011, and an additional 91 Round 2 metropolitan statistical areas on July 1, 2013. Bids are submitted during a 60-day bidding period allowing suppliers adequate time to prepare and submit their bids. We then evaluated each submission and awarded contracts to qualified suppliers in accordance with the requirements of section 1847(b)(2) of the Act, § 414.414, which specifies conditions for awarding contracts, and § 414.416, which specifies how single payment amounts are established.
“Item” is defined in our regulations at 414.402 as a product included in a CBP that is identified by a HCPCS code, which may be specified for competitive bidding, or a combination of codes and/or modifiers, and includes the services directly related to the furnishing of that product to the beneficiary. Item weight is a number assigned to an item based on its beneficiary utilization rate using national data when compared to other items in the same product category. A product category is a grouping of similar items that are used to treat a similar medical condition. Pursuant to § 414.414(e)(3), CMS evaluates bids for items within a product category by establishing a composite bid for each supplier and network that submitted a bid for the product category. A composite bid is the sum of a supplier's weighted bids for all items within a product category for purposes of allowing a comparison across bidding suppliers. Because suppliers bid for multiple items of similar equipment within a product category, the lowest bid for each item will not always be submitted by the same supplier. Evaluating single bids for individual items would not determine which suppliers should be selected to be contract suppliers because different suppliers may submit the lowest bids for different items. We established this provision (72 FR 18040) for using a composite bid as a way to aggregate a supplier's bids for individual items within a product category into a single bid for the whole product category. This allows us to determine which suppliers can offer the lowest expected costs to Medicare for all items in a product category.
To compute the composite bid for a product category, we multiply a supplier's bid for each item in a product category by the item's weight and sum these numbers across items. The weight of an item is based on the utilization of the individual item compared to other items within that product category based on historic Medicare claims. The sum of each supplier's weighted bids for every item in a product category is the supplier's composite bid for that product category. When an item receives a very low weight within its product category, suppliers have little incentive to bid lower for this item because the bids have a minimal effect on the composite bid of the suppliers, whereas the bids for higher weighted items have a significant effect on the supplier's composite bid. This results in price inversions, as discussed further below.
As explained in section VI above, price inversions may occur when items that are similar in terms of the general purpose they serve (for example, walkers), but have different features (for example, wheels, folding capability, etc.), fall within the same product category and have different item weights, therefore having varying degrees of influence on a supplier's composite bid. An item in a product category that is rented and/or purchased by beneficiaries more often than another similar item(s) in the product category has a higher item weight than the other similar item(s) in the product category, and typically will have a higher fee schedule amount at the time the competition takes place than the other similar item(s) in the product category. In a price inversion, an SPA is established for the higher volume item with the higher fee schedule amount that is lower than the SPA(s) established for the other similar item(s) that had lower fee schedule amounts at the time the competition took place. For example, prior to the implementation of the Round 2 CBPs in July 2013, the 2013 rental fee schedule amounts in Akron, Ohio for the infrequently furnished Group 1 power wheelchair (K0816) and portable Group 2 power wheelchair (K0821) were significantly lower than the 2013 rental fee schedule amount for the heavily utilized Group 2 power wheelchair (K0823). Table 19 below shows these fee schedule amounts and also includes national data for calendar year 2012 indicating the percentage of claims for all standard power wheelchairs furnished in 2012 attributed to each code.
Because codes K0816 and K0821 had comparatively low utilization and received very low weights within the product category, suppliers had little incentive to bid lower for these items than for K0823, since the bids for K0816 and K0821 had a minimal effect on the suppliers' composite bids, while the bids for K0823 had a significant effect on the suppliers' composite bids. This resulted in the price inversions described in the Table 20 below, whereby the payment rate for code K0816 was 16 percent lower than the SPA for code K0823 before competitive bidding, but 39 percent higher than the SPA for code K0823 after competitive bidding. Similarly, the payment rate for code K0821 was 18 percent lower than the SPA for code K0823 before competitive bidding, but 43 percent higher than the SPA for code K0823 after competitive bidding.
The 2012 and 2015 utilization percentages above are the national data for all areas, including areas that are not CBAs. As the tables above show, some utilization of standard power wheelchairs shifted from Group 2 non-portable power wheelchairs to less durable and lower performing Group 1 and Group 2 portable power wheelchairs. This results in the beneficiaries receiving items without additional features at a higher SPA price than items with these additional features. It also undermines the purpose of the CBP and savings intended by the Act and implementation of the program.
The true magnitude of the problem of price inversions is best illustrated by data for power wheelchairs furnished in the Round 2 CBAs. Under the Round 2 competitions and contracts that took effect on July 1, 2013, code K0816 received a very low item weight based on the low utilization rate for this item whereas code K0823 received a very high item weight. The average rental fee schedule amount of $471.38 for code K0816 in 2013 decreased to an average SPA of $344.32 under the CBP, a 27 percent decrease. In comparison, the average reduction in the rental payment amount for code K0823 under Round 2 2013 was 49 percent; from an average rental fee schedule amount in 2013 of $563.26 to an average SPA of $287.05.
After the SPAs took effect in the Round 2 CBAs, we found trends indicating increased expenditures or total allowed charges for code K0816 in the Round 2 CBAs, but a decrease in expenditures or total allowed charges for code K0823 in the Round 2 CBAs. Also, under the Round 2 competition, total allowed charges from July 2013 through December 2015 (2.5 years) for K0816 increased by 1,159 percent as compared to the total allowed charges from January 2011 through June 2013 (2.5 years). By comparison, total allowed charges for K0823 for these same time periods and areas decreased by 86 percent. This inversion in both charges and utilization was more pronounced in certain CBAs than others. In the Atlanta-Sandy Springs-Marietta, Georgia CBA, allowed charges for K0816 (SPA = $361.59) increased by 10,239 percent from $8,010 to $828,995, while allowed charges for K0823 (SPA = $281.89) decreased by 87 percent from $11,051,027 to $1,477,062. We found the same phenomenon for hospital beds where utilization of non-electric hospital beds (code E0250) increased by 214 percent in the Round 2 CBAs while utilization of semi-electric beds (code E0260) decreased by 63 percent. Therefore, the data shows that due to unbalanced bidding in various CBAs, item utilization is shifting from certain items to others, and Medicare is now paying more for these items under the CBP than it was before the CBP was implemented for these items in these CBAs. This is an unacceptable outcome because it results in the beneficiary receiving an item with less functionality (for example, a manual hospital bed rather than a semi-electric hospital bed) at a higher cost for both the Medicare program and the beneficiary than the item with more functionality.
To avoid the aforementioned price inversions, we are proposing in § 414.412(d)(2), that in situations where we find that a product category includes
Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping of similar items with different features (for example, standard power wheelchairs); however, rather than submitting bids for each individual HCPCS code for each item, a supplier would make one bid that should take into account the cost of furnishing all of the similar items. For example, a $300 bid for K0823 would automatically establish the payment amounts for all the other power wheelchairs in the grouping, so that K0816 would be .84 times $300, and K0829 would be 1.58 times $300 (as shown in the Table 21 below). The supplier may have to adjust its initial K0823 bid before deciding on a final bid, depending on the utilization of the lower volume items in the grouping, and its targeted total revenue for the grouping according to its item weights. The supplier would also be educated at the time of bidding that the SPAs for the other similar items would be based on its bid for the lead item, and the supplier is therefore submitting bids for all of these items when bidding on the lead item. Thus, to avoid cases of price inversions, the supplier is submitting a bid for an item (for example, standard power wheelchair), and for lead item bidding purposes, an “item” is a product that is identified by a combination of codes, as described in § 414.402. We also believe that the proposed lead item-focused bidding method would greatly reduce the burden on suppliers of formulating and submitting multiple bids for similar items because it would require less time to enter their bids and would reduce the chances of keying errors when submitting bids. The items subject to this proposed rule would include a broader set of items than those subject to the proposed rule under section VI above. Namely all codes for walkers, hospital beds, and standard power wheelchairs would be subject to this proposed rule and not just those codes for walkers, hospital beds, and standard power wheelchairs where price inversions have already occurred. The lead item bidding method is intended to prevent future price inversions for a grouping of similar items, including codes for items (for example, total electric hospital beds) where price inversions have not occurred thus far, but where we believe price inversions would be likely based on information about the fee schedule amounts and the utilization of these items. By applying the lead item bidding method to all hospital beds, including total electric hospital beds, this prevents price inversions from occurring for all hospital beds. We also believe it is a more efficient method for implementing CBPs and pricing.
To identify the lead item, we propose using allowed services from calendar year 2012 for the first time this bidding method is used for specific items in specific CBAs. We did not observe price inversions under the Round 1 competitions and contracts that were in effect from January 2011 through December 2013. The price inversions began with the Round 2 competitions and contracts that began on July 1, 2013; therefore, we propose using data for allowed services from calendar year 2012 to ensure that the effects of price inversions do not impact the utilization of the various items that is used to identify the lead item. Once this bidding method has been used in all competitions for an item (for example, standard power wheelchairs), we propose that the lead item would be identified for future competitions based on allowed services for the items at the time the subsequent competitions take place rather than the allowed services from calendar year 2012. For example, using allowed services from calendar year 2012 is necessary to identify the lead items initially since utilization of items for years subsequent to 2012 could be affected by the price inversions that began with the Round 2 competitions and contracts on July 1, 2013. Once the lead item bidding method is implemented for a grouping of similar items, and the price inversions are eliminated, utilization of items for years subsequent to the point at which the price inversions are eliminated can be used for the purpose of identifying the lead item because they would not be affected by price inversions. This proposed rule would also help to prevent price inversions in adjusted fee schedule amounts using competitive bidding SPAs. We propose to announce which items would be subject to this bidding method at the start of each competition in each CBA where this bidding method is used.
The following tables 21, 22, and 23 show how the lead item for three groupings of similar items (standard power wheelchairs, walkers, and hospital beds, respectively) would be identified using 2012 allowed services and how the SPAs would be established based on the method described above. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping of similar items. In the charts below, the lead items identified would be the lead items in initial competitions where the lead item bidding method is used. The first proposed category for lead item bidding is standard power wheelchairs.
Rather than submitting 14 individual bids for each of the 14 items, the supplier would submit one bid for the lead item. The SPA for lead item K0823 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental amounts pursuant to § 414.408(h)(2). The SPAs for the other items would be based on the relative difference in fees for the other items as compared to the lead item. For example, if the SPA for code K0823 is $300.00, the SPA for code K0825 would be equal to $330.00, or $300.00 multiplied by 1.1. Similarly, if the SPA for code K0823 is $300.00, the SPA for code K0816 would be equal to $252.00, or $300.00 multiplied by 0.84. Suppliers submitting bids would be educated in advance that their bid for code K0823 is a bid for all 14 codes and bidding suppliers would factor this into their decision on what amount to submit as their bid for the lead item. This would avoid price inversions and would carry over the relative difference in item weight that establishes Medicare payment amounts for standard power wheelchairs under the fee schedule into the CBPs. The second proposed category for lead item bidding is walkers as shown in Table 22 below. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping.
Rather than submitting 9 individual bids for each of the 9 items, the supplier would submit one bid for the lead item. The SPA for lead item E0143 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental and purchase amounts per § 414.408(f) and (h)(7). We propose to include a new section 414.416(b)(3) that would include the lead item bidding method. The SPAs for the other items would be based on the relative difference in fees for the item compared to the lead item, following the rules for inexpensive or routinely purchased items at § 414.408(f) and (h)(7), and, for E0144, following the rules for capped rental items at § 414.408(h)(1). For example, if the SPA for purchase for code E0143 is $80.00, Medicare payment for rental of E0143 would be $8.00 per month in accordance with § 414.408(h)(7), and the SPA for purchase of E0143 used would be $60.00. The SPAs for code E0135 would be equal to $56.80 ($80.00 multiplied by 0.71), for purchase of a new E0135 walker, $5.68 per month for rental of E0135, and $42.60 for purchase of a used E0135 walker. The SPAs for rental of code E0144 would be equal to $21.92 ($8.00 multiplied by 2.74) for rental months 1 through 3, and $16.44 for rental months 4 through 13. Suppliers submitting bids would be educated in advance that their bid for code E0143 is a bid for all 9 codes and bidding suppliers would factor this into their decision on what amount to submit as their bid for the lead item. This would avoid price inversions and would carry over the relative difference in item weights that establish Medicare payment amounts for walkers under the fee schedule into the CBPs.
The third proposed category for lead item bidding is hospital beds as shown in the Table 23. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping.
Rather than submitting 20 individual bids for each of the 20 items, the supplier would submit one bid for the lead item. The SPA for lead item E0260 would be based on the median of the bids for this code, following the rules laid out in § 414.416(b) and for calculating rental amounts per § 414.408(h)(1). The SPAs for the other items would be based on the relative difference in the average of the 2015 fee schedule amounts for the item compared to the lead item. For example, if the SPA for code E0260 is $75.00, the SPA for code E0261 would be equal to $69.00, or $75.00 multiplied by 0.92. Suppliers submitting bids would be educated in advance that their bid for code E0260 is a bid for all 20 codes and bidding suppliers would factor this into their decision on what amount to submit as their bid for the lead item.
The fourth through seventh proposed categories for lead item bidding are as are shown in Table 24, Table 25 and Table 26 below. Under our proposal, when bidding for the lead item, a supplier is bidding to furnish the entire grouping.
In summary, we propose to revise § 414.412(d) to add this bidding method as an alternative to the current method for submitting bid amounts for each item in the seven groupings of similar items identified above. Suppliers participating in future CBPs may be required to use this method when submitting bids for these groups of similar items. Also, we propose to revise § 414.416(b) to add the method for calculating SPAs for items within each grouping of similar items based on the SPAs for lead items within each grouping of similar items. We believe that the proposed method would better accomplish the CBP objectives, which include reducing the amount Medicare pays for DMEPOS and limiting the financial burden on beneficiaries by reducing their out-of-pocket expenses for DMEPOS they obtain through the CBP (72 FR 17996).
We believe this approach to bidding would safeguard beneficiaries from receiving items with fewer features simply because of the price inversions. We also believe that the proposed lead item bidding method would greatly reduce the burden on suppliers of formulating and submitting multiple bids for similar items because it would require less time to enter bids and would reduce the chances of keying errors when submitting bids. Finally, we believe this approach would safeguard beneficiaries and the Trust Fund from paying higher amounts for items with fewer features.
We are soliciting comments on this section.
Under the DMEPOS CBP, Medicare sets payment amounts for selected DMEPOS items and services furnished to beneficiaries in CBAs based on bids submitted and accepted by Medicare. For competitively bid items, these new payment amounts, referred to as single payment amounts (SPAs), replace the fee schedule payment methodology. Section 1847(b)(5) of the Act provides that Medicare payment for these competitively bid items and services is made on an assignment-related basis and is equal to 80 percent of the applicable single payment amount, less any unmet part B deductible described in section 1833(b) of the Act. Section 1847(b)(2)(A)(iii) of the Act prohibits the Secretary from awarding a contract to an entity unless the Secretary finds that the total amounts to be paid to contractors in a CBA are expected to be less than the total amounts that would otherwise be paid. This requirement guarantees savings to both the Medicare program and its beneficiaries. The CBP also includes provisions to ensure beneficiary access to quality DMEPOS items and services: Section 1847 of the Act directs the Secretary to award contracts to entities only after a finding that the entities meet applicable quality and financial standards and beneficiary access to a choice of multiple suppliers in the area is maintained.
We implemented Round 1 of the DMEPOS CBP on January 1, 2011, and the Round 1 Recompete on January 1, 2014. Round 2 of the DMEPOS CBP and the national mail order program were implemented on July 1, 2013, and Round 2 and national mail order Recompete will be implemented on July 1, 2016. The programs phased in under Round 1 and 2 are in place in approximately 100 metropolitan statistical areas (MSAs) throughout the nation, including Honolulu, Hawaii. A 60-day bidding window allows bidders adequate time to prepare and submit their bids. § 414.412 specifies the rules for submission of bids under a CBP. Each bid submission is evaluated and contracts are awarded to qualified suppliers in accordance with the requirements of section 1847(b)(2) of the Act and § 414.414, which specifies conditions for awarding contracts.
Sections 1847(b)(6)(A)(i) and (b)(6)(A)(ii) of the Act provide that payment will not be made under Medicare part B for items and services furnished under a CBP unless the supplier has submitted a bid to furnish those items and has been awarded a contract. Therefore, in order for a supplier that furnishes competitively bid items in a CBA to receive payment for those items, the supplier must have submitted a bid to furnish those particular items and must have been awarded a contract to do so.
The April 10, 2007 final rule (Medicare Program; Competitive Acquisition for Certain Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (DMEPOS) and Other Issues; Final Rule) finalized requirements for providers to submit bids under the DMEPOS CBP (§ 414.412(b)) (79 FR 18026). § 414.412 outlines the requirements associated with submitting bids under the competitive bidding process. Furthermore, § 414.412(b)(2) states that the bids submitted for each item in a product category cannot exceed the payment amount that would otherwise apply to the item under Subpart C or Subpart D of part 414, which is the fee schedule amount. Therefore, under our current policy, bid amounts that are submitted under the CBP cannot exceed the fee schedule amount. Contracts cannot be awarded in a CBA if total payments under the contracts are expected to be greater than what would otherwise be paid. In the preamble of the CY 2015 final rule that implemented the methodologies to adjust fee schedule amounts using information from CBPs, we indicated that the adjusted fee schedule amounts become the new bid limits (79 FR 66232).
Sections 1834(a)(1)(F)(ii) and (iii), 1834(h)(2)(H)(ii), and 1842(s)(3)(B) of the Act mandate adjustments to the fee schedule amounts for certain DMEPOS items furnished on or after January 1, 2016, in areas that are not CBAs, based on information from CBPs. Section 1842(s)(3)(B) of the Act also provides authority for making adjustments to the fee schedule amounts for enteral nutrients, equipment, and supplies (enteral nutrition) based on information from the CBPs. In the CY 2015 final rule (79 FR 66223), we finalized the methodologies for adjusting DMEPOS fee schedule amounts using information from CBPs at § 414.210(g).
If the fee schedule amounts are adjusted as new SPAs are implemented under the CBPs, and these fee schedule amounts and subsequent adjusted fee schedule amounts continue to serve as the bid limits under the programs, the SPAs under the programs can only be lower under future competitions because the bidders cannot exceed the bid limits in the CBP. To continue using the adjusted fee schedule amounts as the bid limits for future competitions does not allow SPAs to fluctuate up or down as the cost of furnishing items and services goes up or down over time.
Section 1847(b)(2)(A)(iii) of the Act prohibits the awarding of contracts under the program if total payments to contract suppliers in an area are expected to be more than would otherwise be paid. For the purpose of implementing section 1847(b)(2)(A)(iii) of the Act, we propose to revise § 414.412(b) to use the unadjusted fee schedule amounts (the fee schedule amounts that would otherwise apply if no adjustments to the fee schedule amounts based on information from CBPs had been made) for the purpose of establishing limits on bids for individual items for future competitions (including re-competes). We are proposing this change because we believe the general purpose of the DMEPOS CBP is to establish reasonable payment amounts for DMEPOS items and services based on competitions among suppliers for furnishing these items and services, with bids from suppliers being based in part on the suppliers' costs of furnishing the items and services at that point in time. We believe the intent of the program is to replace unreasonably high fee schedule amounts for DMEPOS items and services with lower, more reasonable amounts as a result of the competitive bidding. We believe that as long as the amounts established under CBPs are lower than the fee schedule amounts that would otherwise apply had the DMEPOS CBP not been implemented, savings will continue to be generated by the programs.
For competitions held thus far for contract periods starting on January 1, 2011, July 1, 2013, January 1, 2014, and July 1, 2016, the unadjusted fee schedule amounts were used as the bid limits for all items in all CBAs, and the SPAs for each subsequent competition were generally lower than the SPAs for the preceding competitions. We believe that competition for contracts under the programs will continue to keep bid amounts low and, together with utilizing unadjusted fee schedule amounts as bid limits, ensure that total payments under the program will be less than what would otherwise be paid. We believe that prices established through the competitions should be allowed to fluctuate both up and down over time as long as they do not exceed the previous fee schedule amounts that would otherwise have been paid if the CBP had not been implemented, and savings below the previous fee schedule amounts are achieved. This would not apply to drugs included in a CBP which would otherwise be paid under Subpart I of part 414 of 42 CFR based on 95 percent of the average wholesale price in effect on October 1, 2003.
In addition, the amount of the SPAs established under the program is only one factor affecting total payments made to suppliers for furnishing DMEPOS items and services. Although the bid limits were created and are used for implementation of section 1847(b)(2)(A)(iii) of the Act, they are not the only factor that affects total payments to suppliers. The DMEPOS CBP is effective in reducing fraud and abuse by limiting the number of entities that can submit claims for payment, while ensuring beneficiary access to necessary items and services in CBAs. Section 1847(b)(5) of the Act requires that payment to contract suppliers be made on an assignment-related basis and limits beneficiary cost sharing to 20 percent of the SPA. We plan to take all of these factors into account before awarding contracts for subsequent competitions in order to determine if total payments to contract suppliers in an area are expected to be less than would otherwise be paid.
We are proposing to revise § 414.412(b) to specify that the bids submitted for each individual item of DMEPOS other than drugs cannot exceed the fee schedule amounts established in accordance with sections 1834(a), 1834(h), or 1842(s) of the Act for DME, off-the-shelf (OTS) orthotics, and enteral nutrition, respectively, as if adjustments to these amounts based on information from CBPs had not been made. Specifically, the bid limits for DME would be based on the 2015 fee schedule amounts established in accordance with section 1834(a)(1)(B)(ii) of the Act, prior to application of section 1834(a)(1)(F)(ii) and (iii), but updated for subsequent years based on the factors provided at section 1834(a)(14) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1834(a), without applying the adjustments mandated by section 1834(a)(1)(F)(ii) of the Act. The bid limits for OTS orthotics would also be based on the 2015 fee schedule amounts established in accordance with section 1834(h)(1)(B)(ii) of the Act, prior to application of section 1834(h)(1)(H), but updated for subsequent years based on the factors provided at section 1834(h)(4) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1834(h), without applying the adjustments authorized by section 1834(h)(1)(H) of the Act. The bid limits for enteral nutrients, equipment, and supplies (enteral nutrition) would be based on the 2015 fee schedule amounts established in accordance with section 1842(s)(1) of the Act, prior to application of section 1842(s)(3), but updated for subsequent years based on the factors provided at section 1842(s)(1)(B)(ii) of the Act. In other words, the bid limits would be based on fee schedule amounts established in accordance with section 1842(s)(1), without applying the adjustments authorized by section 1842(s)(3)(B) of the Act.
Finally, with respect to the alternative bidding rules proposed in section VII. above, when evaluating bids for a grouping of similar items in a product category submitted in the form of a single bid for the highest volume item in the grouping, or lead item, we propose to use the weighted average fee schedule amounts for the grouping of similar items in order to establish the bid limit for the purpose of implementing this proposed provision. We are proposing to revise § 414.412(b)(2) to use total nationwide allowed services for all areas for the individual items, initially from calendar year 2012, to weight the fee schedule amount for each item for the purpose of determining a bid limit for the lead item based on the weighted average fee schedule amounts for the entire grouping of similar items. This would ensure that the payment amounts established under the CBPs do not exceed the fee schedule amounts that would otherwise apply to the grouping of similar items as a whole. Table 28 below illustrates the data that would be used to calculate the bid limit for the lead item (code E0143) in the grouping of walkers for a CBA located in the state of Maryland using 2015 fee schedule amounts for illustration purposes. The item weight for each code is based on 2012 total nationwide allowed services for the code divided by total nationwide
Summing the 2015 fee schedule amounts multiplied by the weights for each item results in a bid limit of $117.37 for lead item E0143. Bids submitted for the lead item E0143 for walkers for a CBA located in the state of Maryland would not be able to exceed $117.37 in this example.
We therefore propose to amend § 414.412(b) to establish this method for determining bid limits for lead items identified in accordance with proposed § 414.412(d)(2) in section VII above.
We are soliciting comments on this proposed rule.
The Medicare and Medicaid programs generally serve distinct populations, but more than ten million individuals (“dual eligible beneficiaries”) were enrolled in both programs in 2014.
Both Medicare and Medicaid cover Durable Medical Equipment (DME), which can be essential to dual eligible beneficiaries' mobility, respiratory function, and activities of daily living. However, the programs' different eligibility, coverage, and supplier rules can impact access to medically-appropriate DME and repairs of existing equipment for the population enrolled in both benefits.
CMS seeks to examine how overlapping but differing coverage standards for DME under Medicare and Medicaid may affect access to care for beneficiaries and administrative processes for providers and suppliers. In response to a May 2011 Request for Information, CMS received over one hundred comments from a range of stakeholders regarding 29 areas of program alignment opportunities, including DME.
According to stakeholders, a common barrier to DME access stems from conflicting approval processes among Medicare and Medicaid that can leave suppliers uncertain about whether and how either program will cover items. Medicare is the primary payer for DME and other medical benefits covered by both programs. Medicaid typically pays Medicare cost-sharing amounts and may cover DME that Medicare does not, including certain specialized equipment that promotes independent living. Medicaid pays secondary to most other legally liable payers, including Medicare, and requires those payers to pay to the limit of their legal liability before any Medicaid payment is available. Many of the Medicare requirements related to DME, including the definition and scope of the benefit, are mandated by the statute; therefore, we do not have the authority to bypass or alter these requirements. Medicare generally only processes claims after the equipment is delivered. Because suppliers lack assurance regarding how Medicare or Medicaid will cover DME at the point of sale—and dual eligible beneficiaries cannot pay out-of-pocket up front—suppliers may refuse to provide needed DME.
Other barriers may emerge for beneficiaries who have Medicaid first and get DME prior to enrolling in Medicare. Stakeholders report that many individuals may have difficulty getting coverage for repairs on equipment obtained through Medicaid coverage, since Medicare will only pay for repairs after making a new medical necessity determination. Additionally, not all Medicaid-approved DME suppliers are Medicare-approved suppliers, meaning beneficiaries may need to change suppliers after enrolling in Medicare.
CMS seeks to obtain additional information to help target efforts to promote timely access to DME benefits
Please provide comments on the scope of the following issues related to DME access for dual eligible beneficiaries:
• Obstacles to timely receipt of needed DME and repairs due to conflicting program requirements;
• Challenges or opportunities faced by Medicaid beneficiaries who newly qualify for Medicare, including challenges related to new and preexisting items, repairs, and providers;
• The percentage of Medicare competitive bidding contractors in the state which accept Medicaid;
• The role of prior authorization policies under either program and whether these policies offer suppliers sufficient advance notice regarding coverage;
• Impacts on beneficiaries from delayed access to needed equipment and repairs;
• If access problems are more pronounced for certain categories of equipment, the categories of DME for which the access problems arise the most frequently or are most difficult to resolve;
• Challenges faced by suppliers in meeting different supporting documentation and submission requirements, and
• Other prevalent access challenges due to DME program misalignments.
We also invite feedback regarding potential regulatory or legislative reforms to address DME program misalignments including:
• State Medicaid program policies that promote coordination of benefits and afford beneficiaries full access to benefits;
• Strategies to promote access to timely, effective repairs, including from suppliers who that did not originally furnish the equipment;
• Policies to address challenges faced when beneficiaries transition from Medicaid-only to dual eligible status; and
• Other ways to promote timely DME access for dual eligible beneficiaries, without introducing new program integrity risks or increasing total expenditures in either Medicare or Medicaid.
Please include specific examples when possible while avoiding the transmission of protected information. Please also include a point of contact who can provide additional information upon request.
CMS seeks input on innovative approaches to care delivery and financing for beneficiaries with end-stage renal disease (ESRD). This input could include ideas related to innovations that would go above and beyond the Comprehensive ESRD Care (CEC) Model with regard to financial incentives, populations or providers engaged, or the scale of change, among other topics. We will consider information received as we develop future payment models in this area, and as we launch solicitation for a second round of entry into the CEC Model to begin on January 1, 2017.
The CEC Model is a CMS test of a dialysis-specific Accountable Care Organization (ACO) model. In the model, dialysis clinics, nephrologists and other providers join together to create an End-Stage Renal Disease Seamless Care Organization (ESCO) to coordinate care for aligned beneficiaries. ESCOs are accountable for clinical quality outcomes and financial outcomes measured by Medicare Part A and B spending, including all spending on dialysis services for their aligned ESRD beneficiaries. This model encourages dialysis providers to think beyond their traditional roles in care delivery and supports them as they provide patient-centered care that will address beneficiaries' health needs, both in and outside of the dialysis clinic.
Section 1115A of the Social Security Act (the Act), as added by section 3021 of the Affordable Care Act, authorizes the Innovation Center to test innovative payment and service delivery models that reduce spending under Medicare, Medicaid or The Children's Health Insurance Program (CHIP), while preserving or enhancing the quality of care. We seek to gather responses to the following questions that will help us to develop and refine innovative payment models related to kidney care.
Questions:
1. How could participants in alternative payment models (APMs) and advanced alternative payment models (AAPMs) coordinate care for beneficiaries with chronic kidney disease and to improve their transition into dialysis?
2. How could participants in APMs and AAPMs target key interventions for beneficiaries at different stages of chronic kidney disease?
3. How could participants in APMs and AAPMs better promote increased rates of renal transplantation?
4. How could CMS build on the CEC Model or develop alternative approaches for improving the quality of care and reducing costs for ESRD beneficiaries?
5. Are there specific innovations that are most appropriate for smaller dialysis organizations?
6. How could primary-care based models better integrate with APMs or AAPMs focused on kidney care to help prevent development of chronic kidney disease in patients and progression to ESRD? Primary-care based models may include patient-centered medical homes or other APMs.
7. How could APMs and AAPMs help reduce disparities in rates of CKD/ESRD and adverse outcomes among racial/ethnic minorities?
8. Are there innovative ways APMs and AAPMs can facilitate changes in care delivery to improve the quality of life for CKD and ESRD patients?
9. Are there specific innovations that are most appropriate for evaluating patients for suitability for home dialysis and promoting its use in appropriate populations?
10. Are there specific innovations that could most effectively be tested in a potential mandatory model?
For additional information on the Comprehensive ESRD Care Model and how to apply, click on the Request for Applications located on the Innovation Center Web site at:
In the CY 2013 ESRD PPS final rule (77 FR 67520), we revised § 413.89(h)(3) to set forth the percentage reduction in allowable bad debt payment required by section 1861(v)(1)(W) of the Act for ESRD facilities for cost reporting periods beginning during fiscal year 2013, fiscal year 2014 and subsequent fiscal years. We also revised § 413.89(h)(3) to set forth the applicability of the cap on bad debt reimbursement to ESRD facilities for cost reporting periods beginning between October 1, 2012 and December 31, 2012. In addition, in that rule, we removed and reserved § 413.178, since there were revised provisions set out at § 413.89.
As a part of these revisions, we intended to correct the cross-reference in section §§ 413.194 and 413.215 so that § 413.89(h)(3) was referenced instead of § 413.178. We inadvertently omitted the regulations text that would have made those changes. Therefore, in
HHS has a number of initiatives designed to improve health and health care quality through the adoption of health information technology (health IT) and nationwide health information exchange. As discussed in the August 2013 Statement “Principles and Strategies for Accelerating Health Information Exchange” (available at
The Office of the National Coordinator for Health Information Technology (ONC) has released a document entitled “Connecting Health and Care for the Nation: A Shared Nationwide Interoperability Roadmap Version 1.0 (Roadmap) (available at
In addition, ONC has released the 2016 Interoperability Standards Advisory (available at
We encourage stakeholders to utilize health information exchange and certified health IT to effectively and efficiently help providers improve internal care delivery practices, support management of care across the continuum, enable the reporting of electronically specified clinical quality measures, and improve efficiencies and reduce unnecessary costs. As adoption of certified health IT increases and interoperability standards continue to mature, HHS will seek to reinforce standards through relevant policies and programs.
Under the Paperwork Reduction Act of 1995, we are required to provide 60-day notice in the
In order to fairly evaluate whether an information collection requirement should be approved by OMB, section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 requires that we solicit comment on the following issues:
• 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 section II and III of this proposed rule, we are proposing changes to regulatory text for the ESRD PPS in CY 2017 as well as the inclusion of Subpart K for AKI. However, the changes that are being proposed do not impose any new information collection requirements.
This proposed rule does not impose any new information collection requirements in the regulation text, as specified above. However, this proposed rule does make reference to several associated information collections that are not discussed in the regulation text contained in this document. The following is a discussion of these information collections.
In the CY 2016 ESRD PPS Final Rule (80 FR 69069), we stated that it was reasonable to assume that Medical Records and Health Information Technicians, who are responsible for organizing and managing health information data,
In the CY 2016 ESRD PPS Final Rule (80 FR 69070), we estimated that the time required to submit measure data using CROWNWeb is 2.5 minutes per data element submitted, which takes into account the small percentage of data that is manually reported, as well as the human interventions required to modify batch submission files such that they meet CROWNWeb's internal data validation requirements.
Section IV.C.8. in this proposed rule outlines our data validation proposals for PY 2019. Specifically, for the CROWNWeb validation, we propose to randomly sample records from 300 facilities as part of our continuing pilot data-validation program. Each sampled facility would be required to produce approximately 10 records, and the sampled facilities will be reimbursed by our validation contractor for the costs associated with copying and mailing the requested records. The burden associated with these validation requirements is the time and effort necessary to submit the requested records to a CMS contractor. We estimate that it will take each facility approximately 2.5 hours to comply with this requirement. If 300 facilities are asked to submit records, we estimate that the total combined annual burden for these facilities will be 750 hours (300 facilities × 2.5 hours). Since we anticipate that Medical Records and Health Information Technicians or similar administrative staff would submit this data, we estimate that the aggregate cost of the CROWNWeb data validation would be approximately $19,088 (750 hours × $25.45/hour) total of approximately $64 ($19,088/300 facilities) per facility in the sample. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-1289).
Under the proposed data validation study for validating data reported to the NHSN Dialysis Event Module, we propose to randomly select 150 facilities. A CMS contractor will send these facilities requests for medical records for all patients with “candidate events” during the evaluation period. Overall, we estimate that, on average, quarterly lists will include two positive blood cultures per facility, but we recognize these estimates may vary considerably from facility to facility. We estimate that it will take each facility approximately 60 minutes to comply with this requirement (30 minutes from each of the two quarters in the evaluation period). If 150 facilities are asked to submit records, we estimate that the total combined annual burden for these facilities will be 150 hours (150 facilities × 1 hour). Since we anticipate that Medical Records and Health Information Technicians or similar administrative staff would submit this data, we estimate that the aggregate cost of the NHSN data validation would be $3,817.50 (150 hours × $25.45/hour) total of $25.45 ($3,817.50/150 facilities) per facility in the sample. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-NEW).
We proposed to include, beginning with the PY 2020 ESRD QIP, a reporting measure requiring facilities to report in CROWNWeb an ultrafiltration rate at least once per month for each qualifying patient. We estimate the burden associated with this measure to be the time and effort necessary for facilities to collect and submit the information required for the Ultrafiltration Rate Reporting Measure. We estimated that approximately 6,454 facilities will treat 548,430 ESRD patients nationwide in PY 2020. The Ultrafiltration Rate Reporting Measure requires facilities to report 13 elements per patient per month (156 elements per patient per year) and we estimate it will take facilities approximately 0.042 hours (2.5 minutes) to submit data for each data element. Therefore, the estimated total annual burden associated with reporting this measure in PY 2020 is approximately 3,593,313 hours (548,430 ESRD patients nationwide × 156 data elements/year × 0.042 hours per element), or approximately 553 hours per facility. We anticipate that Medical Records and Health Information Technicians or similar administrative staff will be responsible for this reporting. We therefore believe the cost for all ESRD facilities to comply with the reporting requirements associated with the ultrafiltration rate reporting measure would be approximately $91,449,815.80 (3,593,313 × $25.45/hour), or $14,082.20 per facility. The burden associated with these requirements is captured in an information collection request (OMB control number 0938-NEW).
Because of the large number of public comments we normally receive on
We have examined the impacts of this rule 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) and the Congressional Review Act (5 U.S.C. 804(2).
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, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (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 (RIA) must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule is not economically significant within the meaning of section 3(f)(1) of the Executive Order, since it does not meet the $100 million threshold. However, OMB has determined that the actions
This rule proposes a number of routine updates and several policy changes to the ESRD PPS in CY 2017. The proposed routine updates include the CY 2017 wage index values, the wage index budget-neutrality adjustment factor, and outlier payment threshold amounts. Other proposed policy changes include implementation of policy related to payment for hemodialysis treatments furnished more than three times per week and changes to the home dialysis training policy. Failure to publish this proposed rule would result in ESRD facilities not receiving appropriate payments in CY 2017 for renal dialysis services furnished to ESRD patients and to patients with AKI in accordance with section 1861(s)(2)(F) of the Act.
This rule proposes to implement the provisions in TPEA which provide for coverage and payment for renal dialysis services furnished by ESRD facilities to individuals with AKI. Failure to publish would result in a failure to comply with the requirements of the Act, as added by the TPEA.
This rule proposes to implement requirements for the ESRD QIP, including a proposal to adopt a measure set for the PY 2020 program, as directed by section 1881(h) of the Act. Failure to propose requirements for the PY 2020 ESRD QIP would prevent continuation of the ESRD QIP beyond PY 2019. In addition, proposing requirements for the PY 2020 ESRD QIP provides facilities with more time to review and fully understand new measures before their implementation in the ESRD QIP.
This rule proposes a requirement for the DMEPOS CBP for bid surety bonds and state licensure in accordance with section 1847 of the Act, as amended by section 522(a) of MACRA. The rule also proposes an appeals process for all breach of contract actions CMS may take.
This rule also proposes a methodology for adjusting DMEPOS fee schedule amounts for similar items with different features using information from the DMEPOS CBPs, a methodology for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and revising bid limits for individual items under DMEPOS CBP.
We estimate that the proposed revisions to the ESRD PPS will result in an increase of approximately $50 million in payments to ESRD facilities in CY 2017, which includes the amount associated with updates to the outlier thresholds, home dialysis training policy, payment for hemodialysis treatments furnished more than 3 times per week, and updates to the wage index. We are estimating approximately $2.0 million that would now be paid to ESRD facilities for dialysis treatments provided to AKI beneficiaries.
For PY 2019, we anticipate that the new burdens associated with the collection of information requirements will be approximately $21 thousand, totaling an overall impact of approximately $15.5 million as a result of the PY 2019 ESRD QIP.
We anticipate that DMEPOS CBP bidding entities will be impacted by the bid surety bond requirement. The state licensure requirement will have no new impact on the supplier community because this is already a basic supplier eligibility requirement at § 414.414(b)(3), and the appeals process for breach of contract actions may have a beneficial, positive impact on suppliers.
Overall, the bid surety bond requirement may have a positive financial impact on the CBP as we anticipate that the requirement will provide an additional incentive for bidding entities to submit substantiated bids. However, there will be an administrative burden for implementation of the bid surety bond requirement for CMS. We expect minimal administrative costs associated with the state licensure and appeals process for breach of DMEPOS CBP contract proposed rules.
We do not anticipate that the proposed DMEPOS Competitive Bidding regulations will have an impact on Medicare beneficiaries.
We estimate that our proposal for a methodology for adjusting DMEPOS fee schedule amounts for similar items with different features using information from the DMEPOS CBPs, proposed change for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and proposed revision to the bid limits for items under the DMEPOS CBP will have no significant impact on the suppliers, beneficiaries, Part B trust fund and economy as a whole.
To understand the impact of the changes affecting payments to different categories of ESRD facilities, it is necessary to compare estimated payments in CY 2016 to estimated payments in CY 2017. To estimate the impact among various types of ESRD facilities, it is imperative that the estimates of payments in CY 2016 and CY 2017 contain similar inputs. Therefore, we simulated payments only for those ESRD facilities for which we are able to calculate both current payments and new payments.
For this proposed rule, we used the December 2015 update of CY 2015 National Claims History file as a basis for Medicare dialysis treatments and payments under the ESRD PPS. We updated the 2015 claims to 2016 and 2017 using various updates. The updates to the ESRD PPS base rate are described in section II.B.3 of this proposed rule. Table 29 shows the impact of the estimated CY 2017 ESRD payments compared to estimated payments to ESRD facilities in CY 2016.
Column A of the impact table indicates the number of ESRD facilities for each impact category and column B indicates the number of dialysis treatments (in millions). The overall effect of the proposed changes to the outlier payment policy described in section II.B.3.c of this proposed rule is shown in column C. For CY 2017, the impact on all ESRD facilities as a result of the changes to the outlier payment policy would be a 0.2 percent increase in estimated payments. Nearly all ESRD facilities are anticipated to experience a positive effect in their estimated CY 2017 payments as a result of the proposed outlier policy changes.
Column D shows the effect of the proposed CY 2017 wage indices. The categories of types of facilities in the impact table show changes in estimated payments ranging from a 0.5 percent decrease to a 0.5 percent increase due to these proposed updates.
Column E reflects the overall impact, that is, the effects of the proposed outlier policy changes, the proposed wage index, the effect of the change in the home dialysis training add-on from $50.16 to $95.57 and the effect of the payment rate update. The ESRD PPS payment rate update is 0.35 percent, which reflects the proposed ESRDB market basket percentage increase factor for CY 2017 of 2.1 percent, the 1.25 percent reduction as required by the section 1881(b)(14)(F)(i)(I) of the Act, and the MFP adjustment of 0.5 percent. We expect that overall ESRD facilities would experience a 0.5 percent increase in estimated payments in 2017. The categories of types of facilities in the impact table show impacts ranging from an increase of 0.1 percent to an increase of 1.0 percent in their 2017 estimated payments.
Under the ESRD PPS, Medicare pays ESRD facilities a single bundled payment for renal dialysis services, which may have been separately paid to other providers (for example, laboratories, durable medical equipment suppliers, and pharmacies) by Medicare prior to the implementation of the ESRD PPS. Therefore, in CY 2017, we estimate
We estimate that Medicare spending (total Medicare program payments) for ESRD facilities in CY 2017 would be approximately $9.7 billion. This estimate takes into account a projected increase in fee-for-service Medicare dialysis beneficiary enrollment of 1.5 percent in CY 2017.
Under the ESRD PPS, beneficiaries are responsible for paying 20 percent of the ESRD PPS payment amount. As a result of the projected 0.5 percent overall increase in the proposed ESRD PPS payment amounts in CY 2017, we estimate that there will be an increase in beneficiary co-insurance payments of 0.5 percent in CY 2017, which translates to approximately $10 million.
In section II.B.1 of this proposed rule, we propose payment for hemodialysis furnished more than 3 times per week. We considered not proposing the payment changes; however, without the proposed changes, facilities would continue to be unable to appropriately bill all of the HD treatments they furnish causing the total number of treatments in our claims data to be understated, and thus the improvement to payment and data collection would not be achieved.
In section II.B.2, we propose changes to the home dialysis training add-on based on the average number of hours for PD and HD and weighted by the percentage of total treatments for each modality. We considered an approach to update the current training add-on amount annually using the market basket increase or the wage and price proxy in the market basket. However, under either approach, the increase to the training add-on payment was small and would not incentivize home dialysis training.
We analyzed CY 2015 hospital outpatient claims to identify the number of treatments furnished historically for AKI patients. We identified 7,155 outpatient claims with AKI that also had dialysis treatments that were furnished in CY 2015. Since the data for 2015 is not complete, we inflated the 7,155 treatments by 22 percent to 8,729 treatments. This inflation factor was determined by comparing the 2014 treatment counts submitted and processed by June 30, 2015 to the 2014 treatment counts submitted and processed by January 8, 2015. We then further inflated the 8,729 treatments to 2017 values using estimated population growth for fee-for service non-ESRD beneficiaries. This results in an estimated 8,938 treatments that would now be paid to ESRD facilities for furnishing dialysis to beneficiaries with AKI. Using the CY 2017 proposed ESRD base rate of $231.04 and an average wage index multiplier, we are estimating approximately $2.0 million that would now be paid to ESRD facilities for dialysis treatments provided to AKI beneficiaries.
Ordinarily, we would provide a table showing the impact of this provision on various categories of ESRD facilities. Because we have no way to project how many patients with AKI requiring dialysis will choose to have dialysis treatments at an ESRD facility, we are unable to provide a table at this time.
Under section 1834(r) of the Act, as added by section 808(b) of TPEA, we are proposing a payment rate for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. The only two Medicare providers authorized to provide these outpatient renal dialysis services are hospital outpatient departments and ESRD facilities. The decision about where the renal dialysis services are furnished is made by the patient and their physician. Therefore, this proposal will have zero impact on other Medicare providers.
We anticipate an estimated $2.0 million being redirected from hospital outpatient departments to ESRD facilities in CY 2017 as a result of some AKI patients receiving renal dialysis services in the ESRD facility at the lower ESRD PPS base rate versus continuing to receive those services in the hospital outpatient setting.
Currently, beneficiaries have a 20 percent co-insurance obligation when they receive AKI dialysis in the hospital outpatient setting. When these services are furnished in an ESRD facility, the patients would continue to be responsible for a 20 percent co-insurance. Because the AKI dialysis payment rate paid to ESRD facilities is lower than the Outpatient Prospective Payment System's payment amount, we would expect beneficiaries to pay less co-insurance when AKI dialysis is furnished by ESRD facilities.
In section III.B.2 of this proposed rule, we propose policy related to the implementation of section 808(b) of TPEA, which amended section 1834 by adding a new paragraph (r) which provides payment for renal dialysis services furnished by ESRD facilities to beneficiaries with AKI. We considered adjusting the AKI payment rate by including the ESRD PPS case-mix adjustments, other adjustments at 1881(b)(14)(D), as well as not paying separately for AKI specific drugs and labs. We ultimately determined that treatment for AKI is substantially different from treatment for ESRD and the case-mix adjustments applied to ESRD patients may not be applicable to AKI patients and as such, including those policies and adjustment would be inappropriate.
The ESRD QIP provisions are intended to prevent possible reductions in the quality of ESRD dialysis facility services provided to beneficiaries as a result of payment changes under the ESRD PPS. The methodology that we are proposing to use to determine a facility's TPS for the PY 2020 ESRD QIP is described in sections III.F.6 and III.F.7 of this proposed rule. Any reductions in ESRD PPS payments as a result of a facility's performance under the PY 2020 ESRD QIP would apply to ESRD PPS payments made to the facility in CY 2020.
We estimate that, of the total number of dialysis facilities (including those not receiving a TPS), approximately 48 percent or 2,840 of the facilities would likely receive a payment reduction in PY 2020. Facilities that do not receive a TPS are not eligible for a payment reduction.
In conducting our impact assessment, we have assumed that there will be 6,454 dialysis facilities paid through the PPS. Table 30 shows the overall estimated distribution of payment reductions resulting from the PY 2020 ESRD QIP.
To estimate whether or not a facility would receive a payment reduction in PY 2020, we scored each facility on achievement and improvement on several measures we have previously finalized and for which there were available data from CROWNWeb and Medicare claims. Measures used for the simulation are shown in Table 31.
Clinical measure topic areas with less than 11 cases for a facility were not included in that facility's Total Performance Score. Each facility's Total Performance Score was compared to an estimated minimum Total Performance Score and an estimated payment reduction table that were consistent with the proposals outlined in Section III.G.9 of this proposed rule. Facility reporting measure scores were estimated using available data from CY 2015. Facilities were required to have a score on at least one clinical and one reporting measure in order to receive a Total Performance Score.
To estimate the total payment reductions in PY 2020 for each facility resulting from this proposed rule, we multiplied the total Medicare payments to the facility during the one-year period between January 2015 and December 2015 by the facility's estimated payment reduction percentage expected under the ESRD QIP, yielding a total payment reduction amount for each facility: (Total ESRD payment in January 2015 through December 2015 times the estimated payment reduction percentage). For PY 2020, the total payment reduction for all of the 1,996 facilities expected to receive a reduction is approximately $22 million ($21,990,410). Further, we estimate that the total costs associated with the collection of information requirements for PY 2020 described in section VIII.1.b of this proposed rule would be approximately $91,449,815 million for all ESRD facilities. As a result, we estimate that ESRD facilities will experience an aggregate impact of approximately $113 million ($91,449,815 + $21,990,410 = $113,440,225) in PY 2020, as a result of the PY 2020 ESRD QIP.
Table 32 below shows the estimated impact of the finalized ESRD QIP payment reductions to all ESRD facilities for PY 2020. The table details the distribution of ESRD facilities by facility size (both among facilities considered to be small entities and by number of treatments per facility), geography (both urban/rural and by region), and by facility type (hospital based/freestanding facilities). Given that the time periods used for these calculations will differ from those we propose to use for the PY 2020 ESRD QIP, the actual impact of the PY 2020 ESRD QIP may vary significantly from the values provided here.
For instance, an authorized surety may establish a preliminary charge amount of 2 percent of the total bond amount to obtain a $100,000 bid surety bond. We anticipate that the authorized surety may adjust their charge percentage based on the number of CBAs in which a bidding entity bids, that is, a bulk discount. Bidding entities that purchase multiple bid surety bonds from the authorized surety would likely receive a reduced charge per bid surety bond as compared to a bidding entity that only purchases a single bid surety bond. We also expect that authorized sureties will evaluate each bidding entity's credit score(s) to either establish an appropriate charge percentage or to decide not to issue a bond if the bidding entity's credit score is too low. Lastly, we anticipate that an authorized surety may also request documentation from prior rounds of bidding to understand the bidding entity's experience with contract acceptance. Bidding entities that have accepted more contract offers in the prior round without any contract rejections may be viewed by an authorized surety as less risky than a bidding entity who has rejected numerous contract offers with few or no contract acceptance.
On January 1, 2019, CMS will be combining all CBAs into a consolidated round of competition. As a result, we estimate the aggregate total out of pocket cost for bidding entities to bid in this competition to be $26,000,000. This estimate is based upon the approximately 13,000 distinct bidders for CBAs included in both the Round 2 Recompete and Round 1 2017 multiplied by a $2,000 per bid surety bond price. Given the unknown variables with this new type of bond, we are seeking comments on how the authorized sureties will set the purchase amount for bidding entities in order to finalize a more accurate estimate.
We do anticipate that there will be an impact on small suppliers. We are seeking comments on whether we should have a reduced bid surety bond amount for a particular subset of suppliers, for example, small suppliers as defined by the CBP. In terms of a small supplier obtaining a bond, the Small Business Administration (SBA) has a statement on their Web site stating that their guarantee “encourages surety companies to bond small businesses,” and as such we anticipate that small suppliers will be able to reach out to the SBA if they encounter difficulty in obtaining a bond.
As a result of the implementation of this proposed rule, we anticipate that this requirement may deter some suppliers from bidding, which would result in a lower number of bids submitted to the DMEPOS CBP. We are seeking comments on the impact of the bid surety bond requirement on supplier participation in the DMEPOS CBP.
As a result of the implementation of this proposed rule, we anticipate that this regulation may deter some bidding entities from bidding, which would result in a lower number of bids submitted to the DMEPOS CBP. This reduction could reduce competition and lead to a decreased number of contract suppliers and, as a result, less savings from the program.
Additionally, we expect that there will be an administrative burden for implementing the bid surety bond requirement, which includes educating bidding entities, updating CMS bidding and contracting systems, and verifying that the bonds are valid.
The proposed CBP requirements for bid surety bond, state licensure and appeals process for a breach of contract actions are not expected to have an impact on Medicare beneficiaries.
Section 1847(a)(1)(G) of the Act, as amended by section 522(a) of MACRA, provides that a bidding entity may not submit a bid for a CBA unless, as of the deadline for bid submission, the entity has (1) obtained a bid surety bond, and (2) provided proof of having obtained the bid surety bond for each CBA associated with its bid(s) in a form specified by the Secretary. No alternatives to this bid surety bond requirement were considered. However, while we are proposing that the bid surety bond be in an amount of $100,000, we are seeking comments on whether a lower bond amount for a certain subset of bidding entities, for example, small suppliers as defined by 42 CFR 414.402, would be appropriate. Additionally, we are seeking comments on the impact of the bid surety bond requirement on participation in the DMEPOS CBP. No alternatives were considered for the state licensure requirement, as § 414.414(b)(3) of the regulations already requires suppliers to have state and local licensure.
For appeals for breach of contract actions, we believe that it would be beneficial to expand the appeals process to any of the breach of contract actions that CMS may take pursuant to § 414.422(g)(2). The alternative is to retain the current appeals process for terminations, while still allowing suppliers to appeal other breach of contract actions through an undefined process. However, in order to provide an opportunity for notice and comment, we believe that the better option is to revise the current regulations to allow for a clear and defined appeals process for any breach of contract action that CMS may take.
We estimate that our proposal for a methodology for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from the DMEPOS CBPs will generate small savings by lowering the price of similar items to be equal to the weighted average of the SPAs for the items based on the item weights assigned under competitive bidding. The reduced price causes lower copayments to the beneficiary. We believe our proposal would also prevent beneficiaries from potentially receiving lower cost items at higher coinsurance rates. Suppliers will be impacted little by the methodological change because the proposal has a small saving attached to it.
We estimate that our proposal for a methodology for determining single payment amounts for certain groupings of similar items with different features under the DMEPOS CBPs will generate small savings by not allowing SPAs for similar items without features to be priced higher than items with features. Our proposal would benefit beneficiaries who would have lower coinsurance payments as a result of this proposal. We believe our proposal would also prevent beneficiaries from potentially receiving lower cost items at higher coinsurance rates. Suppliers will have a reduced administrative burden due to the fact that bidding is simplified.
We estimate our proposed revision to the bid limits for items under the DMEPOS CBP will not have a
As required by OMB Circular A-4 (available at
The Regulatory Flexibility Act (September 19, 1980, Pub. L. 96-354) (RFA) requires agencies to analyze options for regulatory relief of small entities, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions.
We do not believe ESRD facilities are operated by small government entities such as counties or towns with populations of 50,000 or less, and therefore, they are not enumerated or included in this estimated RFA analysis. Individuals and States are not included in the definition of a small entity.
For purposes of the RFA, we estimate that approximately 15 percent of ESRD facilities are small entities as that term is used in the RFA (which includes small businesses, nonprofit organizations, and small governmental jurisdictions). This amount is based on the number of ESRD facilities shown in the ownership category in Table 32. Using the definitions in this ownership category, we consider the 568 facilities that are independent and the 354 facilities that are shown as hospital-based to be small entities. The ESRD facilities that are owned and operated by LDOs and regional chains would have total revenues of more than $38.5 million in any year when the total revenues for all locations are combined for each business (individual LDO or regional chain), and are not, therefore, included as small entities.
For the ESRD PPS updates proposed in this rule, a hospital-based ESRD facility (as defined by ownership type) is estimated to receive a 0.7 percent increase in payments for CY 2017. An independent facility (as defined by ownership type) is also estimated to receive a 0.4 percent increase in payments for CY 2017.
We are unable to estimate whether patients will go to ESRD facilities for AKI dialysis, however, we have estimated there is a potential for $2.0 million in payment for AKI dialysis treatments that could potentially be furnished in ESRD facilities. As a result, this proposed rule is not estimated to have a significant impact on small entities.
We estimate that of the 2,840 ESRD facilities expected to receive a payment reduction in the PY 2020 ESRD QIP, 349 are ESRD small entity facilities. We present these findings in Table 21 (“Estimated Distribution of PY 2020 ESRD QIP Payment Reductions”) and Table 23 (“Impact of Proposed QIP Payment Reductions to ESRD Facilities for PY 2020”) above. We estimate that the payment reductions will average approximately $11,510 per facility across the 2,840 facilities receiving a payment reduction, and $13,884 for each small entity facility. Using our estimates of facility performance, we also estimated the impact of payment reductions on ESRD small entity facilities by comparing the total estimated payment reductions for 922 small entity facilities with the aggregate ESRD payments to all small entity facilities. We estimate that there are a total of 922 small entity facilities, and that the aggregate ESRD PPS payments to these facilities would decrease 0.49 percent in PY 2020.
We anticipate that the bid surety bond provision will have an impact on all suppliers, including small suppliers; therefore, we are requesting comments regarding the bid bond amount. The state licensure and appeal of preclusion proposed rules are not expected to have an impact on any supplier.
We expect our proposals for a methodology for adjusting DMEPOS fee schedule amounts for certain groupings of similar items with different features using information from the DMEPOS CBPs, our proposed change for submitting bids for a grouping of two or more similar items with different features, our proposal for determining single payment amounts for similar items with different features under the DMEPOS CBPs, and our proposed revision to the bid limits for items under the DMEPOS CBP will not have a significant impact on a substantial number of small suppliers. Although suppliers furnishing items and services outside CBAs do not have to compete and be awarded contracts in order to continue furnishing these items and services, the fee schedule amounts for these items and services will be more equitable using the proposals established as a result of this rule. We believe that these rules will have a positive impact on suppliers because it reduces the burden and time it takes for suppliers to submit bids and data entry. It will also allow for suppliers to furnish items necessary to beneficiaries while getting compensated a reasonable payment.
Therefore, the Secretary has determined that this proposed rule would not have a significant economic impact on a substantial number of small entities. We solicit comment on the RFA analysis provided.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. Any such regulatory impact analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a metropolitan statistical area and has fewer than 100 beds. We do not believe this proposed rule will have a significant impact on operations of a substantial number of small rural hospitals because most dialysis facilities are freestanding. While there are 139 rural hospital-based dialysis facilities, we do not know how many of them are based at hospitals with fewer than 100 beds. However, overall, the 139 rural hospital-based dialysis facilities will experience an estimated 0.1 percent decrease in payments. As a result, this proposed rule is not estimated to have a significant impact on small rural hospitals. Therefore, the Secretary has determined that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2016, that is approximately $146 million. This proposed rule does not include any mandates that would impose spending costs on State, local, or Tribal governments in the aggregate, or by the private sector, of $141 million.
Executive Order 13132 on Federalism (August 4, 1999) establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it will not have substantial direct effects on the rights, roles, and responsibilities of States, local or Tribal governments.
This proposed rule is subject to the Congressional Review Act provisions of the Small Business Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801
In accordance with the provisions of Executive Order 12866, this proposed rule was reviewed by the Office of Management and Budget.
The Addenda for the annual ESRD PPS proposed and final rulemakings will no longer appear in the
Health facilities, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Administrative practice and procedure, Health facilities, Health professions, Kidney diseases, Medicare, Reporting and recordkeeping requirements.
Conditions for Coverage for End-Stage Renal Disease Facilities.
For the reasons set forth in the preamble, the Centers for Medicare & Medicaid Services proposes to amend 42 CFR Chapter IV as set forth below:
42 U.S.C. 1302; 42 U.S.C. 1395d(d); 42 U.S.C. 1395f(b); 42 U.S.C. 1395g; 42 U.S.C. 1395l(a), (i), and (n); 42 U.S.C. 1395x(v); 42 U.S.C. 1395hh; 42 U.S.C. 1395rr; 42 U.S.C. 1395tt; 42 U.S.C. 1395ww; sec. 124 of Pub. L. 106-113, 113 Stat. 1501A-332; sec. 3201 of Pub. L. 112-96, 126 Stat. 156; sec. 632 of Pub. L. 112-240, 126 Stat. 2354; sec. 217 of Pub. L. 113-93, 129 Stat. 1040; sec. 204 of Pub. L. 113-295, 128 Stat. 4010; and sec. 808 of Pub. L. 114-27, 129 Stat. 362.
(a) * * *
(1) A facility that disputes the amount of its allowable Medicare bad debts reimbursed by CMS under § 413.89(h)(3) may request review by the contractor or the Provider Reimbursement Review Board (PRRB) in accordance with subpart R of part 405 of this chapter.
(b) In addition to the per-treatment payment amount, as described in § 413.215(a), the ESRD facility may receive payment for bad debts of Medicare beneficiaries as specified in § 413.89(h)(3) of this part.
This subpart implements section 1834(r) of the Act by setting forth the principles and authorities under which CMS is authorized to establish a payment amount for renal dialysis services furnished to beneficiaries with an acute kidney injury in or under the supervision of an ESRD facility that meets the conditions of coverage in part 494 of this chapter and as defined in § 413.171.
For purposes of the subpart, the following definition applies:
The amount of payment for AKI dialysis services shall be the base rate for renal dialysis services determined for such year under section 1881(b)(14), that is, the ESRD base rate as set forth in § 413.220, updated by the ESRD bundled market basket percentage increase factor minus a productivity adjustment as set forth in § 413.196(d)(1), adjusted for wages as set forth in § 413.231, and adjusted by any other amounts deemed appropriate by the Secretary under § 413.373.
The payment rate for AKI dialysis may be adjusted by the Secretary (on a budget neutral basis for payments under section 1834(r)) by other adjustment factor under subparagraph (D) of section 1881(b)(14) of the Act.
(a) The AKI dialysis payment rate applies to renal dialysis services (as defined in subparagraph (B) of section 1881(b)(14) of the Act) furnished under Part B by a renal dialysis facility or provider of services paid under section 1881(b)(14) of the Act.
(b) Other items and services furnished to beneficiaries with AKI that are not considered to be renal dialysis services as defined in § 413.171, but that are related to their dialysis treatment as a result of their AKI, would be separately payable, that is, drugs, biologicals, laboratory services, and supplies that ESRD facilities are certified to furnish and that would otherwise be furnished to a beneficiary with AKI in a hospital outpatient setting.
(a) Changes to the methodology for payment for renal dialysis services furnished to beneficiaries with AKI as well as any adjustments to the AKI payment rate other than wage index will be adopted through notice and comment rulemaking.
(b) Annual updates in the AKI dialysis payment rate as described in § 413.372 that do not include those changes described in paragraph (a) are
(c) Effective for cost reporting periods beginning on or after January 1, 2017, on an annual basis CMS updates the AKI dialysis payment rate.
Secs. 1102, 1871, and 1881(b)(1) of the Social Security Act (42 U.S.C. 1302, 1395hh, and 1395rr(b)(1)).
(g) * * *
(6)
(i) In situations where a price inversion defined in § 414.402 occurs under the DMEPOS Competitive Bidding Program in a competitive bidding area (CBA) following a competition for a grouping of similar items identified in paragraph (g)(6)(ii) of this section, prior to adjusting the fee schedule amounts under § 414.210(g) the single payment amount for each item in the grouping of similar items in the CBA is adjusted to be equal to the weighted average of the single payment amounts for the items in the grouping of similar items in the CBA.
(ii) The groupings of similar items subject to this rule include—
(A) Enteral infusion pumps (HCPCS codes B9000 and B9002).
(B) Hospital beds (HCPCS codes E0250, E0251, E0255, E0256, E0260, E0261, E0290, E0291, E0292, E0293, E0294, E0295, E0301, E0302, E0303, and E0304).
(C) Mattresses and overlays (HCPCS codes E0277, E0371, E0372, and E0373).
(D) Power wheelchairs (HCPCS codes K0813, K0814, K0815, K0816, K0820, K0821, K0822, and K0823).
(E) Seat lift mechanisms (HCPCS codes E0627, E0628, and E0629).
(F) TENS devices (HCPCS codes E0720 and E0730).
(G) Walkers (HCPCS codes E0130, E0135, E0141, and E0143).
(iii) The weight for each item (HCPCS code) used in calculating the weighted average described in paragraph (g)(6)(ii) of this section is equal to the proportion of total nationwide allowed services furnished in calendar year 2012 for the item (HCPCS code) in the grouping of similar items, relative to the total nationwide allowed services furnished in calendar year 2012 for each of the other items (HCPCS codes) in the grouping of similar items.
(b) * * *
(2) The bids submitted for each item in a product category cannot exceed the payment amount that would otherwise apply to the item under Subpart C, without the application of § 414.210(g), or Subpart D, without the application of § 414.105, or Subpart I of this part. The bids submitted for items in accordance with paragraph (d)(2) of this section cannot exceed the weighted average, weighted by total nationwide allowed services, as defined in § 414.202, of the payment amounts that would otherwise apply to the grouping of similar items under Subpart C, without the application of § 414.210(g), or Subpart D, without the application of § 414.105.
(d)
(2) An exception to paragraph (d)(1) of this section can be made in situations where price inversions defined in § 414.402 have occurred in past competitions for items within groupings of similar items within a product category. In these situations, an alternative method for submitting bids for these combinations of codes may be announced at the time the competition begins. Under this alternative method, the combination of codes for the similar items is the item for bidding purposes, as defined under § 414.402. Suppliers submit bids for the code with the highest total nationwide allowed services for calendar year 2012 (the “lead item”) within the grouping of codes for similar items, and the bids for this code are used to calculate the single payment amounts for this code in accordance with § 414.416(b)(1). The bids for this code would also be used to calculate the single payment amounts for the other codes within the grouping of similar items in accordance with § 414.416(b)(3). For subsequent competitions, the lead item is identified as the code with the highest total nationwide allowed services for the most recent and complete calendar year that precedes the competition. The groupings of similar items subject to this rule include—
(i) Enteral infusion pumps (HCPCS codes B9000 and B9002).
(ii) Hospital beds (HCPCS codes E0250, E0251, E0255, E0256, E0260, E0261, E0266, E0265, E0290, E0291, E0292, E0293, E0294, E0295, E0296, E0297, E0301, E0302, E0303, and E0304).
(iii) Mattresses and overlays (HCPCS codes E0277, E0371, E0372, and E0373).
(iv) Power wheelchairs (HCPCS codes K0813, K0814, K0815, K0816, K0820, K0821, K0822, K0823, K0824, K0825, K0826, K0827, K0828, and K0829).
(v) Seat lift mechanisms (HCPCS codes E0627, E0628, and E0629).
(vi) TENS devices (HCPCS codes E0720 and E0730).
(vii) Walkers (HCPCS codes E0130, E0135, E0140, E0141, E0143, E0144, E0147, E0148, and E0149).
(h)
(2)
(A) The name of the bidding entity as the principal/obligor;
(B) The name and National Association of Insurance Commissioners number of the authorized surety;
(C) CMS as the named obligee;
(D) The conditions of the bond;
(E) The CBA covered by the bond;
(F) The bond number;
(G) The date of issuance; and
(H) The bid bond value of $100,000.00.
(ii) The bid surety bond must be maintained until it is either collected upon due to forfeiture or the liability is returned for not meeting bid forfeiture conditions.
(3)
(ii) Where the bid(s) does not meet the specified forfeiture conditions in paragraph (h)(3)(i) of this section, the bid surety bond liability will be returned within 90 days of the public announcement of contract suppliers for the CBA. CMS will notify the bidding entity that it did not meet the specified forfeiture requirements and the bid surety bond will not be collected by CMS.
(4)
(ii) A bidding entity, whose composite bid is at or below the median composite bid rate, that—
(A) Accepts a contract award and
(B) Is found to be in breach of contract for nonperformance of the contract to avoid forfeiture of the bid surety bond will have its contract terminated and will be precluded from participation in the DMEPOS Competitive Bidding Program.
(b) * * *
(3) Each supplier must have all State and local licenses required to perform the services identified in the request for bids. CMS may not award a contract to any entity in a CBA unless the entity meets applicable State licensure requirements.
(b) * * *
(3) In the case of competitions where bids are submitted for an item that is a combination of codes for similar items within a product category as identified under § 414.412(d)(2), the single payment amount for each code within the combination of codes is equal to the single payment amount for the lead item or code with the highest total nationwide allowed services multiplied by the ratio of the average of the 2015 fee schedule amounts for all areas (
(g)
(2) In the event a contract supplier breaches its contract, CMS may take one or more of the following actions, which will be specified in the notice of breach of contract:
(i) Suspend the contract supplier's contract;
(ii) Terminate the contract;
(iii) Preclude the contract supplier from participating in the competitive bidding program; or
(iv) Avail itself of other remedies allowed by law.
This section implements an appeals process for suppliers that CMS has determined are in breach of their Medicare DMEPOS Competitive Bidding Program contract and where CMS has issued a notice of breach of contract indicating its intent to take action(s) pursuant to § 414.422(g)(2).
(a)
(b)
(2)
(i) The details of the breach of contract.
(ii) The action(s) that CMS is taking as a result of the breach of the contract pursuant to § 414.422(g)(2), and the duration of or timeframe(s) associated with the action(s), if applicable.
(iii) The right to request a hearing by a CBIC hearing officer and, depending on the nature of the breach, the supplier may also be allowed to submit a corrective action plan (CAP) in lieu of requesting a hearing by a CBIC hearing officer, as specified in paragraph (c)(1)(i) of this section.
(iv) The address to which the written request for a hearing must be submitted.
(v) The address to which the CAP must be submitted, if applicable.
(vi) The effective date of the action(s) that CMS is taking is the date specified by CMS in the notice of breach of contract, or 45 days from the date of the notice of breach of contract unless:
(A) A timely hearing request has been filed; or
(B) A CAP has been submitted within 30 days of the date of the notice of breach of contract where CMS allows a supplier to submit a CAP.
(c)
(ii) If a supplier chooses not to submit a CAP, if CMS determines that a supplier's CAP is insufficient, or if CMS does not allow the supplier the option to submit a CAP, the supplier may request a hearing on the breach of contract action(s).
(2)
(ii) Suppliers will only have the opportunity to submit a CAP when they are first notified that they have been determined to be in breach of contract. If the CAP is not acceptable to CMS or is not properly implemented, suppliers will receive a subsequent notice of breach of contract. The subsequent notice of breach of contract may, at CMS' discretion, allow the supplier to submit another written CAP pursuant to paragraph (1)(i) of this section.
(d)
(2) To identify the timeframes by which the supplier will implement each of the components of the CAP.
(e)
(2) If CMS accepts the CAP, including the supplier's designated timeframe for its completion, the supplier must provide a follow-up report within 5 days after the supplier has fully implemented the CAP that verifies that all of the deficiencies identified in the CAP have been corrected in accordance with the timeframes accepted by CMS.
(3) If the supplier does not implement a CAP that was accepted by CMS, or if CMS does not accept the CAP submitted by the supplier, then the supplier will receive a subsequent notice of breach of contract, as specified in paragraph (b) of this section.
(f)
(2) A supplier that wishes to appeal the breach of contract action(s) specified in the notice of breach of contract must submit a written request to the CBIC. The request for a hearing must be received by the CBIC within 30 days from the date of the notice of breach of contract.
(3) A request for hearing must be in writing and submitted by an authorized official of the supplier.
(4) The appeals process for the Medicare DMEPOS Competitive Bidding Program is not to be used in place of other existing appeals processes that apply to other parts of Medicare.
(5) If the supplier is given the opportunity to submit a CAP and a CAP is not submitted and the supplier fails to timely request a hearing, the breach of contract action(s) will take effect 45 days from the date of the notice of breach of contract.
(g)
(2) The hearing may be held in person or by telephone at the parties' request.
(3) The scheduling notice to the parties must indicate the time and place for the hearing and must be sent to the parties at least 30 days before the date of the hearing.
(4) The hearing officer may, on his or her own motion, or at the request of a party, change the time and place for the hearing, but must give the parties to the hearing 30 days' notice of the change.
(5) The hearing officer's scheduling notice must provide the parties to the hearing the following information:
(i) A description of the hearing procedure.
(ii) The specific issues to be resolved.
(iii) The supplier has the burden to prove it is not in violation of the contract or that the breach of contract action(s) is not appropriate.
(iv) The opportunity for parties to the hearing to submit additional evidence to support their positions, if requested by the hearing officer.
(v) A notification that all evidence submitted, both from the supplier and CMS, will be provided in preparation for the hearing to all affected parties at least 15 days prior to the scheduled date of the hearing.
(h)
(2) The supplier's evidence must be submitted with its request for a hearing.
(3) If the supplier fails to submit the evidence at the time of its submission, the Medicare DMEPOS supplier is precluded from introducing new evidence later during the hearing process, unless permitted by the hearing officer.
(4) CMS also has the opportunity to submit evidence to the hearing officer within 10 days of receiving the scheduling notice.
(5) The hearing officer will share all evidence submitted by the supplier and/or CMS, with all parties to the hearing at least 15 days prior to the scheduled date of the hearing.
(i)
(1) Conduct the hearing and decide the order in which the evidence and the arguments of the parties are presented;
(2) Determine the rules on admissibility of the evidence;
(3) Examine the witnesses, in addition to the examinations conducted by CMS and the contract supplier;
(4) The CBIC may assist CMS in the appeals process including being present at the hearing, testifying as a witness, or performing other, related ministerial duties;
(5) Determine the rules for requesting documents and other evidence from other parties;
(6) Ensure a complete record of the hearing is made available to all parties to the hearing;
(7) Prepare a file of the record of the hearing which includes all evidence submitted as well as any relevant documents identified by the hearing officer and considered as part of the hearing; and
(8) Comply with all applicable provisions of 42 U.S.C. Title 18 and related provisions of the Act, the applicable regulations issued by the Secretary, and manual instructions issued by CMS.
(j)
(2) The recommendation(s) will explain the basis and the rationale for the hearing officer's recommendation(s).
(3) The hearing officer must include the record of the hearing, along with all evidence and documents produced during the hearing along with its recommendation(s).
(k)
(2) After reviewing the hearing officer's recommendation(s), CMS' decision(s) will be made within 30 days from the date of receipt of the hearing officer's recommendation(s). In situations where there is more than one breach of contract action presented at the hearing, and the hearing officer issues multiple recommendations, CMS will render separate decisions for each breach of contract action.
(3) A notice of CMS' decision will be sent to the supplier and the hearing officer. The notice will indicate:
(i) If any breach of contract action(s) included in the notice of breach of contract, specified in paragraph (b)(1) of this section, still apply and will be effectuated, and
(ii) The effective date for any breach of contract action specified in paragraph (k)(3)(i) of this section.
(4) This decision(s) is final and binding.
(l)
(ii) The supplier must notify all beneficiaries who are receiving rented competitive bid items or competitive bid items on a recurring basis of the suspension of their contract.
(A) The notice to the beneficiary from the supplier must be provided within 15 days of receipt of the final notice.
(B) The notice to the beneficiary must inform the beneficiary that they must select a new contract supplier to furnish these items in order for Medicare to pay for these items.
(2)
(ii) The supplier must notify all beneficiaries, who are receiving rented competitive bid items or competitive bid items received on a recurring basis, of the termination of their contract.
(A) The notice to the beneficiary from the supplier must be provided within 15 days of receipt of the final notice of termination.
(B) The notice to the beneficiary must inform the beneficiary that they are going to have to select a new contract supplier to furnish these items in order for Medicare to pay for these items.
(3)
(4)
Secs. 1102 and 1871 of the Social Security Act (42 U.S.C. 1302 and 1395hh).
(a) * * *
(3) Section 1861(s)(2)(F) of the Act, which describes “medical and other health services” covered under Medicare to include home dialysis supplies and equipment, self-care home dialysis support services, and institutional dialysis services and supplies, for items and services furnished on or after January 1, 2011, renal dialysis services (as defined in section 1881(b)(14)(B)), including such renal dialysis services furnished on or after January 1, 2017, by a renal dialysis facility or provider of services paid under section 1881(b)(14) to an individual with acute kidney injury (as defined in section 1834(r)(2)).
(7) Section 1861(s)(2)(F) of the Act, which authorizes coverage for renal dialysis services furnished on or after January 1, 2017 by a renal dialysis facility or provider of services currently paid under section 1881(b)(14) of the Act to an individual with AKI.
Federal Energy Regulatory Commission.
Final rule.
The Federal Energy Regulatory Commission (Commission) is revising its regulations to address certain practices that fail to compensate resources at prices that reflect the value of the service resources provide to the system, thereby distorting price signals, and in certain instances, creating a disincentive for resources to respond to dispatch signals. We require that each regional transmission organization and independent system operator align settlement and dispatch intervals by: Settling energy transactions in its real-time markets at the same time interval it dispatches energy; settling operating reserves transactions in its real-time markets at the same time interval it prices operating reserves; and settling intertie transactions in the same time interval it schedules intertie transactions. We also require that each regional transmission organization and independent system operator trigger shortage pricing for any interval in which a shortage of energy or operating reserves is indicated during the pricing of resources for that interval. Adopting these reforms will align prices with resource dispatch instructions and operating needs, providing appropriate incentives for resource performance.
This rule will become effective September 13, 2016.
1. In this Final Rule, we address certain practices that fail to compensate resources at prices that reflect the value of the service resources provide to the system, thereby distorting price signals, and in certain instances, creating a disincentive for resources to respond to dispatch signals. We require, pursuant to section 206 of the Federal Power Act (FPA),
(2) settling operating reserves transactions in its real-time markets at the same time interval it prices operating reserves;
2. Some current RTO/ISO settlement practices fail to reflect the value of providing a given service, thereby distorting price signals and failing to provide appropriate signals for resources to respond to the actual operating needs of the market. One such practice occurs when RTOs/ISOs dispatch resources every five minutes but perform settlements based on an hourly integrated price, or when RTOs/ISOs schedule intertie transactions every fifteen minutes, but perform settlements on an hourly integrated price. This misalignment between dispatch and settlement intervals distorts the price signals sent to resources and fails to reflect the actual value of resources responding to operating needs because compensation will be based on average output and average prices across an hour, rather than output and prices during the periods of greatest need within a particular hour.
3. We also find that a second problem occurs if there is a mismatch between the time when a system experiences a shortage of energy and operating reserves and the time when prices reflect the shortage condition. This can be particularly problematic when, for example, an RTO's/ISO's market rules require a shortage to last a minimum time period before triggering shortage pricing. In this instance, short-term prices fail to reflect system conditions and potential reliability costs, as well as the value of both internal and external market resources responding to a dispatch signal. In addition, inaccurate price signals are provided to market participants if shortage pricing is still in effect after the shortage has been resolved.
4. To address these problems associated with differing dispatch intervals and settlement intervals, as well as with shortage pricing triggers, we are setting forth the settlement interval requirements and the shortage pricing requirement in this Final Rule.
5. As set forth in the NOPR, we reiterate the goals of price formation are to: (1) Maximize market surplus for consumer and suppliers; (2) provide correct incentives for market participants to follow commitment and dispatch instructions, make efficient investments in facilities and equipment, and maintain reliability; (3) provide transparency so that market participants understand how prices reflect the actual marginal cost of serving load and the operational constraints of reliably operating the system; and, (4) ensure that all suppliers have an opportunity to recover their costs.
6. As noted in the NOPR, the reforms adopted in this Final Rule advance at least two of the Commission's goals
7. Second, the proposed reforms will also help provide transparency and certainty so that market participants understand how compensation and prices reflect the actual marginal cost of serving load and the operational constraints of reliably operating the system. Requiring settlement intervals to match dispatch intervals will make resource compensation more transparent by, among other things, increasing the proportion of resource payment provided through payments of energy and operating reserves rather than uplift. Further, requiring RTOs/ISOs to trigger shortage pricing for an interval in which a shortage of energy or operating reserves is indicated during the pricing of resources for that interval will ensure that prices transparently reflect the operational constraints of reliably operating the system. This increased transparency, in turn, better informs decisions to build or maintain resources and enhances consumers' ability to hedge. The benefits summarized above and discussed in detail below would ultimately help to ensure just and reasonable rates.
8. As discussed below, we require each RTO/ISO to submit a compliance filing with the tariff changes needed to implement this Final Rule within 120 days of the Final Rule's effective date. We will allow a further 12 months from the compliance filing date for the tariff changes implementing reforms to settlement intervals to be effective, and 120 days from that same compliance filing date for the tariff changes implementing shortage pricing reforms to be effective.
9. The Commission has addressed price formation in organized markets on prior occasions. For example, in Order No. 719, the Commission addressed shortage pricing
10. In June 2014, the Commission initiated a proceeding, in Docket No. AD14-14-000, to evaluate issues regarding price formation in the energy and ancillary services markets operated by RTOs/ISOs (price formation proceeding). In the notice initiating that proceeding, the Commission stated that there may be opportunities for the RTOs/ISOs to improve the energy and ancillary services price formation process. As set forth in the notice, locational marginal prices (LMP) and market-clearing prices used in energy and ancillary services markets ideally “would reflect the true marginal cost of production, taking into account all physical system constraints, and these prices would fully compensate all resources for the variable cost of providing service.”
11. In its January 2015 Notice Inviting Comments, the Commission requested comments on questions that arose from the price formation technical workshops.
12. On September 17, 2015, the Commission issued a NOPR proposing to require that each RTO/ISO: (1) Settle energy transactions in its real-time markets at the same time interval it dispatches and prices energy, and settle operating reserves transactions in its real-time markets at the same time interval it prices operating reserves; and (2) trigger shortage pricing for any dispatch interval during which a shortage of energy or operating reserves occurs.
13. In the NOPR,
14. Commenters generally agree with the Commission's preliminary finding regarding the settlement interval proposal. For example, EPSA states that “[w]hen real-time settlements for generation or dispatchable demand are calculated based on hourly prices that are the simple average of sub-hourly prices resulting from the actual dispatch, there is a distortion to the real-time price signal impacting both reliability and efficiency.”
15. In some instances, commenters assert that the Commission should not affirm its preliminary finding on the settlement interval proposal. APPA and NRECA assert that Commission approval of any five-minute settlement implementation process should require vetting and approval by the RTOs'/ISOs' stakeholders.
16. Based on analysis of the record, we adopt our preliminary findings, and, as described in detail below, conclude that certain RTO/ISO settlement practices are not just and reasonable and are unduly discriminatory and preferential. Accordingly, we direct each RTO/ISO to align its settlement and dispatch intervals by settling energy transactions in its real-time markets at the same time interval it dispatches energy, settling operating reserves transactions in its real-time markets at the same time interval it prices operating reserves, and settling intertie transactions in the same time interval it schedules intertie transactions, as discussed further herein.
17. In the NOPR, the Commission proposed to require that each RTO/ISO settle energy transactions in its real-time markets at the same time interval it dispatches energy. The Commission preliminarily found the use of hourly integrated prices for real-time settlement may have the unintended effect of distorting price signals, and, in certain instances, contributing to market participants' failing to respond appropriately to operating needs.
18. To remedy any potentially unjust and unreasonable rates caused by the use of hourly integrated prices for real-time settlement, the Commission proposed in the NOPR to require that each RTO/ISO settle energy transactions in its real-time markets at the same time interval it dispatches energy.
19. The Commission explained that in the short-term, the settlement interval proposal should improve incentives for resources to respond quickly to dispatch instructions, which should in turn lead to operators taking fewer out-of-market actions to ensure that supply meets demand. The Commission noted that by improving resources' response to dispatch instructions, the settlement interval proposal would result in a more efficient use of generation resources to the benefit of all consumers. In the long-term, the Commission maintained that these reforms should provide more accurate price signals, which should provide, together with other market price signals, the appropriate incentives to build or maintain resources that can respond to energy or operating reserve deficiencies.
20. In addition, the Commission noted, where settlement and dispatch intervals are aligned, resources dispatched economically during high-priced periods would receive those higher prices rather than an hourly average of the dispatch interval LMPs, thereby reducing the need to make uplift payments.
21. The Commission proposed requiring that each RTO/ISO “settle operating reserves transactions in its real-time markets at the same time interval it prices operating reserves.”
22. The following table describes how each RTO/ISO currently dispatches and settles real-time energy transactions:
23. The RTOs/ISOs
24. The PJM Market Monitor explains that the synchronized and regulation reserves markets in PJM clear hourly but already incorporate five-minute LMP data for calculating opportunity costs. The PJM Market Monitor states that the offer price in PJM's synchronized reserve market includes both the direct short-run marginal cost of providing synchronized reserves, which does not vary every five minutes, and the opportunity cost of providing synchronized reserves, which does vary with five-minute LMPs. The PJM Market Monitor explains that PJM currently updates the opportunity cost every five minutes using five-minute LMP data for the Tier 2 synchronized reserve market and recalculates the market clearing price every five minutes, with settlement based on the average of the five-minute clearing price.
25. The PJM Market Monitor explains that, in PJM's regulation market, the offer price includes both the direct short-run marginal cost of providing regulation, which does not vary every five minutes, and the opportunity cost of providing regulation, which varies with five-minute LMPs. The PJM Market Monitor adds that PJM currently updates the opportunity cost every five minutes using five-minute LMP data for the regulation market and recalculates the clearing price every five minutes, with settlement based on the average of five-minute clearing prices. The PJM Market Monitor also notes that PJM purchases other forms of operating reserves on a cost basis, including Tier 1 synchronized reserves, non-synchronized reserves, and day-ahead scheduling reserves.
26. NYISO explains that it uses five-minute intervals to settle its real-time markets for energy, regulation service, and operating reserves.
27. Twenty-seven of the thirty commenters providing input on this issue generally support the NOPR's proposed settlement interval reform.
28. The ISO/RTO Council supports the Commission's goals of aligning prices with resource dispatch instructions and operating needs and specifically supports the settlement interval proposal for energy transactions. The ISO/RTO Council states that the proposed settlement interval reform will make resource compensation more transparent by increasing the proportion of payments to resources through the price paid for energy as opposed to uplift.
29. In separate comments, NYISO, ISO-NE., MISO, and PJM support the settlement interval proposal for both energy and operating reserve transactions. Likewise, in separate comments, CAISO supports the settlement interval proposal for energy transactions, but does not support requiring RTOs/ISOs to settle all real-time operating reserves transactions at the same interval as real-time energy dispatch and settlement intervals.
30. CAISO states that the settlement interval proposal would improve market efficiency, and that accurate price signals provide market participants with incentives to develop needed capabilities and to offer those capabilities into the market.
31. However, CAISO does not support requiring RTOs/ISOs to settle all real-time operating reserves transactions at the same interval as real-time energy dispatch and settlement intervals.
32. NYISO supports the settlement interval proposal and asserts that its use of five-minute intervals to settle its real-time markets for energy, regulation service, and operating reserves, has provided significant incentives for resources to follow dispatch instructions and opportunities for supply resources to obtain full payment for their performance based on actual system conditions.
33. ISO-NE contends that settling on sub-hourly or five-minute intervals would help to improve price signals and resource compensation.
34. MISO asserts that the inconsistency between dispatch and settlements may produce financial outcomes that do not align with the guiding principles of co-optimized (energy and ancillary services) security constrained economic dispatch.
35. PJM states that ancillary services, including operating reserves, should settle on the same interval as energy because they are co-optimized. PJM argues that not doing so could yield discrepancies between the prices used to settle each product and could therefore undo enhancements made since implementation of Order No. 719, reduce market efficiencies, disrupt operations, and hinder proper price formation.
36. The PJM Market Monitor agrees that it would be appropriate to implement five-minute pricing for the reasons stated in the NOPR, and that implementing five-minute settlements will contribute significantly to reducing uplift payments in PJM, an ongoing goal in the PJM region.
37. Potomac Economics, which serves as the market monitor for ISO-NE., MISO, and NYISO, argues that hourly settlements encourage resources not to follow dispatch instructions or to decrease their flexibility by restricting dispatch ranges and offering slower ramp rates, and states that MISO pays uplift to alleviate these issues. Potomac Economics cites its 2014 MISO State of the Market Report to show how five-minute settlements would change total payments to resources compared to current hourly settlements. This analysis showed that fossil-fueled resources in 2014 received settlements that were $35 million less than they would have received if the settlement were based on five-minute prices and output, and that only one-fifth of this lost value was paid via uplift. In contrast, Potomac Economics represents that non-fossil resources were paid on net in hourly revenues slightly above what they would have received with five-minute settlements. Potomac Economics asserts that five-minute settlement provides greater compensation to fossil resources, more accurately representing the flexibility fossil resources provide to the system. In contrast, Potomac Economics argues that hourly settlement overvalues wind resources because such resources cannot ramp up in response to higher prices, are negatively correlated with load and contribute to higher congestion at higher output levels.
38. The SPP Market Monitor agrees with the Commission's preliminary finding that aligning settlement and dispatch intervals would make resource compensation more transparent by increasing the proportion of resource payments made through energy and operating reserve payments instead of uplift.
39. Many commenters expressly support the NOPR's settlement interval proposal, citing many of the benefits that were outlined in the NOPR.
40. More specifically, Exelon asserts that the settlement interval proposal will support ongoing market improvements, such as ISO-NE's performance incentive mechanism, effective in June 2018, that will pay resources bonuses or impose penalties based on performance during operating reserve shortages that last five minutes or longer. Exelon argues that ISO-NE's market must settle at five-minute intervals to implement this mechanism completely.
41. According to EDP Renewables, greater participation of fast ramping renewable resources will also enhance resource adequacy, produce cost savings for consumers, and improve grid resilience.
42. Some commenters also argue that the settlement interval proposal will reduce market inefficiencies and lead to greater investment. PSEG asserts that the proposed reforms correct market flaws that have caused inefficiencies in both price signals and resource dispatch decisions.
43. EPSA argues that implementing sub-hourly settlement intervals is needed to obtain the full benefits of other price formation reforms to improve the accuracy with which real-time prices communicate the time-dependent and location-dependent value of incremental energy and ancillary services.
44. TAPS does not oppose the settlement interval proposal, as long as it does not impose an undue burden on load serving entities.
45. EPSA supports the settlement interval proposal for operating reserves. It argues that real-time operating reserves should be co-optimized in the dispatch and settled with energy for every hourly sub-interval (generally five minutes) to ensure that resources are compensated for following RTO/ISO instructions and are indifferent to providing either energy or operating reserves during periods of high energy or operating reserves prices.
46. Dominion supports the settlement interval proposal for operating reserves. However, Dominion argues that only specific reserve products should settle at the same interval that they are priced and that other types of settlement provisions, such as make-whole payments, should not.
47. PSEG supports applying the proposed settlement intervals to both real-time energy transactions and real-time operating reserves. PSEG explains that given the linkage between energy transactions and reserve services, settling those products on different intervals would introduce dislocations, and incent resource actions that could disrupt these co-optimization objectives, essentially undermining the Commission's objectives in the NOPR.
48. The New Jersey Board concurs with the PJM Market Monitor that no changes should be made in PJM's synchronized reserve and regulation markets given that the opportunity cost component in these ancillary services markets, which is the only cost component subject to five-minute changes in LMP, already accounts for the five-minute interval changes.
49. Several commenters oppose the settlement interval proposal. Direct Energy states that the Commission should solicit information from RTOs/ISOs to determine whether existing generation resources are able to respond effectively to five-minute price signals before determining whether any settlement interval reform is warranted.
50. Duke, APPA and NRECA, and Concerned Cooperatives argue that the Commission should refrain from requiring a one-size-fits-all approach.
51. Concerned Cooperatives argue that the benefits of moving to five-minute settlements will not offset the cost. They state that the Potomac Economics report cited in the NOPR shows that switching to matching intervals would force MISO market participants to expend millions of dollars on upgrades and operation and maintenance (O&M) costs, without realizing lower rates. Instead, those participants would face an annual increase of approximately $28 million, after netting the estimated $6.6 million system benefit from the increased payments to generators of about $35 million dollars.
52. Concerned Cooperatives further argue that the Commission relies solely upon a letter filed in Docket No. AD14-14-000
53. We adopt the NOPR proposal to require that each RTO/ISO settle energy transactions in its real-time markets at the same time interval it dispatches energy, as discussed below.
54. As discussed below, providing the correct incentives for market participants to follow commitment and dispatch instructions, make efficient investments in facilities and equipment, maintain reliability, and increase transparency is fundamental to proper formation of energy prices, helping to ensure just and reasonable rates, terms and conditions of service.
55. One important element of ensuring reliable grid operations is resources following dispatch instructions. The requirement that each RTO/ISO settle energy transactions at the same interval it dispatches energy sends accurate market signals of power system conditions, thus encouraging resources to follow commitment and dispatch instructions, a point noted by ISO-NE.
56. The settlement interval requirement for energy transactions also provides an incentive to make efficient investments in facilities and equipment.
57. The settlement interval requirement for energy transactions should help in maintaining reliability because resources will have a greater incentive to follow dispatch instructions, as noted by Exelon.
58. The settlement interval requirement for energy transactions also results in more accurate market prices, reducing the need for out-of-market operator actions. Under an hourly
59. Taken together, the benefits we expect as a result of this settlement reform will ensure that rates are just and reasonable and not unduly discriminatory or preferential.
60. We are not persuaded by the arguments opposing the settlement interval proposal. Underlying much of the opposition is the assumption that many resources cannot take advantage of five-minute settlement intervals because they are not flexible enough to respond to five-minute dispatch. For example, Direct Energy argues that RTOs/ISOs should report the types of resources able to effectively modify their output to respond to five-minute price signals.
61. We are not persuaded by Concerned Cooperatives' argument that the settlement interval proposal should be rejected because market participants, such as Concerned Cooperatives, funding the reform do not have a large fraction of their positions in the real-time market and therefore will not benefit significantly from it.
62. We also disagree with Concerned Cooperatives' statement that the Commission relied upon a single document to support its finding without additional analysis.
63. Concerned Cooperatives express concern that adopting five-minute settlement intervals could result in errors and disputes that could lead to resettlement and uncertainty for the market.
64. Concerned Cooperatives also assert that the objective of incenting market participants to follow dispatch instructions or invest in upgrades must be considered in the context of existing market rules that already may provide incentives for investment in faster ramping capability.
65. Contrary to Concerned Cooperatives' argument, we are not persuaded to abandon the settlement interval proposal because a Potomac Economics report indicates that it would have resulted in an additional $28 million in increased energy costs on the MISO system in 2014.
66. Additionally, some commenters argue that other types of settlement provisions, such as make-whole payments, should not be subject to settlement interval reform. We would like to clarify that the Final Rule does not apply to make-whole payments for units dispatched out-of-merit.
67. We disagree with the recommendation of some commenters that the decision to modify settlement intervals should be subject to a stakeholder process.
68. We conclude that the settlement interval requirement for energy transactions should ensure that hourly settlement practices do not distort five-minute price signals in RTOs/ISOs. Instead, the compensation provided to resources must reflect the value of a resource providing given services to ensure appropriate economic incentives to meet system needs.
69. We adopt the proposal in the NOPR that RTOs/ISOs settle real-time operating reserves transactions at the same time interval that they price operating reserves. This requirement for operating reserves will accomplish the Commission's price formation goals and thereby ensure just and reasonable rates, and will further preserve the co-optimization of operating reserves with energy. Under the settlement interval requirement for operating reserves, to the extent that an RTO/ISO prices operating reserves transactions at a different time interval than it prices internal real-time energy transactions, that RTO/ISO need only settle operating reserves transactions at the same time interval that they are priced. Thus, we will not require an RTO/ISO to settle operating reserves transactions on the same time interval as it settles energy transactions. This will preserve the existing energy and operating reserves co-optimization methodologies of the various RTOs/ISOs.
70. The settlement interval requirement increases transparency and provides the correct incentives to maintain reliability. It also meets the Commission's other price formation goals of encouraging resources to follow the RTO's/ISO's commitment and dispatch instructions and to make efficient investments. The reform to the settlement interval for operating reserves will increase reliability because resource owners will have a greater incentive to adequately maintain their equipment, conduct maintenance during non-peak periods, and invest in new and upgraded equipment. Similar to energy settlement intervals, requiring settlement intervals of operating reserves transactions to match the intervals upon which those reserves are priced will reduce the need for payments made through uplift, make resource compensation more transparent and help ensure that there are adequate operating reserves to maintain reliability. Finally, co-optimized energy and reserve prices are designed so that a resource is indifferent between providing energy or operating reserves. Ensuring that energy and operating reserve settlements are done on the same basis will preserve this indifference and create an incentive for a resource to provide the service the RTO/ISO has instructed it to provide. The reform to operating reserve settlements will, by achieving the Commission's price formation goals and preserving the co-optimization of energy and operating reserves, ensure that rates are just and reasonable.
71. While, as discussed above, some commenters also support RTOs/ISOs settling all real-time operating reserves transactions at the same time interval that they dispatch real-time energy,
72. NYISO states that, although it uses sub-hourly settlements in its real-time market, in certain cases, the Commission has approved NYISO performing settlements on an hourly basis, and NYISO argues it should not be required to bring those settlements into alignment with its normal dispatch intervals.
73. Although generally supporting the settlement interval requirement for operating reserves, some commenters question whether such a requirement should apply to all reserve products or assert that regional variations should be considered.
74. The Commission sought comment on whether the proposed reforms are appropriate for intertie transactions scheduled on intervals different from
75. The ISO/RTO Council asserts that aligning dispatch and pricing should also apply to intertie transactions, adding that this would prevent price discrepancies and may reduce uplift.
76. PJM asserts that intertie transactions should be included in the scope of the Final Rule, noting that it plans to settle intertie transactions on a five-minute basis, consistent with its proposal for its real-time energy market. PJM suggests that, where a transaction is curtailed or the MW quantity is reduced during a fifteen-minute interval due to a reliability directive, each five-minute interval in the transaction should settle on the integrated transaction MW quantity that flowed during the five-minute interval.
77. ISO-NE argues that external interties should settle no less often than the intervals for which they are scheduled. ISO-NE represents that its proposals to implement sub-hourly settlements would fully meet this objective at all its external interfaces.
78. CAISO notes that it already schedules and settles intertie transactions and internal resources on a fifteen-minute basis.
79. CAISO asserts that a blanket requirement that hourly intertie schedules revert to hourly pricing, as was previously the case under its prior market design, would result in the same adverse market outcomes it resolved through its fifteen-minute market enhancement.
80. The PJM Market Monitor asserts that intertie transactions in PJM cannot be measured accurately enough to support five-minute settlements, noting that accurate measurement is difficult because of differences between actual and scheduled flows. The PJM Market Monitor thus recommends that settlements be based on the same fifteen-minute interval used for external scheduling intervals. The PJM Market Monitor asserts that this approach would more accurately reflect LMP during the actual time period of the transaction and would make the period and settlement of the transaction consistent.
81. The PJM Market Monitor states that alternative settlement approaches include using the integrated price over the same fifteen-minute interval used in scheduling and using five-minute interval settlements.
82. The New Jersey Board, EEI, EPSA, Dominion, and EDP Renewables concur with the PJM Market Monitor that intertie settlements should be at fifteen-minute intervals, the same interval as external scheduling.
83. Golden Spread states that alignment between dispatch and settlement intervals is generally desirable for the reasons listed in the NOPR, and notes that it believes SPP already aligns dispatch and settlement intervals for intertie transactions on a five-minute basis.
84. ANGA, PSEG, and the Financial Marketers Coalition assert that the logic underlying the proposed settlement reform as applied to internal transactions should apply equally to intertie transactions, and ANGA recommends that the Commission consider evolving these interfaces to five-minute dispatch and settlement, perhaps over the next three to five years.
85. Although it generally agrees that the settlement interval proposal should apply equally to internal and intertie transactions, Financial Marketers Coalition states that, in CAISO, clearing some transactions (such as load and generation) on a five-minute price and others (such as internal and intertie convergence bids) on a fifteen-minute price has yielded price divergence instead of convergence.
86. Inertia Power and DC Energy argue that intertie economic dispatch intervals cannot easily be aligned with internal real-time energy dispatch but emphasize the importance of maintaining the highest possible consistency across the seams to ensure a more efficient, resilient, and reliable electrical system.
87. Duke states that the issue of whether to apply the settlement interval proposal to intertie transactions should be discussed in the RTO/ISO stakeholder processes and that they should be treated comparably to reforms to internal transactions.
88. Based upon the comments received on this issue, we modify the regulatory text proposed in the NOPR to require each RTO/ISO to settle intertie transactions in the same time interval that it schedules intertie transactions. The settlement interval requirement for intertie transactions will facilitate the coordination of the scheduling and settlement of intertie transactions, and will discourage inefficient practices such as the chasing of inaccurate intertie prices. For example, if there are very high prices in the first fifteen minutes of an hour, resources will know that for that entire operating hour, there will be a high integrated hourly price. This provides an incentive for resources to increase the volume of intertie transactions for the remainder of the hour, even if the price for the subsequent fifteen-minute interval is much lower reflecting that it may no
89. However, a difference of opinion exists between PJM and the PJM Market Monitor. PJM supports moving to a five-minute settlement interval for intertie transactions while the PJM Market Monitor supports aligning the settlement interval for intertie transactions with the fifteen-minute scheduling interval for these transactions.
90. If an RTO/ISO settles or proposes to settle intertie transactions using a shorter time interval than by which it schedules such transactions, the RTO/ISO may propose to do so in its compliance filing and demonstrate that such a proposal is consistent with or superior to the Commission's intertie reforms. The compliance filing proceeding will provide a forum in which to consider alternative practices and resolve disputes that may arise within regions, as well as provide for the development of a more complete record on these issues.
91. We decline to clarify for CAISO that the availability of hourly block intertie bidding options would not violate the settlement interval requirement for interties. Such a determination is more appropriately made upon reviewing CAISO's compliance filing and CAISO should justify its proposed treatment for intertie transactions there.
92. Several commenters discuss the application of the settlement interval proposal to demand response resources even though the Commission did not specifically solicit those comments and did not make a separate proposal concerning demand response resources apart from other resources considered in the NOPR.
93. The PJM Market Monitor, with the New Jersey Board concurring, recommends that five-minute pricing in energy markets explicitly cover all resources providing energy, including demand side and storage resources.
94. Public Interest Organizations also urge the Commission to make clear that its proposed reforms apply to all resources able to participate in wholesale energy markets.
95. AEMA states that it recommends that demand response resources have the option to continue to settle on the basis of one-hour meter readings. AEMA asserts that demand resources use hourly intervals because only hourly interval metering may be available and even new advanced metering infrastructure is only capable of fifteen minute interval data, whereas settling on five-minute intervals could entail adding an expense that is an economic barrier to entry for some resources.
96. AEMA also states that few demand response resources have the operational communications to modify their demand at frequent intervals and that frequent demand changes would require more robust communications than may be economic.
97. AEMA explains that much of the current energy-related demand response participation relies on the commitment to dispatch for one or more hours and if the bid-offer is accepted for demand response resources, those resources are eligible for uplift payments if the energy prices fall below their bid-offer during their committed dispatch time. AEMA requests that these bid offer guarantees continue to be incorporated in the Final Rule.
98. In using the term “resource” in the NOPR, the Commission intended for the settlement interval proposal to apply to all supply resources, including demand response resources. We find that, as with other resources, aligning the price signal and dispatch signal provides demand response resources capable of following a given dispatch signal the incentive to do so, resulting in a more efficient use of demand response resources in the real-time energy and operating reserve markets. As stated above, all RTOs/ISOs have a combination of resources, some of which can respond within five minutes and some that cannot, and that includes demand response resources. It is important to provide a price signal to all resources, regardless of type or capability, as this will provide proper compensation to those resources capable of responding to five-minute dispatch signals, and will incentivize such capability to those resources that do not currently have it.
99. In response to concerns about the need to upgrade metering technology for demand response resources, we note that this Final Rule does not contemplate requiring any new metering capability, such as five-minute revenue quality metering, and that such metering is not necessary for implementation given RTOs'/ISOs' ability to create five-minute load and generation profiles using telemetry and hourly revenue quality data. We also do not require any changes to baseline methodologies. Although a more granular baseline may provide additional value, RTOs/ISOs need not change their baseline methodology to comply with this Final Rule. Finally, we find that AEMA's arguments regarding the Net Benefits Price Threshold
100. A number of commenters state the proposed rule did not specify whether the settlement interval proposal would apply to load,
101. EEI, PSEG, SCE, AEMA, EPSA and CAISO recommend that the Commission not apply the settlement reform to load.
102. PJM, however, states that it is advantageous to apply the proposed rule to load, and proposes to settle load on the same interval as dispatch intervals by using a combination of state-estimator and telemetry data for each settlement interval.
103. Mr. Centolella states that advancing load settlements to reflect the actual interval demand of each load serving entity's customers could remove an important barrier to developing the next generation of responsive demand. Mr. Centolella also encourages the Commission to work with states to optimize collecting customer data, and to evaluate how to support efficient price formation related to the load data used in wholesale settlements.
104. We clarify that the Commission did not propose to apply the settlement interval proposal to load. We also clarify that adoption of the settlement interval requirements are not intended to change how load is metered. The Commission's basis for requiring changes to the settlement interval focused exclusively on supply resources rather than load. As a result, we have no record to require any changes to the settlement interval for load. However, we are not prohibiting settling load on a five-minute basis, and will evaluate any such proposals on a case-by-case basis in separate proceedings submitted pursuant to section 205 of the FPA.
105. In the NOPR, the Commission stated that shortage prices send a short-term price signal to provide an incentive for the performance of existing resources and help to maintain reliability. The Commission noted that some RTOs/ISOs currently restrict the use of shortage pricing to certain causes of shortages, or some RTOs/ISOs require a shortage to exist for a minimum amount of time before triggering shortage pricing.
106. The Commission also noted that its rationale regarding shortage pricing was similar to the rationale the Commission relied on in Order No. 719, in which the Commission determined that “rules that do not allow for prices to rise sufficiently during an operating reserve shortage to allow supply to meet demand are unjust, unreasonable, and may be unduly discriminatory” and that such rules “may not produce prices that accurately reflect the value of energy.”
107. Commenters generally support the rationale provided by the Commission in support of the need for reform. For example, as discussed below, MISO, NYISO and ISO-NE all support the need for reform, and CAISO supports the conceptual need, but requests further clarifications. EEI and EPSA also support the Commission's shortage pricing proposal. Conversely, SPP and PJM, in joint comments, oppose implementing shortage pricing in all dispatch intervals, and request revisions if the Commission adopts its proposed reforms.
108. Based on analysis of the record, we adopt our preliminary findings and conclude that existing shortage pricing triggers that do not invoke shortage pricing when there is a shortage (regardless of duration or cause) are unjust and unreasonable and are unduly discriminatory and preferential. Thus, there is a need to reform the use of shortage pricing in RTO/ISO markets, as discussed further herein.
109. In order to remedy the potentially unjust and unreasonable rates caused by restrictions on shortage pricing, the Commission proposed to require that RTOs/ISOs institute mechanisms that trigger shortage pricing for any dispatch interval during which a shortage of energy or operating reserves occurs.
110. MISO states that it supports shortage pricing reform and maintains that MISO's current practices are already consistent with the Commission's proposal. Specifically, MISO states its operating reserve demand curve is used in the five-minute dispatch interval and triggers shortage pricing in any five-minute interval in which operating reserve requirements cannot be fully satisfied, regardless of duration or causation.
111. ISO-NE supports the shortage pricing proposal and asserts that its current market rules and real-time pricing systems already comply with the proposed requirement.
112. NYISO supports the shortage pricing proposal, and states that it uses demand curves to price all reserve shortages, regardless of their duration. NYISO adds that it currently implements shortage pricing in its day-ahead and real-time markets using various demand curves for operating reserves, regulating reserves, and transmission security, where the demand curves represent the escalating value of each product as the level of any shortage increases.
113. CAISO agrees with the concept behind the shortage pricing reform and supports its implementation, subject to certain clarifications. CAISO expects that its existing tariff provisions implementing scarcity pricing for energy and ancillary services already comply with the NOPR's proposal. CAISO explains that, in any fifteen-minute interval of the fifteen-minute market, it will co-optimize the procurement of energy and ancillary services based on submitted supply bids and the forecast of demand and its ancillary services requirements. CAISO further explains that, in any given fifteen-minute interval, if effective supply bids are insufficient to clear forecasted demand, scarcity pricing will trigger and thereby indicate a shortage of supply for that applicable fifteen-minute interval. CAISO states that, similarly, if ancillary services bids are not sufficient to meet the ancillary services procurement target, ancillary services scarcity pricing will trigger for that interval.
114. CAISO notes that within a fifteen-minute operating interval it may need to deploy operating reserves to address a contingency in the case of operating reserves, or in the case of regulation to continuously balance supply and demand. CAISO states that it is important that the Final Rule clarify that the deployment of operating reserves or regulation does not necessarily mean a shortage exists. CAISO notes that in some cases the deployment of reserves is made through alternative deployment mechanisms and not in the co-optimization function of the market.
115. PJM and SPP filed joint comments opposing triggering shortage pricing in any dispatch interval in which a shortage of energy or operating reserves occurs. First, PJM and SPP state that they support shortage pricing only when “a shortage of a particular product exists that presents reliability concerns.”
116. PJM and SPP further state that they have in place rules related to this issue consistent with the principles and goals of shortage pricing. PJM and SPP urge the Commission to provide flexibility by allowing RTOs/ISOs to implement shortage pricing in the context of their regional rules. This, PJM and SPP assert, will ensure that inefficient pricing does not result.
117. PJM and SPP argue that allowing transient periods of shortage to trigger shortage pricing could overstate the severity of the operating condition and result in prices that do not accurately reflect operating conditions on the system, or last long enough to allow market participants responding to them to take meaningful action. In fact, PJM and SPP assert that responses may occur after the relevant interval has passed, which could be counterproductive operationally and economically. PJM and SPP pose two examples to illustrate this point. As the first example, they posit: PJM carrying the required amount of reserves when a market seller of a generation resource lowers the resource's economic maximum capability, for a brief time (ten minutes or less), causing PJM to have less reserves than its requirement. Currently, PJM can recover these reserves by re-executing its dispatch engine and re-dispatching its system; but under the shortage pricing reform, this could invoke shortage pricing, which would then attract more suppliers than needed and create disincentives for resources to back down once the event was over. In another example, they posit: PJM has scheduled a resource with a ten-minute start-up time to come online to provide energy so that another resource may be reduced to provide reserves; but if the resource scheduled to come online actually takes twenty minutes instead of ten, shortage pricing would be triggered under the shortage pricing proposal, and the second resource, instead of having its output reduced to provide reserves would now need to continue to provide energy, thus potentially leaving PJM short on reserves for a brief period.
118. PJM and SPP introduce another hypothetical scenario from the SPP region. PJM and SPP state that SPP can temporarily use operating reserves to meet energy requirements during transient periods when system conditions do not present reliability concerns. PJM and SPP argue that while this may technically compromise the operating reserve requirement, the condition is transient and is recovered in less than ten minutes. According to PJM and SPP, this is not an operating reserve shortage, but rather a transient reallocation of capacity to manage temporary energy needs caused by the operational characteristics of resources. PJM and SPP further state that the examples described above do not present emergency conditions or
119. In order to “recognize and respect the fact that not all instances of shortages justify shortage pricing,” PJM and SPP propose alternative language for any Final Rule on shortage pricing:
Each RTO/ISO must establish tariff provisions that implement shortage pricing for pre-defined operating conditions related to a shortage of energy or operating reserves. The Commission will allow each RTO/ISO to develop those provisions based on their regional circumstances, provided that the rules are consistent with shortage pricing principles and are designed to facilitate the goals of this [Final Rule]. The Commission expects that each RTO/ISO will explain why their provisions, or why their current rules, comply with this rule.
120. PJM and SPP further assert that a universal shortage pricing rule requiring shortage pricing even for transient circumstances would require the implementation of operating reserve demand curves that distinguish prices relative to varying degrees of shortage. PJM and SPP explain further that in PJM's case, the current operating reserve demand curves are a step function, which would need to be changed, and in SPP's case it would likely consider the implementation of a pricing gradient demand curve based on different degrees of shortages and their impact on reliability, rather than steep step curves.
121. Potomac Economics explains that all the markets that it monitors (ISO-NE, NYISO, and MISO) are designed to price all shortages, regardless of duration.
122. Potomac Economics states that transitory shortages typically occur when the system is ramp-constrained, and that these are true shortages, because if a large contingency occurs during this period (
123. Potomac Economics also states that allowing offline resources to set real-time energy and ancillary services prices can be efficient, but there are also conditions under which the use of these resources can artificially lower energy prices and obscure shortages.
124. Potomac Economics recommends that the Commission require RTOs/ISOs to demonstrate that their real-time pricing models do not allow offline units to set prices in a manner that undermines its real-time shortage pricing. Potomac Economics believes that this can be demonstrated by the RTO/ISO describing how and when offline units set real-time prices and showing that when offline units have set price historically that they are generally committed and dispatched as well. Potomac Economics further asserts that if the RTOs/ISOs cannot demonstrate this in their compliance filing, then they may need to make changes to their pricing models to ensure that they satisfy the Commission's price formation goals.
125. The PJM Market Monitor states that five-minute shortage pricing would correctly reflect actual shortage conditions and should be implemented if PJM can accurately measure the level of reserves on a five-minute basis, which the PJM Market Monitor understands that PJM currently cannot do. The PJM Market Monitor asserts that, without accurate measurement of reserves at minute-by-minute granularity, system operators cannot know with certainty that a shortage condition exists, thus masking the trigger for five-minute shortage pricing. The PJM Market Monitor recommends that if PJM cannot measure operating reserves on a five-minute basis, the Commission should direct PJM to develop methods to do so. The PJM Market Monitor asserts that if RTOs/ISOs cannot demonstrate that they can accurately measure reserves at minute-by-minute granularity, they should not implement five-minute shortage pricing until they have that capability.
126. The SPP Market Monitor supports the Commission's proposal to require RTOs/ISOs to trigger shortage pricing for any dispatch interval during which a shortage of energy and operating reserves occurs. The SPP Market Monitor states that SPP's Integrated Marketplace uses administratively-determined scarcity pricing demand curves to set prices during capacity shortages. The SPP Market Monitor explains that, during shortages, quick-start and fast-ramping resources—which generally have higher costs and low capacity factors—earn a significant portion of their annual revenue. The SPP Market Monitor asserts that scarcity pricing serves as an important mechanism for sending correct price signals to these resources; however, the SPP Market Monitor states that SPP is not sending this price signal during ramp-constrained operating reserve shortages since the SPP market rules do not allow insufficient ramping capability to trigger scarcity pricing of operating reserves.
127. Several other commenters express support for shortage pricing reform. These commenters agree that the proposed shortage pricing reform will increase transparency, create incentives to trigger quick response from supply, promote investment in resources that
128. Several commenters support the Commission's shortage pricing proposal, arguing that market clearing prices should reflect shortage or emergency situations so that generators are provided transparent price signals that reflect the market conditions.
129. Some commenters state that the shortage pricing proposal will provide an incentive for existing resources to offer their supply and to be available if shortages occur and will provide an incentive for incremental investments to enable existing or new generation or dispatchable demand to respond to shortages, regardless of duration.
130. ANGA states that while a shortage may be transient and last only a single five-minute interval, some resources are able to move quickly enough to meet these shifts in demand and, hence, reduce overall system instability. Further, ANGA maintains, allowing prices to respond to these small shortages also sends a long-term price signal to the market, highlighting where and what types of resources are needed on the system, which improves overall system reliability. ANGA also agrees with EPSA's position, recorded in the NOPR, that all markets should prioritize establishing shortage pricing based on operating reserve demand curves and co-optimized with the energy market. ANGA states that this is a least-cost solution and recommends that the Commission direct the RTOs/ISOs to include in their compliance filing a plan for modifying their rules, to the extent necessary, to include these features in both the day-ahead and real-time markets.
131. Powerex supports the Commission's proposal to require RTOs/ISOs to apply shortage pricing for any dispatch interval during which a shortage of energy or operating reserves occurs.
132. EDP Renewables states that the Commission's shortage pricing proposal would result in more accurate price signals than under existing market rules, and therefore would encourage greater investment in new production and storage technologies with the ability to respond quickly to shortages.
133. Exelon and Inertia Power assert that implementing shortage pricing for any interval during which a shortage could occur will provide the right incentives for generating resources and will promote adequate incentives for resource adequacy. Exelon and Inertia Power state that it is economically more efficient for prices to reflect the value of the marginal resource during shortage periods, and that this is particularly true in instances where generation resources must compete with alternatives, such as exporting power to a neighboring market or not consuming a scarce fuel.
134. PSEG states that it supports the shortage pricing proposal, that the proposal would address concerns about transparency, and that it would accomplish Order No. 719's objective of enhancing market efficiency by establishing a price that reflects the value of the loss of load and encourage resources to respond to shortage events.
135. Golden Spread supports the Commission's proposed shortage pricing reform and argues that even the smallest amount of operating reserve and energy shortage should be reflected in scarcity pricing.
136. DTE states that, as a member of MISO, it has largely supported the changes MISO has made through ELMP to ensure that generators are provided
137. Several commenters propose changes to the shortage pricing reform, or identify implementation issues in specific RTOs/ISOs.
138. Golden Spread, for example, states that the current SPP rules allow the temporary use of operating reserves to meet energy requirements during transient periods without invoking shortage pricing; in other words, SPP's rules encourage “price manipulation” undermining the transparency needed to incentivize longer term economic and reliable solutions.
139. Golden Spread identifies examples of issues with certain SPP processes that it argues need to be addressed to comply with this reform and provides the following recommendations to resolve them: (1) Relax constraints to allow economic dispatch to solve when there is a resource capacity constraint, global power balance constraint, resource ramp constraint or operating constraint;
140. ELCON states that the shortage pricing proposal should be adopted only if the Commission promotes the development of technology-neutral fast-ramp products paid to provide the specific shortage service, and for which compensation would not inflate real-time LMPs.
141. Several commenters oppose the shortage pricing proposal. Several commenters argue that while the NOPR does not address the price level of the shortage pricing, to the extent that RTOs/ISOs do change shortage pricing triggers, the RTOs/ISOs should also evaluate whether shortage pricing levels remain just and reasonable.
142. APPA and NRECA assert that it is important to understand how various resource types would respond to price signals created by the shortage pricing proposal. Specifically, they assert that the NOPR did not discuss whether a five-minute shortage pricing event would produce a sufficient response or only reflect a transient shortage resolvable without resorting to shortage pricing.
143. APPA and NRECA question the extent to which shortage pricing would improve short-term system efficiency. They comment that existing variations among RTOs/ISOs in shortage pricing approaches create an opportunity to analyze the efficacy of more frequent shortage events. They request that the Commission direct the RTOs/ISOs to provide evidence or examine whether the theoretical benefits of the shortage pricing proposal can be validated with actual resource decisions. APPA and NRECA caution that, without such analysis, entities, such as generators already online that cannot easily ramp up or down or financial marketers, could benefit financially without contributing to system efficiency.
144. On the topic of long-term incentives, several commenters assert that no evidence exists that price signals as volatile and transient as shortage prices would be the basis for capital investments, whether to improve flexibility, whether to delay or avoid retirements, and especially not for the construction of new resources. APPA and NRECA assert that, even with a slight uptick in merchant plant construction compared to prior years, 95 percent of new construction was built under contract in 2014, and 98 percent of new construction was built under contract in 2013.
145. Concerned Cooperatives contend that the RTOs/ISOs could develop better products, such as a fast-ramping product, that could encourage investment in more flexible resources without having to pay every resource a high price during shortage intervals of short duration.
146. ODEC states that, in the example provided by PJM, if a unit is slow in coming online for a five-minute interval, it is not clear that shortage pricing would not over-compensate a resource, or if supply can even respond to such a short-term event in sufficient time for the price signal to create an incentive to change behavior. ODEC states that it therefore believes that shortage pricing during transient shortages may be unjust and unreasonable because it will increase prices paid by load without corresponding benefits.
147. APPA and NRECA also express concern that more frequent shortage pricing creates incentives to exercise market power and game market rules due to the potential for higher energy and operating reserve prices. They assert that if the proposal moves forward, each RTO/ISO should be required to reevaluate its market power mitigation rules and propose new or additional mitigation measures if necessary.
148. Concerned Cooperatives also argue that if the Commission issues a final rule in this proceeding, RTOs/ISOs must be required to demonstrate that their shortage pricing mechanisms comply with four overarching principles, by providing for (1) prices that reflect the marginal costs of meeting the shortage; (2) a cap that is designed to mitigate adverse financial impacts on parties who are short; (3) prices that escalate with greater levels of shortage, because marginal costs will vary by shortage; and (4) a mechanism to ensure that revenues earned through shortage pricing are not duplicated by capacity market revenues.
149. The New Jersey Board urges the Commission to allow PJM to retain its current shortage pricing mechanism—a thirty-minute look-ahead dispatch algorithm that identifies reserve shortages as only those lasting a minimum of thirty minutes. The New Jersey Board agrees with PJM that five-minute shortfalls are not necessarily symptomatic of system stress, but are merely transient shortfalls that can be quickly addressed through system re-dispatch.
150. More broadly, TAPS argues that any price signal during transient scarcity events is meaningless because resources cannot respond in time to the higher prices.
151. Regarding definitions, Direct Energy asserts that a true shortage implies that insufficient capacity exists on an RTO's/ISO's system to meet energy and reserve requirements. In contrast, Direct Energy argues, transient shortage conditions are not true shortages because they simply reflect the operating characteristics of the generators being used to meet energy and reserve targets. Direct Energy argues that in a transient shortage condition, the RTO/ISO has the capacity to meet energy and reserve requirements and the transient shortage period represents the period of time it takes to deploy generation resources to meet those targets.
152. Direct Energy claims the response an RTO/ISO receives based on the shortage pricing signals sent during transient shortage conditions is likely to cause a control issue when generation already being ramped through RTO/ISO dispatch to resolve the shortage condition hits its dispatch targets. Further, Direct Energy argues unjust and unreasonably higher prices would result from targeting “transient” shortages because of the impact of shortage pricing penalty factors in transient shortage circumstances, because the shortage pricing reserve penalty factors would be applied to a marginal unit providing energy that is not the highest opportunity cost reserve unit. Thus, Direct Energy argues the Commission should either revise its proposal to reflect issues with transient shortages of operating reserves, or permit individual RTOs/ISOs to evaluate this proposal and consider tariff revisions to address true shortages and to send appropriate price signals.
153. Concerned Cooperatives and APPA and NRECA argue that the NOPR does not account for differences among the RTOs/ISOs, maintaining that shortage pricing issues should be resolved through individual stakeholder processes.
154. Concerned Cooperatives also note that the NOPR fails to provide a comparison of the market design in RTO/ISO-administered markets that trigger shortage pricing for a shortage event of any duration and those that use longer duration events as the trigger.
155. Several commenters point to various efforts in RTOs/ISOs that may impact shortage pricing. Concerned Cooperatives argue that the Commission should not address price formation issues in a piecemeal fashion, as changes to one element will impact the
156. The New Jersey Board, APPA and NRECA and ODEC all acknowledge PJM's Capacity Performance Program
157. Concerned Cooperatives note that the NOPR fails to identify the number of additional shortages that would be triggered in RTO/ISO markets that do not invoke shortage pricing for a single settlement interval. They argue that the NOPR also fails to quantify what that cost might potentially be for consumers, particularly in PJM, which recently sought to increase its energy offer caps to $2,000 per MWh which could produce LMPs of $3,700 per MWh during shortage events. Concerned Cooperatives state that the NOPR provides no evidence that prices at this level are just and reasonable for a five-minute shortage where a resource cannot respond and/or the event is triggered by an artificial shortage.
158. PG&E urges the Commission to examine transient shortages and their attendant price spikes, and resolve modeling issues that are causing these shortages. PG&E understands that shortage pricing might be appropriate to the extent that such pricing provides a meaningful price signal to resources. However, PG&E argues that most price spikes in the CAISO over the past five years have been so short that they have not provided a meaningful opportunity for resources to respond.
159. PG&E notes that CAISO is already taking significant steps to address modeling issues that create transient shortages and attendant transient price spikes. For example, PG&E states that CAISO is working to augment the real-time dispatch function with a Flexible Ramping Product which will help avoid ramp-induced shortages that cause scarcity conditions in real-time. PG&E also explains that CAISO is considering applying different penalty prices for infeasibilities depending on the level of constraint relaxation, which will more appropriately reflect the cost of constraint violations. PG&E asserts that a small violation of the power balance constraint may be covered by deploying regulation reserves at a smaller cost per megawatt-hour than a larger violation, which may require more costly load shedding.
160. Dominion states that it is concerned that some shortages are merely transient in nature due to slight differences in modeling and the ramping of generation, and may not warrant sending a shortage price signal to the market. Dominion argues that issues regarding transient shortages should be addressed prior to implementation of the proposed reforms.
161. For the reasons discussed below, we adopt the NOPR shortage pricing proposal and modify the regulatory text to clarify that shortage pricing is required only when a shortage of energy or operating reserves is indicated by the RTO's/ISO's software.
162. Specifically, we require each RTO/ISO to trigger shortage pricing for any interval in which a shortage of energy or operating reserves is indicated during the pricing of resources for that interval. As stated in the NOPR, the shortage pricing requirement should “ensure that a resource is compensated based on a price that reflects the value of the service the resource provides.”
163. We find that the shortage pricing requirement will help ensure that prices rise sufficiently and appropriately to allow supply to meet demand during an operating reserve shortage, and thus will more accurately reflect the value a
164. As for incentives to follow dispatch, as noted in the NOPR, if a resource is compensated based on a price that reflects the value of the service the resource provides, the resource will have appropriate incentives to address energy or reserve shortages. As explained by Potomac Economics, the higher prices (relative to non-shortage price intervals) resulting from the shortage pricing proposal will enhance resource flexibility by leading to: (1) Faster resource ramp rates; (2) wider dispatch ranges and not self-scheduling resources; (3) shorter start times for natural gas turbines; and (4) an incentive to build more flexible, fast-ramping generating resources and to perform maintenance on existing resources that increases their flexibility.
165. A number of commenters cite the role of appropriate shortage pricing in creating an incentive for market participants to make investments that will alleviate shortages in the future.
166. With regard to transparency, an RTO's/ISO's action to establish prices at the times of shortage, including transient shortages, makes the shortage apparent to all market participants. This maximizes the opportunities and incentives for all system resources to take actions to address the shortage.
167. In response to commenters like CAISO, we clarify that we did not intend to impose shortage pricing if a shortage occurs during an interval for which the prices and dispatch decisions have already been set. We did not intend that, for example,
168. Also, the shortage pricing proposal did not intend to require any changes to existing pricing methods, such as ELMP in MISO that allows offline resources to set energy prices, and we agree that the use of offline resources can result in efficient pricing.
169. In opposing the proposal, PJM and SPP argue that an energy or operating reserve shortage that the RTO/ISO expects to be resolved quickly (
170. We disagree that an energy or operating reserve shortage that the RTO/ISO expects to be resolved quickly should not trigger shortage pricing. Such a shortage presents exactly the type of mismatch between system conditions and pricing that the reform was meant to remedy. Thus, by adopting the proposed shortage pricing reform, we require PJM and SPP to modify their existing shortage pricing mechanisms.
171. As summarized above, PJM and SPP provide three hypothetical situations in their joint comments to describe situations where they argue shortage pricing should not apply.
172. PJM, SPP, and Direct Energy have also not shown that applying shortage pricing to transient shortages will create control issues and increase uplift.
173. PJM and SPP state that application of the shortage pricing reform to transient shortages would likely require the implementation of operating reserve demand curves that distinguish prices relative to varying degrees of shortage.
174. We disagree with TAPS, Concerned Cooperatives, APPA, and NRECA that the only effect of requiring RTOs/ISOs to trigger shortage prices in transient events is to provide extra revenue to generators already in the market.
175. We disagree with the views of those commenters
176. TAPS recommends that the Commission direct each RTO/ISO to propose new shortage prices for transient shortages that do not exceed the value of the incremental benefit (if any) provided by an additional megawatt in those circumstances, or to demonstrate that the RTO's/ISO's existing shortage prices applicable in such circumstances already meet that standard.
177. The PJM Market Monitor identifies an implementation issue, which may be unique to PJM. The PJM Market Monitor asserts that PJM cannot accurately measure the actual level of operating reserves on a five-minute basis. To address this, the PJM Market Monitor and the New Jersey Board recommend that the Commission direct PJM to develop this measurement capability before it implements the shortage pricing proposal.
178. Concerned Cooperatives maintains that the shortage pricing proposal may not achieve the price formation objective of increased transparency because generators may not be capable of responding fast enough to shortage pricing triggered during transient events.
179. Concerned Cooperatives, ODEC, ELCON, and PG&E suggest that the Commission should not adopt the shortage pricing proposal because other initiatives, such as PJM's Reliability Pricing Model modifications and fast ramping products, already provide adequate incentives for resource performance and send the signals needed for generation investment.
180. Concerned Cooperatives express concern that the Commission does not require the RTOs/ISOs to include, in their compliance filings, an analysis to ensure that consumers remain protected against the exercise of market power when the proposed reforms are implemented.
181. In the NOPR, the Commission proposed that RTOs/ISOs submit compliance filings on both the proposed settlement reform and the proposed shortage pricing reform four months from the effective date of the Final Rule; that the proposed settlement reform become effective twelve months from the date of the compliance filings for implementation of reforms to settlement systems; and that the shortage pricing proposal become effective four months from the date of the compliance filings for implementation of reforms to shortage pricing triggers.
182. As described below, some commenters sought more time to submit compliance filings and questioned (1) whether the Commission provided enough time to implement the settlement proposal; and (2) whether the Commission should extend implementation of the shortage pricing proposal to allow for simultaneous implementation of shortage pricing proposal with the settlement proposal.
183. The ISO/RTO Council argues that the Commission should not force the RTOs/ISOs to substantially reform their existing market structure to comply with the shortage pricing proposal.
184. ISO-NE supports the implementation timeline for the shortage pricing proposal because it believes that its market already meets the NOPR proposal.
185. MISO states that it already has a project in progress to replace the current software systems that perform market and transmission settlements processing,
186. PJM asserts that it can make a compliance filing four months after the date of the Final Rule, but is concerned that insufficient time was suggested for implementation.
187. CAISO also states that, depending upon the specifics of the Final Rule, extra time may be necessary for a complete compliance filing.
188. Several commenters urge flexibility in the implementation timelines.
189. NEPOOL, Golden Spread, and TAPS echo the statements of EEI,
190. Although TAPS argues against the proposed shortage pricing rule, it states that if the rule is adopted, then needed administrative shortage pricing level modifications should become effective when other shortage pricing modifications become effective.
191. Some commenters commented on the amount of time allowed to submit a compliance filing. With regard to the settlement interval proposal, Concerned Cooperatives state that because it could take over a year to determine what market rules may need modification and to subsequently implement those changes, the Commission should require a compliance filing after one year so that RTOs/ISOs can discuss implementation issues with stakeholders.
192. PSEG states that, in markets where the current equipment can be utilized, the twelve-month implementation timeline proposed by the NOPR would be reasonable.
193. ODEC asserts that, instead of requiring implementation within twelve months of the compliance filings, if the Commission determines PJM must settle resources at the same interval those resources are dispatched, then the Commission should require each RTO/ISO to submit a proposed plan for compliance and implementation of the Final Rule.
194. Exelon maintains that the implementation period for the five-minute settlement interval proposal should be 18 months because of the equipment changes that will be necessary for generators in the RTOs/ISOs that do not currently use five-minute pricing.
195. Ameren argues the timeline proposed in the NOPR is too short and could potentially increase both costs and risks to the detriment of their customers.
196. Dominion and IPL point out that implementation timing and specifics for market participants will depend upon when the RTOs/ISOs finalize their own implementation details, and it argues that the proposed twelve-month implementation period for settlement interval reforms does not appropriately take this factor into account.
197. DTE states that it would need a minimum of eighteen months and “several million dollars” to implement necessary changes to its settlement system,
198. APPA and NRECA request that RTOs/ISOs ensure all market participants either have the necessary metering and billing systems in place or have sufficient time to add required systems.
199. Only one entity, Direct Energy, requested an indefinite delay of implementation: Specifically, for the five-minute settlement proposal, arguing that the underlying technology of many supply resources is not advanced enough to ensure the efficiency the Commission states it seeks in the NOPR.
200. Some commenters argue that the Commission should synchronize implementation of the shortage pricing reform with the settlement interval proposal due to their interrelated nature.
201. In the NOPR, the Commission noted that while adopting the proposed reforms might provide significant benefits, implementing and modifying settlement systems can be complex and costly.
202. While the NOPR did not propose that a cost-benefit analysis must be performed in conjunction with the proposed reforms, some commenters discuss whether a formal cost-benefit analysis is necessary prior to implementation of the proposals. APPA and NRECA, Concerned Cooperatives, Ameren, and IPL claim that a cost-benefit analysis is necessary before implementation.
203. Some commenters opine on how they perceive the costs relate to the benefits of the proposed reforms. Duke expresses concerns that the costs of aligning dispatch and settlement intervals will exceed the benefits. Duke acknowledges that the potential impact of these reforms is not currently knowable, given that MISO and PJM have not proposed new market rules and system changes.
204. Because the reforms required in this Final Rule are targeted and specific, we believe RTOs/ISOs will have sufficient time to develop and file tariff changes to adopt these limited reforms, contrary to the concerns of commenters such as Concerned Cooperatives and TAPS. In the NOPR, the Commission recognized that implementation of the settlement reform could take up to a year after the compliance filings were submitted.
205. Of the entities required to submit a compliance filing, PJM, MISO, and ISO-NE either support the compliance deadline or believe that they can meet the compliance deadline once a Final Rule is published in the
206. As previously noted, comments on the implementation schedule focused on two areas: (1) Whether the Commission provided enough time to implement the settlement reform proposal; and (2) whether the Commission should extend implementation of the shortage pricing reform proposal to allow for simultaneous implementation of shortage pricing with settlement reform. Based upon the comments received, we retain the current implementation schedule, but will consider requests for extensions of time to extend the implementation dates when the RTOs/ISOs submit their compliance filings. The RTOs/ISOs will have had 120 days as they prepare their compliance filings to assess the feasibility of implementing the reforms set forth in this Final Rule. It is premature at this time to extend the implementation timelines when affected parties are only just starting to analyze what actions they must take in order to implement the requirements of the Final Rule.
207. Moreover, when the RTOs/ISOs submit their respective compliance filings, we will consider whether it is appropriate to permit the RTO/ISO to synchronize implementation of shortage pricing with the settlement interval based upon the facts presented at that time. We expect that any RTO/ISO seeking to synchronize shortage pricing with the settlement interval will set forth compelling reasons as to why it is necessary based upon the unique nature of the RTO/ISO.
208. We will not dictate how RTOs/ISOs must implement the reforms set forth in the Final Rule from a technical perspective. Nevertheless, we recommend that wherever possible, the RTO/ISO should consider using existing metering equipment and current data collection processes, such as the process currently being explored by PJM.
209. With regard to the comments concerning the costs of implementing the NOPR proposals, we find that some of these costs appear to be overstated, taken as a whole. For example, PJM's use of its state estimator and telemetry may reduce, if not eliminate, the need for new five-minute revenue quality meters; and it is unclear, in the case of the Concerned Cooperatives, why costs equal to several more full-time employees would need to be incurred on an annual basis as a result of the NOPR reform. In any event, we find that the value of the benefits of more accurate pricing under the proposed rule described in the NOPR, as recognized by the vast majority of commenters in this proceeding, and the net present value of the future increases in market surplus, although difficult to quantify with precision, are likely to outweigh any one-time implementation costs.
210. We reject the proposal to require RTOs/ISOs to conduct a cost-benefit analysis before implementing the settlement reform.
211. Commenters raised issues that are not discussed above and that are outside of the scope of this rulemaking. EPSA states that the Commission and RTOs/ISOs must move expeditiously on the reforms proposed in the NOPR as well as others identified in the price formation proceeding that encourage economically efficient decisions about resource entry and exit.
212. PJM Power Providers and Exelon urge the Commission to focus on reducing uplift and remedying its causes as well as market power mitigation, operator actions, and other issues.
213. ELCON, Westar, TAPS, and Inertia Power and DC Energy recognize the interconnected nature of the issues in the price formation proceeding. ELCON urges the Commission to consolidate any additional price formation proposals into a single NOPR.
214. EEI and EPSA reiterate their prior comments regarding common principles that should guide the discussion of price formation: (1) Dispatch-based pricing; (2) efficient commitment that will provide accurate day-ahead and real-time price signals; and (3) transparency with regard to out-of-market actions and payments.
215. Westar requests that the Commission encourage RTOs/ISOs to clarify what costs may constitute marginal costs.
216. Financial Marketers Coalition and XO Energy assert that while the NOPR addresses settlement intervals for generation (supply), similar reforms are needed for the intervals in which load is forecasted, bid and settled in order to eliminate the mismatch between generation and load.
217. Entergy Nuclear Power Marketing and NEI state that although the reforms proposed in the NOPR will improve price formation for resources operating in real-time, they will not improve the outlook for baseload resources such as nuclear plants typically fully committed in the day-ahead market.
218. NEI recommends various changes to price formation to better ensure that the market clearing price reflects all of the costs associated with reliably providing service to the market.
219. With respect to other issues, DTE requests clarification from the Commission that market participants will not have to change the manner in which they currently net purchases and sales for purposes of FERC Form No. 1.
220. Referencing the NOPR's discussion of the role that look-ahead tools can play in mitigating seemingly artificial shortages, the SPP Market Monitor also requests the Commission clarify that look-ahead models incorporate administrative pricing in their least cost evaluation before choosing unit commitments to relieve shortages.
221. Powerex argues that further Commission action is necessary to ensure that RTOs/ISOs refrain from using more general tariff provisions and non-tariff protocols, including out-of-market procurement and other operator interventions, to prevent shortage pricing from being triggered or otherwise prevent scarcity from being reflected in market prices.
222. Dominion questions if the proposed settlement reforms require further consideration of the interactions between the day-ahead and real-time markets. Specifically, Dominion suggests that changes may be necessary to how the RTOs/ISOs calculate generator deviations in the real-time market from their day-ahead schedules.
223. ESA requests that the Commission consider five-minute scheduling once it implements five-minute intervals to better access the greater operational flexibility of fast-ramping resources like energy storage.
224. Powerex requests that the Commission require each RTO/ISO to: (1) Identify all out-of-market actions or procurement tools that it uses, or is authorized to use, to manage its system; and (2) propose tariff amendments to ensure that these actions are appropriately reflected in prices or, alternatively, demonstrate that its existing tariff provisions already achieve such a result.
225. Appian Way states that the instant proposals encompassed by this NOPR are insufficient to ensure proper shortage pricing. Appian Way adds that some RTOs/ISOs will continue to have defective pricing unless and until the Commission requires them to establish pricing rules that ensure prices rise to scarcity levels when shortage conditions occur that require the RTO/ISO to call
226. Inertia Power and DC Energy state that when operating reserves and other ancillary services are priced “out of market,” it prevents the triggering of shortage pricing and circumvents the intent of the NOPR.
227. Potomac Economics states that the Commission's focus on shortage pricing should extend to transmission shortages.
228. Public Interest Organizations state that if the Commission carries out the shortage pricing proposal as set forth in the NOPR, it should simultaneously ensure that demand-side resources can respond to those prices to reduce the potential for unjust and unreasonable rates.
229. Mr. Lively maintains that shortages should be viewed as a continuum, not as a shortage versus non-shortage issue. Mr. Lively cites a paper he wrote that discusses using Area Control Error (ACE) in a pricing mechanism to adjust the nominal price of electricity to determine a settlement price.
230. We appreciate the concerns raised by numerous commenters requesting that the Commission undertake various initiatives, as set forth above. However, we find that the requested initiatives go beyond the scope of this rulemaking. Many of the issues raised by commenters may be relevant in other price formation proceedings,
231. The Paperwork Reduction Act (PRA)
232. In this Final Rule, we are amending the Commission's regulations to improve the operation of organized wholesale electric power markets operated by RTOs and ISOs. We require that each RTO/ISO align settlement and dispatch intervals by: (1) Settling energy transactions in its real-time markets at the same time interval it dispatches energy; (2) settling operating reserves transactions in its real-time markets at the same time interval it prices operating reserves; and (3) settling intertie transactions in the same time interval it schedules intertie transactions. We also require that each RTO/ISO trigger shortage pricing for any interval that prices both energy and operating reserves in which a shortage of energy or operating reserves is indicated during the pricing of resources for that interval. The reforms required in this Final Rule require a one-time tariff filing due 120 days after the effective date of this Final Rule. With regard to those RTOs/ISOs that believe that they already comply with the reforms required here, they can demonstrate their compliance in their compliance filing. The Commission will submit the proposed reporting requirements to OMB for its review and approval under section 3507(d) of the Paperwork Reduction Act.
233. Although the Commission stated in the NOPR that it expects the adoption of the reforms proposed to provide significant benefits,
234. The Commission received responses regarding the costs of implementing the reforms described in the NOPR;
Legal (code 23-0000), $128.94
Computer and Mathematical (code 15-0000), $60.54
Information Security Analyst (code 15-1122), $57.99
Accountant and Auditor (code 13-2011), $53.78
Information and Record Clerk (code 43-4199), $37.69
Electrical Engineer (code 17-2071), $64.20
Economist (code 19-3011), $74.43
Computer and Information Systems Manager (code 11-3021), $91.63
Management (code 11-0000), $88.94
The average hourly cost (salary plus benefits), weighting all of these skill sets evenly, is $73.13. For the calculations here, the Commission rounds it to $73 per hour.
235. Interested persons may obtain information on the reporting requirements by contacting the following: Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426 [Attention: Ellen Brown, Office of the Executive Director], email:
236. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
237. The Regulatory Flexibility Act of 1980 (RFA)
238. This rule applies to six RTOs/ISOs (all of which are transmission organizations). The three RTOs/ISOs that do not currently align real-time settlement with dispatch intervals will have to incur a one-time cost to upgrade their hardware and software. These enhancements will be needed to allow the RTOs/ISOs to process settlement data on a more granular level. That one-time cost (spread over Years 1 and 2) for hardware and software for each of those three RTOs/ISOs is estimated to be an average of $3 million (a total of $9 million for those three RTOs/ISOs). The average estimated burden cost (one-time in Year 1) to each of the RTOs/ISOs is $8,760 (total of $52,560 for all six RTOs/ISOs). Therefore the estimated total cost (burden, hardware, and software) over Years 1 and 2 for all six RTOs/ISOs is $9,052,560.
239. The RTOs/ISOs, however, are not small entities, as defined by the RFA.
240. In addition to publishing the full text of this document in the
241. From FERC's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
242. User assistance is available for eLibrary and the FERC's Web site during normal business hours from FERC Online Support at (202) 502-6652 (toll free at 1-866-208-3676) or email at
243. These regulations are effective September 13, 2016. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996.
Electric power rates, Electric utilities, Reporting and recordkeeping requirements.
By the Commission.
In consideration of the foregoing, the Commission amends part 35, chapter I, title 18,
16 U.S.C. 791a-825r, 2601-2645; 31 U.S.C. 9701; 42 U.S.C. 7101-7352.
(g) * * *
(1) * * *
(iv) * * *
(A) Each Commission-approved independent system operator and regional transmission organization must modify its market rules to allow the market-clearing price during periods of operating reserve shortage to reach a level that rebalances supply and demand so as to maintain reliability while providing sufficient provisions for mitigating market power. Each Commission-approved independent system operator and regional transmission organization must trigger shortage pricing for any interval in which a shortage of energy or operating reserves is indicated during the pricing of resources for that interval.
(vi)
The following is a list of the entities that filed comments in this proceeding, along with the short name/acronym used in this Final Rule. Unless otherwise noted, all comments were submitted on November 30, 2015.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA or Agency) is issuing this proposed rule to amend the 1994 tentative final monograph or proposed rule (the 1994 TFM) for over-the-counter (OTC) antiseptic drug products. In this proposed rule, we are proposing to establish conditions under which OTC consumer antiseptic products intended for use without water (referred to throughout as consumer antiseptic rubs or consumer rubs) are generally recognized as safe and generally recognized as effective (GRAS/GRAE). In the 1994 TFM, certain antiseptic active ingredients were proposed as being GRAS for antiseptic rub use by consumers based on safety data evaluated by FDA as part of its ongoing review of OTC antiseptic drug products. However, in light of more recent scientific developments and changes in the use patterns of these products, we are now proposing that additional safety data are necessary to support the safety of antiseptic active ingredients for this use. We also are proposing that all consumer antiseptic rub active ingredients have in vitro data characterizing the ingredient's antimicrobial properties and in vivo clinical simulation studies showing that specified log reductions in the amount of certain bacteria are achieved using the ingredient.
Submit electronic or written comments by December 27, 2016. See section IX of this document for the proposed effective date of a final rule based on this proposed rule.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”). We note however, that the OTC drug monograph process is a public process; and, the Agency intends to consider only non-confidential material that is submitted to the docket for this rulemaking or that is otherwise publicly available in evaluating if a relevant ingredient is GRAS/GRAE.
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Anita Kumar, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5445, Silver Spring, MD 20993, 301-796-1032.
FDA is proposing to amend the 1994 TFM for OTC antiseptic drug products that published in the
FDA is proposing to establish new conditions under which active ingredients used in OTC consumer antiseptic products intended to be used without water are GRAS/GRAE based on FDA's reevaluation of the safety and effectiveness data requirements proposed in the 1994 TFM for what were then referred to as antiseptic hand washes (which included the products we refer to in this document as consumer antiseptic rubs or consumer rubs). We are conducting this reevaluation based on the comments received, input from subsequent public meetings, and our independent evaluation of other relevant scientific information we have identified and placed in the docket. This proposed rule applies to active ingredients used in consumer antiseptic rub products that are sometimes referred to as rubs, leave-on products, or hand “sanitizers,” as well as to consumer antiseptic wipes. These products are intended to be used when soap and water are not available, and are left on and not rinsed off with water. We will refer to them here as consumer antiseptic rubs or consumer rubs. In separate rulemakings (78 FR 76444, December 17, 2013; 80 FR 25166, May 1, 2015), we proposed conditions under which OTC consumer antiseptic washes and OTC antiseptics intended for use by health care professionals in a hospital setting or other health care situation outside the hospital are GRAS/GRAE. Those antiseptic products are not addressed in this proposed rule.
We are proposing that additional safety and effectiveness data are necessary to support a GRAS/GRAE determination for OTC antiseptic rub active ingredients intended for use by consumers. The effectiveness data, the safety data, and the effect on the previously proposed classification of active ingredients are described briefly in this summary. Because no ingredients currently meet the criteria for a GRAS/GRAE determination in this proposed rule, this rulemaking does not specifically address requirements for anticipated final formulation testing (
A determination that a drug product containing a particular active ingredient would be GRAE for a particular intended use requires consideration of the benefit-to-risk ratio for the drug under the specified conditions of use. New information on potential risks posed by the use of certain consumer antiseptic products, as well as input from the Nonprescription Drugs Advisory Committee (NDAC) that met in March 2005 (the March 2005 NDAC) and October 2005 (the October 2005 NDAC), has prompted us to reevaluate the data needed for classifying active ingredients used in consumer rubs as GRAE. The reevaluation of effectiveness will help to ensure that the level of effectiveness achieved is adequate to offset newly identified safety concerns (see new information described in the safety section of this executive summary). We continue to propose the use of surrogate endpoints (bacterial log reductions) as a demonstration of effectiveness for consumer antiseptic rubs combined with in vitro testing to characterize the antimicrobial activity of the ingredient. However, the log reductions required for the demonstration of effectiveness for consumer rubs have been revised based on the recommendations of the March 2005 and October 2005 NDAC meetings, comments received after the 1994 TFM, and other information we reviewed.
We have evaluated the available literature, the data, and other information that were submitted to the rulemaking on the effectiveness of consumer rub active ingredients, as well as the recommendations from the public meetings held by the Agency on antiseptics. We propose that the record contain additional log reduction data to demonstrate the effectiveness of consumer rub active ingredients. We are also asking for data and information to be submitted about the impact of product use factors (such as volume of product per application) on efficacy to help inform labeling and requirements for final formulation testing.
Several important scientific developments that affect the safety evaluation of consumer rub active ingredients have occurred since FDA's 1994 evaluation of the safety of these active ingredients under the OTC Drug Review. Improved analytical methods now exist that can detect and more accurately measure these active ingredients at lower levels in the bloodstream and tissue. Consequently, we now know that, at least for certain consumer antiseptic rub ingredients, systemic exposure is higher than previously thought (Refs. 1 through 5), and new information is available about the potential risks from systemic absorption and long-term exposure. These data are particularly important given the increased use of consumer antiseptic rubs since the publication of
The previously proposed GRAS determinations were based on safety principles that have since evolved significantly because of advances in technology, development of new test methods, and experience with performing test methods. The standard battery of tests that were used to determine the safety of drugs has changed over time to incorporate improvements in safety testing. To ensure that consumer antiseptic rub active ingredients are GRAS, data that meet current safety standards are needed.
Based on these developments, we are now proposing that additional safety data are needed for each consumer antiseptic rub active ingredient to support a GRAS classification. The data described in this proposed rule are the minimum data necessary to establish the safety of antiseptic active ingredients used in consumer antiseptic rub products in light of the new safety information. Consumers may use antiseptic rubs on a daily, long-term (
Three active ingredients are being evaluated for use as a consumer antiseptic rub in this proposed rule: Alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride (sometimes referred to as ADBAC). As part of this proposed rule, FDA evaluated new data submitted after publication of the 1994 TFM for each of these three ingredients.
In the 1994 TFM (59 FR 31402 at 31435), alcohol (60 to 95 percent) was proposed to be classified as GRAS/GRAE (59 FR 31402 at 31435 to 31436) for use as what was then called an antiseptic hand wash (a use which included both products intended to be rinsed off (washes) and those intended to be left on (rubs)). Isopropyl alcohol (70 to 91.3 percent) was proposed to be categorized in Category III in the 1994 TFM because of a lack of adequate effectiveness data for use as an antiseptic hand wash (59 FR 31402 at 31435 to 31436). However, we now propose that both alcohol and isopropyl alcohol need additional safety and effectiveness data to support a classification of GRAS/GRAE for consumer antiseptic rub use. Our detailed evaluation of the effectiveness and safety of the active ingredients for which data were submitted can be found in sections VII.A and VIII.D.
In the 1994 TFM, FDA categorized benzalkonium chloride in Category III because of a lack of adequate safety and effectiveness data for its use as an antiseptic hand wash (59 FR 31402 at 31435). We have evaluated safety data received in response to the 1994 TFM and the consumer antiseptic wash proposed rule published in the
If we do not receive sufficient data to support monograph conditions for consumer antiseptic rub products containing these active ingredients, these active ingredients may not be included in the future OTC consumer antiseptic rub final monograph. Any consumer antiseptic rub product containing the active ingredients being considered under this rulemaking that are not included in a future final monograph could seek approval to market by submitting new drug applications (NDAs) under section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355). After a final monograph is established, NDA deviations might be submitted for these products in accordance with 21 CFR 330.11, limiting the scope of review necessary to obtain approval.
The impact of the proposed rule on the OTC consumer antiseptic rub product industry will depend on the outcome of tests to determine whether three antiseptic ingredients—alcohol, isopropyl alcohol, and benzalkonium chloride—are GRAS/GRAE. It is possible that none, one, two, or all three of the ingredients will be determined to be GRAS/GRAE. We consider two extreme scenarios to capture the entire range of total costs: (1) All three ingredients are deemed to be GRAS/GRAE or (2) none of the ingredients is deemed to be GRAS/GRAE.
The range of estimated costs is wide because the number of products that would need to be reformulated and relabeled depends on whether or not an antiseptic ingredient is deemed to be GRAS/GRAE. A small number of products contain active ingredients which FDA has determined are not eligible for use in consumer antiseptic rubs and these products will need to be reformulated and relabeled (scenario 1). However, in scenario 2 (and intermediate scenarios), the resulting costs are higher because a greater number of products will need to be reformulated and relabeled as a result of tests failing to show GRAS/GRAE status.
The total upfront costs of the proposed regulation—which include the expenditures to reformulate and relabel products that contain nonmonograph ingredients—are estimated to range from $0.34 million to $1.02 million for scenario 1 and from $15.99 million to $47.09 million for scenario 2. Annualizing upfront costs over a 10-year period at a discount rate of 3% for scenario 1, the costs of the proposed rule are estimated to be between $0.04 million and $0.12 million per year; the corresponding estimated cost at a discount rate of 7% is between $0.05 million and $0.14 million per year. In scenario 2, none of the ingredients is determined to be GRAS/E and we expect that manufacturers will reformulate their products to be free of antiseptics and relabel them to reflect the change in ingredients. Annualizing upfront costs over a 10-year period at a discount rate of 3% for scenario 2, the costs of the proposed rule are estimated to be between $1.87 million and $5.52 million per year; the corresponding estimated cost at a discount rate of 7% is between $2.28 million and $6.70 million per year. We assume that health risk falls with reduced exposure to potentially unsafe or ineffective antiseptic ingredients in consumer antiseptic rubs. We estimate that the proposed rule will reduce exposure to potentially unsafe or ineffective antiseptic ingredients in consumer antiseptic rubs by between 110 and 67,272,847 pounds.
In the following sections, we provide a brief description of terminology used in the OTC Drug Review regulations and an overview of OTC topical antiseptic drug products, and then describe in more detail the OTC consumer antiseptic rubs that are the subject of this proposed rule.
To conform to terminology used in the OTC Drug Review regulations (§ 330.10 (21 CFR 330.10)), the September 1974 advance notice of proposed rulemaking (39 FR 33103, September 13, 1974) (1974 ANPR) was designated as a “proposed monograph.” Similarly, the notices of proposed rulemaking, which were published in the
The OTC drug procedural regulations in § 330.10 use the terms “Category I” (generally recognized as safe and effective and not misbranded), “Category II” (not generally recognized as safe and effective or misbranded), and “Category III” (available data are insufficient to classify as safe and effective, and further testing is required). Section 330.10 provides that any testing necessary to resolve the safety or effectiveness issues that formerly resulted in a Category III classification, and submission to FDA of the results of that testing or any other data, must be done during the OTC drug rulemaking process before the establishment of a final monograph (
At the final monograph stage, FDA does not use the terms “Category I,” “Category II,” and “Category III.” In place of Category I, the term “monograph conditions” is used; in place of Categories II and III, the term “nonmonograph conditions” is used.
The OTC topical antimicrobial rulemaking has had a broad scope, encompassing drug products that may contain the same active ingredients, but that are labeled and marketed for different intended uses. In 1974, the Agency published an ANPR for topical antimicrobial products that encompassed products for both health care and consumer use. The 1974 ANPR covered seven different intended uses for these products: (1) Antimicrobial soap; (2) health care personnel hand wash; (3) patient preoperative skin preparation; (4) skin antiseptic; (5) skin wound cleanser; (6) skin wound protectant; and (7) surgical hand scrub (39 FR 33103 at 33140). FDA subsequently identified skin antiseptics, skin wound cleansers, and skin wound protectants as antiseptics used primarily by consumers for first aid use and referred to them collectively as “first aid antiseptics.” We published a separate TFM covering the first aid antiseptics in the
The four remaining categories of topical antimicrobials were addressed in the 1994 TFM. The 1994 TFM covered: (1) Antiseptic hand wash (
In the 1974 ANPR, we distinguished antimicrobial soaps used by consumers from professional use antiseptics, such as health care personnel hand washes. (See section II.C about the term “antimicrobial soaps.”) In contrast, in the 1994 TFM, we proposed that both antiseptic hand washes (
As we did in the 2013 Consumer Wash PR, we refer to the group of products covered by this proposed rule as “consumer antiseptics.” Consumer antiseptic drug products addressed by this proposal include consumer antiseptic hand rubs (commonly called hand sanitizers) and antiseptic wipes.
In this proposed rule, FDA proposes the establishment of a monograph for OTC consumer antiseptics that are intended for use as an antiseptic rub, but that are not identified as “first aid antiseptics” in the 1991 First Aid TFM. When the 1994 TFM was published, the term for daily consumer use antiseptics was changed to “antiseptic hand wash.” In response to this change, we received comments that the term “antiseptic hand wash” did not include all of the consumer products on the market, such as hand rubs and body washes. Therefore, in this proposed rule, we use the term “consumer antiseptic,” which is a broad term and meant to include all of the types of antiseptic products used on a frequent or daily basis by consumers. However, this proposed rule covers only consumer antiseptic rubs and does not include consumer antiseptic hand washes or body washes.
The 1994 TFM did not distinguish between products that we are now calling “antiseptic washes” and products we are now calling “antiseptic rubs.” Washes are rinsed off with water, and include consumer hand washes and body washes, and health care personnel hand washes and surgical hand scrubs. Rubs are sometimes referred to as “leave-on products” and are not rinsed off after use. They are intended to be used when soap and water are not available. Consumer antiseptic rubs include “hand sanitizers” and wipes. The 1994 TFM also did not distinguish between consumer antiseptic washes and rubs, and health care hand washes and rubs. This proposed rule covers only consumer antiseptic rubs. Completion of the monograph for consumer antiseptic rubs and certain other monographs for the active ingredient triclosan are subject to a Consent Decree entered by the U.S. District Court for the Southern District of New York on November 21, 2013, in
Because of the complexity of this proposed rule, we are providing a comment period of 180 days. Moreover, new data or information may be submitted to the docket via
We note that the OTC Drug Review is a public process and any data submitted is public. There is no requirement or expectation that more than one set of data will be submitted to the docket for a particular active ingredient, and it does not matter who submits the data. In addition, data and other information for a single active ingredient may be submitted by any interested party and not all data for an ingredient must be submitted by a single party.
In this section, we describe the significant rulemakings and public meetings relevant to this proposed rule, and how we are responding to comments received in response to the 1994 TFM.
A summary of the significant
In addition to the
In response to the 1994 TFM, FDA received approximately 160 comments from drug manufacturers, trade associations, academia, testing laboratories, consumers, health professionals, and law firms. In response to the 2013 Consumer Wash PR, we received safety data regarding benzalkonium chloride that is relevant to this ingredient's use in a consumer rub and these data are evaluated in section VIII.D.2. Copies of the comments received are on public display at
This proposed rule constitutes FDA's evaluation of submissions made in response to the 1994 TFM to support the safety and effectiveness of OTC consumer antiseptic rub active ingredients (Ref. 12). We reviewed the available literature and data and the comments submitted to the rulemaking and are proposing that adequate data for a determination of safety and effectiveness are not yet available for the consumer antiseptic rub active ingredients.
In this section of the proposed rule, we describe the requirements for eligibility for the OTC Drug Review and the ingredients submitted to the OTC Drug Review that lack adequate evidence of eligibility for evaluation as consumer antiseptic rub products.
An OTC drug is covered by the OTC Drug Review if its conditions of use existed in the OTC drug marketplace on or before May 11, 1972 (37 FR 9464) (Ref. 13).
The following list includes those active ingredients that were addressed in the 1994 TFM for use as an antiseptic hand wash or health care personnel hand wash, and which currently do not have adequate evidence of eligibility for evaluation under the OTC Drug Review for use in a consumer antiseptic rub. Our review of the labeling submitted to the Panel or to FDA at a later time did not identify evidence demonstrating eligibility for the following active ingredients:
Following the publication of the 1994 TFM, FDA received submissions for the first time requesting that the following compounds be added to the monograph (Refs. 14 through 20):
These compounds were not addressed in prior FDA documents related to the monograph and were not evaluated for antiseptic hand wash use by the Antimicrobial I Panel. The submissions received by the Agency to date do not include documentation demonstrating the eligibility of any of these compounds for inclusion in the topical antimicrobial monograph (Ref. 21). Because of their lack of eligibility, effectiveness and safety information that has been submitted to the rulemaking for these consumer antiseptic rub active ingredients are not discussed in this proposed rule for such use. However, if documentation of the type described in section IV.A is submitted, these active ingredients could be determined to be eligible for evaluation for use as a consumer antiseptic rub.
FDA may determine that an active ingredient is not GRAS/GRAE for a given OTC use (
Table 3 lists the OTC consumer antiseptic active ingredients eligible for evaluation under the OTC Drug Review for use in consumer rubs, the classification proposed in the 1994 TFM, and the classification being proposed in this rulemaking. For each active ingredient, data that have been submitted to the public docket (for the topical antimicrobial rulemaking) and evaluated by FDA and the description of data still lacking in the administrative record are described in detail in section VIII.
In the 1994 TFM, alcohol was classified as Category I, isopropyl alcohol was classified as Category IIIE, and benzalkonium chloride was classified as Category IIISE for use as an antiseptic hand wash or health care
OTC regulations (§§ 330.10(a)(4)(ii) and 314.126(b) (21 CFR 330.10(a)(4)(ii) and 314.126(b))) define the standards for establishing that an OTC drug containing a particular active ingredient would be GRAE for its intended use. These regulations provide that supporting investigations must be adequate and well-controlled, and able to distinguish the effect of a drug from other influences such as a spontaneous change in the course of the disease, placebo effect, or biased observation. In general, such investigations include controls that are adequate to provide an assessment of drug effect, are adequate measures to minimize bias, and use adequate analytical methods to demonstrate effectiveness. For active ingredients being evaluated in the OTC Drug Review, this means that a demonstration of the contribution of the active ingredient to any effectiveness observed is required before an ingredient can be determined to be GRAE for OTC drug use.
In the 1994 TFM, we continued to apply a log reduction standard (a clinical simulation standard) for establishing effectiveness of consumer antiseptics originally proposed in the 1978 TFM (59 FR 31402 at 31412) for the proposed intended use of decreasing bacteria on the skin. The 1994 TFM log reduction standard for effectiveness is based on a surrogate endpoint (
FDA has already relied on clinical simulation studies as a standard for evaluating effectiveness of hand antiseptic drug products approved under NDAs, which are proven to be an effective measure to lower the surgical site infection rate (Refs. 25 through 27). In addition, in our recently revised standards for evaluating the effectiveness of health care antiseptics published in May 2015 (80 FR 25166), we relied on clinical simulation studies based on the recommendations of the March 2005 NDAC. In contrast, in the 2013 Consumer Wash PR, we proposed an efficacy standard for consumer antiseptic washes that relies on clinical outcome trials, also based on NDAC recommendations. As noted previously, consumer antiseptic rub products are generally used when soap and water are not available, so consumers lack a readily available alternative. As such, we continue to propose a log reduction standard to demonstrate the general recognition of effectiveness for consumer antiseptic rubs in accordance with our standards for health care antiseptics, which contain the same active ingredients (
As discussed in section VII.A, we have evaluated the available effectiveness studies that were submitted to the OTC Drug Review or retrieved through the published literature to support the effectiveness for consumer antiseptic rubs using the log reduction criteria most recently proposed in the 1994 TFM (59 FR 31402 at 31448) (Refs. 28 and 29). We found that the available studies are not adequate to support a GRAE determination for any consumer antiseptic rub active ingredient under either the final formulation effectiveness testing criteria proposed in the 1994 TFM or under the GRAE criteria proposed in this proposed rule (see table 4).
We have also evaluated all the studies that were submitted to the OTC Drug Review and have searched the published literature for studies performed in consumer use settings that would provide the direct evidence of a clinical benefit from the use of consumer antiseptic rubs (Ref. 24). We are defining a clinical benefit here as a reduction in the number of infections in a population that uses the consumer antiseptic rubs. Although a definitive link between consumer antiseptic rubs and reduced infection rates has not been established, some public health agencies recommend the use of consumer antiseptic rubs when soap and water are not available (Refs. 22, 23).
Most of the available data to support the effectiveness of consumer antiseptic rubs are based on clinical simulation studies, such as the ones described in the 1994 TFM (59 FR 31402 at 31444). The premise behind these studies as described in the 1994 TFM is that bacterial reductions translate to a reduced risk for infection. However, currently, there are no clinical data that demonstrate that the specific bacterial log reductions that we have relied upon as a demonstration of effectiveness lead to a specific reduction in infections. In our view, although a lower number of bacteria on hands may not directly translate into a reduced chance of infection, a reduced bacterial load does decrease the opportunity for infection when used in situations with no other options for hand cleansing. In this case, rather than comparing using consumer antiseptic rubs to hand washing with soap and water, we are comparing them to the alternative of not cleaning the hands. In addition, because we believe that the consumer antiseptic rubs are intended to provide immediate reduction of bacteria rather than a persistent benefit, we are proposing that log reductions be measured after a single bacterial challenge (see table 4), rather than after repeated contamination.
We have evaluated all clinical simulation studies that were submitted to the OTC Drug Review for evidence of the effectiveness of consumer antiseptic rub active ingredients under the log reduction criteria proposed in the 1994
Overall, the studies used a variety of study designs, including nonstandard study designs. In some cases, data submitted to the OTC Drug Review were in the form of technical reports or published articles without any study details. There is insufficient information to evaluate the scientific merit of studies described in abstracts and technical reports. Most importantly, none of the evaluated studies were adequately controlled to demonstrate the contribution of the active ingredient to the effectiveness observed in the studies (43 FR 1210 at 1240) and, therefore, cannot be used to demonstrate that the active ingredient tested is GRAE.
In general, the evaluated studies also had at least one of the following deficiencies:
• Some studies that were described as using a standardized method (American Society for Testing and Materials (ASTM)
• Many studies did not include appropriate controls; for example, most studies did not include a vehicle control or an active control (59 FR 31402 at 31448), and some studies that included an active control failed to use the control product according to its labeled directions (59 FR 31402 at 31448).
• Many studies did not provide sufficient detail concerning neutralizer use (43 FR 1210 at 1244) or validation of neutralizer effectiveness.
• The studies evaluated a small number of subjects (59 FR 31402 at 31449).
• Some studies did not sample all of the time points specified by the test method (59 FR 31402 at 31448).
FDA's detailed evaluation of the data is filed in Docket No. FDA-2016-N-0124, available at
Although we are not currently proposing to require clinical outcome studies to support a GRAE determination in this proposed rule, FDA identified and evaluated clinical outcome studies from the published literature that could potentially provide evidence of effectiveness for the use of consumer antiseptic rubs (Ref. 24). In our view, clinical outcome studies evaluating the effectiveness of consumer rubs should be adequately controlled and include a placebo or negative control arm to show the effect of an active ingredient. Among the reviewed studies and published literature, there are only a few studies that use these specified parameters for evaluating the effectiveness of consumer antiseptic rubs (Ref. 25). Overall, most of the studies were confounded, underpowered, and/or not properly controlled.
Our detailed review of consumer hand rubs studies is available in Docket No. FDA-2016-N-0124 (Ref. 24). None of the alcohol-based hand rub studies demonstrating benefit were adequately controlled, thus they could not demonstrate the contribution of the antiseptic active ingredient to the observed clinical outcome of reduced infection rates. In general, the studies had the following design flaws:
• No comparison to vehicle.
• Small sample size.
• Lack of randomization, blinding, or both.
• Inadequate statistical power and, in some cases, a failure to analyze results for statistical significance.
• Inadequate description of methodology and data collection methods.
• Failure to observe and document hand rub application technique.
One clinical outcome study was identified that was randomized, blinded, and placebo-controlled and was well designed to evaluate the effectiveness of a particular antiseptic active ingredient (Ref. 31). Although it had several significant limitations that prevent it from being sufficient to establish effectiveness for use of the active ingredient in a consumer antiseptic rub, this study is the best among the available studies that evaluate the impact of consumer antiseptic rubs on infections.
This clinical outcome study performed in Sweden compared the effectiveness of a 70-percent alcohol-containing consumer antiseptic rub as an adjunct to hand washing with plain soap and water in childcare centers (Ref. 31). The study included 60 childcare centers (30 matched pairs) from 10 counties with a mean number of 50 children in each center. One childcare center from each matched pair was randomized to the intervention group, with the other serving as the control group. The intervention groups were provided instructions (verbal and written), and children and staff were asked to wash hands with plain soap and water, then rub with a 70-percent alcohol-containing consumer antiseptic rub. Control groups followed the same hand-washing protocol without the hand rub. The primary outcome was the rate of illness absenteeism. Parents were asked to report every episode when the child was absent from childcare because of illness, including the dates of absence, symptoms, and any medical treatment. There were 0.37 absences per 100 child hours in the control group, compared to 0.33 in the intervention group. The effect of the intervention was a 12-percent reduction in absenteeism. Based on the amount of hand rub used during the study, the estimated frequency of hand rub use by each child was two to six times per day. Although the study is well designed, there are several significant limitations, such as the following:
• No clinical or microbiological evaluation of illness.
• No specific infection was studied.
• Children kept home based on parent choice not addressed in the statistical analysis.
• Degree of illness and symptoms to keep child home varied among parents.
In the 1994 TFM, we proposed that the effectiveness of antiseptic active ingredients could be supported by a combination of in vitro studies and in vivo clinical simulation testing as described in 21 CFR 333.470 (59 FR 31402 at 31444). In vitro studies are designed to demonstrate the product's spectrum and kinetics of antimicrobial activity, as well as the potential for the development of resistance associated with product use. In vivo test methods and evaluation criteria are based on the premise that bacterial reductions can be adequately demonstrated using tests that simulate conditions of actual use for OTC consumer antiseptic rub products and that those reductions are reflective of bacterial reductions that would be achieved during use. For the use of antiseptic rubs, some public health agencies (Ref. 22) recommend their use when soap and water are not available, and when there is no other reasonably available alternative for the consumer.
In addition to the standards described in section VII.B, the effectiveness of consumer antiseptic rubs can be affected by a variety of other factors related to product formulation and use. Section VII.C discusses these factors, which includes the number of times per day a
The 1994 TFM proposed that the in vitro antimicrobial activity of an active ingredient could be demonstrated by a determination of the in vitro spectrum of antimicrobial activity, minimum inhibitory concentration (MIC) testing against 25 fresh clinical isolates and 25 laboratory strains, and time-kill testing against 23 laboratory strains (59 FR 31402 at 31444). Comments received in response to the 1994 TFM objected to the proposed in vitro testing requirements, stating that they were overly burdensome (Ref. 32). Submissions of in vitro data submitted to support the effectiveness of antiseptic active ingredients were far less extensive than what was proposed in the 1994 TFM (Ref. 33). Although we agree that the in vitro testing proposed in the 1994 TFM is not warranted for testing every final formulation of an antiseptic product that contains a GRAE ingredient, we believe that a GRAE determination for a consumer antiseptic active ingredient should be supported by adequate in vitro characterization of the antimicrobial activity of the ingredient. In addition, we now propose the option of assessing the minimum bactericidal concentration (MBC) as an alternative to testing the MIC to demonstrate the broad spectrum activity of the antiseptic. The ability of an antiseptic to kill microorganisms, rather than inhibit them, is more relevant for a topical product. Because GRAE status is a very broad determination that can apply to many different formulations of an active ingredient, we continue to propose that an evaluation of the spectrum and kinetics of antimicrobial activity of a consumer antiseptic rub active ingredient should be evaluated by the following testing:
• A determination of the in vitro spectrum of antimicrobial activity against potential pathogens (listed in this section) that may be encountered in consumer use settings where soap and water are not readily available. MIC or MBC testing of 25 representative clinical isolates and 25 reference (
• Time-kill testing of each of the following ATCC strains to assess how rapidly the antiseptic active ingredient produces its effect. The dilutions and time points tested should be relevant to the actual use pattern of the final product.
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We propose that a consumer antiseptic rub active ingredient be considered bactericidal at the concentration and contact time that demonstrates a 3-log
Despite the fact that the in vitro data submitted to support the effectiveness of antiseptic active ingredients were far less extensive than proposed in the 1994 TFM, manufacturers may have data of this type on file from their own product development programs that have not been submitted to the rulemaking. Furthermore, published data may be available that would satisfy some or all these data requirement. Data from these in vitro studies, as well as data from the literature, may be used to inform labeling, in particular, if there are specific organisms for which an active ingredient does not have significant activity. It is anticipated that if data supporting use of a consumer antiseptic demonstrate lack of activity against a particular organism that requires labeling, that labeling would also be relevant in the health care setting.
Based on the recommendations of the March 2005 NDAC meeting for health care antiseptic products, we continue to propose the use of bacterial log reductions as a means of demonstrating that consumer antiseptic rubs are GRAE (Ref. 8). The 1994 TFM also proposed final formulation testing for antiseptic hand washes (59 FR 31402 at 31448). We are not discussing the final formulation testing here because we are not proposing that any of the ingredients are GRAS/GRAE. Although, as previously noted, these proposed test methods are intended to evaluate the effectiveness of antiseptic final formulations, this type of clinical simulation testing when adequately controlled can also be used to demonstrate that an active ingredient is GRAE for use in a consumer antiseptic rub product. Based on our experience with the approval of NDA antiseptic products, and input from the March 2005 and October 2005 NDAC meetings, we recommend that the bacterial log reduction studies used to demonstrate that an active ingredient is GRAE for use in consumer antiseptic rub drug products include the following:
• A vehicle control to show the contribution of the active ingredient to effectiveness. The test product should be statistically superior to the vehicle control for the clinical simulation to be considered successful at showing that the test product is effective for use in consumer antiseptic rub products. Products with vehicles that have antimicrobial activity should consider using a negative control, such as saline, rather than a vehicle control.
• An active control to validate the study conduct, to assure that the expected results are produced. For the results to be valid, the active control should meet the appropriate log reduction criteria.
• A sample size large enough to show statistically significant differences from the results achieved using the vehicle, and meeting the threshold of at least a 70-percent success rate for the test product, including justification that the number of subjects tested is adequate for the test.
• Use of an appropriate neutralizer in all recovery media (
• An analysis of the proportion of subjects who meet the log reduction criteria based on a two-sided statistical test for superiority to vehicle and a 95-percent confidence interval approach.
To establish that a particular active ingredient is GRAE for use in consumer antiseptic rubs, clinical simulation studies using the parameters described in this section should be evaluated using log reduction criteria similar to those proposed in the 1994 TFM (59 FR 31402 at 31448). Our current criteria are laid out in table 4. We have revised the log reduction criteria proposed for consumer antiseptic rubs based on the recommendations of the March 2005 NDAC and comments to the 1994 TFM, which argued that the demonstration of a cumulative antiseptic effect for these products is unnecessary. We agree that the critical element of the effectiveness is that a product must be effective after the first application because that represents the way in which consumer antiseptic rub products are used (59 FR 31402 at 31442). For these reasons, log reduction criteria are proposed only for a single application of the test product rather than multiple applications. Given that we are no longer requiring a cumulative antiseptic effect, the log reduction criteria were revised to reflect this single application and fall between the log reductions previously proposed for the first and last applications. The GRAE criteria proposed for consumer antiseptic rubs are based on log reductions achieved by antiseptics as shown in the published literature (Refs. 28 and 29) as well as those evaluated under the NDA process. Table 4 shows the log reductions that we would expect an effective consumer antiseptic rub active ingredient to meet to show that it is GRAE.
Establishing GRAE status of active ingredients is one important aspect of ensuring the efficacy of OTC consumer antiseptic rub products. The standards for a GRAE determination for consumer antiseptic rubs have been described (see section VII.B). These standards will help determine final monograph active ingredients, as well as their permitted concentrations and the skin application time needed for the active ingredient to achieve adequate bacterial reduction. However, the efficacy of any particular final formulation of a consumer antiseptic rub appears to be affected by a variety of other factors related to product formulation and use.
These factors include the number of times per day a product is used and the volume used in each use. The number of times per day that a consumer antiseptic rub product is applied has been shown to be positively correlated with a reduction in illness-related absenteeism in a kindergarten school (Ref. 34). In addition, more specific measures of application parameters have been assessed. The volume of product applied and the skin coverage achieved by the applied volume appear to have an impact on efficacy of antiseptic rub products containing alcohol. In comparing five different application volumes of 70 percent ethanol gel with 85 percent ethanol gel and 70 percent ethanol foam, Kampf et al. (2013) demonstrated that the label recommended volume of 1.1 milliliters (mL) for the 70 percent ethanol products was not sufficient to achieve efficacy in in vivo efficacy testing according to ASTM methods (Ref. 35). The recommended application of 2 mL of 85 percent gel, as well as higher than recommended volumes of the 70 percent products, met efficacy criteria under ASTM E 2755-10 and ASTM E 1174-06 methods used in this study. In the same study, insufficient skin coverage with lower application volumes (1.1 mL) was suggested as the reason for failure to achieve efficacy. Failure to achieve effectiveness with the lower volume was based on observation of gaps in skin coverage after volunteers applied products containing fluorescent dye to their hands. In a similar study, Kampf (2008) assessed the efficacy and coverage of four hand rub products (foam or gel formulation unspecified) containing 85 percent, 62 percent, 61 percent, or 60 percent ethanol (Ref. 36). At an application volume of 2.4 mL, the 60 percent and 61 percent ethanol formulations failed to meet in vivo ASTM efficacy criteria while 2.4 mL application volumes of 62 percent and 85 percent ethanol formulations met the criteria. Application volumes of 3.6 mL met efficacy criteria for all ethanol concentrations tested (Ref. 36).
Given that the applied volume of product may have consequences for product efficacy, the factors that may affect application volume are of interest. Variability has been demonstrated in the output of both gel and foam antiseptic rub dispensers. Macinga et al. (2013) measured output from a single wall-mounted dispenser and among wall-dispensers from different manufacturers (Ref. 37). In dispensing five different gel formulations containing varying percentages of ethanol or isopropanol, dispensers from five different manufacturers had outputs that ranged from 0.9 to 1.3 mL per actuation. In dispensing three different foam formulations each containing 70 percent ethanol, foam dispensers from three different manufacturers ranged from 0.6 to 1.1 mL per actuation. Furthermore, the volume of product that individuals choose to apply may be affected, independent of labeled instruction, by factors such as the time it takes hands to dry after application. Kampf et al. (2010) assessed four foam formulations, each containing 62 percent ethanol, and found that the amount (weight) of foam applied was significantly correlated with the perceived drying time (Ref. 38). There is also evidence that final formulation affects efficacy. Different products containing the same concentration of active ingredient have been shown to perform differently when tested by in vivo bacterial reduction testing (ASTM 1174) (Ref. 39). One “novel” gel formulation and one “novel” foam formulation, each
Understanding the impact of product-related parameters, such as formulation, dose applied, and application volume, to be used according to the labeling is imperative. We also need to understand the extent to which variability in product-related parameters must be reduced to ensure that products achieve the results expected based on their use of GRAE ingredients. Given the data demonstrating that efficacy varies with dose, application volume, and formulation, final formulation efficacy testing will be necessary for consumer antiseptic rub products in order to confirm effectiveness and label the product appropriately for use. However, because no ingredient has sufficient data to support GRAS/GRAE status in this rulemaking, we are not proposing specific final formulation testing or labeling at this time. Instead, we are requesting data to allow the assessment of the impact of various application parameters on efficacy and the interaction among them (
In the 1994 TFM, 11 active ingredients were proposed to be classified as GRAS for antiseptic hand wash use, which includes 2 active ingredients (alcohol and isopropyl alcohol) that are eligible for consumer antiseptic rub use (59 FR 31402 at 31435). As described in section II.C, consumer antiseptic hand rubs were not addressed separately from antiseptic hand washes in the 1994 TFM. There have since been a number of important scientific developments affecting our evaluation of the safety of the active ingredients in consumer antiseptic rubs, causing us to reassess the data necessary to support a GRAS determination. There is now new information regarding systemic exposure to antiseptic active ingredients (Refs. 1 through 5). The potential for widespread antiseptic use to promote the development of antibiotic-resistant bacteria also needs to be evaluated. Furthermore, additional experience with, and knowledge about, safety testing has led to improved testing methods. Improvements include study designs that are more capable of detecting potential safety risks. Based on our reassessment, we are proposing new GRAS data standards for consumer antiseptic rub active ingredients. To fully address these new safety concerns, additional safety data will be necessary to support a GRAS determination for all consumer antiseptic rub active ingredients.
Many of the safety considerations for consumer antiseptic rubs are based on FDA's view that the use of consumer antiseptic rubs is a “chronic” use as that term is defined by the International Council on Harmonisation (ICH).
Since the 1994 TFM was published, new data have become available indicating that systemic exposure to topical antiseptic active ingredients may be greater than previously thought. Systemic exposure refers to the presence of antiseptic active ingredients inside and throughout the body. Because of advances in technology, our ability to detect antiseptic active ingredients in body fluids such as serum and urine is greater than it was in 1994. For example, studies have shown detectable blood alcohol levels after use of alcohol-containing hand rubs (Refs. 1, 4, and 5). We believe that any consequences of this systemic exposure should be identified and assessed to support our risk-benefit analysis for consumer antiseptic use.
Given the frequent repeated use of consumer antiseptic rubs, systemic exposure may occur. Although some systemic exposure data exist for all three consumer antiseptic rub active ingredients, data on systemic absorption after maximal use are lacking. Currently, there is also a lack of data to assess the impact of important drug use factors that can influence systemic exposure such as dose, application frequency and method, duration of exposure, product formulation, skin condition, and age. Depending on the systemic absorption of the ingredient, variability in absorption anticipated between formulations, and the safety margin for toxic effects, final formulation safety testing for particular ingredients may be needed to assure that substantially different absorption that might significantly change the margin of safety is not anticipated for a new formulation. FDA does not address final formulation testing in this rulemaking because no ingredients have been proposed as GRAS/GRAE. However, FDA recently described final formulation safety testing for another class of OTC dermal products regulated under the OTC drug monograph (Ref. 41).
The evaluation of the safety of drug products involves correlating findings from animal toxicity studies to the level of drug exposure obtained from pharmacokinetic studies in animals and humans. Our administrative record lacks the data necessary to define a margin of safety for the potential chronic use of consumer antiseptic rub active ingredients. Thus, we are continuing to propose that both animal and human pharmacokinetic (PK) data are necessary for consumer antiseptic rub active ingredients. This information will help identify any potential safety concerns and help determine the safety margin for OTC human use.
One potential effect of systemic exposure to consumer antiseptic active ingredients that has come to our attention since publication of the 1994 TFM is data suggesting that some antiseptic active ingredients have hormonal effects. Ingredients in topical antiseptic products can cause alterations in the thyroid of neonatal and adolescent animals (Refs. 42 through 51). Hormonally active compounds have been shown to affect not only the exposed organism, but also subsequent generations (Ref. 52). These effects may not be related to direct deoxyribonucleic acid (DNA) mutation, but rather to alterations in factors that regulate gene expression (Ref. 53).
A hormonally active compound that causes reproductive system disruption in the fetus or infant may have effects that are not apparent until many years after initial exposure. There are also critical times in fetal development when a change in hormonal balance that would not cause any lasting effect in an adult could cause a permanent developmental abnormality in a child. For example, untreated hypothyroidism during pregnancy has been associated with cognitive impairment in the offspring (Refs. 54 through 56).
Because consumer antiseptic rubs are used chronically and are likely to be used by sensitive populations such as children and pregnant women,
In the 2013 Consumer Wash PR and 2015 Health Care Antiseptic PR, FDA raised the concern of the development of antiseptic resistance and its potential impact on the development of antibiotic resistance (78 FR 76444 at 76454 and 80 FR 25166 at 25180). This concern was based on numerous reports of laboratory studies demonstrating the development of reduced susceptibility to certain antiseptic active ingredients and antibiotics after growth in nonlethal amounts of the antiseptic (
A GRAS determination for consumer antiseptic rub active ingredients must be supported by both nonclinical (animal) and clinical (human) studies.
To assist manufacturers or others who wish to provide us with the information we expect will establish GRAS status for these active ingredients, we are including specific information, based in part on existing FDA guidance, about the other kinds of studies to consider conducting and submitting. We have published guidance documents describing the nonclinical safety studies that a manufacturer should perform when seeking to market a drug product under an NDA (Refs. 40, 57 through 63). These guidance documents also provide relevant guidance for performing the nonclinical studies necessary to determine GRAS status for a consumer antiseptic rub active ingredient. Because consumer antiseptic rubs may be used repeatedly and in sensitive populations, we propose that consumer antiseptic rub active ingredients will need to be tested for carcinogenic potential, developmental and reproductive toxicity (DART), and other potential effects as described in more detail in this section.
The safety studies that are described in the existing FDA guidances (Refs. 40, 57 through 63) provide a framework for the types of studies that are needed for FDA to assess the safety of each consumer rub active ingredient according to modern scientific standards and make a GRAS determination. A description of each type of study and how we would use this information to improve our understanding of the safety of consumer antiseptic rub active ingredients is provided in table 5.
These studies represent FDA's current thinking on the data needed to support a GRAS determination for an OTC antiseptic active ingredient and are similar to those recommended by the Antimicrobial I Panel (described in the ANPR (39 FR 33103 at 33135)) as updated by the recommendations of the 2014 NDAC. However, even before the September 2014 NDAC meeting, the Panel's recommendations for data to support the safety of an OTC topical antimicrobial active ingredient included studies to characterize the following:
• Degree of absorption through intact and abraded skin and mucous membranes.
• Tissue distribution, metabolic rates, metabolic fates, and rates and routes of elimination.
• Teratogenic and reproductive effects.
• Mutagenic and carcinogenic effects.
Because the available data indicate that some dermal products, including at least some antiseptic active ingredients, are absorbed after topical application in humans and animals, it is necessary to assess the effects of long-term dermal and systemic exposure to these ingredients. This is particularly important for populations, such as pregnant women (and fetuses), lactating women, and children, who may have greater potential to experience deleterious developmental effects from drug exposure. Human exposure data can then be compared to drug levels in animals known to produce adverse effects in order to calculate a safety margin.
Based on input from the September 2014 NDAC meeting, the Agency has also determined that results from a human PK maximal usage trial (MUsT) are needed to support a GRAS determination. This trial design is also referred to as a maximal use PK trial and is described in FDA's 2005 draft guidance for industry on developing drugs for treatment of acne vulgaris (Ref. 62). The purpose of the MUsT is to evaluate systemic exposure under conditions that would maximize the potential for drug absorption in a manner consistent with possible “worst-case” real world use of the product. In a MUsT, the collected plasma samples are analyzed, and the resulting in vivo data could be used to estimate a safety margin based on animal toxicity studies.
A MUsT to support a determination that an active ingredient is GRAS for use in consumer antiseptics is conducted by obtaining an adequate number of PK samples following administration of the active ingredient. For studies of active ingredients to be used in topically applied products like these, for which there is less information available and for which crossover designs are not feasible, a larger number of subjects are required compared to studies of orally administered drug products. A MUsT using 50 to 75 subjects per cohort should be sufficient to get estimates of the PK parameters from a topically applied consumer antiseptic.
The MUsT should attempt to maximize the potential for drug absorption to occur by considering the following design elements (Ref. 65):
• Adequate number of subjects (steps should be taken to ensure that the target population (for example, age, gender, race) is properly represented).
• Frequency of dosing (
• Duration of dosing.
• Use of highest proposed strength (
• Total involved surface area to be treated at one time (
• Amount applied per square centimeter.
• Method of application (
• Sensitive and validated analytical methods.
It also is important that the MUsT reflect maximal use conditions of consumer antiseptic rubs using different formulations to fully characterize the active ingredient's potential for dermal penetration. There are very limited data on the maximal number of uses of antiseptic rubs in consumer settings. Consumer antiseptic rubs used in institutional settings, such as daycare centers, schools, and office buildings, would be used (as per label directions) at higher rates than in domestic households, and thus would represent maximal use. Kinnula et al. (2009) surveyed workers in child daycare centers in Finland to determine how commonly alcohol-containing hand rub gels were applied daily (Ref. 66). The respondents (n = 128) reported applying the alcohol hand rub gels up to 50 times per day. Using the upper limit of applications per day of antiseptic hand rubs from this study, FDA is considering 50 times per day as the maximal use of consumer hand rubs in a consumer setting.
It should be noted that a systemic carcinogenicity study will not be required for an ingredient if a MUsT results in a steady state blood level less than 0.5 nanograms (ng)/mL, and an adequately conducted toxicology program demonstrates that there are no other signals for the ingredient or any known structurally similar compound indicating the potential for adverse effects at lower levels. The threshold value of 0.5 ng/mL is based on the principle that the level would approximate the highest plasma level below which the carcinogenic risk of any unknown compound would be less than 1 in 100,000 after a single dose.
The lack of absorption in a MuST does not alleviate the need to assess dermal carcinogenicity because the magnitude of exposure to the skin can be much higher than would be covered by systemic studies. In addition, systemic exposure to the parent compound and metabolites can differ significantly for a dermally applied product because the skin has metabolic capability and first-pass metabolism is bypassed via this route of administration.
To fulfill the maximum human exposure requirement, the MUsT study should meet appropriate design standards using the highest concentration sought under this proposed rule in formulations expected to produce the highest in vivo absorption. The assay used in the MUsT should be properly validated according to current Good Laboratory Practices and consistent with FDA guidance for industry: “Bioanalytical Method Validation” (Ref. 67).
We expect that the 0.5 ng/mL concentration will be sufficiently above the assay's limit of quantitation-limit of detection to allow a signal: Noise ratio that assures confidence in the derived concentrations (in the case of “exaggerated” values) or lack of concentrations.
We propose that data are also needed to assess whether consumer antiseptic rub active ingredients have hormonal effects that could produce developmental or reproductive toxicity. There are several factors common to antiseptic products that make it necessary to assess their full safety profile prior to classifying an antiseptic active ingredient as GRAS for use in consumer antiseptic rub products. These factors are as follows:
• Evidence of systemic exposure to several of the antiseptic active ingredients.
• Exposure to multiple sources of antiseptic active ingredients that may be hormonally active compounds.
• Exposure to antiseptic active ingredients may be long term for some users.
According to FDA's 2015 guidance on nonclinical evaluation of endocrine-related drug toxicity (Ref. 63), endocrine effects may be identified from the standard battery of toxicity tests conducted during drug development and may not require additional separate studies.
Since the 1994 TFM published, the issue of antiseptic resistance and whether bacteria that exhibit antiseptic resistance have the potential for antibiotic cross-resistance has been the subject of much study and scrutiny. One of the major mechanisms of antiseptic and antibiotic cross-resistance is changes in bacterial efflux activity at nonlethal concentrations of the antiseptic (Refs. 68 through 73). Efflux pumps are an important nonspecific bacterial defense mechanism that can confer resistance to a number of substances toxic to the cell, including antibiotics (Refs. 74 and 75). The development of bacteria that are resistant to antibiotics is an important public health issue, and additional data may tell us whether use of antiseptics in consumer settings may contribute to the selection of bacteria that are less susceptible to both antiseptics and antibiotics. Therefore, we are requesting additional data and information to address this issue for ingredients other than alcohol or isopropyl alcohol (see section VIII.D).
FDA believes that a tiered approach is an efficient means of developing data to address this issue. Laboratory studies in conjunction with a literature review are a feasible first step in evaluating the impact of exposure to nonlethal amounts of antiseptic active ingredients on antiseptic and antibiotic bacterial susceptibilities. However, only limited data exist on the effects of antiseptic exposure on the bacteria that are predominant in the oral cavity, gut, skin flora, and the environment (Ref. 76). These organisms represent pools of resistance determinants that are potentially transferable to human pathogens (Refs. 77 and 78). Thus, broader laboratory testing of consumer antiseptic active ingredients would more clearly define the scope of the impact of antiseptic active ingredients on the development of antibiotic resistance and may be able to identify those antiseptic active ingredients for which the development of resistance is not a concern. Laboratory studies evaluating the antiseptic and antibiotic susceptibilities of bacteria grown in the presence of sublethal concentrations of antiseptic active ingredients could help support a GRAS determination for antiseptic active ingredients intended for use in OTC consumer antiseptic drug products. The following types of organisms should be evaluated:
• Human bacterial pathogens.
• Nonpathogenic organisms, opportunistic pathogens, and obligate anaerobic bacteria that make up the resident microflora of the human skin, gut, and oral cavity.
• Food-related bacteria such as
• Nonpathogenic organisms and opportunistic pathogens from relevant environmental sources (
For antiseptic active ingredients that demonstrate an effect on antiseptic and
• Information about the mechanism(s) of antiseptic action (for example, membrane destabilization or inhibition of fatty acid synthesis), and whether there is a change in the mechanism of action with changes in antiseptic concentration.
• Information clarifying the bacteria's mechanism(s) for the development of resistance or reduced susceptibility to the antiseptic active ingredient (for example, efflux mechanisms).
• Data characterizing the potential for reduced antiseptic susceptibility caused by the antiseptic active ingredient to be transferred to other bacteria that are still sensitive to the antiseptic.
• Data characterizing the concentrations and antimicrobial activity of the antiseptic active ingredient in biological and environmental compartments (for example, bacteria found on human skin, in the gut, and in environmental matrices).
• Data characterizing the antiseptic and antibiotic susceptibility levels of environmental isolates of bacteria in areas of prevalent antiseptic use, such as in the home or in schools.
We have identified for each consumer antiseptic rub active ingredient whether the studies outlined in section VIII.C are publicly available. Table 6 lists the types of studies available for each antiseptic active ingredient eligible for use as a consumer rub proposed as Category I or Category III in the 1994 TFM and indicates whether the currently available data are adequate to serve as the basis of a GRAS determination. Although we have some data from submissions to the rulemaking and from information we have identified in the literature, our administrative record is incomplete for at least some types of safety studies for each of the active ingredients (see table 6). As noted previously, only information that is part of the administrative record for this rulemaking can form the basis of a GRAS/GRAE determination.
We recognize that data and information submitted in response to the 2013 Consumer Wash PR or 2015 Health Care Antiseptic PR may be relevant to this proposed rule. At the time of publication of this proposed rule, FDA's review of all submissions made to the 2015 Health Care Antiseptic PR has not been completed. FDA requests that any information relevant to consumer antiseptic rub active ingredients be resubmitted under this docket (FDA-2016-N-0124).
In the remainder of this section, we discuss the existing data and data gaps for alcohol, benzalkonium chloride and isopropyl alcohol, the consumer antiseptic rub active ingredients that were proposed as GRAS in the 1994 TFM, and explain why these active ingredients are no longer proposed as GRAS for use in consumer antiseptic hand rubs (
In the 1994 TFM, FDA proposed to classify alcohol as GRAS for all health care antiseptic uses based on the recommendation of the Advisory Review Panel on OTC Miscellaneous External Drug Products (Miscellaneous External Panel), which concluded that the topical application of alcohol is safe (59 FR 31402 at 31412). In the 2013 Consumer Wash PR, FDA proposed to separately evaluate the safety and effectiveness of the OTC antiseptic drug products by use setting, specifically health care and consumer antiseptic products. As defined in the 2013 Consumer Wash PR, consumer
a.
As discussed in more detail in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25185 to 25187), FDA has reviewed the following and found them to be sufficient to characterize the safety of alcohol for use in consumer antiseptic rubs:
• Animal ADME data demonstrating absorption of alcohol both in vitro and in vivo (Refs. 82 through 86).
• Dermal and oral carcinogenicity data in animals and oral carcinogenicity data in humans (Refs. 87 through 93).
• DART human data (Refs. 94 and 95).
• Data on the hormonal effects of alcohol in animals and humans (Refs. 96 through 102).
• Data on the antimicrobial mechanism of alcohol (Refs. 103 through 106). Alcohol readily evaporates from the skin after topical application, and the resulting lack of antiseptic residue on the skin suggests that the topical application of alcohol is not likely to contribute to the development of antimicrobial resistance (Refs. 103, 105).
A variety of alcohol-based hand rub product formulations and alcohol concentrations have been used in these studies. Based on the available data, which represents moderate hand rub use (7.5 to 40 hand rub applications per hour, studied for 30 to 240 minutes), the highest observed exposure was 1,500 milligrams (mg) of alcohol (Ref. 4), which is the equivalent of 10 percent of an alcohol-containing drink. See also the discussion of occupational exposure to alcohol via the dermal route (Ref. 107) in the alcohol carcinogenicity section of the 2015 Health Care Antiseptic PR (80 FR 25166 at 25186).
Although these data do indicate absorption of alcohol does occur after topical administration of alcohol-containing antiseptic rubs, we did not find the exposure conditions of these studies comparable to exposure that are required by our current MUsT standards specified in section VIII.C.2. Consequently, human pharmacokinetic data under maximal use conditions as determined by a MUsT are needed to make a GRAS determination for the alcohol-containing consumer antiseptic rubs.
b.
In summary, our administrative record for the safety of alcohol is incomplete with respect to the following:
• Human pharmacokinetic studies under maximal use conditions when applied topically (MUsT), including documentation of validation of the methods used to measure alcohol and its metabolites.
In the 1994 TFM, FDA categorized benzalkonium chloride as Category III because of a lack of adequate safety data for its use as both a health care antiseptic and consumer antiseptic product (59 FR 31402 at 31435). FDA also is proposing to classify benzalkonium chloride as Category III for the indication of consumer antiseptic rubs. Thus, additional safety data are still needed to make a GRAS determination for benzalkonium chloride for use as a consumer antiseptic rub.
In the 2013 Consumer Wash PR, FDA identified the safety data needed to make a GRAS determination for benzalkonium chloride as an ingredient in consumer antiseptic wash products. The safety gaps listed were human and animal pharmacokinetic data, reproductive toxicity studies, potential hormonal effects, carcinogenicity (oral and dermal) studies, and potential of the development of antimicrobial resistance to benzalkonium chloride. As was summarized in the 2015 Health Care Antiseptic PR, the safety of benzalkonium chloride has been reviewed and was determined to be safe for use in disinfectants and cosmetic products by the Environmental Protection Agency (EPA) and the Cosmetic Ingredient Review (an industry panel), respectively (Refs. 108 and 109). The data cited in both of these evaluations are proprietary and only summaries of the data are publicly available. Consequently, these studies are not available to FDA and FDA cannot conduct a complete evaluation of them. Safety assessments with study summaries do not constitute an adequate record on which to base a GRAS classification (§ 330.10(a)(4)(i)). For FDA to evaluate this data with respect to the safety of benzalkonium chloride for this rulemaking, the full study reports and data sets must be submitted to the rulemaking docket or otherwise be publicly available.
In response to the call for data in the 2013 Consumer Wash PR, a manufacturing consortium submitted the following studies to the 2013 Consumer Wash PR docket (Refs. 110 through 121):
• An embryofetal toxicity study in the rabbit;
• an embryofetal toxicity study in the rat;
• a 2-generation study in the rat;
• a 90 day subchronic dietary study in rats;
• a 90 day subchronic dermal toxicity study in rats;
• a 1-year chronic dietary toxicity study in dogs;
• an ADME study in rats;
• a rat oral carcinogenicity study; and
• a mouse oral carcinogenicity study.
All of these studies have been reviewed by FDA. Some of the data were found to be adequate to fill some of the safety data gaps for a GRAS determination for benzalkonium chloride. Data gaps remain for the following endpoints: Human pharmacokinetic data under maximal use condition, animal dermal carcinogenicity and animal ADME data, and data on antimicrobial resistance to benzalkonium chloride.
a.
In a separate group of animals tested in the same study, a single low-dose of 10 mg/kg benzalkonium chloride was administered to rats of both sexes. The average amount of radioactivity recovered following IV dosing was 45 to 55 percent in the feces and 20 to 30 percent in the urine. Tissue residues of radioactivity were less than 1 percent of the orally administered dose in all groups and 30 to 35 percent of the IV dose. No significant changes were noted when comparing the ADME profile of high dose versus low dose-treated rats. Although the available ADME data from nondermal routes of exposure are sufficient to characterize the ADME profile of benzalkonium chloride following nondermal exposure, they are not sufficient to characterize the ADME profile after dermal exposure. Studies on animal ADME after dermal exposure to benzalkonium chloride will need to be submitted to FDA for review, in order to complete a GRAS determination for benzalkonium chloride.
A 1-year chronic oral toxicity study in dogs was also submitted. Dogs were chronically administered benzalkonium chloride via feeding in concentrations ranging from 0 to 1,200 ppm for 1 year (Ref. 114). Changes in body weight included reduced absolute body weight and reduced body weight gain in males and females in the highest group tested (1,200 ppm), which correlated with a reduction in food consumption. At 1,200 ppm, cholesterol levels were reduced by about 10 percent in both males and females (p ≤ 0.01). No specific organ toxicity was identified. Based on the changes in body weight and food consumption at 1,200 ppm, a NOAEL of 400 ppm was determined, which corresponds to 13.1 and 14.6 mg/kg/day in males and females, respectively.
In the dermal toxicity study, rats were topically exposed to benzalkonium chloride in concentrations ranging from 0 (water) to 1.0 percent (which correspond to 0 to 20 mg/kg/day) over a 13-week treatment period (Ref. 113). Slight local irritation and hyperkeratosis (thickening of the epidermis) were observed in all treatment groups (including control) in both sexes. All findings were limited to the treatment site. Under the conditions of this study, the NOAEL was 20 mg/kg (1.0 percent). Toxicokinetic data were not collected; therefore, systemic exposure to benzalkonium chloride was not characterized. Consequently, dermal ADME (toxicokinetic) data is still needed to characterize benzalkonium chloride.
A 78-week dietary carcinogenicity study was conducted in mice with benzalkonium chloride concentrations of 500, 1,000, and 1,500 ppm, corresponding to approximately 15, 73, and 229 mg/kg/day in males and 18, 92, 289 mg/kg/day in females (Refs. 120 and 121). Findings were limited to decreased body weight in both males and females treated with the highest dose compared to controls (7 percent and 5 percent at week 78 in males and females, respectively). There were no treatment-related increases in the incidence of neoplasms at any of the doses tested.
A 2-year oral carcinogenicity study was conducted in rats with benzalkonium chloride concentrations of 300, 1,000, and 2,000 ppm, corresponding to 13, 44, and 88 mg/kg/day, respectively, in males, and to 17, 57, and 116 mg/kg/day, respectively, in females (Refs. 117 through 119). No treatment-related increases in the incidence of neoplasms were observed at any of the tested doses.
There were no treatment-related neoplasms in either oral carcinogenicity study. Though the mouse study is suboptimal because of its relatively short duration (78 weeks), we believe these two studies are adequate to fill the oral carcinogenicity data gap for benzalkonium chloride.
No dermal carcinogenicity studies of benzalkonium chloride have been submitted to FDA. The available data are not adequate to assess the carcinogenic potential of benzalkonium chloride. We propose that dermal carcinogenicity studies are still needed to complete a GRAS determination for benzalkonium chloride.
In a developmental toxicity study in rats, the animals were administered benzalkonium chloride (10, 30, and 100 mg/kg/day) (Ref. 112). There were no treatment-related differences in gestational parameters, including total number of embryonic implantations, number of viable and nonviable implants. There were also no treatment-related effects on fetal body weights per litter, or on the incidences of external, visceral, or skeletal malformations/variations. Based on these findings, a NOAEL for maternal toxicity was considered to be 10 mg/kg/day and for developmental toxicity 100 mg/kg/day.
A two-generation reproduction and development study in rats was submitted for review. Rats were exposed to benzalkonium chloride in the feed (Ref. 116). The exposure to benzalkonium chloride up to the highest dose tested of 2,000 mg/kg did not result in parental toxicity. No treatment-related reproductive effects were observed in any of the treatment groups. Findings were limited to decreases in body weight accompanied by a decrease in food consumption among treated females at 2,000 mg/kg/day and a decrease in pup body weight. Based on these findings, a NOAEL for adults and offspring was considered to be 1000 ppm (62.5 mg/kg/day).
The submitted DART studies are adequate and no additional DART studies are needed for benzalkonium chloride.
In summary, our administrative record for the safety of benzalkonium chloride is incomplete with respect to the following:
• Human pharmacokinetic studies under maximal use conditions when applied topically (MUsT), including documentation of validation of the methods used to measure benzalkonium chloride and its metabolites;
• Animal dermal ADME;
• Dermal carcinogenicity; and
• Data from laboratory studies that assess the potential for the development of resistance to benzalkonium chloride and cross-resistance to antibiotics as discussed in section VIII.C.
In the 1994 TFM, FDA proposed to classify isopropyl alcohol (70 to 91.3 percent) as GRAS for all consumer antiseptic washes (59 FR 31402 at 31435). FDA is now proposing to classify isopropyl alcohol as Category III for use in consumer antiseptic rubs. The GRAS determination in the 1994 TFM was based on the recommendations of the Miscellaneous External Panel, which based its recommendations on human absorption data and blood isopropyl alcohol levels (47 FR 22324 at 22329). There was no comprehensive nonclinical review of the toxicity profile of isopropyl alcohol, nor was there a nonclinical safety evaluation of the topical use of isopropyl alcohol.
a.
As discussed in more detail in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25190-25193), FDA has reviewed the following data and found the data to be sufficient to characterize the safety of isopropyl alcohol:
• DART data (Refs. 130 through 135).
• Data on the antimicrobial mechanism of isopropyl alcohol (Refs. 103 through 106, 136 through 138). Isopropyl alcohol readily evaporates from the skin after topical application. The lack of antiseptic residue on the skin indicates that the topical application of isopropyl alcohol is not likely to contribute to the development of antimicrobial resistance (Refs. 103, 105). Additional data on the development of antimicrobial resistance are not needed to make a GRAS determination.
No new data has been made available to FDA since publication of the 1994 TFM that can fill any of the remaining safety data gaps for isopropyl alcohol. The following areas of safety assessment, which were identified in the 1994 TFM and discussed in detail in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25190-25193), are being updated in this document:
• Human absorption data (Refs. 1, 139 through 142). However, the data submitted and found in the literature to date do not cover maximal use of these products in an institutional setting as detailed in section VIII.C.2.
• Animal ADME data following dermal and systemic exposure to isopropyl alcohol (Refs. 143 through 149). The available dermal exposure studies have demonstrated that there is some systemic exposure to isopropyl alcohol following dermal application. However, the extent of that exposure has not been fully characterized. Moreover, absorption data following dermal absorption in animals are still needed to determine the extent of systemic exposure following maximal dermal exposure to isopropyl alcohol-containing consumer antiseptic rub products.
• Systemic and dermal carcinogenicity data in animal models. Available data for chronic exposure to isopropyl alcohol include inhalation carcinogenicity data in rodents (Refs. 150 and 151) and a chronic 1-year dermal toxicity study in mice (Ref. 149). However, these data are not adequate to assess the systemic or dermal carcinogenic potential of isopropyl alcohol.
• Data on the hormonal effects of isopropyl alcohol. The existing data are not adequate to characterize the potential for hormonal effects of isopropyl alcohol. However, additional studies may not be needed to assess the potential hormonal effects of isopropyl alcohol if assessment of potential hormonal activity can be derived from existing (reproductive and developmental studies; chronic general toxicity data) and additional pending isopropyl alcohol (systemic and dermal carcinogenicity and ADME data) nonclinical studies, provided the appropriate endpoints are assessed.
Thus, we believe the existing evaluations need to be supplemented to fully evaluate the safety of isopropyl alcohol. As described in more detail in the 2015 Health Care Antiseptic PR (80 FR 25166 at 25190-25193), we propose that human pharmacokinetic studies under maximal use conditions when applied topically (MUsT), animal ADME studies (dermal absorption), systemic and dermal carcinogenicity studies, and data on hormonal effects are still needed to complete a GRAS determination for isopropyl alcohol.
In summary, our administrative record for the safety of isopropyl alcohol is incomplete with respect to the following:
• Human pharmacokinetic studies under maximal use conditions when applied topically (MUsT), including documentation of validation of the methods used to measure isopropyl alcohol and its metabolites;
• animal ADME (dermal absorption);
• dermal carcinogenicity;
• systemic carcinogenicity (may be waived if the MUsT data do not show absorption); and
• hormonal effects (could be derived from other endpoints).
Based on the currently available data, this proposed rule finds that additional data are necessary to establish the safety and effectiveness of consumer antiseptic rub active ingredients for use in OTC consumer antiseptic rub drug products. Accordingly, consumer antiseptic rub active ingredients would be nonmonograph in any final rule based on this proposed rule. We recognize, based on the scope of products subject to this monograph, that manufacturers will need time to comply with a final rule based on this proposed rule. However, because of the potential effectiveness and safety considerations raised by the data for some antiseptic active ingredients evaluated, we believe that an effective date later than 1 year after publication of the final rule would not be appropriate or necessary. Consequently, any final rule that results
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this proposed rule is a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the consumer antiseptic rub product industry is mainly composed of establishments with 500 or fewer employees, we tentatively conclude that the proposed rule may 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 1 year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) 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.
There are three active ingredients being evaluated for use as a consumer antiseptic rub in this proposed rule: Alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride. The impact of the proposed rule on OTC consumer antiseptic rub product industry will depend on the outcome of tests to determine whether these three active antiseptic ingredients are GRAS/GRAE. It is possible that none, one, two, or all three of the ingredients will be determined to be GRAS/GRAE. We consider two extreme scenarios to capture the entire range of total costs: (1) All three ingredients are deemed to be GRAS/GRAE or (2) none of the ingredients is deemed to be GRAS/GRAE.
In table 7, we provide a summary of the estimated costs of the proposed rule for the two scenarios. The costs of the proposed rule involve product reformulation and relabeling of products. It is important to note that, to demonstrate that an antiseptic active ingredient is GRAS/E, some manufacturers will also incur additional costs associated with safety and effectiveness testing. We note that the testing costs for this proposed rule are not attributed here because these costs will be realized if manufacturers conduct the testing discussed in the proposed rule for health care antiseptics (80 FR 25166) and we do not count costs twice. However, we estimate these costs in this analysis to promote transparency in the event that this rule is finalized before the health care antiseptics proposed rule or manufacturers conduct the testing for the three ingredients discussed in this rule but do not conduct the testing for these ingredients for the health care antiseptic proposed rule
In scenario 1, all three ingredients are determined to be GRAS/E and manufacturers of products containing other ingredients will no longer be able to market these products under consumer antiseptic rub labels pursuant to the topical antimicrobial monograph. We expect that these manufacturers will reformulate their products to contain one of the monograph ingredients and relabel their products to reflect the change in ingredients. Annualizing upfront costs over a 10-year period at a discount rate of 3% for scenario 1, the costs of the proposed rule are estimated to be between $0.04 million and $0.12 million per year; the corresponding estimated cost at a discount rate of 7% is between $0.05 million and $0.14 million per year. In scenario 2, none of the ingredients is determined to be GRAS/E and we expect that manufacturers will reformulate their products to be free of antiseptics and relabel them to reflect the change in ingredients. Annualizing upfront costs over a 10-year period at a discount rate of 3% for scenario 2, the costs of the proposed rule are estimated to be between $1.87 million and $5.52 million per year; the corresponding estimated cost at a discount rate of 7% is between $2.28 million and $6.70 million per year.
A potential benefit of the proposed rule is that the removal of potentially harmful antiseptic active ingredients in consumer antiseptic rub products will prevent health consequences associated with exposure to such ingredients. FDA lacks the necessary information to estimate the impact of exposure to antiseptic active ingredients in consumer antiseptic rub products on human health outcomes. We are, however, able to estimate the reduction in the aggregate exposure to antiseptic active ingredients found in currently marketed consumer antiseptic rub products. As with the total costs, the reduction in aggregate exposure to antiseptic active ingredients in consumer rub products depends on the outcome of testing and the determination of GRAS/E status of the three ingredients that require testing. The proposed rule will lead to an estimated reduction that ranges from 110 pounds to 254 pounds per year in scenario 1 and from 13,080,963 and 67,272,847 pounds per year in scenario 2. Absent information on the change in the short- and long-term health risks associated with a one pound increase in exposure to each antiseptic active ingredient in consumer antiseptic rub products, we are unable to translate the aggregate exposure figures into monetized benefits.
FDA also examined the economic implications of the rule as required by the Regulatory Flexibility Act. If a rule will have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. This proposed rule could impose a significant economic impact on a substantial number of small entities. For small entities, we estimate the rule's one-time costs to roughly range between 0.001 and 0.16 percent of average annual value of shipments for a small business. In the Initial Regulatory Flexibility Analysis, we assess regulatory options that would reduce the proposed rule's burden on small entities, such as extending relabeling compliance times to 18 months (rather than 12 months).
The full analysis of economic impacts is available in the docket for this proposed rule (Docket No. FDA-2016-N-0124) and at
This proposed rule contains no collections of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have determined under 21 CFR 25.31(a) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. Section 4(a) of the Executive order requires agencies to “construe . . . a Federal statute to preempt State law only where the statute contains an express preemption provision or there is some other clear evidence that the Congress intended preemption of State law, or where the exercise of State authority conflicts with the exercise of Federal authority under the Federal statute.” The sole statutory provision giving preemptive effect to this proposed rule is section 751 of the FD&C Act (21 U.S.C. 379r). We have complied with all of the applicable requirements under the Executive order and have determined that the preemptive effect of this proposed rule, if finalized, would be consistent with Executive Order 13132. Through publication of this proposed rule, we are providing notice and an opportunity for State and local officials to comment on this rulemaking.
The following references are on display in the Division of Dockets Management (see
Administrative practice and procedure, Drugs, Labeling, Medical devices, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 310, as proposed to be amended December 17, 2013, at 78 FR 76444, and May 1, 2015, at 80 FR 25166, is proposed to be further amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 360j, 360hh-360ss, 361(a), 371, 374, 375, 379e, 379k-1; 42 U.S.C. 216, 241, 242(a), 262.
The additions to read as follows:
(a) * * *
(27) * * *
(v)
(d) * * *
(43) [DATE 1 YEAR AFTER DATE OF PUBLICATION OF THE FINAL RULE IN THE
Environmental Protection Agency (EPA).
Proposed rule.
In this action, the Environmental Protection Agency (EPA) is proposing design details of the Clean Energy Incentive Program (CEIP). The CEIP is a program that states have the option to adopt if they wish to incentivize certain early emission reduction projects under the Carbon Pollution Emission Guidelines for Existing Stationary Sources: Electric Utility Generating Units (also known as the Clean Power Plan Emission Guidelines (EGs)). The framework for the CEIP was established in the Clean Power Plan EGs, where the EPA also noted that the design details of the program would be developed in a follow-on action. This proposal addresses those design details. In addition, we are re-proposing the CEIP-related aspects of the proposed rate-based and mass-based model trading rules—referred to in this action as optional example regulatory text. This proposal is consistent with the Supreme Court's orders staying the Clean Power Plan during judicial review. The timing elements of the CEIP may be adjusted, if necessary, upon resolution of the petitions for review of the Clean Power Plan.
To register to speak at the hearing, please use the online registration form available at
The hearing will provide interested parties the opportunity to present data, views, or arguments concerning the proposed action. The EPA will make every effort to accommodate all speakers who wish to register to speak at the hearing venue on the day of the hearing. 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. Verbatim transcripts of the hearing and written statements will be included in the docket for the rulemaking. The EPA plans for the hearing to run on schedule; however, due to on-site schedule fluctuations, actual speaking times may shift slightly.
Because this hearing will be 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. If your driver's license is issued by American Samoa, Illinois, Minnesota, Missouri, New Mexico, or the state of Washington, you must present an additional form of identification to enter the federal building. Acceptable alternative forms of identification include: Federal employee badges, passports, enhanced driver's licenses, and military identification cards. In addition, you will need to obtain a property pass for any personal belongings you bring with you. Upon leaving the building, you will be required to return this property pass to the security desk. No large signs will be allowed in the building, cameras may only be used outside of the building, and demonstrations will not be allowed on federal property for security reasons.
Attendees will be asked to go through metal detectors. To help facilitate this process, please be advised that you will be asked to remove all items from all pockets and place them in provided bins for screening; remove laptops, phones, or other electronic devices from their carrying case and place in provided bins for screening; avoid shoes with metal shanks, toe guards, or supports as a part of their construction; remove any metal belts, metal belt buckles, large jewelry, watches and follow the instructions of the guard if identified for secondary screening. Additionally, no weapons (
Dr. Tina Ndoh, Sector Policies and Programs Division, Office of Air Quality Planning and Standards (D243-04), Environmental Protection Agency, Research Triangle Park, North Carolina 27711; telephone number: (919) 541-2750; email address:
A. What should I consider as I prepare my comments for the EPA?
Do not submit information that you consider to be CBI electronically through
If you have any questions about CBI or the procedures for claiming CBI, please consult the person identified in the
The CEIP is a program that states have the option to adopt if they wish to incentivize certain early emission reduction projects under the Carbon Pollution EGs for Existing Stationary Sources: Electric Utility Generating Units (also known as the Clean Power Plan EGs).
In the final Clean Power Plan, the EPA finalized a requirement that states wishing to participate in the CEIP must indicate by September 6, 2016, at a minimum, their intention to participate in the CEIP. On February 9, 2016, the Supreme Court stayed the Clean Power Plan during the pendency of the litigation. As a result of the stay, states are not required to provide such notice by September 6, 2016. The EPA will provide further direction on submittal timing requirements, as well as any other adjustments in timing that may be needed, upon the resolution of the judicial petitions for review of the Clean Power Plan. We discuss in more detail the relationship of this action to the Supreme Court's stay in section II.C of this preamble. For purposes of this proposal, however, we will use the original dates in the Clean Power Plan and the CEIP, with the expectation that all timing issues will be dealt with upon the resolution of the litigation.
In the event that the EPA finalizes a federal plan for a state, it continues to be the EPA's intention that the CEIP will be available in that state. The EPA believes the optional example regulatory provisions we are proposing, as presumptively approvable for state use or adoption, could suitably function as the CEIP provisions in a potential federal plan. We solicit comments on this aspect of the proposal. However, the EPA will not promulgate a federal plan until some period of time after the petitions for review of the Clean Power Plan are resolved and the stay is lifted. The EPA lacks authority to promulgate a federal plan for a state in the absence of a finding by the Agency that a state has failed to submit a plan by a legal deadline or a final action disapproving a required state plan. During the pendency of the Supreme Court's stay, states are not obliged to submit plans and therefore the EPA could not take either such action or promulgate any final federal plan for any state under the Clean Power Plan EGs. As explained later in this action, there are also pathways whereby a state could implement the CEIP under a duly promulgated federal plan.
While the legal effectiveness of the Clean Power Plan is currently stayed, the EPA has determined that it is appropriate to move forward with the design details of the CEIP component of the Clean Power Plan at this time. States have the authority to continue moving forward on their own volition with the design of state plans, and the EPA retains the authority to continue working with states as they do so. For states that, at their own discretion, wish to continue plan development, this action will help them understand what must be included in a state plan if they wish to opt into the CEIP. In addition, the proposal is responsive to the states that requested EPA provide additional detail on the design details of the CEIP as soon as possible. The EPA acknowledged to the public in the October 23, 2015, notice of final rulemaking that it would need to take a future action on the CEIP because there are aspects of the CEIP that need to be completed in order for the program to be able to be implemented (80 FR 64830). Indeed, commenters on the model rules and federal plan proposal, including states, requested that the Agency expeditiously complete the design details of the CEIP.
The CEIP is an incentive program in which both the states, should they elect to participate, and the EPA play a role. The program operates by means of states allocating or issuing early action compliance instruments—called early action allowances or early action emission rate credits (ERCs)—which are then matched by EPA with additional compliance instruments—called matching allowances or matching ERCs. States in turn provide these awarded matching compliance instruments to the providers of eligible CEIP RE and low-income community projects that received the early action allowances or early action ERCs from the state.
The EPA designed the CEIP to be an implementable option for states using mass-based plans and states using rate-based plans. The final Clean Power Plan specified the number of early action ERCs that a state may award to CEIP-eligible project providers per MWh of generation or savings achieved in 2020 and/or 2021 under a rate-based plan, but stated that the EPA would speak to the award of early action allowances under a mass-based plan in a future action. Awards of early action ERCs, and the EPA's proposed approach for the award of early action allowances, are discussed in section III.A of this preamble.
In the final Clean Power Plan, the EPA stated that, in the case of eligible CEIP solar and wind projects,
The overall size of the EPA matching pool available to all CEIP-participating states has been set at 300 million short tons of CO
Eligible CEIP projects must be located in or benefit a state that has one or more affected EGUs with an approved final plan that includes requirements establishing its participation in the CEIP. For purposes of the CEIP, we propose that “benefit” a state means that the electricity is generated or saved with the intention to meet or reduce electricity demand in the CEIP-participating state.
Additionally, in the final Clean Power Plan, we stated that eligible projects must commence construction (in the case of solar and wind projects) or commence operations (in the case of low-income EE projects) following the submission of a final state plan, or September 6, 2018, for a state that chooses not to submit a final plan by that date. As discussed later in this preamble, we are proposing to adjust this timing requirement to remove final state plan submittal as a triggering event for eligibility.
A CEIP-participating state must include requirements in its plan for determining CEIP project eligibility and quantifying and verifying the MWh of generation or savings from an eligible project. These requirements must be consistent with the requirements included in the final Clean Power Plan EGs for the issuance of ERCs.
The CEIP is an optional component of the Clean Power Plan, and the Clean Power Plan is an exercise of the EPA's authority under section 111(d) of the CAA, 42 U.S.C. 7411(d). The legal authority and rationale supporting the Clean Power Plan are discussed in the final rulemaking and accompanying Legal Memorandum.
The EPA established the CEIP in the final Clean Power Plan EGs, and took final action with respect to certain key design parameters for the program while identifying other details of the program that would be determined through a future action.
The CEIP is optional for states; states are not required to implement this incentive program for early action. However, if a state does choose to participate in the CEIP, it must follow the requirements specified in the final Clean Power Plan EGs as well as any additional requirements that may be finalized through this rulemaking action. Additionally, as discussed in section II.C of this preamble, in instances of federal plan promulgation, the EPA's intent is that the CEIP would also be available. Even in the case of a federal plan, states would have an ability to implement the CEIP, but if they chose not to, the EPA would implement the CEIP in those states. Thus, we invite comment on the CEIP provisions we are proposing as optional example CEIP regulatory text, including to the extent that text may be applied by the EPA through a federal plan.
This action is undertaken pursuant to the authority in section 111(d) of the CAA, as well as the Agency's general rulemaking authority as necessary to carry out the functions of the CAA, 42 U.S.C. 7411(d), 7601(a). This rulemaking action is subject to the rulemaking provisions of the CAA set forth in section 307(d), 42 U.S.C. 7607(d). This action is nationally applicable because it would establish additional requirements for states that choose to opt into the CEIP.
The EPA's action in this proposal is consistent with, and the EPA's authority to proceed with this action is unaffected by, the Supreme Court's orders in
A stay has the effect of “halting or postponing some portion of [a] proceeding, or [ ] temporarily divesting an order of enforceability.”
The EPA has not been enjoined by any court from continuing to work with state partners in the development of frameworks to reduce CO
This action proposes several changes and additions to the CEIP, which is an optional program, and proposes optional example regulatory text for use by states in the design of their plans. This is wholly consistent with the EPA's statutory authorities and the precedents discussed later in this preamble, and is consistent with and unaffected by the February 9, 2016 stay orders. A state may participate in the CEIP only after the EPA approves a required state plan or the EPA promulgates a federal plan for that state that includes the CEIP. These actions will not occur until sometime after the judicial stay has been lifted. Thus, this action is consistent with, and the EPA's authority to proceed with this action is unaffected by, the stay.
Furthermore, we note that in addition to its CAA section 111 and CAA section 301 authority to engage in this rulemaking, the EPA possesses multiple other authorities under the CAA that direct it to engage in capacity building and provide technical and financial assistance to states in order to effectuate the air pollution reduction objectives of the CAA.
The EPA may, among other things, “collect and disseminate, in cooperation with other Federal departments and agencies, and with other public and private agencies, institutions, and organizations having related responsibilities . . . information pertaining to air pollution and the prevention and control thereof.”
Taken together, these provisions both establish that the EPA has the authority, and illustrate why the EPA would have good reason, to continue coordinating and assisting in the development of CO
The EPA has proceeded under a similar understanding of its authority when CAA rules have been judicially stayed pending review in the past. When the D.C. Circuit Court stayed the Cross-State Air Pollution Rule (CSAPR),
Similarly, when the D.C. Circuit Court stayed the nitrogen oxide (NO
While none of the Clean Power Plan's deadlines can be enforced while the stay remains in effect, at this point it is not clear whether and to what extent those deadlines will necessarily be tolled once the stay is lifted. Some of the stay applicants expressly requested that all of the Clean Power Plan's deadlines be tolled for the period between the Clean Power Plan's publication and the final disposition of their lawsuits.
Because it is currently unclear what adjustments, if any, will need to be made to implementation timing, the EPA is in general in this action maintaining the timing elements of the
As noted previously, the EPA took final action in the Clean Power Plan to establish the CEIP, and finalized certain aspects of the CEIP at 40 CFR 60.5737, while identifying other details that it would address in a future action.
In the proposed federal plan and model trading rules for the Clean Power Plan, the EPA expressed its intent to implement the CEIP in states that may become subject to a federal plan;
The EPA has determined to remove these CEIP provisions from the larger model trading rules rulemaking, and to re-propose optional example regulatory text for the CEIP as part of this proposal. With regard to the proposed federal plans, the EPA is not re-proposing CEIP federal plan provisions in this action, but invites comment on the presumptively approvable example approach, including to the extent it provides additional detail on the approach that EPA could take in a federal plan. As proposed in this action, this example text provides greater specificity than the October 23, 2015 proposal on the requirements that may be included in any potential future federal plan CEIP.
In some instances, those proposed provisions are being re-proposed without significant changes; in others, proposed CEIP revisions to the EGs presented in this action necessitated corresponding changes to the mass- and rate-based optional example regulatory text. However, the October 2015 proposal did not contain specific proposals for certain design details that are now being proposed here. The EPA intends to finalize the CEIP optional example rule text included in this action in conjunction with the finalization of the other CEIP design details proposed in this action. We do not intend to include the CEIP optional example rule text as part of the finalized model trading rules. Nonetheless, the finalized CEIP optional example rule provisions could be integrated with the finalized mass-based or rate-based model trading rules when EPA finalizes this CEIP rulemaking, where a state chooses to implement the CEIP. Thus, the CEIP optional example rule text is being proposed in the same subpart of the Code of Federal Regulations as the full model trading rules, in order to facilitate states wishing to adopt a model rule that includes the CEIP.
Since the CEIP is an optional program, should the Agency not be able to approve a state's CEIP, the Agency believes that the provisions would be severable and not impact the Agency's ability to approve the remainder of a state's final plan submission. In addition, because the CEIP is an optional program, the Agency does not anticipate that it would promulgate a partial federal plan addressing the CEIP in the circumstance where a state plan is approvable but its CEIP provisions are not. However, consistent with what we stated in the October 2015 federal plan and model trading rules proposal, the EPA continues to intend to implement the CEIP if it were to promulgate a full federal plan for a particular state,
In addition, in the event that the EPA promulgates CEIP provisions as part of a federal plan for a particular state, the state may subsequently be able to take over the implementation of the CEIP through one of two separate mechanisms. The state may either take a delegation of the federal plan (or a partial delegation covering just the CEIP), or the state may submit a partial
The general process for delegation of federal plans under section 111(d) was explained in the October 2015 proposal,
States may also be in a position to take over direct implementation of the CEIP in their own right through a partial state plan. As we proposed in the October 2015 federal plan and model trading rules proposal, the EPA may approve partial state plans to implement a portion of the EGs under section 111(d). The EPA specifically recognized that certain aspects of the Clean Power Plan implementation may be appropriate for states to handle through a partial state plan, for instance, decisions as to the method of allocation of allowances under a mass-based federal plan.
Finally, we note that in the October 23, 2015, model trading rules and federal plan proposal the EPA requested comment on a number of details regarding CEIP program design that were not limited to the federal plan and model trading rules, but pertained to general design parameters or details not addressed in the final EGs.
The EPA values the comments related to the topics that have been submitted to date, both on the October 23, 2015, proposal as well as to the CEIP non-regulatory docket that closed on December 15, 2015. We have reviewed and considered the comments submitted through the federal plan and model trading rules rulemaking docket that closed on January 21, 2016, as well as the non-regulatory docket. These comments have informed various aspects of this proposal. We encourage those who have submitted comments already on the CEIP to re-submit those comments and/or any updated or additional comments through the comment submittal process for this rulemaking proposal. We heard from many stakeholders that they would like an opportunity to comment on a more developed proposal regarding these CEIP topics; the EPA is responding to those requests by issuing this proposal, which provides a new opportunity to submit comments on the CEIP topics addressed here. In order to ensure that the EPA considers and responds to your comments on these CEIP topics, you must submit your comments on this proposal, following the process explained in the section titled
In an effort to obtain stakeholder feedback on the CEIP, the EPA engaged in broad outreach activities. Approximately 750 stakeholders (potential project providers, environmental justice (EJ) groups, community groups, state and local governments, tribes and environmental non-governmental organizations) participated in at least one of four listening sessions on the CEIP. These listening sessions were part of an overall outreach effort that also included two workshops focused on community concerns, dozens of stakeholder meetings, conference appearances and one-on-one discussions since August 2015 that helped to inform this proposal.
Additionally, the EPA opened a non-regulatory docket (EPA-HQ-OAR-2015-0734) requesting pre-proposal input on the design details of the CEIP covered in this package. Specifically, the EPA requested input on the following: (1) What the EPA should consider when defining criteria, terms and requirements under the CEIP; (2) what the EPA should consider regarding the timing and distribution of EPA matching allowances or ERCs under the CEIP; and (3) what the EPA should consider when designing the mechanics of the CEIP. The non-regulatory docket received more than 5,000 comments.
While not within the scope of our requests, many commenters supported the inclusion of the CEIP in the Clean Power Plan. These commenters stated, however, that the CEIP project eligibility start date tied to submission of a final state plan, and the limitation of CEIP matching awards for eligible energy savings or generation to the years 2020 and 2021 only, were too restrictive. With regard to the project eligibility start date, commenters asserted that RE and EE projects take time to design, implement and begin generating/saving MWh, especially those that are developed with, by, and for low-income households and communities. Again, while not all of these topics are within the scope of this action, in response to some of these concerns, the EPA is proposing a modification to make clear when eligibility may begin for projects, as discussed further in section III.C of this preamble.
With regard to apportionment of the EPA matching pool of allowances and ERCs among the states, the majority of commenters felt that the pro-rata distribution method identified in the final Clean Power Plan EGs, whereby each state's share is based on the amount of reductions from 2012 levels the affected EGUs in the state are required to achieve relative to those in the other CEIP-participating states (80 FR 64830; October 23, 2015), was the appropriate apportionment method. Some commenters suggested that, rather than apportioning the matching pool among the states, the pool should instead be available on a first-come, first served basis to eligible CEIP project developers, regardless of where such projects take place. The EPA agrees with the majority of commenters that supported a state-by-state apportionment, as the Agency believes this is consistent with the state plan structure of the Clean Power Plan, and it ensures that all states that choose to
Some commenters stated that the EPA matching pool of 300 million short tons of CO
With regard to the definition of low-income community, many commenters suggested each state should have flexibility to choose the definition(s) that may be employed by project providers seeking early action awards from the state. Commenters supported the use of definitions of low-income currently used by other federal incentive programs, such as 80 percent of the area median income,
With regard to the criteria for eligible EE projects in low-income communities, commenters suggested that eligibility go beyond single family residential projects and that states should consider additional factors such as economic development and job creation when prioritizing EE and RE projects. Requirements for CEIP-eligible projects are discussed in section III.C of this preamble.
Although the EPA did not request comment on the types of RE projects that should be eligible for consideration, several commenters requested that, in addition to wind and solar resources, the EPA consider including geothermal, biomass and hydropower, as well as other generating technologies such as combined heat and power (CHP) and waste heat to power (WHP). One commenter requested that nuclear generation be considered as an eligible RE technology, however, several other commenters explicitly stated that the EPA should not consider nuclear as an eligible RE technology. The Agency also received several petitions for reconsideration on the final Clean Power Plan requesting that the scope of CEIP eligibility be expanded.
Commenters requested that the EPA provide early guidance on a methodology for representing the 300 million short tons of CO
The majority of commenters asserted that EM&V requirements used to quantify CEIP-eligible MWh generated or saved should be flexible and transparent, should not be overly burdensome (
The EPA also received comments on what, if any, reapportionment process should take place for EPA matching allowances or ERCs that a state is eligible to receive, but that the state does not ultimately access because it chooses not to opt in to the CEIP, or the CEIP provisions of its otherwise approved state plan are disapproved by the EPA. Commenters were nearly evenly divided on whether these “extra” matching allowances or ERCs should be reapportioned to CEIP-participating states on a pro-rata basis, or whether they should be made available to CEIP-participating states on a first-come, first-served basis, based on state awards of early action allowances or ERCs to eligible CEIP projects. Other commenters stated that EPA matching allowances or ERCs that are apportioned to a state, but ultimately are not used by that state because it chooses not to opt in to the CEIP, should not be reapportioned among CEIP-participating states. Based on some stakeholder concerns and further consideration by the Agency, the EPA is not including provisions for reapportionment among states in this proposal. See section III.A of this preamble for a discussion on the reasons for excluding reapportionment provisions for any remaining CEIP credits, and a request for comment on whether reapportionment should be included in the CEIP.
Many commenters supported broad geographic eligibility for participation in the CEIP, including supporting the inclusion of projects located in states, tribal lands and territories without affected EGUs, or for whom the EPA has not yet established goals under the Clean Power Plan EGs. Please see section III.D for a discussion on CEIP participation for states, tribes and territories for which the EPA has not established goals.
In this section, we discuss the proposed design details for several elements of the CEIP. Section III.A presents the proposed provisions for matching allowances and ERCs to be issued by the EPA from the matching pool of 300 million short tons of CO
Section III.B of this preamble discusses requirements for states that choose to participate in the CEIP. It includes requirements for allocation of early action allowances or issuance of early action ERCs by a state; requirements for a proposed process by which EPA matching allowances or matching ERCs would be awarded; options for meeting the requirement finalized in the Clean Power Plan EGs to maintain the stringency of mass-based or rate-based CO
Section III.C of this preamble discusses requirements for CEIP-eligible projects, including eligible RE projects and eligible low-income community projects. This includes a proposal to clarify the term “project” to also include programs that deploy eligible RE technologies and implement demand-side EE. It also includes a proposal to clarify the definition of “commence construction” as applied to RE projects, as well as a discussion of the option for a state to use an Agent for reviewing CEIP project applications, allocating early action allowances, and issuing early action ERCs. In addition, this section proposes the expansion of eligible CEIP RE projects to include, in addition to wind and solar, two other RE technologies: Geothermal and hydropower. The section also proposes an expansion of technologies implemented in low-income communities that would be eligible to receive a two-for-one CEIP award. Specifically, we propose that solar projects implemented to serve low-income communities that provide direct electricity bill benefits to low-income community ratepayers also be eligible for a two-for-one award in addition to the demand-side EE technologies that are already included. For this reason, we now refer to this reserve as the ‘low-income community’ reserve instead of the former ‘demand-side EE’ reserve. Finally, this section proposes that states have flexibility to determine the types of demand-side EE projects they may deem eligible for CEIP awards (such as projects for residences and non-profit commercial buildings, or transmission and distribution projects that reduce electricity use on the customer side of the meter), so long as they are implemented in communities that meet the state's approved definition(s) for “low-income community.”
Section III.D of this preamble discusses CEIP participation for states, tribes and territories for which the EPA has not established goals in the Clean Power Plan EGs. This includes a proposal that may further enhance the ability of project providers located in Indian country without affected EGUs to participate in the CEIP, a request for comment on how to determine the appropriate portion of the matching pool that should be apportioned to the non-contiguous states and territories, if they choose to participate in the CEIP, and a discussion of how eligible CEIP projects developed in states without affected EGUs may receive early action allowances or ERCs from another state that has chosen to participate in the CEIP.
As discussed in section II.A of this preamble, the EPA established an overall matching pool of 300 million short tons of CO
Additionally, this action proposes a division of the matching pool that would establish the portion of the matching pool available to each CEIP-participating state for awards to eligible CEIP RE projects, and the portion of the matching pool available to each CEIP-participating state for awards to eligible CEIP low-income community projects.
As stated in the preamble of the final Clean Power Plan, the EPA determined that the matching pool of 300 million short tons of CO
The EPA is using the relationship between tons of CO
The EPA is using the relationship between MWh and ERCs that was established in the final Clean Power Plan EGs, along with an adjustment identical to that applied when setting the matching pool at 300 million short tons, in order to determine the overall number of matching ERCs available through the EPA matching pool. Under a rate-based state plan, each MWh of generation or savings from an eligible resource that meets all applicable requirements of the EGs may be issued one ERC by a state. The EPA is proposing to establish the size of the matching pool, in the form of ERCs, based on the projection of 400 million MWh of wind and solar generation in 2020 and 2021, with the application of the same conservative downward adjustment the EPA used to adjust 320 million short tons of CO
The establishment of the matching pool in terms of both allowances and ERCs does not have any bearing on the final Clean Power Plan's provisions that allowances from a mass-based emission budget trading program may not be used for compliance in a rate-based emission trading program and that ERCs may not be used for compliance in a mass-based emission budget trading program. Allowances and ERCs are distinct tradable compliance instruments used by states implementing mass-based and rate-based emission standards, respectively, and are not interchangeable under the Clean Power Plan EGs,
The final Clean Power Plan EGs specified the ERC award ratios (both by a state and the EPA) for MWh of generation or energy savings achieved by an eligible project under the CEIP.
For example, if a CEIP-eligible RE project generates 50 MWh in 2020, the project would be eligible to receive 25 early action ERCs from the state and 25 matching ERCs from the EPA, for a total award of 50 ERCs. As another example, if a CEIP-eligible low-income community project saves 50 MWh in 2020, the project would be eligible to receive 50 early action ERCs from the state and 50 matching ERCs from the EPA, for a total award of 100 ERCs.
While the final Clean Power Plan EGs specified the ERC award ratios for CEIP-eligible MWh that may be used by rate-based states, we stated that the Agency would propose in a future action the allowance award ratios for CEIP-eligible MWh that mass-based states may use. As follows, in this action the EPA is proposing that the allocation of early action allowances by a state, and the award of matching allowances by the EPA, will be based on a 0.8 short tons of CO
For eligible CEIP RE projects under a mass-based program, the proposed 0.8 short tons of CO
Given the two-to-one award available to low-income community projects, for each MWh of CEIP-eligible energy savings or generation from a low-income community project under a mass-based program, a CEIP project provider would be eligible to receive 0.8 early action allowances from the state and 0.8 matching allowances from the EPA, for a total award of 1.6 allowances per MWh. For example, if a CEIP-eligible low-income community project saves 50 MWh in 2020, the total combined award available to the project would be 80 allowances (
In the final Clean Power Plan EGs, the EPA expressed its intent to divide the matching pool of 300 million short tons of CO
The EPA is proposing that a CEIP-participating state may allocate early action allowances or issue early action ERCs up to an amount equivalent to the number of matching allowances or matching ERCs the state is eligible to receive from the EPA for each reserve, as listed in tables 1 and 2 of this preamble. Allowances or ERCs that are designated for one reserve may not be re-designated for the other reserve, (
The proposal for the 50 percent/50 percent apportionment is based in part upon the EPA's analysis of the potential MWh that may be achieved by wind, solar, geothermal, hydropower, and low-income EE projects in 2020 and 2021, as well as upon stakeholder feedback regarding the appropriate apportionment between these two reserves.
As discussed in section III.C of this preamble, the EPA is proposing to replace the term “commence construction” for CEIP-eligible RE projects with the term “commence commercial operation,” as well as to make an associated change in the date of project eligibility to on or after January 1, 2020. The EPA is not reopening the decision to set the size of the CEIP matching pool at 300 million short tons. However, we note that even under the proposed changes to project eligibility, and the updated assumptions as discussed in the TSD to this action titled “Renewable Energy and Low Income Energy Efficiency Potential,” the EPA projects that energy generation from potentially eligible CEIP wind, solar, geothermal and hydropower projects will not exceed 400 million MWh in 2020 and 2021 combined. Thus, even if the EPA were considering a change in the magnitude of the CEIP (which it is not), new information and assumptions at this point would not lead the Agency to a different result in terms of the appropriate size of the CEIP matching pool, in light of the objectives for the CEIP identified in the final EGs, 80 FR at 64829-64832.
Further, the EPA proposes, in line with the discussion in the final EGs, that 50 percent of the matching pool would be the appropriate amount to apportion to the RE reserve. With regard to wind and solar potentials, at the time of promulgation of the Clean Power Plan EGs, the EPA projected that the deployment rates for wind and solar energy would remain relatively modest in the years leading up to the start of the interim plan performance period (
At the same time, the EPA believes that the remaining 50 percent of the CEIP matching pool remains the appropriate size for the low-income community reserve, leaving a more-than adequate margin to accommodate large-scale deployment of both demand-side EE projects and solar projects implemented to serve low-income communities. As discussed in section III.C of this preamble, the EPA is proposing to clarify the term “commence operation” for CEIP-eligible low-income demand-side EE projects, and to make a change in the date of eligibility for such projects such that they may commence operation on or after September 6, 2018. In addition, also as discussed in section III.C of this preamble, the EPA is proposing to replace the term “commence construction” for CEIP-eligible RE projects (including solar projects implemented to serve low-income communities) with the term “commence commercial operation” and to make an associated change in the eligibility date for such projects to January 1, 2020.
Given that eligible low-income community projects may receive CEIP awards on a two MWh to one MWh basis (as discussed in section III.A of this preamble), with half of the award coming from the state, and half of the award coming from the EPA, these 39 million MWh of low-income energy efficiency savings and 8 million MWh of solar generation implemented to serve low-income communities would be eligible to receive approximately 47 million matching ERCs, or 38 million matching allowances.
In light of this analysis, and in agreement with stakeholder comment that the EPA should apportion the matching allowances and ERCs evenly between a reserve for RE projects and a reserve for low-income community projects, the EPA is proposing that the matching pool be divided evenly between the two reserves, with 50 percent of the matching pool (150 million allowances, or 187.5 million ERCs) made available for RE projects and 50 percent of the matching pool (150 million allowances, or 187.5 million ERCs) made available for low-income community projects.
This apportionment is appropriate for several policy and technology-driven reasons. The apportionment achieves the policy objective of the CEIP, which is to ensure incentives for deployment of additional projects in both reserves (RE projects as well as low-income community projects). Whereas some stakeholders requested that we apportion the matching pool such that low-income community projects be eligible to receive more than 50 percent of the matching pool, our analyses do not support the need for a reserve for low-income community projects larger than 150 million allowances/187.5 million ERCs in order to meet demand during the CEIP period, even with the two-to-one award for such projects. However, the EPA requests information and data that may support a larger reserve for low-income community projects.
The proposal would also add solar projects implemented to serve low-income communities as eligible low-income community CEIP projects. This expansion of the CEIP scope in low-income communities promotes emission reductions and will help these communities better harness the benefits of energy efficiency and solar resources. More specifically, this expansion of the CEIP scope will provide low-income communities a greater opportunity to reach the full scale of opportunity presented by the reserve of matching allowances and ERCs for low-income community projects.
The EPA further believes that the 50-50 apportionment is an appropriate choice based on the rapidly evolving pace of technology and consumer demand for energy in the United States. Several analysts have noted that the electric power sector will undergo transformative changes from a number of factors, particularly lower costs for distributed generation, technology improvements in RE resources, and rapid innovation in energy efficiency technologies (
The apportionment of the two reserves, on a state-by-state basis, is included in tables 1 and 2.
The EPA seeks comment on all aspects of the proposed 50 percent/50 percent division of the 300 million short ton matching pool into a reserve for RE projects and a reserve for low-income community projects. In particular, the EPA seeks comment on the extent to which the recent extension of the federal tax credits for wind and solar resources will help to meet the CEIP's objectives with respect to promoting increased deployment of RE resources, including wind and solar, over the period leading up to 2022. The EPA notes that DOE's National Renewable Energy Laboratory has published an analysis which found that with these tax credits in place, roughly 100 gigawatts of additional wind and solar capacity would be added by the end of 2021.
The final Clean Power Plan EGs expressed the EPA's intent to apportion the 300 million ton matching pool among states based on the amount of reductions from 2012 levels the affected EGUs in the state are required to achieve relative to those in other participating states (80 FR 64830, October 23, 2015). Tables 1 and 2 show the state-level shares that result from this calculation approach, including the number of allowances (of the 300 million allowance total) or ERCs (of the 375 million ERC total) that would be available to a CEIP-participating state depending on the choice of a mass-based or rate-based state plan. See the TSD to this action, titled “Apportionment of the Matching Pool among the States,” for further discussion of the calculation approach.
As discussed in section III.A, the EPA proposes to divide each state's share of the matching pool into a portion for RE projects and a portion for low-income community projects. An apportionment between the two reserves of 50 percent for RE and 50 percent for low-income community projects is shown in tables 1 and 2 of this preamble. The EPA is proposing that only those states with EGUs subject to the final Clean Power Plan EGs and that have submitted a final plan with approved CEIP provisions, as well as those states for whom the EPA may implement a federal plan, will receive an apportionment of the matching pool that the EPA is making available under the CEIP.
The preamble to the final Clean Power Plan EGs indicated that, following receipt of final state plans, the EPA would execute a reapportionment of matching allowances or ERCs among the states, if it proves necessary. However, some stakeholders during the informal outreach period raised concerns around the timing in which the EPA would know that additional matching allowances or ERCs are available for reapportionment and whether a later reapportionment would be capable of addressing remaining unmet-demand for eligible CEIP projects. The EPA agrees that timing considerations may create a degree of uncertainty that makes reapportionment among states inappropriate. Additionally, as discussed in section III.A, the wind and solar tax credit extensions could also impact the imperative for reapportionment. Therefore, the EPA is not including reapportionment provisions in the CEIP.
The EPA also recognizes that there may be administrative challenges that may not support reapportioning of matching allowance/ERCs to states participating in the CEIP. From an administrative perspective, reapportioning CEIP allowances/ERCs after the known CEIP participants are determined, but before the CEIP program begins, may not be feasible depending on when state plans are submitted and approved, including approvable CEIP provisions. In addition, if a reapportionment were to occur, it could occur when the state has already begun to implement its CEIP, thus providing an element of uncertainty for states and project providers.
Reapportionment of matching allowances/ERCs may also influence a state's decision to opt-in to the CEIP, based on considerations that neighboring states could receive additional matching allowances/ERCs if the state chooses not to opt-in to the program. This could be perceived as a ‘double-disadvantage’: Not only is the state electing to not receive matching allowances/ERCs, it is also electing to have other states' matching allowance/ERC shares increased. This consideration could lead to a perverse incentive for a state to opt-in to the program in an effort to shield their original share of the matching pool from reapportionment, but not follow through on program implementation. Lastly, the EPA expects that most states will opt to take advantage of the benefits provided by the CEIP, and therefore as such, do not expect a large pool of remaining matching allowances or ERCs would be available for reapportionment. In lieu of reapportioning matching allowances or matching ERCs that are not claimed by a state that chooses not to opt-in to the CEIP, the EPA would simply retire these unclaimed matching allowances or ERCs on January 1, 2023.
Although we are not including reapportionment provisions in this proposal, we are seeking comment on whether these provisions should be included. In the case of reapportionment, only those states with
State plans that include implementation of the CEIP must meet certain requirements to ensure effective administration of the state's CEIP. Several basic requirements have already been established in the final EGs at 40 CFR 60.5737. This section summarizes those requirements and also proposes additional requirements necessary for implementation of a state CEIP and the related award of EPA matching allowances or ERCs. This section also discusses relevant proposed optional example rule provisions for the CEIP, which would constitute a presumptively approvable approach for meeting these CEIP requirements.
A state plan that implements the CEIP must include requirements that specify the process for application for, and allocation/issuance of, early action allowances or ERCs under the CEIP, as applicable.
We note the requirement in the final EGs, which we are not reopening, that if a final state plan includes CEIP provisions, the entire plan, including the CEIP, is subject to the requirements for meaningful engagement and public comment. In addition, the EPA is proposing in this action that a state plan must not prohibit an eligible CEIP project from receiving early action allowances or ERCs on the basis that the project is located in Indian country.
Many of the requirements listed previously were established in the final Clean Power Plan EGs (80 FR 64692). This proposal includes additions and
As finalized in the Clean Power Plan EGs, states opting into the CEIP must include requirements in their plans for allocation or issuance of early action allowances or early action ERCs, respectively, that meet the requirements for the issuance of ERCs (see final rule preamble, section VIII.K.2, and regulatory text at 40 CFR 60.5737(e)). Such a requirement applies to both mass-based and rate-based state plans including the CEIP, as the CEIP is based on eligible MWh of energy savings or RE generation, and these MWh must be quantified and verified appropriately in order to demonstrate eligibility for awards of early action and matching allowances or ERCs. Where relevant, the proposed CEIP optional example regulatory text cross-references applicable provisions in the proposed mass-based and rate-based model trading rules, respectively, that address such requirements.
The state plan requirements for implementation of the CEIP summarized previously apply regardless of whether a state is allocating early action allowances under a mass-based emission budget trading program or issuing early action ERCs under a rate-based emission trading program. In addition, these provisions must specify requirements for eligible projects under the CEIP, including the requirement that EE projects are implemented in “low-income communities.”
Where a state plan includes a mass-based emission budget trading program, the plan will need to include requirements that support the allocation of early action allowances under the state CEIP. A number of these are additional requirements that are not necessary under an approvable mass-based emission budget trading program that does not include a state CEIP. However, many of these additional requirements are similar to those that would be entailed for the administration of allowance set-asides to address potential leakage to new sources in the absence of the CEIP, if the state chooses such set-asides as the means for addressing potential leakage. In general, administering an allowance set-aside involves provisions to address entities that are eligible to receive allowances from a set-aside and specification of the method for allocating allowances from the set-aside. As a result, to the extent that a state decides to implement one or more allowance set-asides as part of its plan, even in the absence of the CEIP, a similar framework to the one summarized previously would likely be established in many cases.
These additional requirements include regulatory provisions that address the eligibility of resources for state allowance allocation under the CEIP, and the process for such allocation, including: Requirements for submission of eligibility applications, which include EM&V plans; requirements for EM&V; requirements for submission of periodic M&V reports; requirements for accreditation of independent verifiers; requirements for independent verifier reports (which must accompany both eligibility applications and M&V reports); and necessary tracking system capabilities that provide for the required two-step process for application for early action allowances that is consistent with the required two-step process for the issuance of ERCs.
In addition, the requirements for allocation of early action allowances under a state CEIP must include provisions for how allowances will be allocated based on the number of quantified and verified MWh reported by an eligible resource (
Where a state is implementing a rate-based emission trading program, the state plan will include necessary provisions for the issuance of ERCs, as previously described. These are the same requirements that are necessary to support state issuance of early action ERCs under the CEIP. As a result, the state plan would require limited additional requirements in order to implement the CEIP, beyond those required for a rate-based state plan in general. These additional requirements include provisions establishing the eligibility of projects under the CEIP and provisions to address maintenance of CO
The EPA is proposing that state plan requirements for the request of EPA matching allowances or ERCs must be consistent with the following process.
The EPA is proposing that it will establish an EPA matching allowance or ERC account for each state in the relevant tracking system for each state mass-based emission budget trading program (in the case of matching allowances) and rate-based emission trading program (in the case of matching ERCs). The EPA proposes to grant states the ability to transfer EPA matching allowances or ERCs from the EPA matching account, on behalf of the EPA, under the conditions described later in this preamble.
The state plan must specify the conditions under which the state will authorize such transfers of EPA matching allowances or ERCs from the EPA matching account to the designated account of an eligible CEIP project. Those state plan provisions must specify that a transfer of EPA matching allowances or ERCs may only occur subsequent to a state allocation or issuance of early action allowances or ERCs, in accordance with requirements for such state early action awards specified in the state plan; must be made in accordance with the award ratios established in the EGs (and specified in the state plan); and must correspond with the number of early action allowances or ERCs allocated or issued to an eligible CEIP project. The EPA is also proposing that, when awarding matching allowances or ERCs on behalf of the EPA, a state must assign a vintage for each awarded matching allowance or ERC that corresponds to the vintage of the related early action allowance or ERC on the basis of which the matching allowance or ERC was awarded.
The state plan must adequately describe how the tracking system used to administer the state mass-based emission budget trading program or rate-based emission trading program will provide transparent public access to transfers of EPA matching allowances or ERCs from the EPA matching account. This includes tracking system access to CEIP project documentation related to the state allocation or issuance of early action allowances or ERCs, respectively. Furthermore, the tracking system must provide a mechanism for tracking the awarded EPA matching allowances or ERCs back to the relevant CEIP project documentation, and documentation of the state award of early action allowances or ERCs for which the EPA matching award was made.
These state plan provisions must specify that the state will transfer EPA matching allowances or ERCs from the EPA matching account on a regular established schedule, and no sooner than 60 days from the date of the relevant state award of early action allowances or early action ERCs for an eligible CEIP project. Prior to this date, the EPA may place a hold on state transfers from the EPA matching account, if it has questions about the proper state allocation of early action allowances or issuance of early action ERCs consistent with the requirements and process established in the approved state plan, or if there is evidence of potential improper state awards. The EPA believes that this approach balances streamlined implementation of the CEIP with appropriate safeguards to ensure the integrity of the CEIP. The EPA requests comment on this provision to provide for a delay between allocation or issuance of early action allowances or ERCs and the award of matching allowances or ERCs.
The Clean Power Plan EGs require that states opting in to the CEIP include in their state plans a mechanism that ensures that the allocation of early action allowances or issuance of early action ERCs to CEIP-eligible parties will not impact the CO
Addressing maintenance of stringency under a mass-based state plan is straightforward. A state must address this plan requirement by implementing the CEIP through an allowance set-aside from the established state emission budget. Since allowances are being distributed from a finite emission budget, allocation of allowances from that budget for CEIP early actions cannot result in an increase in the allowable CO
For a rate-based emission trading program included in a state plan implementing the CEIP, addressing the plan requirement to maintain the stringency of CO
In this program context, the state is implementing the CEIP by issuing early action ERCs for MWh of generation or savings achieved by CEIP-eligible projects during 2020 and/or 2021, before the plan performance period begins in 2022.
State-issued early action ERCs for CEIP-eligible MWh generation or savings in 2020 and/or 2021 will result in a larger total number of potential ERCs available for use by affected EGUs than would have otherwise been available in the absence of the CEIP. As finalized in the EGs, a state plan must account for these early action ERCs during the plan performance period, or there will be an impact on the aggregate CO
As described later in this preamble, the EPA is proposing a specific presumptively approvable approach that rate-based states opting in to the CEIP may choose to use to meet the plan requirement to maintain the stringency of CO
The proposed presumptively approvable approach is as follows: A rate-based state opting in to the CEIP would apply an adjustment factor to all quantified and verified MWh from eligible ERC resources that are achieved during the first interim step (2022-2024) of the plan performance period, to account for the number of early action ERCs issued by a state under the CEIP for MWh achieved during 2020 and/or 2021. The state would apply this adjustment factor to the quantified and verified MWh reported by each eligible ERC resource, regardless of whether that resource received early action ERCs under the CEIP. This presumptively approvable approach would enable a state to fully account for the issuance of early action ERCs during the first interim step (2022-2024) of the plan performance period (
The adjustment factor to be used in the presumptively approvable approach is determined by the following equation:
This equation calculates the adjustment factor (a fraction) that a rate-based state opting in to the CEIP would apply to the total quantified and verified MWh reported to that state by each individual eligible ERC resource for actions undertaken during the first interim step of the plan performance period (2022-2024). Once applied, this factor “adjusts” the number of ERCs that an eligible ERC resource may receive for actions undertaken during the first interim step of the plan performance period, to account for the early action ERCs the state issued to CEIP-eligible providers for MWh achieved in 2020 and/or 2021.
The following is an example calculation of the adjustment factor, for a scenario that assumes that 300 early action ERCs are issued by a state under the CEIP, and that, during the year 2022 (the first year of the first interim step period), all eligible ERC resources report 1,000 MWh to the state:
Based on application of the adjustment factor, each eligible ERC resource would receive a number of ERCs equal to the MWh it reported, multiplied by the adjustment factor of 0.9. In aggregate, all eligible ERC resources would receive 900 ERCs total for the 1,000 MWh total they reported in 2022.
This proposed presumptively approvable approach for maintaining stringency in a rate-based program provides a number of advantages. First, the approach provides a transparent way of demonstrating that the number of ERCs issued by a state under the CEIP is being fully accounted for during the plan performance period. Second, the proposed approach applies the same adjustment factor to all eligible ERC resources. This approach would provide greater assurance that early action ERCs are fully accounted for during the plan performance period than if an adjustment was only applied to the eligible ERC resources that received early action ERCs. It is uncertain that there would be sufficient MWh of energy generation or savings achieved by these resources during the plan performance period to fully account for the early action ERCs that were issued to those individual CEIP projects and providers.
The EPA understands that there is a potential disadvantage to this approach. This method of applying the adjustment factor to all eligible ERC resources would reduce the number of ERCs issued to eligible ERC resources that did not participate in the CEIP, relative to their total quantified and verified MWh during the plan performance period. These eligible ERC resources would not have received early action incentives through the CEIP, yet would see a reduction in the potential incentives they could receive during the plan performance period. Nonetheless, the EPA also notes that such an incentive structure could provide further encouragement for projects and programs to participate in the CEIP, if it were implemented through a state plan.
The EPA seeks comment on this proposed presumptively approvable approach, including the timing for and duration of the adjustment period to be incorporated into the adjustment factor equation. The EPA also requests comment on alternative approaches the agency could consider as presumptively approvable methods to maintain the stringency of CO
A key element of the CEIP as finalized in the EGs is the establishment of incentives specific to projects implemented in low-income communities. As discussed in the final EGs, the additional incentive offered for low-income community projects is an effort to help overcome historical barriers to the deployment of energy efficiency projects in low-income communities (80 FR 64831). Incentivizing these projects will place affected EGUs in a better position to meet their emission reduction obligations under the EGs and improve the cost of implementation of the EGs, consistent with Congress' design in section 111 of the CAA. At the same time, the Agency believes that a focus on low-income communities will also deliver economic and environmental benefits to a more expansive set of underserved populations, including
Proposing how states may develop their definition of “low income community” is a critical part of this action. In the context of the CEIP, the EPA is interpreting the term “community” in a manner consistent with the Council on Environmental Quality's
In establishing requirements for a definition of “low-income community,” the EPA considered several key principles. One principle is a desire to establish requirements that are clear and easy for states to implement as they develop their plans. The EPA believes that use of existing federal, state, and local definitions will provide the most clarity and ease of implementation. Another principle for the Agency is that a state's definition should provide transparency and consistency for all stakeholders with an interest in the CEIP, including project providers and communities that may benefit from implementation of CEIP-eligible projects. To further these principles, the EPA emphasizes that, by establishing clear definitions for a “low-income community” in the state plan, a state can make the process easier to implement and more transparent for all parties. Additional guidance on low-income community project eligibility is discussed in section III.C of this preamble.
A state plan that includes implementation of the CEIP must establish eligibility requirements for projects under the CEIP, including a requirement that eligible CEIP low-income community projects must be implemented in a low-income community.
It is reasonable to enable a state to include more than one definition of “low-income” in its state plan, to allow eligibility for a range of different types of programs (
The EPA is proposing that these federal level definitions (NMTC, HUD Qualified Census Tracts, WAP, and the FPLG) are each presumptively approvable definitions that may be used in final state plans.
If a state includes more than one definition, it must have clear and consistent criteria for applying the multiple definitions. For instance, a state may use one definition for one type of program and another definition for another type of program, but it should not choose between the definitions for a specific program in such a way that would allow for arbitrary inclusion or exclusion of individual projects.
During the public outreach sessions on the CEIP in the fall of 2015, commenters raised concerns about the appropriateness of using state-based definitions. Specifically, some commenters stated that some state-specific definitions may either exclude some low-income electricity consumers or be overly inclusive of higher-income households or institutions that do not serve low-income residents. The EPA is requesting further comment on these
Additionally, some commenters have expressed concerns over needing appropriate safeguards to ensure that low-income communities are the beneficiaries of eligible CEIP energy-efficiency projects. Some commenters have suggested that states consider limiting the total population within a state that could be considered as `low-income'. Others have suggested that states consider evaluating the number of high-income households that would be included under their proposed definition of low-income. Another commenter asked that states consider whether restrictions on the types of commercial and transmission and distribution projects are appropriate, (
The EPA requests comments on the suitability for a federal plan of the existing federal definitions listed previously (specifically: NMTC, HUD Qualified Census Tracts, WAP, and the FPLG), as well as any existing state or local definitions for programs in that state. This would be consistent with the flexibility granted to states under a state plan, as discussed previously.
As a state contemplates possible definitions of “low-income community” it may be appropriate to consider the range of factors specific to the state that impact the energy burden
The EPA is proposing that state plans implementing the CEIP must include requirements for actions that will be taken if early action allowances or ERCs are improperly allocated or issued by the state.
The EPA is proposing that if a state or the EPA finds that any early action state allowances or ERCs have been improperly allocated or issued, then the EPA will bar award of matching allowances or ERCs to those projects that received improperly allocated or issued early action allowances or early action ERCs.
In the case where matching allowances or ERCs are awarded on the basis of improperly allocated or issued early action allowances or ERCs, the EPA is proposing that the EPA matching allowances or ERCs must be subject to requirements in a state plan that address improper allocation or issuance. The EPA has determined this approach is necessary because the EPA matching allowances or ERCs are compliance instruments that are indistinct from state-issued early action allowances or ERCs, and the award of the EPA matching instruments is predicated on the proper issuance of the state instruments. Both the state-issued compliance instrument and the EPA matching compliance instrument may be used by an affected EGU to comply with either a mass-based emission standard (allowances) or a rate-based emission standard (ERCs).
The EPA is proposing that state plans must include requirements specifying how improper allocation or issuance of early action allowances or ERCs will be addressed. The EPA is proposing that these plan requirements must apply to both state-allocated early action allowances and state-issued early action ERCs, as well as to the matching allowances or ERCs awarded by the EPA.
Where a state plan includes a rate-based emission trading program, the final Clean Power Plan EGs include requirements that a state plan must include provisions that address the improper issuance of ERCs.
We propose that these finalized EGs provisions (which have already been promulgated and are not being reopened) and the corresponding proposed model rule provisions, are equally appropriate and would suffice for purposes of improper state issuance of early action ERCs under the CEIP.
Thus, the EPA is proposing that where a state implements the CEIP, those same provisions addressing state-issued early action ERCs in an approvable plan must also apply to any related EPA-awarded matching ERCs. Where any early action ERCs are found to be improperly issued by a state, the same requirements must apply to the matching EPA ERCs awarded on the basis of the original state-issued ERCs.
Where a state plan includes a mass-based emission budget trading program, the EPA is proposing to amend the final Clean Power Plan EGs to require that a state plan must include provisions like those in a rate-based plan under the EGs to address the improper state allocation of early-action allowances under a state CEIP. While mass-based plans under the EGs are required to include provisions for adjustment in the case of incorrect allocations,
This is due to the availability of the matching allowances under the CEIP. State allocation of early action allowances under the CEIP is the necessary predicate for the award of EPA matching allowances, which would functionally expand the emission budget for affected EGUs under the state plan. These EPA matching allowances that are awarded to the state, if based on improper allocation by the state under its CEIP set aside, could potentially erode the integrity of a mass-based emission trading program under the Clean Power Plan.
Because of the distinctions between the impact of state-allocated early action allowances and the award of EPA matching allowances described previously, the EPA is proposing an approach for mass-based state plans where a state plan must include provisions comparable to the improper issuance provisions for ERCs in a rate-based program that apply to the EPA matching allowances. A state plan could include different requirements that apply for the improperly state-allocated early action allowances under the CEIP. Under this proposed approach, application of the improper allocation provisions in an approved state plan would be triggered based on a finding by the state or the EPA that early action allowances were improperly allocated by the state under the CEIP. The remedies under the improper allocation provisions would address the EPA matching allowances, which resulted in a functional expansion of the state emission budget.
In the final EGs, we specified certain criteria for eligible projects, including the date after which eligible RE projects must “commence construction” and the date after which eligible EE projects must “commence operation.” 40 CFR 60.5737. We requested comment in the proposed model trading rules and federal plan on what, if any, additional criteria should apply to determine eligibility for CEIP projects. 80 FR 65026. Accordingly, we are proposing to clarify the eligibility criteria for CEIP projects, guided by the objectives for the CEIP identified in the final Clean Power Plan,
We received significant input from a wide range of stakeholders about requirements for eligible CEIP projects. We considered this feedback carefully in developing this proposal. In this action, we propose to clarify the term “project” as used in the Clean Power Plan EGs for purposes of the CEIP. Additionally, in this action we propose to replace the definition of “commence construction” as applied to eligible RE projects, as well as to clarify the definition of “commence operations” as applied to eligible low-income EE projects. We are also proposing to remove the existing language from Section 60.5815, paragraph (c) of the Clean Power Plan EGs which pertained to EM&V requirements for the CEIP allowance set-aside, as duplicative, and we are clarifying and consolidating the EM&V requirements for eligible CEIP projects in this action.
The Clean Power Plan EGs specify that solar and wind, as well as low-income EE, “projects,” are eligible for the award of early action allowances and ERCs under the CEIP.
In this action the EPA is proposing to replace the term “commence construction” for CEIP-eligible RE projects with the term “commence commercial operation,” as well as to clarify the term “commence operations” for CEIP-eligible low-income community projects. The Agency believes that “commence commercial operation” is more consistent with the intent of the Clean Power Plan EGs. In addition, the Agency wishes to avoid any confusion with the term “commence construction” as used in other contexts under sections 111 and 112 of the CAA.
The Agency heard from several commenters during the CEIP outreach sessions and in comments submitted to the non-regulatory docket that “commence construction” could be understood to encompass such activities as entering into contracts for eligible RE projects. If this were the Agency's intent, according to these stakeholders, then the effect would be to render many RE projects ineligible as a result of early project development activities that may have occurred prior to the start date of eligibility. This was not the intent of the Agency, and we believe it is appropriate to correct this terminology to more accurately reflect the Agency's intent; that is, RE projects (including those in low-income communities) should be eligible to participate in the CEIP if they commence commercial operation on or after the eligibility start date. By replacing the term “commence construction” with “commence commercial operation,” the EPA would be taking an approach to eligibility for RE projects that is consistent with the
With respect to the term “commence operations” for CEIP-eligible demand-side EE projects implemented in low-income communities, the EPA is proposing to establish a definition that is consistent with the proposed replacement of “commence construction” with “commence commercial operation” discussed previously. That is, the EPA is proposing that the term “commence operations” be defined as the date that a CEIP-eligible low-income community demand-side EE project is delivering quantifiable and verifiable electricity savings.
In light of the proposed corrected terminology from “commenced construction” to “commenced commercial operations”, the EPA is proposing to revise the date for eligible CEIP RE projects (including those implemented in low-income communities) to commence commercial operation to January 1, 2020, or commence operations, in the case of low-income demand-side EE projects, to September 6, 2018. First, the proposal to no longer use the date of final state plan submittal as a potential eligibility start-date would remove a source of uncertainty given the Supreme Court's stay of the Clean Power Plan EGs in
Second, in the case of RE projects looking to become eligible CEIP projects, the date of January 1, 2020 for eligibility for projects that have commenced commercial operations reflects the initial intent of the timing finalized in the Clean Power Plan EGs. The previous language that based eligibility timing on when a project “commenced construction” considered the build-out time that would be required from the time of a project's initial conception. Since the CEIP is designed primarily to encourage additional renewable deployment, establishing a date of January 1, 2020 supports the overarching goal of the CEIP to encourage such deployment.
For eligible CEIP low-income community demand-side EE projects, some commenters have requested that the EPA should allow an expanded ramp-up period for projects. Commenters stated that while energy efficiency programs can be deployed quickly, adequate ramp-up time must be allowed to thoughtfully design and target programs, and to achieve desired levels of volume. The EPA agrees with this comment, and the additional time needed for adequate design and targeting of eligible CEIP low-income community demand-side EE projects is reflected in the eligibility date of September 6, 2018. Additionally, we agree with commenters' assertions that eligible CEIP low-income community demand-side EE projects need ramp-up time to ensure that they realize the full benefits of the CEIP following project deployment.
Given that the CEIP project eligibility approach included in the final Clean Power Plan EGs was tied to commencement of construction after submission of a state plan, and that there may be additional relevant factors not considered here, EPA seeks comment on whether the proposed approach described above, the approach included in the final Clean Power Plan EGs, or a combination of the two approaches, would best serve the goals of the CEIP.
3. Option to use an Agent for reviewing CEIP project applications, allocating early action allowances, and issuing early action ERCs. As discussed in section III.B of this preamble, a state plan that implements the CEIP must specify a process for application, and allocation/issuance of, early action allowances or ERCs under the CEIP to eligible project providers. The proposed rate- and mass-based model trading rules include related provisions that, when finalized, would constitute a presumptively approvable approach for meeting relevant EGs requirements (80 FR 64966-65116), and the EPA is proposing optional example provisions in this action to cross-reference those provisions under the CEIP.
This process, defined by the state in its plan requirements, may be implemented by the state itself, or alternatively the state may delegate this function to a qualified agent. The ability to rely on agents is discussed further in the final Clean Power Plan EGs at 80 FR 64906.
In the event of a federal plan, the EPA anticipates that it would serve the same role as the state, and thus the EPA, or an agent(s) it may designate, would review project applications and reports of quantified and verified MWh in advance of allocating early action and matching allowances, and issuing early action and matching ERCs to eligible project providers.
4. Eligible CEIP RE projects. In 40 CFR 60.5737 of the final EGs, the EPA established that eligible CEIP RE project types are those that “generate metered MWh from any type of wind or solar resources.” In order to streamline the requirements for eligible CEIP wind and solar resources, as well as to clarify the requirements for geothermal and
The limitation of eligible CEIP RE technologies to wind and solar in the Clean Power Plan EGs was based partially on the concern from commenters on the Clean Power Plan proposal that there could be an unintended shift in investment away from RE to natural gas, and partially on the fact that these technologies—in addition to being essential for longer-term climate strategies—generally can be deployed with shorter lead times than other technologies (
In addition, stakeholders have noted that other types of clean generating technologies, in addition to wind and solar, could be deployed during the CEIP timeframe,
The EPA believes that our initial determination of criteria for eligible technologies remains appropriate, and, therefore, are retaining those criteria. The criteria we identified in the final Clean Power Plan that drove our determination of eligible technology types for the CEIP were that they are zero-emitting and essential to longer term climate strategies, and require lead times of relatively shorter duration given the time-limited nature of the CEIP and to counteract the potential shift in investment from RE to natural gas in the lead up to the start of the interim performance period. See 80 FR 64831.
As noted in section II.D. of this preamble, some commenters requested that other RE technologies, including geothermal, biomass, hydropower, as well as other generating technologies such as combined heat and power (CHP) and waste heat to power (WHP) be considered as eligible technologies for the CEIP. While we do not believe that it is appropriate to expand the list of eligible CEIP technologies to include all those suggested by commenters, we believe that two other RE technologies, specifically geothermal and hydropower, meet the criteria for CEIP eligibility that were identified in the final CPP. Thus, in this action we are proposing to expand the list of CEIP-eligible RE technologies beyond wind and solar resources alone only to two other zero-emitting technologies: Geothermal and hydropower.
5. Eligible CEIP low-income community projects. The Clean Power Plan EGs established that demand-side energy efficiency projects implemented in low-income communities would be eligible for the two-to-one CEIP incentive. This section discusses eligible low-income EE projects, and also presents a proposal that solar projects implemented to serve low-income communities that provide direct electricity bill benefits to low-income ratepayers also be eligible for the two-to-one incentive.
Demand-side energy efficiency refers to an extensive array of technologies, practices and measures that are applied throughout all sectors of the economy to reduce electricity demand while providing the same, and sometimes better, level and quality of service.
The Department of Energy, in cooperation with industry, has developed a suite of quality assurance resources that address work quality, training and workforce certification. The EPA has also developed resources to assist program managers with implementing residential and commercial energy efficiency programs under the auspices of the ENERGY STAR program as well as resources that address indoor air quality and energy efficiency. These resources are applicable to all energy efficiency retrofit programs, including low-income, regardless of design, administration or scope. States are encouraged to consider use of DOE's
A number of states have already implemented successful low-income EE projects and programs that can serve as examples to other states as they consider the project types that may be possible through the CEIP. We present examples of two of these projects in section III.C of this preamble.
The EPA is proposing to include solar projects implemented to serve low-income communities that provide direct electricity bill benefits to low-income community ratepayers as eligible for the two-to-one matching award from the reserve established for low-income EE projects. This would be a change from the CEIP provisions included in the Clean Power Plan EGs, which limited projects eligible for the two-to-one match to low-income EE projects alone. However, during the outreach sessions in the fall of 2015, stakeholders suggested solar projects in low-income communities face many of the same barriers to deployment as do EE projects, and provide the same environmental benefit in terms of displacing carbon-emitting generation. Based on such input from stakeholders and other information, the EPA believes that solar technology—particularly distributed, rooftop, or community solar—is particularly well suited among zero-emitting RE resources to implementation in low-income communities, as it is relatively affordable compared to other distributed RE technologies, it is already widely available for installation, and the primary barriers to deployment are economic rather than technical. Enabling such projects to receive the two-to-one match would serve the same basic purpose of improving cost impacts and expanding compliance opportunities for affected EGUs under the Clean Power Plan. In addition, as discussed in section III.A of this preamble, the EPA's preliminary analysis shows that the MWh savings potential for eligible low-income EE projects is relatively low even with the CEIP as a driver, and as a result it may be appropriate to enable equally beneficial solar projects implemented in low-income communities to be eligible for awards from the matching allowance/ERC reserve for low-income community projects.
By including such provisions in the CEIP, any type of solar project implemented to serve a low-income community that provides direct electricity bill benefits to low-income community ratepayers would be eligible for a two-to-one award from the low-income community reserve of the matching pool.
Some of the types of solar projects that the EPA envisions could qualify for awards from the low-income community reserve include roof-top solar and community-owned solar projects.
The EPA solicits comment on the types of solar technologies and programs that could be eligible for the low-income community reserve of the matching pool, and how states may be able to determine benefits delivered to low-income community ratepayers. We also solicit comment on whether wind generation, geothermal, or hydropower may provide similar ratepayer benefits to low-income communities. The intent of the low-income community reserve in the matching pool is to make awards available to projects that provide direct electricity bill benefits to low-income ratepayers, and the EPA's objective is to
a. Examples of EE and RE projects implemented in low-income communities. This section presents three examples of low-income EE and RE programs currently underway in states around the country: Energy Outreach Colorado (EOC), the PECO Conservation Voltage Reduction Program, and the Multifamily Affordable Solar Housing (MASH) Program in California. These examples may be of assistance to states exploring the development of EE and RE programs in low-income communities.
The first example is EOC, an independent non-profit organization that works to ensure all Coloradans can meet their home energy needs through emergency bill payment and furnace repair assistance, energy efficiency improvements, consumer behavior change and advocacy for the energy needs of low-income households.
The second example is the PECO Conservation Voltage Reduction (CVR) program, a program implemented in the state of Pennsylvania to achieve load reductions through changes in voltage regulation parameters at the substation/transformer level.
The last example is the Multifamily Affordable Solar Housing (MASH) Program, overseen by the California Public Utilities Commission. This program has brought solar energy to thousands of multifamily building owners and tenants across the state. MASH offers an up-front rebate to offset the costs of new solar energy systems for qualified, existing multifamily low-income housing. The program uses “virtual net metering” to allow the tenants to benefit from lower electricity bills due to the energy generated by the solar energy system. From 2008 to 2015, MASH has led to the installation of more than 23 MW of solar capacity across nearly 360 projects
Many tribes have expressed interest in participating in the CEIP even though they do not have EGUs subject to the Clean Power Plan EGs. These tribes have the potential to develop RE and low-income community projects that could qualify as eligible CEIP projects. As finalized in the EGs, such projects would in general be able to apply and receive early action allowances or early action ERCs through state plans that include the CEIP. However, several tribes have expressed concern that requiring tribes to participate in the CEIP by applying for early action ERCs or allowances from CEIP-participating states would infringe upon their sovereign rights. In addition, some stakeholders have expressed concern that without explicit direction to deploy projects on tribal lands, project providers will opt to invest in CEIP-eligible projects only on the lands of CEIP-participating states, and not on tribal lands. Lastly, tribes have also expressed concern that in order to remain competitive in wind and solar deployment, they must consider CEIP participation as part of their strategy.
The EPA does not agree that the CEIP would result in an infringement on tribal sovereignty, because neither the Clean Power Plan nor the CEIP impose legal obligations on tribes without affected EGUs or authorize states to impose such obligations. Rather, the Clean Power Plan and the CEIP provide
Nonetheless, the EPA invites comment on an approach that may further enhance the ability of project providers located in Indian country without affected EGUs to participate in the CEIP. The approach for which we seek comment would be to include as a condition of participation in the CEIP a requirement that state plans may not disqualify an otherwise eligible CEIP project on the basis that it is located in Indian country or in any way apply different requirements to applications for CEIP projects located in Indian country. This approach would provide tribes and project developers in Indian country with assurance that their projects will be given the same consideration as all other projects that are located in or benefit a CEIP-participating state. In such a scenario, a project in Indian country would be eligible for an early action award from the state, and the complementary matching award from the EPA.
The EPA also invites comment on other possible approaches that may enable CEIP-eligible projects located in Indian country to participate in the CEIP.
As stated in the final Clean Power Plan, the EPA did not finalize emission guidelines for the fossil-fuel fired EGUs in Alaska, Hawaii, Guam or Puerto Rico because of the lack of suitable data and analytic tools needed to develop area-appropriate building block targets (
The EPA acknowledges that project providers that may be located in non-contiguous states and territories are interested in the opportunity to participate in the CEIP. The Agency recognizes that these projects should have opportunities and access to the same early action incentives as the contiguous states. However, the Agency believes such opportunities can only be available at the point that emissions guidelines are put in place for these jurisdictions. Projects in these non-contiguous jurisdictions are not connected to the contiguous U.S. electrical grid and cannot be said to be located in or benefit a CEIP state, and are thus ineligible to generate either ERCs or early action ERCs or early action allowances under the final Rule and this proposal. 40 CFR 60.5800(a)(2).
Nonetheless, the EPA anticipates making available CEIP participation for these remaining states and territories when the Agency finalizes emission guidelines for fossil-fuel fired EGUs in these states and territories. The EPA anticipates that matching allowances or ERCs for noncontiguous states and territories would be apportioned from the existing matching pool of 300 million short tons of CO
The EPA is taking comment on how to determine the appropriate portion of the matching pool that should be apportioned to the non-contiguous states and territories, if they choose to participate in the CEIP. The EPA could attempt to estimate the pro rata share of the matching pool for each of the non-contiguous states and territories with affected EGUs before the emission performance goals have been finalized for these jurisdictions. The Agency requests comment on approaches that could be used to estimate the appropriate share for these locations while their goals are still undetermined. Alternatively, the EPA could defer apportioning the matching allowances or ERCs to these states and territories until such time when their emission performance goals are established. At that future time, the matching shares would be calculated by applying the methodology described in this action and the matching shares apportioned to the contiguous states would be adjusted. The EPA is soliciting comments on both of these approaches.
For the contiguous U.S. states, the EPA is providing the opportunity for participation in the CEIP only for those states with approved state plans and those states that may become subject to a federal plan. Since states without affected EGUs do not have an obligation to submit a state plan for EPA approval under CAA section 111(d), there is no clear path for inclusion of these states in the CEIP.
However, eligible projects developed in those states without affected EGUs may apply for and receive early action allowances or ERCs from another state that has chosen to participate in the CEIP. The developers of such eligible RE and low-income community projects may receive early action allowances or ERCs from another state, so long as the project benefits the state providing the award and that state has an approved final plan establishing its participation in the CEIP. The final EGs recognized the potential CEIP eligibility of projects that “benefit” a state even if they are not located in that state. 80 FR 64830. In the Clean Power Plan, however, we did not explain what “benefit” means in the context of the CEIP. For purposes of the CEIP, we propose that “benefit” a state means that the electricity is generated or saved with the intention to meet or reduce electricity demand in the CEIP participating State.
This approach is intended to parallel the approach to providing ERCs to RE projects that are located in a mass-based plan state for use in compliance under a rate-based plan. 40 CFR 60.5800(a)(3)(ii). A project could meet this test by submitting documentation such as a power purchase agreement, see 80 FR 64913.
As discussed in the Clean Power Plan EGs, the additional incentive offered for low-income community projects by the CEIP, in addition to supporting affected EGU compliance and reducing costs by rewarding emission reduction measures that occur earlier than the performance period under the EGs, will help overcome historic barriers to the deployment of energy efficiency and solar projects in low-income communities. Bringing these energy efficiency and solar projects to low-income communities can also provide low-income ratepayer benefits (80 FR 64831).
In response to stakeholder concerns during the outreach session that the program does not explicitly direct its benefits towards EJ communities, the EPA examined the characteristics of different communities that may benefit from the CEIP, and our analysis demonstrates that by making EE projects in low-income communities eligible for the CEIP, the projects can also provide benefits to other underserved populations, including minority communities. A complete discussion of the methodology and results reported in this section is available in the TSD to this action titled “Community and Environmental Justice Considerations”.
We performed two analyses to look at how minority populations could be assisted by energy efficiency projects or programs that may be located in low-income populations.
For the first analysis we examined, on a national level, the relationship between low-income and minority populations. Income and race data are drawn from the U.S. Census Bureau's Report, Income and Poverty in the United States: 2014.
While the first analysis focused on the overlap between income and race at the national-level, we also investigated the geographic overlap between low-income and minority populations, because, as noted in section III.B of this preamble, the EPA expects that both household-based definitions and geographically-based definitions may be used to identify eligible projects in “low-income communities”. The second analysis compares demographic data by Census block group using the 2008-2012 American Community Survey (ACS) five-year summary file, available through EPA's EJSCREEN tool.
In the second approach, for each state, we used the pre-calculated means for low-income and minority populations in that state, available in the EJSCREEN data files. We compared the share of the population that is low-income or minority in each block group to that state's mean. If a block group exceeded the state mean for low-income or minority, then it was considered low-income or minority, respectively. We found that 70 percent of minority block groups are also low-income, which is the same as was found using the national percentages.
These analyses support a conclusion that providing fully one half of the CEIP incentives to the low-income community reserve will provide additional benefits to EJ communities, and will be an important tool to bring the public health and economic advantages of clean energy to traditionally overburdened communities. We welcome comments on this analysis and the elements of the CEIP from this perspective.
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. This action raises novel legal or policy issues. As noted earlier, the EPA took final action in the Clean Power Plan to establish the framework for the CEIP, while identifying other design details that it would address in a future action. For example, in the final Clean Power Plan, the Agency established the CEIP framework, including the overall size of the matching pool available to CEIP-participating states and the matching award the EPA will make to qualifying RE and low-income community projects per MWh of electricity generation or savings.
This action proposes design details of the CEIP that are consistent with the framework established in the final Clean Power Plan. Given that the framework of the CEIP has already been established in the Clean Power Plan EGs, the design details proposed in this action are not expected to result in significant costs, benefits, or economic impacts, beyond those associated with the Clean Power Plan EGs.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. As previously discussed, the CEIP is an optional program that offers incentives for voluntary early actions involving RE and low-income energy efficiency. This action will not impose any requirements on small entities. Instead, this action proposes requirements that would need to be met by states in the event that states voluntarily opt into the CEIP under the Clean Power Plan. In the event of a federal plan, EPA continues to intend that it would implement the CEIP directly. Even where a state chooses to participate in the CEIP, small entities would not be subject to requirements except to the extent that they wish to voluntarily apply to receive early action ERCs or allowances, in which case certain conditions would apply.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The costs involved in this action are imposed only by voluntary participation in an optional program. UMRA generally excludes from the definition of “federal intergovernmental mandate” duties that arise from participation in a voluntary federal program.
This proposed rule does not have federalism implications. The EPA believes, however, that this proposed rule may be of significant interest to state and local governments. Consistent with the EPA's policy to promote communications between the EPA and state and local governments, the EPA consulted with state and local officials early in the process of developing the Clean Power Plan EGs to permit them to have meaningful and timely input into its development.
This action does not have tribal implications as specified in Executive Order 13175. There are no substantial costs imposed on tribes, and no actions taken that preempt tribal law. Thus, consultation under Executive Order 13175 is not required for this action.
Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, the EPA consulted with tribal officials during the development of this action. The EPA invited all tribes to government-to-government consultations and held consultations with the Forest County Potawatomi Indian Community, Navajo Nation, Ute Tribe of Uintah and Ouray Reservation, Blue Lake Rancheria and Gila River Indian Community. We also held technical and informational meetings with the Navajo Nation and the Ute Tribe of Uintah and Ouray Reservation. Additionally, the EPA held outreach and information workshops geared towards tribal audiences in Las Vegas, NV, Farmington, NM, and Tuba City, AZ.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not meet the definition in section 2-202.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. The CEIP was finalized in the final Clean Power Plan, and this action provides design details for the program. The design details do not incorporate any provisions that are expected to have any adverse energy impacts.
This rulemaking does not involve technical standards.
The EPA believes that this action will not have disproportionately high and adverse human health or environmental effects on minority populations, low-income populations, and/or indigenous peoples as specified in Executive Order 12898 (59 FR 7629; February 16, 1994) establishes federal executive policy on EJ. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make EJ part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. The EPA defines EJ as the fair treatment and meaningful involvement of all people regardless of race, color, national origin, or income with respect to the development, implementation, and enforcement of environmental laws, regulations, and policies.
The EPA has conducted extensive outreach and engagement with EJ and tribal communities as we have developed this proposed rule. Section V of this preamble, titled Community and Environmental Justice Considerations, provides details on the outreach and engagement efforts conducted. The goal of these efforts was two-fold: First, the Agency sought to provide EJ and tribal communities with background information on the CEIP; and second, the Agency sought input from both groups on key provisions of the program.
Whereas one priority of the CEIP is to overcome barriers to deployment of energy efficiency projects in low-income communities, thus, achieving emission reductions and providing compliance benefits to affected EGUs by providing these incentives in low-income communities, we believe that there will be considerable benefits provided to EJ and tribal communities. Our analysis indicates that by making the CEIP available to low-income populations, there is a significant segment of the population identified as minority, linguistically isolated, less than high school diploma, or under age 5 or over age 64 (factors typically considered when assessing EJ concerns), that are also potentially eligible to benefit from the CEIP. The full EJ analysis conducted for this proposal is summarized in section V of this preamble and details can be found in the document,
Environmental protection, Administrative practices and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
Environmental protection, Administrative practices and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I, part 60 of the Code of Federal Regulations is proposed to be amended and title 40, chapter I, part 62 of the Code of the Federal Regulations, as proposed to be amended at 80 FR 64966, October 23, 2015, is proposed to be further amended as follows:
42 U.S.C. 7401
(a) This section establishes the Clean Energy Incentive Program (CEIP). Participation in this program is optional. Under the CEIP, States may allocate early action allowances or issue early action emission rate credits (ERCs) to projects in paragraphs (a)(1) and (2) of this section.
(1) Early action allowances or ERCs may be issued to Eligible CEIP renewable energy (RE) projects that generate electricity during calendar years 2020 or 2021.
(2) Early action allowances or ERCs may be issued to eligible CEIP low-income community projects that reduce electricity end-use or generate electricity and serve a low-income community during calendar years 2020 or 2021.
(b) For the CEIP the matching pool of allowances and ERCs for each State is specified in Tables 5 and 6 of this subpart.
(1) A State that participates in the CEIP, in accordance with the requirements of this section, will award on behalf of the EPA, matching allowances or ERCs, as applicable under its plan, from the State's apportioned matching allowances or ERCs specified in Tables 5 or 6 of subpart UUUU, as applicable.
(2) Each State's apportionment in tables 5 and 6 of this subpart is divided into a reserve of matching allowances or ERCs that may be awarded to eligible CEIP RE projects, and a reserve that may be awarded to eligible CEIP low-income community projects. Matching allowances or ERCs in each reserve may be awarded by a State on behalf of the EPA only for the eligible CEIP project type specified for the reserve.
(3) Any matching allowances or ERCs that are not awarded by January 1, 2023 will be retired by the EPA.
(c) If you participate in the CEIP, your plan must include the requirements in paragraphs (c)(1) through (10) of this section.
(1) Requirements that define the CEIP projects that will be eligible under your State's CEIP and that meet the requirements included in paragraphs (d) and (e) of this section.
(2) Requirements that restrict early action allowances to be allocated, or early action ERCs to be issued, only for electricity generation or savings achieved by eligible CEIP projects on or after January 1, 2020, and no later than December 31, 2021.
(3) Requirements for the process for the allocation of early action allowances, or the issuance of early action ERCs, to eligible CEIP projects that meet the requirements of § 60.5805 for ERC eligible resources.
(4) Requirements for a tracking system that meets the requirements of § 60.5810 in the case of a rate-based plan or § 60.5820 in the case of a mass-based plan.
(5) Requirements for EM&V plans that meet the requirements of § 60.5830.
(6) Requirements for monitoring and verification (M&V) reports that meet the requirements of § 60.5835.
(7) A mechanism that ensures that the issuance of early action allowances or ERCs would have no impact on the emission performance by affected EGUs required to meet rate-based or mass-based emission standards during the interim and final performance periods. Where a state issues early action ERCs, the mechanism must account for the issued early action ERCs on a one-for-one basis during the first step of the interim period.
(8) The definition(s) of “low-income community” you will apply to determine eligibility of CEIP low-income community projects. You must select a definition(s) that exists under a federal law, or under a state or local law in your state, or under a utility-administered program in your state, as of October 23, 2015. Routine updates of underlying federal, state or local data do not constitute a new definition for the purposes of this section.
(i) You may select different definitions for low-income community eligibility that consider geographic scale and/or different types of projects, but you must apply the selected definitions consistently across the State.
(ii) [Reserved]
(9) Requirements for recordkeeping and reporting that are consistent with the applicable requirements in § 60.5860(c) and (d). Where requirements at § 60.5860(c) refer to ERCs, such requirements must also apply, as applicable under your plan, to early action ERCs, matching ERCs, early action allowances, and matching allowances under the CEIP. Where requirements in § 60.5860(d) refer to ERCs or allowances, such requirements must also apply, as applicable under your plan, to early action ERCs, matching ERCs, early action allowances, and matching allowances under the CEIP.
(10) Your plan must not prohibit an eligible CEIP project from receiving early action ERCs or allowances on the basis that the project is located in Indian country.
(d) An RE project must meet the requirements in paragraphs (d)(1) through (4) of this section to be considered an eligible CEIP RE project.
(1) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(2) The project must either:
(i) Be located in a State participating in the CEIP, including Indian country within the borders of a State participating in the CEIP; or
(ii) Benefit a State participating in the CEIP or Indian country within the borders of a State participating in the CEIP.
(3) The project must commence commercial operation on or after January 1, 2020.
(4) The project must generate electricity from a wind, solar, geothermal, or hydropower RE resources, measured in MWh consistent with the requirements of 60.5830(c)(1).
(e) A low-income community demand-side EE project must meet the requirements of paragraphs (e)(1) through (5) of this section to be
(1) The project must save electricity in residences or buildings that are connected to the electric grid in the contiguous United States.
(2) The project must either:
(i) Be located in a State participating in the CEIP, including Indian country within the borders of a State participating in the CEIP; or
(ii) Benefit a State or Indian country within the borders of a State participating in the CEIP.
(3) The project must commence operation on or after September 6, 2018.
(4) The project must save electricity measured in MWh consistent with the requirements of § 60.5830(c)(2).
(5) The project must be implemented in a “low-income community” as defined in your plan for purposes of the CEIP and consistent with the requirements in paragraph (c)(8) of this section.
(6) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(7) The project must commence commercial operation on or after January 1, 2020.
(8) The project is a solar RE resource and is implemented to serve a low-income community, by providing direct electricity bill benefits to low-income community ratepayers. Such a project would be eligible for an award from the low-income community reserve of the matching pool for the energy generation that exclusively benefits low-income ratepayers, measured in MWh consistent with the requirements of § 60.5830(c)(1).
(f) Upon the EPA's approval of your plan that includes approved CEIP provisions, or upon promulgation of a federal plan for your State that includes the CEIP, the EPA will deposit your apportioned matching allowances or ERCs, as listed in tables 5 and 6 of subpart UUUU, into an account within your EPA-approved or EPA-administered tracking system. Following your allocation or issuance of early action allowances or ERCs to an eligible CEIP project provider, you must then award to the project provider matching allowances or ERCs on behalf of the EPA, according to paragraphs (f)(1) through (3) of this section.
(1) You must award matching allowances or ERCs on behalf of the EPA from your account no sooner than 60 days following State allocation or issuance of early action allowances or ERCs to a project provider.
(2) The EPA retains the authority to obtain documentation from you at any time to determine that your allocation of early action allowances or issuance of early action ERCs is in accordance with the requirements of this section.
(3) The EPA retains the authority to place a hold on your account, preventing the award of matching allowances or ERCs to an eligible CEIP project provider, if the EPA believes that you did not allocate early action allowances or issue early action ERCs in accordance with the requirements of this section.
(g) You must allocate early action allowances or issue early action ERCs, and you must award matching allowances or award matching ERCs on behalf of the EPA, according to paragraphs (g)(1) and (2) of this section.
(1) Allocation of early action allowances and award of matching allowances, is based on a 0.8 short ton of CO
(i) For eligible CEIP RE projects, you must calculate early action allowances and matching allowances to be allocated and awarded to the project provider according to the following equations:
(ii) For eligible CEIP low-income community projects, you must calculate early action allowances and matching allowances to be allocated and awarded to the project provider according to the following equations:
(2) Early action and matching ERCs will be issued and awarded such that:
(i) For every two MWh of electricity generated by an eligible CEIP RE project, you must issue one early action ERC to the project provider, and award on behalf of the EPA one matching ERC to the project provider.
(ii) For every two MWh in end-use electricity savings achieved by an eligible CEIP low-income community project, you must issue two early action ERCs to the project provider, and award on behalf of the EPA two matching ERCs to the project provider.
(3) A State may only allocate early action allowances from its established emission budget for the 2022-2024 interim step period.
(4) When awarding matching allowances or ERCs on behalf of the EPA, a State must assign a vintage for each awarded matching allowance or ERC that corresponds to the vintage of the related early action allowance or ERC on the basis of which the matching allowance or ERC was awarded.
(5) A State may only allocate or issue early action allowances or ERCs to eligible CEIP projects in a total amount not to exceed the number of matching allowances or ERCs apportioned to the State in Tables 5 or 6 of this subpart.
(d) Your plan must require the owner or operator of an affected EGU covered by your plan to include in a report submitted to you at the end of each compliance period the information in paragraphs (d)(1) through (6) of this section.
* * *
(6) If the owner or operator of an affected EGU is complying with an emission standard by using allowances, they must include in the report a list of all unique allowance serial numbers that were retired in the compliance period, and, for each allowance, the date an allowance was surrendered and retired.
(e) If your plan includes the CEIP, you must keep records of all information relied upon in support of any demonstration of CEIP requirements and supporting documentation, including records of all data submitted by a CEIP project provider, and submitted by the owner or operator of each affected EGU, that is used to determine compliance with each affected EGU emission standard or requirements in an approved State plan, consistent with the affected EGU requirements listed in § 60.5860. You must keep such records at a minimum for 10 years from the date the record is submitted to you. Each record must be in a form suitable and readily available for expeditious review.
(a) In lieu of the annual report required under § 60.25(e) and (f) of this part, you must report the information in paragraphs (b) through (f) and, if your plan includes the CEIP, (i) of this section.
(h) If your plan includes the CEIP, you must submit a report that includes the following information due no later than July 1, 2023: A list of all unique early action emission rate credit or early action allowance serial numbers that were issued or allocated by you for MWh from eligible CEIP projects from January 1, 2020 through December 31, 2021 (including all matching emission rate credit or allowance serial numbers) and identification information about each CEIP project sufficient to demonstrate that it is qualified to be issued or allocated such early action emission rate credits or early action allowances, and any other information specified in your plan.
42 U.S.C. 7401
(a) The CEIP will be administered according to the procedures in this section and those sections hereby cross-referenced in this section if the State elects to participate in the CEIP program. If the State does not elect to participate in the CEIP, the provisions
(b) The State will allocate early action allowances for electricity generation or savings achieved in the calendar years 2020 or 2021 to eligible CEIP projects that meet the requirements of § 62.16245 (c)(2) to be classified as an eligible CEIP RE project or eligible CEIP demand-side EE project.
(c) The State will allocate early action allowances to eligible CEIP projects up to the amounts specified for the Renewable Energy Reserve and the Low-Income Community Reserve, respectively, for the State in Table 4 of this subpart and pursuant to the requirements set forth in § 62.16235(e).
(d) The State will award matching allowances on behalf of the EPA from the State's account of matching allowances. Matching allowance awards will be made according to the ratio set forth in paragraph (e) of this section, and in an amount up to the amounts specified for the Renewable Energy Reserve and Low-Income Community Reserve, respectively, for the State as established in Table 5 of subpart UUUU of Part 60 of this chapter.
(e) The State will allocate early action allowances and award matching allowances on behalf of the EPA as follows. Allocation of early action allowances and award of matching allowances, is based on a 0.8 short ton of CO
(1) For eligible CEIP RE projects, early action allowances and matching allowances to be allocated and awarded to the project provider will be calculated according to the following equations:
(2) For eligible CEIP low-income community projects, the State will calculate early action allowances and matching allowances to be allocated and awarded to the project provider according to the following equations:
(e) The state will set aside a portion of allowances for a Clean Energy Incentive Program Set-Aside covered under this subpart. The Clean Energy Incentive Program Set-Aside will contain the amount of allowances for the state shown in Table 4 of this section. Such amount will be reserved from the state's total emission budget for the first compliance period (2022-2024) as established in Table 1 of this subpart.
(b) * * *
(3)
(c)(1)
(2)
(i) An eligible CEIP RE project is a project that meets the requirements of paragraphs (c)(2)(i)(A) through (D) of this section.
(A) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(B) The project must either:
(C) The project must commence commercial operation on or after January 1, 2020.
(D) The project must generate electricity from a wind, solar, geothermal, or hydropower RE resources, measured in MWh consistent with the requirements of § 62.16260(c)(1) or (2) as applicable.
(ii) A low-income community demand-side EE project must meet the requirements of paragraphs (c)(2)(ii)(A) through (E) of this section to be considered an eligible CEIP low-income community project. A low-income community renewable energy project must meet the requirements of paragraphs (c)(2)(ii)(B) and (c)(2)(ii)(E) through (H) of this section to be considered an eligible CEIP low-income community project.
(A) The project must save electricity in residences or buildings that are connected to the electric grid in the contiguous United States.
(B) The project must either:
(C) The project must commence operation on or after September 6, 2018.
(D) The project must save electricity measured in MWh consistent with the requirements of § 62.16260(c)(7).
(E) The project must be implemented in a “low-income community” as defined under paragraph (c)(2)(iii) of this section.
(F) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(G) The project must commence commercial operation on or after January 1, 2020.
(H) The project is a solar RE resource and is implemented to serve a low-income community, by providing direct electricity bill benefits to low-income community ratepayers. Such a project would be eligible for an award from the low-income community reserve of the matching pool for the energy generation that exclusively benefits low-income ratepayers, measured in MWh consistent with the requirements of § 60.5830(c)(1) of this chapter.
(iii) For an eligible CEIP low-income community project, the project eligibility application must identify which one of the following definitions is used to establish the “low-income community” that the project will serve:
(A) The definition of low-income used by the New Market Tax Credit Program;
(B) The definition of low-income used by the Department of Housing and Urban Development's Qualified Census Tracts;
(C) The definition of low-income used by the Department of Energy's Weatherization Assistance Program Income Guidelines; or
(D) The definition of low-income used by the Federal Poverty Level Guidelines.
(3)
(4)
(i)
(A) Identification of the authorized account representative of the eligible CEIP project, including the authorized account representative's name, address, email address, telephone number, and allowance tracking system account number;
(B) Project identification information under paragraph (a)(3)(i)(B) of this section, to the extent applicable, and information demonstrating that the project meets the criteria of paragraph (c)(2) of this section, and paragraph (a)(2)(v) of this section;
(C) Certification required under paragraph (a)(3)(ii)(C) of this section;
(D) An EM&V plan required under paragraph (a)(3)(ii)(D) of this section that meets the requirements of § 62.16260;
(E) Verification report from an accredited independent verifier who meets the requirements of § 62.16275 and § 62.16280 and that meets the requirements of paragraph (a)(3)(ii)(E) of this section and § 62.16270.
(F) The authorization under paragraph (a)(3)(ii)(F) of this section;
(G) The statement required under paragraph (a)(3)(ii)(G) of this section.
(ii)
(5)
(6)
(7)
(8)
(a) The Clean Energy Incentive Program (CEIP) will be administered according to the procedures in this section and those sections hereby cross-referenced in this section if the State elects to participate in the CEIP. If the state does not elect to participate in the CEIP, the provisions included in this section and those sections hereby cross-referenced in this section, solely with respect to implementation of a CEIP, shall not apply.
(b) The state will issue early action ERCs for electricity generation or savings achieved in the calendar years 2020 or 2021 to eligible CEIP projects that meet the requirements of § 62.16435 (d) to be classified as an eligible CEIP RE project or an eligible CEIP low-income community project.
(c) The state will issue early action ERCs to eligible CEIP projects up to the amounts specified for the Renewable Energy Reserve and the Low-Income Reserve, respectively, for the State in Table 4 of this subpart and pursuant to the requirements set forth in this section.
(d) The state will award matching ERCs on behalf of the EPA from the State's account of matching ERCs. Matching ERC awards will be made according to the ratio set forth in paragraph (e) of this section, and in an amount up to the amounts specified for the Renewable Energy Reserve and Low-Income Reserve, respectively, for the state as established in Table 6 of subpart UUUU of Part 60 of this chapter.
(e) The issuance of early action ERCs by the state, and the award of matching ERCs by the state on behalf of the EPA, will be executed according to paragraphs (e)(1) and (2) of this section.
(1) For eligible CEIP RE projects that generate metered MWh of electricity: For every two MWh generated, the project will receive one early action ERC and one matching ERC.
(2) For eligible CEIP low-income community projects: For every two MWh in end-use electricity savings achieved or for every two MWh of electricity generated, the project will receive two early action ERCs and two matching ERCs.
(f) The process for ERC issuance provided in § 62.16445, the requirements for evaluation, measurement, and verification in § 62.16455, the requirements for monitoring and verification reports in § 62.16460, the requirements for independent verifiers in §§ 62.16470 through 62.16480, and the requirements for verification reports in § 62.16465, shall apply to the issuance of early action ERCs to eligible CEIP projects and shall also be the basis for the award of matching ERCs to eligible CEIP projects.
(1) The process for revocation of qualification status under § 62.16440 shall apply.
(2) The process for error adjustments or misstatement, and suspension of ERC issuance under § 62.16450 shall apply.
(3) The reporting requirements of § 62.16555 and the recordkeeping requirements of § 62.16560 shall apply with respect to both early action ERCs issued by the state and matching ERCs awarded by the state on behalf of the EPA.
(g) To account for the State issuance of early action ERCs to eligible CEIP projects, the quantified and verified MWh from any eligible resource during the first interim step period (2022 through 2024) that are the basis for the issuance of ERCs will be adjusted according to paragraphs (g)(1) and (2) of this section.
(1) Quantified and verified MWh reported by an eligible resource will be multiplied by an adjustment factor calculated in accordance with paragraph (g)(2) of this section. When applying the adjustment factor, the calculated number of MWh for which ERCs may be issued by the State is rounded down to the nearest integer.
(2) The adjustment factor will be determined by the following equation:
(d)(1) If a State chooses to establish a CEIP under § 62.16431, then eligible CEIP projects are those that meet the requirements of paragraph (d)(2) of this section.
(2) To be eligible to receive early action ERCs from the CEIP, and related EPA matching ERCs, an eligible CEIP project must meet the requirements in paragraph (d)(2)(i) of this section for an eligible CEIP RE project and paragraph (d)(2)(ii) of this section for an eligible CEIP low-income community project. Any project that does not meet the applicable requirements of paragraphs (d)(2)(i) or (ii) of this section cannot be issued early action ERCs and awarded related EPA matching ERCs.
(i) An eligible CEIP RE project is a project that meets the requirements or paragraphs (d)(2)(i)(A) through (D) of this section.
(A) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(B) The project must either:
(C) The project must commence commercial operation on or after January 1, 2020.
(D) The project must generate electricity from a wind, solar, geothermal, or hydropower RE resources, measured in MWh consistent with the requirements of § 62.16455(c)(1) or (2), as applicable.
(ii) A low-income community demand-side EE project must meet the requirements of paragraphs (d)(2)(ii)(A) through (E) of this section to be considered an eligible CEIP low-income community project. A low-income community renewable energy project must meet the requirements of paragraphs (d)(2)(ii)(B) and (d)(2)(ii)(E) through (H) of this section to be considered an eligible CEIP low-income community project.
(A) The project must save electricity in residences or buildings that are connected to the electric grid in the contiguous United States.
(B) The project must either:
(C) The project must commence operation on or after September 6, 2018.
(D) The project must save electricity measured in MWh consistent with the requirements of § 62.16455(c)(7).
(E) The project must be implemented in a “low-income community” as defined under paragraph (d)(2)(iii) of this section.
(F) The project must be connected to and deliver energy to the electric grid in the contiguous United States.
(G) The project must commence commercial operation on or after January 1, 2020.
(H) The project is a solar RE resource and is implemented to serve a low-income community, by providing direct electricity bill benefits to low-income community ratepayers. Such a project would be eligible for an award from the low-income community reserve of the matching pool for the energy generation that exclusively benefits low-income ratepayers, measured in MWh consistent with the requirements of § 60.5830(c)(1) of this chapter.
(iii) For an eligible CEIP low-income community project the project eligibility application must identify which one of the following definitions is used to establish the “low-income community” that the project will serve:
(A) The definition of low-income used by the New Market Tax Credit Program;
(B) The definition of low-income used by the Department of Housing and Urban Development's Qualified Census Tracts;
(C) The definition of low-income used by the Department of Energy's Weatherization Assistance Program Income Guidelines; or
(D) The definition of low-income used by the Federal Poverty Level Guidelines.
(g)
Category | Regulatory Information | |
Collection | Federal Register | |
sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
Publisher | Office of the Federal Register, National Archives and Records Administration |