| Page Range | 22511-22909 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 22650 - Sunshine Act Meeting | |
| 81 FR 22594 - Sunshine Act Meeting | |
| 81 FR 22628 - Notice of Availability of the Final Environmental Impact Statement for the Continental Divide-Creston Natural Gas Development Project, Wyoming | |
| 81 FR 22595 - Sunshine Act Meeting; Board Member Meeting | |
| 81 FR 22567 - Announcement of Grant Application Deadlines and Funding Levels | |
| 81 FR 22623 - Accreditation of Dixie Services Inc., as a Commercial Laboratory | |
| 81 FR 22583 - Announcement of an Open Public Meeting | |
| 81 FR 22624 - Accreditation and Approval of Oiltest, Inc., as a Commercial Gauger and Laboratory | |
| 81 FR 22639 - National Commission on Forensic Science Solicitation of Applications for Additional Commission Membership To Support Digital Evidence | |
| 81 FR 22575 - Order Denying Export Privileges | |
| 81 FR 22576 - Order Denying Export Privileges | |
| 81 FR 22700 - Marine Highway Projects Open Season | |
| 81 FR 22580 - National Wetland Plant List | |
| 81 FR 22625 - Agency Information Collection Activities: Prior Disclosure | |
| 81 FR 22575 - Foreign-Trade Zone (FTZ) 183-Austin, Texas; Authorization of Proposed Production Activity, Samsung Austin Semiconductor, L.L.C., Subzone 183B, (Semiconductors), Austin, Texas | |
| 81 FR 22575 - Foreign-Trade Zone (FTZ) 20-Newport News, Virginia; Authorization of Proposed Production Activity, Canon Virginia, Inc., Subzone 20D, (Toner Cartridges and Bottles); Newport News, Virginia | |
| 81 FR 22577 - Calcium Hypochlorite From the People's Republic of China: Rescission of Countervailing Duty Administrative Review; 2014-2015 | |
| 81 FR 22595 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 81 FR 22580 - Endangered and Threatened Species; Take of Anadromous Fish | |
| 81 FR 22578 - Narrow Woven Ribbons With Woven Selvedge From Taiwan; Final Results of Antidumping Duty Administrative Review; 2013-2014 | |
| 81 FR 22520 - Orders: Reporting by Regulated Entities of Stress Testing Results as of December 31, 2015; Summary Instructions and Guidance | |
| 81 FR 22700 - Notice of Request To Release Airport Property | |
| 81 FR 22620 - Tobacco Farm Site Tours Program | |
| 81 FR 22615 - Radiation Biodosimetry Medical Countermeasure Devices; Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 22525 - Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers | |
| 81 FR 22626 - Agency Information Collection Activities: Application for Travel Document (Carrier Documentation), Form I-131A; New Collection | |
| 81 FR 22546 - Drawbridge Operation Regulation; Isle of Wight (Sinepatuxent) Bay, Ocean City, MD | |
| 81 FR 22627 - Notice of Realty Action: Recreation and Public Purposes Act Classification, Clark County, NV (N-80613) | |
| 81 FR 22608 - AbbVie Inc.; Withdrawal of Approval of New Drug Applications for ADVICOR and SIMCOR | |
| 81 FR 22619 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Inspection by Accredited Persons Program | |
| 81 FR 22702 - Proposed Agency Information Collection Activities; Comment Request | |
| 81 FR 22514 - Energy Conservation Program for Consumer Products and Certain Commercial and Industrial Equipment: Determination of Portable Air Conditioners as a Covered Consumer Product | |
| 81 FR 22592 - Information Collection Being Submitted for Review and Approval to the Office of Management and Budget | |
| 81 FR 22593 - Information Collections Being Reviewed by the Federal Communications Commission Under Delegated Authority | |
| 81 FR 22549 - Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph Proposed Rule; Reopening of the Comment Period | |
| 81 FR 22612 - AbbVie Inc. et al; Withdrawal of Approval of Indications Related to the Coadministration With Statins in Applications for Niacin Extended-Release Tablets and Fenofibric Acid Delayed-Release Capsules | |
| 81 FR 22548 - Appliance Standards and Rulemaking Federal Advisory Committee: Notice of Open Meetings for the Dedicated Purpose Pool Pumps (DPPP) Working Group To Negotiate a Notice of Proposed Rulemaking (NOPR) for Energy Conservation Standards | |
| 81 FR 22585 - SeaOne Gulfport, LLC; Application for Long-Term, Multi-Contract Authorization To Export Natural Gas Contained in Compressed Gas Liquid to Non-Free Trade Agreement Countries | |
| 81 FR 22549 - Country-by-Country Reporting; Hearing | |
| 81 FR 22606 - Public Meeting on Patient-Focused Drug Development for Neuropathic Pain Associated With Peripheral Neuropathy | |
| 81 FR 22614 - Public Meeting on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use | |
| 81 FR 22610 - Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability | |
| 81 FR 22611 - Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability | |
| 81 FR 22617 - Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability | |
| 81 FR 22649 - Agency Information Collection Activities; Proposed Collections; Comment Request | |
| 81 FR 22544 - Special Local Regulation, Daytona Beach Grand Prix of the Seas; Atlantic Ocean, Daytona Beach, FL | |
| 81 FR 22648 - Agency Information Collection Activities: Account Based Disclosures in Connection With Truth in Savings; Comment Request | |
| 81 FR 22602 - Submission for OMB Review; Use of Project Labor Agreements for Federal Construction Projects | |
| 81 FR 22604 - Submission for OMB Review; Central Contractor Registration | |
| 81 FR 22601 - Submission for OMB Review; Taxpayer Identification Number Information | |
| 81 FR 22603 - Submission for OMB Review; Accident Prevention Plans and Recordkeeping | |
| 81 FR 22698 - Agency Information Collection Activities: Proposed Request and Comment Request | |
| 81 FR 22707 - Special Medical Advisory Group, Notice of Meeting | |
| 81 FR 22651 - Business and Operations Advisory Committee Meeting | |
| 81 FR 22627 - Housing Counseling Federal Advisory Committee; Charter Reestablishment | |
| 81 FR 22622 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 22586 - Notice of Public Availability of FY 2015 Service Contract Inventories and Supplemental Data | |
| 81 FR 22590 - Northern Natural Gas Company; Notice of Intent To Prepare an Environmental Assessment for the Planned Northern Lights 2017 Expansion Project, Request for Comments on Environmental Issues | |
| 81 FR 22589 - Wisconsin Public Service Corporation; Notice of Application Tendered for Filing With the Commission and Establishing Procedural Schedule for Licensing and Deadline for Submission of Final Amendments | |
| 81 FR 22588 - Energy Resources USA Inc.; Notice of Preliminary Permit Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Competing Applications | |
| 81 FR 22589 - Deschutes Valley Water District; Notice of Availability of Environmental Assessment | |
| 81 FR 22587 - Hawks Nest Hydro, LLC; Notice of Application Accepted for Filing, Soliciting Motions To Intervene and Protests, Ready for Environmental Analysis, and Soliciting Comments, Recommendations, Preliminary Terms and Conditions, and Preliminary Fishway Prescriptions | |
| 81 FR 22589 - Yuba County Water Agency; Notice Soliciting Comments on Final Technical Memoranda | |
| 81 FR 22605 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 22707 - Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board; Notice of Meetings | |
| 81 FR 22707 - Veterans Rural Health Advisory Committee Meeting | |
| 81 FR 22702 - Denial of Motor Vehicle Defect Petition | |
| 81 FR 22648 - Notice of Information Collection | |
| 81 FR 22584 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for Strengthening Historically Black Graduate Institutions (HBGI) | |
| 81 FR 22638 - Importer of Controlled Substances Registration: Johnson Matthey, Inc. | |
| 81 FR 22632 - Certain Laser Abraded Denim Garments; Commission Determination To Review Order No. 43, and on Review Vacating That Order as Moot; Termination of the Investigation | |
| 81 FR 22638 - Importer of Controlled Substances Registration: Meridian Medical Technologies | |
| 81 FR 22634 - Manufacturer of Controlled Substances Registration: Cody Laboratories, Inc. | |
| 81 FR 22634 - Importer of Controlled Substances Registration: Research Triangle Institute | |
| 81 FR 22631 - Record of Decision for the Channel Islands National Park General Management Plan/Wilderness Study, Santa Barbara County, California | |
| 81 FR 22574 - Agenda and Notice of Public Meeting of the New Mexico Advisory Committee | |
| 81 FR 22573 - Public Meeting of the Hawai`i State Advisory Committee | |
| 81 FR 22572 - Notice of Public Meeting of the California State Advisory Committee | |
| 81 FR 22630 - Record of Decision for Development Concept Plans for Cottonwood Cove and Katherine Landing, Lake Mead National Recreation Area, Nevada and Arizona | |
| 81 FR 22639 - Privacy Act of 1974; System of Records | |
| 81 FR 22625 - Extension of Agency Information Collection Activity Under OMB Review: Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery | |
| 81 FR 22511 - Tart Cherries Grown in the States of Michigan, et al.; Revision of Exemption Requirements | |
| 81 FR 22513 - Specialty Crop Block Grant Program Regulation; Removal of a Final Rule | |
| 81 FR 22520 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship | |
| 81 FR 22659 - Nuveen Fund Advisors, LLC, et al.; Notice of Application | |
| 81 FR 22681 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Filing of Proposed Rule Change To List and Trade Under BZX Rule 14.11(c)(4) Shares of the Following Series of Market Vectors ETF Trust: Market Vectors 6-8 Year Municipal Index ETF; Market Vectors 8-12 Year Municipal Index ETF; and Market Vectors 12-17 Year Municipal Index ETF | |
| 81 FR 22673 - Self-Regulatory Organizations; International Securities Exchange, LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend the Schedule of Fees | |
| 81 FR 22674 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To Amend Rules 4702 and 4703 | |
| 81 FR 22656 - Self-Regulatory Organizations; New York Stock Exchange LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending Its Price List To Adopt a Rebate Program for the NYSE BondsSM | |
| 81 FR 22678 - Self-Regulatory Organizations; NASDAQ BX, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend Fees Under Rule 7018(a) | |
| 81 FR 22691 - Self-Regulatory Organizations; Bats EDGX Exchange, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Adopt Rule 8.17 To Provide a Process for an Expedited Suspension Proceeding and Rule 12.15 To Prohibit Layering and Spoofing | |
| 81 FR 22676 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services | |
| 81 FR 22651 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, To List and Trade Shares of RiverFront Dynamic US Dividend Advantage ETF and RiverFront Dynamic US Flex-Cap ETF under NYSE Arca Equities Rule 8.600 | |
| 81 FR 22675 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend the Redistribution Fee Set Forth in OPRA's Fee Schedule | |
| 81 FR 22668 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend the Professional Subscriber Device-Based Fees Set Forth in OPRA's Fee Schedule | |
| 81 FR 22670 - Options Price Reporting Authority; Notice of Filing and Immediate Effectiveness of Proposed Amendment to the Plan for Reporting of Consolidated Options Last Sale Reports and Quotation Information To Amend Certain Provisions of the OPRA's Fee Schedule | |
| 81 FR 22596 - Enforcement Policy Statement on Deceptively Formatted Advertisements | |
| 81 FR 22594 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 22567 - Forest Resource Coordinating Committee | |
| 81 FR 22633 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-Advanced Media Workflow Association, Inc. | |
| 81 FR 22633 - Notice Pursuant to the National Cooperative Research and Production Act of 1993-IMS Global Learning Consortium, Inc. | |
| 81 FR 22621 - Agency Information Collection Activities: Proposed Collection: Public Comment Request | |
| 81 FR 22621 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 22622 - Center for Scientific Review; Notice of Closed Meeting | |
| 81 FR 22632 - Certain Tissue Paper Products From China; Cancellation of Hearing for Full Five-Year Review | |
| 81 FR 22573 - Notice of Public Meeting of the Alaska State Advisory Committee | |
| 81 FR 22650 - Meetings of Humanities Panel | |
| 81 FR 22640 - Program Year (PY) 2016 Workforce Innovation and Opportunity Act (WIOA) Allotments; PY 2016 Wagner-Peyser Act Final Allotments and PY 2016 Workforce Information Grants | |
| 81 FR 22550 - Proposed Priorities-Enhanced Assessment Instruments | |
| 81 FR 22530 - Procedures for Handling Retaliation Complaints Under Section 402 of the FDA Food Safety Modernization Act | |
| 81 FR 22709 - Endangered and Threatened Wildlife and Plants; Withdrawal of the Proposed Rule To List the West Coast Distinct Population Segment of Fisher | |
| 81 FR 22809 - Protection of Stratospheric Ozone: Proposed New Listings of Substitutes; Changes of Listing Status; and Reinterpretation of Unacceptability for Closed Cell Foam Products Under the Significant New Alternatives Policy Program; and Revision of Clean Air Act Section 608 Venting Prohibition for Propane | |
| 81 FR 22697 - Requiring Electronic Access to the Electronic Folder by Certain Claimant Representatives | |
| 81 FR 22555 - Aquatic Life Criteria for Copper and Cadmium in Oregon |
Agricultural Marketing Service
Forest Service
Rural Utilities Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Engineers Corps
Federal Energy Regulatory Commission
Agency for Healthcare Research and Quality
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Transportation Security Administration
U.S. Citizenship and Immigration Services
U.S. Customs and Border Protection
Fish and Wildlife Service
Land Management Bureau
National Park Service
Antitrust Division
Drug Enforcement Administration
Employment and Training Administration
Occupational Safety and Health Administration
National Endowment for the Humanities
Federal Aviation Administration
Maritime Administration
National Highway Traffic Safety Administration
Comptroller of the Currency
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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Agricultural Marketing Service, USDA.
Affirmation of interim rule as final rule.
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim rule implementing a recommendation from the Cherry Industry Administrative Board (Board) that revised the exemption provisions under the marketing order for tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin (order). The Board locally administers the order and is comprised of growers and handlers operating within the production area. The interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. The interim rule also revised the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage handlers to participate in new market and market expansion activities to facilitate sales and help ensure impartiality during the review process.
Effective April 19, 2016.
Jennie M. Varela, Marketing Specialist, or Christian D. Nissen, Regional Director, Southeast Marketing Field Office, Marketing Order and Agreement Division, Specialty Crops Program, AMS, USDA; Telephone: (863) 324-3375, Fax: (863) 291-8614, or Email:
Small businesses may obtain information on complying with this and other marketing order regulations by viewing a guide at the following Web site:
This final rule is issued under Marketing Order No. 930, as amended (7 CFR part 930), regulating the handling of tart cherries grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Orders 12866, 13563, and 13175.
This final rule continues in effect the provisions of the interim rule that revised the exemption provisions prescribed under the order. The interim rule changed the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. The interim rule also revised the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. These changes were unanimously recommended by the Board at its meeting on June 25, 2015.
Section 930.59 of the order authorizes handler diversion. When volume regulation is in effect, handlers may fulfill any restricted percentage requirement in full or in part by acquiring diversion certificates or by voluntarily diverting cherries or cherry products in a program approved by the Board, rather than placing cherries in an inventory reserve.
Section 930.159 of the order's administrative rules specifies methods of handler diversion, including using cherries or cherry products for exempt purposes prescribed under § 930.162. Section 930.162 establishes the terms and conditions of exemption that must be satisfied for handlers to receive diversion certificates for exempt uses. Section 930.162(b) defines the activities which qualify for exemptions under new market development and market expansion and the period for which they are eligible for diversion credit. New market development and market expansion activities include, but are not limited to, sales of cherries into markets that are not yet commercially established, product line extensions, or segmentation of markets along geographic or other definable characteristics.
Section 930.162(d) establishes a Board-appointed subcommittee to review the applications for exemption or renewal of exemption and to either approve or deny the exemption. Prior to this change, this section specified that the subcommittee consist of three members, including the Board manager, or a Board member acting in the manager's stead, the public member, and one industry person who is not on the Board.
The order provides for the use of volume regulation to stabilize prices and improve grower returns during periods of oversupply. At the beginning of each season, the Board examines production and sales data to determine whether a volume regulation is necessary and, if so, announces free and restricted percentages to limit the volume of tart cherries on the market. Free percentage cherries can be used to supply any available market, including domestic markets for pie filling, water packed, and frozen tart cherries. Restricted percentage cherries can be placed in reserve or be used to earn diversion credits as prescribed in §§ 930.159 and 930.162 of the order's administrative rules. These activities include, in part, the development of new products, new market development and market expansion, the development of export markets, and charitable contributions.
In 2012, the Board made a series of changes to the volume control
In revisiting this change, the Board recognized that the underlying rationale for having reduced the duration of diversion credit for new market development and market expansion was no longer an issue. Since that change, the method for calculating average sales for the purpose of volume regulation has been adjusted so that only export sales are excluded from the average sales calculation. Consequently, all sales from market development and market expansion activities are now included as sales when calculating a restriction. Therefore, increasing the number of years new market development and market expansion projects are eligible to receive diversion credit from one year to three years will not significantly impact the calculations for free and restricted percentages.
Further, since limiting these activities to one year, participation in new market development and market expansion activities has dropped dramatically. In years prior to changing from three years to one year, applications for new market activities numbered around 20 to 25 a season. During the 2014-15 season, the first season with volume regulation under the one-year limitation, applications dropped to eight. Handlers stated that it was not worth the time and effort to develop one of these projects if the benefit was only for a single year. It was reported that the shortened time frame did not allow handlers to recoup the resources needed to establish one of these projects.
The Board affirmed its support for new market development and market expansion diversion credit programs. Accordingly, the Board voted unanimously to change the exemption provisions applicable to handler diversion activities by increasing the number of years that new market development and market expansion activities are eligible for diversion credit back to three years. The Board also noted that projects approved for the 2014-15 season would be allowed to continue and be subject to the new three-year cycle.
This action also continues in effect a revision to the composition of the subcommittee appointed to review exemption applications. The subcommittee was formed to assist Board staff members in reviewing and granting exemptions. The subcommittee reviews applications to use restricted cherries for activities related to new product development, new market development and market expansion, the development of export markets, and for experimental purposes. Prior to this change, the previous provisions (§ 930.162(d)) stated that the subcommittee consists of the manager of the Board or a Board member acting in their stead, the public member, and one industry member who is not on the Board. The Board recommended changing the composition of the subcommittee to help ensure impartiality so that no one affiliated with a handler was part of the review process.
Consequently, the Board recommended revising the subcommittee to consist of three members, all of whom are not affiliated with a handler but have industry knowledge. One of these members shall be the public member or the alternate public member, if available to serve. The subcommittee will also include a similarly qualified alternate should one of the other members be unable to serve.
The Board made several other recommendations for changes to the regulations under the order at its June 25, 2015, meeting. These changes are being considered under a separate action.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 600 producers of tart cherries in the regulated area and approximately 40 handlers of tart cherries who are subject to regulation under the order. Small agricultural producers are defined by the Small Business Administration (SBA) as those having annual receipts of less than $750,000 and small agricultural service firms have been defined as those having annual receipts of less than $7,500,000 (13 CFR 121.201).
According to the National Agricultural Statistics Service and Board data, the average annual grower price for tart cherries during the 2014-15 season was $0.35 per pound, and total utilization was around 300 million pounds. Therefore, average receipts for tart cherry producers were around $175,800, well below the SBA threshold for small producers. In 2014, The Food Institute estimated an f.o.b. price of $0.96 per pound for frozen tart cherries, which make up the majority of processed tart cherries. Using this data, average annual handler receipts were about $6.9 million, which is also below the SBA threshold for small agricultural service firms. Assuming a normal distribution, the majority of producers and handlers of tart cherries may be classified as small entities.
This final rule continues in effect the action that revised § 930.162 of the regulations regarding exemptions by changing the number of years that new market development and market expansion projects are eligible for handler diversion credit from one year to three years. This rule also continues in effect the revision to the composition of the subcommittee which reviews exemption requests. These changes are intended to encourage the use of new market development and market expansion activities to facilitate sales and to help ensure impartiality during the review process. The authority for these actions is provided in § 930.59 of the order.
It is not anticipated that this action will impose additional costs on handlers or growers, regardless of size. Rather, this should help handlers receive better returns on their new market development and market expansion projects by providing additional time for the handlers to receive diversion credit for those activities. This should provide more opportunity for them to recoup the time and resources required to establish these projects.
In addition, changing the number of years that these projects are eligible for
The change in composition of the subcommittee is administrative in nature and is not expected to result in any additional costs.
This rule is expected to benefit the industry. The effects of this rule are not expected to be disproportionately greater or less for small handlers or producers than for larger entities.
The Board discussed alternatives to these changes, including not changing the number of years that new market development and market expansion projects were eligible for diversion credit. The Board agreed that increasing the number of years that new market development and market expansion projects are eligible for diversion credit from one year to three years provides handlers with more incentive to utilize these programs while not impacting the calculations for free and restricted percentages.
Another alternative considered was maintaining the previous composition of the subcommittee responsible for reviewing exemption requests. However, the Board wanted to specify that the subcommittee be composed of members who are not affiliated with any handler. Therefore, for the reasons mentioned above, these alternatives were rejected.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0177, (Tart Cherries Grown in the States of Michigan, New York, Pennsylvania, Oregon, Utah, Washington, and Wisconsin). No changes in those requirements as a result of this action are necessary. Should any changes become necessary, they would be submitted to OMB for approval.
This rule will not impose any additional reporting or recordkeeping requirements on either small or large tart cherry handlers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
As noted in the initial regulatory flexibility analysis, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this final rule. Further, the public comment received concerning the proposal did not address the initial regulatory flexibility analysis.
In addition, the Board's meeting was widely publicized throughout the tart cherry industry, and all interested persons were invited to attend and participate in Board deliberations on all issues. Like all Board meetings, the June 25, 2015, meeting was a public meeting, and all entities, both large and small, were able to express views on this issue.
An interim rule concerning this action was published in the
One comment was received during the comment period in response to the interim rule. The commenter, a producer, supported part of the action but offered an alternative to the membership of the subcommittee.
The commenter supported the expansion of handler diversion credits for new market development and market expansion projects from one year to three years. The commenter agreed with the Board's finding that it will encourage growth in the industry.
Regarding the change to the membership of the approval subcommittee, the commenter suggested that membership should be further modified to include cherry growers that are not also handlers. However, the Board's intent in making the revision to the subcommittee requirements was, in part, to ensure impartiality. Consequently, the Board recommended that the subcommittee be composed of members who are not affiliated with any handler. Even growers who are not handlers themselves have a business relationship with the handlers to which they sell.
The additional points in the comment were not relevant to the interim rule. Accordingly, no changes will be made to the interim rule, based on the comment received. Therefore, for the reasons given in the interim rule, we are adopting the interim rule as a final rule, without change.
To view the interim rule and the comment that was received, go to:
This action also affirms information contained in the interim rule concerning Executive Orders 12866, 12988, 13175, and 13563; the Paperwork Reduction Act (44 U.S.C. Chapter 35); and the E-Gov Act (44 U.S.C. 101).
After consideration of all relevant material presented, it is found that finalizing the interim rule, without change, as published in the
Marketing agreements, Reporting and recordkeeping requirements, Tart cherries.
Agricultural Marketing Service.
Final rule; removal.
The Agricultural Marketing Service (AMS) is rescinding and removing from the Code of Federal Regulations 7 CFR part 1290 entitled “Specialty Crop Block Grant Program” (SCBGP) in its entirety. This regulation implemented the SCBGP for the fiscal years 2006 to 2008 and is now obsolete.
Effective April 19, 2016.
Trista Etzig, Grants Division Director; Telephone: (202) 720-8356; email:
SCBGP is authorized under the Specialty Crop Competitiveness Act of 2004 (7 U.S.C. 1621 note).
AMS published 7 CFR part 1290, as a Final rule, in the
The grant agreements that 7 CFR part 1290 affected have expired and the regulations are now obsolete. Therefore, the AMS is rescinding and removing the regulation implementing the SCBGP from 2006 to 2008 in its entirety.
Agriculture, Reporting and recordkeeping requirements, Specialty crop block grants.
For the reasons set forth in the preamble, under the authority of 7 U.S.C. 1621 note, 7 CFR part 1290 is removed.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final determination.
The U.S. Department of Energy (DOE) is classifying portable air conditioners (ACs) as a covered product under the Energy Policy and Conservation Act (EPCA), as amended. This classification is based on DOE's determination that portable ACs are a type of consumer product that meets the requisite criteria specified in EPCA. Specifically, DOE has determined that classifying portable ACs as a covered product is necessary or appropriate to carry out the purposes of EPCA, and that average U.S. household energy use by portable ACs is likely to exceed 100 kilowatt-hours (kWh) per year.
This rule is effective May 18, 2016.
This rulemaking can be identified by docket number EERE-2013-BT-STD-0033 and/or Regulatory Information Number (RIN) 1904-AD02.
A link to the docket Web page can be found at:
For further information on how to review the docket, contact Ms. Brenda Edwards at (202) 586-2945 or by email:
Mr. Bryan Berringer, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Office, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-0371. Email:
Ms. Sarah Butler, U.S. Department of Energy, Office of the General Counsel, GC-33, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 586-1777. Email:
Title III of the Energy Policy and Conservation Act (EPCA), as amended (42 U.S.C. 6291
(1) Classifying the product as a covered product is necessary for the purposes of EPCA; and
(2) The average annual per-household energy use by products of such type is likely to exceed 100 kilowatt-hours (kWh) per year. (42 U.S.C. 6292(b)(1))
For the Secretary to prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) for covered products added pursuant to 42 U.S.C. 6292(b)(1), he must also determine that:
(1) The average household energy use of the products has exceeded 150 kWh per household for a 12-month period;
(2) The aggregate 12-month energy use of the products has exceeded 4.2 terawatt-hours (TWh);
(3) Substantial improvement in energy efficiency is technologically feasible; and
(4) Application of a labeling rule under 42 U.S.C. 6294 is unlikely to be sufficient to induce manufacturers to produce, and consumers and other persons to purchase, covered products of such type (or class) that achieve the maximum energy efficiency that is technologically feasible and economically justified. (42 U.S.C. 6295(l)(1))
Portable ACs are movable units typically designed to provide 8,000-14,000 British thermal units (Btu) per hour (hr) of cooling capacity
DOE has not previously conducted an energy conservation standards rulemaking for portable ACs. On July 5, 2013, DOE published in the
With respect to the test procedure rulemaking, DOE initially published a notice of data availability (NODA) on May 9, 2014, in which it discussed various industry test procedures and presented results from its investigative testing. 79 FR 26639. In the NODA, DOE evaluated existing methodologies and alternate approaches adapted from these methodologies that could be incorporated in a future DOE test procedure for portable ACs.
After reviewing comments and information received on the NODA, DOE published a test procedure notice of proposed rulemaking (NOPR) on February 25, 2015, in which it proposed to establish test procedures for portable ACs that would measure the energy efficiency, energy use, and estimated annual operating cost of portable ACs during a representative average use period and that would not be unduly burdensome to conduct, as required under 42 U.S.C. 6293(b)(3)). 80 FR 10211. The proposed test procedures were based upon industry methods to determine energy consumption in active modes, standby modes, and off mode, with certain modifications to ensure the test procedures would be repeatable and representative. Based on comments from interested parties on the NOPR, DOE subsequently published a supplemental notice of proposed rulemaking (SNOPR) on November 27, 2015, in which it proposed revisions to the test procedure proposed in the NOPR to improve repeatability, reduce test burden, and ensure that the test procedure is representative of typical consumer usage. 80 FR 74020.
With respect to the energy conservation standards rulemaking, DOE published a notice of public meeting and notice of availability of a preliminary technical support document (TSD) for portable ACs on February 27, 2015. 80 FR 10628. The TSD describes the details of DOE's preliminary analysis. DOE held a public meeting to discuss and receive comments on the preliminary analysis it conducted. The meeting covered the analytical framework, models, and tools that DOE used to evaluate potential standards; the results of preliminary analyses performed by DOE for this product; the potential energy conservation standard levels derived from these analyses that DOE could consider for this product; and other issues relevant to the development of energy conservation standards for portable ACs.
After considering comments and information submitted on the preliminary analysis, DOE expects to complete a full analysis of both the burdens and benefits of potential energy conservation standards in a NOPR, pursuant to 42 U.S.C. 6295(o). Because DOE is classifying portable ACs as a covered product under 42 U.S.C. 6292(b)(1), DOE will also consider as part of any energy conservation standard NOPR whether portable ACs satisfy the requirements of 42 U.S.C. 6295(l)(1). After the publication of the standards NOPR, DOE will afford interested parties an opportunity during a period of not less than 60 days to provide oral and written comment. After receiving and considering the comments on the NOPR and not less than 90 days after the publication of the NOPR, DOE will issue the final rule prescribing any new energy conservation standards for portable ACs.
In the NOPD, DOE proposed the following definition of “portable air conditioner” to determine the potential scope of which products would potentially be regulated as a covered product. The proposed definition also provided clarity for interested parties with respect to the test procedure and energy conservation standards rulemakings as DOE continued its analyses. DOE initially proposed that a portable AC was:
A consumer product, other than a “packaged terminal air conditioner,” which is powered by a single phase electric current and which is an encased assembly designed as a portable unit that may rest on the floor or other elevated surface for the purpose of providing delivery of conditioned air to an enclosed space. It includes a prime source of refrigeration and may include a means for ventilating and heating.
DOE noted that this proposed definition would be mutually exclusive to the current definition for a room AC, which is “designed as a unit for mounting in a window or through the wall.” (10 CFR 430.2)
In response to the NOPD, DOE received several comments from interested parties regarding the kinds of products that would be included under the proposed definition of a portable AC. DOE addressed these comments in the test procedure NOPR and proposed a revised definition to further refine the definition and exclude other similar products. Specifically, DOE proposed the definition:
An encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” designed as a portable unit for delivering cooled, conditioned air to an enclosed space, that is powered by single-phase electric current, which may rest on the floor or other elevated surface. It includes a source of refrigeration and may include additional means for air circulation and heating.
DOE received multiple comments from interested parties in response to the proposed definition in the test procedure NOPR, focusing on the distinction between portable ACs intended for consumer versus commercial applications.
DENSO Products and Services Americas, Inc. (DENSO) noted that portable ACs are used in both residential and commercial settings, and that the typical distinction between the two settings is the use of single-phase versus three-phase power. However, DENSO expressed concern about the proposed definition because some portable ACs with single-phase power may be used in commercial or industrial applications. (DENSO, TP Public Meeting Transcript, No. 13 at pp. 21-22)
Oceanaire and the National Association of Manufacturers (NAM) supported the exclusion of commercial portable ACs from coverage, given the limited size of the industry and small number of units produced. These commenters stated that requiring additional testing would have a significant negative impact on this niche market. According to Oceanaire and DENSO, annual shipments of commercial portable ACs are only 15,000, as compared to the 973,700 annual shipments of consumer portable ACs in the United States that DOE estimated in its preliminary analysis for portable AC energy conservation standards. (Oceanaire, No. 10 at p. 3; NAM, No. 17 at pp. 1, 3; DENSO, TP NOPR No. 14 at p. 4)
To identify products that are commonly referred to as portable ACs but that it contends should be excluded from coverage as consumer products, Oceanaire referred to NAM's definition of a commercial portable AC and the following characteristics it believes are common to commercial portable ACs: (1) A minimum evaporator inlet air flow of 265 cubic feet per minute (CFM) and minimum condenser air flow of 500 CFM at standard temperature, pressure, and rated voltage; (2) a minimum refrigerant charge of 14 ounces per unit; (3) an internal condensate tank of a minimum 2-gallon capacity or a condensate pump capable of a minimum 15-foot head pressure; and (4) a minimum weight of 110 pounds. Oceanaire also stated that cooling capacities of commercial portable ACs typically range up to 65,000 Btu/hr. (Oceanaire, TP NOPR No. 10 at p. 1-2; NAM, TP NOPR No. 17 at p. 3)
A number of commenters asserted that the installation locations, operating conditions, use cases, and necessary product construction for commercial portable ACs are substantially different than those for consumer portable ACs. Oceanaire, NAM, and DENSO cited examples of permanent installations for commercial portable ACs, including steel mills, auto repair shops, cosmetics and food product processing facilities, and other environments that are subject to extreme temperature, humidity, and corrosive conditions. Oceanaire further noted that commercial portable ACs are also used to address temporary or emergency short-term conditions, and are purchased by rental companies that provide temporary service to a variety of businesses. Oceanaire described the construction of commercial portable ACs as having 18 gauge and thicker steel cabinetry and support structures to meet the needs of commercial and industrial customers, and according to Oceanaire, such portable ACs have an average lifetime of 10 years. (Oceanaire, TP NOPR No. 10 at p. 2; NAM, TP NOPR No. 17 at pp. 2-3; DENSO, TP NOPR No. 14 at p. 1)
For the aforementioned reasons, Oceanaire and NAM stated that they believe that commercial portable ACs do not qualify under the provisions of EPCA as a covered product. (Oceanaire, TP NOPR No. 10 at p. 2; NAM, TP NOPR No. 17 at p. 3)
In the test procedure NOPR, DOE stated that portable ACs are not currently a covered product, and did not propose to classify commercial portable ACs as a covered product. Rather, consistent with the authority under EPCA to classify additional types of “consumer product” not otherwise specified in Part A as covered products, DOE proposed to classify “portable ACs” as a covered product.
EPCA defines “consumer product” as any article of a type that consumes, or is designed to consume, energy and which, to any significant extent, is distributed in commerce for personal use or consumption by individuals. (42 U.S.C. 6291(1)) EPCA further specifies that the definition of a consumer product applies “without regard to whether the product is in fact distributed in commerce for personal use or consumption by an individual.” (42 U.S.C. 6291(1)(B)) Under the definition of “portable air conditioner” proposed by DOE, portable ACs clearly meet EPCA's definition of “consumer product.”
Although the definition of consumer product does not depend on whether the product is, in fact, distributed in commerce for personal use or consumption by an individual, DOE has proposed a definition of “portable air conditioner” that excludes units that could normally not be used in a residential setting by limiting the definition to include only portable ACs powered by single-phase electric current. As such, a product that requires three-phase power, a characteristic that is not appropriate for consumer products, would not be covered under DOE's definition. Conversely, any product with single-phase power that otherwise meets the definition of a portable AC would be considered by DOE to be a portable AC regardless of the manufacturer-intended application or installation location.
Moreover, air flow rates, refrigerant charge, condensate handling system, and product weight are not attributes that inherently determine suitability for consumer use. For example, DOE identified multiple portable ACs marketed as consumer products with evaporator air flow rates greater than 265 CFM, the threshold suggested by Oceanaire and NAM, and rugged construction with correspondingly higher weight that may be desirable in some residential applications such as garages or temporary attic cooling. Further, a portable AC that meets the single-phase power requirement in the portable AC definition would not meet certain minimum thresholds for some of the product attributes in NAM's definition of a commercial portable AC, such that the power requirement would have the same effect as if the definition were to specifically include those thresholds.
For these reasons, DOE is establishing in 10 CFR 430.2 the definition of “portable air conditioner” proposed in the test procedure NOPR with minor editorial revisions that do not modify the intent or scope of the definition:
A portable encased assembly, other than a “packaged terminal air conditioner,” “room air conditioner,” or “dehumidifier,” that delivers cooled, conditioned air to an enclosed space, and is powered by single-phase electric current. It includes a source of refrigeration and may include additional means for air circulation and heating.
The following sections describe DOE's determination that portable ACs fulfill the criteria for being added as a covered product pursuant to 42 U.S.C. 6292(b)(1). As stated previously, DOE may classify a type of consumer product as a covered product if (1) classifying products of such type as covered products is necessary and appropriate to carry out the purposes of EPCA; and (2) the average annual per-household energy use by products of such type is likely to exceed 100 kWh (or its Btu equivalent) per year.
DOE tentatively concluded in the NOPD that coverage of portable ACs is necessary or appropriate to carry out the purposes of EPCA, which include: (1) To conserve energy supplies through energy conservation programs, and,
The Appliance Standards Awareness Project (ASAP), Alliance to Save Energy (ASE), American Council for an Energy-Efficient Economy (ACEEE), Consumers Union (CU), and Northwest Energy Efficiency Alliance (NEEA) (hereinafter the “Joint Commenters”) and AHAM supported DOE's proposed determination that classifying portable ACs as a covered product is necessary or appropriate to carry out the purposes of EPCA. (AHAM, No. 6 at pp. 1-2; Joint Commenters, No. 4 at p. 2) The Joint Commenters further recommended that DOE classify portable ACs as a covered product to enable subsequent development of test procedures and consideration of energy conservations standards for portable ACs because: (1) Shipments are growing; (2) portable ACs have high per-unit energy use; and (3) competing products (such as room ACs) are currently covered. (Joint Commenters, No. 4 at p. 2)
DOE, therefore, reaffirms its tentative conclusion in the NOPD and determines that classifying portable ACs as a covered product is necessary and appropriate to carry out the purposes of EPCA. In consideration of the potential for improved energy efficiency of portable ACs and associated national energy savings, DOE has developed a proposed test procedure in a recent rulemaking that would establish appendix CC, and is currently addressing potential energy conservation standards for portable ACs in a standards rulemaking.
In the NOPD, DOE estimated the average household portable AC energy use of portable ACs. DOE based its calculations on a review of the current market and a comparison to room AC energy use, and determined that the typical rated energy efficiency ratio (EER) of portable ACs is approximately 9.5, with a large available range (approximately 8.2-14.3), and that typical cooling capacities range from 8,000-14,000 Btu/hr. DOE further estimated average per-household annual electricity consumption of a portable AC, based on a typical unit with EER 9.5, to be approximately 650 kWh/yr (750 kWh/yr for EER 8.2, and 400 kWh/yr for EER 14.3). DOE also noted that one set of laboratory tests
AHAM agreed with the result of DOE's estimate of portable AC annual energy use, although it did not agree with DOE's methodology. Specifically, AHAM suggested that the usage profiles of portable ACs differ from those for room ACs, which were the basis for DOE's analysis. AHAM stated its belief that portable ACs are used for a shorter period of time because some consumers may use them to supplement conditioned air in a particular space or area of a room instead of as the primary means of cooling. Nevertheless, AHAM stated that it does not believe that these differences would change the determination that per-household energy use for portable ACs is likely to exceed 100 kWh/yr. (AHAM, No. 6 at pp. 2-3) The California IOUs stated that DOE's estimate of annual energy use for a typical portable AC unit is significant and comparable to the per-unit energy use of many major household appliances. (California IOUs, No. 5 at p. 3) DOE solicited, but did not receive, portable AC usage data in both the test procedure and energy conservation standards rulemakings. DOE agrees, however, that the potential differences between portable AC and room AC usage would not change DOE's initial determination that portable ACs meet the threshold per-household energy use, particularly because DOE's estimates were at least a factor of four greater than the 100 kWh/yr requirement. Therefore, DOE determines here that average annual per-household energy use by portable ACs is likely to exceed 100 kWh (or its Btu equivalent) per year.
Accordingly, DOE has determined that portable ACs meet the statutory requirements under 42 U.S.C 6292(b)(1), and therefore classifies portable ACs as a covered product. DOE amends the definition of covered product in 10 CFR 430.2 to reflect this determination.
DOE has reviewed this final determination of coverage for portable ACs under the following executive orders and acts.
The Office of Management and Budget (OMB) has determined that coverage determination rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this final action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the OMB.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed this final determination under the provisions of the Regulatory Flexibility Act and the policies and procedures published on February 19, 2003. This final determination sets no standards; it only positively determines that future standards may be warranted and should be explored in an energy conservation standards and test procedure rulemaking. Economic impacts on small entities would be considered in the context of such rulemakings. On the basis of the foregoing, DOE certifies that the determination has no significant economic impact on a substantial number of small entities. Accordingly, DOE has not prepared a regulatory flexibility analysis for this final determination. DOE will transmit this certification and supporting statement of factual basis to the Chief Counsel for Advocacy of the Small Business Administration for review under 5 U.S.C. 605(b).
This final determination, which concludes that portable ACs meet the criteria for a covered product for which the Secretary may prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p), imposes no new information or record-keeping requirements. Accordingly, the OMB clearance is not required under the Paperwork Reduction Act. (44 U.S.C. 3501
In this notice, DOE positively determines that portable ACs meet the criteria for classification as covered products and that future standards may be warranted to regulate their energy use. Should DOE pursue that option, the relevant environmental impacts would be explored as part of that rulemaking. As a result, DOE has determined that this action falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order (E.O.) 13132, “Federalism” 64 FR 43255 (Aug. 10, 1999), imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to assess carefully the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in developing regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process that it will follow in developing such regulations. 65 FR 13735 (Mar. 14, 2000). DOE has examined this final determination and concludes that it does not preempt State law or have substantial direct effects on the States, on the relationship between the Federal government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the product that is the subject of this final determination. States can petition DOE for exemption from such preemption to the extent permitted, and based on criteria, set forth in EPCA. (42 U.S.C. 6297) No further action is required by E.O. 13132.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of E.O. 12988, “Civil Justice Reform” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the duty to: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of E.O. 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation specifies the following: (1) The preemptive effect, if any; (2) any effect on existing Federal law or regulation; (3) a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) the retroactive effect, if any; (5) definitions of key terms; and (6) other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of E.O. 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether these standards are met, or whether it is unreasonable to meet one or more of them. DOE completed the required review and determined that, to the extent permitted by law, this final determination meets the relevant standards of E.O. 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4, codified at 2 U.S.C. 1501
Section 654 of the Treasury and General Government Appropriations Act of 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This final determination does not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
Pursuant to E.O. 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (Mar. 15, 1988), DOE determined that this final determination does not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
The Treasury and General Government Appropriation Act of 2001 (44 U.S.C. 3516, note) requires agencies to review most disseminations of information they make to the public under guidelines established by each agency pursuant to general guidelines issued by the OMB. The OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this final determination under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgates a final rule or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under E.O. 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of the Office of Information and Regulatory Affairs (OIRA) as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the proposal is implemented, and of reasonable alternatives to the proposed action and their expected benefits on energy supply, distribution, and use.
DOE has concluded that this regulatory action establishing certain definitions and determining that portable ACs meet the criteria for a covered product for which the Secretary may prescribe an energy conservation standard pursuant to 42 U.S.C. 6295(o) and (p) does not have a significant adverse effect on the supply, distribution, or use of energy. This action is also not a significant regulatory action for purposes of E.O. 12866, and the OIRA Administrator has not designated this final determination as a significant energy action under E.O. 12866 or any successor order. Therefore, this final determination is not a significant energy action. Accordingly, DOE has not prepared a Statement of Energy Effects.
On December 16, 2004, OMB, in consultation with the Office of Science and Technology Policy (OSTP), issued its Final Information Quality Bulletin for Peer Review (the Bulletin). 70 FR 2664 (Jan. 14, 2005). The Bulletin establishes that certain scientific information shall be peer reviewed by qualified specialists before it is disseminated by the Federal government, including influential scientific information related to agency regulatory actions. The purpose of the Bulletin is to enhance the quality and credibility of the Government's scientific information. DOE has determined that the analyses conducted for the regulatory action discussed in this document do not constitute “influential scientific information,” which the Bulletin defines as “scientific information the agency reasonably can determine will have or does have a clear and substantial impact on important public policies or private sector decisions.” 70 FR 2667 (Jan. 14, 2005). The analyses were subject to pre-dissemination review prior to issuance of this rulemaking.
DOE will determine the appropriate level of review that would apply to any future rulemaking to establish energy conservation standards for portable ACs.
The Secretary of Energy has approved publication of this final determination.
Administrative practice and procedure, Confidential business information, Energy conservation, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, DOE amends part 430 of chapter II of title 10, Code of Federal Regulations as set forth below:
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(1) Of a type specified in section 322 of the Act, or
(2) That is a ceiling fan, ceiling fan light kit, medium base compact fluorescent lamp, dehumidifier, battery charger, external power supply, torchiere, or portable air conditioner.
Federal Housing Finance Agency.
Orders.
In this document, the Federal Housing Finance Agency (FHFA) provides notice that it issued Orders, dated March 2, 2016, with respect to stress test reporting as of December 31, 2015, under section 165(i)(2) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act). Summary Instructions and Guidance accompanied the Orders to provide testing scenarios.
Effective April 18, 2016. Each Order is applicable March 2, 2016.
Naa Awaa Tagoe, Senior Associate Director, Office of Financial Analysis, Modeling and Simulations, (202) 649-3140,
FHFA is responsible for ensuring that the regulated entities operate in a safe and sound manner, including the maintenance of adequate capital and internal controls, that their operations and activities foster liquid, efficient, competitive, and resilient national housing finance markets, and that they carry out their public policy missions through authorized activities.
For the convenience of the affected parties and the public, the text of the Orders follows below in its entirety. You may access these Orders and the Summary Instructions and Guidance from FHFA's Web site at
The text of the Orders is as follows:
Each regulated entity shall report to FHFA and to the Board of Governors of the Federal Reserve System the results of the stress testing as required by 12 CFR 1238, in the form and with the content described therein and in the Summary Instructions and Guidance, with Appendices 1 through 12 thereto, accompanying this Order and dated March 2, 2016.
This Order is effective immediately.
Signed at Washington, DC, this 2nd day of March, 2016.
Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA, we) is amending the animal drug regulations to reflect application-related actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during January and February 2016. FDA is also informing the public of the availability of summaries of the basis of approval and of environmental review documents, where applicable. The animal drug regulations are also being
This rule is effective April 18, 2016.
George K. Haibel, Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5689,
FDA is amending the animal drug regulations to reflect approval actions for NADAs and ANADAs during January and February 2016, as listed in table 1. In addition, FDA is informing the public of the availability, where applicable, of documentation of environmental review required under the National Environmental Policy Act (NEPA) and, for actions requiring review of safety or effectiveness data, summaries of the basis of approval (FOI Summaries) under the Freedom of Information Act (FOIA). These public documents may be seen in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday. Persons with access to the Internet may obtain these documents at the CVM FOIA Electronic Reading Room:
Also, FDA is amending the regulations to reflect the approval of several minor supplemental applications that revised classes of food-producing animals in indications and in food safety warnings for decoquinate and robenidine in medicated feeds. A food safety precautionary statement has also been revised for use of monensin in medicated chicken feed.
Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee, Mission, KS 66201 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
Also, Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd., St. Joseph, MO 64503 has informed FDA that it has transferred ownership of, and all rights and interest in, the following applications to Phibro Animal Health Corp., GlenPointe Centre East, 3d floor, 300 Frank W. Burr Blvd., Suite 21, Teaneck, NJ 07666.
In addition, Zoetis, Inc., 333 Portage St., Kalamazoo, MI 49007 has informed FDA that it has transferred ownership of, and all rights and interest in, the following approved applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113 Sofia, Bulgaria:
As provided in the regulatory text of this document, the animal drug regulations are amended to reflect these changes of sponsorship.
FDA has noticed that it failed to amend all necessary regulations to reflect the change of sponsorship of an oxytetracycline soluble powder (80 FR 13226, March 13, 2015). At this time, we are amending 21 CFR 529.1660 to include the drug labeler code for the new sponsor. This action is being taken to improve the accuracy of the regulations.
FDA has also noticed that in § 558.355 (21 CFR 558.355) use of bacitracin methylenedisalicylate at 100 to 200 grams/ton in combination with monensin in broiler and replacement chicken feeds was codified in error for NADA 141-140 (66 FR 13236, March 5, 2001). At this time, § 558.355 is amended by removing paragraphs (f)(1)(xxx) and (f)(4)(v). In addition, paragraph (f)(4)(iv), a remnant of a previous technical amendment (79 FR 10963, February 27, 2014), is also being removed. We have also noticed that certain paragraphs describing approved conditions of use were removed in error from § 558.355 during codification of a supplemental application to NADA 138-456 that increased the dose range for monensin used in combination with bacitracin methylenedisalicylate in broiler chicken feed (57 FR 6554, February 26, 1992). At this time, § 558.355 is amended by adding paragraphs (f)(1)(xxiv)(
FDA has noticed that in error we removed the approved conditions of use for gleptoferron, an injectable iron used to prevent anemia in young piglets. At this time, 21 CFR 522.1055 is being added. This action is being taken to improve the accuracy of the regulations.
This rule does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a rule of “particular applicability.” Therefore, it is not subject to the
Animal drugs.
Animal drugs, Food.
Animal drugs, Animal feeds.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR parts 520, 522, 524, 529, 556, and 558 are amended as follows:
21 U.S.C. 360b.
The revisions read as follows:
(b) * * *
(1) Nos. 000010, 016592, 054771, and 069254 for use as in paragraph (d) of this section.
(2) No. 066104 for use as in paragraphs (d)(4)(i)(A), (d)(4)(i)(B), and (d)(4)(ii) through (d)(4)(iv) of this section.
(e) * * *
(6)
(ii)
(iii)
(a)
(b)
(c)
(2)
(3)
(b)
(1) No. 016592 for use as in paragraph (d) of this section.
(2) Nos. 054925, 061623, and 076475 for use as in paragraphs (d)(1) and (d)(2) of this section.
(a)
(b)
(c)
(2)
(3)
(d) * * *
(1) * * *
(iii)
(2) * * *
(iii)
21 U.S.C. 360b.
(a)
(b)
(1) No. 043264 for use as in paragraphs (c)(1)(i), (c)(2)(i), and (c)(3) of this section.
(2) No. 058198 for use as in paragraphs (c)(1)(ii), (c)(2)(ii), and (c)(3) of this section.
(c)
(ii) Dosage requirements are variable and must be individualized on the basis of the response of the patient to therapy. Initial dose of 1 milligram per pound (0.45 kilogram) of body weight every 25 days, intramuscularly. Usual dose is 0.75 to 1.0 milligram per pound of body weight every 21 to 30 days.
(2)
(ii) For use as replacement therapy for the mineralocorticoid deficit in dogs with primary adrenocortical insufficiency.
(3)
(a)
(b)
(c)
(1)
(ii) Administer 200 mg of elemental iron intramuscularly for treatment of iron deficiency anemia.
(2) [Reserved]
21 U.S.C. 360b.
21 U.S.C. 360b.
21 U.S.C. 342, 360b, 371.
(b) * * *
(3)
(ii) [Reserved]
(c)
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
(c) * * *
(2)
The revisions read as follows:
(f) * * *
(1) * * *
(xxiv)
(
(
(xxv)
Food and Drug Administration, HHS.
Final order.
The Food and Drug Administration (FDA) is issuing a final order to reclassify external pacemaker pulse generator (EPPG) devices, which are currently preamendments class III devices (regulated under product code
This order is effective April 18, 2016.
Hina Pinto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1652, Silver Spring, MD 20993, 301-796-6351,
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub. L. 108-214), the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85), and the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144), among other amendments, establishes a comprehensive system for the regulation of medical devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c) establishes three categories (classes) of devices, reflecting the regulatory controls needed to provide reasonable assurance of their safety and effectiveness. The three categories of devices are class I (general controls), class II (special controls), and class III (premarket approval).
Under section 513(d) of the FD&C Act, devices that were in commercial distribution before the enactment of the 1976 amendments, May 28, 1976 (generally referred to as preamendments devices), are classified after FDA has: (1) Received a recommendation from a device classification panel (an FDA advisory committee); (2) published the panel's recommendation for comment, along with a proposed regulation classifying the device; and (3) published a final regulation classifying the device. FDA has classified most preamendments devices under these procedures.
A preamendments device that has been classified into class III and devices found substantially equivalent by means of premarket notification (510(k)) procedures to such a preamendments device or to a device within that type (both the preamendments and substantially equivalent devices are referred to as preamendments class III devices) may be marketed without submission of a premarket approval application (PMA) until FDA issues a final order under section 515(b) of the FD&C Act (21 U.S.C. 360e(b)) requiring premarket approval or until the device is subsequently reclassified into class I or class II.
Devices that were not in commercial distribution prior to May 28, 1976 (generally referred to as postamendments devices), are automatically classified by section 513(f) of the FD&C Act into class III without any FDA rulemaking process. Those devices remain in class III and require premarket approval unless, and until, the device is reclassified into class I or II or FDA issues an order finding the device to be substantially equivalent, in accordance with section 513(i) of the FD&C Act, to a predicate device that does not require premarket approval. The Agency determines whether new devices are substantially equivalent to predicate devices by means of premarket notification procedures in section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and 21 CFR part 807.
A postamendments device that has been initially classified in class III under section 513(f)(1) of the FD&C Act may be reclassified into class I or class II under section 513(f)(3) of the FD&C Act. Section 513(f)(3) of the FD&C Act provides that FDA acting by order can reclassify the device into class I or class II on its own initiative, or in response to a petition from the manufacturer or importer of the device. To change the classification of the device, the proposed new class must have sufficient regulatory controls to provide reasonable assurance of the safety and effectiveness of the device for its intended use.
On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA amended section 513(e) of the FD&C Act, changing the mechanism for reclassifying a device under that section from rulemaking to an administrative order.
Section 513(e) of the FD&C Act provides that FDA may, by administrative order, reclassify a device based upon “new information.” FDA can initiate a reclassification under section 513(e) of the FD&C Act or an interested person may petition FDA to reclassify an eligible device type. The term “new information,” as used in section 513(e) of the FD&C Act, includes information developed as a result of a reevaluation of the data before the Agency when the device was originally classified, as well as information not presented, not available, or not developed at that time. (See,
Reevaluation of the data previously before the Agency is an appropriate basis for subsequent action where the reevaluation is made in light of newly available authority (see
Section 513(e)(1) of the FD&C Act sets forth the process for issuing a final order to reclassify a device under that section. Specifically, prior to the issuance of a final order reclassifying a device, the following must occur: (1) Publication of a proposed order in the
As noted in the proposed order, on March 9, 1979, the Agency published a proposed rule for the classification of EPPG devices into class III (44 FR 13284). FDA subsequently published a final rule classifying EPPG devices into class III under § 870.3600 (21 CFR 870.3600) after receiving no comments on the March 9, 1979, proposed rule (45 FR 7904, February 5, 1980). In 1987, FDA published a final rule to codify language clarifying that no effective date had been established for the requirement for premarket approval for EPPG devices (52 FR 17732, May 11, 1987). In 2009, FDA published an order (the “515(i) Order”) requiring manufacturers of remaining class III devices for which regulations requiring PMAs had not been issued, including EPPGs, to submit a summary of information concerning those devices by August 7, 2009 (74 FR 16214, April 9, 2009). On October 17, 2011, FDA published a proposed rule proposing the reclassification of EPPG devices from class III to class II (76 FR 64224), which the Agency subsequently withdrew on September 15, 2014 (79 FR 54927). FDA withdrew the proposed rule in response to the new process for reclassifications under section 513(e) of the FD&C Act, as amended by FDASIA, and new information, including new information discussed during the 2013 Panel meeting.
Single and dual chamber PSAs have historically been classified with EPPG devices. Single and dual chamber PSAs combine the functionality of a single or dual chamber EPPG, which is currently a class III device, and the functionality of a pacemaker electrode function tester, which is regulated as a class II device under § 870.3720 (21 CFR 870.3720). Single and dual chamber PSA devices have been found substantially equivalent to EPPG devices through the 510(k) process. TCPSA devices have not been determined to be substantially equivalent to a predicate device through the 510(k) process and, because TCPSAs were not on the market before May 28, 1976, TCPSAs have been reviewed through the PMA process as postamendments class III devices. This order creates a new classification regulation for single, dual, and triple chamber PSA devices, which combine the functionality of an EPPG and the functionality of a pacemaker electrode function tester.
As discussed in the proposed order, FDA considered the available information on these devices (EPPG and PSA devices) and concluded that reclassifying these devices to class II, subject to the identified special controls, would provide reasonable assurance of their safety and effectiveness. As required by section 513(e)(1) of the FD&C Act, FDA convened a meeting of a device classification panel described in section 513(b) of the FD&C Act to discuss whether EPPG and PSA devices should be reclassified or remain in class III on September 11, 2013 (78 FR 49272). The reclassification of EPPG and PSA devices was supported by the 2013 Panel. The 2013 Panel recommended that EPPG devices (including single and dual chamber PSAs) be reclassified to class II with special controls when intended for cardiac rate control or prophylactic arrhythmia prevention. In addition, the 2013 Panel agreed that EPPG devices are life-supporting and, per § 860.93 (21 CFR 860.93), explained that its rationale for recommending that EPPG devices be reclassified to class II was based on the proposed special controls FDA presented, which the 2013 Panel believed were adequate (along with general controls) to mitigate the risks of the device.
The 2013 Panel also recommended that TCPSA devices be reclassified to class II with special controls when intended for use during the pulse generator implant procedure. The 2013 Panel acknowledged that TCPSA devices are life-supporting devices and provided the following rationale per § 860.93 for recommending that TCPSA devices be reclassified to class II: (1) These devices are used only during the implant procedure where backup monitoring is continuous, hazards can be recognized and treated immediately, and where there is a reasonable expectation that users are adequately trained; (2) these devices are not intended to provide the long-term hemodynamic benefit of biventricular pacing or cardiac resynchronization therapy; and (3) the recommended special controls will mitigate the health risks associated with the device. The 2013 Panel transcript and other meeting materials are available on FDA's Web site (Ref. 1). Since the 2013 Panel meeting, FDA has not become aware of new information that would provide a basis for a device classification panel to make a different recommendation or different findings.
In response to the September 15, 2014, proposed order to reclassify EPPG and PSA devices (79 FR 54927), FDA received two comments. FDA previously received three sets of comments on the October 17, 2011, proposed rule to reclassify EPPG devices that was subsequently withdrawn (79 FR 54927). The Agency has considered all of these comments in drafting this final order.
The comments and FDA's responses to the comments are summarized in this section. Certain comments are grouped together under a single number because the subject matter of the comments is similar. The number assigned to each comment is purely for organizational purposes and does not signify the comment's value or importance or the order in which it was submitted.
(Comment 1) Four comments suggested that EPPG devices are life-sustaining and should be subject to premarket approval to provide better assurance of safety and effectiveness; as such, the comments asserted that EPPG devices should remain in class III. Further, one comment indicated that the proposed special controls are not sufficient to mitigate the risks associated with EPPG devices. Three other comments also discussed the risks associated with these devices and the need for adequate mitigation through premarket approval.
(Response 1) These comments were considered by FDA in drafting this final order. Per 21 CFR 860.3(c)(3), a device is in class III if two conditions are met: (1) Insufficient information exists to determine that general controls are sufficient to provide reasonable assurance of its safety and effectiveness or that application of special controls described in 21 CFR 860.3(c)(2) would provide such assurance, and (2) the device is life-supporting or life-sustaining, or for a use which is of substantial importance in preventing impairment of human health, or if the device presents a potential unreasonable risk of illness or injury. FDA has concluded that for EPPG devices, special controls will provide reasonable assurance of safety and effectiveness to appropriately mitigate risks to health. Therefore, these life-supporting devices can be reclassified into class II. As discussed in section II, the 2013 Panel agreed with FDA's recommendation of class II for EPPG and TCPSA devices.
EPPG devices are therapeutic devices designed to be used temporarily and in a controlled clinical setting. The expected presence of clinical support
(Comment 2) Three comments referenced the number of medical device reports (MDRs) associated with EPPG devices and suggested that MDR data support keeping EPPG devices in class III. Two of those comments also discussed the number of MDR reports for malfunctions associated with EPPG devices and suggested that this shows the performance standards that have been developed and used to support EPPG marketing applications are insufficient to provide reasonable assurance of safety and effectiveness.
(Response 2) Increased premarket regulatory requirements cannot be assumed to result in fewer MDRs, nor are MDRs necessarily an indicator of poor device performance. FDA performed multiple analyses of MDRs for EPPG devices in the Manufacturer and User Facility Device Experience (MAUDE) database. The Agency's analysis of the available data shows that over 85 percent of reports had either no patient involvement or no known consequences to the patient. These types of malfunction reports were generally discovered during routine servicing, which may be anticipated for reusable electrical devices. FDA's MDR analyses were conducted multiple times during the reclassification process and showed trends of increased reporting, but with an associated sharp decline in the relative number of death and injury reports over the last several years (
FDA also reviewed device recalls for EPPGs over the past 15 years and did not find evidence indicating the need for class III premarket approval regulation of these devices. FDA presented its analysis of MDR and recall data to the 2013 Panel that ultimately recommended reclassification of EPPG devices from class III to class II (special controls). The 2013 Panel identified no new or different risks for EPPG devices based on that information. Therefore, FDA believes that the identified special controls provide adequate mitigation of the health risks posed by the EPPG device.
(Comment 3) One comment suggested that EPPG devices remain in class III and require PMAs because FDA failed to identify new information on which to base the reclassification recommendation, specifically noting: (1) Performance standards developed in support of PMAs are not publicly available, and (2) FDA used information submitted in response to the 515(i) Order that was not publicly available in the Agency's analysis of risks to health for EPPG devices.
(Response 3) FDA's presentation to the 2013 Panel included a summary of the available safety and effectiveness information for EPPG devices, including FDA's analysis of adverse event reports from FDA's MAUDE database and available literature. The 2013 Panel agreed with FDA's conclusion that the available scientific evidence is adequate to support reasonable assurance of the safety and effectiveness of EPPG devices and to reclassify EPPG devices to class II. While the 2013 Panel agreed with the identified risks to health presented at the September 11, 2013, meeting, it recommended that FDA consider rewording some of the language for clarity and also to ensure that certain hazards, such as asynchronous pacing and arrhythmia induction, are included in the risks to health. FDA agreed with the 2013 Panel's recommendations and modified the risks to health accordingly as outlined in section V of the 2014 proposed order. The Agency identified in the proposed order special controls, including non-clinical performance testing data and labeling that, together with general controls (including prescription use), would provide reasonable assurance of the safety and effectiveness of EPPG devices. Since the 2013 Panel, FDA has not become aware of new information that would provide a basis for a different recommendation or finding for these devices.
Information submitted in response to the 2009 515(i) Order that FDA used in its reclassification determination was incorporated in what the Agency presented to the 2013 Panel (see Ref. 1). In addition, that information was listed in the September 15, 2014, proposed order and is publicly available through other sources. The information presented to the 2013 Panel and discussed in the 2014 proposed order also identified and provided information regarding the two recognized consensus standards that address various aspects of design and performance of EPPG devices (IEC 60601-1 and IEC 60601-2-31). The information provided by these consensus standards is particularly important as design control measures and aided in forming part of the basis for FDA's reclassification determination. Therefore, the information that forms the basis for FDA's reclassification determination has been made publicly available.
(Comment 4) One comment suggested that PSA devices remain in class III because the special controls rely heavily on labeling to mitigate risks, and expressed doubt that labeling would be sufficient to protect the health of patients.
(Response 4) It should be noted that labeling is not the only mitigation that is proposed to reasonably assure safety and effectiveness of PSAs. Further, neither FDA nor the 2013 Panel believed that clinical performance testing was necessary to provide reasonable assurance of safety or effectiveness. The environment of care for PSAs is limited to the surgical implant suite, which must have backup pacing, defibrillation and resuscitation equipment, and capabilities including intensive care level monitoring of heart rhythm and patient vital signs. Therefore, FDA believes that the non-clinical performance testing and labeling special controls, in addition to general controls, can be established to mitigate the identified risks and provide reasonable assurance of the safety and effectiveness of PSA devices when indicated for use during the implant procedure of pacemakers and defibrillators for the evaluation of the placement and integrity of pacing leads to determine the appropriate pacing parameters for the implanted device. Furthermore, the 2013 Panel agreed that the special controls would mitigate the health risks associated with the PSA devices.
Based on the information discussed in the preamble to the proposed order (79 FR 54927, September 15, 2014), the comments received, a review of the
Following the effective date of this final order, firms marketing an EPPG or PSA device must comply with the applicable mitigation measures set forth in the codified special controls. Manufacturers of EPPG or PSA devices that have not been legally marketed prior to the effective date of this final order, or models (if any) that have been marketed but are required to submit a new 510(k) under 21 CFR 807.81(a)(3) because the device is about to be significantly changed or modified, must obtain 510(k) clearance and demonstrate compliance with the special controls included in this final order, before marketing the new or changed device.
Section 510(m) of the FD&C Act provides that FDA may exempt a class II device from the premarket notification requirements under section 510(k) of the FD&C Act if FDA determines that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device. FDA has determined that premarket notification is necessary to provide reasonable assurance of safety and effectiveness of EPPG and PSA devices for their intended uses, and therefore, these device types are not exempt from premarket notification requirements.
The Agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final order refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; and the collections of information under 21 CFR part 801 have been approved under OMB control number 0910-0485.
Prior to the amendments by FDASIA, section 513(e) of the FD&C Act provided for FDA to issue regulations to reclassify devices. Although section 513(e) as amended requires FDA to issue final orders rather than regulations, FDASIA also provides for FDA to revoke previously promulgated regulations by order. FDA will continue to codify classifications and reclassifications in the Code of Federal Regulations (CFR). Changes resulting from final orders will appear in the CFR as changes to codified classification determinations or as newly codified orders. Therefore, pursuant to section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in this final order, we are revoking the requirements in § 870.3600 related to the classification of EPPG devices as class III devices, and codifying the reclassification of EPPG and PSA devices into class II (special controls).
The following reference is on display in the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday. FDA has verified the Web site address, as of the date this document publishes in the
1. The panel transcript and other meeting materials for the September 11, 2013, Circulatory System Devices Panel are available on FDA's Web site at
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 870 is amended as follows:
21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
(a)
(b)
(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
(v) Appropriate electromagnetic compatibility information must be included.
(a)
(b)
(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the PSA. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals. Triple chamber devices should clearly identify atrial, right ventricular, and left ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
(v) Labeling must limit the use of external pacing to the implant procedure; and
(vi) Appropriate electromagnetic compatibility information must be included.
Occupational Safety and Health Administration, Labor.
Final rule.
This document provides the final text of regulations governing the employee protection (retaliation or whistleblower) provision found at section 402 of the FDA Food Safety Modernization Act (FSMA), which added section 1012 to the Federal Food, Drug, and Cosmetic Act. An interim final rule governing these provisions and requesting public comment was published in the
This final rule is effective on April 18, 2016.
Cleveland Fairchild, Program Analyst, Directorate of Whistleblower Protection Programs, Occupational Safety and Health Administration, U.S. Department of Labor, Room N-4618, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2199. This is not a toll-free number. Email:
The FDA Food Safety Modernization Act (Pub. L. 111-353, 124 Stat. 3885), was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C) to add section 1012, 21 U.S.C. 399d, which provides protection to employees against retaliation by an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food for engaging in certain protected activities. Section 1012 protects employees against retaliation because they provided or are about to provide to their employer, the
Section 1012 became effective upon enactment on January 4, 2011. Although the Food and Drug Administration of the U.S. Department of Health and Human Services (FDA) generally administers the FD&C, the Secretary of Labor is responsible for enforcing the employee protection provision set forth in section 1012 of the FD&C. These rules establish procedures for the handling of whistleblower complaints under section 1012 of the FD&C. Throughout this rule, FSMA refers to section 402 of the FDA Food Safety Modernization Act, codified as section 1012 of the Federal Food, Drug and Cosmetic Act.
FSMA's whistleblower provisions include procedures that allow a covered employee to file, within 180 days of the alleged retaliation, a complaint with the Secretary of Labor (Secretary). Upon receipt of the complaint, the Secretary must provide written notice to the person or persons named in the complaint alleged to have violated the FSMA (respondent) of the filing of the complaint, the allegations contained in the complaint, the substance of the evidence supporting the complaint, and the rights afforded the respondent throughout the investigation. The Secretary must then, within 60 days of receipt of the complaint, afford the complainant and respondent an opportunity to submit a response and meet with the investigator to present statements from witnesses, and conduct an investigation.
The statute provides that the Secretary may conduct an investigation only if the complainant has made a prima facie showing that the protected activity was a contributing factor in the adverse action alleged in the complaint and the respondent has not demonstrated, through clear and convincing evidence, that it would have taken the same adverse action in the absence of that activity (see section 1987.104 for a summary of the investigation process). OSHA interprets the prima facie case requirement as allowing the complainant to meet this burden through the complaint as supplemented by interviews of the complainant.
After investigating a complaint, the Secretary will issue written findings. If, as a result of the investigation, the Secretary finds there is reasonable cause to believe that retaliation has occurred, the Secretary must notify the respondent of those findings, along with a preliminary order that requires the respondent to, where appropriate: Take affirmative action to abate the violation; reinstate the complainant to his or her former position together with the compensation of that position (including back pay) and restore the terms, conditions, and privileges associated with his or her employment; and provide compensatory damages to the complainant, as well as all costs and expenses (including attorney fees and expert witness fees) reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the order was issued.
The complainant and the respondent then have 30 days after the date of the Secretary's notification in which to file objections to the findings and/or preliminary order and request a hearing before an administrative law judge (ALJ) at the Department of Labor. The filing of objections under FSMA will stay any remedy in the preliminary order except for preliminary reinstatement. If a hearing before an ALJ is not requested within 30 days, the preliminary order becomes final and is not subject to judicial review.
If a hearing is held, the statute requires the hearing to be conducted “expeditiously.” The Secretary then has 120 days after the conclusion of any hearing in which to issue a final order, which may provide appropriate relief or deny the complaint. Until the Secretary's final order is issued, the Secretary, the complainant, and the respondent may enter into a settlement agreement that terminates the proceeding. Where the Secretary has determined that a violation has occurred, the Secretary, where appropriate, will assess against the respondent a sum equal to the total amount of all costs and expenses, including attorney and expert witness fees, reasonably incurred by the complainant for, or in connection with, the bringing of the complaint upon which the Secretary issued the order. The Secretary also may award a prevailing employer reasonable attorney fees, not exceeding $1,000, if the Secretary finds that the complaint is frivolous or has been brought in bad faith.
Within 60 days of the issuance of the final order, any person adversely affected or aggrieved by the Secretary's final order may file an appeal with the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit where the complainant resided on the date of the violation.
FSMA permits the employee to seek de novo review of the complaint by a United States district court in the event that the Secretary has not issued a final decision within 210 days after the filing of the complaint, or within 90 days after receiving a written determination. The court will have jurisdiction over the action without regard to the amount in controversy, and the case will be tried before a jury at the request of either party.
FSMA also provides that nothing therein preempts or diminishes any other safeguards against discrimination, demotion, discharge, suspension, threats, harassment, reprimand, retaliation, or any other manner of discrimination provided by Federal or State law. Finally, FSMA states that nothing therein shall be deemed to diminish the rights, privileges, or remedies of any employee under any Federal or State law or under any collective bargaining agreement, and the rights and remedies in FSMA may not be waived by any agreement, policy, form, or condition of employment.
On February 13, 2014, OSHA published in the
In response, OSHA received comments that were responsive to the rule from two organizations. Comments were received from the Roll Law Group (Roll), on behalf of Paramount Farming Company LLC, Paramount Farms International LLC, Pom Wonderful LLC, and Paramount Citrus Holdings LLC, and; Kalijarvi, Chuzi, Newman & Fitch, P.C. (Kalijarvi). OSHA also received one comment that was not responsive to the rule.
OSHA has reviewed and considered the comments and now adopts this final rule with minor revisions. The following discussion addresses the
Roll commented that OSHA should “ensure that the rules not only protect employee rights and promote food safety, but uphold equality and fairly address the concerns of both parties involved in these types of matters.” OSHA agrees, and notes that its procedures are designed to ensure a fair process for both parties.
Kalijarvi commented that “Congress passed the FSMA to protect people from getting sick and dying. When Congress passes a law to accomplish a remedial purpose, that purpose should be central to decisions about interpretation and application of the law.” Kalijarvi elaborated that decisions under FSMA should be made with an eye towards furthering the statute's remedial purpose. In addition, Kalijarvi commented that OSHA's discussion of the reasonable belief doctrine serves as a helpful reminder that “a complainant's whistleblower activity will be protected when it is based on a reasonable belief that any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C, has been violated.” OSHA believes that, generally, support for the remedial nature of the FSMA is found in the statute itself.
This section describes the purpose of the regulations implementing FSMA and provides an overview of the procedures covered by these regulations. No comments were received on this section, and no changes were made to it.
This section includes general definitions from the FD&C, which are applicable to the whistleblower provisions of FSMA. The FD&C states that the term “person” includes an individual, partnership, corporation, and association.
This section describes the activities that are protected under FSMA, and the conduct that is prohibited in response to any protected activities. Under FSMA, an entity engaged in the manufacture, processing, packing, transporting, distribution, reception, holding, or importation of food may not retaliate against an employee because the employee “provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of this chapter or any order, rule, regulation, standard, or ban under this chapter.” 21 U.S.C. 399d(a)(1). FSMA also protects employees who testify, assist or participate in proceedings concerning such violations.
In order to have a “reasonable belief” under FSMA, a complainant must have both a subjective, good faith belief and an objectively reasonable belief that the complained-of conduct violated the FD&C or any order, rule, regulation, standard, or ban under the FD&C.
No comments were received on this section, and no changes were made to it.
This section explains the requirements for filing a retaliation complaint under FSMA. According to section 1012(b)(1) of the FD&C, a complaint must be filed within 180 days of when the alleged violation occurs. Under
Complaints filed under FSMA need not be in any particular form. They may be either oral or in writing. If the complainant is unable to file the complaint in English, OSHA will accept the complaint in any language. With the consent of the employee, complaints may be filed by any person on the employee's behalf.
OSHA notes that a complaint of retaliation filed with OSHA under FSMA is not a formal document and need not conform to the pleading standards for complaints filed in federal district court articulated in
No comments were received on this section, and no changes were made to it.
This section describes the procedures that apply to the investigation of complaints under FSMA. Paragraph (a) of this section outlines the procedures for notifying the parties and the FDA of the complaint and notifying the respondent of its rights under these regulations. Paragraph (b) describes the procedures for the respondent to submit its response to the complaint. Paragraph (c) describes OSHA's procedures for sharing a party's submissions during a whistleblower investigation with the other parties to the investigation. Paragraph (d) of this section discusses confidentiality of information provided during investigations.
Paragraph (e) of this section sets forth the applicable burdens of proof. FSMA requires that a complainant make an initial prima facie showing that protected activity was “a contributing factor” in the adverse action alleged in the complaint,
If the complainant does not make the required prima facie showing, the investigation must be discontinued and the complaint dismissed.
Assuming that an investigation proceeds beyond the gatekeeping phase, the statute requires OSHA to determine whether there is reasonable cause to believe that protected activity was a contributing factor in the alleged adverse action. A contributing factor is “any factor which, alone or in connection with other factors, tends to affect in any way the outcome of the decision.”
If OSHA finds reasonable cause to believe that the alleged protected activity was a contributing factor in the adverse action, OSHA may not order relief if the employer demonstrates by clear and convincing evidence that it would have taken the same action in the absence of the protected activity.
Paragraph (f) describes the procedures OSHA will follow prior to the issuance of findings and a preliminary order when OSHA has reasonable cause to believe that a violation has occurred.
Roll commented that this section of the IFR did not explicitly state that the respondent has the right to receive copies of the substantive evidence provided by the complainant, and Roll states that it is “essential that both
Roll also commented that the IFR did not provide the complainant and the respondent equal opportunity to respond to the each other's submissions to OSHA. OSHA has revised paragraph (c) to clarify that OSHA will ensure that each party is provided with an opportunity to respond to the other party's submissions.
Apart from the changes to paragraph (c) described above, OSHA has reworded paragraphs (a) and (f) slightly to clarify the paragraphs without changing their meaning.
This section provides that, on the basis of information obtained in the investigation, the Assistant Secretary will issue, within 60 days of the filing of a complaint, written findings regarding whether or not there is reasonable cause to believe that the complaint has merit. If the findings are that there is reasonable cause to believe that the complaint has merit, the Assistant Secretary will order appropriate relief, including preliminary reinstatement, affirmative action to abate the violation, back pay with interest, and compensatory damages. The findings and, where appropriate, preliminary order, advise the parties of their right to file objections to the findings of the Assistant Secretary and to request a hearing. The findings and, where appropriate, preliminary order, also advise the respondent of the right to request an award of attorney fees not exceeding $1,000 from the ALJ, regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. If no objections are filed within 30 days of receipt of the findings, the findings and any preliminary order of the Assistant Secretary become the final decision and order of the Secretary. If objections are timely filed, any order of preliminary reinstatement will take effect, but the remaining provisions of the order will not take effect until administrative proceedings are completed.
As explained in the IFR, in ordering interest on back pay under FSMA, the Secretary has determined that interest due will be computed by compounding daily the Internal Revenue Service interest rate for the underpayment of taxes, which under 26 U.S.C. 6621 is generally the Federal short-term rate plus three percentage points. 79 FR 8623. The Secretary has long applied the interest rate in 26 U.S.C. 6621 to calculate interest on backpay in whistleblower cases.
As explained in the IFR, in ordering back pay, OSHA will require the respondent to submit the appropriate documentation to the Social Security Administration (SSA) allocating the back pay to the appropriate calendar quarters. Requiring the reporting of back pay allocation to the SSA serves the remedial purposes of FSMA by ensuring that employees subjected to retaliation are truly made whole.
Finally, as noted in the IFR, in limited circumstances, in lieu of preliminary reinstatement, OSHA may order that the complainant receive the same pay and benefits that he or she received prior to termination, but not actually return to work.
Roll commented on the discussion in the IFR of “economic reinstatement”
OSHA declines to adopt specific guidelines pertaining to front pay awards in these rules. As explained in the IFR, the appropriateness of “economic reinstatement” or front pay as an alternative to the default statutory remedy of reinstatement has long been recognized. OSHA believes that relevant case law more appropriately addresses the parameters for issuing an award of front pay in lieu of reinstatement.
Kalijarvi requested that the rule include a reference to
For these reasons, OSHA has made no changes to the text of this section.
To be effective, objections to the findings of the Assistant Secretary must be in writing and must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, within 30 days of receipt of the findings. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of the filing; if the objection is filed in person, by hand-delivery or other means, the objection is filed upon receipt. The filing of objections also is considered a request for a hearing before an ALJ. Although the parties are directed to serve a copy of their objections on the other parties of record, as well as the OSHA official who issued the findings and order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards, the failure to serve copies of the objections on the other parties of record does not affect the ALJ's jurisdiction to hear and decide the merits of the case.
The timely filing of objections stays all provisions of the preliminary order, except for the portion requiring reinstatement. A respondent may file a motion to stay the Assistant Secretary's preliminary order of reinstatement with the Office of Administrative Law Judges. However, such a motion will be granted only based on exceptional circumstances. The Secretary believes that a stay of the Assistant Secretary's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief,
No comments were received on this section, and no changes were made to it.
This section adopts the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges as set forth in 29 CFR part 18 subpart A. This section provides that the hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo, on the record. As noted in this section, formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.
No comments were received on this section, and no changes were made to it.
The Assistant Secretary, at his or her discretion, may participate as a party or amicus curiae at any time in the administrative proceedings under FSMA. For example, the Assistant Secretary may exercise his or her discretion to prosecute the case in the administrative proceeding before an ALJ; petition for review of a decision of an ALJ, including a decision based on a settlement agreement between the complainant and the respondent, regardless of whether the Assistant Secretary participated before the ALJ; or participate as amicus curiae before the ALJ or in the ARB proceeding. Although OSHA anticipates that ordinarily the Assistant Secretary will not participate, the Assistant Secretary may choose to do so in appropriate cases, such as cases involving important or novel legal issues, multiple employees, alleged violations that appear egregious, or where the interests of justice might require participation by the Assistant Secretary. The FDA, if interested in a proceeding, also may participate as amicus curiae at any time in the proceedings.
No comments were received on this section, though minor changes were made as needed to clarify the provision without changing its meaning.
This section sets forth the requirements for the content of the decision and order of the ALJ, and includes the standard for finding a violation under FSMA. Specifically, the complainant must demonstrate (
Paragraph (c) of this section further provides that OSHA's determination to dismiss the complaint without an investigation or without a complete investigation under section 1987.104 is not subject to review. Thus, section 1987.109(c) clarifies that OSHA's determinations on whether to proceed with an investigation under FSMA and whether to make particular investigative findings are discretionary decisions not subject to review by the ALJ. The ALJ hears cases de novo and, therefore, as a general matter, may not remand cases to OSHA to conduct an investigation or make further factual findings.
Paragraph (d) notes the remedies that the ALJ may order under FSMA and, as discussed under section 1987.105 above, provides that interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and that the respondent will be required to submit appropriate documentation to the SSA allocating any back pay award to the appropriate calendar quarters. Paragraph (e) requires that the ALJ's decision be served on all parties to the proceeding, OSHA, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. Paragraph (e) also provides that any ALJ decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the ARB. If no timely petition for review is filed with the ARB, the decision of the ALJ becomes the final decision of the Secretary and is not subject to judicial review.
No comments were received on this section, and no changes were made to it.
Upon the issuance of the ALJ's decision, the parties have 14 days within which to petition the ARB for review of that decision. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing of the petition; if the petition is filed in person, by hand delivery or other means, the petition is considered filed upon receipt.
The appeal provisions in this part provide that an appeal to the ARB is not a matter of right but is accepted at the discretion of the ARB. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. The ARB has 30 days to decide whether to grant the petition for review. If the ARB does not grant the petition, the decision of the ALJ becomes the final decision of the Secretary. If a timely petition for review is filed with the ARB, any relief ordered by the ALJ, except for that portion ordering reinstatement, is inoperative while the matter is pending before the ARB. If the ARB accepts a petition for review, the ALJ's factual determinations will be reviewed under the substantial evidence standard.
Kalijarvi submitted several comments related to this section of the rule. Kalijarvi requested the removal of the portion of the rule stating that objections not raised in the petition for review to the ARB may be considered waived. Instead, Kalijarvi requested that the provision be altered to instruct parties to identify in their petitions for review the legal conclusions or orders to which they object so that the ARB may determine whether the review presents issues worthy of full briefing. OSHA declines to revise the rule as Kalijarvi has proposed. OSHA notes that the IFR used the phrase “may” be deemed waived, indicating that the parties are not necessarily barred from subsequently raising grounds in addition to those included in the initial petition. Further, OSHA's inclusion of this provision is not intended to limit the circumstances in which parties can add additional grounds for review as a case progresses before the ARB; rather, the rules include this provision to put the public on notice of the possible consequences of failing to specify the basis of an appeal to the ARB. OSHA recognizes that, while the ARB has held in some instances that an exception not specifically urged may be deemed waived, the ARB also has found that the rules provide for exceptions to this general rule.
Kalijarvi also requested that the deadline for filing a petition for review with the ARB be extended past 14 days, and for this section to allow explicitly for the parties to file a motion to extend the time for submitting a petition for review. Kalijarvi further requested that OSHA explain how the current text of the section furthers FSMA's remedial purpose. OSHA declines to extend the time limit to petition for review because the shorter review period is consistent with the practices and procedures followed in OSHA's other whistleblower programs. Furthermore, as Kalijarvi acknowledges in its comment, parties may file a motion for extension of time to appeal an ALJ's decision, and the ARB has discretion to grant such extensions. OSHA believes that mentioning a motion for an extension of time in these rules, where no other motions are mentioned, could lead the public to mistakenly conclude that the 14 day deadline may be waived as a matter of right, where such is not the case.
OSHA believes that this section furthers the remedial purpose of FSMA by informing the public of the option of requesting ARB review of ALJ decisions as well as the deadlines associated with such review.
This section also provides that, based on exceptional circumstances, the ARB may grant a motion to stay an ALJ's preliminary order of reinstatement under FSMA, which otherwise would be effective, while review is conducted by the ARB. The Secretary believes that a stay of an ALJ's preliminary order of reinstatement under FSMA would be appropriate only where the respondent can establish the necessary criteria for equitable injunctive relief,
If the ARB concludes that the respondent has violated the law, it will order the respondent to take appropriate affirmative action to abate the violation, including reinstatement of the complainant to that person's former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of employment, and compensatory damages. At the request of the complainant, the ARB will assess against the respondent all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily, and the respondent will be required to submit appropriate documentation to the Social Security Administration (SSA) allocating any back pay award to the appropriate calendar quarters. If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon
No changes were made to this section, and other than the comments discussed above, no additional comments were received on this section.
This section provides the procedures and time periods for withdrawal of complaints, the withdrawal of findings and/or preliminary orders by the Assistant Secretary, and the withdrawal of objections to findings and/or orders. It permits complainants to withdraw their complaints orally and provides that, in such circumstances, OSHA will confirm a complainant's desire to withdraw in writing. It also provides for approval of settlements at the investigative and adjudicative stages of the case.
Roll commented that this provision should state explicitly that settlements may be conducted in a confidential manner and outside of the administrative proceedings. Because the IFR did not plainly provide such assurances, Roll expressed concern that “the lack of confidentiality will work as a disincentive for both parties . . . [and] will ultimately lead to fewer out-of-court settlements. . . .” Roll further commented that this section should include guidelines regarding when the Secretary will approve or disapprove a settlement agreement, as well as an explanation regarding the settlement options that are available to the parties.
OSHA is not making any changes to the rule in response to this comment. This section implements FSMA's statutory provision that “[a]t any time before issuance of a final order, a proceeding under this subsection may be terminated on the basis of a settlement agreement entered into by the Secretary, the complainant, and the person alleged to have committed the violation.” 21 U.S.C. 399(b)(3)(A). However, OSHA notes that the Secretary has always recognized that parties may efficiently resolve cases in negotiations between themselves. The Secretary's policy is to approve privately negotiated settlements, provided that each settlement is reviewed by the Secretary to ensure that the terms are fair, adequate, reasonable, and consistent with the purpose and intent of the relevant whistleblower statute and the public interest.
As to Roll's confidentiality concerns, OSHA, an ALJ or the ARB will not approve an agreement that states or implies that any of these entities, or DOL more generally, is party to a confidentiality agreement. Moreover, as noted in paragraph (e) of this section, any settlement approved by OSHA, the ALJ, or the ARB will constitute the final order of the Secretary, and as such, an approved agreement is an official government record that is subject to applicable public disclosure rules.
This section describes the statutory provisions for judicial review of decisions of the Secretary and requires, in cases where judicial review is sought, the ALJ or the ARB to submit the record of proceedings to the appropriate court pursuant to the rules of such court. No comments were received on this section, and no changes were made to it.
This section describes the Secretary's power under FSMA to obtain judicial enforcement of orders and the terms of settlement agreements. FSMA expressly authorizes district courts to enforce orders, including preliminary orders of reinstatement, issued by the Secretary.
No comments were received on this section. OSHA has revised this section slightly to more closely parallel the provisions of the statute regarding the proper venue for an enforcement action.
This section sets forth provisions that allow a complainant to bring an original de novo action in district court, alleging the same allegations contained in the complaint filed with OSHA, under certain circumstances. FSMA permits a complainant to file an action for de novo review in the appropriate district court if there has been no final decision of the Secretary within 210 days of the filing of the complaint, or within 90 days after receiving a written determination. “Written determination” refers to the Assistant Secretary's written findings issued at the close of OSHA's investigation under section 1987.105(a).
However, the Secretary believes that FSMA does not permit complainants to initiate an action in federal court after the Secretary issues a final decision, even if the date of the final decision is more than 210 days after the filing of the complaint or within 90 days of the complainant's receipt of the Assistant Secretary's written findings. The purpose of the “kick-out” provision is to aid the complainant in receiving a prompt decision. That goal is not implicated in a situation where the complainant already has received a final decision from the Secretary. In addition, permitting the complainant to file a new case in district court in such circumstances conflicts with the parties' right to seek judicial review of the Secretary's final decision in the court of appeals.
Under FSMA, the Assistant Secretary's written findings become the final order of the Secretary, not subject to judicial review, if no objection is filed within 30 days.
This section also requires that, within seven days after filing a complaint in district court, a complainant must provide a file-stamped copy of the complaint to OSHA, the ALJ, or the ARB, depending on where the proceeding is pending. In all cases, a copy of the complaint also must be provided to the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the U.S. Department of Labor's Associate Solicitor for Fair Labor Standards. This provision is necessary to notify the agency that the complainant has opted to file a complaint in district court. This provision is not a substitute for the complainant's compliance with the requirements for service of process of the district court complaint contained in the Federal Rules of Civil Procedure and the local rules of the district court where the complaint is filed. This section also incorporates the statutory provisions which allow for a jury trial at the request of either party in a district court action, and which specify the remedies and burdens of proof in a district court action.
In response to the IFR preamble's statement that the purpose of the “kick-out” provision is to “aid the complainant in receiving a prompt decision,” Kalijarvi commented that the kick-out provision offers additional benefits to complainants, such as an opportunity to receive a jury determination of damages. Indeed, Paragraph (a) of this section provides that an action brought under this section is entitled to trial by jury. OSHA appreciates Kalijarvi's comment, but has left the text of the rule unchanged.
This section provides that in circumstances not contemplated by these rules or for good cause the ALJ or the ARB may, upon application and notice to the parties, waive any rule as justice or the administration of FSMA requires. No comments were received on this section, and no changes were made to it.
This rule contains a reporting provision (filing a retaliation complaint, Section 1987.103) which was previously reviewed and approved for use by the Office of Management and Budget (OMB) under the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13). The assigned OMB control number is 1218-0236.
The notice and comment rulemaking procedures of section 553 of the Administrative Procedure Act (APA) do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). This is a rule of agency procedure, practice, and interpretation within the meaning of that section, since it provides procedures for the Department's handling of retaliation complaints. Therefore, publication in the
Furthermore, because this rule is procedural and interpretative rather than substantive, the normal requirement of 5 U.S.C. 553(d) that a rule is effective 30 days after publication in the
The Department has concluded that this rule is not a “significant regulatory action” within the meaning of section 3(f)(4) of Executive Order 12866, as reaffirmed by Executive Order 13563, because it is not likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in Executive Order 12866. Therefore, no regulatory impact analysis under Section 6(a)(3)(C) of Executive Order 12866 has been prepared.
For this reason, and because no notice of proposed rulemaking has been published, no statement is required under Section 202 of the Unfunded Mandates Reform Act of 1995, 2 U.S.C. 1531
The notice and comment rulemaking procedures of Section 553 of the APA do not apply “to interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice.” 5 U.S.C. 553(b)(A). Rules that are exempt from APA notice and comment requirements are also exempt from the Regulatory Flexibility Act (RFA).
Administrative practice and procedure, Employment, Food safety, Investigations, Reporting and recordkeeping requirements, Whistleblower.
This document was prepared under the direction and control of David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health.
Accordingly, for the reasons set out in the preamble, 29 CFR part 1987 is revised to read as follows:
21 U.S.C. 399d; Secretary of Labor's Order No. 1-2012 (Jan. 18, 2012), 77 FR 3912 (Jan. 25, 2012); Secretary of Labor's Order No. 2-2012 (Oct. 19, 2012), 77 FR 69378 (Nov. 16, 2012).
(a) This part sets forth the procedures for, and interpretations of, section 402 of the FDA Food Safety Modernization Act (FSMA), Public Law 111-353, 124 Stat. 3885, which was signed into law on January 4, 2011. Section 402 of the FDA Food Safety Modernization Act amended the Federal Food, Drug, and Cosmetic Act (FD&C), 21 U.S.C. 301
(b) This part establishes procedures under section 1012 of the FD&C for the expeditious handling of retaliation complaints filed by employees, or by persons acting on their behalf. The rules in this part, together with those codified at 29 CFR part 18, set forth the procedures under section 1012 of the FD&C for submission of complaints, investigations, issuance of findings and preliminary orders, objections to findings and orders, litigation before administrative law judges, post-hearing administrative review, and withdrawals and settlements. In addition, the rules in this part provide the Secretary's interpretations on certain statutory issues.
As used in this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(j)
(k)
(l)
(m)
(n) Any future statutory amendments that affect the definition of a term or terms listed in this section will apply in lieu of the definition stated herein.
(a) No covered entity may discharge or otherwise retaliate against, including, but not limited to, intimidating, threatening, restraining, coercing, blacklisting or disciplining, any employee with respect to the employee's compensation, terms, conditions, or privileges of employment because the employee, whether at the employee's initiative or in the ordinary course of the employee's duties (or any person acting pursuant to a request of the employee), has engaged in any of the activities specified in paragraphs (b)(1) through (4) of this section.
(b) An employee is protected against retaliation because the employee (or any person acting pursuant to a request of the employee) has:
(1) Provided, caused to be provided, or is about to provide or cause to be provided to the employer, the Federal Government, or the attorney general of a State information relating to any violation of, or any act or omission the employee reasonably believes to be a violation of any provision of the FD&C or any order, rule, regulation, standard, or ban under the FD&C;
(2) Testified or is about to testify in a proceeding concerning such violation;
(3) Assisted or participated or is about to assist or participate in such a proceeding; or
(4) Objected to, or refused to participate in, any activity, policy, practice, or assigned task that the employee (or other such person) reasonably believed to be in violation of any provision of the FD&C, or any order, rule, regulation, standard, or ban under the FD&C.
(a)
(b)
(c)
(d)
(a) Upon receipt of a complaint in the investigating office, OSHA will notify the respondent of the filing of the complaint, of the allegations contained in the complaint, and of the substance of the evidence supporting the complaint. Such materials will be redacted, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. OSHA will also notify the respondent of its rights under paragraphs (b) and (f) of this section and § 1987.110(e). OSHA will provide an unredacted copy of these same materials to the complainant (or the complainant's legal counsel if complainant is represented by counsel) and to the FDA.
(b) Within 20 days of receipt of the notice of the filing of the complaint provided under paragraph (a) of this section, the respondent and the complainant each may submit to OSHA a written statement and any affidavits or documents substantiating its position. Within the same 20 days, the respondent and the complainant each may request a meeting with OSHA to present its position.
(c) During the investigation, OSHA will request that each party provide the other parties to the whistleblower complaint with a copy of submissions to OSHA that are pertinent to the whistleblower complaint. Alternatively, if a party does not provide its submissions to OSHA to the other party, OSHA will provide them to the other party (or the party's legal counsel if the party is represented by counsel) at a time permitting the other party an opportunity to respond. Before providing such materials to the other party, OSHA will redact them, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. OSHA will also provide each party with an opportunity to respond to the other party's submissions.
(d) Investigations will be conducted in a manner that protects the confidentiality of any person who provides information on a confidential basis, other than the complainant, in accordance with part 70 of this title.
(e)(1) A complaint will be dismissed unless the complainant has made a prima facie showing (
(2) The complaint, supplemented as appropriate by interviews of the complainant, must allege the existence of facts and evidence to make a prima facie showing as follows:
(i) The employee engaged in a protected activity;
(ii) The respondent knew or suspected that the employee engaged in the protected activity;
(iii) The employee suffered an adverse action; and
(iv) The circumstances were sufficient to raise the inference that the protected activity was a contributing factor in the adverse action.
(3) For purposes of determining whether to investigate, the complainant will be considered to have met the required burden if the complaint on its
(4) Notwithstanding a finding that a complainant has made a prima facie showing, as required by this section, further investigation of the complaint will not be conducted if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of the complainant's protected activity.
(5) If the respondent fails to make a timely response or fails to satisfy the burden set forth in paragraph (e)(4) of this section, OSHA will proceed with the investigation. The investigation will proceed whenever it is necessary or appropriate to confirm or verify the information provided by the respondent.
(f) Prior to the issuance of findings and a preliminary order as provided for in § 1987.105, if OSHA has reasonable cause, on the basis of information gathered under the procedures of this part, to believe that the respondent has violated FSMA and that preliminary reinstatement is warranted, OSHA will contact the respondent (or the respondent's legal counsel if respondent is represented by counsel) to give notice of the substance of the relevant evidence supporting the complainant's allegations as developed during the course of the investigation. This evidence includes any witness statements, which will be redacted to protect the identity of confidential informants where statements were given in confidence; if the statements cannot be redacted without revealing the identity of confidential informants, summaries of their contents will be provided. The complainant will also receive a copy of the materials that must be provided to the respondent under this paragraph. Before providing such materials, OSHA will redact them, if necessary, consistent with the Privacy Act of 1974, 5 U.S.C. 552a, and other applicable confidentiality laws. The respondent will be given the opportunity to submit a written response, to meet with the investigators, to present statements from witnesses in support of its position, and to present legal and factual arguments. The respondent must present this evidence within 10 business days of OSHA's notification pursuant to this paragraph, or as soon thereafter as OSHA and the respondent can agree, if the interests of justice so require.
(a) After considering all the relevant information collected during the investigation, the Assistant Secretary will issue, within 60 days of the filing of the complaint, written findings as to whether or not there is reasonable cause to believe that the respondent has retaliated against the complainant in violation of FSMA.
(1) If the Assistant Secretary concludes that there is reasonable cause to believe that a violation has occurred, the Assistant Secretary will accompany the findings with a preliminary order providing relief to the complainant. The preliminary order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The preliminary order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.
(2) If the Assistant Secretary concludes that a violation has not occurred, the Assistant Secretary will notify the parties of that finding.
(b) The findings and, where appropriate, the preliminary order will be sent by certified mail, return receipt requested (or other means that allow OSHA to confirm receipt), to all parties of record (and each party's legal counsel if the party is represented by counsel). The findings and, where appropriate, the preliminary order will inform the parties of the right to object to the findings and/or order and to request a hearing, and of the right of the respondent to request an award of attorney fees not exceeding $1,000 from the administrative law judge (ALJ), regardless of whether the respondent has filed objections, if the respondent alleges that the complaint was frivolous or brought in bad faith. The findings and, where appropriate, the preliminary order also will give the address of the Chief Administrative Law Judge, U.S. Department of Labor. At the same time, the Assistant Secretary will file with the Chief Administrative Law Judge a copy of the original complaint and a copy of the findings and/or order.
(c) The findings and any preliminary order will be effective 30 days after receipt by the respondent (or the respondent's legal counsel if the respondent is represented by counsel), or on the compliance date set forth in the preliminary order, whichever is later, unless an objection and/or a request for hearing has been timely filed as provided at § 1987.106. However, the portion of any preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and the preliminary order, regardless of any objections to the findings and/or the order.
(a) Any party who desires review, including judicial review, of the findings and/or preliminary order, or a respondent alleging that the complaint was frivolous or brought in bad faith who seeks an award of attorney fees under FSMA, must file any objections and/or a request for a hearing on the record within 30 days of receipt of the findings and preliminary order pursuant to § 1987.105. The objections, request for a hearing, and/or request for attorney fees must be in writing and state whether the objections are to the findings, the preliminary order, and/or whether there should be an award of attorney fees. The date of the postmark, facsimile transmittal, or electronic communication transmittal is considered the date of filing; if the objection is filed in person, by hand delivery or other means, the objection is filed upon receipt. Objections must be filed with the Chief Administrative Law Judge, U.S. Department of Labor, and copies of the objections must be mailed at the same time to the other parties of
(b) If a timely objection is filed, all provisions of the preliminary order will be stayed, except for the portion requiring preliminary reinstatement, which will not be automatically stayed. The portion of the preliminary order requiring reinstatement will be effective immediately upon the respondent's receipt of the findings and preliminary order, regardless of any objections to the order. The respondent may file a motion with the Office of Administrative Law Judges for a stay of the Assistant Secretary's preliminary order of reinstatement, which shall be granted only based on exceptional circumstances. If no timely objection is filed with respect to either the findings or the preliminary order, the findings and/or the preliminary order will become the final decision of the Secretary, not subject to judicial review.
(a) Except as provided in this part, proceedings will be conducted in accordance with the rules of practice and procedure for administrative hearings before the Office of Administrative Law Judges, codified at subpart A of part 18 of this title.
(b) Upon receipt of an objection and request for hearing, the Chief Administrative Law Judge will promptly assign the case to an ALJ who will notify the parties, by certified mail, of the day, time, and place of hearing. The hearing is to commence expeditiously, except upon a showing of good cause or unless otherwise agreed to by the parties. Hearings will be conducted de novo on the record. ALJs have broad discretion to limit discovery in order to expedite the hearing.
(c) If both the complainant and the respondent object to the findings and/or order, the objections will be consolidated and a single hearing will be conducted.
(d) Formal rules of evidence will not apply, but rules or principles designed to assure production of the most probative evidence will be applied. The ALJ may exclude evidence that is immaterial, irrelevant, or unduly repetitious.
(a)(1) The complainant and the respondent will be parties in every proceeding and must be served with copies of all documents in the case. At the Assistant Secretary's discretion, the Assistant Secretary may participate as a party or as amicus curiae at any time at any stage of the proceeding. This right to participate includes, but is not limited to, the right to petition for review of a decision of an ALJ, including a decision approving or rejecting a settlement agreement between the complainant and the respondent.
(2) Parties must send copies of documents to OSHA and to the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, only upon request of OSHA, or when OSHA is participating in the proceeding, or when service on OSHA and the Associate Solicitor is otherwise required by the rules in this part.
(b) The FDA, if interested in a proceeding, may participate as amicus curiae at any time in the proceeding, at the FDA's discretion. At the request of the FDA, copies of all documents in a case must be sent to the FDA, whether or not the FDA is participating in the proceeding.
(a) The decision of the ALJ will contain appropriate findings, conclusions, and an order pertaining to the remedies provided in paragraph (d) of this section, as appropriate. A determination that a violation has occurred may be made only if the complainant has demonstrated by a preponderance of the evidence that protected activity was a contributing factor in the adverse action alleged in the complaint.
(b) If the complainant has satisfied the burden set forth in the prior paragraph, relief may not be ordered if the respondent demonstrates by clear and convincing evidence that it would have taken the same adverse action in the absence of any protected activity.
(c) Neither OSHA's determination to dismiss a complaint without completing an investigation pursuant to § 1987.104(e) nor OSHA's determination to proceed with an investigation is subject to review by the ALJ, and a complaint may not be remanded for the completion of an investigation or for additional findings on the basis that a determination to dismiss was made in error. Rather, if there otherwise is jurisdiction, the ALJ will hear the case on the merits or dispose of the matter without a hearing if the facts and circumstances warrant.
(d)(1) If the ALJ concludes that the respondent has violated the law, the ALJ will issue an order that will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.
(2) If the ALJ determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ALJ determines that a complaint was frivolous or was brought in bad faith, the ALJ may award to the respondent a reasonable attorney fee, not exceeding $1,000.
(e) The decision will be served upon all parties to the proceeding, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor. Any ALJ's decision requiring reinstatement or lifting an order of reinstatement by the Assistant Secretary will be effective immediately upon receipt of the decision by the respondent. All other portions of the ALJ's order will be effective 14 days after the date of the decision unless a timely petition for review has been filed with the Administrative Review Board (ARB), U.S. Department of Labor. The decision of the ALJ will become the final order of the Secretary unless a petition for review is timely filed with the ARB and the ARB accepts the petition for review.
(a) Any party desiring to seek review, including judicial review, of a decision of the ALJ, or a respondent alleging that the complaint was frivolous or brought in bad faith who seeks an award of attorney fees, must file a written petition for review with the ARB, which has been delegated the authority to act for the Secretary and issue final decisions under this part. The parties should identify in their petitions for review the legal conclusions or orders to which they object, or the objections may be deemed waived. A petition must be filed within 14 days of the date of the decision of the ALJ. The date of the
(b) If a timely petition for review is filed pursuant to paragraph (a) of this section, the decision of the ALJ will become the final order of the Secretary unless the ARB, within 30 days of the filing of the petition, issues an order notifying the parties that the case has been accepted for review. If a case is accepted for review, the decision of the ALJ will be inoperative unless and until the ARB issues an order adopting the decision, except that any order of reinstatement will be effective while review is conducted by the ARB, unless the ARB grants a motion by the respondent to stay that order based on exceptional circumstances. The ARB will specify the terms under which any briefs are to be filed. The ARB will review the factual determinations of the ALJ under the substantial evidence standard. If no timely petition for review is filed, or the ARB denies review, the decision of the ALJ will become the final order of the Secretary. If no timely petition for review is filed, the resulting final order is not subject to judicial review.
(c) The final decision of the ARB will be issued within 120 days of the conclusion of the hearing, which will be deemed to be 14 days after the date of the decision of the ALJ, unless a motion for reconsideration has been filed with the ALJ in the interim. In such case the conclusion of the hearing is the date the motion for reconsideration is denied or 14 days after a new decision is issued. The ARB's final decision will be served upon all parties and the Chief Administrative Law Judge by mail. The final decision will also be served on the Assistant Secretary and on the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor, even if the Assistant Secretary is not a party.
(d) If the ARB concludes that the respondent has violated the law, the ARB will issue a final order providing relief to the complainant. The final order will require, where appropriate: Affirmative action to abate the violation; reinstatement of the complainant to his or her former position, together with the compensation (including back pay and interest), terms, conditions, and privileges of the complainant's employment; and payment of compensatory damages, including, at the request of the complainant, the aggregate amount of all costs and expenses (including attorney and expert witness fees) reasonably incurred. Interest on back pay will be calculated using the interest rate applicable to underpayment of taxes under 26 U.S.C. 6621 and will be compounded daily. The order will also require the respondent to submit appropriate documentation to the Social Security Administration allocating any back pay award to the appropriate calendar quarters.
(e) If the ARB determines that the respondent has not violated the law, an order will be issued denying the complaint. If, upon the request of the respondent, the ARB determines that a complaint was frivolous or was brought in bad faith, the ARB may award to the respondent a reasonable attorney fee, not exceeding $1,000.
(a) At any time prior to the filing of objections to the Assistant Secretary's findings and/or preliminary order, a complainant may withdraw his or her complaint by notifying OSHA, orally or in writing, of his or her withdrawal. OSHA then will confirm in writing the complainant's desire to withdraw and determine whether to approve the withdrawal. OSHA will notify the parties (and each party's legal counsel if the party is represented by counsel) of the approval of any withdrawal. If the complaint is withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section. A complainant may not withdraw his or her complaint after the filing of objections to the Assistant Secretary's findings and/or preliminary order.
(b) The Assistant Secretary may withdraw the findings and/or preliminary order at any time before the expiration of the 30-day objection period described in § 1987.106, provided that no objection has been filed yet, and substitute new findings and/or a new preliminary order. The date of the receipt of the substituted findings or order will begin a new 30-day objection period.
(c) At any time before the Assistant Secretary's findings and/or order become final, a party may withdraw objections to the Assistant Secretary's findings and/or order by filing a written withdrawal with the ALJ. If the case is on review with the ARB, a party may withdraw a petition for review of an ALJ's decision at any time before that decision becomes final by filing a written withdrawal with the ARB. The ALJ or the ARB, as the case may be, will determine whether to approve the withdrawal of the objections or the petition for review. If the ALJ approves a request to withdraw objections to the Assistant Secretary's findings and/or order, and there are no other pending objections, the Assistant Secretary's findings and/or order will become the final order of the Secretary. If the ARB approves a request to withdraw a petition for review of an ALJ decision, and there are no other pending petitions for review of that decision, the ALJ's decision will become the final order of the Secretary. If objections or a petition for review are withdrawn because of settlement, the settlement must be submitted for approval in accordance with paragraph (d) of this section.
(d)(1)
(2)
(e) Any settlement approved by OSHA, the ALJ, or the ARB will constitute the final order of the Secretary and may be enforced in United States district court pursuant to § 1987.113.
(a) Within 60 days after the issuance of a final order under §§ 1987.109 and 1987.110, any person adversely affected or aggrieved by the order may file a petition for review of the order in the United States Court of Appeals for the circuit in which the violation allegedly occurred or the circuit in which the
(b) A final order is not subject to judicial review in any criminal or other civil proceeding.
(c) If a timely petition for review is filed, the record of a case, including the record of proceedings before the ALJ, will be transmitted by the ARB or the ALJ, as the case may be, to the appropriate court pursuant to the Federal Rules of Appellate Procedure and the local rules of such court.
Whenever any person has failed to comply with a preliminary order of reinstatement, or a final order, including one approving a settlement agreement, issued under FSMA, the Secretary may file a civil action seeking enforcement of the order in the United States district court for the district in which the violation was found to have occurred or in the United States district court for the District of Columbia. Whenever any person has failed to comply with a preliminary order of reinstatement, or a final order, including one approving a settlement agreement, issued under FSMA, a person on whose behalf the order was issued may file a civil action seeking enforcement of the order in the appropriate United States district court.
(a) The complainant may bring an action at law or equity for de novo review in the appropriate district court of the United States, which will have jurisdiction over such an action without regard to the amount in controversy, either:
(1) Within 90 days after receiving a written determination under § 1987.105(a) provided that there has been no final decision of the Secretary; or
(2) If there has been no final decision of the Secretary within 210 days of the filing of the complaint.
(b) At the request of either party, the action shall be tried by the court with a jury.
(c) A proceeding under paragraph (a) of this section shall be governed by the same legal burdens of proof specified in § 1987.109. The court shall have jurisdiction to grant all relief necessary to make the employee whole, including injunctive relief and compensatory damages, including:
(1) Reinstatement with the same seniority status that the employee would have had, but for the discharge or discrimination;
(2) The amount of back pay, with interest;
(3) Compensation for any special damages sustained as a result of the discharge or discrimination; and
(4) Litigation costs, expert witness fees, and reasonable attorney fees.
(d) Within seven days after filing a complaint in federal court, a complainant must file with OSHA, the ALJ, or the ARB, depending on where the proceeding is pending, a copy of the file-stamped complaint. In all cases, a copy of the complaint also must be served on the OSHA official who issued the findings and/or preliminary order, the Assistant Secretary, and the Associate Solicitor, Division of Fair Labor Standards, U.S. Department of Labor.
In special circumstances not contemplated by the provisions of the rules in this part, or for good cause shown, the ALJ or the ARB on review may, upon application, after three days notice to all parties, waive any rule or issue such orders that justice or the administration of FSMA requires.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a special local regulation on the waters of the Atlantic Ocean east of Daytona Beach, Florida during the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. This action is necessary to provide for the safety of life on the navigable waters surrounding the event. This special local regulation will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. This rulemaking prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port (COTP) Jacksonville or a designated representative.
This rule is effective from April 22, 2016 through April 24, 2016 and will be enforced daily from 8 a.m. to 5 p.m.
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 Lieutenant Allan Storm, Sector Jacksonville, Waterways Management Division, U.S. Coast Guard; telephone 904-714-7616, email
On December 7, 2015, Powerboat P1-USA, LLC notified the Coast Guard that it will conduct a series of high speed boat races in the Atlantic Ocean, offshore from Daytona Beach, FL from April 22 through 24, 2016. In response, on February 4, 2016, the Coast Guard published a notice of proposed rulemaking (NPRM) titled Special Local Regulation, Daytona Beach Grand Prix of the Seas; Daytona Beach, FL (81 FR 5967). There we stated why we issued the NPRM and invited comments on our proposed regulatory action related to this boat race. During the comment period that ended March 7, 2016, we received 3 comments.
Under good cause provisions in 5 U.S.C. 553(d)(3), we are making this rule effective less than 30 days after its publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1233. The COTP Jacksonville determined that potential hazards associated with high speed boat races necessitate the establishment of a special local
As noted above, we received three comments on the NPRM published February 4, 2016. Two comments received were in support of the rule. The third comment received was opposed to the rule. The comment opposed to the rule disputed the following items: (1) The Coast Guard's position that this high speed boat race poses an extra hazard to the safety of life on the navigable waters surrounding the event, (2) the need to establish a special local regulation to mitigate the hazards associated with this event, (3) the need for Coast Guard presence to enforce the rule (due to monetary cost to taxpayers), and (4) the determination that this rule is not a “significant regulatory action.” In regard to significant regulatory action, the commenter stated that this rule “encroaches on rights of mariners to be in a public area.”
A marine event is defined as an organized event of limited duration on the navigable waters of the United States conducted according to a prearranged schedule which presents an extra or unusual hazard to the safety of human life that cannot be protected by existing navigation. Prior to taking any regulatory action and to considering the establishment of a special local regulation, the Coast Guard utilizes a risk-informed decision making process to determine if an event meets the definition of a marine event as outlined in 33 CFR 100.05 and is likely to introduce an extra or unusual hazard to the safety of human life. The primary risk factors for determining that this is a marine event included: (1) The expected involvement of an unusually large concentration of traffic on the water that may interfere with routine navigation and (2) the event includes an inherently hazardous competition where craft are expected to travel at high speeds. Once the Coast Guard made the marine event determination, we proposed a safety risk-mitigation tool. In this case, it is the establishment of a special local regulation. Based on an analysis of the factors addressed above, the commenter's position that this race is not a marine event justifying Coast Guard action is not supportable.
For the enforcement of this rule, the Coast Guard does not need to be on scene. As stated in the regulatory text at the end of this document, the COTP may utilize Federal, state, and local officers (designated representatives) for the enforcement of the regulated area.
A “significant regulation” under Executive Order 12866, is one that has an impact on the economy of more than $100 million or one that adversely affects in a material way the economy or a sector of the economy; creates a serious inconsistency or interferes with another agency; materially alters the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients; or raises a novel issue of law or policy. For the reasons stated in section V.A below, the Coast Guard determines that this rule is not a significant regulatory action. It is one of a category of regulations considered “routine and frequent” by the Office of Management and Budget.
This rule establishes a special local regulation for the Daytona Beach Grand Prix of the Seas, a series of high-speed personal watercraft boat races. The regulated area includes the waters of the Atlantic Ocean offshore from Daytona Beach, Florida and will be enforced daily 8 a.m. to 5 p.m., from April 22 through April 24, 2016. Approximately 90 high-speed personal watercraft are anticipated to participate in the races. The regulated area would encompass an approximated offshore area that is 1,350 yards wide extending 600 yards south of the Daytona Beach pier to 1,900 yards north of the pier. No vessel or person will be permitted to enter the regulated area 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 Coast Guard has determined that this temporary final rule is not a significant regulatory action for the following reasons: (1) The special local regulation would be enforced for a total of only 27 hours over the course of three days; (2) although persons and vessels would not be able to enter, transit through, anchor in, or remain within the regulated area without authorization from the COTP Jacksonville or a designated representative, they would be able to operate in the surrounding area during the enforcement period; (3) persons and vessels would still be able to enter, transit through, anchor in, or remain within the regulated area if authorized by the COTP Jacksonville or a designated representative; and (4) the Coast Guard would provide advance notification of the special local regulation to the local maritime community via Broadcast Notice to Mariners or by on-scene designated representative.
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 regulated 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
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 a special local regulation that would prohibit persons and vessels from transiting through a 2,500 yard by 1,350 yard regulated area during a three day racing event lasting nine hours daily. It is categorically excluded from further review under paragraphs 34(h) and 35(a) 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, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 100 as follows:
33 U.S.C. 1233.
(a)
(b)
(c)
(2) Persons and vessels desiring to enter, transit through, anchor in, or remain within the regulated area may contact the COTP Jacksonville by telephone at 904-714-7557, or a designated representative via VHF-FM radio on channel 16 to request authorization. If authorization is granted, all persons and vessels receiving such authorization must comply with the instructions of the COTP Jacksonville or designated representative.
(3) The Coast Guard will provide notice of the regulated area through Broadcast Notice to Mariners via VHF—FM channel 16 or by on-scene designated representatives.
(d)
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the US 50 (Harry W. Kelly Memorial) Bridge across the Isle of Wight (Sinepatuxent) Bay, mile 0.5, at Ocean City, MD. The deviation is necessary to accommodate participants of the 2016 “Island 2 Island” Half Marathon.
The deviation is effective from 8 a.m. to 10:30 a.m. on Saturday, April 30, 2016.
The docket for this deviation, [USCG-2016-0295] is available at
If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email
The OC Tri-Running Sports, on behalf of the Maryland State Highway Administration, who owns the US 50 (Harry W. Kelly Memorial) Bridge has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.559, to facilitate the 2016 “Island 2 Island” Half Marathon.
Under this temporary deviation, the bridge will be closed to navigation from 8 a.m. to 10:30 a.m. on April 30, 2016. The closure has been requested to ensure the safety of the increased volumes of runners and spectators that will be participating in the “Island 2 Island” Half Marathon on April 30, 2016.
The bridge is a Double Bascule bridge and has a vertical clearance in the closed position of 13 feet above mean high water. Vessels able to pass through the bridge in the closed position may do so at anytime. The bridge will not be able to open for emergencies and there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local Notice and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Notice of public meetings.
The Department of Energy (DOE) announces public meetings and webinars for the DPPP Working Group. The Federal Advisory Committee Act requires that agencies publish notice of an advisory committee meeting in the
See
The meetings will be held at U.S. Department of Energy, Forrestal Building, Room 8E-089, 1000 Independence Avenue SW., Washington, DC 20585 unless otherwise stated in the
On July 30, 2015, ASRAC met and unanimously passed the recommendation to form a dedicated purpose pool pumps (DPPP) working group to meet and discuss and, if possible, reach consensus on proposed Federal rules that would apply to this equipment. The ASRAC Charter allowed for 3 months of working group meetings to establish the scope, metric, definitions, and test procedure for dedicated purpose pool pumps and decide on a path forward at that time. The working group met this requirement and now more time is required to discuss potential energy conservation standards for this equipment. On January 20, 2016, ASRAC met and recommended that the DPPP Working Group continue its work to develop and recommend potential energy conservation standards for this equipment. This notice announces the next series of meetings for this working group.
DOE will host public meetings and webinars on the below dates. Meetings will be hosted at DOE's Forrestal Building, unless otherwise stated.
Members of the public are welcome to observe the business of the meeting and, if time allows, may make oral statements during the specified period for public comment. To attend the meeting and/or to make oral statements regarding any of the items on the agenda, email
Due to the REAL ID Act implemented by the Department of Homeland Security (DHS) recent changes have been made regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver's licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required.
DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, Louisiana, New York, American Samoa, Maine, Oklahoma, Arizona, Massachusetts, Washington, and Minnesota.
Acceptable alternate forms of Photo-ID include: U.S. Passport or Passport Card; an Enhanced Driver's License or Enhanced ID-Card issued by the states of Minnesota, New York or Washington (Enhanced licenses issued by these states are clearly marked Enhanced or Enhanced Driver's License); A military ID or other Federal government issued Photo-ID card.
Food and Drug Administration, HHS.
Proposed rule; reopening of the comment period.
The Food and Drug Administration (FDA) is reopening the comment period for the proposed rule, published in the
Submit either electronic or written comments by May 18, 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
Diana J. Pomeranz, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6208, Silver Spring, MD 20993-0002, 240-402-4654.
In the
On March 21, 2016, FDA received a request to allow interested persons additional time to comment. The requester asserted that the time period of 90 days was insufficient to respond fully to FDA's specific requests for comments and to thoroughly evaluate and address pertinent issues. Accordingly, we are reopening the comment period.
Internal Revenue Service (IRS), Treasury.
Notice of a public hearing on notice of proposed rulemaking.
This document provides a notice of public hearing on proposed regulations that would require annual country-by-country reporting by certain United States persons that are the ultimate parent entity of a multinational enterprise group.
The public hearing is being held on Friday, May 13, 2016, at 10 a.m. The IRS must receive outlines of the topics to be discussed at the public hearing by Friday, April 29, 2016.
The public hearing is being held in the IRS Auditorium, Internal Revenue Service Building, 1111 Constitution Avenue NW., Washington, DC 20224. Due to building security procedures, visitors must enter at the Constitution Avenue entrance. In addition, all visitors must present photo identification to enter the building.
Send Submissions to CC:PA:LPD:PR (REG-109822-15), Room 5205, Internal Revenue Service, P.O. Box 7604, Ben Franklin Station, Washington, DC 20044. Submissions may be hand-delivered Monday through Friday to CC:PA:LPD:PR (REG-109822-15), Couriers Desk, Internal Revenue Service, 1111 Constitution Avenue NW., Washington, DC 20224 or sent electronically via the Federal eRulemaking Portal at
Concerning the proposed regulations, Melinda Harvey at (202) 317-6934; concerning submissions of comments, the hearing and/or to be placed on the building access list to attend the hearing Oluwafunmilayo Taylor at (202) 317-6901 (not toll-free numbers).
The subject of the public hearing is the notice of proposed rulemaking (REG-109822-15) that was published in the
The rules of 26 CFR 601.601(a)(3) apply to the hearing. Persons who wish to present oral comments at the hearing that submitted written comments by March 22, 2016, must submit an outline of the topics to be addressed and the amount of time to be denoted to each topic by Friday, April 29, 2016.
A period of 10 minutes is allotted to each person for presenting oral comments. After the deadline for receiving outlines has passed, the IRS will prepare an agenda containing the schedule of speakers. Copies of the agenda will be made available, free of charge, at the hearing or in the Freedom of Information Reading Room (FOIA RR) (Room 1621) which is located at the 11th and Pennsylvania Avenue NW., entrance, 1111 Constitution Avenue NW., Washington, DC 20224.
Because of access restrictions, the IRS will not admit visitors beyond the immediate entrance area more than 30 minutes before the hearing starts. For information about having your name placed on the building access list to attend the hearing, see the
Office of Elementary and Secondary Education, Department of Education.
Proposed priorities.
The Assistant Secretary for Elementary and Secondary Education proposes priorities under the Enhanced Assessment Instruments Grant program, also called the Enhanced Assessment Grants (EAG) program. The Assistant Secretary may use one or more of these priorities for competitions using funds from fiscal year (FY) 2016 and later years. Depending on the availability of funds and the use of other priorities under the EAG authority, the Assistant Secretary may also choose not to use one or more of these priorities for competitions using funds from FY 2016 and later years. These proposed priorities are designed to support projects to improve States' assessment systems.
We must receive your comments on or before May 18, 2016.
Submit your comments through the Federal eRulemaking Portal or via postal mail, commercial delivery, or hand delivery. We will not accept comments submitted by fax or by email or those submitted after the comment period. To ensure that we do not receive duplicate copies, please submit your comments only once. In addition, please include the Docket ID and the term “Enhanced Assessment Grants—Comments” at the top of your comments.
•
•
The Department of Education's (Department's) policy is to make all comments received from members of the public available for public viewing in their entirety on the Federal eRulemaking Portal at
Donald Peasley. Telephone: (202) 453-7982 or by email:
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
We invite you to assist us in complying with the specific requirements of Executive Orders 12866 and 13563 and their overall requirement of reducing regulatory burden that might result from these proposed priorities. Please let us know of any further ways we could reduce potential costs or increase potential benefits while preserving the effective and efficient administration of the program.
During and after the comment period, you may inspect all public comments about these proposed priorities by accessing regulations.gov. You may also inspect the comments in room 3e124, 400 Maryland Avenue SW., Washington, DC, between the hours of 8:30 a.m. and 4:00 p.m., Washington, DC time, Monday through Friday of each week except Federal holidays.
This notice contains three proposed priorities.
Section 6112 of the ESEA, as amended by the NCLB, and section 1203(b)(1) of the ESEA, as amended by the ESSA, authorize the Department to make competitive grant awards to State educational agencies (SEAs) and consortia of SEAs to help them enhance the quality of their assessment instruments and assessment systems.
The grants awarded under this competitive grant award program in section 6112 will also lay the groundwork for some new opportunities in the recently reauthorized Elementary and Secondary Education Act of 1965, as amended by the Every Student Succeeds Act. For example, the reauthorization of ESEA, will allow up to seven States or consortia of States to receive an initial demonstration authority to establish an innovative assessment and accountability system for a new approach to assessment for a trial period of up to five years. This can provide SEAs with an opportunity to demonstrate what is possible when assessment systems are redesigned with student learning at the center. The EAG program provides SEAs with support to develop innovative assessment tools and approaches which have the potential to be used by all States, including those approved under the innovative assessment and accountability demonstration authority, and be more widely adopted at scale. In addition, the EAG program provides SEAs with support in developing innovative summative assessment tools and approaches that can be used within the broader context of the multiple measures of student achievement and school accountability of the new ESSA and the President's Testing Action Plan.
Through this notice, the Department proposes three additional priorities for the EAG program that are designed to support States in continuously improving their assessment systems to measure college- and career-readiness. We believe that an essential part of educating students involves assessing students' progress toward meeting the high standards they need to be ready for college and the workplace. Assessments provide necessary information for States, districts, educators, families, the public, and students themselves to measure progress and improve outcomes for all learners. As such, we recognize the importance of continuously improving and innovating to ensure assessments are fair, of high quality and not duplicative, can be completed in the minimum necessary time while validly and reliably measuring a student's knowledge and skills, and reflect the expectation that students will be prepared for success in college and careers.
Although traditional assessment items such as multiple-choice questions have advantages, innovative item types such as performance tasks, simulations, and interactive, multi-step, technology-rich items that support competency-based assessments or portfolio assessments which demonstrate applied skills, have the potential to provide a more comprehensive view of a student's knowledge and mastery of standards. Examples include: Items that provide multi-step mathematics problems where students demonstrate their approaches to solving each step; items that permit graphs or other visual response types; and simulated game environments where students interact with stimuli and interaction information is collected.
As States implement more rigorous standards, it is important that assessment strategies are aligned with the higher-level cognitive skills students are expected to master.
We believe that good assessments should require the same kind of complex work that students do in an effective classroom or in the real world, including demonstration and application of knowledge and skills. Further, assessments should present information and questions that push students' critical thinking skills so that students gain valuable experience while taking them. The inclusion of new, innovative item types will help to ensure that taking an assessment is a worthwhile experience for students.
Modular assessment approaches also can help SEAs and LEAs support students and educators in a number of significant ways by breaking down large, summative assessment forms with many items into smaller forms with fewer items (
Modules can also provide educators with more individualized, easily-integrated assessments which are used together to provide a summative analysis of each learner.
(a) Develop, evaluate, and implement new, innovative item types for use in summative assessments in reading/language arts, mathematics, or science;
(1) Development of innovative item types under paragraph (a) may include, for example, performance tasks; simulations; or interactive, multi-step, technology-rich items that can support competency-based assessments or portfolio projects;
(2) Projects under this priority must be designed to develop new methods for collecting evidence about a student's knowledge and abilities and ensure the quality, validity, reliability, and fairness of the assessment and comparability of student data; or
(b) Develop new approaches to transform traditional, end-of-year summative assessment forms with many items into a series of modular assessment forms, each with fewer items.
(1) To respond to paragraph (b), applicants must develop modular assessment approaches which can be used to provide timely feedback to educators and parents as well as be combined to provide a valid, reliable, and fair summative assessment of individual learners.
(c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan such that their projects can serve as models and resources that can be shared with States across the Nation.
With continued advancements in technology to support and enhance education in the classroom, it is also becoming possible to improve the testing experience for students by using technology to automatically score non-multiple choice assessment items. Automated scoring can decrease the time needed for scoring and releasing results, lower costs, improve score consistency, and reduce the need for training of, and coordination among, human scorers.
Building on the work done to date and developing better technological tools to score assessments would be advantageous to SEAs, LEAs, educators, and students. Automated scoring would allow SEAs to incorporate more non-multiple choice items, such as essays and constructed responses, in assessments while not adding significantly to the time or cost to score the tests. Assessment results could be returned more quickly to students and educators, who could in turn respond to the results data through timely implementation of additional teaching, supports, or interventions that would help students master content.
Score reporting, when done well, provides valuable feedback to educators that can be used to guide instruction and supports for students. This feedback is most relevant when it is available soon after the assessment is administered and when it is actionable for students, parents, and educators. The Department also recognizes a need to improve the design and content of the reports such that they clearly communicate information to stakeholders.
Efforts to improve the usefulness of score reports could include: Incorporating information about what students' results mean; including multiple levels of information (
(a) Develop innovative tools that leverage technology to score assessments;
(1) To respond to paragraph (a), applicants must propose projects to reduce the time it takes to provide test results to educators, parents, and students and to make it more cost-effective to include non-multiple choice items on assessments. These innovative tools must improve automated scoring of student assessments, in particular non-multiple choice items in reading/language arts, mathematics, and science; or
(b) Propose projects, in consultation with organizations representing parents, students, and teachers, to address needs related to score reporting and improve the utility of information about student performance included in reports of assessment results and provide better and more timely information to educators and parents;
(1) To respond to paragraph (b), applicants must include one or more of the following in their projects:
(i) Developing enhanced score reporting templates or digital mechanisms for communicating assessment results and their meaning;
(ii) Improving the assessment literacy of educators and parents to improve the interpretation of test results to support teaching and learning in the classroom; and
(iii) Developing mechanisms for secure transmission and individual use of assessment results by students and parents.
(c) Applicants proposing projects under either paragraph (a) or (b) must provide a dissemination plan such that their projects can serve as models and resources that can be shared with States across the Nation.
In response to this issue, some SEAs, local educational agencies (LEAs), and schools are currently in the process of reviewing assessments administered to students in kindergarten through grade 12 to better understand if each assessment is of high quality, maximizes instructional goals, has clear purpose and utility, and is designed to provide information on students' progress toward achieving proficiency on State standards. To support such efforts, the Department made the development of tools to inventory State and local assessment systems an invitational priority in the FY 2015 EAG competition. Through this proposed priority, the Department would fund States that are reviewing and streamlining their statewide assessments and working with some or all of their LEAs to review and streamline local assessments, including eliminating redundant and unnecessary assessments.
This priority would support the identification of promising practices that could be followed by other SEAs, LEAs, and schools to maximize the utility of their assessments to parents, educators, and students.
(a) Under this priority, SEAs must—
(1) Review statewide and local assessments to ensure that each test is of high quality, maximizes instructional goals, has a clear purpose and utility, and is designed to help students demonstrate mastery of State standards;
(2) Determine whether assessments are serving their intended purpose to help schools meet their goals and to eliminate redundant and unnecessary testing; and
(3) Review State and LEA activities related to test preparation to make sure those activities are focused on academic content and not on test-taking skills.
(b) To meet the requirements in paragraph (a), SEAs must ensure that tests are—
(1) Worth taking, meaning that assessments are a component of good instruction and require students to perform the same kind of complex work they do in an effective classroom and the real world;
(2) High quality, resulting in actionable, objective information about students' knowledge and skills, including by assessing the full range of relevant State standards, eliciting complex student demonstrations or applications of knowledge, providing an accurate measure of student achievement, and producing information that can be used to measure student growth accurately over time;
(3) Time-limited, in order to balance instructional time and the need for assessments, for example, by eliminating duplicative assessments and assessments that incentivize low-quality test preparation strategies that consume valuable classroom time;
(4) Fair for all students and used to support equity in educational opportunity by ensuring that accessibility features and accommodations level the playing field so tests accurately reflect what all students, including students with disabilities and English learners, know and can do;
(5) Fully transparent to students and parents, so that States and districts can clearly explain to parents the purpose, the source of the requirement (if appropriate), and the use by teachers and schools, and provide feedback to parents and students on student performance; and
(6) Tied to improving student learning as tools in the broader work of teaching and learning.
(c) Approaches to assessment inventories under paragraph (a) must include:
(1) Review of the schedule for administration of all assessments required at the Federal, State, and local levels;
(2) Review of the purpose of, and legal authority for, administration of all assessments required at the Federal, State, and local levels; and
(3) Feedback on the assessment system from stakeholders, which could include information on how teachers, principals, other school leaders, and administrators use assessment data to inform and differentiate instruction, how much time teachers spend on assessment preparation and administration, and the assessments that administrators, teachers, principals, other school leaders, parents, and students do and do not find useful.
(d) Projects under this priority—
(1) Must be no longer than 12 months;
(2) Must include a longer-term project plan, understanding that, beginning with FY 2017, there may be dedicated Federal funds for assessment audit work as authorized under section 1202 of the ESEA, as amended by the ESSA, and understanding that States and LEAs may use other Federal funds, such as the State assessment grant funds, authorized under section 1201 of the ESEA, as amended by the ESSA, consistent with the purposes for those funds, to implement such plans; and
(3) Are eligible to receive a maximum award of $200,000.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
We will announce the final priorities in a notice in the
This notice does
As part of its continuing effort to reduce paperwork and respondent burden, the Department provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)). This helps ensure that: the public understands the Department's collection instructions, respondents can provide the requested data in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the Department can properly assess the impact of collection requirements on respondents.
These proposed priorities contain information collection requirements that are approved by OMB under the Departmental application control number 1894-0006; this proposed regulation does not affect the currently approved data collection.
Under Executive Order 12866, the Secretary must determine whether this proposed regulatory action is “significant” and, therefore, subject to the requirements of the Executive order and subject to review by the Office of Management and Budget (OMB). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may—
(1) Have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities in a material way (also referred to as an “economically significant” rule);
(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles stated in the Executive order.
This proposed regulatory action is not a significant regulatory action subject to review by OMB under section 3(f) of Executive Order 12866.
We have also reviewed this proposed regulatory action under Executive Order 13563, which supplements and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. To the extent permitted by law, Executive Order 13563 requires that an agency—
(1) Propose or adopt regulations only upon a reasoned determination that their benefits justify their costs (recognizing that some benefits and costs are difficult to quantify);
(2) Tailor its regulations to impose the least burden on society, consistent with obtaining regulatory objectives and taking into account—among other things and to the extent practicable—the costs of cumulative regulations;
(3) In choosing among alternative regulatory approaches, select those approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity);
(4) To the extent feasible, specify performance objectives, rather than the behavior or manner of compliance a regulated entity must adopt; and
(5) Identify and assess available alternatives to direct regulation, including economic incentives—such as user fees or marketable permits—to encourage the desired behavior, or provide information that enables the public to make choices.
Executive Order 13563 also requires an agency “to use the best available techniques to quantify anticipated present and future benefits and costs as accurately as possible.” The Office of Information and Regulatory Affairs of OMB has emphasized that these techniques may include “identifying changing future compliance costs that might result from technological innovation or anticipated behavioral changes.”
We are issuing these proposed priorities only on a reasoned determination that their benefits would justify their costs. In choosing among alternative regulatory approaches, we selected those approaches that would maximize net benefits. Based on the analysis that follows, the Department believes that this regulatory action is consistent with the principles in Executive Order 13563.
We also have determined that this regulatory action would not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
In accordance with both Executive orders, the Department has assessed the potential costs and benefits, both quantitative and qualitative, of this regulatory action. The potential costs are those resulting from statutory requirements and those we have determined as necessary for administering the Department's programs and activities.
The proposed priorities included in this notice would benefit students, parents, educators, administrators, and other stakeholders by improving the quality of State assessment instruments and systems. The proposed priority for an inventory of State and local assessment systems would encourage States to ensure that assessments are of high quality, maximize instructional goals, and have clear purpose and utility. Further, it would encourage States to eliminate unnecessary or redundant tests. The proposed priority for improving assessment scoring and score reporting would allow for States to score non-multiple choice assessment items more quickly and at a lower cost
This document provides early notification of our specific plans and actions for this program.
You may also access documents of the Department published in the
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) proposes to establish federal Clean Water Act (CWA) aquatic life criteria for freshwaters under the state of Oregon's jurisdiction, to protect aquatic life from the effects of exposure to harmful levels of copper and cadmium. In 2013, EPA determined that the freshwater acute cadmium criterion and freshwater acute and chronic copper criteria that Oregon adopted in 2004 did not meet CWA requirements to protect aquatic life in the state. Therefore, EPA proposes to establish federal freshwater criteria for cadmium and copper that take into account the best available science, EPA policies, guidance and legal requirements, to protect aquatic life uses in Oregon.
Comments must be received on or before June 2, 2016.
Submit your comments, identified by Docket ID No. EPA-HQ-OW-2016-0012, at
EPA is offering two virtual public hearings so that interested parties may also provide oral comments on this proposed rule. The first hearing will be on Monday, May 16, 2016 from 4:00pm to 6:00pm Pacific Time. The second hearing will be on Tuesday, May 17, 2016 from 9:00am to 11:00am Pacific Time. For more details on the public hearings and a link to register, please visit
Erica Fleisig, Office of Water, Standards and Health Protection Division (4305T), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: (202) 566-1057; email address:
This proposed rule is organized as follows:
Copper and cadmium naturally occur at low levels in surface waters but, at higher concentrations, can be toxic to aquatic life. Anthropogenic activities such as coal combustion, mining, electroplating, iron and steel production, and use of pigments, fertilizers and pesticides, can increase levels of cadmium in the environment. Sources of elevated copper in the environment include mining, fabrication of paper, metal products and electronics, and discharges from wastewater treatment plants.
Entities such as industries, stormwater management districts, or publicly owned treatment works (POTWs) that discharge pollutants to freshwaters of the United States under the state of Oregon's jurisdiction could be indirectly affected by this rulemaking, because federal WQS promulgated by EPA would be applicable to CWA regulatory programs, such as National Pollutant Discharge Elimination System (NPDES) permitting. Citizens concerned with water quality in Oregon could also be interested in this rulemaking. Categories and entities that could potentially be affected include the following:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities that could be indirectly affected by this action. Any parties or entities who depend upon or contribute to the water quality of Oregon's waters could be affected by this proposed rule. To determine whether your facility or activities could be affected by this action, you should carefully examine this proposed rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
CWA section 101(a)(2) establishes a national goal wherever attainable of “water quality which provides for the protection and propagation of fish, shellfish, and wildlife and provides for recreation in and on the water . . . ” These are commonly referred to as the “fishable/swimmable” goals of the CWA.
CWA section 303(c) (33 U.S.C. 1313(c)) directs states to adopt WQS for their waters subject to the CWA. CWA section 303(c)(2)(A) and EPA's implementing regulations at 40 CFR part 131 require, among other things, that a state's WQS specify designated uses of the waters, and water quality criteria that protect those uses. EPA's regulations at 40 CFR 131.11(a)(1) provide that “[s]uch criteria must be based on sound scientific rationale and must contain sufficient parameters or constituents to protect the designated use.” In addition, 40 CFR 131.10(b) provides that “[i]n designating uses of a water body and the appropriate criteria for those uses, the [s]tate shall take into consideration the water quality standards of downstream waters and shall ensure that its water quality standards provide for the attainment and maintenance of the water quality standards of downstream waters.”
States are required to review applicable WQS at least once every three years and, if appropriate, revise or adopt new standards (CWA section 303(c)(1)). Any new or revised WQS must be submitted to EPA for review and approval or disapproval (CWA section 303(c)(2)(A) and (c)(3)). If EPA determines that a WQS that a state submits to EPA for review does not meet the requirements of the CWA, EPA must notify the state of the changes necessary to meet CWA requirements (CWA section 303(c)(3)). CWA section 303(c)(3) and (c)(4) further specify that if a state does not make those changes within 90 days of notification, EPA must promptly prepare and publish a revised or new WQS for the state. Under CWA section 303(c)(4)(B), the Administrator is authorized to determine, even in the absence of a state submission, that a new or revised standard is needed to meet CWA requirements.
Under CWA section 304(a), EPA periodically publishes criteria recommendations for states to consider when adopting water quality criteria for particular pollutants to meet the CWA section 101(a)(2) goals. In establishing numeric criteria, states should adopt water quality criteria based on EPA's CWA section 304(a) criteria, section 304(a) criteria modified to reflect site-specific conditions, or other scientifically defensible methods (40 CFR 131.11(b)(1)). Ultimately, whatever methods are used, criteria must protect the designated use and be based on sound scientific rationale (40 CFR 131.11(a)(1)).
On July 8, 2004, Oregon submitted 89 revised aquatic life criteria for 25 toxic pollutants to EPA for review under CWA 303(c). Many of Oregon's revised criteria were the same as EPA's nationally recommended 304(a) aquatic life criteria at the time. A subsequent consent decree between EPA and Northwest Environmental Advocates established deadlines for EPA to complete its CWA 303(c) review of Oregon's aquatic life criteria. Prior to taking a final action on the aquatic life criteria, EPA requested formal consultation with the National Marine Fisheries Service (NMFS) and the U.S. Fish and Wildlife Service (USFWS) on its proposed approval of the criteria, consistent with section 7 of the Endangered Species Act (ESA). EPA initiated this consultation on January 14, 2008, by submitting a biological evaluation to the NMFS and USFWS, which contained an analysis of the potential effects of EPA's proposed approval of Oregon's criteria on
On July 31, 2012, the USFWS provided its biological opinion to EPA. The biological opinion found that EPA's proposed approval of Oregon's aquatic life criteria would not jeopardize the continued existence of endangered species for which USFWS was responsible. However, on August 14, 2012, the NMFS concluded in its biological opinion that seven of Oregon's revised freshwater criteria would jeopardize the continued existence of endangered species in Oregon for which the NMFS was responsible. These seven criteria were the freshwater criteria Oregon adopted to protect aquatic life from adverse acute and chronic effects from ammonia, copper, and aluminum,
On January 31, 2013, EPA disapproved several of Oregon's revised aquatic life criteria under CWA 303(c), including the acute cadmium freshwater criterion, and the acute and chronic freshwater ammonia, copper, and aluminum criteria that the NMFS concluded would jeopardize endangered species in Oregon.
Under the Agency's CWA section 304(a) authority, EPA develops methodologies and specific criteria to protect aquatic life and human health. These methodologies and criteria are subject to public as well as scientific expert review before EPA releases them as formal agency recommendations for states to consider when developing and adopting water quality criteria. To derive criteria for the protection of aquatic life, EPA follows its
Numeric criteria derived using EPA's 1985 Guidelines are expressed as short-term (acute) and long-term (chronic) values. The combination of a criteria maximum concentration (CMC), a one-hour average value, and a criteria continuous concentration (CCC), a four-day average value, protects aquatic life from acute and chronic toxicity, respectively.
Since fresh and salt waters have different chemical compositions and different species assemblages, it is necessary to derive separate acute and chronic criteria for fresh and salt waters. Additionally, criteria may be based on certain water characteristics (
The 1985 Guidelines specify that it is necessary to have toxicity test data from a minimum of eight families of aquatic organisms to derive criteria. These families are intended to be representative of a wide spectrum of aquatic life, and act as surrogates for untested species. Therefore, the specific test organisms do not need to be present in the water(s) where the criteria will apply. However, states may develop site-specific criteria using species residing at the site if they maintain similar broad taxonomic representation. EPA derives acute criteria from 48- to 96-hour tests of lethality or immobilization. EPA derives chronic criteria from longer term (often longer than 28-day) tests that measure survival, growth, or reproduction. If sufficient chronic toxicity data are not available, chronic criteria are set by determining a ratio of acutely toxic to chronically toxic concentrations. Where appropriate, EPA recommends that criteria are lowered to protect commercially or recreationally important species.
For more detailed information on how EPA derives protective aquatic life criteria, see the 1985 Guidelines.
Water hardness (determined by the presence of calcium and magnesium ions, and expressed as calcium carbonate, CaCO
EPA previously published final 304(a) recommended aquatic life criteria for cadmium in 2001.
USEPA. 2001.
To protect aquatic life in Oregon's freshwaters from acute toxic effects from cadmium, EPA proposes the one-hour average CMC not exceed e
Where site-specific hardness data are unavailable, EPA proposes to use a default hardness concentration of 25 mg/L (as CaCO
For a map of Level III ecoregions in the continental United States, see
EPA's proposal to use a default hardness of 25 mg/L in the absence of sufficiently representative ambient hardness data should not be confused with use of a low-end hardness floor
In describing potential remedies to address EPA's January 2013 disapproval, EPA noted that “new scientific data on the toxicity of cadmium [are] now available and would need to be reviewed regarding their quality and relevance prior to being considered in developing an updated recommendation for a specific numeric criterion protective of Oregon aquatic life.”
When calculating a hardness-based criterion value, Oregon should consider the following when defining a site to which the acute cadmium criterion applies: (1) Metals are generally persistent, so calculating the criterion using hardness values from a small site at or near the discharge point could result in a criterion that is not protective of areas that are outside the defined site, and (2) as the size of a site increases, the spatial and temporal variability is likely to increase; thus, more water samples may be required to adequately characterize the entire site.
When setting Water Quality-Based Effluent Limitations (WQBELs), Oregon should determine the water body's ambient hardness level under critical conditions (
Substantial changes in a site's ambient hardness will likely affect the resulting acute cadmium criterion at that site. Therefore, EPA recommends that Oregon periodically revisit each water body's acute cadmium criterion and re-run the equation when changes in water hardness are evident or suspected at a site, and also as additional monitoring data become available.
In 2007, EPA issued revised section 304(a) national recommended freshwater aquatic life criteria for copper that represent the best available science and understanding of the interaction between water chemistry and copper toxicity.
Along with the criteria recommendations, EPA released supplementary materials related to using the BLM on a site-specific basis to derive criteria. Training materials that EPA released in 2007 discussed considerations such as collecting sufficiently representative data to account for a site's spatial and temporal variability, properly defining the site to which the BLM-derived criterion applies, reconciling multiple model runs, and estimating input parameters when site-specific data are lacking.
To protect aquatic life in Oregon's freshwaters, EPA proposes the CMC and CCC based on the 2007 304(a) recommended copper BLM. EPA proposes to express the CMC as a one-hour average dissolved copper concentration (in µg/L) and the CCC as a four-day average dissolved copper concentration (in µg/L), and that the CMC and CCC are not to be exceeded more than once every three years.
As with hardness data used to determine the acute cadmium criterion discussed earlier, EPA recommends that Oregon collect ambient data to determine protective copper criteria by site. In the absence of sufficiently representative ambient data to run the BLM, EPA proposes default input values
Finally, EPA proposes that in order to calculate final acute and chronic copper criteria, Oregon use a value not to exceed the 10th percentile of individual BLM outputs for the site. While the 10th percentile should be protective in a majority of cases, certain circumstances may warrant use of a more stringent BLM output. When 10 or fewer data points are available for a given site, EPA proposes that Oregon use the lowest individual acute and chronic BLM outputs as the final acute and chronic criteria. EPA solicits comment on this approach, as well as alternative percentiles or approaches to reconciling individual copper BLM outputs into final acute and chronic copper criteria values.
EPA's proposed acute and chronic copper criteria for Oregon's freshwaters are as follows:
Acute (CMC) and chronic (CCC) freshwater copper criteria shall be developed using EPA's 2007
Where sufficiently representative ambient data for DOC, calcium, magnesium, sodium, potassium, sulfate, chloride, or alkalinity are not available, the state shall use the 10th percentile estimated values from Table 1 based on the applicable ecoregion (or Table 2, based on the applicable ecoregion and stream order).
The final copper criteria shall be calculated as no greater than the 10th percentile of the distribution of individual BLM outputs at a site. If 10 or fewer BLM outputs are available for a given site, the lowest individual acute and chronic BLM output values shall be used as the final acute and chronic copper criteria for that site.
EPA's 2007 copper BLM represents the latest scientific knowledge on copper speciation and bioavailability. In describing potential remedies to address EPA's January 2013 disapproval, EPA noted that Oregon could use the 2007 copper BLM. The model provides predictable and repeatable outcomes, and EPA is proposing protective default inputs to use in the absence of site-specific data. EPA proposes that the combination of the 2007 copper BLM and default inputs will protect aquatic life in Oregon.
EPA's proposed copper criteria for Oregon will be the first BLM-based criteria in Oregon and, therefore, the state does not have associated implementation methods. EPA strongly recommends that Oregon develop such methods, and give similar consideration to site selection, characterization of critical conditions, and data representativeness, as discussed for cadmium earlier in this proposed rule. Aquatic organisms are more sensitive to copper when corresponding DOC and pH levels in the water are low, so Oregon should ensure that sufficiently representative data are collected for the BLM's input parameters to have confidence that critical conditions are adequately characterized.
When Oregon derives copper criteria using the BLM, to promote transparency and ensure predictable and repeatable outcomes, EPA recommends that the state make each criterion and the geographic extent of the site to which the criterion applies publicly available on the state's Web site along with information such as:
1. The number of sampling events used to derive the criterion;
2. Whether the criterion relied on site-specific data, estimated data, or a combination of both; and
3. The date when the criterion was developed.
Finally, as discussed earlier with respect to ambient hardness levels, substantial changes in a site's water chemistry will likely affect any resulting copper criterion at that site. In addition, with regular monitoring and a robust, site-specific dataset, criteria can be developed that more accurately reflect site conditions and copper bioavailability than criteria set using default values or limited data sets. Therefore, EPA recommends that Oregon periodically revisit its copper criteria and re-run the BLM when changes in water chemistry are evident or suspected at a site, and also as additional monitoring data become available.
EPA's proposed methodology for deriving protective acute and chronic copper criteria described in the preceding paragraphs is not necessarily the only scientifically defensible and protective approach, and consistent with 40 CFR 131.11(b)(1)(iii), Oregon has the option to establish criteria based on other scientifically defensible methods. In 2015, the Oregon Department of Environmental Quality (DEQ) conducted an analysis of the copper BLM in preparation for adopting revised copper criteria to address EPA's 2013 disapproval. DEQ has spent significant time and resources collecting BLM input parameters at 138 locations across the state, as well as evaluating various methods to develop defaults that can be used in the absence of sufficiently representative ambient data. To date, DEQ has generally modeled its approach after the methodology presented in EPA's
EPA is proposing that the final EPA rule regulatory text will incorporate one EPA document by reference. In accordance with the requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference EPA's 2007
To ensure that the proposed criteria are applied appropriately to protect Oregon's aquatic life uses, EPA is proposing critical low-flow values for Oregon to use in calculating the available dilution for the purposes of determining the need for and establishing WQBELs in NPDES permits. Dilution is one of the primary mechanisms by which the concentrations of contaminants in effluent discharges are reduced following their introduction into a receiving water. Low flows can exacerbate the effects of effluent discharges because, during a low-flow event, there is less water available for dilution, resulting in higher instream pollutant concentrations. If criteria are implemented using inappropriate critical low-flow values (
EPA's March 1991
The criteria in this proposed rule, once finalized, would apply at the point of discharge unless Oregon authorizes a mixing zone. Where Oregon authorizes a mixing zone, the criteria would apply at the locations allowed by the mixing zone (
As noted earlier in this proposed rule, the NMFS 2012 biological opinion concluded that the acute cadmium and acute and chronic copper criteria that Oregon adopted in 2004 would jeopardize the continued existence of endangered species in Oregon. The opinion also contained RPAs for cadmium and copper that would avoid the likelihood of jeopardy to endangered species in Oregon. EPA will continue to work closely with the NMFS to ensure that the acute cadmium criterion that EPA ultimately finalizes is protective of federally listed species in Oregon. For copper, the NMFS further clarified in January 2016 that adoption of EPA's 2007 copper BLM, which EPA is proposing in this rule, would be consistent with the 2012 RPA.
Under the CWA, Congress gave states primary responsibility for developing and adopting WQS for their waters (CWA section 303(a)-(c)). Although EPA is proposing cadmium and copper aquatic life criteria for Oregon's freshwaters to remedy EPA's 2013 disapproval, Oregon continues to have the option to adopt and submit to EPA acute cadmium and acute and chronic copper criteria for the state's freshwaters consistent with CWA section 303(c) and EPA's implementing regulations at 40 CFR part 131. EPA encourages Oregon to expeditiously adopt protective aquatic life criteria. Consistent with CWA section 303(c)(4), if Oregon adopts and submits cadmium and/or copper aquatic life criteria, and EPA approves such criteria before finalizing this proposed rule, EPA would not proceed with the promulgation for those waters and/or pollutants for which EPA approves Oregon's criteria.
If EPA finalizes this proposed rule, and Oregon subsequently adopts and submits cadmium and/or copper aquatic life criteria, EPA proposes that once EPA approves Oregon's WQS, the EPA-approved criteria in Oregon's WQS would become the applicable criteria for CWA purposes and EPA's promulgated criteria would no longer be applicable criteria. EPA would undertake a rulemaking to withdraw the federal criteria for cadmium and/or copper, but that process would not delay Oregon's approved criteria from becoming the sole applicable criteria for CWA purposes.
Oregon will have considerable discretion to implement these aquatic life criteria, once finalized, through various water quality control programs. Among other things, EPA's regulations: (1) Specify how states and authorized tribes establish, modify or remove designated uses, (2) specify the requirements for establishing criteria to protect designated uses, including criteria modified to reflect site-specific conditions, (3) authorize states and authorized tribes to adopt WQS variances to provide time to achieve the applicable WQS, and (4) allow states and authorized tribes to include compliance schedules in NPDES permits. Each of these approaches are discussed in more detail below.
EPA's proposed cadmium and copper criteria apply to freshwaters in Oregon where the protection of fish and aquatic life is a designated use (see Oregon Administrative Rules at 340-041-8033, Table 30). The federal regulations at 40 CFR 131.10 provide information on establishing, modifying, and removing designated uses. If Oregon removes designated uses such that no fish or aquatic life uses apply to any particular water body affected by this rule and adopts the highest attainable use,
The regulations at 40 CFR 131.11 specify requirements for modifying water quality criteria to reflect site-specific conditions. In the context of this rulemaking, a site-specific criterion (SSC) is an alternative value to the federal freshwater cadmium or copper aquatic life criteria that would be applied on a watershed, area-wide, or water body-specific basis that meets the regulatory test of protecting the designated use, being scientifically defensible, and ensuring the protection and maintenance of downstream WQS. A SSC may be more or less stringent than the otherwise applicable federal criteria. A SSC may be appropriate when further scientific data and analyses can bring added precision to express the concentration of cadmium and/or copper that protects the aquatic life-related designated use in a particular water body.
40 CFR part 131 defines WQS variances at § 131.3(o) as time-limited designated uses and supporting criteria for a specific pollutant(s) or water quality parameter(s) that reflect the highest attainable conditions during the term of the WQS variance. WQS variances adopted in accordance with 40 CFR part 131 allow states and authorized tribes to address water quality challenges in a transparent and predictable way. Variances help states and authorized tribes focus on making incremental progress in improving water quality, rather than pursuing a downgrade of the underlying water quality goals through a designated use change, when the current designated use is difficult to attain. Oregon has
EPA's regulations at 40 CFR 122.47 and 40 CFR 131.15 allow states and authorized tribes to include permit compliance schedules in their NPDES permits if dischargers need additional time to meet their WQBELs based on the applicable WQS. EPA's updated regulations at 40 CFR part 131 also include provisions authorizing the use of permit compliance schedules to ensure that a decision to allow permit compliance schedules includes public engagement and transparency (80 FR 51022, August 21, 2015). Oregon already has an EPA-approved regulation authorizing the use of permit compliance schedules (see OAR 340-041-0061), consistent with 40 CFR 131.15. That state regulation is not affected by this rule, and Oregon is authorized to grant compliance schedules, as appropriate, based on the federal criteria.
EPA's proposed cadmium and copper criteria may serve as a basis for development of NPDES permit limits. Oregon has NPDES permitting authority, and retains considerable discretion in implementing standards. EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA's proposed criteria. This analysis is documented in
Any NPDES-permitted facility that discharges cadmium or copper in Oregon could potentially incur compliance costs. The types of affected facilities could include industrial facilities and POTWs discharging treated wastewater to surface waters (
For this analysis, EPA did not estimate the potential for costs to stormwater or nonpoint sources such as agricultural runoff. EPA recognizes that Oregon may require controls for nonpoint sources. However, it is difficult to model and evaluate the potential cost impacts of this rule to those sources because they are intermittent, variable, and occur under hydrologic or climatic conditions associated with precipitation events. Also, baseline total maximum daily loads (TMDLs) for waters with baseline impairment for cadmium or copper have not yet been developed. Therefore, determining which waters would not achieve standards based on the proposed aquatic life criteria after complying with existing (baseline) regulations and policies may not be possible.
For economic analysis purposes, EPA developed hypothetical applications of the proposed cadmium and copper criteria using conservative estimates for hardness and the BLM inputs, respectively. The criteria that EPA derived for the cost analysis would likely be different from and possibly lower (more stringent) than the actual criteria applications that Oregon would derive using ambient data from each water body. As described earlier in this proposed rule, EPA recommends that Oregon collect sufficiently representative ambient data to derive the most accurate and protective cadmium and copper aquatic life criteria.
Using the criteria derived for the cost analysis, EPA identified 10 point source facilities that could potentially be affected by the rule—all are major dischargers. Major facilities are typically those that discharge more than 1 million gallons per day (mgd). Of these potentially affected facilities, 7 are POTWs and 3 are industrial dischargers. EPA did not include facilities covered by general permits in its analysis because data for such facilities are limited, and flows are usually much lower. EPA did not have cadmium or copper effluent data to evaluate minor facilities for this preliminary analysis.
EPA estimated costs for the 10 potentially affected facilities. EPA evaluated existing baseline permit conditions, reasonable potential to exceed estimates of the aquatic life criteria based on the proposed rule, and potential to exceed projected effluent limitations based on available effluent monitoring data. In instances of exceedances of projected effluent limitations under the proposed criteria, EPA determined the likely compliance scenarios and costs. Only compliance actions and costs that would be needed above the baseline level of controls are attributable to the proposed rule.
EPA assumed that dischargers would pursue the least cost means of compliance with WQBELs. Incremental compliance actions attributable to the proposed rule may include pollution prevention, end-of-pipe treatment, and alternative compliance mechanisms (
Based on the results for 10 facilities, EPA estimated a total incremental annual cost attributable to the proposed criteria of approximately $0.1 million to $18.2 million at a 3% discount rate.
If the revised criteria result in an incremental increase in impaired waters, resulting in the need for TMDL development, there could also be some costs to nonpoint sources of metals. Using available ambient monitoring data, EPA compared cadmium and copper concentrations to the baseline and proposed criteria, identifying waterbodies that may be incrementally impaired (
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review. The proposed rule does not establish any requirements directly applicable to regulated entities or other sources of toxic pollutants. However, these WQS may serve as a basis for development of NPDES permit limits. Oregon has NPDES permitting authority, and retains considerable discretion in implementing standards. In the spirit of Executive Order 12866, EPA evaluated the potential costs to NPDES dischargers associated with state implementation of EPA's proposed criteria. This analysis,
This action does not impose an information collection burden under the PRA. While actions to implement these WQS could entail additional paperwork burden, this action does not directly contain any information collection, reporting, or record-keeping requirements.
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. Small entities, such as small businesses or small governmental jurisdictions, are not directly regulated by this rule.
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. As these water quality criteria are not self-implementing, the action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. This rule does not alter Oregon's considerable discretion in implementing these WQS, nor would it preclude Oregon from adopting WQS that meet the requirements of the CWA, either before or after promulgation of the final rule, which would eliminate the need for federal standards upon EPA approval. Thus, Executive Order 13132 does not apply to this action.
In the spirit of Executive Order 13132 and consistent with EPA policy to promote communications between EPA and state and local governments, EPA specifically solicits comments on this proposed action from state and local officials.
This action does not have tribal implications as specified in Executive Order 13175. This proposed rule does not impose substantial direct compliance costs on federally recognized tribal governments, nor does it substantially affect the relationship between the federal government and tribes, or the distribution of power and responsibilities between the federal government and tribes. Thus, Executive Order 13175 does not apply to this action.
Many tribes in the Pacific Northwest hold reserved rights to take fish for subsistence, ceremonial, religious, and commercial purposes. EPA developed the criteria in this proposed rule to protect aquatic life in Oregon from the effects of exposure to harmful levels of cadmium and copper. Protecting the health of fish in Oregon will, therefore, support tribal reserved fishing rights, including treaty-reserved rights, where such rights apply in waters under state jurisdiction.
Consistent with the EPA Policy on Consultation and Coordination with Indian Tribes, EPA consulted with tribal officials during the development of this action. On November 23, 2015, EPA sent a letter to tribal leaders in Oregon offering to consult on the proposed cadmium and copper criteria in this rule. On December 15, 2015, EPA held a conference call with tribal water quality technical contacts to explain EPA's proposed action and timeline. Formal consultation on the proposed action was not requested by any of the tribes. EPA will continue to communicate with the tribes prior to its final action.
EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of 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 proposed rulemaking does not involve technical standards.
The human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The criteria in this proposed rule will support the health and abundance of aquatic life in Oregon, and will therefore benefit all communities that rely on Oregon's ecosystems.
Environmental protection, Indians—lands, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control.
For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 131 as follows:
33 U.S.C. 1251
(a)
(b)
(c)
(d)
(2) The criteria established in this section are subject to Oregon's general rules of applicability in the same way and to the same extent as are other federally promulgated and state-adopted numeric criteria when applied to freshwaters in Oregon where fish and aquatic life are a designated use.
(i) For all waters with mixing zone regulations or implementation procedures, the criteria apply at the appropriate locations within or at the boundary of the mixing zones; otherwise the criteria apply throughout the water body including at the end of any discharge pipe, conveyance or other discharge point.
(ii) The state shall not use a low flow value that is less stringent than the values listed below for waters suitable for the establishment of low flow return frequencies (
Forest Service, USDA.
Notice of meeting.
The Forest Resource Coordinating Committee (Committee) will meet in Washington, DC. The Committee is authorized under section 8005 of the Food, Conservation, and Energy Act of 2008 (the Act) (Pub. L. 110-246). Additional information concerning the Committee, including the meeting agenda, supporting documents and minutes, can be found by visiting the Committee's Web site at
The meeting will be held on the following dates:
1. May 25, 2016, from 8:00 a.m. to 5:00 p.m. Eastern Daylight Time (EDT); and
2. May 25, 2016, from 8:00 a.m. to 5:00 p.m. EDT.
The meeting is subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held at the USDA Forest Service, Sidney R. Yates Building, Pinchot Conference Room, 201 14th Street SW., Washington, DC. Members of the public should RSVP to facilitate entry into the Yates Building.
Written comments may be submitted as described under
Andrea Bedell-Loucks, Designated Federal Officer, by phone at 202-205-1190; or Lori McKean, Committee Coordinator, by phone at 570-296-9672.
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 Daylight Time, Monday through Friday.
The purpose of the meeting is to:
1. Learn how to frame recommendations;
2. Hear about Office of Sustainability & Climate Changes' State & Private Forestry Climate Change Performance Scorecard; and
3. Refine outreach strategies to key partners.
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 submit a request in writing by May 13, 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 May 1, 2016. Written comments and time requests for oral comments must be sent to Andrea Bedell-Loucks, 1400 Independence Avenue SW., Mailstop 1123, Washington, DC 20250; or by email to
Rural Utilities Service, USDA.
Notice of Funds Availability (NOFA).
The Rural Utilities Service (RUS), an agency of the United States Department of Agriculture (USDA), herein referred to as RUS or the Agency, announces its Community Connect Grant Program application window for Fiscal Year (FY) 2016. This notice is being issued in order to allow potential applicants time to submit proposals and give the Agency time to process applications within the current fiscal year.
In addition to announcing the application window, RUS announces the minimum and maximum amounts for Community Connect grants applicable for the fiscal year. The Community Connect Grant Program regulation can be found at 7 CFR part 1739 (Subpart A).
Submit completed paper or electronic applications for grants according to the following deadlines:
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• If the submission deadline falls on Saturday, Sunday, or a Federal holiday, the application is due the next business day.
Copies of the FY 2016 Application Guide and materials for the Community Connect Grant Program may be obtained through:
(1) The Community Connect Web site at
(2) The RUS Office of Loan Origination and Approval at 202-720-0800.
(1)
(2)
Shawn Arner, Deputy Assistant Administrator, Office of Loan Origination and Approval, Rural Utilities Service, U.S. Department of Agriculture, telephone: (202) 720-0800, fax: 1-884-885-8179.
The purpose of the Community Connect Grant Program is to provide financial assistance in the form of grants to eligible applicants that will provide broadband service to currently unserved, lower-income, and extremely rural areas. This broadband service is intended to foster economic growth and deliver enhanced educational, health care, and public safety services on a community-oriented connectivity basis. RUS will give priority to rural areas that have the greatest need for broadband services, based on the criteria contained herein.
Grant authority will be used for the deployment of broadband service to extremely rural, lower-income communities on a community-oriented connectivity basis. By cultivating the deployment of new broadband services, the community-oriented connectivity concept will stimulate innovative uses and practical applications of the new broadband facilities in order to improve economic development and provide enhanced educational and health care opportunities in rural areas. Such an approach will also give rural communities the opportunity to benefit from the advanced technologies necessary to achieve these goals. The regulation for the Community Connect Program can be found at 7 CFR part 1739 (Subpart A).
As in years past, the FY 2016 Community Connect Grant Application Guide has been updated based on program experience. All applicants should carefully review and prepare their applications according to instructions in the FY 2016 Application Guide and sample materials. Expenses incurred in developing applications will be at the applicant's own risk.
$11,740,000 is available for grants. Under 7 CFR 1739.2, the Administrator established a minimum grant amount of $100,000 and a maximum grant amount of $3,000,000 for FY 2016.
The standard grant agreement, which specifies the term of each award, is available at
While prior Community Connect grants cannot be renewed, existing Community Connect awardees may submit applications for new projects, which the Agency will evaluate as new applications. All grant applications must be submitted during the application window.
a. Only entities legally organized as one of the following are eligible for Community Connect Grant Program financial assistance:
i. An incorporated organization;
ii. An Indian tribe or tribal organization, as defined in 25 U.S.C. 450b;
iii. A state or local unit of government; or
iv. A cooperative, private corporation, or limited liability company organized on a for-profit or not-for-profit basis.
b. Applicants must have the legal capacity and authority to enter into contracts, to comply with applicable federal statutes and regulations, and to own and operate the broadband facilities as proposed in their application.
c. Applicants must have an active registration with current information in the System for Award Management (SAM) (previously the Central Contractor Registry (CCR)) at
a. Individuals and partnerships are not eligible for financial assistance.
b. Corporations that have been convicted of a Federal felony within the past 24 months are not eligible. Any corporation that has been assessed to have any unpaid federal tax liability, for which all judicial and administrative remedies have been exhausted or have lapsed and is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability, is not eligible for financial assistance.
c. In accordance with the Consolidated Appropriations Act, 2016, Sections 743-4, an entity that requires employees or contractors of such entity seeking to report fraud, waste, or abuse to sign internal confidentiality agreements or statements prohibiting or otherwise restricting such employees or contractors from lawfully reporting such waste, fraud, or abuse to a designated investigative or law enforcement representative of a Federal department or agency authorized to receive such information is not eligible for financial assistance.
The Community Connect Program requires matching contributions for grants. See 7 CFR 1739.14 and the FY 2016 Application Guide for information on required matching contributions.
a. Grant applicants must demonstrate matching contributions in cash of at least fifteen percent (15%) of the total amount of financial assistance requested. Matching contributions must be used for eligible purposes of Community Connect grant assistance, as discussed in 7 CFR 1739.12, 7 CFR 1739.13, and Section D(6) of this Notice for more information.
b. Applications that do not provide sufficient documentation of the required fifteen percent match will be declared ineligible.
Eligible projects must propose to fulfill the following requirements (see 7 CFR 1739.11 for more information):
a. Minimum Broadband Service Requirements. Until otherwise revised in the
b. Minimum Broadband Grant Speed. The minimum bandwidth that an applicant must propose to deliver to every customer in the proposed funded service area is ten megabits downstream and one megabit upstream for both fixed and mobile service to the customer.
c. Rural Area. A Rural Area refers to any area, as confirmed by the most recent decennial Census of the United States, which is not located within:
i. A city, town, or incorporated area that has a population of greater than 20,000 inhabitants; or
ii. An urbanized area contiguous and adjacent to a city or town that has a population of greater than 50,000 inhabitants. For purposes of the definition of Rural Area, an urbanized area means a densely populated territory as defined in the most recent decennial Census.
d. Proposed Funded Service Area (PFSA). Applicants must propose a contiguous geographic area within an eligible Rural Area or eligible Rural Areas, in which Broadband Service does not currently exist, and where the applicant proposes to offer service at the Broadband Grant Speed to all residential and business customers. A PFSA must not overlap with the Service Areas of current RUS borrowers and grantees.
e. Critical Community Facilities. Applicants must propose to offer service, free of charge to users, at the Broadband Grant Speed to all Critical Community Facilities located within the Proposed Funded Service Area for at least two (2) years.
f. Community Center. Applicants must propose to provide a Community Center with at least two (2) Computer Access Points and wireless access at the Broadband Grant Speed free of charge to users for at least two (2) years.
The FY 2016 Application Guide provides specific detailed instructions for each item in a complete application. The Agency emphasizes the importance of including every required item and strongly encourages applicants to follow the instructions carefully, using the examples and illustrations in the FY 2016 Application Guide. Applications submitted by the application deadline, but have critical missing items will be returned as ineligible. The Agency will not solicit or consider scoring or eligibility information that is submitted after the application deadline. However, depending on the specific scoring criteria, applications that do not include all items necessary for scoring may still be eligible applications, but may not receive full or any credit if the information cannot be verified. See the FY 2016 Application Guide for a full discussion of each required item. For requirements of completed grant applications, refer to 7 CFR 1739.15.
The FY 2016 Application Guide, copies of necessary forms and samples, and the Community Connect Grant Program Regulation are available at:
a. Electronic copies at
b. Paper copies from the Rural Utilities Service, Office of Loan Origination and Approval, 202-720-0800.
a. Carefully review the Community Connect Application Guide and the 7 CFR part 1739, which detail all necessary forms and worksheets. A table summarizing the necessary components of a complete application can be found at Section D(2)(d).
b. Submission of Application Items. Given the high volume of program interest, applicants should submit the required application items in the order indicated in the FY 2016 Application Guide. Applications that are not assembled and tabbed in the specified order prevent timely determination of eligibility. For applications with inconsistencies among submitted copies, the Agency will base its evaluation on the original signed application received.
c. Additional Information. The Agency may ask for additional or clarifying information for applications submitted by the deadline which appear to meet the eligibility requirements, but require further review.
d. Table of Required Elements of a Completed Grant Application. This table summarizes the items required for submission and the category into which they fall.
e. Number of copies of submitted applications.
i. Applications submitted on paper. Submit the original application and two (2) copies to RUS.
ii. Applications submitted electronically. Submit the electronic application once. Carefully read the FY 2016 Application Guide for guidance on submitting an electronic application. Applicants should identify and number each page in the same manner as the paper application.
The applicant for a grant must supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number as part of the application. The Standard Form 424 (SF-424) contains a field for the DUNS number. The applicant can obtain the DUNS number free of charge by calling Dun and Bradstreet. Go to
Prior to submitting a paper or an electronic application, the applicant must register in the System for Award Management (SAM) at
a. Paper applications must be postmarked and mailed, shipped, or sent overnight no later than June 17, 2016 to be eligible for FY 2016 grant funding. Late applications, applications which do not include proof of mailing or shipping, and incomplete applications are not eligible for FY 2016 grant funding. If the submission deadline falls on Saturday, Sunday, or a Federal holiday, the application is due the next business day. In the event of an incomplete application, the Agency will notify the applicant in writing, return the application, and terminate all further action.
i. Address paper applications to the Telecommunications Program, RUS, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 2808, STOP 1597, Washington, DC 20250-1597. Applications should be marked, “Attention: Deputy Assistant Administrator, Office of Loan Origination and Approval.”
ii. Paper applications must show proof of mailing or shipping by the deadline consisting of one of the following:
A. A legibly dated U.S. Postal Service (USPS) postmark;
B. A legible mail receipt with the date of mailing stamped by the USPS; or
C. A dated shipping label, invoice, or receipt from a commercial carrier.
iii. Due to screening procedures at the U.S. Department of Agriculture, packages arriving via regular mail through the USPS are irradiated, which can damage the contents and delay delivery to the Community Connect Program. RUS encourages applicants to consider the impact of this procedure in selecting their application delivery method.
b. Electronic grant applications must be received no later than June 17, 2016 to be eligible for FY 2016 funding. Late or incomplete applications will not be eligible for FY 2016 grant funding.
i. Applications will not be accepted via fax or electronic mail.
ii. Electronic applications for grants must be submitted through the Federal government's Grants.gov initiative at
iii. Grants.gov requires some credentialing and online authentication procedures. These procedures may take several business days to complete. Therefore, the applicant should complete the registration, credentialing, and authorization procedures at Grants.gov before submitting an application.
iv. Dun and Bradstreet Data Universal Numbering System. The applicant for a grant must supply a Dun and Bradstreet Data Universal Numbering System (DUNS) number as part of the application. See section D(3) of this Notice for more information.
v. System for Award Management. Grants.gov requires that the applicant's organization is registered in the System for Award Management (SAM). Be sure to obtain the organization's SAM listing well in advance of the application deadline. See section D(4) of this Notice for more information.
vi. RUS encourages applicants who wish to apply through Grants.gov to submit their applications in advance of the deadline.
vii. If system errors or technical difficulties occur, use the customer support resources available at the Grants.gov Web site.
a. Eligible grant purposes.
Grant funds may be used to finance:
i. The construction, acquisition, or leasing of facilities, including spectrum, land or buildings to deploy service at the Broadband Grant Speed to all participating Critical Community Facilities and all required facilities needed to offer such service to all residential and business customers
ii. The improvement, expansion, construction, or acquisition of a Community Center that furnishes free internet access at the Broadband Grant Speed and provision of Computer Access Points. Grant funds provided for such costs shall not exceed the lesser of ten percent (10%) of the grant amount requested or $150,000; and
iii. The cost of bandwidth to provide service free of charge at the Broadband Grant Speed to Critical Community Facilities for the first two (2) years of operation.
b. Ineligible grant purposes.
Grant funds may not be used to finance:
i. The duplication of any existing Broadband Service provided by another entity;
ii. Operating expenses other than the cost of bandwidth for two (2) years to provide service at the Broadband Grant Speed to Critical Community Facilities; or
iii. Any other operating expenses not specifically permitted in 7 CFR 1739.12.
c. Other. For more information, see 7 CFR 1739.3 for definitions, 7 CFR 1739.12 for eligible grant purposes, and 7 CFR 1739.13 for ineligible grant purposes.
Grant applications are scored competitively and are subject to the criteria listed below (total possible points: 115. See 7 CFR 1739.17 and the FY 2016 Application Guide for more information on the scoring criteria):
a. Needs Category. An analysis of the challenges of the following criteria, laid out on a community-wide basis, and how the project proposes to address these issues (up to 50 points):
i. Economic characteristics;
ii. Educational challenges;
iii. Health care needs; and
iv. Public safety issues.
b. Stakeholder Involvement Category. The extent of the Project's planning, development, and support from local residents, institutions, and Critical Community Facilities (up to 40 points);
c. Experience Category. The level of experience and past success of broadband systems operation for the management team (up to 10 points);
d. Special Consideration Areas Category. In accordance with 7 CFR 1739.1(a), applicants may receive special consideration if they submit documentation demonstrating that they will provide broadband service within the following areas (15 points):
i. Tribal jurisdiction or trust areas,
iii. Promise Zone (for further information, see the
iv. Strike Force area (for further information, see the
e. In making a final selection among and between applications with comparable rankings and geographic distribution, the Administrator may take into consideration the characteristics of the Proposed Funded Service Area (PFSA), as identified in 7 CFR 1739.17(d).
Grant applications are ranked by the final score. RUS selects applications based on those rankings, subject to the availability of funds and consistent with 7 CFR 1739.17. In addition, it should be noted that an application receiving fewer points can be selected over a higher scoring application in the event that there are insufficient funds available to cover the costs of the higher scoring application, as stated in 7 CFR 1739.16(f).
a. In addition to the scoring criteria that rank applications against each other, the Agency evaluates grant applications on the following items, in accordance with 7 CFR 1739.16:
i. Financial feasibility. A proposal that does not indicate financial feasibility or that is not sustainable will not be approved for an award.
ii. Technical considerations. An application that contains flaws that would prevent the successful implementation, operation, or sustainability of the project will not be approved for an award.
b. Applications conforming with this part will then be evaluated competitively and ranked by a panel of RUS employees that the Administrator of RUS selects, and will be awarded points as described in the scoring criteria in 7 CFR 1739.17. Applications will be ranked and grants awarded in order until all grant funds are expended.
d. The Agency reserves the right to offer the applicant a lower amount than the amount proposed in the application, as stated in 7 CFR 1739.16(g).
a. Successful applications.
i. Recipient notification. RUS notifies applicants whose projects are selected for awards by mailing or emailing a copy of the award letter. The receipt of an award letter does not authorize the applicant to commence performance under the award. After sending the award letter, the Agency will send an agreement that contains all the terms and conditions, as referenced in 7 CFR 1739.18 and Section B of this Notice. A copy of the standard agreement is posted on the RUS Web site at
The items listed in this Notice, the Community Connect Grant Program regulation, the FY2016 Application Guide, and accompanying materials implement the appropriate administrative and national policy requirements, which include, but are not limited to:
a. Executing a Community Connect Grant Agreement;
b. Using Form SF 270, “Request for Advance or Reimbursement,” to request reimbursements (along with the submission of receipts for expenditures, timesheets, and any other documentation to support the request for reimbursement);
c. Providing annual project performance activity reports until the expiration of the award;
d. Ensuring that records are maintained to document all activities and expenditures utilizing Community Connect grant funds and matching funds (receipts for expenditures are to be included in this documentation);
e. Providing a final project performance report;
f. Complying with policies, guidance, and requirements as described in the following applicable Code of Federal Regulations, and any successor regulations;
i. 2 CFR parts 200 and 400 (Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards),
ii. 2 CFR part 417 (Nonprocurement Debarment and Suspension),
iii. 2 CFR part 180 (Government-wide Debarment and Suspension);
g. Signing Form AD-3031 (“Assurance Regarding Felony Conviction or Tax Delinquent Status for Corporate Applicants”) (for corporate applicants only); and
h. Complying with Executive Order 13166, “Improving Access to Services for Persons with Limited English Proficiency.” For information on limited English proficiency and agency-specific guidance, go to
a. Performance reporting. All recipients of Community Connect Grant Program financial assistance must provide annual performance activity reports to RUS until the project is complete and the funds are expended. A final performance report is also required; the final report may serve as the last annual report. The final report must include an evaluation of the success of the project in meeting the Community Connect Grant Program objectives. See 7 CFR 1739.19 and 2 CFR 200.328 for additional information on these reporting requirements.
b. Financial reporting. All recipients of Community Connect Grant Program financial assistance must provide an annual audit, beginning with the first year in which a portion of the financial assistance is expended. Audits are governed by United States Department of Agriculture audit regulations. See 7 CFR 1739.20 and 2 CFR part 200 (Subpart F) for a description of the financial reporting requirements.
c. Recipient and Sub-recipient Reporting. The applicant must have the necessary processes and systems in place to comply with the reporting requirements for first-tier sub-awards and executive compensation under the Federal Funding Accountability and Transparency Act of 2006 in the event the applicant receives funding unless such applicant is exempt from such reporting requirements pursuant to 2 CFR 170.110(b). The reporting requirements under the Transparency Act pursuant to 2 CFR 170 are as follows:
i. First Tier Sub-Awards of $25,000 or more (unless they are exempt under 2 CFR part 170) must be reported by the Recipient to
ii. The Total Compensation of the Recipient's Executives (the five most highly compensated executives) must be reported by the Recipient (if the Recipient meets the criteria under 2 CFR part 170) to
iii. The Total Compensation of the Sub-recipient's Executives (the five most highly compensated executives) must be reported by the Sub-recipient (if the Sub-recipient meets the criteria under 2 CFR part 170) to the Recipient by the end of the month following the month in which the sub-award was made.
d. Record Keeping and Accounting. The contract will contain provisions related to record keeping and accounting requirements.
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USDA prohibits discrimination against its customers, employees, and applicants for employment on the bases of race, color, national origin, age, disability, sex, gender identity, religion, reprisal, and where applicable, political beliefs, marital status, familial or parental status, sexual orientation, or all or part of an individual's income is derived from any public assistance program, or protected genetic information in employment or in any program or activity conducted or funded by USDA. (Not all prohibited bases will apply to all programs and/or employment activities.)
a. Equal Employment Opportunity Complaint. Individuals who wish to file an employment complaint must contact their Agency's EEO Counselor within 45 days of the date of the alleged discriminatory act, event, or in the case of a personnel action. Additional information can be found online at
b. Program Discrimination Complaint. Individuals who wish to file a Program Discrimination Complaint must complete the USDA Program Discrimination Complaint Form (PDF), found online at
Individuals who are deaf, hard of hearing, or have speech disabilities and wish to file either an EEO or program complaint may contact USDA through the Federal Relay Service at (800) 877-8339 (English) or (800) 845-6136 (Spanish).
Persons with disabilities who wish to file a program complaint, please see information above on how to contact USDA by mail or email. Individuals who require alternative means of communication for program information (
U.S. Commission on Civil Rights.
Announcement of public meeting.
Wednesday, June 1, 2016, 12:00 p.m.-1:00 p.m. (Pacific 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 California State Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Pacific Time) Wednesday, June 1, 2016, for the purpose of considering the Committee's report on voting integrity in California.
This meeting is available to the public through the following toll-free call-in number: 888-427-9419; when
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. The comments must be received in the Western Regional Office of the Commission by Friday, July 1, 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
Dial: 888-427-9419.
Conference ID: 1107449.
Angela French-Bell, DFO, at (213) 894-3437 or
U.S. Commission on Civil Rights.
Announcement of Public Meeting.
Monday, May 23, 2016, 2:00-3:00 p.m. (UTC-10).
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 Hawai`i State Advisory Committee (Committee) to the Commission will be held at 2:00 p.m. (Hawaiian Time) Monday, May 23, 2016, for the purpose of considering new topics for the Hawai`i State Advisory Committee's new project for FY 2016.
This meeting is available to the public through the following toll-free call-in number: 888-428-9473; when prompted, please provide conference ID number: 1594001. 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. The comments must be received in the Western Regional Office of the Commission by Thursday, June 23, 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
Angela French-Bell, DFO, at (213) 894-3437 or
U.S. Commission on Civil Rights.
Announcement of public meeting.
Wednesday, April 27, 2016 & Monday, May 16, 2016.
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 Advisory Committee (Committee) to the Commission will be held at 12:00 p.m. (Alaska Time) Wednesday, April 27, 2016, and Monday, May 16, 2016 for the purpose of considering and voting upon new topics for the Alaska Advisory Committee's new project for FY 2016.
These meetings are available to the public through the following toll-free call-in numbers: April 27, 2016: 888-417-8465; when prompted, please provide conference ID number: 7924734. May 16, 2016: 888-556-4997; when prompted, please provide conference ID number: 4783937. 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, May 27, 2016, and Thursday, June 16, 2016, respectively. 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
Agenda For April 27, 2016:
Agenda For May 16, 2016:
Angela French-Bell, DFO, at (213) 894-3437 or
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the New Mexico Advisory Committee to the Commission will convene at 10:00 a.m. (MDT) on Thursday, May 5, 2016, via teleconference. The purpose of the meeting is to review progress of planning for briefing meeting on the approved project Elder Abuse. The committee will also discuss if there is a need to establish subcommittees.
Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-452-4023; Conference ID: 4078555. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. 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 phone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-977-8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1-888-452-4023, Conference ID: 4078555. Members of the public are invited to submit written comments; the comments must be received in the regional office by Monday, April 25, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
AGENDA:
Thursday, May 5, 2016, at 10:00 a.m. (MDT).
To be held via teleconference:
Malee V. Craft, DFO,
On December 14, 2015, Canon Virginia, Inc., operator of Subzone 20D, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facilities in Newport News, Virginia.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On December 14, 2015, Samsung Austin Semiconductor, L.L.C., operator of Subzone 183B, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board for its facility in Austin, Texas.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
On July 17, 2014, in the U.S. District Court for the District of New Hampshire, Paweena Pechner, a/k/a Paweena Montasood (“Pechner”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Pechner knowingly and willfully caused to be exported from the United States to Thailand firearms which were designated as defense articles on the United States Munitions List, without having obtained from the United States Department of State a license or written approval for the export of these defense articles. Pechner was sentenced to probation for two years, assessed a penalty of $600, and fined $3,000.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS received notice of Pechner's conviction for violating the AECA, and has provided notice and an opportunity for Pechner to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS received a submission from Pechner. Based upon my review and consideration of that submission, and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Pechner's export privileges under the Regulations for a period of ten (10) years from the date of Pechner's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Pechner had an interest at the time of her conviction.
Pursuant to Sections 766.25(h) and 766.23 of the Regulations, the Director of BIS's Office of Exporter Services, in consultation with the Director of BIS's Office of Export Enforcement, may, in order to prevent evasion of a denial order, make a denial order applicable not only to the respondent, but also to other persons related to the respondent by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business.
As provided in Section 766.23 of the Regulations, BIS gave notice to CheapShop4You LLC (“CheapShop4You”) that its export privileges under the Regulations could be denied for up to ten (10) years due to its relationship with Pechner and that BIS believed that naming CheapShop4You as a person related to Pechner would be necessary to prevent evasion of a denial order imposed against Pechner. In providing such notice, BIS gave CheapShop4You an opportunity to oppose its addition to the Pechner Denial Order as a related party.
Having received and reviewed a submission from Pechner, I have decided, following consideration of that
CheapShop4You, a company associated with Pechner, is an online personal shopping business, which Pechner used to accept, process, and export, both lawfully and unlawfully, shipments to customers. CheapShop4You is co-located at Pechner's residence, and Pechner is listed as its registered agent with the New Hampshire Secretary of State. Therefore, CheapShop4You is related to Pechner within the meaning of Section 766.23. BIS also has reason to believe that CheapShop4You should be added as a related person in order to prevent evasion of this Denial Order.
Accordingly, it is hereby
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
A. Export or reexport to or on behalf of a Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by a Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby a Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from a Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from a Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by a Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by a Denied Person, if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
On May 7, 2015, in the U.S. District Court for the Eastern District of Pennsylvania, Alexandre Astakhov (“Astakhov”), was convicted of violating Section 38 of the Arms Export Control Act (22 U.S.C. 2778 (2012)) (“AECA”). Specifically, Astakhov knowingly and willfully attempted to export from the United States to Russia, and aided and abetted the attempted export of, defense articles, that is two L-3 CNVD-T thermal clip-on night vision devices, which were designated as a defense article on the United States Munitions List, without having first obtained from the Department of State a license for such export or written authorization for such export. Astakhov was sentenced to 39 months of imprisonment, three years of supervised release, 150 hours of community service, a criminal fine of $2,500 and a $200 assessment.
Section 766.25 of the Export Administration Regulations (“EAR” or “Regulations”)
BIS has received notice of Astakhov's conviction for violating the AECA, and has provided notice and an opportunity for Astakhov to make a written submission to BIS, as provided in Section 766.25 of the Regulations. BIS has received a submission from Astakhov.
Based upon my review and consultations with BIS's Office of Export Enforcement, including its Director, and the facts available to BIS, I have decided to deny Astakhov's export privileges under the Regulations for a period of 10 years from the date of Astakhov's conviction. I have also decided to revoke all licenses issued pursuant to the Act or Regulations in which Astakhov had an interest at the time of her conviction.
Accordingly, it is hereby ORDERED:
First, from the date of this Order until May 7, 2025, Alexandre Astakhov, with a last known address of Register Number: 68614-066, USP Lewisburg, U.S. Penitentiary, Federal Prison Camp, P.O. Box 2000, Lewisburg, PA 17837, and when acting for or on his behalf, his successors, assigns, employees, agents or representatives (the “Denied Person”), may not, directly or indirectly, participate in any way in any transaction involving any commodity, software or technology (hereinafter collectively referred to as “item”) exported or to be exported from the United States that is subject to the Regulations, including, but not limited to:
A. Applying for, obtaining, or using any license, License Exception, or export control document;
B. Carrying on negotiations concerning, or ordering, buying, receiving, using, selling, delivering, storing, disposing of, forwarding, transporting, financing, or otherwise servicing in any way, any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations; or
C. Benefitting in any way from any transaction involving any item exported or to be exported from the United States that is subject to the Regulations, or in any other activity subject to the Regulations.
Second, no person may, directly or indirectly, do any of the following:
A. Export or reexport to or on behalf of the Denied Person any item subject to the Regulations;
B. Take any action that facilitates the acquisition or attempted acquisition by the Denied Person of the ownership, possession, or control of any item subject to the Regulations that has been or will be exported from the United States, including financing or other support activities related to a transaction whereby the Denied Person acquires or attempts to acquire such ownership, possession or control;
C. Take any action to acquire from or to facilitate the acquisition or attempted acquisition from the Denied Person of any item subject to the Regulations that has been exported from the United States;
D. Obtain from the Denied Person in the United States any item subject to the Regulations with knowledge or reason to know that the item will be, or is intended to be, exported from the United States; or
E. Engage in any transaction to service any item subject to the Regulations that has been or will be exported from the United States and which is owned, possessed or controlled by the Denied Person, or service any item, of whatever origin, that is owned, possessed or controlled by the Denied Person if such service involves the use of any item subject to the Regulations that has been or will be exported from the United States. For purposes of this paragraph, servicing means installation, maintenance, repair, modification or testing.
Third, after notice and opportunity for comment as provided in Section 766.23 of the Regulations, any other person, firm, corporation, or business organization related to Astakhov by ownership, control, position of responsibility, affiliation, or other connection in the conduct of trade or business may also be made subject to the provisions of this Order in order to prevent evasion of this Order.
Fourth, in accordance with Part 756 of the Regulations, Astakhov may file an appeal of this Order with the Under Secretary of Commerce for Industry and Security. The appeal must be filed within 45 days from the date of this Order and must comply with the provisions of Part 756 of the Regulations.
Fifth, a copy of this Order shall be delivered to the Astakhov. This Order shall be published in the
Sixth, this Order is effective immediately and shall remain in effect until May 7, 2025.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) is rescinding the administrative review of the countervailing duty order on calcium hypochlorite from the People's Republic of China (“PRC”) for May 27, 2014 through December 31, 2015.
Katie Marksberry, AD/CVD Operations, Office V, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-7906.
On March 3, 2016, based on a timely request for review on behalf of Haixing Jingmei Chemical Products Sales Co. Ltd. (“Jingmei”) and Haixing Eno Chemical Co., Ltd. (“Eno”),
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the party that requested the review withdraws its request within 90 days of the publication of the notice of initiation of the requested review. In this case, Jingmei and Eno timely withdrew their request by the 90-day deadline, and no other party requested an administrative review of the countervailing duty order. As a result, pursuant to 19 CFR 351.213(d)(1), we are rescinding the administrative review of calcium hypochlorite from the PRC for the period May 27, 2014 through December 31, 2015, in its entirety.
Both Jingmei and Eno are subject to an ongoing new shipper review covering the same period of review as this administrative review.
This notice also serves as a final reminder to parties subject to administrative protective order (“APO”) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3), which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which is subject to sanction.
This notice is issued and published in accordance with sections 751(a)(1) and 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On October 7, 2015, the Department of Commerce (the Department) published the
David Crespo or Alice Maldonado, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-3693 and (202) 482-4682, respectively.
On October 7, 2015, the Department published the
On February 3, 2016, the Department postponed the final results by 60 days.
The merchandise subject to this order
All issues raised in the case and rebuttal briefs are addressed in the Issues and Decision Memorandum. A list of the issues which parties raised and to which we respond in the Issues and Decision Memorandum is attached to this notice as Appendix I. The Issues and Decision Memorandum is a public document and is on file electronically via Enforcement and Compliance's AD and Countervailing Duty (CVD) Centralized Electronic Service System (ACCESS). ACCESS is available to registered users at
Based on a review of the record and our analysis of the comments received, we made no changes to the margin calculations for Roung Shu or to the rate assigned to A-Madeus in these final results. For further discussion,
The POR is September 1, 2013, through August 31, 2014.
We are assigning the following weighted-average dumping margins to the firms listed below:
Pursuant to section 751(a)(2)(C) of the Act, and 19 CFR 351.212(b)(1), the Department has determined, and U.S. Customs and Border Protection (CBP) shall assess, antidumping duties on all appropriate entries of subject merchandise and deposits of estimated duties, where applicable, in accordance with the final results of this review. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this administrative review.
Pursuant to the
For A-Madeus, we will base the assessment rate assigned to the corresponding entries on the margin listed above, using the same methodology stated in the
The following deposit requirements will be effective upon publication of the notice of final results of administrative review for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the date of publication, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rates for Roung Shu and A-Madeus will be equal to the dumping margins established in the final results of this administrative review (except, if the rate is zero or
This notice also serves as a final reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This notice is published in accordance with section 751(a)(1) and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; availability of permit application and request for comment.
Notice is hereby given that NMFS has received an update to an application for a direct take permit, in the form of a Hatchery and Genetic Management Plan (HGMP), from the Chelan County Public Utility District (PUD) pursuant to the Endangered Species Act (ESA). The HGMP specifies the operation of a portion of a hatchery program rearing salmon in the Methow Basin within the State of Washington. This document serves to notify the public of the availability of the update to the existing permit application for comment prior to a decision by NMFS whether to issue the permit for the proposed hatchery program. NMFS also notifies the public of the intention to issue a separate ESA permit to the Confederated Tribes and Bands of the Yakama Nation for operation of a component of the program described in the application update.
Comments must be received at the appropriate address or email mailbox (see
Written comments on the application should be addressed to the NMFS Sustainable Fisheries Division, 1201 NE. Lloyd Boulevard, Suite 1100, Portland, OR 97232, or faxed to 503-872-2737. Comments may be submitted by email. The mailbox address for providing email comments is:
Charlene Hurst, at phone number: (503) 230-5409, or via email:
Chinook salmon (
Steelhead (
Section 9 of the ESA and Federal regulations prohibit the “taking” of a species listed as endangered or threatened. The term “take” is defined under the ESA to mean harass, harm, pursue, hunt, shoot, wound, kill, trap, capture, or collect, or to attempt to engage in any such conduct. NMFS may issue permits to take listed species for any act otherwise prohibited by section 9 for scientific purposes or to enhance the propagation or survival of the affected species under section 10(a)(1)(A) of the ESA. NMFS regulations governing permits for threatened and endangered species are promulgated at 50 CFR 222.307.
The Methow spring Chinook hatchery program is an ongoing hatchery program designed to meet conservation and mitigation responsibilities related to impacts from development in the Methow and Columbia River basins. On November 13, 2012, NMFS received an ESA section 10(a)(1)(A) permit application from the Douglas and Grant County PUDs and the Washington Department of Fish and Wildlife (WDFW) for the Methow spring Chinook hatchery program. The permit application was in the form of an HGMP and was made available for public comment on December 10, 2013 (78 FR 74116).
On March 29, 2016, the Chelan County PUD submitted an HGMP updating a portion of the original permit application. The HGMP includes a gene flow management plan, a reduction in the number of juveniles released, and a description of an additional remote acclimation/release site. A separate section 10(a)(1)(A) permit would be issued to the Confederated Tribes and Bands of the Yakama Nation for operation of this additional remote acclimation/release site, as described in the Chelan County PUD HGMP.
This notice is provided pursuant to section 10(c) of the ESA. NMFS will evaluate the permit application, associated documents, and comments submitted thereon to determine whether the application meets the requirements of section 10(a)(1)(A) of the ESA. If it is determined that the requirements are met, permits will be issued to WDFW, the PUDs, and the Confederated Tribes and Bands of the Yakama Nation. NMFS will publish a record of its final action in the
Army Corps of Engineers, DoD.
Final notice.
The U.S. Army Corps of Engineers (Corps), as part of an interagency effort with the U.S. Environmental Protection Agency (EPA), the U.S. Fish and Wildlife Service (FWS) and the U.S. Department of Agriculture Natural Resources Conservation Service (NRCS), is announcing the availability of the final 2016 National Wetland Plant List (NWPL). The NWPL is used to determine whether the hydrophytic vegetation parameter is met when conducting wetland determinations under the Clean Water Act and the Wetland Conservation Provisions of the Food Security Act. Other applications of the list include wetland restoration, establishment, and enhancement projects. The list will become effective on May 1, 2016 and will be used in any wetland delineation performed after this date. Delineations received prior to this date may still use the 2014 NWPL, or you may choose to use the 2016 list. Always reference the list used on any wetland delineation/determination forms.
The 2016 NWPL will become effective on May 1, 2016.
U.S. Army Corps of Engineers, Attn: CECW-CO-R, 441 G Street NW., Washington, DC 20314-1000.
Karen Mulligan, Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, Washington, DC 20314-1000, by phone at 202-761-4664 or by email at
The NWPL has undergone several revisions since its inception in 1988. The Corps led interagency efforts to update the list in 2012, 2013, and 2014. The 2012 list contained 7,828 species,
The NWPL was first published by the FWS in 1988 and first updated in 2012 to include 7,828 species. The 2014 update contained 8,061 species (Lichvar et al. 2014). Four were rated UPL in all regions where they occur, so there were a total of 8,057 species that occur in wetlands. This update contains 8,092 species, a net change of 35 more species (39 species added in the SPI, six new species in the Continental U.S. (CONUS), and removal of ten UPL species). These 8,092 species have 27,984 unique ratings since each can occur in more than one of the ten regions. The 2016 list includes changes in plant indicator status (OBL, FACW, FAC, FACU and UPL designations) from the 2014 list for 186 species found in the CONUS. Since these 186 species can occur in multiple Corps delineation regions, each having a unique rating, there were a total of 306 rating changes. The indicator status (rating) represents the likelihood that a particular plant occurs in a wetland or upland. The specific breakout of the 306 rating changes was: 49 percent (150 ratings) were assigned wetter indicator ratings and 51 percent (156 ratings) species were assigned drier indicator ratings. Ratings for 41 species were wetter in one region and drier in another region and ratings of three species did not change. In the SPI, there were 189 ratings changes, for a grand total of 495 rating changes in the entire list. A summary of rating changes by region and the response to the technical comments is available at:
In response to the September 14, 2015,
Most comments pertained to the rating of specific species in several regions, some supported ratings changes and some did not. The rationale for all ratings changes is provided in the response to technical comments document. One commenter was concerned with the inclusion of invasive/non-native species on the NWPL and how ratings are assigned to these species. Nativity to a particular region of the country is irrelevant for the purpose of assigning wetland indicator ratings. Instead, wetland ratings are based on how often a plant species is found to occur in wetlands vs. uplands (Lichvar et al. 2012, Lichvar and Minkin 2008). For both native and non-native species, wetland indicator ratings are assigned based on the NWPL Review Standard. The Review Standard involves a review of literature citations, herbaria records, and field observations. RPs and NP assign final ratings based on this evidence and professional experience.
Another commenter expressed concerns that the process for requesting changes to ratings is a burden on the public with regard to time or cost. The time and cost of requesting a rating change is minimal and reasonable; an individual or group simply needs to explain the rationale behind their proposed rating change in order to begin an open dialog on the current wetland rating. The change requests are processed by the RPs and NP, through which the NWPL Review Standard is applied to the species in question.
One commenter requested the inclusion of non-governmental, private-sector and academic experts on the NWPL panels, stating that government-only membership prevents the public from benefiting from expertise of botanists and other experts who are not federal employees. We do not feel that private sector or academic representatives should serve on the interagency regional or national panels as voting members. We encourage outside entities to provide input into the ratings process by providing scientific information, field data, literature reviews, and the like during the
A final concern was the lack of habitat descriptions from the literature for many NWPL species. One commenter suggested removing from the NWPL all species that lack literature. Another criticized the lack of literature from a particular Corps region. The Corps has developed a future plan for collecting habitat citations for all the species that lack them. Ratings of these species will be re-examined in light of any new data according to this timeline: Habitat citations for species that occur in the largest number of U.S. counties will be compiled in 2016, for review during the 2017 NWPL update. Supporting literature for species that occur in fewer counties will be compiled in 2018, for the 2019 NWPL update. Consistent with the current and past updates to the
Supporting documentation will be obtained from trustworthy sources, and the use of state, regional, and national floras or peer-reviewed journal articles is preferred. Online references and herbarium records will expedite data gathering provided the source is reliable. The number of citations/records considered adequate will vary with each species' range. Species with broad ranges that occur in several Corps regions will require more documentation than a species that is endemic to one or two counties. Likewise, few regionally specific references are available for species whose range recently expanded into a new Corps region. For instance, habitat references for species with recent range expansions into the South Pacific Islands, and the Caribbean may be difficult to obtain. Under these circumstances, citations from adjacent states or regions will be considered. During updates these citations from adjacent regions may be used to help guide decisions in regions that lack habitat citations due to recent range expansions. We believe that a minimum of ten citations or herbarium records for each species that currently lacks references is adequate for most species. Fewer records for rare or endemic species may be acceptable. The Corps welcomes public participation in this ongoing effort to improve wetland indicator ratings. Recent habitat citations for wetland plant species that lack literature may be contributed via email (
The Corps believes we have adequately reviewed the comments and allowed for public and agency input for the proposal. More extensive response to comments can be viewed at
The Corps, in cooperation with the USEPA, USFWS and NRCS, is publishing final wetland indicator statuses for the 2016 NWPL. The final NWPL is available at
In compliance with the principles in the President's Memorandum of June 1, 1998, (63 FR 31855) regarding plain language, this preamble is written using plain language. The use of “we” in this notice refers to the Corps. We have also used the active voice, short sentences, and common everyday terms except for necessary technical terms.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. For the Corps Regulatory Program under Section 10 of the Rivers and Harbors Act of 1899, Section 404 of the Clean Water Act, and Section 103 of the Marine Protection, Research and Sanctuaries Act of 1972, the current OMB approval number for information collection requirements is maintained by the Corps of Engineers (OMB approval number 0710-0003, which expires on August 31, 2015 (extension request currently in review). This update will not have an effect on the paperwork burden because a wetland delineation is not required for a complete application for most permit types. The delineation of special aquatic sites for a complete preconstruction notification only applies to nationwide permits (NWP) and any additional hours will be included in the burden estimate for the 2017 NWP rulemaking.
The action will not substantially change paperwork burdens on the regulated public because the use of 2016 NWPL will merely be substituted for the 2014 list currently used in the application process in jurisdictional determinations. Further, the NWPL can be viewed on-line or merged into existing documents (
Under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821), we must determine whether the regulatory action is “significant” and therefore subject to review by OMB and the requirements of the Executive Orders. The Executive Orders define “significant regulatory action” as one that is likely to result in a rule that may:
(1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;
(2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another agency;
(3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
Pursuant to the terms of Executive Orders 12866 and 13563, we determined that this action is not a “significant regulatory action” and therefore, it is not subject to review under requirements of the Executive Orders.
Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), requires the Corps to develop an
The Regulatory Flexibility Act generally requires an agency to prepare a regulatory flexibility analysis of any rule subject to notice-and-comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions.
For purposes of assessing the impacts of the proposed issuance and modification of NWPs on small entities, a small entity is defined as: (1) A small business based on Small Business Administration size standards; (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; or (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.
After considering the economic impacts of the action on small entities, we certify that the updates to the NWPL will not have a significant impact on a substantial number of small entities since it does not change the Corps' current wetland delineation/identification procedures, or the circumstances under which a wetland delineation is required to make a decision on a Department of the Army permit application. The NWPL is only used to determine if a site has wetland plant community and is not the sole factor for determining whether a site is a wetland under the Clean Water Act. To be considered a wetland under the Clean Water Act, the site must also have wetland hydrology and hydric soils.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA), Public Law 104-4, establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under Section 202 of the UMRA, the agencies generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating a rule for which a written statement is needed, Section 205 of the UMRA generally requires the agencies to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective, or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows an agency to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the agency publishes with the final rule an explanation why that alternative was not adopted. Before an agency establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed, under Section 203 of the UMRA, a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of regulatory proposals with significant federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements.
We have determined that the NWPL issued today does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. The use of the NWPL is consistent with current agency practice, does not impose new substantive requirements and therefore does not contain a Federal mandate that may result in expenditures of $100 million or more for State, local, and Tribal governments, in the aggregate, or the private sector in any one year. Therefore, the NWPL issued today is not subject to the requirements of Sections 202 and 205 of the UMRA. For the same reasons, we have determined that the NWPL update contains no regulatory requirements that might significantly or uniquely affect small governments. Therefore, the issuance of the NWPL is not subject to the requirements of Section 203 of UMRA.
A decision document has been prepared for this action after all comments received were evaluated. The decision document is available through Headquarters, U.S. Army Corps of Engineers, Operations and Regulatory Community of Practice, 441 G Street NW., Washington, DC 20314-1000.
We utilize the NWPL in conducting wetland determinations under the authority of Section 404 of the Clean Water Act (33 U.S.C. 1344) and Section 10 of the Rivers and Harbors Act of 1899 (33 U.S.C. 401
National Advisory Council on Indian Education, Department of Education.
Announcement of an Open Public Meeting.
This notice sets forth the schedule of an upcoming public meeting conducted by the National Advisory Council on Indian Education (NACIE). Notice of the meeting is required by section 10(a)(2) of the Federal Advisory Committee Act and intended to notify the public of its opportunity to attend. In order to facilitate the Secretary's attendance, this notice is being published less than 15 days prior to the scheduled meeting date.
The NACIE meeting will be held on April 25-26, 2016; April 25, 2016—8:30 a.m.-4:00 p.m. Eastern Daylight Saving Time, April 26, 2015—9:00 a.m.-1:00 p.m. Eastern Daylight Saving Time.
The meeting location is 400 Maryland Ave., Room 3C100, SW., Washington, DC 20202.
Tina Hunter, Designated Federal Official, Office of Elementary and Secondary
NACIE's Statutory Authority and Function: The National Advisory Council on Indian Education is authorized by § 6141 of the Elementary and Secondary Education Act, as amended by Every Student Succeeds Act (ESSA). The Council is established within the Department of Education to advise the Secretary of Education on the funding and administration (including the development of regulations, and administrative policies and practices) of any program over which the Secretary has jurisdiction and includes Indian children or adults as participants or programs that may benefit Indian children or adults, including any program established under Title VI, part A of the Elementary and Secondary Education Act as amended by ESSA. The Council submits to the Congress, not later than June 30 of each year, a report on the activities of the Council that includes recommendations the Council considers appropriate for the improvement of Federal education programs that include Indian children or adults as participants or that may benefit Indian children or adults, and recommendations concerning the funding of any such program.
One of the Council's responsibilities is to develop and provide recommendations to the Secretary of Education on the funding and administration (including the development of regulations, and administrative policies and practices) of any program over which the Secretary has jurisdiction that can benefit Indian children or adults participating in any program which could benefit Indian children.
All attendees must RSVP for the meeting and sign up to provide a public comment no later than April 20, 2016. Speakers will be allowed to provide comments for no more than five (5) minutes. Members of the public interested in submitting written comments may do so via email at
The purpose of the meeting is to convene the Council to conduct the following business: (1) Final discussion, review and approval of the 2015 recommendations to the Secretary; (2) Present recommendations to the Secretary or Proxy; (3) Overview of ESSA and discuss the impact on Indian Programs with regard to NACIE, and; (4) Conduct discussions and begin work on the development of the annual report to Congress that should be submitted no later than June 30, 2016.
The National Advisory Council on Indian Education is authorized by Section 6141 of the Elementary and Secondary Education Act, as amended by ESSA.
Office of Postsecondary Education (OPE), Department of Education (ED).
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before May 18, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Winston Skerrett, 202-453-7605.
The Department of Education (ED), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed, revised, and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. ED is soliciting comments on the proposed information collection request (ICR) that
Office of Fossil Energy, DOE.
Notice of application.
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on September 18, 2015, by SeaOne Gulfport, LLC (SeaOne), requesting long-term, multi-contract authorization to export up to a total of 1.0 billion cubic feet per day (Bcf/d) of natural gas contained in Compressed Gas Liquid (CGL) by vessel
Protests, motions to intervene or notices of intervention, as applicable, requests for additional procedures, and written comments are to be filed using procedures detailed in the Public Comment Procedures section no later than 4:30 p.m., Eastern time, June 17, 2016.
The Application will be reviewed pursuant to section 3(a) of the NGA, 15 U.S.C. 717b(a), and DOE will consider any issues required by law or policy. To the extent determined to be relevant, these issues will include the domestic need for the natural gas proposed to be exported, the adequacy of domestic natural gas supply, U.S. energy security, and the cumulative impact of the requested authorization and any other natural gas export application(s) previously approved on domestic natural gas supply and demand fundamentals. DOE may also consider other factors bearing on the public interest, including the impact of the proposed exports on the U.S. economy (including GDP, consumers, and industry), job creation, the U.S. balance of trade, and international considerations; and whether the authorization is consistent with DOE's policy of promoting competition in the marketplace by allowing commercial parties to freely negotiate their own trade arrangements. As part of this analysis, DOE will consider the following two studies examining the cumulative impacts of exporting domestically produced LNG insofar as they may be applicable to this proceeding:
•
•
•
The National Environmental Policy Act (NEPA), 42 U.S.C. 4321
In response to this Notice, any person may file a protest, comments, or a motion to intervene or notice of intervention, as applicable. Due to the complexity of the issues raised by the Applicant, interested parties will be provided 60 days from the date of publication of this Notice in which to submit their comments, protests, motions to intervene, or notices of intervention.
Any person wishing to become a party to the proceeding must file a motion to intervene or notice of intervention. The filing of comments or a protest with respect to the Application will not serve to make the commenter or protestant a party to the proceeding, although protests and comments received from persons who are not parties will be considered in determining the appropriate action to be taken on the Application. All protests, comments, motions to intervene, or notices of intervention must meet the requirements specified by the regulations in 10 CFR part 590.
Filings may be submitted using one of the following methods: (1) Emailing the filing to
A decisional record on the Application will be developed through responses to this notice by parties, including the parties' written comments and replies thereto. Additional procedures will be used as necessary to achieve a complete understanding of the facts and issues. If an additional procedure is scheduled, notice will be provided to all parties. If no party requests additional procedures, a final Opinion and Order may be issued based on the official record, including the Application and responses filed by parties pursuant to this notice, in accordance with 10 CFR 590.316.
The Application is available for inspection and copying in the Office of Regulation and International Engagement docket room, Room 3E-042, 1000 Independence Avenue SW., Washington, DC 20585. The docket room is open between the hours of 8:00 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays.
The Application and any filed protests, motions to intervene or notice of interventions, and comments will also be available electronically by going to the following DOE/FE Web address:
Federal Energy Regulatory Commission, DOE.
Notice of Public Availability of FY 2015 Service Contract Inventories and Supplemental Data.
In accordance with Section 743 of Division C of the Consolidated Appropriations Act of 2010 (
The service contract inventory provides information on service contract actions over $25,000 that FERC completed in FY 2015. The information is organized by function to show how contracted resources are distributed throughout the agency. The inventory has been developed in accordance with guidance issued on November 5, 2010, by the Office of Management and Budget's Office of Federal Procurement Policy (OFPP).
OFPP's guidance is available at
On December 19, 2011, OFPP issued additional guidance available at
FERC has posted its FY 2015 inventory and summary at the following link:
Katharine Lindner, Acquisition Services Division, Office of the Executive Director, Federal Energy Regulatory
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, recommendations, preliminary terms and conditions, and preliminary fishway prescriptions using the Commission's eFiling system at
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now ready for environmental analysis.
l.
The existing license for the Hawks Nest Hydroelectric Project requires that the project release a continuous minimum flow of 100 cubic feet per second into the bypassed reach between the dam and the powerhouse (Article 402). Hawks Nest Hydro proposes to continue run-of-river operation and increase the existing minimum flow for the bypassed reach. The project generates an annual average of 544,253 megawatt-hours.
The Glen Ferris Hydroelectric Project is currently operated in a run-of-river mode with no usable storage capacity. Hawks Nest Hydro proposes to continue run-of-river operation. The project generates an annual average of 41,482 megawatt-hours.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Register online at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, and .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
o.
The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
q.
On February 19, 2016, Energy Resources USA Inc. filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Bosher Dam Hydroelectric Project (Bosher Project or project) to be located at the existing Bosher Dam on the James River, about 2 miles southwest of Tuckahoe, in Henrico County, Virginia. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
Deadline for filing comments, motions to intervene, competing applications (without notices of intent), or notices of intent to file competing applications: 60 days from the issuance of this notice. Competing applications and notices of intent must meet the requirements of 18 CFR 4.36.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, notices of intent, and competing applications using the Commission's eFiling system at
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary”
On March 31, 2016, Yuba County Water Agency, licensee for the Yuba River Project, filed Technical Memoranda 7-11 and 7-11a,
The Commission is soliciting comments on these memoranda. Any comments should be filed within 30 days from the date of this notice. The Commission strongly encourages electronic filing. Please file all documents using the Commission's eFiling system at
Once the Commission has determined that it has sufficient information to process the license application, it will issue a notice that the application is ready for environmental analysis, requesting comments, recommendations, terms and conditions, or prescriptions.
For further information, contact Alan Mitchnick at (202) 502-6074.
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the Deschutes Valley Water District's (licensee) application to amend the license in order to construct and operate fish passage facilities at the Opal Springs Hydroelectric Project No. 5891. The project is located on the Crooked River in Jefferson County, Oregon. The project occupies federal lands administered by the U.S. Bureau of Land Management.
The application, filed with the Commission on October 8, 2015, contains an Environmental Analysis in its Exhibit E. After independent review of the licensee's Exhibit E, Commission staff has decided to adopt the licensee's Environmental Analysis and issue it as staff's Environmental Assessment (EA). The EA analyzes the potential environmental impacts of construction and operation of fish passage facilities plus the proposed mitigation measures and concludes that granting the proposed amendment would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the EA is on file with the Commission and is available for public inspection. The EA may be viewed on the Commission's Web site at
A copy of the EA may also be accessed using this link:
You may also register online at
All comments must be filed within 30 days of the date of this notice and should reference Project No. 5891-009. The Commission strongly encourages electronic filing. Please file comments using the Commission's efiling system at
For further information, contact Jennifer Ambler at (202) 502-8586 or
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. This application is not ready for environmental analysis at this time.
k.
The project is operated in a limited peaking mode, with maximum allowed daily reservoir fluctuations of approximately 0.8 feet (1,435.5 feet NGVD to 1,434.7 feet NGVD). During normal peaking operations, the reservoir is drawn down from the maximum pond elevation during the day and refilled at night providing one peaking cycle per day. The amount of fluctuation is determined primarily by the volume of water which can normally be restored to the Tomahawk reservoir during off-peak hours. During low flow periods, the project is required to maintain a minimum flow of 162 cubic feet per second (cfs) or inflow, whichever is less. The operation of the Tomahawk Project is coordinated with the downstream WPS Projects (Grandfather Falls and Alexander Projects) and with the Grandmother Falls Project to make the most effective use of the available water resource.
The normal tailwater elevation of the project is 1,419.5 feet NGVD. The impoundment provides about 14.5 feet of gross head for power generation purposes. The hydraulic capacity of the project is 2,634 cfs and water flowing through the turbines is discharged via the draft tubes into the tailrace immediately below the dam. Electricity generated from the project is transmitted from the powerhouse via two 2.5-kV generator leads and a 3.75 MVA 2.4/24.9-kV three-phase transformer to the adjacent substation and into Wisconsin Public Service Corporation's distribution system. Wisconsin Public Service Corporation is proposing to continue current operations at the Project for the term of the new license.
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
m. You may also register online at
n.
The application will be processed according to the following preliminary Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
o. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of the notice of ready for environmental analysis.
The staff of the Federal Energy Regulatory Commission (FERC or Commission) will prepare an environmental assessment (EA) that will discuss the environmental impacts of the Northern Lights 2017 Expansion Project involving construction and operation of facilities by Northern Natural Gas Company (Northern) in Dakota County, Minnesota. The Commission will use this EA in its decision-making process to determine whether the project is in the public convenience and necessity.
This notice announces the opening of the scoping process the Commission will use to gather input from the public and interested agencies on the project. You can make a difference by providing us with your specific comments or concerns about the project. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. Your input will help the Commission staff determine what issues they need to evaluate in the EA. To ensure that your comments are timely and properly recorded, please send your comments so
If you sent comments on this project to the Commission before the opening of this docket on September 28, 2015, you will need to file those comments in Docket No. PF15-33-000 to ensure they are considered as part of this proceeding.
This notice is being sent to the Commission's current environmental mailing list for this project. State and local government representatives should notify their constituents of this planned project and encourage them to comment on their areas of concern.
If you are a landowner receiving this notice, a pipeline company representative may contact you about the acquisition of an easement to construct, operate, and maintain the planned facilities. The company would seek to negotiate a mutually acceptable agreement. However, if the Commission approves the project, that approval conveys with it the right of eminent domain. Therefore, if easement negotiations fail to produce an agreement, the pipeline company could initiate condemnation proceedings where compensation would be determined in accordance with state law.
A fact sheet prepared by the FERC entitled “An Interstate Natural Gas Facility On My Land? What Do I Need To Know?” is available for viewing on the FERC Web site (
For your convenience, there are three methods you can use to submit your comments to the Commission. The Commission will provide equal consideration to all comments received, whether filed in written form or provided verbally. The Commission encourages electronic filing of comments and has expert staff available to assist you at (202) 502-8258 or
(1) You can file your comments electronically using the
(2) You can file your comments electronically by using the
(3) You can file a paper copy of your comments by mailing them to the following address. Be sure to reference the project docket number (PF15-33-000) with your submission: Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street NE., Room 1A, Washington, DC 20426.
Northern plans to construct and operate approximately 4.8 miles of branch line loop
The Northern Lights 2017 Expansion Project would consist of the following facilities:
• 2.0 miles extending the existing 8-inch-diameter Princeton branch line loop and a new associated valve;
• 2.8 miles extending the existing 12-inch-diameter St. Cloud branch line loop and a new associated valve;
• a 15,900-horsepower Solar Mars turbine compressor unit at the Faribault Compressor Station; and
• cathodic protection test stations.
The general location of the project facilities is shown in appendix 1.
Construction of the planned facilities would disturb about 112.4 acres of land for the aboveground facilities and the pipeline. In addition to its existing facilities, Northern would maintain about 2.1 acres for permanent operation of the project's facilities following construction; the remaining acreage would be restored and revert to former uses. Most of the facilities would be located within Northern's existing easements, offset 20 to 25 feet from Northern's existing pipelines, and thus not require any new permanent easements.
The National Environmental Policy Act (NEPA) requires the Commission to take into account the environmental impacts that could result from an action whenever it considers the issuance of a Certificate of Public Convenience and Necessity. NEPA also requires us
In the EA we will discuss impacts that could occur as a result of the construction and operation of the planned project under these general headings: Geology and soils; land use; water resources, fisheries, and wetlands; cultural resources; vegetation and wildlife; air quality and noise; endangered and threatened species; public safety; and cumulative impacts.
We will also evaluate possible alternatives to the planned project or portions of the project, and make recommendations on how to lessen or avoid impacts on the various resource areas.
Although no formal application has been filed, we have already initiated our NEPA review under the Commission's pre-filing process. The purpose of the pre-filing process is to encourage early involvement of interested stakeholders and to identify and resolve issues before the FERC receives an application. As part of our pre-filing review, we have begun to contact some federal and state agencies to discuss their involvement in the scoping process and the preparation of the EA.
The EA will present our independent analysis of the issues. The EA will be available in the public record through eLibrary. Depending on the comments received during the scoping process, we
With this notice, we are asking agencies with jurisdiction by law and/or special expertise with respect to the environmental issues related to this project to formally cooperate with us in the preparation of the EA.
In accordance with the Advisory Council on Historic Preservation's implementing regulations for section 106 of the National Historic Preservation Act, we are using this notice to initiate consultation with the Minnesota State Historic Preservation Office (SHPO), and to solicit their views and those of other government agencies, interested Indian tribes, and the public on the project's potential effects on historic properties.
The environmental mailing list includes federal, state, and local government representatives and agencies; elected officials; environmental and public interest groups; Native American tribes; other interested parties; and local libraries and newspapers. This list also includes all affected landowners (as defined in the Commission's regulations) who are potential right-of-way grantors, whose property may be used temporarily for project purposes, or who own homes within certain distances of aboveground facilities, and anyone who submits comments on the project. We will update the environmental mailing list as the analysis proceeds to ensure that we send the information related to this environmental review to all individuals, organizations, and government entities interested in and/or potentially affected by the planned project.
If we publish and distribute the EA, copies will be sent to the environmental mailing list for public review and comment. If you would prefer to receive a paper copy of the document instead of the CD version or would like to remove your name from the mailing list, please return the attached Information Request (appendix 2).
Once Northern files its application with the Commission, you may want to become an “intervenor” which is an official party to the Commission's proceeding. Intervenors play a more formal role in the process and are able to file briefs, appear at hearings, and be heard by the courts if they choose to appeal the Commission's final ruling. An intervenor formally participates in the proceeding by filing a request to intervene. Motions to intervene are more fully described at
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 (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. 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
Finally, public meetings or site visits will be posted on the Commission's calendar located at
Dated: April 11, 2016.
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a
Written comments should be submitted on or before May 18, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contacts below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, OMB, via email
For additional information or copies of the information collection, contact Nicole Ongele at (202) 418-2991. To view a copy of this information collection request (ICR) submitted to OMB: (1) Go to the Web page
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before June 17, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicole Ongele, FCC, via email to
For additional information about the information collection, contact Nicole Ongele at (202) 418-2991.
Federal Election Commission.
Tuesday, March 15, 2016 at 10:00 a.m. and Wednesday, March 16, 2016 at the conclusion of the Open Meeting.
999 E Street NW., Washington, DC.
This meeting will be closed to the public.
This meeting was continued on April 12, 2016.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Federal Maritime Commission.
April 20, 2016-10 a.m.
800 North Capitol Street NW., First Floor Hearing Room, Washington, DC.
The meeting will be held in Open Session.
Karen V. Gregory, Secretary, (202) 523 5725.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments
A. Federal Reserve Bank of Minneapolis (Jacquelyn K. Brunmeier, Assistant Vice President) 90 Hennepin Avenue, Minneapolis, Minnesota 55480-0291:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 13, 2016.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841
The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States.
Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than May 12, 2016.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
1.
B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
1.
April 25, 2016, 8:30 a.m. (In Person).
10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002.
Federal Retirement Thrift Investment Board Member Meeting, April 25, 2016, 8:30 a.m. (In-Person).
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Federal Trade Commission.
Commission policy statement.
The Federal Trade Commission has issued an Enforcement Policy Statement on Deceptively Formatted Advertisements. The Statement describes the underlying consumer protection principles that guide the Commission's enforcement actions, advisory opinions, and other guidance addressing various forms of deceptively formatted advertising, including advertising and promotional messages integrated into and presented as non-commercial content.
The Commission announced the issuance of the Statement on December 22, 2015.
Laura Sullivan (202-326-3327) or Michael Ostheimer (202-326-2699), Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The Federal Trade Commission issues this enforcement policy statement regarding advertising and promotional messages integrated into and presented as non-commercial content.
Section 5 of the FTC Act prohibits “unfair or deceptive acts or practices in or affecting commerce.” As the Commission set forth in its 1983 Policy Statement on Deception, a representation, omission, or practice is deceptive if it is likely to mislead consumers acting reasonably under the circumstances and is material to consumers—that is, it would likely affect the consumer's conduct or decisions with regard to a product or service.
The Commission has long held the view that advertising and promotional messages that are not identifiable as advertising to consumers are deceptive if they mislead consumers into believing they are independent, impartial, or not from the sponsoring advertiser itself. Knowing the source of an advertisement or promotional message typically affects the weight or credibility consumers give it. Such knowledge also may influence whether and to what extent consumers choose to interact with content containing a promotional message. Over the years, the Commission has challenged as deceptive a wide variety of advertising and other commercial message formats, including “advertorials” that appeared as news stories or feature articles, direct-mail ads disguised as book reviews, infomercials presented as regular television or radio programming, in-person sales practices that misled consumers as to their true nature and purpose, mortgage relief ads designed to look like solicitations from a government agency, emails with deceptive headers that appeared to originate from a consumer's bank or mortgage company, and paid endorsements offered as the independent opinions of impartial consumers or experts.
With the emergence of digital media and changes in the way publishers monetize content, online advertising known as “native advertising” or “sponsored content,” which is often indistinguishable from news, feature articles, product reviews, editorial, entertainment, and other regular content, has become more prevalent. In digital media, a publisher, or an authorized third party, can easily and inexpensively format an ad so it matches the style and layout of the content into which it is integrated in ways not previously available in traditional media. The effect is to mask the signals consumers customarily have relied upon to recognize an advertising or promotional message.
At the same time, the business models of many publishers also have undergone significant change, as, increasingly, consumers are able to skip or block digital ads while watching digitized programming or browsing publisher content. Consequently, many publishers have begun to offer advertisers formats and techniques that are closely integrated with and less distinguishable from regular content so that they can capture the attention and clicks of ad-avoiding consumers.
Regardless of the medium in which an advertising or promotional message is disseminated, deception occurs when consumers acting reasonably under the circumstances are misled about its nature or source, and such misleading impression is likely to affect their decisions or conduct regarding the advertised product or the advertising. This statement sets forth generally applicable standards on which the Commission relies in making such a determination.
The principle that advertising and promotional messages should be identifiable as advertising is found in Commission and staff policy guidance,
The Commission first addressed the issue of print advertisements appearing in a news format in a 1967 press release and subsequent 1968 advisory opinion.
Two decades later, in a case against a bookseller, the Commission applied this same analysis and concluded there was reason to believe that the bookseller violated the FTC Act through a deceptive direct-mail ad formatted to appear as if it were a book review torn out of a magazine, with a personalized note attached.
During the 1980s, after the Federal Communications Commission removed its ban on program-length commercials, such advertisements, known as infomercials, began to air on television and radio.
More recently, the Commission has brought a series of cases concerning ads disguised to look like news reports on weight-loss pills and other products, where a purported journalist tested the advertised product and authored the story.
In another recent case, the Commission challenged as deceptive a Web site purported to originate from an independent scientific organization. The Commission alleged that dietary supplement marketers misrepresented that their Web site promoting the health benefits of their children's supplements was an independent, objective resource for scientific and other information on treating a specific health condition, and that they failed to disclose their relationship to the Web site.
The Commission also has challenged advertisements misrepresenting that a government agency endorsed or was
In 2002, when online search was a relatively new medium, FTC staff issued guidance concerning the potential for consumers to be deceived by paid ads formatted to appear as the regular search results that search engines return in response to consumers' queries.
Other formats that mislead consumers about a commercial message's nature or purpose also have been alleged or found to be deceptive, such as misleading sales visits and calls and emails with falsified sender information. An early example of such a challenge was a 1976 case against an encyclopedia seller.
In 1994, concerned about deception and abuse occurring in the telemarketing of goods and services, Congress enacted the Telemarketing Fraud Act,
When Congress passed the CAN-SPAM Act,
Consumers may also be misled about an advertisement's nature or source as a result of an advertiser's use of consumer and other endorsements. As the Commission stated in the Endorsement Guides, “When there exists a connection between the endorser and the seller of the advertised product that might materially affect the weight or credibility of the endorsement (
Since revising the Endorsement Guides, the Commission has brought a number of cases underscoring this principle.
The recent proliferation of natively formatted advertising in digital media has raised questions about whether these advertising formats deceive consumers by blurring the distinction between advertising and non-commercial content. Natively formatted advertising encompasses a broad range of advertising and promotional messages that match the design, style, and behavior of the digital media in which it is disseminated. The ads can appear in a wide variety of forms, including written narratives, videos, infographics, images, animations, in-game modules, and playlists on streaming services. Often natively formatted ads are inserted into the stream of regular content a publisher offers,
Regardless of an ad's format or medium of dissemination, certain principles undergird the Commission's deceptive format policy. Deception occurs when an advertisement misleads reasonable consumers as to its true nature or source, including that a party other than the sponsoring advertiser is the source of an advertising or promotional message, and such misleading representation is material. In this regard, a misleading representation is material if it is likely to affect consumers' choices or conduct regarding the advertised product or the advertisement, such as by leading consumers to give greater credence to advertising claims or to interact with advertising with which they otherwise would not have interacted.
Although the particular facts will determine whether an advertisement formatted like the material in which it appears is deceptive, this statement sets forth the factors the Commission will consider in making that determination.
In evaluating whether an ad's format is misleading, the Commission considers the net impression the advertisement conveys to reasonable consumers, not statements in isolation.
Applying the net impression standard in its
Any determination of whether an advertisement's format misleads as to the ad's nature or source depends on how reasonable consumers would interpret the ad in a particular situation. To be reasonable, an interpretation or response of consumers to a particular ad need not be the only one nor be shared by a majority of consumers.
In digital media, consumers can encounter natively formatted ads in a wide variety of situations, including in the news feed or main page of a publisher site, or through other means, such as posts in social media, in search results, and in email. In evaluating whether reasonable consumers would recognize ads as such, the Commission will consider the particular circumstances in which the ads are disseminated, including customary expectations based on consumers' prior experience with the media in which it appears and the impression communicated by the ad's format.
The target audience of an ad also may affect whether it is likely to mislead reasonable consumers about its nature or source. Increasingly, in digital media, advertisers can target natively formatted ads to individual consumers and even tailor the ads' messaging to appeal to the known preferences of those consumers.
Certain ads that are formatted like the non-advertising content with which they are presented, however, may be unlikely to mislead consumers acting reasonably. Some ads by the very nature of their promotional message communicated may be inherently obvious as advertising to consumers. For instance, if a natively formatted ad with an image of a particular sports car and the headline “Come and Drive [X] today” were inserted into the news stream of a publisher site, that ad likely would be identifiable as an ad to consumers, even though it was presented in the same visual manner as news stories in the stream.
Finally, in determining the overall impression communicated by an ad, the Commission also will consider any qualifying information contained in the ad.
A disclosure must be made in “simple, unequivocal” language, so that consumers comprehend what it means.
The conspicuousness of the disclosure will depend on the method of delivery and placement within the ad. Depending on the circumstances, a disclosure in the text may not remedy a misleading impression created by the headline because reasonable consumers might glance only at the headline.
To be effective, a disclosure also generally must be made contemporaneously with the misleading claim it is intended to qualify. For example, disclosures that subsequently inform consumers of a natively formatted ad's commercial nature after they have clicked on and arrived at another page will not cure any misleading impression created when the ad is presented in the stream of a publisher site. This approach also reflects and is consistent with long-standing public policy, as codified in the CAN-SPAM Act
Deception occurs when an ad misleads consumers about a material fact.
The Commission presumes that claims made expressly and claims the advertiser intended to make are material.
Although digital media has expanded and changed the way marketers reach consumers, all advertisers, including digital advertisers, must comply with the same legal principles regarding deceptive conduct the Commission has long enforced. This statement sets forth principles of general applicability on which the Commission will rely in determining whether any particular advertising format is deceptive, in violation of Section 5 of the FTC Act. The Commission will find an advertisement deceptive if the ad misleads reasonable consumers as to its nature or source, including that a party other than the sponsoring advertiser is its source. Misleading representations of this kind are likely to affect consumers' decisions or conduct regarding the advertised product or the advertisement, including by causing consumers to give greater credence to advertising claims or to interact with advertising content with which they otherwise would not have interacted.
By direction of the Commission.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Taxpayer Identification Number Information. A notice was published in the
Submit comments on or before May 18, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, GSA, 202-501-1448 or email at
In accordance with 31 U.S.C. 7701(c), a contractor doing business with a Government agency is required to furnish its Tax Identification Number (TIN) to that agency. Also, 31 U.S.C. 3325(d) requires the Government to include, with each certified voucher prepared by the Government payment office and submitted to a disbursing official, the TIN of the contractor receiving payment under the voucher. 26 U.S.C. 6050M, as implemented in the Department of Treasury, Internal Revenue Service (IRS) regulations at Title 26 of the Code of Federal Regulations (CFR), requires heads of Federal executive agencies to report certain information to the IRS. 26 U.S.C. 6041 and 6041A, as implemented in 26 CFR, in part, requires payors, including Government agencies, to report to the IRS, on form 1099, payments made to certain contractors.
To comply with the requirements of 31 U.S.C. 7701(c) and 3325(d), reporting requirements of 26 U.S.C. 6041, 6041A, and 6050M, and implementing regulations issued by the IRS in 26 CFR, FAR clause 52.204-3, Taxpayer Identification, requires a potential Government contractor to submit, among other information, its TIN. The TIN may be used by the Government to collect and report on any delinquent amounts arising out of the contractor's relationship with the Government. A contractor is not required to provide its TIN on each contract in accordance with FAR clause 52.204-3, Taxpayer Identification, when FAR clause 52.204-7, Central Contractor Registration, is inserted in contracts. FAR clause 52.204-7 requires a potential Federal contractor to provide its TIN in the Central Contractor Registration (CCR) system.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0097, Taxpayer Identification Number Information, in all correspondence.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act of 1995, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding Use of Project Labor Agreements for Federal Construction Projects. A notice published in the
Submit comments on or before May 18, 2016.
Submit comments regarding this burden estimate or any other aspect
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Mr. Edward Loeb, Procurement Analyst, Office of Governmentwide Acquisition Policy, at telephone 202-501-0650 or via email to
FAR 22.501 prescribes policies and procedures to implement Executive Order 13502, February 6, 2009 which encourages Federal agencies to consider the use of a project labor agreement (PLA), as they may decide appropriate, on large-scale construction projects, where the total cost to the Government is more than $25 million, in order to promote economy and efficiency in Federal procurement. A PLA is a pre-hire collective bargaining agreement with one or more labor organizations that establishes the terms and conditions of employment for a specific construction project. FAR 22.503(b) provides that an agency may, if appropriate, require that every contractor and subcontractor engaged in construction on the project agree, for that project, to negotiate or become a party to a project labor agreement with one or more labor organizations if the agency decides that the use of project labor agreements will—
(1) Advance the Federal Government's interest in achieving economy and efficiency in Federal procurement, producing labor-management stability, and ensuring compliance with laws and regulations governing safety and health, equal employment opportunity, labor and employment standards, and other matters; and,
(2) Be consistent with law.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 9000-0175, Use of Project Labor Agreements for Federal Construction Projects, in all correspondence.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for an extension of an information collection requirement regarding an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning Accident Prevention Plans and Recordkeeping. A notice published in the
Submit comments on or before May 18, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Mr. Curtis E. Glover, Sr., Procurement Analyst, Contract Policy Division, GSA, telephone 202-501-1448 or email at
The FAR clause at 52.236-13, Accident Prevention, requires Federal construction contractors to keep records of accidents incident to work performed under the contract that result in death, traumatic injury, occupational disease or damage to property, materials, supplies or equipment. Records of personal inquiries are required by the Department of Labor's (DOL) Occupational Safety and Health Administration regulations (OSHA). The records maintained by the contractor are used to evaluate compliance and may be used in workmen's compensation cases. The Federal Acquisition Regulation (FAR) requires records of damage to property, materials, supplies or equipment to provide background information when claims are brought against the Government.
If the contract involves work of a long duration, or hazardous nature, the contracting officer shall insert the clause with its alternate that requires the contractor to submit a written proposed plan for implementing the clause. The plan shall include an analysis of the significant hazards to life, limb, and property inherent in performing the contract and a plan for controlling the hazards. The Accident Prevention Plan (APP) is analyzed by the contracting officer along with the agency safety representatives to determine if the proposed plan will meet the requirements of safety regulations and applicable statutes.
Public comments are particularly invited on: Whether this collection of information is necessary; whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning the Central Contractor Registration database. A notice was published in the
Submit comments on or before May 18, 2016.
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
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Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Governmentwide Policy, GSA, 202-501-1448, or via email at
The Federal Acquisition Regulation (FAR) Subpart 4.11 prescribes policies and procedures for requiring contractor registration in the Central Contractor Registration (CCR) database. The CCR is the primary vendor database for the U.S. Federal Government. CCR collects, validates, stores, and disseminates data
Both current and potential Federal Government vendors are required to register in CCR in order to be awarded contracts by the Federal Government. Vendors are required to complete a one-time registration to provide basic information relevant to procurement and financial transactions. Vendors must update or renew their registration at least once per year to maintain an active status.
The CCR validates the vendor information and electronically share the secure and encrypted data with Federal agency finance offices to facilitate paperless payments through electronic funds transfer. Additionally, CCR shares the data with Federal Government procurement and electronic business systems.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the Federal Acquisition Regulation (FAR), and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project:
This proposed information collection was previously published in the
Comments on this notice must be received by May 18, 2016.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by email at
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by email at
A goal of Healthy People 2020 is to increase Americans' health literacy, defined as “the degree to which individuals have the capacity to obtain, process, and understand basic health information and services needed to make appropriate health decisions.”
Numerous resources have been developed to support health care organizations in their attempts to address limitations in patient health literacy. However, little work has been done to establish valid quality improvement measures that organizations can use to monitor the impact of initiatives aimed at improving patient understanding, navigation, engagement, and self-management. Absent such measures, organizations may be unable to accurately assess whether their initiatives are effective.
This research has the following goals:
1. Identify existing quality improvement measures and gather proposals for additional measures (not generated from patient survey data) that organizations may use to monitor progress related to enhancing patient understanding, navigation, engagement, and self-management; and
2. Identify a set of quality improvement measures that reflects patient priorities, has expert support, and can be recommended for more formal measure development and testing.
This project is being conducted by AHRQ through its contractor, Board of Regents of the University of Colorado, pursuant to AHRQ's statutory authority to conduct and support research on health care and on systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services and with respect to quality measurement and improvement. 42 U.S.C. 299a(a)(1) and (2).
Environmental Scan Interviews: Representatives from 25 health care organizations engaged in relevant quality improvement efforts will be interviewed to obtain information about the quality improvement measures they
The planned environmental scan interviews will provide the information needed to:
• Identify and document the characteristics of relevant quality improvement measures that are already in use; and
• identify additional measures that would be useful to stakeholders in the field.
The findings from these interviews will be used, along with the results from other activities (
Exhibit 1 shows the estimated annualized burden hours for the respondents' time to participate in Environmental Scan Interviews. The Environmental Scan Interviews will be completed by 50 respondents (2 representatives from each of the 25 organizations targeted for participation).
Exhibit 2 shows the estimated annual cost burden associated with the respondents' time to participate in this information collection. The annual cost burden for the Environmental Scan Interviews is estimated to be $4,984.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) 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 upon the respondents, including the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection. All comments will become a matter of public record.
1. U.S. Department of Health and Human Services. Healthy people 2010: Understanding and Improving Health. 2nd ed: U.S. Government Printing Office; 2000.
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a public meeting and an opportunity for public comment on Patient-Focused Drug Development for neuropathic pain associated with peripheral neuropathies. Patient-Focused Drug Development is part of FDA's performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). The public meeting is intended to allow FDA to obtain patient perspectives on the impact of neuropathic pain associated with peripheral neuropathies, patient views on treatment approaches, and decision factors taken into account when selecting a treatment.
The public meeting will be held on June 10, 2016, from 10 a.m. to 4 p.m. Registration to attend the meeting must be received by June 3, 2016 (see
You may submit comments as follows:
Submit electronic comments in the following way:
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• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
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• For written/paper comments submitted to the 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 will post the agenda approximately 5 days before the meeting at:
Meghana Chalasani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-402-6525, FAX: 301-847-8443,
FDA has selected neuropathic pain associated with peripheral neuropathy as the focus of a public meeting under Patient-Focused Drug Development, an initiative that involves obtaining a better understanding of patient perspectives on the severity of a disease and the available therapies for that condition. Patient-Focused Drug Development is being conducted to fulfill FDA performance commitments that are part of the reauthorization of the PDUFA under Title I of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub. L. 112-144). The full set of performance commitments is available at
FDA committed to obtain the patient perspective on at least 20 disease areas during the course of PDUFA V. For each disease area, the Agency is conducting a public meeting to discuss the disease and its impact on patients' daily lives, the types of treatment benefit that matter most to patients, and patients' perspectives on the adequacy of the available therapies. These meetings will include participation of FDA review divisions, the relevant patient communities, and other interested stakeholders.
On April 11, 2013, FDA published a notice in the
As part of Patient-Focused Drug Development, FDA will obtain patient and patient stakeholder input on the impacts of neuropathic pain associated with peripheral neuropathies. Peripheral neuropathy is a neurological disorder that develops as a result of damage to the peripheral nerves and is
The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments, which can be submitted to the public docket (see
1. How would you describe your neuropathic pain associated with peripheral neuropathy? What terms would you use to describe the most bothersome aspects of pain? (Examples may include stabbing sensations, electric shocks, burning or tingling, etc.)
2. Are there specific activities that are important to you but that you cannot do at all or as fully as you would like because of your neuropathic pain? (Examples of activities may include sleeping through the night, daily hygiene, participation in sports or social activities, intimacy with a spouse or partner, etc.)
3. How do your neuropathic pain and its negative impacts affect your daily life on the best days? On the worst days?
4. How has your neuropathic pain changed over time?
5. What worries you most about your condition?
1. What are you currently doing to help treat your neuropathic pain associated with peripheral neuropathy? (Examples may include prescription medicines, over-the-counter products, and other therapies including non-drug therapies). How has your treatment regimen changed over time, and why?
2. How well does your current treatment regimen control your neuropathic pain?
a. How well have these treatments worked for you as your condition has changed over time?
b. Would you define your condition today as being well managed?
3. What are the most significant downsides to your current treatments, and how do they affect your daily life? (Examples of downsides may include bothersome side effects, going to the hospital or clinic for treatment, time devoted to treatment, restrictions on driving, etc.)
4. Assuming there is no complete cure for your neuropathic pain, what specific things would you look for in an ideal treatment for your neuropathic pain? What would you consider to be a meaningful improvement in your condition (for example, specific symptom improvements or functional improvements) that a treatment could provide?
5. If you had the opportunity to consider participating in a clinical trial studying experimental treatments for neuropathic pain, what things would you consider when deciding whether or not to participate? (Examples may include how severe your neuropathic pain is, how well current treatments are working for you, your concern about risks, etc.)
If you wish to attend this meeting, visit
Patients who are interested in presenting comments as part of the initial panel discussions will be asked to indicate in their registration which topic(s) they wish to address. These patients also must send to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the new drug applications (NDAs) for ADVICOR (niacin extended-release (ER) and lovastatin) tablets and SIMCOR (niacin ER and simvastatin) tablets. The holder of these two applications, AbbVie Inc.,
The effective date is April 18, 2016.
For access to the docket to read background documents, go to
Jay Sitlani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-5202.
FDA approved NDA 021249 for ADVICOR on December 17, 2001. ADVICOR is a fixed-combination drug product containing niacin ER and lovastatin in tablet form. The drug is approved in four strengths of niacin ER and lovastatin, respectively: (1) 500 milligrams (mg), 20 mg; (2) 750 mg, 20 mg; (3) 1 gram (g), 20 mg; and (4) 1 g, 40 mg. The approved indication reads as follows:
ADVICOR is indicated for the treatment of primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb; Table 6) in:
The indication was revised subsequent to the initial approval and currently states that ADVICOR is approved for the treatment of hypercholesterolemia when treatment with both Niaspan and lovastatin is appropriate.
FDA approved NDA 022078 for SIMCOR on February 15, 2008. SIMCOR is a fixed-combination drug product containing niacin ER and simvastatin in tablet form. The drug is approved in five strengths of niacin ER and simvastatin, respectively: (1) 500 mg, 20 mg; (2) 500 mg, 40 mg; (3) 750 mg, 20 mg; (4) 1 g, 20 mg; and (5) 1 g, 40 mg. SIMCOR is approved for the following indications:
The labeling includes the following Limitation of Use in the Indications and Usage section of the labeling:
• No incremental benefit of SIMCOR on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin monotherapy and niacin monotherapy has been established.
Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3.), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of ADVICOR and SIMCOR no longer outweigh the risks, and approval should be withdrawn.
FDA requested that AbbVie Inc. voluntarily discontinue marketing of ADVICOR and SIMCOR, and AbbVie Inc. agreed to do so. AbbVie Inc. also has requested in writing that FDA withdraw approval of NDA 021249 and NDA 022078 and waived its opportunity for a hearing.
Therefore, under section 505(e) of the FD&C Act and under authority delegated to the Director of the Center for Drug Evaluation and Research by the Commissioner of Food and Drugs, approval of ADVICOR and SIMCOR is withdrawn. Introduction or delivery for introduction of these products without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
The Agency is required to publish a list of all approved drugs (see section 505(j)(7) of the FD&C Act (21 U.S.C. 355(j)(7)). FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.161 and 314.162(a)(2)). For the reasons summarized in this document, the Agency has determined that ADVICOR and SIMCOR were voluntarily withdrawn from sale for reasons of safety or effectiveness. FDA will remove NDA 021249 for ADVICOR and NDA 022078 for SIMCOR from the list of products published in the Orange Book and will not accept or approve ANDAs that reference either drug product.
The following references are on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” This guidance describes how FDA intends to apply the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 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
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-3110.
FDA is announcing the availability of a draft guidance for industry entitled “Hospital and Health System Compounding Under the Federal Food, Drug, and Cosmetic Act.” Pharmacies located within a hospital or standalone pharmacies that are part of a health system frequently provide compounded drug products for administration within the hospital or health system. Some of these compounders have registered with FDA as outsourcing facilities under section 503B of the FD&C Act (21 U.S.C. 353b) and others are State-licensed pharmacies subject to section 503A of the FD&C Act (21 U.S.C. 353a).
Section 503A, added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:
• Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements);
• section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and
• section 505 (21 U.S.C. 355) (concerning the approval of drugs under
The guidance describes how FDA intends to apply section 503A of the FD&C Act to drugs compounded by licensed pharmacists or physicians in State-licensed hospital or health system pharmacies.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” Section 503B defines an outsourcing facility, in part, as “a facility at one geographic location or address.” FDA has received questions from outsourcing facilities and other stakeholders about the meaning of this term, such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by July 18, 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
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sara Rothman, Center for Drug Evaluation
FDA is announcing the availability of a draft guidance for industry entitled “Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act.”
Section 503B, added to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by the Drug Quality and Security Act in 2013, created a new category of compounders called
• Section 502(f)(1) (concerning labeling requirements);
• Section 505 (concerning drug approval requirements); and
• Section 582 (concerning Drug Supply Chain Security Act requirements).
Section 503B(d)(4) of the FD&C Act defines an outsourcing facility as a facility at one geographic location or address that: (1) Is engaged in the compounding of sterile drugs; (2) has elected to register as an outsourcing facility; and (3) complies with all of the requirements of this section. In addition, an outsourcing facility is not required to be a licensed pharmacy, and it may or may not obtain prescriptions for identified individual patients. Because drugs compounded by outsourcing facilities are not exempt from section 501(a)(2)(B) of the FD&C Act, outsourcing facilities are subject to current good manufacturing practice (CGMP) requirements.
FDA has received questions from outsourcing facilities and other stakeholders about the meaning of the term “facility at one geographic location or address,” such as whether multiple suites used for compounding human drugs at a single street address constitute one or multiple facilities, or whether a single location where human drugs are compounded can be subdivided into separate operations compounding under different standards. FDA is issuing this draft guidance to answer these questions.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the meaning of the term “facility at one geographic location or address” under section 503B of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is withdrawing approval of the indications related to the coadministration with a statin for niacin extended-release (ER) tablets and fenofibric acid delayed-release (DR) capsules. Affected applications include one new drug application (NDA) and seven abbreviated new drug applications (ANDAs) for niacin ER tablets, and one NDA and three ANDAs for fenofibric acid DR capsules. The holders of these applications have requested that FDA withdraw approval of the indications and have waived their opportunities for a hearing.
The effective date is April 18, 2016.
For access to the docket to read background documents, go to
Jay Sitlani, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6282, Silver Spring, MD 20993-0002, 301-796-5202.
FDA first approved NDA 020381 for Niaspan (niacin extended-release) tablets for several indications on July 28, 1997. On March 26, 2009, FDA approved a revised indication that read as follows:
• Niaspan in combination with simvastatin or lovastatin is indicated for the treatment of primary hyperlipidemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb) when treatment with Niaspan, simvastatin, or lovastatin monotherapy is considered inadequate.
In addition, the following Limitation of Use was added to the Indications and Usage section of the labeling:
• No incremental benefit of Niaspan coadministered with simvastatin or lovastatin on cardiovascular morbidity and mortality over and above that demonstrated for niacin, simvastatin, or lovastatin monotherapy has been established. Niaspan has not been studied in Fredrickson Type I and III dyslipidemias.
This indication was revised between March 26, 2009, and April 27, 2015, at which time it was removed from the approved labeling. The Limitation of Use currently reads:
• Addition of Niaspan did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large, randomized controlled trial (AIM-HIGH).
There are seven approved ANDAs that cited Niaspan as the reference listed drug (RLD) and that are approved for the same indications as Niaspan (see table 1).
FDA approved NDA 022224 for Trilipix (fenofibric acid) DR capsules on December 15, 2008, for several indications, including the following:
• Trilipix is indicated as an adjunct to diet in combination with a statin to reduce TG and increase HDL-C in patients with mixed dyslipidemia and CHD (coronary heart disease) or a CHD risk equivalent who are on optimal statin therapy to achieve their LDL-C goal.
CHD risk equivalents comprise:
○ Other clinical forms of atherosclerotic disease (peripheral arterial disease, abdominal aortic aneurysm, and symptomatic carotid artery disease);
○ Diabetes; and
○ Multiple risk factors that confer a 10-year risk for CHD >20 percent.
The following Limitation of Use was included in the Indications and Usage section of the labeling:
• No incremental benefit of Trilipix on cardiovascular morbidity and mortality over and above that demonstrated for statin monotherapy has been established.
Both this indication and the Limitation of Use were removed from the labeling on April 27, 2015.
There are three approved ANDAs that cited Trilipix as the RLD and that are approved for the same indications as Trilipix (see table 2).
Based on the collective evidence from several large cardiovascular outcome trials (Refs. 1-3), the Agency has concluded that the totality of the scientific evidence no longer supports the conclusion that a drug-induced reduction in triglyceride levels and/or increase in HDL-cholesterol levels in statin-treated patients results in a reduction in the risk of cardiovascular events. Consistent with this conclusion, FDA has determined that the benefits of niacin ER tablets and fenofibric acid DR capsules for coadministration with statins no longer outweigh the risks, and the approvals for this indication should be withdrawn.
FDA requested that the application holders voluntarily discontinue marketing of niacin ER tablets and fenofibric acid DR capsules for these indications. The NDA and ANDA holders identified above have requested in writing that FDA withdraw approval of these indications and waived their opportunity for a hearing.
Therefore, under section 505(e) of the FD&C Act and under authority delegated to the Director of the Center for Drug Evaluation and Research by the Commissioner of Food and Drugs, the approvals of the indications related to coadministration with statins for the applications listed in tables 1 and 2 are withdrawn. Introduction or delivery for introduction of these products with these indications in interstate commerce without an approved application is illegal and subject to regulatory action (see sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355(a) and 331(d)).
The following references are on display in the Division of Dockets Management (HFA 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
1. The ACCORD Study Group, “Effects of Combination Lipid Therapy in Type 2 Diabetes Mellitus,”
2. The AIM-HIGH Investigators, “Niacin in Patients with Low HDL Cholesterol Levels Receiving Intensive Statin Therapy,”
3. The HPS2-THRIVE Collaborative Group, “Effects of Extended-Release Niacin with Laropiprant in High-Risk Patients,”
Food and Drug Administration, HHS.
Notice of public meeting; request for comments.
The Food and Drug Administration (FDA or Agency) is announcing a regional public meeting entitled “U.S. Food and Drug Administration and Health Canada Joint Public Consultation on International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).” The meeting will take place on the FDA campus and also be broadcast on the Internet. The goal of this meeting is to provide information and receive comments on the ICH, as well as information related to the upcoming ICH meetings in Lisbon, Portugal, in June 2016. The topics to be discussed in the regional public meeting are the topics for discussion at the forthcoming ICH Assembly Meeting. The purpose of this regional public meeting is to solicit public input prior to the next Assembly and Expert Working Group meetings in Lisbon, Portugal, scheduled for June 11 through 16, 2016, at which the discussion of the topics underway and ICH reforms will continue to progress.
The public meeting will be held on May 6, 2016, from 9 a.m. to 12 p.m., EST. Registration to attend the Webcast and requests for oral presentations must be received by May 4, 2016. Interested persons may submit either electronic or written comments to the public docket (see
The public meeting will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center (Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information please refer to
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
Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301-796-4548,
The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015, the ICH was reformed to make the ICH a true global initiative that expands beyond the previous ICH members. More involvement from
In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. Members of the ICH Management Committee include the European Union; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labor, and Welfare; the Japanese Pharmaceutical Manufacturers Association; FDA; the Pharmaceutical Research and Manufacturers of America; Health Canada; Swissmedic; the World Health Organization; and International Federation of Pharmaceutical Manufacturers and Associations (as Observers). The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site:
If you wish to attend this meeting, visit
Interested persons may present data, information, or views orally or in writing on issues pending at the public Webcast. Public oral presentations will be scheduled between approximately 11:30 a.m. and 12 p.m. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Radiation Biodosimetry Medical Countermeasure Devices.” FDA has developed this guidance to provide industry and Agency staff with recommendations for the types of information that should be submitted to support marketing authorization for radiation biodosimetry medical countermeasure devices.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
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,
• 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
An electronic copy of the guidance document is available for download from the Internet. See the
Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5648, Silver Spring, MD 20993-0002, 301-796-5028.
This guidance provides recommendations for the types of information that should be submitted to support marketing authorization (
This guidance applies to premarket submissions for medical device systems intended to measure biological responses to unintended (non-therapeutic) radiation absorption. Biodosimetry devices are devices used for the purpose of reconstructing the ionizing radiation dose received by individuals or populations using physiological, chemical, or biological markers of exposure found in humans. Biodosimetry technologies may be used at various stages during triage, including both early mass casualty triage and subsequent clinical evaluation. Such exposures could be the result of intentional harm or as a consequence of a disaster. Devices may be designed to give quantitative outputs or qualitative information around a clinical decision making cut-point. Likewise, devices may be designed for use in field triage settings, at patient bedsides, or in Clinical Laboratory Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578) certified clinical laboratories. FDA considered both high-throughput and single-use devices in developing this guidance document.
This guidance only applies to validation of diagnostic biodosimetry devices intended to be used to assess radiation absorption that occurs as a result of non-therapeutic or accidental exposures (
This guidance document does not provide specific study designs; it describes design principles for studies that may be used to establish a reasonable assurance of the safety and effectiveness of biodosimetry devices.
In the
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Radiation Biodosimetry Medical Countermeasure Devices.” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 58 have been approved under OMB control number 0910-0119; the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 814 have been approved under OMB control number 0910-0231; the collections of information in the guidance document entitled “Informed Consent For In Vitro Diagnostic Device Studies Using Leftover Human Specimens That Are Not Individually Identifiable” have been approved under OMB control number 0910-0582; the collections of information in the guidance document entitled “Guidance for Industry and FDA Staff: Administrative Procedures for CLIA Categorization” have been approved under OMB control number 0910-0607; and the collections of information in the guidance document entitled “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the Federal Food, Drug, and Cosmetic Act (the FD&C Act). It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work to finalize the guidance, submit either electronic or written comments on this draft guidance by July 18, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by May 18, 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
Submit comments on information collection issues to the Office of Management and Budget in the following ways:
• Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Sara Rothman, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Room 5197, Silver Spring, MD, 301-796-3110.
FDA is announcing the availability of a draft guidance for industry entitled “Prescription Requirement Under Section 503A of the Federal Food, Drug, and Cosmetic Act.” Section 503A (21 U.S.C. 353a), added to the FD&C Act by the Food and Drug Administration Modernization Act of 1997, describes the conditions that must be satisfied for human drug products compounded by a licensed pharmacist in a State-licensed pharmacy or Federal facility, or by a licensed physician, to be exempt from the following three sections of the FD&C Act:
• Section 501(a)(2)(B) (21 U.S.C. 351(a)(2)(B)) (concerning current good manufacturing practice requirements);
• section 502(f)(1) (21 U.S.C. 352(f)(1)) (concerning the labeling of drugs with adequate directions for use); and
• section 505 (21 U.S.C. 355) (concerning the approval of drugs under new drug applications (NDAs) or abbreviated new drug applications (ANDAs)).
A compounded drug product may be eligible for the exemptions under section 503A of the FD&C Act only if it is, among other things, compounded for an identified individual patient based on the receipt of a valid prescription order or a notation, approved by the prescribing practitioner, on the prescription order that a compounded product is necessary for the identified patient. Among other conditions, to qualify for the exemptions under section 503A of the FD&C Act, the drug product must be compounded by a licensed pharmacist in a State-licensed pharmacy or a Federal facility, or by a licensed physician (section 503A(a)).
This guidance sets forth FDA's policy concerning certain prescription requirements for compounding human drug products for identified individual patients under section 503A of the FD&C Act. It addresses compounding after the receipt of a prescription for an identified individual patient, compounding before the receipt of a prescription for an identified individual patient (anticipatory compounding), and compounding for office use.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the prescription requirement under section 503A of the FD&C Act. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Under the Paperwork Reduction Act of 1995 (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 that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the
With respect to the collection of information associated with this document, FDA invites comments on the following topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Under the draft guidance, if it is not obvious from a prescription order that the prescription is for a compounded drug product, a compounder may consult with the prescriber to determine whether the patient needs a compounded drug and make an appropriate notation on the prescription order. To serve as a basis for compounding under section 503A of the FD&C Act, a notation must document the prescriber's determination that a compounded drug is necessary for the identified patient. FDA recommends using the following statement:
We estimate that annually a total of approximately 3,444 licensed pharmacists and licensed physicians (“number of respondents” in table 1) will make a notation with this statement on approximately 172,200 prescription orders (“total annual disclosures” in table 1). We estimate that the consultation between the compounder and the prescriber and adding the written statement to each prescription will take approximately 5 minutes per prescription order.
In addition, the licensed pharmacist or licensed physician seeking to compound a drug product under section 503A should maintain records of valid prescription orders received for compounded drug products to demonstrate compliance with the prescription requirement in section 503A(a)(1) of the FD&C Act. For example, this includes records of valid prescription orders and of prescription orders bearing notations that the compounded drug product is necessary for the identified individual patient as described in section III.A of this guidance and section 503A(a) of the FD&C Act. Because the time, effort, and financial resources necessary to comply with this collection of information would be incurred by licensed pharmacists and licensed physicians in the normal course of their activities, it is excluded from the definition of
Under the guidance, licensed pharmacists and licensed physicians should also maintain records of the calculations performed to determine the limited quantities of drug products compounded before the receipt of valid prescription orders under the enforcement policy described in section III.B.2 of this guidance and section 503A(a)(2) of the FD&C Act. These records should clearly reflect the quantity of a particular drug product compounded in advance of receiving prescription orders for identified individual patients that the compounder has kept on hand as stock for distribution, and the basis for the quantity the compounder kept in stock. Under the enforcement policy described in section III.B.2 of this guidance, this would include the quantity of the drug product distributed under prescription orders for identified individual patients during the reference period that the licensed pharmacist or licensed physician selected (
We estimate that annually a total of approximately 10,332 licensed pharmacists and licensed physicians (“number of recordkeepers” in table 2) will maintain approximately 103,320 records (“total annual records” in table 2). We estimate that maintaining the records will take approximately 5 minutes per record.
FDA estimates the burden of this collection of information as follows:
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by May 18, 2016.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Pub. L. 107-250) was signed into law on October 26, 2002. Section 201 of MDUFMA added a new paragraph (g) to section 704 of the Federal, Food, Drug, and Cosmetic Act (21 U.S.C. 374), directing FDA to accredit third parties (accredited persons) to conduct inspections of eligible manufacturers of class II or class III devices. FDA's guidance document entitled “Implementation of the Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002;
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA), Center for Tobacco Products (CTP), is announcing an invitation for participation in its voluntary Tobacco Farm Site Tours Program. This program is intended to give CTP staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers in order to gain a better understanding of tobacco farming and the processes involved in curing and preparing tobacco intended for sale to tobacco product manufacturers. This program is not an FDA regulatory inspection, and tobacco farms are not regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer. The purpose of this notice is to invite parties interested in participating in the Tobacco Farm Site Tours Program to submit requests to CTP.
Submit either an electronic or written request for participation in this program by June 17, 2016. See section IV of this document for information on requests for participation.
If your farm is interested in offering a site visit, please submit a request either electronically to
Allison Hoffman, Office of Science, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 5426, Silver Spring, MD 20993-0002, 1-877-287-1373, email:
On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111-31) into law, amending the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and giving FDA authority to regulate tobacco product manufacturing, distribution, and marketing.
CTP's Office of Science is conducting the Tobacco Farm Site Tours Program to provide its staff an opportunity to visit farms that grow tobacco for sale to tobacco product manufacturers (a “tobacco product manufacturer” is defined as any person, including any repacker or relabeler, who manufactures, fabricates, assembles, processes, or labels a tobacco product, or imports a finished tobacco product for sale or distribution in the United States (section 900(20) of the FD&C Act (21 U.S.C. 387(20))). Although farms that grow tobacco are not FDA-regulated entities unless they are also a tobacco product manufacturer or controlled by a tobacco product manufacturer (see section 901(c)(2) of the FD&C Act (21 U.S.C. 387a(c)(2))), tobacco farm site visits will aid the Agency in gaining a better understanding of tobacco farming and the processes involved in curing and preparing tobacco leaf intended for sale to tobacco product manufacturers. The goal for the Tobacco Farm Site Tours Program is for CTP staff to gain firsthand exposure to tobacco farming practices, including cultivation, harvesting, curing, and preparation for sale of tobacco leaf to tobacco product manufacturers.
In the Tobacco Farm Site Tours Program, small groups of CTP staff plan to observe the operations of farms that grow tobacco for sale to tobacco product manufacturers. Please note that FDA does not regulate these farms and the Tobacco Farm Site Tours Program is not an inspection of facilities to determine compliance with the FD&C Act; rather, this program is meant to educate CTP staff and improve their understanding of tobacco farming. It is anticipated that the tobacco farm site tours will take place in the fall of 2016.
CTP hopes to be able to tour small, medium, and large farms, and farms that grow tobacco for different kinds of tobacco products. Final site selections will be based on the availability of funds and resources for the relevant fiscal year as well as the desire to visit a wide variety of types of tobacco farms. FDA plans on visiting nine or fewer farms. All FDA travel expenses associated with the farm site tours will be the responsibility of FDA.
To aid in site selection, your request for participation should include the following information:
• A description of your farm, including the size of the farm;
• A list of the type(s) of tobacco grown and the kinds of tobacco product manufacturers to whom you sell tobacco;
• The physical address(es) of the site(s) for which you are submitting a request; and
• A proposed 1-day tour agenda.
Identify requests for participation with the docket number found in brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see
Health Resources and Services Administration, HHS.
Notice.
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995), the Health Resources and Services Administration (HRSA) announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on this Information Collection Request must be received no later than June 17, 2016.
Submit your comments to
To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email
When submitting comments or requesting information, please include the information request collection title for reference.
OMB No. 0915-0292—Extension.
Abstract: The Federal Office of Rural Health Policy (FORHP), HRSA, conducts an annual data collection of user information for the Black Lung Clinics Program, which has been ongoing with OMB approval since 2004. The purpose of the Black Lung Clinics Program is to reduce the morbidity and mortality associated with occupationally related coal mine dust lung disease through the screening, diagnosis, and treatment of active, inactive, retired, and/or disabled coal miners. Collecting this data provides HRSA with information on how well each grantee is meeting the needs of these miners in their communities.
Need and Proposed Use of the Information: Data from the annual report provides quantitative information about the clinics, specifically: (a) The characteristics of the patients they serve (gender, age, disability level, occupation type); (b) the characteristics of services provided (medical encounters, non-medical encounters, benefits counseling, and outreach); and, (c) the number of patients served. This assessment enables HRSA to provide data required by Congress under the Government Performance and Results Act of 1993. It also ensures that funds are effectively used to provide services that meet the target population needs. HRSA does not plan to make any changes to the performance measures at this time.
Likely Respondents: Black Lung Clinics Program Grantees.
Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information; to search data sources; to complete and review the collection of information; and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below.
HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
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.,
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.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Mental Health Services (CMHS) is requesting approval for the revision of data collection associated with the previously-approved Monitoring of the National Suicide Prevention Lifeline (OMB No. 0930-0274; Expiration, July 31, 2016). The current request will continue previously-cleared efforts to evaluate process and impacts of follow-up services provided to suicidal individuals through the National Suicide Prevention Lifeline Crisis Center Follow-Up (NSPL Follow-Up) program.
The NSPL, or Lifeline, is SAMHSA's 24-hour crisis hotline (1-800-273-TALK [8255]) that serves as a central switchboard, seamlessly connecting callers from anywhere in the U.S. to the closest of its 165 crisis centers within the Lifeline network. Since its inception, the Lifeline has helped more than 6 million people. In 2008, SAMHSA launched the NSPL Follow-up program and began awarding cooperative agreements to crisis centers in the Lifeline network to reconnect with suicidal callers to offer emotional support and ensure they followed up with referrals to treatment. In 2013, the program was expanded to include crisis center follow-up with any suicidal individual referred from a partnering emergency department (ED) or inpatient hospital.
While previous evaluations of the NSPL demonstrated that suicidal callers experienced a reduction in hopelessness and suicidal intent after contacting the Lifeline, 43% of suicidal callers participating in follow-up assessments reported some recurrence of suicidality (
SAMHSA is addressing this need through the NSPL Follow-Up program. The Monitoring of the NSPL will continue to assess whether the NSPL Follow-Up program achieves its intended goals. This revision of the Monitoring of the NSPL represents SAMHSA's desire to expand this process and impacts evaluation to assess follow-up with clients referred to the Lifeline from partnering inpatient hospitals and EDs and continue to improve the methods and standards of service delivery to suicidal individuals receiving crisis center services. This effort will build on information collected through previous and ongoing NSPL evaluations; expand our understanding of the outcomes associated with the NSPL Follow-Up program; and continue to contribute to the evidence base.
This revision requests approval for the removal of one previously-approved instrument and the continuation and renaming of five previously-approved activities. Six crisis centers funded through the NSPL Follow-Up program in FY 2016 will participate in this effort.
Due to the completion of the motivational interviewing/safety planning (MI/SP) training and the fulfillment of data collection goals, the currently-approved MI/SP Counselor Attitudes Questionnaire and its associated burden will be removed.
Each of the five instruments and consents associated with the Monitoring of the NSPL was previously approved by OMB (No. 0930-0274; Expiration, July 31, 2016). Revisions include the following: (1) The term “caller” will be replaced with “client” to reflect the change in respondent type to clients referred from partnering EDs and inpatient hospitals rather than callers, and (2) MI/SP will be removed from the titles of all instruments and consents. No other changes are being made.
The MI/SP Caller Follow-up Interview will be renamed “Client Follow-up Interview.”
The MI/SP Caller Initial Script will be renamed “Client Initial Script.”
The MI/SP Caller Follow-up Consent Script will be renamed “Client Follow-up Consent Script.”
The MI/SP Counselor Follow-up Questionnaire will be renamed “Counselor Follow-up Questionnaire.”
The MI/SP Counselor Consent will be renamed “Counselor Consent.”
The estimated response burden to collect this information associated with the Monitoring of the NSPL annualized over the requested 3-year approval period is presented below:
Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, MD, 20857
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation of Dixie Services, Inc., as a commercial laboratory.
Notice is hereby given, pursuant to CBP regulations, that Dixie Services, Inc., has been accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of September 9, 2015.
The accreditation of Dixie Services, Inc., as commercial laboratory became effective on September 9, 2015. The next triennial inspection date will be scheduled for September 2018.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1300 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 that Dixie Services, Inc., 1706 First St., Galena Park, TX 77547, has been accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12.
Dixie Services, Inc., is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses should request and receive written assurances from the entity that it is accredited by the U.S. Customs and Border Protection to conduct the specific test requested. Alternatively, inquiries regarding the specific test this entity is accredited to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
Notice of accreditation and approval of Oiltest, Inc., as a commercial gauger and laboratory.
Notice is hereby given, pursuant to CBP regulations, that Oiltest, Inc., has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes for the next three years as of December 11, 2014.
Approved Gauger and Accredited Laboratories Manager, Laboratories and Scientific Services Directorate, U.S. Customs and Border Protection, 1331 Pennsylvania Avenue NW., Suite 1500N, Washington, DC 20229, tel. 202-344-1060.
Notice is hereby given pursuant to 19 CFR 151.12 and 19 CFR 151.13, that Oiltest, Inc., 109 Aldene Rd., Building #4, Roselle, NJ 07203, has been approved to gauge petroleum and certain petroleum products and accredited to test petroleum and certain petroleum products for customs purposes, in accordance with the provisions of 19 CFR 151.12 and 19 CFR 151.13. Oiltest, Inc. is approved for the following gauging procedures for petroleum and certain petroleum products per the American Petroleum Institute (API) Measurement Standards:
Oiltest, Inc. is accredited for the following laboratory analysis procedures and methods for petroleum and certain petroleum products set forth by the U.S. Customs and Border Protection Laboratory Methods (CBPL) and American Society for Testing and Materials (ASTM):
Anyone wishing to employ this entity to conduct laboratory analyses and gauger services should request and receive written assurances from the entity that it is accredited or approved by the U.S. Customs and Border Protection to conduct the specific test or gauger service requested. Alternatively, inquiries regarding the specific test or gauger service this entity is accredited or approved to perform may be directed to the U.S. Customs and Border Protection by calling (202) 344-1060. The inquiry may also be sent to
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; extension of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security 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: Prior Disclosure. This is a proposed extension of information collection requirements that were previously approved. CBP is proposing these requirements be extended with no change to the burden hours or to the information collected. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before May 18, 2016 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Tracey Denning, U.S. Customs and Border Protection, Regulations and Rulings, Office of International Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, at 202-325-0265.
This proposed information collection was previously published in the
Transportation Security Administration, DHS.
30-Day notice.
This notice announces that the Transportation Security Administration (TSA) has forwarded the Information Collection Request (ICR), Office of Management and Budget (OMB) control number 1652-0058, abstracted below to OMB for review and approval of an extension of the currently approved collection under the Paperwork Reduction Act (PRA). The ICR describes the nature of the information collection and its expected burden. TSA published a
Send your comments by May 18, 2016. A comment to OMB is most effective if OMB receives it within 30 days of publication.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, OMB. Comments should be addressed to Desk Officer, Department of Homeland Security/TSA, and sent via electronic mail to
Christina A. Walsh, TSA PRA Officer, Office of Information Technology (OIT), TSA-11, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598-6011; telephone (571) 227-2062; email
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(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 using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
From TSA's perspective, qualitative feedback from customers and stakeholders is information that provides useful insights on their perceptions, experiences, opinions, and expectations regarding TSA products or services, provides TSA with an early warning of issues with service, and focuses attention on areas where changes regarding communication, training, or operations might improve delivery of products or services. These collections will allow for ongoing, collaborative, and actionable communications between TSA and its customers and stakeholders. They will also allow feedback to contribute directly to the improvement of program management. The solicitation of feedback will target areas such as: Timeliness, appropriateness, accuracy of information, courtesy, efficiency of service delivery, and resolution of issues with service delivery. Responses will be assessed to plan and inform efforts to improve or maintain the quality of service offered by TSA. If this information is not collected, vital feedback from customers and stakeholders on TSA's services will be unavailable.
As a general matter, information collections will not result in any new system of records containing privacy information and will not ask questions of a sensitive nature. Information gathered is intended to be used only internally for general service improvement and program management purposes and is not intended for release outside of TSA (if released, TSA must indicate the qualitative nature of the information). Feedback collected under this generic clearance provides useful qualitative information, but it does not yield data that can be generalized to the overall population. Qualitative information is not designed or expected to yield statistically reliable or actionable results; it will not be used for quantitative information collections. Depending on the degree of influence the results are likely to have, there may be future information collection submissions for other generic mechanisms that are designed to yield quantitative results.
Below we provide the Transportation Security Administration's projected average estimates for the next three years:
U.S. Citizenship and Immigration Services, Department of Homeland Security.
30-Day notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration Services (USCIS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995. The information collection notice was previously published in the
The purpose of this notice is to allow an additional 30 days for public comments. Comments are encouraged and will be accepted until May 18, 2016. This process is conducted in accordance with 5 CFR 1320.10.
Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, must be directed to the OMB USCIS Desk Officer via email at
You may wish to consider limiting the amount of personal information that you provide in any voluntary submission you make. For additional information please read the Privacy Act notice that is available via the link in the footer of
USCIS, Office of Policy and Strategy,
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice of Charter Reestablishment for Housing Counseling Federal Advisory Committee.
The Department of Housing and Urban Development announces the charter renewal of the Housing Counseling Federal Advisory Committee, a federal advisory committee established pursuant to the Dodd-Frank Wall Street Reform and Consumer Protection Act and the Federal Advisory Committee Act. This charter renewal will take effect on May 1, 2016, and will expire after 2 years.
Marjorie George, Housing Program Technical Specialist, Office of Housing Counseling, U.S. Department of Housing and Urban Development, 200 Jefferson Avenue, Suite 300, Memphis, TN 38103; telephone number 1-901-544-4228 (this is not a toll-free number); email
Pursuant to Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), HUD is giving notice to reestablish the charter for the Housing Counseling Federal Advisory Committee (HCFAC). The HCFAC was established to advise HUD's Office of Housing Counseling (OHC) to meet its mission to provide individuals and families with the knowledge they need to obtain, sustain, and improve their housing through a strong national network of HUD-approved housing counseling agencies and HUD-certified counselors. The HCFAC, however, shall have no role in reviewing or awarding of OHC housing counseling grants and procurement contracts. See the HCFAC Web site for details at
Bureau of Land Management, Interior.
Notice.
The Bureau of Land Management (BLM) has examined and found suitable for classification under the Taylor Grazing Act, and for lease and conveyance under the provisions of the Recreation and Public Purposes (R&PP) Act, as amended, approximately 17.5 acres of public land in Clark County, Nevada. Clark County proposes to use the land for a community park. The 17.5-acre park will help meet future expanding needs in the southwestern part of Las Vegas Valley.
Interested parties may submit written comments regarding the proposed classification for lease and conveyance of the land until June 2, 2016.
Mail written comments to the BLM Field Manager, Las Vegas Field Office, 4701 N. Torrey Pines Drive, Las Vegas, Nevada 89130.
Luis Rodriguez, 702-515-5069, email:
Clark County submitted the parcel of land legally described as:
The area described contains 17.5 acres, more or less, in Clark County.
The parcel is located in the southwest part of the Las Vegas Valley.
In accordance with the R&PP Act, Clark County has filed an application in which it proposes to develop the above-described land as a community park with children's playground area, perimeter walking path, picnic shade areas, restroom facilities, athletic facilities, and ancillary equipment. Additional detailed information pertaining to this application, plan of development, and site plan is located in case file N-80613, which is available for review at the BLM Las Vegas Field Office at the above address. Clark County is a political subdivision of the State of Nevada and is therefore a qualified applicant under the R&PP Act.
Subject to limitations prescribed by law and regulation, prior to patent issuance, the holder of any right-of-way grant within the lease area may be given the opportunity to amend the right-of-way grant for conversion to a new term, including perpetuity, if applicable.
The land identified is not needed for any Federal purpose. The lease and conveyance is consistent with the BLM Las Vegas Resource Management Plan dated October 5, 1998, and would be in the public interest. Clark County has not applied for more than the 640 acre limitation for public purpose uses in a year and has submitted a statement in compliance with the regulations at 43 CFR 2741.4(b).
The lease and conveyance, when issued, will be subject to the provisions of the R&PP Act and applicable regulations of the Secretary of the Interior, and will contain the following reservations to the United States:
1. A right-of-way thereon for ditches or canals constructed by the authority of the United States, Act of August 30, 1890 (43 U.S.C. 945); and
2. All minerals shall be reserved to the United States, together with the right to prospect for, mine, and remove such deposits from the same under applicable law and such regulations as the Secretary of the Interior may prescribe.
Any lease and/or conveyance will also be subject to valid existing rights, will contain any terms or conditions required by law (including, but not limited to, any terms or conditions required by 43 CFR 2741.4), and will contain an appropriate indemnification clause protecting the United States from claims arising out of the lessee's/patentee's use, occupancy, or operations on the leased/patented lands. It will also contain any other terms and conditions deemed necessary and appropriate by the Authorized Officer.
Any lease and conveyance will also be subject to all valid and existing rights.
Upon publication of this notice in the
Interested parties may submit written comments on the suitability of the land for a public park in the Enterprise area. Comments on the classification are restricted to whether the land is physically suited for the proposal, whether the use will maximize the future use or uses of the land, whether the use is consistent with local planning and zoning, or if the use is consistent with State and Federal programs. Interested parties may also submit written comments regarding the specific use proposed in the application and plan of development, and whether the BLM followed proper administrative procedures in reaching the decision to lease and convey under the R&PP Act.
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. Only written comments submitted to the Field Manager, BLM Las Vegas Field Office, will be considered properly filed. Any adverse comments will be reviewed by the BLM Nevada State Director, who may sustain, vacate, or modify this realty action. In the absence of any adverse comments, the decision will become effective on June 17, 2016. The lands will not be available for lease and conveyance until after the decision becomes effective.
43 CFR 2741.5.
Bureau of Land Management, Interior.
Notice of availability.
In accordance with the National Environmental Policy Act of 1969 (NEPA), as amended, and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Rawlins Field Office has prepared a final environmental impact statement (EIS) for the proposed Continental Divide-Creston Natural Gas Development Project (CD-C) in Rawlins, Wyoming, and by this notice announces its availability.
The BLM will not issue a final decision on the proposal for a minimum of 30 days of the date that the Environmental Protection Agency (EPA) publishes this notice in the
The CD-C Final EIS is available for public review at the BLM Rawlins Field Office, 1300 North Third Street, Rawlins, Wyoming; the BLM High Desert District Office, 280 Highway 191 North, Rock Springs, Wyoming; and the BLM Wyoming State Office, 5353 Yellowstone Road, Cheyenne, Wyoming. The Final EIS may also be reviewed online at
Jennifer Fleuret, Project Manager, at (307) 328-4314; 1300 North Third
BP America Production Company (BP) and 20 other companies propose to expand development of natural gas resources and condensate (oil) within the existing Continental Divide/Wamsutter II and Creston Blue Gap natural gas fields. More than 4,700 wells have been drilled in the project area since the 1950s under previous authorizations. Existing surface disturbance from natural gas and oil development in the project area is approximately 49,218 acres, including nearly 8,500 acres of long-term disturbance.
The CD-C project would drill and develop up to 8,950 additional natural gas wells (some of which would also produce condensate (oil)), including 100 to 500 coalbed methane wells, using a combination of vertical and directional drilling techniques over an estimated 15-year period. The total estimated life of the project is 30 to 40 years and includes approximately 47,200 additional acres of disturbance. Planned facilities would include well pads, gas, condensate and water collection pipelines, compressor stations, water disposal systems, an access road network, and an electrical distribution system. All surface facilities would be removed when the project is completed and the land would be re-contoured to near pre-disturbance condition and re-vegetated with native plant communities.
The project is located in the following area:
Those portions of secs. 23 and 24 lying south of the right-of-way granted to the Union Pacific Railroad Company by the United States, serial number WYE-05871;
Those portions of secs. 26 to 31, inclusive, lying south of the right-of-way granted to the Union Pacific Railroad Company by the United States, serial number WYE-05871;
The CD-C project area includes about 1.1 million acres, or 1,672 square miles, in Carbon and Sweetwater counties, Wyoming. Approximately 626,932 acres (58.6 percent) are administered by the BLM Rawlins Field Office, approximately 48,684 acres (4.5 percent) are State of Wyoming owned and approximately 394,470 acres (36.9 percent) are privately-owned. The project area is bisected by Interstate 80 and extends from 25 miles west of Rawlins, Wyoming, to 50 miles east of Rock Springs, Wyoming.
Cooperating agencies for this EIS include the State of Wyoming, with active participation from many state agencies including the State Planning Office, Wyoming Game and Fish Department, State Historic Preservation Office, the Wyoming Department of Environmental Quality and the Wyoming Department of Agriculture. Regional cooperating agencies include Sweetwater and Carbon counties and the Little Snake River and Sweetwater County conservation districts.
The Notice of Intent to prepare the EIS was published on September 8, 2005 (70 FR 53381), and again on March 3, 2006 (71 FR 10989). Public scoping meetings were held in Rawlins, Wyoming, on October 13, 2005, and on April 6, 2006. Fifty comment letters, faxes and emails were received during the extended scoping period. Key issues identified during scoping include:
• Air quality: Potential project and cumulative impacts on air quality, including air quality-related values.
• Cultural resources: The impact on the historical trails and historical travel routes in the project area.
• Hydrology: Potential degradation of surface and/or groundwater quality by project construction and drilling activities.
• Land ownership: The majority of the project area is in the checkerboard pattern of mixed public and private land ownership, complicating landscape scale mitigation on public lands where adjacent sections are nonpublic lands not subject to BLM regulations and requirements.
• Non-native, invasive plant species: The effect of current and projected infestations of non-native, invasive species.
• Rangeland management: Loss of livestock forage and the impact of project-associated hazardous conditions to area livestock operators.
• Special-status species: The impact from project activities upon threatened and endangered and sensitive wildlife species.
• Socioeconomics: The impact of the project on traditional socioeconomic indicators.
• Surface disturbance/reclamation: The extent of existing and proposed surface disturbance and its effect on all resources in the project area; and
• Wildlife habitat: The project's potential to further fragment wildlife habitats and diminish the value of those habitats for many species.
In response, the BLM developed five alternatives to the Proposed Action, which were analyzed in the Draft EIS:
• Alternative A, 100-Percent Vertical Drilling—This alternative assumes that all natural gas wells would be drilled from single-well pads, and that no directional drilling would occur;
• Alternative B, Enhanced Resource Protection—This alternative identifies those resources that may be most at risk from mineral development, defines areas within the CD-C project area where those resource risks are likely to occur, and describes the enhanced protection and mitigations that could diminish those risks;
• Alternative C, Surface Disturbance Cap, Core and Non-Core Areas—This alternative places a cap on unreclaimed surface disturbance caused by mineral development, a 60-acre cap in areas that have seen the greatest mineral development to date and a 30-acre cap in the rest of the project area. The cap is expressed in terms of acres per 640-acre section;
• Alternative D, Directional Drilling—This alternative requires that all future natural gas wells on Federal mineral estate be drilled from multi-well pads, one new multi-well pad per section; and
• Alternative E, No Action—NEPA regulations require that the EIS alternatives analysis “include the alternative of no action” (40 CFR 1502.14(d)). For the analysis in the Draft EIS, this means that the development activities on Federal lands proposed by the CD-C operators would not be approved or authorized. Lease rights on Federal lands or mineral estate granted by the BLM would remain in effect and other, additional or supplemental proposals to develop leased resources, such as oil and/or gas, could be received and would be considered by the BLM as appropriate.
The Draft EIS Notice of Availability was published on December 7, 2012 (77 FR 73049), opening a 90-day public comment period. A public meeting was held on January 15, 2013, and the public comment period closed on March 7, 2013. Over 8,000 individual comment letters were received and identified issues such as the lack of a preferred alternative and concerns associated with each of the alternatives, including feasibility, sufficiency of the analysis and impacts to specific resources as a result of each alternative. Comments were considered and incorporated as appropriate into the Final EIS; however, the analysis of the alternatives and the identified impacts did not significantly change.
The Final EIS differs from the Draft EIS by:
• Dropping Alternative A, 100-Percent Vertical Drilling, from consideration due to public comments on feasibility and the magnitude of total disturbance;
• Amending Alternative D, 100-Percent Directional Drilling, to recognize the impact the restrictions in that alternative would have on well density; as a result, this alternative now analyzes a 20-percent decrease in total wells drilled;
• Redefining the No Action Alternative to include an analysis of impacts associated with development on state and private mineral estate in addition to potential development on Federal mineral estate; and
• Including Alternative F, Agency-Preferred Alternative—This alternative responds to Draft EIS scoping concerns and comments by limiting development to eight wellpads per square mile section, requiring that wellpads be placed in the most environmentally suited areas, and creating a CD-C consultation and coordination group to response to evolving energy issues and concerns relating to the project. This alternative is a reconfiguration of elements of alternatives that were analyzed in the Draft EIS. The CD-C consultation and coordination group and protection measures of Alternative F were originally analyzed in the DEIS under Alternative B; and the emphasis on directional drilling was analyzed in Alternative D.
The Final EIS includes potential landscape scale mitigation strategies. Consistent with Secretarial Order No. 3330 and the BLM's obligations under the Federal Land Policy and Management Act, BLM Wyoming drafted a landscape-scale mitigation appendix, Appendix S, for inclusion in the Final EIS. The appendix has been reviewed by the Washington Office and the cooperating agencies.
Upon conclusion of the 30-day public availability period following the date the EPA publishes the NOA in the
40 CFR 1506.6, 40 CFR 1506.10.
National Park Service, Interior.
Notice of availability.
The National Park Service has prepared and approved a Record of Decision for the Final Environmental Impact Statement for the Development Concept Plans (DCP) for Katherine Landing and Cottonwood Cove. Approval of the DCP concludes an extensive conservation planning and environmental impact analysis effort that began during 2008.
Those wishing to review the Record of Decision may obtain a copy by request to the Superintendent, Lake Mead National Recreation Area, 601 Nevada Way, Boulder City, Nevada 89005 or via telephone request at (702) 293-8978.
Michael Boyles, Acting Chief, Resource Management and Visitor Services, (702) 293-8978.
The National Park Service has prepared and approved a Record of Decision for the Final Environmental Impact Statement for the DCP for Cottonwood Cove and Katherine Land. This process was conducted pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Three alternatives, all including mitigation measures, were evaluated during the DCP process. The “agency preferred” Alternative 3
• Develop new day-use areas (picnic and no-boat areas) in Ski Cove, and designate trail to Cottontail Cove; existing day-use areas in Cottonwood Cove remain.
• Phase out trailer village near the end of the next concession contract pending an economic feasibility analysis. Redevelop site for RV use or concession operated overnight accommodations.
• Expand motel as needed; additional structures double capacity and include meeting space (for hosting meetings and other events).
• Maintain character of Mission 66 structures while responding to changing needs to the extent possible.
• Construct engineered system of diversion dikes and concrete channels to convey the 500 year flood to better protect visitor areas. Maintain the Early Warning Detection System, install flood warning signs, and develop evacuation plan.
• Remove motel; redevelop site for expanded visitor parking near lake. Provide other forms of overnight accommodations (
• Phase out trailer village near the end of the next concession contract pending an economic feasibility analysis. The site would be redeveloped as part of an expanded, accessible campground that would be concessioner-run and would accommodate larger vehicles (larger sites with pull-through parking and hookups, etc.). Some portion of the campground would retain its current configuration for tent/car camping. Cabins may be part of the mix (exact mix of accommodations to be determined).
• Develop new paved loop serving both north and south areas of the development (housing/administration area to campground loop D).
• Consolidate NPS offices and operations (law enforcement/emergency, interpretation offices, etc.) in the vicinity of the NPS maintenance area; retain NPS maintenance area in same location.
• Construct engineered system of diversion dikes, channels, and detention basin to convey predicted maximum flood flows through North and South Katherine Washes.
• Install Early Warning Detection System for Katherine Landing; place flood warning signs and develop an evacuation plan for Katherine Landing and North and South Arizona Telephone Coves.
• Develop new picnic facilities at Cabinsite Point and provide additional parking and allow backcountry camping at some of the former cabin sites.
• Develop picnic area at North Arizona Telephone Cove and design access roads to eliminate or greatly reduce exposure to flood hazards at both North and South Arizona Telephone Coves.
• If launch capacity at Katherine Landing is reduced due to flood control, the park may consider paving and formalizing more of the overflow parking area at Princess Cove and improving the launch at North Arizona Telephone Cove or at Cabinsite Point, to align with established capacity levels set by the Lake Management Plan.
The approved development concept plan/environmental impact statement is a programmatic document covering both Cottonwood Cove and Katherine Landing areas. More detailed information will be developed during the individual project design stage. Based on this further design information, additional natural and cultural resource surveys and further Section 106 and NEPA compliance will be tiered from this document.
National Park Service, Interior.
Notice of availability.
The National Park Service (NPS) has prepared and approved a Record of Decision for the Final Environmental Impact Statement (EIS) and General Management Plan/Wilderness Study (GMP/WS) for Channel Islands National Park. Approval of the GMP/WS culminates an extensive public engagement and environmental impact analysis effort that began in 2001.
Those wishing to review the Record of Decision may obtain a copy by submitting their request to the Superintendent, Channel Islands National Park, 1901 Spinnaker Drive, Ventura, CA 93001.
Russell Galipeau, Superintendent, telephone (805) 508-5702 or email
This process was conducted pursuant to the National Environmental Policy Act of 1969 (42 U.S.C. 4321
The NPS evaluated the environmental consequences of two action alternatives and a no-action alternative. These alternatives described varying means to provide appropriate types and levels of access for visitors and authorized users, preserve wilderness character, protect cultural and natural resources, and adhere to legally required management and preservation objectives.
For a park that includes five remote islands spanning 2,228 square miles of land and sea, the new Channel Islands National Park GMP defines a clear direction for resource preservation and visitor experience over the next 20 to 40 years. The GMP provides a framework for proactive decision making, which will allow park managers to effectively address future opportunities and problems. The approved GMP will also serve as the basis for future detailed management documents, such as five-year strategic plans and project implementation plans.
United States International Trade Commission.
Notice.
Justin Enck ((202) 205-3363), Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
Effective January 6, 2016, the Commission established a schedule for the conduct of this review (81 FR 1643, January 13, 2016). Subsequently, counsel for the domestic interested parties filed a request to appear at the hearing and for consideration of cancellation of the hearing. Counsel indicated a willingness to submit written testimony and responses to any Commission questions in lieu of an actual hearing. No other party has entered an appearance in this review. Consequently, the public hearing in connection with this review, scheduled to begin at 9:30 a.m. on Thursday, April 28, 2016, at the U.S. International Trade Commission Building, is cancelled. Parties to this review should respond to any written questions posed by the Commission in their posthearing briefs, which are due to be filed on May 5, 2016.
For further information concerning this review see the Commission's notice cited above and the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and C (19 CFR part 207).
This review is being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.62 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission (“Commission”) has determined to review Order No. 43 issued by the presiding administrative law judge (“ALJ”). On review, the Commission has determined to vacate Order No. 43 because the law firm disqualification at issue has become moot. This investigation is terminated.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on September 23, 2014, based on a complaint filed by RevoLaze, LLC and TechnoLines, LLC, both of Westlake, Ohio (collectively, “RevoLaze”). 79
However, previously in the investigation, the then-presiding ALJ disqualified complainants' counsel Dentons US LLP (“Dentons US”) in an order that was not an initial determination (“ID”). Order No. 43 (May 7, 2015). Subsequently, the ALJ granted (as an ID) Dentons US's motion to intervene regarding its disqualification, Order No. 82 (Aug. 7, 2013), but denied (as an order) its motion for reconsideration of Order No. 43 as well as its request for leave to seek interlocutory review before the Commission, Order No. 83 (Aug. 7, 2015);
On October 27, 2015, in response to the issuance of an ID (Order No. 106), which terminated the investigation before the ALJ, Dentons US filed a petition for Commission review of Order Nos. 43 and 83.
The Commission has determined to review Order No. 43, and, on review, has determined to vacate the disqualification decision as moot. In view of the final disposition of the investigation as to all respondents, the issue of Dentons US's disqualification has no practical effect on this investigation.
Although the Commission has the discretion to address issues that have become moot, it has determined not to do so here. The disqualification in this investigation turns on whether Dentons US and Dentons Canada LLP as members of Salans FMC Denton Group (“Dentons Verein”) should be treated as a single law firm under the American Bar Association's Model Rules of Professional Conduct (“Model Rules”) in this investigation. Answering that question would require further proceedings, and potentially additional factfinding. In particular, Comment 2 to Model Rule 1.0 sets forth several factors to consider in determining whether a group of lawyers constitute a law firm, including (1) how the lawyers present themselves to the public, (2) whether the lawyers conduct themselves as a law firm, (3) the terms of any formal agreement among the lawyers, and (4) whether the lawyers have mutual access to client information. Here, the record lacks sufficient evidence on these factors, especially as to the third factor, because the Dentons Verein organizational agreements have not been made part of the record of the investigation. The Commission has decided that the added delay, burdens, and expenses that would be incurred by the parties and the Commission in resolving these issues are unjustified given the termination of the investigation as to all respondents.
Accordingly, the Commission has determined to review and vacate Order No. 43, without deciding whether the disqualification in this investigation was appropriate. The reasoning in support of the Commission's decision will be set forth more fully in a forthcoming opinion.
In light of its determination above, the Commission has determined not to review Order No. 83, which denied as untimely a motion of Dentons US and Revolaze for reconsideration of Order No. 43 or for interlocutory review by the Commission.
The Commission notes that in April 2016, it received several submissions from RevoLaze and Dentons US after the deadlines for submissions set forth in 19 CFR 210.43 had passed. The Commission rejects these submissions as untimely and procedurally improper, and did not consider them in making its determination.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
Notice is hereby given that, on March 18, 2016, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, EUN Partnership AISBL, Brussels, BELGIUM; Open Universiteit Nederland, Heerlen, THE NETHERLANDS; D.E. Solution sprl, Brussels, BELGIUM; Poway Unified School District, Poway, CA; American Institutes for Research, Washington, DC; University of Bridgeport, Bridgeport, CT; and Gutenberg Technology, Cambridge, MA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and IMS Global intends to file additional written notifications disclosing all changes in membership.
On April 7, 2000, IMS Global filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on December 29, 2015. A notice was published in the
Notice is hereby given that, on March 23, 2015, pursuant to section 6(a) of the National Cooperative Research and Production Act of 1993, 15 U.S.C. 4301
Also, Ad-ID, New York, NY; CNN/Turner Broadcasting System, Atlanta, GA; Masstech Group, Inc., Markham, Ontario, CANADA; Video Stream Networks (VSN), Barcelona, SPAIN; and SDVI Corporation, Menlo Park, CA, have withdrawn as parties to this venture.
No other changes have been made in either the membership or planned activity of the group research project. Membership in this group research project remains open, and Advanced Media Workflow Association, Inc. intends to file additional written notifications disclosing all changes in membership.
On March 28, 2000, Advanced Media Workflow Association, Inc. filed its original notification pursuant to section 6(a) of the Act. The Department of Justice published a notice in the
The last notification was filed with the Department on December 23, 2015. A notice was published in the
Notice of registration.
Cody Laboratories, Inc. applied to be registered as a manufacturer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Cody Laboratories, Inc. registration as a manufacturer of those controlled substances.
By notice dated December 4, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823(a) and determined that the registration of Cody Laboratories, Inc. to manufacture the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 823(a), and in accordance with 21 CFR 1301.33, the above-named company is granted registration as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for sale to its customers.
Notice of registration.
Research Triangle Institute applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Research Triangle Institute registration as an importer of those controlled substances.
By notice dated July 29, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Research Triangle Institute to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances:
The company plans to import small quantities of the listed controlled substances for the National Institute on Drug Abuse (NIDA) for research activities.
The company plans to import analytical reference standards for distribution to its customers for research and analytical purposes. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances. Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of registration.
Johnson Matthey, Inc. applied to be registered as an importer of certain basic classes of controlled substances. The Drug Enforcement Administration (DEA) grants Johnson Matthey, Inc. registration as an importer of those controlled substances.
By notice dated December 21, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Johnson Matthey, Inc. to import the basic classes of controlled substances is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of the following basic classes of controlled substances:
The company plans to import thebaine derivatives and fentanyl as reference standards.
The company plans to import the remaining listed controlled substances as raw materials, to be used in the manufacture of bulk controlled substances, for distribution to its customers. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.
Approval of permit applications will occur only when the registrant's business activity is consistent with what is authorized under 21 U.S.C. 952(a)(2). Authorization will not extend to the import of FDA approved or non-approved finished dosage forms for commercial sale.
Notice of registration.
Meridian Medical Technologies applied to be registered as an importer of a certain basic class of controlled substance. The Drug Enforcement Administration (DEA) grants Meridian Medical Technologies registration as an importer of this controlled substance.
By notice dated November 27, 2015, and published in the
The DEA has considered the factors in 21 U.S.C. 823, 952(a) and 958(a) and determined that the registration of Meridian Medical Technologies to import the basic class of controlled substance is consistent with the public interest and with United States obligations under international treaties, conventions, or protocols in effect on May 1, 1971. The DEA investigated the company's maintenance of effective controls against diversion by inspecting and testing the company's physical security systems, verifying the company's compliance with state and local laws, and reviewing the company's background and history.
Therefore, pursuant to 21 U.S.C. 952(a) and 958(a), and in accordance with 21 CFR 1301.34, the above-named company is granted registration as an importer of morphine (9300), a basic class of controlled substance listed in schedule II.
The company manufactures a product containing morphine in the United States. The company exports this product to customers around the world. The company has been asked to ensure that its product, which is sold to European customers, meets the standards established by the European Pharmacopeia, administered by the Directorate for the Quality of Medicines (EDQM). In order to ensure that its product will meet European specifications, the company seeks to import morphine supplied by EDQM for use as reference standards.
This is the sole purpose for which the company will be authorized by the DEA to import morphine.
Federal Bureau of Prisons, Department of Justice.
Notice of a modified system of records.
Pursuant to the Privacy Act of 1974, 5 U.S.C. 552a, and Office of Management and Budget (OMB) Circular No. A-130, notice is hereby given that the Federal Bureau of Prisons (Bureau, or BOP), Department of Justice (Department or DOJ) proposes to amend an existing Bureau system of records notice titled, “Inmate Central Records System, JUSTICE/BOP-005”, last modified at 77 FR 24982, on April 26 2012. The Bureau is amending routine use (i) to notify the public that the Bureau will be sharing federal inmate records with the U.S. Department of Veterans Affairs (VA) for matching purposes broader than are covered specifically under 38 U.S.C. 5106, Public Law 94-432.
In accordance with 5 U.S.C. 552a(e)(4) and (11), the public is given a 30-day period in which to comment. Therefore, please submit any comments by May 18, 2016.
The public, OMB, and Congress are invited to submit any comments to the Department of Justice, ATTN: Privacy Analyst, Office of Privacy and Civil Liberties, National Place Building, 1331 Pennsylvania Avenue NW., Suite 1000, Washington, DC 20530, or by facsimile at (202) 307-0693.
Wanda Hunt, Privacy Officer, Bureau of Prisons, 320 First Street NW., Washington, DC 20534, telephone (202) 514-6655.
The Bureau last published a modified Bureau of Prisons Privacy Act system of records notice on April 26, 2012, titled “Inmate Central Records System,” JUSTICE/BOP-005, to reflect a number of changes to the notice, including changes reflecting the overall modernization and technological changes of the Bureau's electronic information systems. This system of records is maintained by the Bureau to cover records relating to the care, classification, subsistence, protection, discipline, and programs of federal inmates.
In this modification, the Bureau proposes to modify an existing routine use, paragraph “(i)”, which was also modified pursuant to the April 26, 2012, system of records notice modification, to allow records from the Inmate Central Records System to be disclosed to any United States Veterans Administration entity or official for the purpose of matching those Bureau records against VA records to determine the eligibility or potential eligibility of Bureau inmates to receive benefits and/or services. The modification will enable BOP to more efficiently: (1) Identify inmates who may potentially be eligible for VA services upon release, (2) assist those inmates while in custody by providing to them information useful for seeking VA services upon release, and (3) evaluate which inmates may be in greater need than the general BOP population for certain BOP-provided inmate services while in custody. The modification will also remove the requirement stating “the VA is to erase the Bureau data after the match has been made” for two reasons. First, this erasure clause may unnecessarily force the VA to immediately erase data, creating difficulty for validation, auditing, and other legitimate purposes. Second, the VA is required to protect the records under the Privacy Act, and erase the data as required by the applicable disposition schedule approved by the National Archives. This system of records notice modification will not affect the existing Privacy Act exemption regulations claimed by the Attorney General.
In accordance with 5 U.S.C.552a(r), the Department has provided a report to OMB and Congress on this modified system of records.
(i) To the United States Department of Veterans Affairs (VA), for the purpose of matching the records against VA records to determine the eligibility or potential eligibility of Bureau inmates to receive veterans' benefits and/or services.
Department of Justice.
Notice of solicitation of applications for additional commission membership for the National Commission on Forensic Science specifically to fill a current vacancy to support digital evidence.
Pursuant to the Federal Advisory Committee Act, as amended, this notice announces the solicitation of applications for additional Commission membership to fill a current vacancy to support digital evidence.
Applications must be received on or before May 18, 2016.
All applications should be submitted to: Jonathan McGrath, Designated Federal Official, 810 Seventh St. NW., Washington, DC 20531, or by email at
Jonathan McGrath, Designated Federal Official, 810 Seventh St. NW., Washington, DC 20531, by email at
Pursuant to the Federal Advisory Committee Act, as amended (5 U.S.C. App.), this notice announces the solicitation of applications for additional Commission membership on the National Commission on Forensic Science to fill current vacancies. The National Commission on Forensic Science was chartered on April 23, 2013 and the charter was renewed on April 23, 2015. There is currently a Commissioner vacancy to support digital evidence. This notice announces the solicitation of applications for Commission membership to fill the digital evidence vacancy.
The Commission is co-chaired by the Department of Justice and National Institute of Standards and Technology. The Commission provides recommendations and advice to the Department of Justice concerning national methods and strategies for: Strengthening the validity and reliability of the forensic sciences (including medico-legal death investigation); enhancing quality assurance and quality control in forensic science laboratories and units; identifying and recommending scientific guidance and protocols for
The duties of the Commission include: (a) Recommending priorities for standards development; (b) reviewing and recommending endorsement of guidance identified or developed by subject-matter experts; (c) developing proposed guidance concerning the intersection of forensic science and the courtroom; (d) developing policy recommendations, including a uniform code of professional responsibility and minimum requirements for training, accreditation and/or certification; and (e) identifying and assessing the current and future needs of the forensic sciences to strengthen their disciplines and meet growing demand.
Members will be appointed by the Attorney General in consultation with the Director of the National Institute of Standards and Technology and the vice-chairs of the Commission. Commission members are selected to fill vacancies to maintain a balance of perspective and diversity of experiences, including Federal, State, and Local forensic science service providers; research scientists and academicians; Federal, State, Local prosecutors, defense attorneys and judges; law enforcement; and other relevant stakeholders. DOJ encourages submissions from applicants with respect to diversity of backgrounds, professions, ethnicities, gender, and geography. The Commission shall consist of approximately 30 voting members. Members will serve without compensation. The Commission generally meets four times each year at approximately three-month intervals. Additional information regarding the Commission can be found here:
Employment and Training Administration, Labor.
Notice.
This notice announces allotments for PY 2016 for WIOA Title I Youth, Adults and Dislocated Worker Activities programs; final allotments for Employment Service (ES) activities under the Wagner-Peyser Act for PY 2016 and Workforce Information Grants allotments for PY 2016.
WIOA allotments for States and the State final allotments for the Wagner-Peyser Act are based on formulas defined in their respective statutes. WIOA requires allotments for the outlying areas to be competitively based rather than based on a formula determined by the Secretary of Labor (Secretary) as occurred under the Workforce Investment Act (WIA). For PY 2016, the Consolidated Appropriations Act, 2016 waives the competition requirement, and the Secretary is using the discretionary formula rationale and methodology for allocating PY 2016 funds for the outlying areas (American Samoa, Guam, the Commonwealth of the Northern Mariana Islands, the Republic of Palau, and the United States Virgin Islands) that was published in the
Comments on the formula used to allot funds to the outlying areas must be received by May 18, 2016.
Submit written comments to the Employment and Training Administration (ETA), Office of Financial Administration, 200 Constitution Avenue NW., Room N-4702, Washington, DC 20210, Attention: Ms. Anita Harvey, email:
Commenters are advised that mail delivery in the Washington area may be delayed due to security concerns. Hand-delivered comments will be received at the above address. All overnight mail will be considered to be hand-delivered and must be received at the designated place by the date specified above.
Please submit your comments by only one method. The Department will not review comments received by means other than those listed above or that are received after the comment period has closed.
WIOA Youth Activities allotments—Evan Rosenberg at (202) 693-3593 or LaSharn Youngblood at (202) 693-3606; WIOA Adult and Dislocated Worker Activities and ES final allotments—Robert Kight at (202) 693-3937; Workforce Information Grant allotments—Donald Haughton at (202) 693-2784. Individuals with hearing or speech impairments may access the telephone numbers above via TTY by calling the toll-free Federal Information Relay Service at 1-877-889-5627 (TTY/TDD).
The Department is announcing WIOA allotments for PY 2016 for Youth Activities, Adults and Dislocated Worker Activities, Wagner-Peyser Act PY 2016 final allotments, and PY 2016 Workforce Information Grant allotments. This notice provides information on the amount of funds available during PY 2016 to States with an approved WIOA Title I and Wagner-Peyser Act Strategic Plan for PY 2016, and information regarding allotments to the outlying areas.
On December 18, 2015, the Consolidated Appropriations Act, 2016, Public Law 114-113 was signed into law (“the Act”). The Act, Division H, Title I, Section 107 of the Act allows the Secretary of Labor (Secretary) to set aside up to 0.75 percent of most operating funds for evaluations. The evaluation provision is consistent with the Federal government's priority on evidence-based policy and programming and provides important opportunities to expand evaluations and demonstrations in the Department to build solid evidence about what works best. In the past, funds for ETA evaluations and demonstrations were separately appropriated and managed by ETA. That separate authority has been replaced by the set aside provision. Funds are transferred to the Department's Chief Evaluation Office to implement formal evaluations and demonstrations in collaboration with ETA. For 2016, the Secretary set aside .25 percent of the Training and Employment Services (TES) and State Unemployment Insurance and Employment Services Operations (SUIESO) appropriations. ETA spread the amount to be set aside for each appropriation among the programs funded by that appropriation with more than $100 million in funding. This includes WIOA Adult, Youth and Dislocated Worker and Wagner-Peyser Employment Service program budgets.
We also have attached tables listing the PY 2016 allotments for programs under WIOA Title I Youth Activities (Table A), Adult and Dislocated Workers Employment and Training Activities (Tables B and C, respectively), and the PY 2016 Wagner-Peyser Act final allotments (Table D). We also have attached the PY 2016 Workforce Information Grant table (Table E).
Under WIA, the Secretary had discretion for determining the methodology for distributing funds to all outlying areas. Under WIOA the Secretary must disseminate the funds through a competitive process. For PY 2016, the Consolidated Appropriations Act, 2016 waives the competition requirement contained in WIOA section 127(b)(1)(B)(ii), 132(b)(1)(A)(ii), and 132(b)(2)(A)(ii) regarding funding to outlying areas (
After the Department calculated the amount for the outlying areas and the Native American program, it was determined that the amount available for PY 2016 allotments to the States is $855,722,367. This total amount was below the required $1 billion threshold specified in WIOA section 127(b)(1)(C)(iv)(IV); therefore, the Department did not apply the WIOA additional minimum provisions. Instead, as required by WIOA, the Department used the Job Training Partnership Act (JTPA) (Pub. L. 97-300), section 262(b)(2) (as amended by section 207 of the Job Training Reform Amendments of 1992, Pub. L. 102-367) minimums of 90 percent of the prior year allotment percentage and 0.25 percent State minimum floor. WIOA also provides that no State may receive an allotment that is more than 130 percent of the allotment percentage for the State for the previous year. The three data factors required by WIOA for the PY 2016 Youth Activities State formula allotments are:
(1) The average number of unemployed individuals for Areas of Substantial Unemployment (ASUs) for the 12-month period, July 2014-June 2015;
(2) Number of excess unemployed individuals or the ASU excess (depending on which is higher) averages for the same 12-month period used for ASU unemployed data; and
(3) Number of economically disadvantaged Youth (age 16 to 21, excluding college students in the workforce and military) from special tabulations of data from the American Community Survey (ACS), which the Department obtained from the Bureau in 2012. The Bureau collected the data used in the special tabulations for
For purposes of identifying ASUs for the within-state Youth Activities allocation formula, States should continue to use the data made available by BLS (as described in the Local Area Unemployment Statistics (LAUS) Technical Memorandum No. S-15-13). For purposes of determining the number of economically disadvantaged Youth for the statutory within-state allocation formula, States should continue to use the special tabulations of ACS data made available to them in 2013 and available at
See TEGL No. 21-12 for further information.
In accordance with WIOA, the Department reserved the total available for the outlying areas at 0.25 percent of the full amount appropriated for Adult Activities (after the evaluations set aside). As discussed in the Youth Activities section above, in PY 2016 the Department will distribute the Adult Activities funding for the outlying areas, using the same principles, formula and data as used for outlying areas for Youth Activities. After determining the amount for the outlying areas, the Department used the statutory formula to distribute the remaining amount available for allotments to the States. The Department did not apply the WIOA minimum provisions for the PY 2016 allotments because the total amount available for the States was below the $960 million threshold required for Adult Activities in WIOA section 132(b)(1)(B)(iv)(IV). Instead, as required by WIOA, the Department calculated minimum allotments using the JTPA section 202(b)(2) (as amended by section 202 of the Job Training Reform Amendments of 1992) minimums of 90 percent of the prior year allotment percentage and 0.25 percent State minimum floor. WIOA also provides that no State may receive an allotment that is more than 130 percent of the allotment percentage for the State for the previous year. The three formula data factors for the Adult Activities program are the same as those used for the Youth Activities formula, except the Department used data for the number of economically disadvantaged Adults (age 18 to 72, excluding college students in the workforce and military).
As noted above, updated data for within-state ASU calculations is available from the Bureau of Labor Statistics (BLS), and States should continue to use the economically disadvantaged Adults data made available to States by the Department in 2013.
Like the Adult Activities program, the Department reserved the total available for the outlying areas at 0.25 percent of the full amount appropriated for Dislocated Worker Activities (after the evaluations set aside). Similar to Youth and Adult funds, instead of competition, in PY 2016 the Department will use the same
(1) Number of unemployed, averages for the 12-month period, October 2014-September 2015;
(2) Number of excess unemployed, averages for the 12-month period, October 2014-September 2015; and
(3) Number of long-term unemployed, averages for the 12-month period, October 2014-September 2015.
In PY 2016, under WIOA the Dislocated Worker formula adopted minimum and maximum provisions. No State may receive an allotment that is less than 90 percent of the State's prior year allotment percentage or more than 130 percent of the State's prior year allotment percentage.
Under section 7(a), 90 percent of funds must be used for labor exchange services and other career services such as job search and placement services to job seekers; appropriate recruitment services for employers; program evaluations; developing and providing labor market and occupational information; developing management information systems; and administering the work test for unemployment insurance claimants. Under section 7(b) of the Wagner-Peyser Act, ten percent of the total sums allotted to each State shall be reserved for use by the Governor to provide performance incentives for ES offices, services for groups with special needs, and for the
National Aeronautics and Space Administration (NASA).
Notice of information collection.
The National Aeronautics and Space Administration, 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 (Pub. L. 104-13, 44 U.S.C. 3506(c)(2)(A)).
All comments should be submitted within 60 calendar days from the date of this publication.
Interested persons are invited to submit written comments on the proposed information collection to NASA Paperwork Reduction Act Clearance Officer, Code JF000, National Aeronautics and Space Administration, Washington, DC 20546-0001 or
Requests for additional information or copies of the information collection instrument(s) and instructions should be directed to Ms. Frances Teel, NASA Clearance Officer, NASA Headquarters, 300 E Street SW., JF000, Washington, DC 20546, or
The Aviation Safety Reporting System (ASRS) is a NASA program developed to enable the voluntary collection of aviation safety incident/situation reports from individuals to include but not limited to pilots, air traffic controllers, dispatchers, cabin crew, and maintenance technicians. The ASRS represents the continuing effort by government, industry, and individuals to maintain and improve aviation safety. The information collected is used by NASA, the Federal Aviation Administration, and the aviation community in the promotion of flight safety.
Data collected is used to identify deficiencies and discrepancies in the National Airspace System, support policy formulation and planning, and strengthen the foundation of aviation safety research. Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
NASA collects the information electronically, however information may also be collected via mail.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of NASA, including whether the information collection has practical utility; (2) the accuracy of NASA's estimate of the burden (including hours and cost) of the proposed collection of information; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including automated collection techniques or the use of other forms of information technology.
Comments submitted in response to this notice will be summarized and included in the request for OMB approval of this information collection. They will also become a matter of public record.
National Credit Union Administration (NCUA).
Notice and request for comment.
NCUA, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the submission for reinstatement of a previously approved collection, as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35). NCUA is soliciting comment on the
Comments should be received on or before June 17, 2016 to be assured consideration.
Interested persons are invited to submit written comments on the information collection to Dawn Wolfgang, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428; Fax No. 703-519-8579; or Email at
Requests for additional information should be directed to the address above.
The Truth in Savings Act, 12 U.S.C. 4301
TISA also directed the National Credit Union Administration (NCUA) to promulgate a TISA regulation governing credit unions. Section 272(b) of TISA, 12 U.S.C. 4311(b), mandated that NCUA regulation be “substantially similar” to those issued by FRB (and now CFPB), but NCUA may take into account the unique nature of credit unions and the limitations under which they may pay dividends.
To implement TISA, NCUA published its TISA regulation, 12 CFR part 707, which applies to all credit unions whose accounts are either insured by, or eligible to be insured by, the National Credit Union Share Insurance Fund, except for any credit union that has been designated as a corporate credit union and any non-automated credit union that has $2 million or less in assets (together, “credit unions”). In addition, the advertising rules apply to any person who advertises an account offered by a credit union. NCUA's TISA regulation requires credit unions to disclose fees, dividend rates and other terms concerning accounts to members or potential members.
NCUA's TISA regulation requires credit unions to provide specific disclosures when an account is opened, when a disclosed term changes or a term account is close to renewal, on periodic statements of account activity, in advertisements, and upon a member's or potential member's request. 12 CFR 707.4, 707.5, 707.6, 707.8. Credit unions that provide periodic statements are required to include information about fees imposed, the annual percentage yield earned during those statement periods, and other account terms. The requirements for creating and disseminating account disclosures, change in terms notices, term share renewal notices, statement disclosures, and advertising disclosures are necessary to implement TISA's purpose of providing the public with information that will permit informed comparisons of accounts at depository institutions.
The collection of information pursuant to Part 707 is triggered by specific events and disclosures and must be provided to consumers within the time periods established under the regulation. To ease the compliance cost (particularly for small credit unions), model clauses and sample forms are appended to the regulation.
Although the regulation requires depository institutions to retain evidence of compliance with the disclosure requirements, the regulation does not specify the types of records that must be retained.
Comments submitted in response to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will become a matter of public record. The public is invited to submit comments concerning: (a) 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; (b) the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used; (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 the information on the respondents, including the use of automated collection techniques or other forms of information technology.
By Gerard Poliquin, Secretary of the Board, the National Credit Union Administration, on April 13, 2016.
National Credit Union Administration (NCUA).
Notice and request for comment.
NCUA, as part of its continuing effort to reduce paperwork
Comments should be received on or before June 17, 2016 to be assured consideration.
Interested persons are invited to submit written comments on the information collection to Troy Hillier, National Credit Union Administration, 1775 Duke Street, Alexandria, Virginia 22314-3428; Fax No. 703-519-8595; or Email at
Requests for additional information should be directed to the address above.
10:00 a.m., Thursday, April 21, 2016.
Board Room, 7th Floor, Room 7047, 1775 Duke Street (All visitors must use Diagonal Road Entrance), Alexandria, VA 22314-3428.
Open.
1. National Credit Union Share Insurance Fund Quarterly Report.
2. NCUA's Rules and Regulations, Incentive-Based Executive Compensation.
3. NCUA's Rules and Regulations, Federal Credit Union Occupancy, Planning, and Disposal of Acquired and Abandoned Premises; Incidental Powers.
11:00 a.m.
11:15 a.m., Thursday, April 21, 2016.
Board Room, 7th Floor, Room 7047, 1775 Duke Street, Alexandria, VA 22314-3428.
Closed.
1. Supervisory Matter. Closed pursuant to Exemption (8).
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
National Endowment for the Humanities, National Foundation on the Arts and the Humanities.
Notice of meetings.
The National Endowment for the Humanities will hold three meetings of the Humanities Panel, a federal advisory committee, during May, 2016. The purpose of the meetings is for panel review, discussion, evaluation, and recommendation of applications for financial assistance under the National Foundation on the Arts and Humanities Act of 1965.
See
The meetings will be held at Constitution Center at 400 7th Street SW., Washington, DC 20506. See
Elizabeth Voyatzis, Committee Management Officer, 400 7th Street SW., Room, 4060, Washington, DC 20506; (202) 606-8322;
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (5 U.S.C. App.), notice is hereby given of the following meetings:
1.
This meeting will discuss applications for the Institutes for College and University Teachers grant program, submitted to the Division of Education Programs.
2.
This meeting will discuss applications for the Seminars for College Teachers grant program, submitted to the Division of Education Programs.
3.
This meeting will discuss applications for the Institutes for Advanced Topics in the Digital Humanities grant program, submitted to the Office of Digital Humanities.
Because these meetings will include review of personal and/or proprietary financial and commercial information given in confidence to the agency by grant applicants, the meetings will be closed to the public pursuant to sections 552b(c)(4) and 552b(c)(6) of Title 5, U.S.C., as amended. I have made this determination pursuant to the authority granted me by the Chairman's Delegation of Authority to Close Advisory Committee meetings dated July 19, 1993.
In accordance with the Federal Advisory Committee Act (Pub. L. 92-463, as amended), the National Science Foundation announces the following meeting:
Welcome/Introductions; BFA/OIRM Updates; Enterprise Risk Management; From Systems to Data and Beyond; Benchmarking; Recommendations of the National Academy of Public Administration (NAPA) Study of NSF's Use of Cooperative Agreements to Support Large Scale Investments in Science and Technology.
Modernization of Business Processes and Workforce Structures: A Discussion of Lessons Learned; Discussion with Chief Operating Officer; Meeting Wrap-Up.
On February 5, 2016, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
The Exchange proposes to list and trade the Shares under NYSE Arca Equities Rule 8.600, which governs the listing and trading of Managed Fund Shares. The Funds are each a series of
The Exchange states that the investment objective of the Fund will be to seek to provide capital appreciation and dividend income. Under normal market conditions,
The Fund may invest in exchange-traded equities issued by small-, mid-, and large-capitalization companies. The Fund may also invest in other exchange-traded funds (“ETFs”)
The Exchange states that in selecting the Fund's portfolio securities, the Sub-Adviser assembles a portfolio of eligible securities based on several core attributes such as value, quality, and momentum. The Sub-Adviser will consider multiple proprietary factors within each core attribute, such as the price-to-book value of a security when determining value, a company's cash as a percentage of the company's market capitalization when determining quality, and a security's three month relative price change when determining momentum. Additionally, within a given sector, security selection will emphasize companies offering a meaningful dividend yield premium over alternative investments within that sector. This dividend yield emphasis is subject to quality screens intended to limit exposure to companies whose financial characteristics suggest the potential for dividend cuts. The Sub-Adviser then assigns each qualifying security a score based on its core attributes, including its dividend growth score, and selects the individual securities with the highest scores for investment. The Exchange states that in doing so, the Sub-Adviser will utilize its proprietary optimization process to maximize the percentage of high-scoring securities included in the portfolio. The Exchange states that the Sub-Adviser will also consider the market capitalization of the companies in which the Fund may invest, the potential for dividend income, and the trading volume of a company's shares in the secondary market.
The Exchange states that the investment objective of the Fund will be to seek to provide capital appreciation. Under normal market conditions,
The Fund may invest in exchange traded equities issued by small-, mid-, and large-capitalization companies. The Fund may also invest in other ETFs
The Exchange states that in selecting the Fund's portfolio securities, the Sub-Adviser assembles a portfolio of eligible securities based on several core attributes such as value, quality, and momentum. According to the Exchange, the Sub-Adviser will consider multiple proprietary factors within each core attribute, such as the price-to-book value of a security when determining value, a company's cash as a percentage of the company's market capitalization when determining quality, and a security's three month relative price change when determining momentum. The Sub-Adviser then assigns each qualifying security a score based on its core attributes and selects the individual securities with the highest scores for investment. In doing so, the Sub-Adviser utilizes its proprietary optimization process to maximize the percentage of high-scoring securities included in the portfolio. The Sub-Adviser will also consider the market capitalization of the companies in which the Fund may invest, and the trading volume of a company's shares in the secondary market.
The Exchange states that while each Fund will, under normal market conditions, principally invest at least 65% of its net assets in the securities and financial instruments as described above, each Fund may invest its remaining assets in the securities and financial instruments described below.
A Fund may invest in other types of equity securities, as follows: Non-exchange traded common stock (including REITs), exchange-traded and non-exchange traded preferred stock (including REITs), exchange-traded and non-exchange traded convertible securities, exchange-traded master limited partnerships (“MLPs”), and exchange-traded business development companies (“BDCs”).
According to the Exchange, a Fund may invest in exchange-traded or over-the-counter (“OTC”) equity securities of
The Exchange states that a Fund may also invest in the following short-term instruments on an ongoing basis to provide liquidity or for other reasons: Money market instruments, cash, and cash equivalents. Cash equivalents include the following: (i) Short-term obligations issued by the U.S. Government; (ii) negotiable certificates of deposit, fixed time deposits, and bankers' acceptances of U.S. and foreign banks and similar institutions; (iii) commercial paper rated at the date of purchase “Prime-1” by Moody's Investors Service, Inc. or “A-1+” or “A-1” by Standard & Poor's or, if unrated, of comparable quality as determined by the Adviser or Sub-Adviser; (iv) repurchase agreements; and (v) money market mutual funds.
In addition, the Exchange states that a Fund may use derivative instruments. Specifically, a Fund may use options, futures, swaps, and forwards, for hedging or risk management purposes or as part of its investment practices.
The Exchange states that a Fund may invest in forward currency contracts. Currency forward contracts may be used to increase or reduce exposure to currency price movements. At the discretion of the Adviser or Sub-Adviser, the Funds may enter into forward currency exchange contracts for hedging purposes to help reduce the risks and volatility caused by changes in foreign currency exchange rates.
A Fund may gain exposure to foreign securities by purchasing U.S. exchange-listed and traded American Depositary Receipts (“ADRs”), non-exchange-listed ADRs, exchange-traded European Depositary Receipts (“EDRs”), and exchange-traded Global Depositary Receipts (“GDRs”, together with ADRs and EDRs, “Depositary Receipts”).
The Exchange states that the Funds may invest in Rule 144A restricted securities.
Each Fund may invest up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including securities that are offered pursuant to Rule 144A under the Securities Act deemed illiquid by the Adviser or Sub-Adviser.
Each Fund may invest up to 10% of its net assets in equity securities traded OTC.
The Funds intend to qualify for and to elect to be treated as separate regulated investment companies under Subchapter M of the Internal Revenue Code.
Each Fund's investments will be consistent with such Fund's investment objective and will not be used to enhance leverage. That is, while each Fund will be permitted to borrow as permitted under the 1940 Act, a Fund's investments will not be used to seek performance that is the multiple or inverse multiple (
Not more than 10% of the net assets of each Fund in the aggregate invested in equity securities (other than non-exchange traded money market funds) shall consist of equity securities whose principal market is not a member of the Intermarket Surveillance Group (“ISG”) or party to a comprehensive surveillance sharing agreement (“CSSA”) with the Exchange. Not more than 10% of the net assets of a Fund in the aggregate invested in futures contracts or options contracts shall consist of futures contracts or exchange-traded options contracts whose principal market is not a member of the ISG or is a market with which the Exchange does not have a CSSA.
After careful review, the Commission finds that the Exchange's proposal to list and trade the Shares is consistent with the Exchange Act and the rules and regulations thereunder applicable to a national securities exchange.
The Exchange has represented that quotation and last sale information for the Shares, U.S. exchange-traded common stocks, as well as other exchange traded equity securities, including Depositary Receipts (excluding ADRs traded OTC and GDRs), preferred securities, convertible securities, REITs, BDCs, CEFs, ETFs, and MLPs (collectively, “Exchange-Traded Equities”) will be available via the Consolidated Tape Association (“CTA”) high-speed line and from the securities exchanges on which they are listed. The Exchange represents that price information for exchange-traded derivative instruments will be available from the applicable exchange and from major market data vendors. The Exchange states that price information for instruments traded OTC (such as common stock traded OTC (including REITs), non-exchange-listed ADRs, preferred securities (including REITs), convertible securities, and cash equivalents) will be available from major market data vendors. Price information for non-U.S. exchange-traded equity securities will be readily available from the exchanges trading such securities as well as automated quotation systems, published or other public sources, or on-line information services. Price information for money market instruments will be available from major market data vendors. Quotation and last sale information for GDRs will be available from the securities exchanges on which they are listed. Information relating to futures, options on futures, and exchange-traded swaps will be available from the exchange on which such instruments are traded. Price information relating to exchange-traded options will be available via the Options Price Reporting Authority. Quotation information from brokers and dealers or pricing services will be available for Rule 144A securities, ADRs traded OTC, and non-exchange-traded derivatives, including forwards, OTC swaps, and OTC options. The Exchange states that pricing information regarding each asset class in which the Funds will invest is generally available through nationally recognized data services providers through subscription agreements.
In addition, the indicative intra-day value, which is the Portfolio Indicative Value, as defined in NYSE Arca Equities Rule 8.600 (c)(3), will be widely disseminated by one or more major market data vendors at least every 15 seconds during the Core Trading Session.
The NAV per Share will be calculated by each Fund's custodian and determined as of the close of the regular trading session on the New York Stock Exchange (“NYSE”) (ordinarily 4:00 p.m., Eastern Time) on each day that the NYSE is open. A basket composition file, which will include the security names and share quantities required to be delivered in exchange for each Fund's Shares, together with estimates and actual cash components, will be publicly disseminated daily prior to the opening of the NYSE via the National Securities Clearing Corporation. Information regarding market price and trading volume for the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services. Information regarding the previous day's closing price and trading volume information for the Shares will be published daily in the financial section of newspapers. The Web site for the Funds will include a form of the prospectus for each Fund and additional data relating to NAV and other applicable quantitative information.
The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Commission notes that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio for each Fund will be made available to all market participants at the same time.
The Exchange represents that trading in Shares of a Fund will be halted if the circuit breaker parameters in NYSE Arca Equities Rule 7.12 have been reached. Trading also may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable.
The Exchange represents that it has a general policy prohibiting the distribution of material, non-public information by its employees. Each of the Adviser and the Sub-Adviser is affiliated with a broker-dealer and has implemented and will maintain a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to a Fund's portfolio.
Prior to the commencement of trading, the Exchange will inform its Equity Trading Permit Holders (“ETP Holders”) in an Information Bulletin (“Bulletin”) of the special characteristics and risks associated with trading the Shares. The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by the Exchange or 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 Exchange represents that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and federal securities laws applicable to trading on the Exchange.
The Exchange represents that it deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. In support of this proposal, the Exchange has also made the following representations:
(1) The Shares will conform to the initial and continued listing criteria under NYSE Arca Equities Rule 8.600.
(2) 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.
(3) The issuer has represented to the Exchange that it will advise the Exchange of any failure by the Funds to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Exchange Act, the Exchange will monitor
(4) The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions.
(5) Trading in the Shares will be subject to the existing trading surveillances, administered by the Exchange or FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws, and these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and federal securities laws applicable to trading on the Exchange.
(6) The Exchange or FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares, Exchange-Traded Equities, and certain exchange-traded options and futures with other markets and other entities that are members of the ISG, and the Exchange, or FINRA on behalf of the Exchange, may obtain trading information regarding trading in the Shares, Exchange-Traded Equities, and certain exchange-traded options and futures from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares, Exchange-Traded Equities, and certain exchange-traded options and futures from markets and other entities that are members of ISG or with which the Exchange has in place a CSSA.
(7) Prior to the commencement of trading of the Shares, the Exchange will inform its ETP Holders in a Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Bulletin will discuss the following: (a) The procedures for purchases and redemptions of Shares in creation units (and that Shares are not individually redeemable); (b) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) the risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated IIV will not be calculated or publicly disseminated; (d) how information regarding the Portfolio Indicative Value and the Disclosed Portfolio is disseminated; (e) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(8) For initial and continued listing, each Fund will be in compliance with Rule 10A-3 under the Exchange Act,
(9) A minimum of 100,000 Shares of each Fund will be outstanding at the commencement of trading on the Exchange.
(10) Under normal market conditions, the RiverFront Dynamic US Dividend Advantage ETF will seek to achieve its investment objective by investing at least 65% of its net assets in a portfolio of exchange-traded equity securities of publicly traded U.S. companies with the potential for dividend growth.
(11) Under normal market conditions, the RiverFront Dynamic US Flex-Cap ETF will seek to achieve its investment objective by investing at least 65% of its net assets in a portfolio of exchange-traded equity securities of publicly traded U.S. companies.
(12) Each Fund may invest up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including securities that are offered pursuant to Rule 144A under the Securities Act deemed illiquid by the Adviser or Sub-Adviser.
(13) Not more than 10% of the net assets of a Fund in the aggregate invested in equity securities (other than non-exchange traded money market funds) shall consist of equity securities whose principal market is not a member of the ISG or party to a CSSA with the Exchange.
(14) Not more than 10% of the net assets of a Fund in the aggregate invested in futures contracts or options contracts shall consist of futures contracts or options contracts whose principal market is not a member of the ISG or is a market with which the Exchange does not have a CSSA.
(15) A Fund's investments in non-U.S. securities, including non-U.S. equity securities, may not exceed 20% of a Fund's net assets, plus the amount of any borrowings for investment purposes, under normal market conditions.
(16) A Fund may invest up to 10% of its net assets in equity securities traded OTC.
(17) The Funds will not invest in leveraged or leveraged inverse ETFs.
(18) A Fund's investments will be consistent with such Fund's investment
This approval order is based on all of the Exchange's representations, including those set forth above, in the Notice, and in Amendment No. 1. The Commission notes that the Funds and the Shares must comply with the requirements of NYSE Arca Equities Rule 8.600 to be initially and continuously listed and traded on the Exchange.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether Amendment No. 1 to the proposed rule change is consistent with the Exchange 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.
The Commission finds good cause to approve the proposed rule change, as modified by Amendment No. 1, prior to the 30th day after the date of publication of notice of Amendment No. 1 in the
Amendment No. 1 supplements the proposed rule change by, among other things, clarifying the scope of the Funds' permitted investments and investment restrictions and providing additional information about the availability of pricing information for the Funds' underlying assets. It also helps the Commission evaluate whether the listing and trading of the Shares of the Funds would be consistent with the protection of investors and the public interest.
Accordingly, the Commission finds good cause, pursuant to Section 19(b)(2) of the Exchange Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend its Price List, effective April 1, 2016, to adopt a rebate program for the NYSE BondsSM system. 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 amend its Price List, effective April 1, 2016, to adopt a rebate program for the NYSE Bonds system.
The Exchange currently charges an execution fee per bond for orders that take liquidity from the NYSE Bonds Book. For executions of one to 10 bonds, the Exchange charges $0.50 per bond; for executions of 11 to 25 bonds, the Exchange charges $0.20 per bond; and for executions of 26 bonds or more, the Exchange charges $0.10 per bond. The execution fees for bonds are subject to a $100.00 maximum fee per execution. The Exchange currently does not provide any rebates for bond transactions, other than rebates for bond liquidity providers that meet the requirements of Rule 88.
The Exchange proposes to adopt the Liquidity Provider Incentive Program, a voluntary rebate program relating to bonds pursuant to which the Exchange would pay Users
As proposed, the rebate amount would be tiered based on the number of CUSIPs quoted by a User, as follows:
To qualify for a rebate, a User would have to provide continuous two-sided quotes for at least eighty percent (80%) of the time during the Core Bond Trading Session
As an incentive for Users to opt in to the Liquidity Provider Incentive Program, the Exchange proposes a lower quoting requirement of 50% that would be applicable for the first calendar month after a User opts in. After the first calendar month, the User would be required to meet the 80% quoting requirement to receive a rebate. A User who first opts in, and who therefore would be subject to the 50% quoting requirement for the first calendar month, and then opts out, would not be entitled to the 50% quoting incentive if that User decides to opt in to the program again at a later date. The 50% quoting incentive would only be available to a User once for the first calendar month after the User first opts in to the Liquidity Provider Incentive Program.
Users that opt in to the Liquidity Provider Incentive Program would be subject to a transaction fee for orders that provide liquidity to the NYSE Bonds Book of $0.50 per bond, and for orders that take liquidity from the NYSE Bonds Book, the current tiered fees would apply,
The Liquidity Provider Incentive Program would be applicable on trading days, as determined by Securities Industry and Financial Markets Association (“SIFMA”),
As noted above, the Liquidity Provider Incentive Program would be voluntary and Users that wish to participate would be required to opt in by notifying the Exchange via electronic email. Users would be required to communicate to the Exchange their intention to opt in, or to opt out if they are already participating in the program, by the end of the Core Bond Trading Session on the first trading day of a calendar month.
The Exchange proposes that if a User meets the quoting requirements for a given month, that User would be entitled to a rebate that month. As proposed, the amount of the rebate would be based on the number of CUSIPs in which the User met the quoting requirement. For example, a User who opts in to the Liquidity Provider Incentive Program on the first trading day of the month and provides a two-sided quote in 500 CUSIPs, whose average maturity is at least five (5) years as of the quote date, for at least 50% of the time during the Core Bond Trading Session for that entire calendar month, would receive a rebate of $10,000 for that month. For subsequent months, this User would be required to provide a
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange also believes it is reasonable and equitable to charge a fee to Users who opt in to the proposed rebate program when they provide liquidity in bonds traded on the Exchange. The proposed maker fee is intended to offset the significant rebates proposed by the Exchange, which would increase as the number of CUSIPs quoted by a User increases. The Exchange further believes the proposed fee change is not unfairly discriminatory because all member organizations that opt in to the Liquidity Provider Incentive Program would be subject to the same fees.
Finally, recognizing the statements of Commissioners who have expressed concern about the state of the U.S. corporate and municipal bond markets as well as recommendations outlined in the Commission's release of its Report on the Municipal Securities Market (Report), the Exchange believes that amending the Exchange's transaction fees for the Bonds system would create an incentive for bonds traders to direct their liquidity to the Exchange, and therefore would be an important element in the democratization of the fixed income market.
The Exchange believes the proposed fee change is consistent with these principles and the proposed Liquidity Provider Incentive Program is intended to provide additional liquidity to the market and add competition to the existing group of liquidity providers. The Exchange believes that by requiring Users to quote within the prescribed parameters for a percentage of the regular trading day, and by paying them a rebate for providing liquidity in large number of bonds, the Exchange is rewarding aggressive liquidity providers in the market, and by doing so, the Exchange will encourage the additional utilization of, and interaction with, the NYSE and provide customers with the premier venue for price discovery, liquidity, and competitive quotes.
In accordance with Section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues that are not transparent. In such an environment, the Exchange must continually review, and consider adjusting its fees and rebates to remain competitive with other exchanges as well as with alternative trading systems and other venues that are not required to comply with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees and credits in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. As a result of all of these considerations, the Exchange does not believe that the proposed change will impair the ability of member organizations or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to 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.
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act, and under section 12(d)(1)(J) for an exemption from sections 12(d)(1)(A) and 12(d)(1)(B) of the Act.
Applicants request an order that would permit (a) series of certain open-end management investment companies to issue shares (“Shares”) redeemable in large aggregations only (“Creation Units”); (b) secondary market transactions in Shares to occur at negotiated market prices rather than at net asset value (“NAV”); (c) certain series to pay redemption proceeds, under certain circumstances, more than seven days after the tender of Shares for redemption; (d) certain affiliated persons of the series to deposit securities into, and receive securities from, the series in connection with the purchase and redemption of Creation Units; (e) certain registered management investment companies and unit investment trusts outside of the same group of investment companies as the series to acquire Shares; and (f) certain series to perform creations and redemptions of Creation Units in-kind in a master-feeder structure.
Nuveen ETF Trust (the “Trust”), Nuveen Fund Advisors, LLC (“Nuveen”), and Nuveen Securities, LLC.
The application was filed on October 2, 2015, and amended on November 17, 2015 and March 4, 2016.
An order granting the requested relief will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving applicants with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on May 9, 2016, and should be accompanied by proof of service on applicants, in the form of an affidavit, or for lawyers, a certificate of service. Pursuant to rule 0-5 under the Act, hearing requests should state the nature of the writer's interest, any facts bearing upon the desirability of a hearing on the matter, the reason for the request, and the issues contested. Persons who wish to be notified of a hearing may request notification by writing to the Commission's Secretary.
The Commission: Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: 333 West Wacker Drive, Chicago, IL 60606.
James D. McGinnis, Attorney-Advisor at (202) 551-3025, or Sara Crovitz, Assistant Chief Counsel, at (202) 551-6862 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete 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
1. The Trust is organized as a Massachusetts business trust. The Trust is, or will be prior to the commencement of operations of the initial series of the Trust (the “Initial Fund”), registered under the Act as an open-end management investment company.
2. Nuveen is registered as an investment adviser under the Investment Advisers Act of 1940 (the “Advisers Act”) and will be the investment adviser to the Initial Fund. Any other Adviser (defined below) will also be registered as an investment adviser under the Advisers Act. An Adviser may enter into sub-advisory agreements with one or more
3. The Trust will enter into a distribution agreement with one or more distributors. Each distributor for a Fund will be a broker-dealer (a “Broker”) registered under the Securities Exchange Act of 1934 (the “Exchange Act”) and will act as distributor and principal underwriter (a “Distributor”) of one or more of the Funds. The Distributor of any Fund may be an affiliated person, as defined in section 2(a)(3) of the Act (“Affiliated Person”), or an affiliated person of an Affiliated Person (“Second-Tier Affiliate”), of that Fund's Adviser and/or Sub-Advisers. No Distributor is or will be affiliated with any national securities exchange as defined in Section 2(a)(26) of the Act (an “Exchange”).
4. Applicants request that the order apply to the Initial Fund and any additional series of the Trust, and any other open-end management investment company or series thereof, that may be created in the future (“Future Funds”) that operate as an exchanged-traded fund (“ETF”) and track a specified index comprised of domestic or foreign equity and/or fixed income securities (each, an “Underlying Index”). Any Future Fund will (a) be advised by Nuveen or an entity controlling, controlled by, or under common control with Nuveen (each, an “Adviser”) and (b) comply with the terms and conditions of the application. The Initial Fund and Future Funds, together, are the “Funds.”
5. Applicants state that a Fund may operate as a feeder fund in a master-feeder structure (“Feeder Fund”). Applicants request that the order permit a Feeder Fund to acquire shares of another registered investment company in the same group of investment companies having substantially the same investment objectives as the Feeder Fund (“Master Fund”) beyond the limitations in section 12(d)(1)(A) of the Act and permit the Master Fund, and any principal underwriter for the Master Fund, to sell shares of the Master Fund to the Feeder Fund beyond the limitations in section 12(d)(1)(B) of the Act (“Master-Feeder Relief”). Applicants may structure certain Feeder Funds to generate economies of scale and incur lower overhead costs.
6. Each Fund, or its respective Master Fund, will hold certain securities, currencies, other assets and other investment positions (“Portfolio Holdings”) selected to correspond generally to the performance of its Underlying Index. Certain of the Funds will be based on Underlying Indexes that will be comprised solely of equity and/or fixed income securities issued by one or more of the following categories of issuers: (i) Domestic issuers and (ii) non-domestic issuers meeting the requirements for trading in U.S. markets. Other Funds will be based on Underlying Indexes that will be comprised solely of foreign and domestic, or solely foreign, equity and/or fixed income securities (“Foreign Funds”).
7. Applicants represent that each Fund, or its respective Master Fund, will invest at least 80% of its assets (excluding collateral held from secuities lending) in the component securities of its respective Underlying Index (“Component Securities”) and TBA Transactions,
8. Future Funds may seek to track Underlying Indexes constructed using 130/30 investment strategies (“130/30 Funds”) or other long/short investment strategies (“Long/Short Funds”). Each Long/Short Fund, or its respective Master Fund, will establish (i) exposures equal to approximately 100% of the long positions specified by the Long/Short Index
9. A Fund, or its respective Master Fund, will utilize either a replication or representative sampling strategy to track its Underlying Index. A Fund, or its respective Master Fund, using a replication strategy will invest in the Component Securities of its Underlying Index in the same approximate
10. The Initial Fund is, and any Future Fund will be, entitled to use its Underlying Index pursuant to either a licensing agreement with the entity that compiles, creates, sponsors or maintains the Underlying Index (each, an “Index Provider”) or a sub-licensing arrangement with the applicable Adviser, which has, or will have, a licensing agreement with such Index Provider.
11. Applicants recognize that Self-Indexing Funds could raise concerns regarding the potential ability of the Affiliated Index Provider to manipulate the Underlying Index to the benefit or detriment of the Self-Indexing Fund. Applicants further recognize the potential for conflicts that may arise with respect to the personal trading activity of personnel of the Affiliated Index Provider who have knowledge of changes to an Underlying Index prior to the time that information is publicly disseminated.
12. Applicants propose that each day that a Fund is open, including any day when it satisfies redemption requests as required by Section 22(e) of the Act(a “Business Day”), each Self-Indexing Fund will post on its Web site, before commencement of trading of Shares on the Exchange on which Shares are primarily listed (the “Listing Exchange”), the identities and quantities of the Portfolio Holdings that will form the basis for the Fund's calculation of its NAV at the end of the Business Day. Applicants believe that requiring Self-Indexing Funds, and their respective Master Funds, to maintain full portfolio transparency will provide an additional alternative mechanism for addressing any such potential conflicts of interest.
13. Applicants do not believe the potential for conflicts of interest raised by an Adviser's use of the Underlying Indexes in connection with the management of the Self-Indexing Funds, their respective Master Funds, and the Affiliated Accounts will be substantially different from the potential conflicts presented by an adviser managing two or more registered funds. Both the Act and the Advisers Act contain various protections to address conflicts of interest where an adviser is managing two or more registered funds and these protections will also help address these conflicts with respect to the Self-Indexing Funds.
14. Each Adviser and any Sub-Adviser has adopted or will adopt, pursuant to Rule 206(4)-7 under the Advisers Act, written policies and procedures designed to prevent violations of the Advisers Act and the rules thereunder. These include policies and procedures designed to minimize potential conflicts of interest among the Self-Indexing Funds, their respective Master Funds, and the Affiliated Accounts, such as cross trading policies, as well as those designed to ensure the equitable allocation of portfolio transactions and brokerage commissions. In addition, Nuveen has adopted policies and procedures as required under section 204A of the Advisers Act, which are reasonably designed in light of the nature of its business to prevent the misuse, in violation of the Advisers Act or the Exchange Act or the rules thereunder, of material non-public information by Nuveen or associated persons (“Inside Information Policy”). Any other Adviser and/or Sub-Adviser will be required to adopt and maintain a similar Inside Information Policy. In accordance with the Code of Ethics
15. To the extent the Self-Indexing Funds, or their respective Master Funds, transact with an Affiliated Person of an Adviser or Sub-Adviser, such transactions will comply with the Act, the rules thereunder and the terms and conditions of the requested order. In this regard, each Self-Indexing Fund's board of directors or trustees (“Board”) will periodically review the Self-Indexing Fund's use of an Affiliated Index Provider. Subject to the approval of the Self-Indexing Fund's Board, an Adviser, Affiliated Persons of the Adviser (“Adviser Affiliates”) and
16. The Shares of each Fund will be purchased and redeemed in Creation Units and generally on an in-kind basis. Except where the purchase or redemption will include cash under the limited circumstances specified below, purchasers will be required to purchase Creation Units by making an in-kind deposit of specified instruments (“Deposit Instruments”), and shareholders redeeming their Shares will receive an in-kind transfer of specified instruments (“Redemption Instruments”).
17. Purchases and redemptions of Creation Units may be made in whole or in part on a cash basis, rather than in kind, solely under the following circumstances: (a) To the extent there is a Cash Amount; (b) if, on a given Business Day, the Fund announces before the open of trading that all purchases, all redemptions or all purchases and redemptions on that day will be made entirely in cash; (c) if, upon receiving a purchase or redemption order from an Authorized Participant, the Fund determines to require the purchase or redemption, as applicable, to be made entirely in cash;
18. Creation Units will consist of specified large aggregations of Shares,
19. Each Business Day, before the open of trading on the Listing Exchange, each Fund will cause to be published through the NSCC the names and quantities of the instruments comprising the Deposit Instruments and the Redemption Instruments, as well as the estimated Cash Amount (if any), for that day. The list of Deposit Instruments and Redemption Instruments will apply until a new list is announced on the following Business Day, and there will be no intra-day changes to the list except to correct errors in the published
20. Transaction expenses, including operational processing and brokerage costs, will be incurred by a Fund when investors purchase or redeem Creation Units in-kind and such costs have the potential to dilute the interests of the Fund's existing shareholders. Each Fund will impose purchase or redemption transaction fees (“Transaction Fees”) in connection with effecting such purchases or redemptions of Creation Units. With respect to Feeder Funds, the Transaction Fee would be paid indirectly to the Master Fund.
21. Shares of each Fund will be listed and traded individually on an Exchange. It is expected that one or more member firms of an Exchange will be designated to act as a market maker (each, a “Market Maker”) and maintain a market for Shares trading on the Exchange. Prices of Shares trading on an Exchange will be based on the current bid/offer market. Transactions involving the sale of Shares on an Exchange will be subject to customary brokerage commissions and charges.
22. Applicants expect that purchasers of Creation Units will include institutional investors and arbitrageurs. Market Makers, acting in their roles to provide a fair and orderly secondary market for the Shares, may from time to time find it appropriate to purchase or redeem Creation Units. Applicants expect that secondary market purchasers of Shares will include both institutional and retail investors.
23. Shares will not be individually redeemable, and owners of Shares may acquire those Shares from the Fund, or tender such Shares for redemption to the Fund, in Creation Units only. To redeem, an investor must accumulate enough Shares to constitute a Creation Unit. Redemption requests must be placed by or through an Authorized Participant. A redeeming investor will pay a Transaction Fee, calculated in the same manner as a Transaction Fee payable in connection with purchases of Creation Units.
24. Neither the Trust nor any Fund will be advertised or marketed or otherwise held out as a traditional open-end investment company or a “mutual fund.” Instead, each such Fund will be marketed as an “ETF.” All marketing materials that describe the features or method of obtaining, buying or selling Creation Units, or Shares traded on an Exchange, or refer to redeemability, will prominently disclose that Shares are not individually redeemable and will disclose that the owners of Shares may acquire those Shares from the Fund or tender such Shares for redemption to the Fund in Creation Units only. The Funds will provide copies of their annual and semi-annual shareholder reports to DTC Participants for distribution to beneficial owners of Shares.
1. Applicants request an order under section 6(c) of the Act for an exemption from sections 2(a)(32), 5(a)(1), 22(d), and 22(e) of the Act and rule 22c-1 under the Act, under section 12(d)(1)(J) of the Act for an exemption from sections 12(d)(1)(A) and (B) of the Act, and under sections 6(c) and 17(b) of the Act for an exemption from sections 17(a)(1) and 17(a)(2) of the Act.
2. Section 6(c) of the Act provides that the Commission may exempt any person, security or transaction, or any class of persons, securities or transactions, from any provision of the Act, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Section 17(b) of the Act authorizes the Commission to exempt a proposed transaction from section 17(a) of the Act if evidence establishes that the terms of the transaction, including the consideration to be paid or received, are reasonable and fair and do not involve overreaching on the part of any person concerned, and the proposed transaction is consistent with the policies of the registered investment company and the general provisions of the Act. Section 12(d)(1)(J) of the Act provides that the Commission may exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provisions of section 12(d)(1) if the exemption is consistent with the public interest and the protection of investors.
3. Section 5(a)(1) of the Act defines an “open-end company” as a management investment company that is offering for sale or has outstanding any redeemable security of which it is the issuer. Section 2(a)(32) of the Act defines a redeemable security as any security, other than short-term paper, under the terms of which the owner, upon its presentation to the issuer, is entitled to receive approximately a proportionate share of the issuer's current net assets, or the cash equivalent. Because Shares will not be individually redeemable, applicants request an order that would permit the Funds to register as open-end management investment companies and issue Shares that are redeemable in Creation Units only.
4. Section 22(d) of the Act, among other things, prohibits a dealer from selling a redeemable security that is currently being offered to the public by or through an underwriter, except at a current public offering price described in the prospectus. Rule 22c-1 under the Act generally requires that a dealer selling, redeeming or repurchasing a redeemable security do so only at a price based on its NAV. Applicants state that secondary market trading in Shares will take place at negotiated prices, not at a current offering price described in a Fund's prospectus, and not at a price based on NAV. Thus, purchases and sales of Shares in the secondary market will not comply with section 22(d) of the Act and rule 22c-1 under the Act. Applicants request an exemption under section 6(c) from these provisions.
5. Applicants assert that the concerns sought to be addressed by section 22(d) of the Act and rule 22c-1 under the Act with respect to pricing are equally satisfied by the proposed method of pricing Shares. Applicants maintain that while there is little legislative history regarding section 22(d), its provisions, as well as those of rule 22c-1, appear to have been designed to (a) prevent dilution caused by certain riskless-trading schemes by principal underwriters and contract dealers, (b) prevent unjust discrimination or preferential treatment among buyers, and (c) ensure an orderly distribution of investment company shares by eliminating price competition from dealers offering shares at less than the published sales price and repurchasing shares at more than the published redemption price.
6. Applicants believe that none of these purposes will be thwarted by permitting Shares to trade in the secondary market at negotiated prices. Applicants state that (a) secondary market trading in Shares does not involve a Fund as a party and will not result in dilution of an investment in Shares, and (b) to the extent different prices exist during a given trading day, or from day to day, such variances occur as a result of third-party market forces, such as supply and demand. Therefore, applicants assert that secondary market transactions in Shares will not lead to discrimination or preferential treatment among purchasers. Finally, applicants contend that the price at which Shares trade will be disciplined by arbitrage opportunities created by the option continually to purchase or redeem Shares in Creation Units, which should help prevent Shares from trading at a material discount or premium in relation to their NAV.
7. Section 22(e) of the Act generally prohibits a registered investment company from suspending the right of redemption or postponing the date of payment of redemption proceeds for more than seven days after the tender of a security for redemption. Applicants state that settlement of redemptions for Foreign Funds will be contingent not only on the settlement cycle of the United States market, but also on current delivery cycles in local markets for the underlying foreign securities held by a Foreign Fund. Applicants state that the delivery cycles currently practicable for transferring Redemption Instruments to redeeming investors, coupled with local market holiday schedules, may require a delivery process of up to fifteen (15) calendar days.
8. Applicants believe that Congress adopted section 22(e) to prevent unreasonable, undisclosed or unforeseen delays in the actual payment of redemption proceeds. Applicants propose that allowing redemption payments for Creation Units of a Foreign Fund to be made within fifteen calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants suggest that a redemption payment occurring within fifteen calendar days following a redemption request would adequately afford investor protection.
9. Applicants are not seeking relief from section 22(e) with respect to Foreign Funds that do not effect creations and redemptions of Creation Units in-kind.
10. Section 12(d)(1)(A) of the Act prohibits a registered investment company from acquiring securities of an investment company if such securities represent more than 3% of the total outstanding voting stock of the acquired company, more than 5% of the total assets of the acquiring company, or, together with the securities of any other investment companies, more than 10% of the total assets of the acquiring company. Section 12(d)(1)(B) of the Act prohibits a registered open-end investment company, its principal underwriter and any other broker-dealer from knowingly selling the investment company's shares to another investment company if the sale will cause the acquiring company to own more than 3% of the acquired company's voting stock, or if the sale will cause more than 10% of the acquired company's voting stock to be owned by investment companies generally.
11. Applicants request an exemption to permit registered management investment companies and unit investment trusts (“UITs”) that are not advised or sponsored by the Advisers and are not part of the same “group of investment companies,” as defined in section 12(d)(1)(G)(ii) of the Act as the Funds (such management investment companies are referred to as “Investing Management Companies,” such UITs are referred to as “Investing Trusts,” and Investing Management Companies and Investing Trusts are collectively referred to as “Funds of Funds”), to acquire Shares beyond the limits of section 12(d)(1)(A) of the Act; and the Funds, and any principal underwriter for the Funds, and/or any Broker registered under the Exchange Act, to sell Shares to Funds of Funds beyond the limits of section 12(d)(1)(B) of the Act.
12. Each Investing Management Company will be advised by an investment adviser within the meaning of section 2(a)(20)(A) of the Act (the “Fund of Funds Adviser”) and may be sub-advised by investment advisers within the meaning of section 2(a)(20)(B) of the Act (each a “Fund of Funds Sub-Adviser”). Any investment adviser to an Investing Management Company will be registered under the Advisers Act. Each Investing Trust will be sponsored by a sponsor (“Sponsor”).
13. Applicants submit that the proposed conditions to the requested relief adequately address the concerns underlying the limits in sections 12(d)(1)(A) and (B), which include concerns about undue influence by a fund of funds over underlying funds, excessive layering of fees and overly complex fund structures. Applicants believe that the requested exemption is consistent with the public interest and the protection of investors.
14. Applicants believe that neither a Fund of Funds nor a Fund of Funds Affiliate would be able to exert undue influence over a Fund.
15. Applicants propose other conditions to limit the potential for undue influence over the Funds, including that no Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Fund) will cause a Fund to purchase a security in an offering of securities during the existence of an underwriting or selling syndicate of which a principal underwriter is an Underwriting Affiliate (“Affiliated Underwriting”). An “Underwriting Affiliate” is a principal underwriter in any underwriting or selling syndicate that is an officer, director, member of an advisory board, Fund of Funds Adviser, Fund of Funds Sub-Adviser, employee or Sponsor of the Fund of Funds, or a person of which any such officer, director, member of an advisory board, Fund of Funds Adviser or Fund of Funds Sub-Adviser, employee or Sponsor is an affiliated person (except that any person whose relationship to the Fund is covered by section 10(f) of the Act is not an Underwriting Affiliate).
16. Applicants do not believe that the proposed arrangement will involve excessive layering of fees. The board of directors or trustees of any Investing Management Company, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“disinterested directors or trustees”), will find that the advisory fees charged under the contract are based on services provided that will be in addition to, rather than duplicative of, services provided under the advisory contract of any Fund, or its respective Master Fund, in which the Investing Management Company may invest. In addition, a Fund of Funds Adviser, or a Fund of Funds' trustee or Sponsor, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Fund, or its respective Master Fund, under rule 12b-1 under the Act) received from a Fund by the Fund of Funds Adviser, trustee or Sponsor or an affiliated person of the Fund of Funds Adviser, trustee or Sponsor, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor or its affiliated person by a Fund, in connection with the investment by the Fund of Funds in the Fund. Applicants state that any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
17. Applicants submit that the proposed arrangement will not create an overly complex fund structure. Applicants note that no Fund, nor its respective Master Fund, will acquire securities of any investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent permitted by exemptive relief from the Commission permitting the Fund, or its respective Master Fund, to purchase shares of other investment companies for short-term cash management purposes or pursuant to the Master-Feeder Relief. To ensure a Fund of Funds is aware of the terms and conditions of the requested order, the Fund of Funds will enter into an agreement with the Fund (“FOF Participation Agreement”). The FOF Participation Agreement will include an acknowledgement from the Fund of Funds that it may rely on the order only to invest in the Funds and not in any other investment company.
18. Applicants also note that a Fund may choose to reject any direct purchase of Shares in Creation Units by a Fund of Funds. To the extent that a Fund of Funds purchases Shares in the secondary market, a Fund would still retain its ability to reject any initial investment by a Fund of Funds in excess of the limits of section 12(d)(1)(A) by declining to enter into a FOF Participation Agreement with the Fund of Funds.
19. Applicants also are seeking the Master-Feeder Relief to permit the Feeder Funds to perform creations and redemptions of Shares in-kind in a master-feeder structure. Applicants assert that this structure is substantially identical to traditional master-feeder structures permitted pursuant to the exception provided in section 12(d)(1)(E) of the Act. Section 12(d)(1)(E) provides that the percentage limitations of section 12(d)(1)(A) and (B) shall not apply to a security issued by an investment company (in this case, the shares of the applicable Master Fund) if, among other things, that security is the only investment security held by the investing investment company (in this case, the Feeder Fund). Applicants believe the proposed master-feeder structure complies with section 12(d)(1)(E) because each Feeder Fund will hold only investment securities issued by its corresponding Master Fund; however, the Feeder Funds may receive securities other than securities of its corresponding Master Fund if a Feeder Fund accepts an in-kind creation. To the extent that a Feeder Fund may be deemed to be holding both shares of the Master Fund and other securities, applicants request relief from section 12(d)(1)(A) and (B). The Feeder Funds would operate in compliance with all other provisions of section 12(d)(1)(E).
20. Sections 17(a)(1) and (2) of the Act generally prohibit an affiliated person of a registered investment company, or an affiliated person of such a person, from selling any security to or purchasing any security from the company. Section 2(a)(3) of the Act defines “affiliated person” of another person to include (a) any person directly or indirectly owning, controlling or holding with power to vote 5% or more of the outstanding voting securities of the other person, (b) any person 5% or more of whose outstanding voting securities are directly or indirectly owned, controlled or held with the power to vote by the other person, and (c) any person directly or indirectly controlling, controlled by or under common control with the other person. Section 2(a)(9) of the Act defines “control” as the power to exercise a controlling influence over the management or policies of a company, and provides that a control relationship will be presumed where one person owns more than 25% of a company's voting securities. The Funds may be deemed to be controlled by an Adviser or an entity controlling, controlled by or under common control with an Adviser and hence affiliated persons of each other. In addition, the Funds may be deemed to be under common control with any other registered investment company (or series thereof) advised by an Adviser or an entity controlling, controlled by or under common control with an Adviser (an “Affiliated Fund”). Any investor, including Market Makers, owning 5% or holding in excess of 25% of the Trust or such Funds, may be deemed affiliated persons of the Trust or such Funds. In addition, an investor could own 5% or more, or in excess of 25% of the outstanding shares of one or more Affiliated Funds making that investor a Second-Tier Affiliate of the Funds.
21. Applicants request an exemption from sections 17(a)(1) and 17(a)(2) of the Act pursuant to sections 6(c) and 17(b) of the Act to permit persons that are Affiliated Persons of the Funds, or Second-Tier Affiliates of the Funds, solely by virtue of one or more of the following: (a) Holding 5% or more, or in excess of 25%, of the outstanding Shares of one or more Funds; (b) an affiliation with a person with an ownership interest described in (a); or (c) holding 5% or more, or more than 25%, of the shares of one or more Affiliated Funds, to effectuate purchases and redemptions “in-kind.”
22. Applicants assert that no useful purpose would be served by prohibiting such affiliated persons from making “in-kind” purchases or “in-kind” redemptions of Shares of a Fund in Creation Units. Both the deposit procedures for “in-kind” purchases of Creation Units and the redemption procedures for “in-kind” redemptions of Creation Units will be effected in exactly the same manner for all purchases and redemptions, regardless of size or number. There will be no discrimination between purchasers or redeemers. Deposit Instruments and Redemption Instruments for each Fund will be valued in the identical manner as those Portfolio Holdings currently held by such Fund and the valuation of the Deposit Instruments and Redemption Instruments will be made in an identical manner regardless of the identity of the purchaser or redeemer. Applicants do not believe that “in-kind” purchases and redemptions will result in abusive self-dealing or overreaching, but rather assert that such procedures will be implemented consistently with each Fund's objectives and with the general purposes of the Act. Applicants believe that “in-kind” purchases and redemptions will be made on terms reasonable to applicants and any affiliated persons because they will be valued pursuant to verifiable objective standards. The method of valuing Portfolio Holdings held by a Fund is identical to that used for calculating “in-kind” purchase or redemption values and therefore creates no opportunity for affiliated persons or Second-Tier Affiliates of applicants to effect a transaction detrimental to the other holders of Shares of that Fund. Similarly, applicants submit that, by using the same standards for valuing Portfolio Holdings held by a Fund as are used for calculating “in-kind” redemptions or purchases, the Fund will ensure that its NAV will not be adversely affected by such securities transactions. Applicants also note that the ability to take deposits and make redemptions “in-kind” will help each Fund to track closely its Underlying Index and therefore aid in achieving the Fund's objectives.
23. Applicants also seek relief under sections 6(c) and 17(b) from section 17(a) to permit a Fund that is an affiliated person, or an affiliated person of an affiliated person, of a Fund of Funds to sell its Shares to and redeem its Shares from a Fund of Funds, and to engage in the accompanying in-kind transactions with the Fund of Funds.
24. To the extent that a Fund operates in a master-feeder structure, applicants also request relief permitting the Feeder Funds to engage in in-kind creations and redemptions with the applicable Master Fund. Applicants state that the customary section 17(a)(1) and 17(a)(2) relief would not be sufficient to permit such transactions because the Feeder Funds and the applicable Master Fund could also be affiliated by virtue of having the same investment adviser. However, applicants believe that in-kind creations and redemptions between a Feeder Fund and a Master Fund advised by the same investment adviser do not involve “overreaching” by an affiliated person. Such transactions will occur only at the Feeder Fund's proportionate share of the Master Fund's net assets, and the distributed securities will be valued in the same manner as they are valued for the purposes of calculating the
Applicants agree that any order of the Commission granting the requested relief will be subject to the following conditions:
1. The requested relief to permit ETF operations will expire on the effective date of any Commission rule under the Act that provides relief permitting the operation of index-based ETFs.
2. As long as a Fund operates in reliance on the requested order, the Shares of such Fund will be listed on an Exchange.
3. Neither the Trust nor any Fund will be advertised or marketed as an open-end investment company or a mutual fund. Any advertising material that describes the purchase or sale of Creation Units or refers to redeemability will prominently disclose that Shares are not individually redeemable and that owners of Shares may acquire those Shares from the Fund and tender those Shares for redemption to a Fund in Creation Units only.
4. The Web site, which is and will be publicly accessible at no charge, will contain, on a per Share basis for each Fund, the prior Business Day's NAV and the market closing price or the midpoint of the bid/ask spread at the time of the calculation of such NAV (“Bid/Ask Price”), and a calculation of the premium or discount of the market closing price or Bid/Ask Price against such NAV.
5. Each Self-Indexing Fund, Long/Short Fund and 130/30 Fund will post on the Web site on each Business Day, before commencement of trading of Shares on the Exchange, the Fund's, or its respective Master Fund's, Portfolio Holdings.
6. No Adviser or any Sub-Adviser to a Self-Indexing Fund, directly or indirectly, will cause any Authorized Participant (or any investor on whose behalf an Authorized Participant may transact with the Fund) to acquire any Deposit Instrument for a Fund, or its respective Master Fund, through a transaction in which a Fund, or its respective Master Fund, could not engage directly.
1. The members of a Fund of Funds' Advisory Group will not control (individually or in the aggregate) a Fund, or its respective Master Fund, within the meaning of section 2(a)(9) of the Act. The members of a Fund of Funds' Sub-Advisory Group will not control (individually or in the aggregate) a Fund, or its respective Master Fund, within the meaning of section 2(a)(9) of the Act. If, as a result of a decrease in the outstanding voting securities of a Fund, the Fund of Funds' Advisory Group or the Fund of Funds' Sub-Advisory Group, each in the aggregate, becomes a holder of more than 25 percent of the outstanding voting securities of a Fund, it will vote its Shares of the Fund in the same proportion as the vote of all other holders of the Fund's Shares. This condition does not apply to the Fund of Funds' Sub-Advisory Group with respect to a Fund, or its respective Master Fund, for which the Fund of Funds' Sub-Adviser or a person controlling, controlled by or under common control with the Fund of Funds' Sub-Adviser acts as the investment adviser within the meaning of section 2(a)(20)(A) of the Act.
2. No Fund of Funds or Fund of Funds Affiliate will cause any existing or potential investment by the Fund of Funds in a Fund to influence the terms of any services or transactions between the Fund of Funds or Fund of Funds Affiliate and the Fund, its respective Master Fund, or a Fund Affiliate.
3. The board of directors or trustees of an Investing Management Company, including a majority of the disinterested directors or trustees, will adopt procedures reasonably designed to ensure that the Fund of Funds Adviser and Fund of Funds Sub-Adviser are conducting the investment program of the Investing Management Company without taking into account any consideration received by the Investing Management Company or a Fund of Funds Affiliate from a Fund, its respective Master Fund, or Fund Affiliate in connection with any services or transactions.
4. Once an investment by a Fund of Funds in the securities of a Fund exceeds the limits in section 12(d)(1)(A)(i) of the Act, the Board of the Fund, or its respective Master Fund, including a majority of the directors or trustees who are not “interested persons” within the meaning of section 2(a)(19) of the Act (“non-interested Board members”), will determine that any consideration paid by the Fund, or its respective Master Fund, to the Fund of Funds or a Fund of Funds Affiliate in connection with any services or transactions: (i) Is fair and reasonable in relation to the nature and quality of the services and benefits received by the Fund, or its respective Master Fund; (ii) is within the range of consideration that the Fund would be required to pay to another unaffiliated entity in connection with the same services or transactions; and (iii) does not involve overreaching on the part of any person concerned. This condition does not apply with respect to any services or transactions between a Fund, or its respective Master Fund, and its investment adviser(s), or any person controlling, controlled by or under common control with such investment adviser(s).
5. The Fund of Funds Adviser, or trustee or Sponsor of an Investing Trust, as applicable, will waive fees otherwise payable to it by the Fund of Funds in an amount at least equal to any compensation (including fees received pursuant to any plan adopted by a Fund, or its respective Master Fund, under rule 12b-l under the Act) received from a Fund, or its respective Master Fund, by the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, or an affiliated person of the Fund of Funds Adviser, or trustee or Sponsor of the Investing Trust, other than any advisory fees paid to the Fund of Funds Adviser, trustee or Sponsor of an Investing Trust, or its affiliated person by the Fund, or its respective Master Fund, in connection with the investment by the Fund of Funds in the Fund. Any Fund of Funds Sub-Adviser will waive fees otherwise payable to the Fund of Funds Sub-Adviser, directly or indirectly, by the Investing Management Company in an amount at least equal to any compensation received from a Fund, or its respective Master Fund, by the Fund of Funds Sub-Adviser, or an affiliated person of the Fund of Funds Sub-Adviser, other than any advisory fees paid to the Fund of Funds Sub-Adviser or its affiliated person by the Fund, or its respective Master Fund, in connection with the investment by the Investing Management Company in the Fund made at the direction of the Fund of Funds Sub-Adviser. In the event that the Fund of Funds Sub-Adviser waives fees, the benefit of the waiver will be
6. No Fund of Funds or Fund of Funds Affiliate (except to the extent it is acting in its capacity as an investment adviser to a Fund) will cause a Fund, or its respective Master Fund, to purchase a security in any Affiliated Underwriting.
7. The Board of a Fund, or its respective Master Fund, including a majority of the non-interested Board members, will adopt procedures reasonably designed to monitor any purchases of securities by the Fund, or its respective Master Fund, in an Affiliated Underwriting, once an investment by a Fund of Funds in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, including any purchases made directly from an Underwriting Affiliate. The Board will review these purchases periodically, but no less frequently than annually, to determine whether the purchases were influenced by the investment by the Fund of Funds in the Fund. The Board will consider, among other things: (i) Whether the purchases were consistent with the investment objectives and policies of the Fund, or its respective Master Fund; (ii) how the performance of securities purchased in an Affiliated Underwriting compares to the performance of comparable securities purchased during a comparable period of time in underwritings other than Affiliated Underwritings or to a benchmark such as a comparable market index; and (iii) whether the amount of securities purchased by the Fund, or its respective Master Fund, in Affiliated Underwritings and the amount purchased directly from an Underwriting Affiliate have changed significantly from prior years. The Board will take any appropriate actions based on its review, including, if appropriate, the institution of procedures designed to ensure that purchases of securities in Affiliated Underwritings are in the best interest of shareholders of the Fund.
8. Each Fund, or its respective Master Fund, will maintain and preserve permanently in an easily accessible place a written copy of the procedures described in the preceding condition, and any modifications to such procedures, and will maintain and preserve for a period of not less than six years from the end of the fiscal year in which any purchase in an Affiliated Underwriting occurred, the first two years in an easily accessible place, a written record of each purchase of securities in Affiliated Underwritings once an investment by a Fund of Funds in the securities of the Fund exceeds the limit of section 12(d)(1)(A)(i) of the Act, setting forth from whom the securities were acquired, the identity of the underwriting syndicate's members, the terms of the purchase, and the information or materials upon which the Board's determinations were made.
9. Before investing in a Fund in excess of the limit in section 12(d)(1)(A), a Fund of Funds and the Trust will execute a FOF Participation Agreement stating without limitation that their respective boards of directors or trustees and their investment advisers, or trustee and Sponsor, as applicable, understand the terms and conditions of the order, and agree to fulfill their responsibilities under the order. At the time of its investment in Shares of a Fund in excess of the limit in section 12(d)(1)(A)(i), a Fund of Funds will notify the Fund of the investment. At such time, the Fund of Funds will also transmit to the Fund a list of the names of each Fund of Funds Affiliate and Underwriting Affiliate. The Fund of Funds will notify the Fund of any changes to the list of the names as soon as reasonably practicable after a change occurs. The Fund and the Fund of Funds will maintain and preserve a copy of the order, the FOF Participation Agreement, and the list with any updated information for the duration of the investment and for a period of not less than six years thereafter, the first two years in an easily accessible place.
10. Before approving any advisory contract under section 15 of the Act, the board of directors or trustees of each Investing Management Company including a majority of the disinterested directors or trustees, will find that the advisory fees charged under such contract are based on services provided that will be in addition to, rather than duplicative of, the services provided under the advisory contract(s) of any Fund, or its respective Master Fund, in which the Investing Management Company may invest. These findings and their basis will be fully recorded in the minute books of the appropriate Investing Management Company.
11. Any sales charges and/or service fees charged with respect to shares of a Fund of Funds will not exceed the limits applicable to a fund of funds as set forth in NASD Conduct Rule 2830.
12. No Fund, or its respective Master Fund, will acquire securities of an investment company or company relying on section 3(c)(1) or 3(c)(7) of the Act in excess of the limits contained in section 12(d)(1)(A) of the Act, except to the extent (i) the Fund, or its respective Master Fund, acquires securities of another investment company pursuant to exemptive relief from the Commission permitting the Fund, or its respective Master Fund, to acquire securities of one or more investment companies for short-term cash management purposes or (ii) the Fund acquires securities of the Master Fund pursuant to the Master-Feeder Relief.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The OPRA Plan amendment revised the OPRA Fee Schedule to establish OPRA's Professional Subscriber Device-Based Fee and made conforming changes in OPRA's Enterprise Rate Professional Subscriber Fee. OPRA's Enterprise Rate Professional Subscriber Fee is available to those Professional Subscribers that elect that rate in place of the regular OPRA device-based fees.
Specifically, effective January 1, 2016, the OPRA Plan Amendment: increased the current $28.50 monthly per device fee by $1.00; increased the Enterprise Rate, from a monthly fee of $28.50 times the number of a Professional Subscriber's U.S.-based registered representatives, to a monthly fee of $29.50 times the number of the Subscriber's U.S.-based registered representatives; and made conforming changes to the minimum monthly fee under the Enterprise Rate. “Professional Subscribers” are persons who subscribe to OPRA data, do not qualify for the reduced fees charged to “Nonprofessional Subscribers,” and do not redistribute the OPRA data to third parties. OPRA permits the counting of “User IDs” as a surrogate for counting “devices” for purposes of its Professional Subscriber Device-based Fees.
The number of devices reported to OPRA as subject to Professional Subscriber Device-Based Fees has been steadily trending downwards over many years. In 2008, OPRA received device-based fees, including enterprise fees, with respect to approximately 210,500 devices. In 2014, OPRA received device-based fees, including enterprise fees, with respect to approximately 148,400 devices. OPRA was receiving device-based fees in the third calendar quarter of 2015 with respect to approximately 134,000 devices—already a reduction of approximately 9.7% from 2014. OPRA believes that this long-term downward trend is the result of the increasing use of trading algorithms and automated trading platforms and other fundamental changes in the securities industry, and OPRA anticipates that this trend is likely to continue.
The increase in the Professional Subscriber Device-Based Fees is consistent with OPRA's past practice of making incremental $1.00 increases in its monthly Professional Subscriber Device-Based Fees.
The text of the amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, the OPRA Web site at
Pursuant to paragraph (b)(3)(i) of Rule 608 of Regulation NMS under the Act, OPRA designated this amendment as establishing or changing fees or other charges collected on behalf of all of the OPRA participants in connection with access to or use of OPRA facilities. OPRA put the change in the Professional Subscriber Device-Based Fee into effect as of January 1, 2016.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the OPRA Plan amendment is consistent with the Act.
• 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.
By the Commission.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”
The purpose of the amendment is to amend the OPRA Fee Schedule to revise the structure and the amounts of OPRA fees for “Non-Display” use of OPRA Data. “Non-Display” use of OPRA data is use of the OPRA data for a purpose other than the display of the data to natural persons or in support of the display of the data or the internal or external redistribution of the data.
OPRA first implemented “Non-Display Application Fees” in 2012.
In 2014, the Consolidated Tape Association (“CTA”) Plan and Consolidated Quotation (“CQ”) Plan participants (collectively, the “CTA/CQ Plan Participants”) proposed to amend the CTA Plan and the CQ Plan (collectively the “CTA/CQ Plans”) to implement fees for Non-Display use of the market data disseminated pursuant to the CTA/CQ Plans.
The OPRA Plan amendment comprehensively revised the structure of OPRA's Non-Display fees so that OPRA's fee structure parallels the Non-Display fee structures implemented by the CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee. In addition, the OPRA Plan amendment revised the amounts of OPRA's Non-Display fees.
The CTA/CQ Plan Participants have defined the term “Non-Display Use,” with respect to the market data disseminated pursuant to the CTA/CQ Plans as referring to “accessing, processing or consuming real-time Network A or Network B quotation information or last sale price information, whether delivered via direct and/or redistributor data feeds, for a purpose other than in support of a data recipient's display or further internal or external redistribution.”
These definitions are broader than OPRA's prior definition of the term “Non-Display Application” which, as noted above, encompassed only “applications . . . used for purposes of generating orders and/or quotations on an automated basis. . . .” For example, the CTA/CQ Plan and Nasdaq/UTP definitions specifically include within their definitions of the term “Non-Display Use” use of their respective datasets for price referencing for smart order routing, operations control programs, investment analysis, order verification, surveillance programs, risk management, compliance and portfolio valuation purposes.
The OPRA Plan amendment replaced the definition of “Non-Display Application” with a definition of the term “Non-Display Use” that parallels the definitions implemented by the CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee. Specifically, the OPRA Plan amendment defined the term “Non-Display Use” as follows:
Non-Display Use refers to the accessing, processing or consuming by an OPRA data feed recipient (either an OPRA vendor or an OPRA professional subscriber) of OPRA market data received on a current basis, whether delivered via data feed directly from OPRA's processor and/or indirect data feed from an OPRA vendor, for a purpose other than in support of the data feed recipient's display or further internal or external redistribution. Non-Display Use includes, without limitation, trading (such as in a “black box” or a trading engine that performs automated trading, algorithmic trading or program trading, or generates arbitrage or program trading orders); automated order or quote generation and/or order pegging; price referencing for algorithmic trading; operations control programs; investment analysis; order verification; surveillance programs; risk management; compliance; and portfolio valuation.
The CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee have each established three “categories” of Non-Display Use. Using the nomenclature established by the CTA/CQ Plan Participants, the three categories are as follows:
Category 1 applies when a data recipient makes non-display uses of real time market data on its own behalf.
Category 2 applies when a data recipient makes non-display uses of real time market data on behalf of its clients.
Category 3 applies when a data recipient makes non-display uses of real time market data for the purpose of internally matching buy and sell orders within the data feed recipient. Category 3 includes matching buy and sell orders on a data recipient's own behalf and/or on behalf of its clients. Category 3 includes, but is not restricted to, use in trading platform(s), such as exchanges, alternative trading systems (“ATSs”), broker crossing networks, broker crossing systems not filed as ATSs, dark pools, multilateral trading facilities, and systematic internalization systems.
The OPRA Plan amendment adopted the three categories of Non-Display Use that have been implemented by the CTA/CQ Plans and the Nasdaq/UTP Plan.
For the first two of these categories of Non-Display Use (“Category 1” and “Category 2” in the CTA/CQ nomenclature), the CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee have established fees on an “Enterprise” basis, so that a recipient of the market data pays only one “Category 1” fee if it makes any Non-Display Use of the market data in Category 1, and only one “Category 2” fee if it makes any Non-Display Use of the market data in Category 2.
For the third of these categories of Non-Display Use (“Category 3” in the CTA/CQ nomenclature), the CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee have established fees on a “per platform” basis. That is, a recipient of the market data is required to pay a fee for Category 3 Non-Display Use on each “platform” that is used for internally matching buy and sell orders.
As is the case with respect to the CTA/CQ Non-Display Use fees and the Nasdaq/UTP Non-Display Use fees, an OPRA data recipient may use OPRA data for one, two or all three categories and therefore be subject to non-display fees for one, two or all three categories. For example, if a broker-dealer uses OPRA data to run compliance programs for the firm (Category 1), to conduct investment analysis on behalf of its customers (Category 2), and to operate an ATS that matches buy and sell orders (Category 3), then the firm would be required to pay OPRA non-display use fees in respect of all three categories.
In order to minimize the administrative burden associated with their Non-Display Use fees, the CTA/CQ Plan Participants and the Nasdaq/UTP Plan Operating Committee do not impose monthly reporting requirements in respect of their Non-Display Use fees, and instead require each recipient of a real-time data feed to make an initial declaration with respect to its Non-Display Use of their respective datasets, a declaration with respect to any changes in its Non-Display Use of their respective datasets, and an annual declaration of its non-display use.
The OPRA Plan amendment adopted fees for Non-Display Use as follows: A monthly fee of $2,000/Enterprise for Category 1 Non-Display Use; a monthly fee of $2,000/Enterprise for Category 2 Non-Display Use; and a monthly fee of $2,000/Platform for Category 3 Non-Display Use.
By way of comparison: The CTA/CQ Plan Participants have established separate monthly Non-Display Fees for Network A of $2,000 for last sale prices plus $2,000 for quotation information in each of the three categories of use, and Non-Display Fees for Network B of $1,000 for last sale prices plus $1,000 for quotation information in each of the three categories of use;
Prior to the OPRA Plan amendment, 59 OPRA data feed recipients were paying OPRA's “Non-Display Application Fee,” which, as described above, was applicable only to any “application used for purposes of generating orders and/or quotations on an automated basis.”
If OPRA's estimate of its annualized revenue from its revised Non-Display fees is accurate, the additional annualized revenue will represent approximately a 4.7% increase in OPRA's total revenues for the year 2014. In terms of a perspective over a longer term, the additional annualized revenue will also represent approximately a 4.7% increase in OPRA's total revenues for the year 2008, approximately a 0.6% increase per year for each year since 2008.
Looking at the additional annualized revenue in another way, the estimated increase in revenue will represent less than two years of revenue lost by OPRA due to decreases in the number of Devices/User IDs that are subject to OPRA's Professional Subscriber Device-Based Fees.
The text of the amendment to the OPRA Plan is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
Pursuant to paragraph (b)(3)(i) of Rule 608 of Regulation NMS under the Act, OPRA designated this amendment as establishing or changing fees or other charges collected on behalf of all of the OPRA participants in connection with access to or use of OPRA facilities. OPRA put the revised Non-Display Application Fees into effect as of January 1, 2016.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the OPRA Plan amendment is consistent with the Act.
• 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.
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act” or “Exchange Act”),
ISE proposes to amend the Schedule of Fees as described in more detail below. The text of the proposed rule change is available on the Exchange's Internet Web site 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 self-regulatory organization has prepared summaries, set forth in Sections A, B and C below, of the most significant aspects of such statements.
The purpose of this proposed rule change is to amend the Schedule of Fees to modify the Regular Order Fee for Responses to Crossing Orders in Select
The Exchange proposes the following two fee changes. First, the Exchange proposes to change the Fee for Responses to Crossing Orders in Select and Non-Select Symbols for all members from $0.47 per contract to $0.50 per contract. Next, the Exchange proposes to change the Fees in Non-Select Symbols charged to Non-ISE Market Maker (“FarMM”),
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The Exchange believes that the proposed fee increases are reasonable and equitable as the proposed fees are set at levels that the Exchange believes will continue to be attractive to market participants that trade on ISE. Moreover, the proposed fees are competitive with fees charged by other options exchanges and remain attractive to members for this reason. For example, ISE's proposed Fee for Responses to Crossing Orders in Select Symbols is the same as ISE Mercury's Fee for Responses to Crossing Orders (excluding Market Makers) in Penny Symbols.
The Exchange also notes that the proposed Fees for Responses to Crossing Orders are not unfairly discriminatory because they apply equally to all members. Additionally, the Exchange further notes that for the Non-Select Symbol Fee, Priority Customers will continue to be charged no fee, while other market participants will continue to pay a fee. The Exchange does not believe that this is unfairly discriminatory as a Priority Customer is by definition not a broker or dealer in
In accordance with Section 6(b)(8) of the Act,
The Exchange has not solicited, and does not intend to solicit, comments on this proposed rule change. The Exchange has not received any unsolicited written comments from members or other interested parties.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of 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 to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On February 10, 2016, The NASDAQ Stock Market LLC filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 11A of the Securities Exchange Act of 1934 (“Act”)
The purpose of the amendment is to amend the OPRA Fee Schedule to revise the description of one of OPRA's Redistribution Fees. Specifically, the purpose of the OPRA Plan amendment is to make clear that OPRA's “reduced rate” Redistribution Fee of $650/month is available only to Vendor Services that are intended for Subscribers that want to query specific OPRA data, and that this fee is not available for any Vendor Service that includes a data streaming capability. In effect, the OPRA Plan amendment returns the applicability of this fee to the scope that it had when it was first implemented in 1999.
An OPRA Redistribution Fee is payable by every OPRA “Vendor.” An OPRA “Vendor” is a recipient of OPRA data that redistributes the data “externally”—that is, to persons outside the data recipient itself. OPRA has had a two-tier Redistribution Fee for many years: the basic OPRA Redistribution Fee has been $1,500/month for many years, and a reduced rate of $650/month has been available for many years.
The OPRA Plan amendment changed the description of the reduced rate of $650/month to specify that the reduced rate is for “Query service only,” rather than “Internet service only,” and revised the footnote that accompanies the reduced rate to state that: “A Vendor's Service qualifies for the `Query service only' rate if the Vendor's Service provides access to OPRA Data only on a `query' basis without any auto-refreshing capability and does not redistribute OPRA Data via dedicated lines or to the systems of one or more other Vendors (sometimes referred to as `downstream Vendors') or to one or more Hosted Solutions.”
When OPRA implemented the “Internet service only” Redistribution Fee, an “Internet service only” was a service that was not suitable for high-speed/high-reliability data transmission and high traffic volumes, and was a service appropriate for retail customers interested in querying specific options quotations and last sale prices.
OPRA estimates that the revised definition of the reduced rate Redistribution Fee is likely to affect between 35 and 45 of its Vendors, out of a total population of roughly 200 Vendors. Many of the remaining 155 to 165 OPRA Vendors also utilize the Internet to disseminate their data services, and pay the regular OPRA Redistribution Fee. Accordingly OPRA believes that the OPRA Plan amendment will cause all Vendors that are similarly situated in terms of the means of dissemination of their data services to be subject to the same OPRA Redistribution Fee.
For an OPRA Vendor that is required to pay the regular Redistribution Fee instead of the reduced rate as a result of the change, the change will result in an increase of $850/month or $10,200/year in its OPRA Redistribution Fees. If the maximum estimated number of 45 Vendors are affected by the change and none cease to be OPRA Vendors, OPRA's annualized revenues would increase by $459,000 as a result of the change, representing approximately a 0.67% increase in OPRA's annualized revenues; any lesser number of Vendors being affected by the change would result in a smaller increase in OPRA's revenues as a result of the change.
The text of the OPRA Plan amendment is available at OPRA, the Commission's Public Reference Room, on OPRA's Web site at
Pursuant to paragraph (b)(3)(i) of Rule 608 of Regulation NMS under the Act, OPRA designated this amendment as establishing or changing fees or other charges collected on behalf of all of the OPRA participants in connection with access to or use of OPRA facilities.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the OPRA Plan amendment is consistent with the Act.
• 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.
By the Commission.
Pursuant to section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services (“Fee Schedule”). The Exchange proposes to implement the fee changes effective April 1, 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 amend the Fee Schedule as follows:
The Exchange proposes to modify the fees that it charges for routing orders to other market centers. Currently, for the Exchange's Tier 1 and Tier 2 customers, the Exchange charges the following routing fees:
• $0.0027 per share in Tape A Securities for orders routed outside the Book to the NYSE;
• $0.0027 per share in Tape A Securities for Primary Only Plus (“PO+”) Orders
• $0.0030 per share in Tape B Securities for orders routed outside the Book to any away market center;
• $0.0028 per share in Tape B Securities for Primary Only (“PO”) Orders
• $0.0030 per share in Tape B Securities for PO+ Orders routed outside the Book to NASDAQ;
• $0.0030 per share in Tape A and Tape C Securities for orders routed outside the Book to any away market center other than NYSE; and
• $0.0030 per share in Tape A and Tape C Securities for PO+ Orders routed outside the Book to NASDAQ.
For Tier 3 customers, the Exchange charges the following routing fees:
• $0.0027 per share in Tape A Securities for orders routed outside the Book to the NYSE;
• $0.0030 per share in Tape B Securities for orders routed outside the Book to any away market center; and
• $0.0030 per share in Tape A and Tape C Securities for orders routed outside the Book to any away market center.
The Exchange proposes to modify the above routing fees by adopting a uniform fee of $0.0030 per share for Tier 1, Tier 2 and Tier 3 customers in Tape A, Tape B and Tape C Securities for orders that remove liquidity, including PO and PO+ Orders, that are routed outside the Book to any away market center.
Currently, for non-tier customers (
• $0.0030 per share in Tape A Securities for orders routed outside the Book to any away market center other than NYSE;
• $0.0029 per share in Tape A Securities for orders routed outside the Book to the NYSE;
• $0.0027 per share in Tape A Securities for PO+ Orders routed to the NYSE that remove liquidity;
• $0.0035 per share in Tape B Securities for orders routed outside the Book to any away market center;
• $0.0028 per share in Tape B Securities for PO and PO+ Orders routed to NYSE MKT that remove liquidity from the NYSE MKT Book; and
• $0.0035 per share in Tape C Securities for orders routed outside the Book to any away market center.
The Exchange proposes to modify the above routing fees by adopting a uniform fee of $0.0035 per share for Basic Rates customers in Tape A, Tape B and Tape C Securities for orders that remove liquidity, including PO and PO+ Orders, that are routed outside the Book to any away market center.
Currently, the Exchange provides credits under Tier 1, Tier 2 and Basic Rates for Mid-Point Passive Liquidity (“MPL”) Orders that provide liquidity.
The Exchange proposes to modify the per share credit payable under Tier 1, Tier 2 and Basic Rates from $0.0025 per share to $0.0020 per share for MPL Orders that provide liquidity in Tape C Securities for ETP Holders and Market Makers that have MPL Adding ADV during the billing month of at least 3 million shares. The Exchange does not propose to make any other change to credits for MPL Orders.
The Exchange recently amended the Fee Schedule to reflect the migration of securities to Pillar, the Exchange's new trading technology platform.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any significant problems that market participants would have in complying with the proposed changes.
The Exchange believes that the proposed rule change is consistent with Section 6(b) of the Act,
The Exchange believes that the proposed change to adopt uniform routing fees for Tier 1, Tier 2, Tier 3 and Basic Rate customers in Tape A, Tape B and Tape C Securities for orders that remove liquidity, including PO and PO+ Orders, that are routed outside the Book to any away market center is equitable and not unfairly discriminatory because it will standardize the routing fee, meaning that the fee would apply uniformly within pricing tiers and all similarly situated ETP Holders and Market Makers would be subject to the same fee. This aspect of the proposed change would therefore result in a more streamlined Fee Schedule.
In addition, the Exchange believes the decrease in the per share credit payable under Tier 1, Tier 2 and Basic Rates for MPL Orders that provide liquidity in Tape C Securities for ETP Holders and Market Makers that have MPL Adding ADV during the billing month of at least 3 million shares is reasonable as it is comparable to the tiered credit available on the NASDAQ Stock Market (“NASDAQ”) for midpoint liquidity, which is currently $0.0017 per share for Tape C Securities when a firm adds greater than 3 million shares of midpoint liquidity.
The Exchange believes that the proposed non-substantive changes to the Fee Schedule are reasonable, equitable and not unfairly discriminatory because the changes are designed to make the Fee Schedule more logical and comprehensive, and therefore easier for market participants to navigate and digest, which is in the public interest.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition. For these reasons, the Exchange believes that the proposal is consistent with the Act.
For the foregoing reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with section 6(b)(8) of the Act,
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that this proposal promotes a competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may 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) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's transaction fees at Rule 7018(a) relating to charges assessed for providing liquidity through the NASDAQ OMX BX Equities System in securities priced at $1 or more per share that it trades to: (i) Eliminate Qualified Market Maker-based criteria and adopt new Consolidated Volume-based criteria required to receive the $0.0014 per share executed charge; and (ii) decrease the $0.0018 per share executed charge, and amend the qualification criteria currently required to receive the charge, for a displayed order entered by a member.
While these amendments are effective upon filing, the Exchange has designated the proposed amendments to be operative on April 1, 2016.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend the Exchange's transaction fees at Rule 7018(a) relating to charges assessed for providing liquidity through the NASDAQ OMX BX Equities System in securities priced at $1 or more per share that it trades to: (i) Eliminate Qualified Market Maker-based criteria and adopt new Consolidated Volume-based criteria required to receive the $0.0014 per share executed charge; and (ii) decrease the $0.0018 per share executed charge, and amend the qualification criteria currently required to receive the charge, for a displayed order entered by a member.
The purpose of the first change is to eliminate the Qualified Market Maker-based criteria required to receive the $0.0014 per share executed charge. Currently, this fee applies to all displayed orders entered by a Qualified Market Maker. A member firm may become a Qualified Market Maker by being a member firm that provides through one or more of its NASDAQ OMX BX Equities System MPIDs more than 0.20% of Consolidated Volume
In lieu of the Qualified Market Maker-based criteria, the Exchange proposes to adopt new Consolidated Volume-based criteria that a member must meet to receive the $0.0014 per share executed charge. Specifically, the Exchange proposes to provide the $0.0014 per share executed charge for a displayed order entered by a member firm that adds liquidity equal to or exceeding 0.25% of total Consolidated Volume during a month.
The Exchange notes that, like the eliminated $0.0014 charge criteria discussed above, the proposed new charge criteria requires a level of Consolidated Volume in return for a reduced charge assessed for displayed orders. Although the proposed level of Consolidated Volume is 0.05% higher than the eliminated charge tier, the proposed new charge criteria does not require the member firm to also qualify as a Qualified Market Maker, which includes certain quoting requirements discussed above.
The purpose of the second change is to decrease the $0.0018 per share executed charge, and amend the qualifications currently required to receive the charge, for a displayed order entered by a member. Under Rule 7018(a), a member firm may receive a $0.0018 per share executed charge for a displayed order if it adds liquidity equal to or exceeding 0.20% of total Consolidated Volume during a month.
The Exchange is proposing to reduce the level of total Consolidated Volume required from 0.20% to 0.15% during a month, in light of the new $0.0014 per share executed charge tier discussed above that requires 0.25% Consolidated Volume to qualify. The Exchange is also proposing to decrease the charge assessed member firms that qualify under the rule from $0.0018 to $0.0017 per share executed. As a consequence of the changes, the amended charge tier will be easier to attain and will provide a further reduced per share executed charge [sic]
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The Exchange believes that eliminating the $0.0014 per share executed charge for a displayed order entered by a Qualified Market Maker is reasonable because the Exchange must, from time to time, assess the effectiveness of the criteria it applies in providing reduced charges, including the nature of the market improving behavior required to receive the reduced charge. The Exchange will modify or eliminate such criteria when it believes the criteria are ineffective, which in turn may allow the Exchange to offer other incentives instead.
In this instance, the Exchange believes the criteria required to receive the $0.0014 per share executed charge were ineffective at providing incentive to market participants to improve the market appreciably. As a consequence, the Exchange believes it is reasonable to eliminate the Qualified Market Maker-based criteria and replace it with new criteria, as discussed below.
The Exchange believes that the new $0.0014 per share executed charge criteria is reasonable because it is similar to the Qualified Market Maker charge tier criteria that the Exchange is proposing to eliminate. Under the existing Qualified Market Maker charge tier, a member firm must be a Qualified Market Maker to receive the $0.0014 per share executed charge for its displayed orders. To be a Qualified Market Maker, a member firm must: (i) Provide through one or more of its NASDAQ OMX BX Equities System MPIDs more than 0.20% of Consolidated Volume during
Under the proposed new charge tier, a member firm must provide a higher level of Consolidated Volume in contrast to the Qualified Market Maker criteria, but is not required to meet the quoting requirements of the Qualified Market Maker criteria. Accordingly, the Exchange believes that the proposed new $0.0014 per share executed charge criteria is reasonable.
The Exchange believes that assessing a $0.0014 per share executed charge and requiring a member to provide a level of Consolidated Volume to qualify for that charge is an equitable allocation and is not unfairly discriminatory because the Exchange will apply the new criteria and assess the charge to all similarly situated members. Any member firm that elects to provide the level of Consolidated Volume required by the tier will receive the charge. In this regard, the Exchange notes that all member firms that could meet the eliminated criteria will have the opportunity to qualify under the new Consolidated Volume-based criteria.
The Exchange believes that the proposed changes to the $0.0018 per share executed charge provided for a displayed order if it is entered by a member firm that adds liquidity equal to or exceeding 0.20% of total Consolidated Volume during a month are reasonable because they better align the reduced charge with the level of Consolidated Volume required to qualify, in light of the proposed changes the Exchange is making to the $0.0014 per share executed charge criteria.
Specifically, the Exchange is reducing the level of Consolidated Volume required to qualify from 0.20%, which is close to the proposed level of Consolidated Volume required to receive the $0.0014 per share executed charge, to 0.15%, which the Exchange believes is better aligned with the charges provided and the criteria required to receive the charges. As a further incentive, the Exchange is proposing to decrease the charge assessed qualifying member firms from $0.0018 to $0.0017 per share executed.
The Exchange believes that it is reasonable to reduce the charge because it may provide greater incentive to member firms to provide the level of Consolidated Volume necessary to receive the reduced charge. Moreover, the reduced charge better aligns the charge tier with the proposed new $0.0014 per share executed charge tier and its 0.25% Consolidated Volume requirement and the $0.0019 per share executed tier, which requires a member to provide 0.10% of total Consolidated Volume to receive that charge.
The Exchange believes that the proposed $0.0017 per share executed charge and changes to the Consolidated Volume requirement are an equitable allocation and are not unfairly discriminatory because the Exchange will apply the same charge to all similarly situated members. Any member firm that elects to provide the level of Consolidated Volume required by the amended tier will receive the reduced charge [sic]
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act. In terms of inter-market competition, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues if they deem fee levels at a particular venue to be excessive, or rebate opportunities available at other venues to be more favorable.
In such an environment, the Exchange must continually adjust its fees to remain competitive with other exchanges and with alternative trading systems that have been exempted from compliance with the statutory standards applicable to exchanges. Because competitors are free to modify their own fees in response, and because market participants may readily adjust their order routing practices, the Exchange believes that the degree to which fee changes in this market may impose any burden on competition is extremely limited. In this instance, the proposed changes to the charges assessed member firms for execution of displayed orders do not impose a burden on competition because the Exchange's execution services are completely voluntary and subject to extensive competition both from other exchanges and from off-exchange venues.
The proposed changes are reflective of this competition and the Exchange's desire to offer lower fees in return for market-improving liquidity, which is ultimately limited by the Exchange's need to cover costs and make a profit. Thus, the Exchange must carefully adjust its access fees with the understanding that if the proposed changes are unattractive to market participants, it is likely that the Exchange will lose market share to other exchanges and off-exchange venues as a result.
In this proposal, the Exchange is modifying qualification criteria and reducing the charges that it assesses its member firms for providing liquidity to the Exchange. The Exchange believes that such changes will support liquidity on the Exchange and are pro-competitive, since any other market is free to provide similar, if not better, fees should they choose to do so. For these reasons, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of 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: (i) Necessary or appropriate in the public interest; (ii) for the protection of investors; or (iii) otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange filed a proposal to list and trade under BZX Rule 14.11(c)(4) the shares of the following series of Market Vectors ETF Trust (the “Trust”): Market Vectors 6-8 Year Municipal Index ETF; Market Vectors 8-12 Year Municipal Index ETF; and Market Vectors 12-17 Year Municipal Index ETF.
The text of the proposed rule change is available at the Exchange's Web site 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 parts of such statements.
The Exchange proposes to list and trade shares (“Shares”) of the following series of the Trust under BZX Rule 14.11(c)(4),
Van Eck Associates Corporation will be the investment adviser (“Adviser”) to the Funds.
According to the Registration Statement, the Fund will seek to replicate as closely as possible, before fees and expenses, the price and yield performance of the Barclays AMT-Free 6-8 Year Intermediate Continuous Municipal Index (the “6-8 Year Index”). As of December 31, 2015, there were 2,894 issues in the 6-8 Year Index. Unless otherwise noted, all statistics related to the 6-8 Year Index presented hereafter were accurate as of December 31, 2015.
To be included in the 6-8 Year Index, a bond must be rated Baa3/BBB- or higher by at least two of the following ratings agencies if all three agencies rate the security: Moody's, S&P and Fitch. If only two of the three agencies rate the security, the lower rating is used to determine index eligibility. If only one of the three agencies rates a security, the rating must be at least Baa3/BBB-. Potential constituents must have an outstanding par value of at least $7 million and be issued as part of a transaction of at least $75 million. The bonds must be fixed rate, have a dated date within the last five years and have an effective maturity of 6 to 8 years. The following types of bonds are excluded from the 6-8 Year Index: bonds subject to the alternative minimum tax, taxable municipal bonds, floating rate bonds and derivatives. The 6-8 Year Index is calculated using a market value weighting methodology.
The composition of the 6-8 Year Index is rebalanced monthly. Interest and principal payments earned by the component securities are held in the 6-8 Year Index without a reinvestment return until month end when they are removed from the 6-8 Year Index. Qualifying securities issued, but not necessarily settled, on or before the month end rebalancing date qualify for inclusion in the 6-8 Year Index in the following month.
The Fund normally invests at least 80% of its total assets in securities that comprise the Fund's benchmark index. The 6-8 Year Index is comprised of publicly traded municipal bonds that cover the U.S. dollar-denominated intermediate term tax-exempt bond market with final maturities of 6-8 years. The Fund's 80% investment policy is non-fundamental and may be changed without shareholder approval upon 60 days' prior written notice to shareholders. To-be-announced transactions (“TBAs”)
While the Fund normally will invest at least 80% of its total assets in securities that compose the 6-8 Year Index, as described above, the Fund may invest its remaining assets in other financial instruments, as described below.
The Fund may invest its remaining assets in securities not included in the 6-8 Year Index including only the following instruments: municipal bonds;
The Fund may invest in repurchase agreements with commercial banks, brokers or dealers to generate income from its excess cash balances and to invest securities lending cash collateral.
The Fund may use exchange-traded futures contracts and exchange-traded or over-the-counter (“OTC”) options thereon, together with positions in cash and money market instruments, to simulate full investment in the 6-8 Year Index.
The Fund may use cleared or non-cleared index, interest rate or credit
The Fund may invest in exchange-traded warrants, which are equity securities in the form of options issued by a corporation which give the holder the right to purchase stock, usually at a price that is higher than the market price at the time the warrant is issued.
The Fund may invest in participation notes, which are issued by banks or broker-dealers and are designed to offer a return linked to the performance of a particular underlying equity security or market.
The Fund will only enter into transactions in derivative instruments with counterparties that the Adviser reasonably believes are capable of performing under the contract and will post as collateral as required by the counterparty.
The Exchange is submitting this proposed rule change because the 6-8 Year Index for the Fund does not meet all of the “generic” listing requirements of Rule 14.11(c)(4) applicable to the listing of index fund shares based on fixed income securities indexes. The 6-8 Year Index meets all such requirements except for those set forth in Rule 14.11(c)(4)(B)(i)(b).
As of December 31, 2015, 95.1% of the weight of the 6-8 Year Index components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding $100 million or more for all maturities of the offering. In addition, the total dollar amount outstanding of issues in the 6-8 Year Index was approximately $57.4 billion and the average dollar amount outstanding of issues in the 6-8 Year Index was approximately $19.8 million. Further, the most heavily weighted component represented 1.07% of the weight of the 6-8 Year Index and the five most heavily weighted components represented 3.0% of the weight of the 6-8 Year Index.
The 6-8 Year Index value, calculated and disseminated at least once daily, as well as the components of the 6-8 Year Index and their percentage weighting, will be available from major market data vendors. In addition, the portfolio of securities held by the Fund will be disclosed on the Fund's Web site at
According to the Registration Statement, the Fund will seek to replicate as closely as possible, before fees and expenses, the price and yield performance of the Barclays AMT-Free 8-12 Year Intermediate Continuous Municipal Index (the “8-12 Year Index”). As of December 31, 2015, there were 5,662 issues in the 8-12 Year Index. Unless otherwise noted, all statistics related to the 8-12 Year Index presented hereafter were accurate as of December 31, 2015.
To be included in the 8-12 Year Index, a bond must be rated Baa3/BBB− or higher by at least two of the following ratings agencies if all three agencies rate the security: Moody's, S&P and Fitch. If only two of the three agencies rate the security, the lower rating is used to determine index eligibility. If only one of the three agencies rates a security, the rating must be at least Baa3/BBB−. Potential constituents must have an outstanding par value of at least $7 million and be issued as part of a transaction of at least $75 million. The bonds must be fixed rate, have a dated date within the last five years and have an effective maturity of 8 to 12 years. The following types of bonds are excluded from the 8-12 Year Index: bonds subject to the alternative minimum tax, taxable municipal bonds, floating rate bonds and derivatives. The 8-12 Year Index is calculated using a market value weighting methodology.
The composition of the 8-12 Year Index is rebalanced monthly. Interest and principal payments earned by the component securities are held in the 8-12 Year Index without a reinvestment return until month end when they are removed from the 8-12 Year Index. Qualifying securities issued, but not necessarily settled, on or before the month end rebalancing date qualify for inclusion in the 8-12 Year Index in the following month.
The Fund normally invests at least 80% of its total assets in securities that comprise the Fund's benchmark index. The 8-12 Year Index is comprised of publicly traded municipal bonds that cover the U.S. dollar-denominated intermediate term tax-exempt bond market with final maturities of 8-12 years. The Fund's 80% investment policy is non-fundamental and may be changed without shareholder approval upon 60 days' prior written notice to shareholders. TBAs representing securities in the 8-12 Year Index may be used by the Fund in seeking performance that corresponds to the 8-12 Year Index and in such cases would count towards the Fund's 80% policy.
While the Fund normally will invest at least 80% of its total assets in securities that compose the 8-12 Year Index, as described above, the Fund may invest its remaining assets in other financial instruments, as described below.
The Fund may invest its remaining assets in securities not included in the 8-12 Year Index including only the
The Fund may invest in repurchase agreements with commercial banks, brokers or dealers to generate income from its excess cash balances and to invest securities lending cash collateral.
The Fund may use exchange-traded futures contracts and exchange-traded or OTC options thereon, together with positions in cash and money market instruments, to simulate full investment in the 8-12 Year Index.
The Fund may use cleared or non-cleared index, interest rate or credit default swap agreements. Swap agreements are contracts between parties in which one party agrees to make payments to the other party based on the change in market value or level of a specified index or asset. The Adviser represents that currently interest rate swaps and credit default swaps on indexes are cleared. However, credit default swaps on a specific security are currently uncleared.
The Fund may invest in exchange-traded warrants, which are equity securities in the form of options issued by a corporation which give the holder the right to purchase stock, usually at a price that is higher than the market price at the time the warrant is issued.
The Fund may invest in participation notes, which are issued by banks or broker-dealers and are designed to offer a return linked to the performance of a particular underlying equity security or market.
The Fund will only enter into transactions in derivative instruments with counterparties that the Adviser reasonably believes are capable of performing under the contract and will post as collateral as required by the counterparty.
The Exchange is submitting this proposed rule change because the 8-12 Year Index for the Fund does not meet all of the “generic” listing requirements of Rule 14.11(c)(4) applicable to the listing of index fund shares based on fixed income securities indexes. The 8-12 Year Index meets all such requirements except for those set forth in Rule 14.11(c)(4)(B)(i)(b).
As of December 31, 2015, 95.1% of the weight of the 8-12 Year Index components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding of $100 million or more for all maturities of the offering. In addition, the total dollar amount outstanding of issues in the 8-12 Year Index was approximately $108.6 billion and the average dollar amount outstanding of issues in the 8-12 Year Index was approximately $19.2 million. Further, the most heavily weighted component represented 0.26% of the weight of the 8-12 Year Index and the five most heavily weighted components represented 1.04% of the weight of the 8-12 Year Index.
The 8-12 Year Index value, calculated and disseminated at least once daily, as well as the components of the 8-12 Year Index and their percentage weighting, will be available from major market data vendors. In addition, the portfolio of securities held by the Fund will be disclosed on the Fund's Web site at
According to the Registration Statement, the Fund will seek to replicate as closely as possible, before fees and expenses, the price and yield performance of the Barclays AMT-Free 12-17 Year Intermediate Continuous Municipal Index (the “12-17 Year Index”). As of December 31, 2015, there were 6,171 issues in the 12-17 Year Index. Unless otherwise noted, all statistics related to the 12-17 Year Index presented hereafter were accurate as of December 31, 2015.
To be included in the 12-17 Year Index, a bond must be rated Baa3/BBB− or higher by at least two of the following ratings agencies if all three agencies rate the security: Moody's, S&P and Fitch. If only two of the three agencies rate the security, the lower rating is used to determine index eligibility. If only one of the three agencies rates a security, the rating must be at least Baa3/BBB−. Potential constituents must have an outstanding par value of at least $7 million and be issued as part of a
The composition of the 12-17 Year Index is rebalanced monthly. Interest and principal payments earned by the component securities are held in the 12-17 Year Index without a reinvestment return until month end when they are removed from the 12-17 Year Index. Qualifying securities issued, but not necessarily settled, on or before the month end rebalancing date qualify for inclusion in the 12-17 Year Index in the following month. TBAs representing securities in the 12-17 Year Index may be used by the Fund in seeking performance that corresponds to the 12-17 Year Index and in such cases would count towards the Fund's 80% policy.
The Fund normally invests at least 80% of its total assets in securities that comprise the Fund's benchmark index. The 12-17 Year Index is comprised of publicly traded municipal bonds that cover the U.S. dollar-denominated intermediate term tax-exempt bond market with final maturities of 12-17 years. The Fund's 80% investment policy is non-fundamental and may be changed without shareholder approval upon 60 days' prior written notice to shareholders.
While the Fund normally will invest at least 80% of its total assets in securities that compose the 12-17 Year Index, as described above, the Fund may invest its remaining assets in other financial instruments, as described below.
The Fund may invest its remaining assets in securities not included in the 12-17 Year Index including only the following instruments: municipal bonds;
The Fund may invest in repurchase agreements with commercial banks, brokers or dealers to generate income from its excess cash balances and to invest securities lending cash collateral.
The Fund may use exchange-traded futures contracts and exchange-traded or over-the-counter (“OTC”) options thereon, together with positions in cash and money market instruments, to simulate full investment in the 12-17 Year Index.
The Fund may use cleared or non-cleared index, interest rate or credit default swap agreements. Swap agreements are contracts between parties in which one party agrees to make payments to the other party based on the change in market value or level of a specified index or asset. The Adviser represents that currently interest rate swaps and credit default swaps on indexes are cleared. However, credit default swaps on a specific security are currently uncleared.
The Fund may invest in exchange-traded warrants, which are equity securities in the form of options issued by a corporation which give the holder the right to purchase stock, usually at a price that is higher than the market price at the time the warrant is issued.
The Fund may invest in participation notes, which are issued by banks or broker-dealers and are designed to offer a return linked to the performance of a particular underlying equity security or market.
The Fund will only enter into transactions in derivative instruments with counterparties that the Adviser reasonably believes are capable of performing under the contract and will post as collateral as required by the counterparty.
The Exchange is submitting this proposed rule change because the 12-17 Year Index for the Fund does not meet all of the “generic” listing requirements of Rule 14.11(c)(4) applicable to the listing of index fund shares based on fixed income securities indexes. The 12-17 Year Index meets all such requirements except for those set forth in Rule 14.11(c)(4)(B)(i)(b).
As of December 31, 2015, 95.3% of the weight of the 12-17 Year Index components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding $100 million or more for all maturities of the offering. In addition, the total dollar amount outstanding of issues in the 12-17 Year Index was approximately $123.5 billion and the average dollar amount outstanding of issues in the 12-17 Year Index was approximately $20 million. Further, the most heavily weighted component represented 0.29% of the weight of the 12-17 Year Index and the five most heavily weighted components represented 1.11% of the weight of the 12-17 Year Index.
The 12-17 Year Index value, calculated and disseminated at least once daily, as well as the components of the 12-17 Year Index and their percentage weighting, will be available from major market data vendors. In addition, the portfolio of securities held by the Fund will be disclosed on the Fund's Web site at
The Exchange represents that: (1) Except for BZX Rule 14.11(c)(4)(B)(i)(b), the 6-8 Year Index, the 8-12 Year Index, and the 12-17 Year Index (together, the “Indices”) currently and will continue to satisfy all of the generic listing standards under BZX Rule 14.11(c)(4); (2) the continued listing standards under BZX Rule 14.11(c) applicable to index fund shares shall apply to the Shares of each Fund; and (3) the Trust is required to comply with Rule 10A-3
With respect to the Funds, the Adviser represents that the nature of the municipal bond market and municipal bond instruments makes it feasible to categorize individual issues represented by CUSIPs (
The Adviser represents that the Funds are managed utilizing the principle that municipal bond issues are generally fungible in nature when sharing common characteristics, and specifically make use of the four categories referred to above. In addition, this principle is used in, and consistent with, the portfolio construction process in order to facilitate the creation and redemption process, and to enhance liquidity (among other benefits, such as reducing transaction costs), while still allowing each Fund to closely track its reference index.
According to the Registration Statement, the net asset value (“NAV”) of each Fund will be determined each business day as of the close of trading (ordinarily 4:00 p.m. Eastern time) on the Exchange. Any assets or liabilities denominated in currencies other than the U.S. dollar are converted into U.S. dollars at the current market rates on the date of valuation as quoted by one or more sources.
The values of each Fund's portfolio securities are based on the securities' closing prices, when available. 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. Fixed income securities are normally valued on the basis of quotes from brokers or dealers, established market makers or an outside independent pricing service using data reflecting the earlier closing of the principal markets for those securities. Prices obtained by an outside independent pricing service may use information provided by market makers or estimates of market values obtained from yield data related to investments or securities with similar characteristics and may use a computerized grid matrix of securities and its evaluations in determining what it believes is the fair value of the portfolio securities. Debt securities and money market instruments with maturities of more than 60 days will typically be priced based on valuations provided by independent, third-party pricing agents. Such values will generally reflect the last reported sales price if the security is actively traded. Short-term investments and money market instruments having a maturity of 60 days or less are valued at amortized cost. Repurchase agreements will generally be valued at bid prices received from independent pricing services as of the announced closing time for trading in such instruments. Futures contracts will be valued at the settlement price established each day by the board or exchange on which they are traded. Exchange-traded options will be valued at the closing price in the market where such contracts are principally traded. OTC options will generally be valued on a basis of quotes obtained from established market makers or by an outside independent pricing service. Swaps, structured notes, participation notes, convertible securities, and TBAs will be valued based on valuations provided by independent, third-party pricing agents. Securities of non-exchange-traded investment companies will be valued at NAV. Exchange-traded instruments, including investment companies and warrants, will be valued at the last reported sale price on the primary exchange or market on which they are traded.
If a market quotation for a security is not readily available or the Adviser believes it does not otherwise accurately reflect the market value of the security at the time the Fund calculates its NAV, the security will be fair valued by the Adviser in accordance with the Trust's valuation policies and procedures approved by the Board of Trustees and in accordance with the 1940 Act. The Fund may also use fair value pricing in
The NAV of the Funds will be determined each business day as of the close of trading, (normally 4:00 p.m. Eastern time) on the exchange. The Funds currently anticipate that a “Creation Unit” will consist of 100,000 Shares, though this number may change from time to time, including prior to the listing of a Fund. The exact number of Shares that will comprise a Creation Unit will be disclosed in the Registration Statement of each Fund. The Trust will issue and sell Shares of the Funds only in Creation Units on a continuous basis through the Distributor, without an initial sales load (but subject to transaction fees), at their NAV per Share next determined after receipt, on any business day, of an order in proper form.
The consideration for purchase of a Creation Unit of a Fund generally will consist of either (i) the in-kind deposit of a designated portfolio of fixed income securities (the “Deposit Securities”) per each Creation Unit and the Cash Component (defined below), computed as described below, or (ii) as permitted or required by the Funds, of cash. The Cash Component together with the Deposit Securities, as applicable, are referred to as the “Fund Deposit,” which represents the minimum initial and subsequent investment amount for Shares. The Cash Component represents 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” enables the Funds to make a complete distribution of dividends on the next dividend payment date, and is an amount equal, on a per Creation Unit basis, to the dividends on all the securities held by each of the Funds (“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 begins on the ex-dividend date for each Fund and ends on the next ex-dividend date.
The Administrator, through the National Securities Clearing Corporation (“NSCC”), makes 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 each Fund. Such Fund Deposit is applicable, subject to any adjustments as described below, in order to effect creations of Creation Units of each Fund until such time as the next-announced Fund Deposit composition is made available.
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,
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 Exchange 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 variable fees described below. 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. Each Fund reserves the right to honor a redemption request by delivering a basket of securities or cash that differs from the Fund Securities.
Orders to redeem Creation Units of the Funds must be delivered through a DTC Participant that has executed the Participant Agreement with the Distributor and with the Trust. A DTC Participant who wishes to place an order for redemption of Creation Units of a Fund to be effected need not be a Participating Party, but such orders must state that redemption of Creation Units of the Fund will instead be effected through transfer of Creation Units of the Fund directly through DTC. An order to redeem Creation Units of a Fund is deemed received by the Administrator on the transmittal date if (i) such order is received by the Administrator not later than 4:00 p.m. Eastern time on such transmittal date; (ii) such order is preceded or accompanied by the requisite number of Shares of Creation Units specified in such order, which delivery must be made through DTC to the Administrator no later than 11:00 a.m. Eastern time, on such transmittal date (the “DTC Cut-Off-Time”); and (iii) all other procedures set forth in the Participant Agreement are properly followed.
After the Administrator has deemed an order for redemption received, the Administrator will initiate procedures to transfer the requisite Fund Securities (or contracts to purchase such Fund Securities) which are expected to be delivered within three business days and the cash redemption payment to the redeeming beneficial owner by the third business day following the transmittal date on which such redemption order is deemed received by the Administrator.
Each Fund's Web site, which will be publicly available prior to the public offering of Shares, will include a form of the prospectus for the Fund that may be downloaded. The Web site will include additional quantitative information updated on a daily basis, including, for the Fund: (1) The prior business day's reported NAV, mid-point of the bid/ask spread at the time of calculation of such NAV (the “Bid/Ask
In addition, for each Fund, an estimated value, defined in BZX Rule 14.11(c)(6)(A) as the “Intraday Indicative Value,” that reflects an estimated intraday value of each Fund's portfolio, will be disseminated. Moreover, the Intraday Indicative Value will be based upon the current value for the components of the daily disclosed portfolio and will be updated and widely disseminated by one or more major market data vendors at least every 15 seconds during the Exchange's Regular Trading Hours.
The dissemination of the Intraday Indicative Value, together with the daily disclosed portfolio, will allow investors to determine the value of the underlying portfolio of the Funds on a daily basis and provide a close estimate of that value throughout the trading day.
Quotation and last sale information for the Shares of each Fund will be available via the Consolidated Tape Association (“CTA”) high speed line. Quotation information for investment company securities (excluding ETFs) may be obtained through nationally recognized pricing services through subscription agreements or from brokers and dealers who make markets in such securities. Price information regarding municipal bonds, convertible securities, and non-exchange traded assets, including investment companies, derivatives, money market instruments, repurchase agreements, structured notes, participation notes, and TBAs is available from third party pricing services and major market data vendors. For exchange-traded assets, including investment companies, futures, warrants, and options, such intraday information is available directly from the applicable listing exchange.
The Shares of each Fund will conform to the initial and continued listing criteria under BZX Rule 14.11(c)(4), except for those set forth in 14.11(c)(4)(B)(i)(b). The Exchange represents that, for initial and/or continued listing, the Funds and the Trust must be in compliance with Rule 10A-3 under the Act.
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 Funds. The Exchange will halt trading in the Shares under the conditions specified in BZX Rule 11.18. 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/or the financial instruments composing the daily disclosed portfolio of the Funds; 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 14.11(c)(1)(B)(iv), which sets forth circumstances under which Shares of a Fund may be halted.
The Exchange deems the Shares to be equity securities, thus rendering trading in the Shares subject to the Exchange's existing rules governing the trading of equity securities. The Exchange will allow trading in the Shares from 8:00 a.m. until 5:00 p.m. Eastern Time and has the appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in BZX Rule 11.11(a), the minimum price variation for quoting and entry of orders in securities traded on the Exchange is $0.01, with the exception of securities that are priced less than $1.00, for which the minimum price variation for order entry is $0.0001.
The Exchange believes that its surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. Trading of the Shares through the Exchange will be subject to the Exchange's surveillance procedures for derivative products, including Index Fund Shares. The Exchange may obtain information regarding trading in the Shares and the underlying shares in exchange traded equity securities via the ISG, from other exchanges that are members or affiliates of the ISG, or with which the Exchange has entered into a comprehensive surveillance sharing
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) BZX Rule 3.7, which imposes suitability obligations on Exchange members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value is disseminated; (4) the risks involved in trading the Shares during the Pre-Opening
In addition, the Information Circular will advise members, prior to the commencement of trading, of the prospectus delivery requirements applicable to the Funds. Members purchasing Shares from the Funds 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.
In addition, the Information Circular will reference that each Fund is subject to various fees and expenses described in the Registration Statement. The Information Circular will also disclose the trading hours of the Shares of the Funds and the applicable NAV calculation time for the Shares. The Information Circular will disclose that information about the Shares of the Funds will be publicly available on the Funds' Web site. In addition, the Information Circular will reference that the Trust is subject to various fees and expenses described in each Fund's Registration Statement.
The Exchange believes that the proposal is consistent with Section 6(b) of the Act
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 listing criteria in BZX Rule 14.11(c). The Exchange believes that its surveillances, which generally focus on detecting securities trading outside of their normal patterns which could be indicative of manipulative or other violative activity, and associated surveillance procedures are adequate to properly monitor the trading of the Shares on the Exchange during all trading sessions and to deter and detect violations of Exchange rules and the applicable federal securities laws. The Exchange will communicate as needed regarding trading in the Shares with other markets or other entities that are members of the Intermarket Surveillance Group (“ISG”), and may obtain trading information regarding trading in the Shares from such markets or entities. The Exchange can also access data obtained from the Municipal Securities Rulemaking Board relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares. The Exchange is able to access, as needed, trade information for certain fixed income securities held by a Fund reported to FINRA's TRACE. FINRA also can access data obtained from the Municipal Securities Rulemaking Board (“MSRB”) relating to municipal bond trading activity for surveillance purposes in connection with trading in the Shares. In addition, the Exchange may obtain information regarding trading in the Shares and the underlying shares in exchange-traded investment companies, futures, options, and warrants from markets or other entities that are members of ISG or with which the Exchange has in place a comprehensive surveillance sharing agreement.
The Index Provider is not a broker-dealer, but is affiliated with a broker-dealer and has implemented a “fire wall” with respect to such broker-dealer regarding access to information concerning the composition and/or changes to the Indices. The Index Provider has also implemented procedures designed to prevent the use and dissemination of material, non-public information regarding the Indices.
As of December 31, 2015, the 6-8 Year Index had the following characteristics: There were 2,894 issues; 9.8% of the weight of components had a minimum original principal amount outstanding of $100 million or more; 95.1% of the weight of components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding of $100 million or more for all maturities of the offering; the total dollar amount outstanding of all issues was approximately $57.4 billion and the average dollar amount outstanding per issue was approximately $19.8 million; the most heavily weighted component represented 1.07% of the 6-8 Year Index and the five most heavily weighted components represented 3.0% of the 6-8 Year Index. Therefore, the Exchange believes that, notwithstanding that the 6-8 Year Index does not satisfy the criterion in BZX Rule 14.11(c)(4)(B)(i), the 6-8 Year Index is sufficiently broad-based to deter potential manipulation in that a substantial portion (95.1%) of the 6-8 Year Index weight is comprised of maturities that are part of a minimum original principal amount outstanding of $100 million or more, and in view of the substantial total dollar amount
As of December 31, 2015, the 8-12 Year Index had the following characteristics: There were 5,662 issues; 5.7% of the weight of components had a minimum original principal amount outstanding of $100 million or more; 95.1% of the weight of components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding of $100 million or more for all maturities of the offering; the total dollar amount outstanding of all issues was approximately $108.6 billion and the average dollar amount outstanding per issue was approximately $19.2 million; the most heavily weighted component represented 0.26% of the 8-12 Year Index and the five most heavily weighted components represented 1.04% of the 8-12 Year Index. Therefore, the Exchange believes that, notwithstanding that the 8-12 Year Index does not satisfy the criterion in BZX Rule 14.11(c)(4)(B)(i), the 8-12 Year Index is sufficiently broad-based to deter potential manipulation in that a substantial portion (95.1%) of the 8-12 Year Index weight is comprised of maturities that are part of a minimum original principal amount outstanding of $100 million or more, and in view of the substantial total dollar amount outstanding and the average dollar amount outstanding of index issues.
As of December 31, 2015, the 12-17 Year Index had the following characteristics: There were 6,171 issues; 8.3% of the weight of components had a minimum original principal amount outstanding of $100 million or more; 95.3% of the weight of components was comprised of individual maturities that were part of an entire municipal bond offering with a minimum original principal amount outstanding of $100 million or more for all maturities of the offering; the total dollar amount outstanding of all issues was approximately $123.5 billion and the average dollar amount outstanding per issue was approximately $20 million; the most heavily weighted component represented 0.29% of the 12-17 Year Index and the five most heavily weighted components represented 1.11% of the 12-17 Year Index. Therefore, the Exchange believes that, notwithstanding that the 12-17 Year Index does not satisfy the criterion in BZX Rule 14.11(c)(4)(B)(i), the 12-17 Year Index is sufficiently broad-based to deter potential manipulation in that a substantial portion (95.3%) of the 12-17 Year Index weight is comprised of maturities that are part of a minimum original principal amount outstanding of $100 million or more, and in view of the substantial total dollar amount outstanding and the average dollar amount outstanding of index issues.
The value, components, and percentage weightings of each of the Indices will be calculated and disseminated at least once daily and will be available from major market data vendors. In addition, the portfolio of securities held by the Funds will be disclosed on the Funds' Web site at
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that a large amount of information will be publicly available regarding the Funds and the Shares, thereby promoting market transparency. The Funds' portfolio holdings will be disclosed on the Funds' Web site daily after the close of trading on the Exchange and prior to the opening of trading on the Exchange the following day. Moreover, the IIV will be widely disseminated by one or more major market data vendors at least every 15 seconds during Regular Trading Hours. The current value of each of the Indices will be disseminated by one or more major market data vendors at least once per 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 will be available via the CTA high-speed line. The Web site for the Funds will include the prospectus for the Funds and additional data relating to NAV and other applicable quantitative information. Moreover, 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. If the Exchange becomes aware that the NAV is not being disseminated to all market participants at the same time, it will halt trading in the Shares until such time as the NAV is available to all market participants. 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 Funds. Trading also 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/or the financial instruments composing the daily disclosed portfolio of each Fund; 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 14.11(c)(1)(B)(iv), which sets forth circumstances under which Shares of a Fund may be halted. If the IIV of any of the Funds or value of the Indices are not being disseminated as required, the Exchange may halt trading during the day in which the interruption to the dissemination of the IIV or index value occurs.
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 additional types of exchange-traded funds that holds municipal bonds and that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, the Exchange has in place surveillance procedures relating to trading in the Shares and may obtain information in the Shares and the underlying shares in exchange-traded investment companies, futures, options, and warrants via ISG from other exchanges that are members of ISG or with which the Exchange has entered into a comprehensive surveillance sharing agreement. In addition, investors will have ready access to information regarding the IIV and quotation and last sale information for the Shares.
For the above reasons, the Exchange believes that 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 purpose of the Act. The Exchange notes that the proposed rule change will facilitate the listing and trading of additional exchange-traded products that will enhance competition among
The Exchange has neither solicited nor received written comments on the proposed rule change.
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 proposal 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, Station Place, 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 filed a proposal to adopt a new rule to clearly prohibit disruptive quoting and trading activity on the Exchange, as further described below. Further, the Exchange proposes to amend Exchange Rules to permit the Exchange to take prompt action to suspend Members or their clients that violate such rule.
The text of the proposed rule change is available at the Exchange's Web site 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 parts of such statements.
The Exchange is filing this proposal to adopt a new rule to clearly prohibit disruptive quoting and trading activity on the Exchange and to amend Exchange Rules to permit the Exchange to take prompt action to suspend Members or their clients that violate such rule. The proposal is identical to the proposal of Bats BZX Exchange, Inc., formerly known as BATS Exchange, Inc. (“BZX”),
As a national securities exchange registered pursuant to Section 6 of the
The process described above, from the identification of disruptive and potentially manipulative or improper quoting and trading activity to a final resolution of the matter, can often take several years. The Exchange believes that this time period is generally necessary and appropriate to afford the subject Member adequate due process, particularly in complex cases. However, as described below, the Exchange believes that there are certain obvious and uncomplicated cases of disruptive and manipulative behavior or cases where the potential harm to investors is so large that the Exchange should have the authority to initiate an expedited suspension proceeding in order to stop the behavior from continuing on the Exchange.
In recent years, several cases have been brought and resolved by an affiliate of the Exchange and other SROs that involved allegations of wide-spread market manipulation, much of which was ultimately being conducted by foreign persons and entities using relatively rudimentary technology to access the markets and over which the Exchange and other SROs had no direct jurisdiction. In each case, the conduct involved a pattern of disruptive quoting and trading activity indicative of manipulative layering
The following two examples are instructive on the Exchange's rationale for the proposed rule change.
In July 2012, Biremis Corp. (formerly Swift Trade Securities USA, Inc.) (the “Firm”) and its CEO were barred from the industry for, among other things, supervisory violations related to a failure by the Firm to detect and prevent disruptive and allegedly manipulative trading activities, including layering, short sale violations, and anti-money laundering violations.
In September of 2012, Hold Brothers On-Line Investment Services, Inc. (the “Firm”) settled a regulatory action in connection with the Firm's provision of a trading platform, trade software and trade execution, support and clearing services for day traders.
The Exchange also notes the current criminal proceedings that have commenced against Navinder Singh Sarao. Mr. Sarao's allegedly manipulative trading activity, which included forms of layering and spoofing in the futures markets, has been linked as a contributing factor to the “Flash Crash” of 2010, and yet continued through 2015.
The Exchange believes that the activities described in the cases above provide justification for the proposed rule change, which is described below.
The Exchange proposes to adopt new Rule 8.17 to set forth procedures for issuing suspension orders, immediately prohibiting a Member from conducting continued disruptive quoting and trading activity on the Exchange. Importantly, these procedures would also provide the Exchange the authority to order a Member to cease and desist from providing access to the Exchange to a client of the Member that is conducting disruptive quoting and trading activity in violation of proposed Rule 12.15.
Under proposed paragraph (a) of Rule 8.17, with the prior written authorization of the Chief Regulatory Officer (“CRO”) or such other senior officers as the CRO may designate, the Office of General Counsel or Regulatory Department of the Exchange (such departments generally referred to as the “Exchange” for purposes of proposed Rule 8.17) may initiate an expedited suspension proceeding with respect to alleged violations of Rule 12.15, which is proposed as part of this filing and described in detail below. Proposed paragraph (a) would also set forth the requirements for notice and service of such notice pursuant to the Rule, including the required method of service and the content of notice.
Proposed paragraph (b) of Rule 8.17 would govern the appointment of a Hearing Panel as well as potential disqualification or recusal of Hearing Officers. The proposed provision is consistent with existing Exchange Rule 8.6 and includes the requirement for a Hearing Officer to be recused in the event he or she has a conflict of interest or bias or other circumstances exist where his or her fairness might reasonably be questioned. In addition to recusal initiated by such a Hearing Officer, a party to the proceeding will be permitted to file a motion to disqualify a Hearing Officer. However, due to the compressed schedule pursuant to which the process would operate under Rule 8.17, the proposed rule would require such motion to be filed no later than 5 days after the announcement of the Hearing Panel and the Exchange's brief in opposition to such motion would be required to be filed no later than 5 days after service thereof. Pursuant to existing Rule 8.6(b), if the Hearing Panel believes the Respondent has provided satisfactory evidence in support of the motion to disqualify, the applicable Hearing Officer shall remove himself or herself and request the Chief Executive Officer to reassign the hearing to another Hearing Officer such that the Hearing Panel still meets the compositional requirements described in Rule 8.6(a). If the Hearing Panel determines that the Respondent's grounds for disqualification are insufficient, it shall deny the Respondent's motion for disqualification by setting forth the reasons for the denial in writing and the Hearing Panel will proceed with the hearing.
Under paragraph (c) of the proposed Rule, the hearing would be held not later than 15 days after service of the notice initiating the suspension proceeding, unless otherwise extended by the Chairman of the Hearing Panel with the consent of the Parties for good cause shown. In the event of a recusal or disqualification of a Hearing Officer the hearing shall be held not later than five days after a replacement Hearing Officer is appointed. Proposed paragraph (c) would also govern how the hearing is conducted, including the authority of Hearing Officers, witnesses, additional information that may be required by the Hearing Panel, the requirement that a transcript of the proceeding be created and details related to such transcript, and details regarding the creation and maintenance of the record of the proceeding. Proposed paragraph (c) would also state that if a Respondent fails to appear at a hearing for which it has notice, the allegations in the notice and accompanying declaration may be deemed admitted, and the Hearing Panel may issue a suspension order without further proceedings. Finally, as proposed, if the Exchange fails to appear at a hearing for which it has notice, the Hearing Panel may order that the suspension proceeding be dismissed.
Under paragraph (d) of the proposed Rule, the Hearing Panel would be authorized to issue a written decision stating whether a suspension order would be imposed. The Hearing Panel would be required to issue the decision not later than 10 days after receipt of the hearing transcript, unless otherwise extended by the Chairman of the Hearing Panel with the consent of the Parties for good cause shown. The Rule would state that a suspension order shall be imposed if the Hearing Panel finds by a preponderance of the evidence that the alleged violation specified in the notice has occurred and that the violative conduct or continuation thereof is likely to result in significant market disruption or other significant harm to investors.
Proposed paragraph (d) would also describe the content, scope and form of a suspension order. As proposed, a suspension order shall be limited to ordering a Respondent to cease and desist from violating proposed Rule 12.15, and/or to ordering a Respondent to cease and desist from providing access to the Exchange to a client of Respondent that is causing violations of Rule 12.15. Under the proposed rule, a suspension order shall also set forth the alleged violation and the significant market disruption or other significant harm to investors that is likely to result without the issuance of an order. The order shall describe in reasonable detail the act or acts the Respondent is to take or refrain from taking, and suspend such Respondent unless and until such action is taken or refrained from. Finally, the order shall include the date and hour of its issuance. As proposed, a suspension order would remain effective and enforceable unless modified, set aside, limited, or revoked pursuant to proposed paragraph (e), as described below. Finally, paragraph (d) would require service of the Hearing Panel's decision and any suspension order consistent with other portions of the proposed rule related to service.
Proposed paragraph (e) of Rule 8.17 would state that at any time after the Office of Hearing Officers served the Respondent with a suspension order, a Party could apply to the Hearing Panel to have the order modified, set aside, limited, or revoked. If any part of a suspension order is modified, set aside, limited, or revoked, proposed paragraph (e) of Rule 8.17 provides the Hearing Panel discretion to leave the cease and desist part of the order in place. For example, if a suspension order suspends Respondent unless and until Respondent ceases and desists providing access to the Exchange to a client of Respondent, and after the order is entered the Respondent complies, the Hearing Panel is permitted to modify the order to lift the suspension portion of the order while keeping in place the cease and desist portion of the order. With its broad modification powers, the Hearing Panel also maintains the
Finally, proposed paragraph (f) would provide that sanctions issued under the proposed Rule 8.17 would constitute final and immediately effective disciplinary sanctions imposed by the Exchange, and that the right to have any action under the Rule reviewed by the Commission would be governed by Section 19 of the Act. The filing of an application for review would not stay the effectiveness of a suspension order unless the Commission otherwise ordered.
The Exchange currently has authority to prohibit and take action against manipulative trading activity, including disruptive quoting and trading activity, pursuant to its general market manipulation rules, including Rule 3.1. The Exchange proposes to adopt new Rule 12.15, which would more specifically define and prohibit disruptive quoting and trading activity on the Exchange. As noted above, the Exchange also proposes to apply the proposed suspension rules to proposed Rule 12.15.
Proposed Rule 12.15 would prohibit Members from engaging in or facilitating disruptive quoting and trading activity on the Exchange, as described in proposed Interpretation and Policies .01 and .02 of the Rule, including acting in concert with other persons to effect such activity. The Exchange believes that it is necessary to extend the prohibition to situations when persons are acting in concert to avoid a potential loophole where disruptive quoting and trading activity is simply split between several brokers or customers.
To provide proper context for the situations in which the Exchange proposes to utilize its proposed authority, the Exchange believes it is necessary to describe the types of disruptive quoting and trading activity that would cause the Exchange to use its authority. Accordingly, the Exchange proposes to adopt Interpretation and Policy .01 and .02, providing additional details regarding disruptive quoting and trading activity. Proposed Interpretation and Policy .01(a), which describes disruptive quoting and trading activity containing many of the elements indicative of layering, would describe disruptive quoting and trading activity as a frequent pattern in which the following facts are present: (a) A party enters multiple limit orders on one side of the market at various price levels (the “Displayed Orders”); and (b) following the entry of the Displayed Orders, the level of supply and demand for the security changes; and (c) the party enters one or more orders on the opposite side of the market of the Displayed Orders (the “Contra-Side Orders”) that are subsequently executed; and (d) following the execution of the Contra-Side Orders, the party cancels the Displayed Orders. Proposed Interpretation and Policy .01(b), which describes disruptive quoting and trading activity containing many of the elements indicative of spoofing, would describe disruptive quoting and trading activity as a frequent pattern in which the following facts are present: (a) A party narrows the spread for a security by placing an order inside the national best bid or offer; and (b) the party then submits an order on the opposite side of the market that executes against another market participant that joined the new inside market established by the order described in (a) that narrowed the spread. The Exchange believes that the proposed descriptions of disruptive quoting and trading activity articulated in the rule are consistent with the activities that have been identified and described in the client access cases described above. The Exchange further believes that the proposed descriptions will provide Members with clear descriptions of disruptive quoting and trading activity that will help them to avoid engaging in such activities or allowing their clients to engage in such activities.
The Exchange proposes to make clear in Interpretation and Policy .02 that, unless otherwise indicated, the descriptions of disruptive quoting and trading activity do not require the facts to occur in a specific order in order for the rule to apply. For instance, with respect to the pattern defined in proposed Interpretation and Policy .01(a) it is of no consequence whether a party first enters Displayed Orders and then Contra-side Orders or vice-versa. However, as proposed, it is required for supply and demand to change following the entry of the Displayed Orders. The Exchange also proposes to make clear that disruptive quoting and trading activity includes a pattern or practice in which some portion of the disruptive quoting and trading activity is conducted on the Exchange and the other portions of the disruptive quoting and trading activity are conducted on one or more other exchanges. The Exchange believes that this authority is necessary to address market participants who would otherwise seek to avoid the prohibitions of the proposed Rule by spreading their activity amongst various execution venues.
In sum, proposed Rule 12.15 coupled with proposed Rule 8.17 would provide the Exchange with authority to promptly act to prevent disruptive quoting and trading activity from continuing on the Exchange. Below is an example of how the proposed rule would operate.
Assume that through its surveillance program, Exchange staff identifies a pattern of potentially disruptive quoting and trading activity. After an initial investigation the Exchange would then contact the Member responsible for the orders that caused the activity to request an explanation of the activity as well as any additional relevant information, including the source of the activity. If the Exchange were to continue to see the same pattern from the same Member and the source of the activity is the same or has been previously identified as a frequent source of disruptive quoting and trading activity then the Exchange could initiate an expedited suspension proceeding by serving notice on the Member that would include details regarding the alleged violations as well as the proposed sanction. In such a case the proposed sanction would likely be to order the Member to cease and desist providing access to the Exchange to the client that is responsible for the disruptive quoting and trading activity and to suspend such Member unless and until such action is taken. The Member would have the opportunity to be heard in front of a Hearing Panel at a hearing to be conducted within 15 days of the notice. If the Hearing Panel determined that the violation alleged in the notice did not occur or that the conduct or its continuation would not have the potential to result in significant market disruption or other significant harm to investors, then the Hearing Panel would dismiss the suspension order proceeding. If the Hearing Panel determined that the violation alleged in the notice did occur and that the conduct or its continuation is likely to
The Exchange reiterates that it already has broad authority to take action against a Member in the event that such Member is engaging in or facilitating disruptive or manipulative trading activity on the Exchange. For the reasons described above, and in light of recent cases like the client access cases described above, as well as other cases currently under investigation, the Exchange believes that it is equally important for the Exchange to have the authority to promptly initiate expedited suspension proceedings against any Member who has demonstrated a clear pattern or practice of disruptive quoting and trading activity, as described above, and to take action including ordering such Member to terminate access to the Exchange to one or more of such Member's clients if such clients are responsible for the activity. The Exchange recognizes that its proposed authority to issue a suspension order is a powerful measure that should be used very cautiously. Consequently, the proposed rules have been designed to ensure that the proceedings are used to address only the most clear and serious types of disruptive quoting and trading activity and that the interests of Respondents are protected. For example, to ensure that proceedings are used appropriately and that the decision to initiate a proceeding is made only at the highest staff levels, the proposed rules require the CRO or another senior officer of the Exchange to issue written authorization before the Exchange can institute an expedited suspension proceeding. In addition, the Exchange believes that it would use this authority in limited circumstances, when necessary to protect investors, other Members and the Exchange. Further, the Exchange believes that the proposed expedited suspension provisions described above that provide the opportunity to respond as well as a Hearing Panel determination prior to taking action will ensure that the Exchange would not utilize its authority in the absence of a clear pattern or practice of disruptive quoting and trading activity.
The Exchange believes that the proposed rule changes are consistent with Section 6(b) of the Act
Further, the Exchange believes that the proposal is consistent with Sections 6(b)(1) and 6(b)(6) of the Act,
The Exchange further believes that the proposal is consistent with Section 6(b)(7) of the Act,
The Exchange does not believe that the proposed rule changes will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. To the contrary, the Exchange believes that each self-regulatory organization should be empowered to regulate trading occurring on their market consistent with the Act and without regard to competitive issues. The Exchange is requesting authority to take appropriate action if necessary for the protection of investors, other Members and the Exchange.
The Exchange has neither solicited nor received written comments on 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)
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 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.
Social Security Administration.
Notice; Implementation of requirement.
This notice provides advance notification of the requirement that, for claims with certified electronic folders pending at the hearing or Appeals Council levels, an appointed representative must access and obtain a claimant's folder through Appointed Representative Services (ARS) in matters for which the representative requests direct fee payment. Except under the limited circumstances described in this notice, we will no longer provide compact disc (CD) copies of the electronic folder to appointed representatives who request direct payment of fees. We are implementing this requirement to improve administrative efficiency, ensure that representatives can provide the best possible service to claimants by using the most up-to-date information in the claim(s) folder, and manage the unprecedented workload pending in the Office of Disability Adjudication and Review (ODAR).
Maren Weight, Office of Disability Adjudication and Review, Social Security Administration, 5107 Leesburg Pike, Falls Church, VA 22041, (703) 605-7100, for information about this notice. For information on eligibility or filing for benefits, call our national toll-free number, 1-800-772-1213 or TTY 1-800-325-0778, or visit our Internet site, Social Security Online, at
For general information or inquiries about the electronic folder, please write to the Office of Electronic Services and Strategic Information, 5107 Leesburg Pike, Suite 1509, Falls Church, VA 22041.
On September 12, 2011, we published final rules that require appointed representatives to conduct business with us electronically at the times and in the manner we prescribe on matters for which the representative requests direct fee payment.
We implemented ARS nationally at the hearing level in November 2010, and, due to its successful application at the hearing level, expanded representative access at the Appeals Council level in June 2011. In part, ARS permits an appointed representative to examine an electronic folder online, download material from the electronic folder, and upload new evidence to the electronic folder in real time. Utilization of ARS has benefited both claimants and representatives, and has improved our efficiency and reduced our costs in associating incoming medical evidence and other information with a folder.
To ensure efficient processing, it also is important that representatives use the most up-to-date claims folder. Use of ARS to access the claims folder assists the representative to prepare for a hearing and also positively affects administrative processes for both the representative and the agency. To illustrate, a representative who accesses a folder through ARS is able to determine immediately whether evidence he or she submitted is missing from the folder, and, if the evidence is not associated, the representative can take steps immediately to address the issue, rather than later when the evidence's absence could delay the hearing. Additionally, a representative who uses ARS can immediately access the status of cases pending at the hearing and Appeals Council levels, which saves the representative a lot of time in determining status and significantly reduces the number of inquiries received by ODAR offices. Due to the unprecedented workload currently pending in ODAR, time and resource savings such as this are vital to our operations. When a representative uses ARS for these types of tasks, hearing office staff has more time to perform other tasks needed to prepare for and schedule hearings.
Therefore, 120 days after the date of publication of this notice in the
In implementing this requirement, we acknowledge a systems limitation in providing electronic folder access through ARS when a claimant has appointed multiple representatives. Currently, in multiple representative situations, only the individual who is designated as the principal representative is able to access a claimant's electronic folder through ARS. Under this mandate, if the principal representative requests direct payment of fees, he or she must use ARS to access the electronic folder, and SSA will not provide this representative CDs of the electronic folder upon request. Since non-principal representatives cannot currently access the electronic folder in multiples representative situations, the new mandate described in this notice does not apply to a non-principal representative. However, when the mandate applies to the principal representative, we will not provide CDs of the electronic folder to other appointed representatives who associate themselves with the principal representative by using the same Employer Identification Number (EIN) as the principal representative when requesting direct payment of fees on that case. (Representatives currently identify case-specific EINs for direct fee payment purposes via Form SSA-1695, Identifying Information for Possible Direct Payment of Authorized Fees). Instead, we expect these representatives to make arrangements with the principal representative to obtain copies of the claimant's folder, if they need to view it. If requested, we will continue to provide CDs of the electronic folder to appointed representatives on the case who are not associated with the same
Additionally, we acknowledge there will be a few situations where case characteristics, our systems, or other technology limitations preclude access to the electronic folder through ARS. For example, if a request for review is pending at the Appeals Council level on a prior claim, and a subsequent application is pending at the hearing level, our system will not allow a representative to access one or both of the electronic folders. Also, if a case has been closed for more than 90 days after a final action or if the Appeals Council establishes a new court case, an appointed representative cannot access the electronic folder through ARS. In these types of situations, we will continue to work with the representative to provide a CD copy of the electronic folder when requested.
We will also provide an exception to those representatives who show that they are unable to register for ARS due to technological issues outside of our control or the control of the representative (
A representative who falls under the terms of this mandate, as described, has an affirmative duty to comply with this requirement. We may investigate to determine if a representative violates this duty or is attempting to circumvent our rules. We may sanction a representative who does not follow these rules, as described in 20 CFR 404.1745-1795 and 416.1545-1595. However, we will not reject or delay a claimant's hearing or process a claim differently if a representative fails to comply with this electronic access requirement.
Claimants, whether they are represented or not, and representatives who are not eligible for or who do not request direct payment of fees in a case, may receive a CD copy of the claimant's electronic folder.
Additional information is available on our Representing Social Security Claimants Web site at
The Social Security Administration (SSA) publishes a list of information collection packages requiring clearance by the Office of Management and Budget (OMB) in compliance with Public Law 104-13, the Paperwork Reduction Act of 1995, effective October 1, 1995. This notice includes revisions of OMB-approved information collections.
SSA is soliciting comments on the accuracy of the agency's burden estimate; the need for the information; its practical utility; ways to enhance its quality, utility, and clarity; and ways to minimize burden on respondents, including the use of automated collection techniques or other forms of information technology. Mail, email, or fax your comments and recommendations on the information collection(s) to the OMB Desk Officer and SSA Reports Clearance Officer at the following addresses or fax numbers.
(OMB), Office of Management and Budget, Attn: Desk Officer for SSA, Fax: 202-395-6974, Email address:
(SSA), Social Security Administration, OLCA, Attn: Reports Clearance Director, 3100 West High Rise, 6401 Security Blvd., Baltimore, MD 21235, Fax: 410-966-2830, Email address:
Or you may submit your comments online through
I. The information collection below is pending at SSA. SSA will submit it to OMB within 60 days from the date of this notice. To be sure we consider your comments, we must receive them no later than June 17, 2016. Individuals can obtain copies of the collection instrument by writing to the above email address.
Statement for Determining Continuing Entitlement for Special Veterans Benefits (SVB)—0960-0782. SSA regularly reviews individuals' claims for Special Veterans Benefits (SVB) to determine their continued eligibility and correct payment amounts. Individuals living outside the United States receiving SVB must report to SSA any changes that may affect their benefits, such as: (1) A change in mailing address or residence; (2) an increase or decrease in a pension, annuity, or other recurring benefit; (3) a return or visit to the United States for a calendar month or longer; or (4) an inability to manage benefits. SSA uses Form SSA-2010, to collect this information. Respondents are beneficiaries living outside the United States collecting SVB.
II. SSA submitted the information collections below to OMB for clearance. Your comments regarding the information collections would be most useful if OMB and SSA receive them 30 days from the date of this publication. To be sure we consider your comments, we must receive them no later than May 18, 2016. Individuals can obtain copies of the OMB clearance packages by writing to
1. Statement for Determining Continuing Eligibility, Supplemental Security Income Payment(s)—20 CFR 416.204—0960-0416. SSA conducts disability redeterminatons to determine if Supplemental Security Income (SSI) recipients (1) met and continue to meet all statutory and regulatory requirements for SSI eligibility and (2) are receiving the correct SSI payment amount. SSA makes these redeterminations through periodic use of Form SSA-8203-BK. SSA conducts
2. Information About Joint Checking/Savings Account—20 CFR 416.1201 and 416.1208—0960-0461. SSA considers a person's resources when evaluating eligibility for SSI. Generally, we consider funds in checking and savings accounts as resources owned by the individuals whose names appear on the account. However, individuals applying for SSI may rebut this assumption of ownership in a joint account by submitting certain evidence to establish the funds do not belong to them. SSA uses Form SSA-2574 to collect information from SSI applicants and recipients who object to the assumption that they own all or part of the funds in a joint checking or savings account bearing their names. SSA collects information about the account from both the SSI applicant or recipient and the other account holder(s). After receiving the completed form, SSA determines if we should consider the account to be a resource for the SSI applicant and recipient. The respondents are applicants and recipients of SSI, and individuals who list themselves as joint owners of financial accounts with SSI applicants or recipients.
3. Plan for Achieving Self-Support (PASS)—20 CFR 416.110(e), 416.1180-1182, 416.1225-1227—0960-0559. The SSI program encourages recipients to return to work. One of the program objectives is to provide incentives and opportunities that help recipients toward employment. The PASS provision allows individuals to use available income or resources (such as business equipment, education, or specialized training) to enter or re-enter the workforce and become self-supporting. In turn, SSA does not count the income or resources recipients use to fund a PASS when determining an individual's SSI eligibility or payment amount. An SSI recipient who wants to use available income and resources to obtain education or training to become self-supporting completes Form SSA-545. SSA uses the information from the SSA-545 to evaluate the recipient's PASS, and to determine eligibility under the provisions of the SSI program. The respondents are SSI recipients who want to develop a return-to-work plan.
4. Registration for Appointed Representative Services and Direct Payment—0960-0732. SSA uses Form SSA-1699 to register appointed representatives of claimants before SSA who:
• Want to register for direct payment of fees;
• Registered for direct payment of fees prior to 10/31/09, but need to update their information;
• Registered as appointed representatives on or after 10/31/09, but need to update their information; or
• Received a notice from SSA instructing them to complete this form.
5. Certificate of Election for Reduced Widow(er)s and Surviving Divorced Spouse's Benefits—20 CFR 404.335—0960-0759. Section 202(q) of the Social Security Act provides SSA the authority to reduce benefits under certain conditions when elected by a Title II beneficiary. However, reduced benefits are not payable to an already entitled spouse (or divorced spouse) who:
• Is at least age 62 and under full retirement age in the month of the number holder's death; and
• Is receiving both reduced spouse's (or divorced spouse's) benefits and either retirement or disability benefits in the month before the month of the number holder's death.
To elect reduced widow(er) benefits, a recipient completes Form SSA-4111. SSA uses the information collected to pay a qualified dually entitled widow(er) (or surviving divorced spouse) who elects to receive a reduced widow(er) benefit. The respondents are qualified dually entitled widow(er)s (or surviving divorced spouse) who elect to receive a reduced widow(er) benefit.
Federal Aviation Administration (FAA), DOT.
Notice of intent to rule on request to release airport property at the Hebron Municipal Airport (HJH), Hebron, Nebraska.
The FAA proposes to rule and invites public comment on the release of land at the Hebron Municipal Airport (HJH), Hebron, Nebraska, under the provisions of 49 U.S.C. 47107(h)(2).
Comments must be received on or before May 18, 2016.
Comments on this application may be mailed or delivered to the FAA at the following address: Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to: William Linton, Airport Manager, Hebron Municipal Airport, Hebron Airport Authority; P.O. Box 256, Hebron, NE 68370-0256, (402) 768-6597.
Lynn D. Martin, Airports Compliance Specialist, Federal Aviation Administration, Airports Division, ACE-610C, 901 Locust Room 364, Kansas City, MO 64106, (816) 329-2644,
The FAA invites public comment on the request to release approximately 0.21± acres of airport property at the Hebron Municipal Airport (HJH) under the provisions of 49 U.S.C. 47107(h)(2). On March 16, 2016, the City of Hebron's Airport Manager requested from the FAA that approximately 0.21± acres of property be released for sale to the Nebraska Department of Roads for the purpose of reconstructing a bridge and road. On April 8, 2016, the FAA determined that the request to release property at Hebron Municipal Airport (HJH) submitted by the Sponsor meets the procedural requirements of the Federal Aviation Administration and the release of the property does not and will not impact future aviation needs at the airport. The FAA may approve the request, in whole or in part, no sooner than thirty days after the publication of this Notice.
The following is a brief overview of the request:
Hebron Municipal Airport (HJH) is proposing the release of a parcel, totaling 0.21± acres. The release of land is necessary to comply with Federal Aviation Administration Grant Assurances that do not allow federally acquired airport property to be used for non-aviation purposes. The sale of the subject property will result in the land at the Hebron Municipal Airport (HJH) being changed from aeronautical to nonaeronautical use and release the surface lands from the conditions of the AIP Grant Agreement Grant Assurances. In accordance with 49 U.S.C. 47107(c)(2)(B)(i) and (iii), the airport will receive fair market value for the property.
Any person may inspect, by appointment, the request in person at the FAA office listed above under
Maritime Administration, Department of Transportation.
Notice of open season for marine highway projects.
The U.S. Department of Transportation (DOT) and Maritime Administration (MARAD) announce that the period for Marine Highway project submissions is being extended to December 31, 2018 (Open Season). The purpose of this notice is to extend the invitation to interested organizations to submit Marine Highway project applications to DOT for review and consideration.
There will be five additional project review periods during the extended Marine Highway Open Season. Table 1 contains the application due dates and review periods for each review period. Qualified projects will be announced shortly after the completion of each review period.
MARAD's Gateway Offices can respond to questions about the Marine Highway Program, Route designations and Project Open Season. Gateway Office contact information is available on the MARAD Web site at
Submit applications to Fred Jones, Office of Marine Highway and Passenger Services, W21-311, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Washington, DC 20590 or via email to
Timothy Pickering, Office of Marine Highway and Passenger Services, W21-312, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Washington, DC 20590. Telephone (202) 366-0704; Fax (202) 366-5904 or email Mr. Pickering at
As originally announced in the
The purpose of the open season call for projects is to seek eligible Marine Highway projects that may establish new or enhance existing Marine Highway services. Eligible projects may be designated as Marine Highway Projects by the Secretary of Transportation. Being designated a Marine Highway Project allows DOT resources to be used to assist public project sponsors, ports and other local transportation or economic development agencies in the development of Marine Highway projects.
The Department's objective through this program is to reduce landside congestion and increase the use of domestic marine transportation by supporting the development of transportation options for shippers. These services provide economic and environmental benefits to the U.S. public at large. Marine Highway Program designated projects can improve safety and system resilience, and serve to reduce transportation-related air emissions, transportation costs for shippers, energy consumption, and costs associated with landside transportation infrastructure.
The Marine Highway Program implementing regulations at 46 CFR part 393 will be amended to reflect the new statutory changes. In the meantime, DOT/MARAD will accept and process project applications that propose to operate or expand service on Marine Highway routes, including those with no parallel landside route.
If new Marine Highway grant funds are appropriated in a fiscal year (FY), it is possible that the review period for the July 1-September 30 review session may be truncated so that projects submitted on June 30 could be made eligible to apply for Marine Highway grant funds in that FY.
Although Marine Highway Projects often involve private entities such as vessel operators, the applications must be sponsored and submitted to DOT/MARAD by a public entity, such as a State Department of Transportation, Metropolitan Planning Organization (MPO), or Port Authority. Public/private partnerships are encouraged.
To be eligible for Marine Highway Project status, the proposed project must (1) use U.S. documented vessels, (2) transport passengers, containerized freight or trailer-based freight, and (3) operate on a designated Marine Highway Route. (Refer to 46 CFR 393.4(c) for a comprehensive description of project eligibility). However, since the number of navigable waterways eligible for designation as a Marine Highway Route was increased in the Coast Guard and Marine Transportation Act of 2012, DOT/MARAD will consider Marine Highway projects that would operate on newly eligible navigable waterways that have been recommended for, but not yet granted, a Marine Highway Route designation. For further information on recommending that a navigable waterway be designated as a Marine Highway Route, please contact your regional Gateway Office. Their contact
49 CFR Sections 1.92 and 1.93.
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation.
Denial of petition for a defect investigation.
This notice sets forth the reasons for the denial of a petition submitted to NHTSA under 49 U.S.C. 30162, requesting that the agency commence a proceeding to determine the existence of a defect related to motor vehicle safety in 2015 Volvo VNL 780 vehicles. After a review of the petition and other information, NHTSA has concluded that further expenditure of the agency's investigative resources on the issues raised by the petition does not appear warranted. The agency accordingly has denied the petition. The petition is hereinafter identified as DP15-006.
Mr. Nate Seymour, Medium & Heavy Duty Vehicle Division, Office of Defects Investigation (ODI), NHTSA, 1200 New Jersey Ave. SE., Washington, DC 20590. Telephone: (202) 366-2069.
By letter dated August 7, 2015, Mr. Albert Cusson and Nancy Younger-Cusson wrote to NHTSA requesting that the agency investigate the issues they previously identified in vehicle owner questionnaires (VOQ) 10701592 and 10747593 filed with the Agency. While the Petitioner's letter did not comply precisely with the requirements for petitions found in 49 CFR 552.4, the Agency is treating it as a petition in accordance with the regulation.
ODI understands these issues to include: Cab sway, cab alignment/bottoming out, and loss of vehicle control due to false triggering of the advanced vehicle safety systems. NHTSA has reviewed the material provided by the petitioners and other pertinent data that the agency gathered as well as test drove the petitioners' vehicle. The results of this review and NHTSA's analysis of the petition's merit is set forth in the DP15-006 Evaluation Report, appearing in the public docket referenced in the heading of this notice.
For the reasons presented in the Evaluation Report, it is unlikely that an order concerning notification and remedy of a safety-related defect would be issued as a result of granting Mr. Albert Cusson and Nancy Younger-Cusson's request. Therefore, in review of the need to allocate and prioritize NHTSA's investigative resources, an investigation on the issues raised by the petition does not appear to be warranted. Therefore, the petition is denied.
49 U.S.C. 30162(d); delegations of authority at CFR 1.95 and 501.8.
Office of the Comptroller of the Currency (OCC), Treasury; Board of Governors of the Federal Reserve System (Board); and Federal Deposit Insurance Corporation (FDIC).
Joint notice and request for comment.
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), the OCC, the Board, and the FDIC (the agencies) may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. The agencies, under the auspices of the Federal Financial Institutions Examination Council (FFIEC), have approved the publication of proposed revisions to the Regulatory Capital Reporting for Institutions Subject to the Advanced Capital Adequacy Framework (FFIEC 101) for public comment. The proposed revisions to the FFIEC 101 are consistent with the revised regulatory capital rule approved by the agencies in July 2013 (regulatory capital rule), as amended by subsequent revisions to the supplementary leverage ratio (SLR).
The proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to all banking organizations subject to the advanced approaches risk-based capital rule (generally, banking organizations with $250 billion or more in total consolidated assets or $10 billion or more in on-balance sheet foreign exposures) (advanced approaches banking organizations), unless the advanced approaches banking organization is (i) a consolidated subsidiary of a bank holding company (BHC), savings and loan holding company (SLHC), or depository institution that is subject to the disclosure requirements in Table 13 of section 173 of the advanced approaches risk-based capital rule (advanced approaches rule), or (ii) a subsidiary of a non-U.S. banking organization that is subject to comparable public disclosure requirements in its home jurisdiction. Advanced approaches banking organizations would begin reporting the proposed SLR data items in FFIEC 101 Schedule A, Tables 1 and 2, effective with the September 30, 2016, reporting date.
Separately, the proposed collection of SLR data in Tables 1 and 2 of FFIEC 101 Schedule A would apply to any U.S. intermediate holding companies (IHCs) formed or designated for purposes of compliance with the Board's Regulation YY (12 CFR 252.153) that are advanced approaches banking organizations, effective with the March 31, 2018, reporting date. Any subsidiary BHC controlled by a foreign banking organization (FBO) that was subject to the SLR requirements prior to the formation of an IHC would complete FFIEC 101 Schedule A, Tables 1 and 2, through the December 31, 2017, reporting date. The agencies would release publicly Tables 1 and 2 of FFIEC 101 Schedule A for all covered banking organizations, including IHCs that are required to complete Schedule A.
At the end of the comment period, the comments will be analyzed to determine the extent to which the FFIEC and the agencies should modify the proposed revisions. The agencies will then submit the proposed revisions to OMB for review and final approval.
Comments must be submitted on or before June 17, 2016.
Interested parties are invited to submit written comments to any or all of the agencies. All comments, which should refer to the OMB control number(s), will be shared among the agencies.
All comments received, including attachments and other supporting materials, are part of the public record and subject to public disclosure. Do not enclose any information in your comment or supporting materials that you consider confidential or inappropriate for public disclosure.
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All public comments are available from the Board's Web site at
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Public Inspection: All comments received will be posted without change to
Additionally, commenters may send a copy of their comments to the OMB desk officer for the agencies by mail to the Office of Information and Regulatory Affairs, U.S. Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503; by fax to (202) 395-6974; or by email to
For further information about the proposed revisions to regulatory reporting requirements discussed in this notice, please contact any of the agency clearance officers whose names appear below. In addition, copies of the proposed revised FFIEC 101 form and instructions can be obtained at the FFIEC's Web site (
The agencies are proposing to extend for three years, with revision, the FFIEC 101, which is currently an approved collection of information for each agency.
Each advanced approaches banking organization is required to file quarterly regulatory capital data on the FFIEC's Regulatory Capital Reporting for Institutions Subject to the Advanced Capital Adequacy Framework (FFIEC 101). The FFIEC 101 information collection is mandatory for institutions subject to the advanced approaches risk-based capital rule (advanced approaches banking organizations): 12 U.S.C. 161 (national banks), 12 U.S.C. 324 (state member banks), 12 U.S.C. 1844(c) (bank holding companies), 12 U.S.C. 1467a(b) (savings and loan holding companies), 12 U.S.C. 1817 (insured state nonmember commercial and savings banks), 12 U.S.C. 1464 (savings associations), and 12 U.S.C. 1844(c), 3106, and 3108 (intermediate holding companies).
The agencies use these data to assess and monitor the levels and components of each reporting entity's capital requirements and the adequacy of the entity's capital under the Advanced Capital Adequacy Framework; to evaluate the impact and competitive implications of the Advanced Capital Adequacy Framework on individual reporting entities and on an industry-wide basis; and to supplement on-site examination processes. The reporting schedules also assist advanced approaches banking organizations in understanding expectations around the system development necessary for implementation and validation of the Advanced Capital Adequacy Framework. Submitted data that are released publicly will also provide other interested parties with information about advanced approaches banking organizations' regulatory capital.
The agencies are inviting comment on two proposed new tables that would be added to FFIEC 101 Schedule A to collect information related to the agencies' SLR disclosures required in Table 13 of section 173 of the advanced approaches rule. Proposed Tables 1 and 2, which will replace existing items 91 through 98 of FFIEC 101 Schedule A,
The proposed revisions to the FFIEC 101 would apply only to an advanced approaches banking organization as described in section 173(a)(2) of the advanced approaches rule.
Separately, each advanced approaches banking organization, regardless of its parallel run status, is required to disclose its SLR, and the numerator and denominator of its SLR, under section 172(d) of the advanced approaches rule.
An IHC formed or designated for purposes of compliance with the Board's Regulation YY (12 CFR 252.153) is required to meet all applicable capital adequacy standards set forth in the Board's Regulation Q, except for subpart E.
Depository institutions that are exempt from filing the FFIEC 101, but remain subject to the SLR, would not need to begin filing the FFIEC 101. Instead, these institutions would report their SLR, and the numerator and denominator of their SLR, under the proposed Call Report revisions discussed above.
The agencies propose to collect the SLR information in Tables 1 and 2 of FFIEC 101 Schedule A quarterly. Each reporting entity would continue to submit the applicable quarterly reports on the same due dates as are currently in effect for the reporting entity for as long as it remains subject to the requirements of section 173(a)(2) of the advanced approaches rule.
To ensure transparency of regulatory capital data reported by internationally active banking organizations, the agencies propose to make public the SLR information collected in proposed SLR Tables 1 and 2 of FFIEC 101 Schedule A, regardless of an advanced approaches banking organization's parallel run status.
For the September 30, 2016, and March 31, 2018, initial report dates, as applicable, banking organizations may provide reasonable estimates for any new or revised items in SLR Tables 1 and 2 of FFIEC 101 Schedule A initially required to be reported as of that date for which the requested information is not readily available. The specific wording of the captions for the new or revised SLR items discussed in this proposal and the numbering of these data items should be regarded as preliminary.
As described in section I.A of this proposal, the proposed SLR items in FFIEC 101 Schedule A, Tables 1 and 2, are aligned with the international leverage ratio common disclosure template to ensure consistency and comparability of reporting of regulatory capital elements by internationally active banking organizations. While the SLR calculated under the SLR rule and this reporting proposal would be the same, the proposed SLR items in Tables 1 and 2 may require different calculation steps than those described in the SLR rule because Tables 1 and 2 have been designed to be consistent with the calculation steps in the international template.
The proposed items are divided into two tables: (1) Summary comparison of accounting assets and total leverage exposure (Table 1) and (2) Supplementary leverage ratio (Table 2). A brief description of each of these tables and the proposed items is provided below.
Proposed Table 1, items 1.1 through 1.8, would collect summary information on accounting assets for purposes of reconciling balance sheet assets reported in published financial statements and total leverage exposure. The proposed items align with those included in Table 1 of the international leverage ratio common disclosure template. Item 1.1 would collect total consolidated assets as of quarter end as reported in published financial statements. Item 1.2 would collect the adjustment for investments in banking, financial, insurance, and commercial entities that are consolidated for accounting purposes but are outside the scope of regulatory consolidation. Item 1.3, adjustment for fiduciary assets recognized on-balance sheet but excluded from total leverage exposure, would be shaded out and not collected, as it is not applicable to U.S. banking organizations. Item 1.4 would collect the accounting and regulatory adjustments required to reconcile what an institution reports on its published financial statements with the amount an institution includes for exposures to derivatives transactions in total leverage exposure (calculated on a quarter end basis), in addition to any off-balance sheet and related regulatory adjustments (calculated using the mean of the amount calculated as of the last day of each of the three months of the reporting quarter). Similarly, item 1.5 would collect the accounting and regulatory adjustments required to reconcile what an institution reports on its published financial statements with the amount an institution includes for exposures to repo-style transactions in its total leverage exposure (calculated on a quarter end basis), in addition to any off-balance sheet and related regulatory adjustments (calculated using the mean of the amount calculated as of the last day of each of the three months of the reporting quarter). Item 1.6 would collect the adjustment for off-balance sheet exposures. Item 1.7 would include two subcomponents where item 1.7a would collect adjustments for deductions from tier 1 capital and item 1.7b would collect adjustments due to the difference in the frequency of certain calculations required for accounting purposes compared to the measurement required for purposes of total leverage exposure. Specifically, 1.7b would adjust an institution's calculations in Table 1, items 1.1, 1.4 and 1.5 that are reported on a quarter end basis to a daily average as required in the calculation of an institution's total leverage exposure as reported in Table 2, item 2.21. Item 1.8 would collect total leverage exposure by summing items 1.1 through 1.6 and subtracting items 1.7a and 1.7b. This item should equal Table 2, item 2.21.
The agencies request comment on whether Table 1 should include an additional reporting item for any other adjustments necessary to reconcile an institution's balance sheet assets reported in published financial statement with total leverage exposure as reported in Table 2, item 2.21. Commenters should also provide a description of the additional adjustments.
Proposed Table 2, items 2.1 through 2.23, would collect detailed information for the calculation of total leverage exposure and the SLR, consistent with the international leverage ratio common disclosure template.
Items 2.1 through 2.3 would collect information about an institution's on-balance sheet exposures. Item 2.1 would collect the balance sheet carrying value of all on-balance sheet assets, net of the allowance for loan and lease losses as defined in the regulatory capital rule (excluding on-balance sheet assets for derivative transactions and repo-style transactions, but including on-balance sheet collateral received in derivative transactions). Item 2.2 would collect deductions from common equity tier 1 capital and additional tier 1 capital, calculated as the sum of existing items 28 and 43 on Schedule A of the FFIEC 101, net of Schedule A, items 11, 14, and certain amounts reported in item
Items 2.4 through 2.11 would collect information about an institution's derivative exposures. Item 2.4 would collect the replacement cost for cleared and non-cleared derivative transactions. Item 2.5 would collect the add-on amounts for potential future exposure (PFE) for all derivative transactions included in item 2.4 (regardless of whether the transaction or the transaction's netting set has a positive or negative fair value). Item 2.6 would collect the gross-up amount for collateral posted in derivative transactions if the collateral is deducted from on-balance sheet assets. Item 2.7 would collect the deduction of receivable assets for qualifying cash variation margin posted in derivative transactions. Item 2.8 would collect exempted exposures to central counterparties in cleared transactions. Item 2.9 would collect the adjusted effective notional principal amount of sold credit protection. Item 2.10 would collect the adjusted effective notional principal amount offsets and PFE deductions for sold credit protection. Item 2.11 would collect total derivative exposures, calculated as the sum of items 2.4, 2.5, 2.6, and 2.9, minus items 2.7, 2.8, and 2.10.
Items 2.12 through 2.16 would collect information about an institution's repo-style transactions. Item 2.12 would collect gross assets for repo-style transactions, with no recognition of netting. Item 2.13 would collect the reduction of the gross value of receivables in reverse repurchase transactions by cash payables in repurchase transactions with the same counterparty. Item 2.14 would collect the counterparty credit risk for all repo-style transactions. Item 2.15 would collect the exposure amount for repo-style transactions where an institution acts as an agent. Item 2.16 would collect total exposures for repo-style transactions, calculated as the sum of items 2.12, 2.14, and 2.15, minus item 2.13.
Items 2.17 through 2.19 would collect information about an institution's off-balance sheet exposures. Item 2.17 would collect off-balance sheet exposures at gross notional amounts. Item 2.18 would collect adjustments for conversion to credit equivalent amounts. Item 2.19 would collect total off-balance sheet exposures, calculated as the difference between items 2.17 and 2.18.
Items 2.20 through 2.22 would collect information about an institution's capital, total leverage exposure, and the SLR. Item 2.20 would collect tier 1 capital as reported in existing item 45 on Schedule A of the FFIEC 101. Item 2.21 would collect total leverage exposure, calculated as the sum of items 2.3, 2.11, 2.16, and 2.19. Item 2.22 would collect the SLR, calculated by dividing item 2.20 by item 2.21.
Item 2.23, the enhanced SLR buffer, is an additional line item that is not included on the international leverage ratio common disclosure template. This item would apply only to advanced approaches BHCs that are subject to the enhanced SLR standard and it would help determine whether the bank holding company is subject to limitations on capital distributions and discretionary bonus payments.
The Legal Entity Identifier (LEI) is a 20-digit alpha-numeric code that uniquely identifies entities that engage in financial transactions. The recent financial crisis spurred the development of a Global LEI System (GLEIS). Internationally, regulators and market participants have recognized the importance of the LEI as a key improvement in financial data systems. The Group of Twenty (G-20) nations directed the Financial Stability Board (FSB) to lead the coordination of international regulatory work and deliver concrete recommendations on the GLEIS by mid-2012, which in turn were endorsed by the G-20 later that same year. In January 2013, the LEI Regulatory Oversight Committee (ROC), including participation by regulators from around the world, was established to oversee the GLEIS on an interim basis. With the establishment of the full Global LEI Foundation in 2014, the ROC continues to review and develop broad policy standards for LEIs. The OCC, the Board, and the FDIC are all members of the ROC.
The LEI system is designed to facilitate several financial stability objectives, including the provision of higher quality and more accurate financial data. In the United States, the Financial Stability Oversight Council (FSOC) has recommended that regulators and market participants continue to work together to improve the quality and comprehensiveness of financial data both nationally and globally. In this regard, the FSOC also has recommended that its member agencies promote the use of the LEI in reporting requirements and rulemakings, where appropriate.
Effective beginning October 31, 2014, the Board started requiring holding companies to provide their LEI on the cover pages of the FR Y-6, FR Y-7, and FR Y-10 reports
Public comment is requested on all aspects of this joint notice. Comments are invited on
(a) Whether the collections of information that are the subject of this notice are necessary for the proper performance of the agencies' functions, including whether the information has practical utility;
(b) The accuracy of the agencies' estimates of the burden of the information collections as they are proposed to be revised, including the validity of the methodology and assumptions used;
(c) Ways to enhance the quality, utility, and clarity of the information to be collected;
(d) Ways to minimize the burden of information collections 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.
Comments submitted in response to this joint notice will be shared among the agencies and will be summarized or included in the agencies' requests for OMB approval. All comments will become a matter of public record.
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 May 25, 2016, room 230 at the Department of Veterans Affairs Central Office, 810 Vermont Ave. NW., Washington, DC 20420 from 8:00 a.m. to 3:30 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 review the potential policy requiring physicians provide
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 Brigid McCarthy, Department of Veterans Affairs, Office of Specialty Care Services (10P4E), 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. McCarthy at (202) 461-5129 or by email.
By Direction of the Secretary.
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Veterans Rural Health Advisory Committee will meet on May 3-4, 2016, at 2815 N. Assembly Street, Building 40, Room 225, Spokane, Washington, from 8:30 a.m. to 5:00 p.m. on both days. The meeting is open to the public.
The purpose of the Committee is to advise the Secretary of Veterans Affairs on health care issues affecting enrolled Veterans residing in rural areas. The Committee examines programs and policies that impact the provision of VA health care to enrolled Veterans residing in rural areas, and discusses ways to improve and enhance VA services for these Veterans.
The agenda will include updates from the Committee Chairman and the Director of the Veterans Health Administration Office of Rural Health, as well as presentations on general health care access and quality topics.
Public comments will be received at 4:30 p.m. on May 4, 2016. Interested parties should contact Mr. Elmer D. Clark, by mail at 810 Vermont Avenue, Mail Code 10P1R, Washington, DC 20420, or via email at
By Direction of the Secretary
The Department of Veterans Affairs (VA) gives notice under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the subcommittees of the Joint Biomedical Laboratory Research and Development and Clinical Science Research and Development Services Scientific Merit Review Board will meet from 8 a.m. to 5 p.m. on the dates indicated below (unless otherwise listed):
The addresses of the meeting sites are:
The purpose of the subcommittees is to provide advice on the scientific quality, budget, safety, and mission relevance of investigator-initiated research proposals submitted for VA merit review evaluation. Proposals submitted for review include diverse medical specialties within the general areas of biomedical, behavioral, and clinical science research.
These subcommittee meetings will be closed to the public for the review, discussion, and evaluation of initial and renewal research proposals, which involve reference to staff and consultant critiques of research proposals. Discussions will deal with scientific merit of each proposal and qualifications of personnel conducting the studies, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Additionally, premature disclosure of research information could significantly frustrate implementation of proposed agency action regarding the research proposals. As provided by subsection 10(d) of Public Law 92-463, as amended by Public Law 94-409, closing the subcommittee meetings is in accordance with Title 5 U.S.C. 552b(c)(6) and (9)(B).
Those who would like to obtain a copy of the minutes from the closed subcommittee meetings and rosters of the subcommittee members should contact Holly Krull, Ph.D., Manager, Merit Review Program (10P9B), Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420, at (202) 632-8522 or by email at
By Direction of the Secretary.
Fish and Wildlife Service, Interior.
Proposed rule; withdrawal.
We, the U.S. Fish and Wildlife Service (Service), withdraw the proposed rule to list the West Coast Distinct Population Segment of fisher (
The withdrawal of our proposed rule, comments, and supplementary documents are available on the Internet at
The October 7, 2014, proposed rule (79 FR 60419) to list the West Coast DPS of fisher as a threatened species is withdrawn as of April 18, 2016.
Jenny Ericson, Deputy Field Supervisor, Yreka Fish and Wildlife Office (see
We use many acronyms and abbreviations throughout this document. To assist the reader, we provide a list of these here for easy reference:
Please refer to the proposed listing rule for the West Coast DPS (79 FR 60419; October 7, 2014) of fisher for a detailed description of the Federal actions concerning this proposed DPS that occurred prior to publication of the proposed listing rule. The proposed listing rule established a 90-day comment period, during which we held one public hearing and seven public information meetings. We received requests to extend this comment period on the proposed rule beyond the January 5, 2015, due date. In order to ensure that the public had an adequate opportunity to review and comment on the proposed rule, we extended the comment period for an additional 30 days to February 4, 2015 (79 FR 76950; December 23, 2014).
On April 14, 2015, we reopened the comment period on our October 7, 2014, proposed rule to list the West Coast DPS of fisher for another 30 days (80 FR 19953). We also announced a 6-month extension of the final listing determination for the proposed West Coast DPS of fisher as a threatened species to acquire new information and comments regarding toxicants and rodenticides and survey information in order to help assess distribution and population trends, due to disagreement regarding the sufficiency or accuracy of the available data related to those issues. The comment period was reopened until May 14, 2015, and we announced that we would publish a listing determination on or before April 7, 2016.
In our October 7, 2014, proposed rule (79 FR 60419), we proposed to list the West Coast DPS of fisher; this DPS included both extant populations of fisher and much of the fisher's historical range from the southern Sierra Nevada of California north through the States of Oregon and Washington. In that proposed rule, we also presented two possible alternative DPS configurations for consideration and comment, and solicited additional possible DPS alternatives from both peer reviewers and the public. Although this presentation of alternative DPS delineations is unusual, it reflects, in part, the high level of uncertainty and wide range of opinions within the Service regarding the appropriate status of the DPS. In our proposed rule, we specifically referenced the complexity of the issues under review in our request for public comment, and throughout the document we noted the tremendous regional variability in the degree to which stressors may be affecting fishers or their habitat. Following thorough consideration of all information available to us, our decision is that the original DPS configuration as presented in the proposed listing rule is most appropriate to serve as the focus of our analysis here (see Figure 1). Thus throughout this document, when we refer to the “analysis area,” we are referring to the area within that DPS boundary.
Although much of the proposed West Coast DPS of fisher is a genetically unique (
A detailed discussion of the proposed West Coast DPS of fisher's description, taxonomy, habitat, life-history characteristics (
We consider a stressor to be any activity or process that may have some negative effect on fishers or their habitat—for example, timber harvest activities or wildfire that results in the removal of denning structures required by fishers for successful reproduction, or mortality of individuals from vehicle collisions, disease, or predation. Stressors are primarily related to human activities, but can be natural events and act on fishers at various scales and intensities throughout the analysis area. All species experience stressors; however, we consider a stressor to rise to the level of a threat to the species (or in this case the proposed West Coast DPS of fishers) if the magnitude of the stressor is such that it is resulting in significant impacts at either the population or rangewide scales to fishers or their habitat. As described in our proposed rule (79 FR 60419, p. 60427), in considering what stressors might constitute threats, we must look beyond the mere exposure of the DPS to the stressor to determine whether the DPS responds to the stressor in a way that causes actual negative impacts to the DPS. In our draft Species Report, we attempted to evaluate the magnitude of the effects of identified stressors to the proposed West Coast DPS of fisher and its habitat by quantifying the severity and scope of those stressors. That analysis required us to make assumptions or extrapolate impacts in an effort to quantify stressors in areas where stressor-specific information was not available. Our presentation of the scope and severity of stressors in quantitative terms may have created a false sense of precision with regard to the level of scientific accuracy underlying these estimates. To avoid this perception, in our final Species Report we use a qualitative approach to describe stressors (
The final Species Report and other materials relating to this final agency action can be found at
At the time of our October 7, 2014, proposed rule, we had concluded that fishers are still absent from much of their historical range (the two original extant populations have not expanded), threats at the time of the 2004 finding are still in place, and some threats since the time of the 2004 Finding have increased or are new. We additionally concluded that it is too early to determine if the reintroduced populations will persist (79 FR 60419, p. 60436). Threats identified in the 2014 proposed rule included habitat loss from wildfire and vegetation management, toxicants, and the cumulative impact and synergistic effects of these and other stressors in small populations.
We have reviewed and considered the best scientific and commercial data available to us, including public comments, Federal and State agency comments, peer review comments, issues articulated at the public hearing and public meetings, and all new information brought to our attention during the public comment periods, relevant to the conservation status of the proposed West Coast DPS of fisher. There was a significant amount of varied scientific, Service, other agency, and public opinion regarding the status of fisher both prior to, and following, the October 7, 2014 (79 FR 60419), proposed listing of the West Coast DPS of fisher. The equivocal nature of the information regarding potential threats and status of the proposed West Coast DPS of fisher at the time of our proposed rule led us to ask the public for input on many questions we posed in the proposed listing rule to help us better understand the degree of threats faced by the proposed DPS and its status. By reconsidering the information available to us prior to the proposed listing as well as all new information received after the proposed rule was published, we have considered all best scientific and commercial information available at this time.
Upon careful consideration and evaluation of all of the information before us, we have arrived at a different conclusion regarding the status of the proposed West Coast DPS of fishers. In our proposed determination, we identified stressors that could impact the fishers in the west coast States negatively and identified some of those stressors (wildfire and fire suppression,
We now conclude that the threats we identified are not of such imminence, intensity, or magnitude that they are manifesting in terms of significant impacts at either the population or rangewide scales. Further, we conclude that in the foreseeable future it is likely that fishers in the west coast States will continue to maintain their populations in the face of these stressors just as they have demonstrated the capacity to do so in recent times. We relied on an evaluation of the foreseeability of those stressors and the foreseeability of the effect of the stressors on the proposed DPS, extending this time period out only so far as we can rely on the data to formulate reliable predictions about the status of the proposed DPS, and not extending so far as to venture into the realm of speculation. In this case, many of the stressors fell into a foreseeable future timeframe within which we concluded the effects of stressors on the proposed DPS could be reliably projected out over a time period of approximately 40 years.
Therefore, we conclude that the stressors acting on the proposed West Coast DPS are not so great that fishers in the DPS are currently in danger of extinction (endangered), or likely to become so within the foreseeable future (threatened). We acknowledge that fishers no longer occur in areas of their historical range in Washington, Oregon, and California, and fishers in the west coast States are not actively expanding their occupied range. However, to meet the statutory standard for listing, we must determine that the proposed DPS is currently in danger of extinction throughout all or a significant portion of its range, or is likely to become so within the foreseeable future. Our evaluation of all of the best scientific and commercial data available does not allow us to draw this conclusion at this time. As we cannot conclude that the proposed West Coast DPS of fisher meets the definition of an endangered or threatened species under the Act, we must withdraw our proposed rule. Our complete rationale for withdrawing our proposal is outlined in the Summary of Factors Affecting the Species and Determination sections of this document.
A thorough review of the taxonomy, life history, and ecology of the fishers in the west coast States is presented in the final Species Report (Service 2016, entire; Docket No. FWS-R8-ES-2014-0041). The fisher is a medium-sized, light-brown to dark blackish-brown mammal, with the face, neck, and shoulders sometimes being slightly gray; the chest and underside often has irregular white patches. The fisher is classified in the order Carnivora, family Mustelidae, a family that also includes weasels, mink, martens, and otters (Service 2016, p. 8). The occurrence of fishers at regional scales is consistently associated with low- to mid-elevation coniferous and mixed conifer and hardwood forests with characteristics of late-successional forests (large-diameter trees, coarse downed wood, and singular features of large snags, tree cavities, or deformed trees). Historically, fishers were well-distributed throughout the analysis area in the habitats described above. In Washington and Oregon, outside of the existing known reintroduced populations, fishers are considered likely extirpated (although on occasion individual fishers may be detected; specific to the Oregon Cascades, ODFW commented that the absence of fishers cannot be determined without dedicated surveys following a peer-reviewed protocol, and it is possible that fishers occur at low population levels). In California, recent survey efforts have not detected fishers in the northern Sierra Nevada, outside of the reintroduced population. Key fisher habitat includes forests with diverse successional stages containing a high proportion of mid- and late-successional characteristics. Throughout their range, fishers are obligate users of tree or snag cavities for denning, and they select resting sites with characteristics of late-successional forests. Late-successional forest characteristics are maintained and recruited in the forest through ecological processes such as fire, insect-related tree mortality, disease, and decay (
Fishers are found only in North America. Fishers on the west coast are found in British Columbia, Washington, Oregon, and California. The proposed West Coast DPS of fishers encompasses the area where fishers historically occurred throughout western Washington, western Oregon, and California to the Sierra Nevada (Service 2016, pp. 25-29). Currently, the fishers in the west coast States include two original native fisher populations (Northern California-Southwestern Oregon Population (NCSO) and the Southern Sierra Nevada Population (SSN)). There are three reintroduced populations—Olympic Peninsula Reintroduced Population (ONP) in Washington, Southern Oregon Cascades (SOC) Reintroduced Population in Oregon, and the Northern Sierra Nevada Reintroduced Population (NSN) in California. Based on survey data and genetic information submitted during the two public comment periods, the SOC and NSN reintroduced populations are now considered to be within the boundary of the NCSO population area (Service 2016, pp. 38-41). An additional reintroduction site in the South Washington Cascades was established in December 2015. Following are brief accounts of the populations and the new reintroduction site in the South Washington Cascades. Primary stressors and conservation activities are introduced in these summaries and described in more detail in the Summary of Factors Affecting the Species section below, and fully evaluated and described in the “Review of Stressors” section of the final Species Report (Service 2016, pp. 53-162). Conservation efforts resulting from the plans and strategies being implemented within each of the population areas are described in detail in the final Species Report in either the “Conservation measures to reduce the stressors related to habitat or range of the species” section (Service 2016, pp. 115-122), or, when applicable, within specific stressor discussions of the final Species Report.
Here we describe (from north to south) the known native and reintroduced populations of fisher within the west coast States, as well as one recent reintroduction:
The Washington Department of Fish and Wildlife (WDFW), in cooperation with Olympic National Park, United States Geological Survey, and others, began to reintroduce fishers onto Park
The Olympic Peninsula population is not physically or demographically connected to any other populations of fishers. Population size and trend information are not known at this time. The most significant stressors on this reintroduced population are predation and collisions with vehicles. Conservation efforts being implemented for this population are associated with the State of Washington Fisher Recovery Plan (Hayes and Lewis 2006), which is focused on reintroduction efforts, and NPS management in accordance with the Organic Act of 1916, as amended (54 U.S.C. 100100) and the National Park Service General Authorities Act of 1970 (54 U.S.C. 100101(b)) (see
The WDFW began a fisher reintroduction project in the South Cascades of Washington State on December 3, 2015. Between December 3, 2015, and February 10, 2016, project employees released 23 fishers from the Cispus Learning Center along the Cispus River, just south of Mount Rainier National Park. This project is the second phase of WDFW's efforts to recover fishers in Washington according to the Washington State Recovery Plan for the Fisher (Hayes and Lewis 2006). The reintroduction plan (Lewis 2013) calls for a total of 160 fishers to be released into the Cascade Mountains at a rate of 40 per year for 4 years (2 years in the South Cascades, 2 years in the North Cascades). The source population for the fishers (British Columbia) is the same as for the Olympic National Park reintroduction. The Washington fisher recovery plan has the goal of establishing multiple self-sustaining populations of fishers in Washington (Hayes and Lewis 2006). We are not referring to this group of fisher individuals in the South Cascades as a population at this time because they have not yet had the opportunity to successfully reproduce. These animals are not physically or demographically connected to any other populations of fishers. At this time, we do not have any direct evidence of stressors affecting these newly reintroduced fishers, although it is likely that the most significant stressors will be predation and collisions with vehicles, and potentially wildfire on the east side of the Cascade crest. HCPs and the NWFP are being implemented within the vicinity of this reintroduction site, thus providing general conservation benefits for these fishers and their habitat (see “Conservation measures to reduce stressors related to habitat or range of the species” in the final Species Report (Service 2016, pp. 115-122). In addition, all reintroduced fishers in the State of Washington would benefit from the implementation of the CCAA under development, as described above, if finalized.
Fishers in the SOC portion of the NCSO population stem from a translocation of 24 fishers from British Columbia and Minnesota to the area west of Crater Lake between 1977 and 1981 (Aubry and Lewis 2003, p. 84). Based on survey and research efforts starting in 1995 genetic evidence shows these fishers continue to persist (Drew
Information is not available on population size for the SOC portion of NCSO population. Recent detections of fisher in areas where they were not previously recorded (
Fishers in the NSN portion of the NCSO population stem from a 2009 to 2012 translocation of 40 fishers from Humboldt, Siskiyou, and Trinity counties, California, to the SPI Stirling Management Unit in Butte, Plumas, and Tehama counties, California. Ongoing monitoring of fishers that were reintroduced have confirmed that fishers born onsite have established home ranges and have successfully reproduced. Trapping efforts in the fall
Population size estimates for the approximately 17,375 mi
Population trend information for the NCSO population is based on two long-term studies. The NCSO population includes the area in both the SOC and NSN reintroduced fisher populations.
(1) The Hoopa study area is approximately 145 mi
(2) The Eastern Klamath Study Area (EKSA) is approximately 200 mi
The major stressors experienced by the NCSO population are wildfire and fire suppression activities, vegetation management, ARs, and, in some areas, predation. Within the Oregon portion of the NCSO population two fishers were tested for the presence of ARs; exposure to ARs were found in both. Conservation measures that benefit fishers include those being implemented within the portion of the range covered by the NWFP, including potential measures associated with section 7 consultations in overlapping northern spotted owl (
The SSN native population of fisher is small and is geographically separated from the remainder of the fishers in the west coast States. The SSN population is found in Mariposa, Madera, Fresno, Tulare, and Kern counties in California. While historically the population extended farther north, today the northern limit is the Merced River in Yosemite National Park in Mariposa County. The southern limit is the forested lands abutting the Kern River Canyon, while the eastern limit is the high-elevation, granite-dominated mountains, and the western limit is the low-elevation extent of mixed-conifer forest. Multiple lines of genetic evidence suggest that the isolation of the SSN population from other populations of fisher within the west coast States is longstanding and predates European settlement (Knaus
No census of the SSN fisher population has been conducted. Estimates for the SSN population range from a low of 100 to a high of 500 individuals (Lamberson
An 8-year monitoring study that sampled 139.5 units (
The major stressors on this population are wildfire and fire suppression activities, vegetation management, high mortality rates from predation, and small population size. Potential conservation measures include the development of the Southern Sierra Nevada Fisher Conservation Strategy (Spencer
Section 4 of the Act and its implementing regulations (50 CFR 424) set forth the procedures for adding species to the Federal Lists of Endangered and Threatened Wildlife and Plants. A species may be determined to be an endangered or threatened species due to one or more of the five factors described in section 4(a)(1) of the Act: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence. Listing actions may be warranted based on any of the above threat factors, singly or in combination. Each of these factors is discussed below.
A thorough analysis and discussion of the stressors that may impact the proposed West Coast DPS of fisher is included in the final Species Report (Service 2016, entire) associated with this document (and available at
Many of the stressors on fisher populations and their habitat are present throughout the proposed DPS's range, although their effects vary across the range. For example, the population and habitat in the SSN population area likely will continue to be more susceptible to the various stressors than will the NCSO population area given SSN's smaller population size and more limited amount of unoccupied, suitable habitat available. Nevertheless, at this point in time, our review and consideration of the best available information does not indicate that loss of or declines in these populations, or a contraction of their ranges, is either ongoing or is likely to occur in the foreseeable future (see “Review of Stressors” section of the final Species Report (Service 2016, pp. 53-162) and Determination section of this document). As discussed in the stressor summaries and Determination sections, below, our evaluation of the best available information leads us to conclude that the native populations will persist into the future (which is also likely for the reintroduced populations, although more time is needed to confirm their persistence with certainty), and that as a whole the proposed West Coast DPS of fisher does not meet the definition of an endangered or threatened species under the Act. Although our finding that the proposed West Coast DPS of fisher is not endangered or threatened does not depend on it, we anticipate that the fishers in the new reintroduction in the South Washington Cascades will likely survive and reproduce (Lewis 2013, pp. 4-5), based on our past experience with other fisher reintroductions. If successful, the South Washington Cascades fisher reintroduction will provide an additional population in the future that would provide even greater insurance against the fisher's risk of extinction in the west coast States caused by possible catastrophic events (see redundancy discussion under the
The stressors that are of highest current or future scope and magnitude within the range of the proposed DPS (
Forest insects and tree diseases were discussed as stressors in the draft Species Report with respect to their influence on habitat loss and fragmentation and the potential synergistic effects associated with climate change (Service 2014, pp. 72, 146, 170-172). However, this stressor was not summarized in the proposed listing rule. We have included a summary of forest insects and diseases in this document.
We recognize that multiple stressors have impacted individuals of the proposed West Coast DPS of fisher and their habitat, as well as populations in some cases, and that these stressors may be considered ongoing (and expected to continue into the future) in certain areas within the proposed DPS's range. Given these ongoing impacts, and the various recommendations or concerns expressed from partners, species experts, and the public, we intend to continue monitoring the biological status of the populations of fisher within California, Oregon, and Washington through active Service-directed science efforts and through the efforts of cooperating Federal, State, and private entities. If at any time in the future the stressors appear to be rising to the level such that listing may be warranted, we will initiate a status review as appropriate.
Following are summary evaluations of stressors assessed for the proposed West Coast DPS of fisher: (1) Wildfire and fire suppression; (2) forest insects and tree diseases; (3) effects of climate change; (4) vegetation management; (5) development (including linear infrastructure); (6) trapping and incidental capture; (7) research activities; (8) disease or predation; (9) collision with vehicles; (10) exposure to toxicants; (11) small population size and isolation; and (12) cumulative or synergistic effects. The inadequacy of existing regulatory mechanisms is also evaluated. We have evaluated these stressors consistent with the five statutory factors set forth in section 4(a)(1) of the Act, although the factors are not set forth in this document.
The final Species Report (found at
The following sections provide a summary of the past, current, and potential future impacts to the proposed West Coast DPS of fisher and its habitat. Please see the final Species Report (Service 2016, pp. 53-162) for a full evaluation of the stressors evaluated for the proposed West Coast DPS of fisher.
Our evaluation of the effects of wildfire on fisher habitat included those activities associated with fire suppression that may result in removal of fisher habitat (for example, backburning, fuel breaks, and snag removal). In our proposed listing rule, we stated that the naturally occurring fire regimes vary widely across the analysis area, and, therefore, the effects of wildfire are also likely to vary geographically (Service 2014, p. 58, 62, Figure 13). In general, high-severity fire has the potential to permanently remove suitable fisher habitat, and is very likely to remove habitat for a period of many decades while the forest regrows. Moderate-severity fire may also remove habitat, but likely in smaller patches and for a shorter length of time. Low-severity fire may reduce some elements of fisher habitat temporarily, but in general is unlikely to remove habitat.
Fishers' behavioral and population responses to fires are unknown within the West Coast range. Based on fisher information outside of the West Coast range and other related species, it is possible that large fires, particularly those of higher severity and larger scale, could cause shifts in home ranges and movement patterns of fishers in the west coast States, lower the fitness of fishers remaining in the burned area (due to increased predation, for example), or create barriers to dispersal. Fire suppression actions and post-fire management have the potential to exacerbate the effects of wildfire on fisher habitat. We indicated previously that the scope and severity for this stressor were the highest for the Sierra Nevada and northern California-southwestern Oregon areas; these are the two areas where the two remaining original native populations of fishers are found. We also stated that because there is evidence of increasing fire severity in yellow pine-mixed-conifer forests, which include the majority of fisher habitat in the Sierra Nevada, the estimate of the severity of stressors related to wildfire is likely to be an underestimate. A number of other conclusions were drawn from our analysis, as described in the “Wildfire and Fire Suppression” section of the proposed listing rule and draft Species Report (Service 2014, pp. 58-71). Overall, we determined that the scope and severity for this stressor were lower throughout most of Oregon and Washington than the Sierra Nevada and northern California-southwestern Oregon areas; however, high-severity fires that remove fisher habitat have the potential to further disrupt habitat connectivity and availability (Service 2014, pp. 57-71).
We concluded in the proposed listing rule that wildfire and fire suppression were a threat to fisher habitat, including in the future, based on known or perceived effects to fishers outside of the West Coast range and other related species and because the frequency and size of wildfires is increasing and will continue to increase in the future. We predicted that large fires (particularly those of higher severity and larger scale) would cause shifts in home ranges and movement patterns, lower the fitness of fishers remaining in the burned area, and create barriers to dispersal. We also:
(1) Considered fire and fire suppression to be particularly problematic in the SSN because of the narrow band of habitat that comprises SSN and the small population size;
(2) Stated that the degree to which fire-related effects impact NCSO was lower than SSN because the NCSO does not exist in a narrow band of habitat and covers a larger area;
(3) Indicated that fire and fire suppression will likely have some negative effect on NCSO because fire will further decrease connectivity in the fragmented habitat of NCSO (noting that it was difficult to fully determine the impact at NCSO because the locations and severities of future fires relative to important habitat components were not known at [that] time; and
(4) Indicated that scope and severity of fire are lower in Washington and Oregon given that much of this area is considered to be unoccupied but that fire could have a negative impact on existing fisher populations if fires occur within or in proximity to occupied areas (again, similar to NCSO, noting that the locations and severities of future fires relative to important habitat components were not known at [that] time).
In conducting our updated analysis of the best scientific and commercial information available, we reviewed information provided by commenters and peer reviewers, and made corrections and clarifications of wildfire information in the final Species Report as necessary, and have clarified the discussion of the effects of wildfire on ecosystems. This approach contributed to our goal of describing as accurately as possible whether the best available information indicates if this stressor is causing impacts to fishers or their habitat in the west coast States, and if so, whether those impacts are resulting in significant impacts to individuals, populations, or the proposed DPS rangewide. For example, in the final Species Report:
(1) We clarified the fire severity categories, particularly as they relate to “mixed-severity” fires (Halofsky
(2) We included and described the significant beneficial aspects of wildfire on the landscape, such as creation or maintenance of some structural elements used by fishers, or how some areas of high-severity fire may contribute to the regeneration of the hardwood component of mixed-conifer forest used by fisher (Cocking
(3) We noted how low-severity fires can be critical in the creation or maintenance of reproductive habitat for fishers by creating fire scars that enhance the formation of cavities that serve as denning sites (Weir
(4) We described how fishers in areas that experience mixed-severity fires could benefit from associated increases in mammalian prey species, including how fishers may use burned forests for foraging (
(5) We noted how fragmentation due to fire can increase risk of predation due to the lack of cover and higher abundance of predators in fragmented landscapes (Naney
(6) We included discussion of studies (Shatford
In sum, these corrections, clarifications, and revised discussions in the final Species Report provide a clearer picture of the degree to which fisher may be able to use burned
When considering all scientific and commercial information available regarding wildfire and fire suppression activities (including new information since the time of the proposed listing rule), we maintain that wildfire is a natural ecological process that occurs throughout the range of the proposed West Coast DPS of fisher. As stated above, there are some indications that wildfire may be increasing in terms of frequency, severity, and magnitude, although these projected increases are greater in California and southern Oregon than areas further north. Whether fires may be increasing in severity is subject to continuing debate; thus, it is necessary for us to use our best professional judgment based on the best fire effects information available. Studies on the effects of wildfire on fisher habitat, although limited, demonstrate a variety of both positive and negative consequences, depending on the specific circumstances (see “Effects of fire on fisher habitat elements” in the final Species Report (Service 2016, pp. 63-65)). If the severity and extent of the fire is such that substantial areas of canopy and large trees are lost, it may take decades for the area to support fisher reproduction. If the fire severity is low or mixed, important habitat elements to fisher can be both created and removed within a home range, such that the burned habitat may continue to support both fisher foraging and reproduction. The degree to which fire may affect fisher populations is unknown, but all indications are that the population response would be specific to the forest type, landscape location, size, and intensity of the fire.
Another factor to consider regarding wildfires is the potential for overlay of future fires with fisher-occupied habitat, and the subsequent potential likelihood of wildfire-displaced fishers moving successfully into nearby suitable unoccupied habitat. Although fishers are not abundant throughout their known current range, their distribution where found covers very large geographic areas of habitat. Because of this broad distribution, even in the event that wildlife frequency and severity increases rather than decreases, it is extremely unlikely that any wildfires would be of such magnitude that they would cover an entire fisher population area. Therefore, while future wildfires may affect individual fishers, with the potential of displacement rather than injury or death, there will likely also be unaffected fishers outside the wildfire zones.
Coupled with this likelihood is the fact that throughout the analysis area, there are numerous areas of suitable but currently unoccupied habitat. While some of these areas may be inaccessible to extant fisher populations, due to being far removed from the known current fisher distribution or to existing landscape patterns that are not conducive to dispersal, there are other areas of suitable unoccupied habitat that are adjacent to occupied habitats or connected to them via dispersal-conducive landscapes. This combination of available and accessible suitable habitat with the likelihood that any future wildfires would be extremely unlikely to affect entire fisher population areas, suggests as it relates to wildfires that habitat is not limiting for fishers across the west coast States. We also note that there are active hazardous fuels reduction plans and projects being actively implemented throughout the analysis area (such as those on Federal lands described in the National Fire Plan, or on private lands in California via California Fire Safe Council or CAL FIRE wildfire prevention grants (see “Conservation measures that may reduce impacts of fire effects” in the final Species Report (Service 2016, pp. 76-77)), which should help reduce the future frequency, size, and severity of wildfires.
Our updated analysis of the best information now available leads us to change our previous conclusion that wildfire and fire suppression rise to the level of a threat, particularly given that the best available data do not indicate habitat impacts are significant at either the population or rangewide scales. In other words, following wildfire events and subsequent salvage operations, no surveys or other information have shown this stressor to be functioning as an operative threat on the fisher's habitat to the degree we considered to be the case at the time of the proposed listing. We have reached this conclusion given:
(1) Our evaluation of past and continued predicted impacts of wildfire in the future across the landscape within the range of the proposed West Coast DPS of fisher;
(2) The beneficial as well as negative aspects of wildfire to fisher habitat;
(3) The beneficial aspects of current and continued management activities into the future to help reduce wildfire impacts (
(4) The presence of suitable but unoccupied habitat available to the fisher throughout the west coast States (although to a greater extent in the northern portion of the proposed DPS's range.), coupled with the extremely low likelihood that future wildfires would impact entire fisher population areas, and the lack of data to demonstrate that this stressor is manifesting itself to a significant degree across the proposed DPS such that the fisher populations in the west coast States are in decline across its range due to significant wildfire impacts to their habitat.
We acknowledge that individual fishers in the proposed West Coast DPS (or potentially portions of one or more populations) likely are impacted as a result of the level of impact this stressor is having on fisher habitat, particularly to a greater extent in the California portions of the proposed DPS's range, and that these impacts to fisher habitat could increase in magnitude in the future within portions of the proposed DPS's range. However, the best available information does not suggest that fisher habitat will experience significant impacts at either the population or rangewide scales in the future as a result of wildlife fire and suppression activities given: (1) Future wildfires are expected to continue at a similar rate and severity across the landscape as has been occurring in the recent past, (2) wildfires are not expected to be high severity in all cases such that they destroy habitat for entire populations, (3) forest ingrowth is expected to continue to provide suitable habitat across the proposed DPS's range to help offset some future wildfire impacts, and (4) future low- or mixed-severity wildfires are expected to continue to provide some benefits to fisher habitat to help offset some future wildfire impacts.
At the time of the proposed rule, we stated that, overall, fisher habitat is likely to be affected by climate change, but the severity will vary, potentially greatly, among different regions, with effects to fishers ranging from negative, neutral, or potentially beneficial. Climate change is likely to alter the structure and tree species composition of fisher habitat, and also result in changes to habitat of prey communities and ultimately prey availability. However, studies of climate change present a range of effects including some that indicate conditions could remain suitable for fisher. Climate throughout the analysis area is projected to become warmer over the next century, and in particular, summers will
Based on our evaluation of the best available information known at this time, we reaffirm our previous conclusion that climate change does not rise to the level of a threat now nor do we anticipate it as a threat in the foreseeable future. Most predictions of future conditions are relatively general in nature, and provide little specificity with regard to timeframes or geographic region of occurrence that would be informative in terms of our consideration of future habitat conditions for fishers within the analysis area. This same viewpoint applies even after taking into consideration new information available since the time of the proposed listing rule. Overall, we place relatively greater weight on studies or models that are more narrowly focused on fisher habitat needs, specifically, or are downscaled to our geographic region of interest. Studies specific to predicting the effects of climate change on suitable fisher habitat have produced a wide range of results. Ecotype conversion to woodland, shrubland, or grassland would result in the loss of suitable fisher habitat. This type of shift is predicted, for example, in the southern Sierra Nevada (Gonzalez
With regard to direct impacts to fishers in the west coast States, fishers may be sensitive, physiologically, to warming summer temperatures (Zielinski
Vegetation management techniques of the past (primarily timber harvest) have been implicated as one of the two primary causes for fisher declines across the United States. Many fisher researchers have suggested that the magnitude and intensity of past timber harvest is one of the main reasons fishers have not recovered in Washington, Oregon, and portions of California, as compared to the northeastern United States (Service 2014, pp. 54-56). At the time of the proposed rule, we stated that vegetation management techniques have, and can, substantially modify the overstory canopy, the numbers and distribution of structural elements, and the ecological processes that create them. There are also areas where habitat may not be the limiting factor for current or potential fisher populations and where habitat is being managed intentionally or incidentally in ways that benefit fisher. For example, the Northwest Forest Plan (NWFP), which was adopted by the U.S. Forest Service and the BLM in 1994 to guide the management of more than 24 million ac (9.7 million ha) of Federal lands in Washington, Oregon, and northwestern California within the range of the northern spotted owl, provides the basis for conservation of the spotted owl and other late-successional and old-growth forest associated species, such as fisher, on Federal lands (USDA Forest Service and USDI BLM 1994, entire). The NWFP incorporates seven land allocations—Congressionally Reserved Areas, Late-Successional Reserves (LSRs), Adaptive Management Areas, Managed Late-Successional Areas, Administratively Withdrawn Areas, Riparian Reserves, and Matrix. Much of the NWFP area currently provides fisher habitat, which is expected to increase over time. The Matrix, which represents only 16 percent of the Federal land within the NWFP area, is the Federal land outside the other six NWFP land allocations and is the area in which most timber harvest and other silvicultural activities are conducted. LSRs, which cover 30 percent of the NWFP area, are expected, in combination with the other allocations and standards and guidelines, to maintain a functional, interactive, late-successional and old-growth forest ecosystem and are designed to serve as habitat for late-successional and old-growth related species including fishers. Stand management is limited in LSRs, is subject to review, and does not
At the time of the proposed rule, we concluded that data limitations in most sub-regions across the analysis area prevented us from quantifying what proportion of the treatments in the data sets we used may be outside the scope of habitat loss or downgrade (
Based on information and comments received from peer reviewers and the public, we reevaluated our analysis (as stated previously) and changed our approach to rely on qualitative evidence to derive a qualitative descriptor of each stressor, rather than extrapolating. Several sources of data currently available provide information on past changes in vegetation in different areas of the proposed West Coast DPS of fisher's range. Because of the large area encompassed by the fisher, these different sources are not directly comparable and do not easily combine to paint a complete picture of the vegetation trends within the west coast States. The limitations of this information were acknowledged in our proposed rule, and we explicitly requested information from the public to better inform our analysis of this stressor and to help us make a final determination. Specifically, we requested information related to the scope and severity of vegetation management on Federal land within the range of the fisher, and scientific or commercial information on the type, scope, and severity of vegetation management (timber harvest, restoration thinning, fuels reduction, etc.) on non-Federal land in Oregon and Washington. We also requested scientific evaluation of our use of the northern spotted owl habitat data as a surrogate for fisher habitat data, and its use in our draft Species Report as the best available data to determine the scope and severity of vegetation management effects on Federal lands.
Currently, there is no analysis that explicitly tracks changes in fisher habitat in recent decades where loss specifically attributable to vegetation management specifically can be determined. Therefore, we used other available information, as described below, and our best professional judgment to analyze the potential effects of this stressor on the proposed West Coast DPS of fisher. After considering the best available data, including comments received from peer reviewers and the public regarding the vegetation management stressor analysis presented in the draft Species Report (Service 2014, pp. 85-96) and summarized in the proposed listing rule, we updated and reconsidered our analysis. Our updated analysis included the use of several different sources of information to depict net forest vegetation changes caused by vegetation management activities within the west coast States. With the exception of the non-Federal timber harvest database in California (CAL FIRE THP 2013), all of these sources are either new or updated since the time of the proposed listing rule (Davis
While historical loss of older forests via timber harvest through much of the 1900s resulted in a substantial loss of fisher habitat in the west coast States, harvest volume has sharply declined throughout this area since 1990, primarily on Federal lands, but also on non-Federal lands. Although timber harvest is still ongoing throughout the west coast States, habitat ingrowth is also occurring, offsetting some of those losses. For example, modeling in the southern Sierra Nevada region indicates that ingrowth of fisher habitat has even replaced habitat lost by all disturbances in the southern Sierra Nevada region since 1990, resulting in a net gain of habitat since that time in that area (see below in this section).
Within the NWFP region, we used information from the draft late-successional and old-growth forest monitoring report (Davis
Although loss of older-forest habitat due to timber harvest on non-Federal lands (21.8 percent since 1993) was substantially greater than on Federal lands (1.2 percent since 1993), in combining all ownerships, the percent loss due to timber harvest over the past 20 years was low (8.2) (Service 2016, Table 6). This translates to a 4.1 percent loss per decade (see Table 6 in the final Species Report). The net loss of habitat, however, is somewhat less because 4.1 percent per decade does not include ingrowth of OGSI-80 stands, which were recruited at a rate of 6 percent over the 20-year period, or 3 percent per decade (Service 2016, Table 6). However, it is not an entirely accurate representation to subtract total ingrowth from total loss to vegetation management without also considering all other disturbances that may be offset by ingrowth. We evaluate net vegetation changes as a result of all disturbance types separately below. The projection of vegetation loss may also be an overestimate given that projections in the NWFP showed older forest recruitment on Federal lands would replace losses to the degree that within
Elsewhere in the west coast States, while we could track vegetation changes over time, the available data did not indicate the amount or types of disturbances affecting the specific vegetation types; that is, we could only determine net vegetation change of a particular vegetation type, not the specific amount of that type that was lost to a specific disturbance type, unlike in the NWFP area. Timber harvest records were available for the Sierra Nevada region, but idiosyncrasies in the Forest Service FACTS database (see Spencer
In the Sierra Nevada region, we approximated fisher habitat change using a GNN vegetation trend analysis to track changes in forests with large structural conditions thought to be associated with fisher habitat. Note that the vegetation category tracked in this analysis is not equivalent to the OGSI-80 forests used by Davis
In the southern Sierra Nevada, fisher habitat appears to be increasing despite losses to vegetation management and recent large wildfires. Within the NWFP area, where we were able to explicitly track loss of older forest structural condition due to vegetation management activities, the scale of loss was at a low level (4.1 percent per decade) and was partly compensated by ingrowth. We incorporated ingrowth by looking at net forest change over time, although we could not quantify amounts lost to specific disturbance types throughout the west coast States; outside of the NWFP area, net loss of forests with larger structural conditions ranged from 1.6 to 4.8 percent per decade, depending on the region, for all disturbance types. Although the habitat types tracked in the GNN analysis for the non-NWFP area is not the same as the OGSI-80 vegetation type tracked in the NWFP area, the net change in the OGSI-80 type (almost 3 percent per decade) is relatively similar to that observed in forests with larger structural condition outside the NWFP area.
Based on our analysis of the best scientific and commercial information available, we find that forest losses were less than 5 percent per decade, either when looking at just total vegetation management loss within the NWFP area, or looking at net loss (
We have found no empirical evidence that vegetation management is manifesting itself to a significant degree across the proposed West Coast DPS in a way that is causing habitat-related impacts that are causing fisher to decline across its range currently, or that suggests an expected decline across its range in the future. Furthermore, there are large areas of suitable but unoccupied habitat available throughout the west coast States where fisher populations occur, although to a greater extent in the northern portion of the proposed DPS's range. Overall across the proposed DPS's range, this suggests that habitat may not currently be a limiting factor for fisher populations in these States, and that these areas likely would help offset any potential future impacts to fisher habitat from potential future vegetation management activities. Overall, the best available scientific and commercial information summarized above and presented in detail in the final Species Report (Service 2016, pp. 98-111) leads us to conclude that impacts from vegetation management do not rise to the level of a threat given the lack of information indicating that these activities are significantly affecting habitat currently at either the population or rangewide scales. We also find that these activities are not likely to significantly affect habitat at either the population or rangewide scales in the foreseeable future because our analysis of loss/alteration of habitat shows the trend to be slightly declining (with actual increases in habitat in the
We stated in the proposed listing rule and draft Species Report, and we reaffirm here, that human population density within the analysis area varies considerably, but density in all areas appear to be increasing. Human population growth within the analysis area may increase needs for housing, services, transportation, and other infrastructure, likely placing ever-greater demands on land, water, and other natural resources. Specifically, human infrastructure growth includes recreational opportunities such as ski area developments, vacation cabins, trails, and campgrounds. Besides permanently removing potential fisher habitat, human developments in rural areas are changing land use from forest to other land cover types, which has the potential to fragment previously continuous habitat or hamper fisher movements. Overall, human developments associated with population growth (including linear and other infrastructure) will likely have an increasing impact on fisher habitat into the future, but the severity varies depending on the type and location of development.
We stated in the proposed listing rule that the scope of the human development stressor (which implied inclusion of linear and other infrastructure) is relatively low throughout the analysis area, with the majority of impacts most likely occurring within the Sierra Nevada, Coastal Washington, and Western Washington Cascades portions of the proposed DPS's range. The best available scientific and commercial information indicates that, although an insignificant amount of suitable habitat is undergoing development such that individual fishers may be impacted, significant impacts to fisher habitat do not appear to be occurring at either the population or rangewide scales, nor is there any indication that these scales of impacts to suitable habitat are likely to occur in the future. Thus, we reaffirm our previous conclusion that development is not a threat to fisher habitat within the proposed West Coast DPS now and in the foreseeable future.
Potential impacts associated with forest insects and tree diseases were described in the “Anthropogenic Influences” section of the draft Species Report (Service 2014, p. 72) and mentioned in the proposed listing rule within the context of potential “anthropogenic mortality stressors” that could be synergistically impacting fisher along with other stressors. Confusion in the draft Species Report resulted in conflation of anthropogenic stressors and stressors related to forest insects and diseases, because they were combined in a single section wherein only insects and diseases were discussed and not anthropogenic factors (Service 2014, p. 72). We revised the final Species Report to separate those stressor discussions and we have provided clarification in the final Species Report regarding these potential anthropogenic stressors (Service 2016, pp. 77-78), including correcting the title of the potential stressor to “Forest Insects and Tree Diseases,” and we provide a stand-alone summary of our analysis of this stressor below.
In the proposed rule, we found that the usual pattern of localized outbreaks and low density of tree-damaging forest insects and tree diseases are beneficial, providing structures conducive to rest and den sites used by fishers or their prey (Service 2014, p. 72). However, we noted that it is possible that large, area-wide epidemics of forest disease and insect outbreaks could potentially displace fishers if canopy cover is lost, and if salvage and thinning prescriptions in response to outbreaks degrade the habitat (Naney
(1) Mountain pine beetle, which is currently known in British Columbia (Weir and Corbould 2008, entire; 2010, entire)); and
(2) Sudden oak death (
At this time, the best available information does not indicate that any forest insects or tree diseases are significantly affecting the proposed DPS currently. Moreover, although some diseases have been present within the west coast States for many years, the best available data do not indicate that they would result in significant impacts to fisher habitat at either the population or rangewide scales in the foreseeable future. Based on our evaluation of the best scientific and commercial information currently available, we find that fishers at the individual, population, and rangewide levels are beneficially affected by forest insects and tree diseases through their creation of structures used by fishers for denning and resting, as well as structures used by fisher prey. Localized outbreaks that result in canopy loss substantial enough to reduce the stand's suitability for fisher habitat may affect individuals, but there is no evidence to indicate any impacts to fishers currently or in the foreseeable future. Thus, forest insects and tree diseases do not constitute a threat to the proposed DPS either currently or in the foreseeable future.
Historical, unregulated fur trapping (prior to the 1930s) appears to have been the primary initial cause of the marked contraction in fisher distribution across the Pacific States. The effects of current trapping, which are limited to incidental capture and an unknown amount of poaching, are significantly reduced compared to the previous effects of widespread unregulated legal trapping of fishers. In our proposed listing rule, we stated that the severity of the potential stressor of trapping and incidental capture is extremely low throughout the analysis area (Service 2014, pp. 106-108), and, therefore, we did not consider trapping to be a threat to the fisher, including in the future. Since that time, minimal new information has become available regarding trapping activities, none of which results in any significant changes or differences in our understanding of this stressor.
Based on our evaluation of the best available information currently known, we reaffirm our previous conclusion that the severity of trapping (and incidental capture) throughout the analysis area is extremely low, and is not expected to increase in the foreseeable future. Our current analysis reveals that where impacts occur as a result of trapping, those impacts are affecting few individuals (
Although scientific research is necessary to fully understand the various aspects of fishers' life-history needs and population status in the west coast States, some research techniques (
Several viral and bacterial diseases are known to affect mustelids, including fishers, but it is unclear how these diseases affect wild populations of fishers. Potential predators of fishers include mountain lions, bobcats, coyotes, and large raptors. Disease and predation are stressors that can cause direct mortality of fishers, and both are documented to occur throughout the analysis area. Minimal new information is available regarding disease or predation since the time of our proposed listing rule, none of which results in any significant changes or differences in our understanding of these stressors.
Based on our evaluation of the best scientific and commercial information currently available, neither disease nor predation are considered threats to fisher. Our analysis reveals that, for both disease and predation, impacts are affecting individuals to a minor degree within the various populations as opposed to significant impacts to entire populations or the proposed DPS rangewide. Additionally, the best available information does not indicate that disease or predation would increase in the future to a significant degree such that fishers in the west coast states are likely to experience significant impacts at either the population or rangewide scales. Thus, we reaffirm our conclusion that the scope and magnitude of impacts resulting from disease or predation do not rise to the level that are considered threats to the proposed DPS, now or in the foreseeable future.
In the proposed listing rule, we stated that roads are sources of vehicle-collision mortality of fishers and disrupt habitat continuity, particularly in high-use, high-speed areas. Collision with vehicles is a stressor that causes direct mortality of fishers, and thus, we found that collision with vehicles has the potential to be a stressor to extant fisher populations. We stated in the proposed rule that vehicle collisions have the potential to occur throughout all occupied areas, but we concluded that vehicle collisions are not a threat to fisher based on known impacts at the individual level. No new information has been discovered or provided since the time of the proposed listing rule to indicate that fisher collisions with vehicles are increasing or decreasing.
Based on our evaluation of the best scientific and commercial information currently available, we reaffirm our previous conclusion that vehicle collisions are not a threat to fisher, both currently and in the future (Service 2016, pp. 137-138). We found that individual fishers may be killed by vehicles in multiple populations, with a greater risk occurring in portions of the fisher populations that also harbor paved, major roads where vehicles travel at fast speeds and possibly at a higher volume of traffic compared to many dirt roads. The best available data indicate that vehicle collisions are a substantial source of anthropogenic mortality for fisher populations, but we have no information to indicate that the frequency of collisions with vehicles is going to increase in the future, or that this source of mortality is having or will have significant impacts at either the population or rangewide scales. Based on the scope and magnitude of this stressor, we reaffirm our conclusion that fisher collisions with vehicles are not a threat to the fisher in the proposed DPS, now or in the foreseeable future.
Anticoagulant rodenticides (ARs), which are intended to kill small pest mammals, impair an animal's ability to produce several key blood clotting factors. Anticoagulant exposure is manifested by such conditions as bleeding nose and gums, extensive bruises, anemia, fatigue, and difficulty breathing. Anticoagulants also damage the small blood vessels, resulting in spontaneous and widespread hemorrhaging. A sublethal dose of an AR can produce significant clotting abnormalities and hemorrhaging, leading to a range of symptoms, such as difficulty moving and the decreased ability to recover from physical injury, which may increase the probability of mortality from other sources.
The final Species Report details the exposure of toxicants to fishers in the west coast States (Service 2016, pp. 141-159), which is summarized herein. Relatively recent research documenting exposure to toxicants in a number of fishers, and mortalities of individual fishers directly caused by ARs, has raised concerns regarding potential individual- and population-level impacts of toxicants. Exposure to ARs, resulting in death in some cases, has been documented in fishers in the two native populations (NCSO and SSN), and the reintroduced ONP population. However, sources of AR exposure in fishers have not been conclusively determined.
The number of fishers determined to have had exposure to toxicants varies across the proposed DPS's range, with the majority of records known from California. Large quantities of ARs have been found at illegal marijuana cultivation sites within occupied fisher habitat on public, private, and tribal lands in California (Gabriel
We stated in the proposed listing rule that the scope of toxicants as a stressor varied across the landscape and that our determination regarding the scope was
Our evaluation of the best scientific and commercial information available regarding toxicants and their effects on fishers at this time leads us to conclude that individual fishers within three populations (
Our analysis of this stressor also includes a further evaluation of a variety of toxicant information (in response to comments by peer reviewers). New information included (but is not limited to):
(1) Concentrations of active ingredients in bait (Erickson and Urban 2004) and a description of how exposure to ARs is confirmed (Vandenbrouke
(2) Clarification or corrections related to ARs found in the dead fishers tested from the ONP population. Happe (2015, pers. comm.) noted that the first released individuals found dead were all captured near residential areas/private lands in British Columbia prior to their release into the Olympic Peninsula. Exposure from legal use of brodifacoum in British Columbia cannot be ruled out because their deaths occurred well within the half-lives reported for brodifacoum persistence in mammalian tissue. Two subsequent mortalities among the translocated individuals on the Olympic Peninsula tested positive for bromadiolone too long after their relocation from British Columbia to have been exposed there. These individuals were found near rural areas where rodenticides could have been used legally. The most recent fisher mortality that tested positive for an AR was born to a translocated female, and was found on the border of the Port Angeles city limits, surrounded by a low-density housing area and commercial development. Thus, AR impacts for the Olympic Peninsula reintroduction area could be from legally applied sources.
(3) Rodent diversity at marijuana cultivation sites. Wengert (2015, pers. comm.) reports that rodent diversity is reduced to only mice at marijuana cultivation sites that are treated with rodenticides, as compared to nearby untreated sites where large-bodied rodents (
(4) Estimating the extent of fisher exposure to ARs and determining the source(s) is difficult because the delay in toxicity caused by ARs and their persistence within food webs can result in contaminated rodents being found within and adjacent to treated areas weeks or months after bait application (Geduhn
The only new regulatory measure of which we are aware of specific to ARs (in addition to those existing regulatory mechanisms identified in the proposed listing rule) is related to the State of California's new 2014 prohibition on the sale of second generation ARs (brodifacoum, bromadiolone, difethialone, and difenacoum) to the general public. While the State of California has prohibited these sales to the general public, they are still widely available and can be purchased by anyone with a State-issued pesticide applicator's license. No records are kept on the sale and use of rodenticides that can be used to determine whether this new measure will reduce the illegal and legal uses of the second-generation ARs (see
Marijuana cultivation sites are present within or near both native fisher populations in the proposed West Coast DPS, and potentially other areas within the west coast States. There are other possible sources of ARs from legal applications in agriculture and around buildings in rural areas. Furthermore, the recent legalization of marijuana in the State of Oregon adds an additional element of uncertainty to evaluation of this stressor, as it is unknown whether or how this policy change may potentially affect exposure rates (for example, whether there may be a trend toward indoor-grow operations, which would potentially reduce exposure of wildlife to ARs). The incidence of fisher exposure to toxicants from all uses across its range is unknown and the best available data are very limited (including known mortalities of only 15 individuals in California). However, the best available information does not suggest that any of the fisher populations where exposure has been documented are in decline, nor does it suggest that significant AR impacts would occur as operative threats on the fisher populations in the west coast States as a whole to the degree that there would likely be significant impacts at either the population or rangewide scales in the future. The best available information at this time does not demonstrate there are significant deleterious sublethal effects in fishers at the population and rangewide scales. In addition, we are not aware of any information that indicates use of ARs will increase within the range of the proposed DPS in the future. Therefore, the best available information does not indicate that exposure to toxicants rises to the level of a threat, and this conclusion is supported by our finding that the proposed West Coast DPS of fisher is not experiencing significant impacts at either the population or rangewide scales, currently or in the foreseeable future.
A principle of conservation biology is that small, isolated populations are subject to an increased risk of extinction from stochastic (random) environmental, genetic, or demographic events. Fishers appear to have several characteristics related to small
A scarcity of verifiable sightings in the Western and Eastern Cascades in Washington and Oregon, coastal Oregon, and the north and central sections of the Sierra Nevada indicates that populations of fishers in southwestern Oregon and California are isolated from fishers elsewhere in North America. Fishers in the west coast States are currently restricted to two extant native populations and three reintroduced populations, the latter of which are known to be relatively small in size.
We concluded at the time of the proposed rule that the isolation of small populations and associated increased risk of extinction from stochastic events constituted a threat to the proposed West Coast DPS of fisher. However, as described above, that conclusion was based largely on the application of general theoretical principles regarding the implications of small population size and isolation for the persistence of some generic species. We continue to recognize that fisher populations in the west coast States are, for the most part, relatively small and geographically isolated from one another (with the likely exception of the NCSO population, which now overlaps the NSN and SOC reintroduced populations), with little opportunity for genetic interchange. However, we note that populations of forest carnivores are often isolated and generally occur in low densities; because we lack specific information about genetic processes in small, isolated forest carnivore populations, it is unknown whether generalities about persistence based on untested theoretical models may apply to fisher (Ruggiero
Estimates of fisher population growth for the NCSO population and the portion of the SSN population surveyed do not indicate any overall positive or negative trend as a result of the various stressors acting upon those populations (Service 2016, pp. 42-50). At this point in time, we do not have information to indicate that these portions of the proposed DPS are expected to change to a negative trend in the foreseeable future given the projected current and future level of impacts from the various stressors, and, in some instances, offsetting beneficial effects from some stressors (
Overall, although fisher populations are relatively small and geographically isolated, our evaluation of the best scientific and commercial information leads us to conclude that the separation of the two native populations is longstanding. The best available information does not suggest any negative consequences in terms of population abundance or other indicators across the west coast States, or that small population size or isolation are likely to cause significant impacts at either the population or rangewide scales in the future. In addition, recent and ongoing reintroductions to establish additional populations of fishers within the west coast States reduce the likelihood of loss to random stochastic events. Based on all of these considerations, we now conclude that small population size and isolation are not threats to the proposed West Coast DPS of fisher, currently or in the foreseeable future.
In this section, we synthesize the information above to evaluate resiliency, redundancy, and representation as they relate to fishers in the proposed West Coast DPS.
The degree of resiliency of a species (or DPS) is influenced by both the degree of genetic diversity across its range and the number of individuals. Resiliency increases with increasing genetic diversity or a higher number of individuals; it decreases when the species has less genetic diversity or fewer individuals. In the case of the proposed West Coast DPS of fisher, resiliency may be slightly lower to some degree because the total population size is considered by some as small, although forest carnivores generally occur at low densities (Ruggiero
From a genetics standpoint, fisher from the ONP population (as well as for
Multiple, interacting populations across a broad geographic area (redundancy) provide insurance against the risk of extinction caused by catastrophic events. As was known at the time of the proposed listing rule, population redundancy continues to exist across the west coast States as a result of the presence of two native populations across southern Oregon (northern California and the Sierra Nevada (NCSO and SSN populations, noting that the SOC and NSN reintroduced populations now have overlapping boundaries with the native NCSO population)), as well as two reintroduction locations, including the ONP population and the new South Washington Cascades reintroduction site. There is also an additional reintroduction site (new as of December 2015 (see
The aggregate number of individuals across multiple populations increases the probability of demographic persistence and preservation of overall genetic diversity by providing an important genetic reservoir (representation). We consider representation across the west coast States to be high, with five different groups (two native (NCSO and SSN) and three reintroduced (ONP, SOC, and NSN)) across California, Oregon, and Washington (although we note it is early to conclude with certainty the persistence of two of these reintroduced populations). Although there may be some risk that any of the small reintroduced populations could fail to persist within the short-term future, the level of representation across the west coast States at this time reduces the likelihood of future extirpation of these fishers. In addition, preliminary results of the recent reintroductions are encouraging, demonstrating successful reproduction and population expansion, and additional reintroduction efforts are both ongoing and planned.
Our current analysis reveals that small population size by itself is not a threat to the proposed West Coast DPS of fisher. A species (or DPS) with a relatively small number of small populations may be a concern when there are significant threats to the species such that one or more populations are likely to be permanently lost. However, fishers in the west coast States comprise three geographically separated populations, including one (NCSO) that overlaps with two reintroduced populations (SOC and NSN), as well as a new (as of December, 2015) reintroduction site in the South Washington Cascades (see
Consistent with our approach for the proposed rule, we took into consideration all of the stressors operating within the west coast States. We previously stated in the proposed rule that the sizes of the fisher populations within the proposed West Coast DPS are reduced from historical levels due to historical trapping and past loss of late-successional habitat and, therefore, are overall more vulnerable to extinction from random events and increases in mortality. We previously evaluated the potential for cumulative effects of multiple stressors, although we were unable in the proposed rule to quantify the scope and severity of these cumulative effects and the variation of these effects between subregions. We did, however, determine that the various stressors were not occurring in equal magnitude across the analysis area and that cumulative effects from these stressors may be occurring more in some subregions than others.
The most likely scenarios for potential cumulative impacts on fisher that we identified previously and reaffirm here are:
• Alterations to habitat could increase fishers' vulnerability to predation.
• Sublethal exposure to ARs could potentially increase the death rates from predation, collisions with vehicles, disease, or intraspecific conflict.
• Stressors associated with the effects of climate change, such as increased risk of wildfire and forest disease, and environmental impacts of human
• Diseases that are currently present among mammal populations and also overlap the fisher's range in the west coast States could be exacerbated by climate change, such that fishers experience impacts at either the population or rangewide scales.
• Development activities could cause increases in fisher collisions with vehicles, conflicts with domestic animals, and infections contracted from domestic animals.
At this time, we find no indication that stressors are manifesting themselves to a significant degree on fishers, both singly or cumulatively, across the west coast States at either the population or rangewide scales currently, nor are they expected to do so in the future. We reach this conclusion because the best available information does not indicate that one or more stressors (by themselves or cumulatively) are expected to interact to such a degree that they would significantly contribute to decreased reproductive viability, reduced distribution, or significant loss of habitat for the proposed West Coast DPS of fisher. Additionally, there is also suitable but unoccupied habitat available throughout the analysis area where fisher populations occur (including in the SSN population area, although to a lesser extent compared to the northern portion of the proposed DPS's range). These areas likely would help offset any potential future impacts to fisher habitat from habitat-related cumulative impacts over the next 40 years.
Overall, we recognize that fishers in the west coast States have been exposed to multiple stressors, in some cases over many decades. The stressors may be impacting some individual fishers or habitat in one or more populations, but those stressors are not acting on the fisher's habitat, populations, or the proposed DPS as a whole such that the stressors are functioning cumulatively as operative threats on the proposed DPS. Thus, the best available scientific and commercial data at this time do not show that combined impacts of the most likely cumulative impact scenarios are resulting in significant impacts at either the population or rangewide scales, including when taking into consideration small population sizes. Fisher populations today in the west coast States are smaller and their range has been reduced compared to historical conditions, which potentially increases the vulnerability of the fisher to cumulative low- or medium-level impacts. However, the best available information does not suggest that current fisher populations in the west coast States are experiencing population declines or further reductions in distribution, which would be indicative of such impacts and likely to be demonstrated through survey information (which is not evident in the best available information). Cumulatively, the stressors to the proposed West Coast DPS of fisher have not manifested in operative threats across the range of the DPS. Moreover, our analysis of the stressors does not indicate that they are expected to increase in the foreseeable future to a degree that their cumulative effects would be significantly different than current levels. Thus, the best available scientific and commercial data do not indicate that these stressors are cumulatively causing now or will cause in the future a substantial decline of the total extant populations of fishers across the range of the proposed West Coast DPS. Therefore, we have determined that the cumulative impacts of these potential stressors do not rise to the level of a threat, now or in the future.
In the final Species Report, we evaluated whether existing regulatory mechanisms may be inadequate to address the stressors impacting fishers in the west coast States. We stated in the proposed listing rule and we reaffirm here that there are many Federal and State existing regulatory mechanisms that provide a benefit to fishers and their habitat. For example, trapping regulations have substantially reduced fisher mortality throughout the analysis area. There are places in the analysis area where forest management practices are explicitly applied to benefit fishers or other species with many similar habitat requirements, such as the northern spotted owl. In addition, some habitat conservation plans (HCPs) are in place and are intended to provide a benefit to fishers and their habitat. Also, as of August 6, 2015, the California Fish and Game Commission voted to list the southern Sierra Nevada Evolutionarily Significant Unit (ESU) of the fisher as a threatened species under the California Endangered Species Act (CESA). Consequently, take, under the CESA definition, is prohibited in the SSN population area.
Take of fishers in Oregon is also prohibited through its designation as a protected nongame species, although the definition of take under Oregon law is different from the definition of take under the Act. The fisher is State-listed as endangered in Washington, where take (
A number of Federal agency regulatory mechanisms pertain to management of fisher (and other species and habitat). Most Federal activities must comply with the National Environmental Policy Act of 1969, as amended (NEPA) (42 U.S.C. 4321
NFMA specifies that the Forest Service must have a land and resource management plan to guide and set standards for all natural resource management activities on each National Forest or National Grassland. In addition, the fisher has been identified as a sensitive species by the Forest Service throughout the analysis area. BLM management is directed by the Federal Land Policy and Management Act of 1976, as amended (43 U.S.C. 1704
In addition, the NWFP was adopted by the Forest Service and BLM in 1994 to guide the management of more than 24 million ac (9.7 million ha) of Federal lands in portions of western Washington and Oregon and northwestern California within the range of the northern spotted owl. The NWFP Record of Decision amends the management plans of National Forests and BLM Districts and is intended to provide the basis for conservation of the spotted owl and other late-successional and old-growth forest associated species on Federal lands. However, the BLM is currently revising their Resource Management Plan (RMP) (a draft RMP/Environmental Impact Statement (EIS) was published in April 2015 (USDI BLM 2015, entire)), which, if approved, would change their management direction from the existing NWFP. Once signed, a revision would replace the NWFP for BLM-administered lands in western Oregon, totaling approximately 2.5 million ac (1.0 million ha). Although a decision has yet to be made, BLM's preferred alternative (Alternative B), as stated in their EIS (USDI BLM 2015, p. 76), would allocate a slightly smaller amount of their landscape to timber harvest management as compared to the NWFP (22 percent and 28 percent, respectively). The BLM preferred alternative, however, shows a larger amount of LSR acreage than what is designated under the NWFP. Another reason is that BLM is adding all stands identified as structurally complex forest, creating scattered patches of older-forest reserves across BLM ownership (USDI BLM 2015, pp. 32-33, 50). Because BLM's decision is not final, our analysis in the final Species Report and summarized in this document is limited to their existing management under the NWFP.
The NWFP is important for fishers because it created a network of late-successional and old-growth forests (LSRs) that currently provide fisher habitat, and the amounts of habitat are expected to increase over time. Also, the National Forest and BLM units with anadromous fish watersheds provide buffers for riparian reserves on either side of a stream, depending on the stream type and size. With limited exceptions, timber harvesting is generally not permitted in riparian habitat conservation areas, and the additional protection guidelines provided by National Forests and BLM for these areas may provide refugia and connectivity among more substantive blocks of fisher habitat. Furthermore, the NWFP, while anticipating losses of late-successional and old-growth forests in the initial decades of plan implementation, projected that recruitment would exceed those losses within 50 to 100 years (Davis
Statutory direction for the 1.6 million ha (4 million ac) of National Park Service lands in the analysis area is provided by provisions of the National Park Service Organic Act of 1916, as amended (54 U.S.C. 100100) Land management plans for the National Parks within the west coast States do not contain specific measures to protect fishers, but areas not developed specifically for recreation and camping are managed toward natural processes and species composition and are expected to maintain fisher habitat. In addition, hunting and trapping are generally prohibited in National Parks (
Several tribes in the analysis area recognize fishers as a culturally significant species, but only a few tribes have fisher-specific guidelines in their forest management plans. Some tribes, while not managing their lands for fishers explicitly, manage for forest conditions conducive to fisher (for example, marbled murrelet (
The threats posed to fishers from the use of rodenticides are described above under “
The fisher is listed as endangered in Washington (Washington Administrative Code 232-12-014, Statutory Authority: RCW 77.12.020 WSR 98-23-013 (Order 98-232), § 232-12-014, filed 11/6/98, effective 12/7/98). This designation imposes stringent fines for poaching and establishes a process for environmental analysis of projects that may affect the fisher. The primary regulatory mechanism on non-Federal forest lands in western Washington is the Washington State Forest Practices Rules, title 222 of the Washington Administrative Code. These rules apply to all commercial timber growing, harvesting, or processing activities on non-Federal lands, and they give direction on how to implement the Forest Practices Act (Revised Code of Washington (RCW) 76.09) and Stewardship of NonIndustrial Forests and Woodlands (RCW 76.13). The rules are administered
In Oregon, the fisher is a protected nongame species (Oregon Administrative Rules (OAR) 635-044-0130). In addition, ODFW does not allow trapping of fishers in Oregon. Although fishers can be injured and/or killed by traps set for other species, known fisher captures are infrequent. State parks in Oregon are managed by the Oregon Parks and Recreation Department, and many State parks in Oregon provide forested habitats suitable for fisher. The Oregon Forest Practice Administrative Rules (OAR chapter 629, division 600) and Forest Practices Act (Oregon Revised Statutes (ORS) 527.610 to 527.770, 527.990(1) and 527.992) (Oregon Department of Forestry (ODF) 2010, entire) apply to all non-Federal and non-Tribal lands in Oregon, regulating activities that are part of the commercial growing and harvesting of trees, including timber harvesting, road construction and maintenance, slash treatment, reforestation, and pesticide and fertilizer use. The OAR provides additional guidelines intended for conserving soils, water, fish and wildlife habitat, and specific wildlife species while engaging in tree growing and harvesting activities, and these rules may result in retention of some structural features (
At the time of the proposed rule, fishers were a Candidate Species in California; thus, take (under the CESA definition) was prohibited during the candidacy period. On June 10, 2015, the California Department of Fish and Wildlife (CDFW) submitted its status review of the fisher to the California Fish and Game Commission, indicating that listing of the fisher in the Southern Sierra Nevada ESU as threatened was warranted, but that fishers in the Northern California ESU were not threatened (CDFW 2015, entire). On August 6, 2015, the California Fish and Game Commission voted to list the southern Sierra Nevada ESU of the fisher as a threatened species under the CESA. Consequently, take, under the CESA definition, is prohibited only in the southern Sierra Nevada portion of the proposed DPS's range. It is also illegal to intentionally trap fishers in California.
The California Environmental Quality Act (CEQA) can provide protections for a species that meets one of several criteria for rarity (CEQA 15380). Fishers throughout the proposed DPS's range in California meet these criteria, and under CEQA a lead agency can require that adverse impacts be avoided, minimized, or mitigated for projects subject to CEQA review that may impact fisher habitat. All non-Federal forests in California are governed by the State's Forest Practice Rules (FPR) under the Z'Berg Nejedly Forest Practice Act of 1973, a set of regulations and policies designed to maintain the economic viability of the State's forest products industry while preventing environmental degradation. FPRs do not contain rules specific to fishers, but they may provide some protection of fisher habitat as a result of timber harvest restrictions.
As required by the Act, we considered the five factors listed in section 4(a)(1)(b) of the Act in assessing whether the proposed West Coast DPS of fisher meets the definition of a threatened or endangered species, including: (A) The present or threatened destruction, modification, or curtailment of its habitat or range; (B) overutilization for commercial, recreational, scientific, or educational purposes; (C) disease or predation; (D) the inadequacy of existing regulatory mechanisms; or (E) other natural or manmade factors affecting its continued existence.
We examined the best scientific and commercial information available regarding the current and foreseeable future potential threats faced by fishers in the west coast States. We relied on an evaluation of the foreseeability of those stressors and the foreseeability of the effect of the stressors on the proposed DPS, extending this time period out only so far as we can rely on the data to formulate reliable predictions about the status of the proposed DPS, and not extending so far as to venture into the realm of speculation. In this case, many of the stressors fell into a foreseeable future timeframe within which we concluded the effects of stressors on the proposed DPS could be reliably projected out over a time period of approximately 40 years. Thus, for the purposes of this determination, we consider the foreseeable future to extend over a time period of roughly 40 years, as previously described in the proposed listing rule, based on the time horizons for which the effects of the various stressors on the proposed DPS can be reliably projected into the future (as described under the various stressor discussions in the Species Report (Service 2016, pp. 54, 58-162)).
At the time of our 2004 12-month finding, the proposed West Coast DPS of fisher was described as having lost much of its historical habitat and range. Specifically, the 2004 12-month finding stated (69 FR 18771, April 8, 2004) that the fisher is considered to be extirpated or reduced to scattered individuals in Washington, extant fisher populations in Oregon are restricted to two genetically distinguishable populations in the southern portion of the State, and extant fisher populations in California consist of two remnant populations located in northwestern California and the southern Sierra Nevada Mountains. Regarding population size, the 2004 12-month finding stated that the relative reduction in the range of the fisher on the West Coast, the lack of detections or sightings over much of its historical distribution, and the high degree of genetic relatedness within some populations indicate the likelihood that extant fisher populations are small (69 FR 18772). In addition, threats to the proposed West Coast DPS of fisher were described, including habitat loss and fragmentation, incidental capture, removal of important habitat elements such as cover, mortality from vehicle collisions, decrease in the prey base, human disturbance, small population size and isolation, and the inadequacy of existing regulatory mechanisms (69 FR 18791). The threats were described as occurring across the fisher's range in the west coast States, resulting in a negative impact on fisher distribution and abundance (69 FR 18792). The 2004 12-month finding also stated that additional reintroduced populations of fishers will reduce the probability that
At the time of our proposed listing in 2014, we found that the proposed West Coast DPS of fisher met the definition of a threatened species (likely to become endangered throughout all or a significant portion of its range within the foreseeable future) based on our analysis of the scope and severity of threats impacting the DPS. We found that the main threats to the proposed West Coast DPS of fisher were habitat loss from wildfire and vegetation management, as well as toxicants, and the cumulative impact and synergistic effects of these and other stressors in small populations. We also stated that the proposed West Coast DPS of fisher was not in danger of extinction throughout all of its range because it existed in: (1) Two separate native populations (one small population estimated at approximately 300 fishers and one with population size estimates ranging from 258 to 4,018 fishers) that have persisted; and (2) three reintroduced populations that provide redundancy, representation, and resiliency for the extant populations. We also determined that the threats acting on the proposed West Coast DPS of fisher were not all imminent and not evenly distributed across the DPS. We found at that time that the proposed DPS was likely to become endangered throughout all of its range in the foreseeable future based on multiple threats impacting the two extant native original populations and the cumulative and synergistic effects of the threats on small populations in the west coast States. We reached that conclusion based on an analysis of the best scientific and commercial information available at that time, as presented in detail in the draft Species Report (Service 2014, entire).
At the time of our proposed listing in 2014, we found there to be considerable uncertainty regarding the level of impacts (magnitude and immediacy of threats) from various stressors potentially affecting the proposed West Coast DPS of fisher. Specifically because of this uncertainty, we sought peer review and public comment on what we clearly identified as several complex issues with regard to the status of the DPS (see Information Requested section of the proposed rule (79 FR 60419)) and our proposal to list as a threatened species. For example, we requested information to assist us in evaluating the magnitude and overall immediacy of threats to fisher populations within the proposed DPS (including toxicants, wildfire, climate change, and vegetation management), and comments on the methodology for developing stressor scope and severity, adequacy in revealing assumptions and uncertainties, appropriateness of data extrapolations, and applicability and interpretation of quantitative stressor values presented in the draft Species Report. Through our initial evaluation of peer review and public comments received, we determined that these complex issues, as they related to our 2014 analysis and the status of fishers in the west coast States, deserved additional analysis. Consequently, we published a 30-day extension of the initial comment period (79 FR 76950; December 23, 2014) and then later opened an additional comment period concurrent with our announcement of a 6-month extension of the final determination of whether to list the West Coast DPS of fisher as a threatened species (80 FR 19953; April 14, 2015). We received a variety of opinions and material (
As indicated above regarding feedback from peer reviewers, the public, and conservation partners, we received a substantial amount of varied scientific, other agency, and public input on our proposal to list the West Coast DPS of fisher. In addition, we held numerous internal Service discussions regarding interpretation of the best available information and what it meant for the status of fisher both prior to and following the October 7, 2014 (79 FR 60419), proposed listing of the West Coast DPS of fisher. During these internal discussions, varied opinions were expressed and vetted. The extensive disparity in comments received (including those from peer reviewers and others) during the open comment periods highlighted the fact that considerable uncertainty remained as to potential threats to fisher and its current and future status.
Our regulations direct us to determine if a species is endangered or threatened due to any one or combination of the five threat factors identified in the Act (50 CFR 424.11(c)). We consider cumulative effects to be the potential threats to the species in totality and combination; this finding constitutes our cumulative effects analysis. The discussions summarized above and provided in detail in the final Species Report evaluated the individual impact of the following potential threats to the proposed West Coast DPS of fisher and its habitat: (1) Wildfire and fire suppression (Factor A); (2) forest insects and tree diseases (Factor A); (3) effects of climate change (Factors A and E); (4) vegetation management (Factor A); (5) development, including linear infrastructure (Factor A); (6) trapping and incidental capture (Factor B); (7) research activities (Factor B); (8) disease or predation (Factor C); (9) collision with vehicles (Factor E); (10) exposure to toxicants (Factor E); (11) small population size and isolation (Factor E); and (12) cumulative or synergistic effects. We also evaluated the inadequacy of existing regulatory mechanisms (Factor D). Our determination as reflected in this document thus is based upon an analysis of these stressors in accordance with the five factors required by the statute. Although this determination utilizes a different structure than what was presented in the proposed rule, where each stressor was analyzed under its particular statutory factor, it contains the same types of analyses that we have previously depicted under the five factor framework.
Upon careful consideration and evaluation of all of the information before us, we have arrived at a different conclusion regarding the status of fishers in the west coast States. In our proposed determination, we identified stressors that could impact the species negatively and identified three of those stressors (wildfire and fire suppression, vegetation management, and small population size and isolation) as threats. We also identified exposure to toxicants (specifically ARs) and cumulative effects from multiple stressors as threats, although there were uncertainties at that time. We applied the standards we had laid out in our proposed rule, which set forth that this determination does not necessarily require empirical proof of a threat. The combination of exposure and some corroborating evidence of how the species is likely impacted could suffice. The mere identification of stressors that could impact a species negatively is not sufficient to compel a finding that listing is appropriate; we require evidence that these stressors are
Under the Act and our implementing regulations, a species may warrant listing if it is an endangered or a threatened species throughout all or a significant portion of its range. The Act defines “endangered species” as any species which is “in danger of extinction throughout all or a significant portion of its range,” and “threatened species” as any species which is “likely to become an endangered species within the foreseeable future throughout all or a significant portion of its range.” The term “species” includes “any subspecies of fish or wildlife or plants, and any distinct population segment [DPS] of any species of vertebrate fish or wildlife which interbreeds when mature.” On July 1, 2014, we published a final policy interpreting the phrase “Significant Portion of its Range” (SPR) (79 FR 37578). The final policy states that (1) if a species is found to be an endangered or a threatened species throughout a significant portion of its range, the entire species is listed as an endangered or a threatened species, respectively, and the Act's protections apply to all individuals of the species wherever found; (2) a portion of the range of a species is “significant” if the species is not currently an endangered or a threatened species throughout all of its range, but the portion's contribution to the viability of the species is so important that, without the members in that portion, the species would be in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range; (3) the range of a species is considered to be the general geographical area within which that species can be found at the time FWS or NMFS makes any particular status determination; and (4) if a vertebrate species is an endangered or a threatened species throughout an SPR, and the population in that significant portion is a valid DPS, we will list the DPS rather than the entire taxonomic species or subspecies. It is important to note that we do not base a determination to list a species on the status of the species in lost historical range; in other words, lost historical range cannot be considered an SPR. The focus of an SPR analysis is the status of the species in its current range.
The SPR policy is applied to all status determinations, including analyses for the purposes of making listing, delisting, and reclassification determinations. The procedure for analyzing whether any portion is an SPR is similar, regardless of the type of status determination we are making. The first step in our analysis of the status of a species is to determine its status throughout all of its range. If we determine that the species is in danger of extinction, or likely to become so in the foreseeable future, throughout all of its range, we list the species as an endangered (or threatened) species and no SPR analysis will be required. If the species is neither an endangered nor a threatened species throughout all of its range, we determine whether the species is an endangered or a threatened species throughout a significant portion of its range. If it is, we list the species as an endangered or a threatened species, respectively; if it is not, we conclude that listing the species is not warranted.
When we conduct an SPR analysis, we first identify any portions of the species' range that warrant further consideration. The range of a species can theoretically be divided into portions in an infinite number of ways. However, there is no purpose to analyzing portions of the range that are not reasonably likely to be significant and either an endangered or a threatened species. To identify only those portions that warrant further consideration, we determine whether there is substantial information indicating that (1) the portions may be significant and (2) the species may be in danger of extinction in those portions or likely to become so within the foreseeable future. We emphasize that answering these questions in the affirmative is not a determination that the species is an endangered or a threatened species throughout a significant portion of its range—rather, it is a step in determining whether a more detailed analysis of the issue is required. In practice, a key part of this analysis is whether the threats are geographically concentrated in some way. If the threats to the species are affecting it uniformly throughout its range, no portion is likely to warrant further consideration. Moreover, if any concentration of threats apply only to portions of the range that clearly do not meet the biologically based definition of “significant” (
If we identify any portions that may be both (1) significant and (2) endangered or threatened, we engage in a more detailed analysis to determine whether these standards are indeed met. The identification of an SPR does not create a presumption, prejudgment, or other determination as to whether the species in that identified SPR is an endangered or a threatened species. We must go through a separate analysis to determine whether the species is an endangered or a threatened species in the SPR.
Depending on the biology of the species, its range, and the threats it faces, it may be more efficient to address the “significant” question first, or the status question first. Thus, if we determine that a portion of the range is not “significant,” we do not need to determine whether the species is an endangered or a threatened species there; if we determine that the species is not an endangered or a threatened species in a portion of its range, we do not need to determine if that portion is “significant.”
Because we determined that the proposed West Coast DPS of fisher is neither endangered nor threatened
Our current evaluation of the best scientific and commercial data available, as described earlier in this document and in our final Species Report, leads us to conclude that the stressors acting upon fishers in the west coast States are not of sufficient imminence, intensity, or magnitude to indicate that they are singly or cumulatively resulting in significant impacts at either the population or rangewide scales currently or in the foreseeable future. Thus, the proposed DPS does not meet the definition of endangered or threatened under the Act. For this SPR analysis we first evaluated whether the proposed West Coast DPS of fisher may be in danger of extinction in portions of its range or likely to become so within the foreseeable future. To make this determination, we considered whether the stressors affecting the entire proposed DPS might be manifesting themselves in the form of significant impacts at the population scale only in certain portions of the range, such that the fisher in those portions may be an endangered or threatened species under the Act.
We have determined that currently and in the foreseeable future:
(1) The stressors affecting the proposed West Coast DPS of fisher occur in most populations within the west coast States but are not having significant impacts at the population scale in any portion of the proposed DPS's range. For example, ARs may be more problematic in certain populations (
(2) The fisher is not exhibiting population declines in any portion of its range.
Thus, at this time, fishers in any portion of their range in the west coast States do not meet the definition of an endangered or threatened species under the Act. Because we determined that no portion of the proposed West Coast DPS of fisher's range
We encourage the continuing development and implementation of positive conservation actions for the benefit of fishers and their habitat, as exemplified by the CCAAs currently underway in association with our State and private conservation partners, to ensure against the future need to reconsider the listing of fisher in the west coast States.
In the proposed rule published on October 7, 2014 (79 FR 60419), we requested that all interested parties submit written comments on the proposal by January 5, 2015. This proposed rule also announced one public hearing and seven public informational meetings held in California, Oregon, and Washington. This comment period was subsequently extended an additional 30 days, as announced on December 23, 2014 (79 FR 76950), and closed on February 4, 2015. Finally, the Service announced the reopening of the comment period on April 14, 2015 (80 FR 19953), for an additional 30 days, and we announced a 6-month extension of the final determination of whether or not to list the proposed West Coast DPS of fisher due to substantial disagreement regarding available information related to toxicants and rodenticides (including law enforcement information and trend data) and related to surveyed versus unsurveyed areas (including data on negative survey results) to help assess distribution and population trends. This second comment period on the proposed listing rule closed on May 14, 2015.
We contacted appropriate Federal and State agencies, scientific experts and organizations, and other interested parties and invited them to comment on the proposal (we additionally solicited peer review at this time; see
During the two comment periods, we received more than 460 comment letters directly addressing the proposed listing of the West Coast DPS of fisher. Submitted comments were both for and against listing the DPS, including some for and against listing different geographic configurations of the DPS. During the November 17, 2014, public hearing, 12 individuals (3 from the same organization) commented on the proposed rule; all were opposed to the proposed listing. All substantive information provided during the comment periods has been incorporated into the final Species Report and, where applicable, summarized or addressed in this withdrawal. As noted in our proposed rule, comments that merely express support for or opposition to a particular action may not meet the standard of information required under section 4(b)(1)(A) of the Act, which directs that determinations as to whether any species is an endangered or threatened species must be made “solely on the basis of the best available scientific and commercial data available” (79 FR at 60422).
A substantial amount of new information was received from peer reviewers and the public (including old information of which we were not aware and some literature published just prior to the proposed listing rule publication), all of which we have reviewed, considered, and incorporated (where applicable and appropriate) into the final Species Report, this
In accordance with our peer review policy published on July 1, 1994 (59 FR 34270), we solicited expert opinion from 27 appropriate and independent specialists with scientific expertise that included familiarity with fisher and their habitat in the west coast States, including biological needs and threats. We received responses from 22 of the peer reviewers.
We reviewed all comments received from the peer reviewers for substantive issues and new information regarding the listing of the proposed West Coast DPS of fisher. Peer reviewer comments are addressed in the following summary and incorporated into this withdrawal document as appropriate.
In the
Our analysis of all the best scientific and commercial data available, including new information received during the open comment periods, reaffirms our initial conclusion that we do not have sufficient data to reliably predict the effect of climate change on fisher populations at this time. For example, some models project that ecotypes that support fisher habitat may decrease in area in response to the effects of climate change. However, as noted in both our draft and final Species Reports, depending on the emissions scenario considered and other variables, various models also predict that fisher habitat may increase in area, remain relatively stable, or shift in range.
We have clarified in the final rule that climate change, by itself, is not a threat. In addition, the cumulative and synergistic effects of climate change and other stressors acting on small populations do not pose a threat to the proposed West Coast DPS of fisher, based on insufficient evidence that climate change acting alone or synergistically on small populations is having significant impacts at either the population or rangewide scales, or is likely to do so within the foreseeable future.
However, as we stated in both the draft and final Species Reports, it is uncertain how these habitat shifts will affect fisher populations, and because modeling projections are done at a large scale, effects to species can be complex, unpredictable, and highly influenced by local level biotic and abiotic factors (Service 2014, p. 80; Service 2016, p. 84, 87-88, 91-95). Because of the uncertainty of the effects of climate change on fisher populations, the Service does not agree with the peer reviewer that we can conclude climate change will have an overall positive impact on fishers.
Another peer reviewer stated that the correlative climate change models we used in the draft Species Report are not robust because the time periods chosen were not random. Thus, the peer reviewer stated that the 8-fold increase is a model extrapolation that is not accurate for the purposes of this analysis.
We received many detection data sets during the public comment period, and this information is currently being reviewed for redundancy against the survey records we had obtained previously. The fisher locality database currently consists of more than 17,000 positive and negative locality data records. As we received new detection information, we reviewed information, and in particular, sought instances where such detections occurred outside the currently expected range. At this time, we cannot reliably conclude whether these new detections are based on improved or increased monitoring methods, or a biological response by fishers, nor is it possible to determine the reason for the detections (
(1) Genetic evidence (Tucker
(2) The SSN population harbors distinctly different habitat, fire regimes, geography, and ownership patterns, suggesting that fishers in this area behave differently, have different needs, and will require a different conservation strategy than the rest of the West Coast fishers.
(3) The SOC and NCSO populations show no genetic exchange despite their relatively close proximity, and thus should not be part of a single DPS.
(4) The introduced fisher populations should not be included in the proposed DPS because they are more closely associated with their source populations as opposed to native populations.
(5) Alternative 2 is the most appropriate configuration based on the small number of animals present [note: we presume the commenter was referring to the SSN population] throughout the identified potentially suitable habitat, and the current risks identified for the small population as compared to the NCSO population.
(6) Alternative 2 is the most appropriate configuration because both nuclear and mtDNA research support a clear division between the Sierra Nevada and the remainder of the fishers in North America. Comprehensive research suggests that the SSN population is a well-supported DPS, with a separate/second DPS along the West Coast being everything north of the SSN population.
(7) The NCSO population should be managed as a separate management unit (although not necessarily a DPS) from the reintroduced populations with British Columbia origins.
(1) Alternative 1 is not reasonable because it would exclude the ONP population based on genetic distinctiveness, yet includes the NCSO and SSN populations despite the fact that they are genetically distinct.
(2) Alternative 1 would result in the exclusion of suitable habitat in Oregon and Washington that may be important to fishers given future climate change predictions.
(3) Alternative 2 is inappropriate because genetic evidence (statistical differences in neutral markers) is not strong enough to split the two Sierra Nevada populations and fails to protect the northern Sierra Nevada population when\if it expands from the reintroduction area. Additionally, there is an absence of samples from the currently unoccupied area to justify splitting the proposed DPS in California.
(4) Alternative 2 is inadequate to improve the fisher's status throughout the west coast.
(5) Neither alternative engenders recovery, although Alternative 1 is better than Alternative 2 because it promotes connectivity.
(6) Excluding much of Oregon and Washington (as in Alternative #1) or the currently unoccupied area in the Sierra Nevada (as in Alternative #2) is contrary to the goal of restoring the species to its historical range.
(7) Neither alternative provides for future climate change concerns that may result in a northward shift of fishers, as well as their habitat and prey. One peer reviewer asserted that this specific area north of the Alternative 1 and 2 boundaries is germane to the proposed DPS's recovery given the species past distribution from British Columbia to California, and the habitat modeling results that indicate future suitable habitat focused north of both the Alternative 1 and 2 boundaries.
(8) Neither alternative is supported by strong evidence for the historical distribution of fishers in significant portions of Washington and Oregon; thus, an effort to conserve the taxon should not exclude areas where their return via management actions is scientifically justified.
(9) Neither alternative includes the SOC population.
(10) Both alternatives prevent what should be a long-term conservation goal of reconnecting all fisher populations to Canada.
(11) Neither alternative provides the combined conservation of preserving the native genetics and expanding the range of the proposed DPS to reoccupy suitable habitat in Washington and Oregon.
One of these eight peer reviewers stated that Alternative 1 or 2 should only be considered if they were found to be the only politically feasible path at the current time to ensure the long-term conservation of fishers in the west coast States. Another one of the eight peer reviewers also stated that a separate DPS for the SSN population would likely be beneficial to allow special management for recovery.
As noted above, we solicited comments from peer reviewers and the public regarding the possibility of different DPS configurations for the West Coast populations of fisher. However, at this time, our end decision is to use the original DPS configuration as presented in the proposed listing rule.
We agree with the peer reviewer that there may be localized expansion of fisher distribution. The peer reviewer's comment that fishers did not historically occur in the coastal strip of old-growth redwood forests is supported by Grinnell
The peer reviewer's assertion that an increase in “. . . population density and abundance in north coastal California” is similar to conclusions presented by Slauson
Both the proposed listing rule and draft Species Report (Service 2014, pp. 13-17) cite numerous studies that suggest fishers are consistently associated with low to mid-elevation coniferous and mixed-conifer and hardwood forests with abundant physical structure. The key aspects of fisher habitat are best represented in areas that are comprised of forests with diverse successional stages containing a high proportion of mid- and late-succcessional characteristics. In addition, fishers avoid larger open areas such as meadows and clearcuts. Extensively logged areas may contain
Multiple commenters provided information on fisher use of managed landscapes and this information was also presented in the draft Species Report (Service 2014, p. 17). In addition, we have noted the historical change in fisher occurrence in the redwood portion of the proposed DPS.
We acknowledge fishers' use of managed landscapes (Federal and non-Federal), multiple seral stages, and potential climate-related influences. We received numerous comments in that regard. Please see our responses to peer review
We further interpret the peer review comment to suggest that forest management may ameliorate the effects of climate change on fisher habitat by shifting forest tree species to those that are more drought resistant (
The peer reviewer also suggested that there should be a strong correlation between the relative amount of late-seral and old-growth forests modeled as high quality fisher habitat not subjected to timber harvest and the persistence of fishers in the west coast. The peer reviewer's brief analysis of this situation suggested that the persistence or recolonization of fishers may not strongly correlate with past timber harvest, particularly in portions of the NCSO population that may have experienced high levels of past timber harvest with fragmented regions of high-quality habitat.
Past trapping of fishers appears to have been the primary initial cause of fisher population losses in the Pacific States (Service 2014, p. 112). Trapping and unregulated harvest varied by location, and were likely influenced by topographic features (Service 2014, pp. 110-111). Localized extirpations or greatly reduced numbers of individual fishers as a result of trapping mean that it became more difficult for remaining fishers to find one another and successfully recolonize previously occupied habitat. Adding to this scenario, large-scale loss of important habitat components from timber harvest also reduced the available habitat and increased fragmentation, making it difficult for remaining fishers to encounter other fishers.
Specific data are not available to quantify the severity of trapping by each sub-region (Service 2014, p. 112). Because of this lack of data, it is difficult to determine if the NCSO population was either not subjected to the trapping pressures observed in other areas, or that the types of timber harvest in the area were more conducive to the persistence of fishers on the landscape.
Our assessment in the final Species Report has been updated to include additional discussion of the effects of fuels reductions treatments on fishers and fisher habitat; although there are many indirect benefits from some treatments, we note that our assessment of the best available scientific information additionally identified some potentially negative effects as well (Service 2016, pp. 99-111).
One peer reviewer noted that the Ashland fisher monitoring project has found that fishers use multiple habitat types, including chaparral (the peer reviewer hypothesizes that the fishers utilize this habitat in the winter while searching for prey). The peer reviewer noted that all habitat types used by fisher in the monitoring project had greater than 60 percent canopy cover. Another peer reviewer noted that fishers in the ONP population seem to be selecting a mosaic of mixed-ownership partially managed forests over old-growth.
Another peer reviewer agreed with the draft Species Report that prey availability may impact the distribution of fishers. The peer reviewer asserted that late-successional habitat, regardless of elevation, was not a limiting factor for fisher home ranges. A fourth peer
Finally, another peer reviewer asserted that fishers in central British Columbia are well-adapted to a mosaic of forest ages and structural types that result from normal fire intervals. The peer reviewer suggested that, based on this evidence, large amounts of old-growth forests might not be ideal for the fisher.
In our draft Species Report, we discuss the use of managed, younger, and mid-seral forests (
In our final Species Report, we have used the best available information to estimate the effects of vegetation management on the proposed West Coast DPS of fisher, including consideration of all comments and new information received during the comment periods on this rulemaking. Excellent sources of new information became available to us for the analysis of the effects of vegetation management within the analysis area, including the recently released NWFP 20-year late-successional old-growth monitoring report (Davis
We received multiple comments on the recruitment of fisher habitat on Federal and non-Federal lands and the extent to which regulatory mechanisms may provide for fisher habitat. Please see additional related responses, such as
Finally, we received two other peer review comments regarding managed lands and prey, and we have incorporated additional discussion of how some forms of vegetation management may affect prey species composition or abundance in our final Species Report. See also our response to peer review
Two of the peer reviewers questioned if using camera traps for fisher detections was ideal for building a habitat model. The first peer reviewer also discussed the results of a study in Idaho, where it was not unusual to have only a single detection of fisher through camera or hair trapping. The peer reviewer stated that in such cases, the density of fishers on the landscape is likely to be low, and so any model that uses detections rather than resident animals may potentially overestimate abundance and include poor-quality habitat. The peer reviewer recommended that the Service build a model based on telemetry and one based on occurrence data, and compare the results of the two models.
Another peer reviewer stated that camera trap detections should not be used unless the model is being used to look at connectivity at a coarse landscape scale. The peer reviewer and other researchers could provide the Service with telemetry and GPS locations to assist in refining the model.
As one peer reviewer noted, survey methods that use scent lures (and bait lures) may not present an accurate picture of fine-scale habitat use because these methods may attract fishers to habitats that they would otherwise not prefer. However, at the large scale of our habitat model, we considered this source of bias to be less important than the type of bias that could be introduced by reliance on telemetry data. Although telemetry data give a relatively accurate picture of the fine-scale habitat use of an individual fisher, at this scale of analysis, the use of telemetry data would do little more than identify telemetry study areas within the overall analysis area. Furthermore, it is likely that most telemetry locations are within 3.1 mi (5 km) of a camera survey location and, therefore, are already represented at the scale of our habitat model. The use of camera, hair snare, and track plate detection data allowed us to develop models that were more representative of the entire SSN and NCSO population areas, rather than focusing on telemetry study areas, some of which contain unique habitat conditions not found elsewhere in the analysis area.
Models based on telemetry locations would likely be very helpful at a finer scale to identify habitats used for particular functions of fisher life history, such as denning, resting, or foraging. Such a model would likely be of great use to land managers who are interested in managing for fisher habitat values, and we would appreciate the opportunity to collaboratively participate with researchers interested in developing a telemetry-based model. However, this particular type of model was less useful for the large-scale analyses presented in the draft and final Species Reports.
With regard specifically to Washington data in the habitat model, we acknowledge that the habitat model is an approximation of fisher habitat on the Olympic Peninsula, and that actual fisher use of the landscape may suggest different areas that are or are not likely to be used by fishers. However, fisher home range data on the Olympic Peninsula is based on the habits of the first reintroduced animals over an approximately 5-year period, and may not reflect all of the habitats that will be used by fishers in the future. Therefore, the habitat model has an appropriate level of accuracy for the purposes of our analysis. We thank the peer reviewer for providing the information, which will be useful in guiding future management decisions.
Every habitat model is not necessarily a simplification of reality. The type of model used and the particular simplifications to be made in a given model must be selected based on the purpose of the model, the input data available, and other practical considerations such as the timeframe allotted for the model's creation. The main purpose of our fisher habitat model was to identify areas on the landscape that might be expected to support some level of fisher presence, both within the current range of fishers and in the portions of the historical range where fishers are rare or absent. Therefore, where reliable fisher detection data were available, we used Maxent models, which are empirically fitted models widely used to answer questions of this nature. Where reliable fisher detection data were not available, we constructed an expert model, which is another standard type of model used in situations where empirically fitted models are not feasible. We note that, contrary to the peer reviewer's comment, we did incorporate information about prey distribution and diversity into the expert models. The dynamic, detailed models of habitat development suggested by the peer reviewer would be needlessly complex for the primary purpose of our modeling effort, although they might have been helpful in analyses of vegetation management (for which we did not use our fisher habitat model) and wildfire (for which we did use our habitat model, but with some caveats). However, even if a model of the type suggested by the peer reviewer were eminently appropriate for the purposes of our evaluation, such a model was not available for us to use.
(1) The habitat model may have overpredicted the amount of suitable habitat in the NCSO region, and that these areas with negative surveys are not truly habitat, perhaps due to the influence of some factor that was not included in the set of environmental inputs to the model.
(2) There may be unoccupied suitable habitat in the NCSO region, which we further discuss in the draft Species Report (Service 2014, p. 39). This possibility could, in turn, have multiple explanations, including a population that has not yet reached carrying capacity following the population reductions due to trapping in the early 20th century, or internal fragmentation preventing the population from occupying all available habitat within the NCSO region.
The second peer reviewer also stated that the eastern Olympic Peninsula and the Kitsap Peninsula are more similar to each other than they are to the Willamette Valley-Puget Trough area, and that that portion of the peninsula has been frequently used by the reintroduced fisher population. The peer reviewer recommended that the entire Olympic Peninsula be included in the Coastal Washington subregion as outlined in the draft Species Report. The third peer reviewer recommended omitting the Kitsap Peninsula entirely due to human development.
We agree that a map showing which verified records were used in the habitat model could improve understanding of our habitat modeling methodology. This would be a good addition to Fitzgerald
We included a number of maps showing reliability ratings to visually
Population size estimates provided in the draft Species Report (Service 2014, pp. 37-43) and final Species Report (Service 2016, pp. 42-53) come from multiple sources and were not all derived in the same manner. We use these estimates as the best available information for overall population size and recognize the uncertainty associated with these estimates. The estimate of NCSO population size as derived from the effective population size was at the lower end of the range of estimates for that population, as presented in the draft Species Report; we note that the upper range estimate of 4,018 individuals that was also presented well exceeds all estimates of population size for the SSN population. Updated population estimate information is found in the
The peer reviewer also raised a concern about an apparent disparity between the population size estimates and detections reported in the draft Species Report. We assigned a numerical reliability rating to each fisher detection and presented the locality records from 1993 to the present for detections with reliability ratings 1 and 2 in Figure 7 of the draft Species Report (Service 2014, pp. 28, 31). The locality data include information from research studies, Federal and non-Federal landowners, and members of the public. This data set includes more records than those presented (and ultimately extrapolated to population estimates) in the scientific studies conducted within portions of the proposed West Coast DPS subregions. Therefore, we understand the concern of the peer reviewer, but we do not agree that the difference between population estimates and detection data is flawed or otherwise undermines support for our conclusions.
Throughout the draft and final Species Reports, we discuss the geographic extent of stressors potentially acting on the NCSO and SSN populations. The SSN population is at the southern extent of the species'
The contention that recent legalization of recreational marijuana in Washington and Oregon may reduce the scope and severity of this threat is unlikely (given the main application of this stressor has not been in Washington or Oregon), and it is too soon to tell what, if any, effect the recent legalization will have on illegal marijuana grow sites and exposure of fishers to rodenticides. There are, as yet, no rodenticide labels that allow application to marijuana as a crop; thus, any use of rodenticides within a marijuana grow, legal or otherwise, would be illegal under State and Federal laws.
We note the uncertainty as to the severity of impact that this stressor may have, given data are minimal across Oregon and Washington in particular, including the lack of information rangewide regarding potential sublethal effects of toxicants to fishers within the proposed West Coast DPS (
The new information we have evaluated provides clarity and corrections to some information presented in the draft Species Report, including the lack of information rangewide regarding potential sublethal effects of ARs to fishers within the proposed West Coast DPS (
The draft Species Report provided the figures used to determine the scope of research-related stressors in Coastal Washington (Service 2014, p. 114). The draft Species Report used the data from ongoing research in the SSN and NCSO populations to calculate severity for research-related stressors (Service 2014, p. 114). We have updated our analysis in the final Species Report to include
Wildfire suppression often includes the removal of snags or other large trees, but the scales at which this happens vary (Service 2014, p. 61). On the other hand, fire also creates many of the structural elements that are of concern to the commenter. While some of these elements may be removed by suppression activities, recruitment of these elements also occurs as a result of fire. We have expanded our discussion of the effects of wildfire in the final Species Report to ensure it is a balanced discussion of both the potential negative and positive effects of fire.
We appreciate the suggestions from the peer reviewer regarding how we may improve our assessment of scope and severity for wildfires. As explained in the
With regard to this withdrawal of the proposed listing rule, there is an extensive amount of varied scientific, Service, other agency, and public opinion regarding the status of the proposed DPS both prior to, and following, the October 7, 2014 (79 FR 60419), proposed listing of the West Coast DPS of fisher. Given this variance and the extensive disparity in comments received (including peer reviewers) during the two open comment periods, we considered it necessary to re-evaluate all of this best available scientific and commercial information previously reviewed, and the new information received, to formulate a final decision. Upon careful consideration and evaluation of all of the information before us, we have arrived at a different conclusion regarding the status of the proposed West Coast DPS of fishers. Specifically, we conclude that the stressors acting upon the proposed West Coast DPS of fisher are not of sufficient imminence, intensity, or magnitude to indicate that that they are singly or cumulatively resulting in significant impacts at either the population or rangewide scales. Based on this current assessment, we find that the proposed West Coast DPS of fisher is not in danger of extinction currently, and is not likely to become endangered within the foreseeable future throughout all or a significant portion of its range. Therefore, the proposed West Coast DPS of fisher does not meet the definition of an endangered or threatened species, and we are withdrawing the proposed rule to list the DPS as a threatened species (see Determination, above).
The fisher's range in the west coast States includes many areas with suitable habitat where fishers probably do not occur, including suitable habitat areas in coastal Mendocino and Sonoma Counties. Additionally, the best scientific and commercial information, which includes that presented by the commenter, does not support the commenter's assertion that fishers are “probably absent” from their lands because: (1) A lack of detections using Zielinski
We appreciate the depth of thought and consideration given by many commenters to the question of deriving a DPS configuration that may be most appropriate for West Coast fishers. Please see our response to
• With regard to the more recently identified stressor of ARs, the NPS does not administer rodenticides in the Olympic, North Cascades, or Mount Rainer National Parks and works with cooperators and concessions to preclude the use of these agents (although the level of potential illegal use in park areas is unknown). In addition, the Federal agency noted that only one of five of the recent fisher mortalities recovered in the Olympic peninsula recovery area (2013-2014) showed AR exposure, and as that individual was recovered just outside the city limits of Port Angeles, they surmise it most likely was exposed at a residential setting. The Federal agency suggested that more recent data indicate the key risk factor of AR exposures for fisher in California may not be as relevant in Washington.
• The high-quality fisher habitat in Washington's national parks and adjacent national forests is minimally threatened by wildfire due to the hyper-oceanic climate with relatively high rainfall, as compared to the more arid eastern slope of the Cascade Mountains and south into portions of Oregon and California.
• The reintroduced Washington population does not share the unique genetic characteristics of the California populations.
(1) There is no evidence that the distribution of the SSN population has contracted from historical levels, and there is no reason to believe that there has been any change in abundance of this population. The locality records presented in the draft Species Report indicated a stable distribution over the last century, and the findings of Tucker
(2) There is no evidence that fishers have declined in abundance in contemporary times. Current estimates of abundance are similar to estimates of carrying capacity, suggesting that the current distribution and abundance of the SSN population remain similar to historical levels. Recent estimates of population growth in the SSN population from the Sierra Nevada Adaptive Management Project suggest it has ranged from stable to positive; there have been no studies indicating negative growth.
(3) There is no evidence that the potential stressors identified in the listing proposal have negatively impacted population dynamics of the SSN population. Without at least correlative evidence of an association between stressors and population decline, it is difficult to argue that the stressors are indeed operative threats that act on the species. As an example, it is acknowledged in the draft Species Report that the impact of AR exposure on vital rates at the population level is unknown. Therefore, although there may be an underlying cause and effect relationship, it is premature to rely on the existing evidence to support a listing.
Additionally, one commenter articulated that if fishers in the west coast States and other fisher populations are genetically divergent, morphologically distinct, or specially adapted to diverse habitats for prehistoric, natural, or evolutionary reasons, then it is logical and scientifically consistent for the Service to reconsider whether the fishers in the west coast States actually contain (within its geographic range and populations) the same natural, prehistoric, and evolutionary separation that the Service relies on to distinguish the proposed West Coast DPS from other fishers.
We solicited comments from peer reviewers and the public regarding the possibility of different DPS configurations for the West Coast population of fishers. We recognize and appreciate that there are many possible approaches to delineating potential DPSs, and that there may be valid arguments in support of (or against) aspects of each (see our response to
The commenter did not provide any support for their statement that fishers in Oregon, at least, would not reconnect with the NCSO population. Recent data shows spatial overlap of individuals from the NCSO and SOC populations, suggesting that these two populations are beginning to intersect. There has been limited monitoring of fishers in Oregon to robustly describe their distribution, but recent and ongoing surveys in the Cascades will better inform our understanding of the distribution of the reintroduced SOC population and its relationship with the NCSO population. Given our current understanding of suitable fisher habitat, it appears that there may be adequate habitat to support fishers in the northern Cascades of Oregon and allow connectivity with extant fishers in the reintroduced SOC population and south to the NCSO population.
We acknowledge the commenter's point that Washington fishers are not likely to reconnect with the NCSO population. The Columbia River is almost certainly a considerable barrier to fisher movement in the proposed DPS. While it may restrict populations from substantially intermingling, it is likely not impenetrable, allowing some genetic mixing of fisher populations over the long term. Please see our response to
At this time, our decision is to use the original DPS configuration as presented in the proposed listing rule. Per section 4 of the Act and its implementing regulations, we have carefully assessed the best scientific and commercial data available regarding the past, present, and future threats to the proposed West Coast DPS of the fisher and are withdrawing our proposal to list this DPS (see Determination, above).
In addition, the lack of evidence for fisher population declines in the west coast States, in conjunction with our assessment of the stressors to the species, was an important consideration
The commenter does not present data indicating what methods were used to determine that the fisher population area across the proposed West Coast DPS has expanded by a half million acres since 1990, nor are any negative survey data for prior years presented. We have no evidence to suggest that any range expansion has occurred such as described by the commenter. Finally, no new data are presented that indicate that fishers are evenly distributed throughout this expansion area. The comment does not present evidence sufficient to support a listing determination. However, based on our assessment of the best scientific and commercial data available, we have concluded that the proposed West Coast DPS of fisher does not meet the definition of an endangered or threatened species under the Act, and we are withdrawing the proposed rule to list the DPS.
While we agree with the second commenter's assertion that fishers may be “well documented” on the commenter's lands, the lack of abundance estimates over time, which are required for a population trend analysis, make it impossible at this time to conclude that the fisher population is stable. However, using the survey methods employed by the commenter, we do agree it is possible to detect
In contrast, four commenters asserted that the existing regulatory mechanisms are inadequate because federally protected lands do not provide sufficient suitable habitat (or protection of essential habitat elements) for fishers. One of these commenters argued that significant timber harvest acreage in California occurs via clearcutting or similar alternative methods, with other acreage also planned for sanitation-salvage logging operations and group-selection silviculture (Haines 2014), none of which (the commenter asserts) benefits the fisher. The second commenter stated that an ESA-listing would help address the lack of adequate pesticide (specifically rodenticide) regulatory mechanisms in Oregon and Washington. The third commenter asserted that reliance on the Federal lands LSR system, which provides conservation targeted at northern spotted owls and other late-seral-dependent species, is not sufficient to ensure conservation and recovery of the fisher because current LSR restrictions allow significant alteration and degradation of fisher habitat.
While fishers may use a mosaic of habitat conditions for which some level of younger industrial forests may be sufficient at the landscape scale, the Oregon FPA requirements for retaining older forest stands are limited to specific conditions such as no-cut retention buffers around streams and protection of specific wildlife sites. These retention areas may or may not be late-successional, depending on what forest stand exists at the time they are put in effect. Even if these stands are late-successional, they occur on a substantially small part of the non-Federally managed landscape compared to the heavily managed portion of industrial forest where little structure is likely to occur.
We have stated in the draft Species Report and in the final Species Report that fishers use and even reproduce in managed forest landscapes if there are sufficient amounts and an adequate distribution of key habitat and structural components important to fishers, noting that younger and mid-seral forests may be suitable for fishers if they retain the necessary structural complexity and features. While this habitat could be provided by timber managers on a discretionary basis, as noted above, the minimum size requirements and lack of long-term retention under the Oregon FPA will not necessarily result in meeting the structural habitat needs of fishers.
We interpret foreseeable future as that extent of time over which the Secretary can reasonably rely on predictions about the future in making determinations about the future conservation status of the species. In the context of the definition of a threatened species, the foreseeable future is the period of time over which events can reasonably be anticipated. Our references to “reliable predictions” are not meant to refer to reliability in a statistical sense of confidence or significance; rather the words “rely” and “reliable” are intended to be used according to their common, non-technical meanings in ordinary usage. In other words, we consider a prediction to be reliable if it is reasonable to depend upon it in making decisions, and if that prediction does not extend past the support of scientific data or reason so as to venture into the realm of speculation. Our approach to defining the general period of time that may be considered to constitute the foreseeable future is in accord with the Department of the Interior Solicitor's opinion on foreseeable future (M-37021, January 16, 2009; p. 9), available on the Internet at
As suggested in the Solicitor's opinion for our analysis of the stressors to the proposed West Coast DPS of fisher, we are relying on an evaluation of the foreseeability of those stressors and the foreseeability of the effect of the stressors on the proposed DPS, extending this time period out only so far as we can rely on the data to formulate reliable predictions about the status of the proposed DPS, and not extending so far as to venture into the realm of speculation. In this case, many of the stressors fell into a foreseeable future timeframe within which we concluded the effects of stressors on the proposed DPS could be reliably projected out over a time period of approximately 40 years. For the stressor of climate change, for example, many different models project changes in temperature, precipitation, or other climatic variables over a period of at least 100 years (see “Climate Change” sections of this document and the final Species Report). As described in the final Species Report, the predicted changes in climatic conditions are generally in agreement under the variety of different emissions scenarios considered until mid-century; after that point, the trajectory of projected changes begin to diverge. For this reason, we conclude that we can reasonably rely on predictions regarding future climate changes over a period of roughly 40 years, up to that mid-century point. Similarly, we conclude it is reasonable to predict changes in forest conditions as a result of vegetation management over approximately the same period of time, based on forest planning horizons and time needed to observe changes in forest conditions (see “Vegetation Management” sections of this document and the final Species Report). For these reasons, we conclude 40 years constitutes a reasonable approximation of that period of time over which we can reliably predict the effects of several of the stressors acting on the proposed West Coast DPS or fisher.
We agree that for some stressors we do not have sufficient data to reliably predict effects on fishers over any specific period of time (for example, disease). For these stressors we could only state that they are “ongoing.” In our final Species Report, we have attempted to be more explicit in our acknowledgment of uncertainty regarding timeframes and effects of such stressors, and to clearly avoid speculation with regard to the potential future effects of a stressor if we do not have sufficient scientific data to provide us with a basis for projection.
Finally, we received many comments regarding the failure of the draft Species Report to account for habitat ingrowth within the 40-year timeframe considered for habitat stressors. We were able to do so in our final Species Report within the area covered by the NWFP (which covers most of the analysis area, with the exception of the southern portion of the proposed West Coast DPS and the area east of the Cascade mountains), using the recent NWFP 20-year late-successional old-growth monitoring report (Davis
We disagree that habitat for fisher should be managed as if it were spotted owl or wolverine habitat. While northern spotted owl and fisher habitat may be similar in some respects, how they use the habitat is different. For example, fisher travel widely within their home ranges while spotted owls are central place foragers (
Finally, several of the commenters point to the “steep decline” in fishers as evidence of the negative impacts of forest mismanagement. We agree that fishers have been lost throughout much of their historical range, but indications are that these past losses were largely due to threats that are no longer functioning as operative threats on the landscape. In our evaluation of all best scientific and commercial data available to us, we do not have evidence that fishers in the proposed West Coast DPS, although reduced from their past abundance and range, are currently experiencing declines.
As described in our draft Species Report, a significant amount of moderate- and high-quality habitat remains available but unoccupied by fishers within the analysis area, for example, within the NCSO population (Service 2014, p. 39). According to the results of our habitat model (presented in Appendix A in the draft Species Report), roughly 16 million acres of intermediate- to high-quality fisher habitat is present in the analysis area, and approximately 11 million acres of lands are currently under some form of protection (NWFP reserves, National Parks, Southern Sierra Fisher
Although some ongoing level of habitat loss and fragmentation is anticipated through vegetation management activities, we have no information to suggest that it will be so great as to result in likely significant impacts to fisher habitat at either the population or rangewide scales. Based upon our evaluation of all the best scientific and commercial data available, in this final determination we have concluded that although past habitat loss was undoubtedly a key factor in the historical declines in range and abundance of fishers throughout the proposed DPS, it is not currently an operative threat on the proposed West Coast DPS of fisher, nor do we have information to indicate that it is likely to become so within the foreseeable future.
In our final Species Report, additional data were available that allowed us to evaluate the stressor of vegetation management without using northern spotted owl habitat as a surrogate. Our final analysis relies instead on the recently released NWFP 20-year late-successional old-growth monitoring report (Davis
In contrast, several commenters asserted that private lands forestry practices are having a negative effect on fisher habitat, including the perspective that these forestry practices (primarily clearcutting) are the primary issue impacting fisher habitat. Two of these commenters specifically highlighted impacts in the Sierra Nevada, including one that presented photographs of habitat loss adjacent to Forest Service lands in the central Sierra Nevada area, and two others who discussed clearcutting concerns near Castle Crags State Park/Dunsmuir in California. Another commenter specifically stated that the practice of clearcutting is occurring on some private lands, and combined with herbicide application to prevent understory competition, is causing a lack of diversity with very few animals present in these areas.
While fishers may use a mosaic of habitat conditions that some level of younger industrial forests may provide at the landscape scale, the Washington FPR requirements for retaining older forest stands is limited to specific conditions such as no-cut retention buffers around streams and protection of specific wildlife sites. These retention areas may or may not be late-successional, depending on what forest stand exists at the time they are put in effect. Even if these stands are late-successional, or are allowed enough time to become late-successional, they occur on a substantially small part of the landscape compared to the heavily managed portion of industrial forest where little structure is likely to occur. Please see
We do not have information that indicates Federal agencies are implementing more regeneration harvest, and the commenter does not provide references or other sources to support this claim. To the contrary, and as noted in the final Species Report (Service 2016, pp. 60-62), timber harvest levels on Federal lands have dropped substantially over the past two and one half decades (Gale
We recognize that fuels treatments, when appropriately applied, may reduce habitat quality at the local scale in the short term to facilitate reducing the scale and severity of future fires in the landscape. We have added a section to our final Species Report titled Conservation Measures That May Reduce Impacts of Fire Effects that discusses some of the key fuels reduction programs being implemented on public lands within the analysis area. An analysis of impacts to groundwater from fuels treatments is outside the scope of this action.
On the other hand, many commenters claimed that there is an abundance of habitat throughout the fisher's range. Several asserted that there is substantial suitable habitat that benefits fishers on Federal lands (LSRs and other NWFP reserves) and outside of the NWFP area, including on private lands and public lands managed under the SNFPA (
While both the draft and final Species Reports document past and ongoing activities that contribute to habitat loss for fisher, we agree that there are large areas of apparently suitable but unoccupied habitat for fisher across
Regarding reduced timber activity since implementation of the NWFP, we note in our final Species Report the overall decline in timber harvest throughout the proposed DPS, not just the NWFP area, since 1990, acknowledging that the high rates of timber harvests that historically affected fishers has dramatically declined. However, we wish to clarify timber management is not limited to Matrix land use allocations under the NWFP. Timber management may occur within Riparian Reserves and late-successional reservess when it is consistent with Aquatic Conservation Strategy objectives and for the development and conservation of late-successional conditions, respectively.
We received multiple comments on fisher use of managed forests and have addressed this in our final Species Report (see our response to
We received numerous comments regarding our use of northern spotted owl habitat as a surrogate for fisher habitat and our assessment of the habitat loss stressor. We were able to utilize other datasets for our analysis in the final Species Report, and did not use northern spotted owl habitat as a surrogate; please see our responses to comments related to northern spotted owl habitat as a surrogate (
We received numerous comments on our quantitative calculations of scope and severity of stressors potentially impacting the proposed West Coast DPS of fisher (see explanation in
We based our assessment of future vegetation management upon the best available scientific and commercial information. As described in the draft Species Report, we considered habitat information completed by others and we used harvest rates over the past 10 years to provide reasonable projections of ongoing and future vegetation management (Service 2014, pp. 85-96). We also acknowledged that there is much variation in harvest rates by landowner and forest type, which lead to assumptions about the scope and severity of future vegetation management (Service 2014, pp. 92-95).
In our final Species Report, in response to peer review, public comment, and new information received during the comment period, we have again evaluated the potential impacts of vegetation management throughout the proposed West Coast DPS of fisher. New data that became available to us allowed us to estimate habitat recruitment throughout most of the analysis area, and address many of the concerns expressed by the commenter. Please also see our responses to
We agree with the State's characterization of the lands in southwestern Washington and the western coastal portions of the Olympic Peninsula, and we also agree that the habitat model likely overestimated the suitability of these landscapes for fishers. Although there was high environmental similarity, in terms of the variables used in the model, between this region and the region for which the model was developed, the relationship between the model variables and the landscape suitability for fishers apparently differs between the two regions (see also our responses to
Regarding differences between the habitat model used in the draft Species Report and the model presented by Lewis and Hayes (2004), as we noted in our response to
Regarding the use of resource selection functions derived from reintroduced fishers on the Olympic Peninsula, please see our response to
With regard to the evaluation of scope and severity of stressors, the habitat model was used only in the evaluation of habitat stressors related to wildfire and linear features. Furthermore, the final Species Report has been revised to emphasize qualitative analyses of these stressors, and the quantitative analyses that relied on the habitat model have been moved to Appendix C. Because the habitat model played such a limited role in the evaluation of stressors, especially in the final Species Report, any uncertainties inherent in the model results had little influence on our conclusions about the effects of the stressors.
We are unable to answer the commenter's question about comparisons between our fisher habitat model and the northern spotted owl habitat surrogate. The quantification of northern spotted owl habitat downgraded or removed on Federal lands was derived from a non-spatial database, so the locations of these areas of downgraded and removed habitat cannot be precisely identified in relation to the fisher habitat map. Furthermore, a variety of methods were initially used to identify the northern spotted owl habitat, including professional judgment by local biologists working in the area of each action. It is likely that most of these designations were made at the scale of a single forested stand or treatment unit, whereas our fisher habitat model was developed at the landscape scale. Even if we knew all of the methods used to designate northern spotted owl habitat and had all of the maps depicting the locations of the now-removed habitat, it would be inappropriate to compare the two directly, because of the difference in scales.
However, we have now developed other methods to determine how much fisher habitat has been altered by
We disagree with the commenter's characterization of our habitat model as “relying on canopy closure.” Although canopy cover was one component of the fisher habitat model used in the draft Species Report, it was not the only component, and it was only used in some of the modeling regions. In the expert models used for the Washington and Oregon Cascades, canopy cover was handled differently on the eastern and western sides of the Cascade Crest, in light of the more open forest conditions that prevail on the east side. The expert models also included a measure that was related to the likely presence of structures that fishers could use for denning and resting, and was not related to canopy cover.
The commenter is correct that the model does not, and is not intended to, predict the specific locations of forest structures needed by fishers, especially given that the model is useful on the landscape scale and not on the scale of individual trees. However, at least in regions where the expert model was used, it does incorporate the likely presence of these structures on the landscape into the assessment of fisher habitat suitability.
For more information, we encourage the commenter to read the updated white paper describing how the habitat model was developed (
We assume that one commenter misunderstood the content contained within Figures 8 and 9 of the draft Species Report. Figure 8 depicts all locality records (reliability ratings 1 through 6) prior to 1993. Figure 9 depicts a subset of these records for the time period between 1953 and 1993 for reliability ratings 1 through 4. Figure 9 is a subset of the data contained in Figure 8 and, therefore, contains fewer points than Figure 8. In our review, the data in these maps are valid and accurate.
The conservation value of some tribal lands for fisher, including the Makah Reservation, was described in the draft Species Report (Service 2014, pp. 127-128). Although recruitment of habitat (ingrowth) on non-Federal lands was not explicitly considered in our draft Species Report, the availability of the NWFP Monitoring Report mentioned above provided us with the data to estimate ingrowth over the past 20 years within that portion of the analysis area that overlaps with the NWFP (which covers most of the proposed West Coast DPS, with the exception of the Sierra Nevada and east of the Cascades). Also see our response to
The lack of scientific certainty regarding a species' range, status, or population trend is not a basis for listing a species under the Act. Although absolute certainty is not required, there must be sound scientific support for a listing decision. Per section 4 of the Act and its implementing regulations, we have carefully assessed the best scientific and commercial data available regarding the past, present, and future threats to the proposed West Coast DPS of the fisher, and we have determined that the threats we identified in the proposed rule are not now, and will not in the foreseeable future, act on the species in such a way that the fisher meets the definition of an endangered or a threatened species. Consequently, we are withdrawing our proposal to list this DPS (see Determination, above).
Similarly, another commenter asserted that the Service neglected to acknowledge what is known about fishers in the NCSO population/region, including overestimated impacts of stressors. This commenter also declared that the analysis of impacts to the NCSO population was arbitrary and capricious, citing numerous studies (
We also wish to correct the commenter's apparent presumption that the recent detection of a single fisher in the Middle Fork Willamette watershed is indicative of a population increase. We have no population estimates for the SOC population, and even if we did, this single sighting would not affect any existing estimate. Second, even without a population estimate, this sighting, while encouraging, is not necessarily indicative of a population expansion of the SOC. There has been little monitoring of the northern portion of this population to assess distribution; furthermore, in the late 1990s a dispersing juvenile male from the SOC population was radio-tracked to the Deschutes National Forest, roughly due east of the recent Middle Fork sighting but across the Cascade crest (Aubry and
As suggested by the commenter, in this document we have clarified that although all species experience stressors, we consider a stressor to rise to the level of a threat to the species (or in this case the DPS) if the magnitude, intensity, or imminence of the stressor is such that it is resulting in significant impacts at either the population or rangewide scales. As described in our proposed rule (79 FR 60419, p. 60427), in considering what stressors might constitute threats, we must look beyond the mere exposure of the DPS to the stressor to determine whether the DPS responds to the stressor in a way that causes actual negative impacts to the DPS. In our draft Species Report, as described above, we attempted to evaluate the magnitude of the effects of identified stressors by quantifying the severity and scope of those stressors. However, that analysis required us to make assumptions or extrapolate impacts in an effort to quantify stressors in areas where stressor-specific information was not available. Our presentation of the scope and severity of stressors in quantitative terms may have created a false sense of the level of scientific accuracy underlying these estimates. To avoid this perception, in our final Species Report we use a qualitative approach to describe stressors (
In our final determination, we specifically evaluated whether there were any indications that the identified stressors acting on the proposed DPS were resulting in any significant impacts at either the population or rangewide scales to fishers or their habitat. The best available data for the NCSO population were included in that assessment. We did not find any indication that the stressors are manifesting themselves to a significant degree across the proposed DPS such that there are significant impacts (
In sum, although we do not have sufficient information to substantiate the claim that the range of fisher is expanding, we do agree there is no evidence that suggests that the present range of fisher has diminished within the past few decades. This was one of the considerations we took into account as we conducted our final evaluation of all of the best scientific and commercial
In contrast, another commenter stressed that insufficient time has passed since the Stirling reintroduction (and other reintroductions) to assess whether fishers will continue to do well in managed forests given those forests are gradually converting to even-aged plantations.
In contrast, several other commenters believed that listing under the Act would increase funding for the Federal Government to combat illegal marijuana growers. Other commenters urged the Service to enact stronger penalties for illegal use of anticoagulant rodenticides and to provide more funding for eradication efforts. One commenter stated that the Service should encourage
The Service does not have the authority to regulate the sale or use of toxicants, including ARs.
We find that although individual fishers within three populations (
Alternatively, another commenter believed the threat from ARs was overstated in the draft Species Report and proposed rule, and that it was unprecedented for the Service to take such a minor threat and state that it was affecting the species on a population level. The commenter stated that only 58 fishers total have been impacted by ARs per the draft Species Report, and added that pesticides in general are so ubiquitous in our environment that they would even be found in human livers.
In reference to the potential effects of ARs on fisher prey, Wengert (2015, pers. comm.) reports that rodent diversity is reduced to only mice at marijuana cultivation sites that are treated with rodenticides, as compared to nearby untreated sites where large-bodied rodents (
With regard to the second commenter's assertions, Gabriel
Overall, the best available information at this time does not support concluding that the impacts described herein rise to the level of a threat, based on the insufficient evidence that ARs or other toxicants are resulting in significant impacts at either the population or rangewide scales (see
We have reviewed the best scientific and commercial information available, including new information received, which enabled us to provide clarity and corrections in the final Species Report (Service 2016, pp. 141-159) to some information that was presented in the draft Species Report (Service 2014, pp. 152-169). Two fisher carcasses from Oregon have been tested for rodenticides, of which both tested positive, and only three fishers can be confidently documented to have been exposed in Washington. Insufficient information exists regarding the extent of AR exposure in Washington and Oregon, and no rangewide studies have occurred to evaluate the population-level impacts across the fisher's range in the west coast States. We note the lack of information rangewide regarding potential sublethal effects of ARs to fishers within the proposed West Coast DPS. Therefore, the best available information does not support concluding that these impacts rise to the level of a threat, based on the insufficient evidence that ARs are having significant impacts at either the population or rangewide scales.
We have reviewed the best scientific and commercial information available, including new information received, which enabled us to provide clarity and corrections in the final Species Report (Service 2016, pp. 141-159) to some information that was presented in the draft Species Report (Service 2014, pp. 152-169). Two fisher carcasses from Oregon have been tested for rodenticides, of which both tested positive, and only three fishers can be confidently documented to have been exposed in Washington. Insufficient information exists regarding the extent of AR exposure in Washington and Oregon, and no rangewide studies have occurred to evaluate the population-level impacts across the fisher's range in the west coast States. We also note a lack of information rangewide regarding potential sublethal effects of ARs to fishers within the proposed West Coast DPS. Therefore, at this time the best available information does not support concluding that these impacts rise to the level of a threat, based on the insufficient evidence that ARs are having significant impacts at either the population or rangewide scales (see
The extent to which the legal use of ARs occurs at agricultural and commercial sites within the range of the fisher is unknown. Two fisher carcasses from Oregon have been tested for rodenticides, of which both tested positive, and only three fishers can be confidently documented to have been exposed in Washington. None of these were in the vicinity of a known marijuana grow site, and the Washington fishers were found near rural areas where rodenticides could have been used legally on private land. While the State of California in 2014 prohibited the sale of the second generation ARs (brodifacoum, bromadiolone, difethialone, and difenacoum) to the general public, they are still widely available in California and can be purchased by anyone with a State-issued pesticide applicator's license. No records are kept on the sale and use of rodenticides that can be used to determine whether this new measure will reduce the illegal and legal uses of the second generation ARs within the range of the fisher. We also note the lack of information rangewide regarding potential sublethal effects of ARs to fishers within the proposed West Coast DPS. No rangewide studies have occurred to evaluate the population-level impacts across the fisher's range in the west coast States. Therefore, the best available information does not support concluding that these impacts rise to the level of a threat, based on the insufficient evidence that ARs are having significant impacts at either the population or rangewide scales (see
The fishers tested by Gabriel
We do note that the special local need label for Rozol pellets requires application designed to reduce the exposure of the product to nontarget species such as fisher (
Regarding our description of the size of the NCSO population in the draft Species Report, we agree that the lower estimate of 258 is calculated from an effective population size based on genetic data. We include this information to represent the best scientific and commercial data available and to indicate the breadth of the range of values available to us on which to base our listing decision. We also have revised our final Species Report to include new population estimate values (Service 2016, pp. 42-48). We realize the remaining references do not come from peer-reviewed literature, but again, this is the best available information, which the Act requires us to use in making our listing decision.
We have carefully assessed the best scientific and commercial data available regarding the past, present, and future threats to the proposed West Coast DPS of the fisher and are withdrawing our proposal to list this DPS (see Determination, above). We reached this conclusion in part because we have no evidence to suggest that any of the potential stressors are having significant impacts at either the population or rangewide scales (see Summary of Factors Affecting the Species, above).
In contrast, several commenters declare that the analysis of stressors in the proposed rule and draft Species Report overestimated actual impacts. One commenter asserted that the Service's threats analysis overestimated the level of impact specifically in the southern Oregon and northern California region. Another commenter claimed that the three primary threats identified by the Service (habitat loss, toxicants, and cumulative and synergistic effects) are diminishing
Alternatively, two other commenters stated that the severity of trapping is low and agreed with our assessment. One commenter asserted that trapping prohibitions have sufficiently reduced the effects of trapping as a stressor. The other commenter, a tribe in Washington, indicated that the threat of trapping is largely nonexistent in Washington (and specifically for the reintroduced population) because leg-hold and kill traps are not legal for use in Washington for general hunting/trapping. Although tribes can still authorize trapping for fur-bearers, they suggested that it is regulated appropriately and has low participation.
In contrast, multiple commenters stated that wildfire is not a significant issue or threat. One commenter stated that (in California) fewer acreage has burned in the past 5 years as compared to the previous 5 years, those fires that do occur are mostly a mosaic of high- and low-intensity burns, and the fires create more fisher habitat (
Fires over the last 5 years (2010 through 2014) in California did burn fewer acres than in the previous 5 years (2005 through 2009); however, extreme fire activity in 2008 was responsible for a large majority of acres burned. A more appropriate comparison would be to view a given year against a 5-year average to determine whether fire activity has increased or decreased. For example, California wildfires burned approximately 308,000 acres in 2015 (
Fire can have either a negative or positive effect on fisher habitat, depending on the specifics of the situation; many variables enter into the final outcome with respect to potential habitat suitability for fisher, and additionally the post-fire landscape may vary in suitability for fishers depending on the aspect of fisher life history under consideration (
• One commenter asserted fire is not a significant threat overall, and stated there is no sound science for the assumption in Naney
• A second commenter stated that the Service fails to attribute the benefits of fire absent fire suppression. Specifically, the commenter stated that, while firebreaks and back-burning may be necessary to stop wildfires, and undeniably inflict impacts that would not accrue absent fire, such practices are, in almost all circumstances, designed to prevent a fire from growing even larger. The commenter suggested that the Service calculate the difference between acres burned and acres projected to burn absent wildfire suppression, and derive a net anthropogenic conservation benefit. The commenter believed that this additional analysis should account for fire management regimes, and explicitly contrast the fire suppression strategies of the ODF against those of the Forest Service. Absent this calculus, the commenter declared the Service's wildfire suppression discussion is meaningless.
• The third commenter questions our reference to Powell and Zielinski (1994, p. 64) for the hypothesis that fishers evolved in forests subject to fires, thus suggesting that management should mimic small, stand-replacing fires. The commenter noted that fishers also evolved in forests with large stand-replacing fires, so by this same logic, burned forests should not have a detrimental effect on fisher survival, even absent high quantities of late-successional conifer forest.
The second commenter suggested that the final Species Report should account for the fact that fire suppression activities would not occur but for a wildfire event. Fire suppression activities are a part of normal fire-fighting activities and occur within fisher habitat. To the extent that fire suppression activities have the potential to impact fisher habitat, we have included a discussion of this stressor in the final Species Report. The additional calculation, and subsequent analysis, suggested by the commenter is outside the scope of this final rulemaking process.
While the logic posed by the third commenter is convincing, there is evidence suggesting that in some areas the frequency and size of wildfires appears to be increasing, which has the potential to alter fisher habitat at rates more rapidly than historically. We acknowledge that fishers utilize burned forest and are not obligate users of late-successional forests; we have also incorporated additional discussion of historical fire regimes in forests inhabited by fishers in the west coast States in our final Species Report. Please also see our responses to
A complete list of all references cited in this document is available on the Internet at
The primary authors of this document are the staff members of the Pacific Southwest Regional Office, Pacific Regional Office, and Yreka Fish and Wildlife Office (see
The authority for this action is the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Environmental Protection Agency (EPA).
Notice of proposed rulemaking.
Pursuant to the U.S. Environmental Protection Agency's (EPA) Significant New Alternatives Policy program, this action proposes to list a number of substances as
Comments must be received on or before June 2, 2016. Any party requesting a public hearing must notify the contact listed below under
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0663, to the
Chenise Farquharson, Stratospheric Protection Division, Office of Atmospheric Programs (Mail Code 6205 T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460; telephone number: 202-564-7768; email address:
Under section 612 of the Clean Air Act (CAA), EPA is required to evaluate substitutes
In the decades since ODS were first invented in the 1920s, American consumers relied on products using ODS for diverse uses including aerosols, air conditioning, insulation, solvent cleaning, and fire protection. The agreement by governments to phase out production of ODS under the
Over the past twenty years, the SNAP program has played an important role in assisting with a continuous smooth transition to safer alternatives, by addressing in concrete and highly technical terms, end-use by end-use, these myriad issues. From the first SNAP framework rule published in 1994, which provided confidence and certainty by identifying safer alternatives in key consumer and industrial uses, the SNAP program has continued to ensure that businesses and consumers have access to information about suitable alternatives. The SNAP program works with many stakeholders, domestically and abroad, to continuously evaluate and provide updates on safer alternatives and new technologies. Thanks to these efforts and the work of individuals, businesses, and organizations, the transitions generally have been successful. Perhaps the best evidence of the program's success has been the lack of fanfare with which so many important consumer and industrial uses have moved to adopt safer SNAP-listed alternatives. When reviewing a substitute, EPA compares the risk posed by that substitute to the risks posed by other alternatives and determines whether that specific substitute under review poses significantly more risk than other alternatives for the same use. EPA recently has begun to review the lists in a broader manner to determine whether substitutes added to the lists early in the program pose significantly more risk than substitutes that have more recently been added. As with initial listing decisions, decisions to change the status of an already listed alternative are based on applying our comparative risk framework.
Global warming potential (GWP) is one of several criteria EPA considers in the overall evaluation of the alternatives under the SNAP program. The President's June 2013 Climate Action Plan (CAP)
In this action, EPA is proposing to list a number of substances as acceptable, subject to use restrictions; to list several substances as unacceptable; and to modify the listing status for certain substances from acceptable to unacceptable. We performed a comparative risk analysis, based on our criteria for review, with other alternatives for the relevant end-uses. For particular substances, EPA found significant potential differences in risk with respect to one or more specific criteria, such as flammability, toxicity, or local air quality concerns, while otherwise posing comparable levels of risk to those of other alternatives in specific end-uses. EPA is also proposing that the existing listing decisions for foam blowing agents apply to closed cell foam products and products containing closed cell foam. See section VI.C.4 for the details of this proposal. Additionally, EPA is proposing to list propane (R-290) as acceptable, subject to use conditions, as a refrigerant in new self-contained commercial ice machines, in new water coolers, and in new very low temperature refrigeration equipment. EPA is proposing to exempt propane in these end-uses from the venting prohibition under CAA section 608(c)(2). See section VI.A.2.a, “What is EPA's proposal regarding whether venting of propane in the end-uses in this action would pose a threat to the environment?” for the details of this proposal.
Per the guiding principles of the SNAP program, this action does not specify that any alternative is acceptable or unacceptable across all sectors and end-uses. Instead, in all cases, EPA considered the intersection between the specific alternative and the particular end-use and the availability of substitutes for those particular end-uses. In the case of refrigeration and air conditioning (AC), we consider new equipment to be a separate end-use from retrofitting existing equipment with a different refrigerant from that for which the equipment was originally designed. EPA is not setting a “risk threshold” for any specific SNAP criterion, such that the only acceptable substitutes pose risk
(1) For refrigeration, we are proposing to list as acceptable, subject to use conditions, as of 30 days after publication of a final rule
• Propane in new commercial ice machines, new water coolers, and new very low temperature refrigeration equipment.
(2) For motor vehicle air conditioning (MVAC) systems, we are proposing to list, as acceptable, subject to use conditions, as of 30 days after publication of a final rule
• HFO-1234yf in newly manufactured medium-duty passenger vehicles (MDPVs), heavy-duty (HD) pickup trucks, and complete HD vans.
(3) For fire suppression and explosion protection end-uses, we are proposing to list as acceptable, subject to use conditions, as of 30 days after publication of a final rule
• 2-BTP as a total flooding agent for use in engine nacelles and auxiliary power units (APUs) on aircraft; and
• 2-BTP as a streaming agent for use in handheld extinguishers in aircraft.
(1) For retrofit residential and light commercial AC and heat pumps—unitary split AC systems and heat pumps, we are proposing to list as unacceptable, as of 30 days after publication of a final rule
• All refrigerants identified as flammability Class 3 in American National Standards Institute (ANSI)/American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) Standard 34-2013; and
• All refrigerants meeting the criteria for flammability Class 3 in ANSI/ASHRAE Standard 34-2013. These include, but are not limited to, refrigerant products sold under the names R-22a, 22a, Blue Sky 22a refrigerant, Coolant Express 22a, DURACOOL-22a, EC-22, Ecofreeeze EF-22a, EF-22a, Envirosafe 22a, ES-22a, Frost 22a, HC-22a, Maxi-Fridge, MX-22a, Oz-Chill 22a, Priority Cool, and RED TEK 22a.
(2) For new residential and light commercial AC and heat pumps, cold storage warehouses, centrifugal chillers, and positive displacement chillers, we are proposing to list as unacceptable, as of 30 days after publication of a final rule
• Propylene and R-443A.
(1) For new centrifugal chillers, we are proposing to list as unacceptable, except as otherwise allowed under a narrowed use limit, as of January 1, 2024
• FOR12A, FOR12B, HFC-134a, HFC-227ea, HFC-236fa, HFC-245fa, R-125/134a/600a (28.1/70/1.9), R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-423A, R-424A, R-434A, R-438A, R-507A, RS-44 (2003 composition), and THR-03.
(2) For new positive displacement chillers, we are proposing to list as unacceptable, except as otherwise allowed under a narrowed use limit, as of January 1, 2024
• FOR12A, FOR12B, HFC-134a, HFC-227ea, KDD6, R-125/134a/600a (28.1/70/1.9), R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-424A, R-434A, R-437A, R-438A, R-507A, RS-44 (2003 composition), SP34E, and THR-03.
(3) For new centrifugal chillers, we are proposing to list as acceptable, subject to narrowed use limits, as of January 1, 2024
• HFC-134a for military marine vessels and HFC-134a and R-404A for human-rated spacecraft and related support equipment
(4) For new positive displacement chillers, we are proposing to list as acceptable, subject to narrowed use limits, as of January 1, 2024
• HFC-134a for military marine vessels and HFC-134a and R-404A for human-rated spacecraft and related support equipment
(5) For new cold storage warehouses, we are proposing to list as unacceptable, as of January 1, 2023
• HFC-227ea, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-423A, R-424A, R-428A, R-434A, R-438A, R-507A, and RS-44 (2003 composition).
(6) For new retail food refrigeration (refrigerated food processing and dispensing equipment), we are proposing to list as unacceptable, as of January 1, 2021
• HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-44 (2003 formulation).
(7) For new household refrigerators and freezers, we are proposing to list as unacceptable, as of January 1, 2021
• FOR12A, FOR12B, HFC-134a, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, and THR-03.
(8) For rigid polyurethane (PU) high-pressure two-component spray foam, we are proposing to list as unacceptable for all uses, except military or space- and aeronautics-related applications, as of January 1, 2020; as acceptable, subject to narrowed use limits, for military or space- and aeronautics-related applications, as of January 1, 2020; and as unacceptable for military or space- and aeronautics-related applications as of January 1, 2025
• HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa, and commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and Formacel TI.
(9) For rigid PU low-pressure two-component spray foam, we are proposing to list as unacceptable for all uses, except military or space- aeronautics-related applications, as of January 1, 2021; as acceptable, subject to narrowed use limits, for military or space- aeronautics-related applications,
• HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa, and commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and Formacel TI.
(10) For rigid PU one-component foam sealants, we are proposing to list as unacceptable, as of January 1, 2020
• HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa, and commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and Formacel TI.
(11) For all foam blowing end-uses except for rigid PU spray foam, we are proposing for all HFCs and HFC blends previously listed as unacceptable for space- aeronautics-related applications as of January 1, 2022 that
• These HFCs and HFC blends would be unacceptable for space- aeronautics-related applications as of January 1, 2025.
(12) For flexible PU foam applications, we are proposing to list as unacceptable, as of 30 days after publication of a final rule
• Methylene chloride.
(13) For integral skin PU foam applications, we are proposing to list as unacceptable, as of January 1, 2017
• Methylene chloride.
(14) For polyolefin foam applications, we are proposing to list as unacceptable, as of January 1, 2020
• Methylene chloride.
(15) For fire suppression total flooding uses, we are proposing to list as unacceptable, as of one year after publication of a final rule
• Perfluorocarbons (PFCs) (C
(1) For all foam blowing end-uses, we are proposing to prohibit
• Use of closed cell foam products and products that contain closed cell foam manufactured with an unacceptable foam blowing agent on or after the later of (1) one year after publication of a final rule or (2) the date of the unacceptability listing.
(2) For fire suppression and explosion protection total flooding end-use, we are proposing to clarify the listing for Powdered Aerosol D (Stat-X®), which is currently listed as both “acceptable” and “acceptable subject to use conditions,” by removing the listing as “acceptable subject to use conditions,” as of 30 days after publication of a final rule.
Potential entities that may be affected by this proposed rule include:
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be regulated by this action. This table lists the types of entities that EPA is now aware could potentially be regulated by this action. Other types of entities not listed in the table could also be regulated. To determine whether your entity is regulated by this action, you should carefully examine the applicability criteria found in 40 CFR part 82. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the
Below is a list of acronyms and abbreviations used in the preamble of this document:
CAA section 612 requires EPA to develop a program for evaluating alternatives to ODS. This program is known as the SNAP program. The major provisions of section 612 are:
Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I (chlorofluorocarbon (CFC), halon, carbon tetrachloride, methyl chloroform, methyl bromide, hydrobromofluorocarbon (HBFC), and chlorobromomethane) or class II hydrochlorofluorocarbon (HCFC)) substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment and (2) is currently or potentially available.
Section 612(c) requires EPA to publish a list of the substitutes that it finds to be unacceptable for specific uses and to publish a corresponding list of acceptable substitutes for specific uses. The list of “acceptable” substitutes is found at
Section 612(d) grants the right to any person to petition EPA to add a substance to, or delete a substance from, the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.
Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.
Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.
Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.
On March 18, 1994, EPA published the initial SNAP rule (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in major industrial use sectors (40 CFR part 82 subpart G). These sectors include the following: Refrigeration and AC; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.
Under the SNAP regulations, anyone who produces a substitute to replace a class I or II ODS in one of the eight major industrial use sectors listed above must provide the Agency with notice and the required health and safety information on the substitute at least 90 days before introducing it into interstate commerce for significant new use as an alternative. 40 CFR 82.176(a). While this requirement typically applies to chemical manufacturers as the person likely to be planning to introduce the substitute into interstate commerce,
The Agency has identified four possible decision categories for substitute submissions: Acceptable; acceptable, subject to use conditions; acceptable, subject to narrowed use limits; and unacceptable.
After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to ensure risks to human health and the environment are not significantly greater than other substitutes. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of CAA section 612 and EPA's SNAP regulations. 40 CFR 82.174(c).
For some substitutes, the Agency may permit a narrow range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. The Agency generally requires a user of a substitute subject to narrowed use limits to demonstrate that no other acceptable substitutes are available for their specific application.
The section 612 mandate for EPA to prohibit the use of a substitute that may present risk to human health or the environment where a lower risk alternative is available or potentially available
In contrast, EPA publishes “notices of acceptability” to notify the public of substitutes that are deemed acceptable with no restrictions. As described in the preamble to the rule initially implementing the SNAP program (59 FR 13044; March 18, 1994), EPA does not believe that rulemaking procedures are necessary to list substitutes that are acceptable without restrictions because such listings neither impose any sanction nor prevent anyone from using a substitute.
Many SNAP listings include “comments” or “further information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs (
The seven guiding principles of the SNAP program, elaborated in the preamble to the initial SNAP rule and consistent with section 612, are discussed below.
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The SNAP program evaluates the risk of alternative compounds compared to available or potentially available substitutes to the ozone depleting compounds which they are intended to replace. The risk factors that are considered include ozone depletion potential (ODP) as well as flammability, toxicity, occupational health and safety, and contributions to climate change and other environmental factors.
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Substitutes found to be acceptable must not pose significantly greater risk than other substitutes, but they do not have to be risk free. A key goal of the SNAP program is to promote the use of substitutes that minimize risks to human health and the environment relative to other alternatives. In some cases, this approach may involve designating a substitute acceptable even though the compound may pose a risk of some type, provided its use does not pose significantly greater risk than other alternatives.
•
EPA does not intend to restrict a substitute if it has only marginally greater risk. Drawing fine distinctions would be extremely difficult. The Agency also does not want to intercede in the market's choice of substitutes by listing as unacceptable all but one substitute for each end-use, and does not intend to restrict substitutes on the market unless a substitute has been proposed or is being used that is clearly more harmful to human health or the environment than other alternatives.
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Central to SNAP's evaluations is the intersection between the characteristics of the substitute itself and its specific end-use application. Section 612 requires that substitutes be evaluated by use. Environmental and human health exposures can vary significantly depending on the particular application of a substitute. Thus, the risk characterizations must be designed to represent differences in the environmental and human health effects associated with diverse uses. This approach cannot, however, imply fundamental tradeoffs with respect to different types of risk to either the environment or to human health.
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The Agency recognizes the need to provide the regulated community with information on the acceptability of various substitutes as soon as possible. To do so, EPA issues notices or determinations of acceptability and rules identifying substitutes as unacceptable; acceptable, subject to use conditions; or acceptable, subject to narrowed use limits, in the
•
The Agency does not issue company-specific product endorsements. In many cases, the Agency may base its analysis on data received on individual products, but the addition of a substitute to the acceptable list based on that analysis does not represent an endorsement of that company's products.
•
In some cases, EPA and other federal agencies have developed extensive regulations under other sections of the CAA or other statutes that address potential environmental or human health effects that may result from the use of alternatives to class I and class II substances. For example, use of some substitutes may in some cases entail increased use of chemicals that contribute to tropospheric air pollution. The SNAP program takes existing regulations under other programs into account when reviewing substitutes.
EPA applies the same criteria for determining whether a substitute is acceptable or unacceptable. These criteria, which can be found at § 82.180(a)(7), include atmospheric effects and related health and environmental effects, ecosystem risks, consumer risks, flammability, and cost and availability of the substitute. To enable EPA to assess these criteria, we require submitters to include various information including ODP, GWP, toxicity, flammability, and the potential for human exposure.
When evaluating potential substitutes, EPA evaluates these criteria in the following groupings:
•
•
(1) Releases in the workplace and in homes;
(2) Releases to ambient air and surface water;
(3) Releases from the management of solid wastes.
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(1) Permissible Exposure Limits (PELs) for occupational exposure;
(2) Inhalation reference concentrations (RfCs) for non-carcinogenic effects on the general population;
(3) Cancer slope factors for carcinogenic risk to members of the general population.
When considering risks in the workplace, if OSHA has not issued a PEL for a compound, EPA then considers Recommended Exposure Limits from the National Institute for Occupational Safety and Health (NIOSH), Workplace Environmental Exposure Limits (WEELs) set by the American Industrial Hygiene Association (AIHA), or threshold limit values (TLVs) set by the American Conference of Governmental Industrial Hygienists (ACGIH). If limits for occupational exposure or exposure to the general population are not already established, then EPA derives these values following the Agency's peer reviewed guidelines. Exposure information is combined with toxicity information to explore any basis for concern. Toxicity data are used with existing EPA guidelines to develop health-based limits for interim use in these risk characterizations.
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(1) Flash point and flammability limits (
(2) Data on testing of blends with flammable components;
(3) Test data on flammability in consumer applications conducted by independent laboratories; and
(4) Information on flammability risk mitigation techniques.
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EPA's consideration of cost in listing decisions is limited to evaluating the cost of the substitute under review pursuant to section 82.180(a)(7)(vii). This is distinct from consideration of costs associated with the use of other alternatives to which the substitute is being compared.
Over the past twenty years, the menu of substitutes has become much broader and a great deal of new information has been developed on many substitutes. Because the overall goal of the SNAP program is to ensure that substitutes listed as acceptable do not pose significantly greater risk to human health and the environment than other substitutes, the SNAP criteria continue to be informed by our current overall understanding of environmental and human health impacts and our experience with and current knowledge about alternatives. Over time, the range of substitutes reviewed by SNAP has changed, and, at the same time, scientific approaches have evolved to more accurately assess the potential environmental and human health impacts of these chemicals and alternative technologies.
Three mechanisms exist for modifying the list of SNAP determinations. First, under section 612(d), the Agency must review and either grant or deny petitions to add or delete substances from the SNAP list of acceptable or unacceptable substitutes. That provision allows any person to petition the Administrator to add a substance to the list of acceptable or unacceptable substitutes or to remove a substance from either list. The second means is through the notifications which must be submitted to EPA 90 days before introduction of a substitute into interstate commerce for significant new use as an alternative to a class I or class II substance. These 90-day notifications are required by CAA section 612(e) for
Finally, since the inception of the SNAP program, we have interpreted the section 612 mandate to find substitutes acceptable or unacceptable to include the authority to act on our own to add or remove a substance from the SNAP lists (59 FR 13044, 13047; March 18, 1994). In determining whether to add or remove a substance from the SNAP lists, we consider whether there are other alternatives that pose lower overall risk to human health and the environment. In determining whether to modify a listing of a substitute we undertake the same consideration, but do so in the light of new data that may not have been available at the time of our original listing decision, including information on substitutes that were not included in our comparative review at the time of our initial listing decision and new information on substitutes previously reviewed.
As described in this document and elsewhere, including in the initial SNAP rule published in the
It has now been over twenty years since the initial SNAP rule was promulgated. When the SNAP program began, the number of substitutes available for consideration was, for many end-uses, somewhat limited. Thus, while the SNAP program's initial comparative assessments of overall risk to human health and the environment were rigorous, often there were few substitutes upon which to apply the comparative assessment. The immediacy of the class I phaseout often meant that EPA listed class II ODS (
Since EPA issued the initial SNAP rule in 1994, the Agency has issued 20 rules and 30 notices that generally expand the menu of options for the various SNAP sectors and end-uses. Thus, comparisons today apply to a broader range of alternatives—both chemical and non-chemical—than at the inception of the SNAP program. Industry experience with these substitutes has also grown during the history of the program.
In addition to an expanding menu of substitutes, developments over the past 20 years have improved our understanding of global environmental issues. With regard to that information, our review of substitutes in this proposed rule includes comparative assessments that consider our evolving understanding of a variety of factors. For example, GWPs and climate effects are not new elements in our evaluation framework, but as is the case with all of our review criteria, the amount of information has expanded and the quality has improved.
To the extent possible, EPA's ongoing management of the SNAP program considers new information, including new substitutes, and improved understanding of the risk to the environment and human health. EPA previously has taken several actions revising listing determinations from acceptable or acceptable with use conditions to unacceptable. On January 26, 1999, EPA listed the refrigerant blend known by the trade name MT-31 as unacceptable for all refrigeration and AC end-uses for which EPA had previously listed this blend as an acceptable substitute (62 FR 30275; June 3, 1997). EPA based this decision on new information about the toxicity of one of the chemicals in the blend.
Another example of EPA revising a listing determination occurred in 2007, when EPA listed HCFC-22 and HCFC-142b as unacceptable for use in the foam sector (72 FR 14432; March 28, 2007). These HCFCs, which are ozone depleting and subject to a global production phaseout, were initially listed as acceptable substitutes since they had a lower ODP than the substances they were replacing and there were no other alternatives that posed lower overall risk at the time of EPA's listing decision. HCFCs offered a path forward for some sectors and end-uses at a time when the number of substitutes was far more limited. In light of the expanded availability of other alternatives with lower overall risk to human health and the environment in specific foam end-uses, and taking into account the 2010 class II ODS phase-down step, EPA changed the listing for these HCFCs in relevant end-uses from acceptable to unacceptable. In that rule, EPA noted that continued use of these HCFCs would contribute to unnecessary depletion of the ozone layer and delay the transition to substitutes that pose lower overall risk to human health and the environment. EPA established a change of status date that recognized that existing users needed time to adjust their manufacturing processes to safely accommodate the use of other substitutes.
In a final rule published on July 20, 2015 (80 FR 42870), various HFCs and HFC-containing blends that were previously listed as acceptable under the SNAP program were listed as unacceptable in various end-uses in the aerosols, foam blowing, and refrigeration and AC sectors where there are other alternatives that pose lower overall risk to human health and the environment for specific uses. The July 2015 rule also changed the status from acceptable to unacceptable for certain HCFCs being phased out of production under the Montreal Protocol and CAA section 605(a). Per the guiding principles of the SNAP program, the July 2015 rule did not specify that any HFCs or HCFCs are unacceptable across all sectors and end-uses. Instead, in all cases, EPA considered the intersection between the specific substitute and the particular end-use and the availability of substitutes for those particular end-uses when making its determinations.
For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Web site at
GWP is one of several criteria EPA considers in the overall evaluation of alternatives under the SNAP program. During the past two decades, the general science on climate change and the potential contributions of greenhouse gases (GHGs) such as HFCs to climate change have become better understood.
On December 7, 2009, at 74 FR 66496, the Administrator issued an endangerment finding determining that, for purposes of CAA section 202(a), the current and projected concentrations of the six key well-mixed greenhouse gases in the atmosphere—CO
Like the ODS they replace, HFCs are potent GHGs.
Annual global emissions of HFCs are projected to rise to about 6.4 to 9.9 gigatons of CO
PFCs are potent GHGs and have very long atmospheric lifetimes. PFCs are produced as a byproduct of various industrial processes associated with aluminum production and the manufacturing of semiconductors, then captured for intentional use or manufactured for use in various industrial applications. PFCs have had limited use in the eight sectors regulated under SNAP. This action includes status change proposals for certain PFCs in fire suppression total flooding and streaming uses.
EPA recently received two petitions requesting EPA to modify certain acceptability listings of high-GWP substances in various end-uses. The petitions were both submitted on October 6, 2015. The first was submitted by the Natural Resource Defense Council (NRDC) and the Institute for Governance and Sustainable Development (IGSD) and the second by the Environmental Investigation Agency (EIA).
The NRDC and IGSD petition requests that EPA change the listing status of certain high-GWP chemicals they believe are used most frequently in the United States in various end-uses in the refrigeration and AC, foam blowing, and fire suppression and explosion protection sectors. The EIA petition requests that EPA list additional high-GWP HFCs as unacceptable or acceptable, subject to use restrictions, in a number of end-uses in the refrigeration and AC, and fire suppression and explosion protection sectors. EIA requests that the schedule for changing the status of the substances listed in their petition be based on a three tiered approach: (1) January 1, 2017, or one year following the passage of a final rule for SF
Parts of two other previously submitted SNAP petitions that EPA found to be incomplete are also relevant to this rulemaking. In a petition EIA submitted to EPA on April 26, 2012, EIA stated that, “in light of the comparative nature of the SNAP program's evaluation of substitutes and given that other acceptable substitutes are on the market or soon to be available,” EPA should “remove HFC-134a and HFC-134a blends from the list of acceptable substitutes for any ozone depleting substance in any non-essential uses under EPA's SNAP program.” Additionally, NRDC, EIA, and IGSD filed a petition on April 27, 2012, requesting that EPA remove HFC-134a from the list of acceptable substitutes in household refrigerators and freezers, and stand-alone retail food refrigerators and freezers, among other things. On August 7, 2013, EPA found both petitions to be incomplete.
This action is consistent with a provision in the President's CAP announced June 2013:
Moving forward, the Environmental Protection Agency will use its authority through the Significant New Alternatives Policy Program to encourage private sector investment in low-emissions technology by identifying and approving climate-friendly chemicals while prohibiting certain uses of the most harmful chemical alternatives.
The CAP further states: “to reduce emissions of HFCs, the United States can and will lead both through international diplomacy as well as domestic actions.” This proposed rule is also consistent with that call for leadership through domestic actions. As regards international leadership, for the past six years, the United States, Canada, and Mexico have proposed an amendment to the Montreal Protocol to phase down the production and consumption of HFCs. Global benefits of the amendment proposal are estimated to yield significant reductions in emissions of over 90 GtCO
This action also addresses certain aspects of the various petitions referred to above in section IV.A. While the two recent petitions have not been found complete and earlier petitions have been found incomplete, EPA possesses sufficient information to propose action on some of the end-uses covered by the petitions. EPA's action is responsive to certain aspects of the petitions that relate to the refrigeration and AC, foam blowing, and fire suppression and explosion protection sectors; EPA is proposing to change the listing from acceptable to unacceptable for:
• HFC-134a in new centrifugal chillers, new positive displacement chillers, new household refrigerators and freezers, and rigid PU spray foam;
• R-404A, R-410A, R-410B, and R-507A in new centrifugal chillers, new positive displacement chillers, new household refrigerators and freezers, and new cold storage warehouses;
• R-407A in new cold storage warehouses;
• R-421A, R-422B, R-422C, R-422D, R-424A, and R-434A in new centrifugal chillers and new positive displacement chillers;
• HFC-227ea in new cold storage warehouses, new centrifugal chillers, and new positive displacement chillers;
• HFC-245fa, HFC-365mfc, and HFC-227ea in rigid PU spray foam;
• HFC-245fa and HFC-227ea in new centrifugal chillers and new positive displacement chillers;
• PFCs (
• a number of refrigerant blends with higher GWPs in certain new refrigeration and AC equipment.
EPA is also requesting comment and updated information on total flooding uses of SF
Throughout the process of our discussions with the regulated community, we have sought to convey our continued understanding of the role that certainty plays in enabling the robust development and uptake of alternatives. As noted above, some of the key strengths of the SNAP program, such as its substance and end-use specific consideration, its multi-criteria basis for action, and its petition process, tend to militate against measures some have advocated could provide more certainty, such as setting specific numerical criteria for environmental evaluations (
The statutory requirements concerning venting, release, or disposal of refrigerants and refrigerant substitutes are under CAA section 608, and EPA's authority to promulgate the regulatory revisions in this action is based in part on CAA section 608. Section 608 of the Act as amended, titled
Section 608(c)(1) further exempts from this self-effectuating prohibition
Section 608(c)(2) extends the prohibition in section 608(c)(1) to knowingly venting or otherwise knowingly releasing or disposing of any refrigerant substitute for class I or class II substances by any person maintaining, servicing, repairing, or disposing of appliances or IPR. This prohibition applies to any substitute unless the Administrator determines that such venting, releasing, or disposing does not pose a threat to the
Regulations promulgated under CAA section 608, published on May 14, 1993 (58 FR 28660), established a recycling program for ozone-depleting refrigerants recovered during the servicing and maintenance of refrigeration and AC appliances. In the same 1993 rule, EPA also promulgated regulations implementing the section 608(c) prohibition on knowingly venting, releasing, or disposing of class I or class II controlled substances. These regulations were designed to substantially reduce the use and emissions of ozone-depleting refrigerants.
EPA issued a final rule on March 12, 2004 (69 FR 11946) and a second rule on April 13, 2005 (70 FR 19273) clarifying how the venting prohibition in section 608(c) applies to substitutes for CFC and HCFC refrigerants (
As explained in an earlier EPA rulemaking concerning refrigerant substitutes, EPA has not promulgated regulations requiring certification of refrigerant recycling/recovery equipment intended for use with substitutes to date (70 FR 19275; April 13, 2005). The Agency has recently proposed, but not yet finalized, regulations to address certification of such equipment used to recover and/or recycle refrigerants that are not exempt from the venting prohibition (80 FR 69458; November 9, 2015). However, as EPA has noted, the lack of a current regulatory provision should not be considered as an exemption from the venting prohibition for substitutes that are not expressly exempted in § 82.154(a) (80 FR 69466, 69478). EPA has also noted that, in accordance with section 608(c) of the Act, the regulatory prohibition at § 82.154(a) reflects the statutory references to
On May 23, 2014 (79 FR 29682), EPA exempted from the venting prohibition three HC refrigerant substitutes listed as acceptable, subject to use conditions, in the specified end-uses: Isobutane and R-441A, as refrigerant substitutes in household refrigerators, freezers, and combination refrigerators and freezers; and propane as a refrigerant substitute in retail food refrigerators and freezers (stand-alone units only). Similarly, on April 10, 2015 (80 FR 19453), EPA exempted from the venting prohibition four HC refrigerant substitutes listed as acceptable, subject to use conditions, in the specified end-uses: Isobutane and R-441A, in retail food refrigerators and freezers (stand-alone units only); propane in household refrigerators, freezers, and combination refrigerators and freezers; ethane in very low temperature refrigeration equipment and equipment for non-mechanical heat transfer; R-441A, propane, and isobutane in vending machines; and propane and R-441A in self-contained room air conditioners for residential and light commercial AC and heat pumps. Those regulatory exemptions do not apply to blends of HCs with other refrigerants or containing any amount of any CFC, HCFC, HFC, or PFC.
In those actions, EPA determined that for the purposes of CAA section 608(c)(2), the venting, release, or disposal of such HC refrigerant substitutes in the specified end-uses does not pose a threat to the environment, considering both the inherent characteristics of these substances and the limited quantities used in the relevant applications. EPA further concluded that other authorities, controls, or practices that apply to such refrigerant substitutes help to mitigate environmental risk from the release of those HC refrigerant substitutes.
In addition to the prohibition on knowingly releasing ozone-depleting and substitute refrigerants during the maintenance, service, repair, and disposal of appliances, the existing regulations established under CAA section 608 require that persons servicing or disposing of air-conditioning and refrigeration equipment observe certain service practices that reduce emissions of ozone-depleting refrigerant. The current regulatory provisions only apply to ozone-depleting refrigerants and appliances containing ozone-depleting refrigerants. The current requirements include: Requiring that technicians be certified to work on appliances; restricting the sale of refrigerant to certified technicians; specifying the proper evacuation levels before opening up an appliance; requiring the use of certified refrigerant recovery and/or recycling equipment; requiring the maintenance and repair of appliances that meet certain size and leak rate thresholds; requiring that refrigerants be removed from appliances prior to disposal; requiring that air-conditioning and refrigeration equipment be provided with a servicing aperture or process stub to facilitate refrigerant recovery; requiring that refrigerant reclaimers be certified in order to reclaim and sell used refrigerant; and establishing standards for technician certification programs, recovery equipment, and quality of reclaimed refrigerant.
On November 9, 2015 (80 FR 69457), EPA proposed to update these existing requirements found in 40 CFR part 82, subpart F that currently apply to ozone-depleting refrigerants and then to generally extend those requirements, as appropriate, to non-ozone-depleting substitute refrigerants, including but not limited to HFCs and PFCs. However, as proposed, the rule requirements would not extend to substitute refrigerants that are exempt from the venting prohibition. This proposed rule would also streamline the regulations at 40 CFR part 82, subpart F to improve clarity. For more information on this proposed rule, see docket EPA-HQ-OAR-2015-0453.
EPA is proposing to list certain newly submitted alternatives as acceptable, subject to use conditions, and other newly submitted alternatives as unacceptable. EPA is also proposing to modify the listings from acceptable to
In each listing decision, EPA is considering the intersection between the specific alternative and the particular end-use, per the guiding principles stated above. This action does not propose that any specific alternative is acceptable or unacceptable across all sectors and end-uses. EPA is also not proposing that, for any specific sector, the only acceptable substitutes are non-fluorinated. EPA recognizes that both fluorinated (
In determining whether to modify the previous listing decisions for substitutes based on whether other alternatives are available that pose lower risk to human health and the environment, we considered, among other things: Scientific findings, information provided by the Technology and Economic Assessment Panel (TEAP) that supports the Montreal Protocol, journal articles, submissions to the SNAP program, the regulations and supporting dockets for other EPA rulemakings, presentations and reports presented at domestic and international conferences, and materials from trade associations and professional organizations. The materials on which we have relied may be found in the docket for this rulemaking (EPA-HQ-OAR-2015-0663). Key references are highlighted in section VIII of today's notice.
Here, as in the July 20, 2015, final rule, the proposed change of status dates are based upon EPA's understanding of the availability of alternatives, considering factors such as commercial availability and supply of alternatives, time required to work through technical challenges with using alternatives, and time required to meet other federal regulatory requirements with redesigned equipment or formulations.
Under the SNAP criteria for review in 40 CFR 82.180(a)(7), consideration of cost is limited to cost of the substitute under review, and that consideration does not include the cost of transition when a substitute is found unacceptable. EPA requires information on cost and availability of substitutes as part of SNAP submissions in order to judge how widely a substitute might be used, and therefore, what its potential environmental and health effects might be. The SNAP criteria do not identify other cost considerations and thus we have not historically used cost information independent of environmental and health effects to determine the acceptability of substitutes under review—that is, we have never determined a substitute under review to be unacceptable or acceptable on the basis of its cost. When considering a change of status for substitutes already listed as acceptable, the SNAP program has not considered the costs of transition away from HFCs, HFC blends, PFCs, and other alternatives affected by the changes of status as part of determining the status of the substitute or the availability of other alternatives for the same uses.
We are not addressing in this rulemaking whether to revise the regulatory criteria to include an expanded role for the consideration of costs in SNAP listing decisions. We have simply applied the existing regulatory criteria in determining whether to change the listing status of the substitutes addressed in this action.
Nevertheless, EPA has estimated the costs of the proposed changes of status in this action in order to provide information to the public and to meet various statutory and executive order requirements. We have estimated costs
In addition, we have analyzed costs and impacts on small businesses in a document titled, “Economic Impact Screening Analysis for Regulatory Changes to the Listing Status of High-GWP Alternatives used in Refrigeration and Air Conditioning, Foams, and Fire Suppression.”
The refrigeration and air conditioning and fire suppression end-uses that would be affected by this proposed rule were not affected by the changes of status promulgated in the July 20, 2015, final rule. For the foams sector, the rigid PU spray foam end-use was not affected by the changes of status in the July 20, 2015, final rule. For some other foam end uses, we changed the status in the July 20, 2015, final rule with respect to use of the blowing agent and are now proposing to change the status with respect to use of closed cell foam products and products containing closed cell foam that are manufactured or imported using these foam-blowing agents.
EPA notes that it may be reasonable for several of the end-uses to be broken down further. Consistent with previous practice and as EPA is proposing in certain instances in this proposal, EPA could consider adopting narrowed use limits. We could also consider adopting temporary narrowed use limits for a specific application within an end-use if the Agency determined that substitutes would be available for all but that specific application as of a particular date. In that case, for applications in that end-use not covered by the narrowed use limit, the proposed rule would list the substitute as unacceptable as of that date. For the specific application at issue, the proposed rule could contain both a temporary narrowed use limit with an expiration date and a listing as unacceptable upon the expiration of the narrowed use limit. Any end user within the covered application would need to comply with the requirement to analyze and document that there are no other alternatives that are technically feasible for their specific end-use in order to use the substitute identified in the narrowed use limit.
EPA requests comment on all aspects of this proposal, including proposed decisions to list additional substitutes as acceptable in certain end uses, to list new substitutes as unacceptable in certain end uses and to change the listing status of certain substitutes from acceptable to unacceptable, subject to narrowed use limits or unacceptable, and the dates when the change of status would apply to users of these substitutes. EPA is particularly interested in information concerning whether the supply of substitutes is sufficient to meet the dates proposed in this action or whether there are technical challenges in meeting a proposed change of status date. EPA is also interested in whether EPA should adopt a temporary narrowed use limit for a specific application of an end-use in the final rule. In such a case, the commenter should explain why other alternatives would not be available for the specific application of that end-use and for what period of time. EPA is also requesting comments on the determination that the SNAP listing decisions for foam blowing agents would apply to closed cell foam products and products containing closed cell foam that are manufactured or imported after one year after publication of a final rule. In addition, EPA is requesting comments on its proposed decision regarding the venting prohibition under section 608. More specific requests for comment are included with the discussion of each of the proposed decisions.
EPA is proposing to list propane (R-290) as acceptable, subject to use conditions, as a refrigerant in new self-contained commercial ice machines, in new water coolers, and in new very low temperature refrigeration equipment. The proposed use conditions include conditions requiring conformity with industry standards, limits on charge size, and requirements for warnings and markings on equipment. The use conditions are detailed below in section VI.A.1.c, “What are the proposed use conditions?”
Commercial ice machines are used in commercial establishments to produce ice for consumer use, such as in hotels, restaurants, and convenience stores. Many commercial ice machines are self-contained units, while some have the condenser separated from the portion of the machine making the ice and have refrigerant lines running between the two. The proposed listing applies only to self-contained commercial ice machines.
Water coolers are self-contained units providing chilled water for drinking. They may or may not feature detachable containers of water.
Very low temperature refrigeration equipment is intended to maintain temperatures considerably lower than for refrigeration of food—generally, −80 °C (−170 °F) or lower. In some cases, very low temperature refrigeration equipment may use a refrigeration system with two refrigerant loops containing different refrigerants or with a direct expansion (DX) refrigeration loop coupled with an alternative refrigeration technology (
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks (
The ODP is the ratio of the impact on stratospheric ozone of a substance compared to the impact of an identical mass of CFC-11. Thus, the ODP of CFC-11 is defined to be one. Other ODS have ODPs that range from 0.01 to 10.0.
Propane has an ODP of zero.
The GWP is a means of quantifying the potential integrated climate forcing of various greenhouse gases relative to a value of one for CO
The overall GHG effects of these refrigerants in various end-uses depend upon the design of the appliances, since the “indirect” GHG emissions associated with electricity consumption typically exceed the GHG emissions from the refrigerants over the full lifecycle of refrigerant-containing products.
In addition to global impacts on the atmosphere, EPA evaluated potential impacts of propane and other HC refrigerants on local air quality. Propane is a VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of State Implementation Plans (SIPs) to attain and maintain the National Ambient Air Quality Standards (NAAQS). Potential emissions of VOC from all substitutes for all end-uses in the refrigeration and AC sector are addressed by the venting prohibition under CAA section 608. Under that prohibition, refrigerant substitutes (and thus the VOC they contain) may only be emitted where EPA issues a final determination exempting a refrigerant substitute from the venting prohibition on the basis that venting, releasing or disposing of such substance does not pose a threat to the environment, as proposed elsewhere in this action (see section VI.A.2.a, “What is EPA's proposal regarding whether venting of propane in the end-uses in this action would pose a threat to the environment?” below). EPA estimates that potential emissions of HCs, including propane, when used as refrigerant substitutes in all end-uses in the refrigeration and AC sector, have little impact on local air quality, with the exception of unsaturated HCs such as propylene.
EPA analyzed a number of scenarios to consider the potential impacts on local air quality if HC refrigerants were used widely.
In a less conservative analysis potential impacts on ambient ozone levels, EPA looked at a set of end-uses that would be more likely to use HC refrigerants between now and 2030, including end-uses where they previously have been listed as acceptable and where they are proposed to be acceptable under this rule. For example, we assumed use of propane in water coolers and commercial ice machines and in end-uses where it is listed as acceptable, including room air conditioners and household and retail food refrigeration equipment and we assumed the use of other HCs such as isobutane in household and retail food refrigeration equipment and R-441A in room air conditioners and household and retail food refrigeration equipment. For further information on the specific assumptions, see the docket for this rulemaking
Because of the relatively low air quality impacts of propane if it is
Propane is highly volatile and typically evaporates or partitions to air, rather than contaminating surface waters. Propane's effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other alternatives for these uses.
Propane's flammability risks are of potential concern because commercial ice machines, water coolers, and very low temperature refrigeration equipment have traditionally used refrigerants that are not flammable. Without appropriate use conditions, the flammability risk posed by propane would be higher than non-flammable refrigerants because individuals may not be aware that their actions could potentially cause a fire. In this section, we discuss the flammability risks posed by propane and identify proposed use conditions that would mitigate those risks such that propane would not pose significantly greater risk due to flammability than other substitutes in these end-uses.
Because of its flammability, propane could pose a significant safety concern for workers and consumers in the end-uses addressed in this proposal if it is not handled correctly. In the presence of an ignition source (
To determine whether flammability would be a concern for service personnel or for consumers, EPA analyzed a plausible worst-case scenario to model a catastrophic release of propane. The worst-case scenario analysis for water coolers and for very low temperature refrigeration equipment revealed that even if the unit's full charge is emitted within one minute, the leaked refrigerant concentration did not reach propane's LFL of 2.1%, provided that the charge sizes were no greater than those specified in the relevant standard from UL.
In evaluating potential toxicity impacts of propane on human health in these end-uses, EPA considered both occupational and consumer risks. In general when evaluating non-cancer toxicity risks of a substitute, we use measured exposure concentrations if available, or modeled exposure concentrations using conservative assumptions appropriate to an end-use, and compare these exposure levels to recommended or required exposure limits for a compound that are intended to protect against adverse health effects. Where measured or modeled exposure levels are below relevant exposure limits for a chemical, we consider toxicity risks to be acceptable. Other acceptable substitutes listed for these end-uses have been evaluated for toxicity in this manner, including ethane for very low temperature refrigeration, ammonia for commercial ice machines, and a number of HFC blends for all three end-uses.
EPA investigated the risk of asphyxiation and of exposure to toxic levels of refrigerant for a worst-case scenario and a typical use. In the worst-case scenario of a catastrophic leak, we modeled release of the unit's full charge within one minute into a confined space to estimate concentrations that might result. We considered a conservatively small space appropriate to each end-use, such as a small galley kitchen of 18 m
To evaluate the toxicity of propane, EPA estimated the maximum time weighted average (TWA) exposure both for a short-term exposure scenario, with a 30-minute TWA exposure, and for an 8-hour TWA that would be more typical of occupational exposure for a technician servicing the equipment or a worker disposing of appliances. We compared these short-term and long-term exposure values to relevant industry and government workplace exposure limits for propane. The modeling results indicate that both the
A similar analysis of asphyxiation risks considered whether a worst-case release of refrigerant in the same room sizes would result in oxygen concentrations of 12 percent or less. This analysis found that impacts on oxygen concentrations were minimal, with oxygen concentrations remaining at approximately 21 percent.
For equipment with which consumers might come into contact, such as water coolers and commercial ice machines, EPA performed a consumer exposure analysis. In this analysis, we examined potential catastrophic release of the entire charge of the substitute in one minute under a worst-case scenario. We did not examine exposure to consumers in very low temperature refrigeration, as equipment for this end-use would typically be used in the workplace, such as in laboratories, and not in a home or public space. The analysis was undertaken to determine the 30-minute TWA exposure levels for the substitute, which were then compared to the toxicity limit to assess the risk to consumers.
EPA considered toxicity limits for consumer exposure that reflect a short-term exposure such as might occur at home or in a store or other public setting where a member of the general public could be exposed and could then escape. The toxicity limit that we used in our analysis of consumer exposure was an AEGL-1 of 6,900 ppm over 30 minutes. The analysis of consumer exposure assumed that 100 percent of the unit's charge would be released over one minute, at which time the concentration of refrigerant would peak in an enclosed space, and then steadily decline. Refrigerant concentrations were modeled under two air change scenarios, believed to represent the baseline of potential flow rates for a home or public space, assuming flow rates of 2.3 air changes per hour (ACH) in a household kitchen and 20 ACH in a restaurant kitchen.
Based upon our analysis, workplace and consumer exposure to propane when used in these end-uses according to the proposed use conditions is not expected to exceed relevant exposure limits. Thus, propane does not pose significantly greater toxicity risks to other acceptable refrigerants in these end-uses. For further information, including EPA's risk screens and risk assessments as well as information from the submitters of propane as a substitute refrigerant, see docket EPA-HQ-OAR-2015-0663.
In order to ensure that use of propane in these three end-uses would not cause greater risk to human health or the environment than use of other alternatives, we have identified and are proposing use conditions to address flammability and toxicity concerns. The proposed use conditions include conditions consistent with industry standards, limits on charge size, and requirements for warnings and markings on equipment.
EPA is proposing that, in the specified end-uses, propane be limited to use only in new equipment
EPA is proposing that propane be used only in equipment that meets all requirements in the relevant supplements for flammable refrigerants in certain applicable UL standards for refrigeration and AC equipment. Specifically, Supplement SA to the 8th edition of UL 563 standard, dated July 31, 2009, applies to self-contained commercial ice machines using flammable refrigerants;
UL has tested equipment for flammability risk in household and retail food refrigeration and for commercial freezers for very low temperature refrigeration. Further, UL has developed acceptable safety standards including requirements for construction, for markings, and for performance tests concerning refrigerant leakage, ignition of switching components, surface temperature of parts, and component strength after being scratched. These standards were developed in an open and consensus-based approach, with the assistance of experts in the AC and refrigeration industry as well as experts involved in assessing the safety of products. While similar standards exist from other bodies such as the International Electrotechnical Commission (IEC), we
EPA is proposing use conditions that limit the amount of propane allowed in each refrigerant circuit to 150 g.
EPA is proposing limitations on refrigerant charge size for self-contained commercial ice machines, water coolers, and very low temperature refrigeration equipment that reflect the UL 563, UL 399, and UL 471 standards. As discussed above in paragraph ii of this section, we believe UL standards are appropriate because they are the most applicable to and recognized by the U.S. market and offer requirements developed by a consensus of experts.
UL Standards 563 (ice machines), 399 (water coolers), and 471 (commercial stand-alone refrigeration equipment) limit the amount of refrigerant leaked to 150 grams (5.29 ounces). We note that the charge size limit for propane in the UL standards is in line with the IEC 60335-2-89 standard addressing these end-uses, which also has a charge size limit of 150 grams.
EPA proposes that equipment designed for use with propane must have distinguishing color-coded hoses and piping to indicate use of a flammable refrigerant. This will help technicians immediately identify the use of a flammable refrigerant, thereby reducing the risk of using sparking equipment or otherwise having an ignition source nearby. The AC and refrigeration industry currently uses distinguishing colors as means to identify different refrigerants. Likewise, distinguishing coloring has been used elsewhere to indicate an unusual and potentially dangerous situation, for example in the use of orange-insulated wires in hybrid electric vehicles. Currently, no industry standard exists for color-coded hoses or pipes for propane. EPA is proposing that all such refrigerator tubing be colored red Pantone matching system (PMS) #185 to match the red band displayed on the container of flammable refrigerants under the Air Conditioning, Heating and Refrigeration Institute (AHRI) Guideline “N” 2014, “2014 Guideline for Assignment of Refrigerant Container Colors.”
EPA is particularly concerned with ensuring adequate and proper notification for servicing and disposal of appliances containing flammable refrigerants. The use of color-coded hoses, as well as the use of warning labels discussed below, is necessary to ensure flammable refrigerants can be used without presenting significantly more risk than other alternatives and would be consistent with other general industry practices. This proposed approach is consistent with the approach adopted in our previous rules on flammable refrigerants (76 FR 78832, December 20, 2011; 80 FR 19453, April 10, 2015).
As a use condition, EPA is proposing to require labeling of self-contained commercial ice machines, water coolers, and, very low temperature refrigeration equipment. EPA is proposing the warning labels on the equipment contain letters at least
• “DANGER—Risk of Fire or Explosion. Flammable Refrigerant Used. Do Not Use Mechanical Devices To Defrost Refrigerator. Do Not Puncture Refrigerant Tubing.” This marking must be provided on or near any evaporators that can be contacted by the consumer.
• “DANGER—Risk of Fire or Explosion. Flammable Refrigerant Used. To Be Repaired Only By Trained Service Personnel. Do Not Puncture Refrigerant Tubing.” This marking must be located near the machine compartment.
• “CAUTION—Risk of Fire or Explosion. Flammable Refrigerant Used. Consult Repair Manual/Owner's Guide Before Attempting To Service This Product. All Safety Precautions Must be Followed.” This marking must be located near the machine compartment.
• “CAUTION—Risk of Fire or Explosion. Dispose of Properly In Accordance With Federal Or Local Regulations. Flammable Refrigerant Used.” This marking must be provided on the exterior of the refrigeration equipment.
• CAUTION—Risk of Fire or Explosion Due To Puncture Of Refrigerant Tubing; Follow Handling Instructions Carefully. Flammable Refrigerant Used.” This marking must be provided near all exposed refrigerant tubing.
The warning label language is similar to or exactly the same as that required in UL standards: For commercial ice machines in UL 563 in section SB6.1, for water coolers in UL 399 in section SA6.1, and for commercial refrigerators and freezers, including very low temperature freezers, in UL 471 in section SB6.1.
It would be difficult to see warning labels with the minimum lettering height requirement of
In addition to establishing regulatory use conditions, which are binding on end users, EPA may also make recommendations for use of a substitute. EPA is proposing to recommend that only technicians specifically trained in handling flammable refrigerant substitutes dispose of or service refrigeration and AC equipment containing these substances. Trained technicians should know how to minimize the risk of fire and the procedures for using flammable refrigerant substitutes safely. Releases of large quantities of flammable refrigerants during servicing and manufacturing, especially in enclosed, poorly ventilated spaces or in areas where large amounts of refrigerant are stored, could cause an explosion if an ignition source exists nearby. For these reasons, technicians should be properly trained to handle flammable refrigerant substitutes when maintaining, servicing, repairing, or disposing of water coolers, commercial ice machines, and very low temperature freezers. In addition, EPA recommends that if propane would be vented, released, or disposed of (rather than recovered), as is proposed for the specified end-uses in this rule, the release should be in a well-ventilated area, such as outside of a building. Ensuring proper ventilation and avoiding ignition sources are recommended practices, whether venting or recovering a flammable refrigerant.
The Australian Institute of Refrigeration, Air Conditioning and Heating (AIRAH) provides useful guidance on safety precautions technicians can follow when servicing equipment containing flammable refrigerants or when venting refrigerant. One of those practices is to connect a hose to the appliance to allow for venting the refrigerant outside.
We are aware that at least two organizations in the United States, Refrigeration Service Engineers Society (RSES) and the ESCO Institute, have developed technician training programs in collaboration with refrigeration equipment manufacturers and users that address safe use of flammable refrigerant substitutes. In addition, EPA has reviewed several training programs provided as part of SNAP submissions from persons interested in flammable refrigerant substitutes. The agency intends to update the test bank for technician certification under CAA section 608 as we have done previously, and will consider including additional questions on flammable refrigerants. By adding such questions to the test bank, EPA would supplement but would not replace technician training programs currently provided by non-government entities. EPA will seek additional information and guidance on how best to incorporate this content through a separate process outside the scope of this final rule.
EPA proposes that this listing would apply 30 days after the date of publication of a final rule. This date, the same as the proposed effective date of this regulation, allows for the safe use of this substitute at the earliest opportunity.
For some of the types of equipment covered in this proposal, DOE has established energy conservation standards. For example, DOE energy conservation standards apply to automatic commercial ice machines.
Below in section VI.A.2 of this document, EPA is proposing to exempt propane from the venting prohibition under CAA section 608 when propane is used as a refrigerant in self-contained commercial ice machines, water coolers, or very low temperature refrigeration equipment.
EPA requests comment on all aspects of the proposed listing of propane as an acceptable refrigerant in self-contained commercial ice machines, water coolers, and very low temperature refrigeration equipment, including the proposed use conditions discussed in section VI.A.1.c. We request comment on our risk screens and the assumptions and exposure and flammability levels EPA used to evaluate risk. We are particularly interested in comment of two of the proposed use conditions: (1) The use of red marking for pipes, hoses and other devices including direct color application on the applicable parts of the system, such as a red plastic sleeve (see section VI.A.1.c.iv, “Color-coded hoses and piping”); and (2) the UL standards that EPA proposes to incorporate by reference (
EPA is proposing to list the refrigerant substitute propane under the SNAP program as acceptable, subject to use conditions, in newly manufactured water coolers, self-contained commercial ice machines, and very low temperature refrigeration equipment. EPA is also proposing to exempt propane in these end-uses from the venting prohibition under CAA section 608(c)(2). For purposes of CAA section 608(c)(2), EPA considers two factors in determining whether or not venting, release, or disposal of a refrigerant substitute during the maintenance, servicing, repairing, or disposing of appliances poses a threat to the environment. See 69 FR 11948, March 12, 2004; 79 FR 29682, May 23, 2014; and 80 FR 19453, April 10, 2015. First, EPA analyzes the threat to the environment due to inherent characteristics of the refrigerant substitute, such as GWP. Second, EPA determines whether and to what extent venting, release, or disposal actually takes place during the maintenance, servicing, repairing, or disposing of appliances, and to what extent such actions are controlled by other authorities, regulations, or practices. To the extent that such releases are adequately controlled by other authorities, EPA defers to those authorities.
EPA has evaluated the potential environmental impacts of releasing into the environment propane, the substitute that we are proposing to list under the SNAP program as acceptable, subject to use conditions, in water coolers, self-contained commercial ice machines, and very low temperature refrigeration equipment. In particular, we assessed the potential impact of the release of propane on local air quality and its ability to decompose in the atmosphere, its ODP, its GWP, and its potential impacts on ecosystems.
As explained above in section VI.A.1.b.i, “Environmental impacts,” propane's ODP is zero, its GWP is approximately three, and its effects on aquatic life are expected to be small. As to potential effects on local air quality, based on the analysis and modeling results described in section VI.A.1.b.i of this preamble, EPA proposes to conclude that release of propane from the end-uses proposed in this action, in addition to the HCs previously listed as acceptable, subject to use conditions, for their specific end-uses, is expected to have little impact on local air quality. In this regard, EPA finds particularly noteworthy that even assuming 100 percent market penetration of propane and the other acceptable HCs in the proposed and acceptable end-uses, which is a conservative assumption, the highest impact for a single 8-hour average concentration based on this analysis would be 0.03 ppb in Los Angeles.
In addition, when examining all HC substitute refrigerants in those uses for which UL currently has standards in place, for which the SNAP program has already listed the uses as acceptable, subject to use conditions, or for which the SNAP program is reviewing a submission, including those in this rule, we found that even if all the refrigerant in appliances in end-uses proposed as acceptable, subject to use conditions in this proposed rule and listed as acceptable in previous rules were to be emitted, there would be a worst-case impact of less than 0.15 ppb for ground-level ozone in the Los Angeles area.
As discussed above in sections VI.A.1.b.ii, “Flammability” and VI.A.1.b.iii, “Toxicity,” EPA's SNAP program evaluated the flammability and toxicity risks from propane in the proposed end-uses in this rule. EPA is providing some of that information in this section as well.
Propane is classified as an A3 refrigerant by ASHRAE Standard 34-2010 and subsequent addenda, indicating that it has low toxicity and high flammability. Propane has an LFL of 2.1%. To address flammability risks, this proposal provides recommendations for its safe use (see section VI.A.1.d, “What recommendations does EPA have for the safe use of propane?” above). The SNAP program's analysis suggests that the proposed use conditions in this proposed rule will mitigate flammability risks.
Like most refrigerants, at high concentrations HCs can displace oxygen and cause asphyxiation. Various industry and regulatory standards exist to address asphyxiation and toxicity risks. The SNAP program's analysis of asphyxiation and toxicity risks suggests that the proposed use conditions in this proposed rule would mitigate asphyxiation and toxicity risks. Furthermore, it is the Agency's understanding that flammability risks and occupational exposures to HCs are adequately regulated by OSHA and building and fire codes at a local and national level.
EPA expects that existing authorities, controls, and/or practices will mitigate environmental risk from the release of propane. Analyses performed for both this proposed rule and the SNAP rules issued in 1994, 2011, and 2015 (59 FR 13044, March 17, 1994; 76 FR 38832, December 20, 2011; and 80 FR 19453, April 10, 2015, respectively)) indicate that existing regulatory requirements and industry practices limit and control the emission of propane. As explained below, EPA proposes that the limits and controls under other authorities, regulations, or practices adequately control the release of and exposure to propane and mitigate risks from any possible release.
As mentioned above, the determination of whether venting, release, or disposal of a substitute refrigerant poses a threat to the environment includes considering
Industry service practices and OSHA standards and guidelines that address HC refrigeration equipment include monitoring efforts, engineering controls, and operating procedures. OSHA requirements that apply during servicing include continuous monitoring of explosive gas concentrations and oxygen levels. In general, HC emissions from refrigeration systems are likely to be significantly smaller than those emanating from the industrial process and storage systems, which are controlled for safety reasons. In the SNAP listings in section VI.A.1.c, “What are the proposed use conditions?” we note that the amount of refrigerant substitute from a refrigerant loop is limited to 150 g in the end-uses proposed in this rule. This indicates that HC emissions from such uses are likely to be relatively small.
The release and/or disposal of many refrigerant substitutes, including propane, are controlled by other authorities including various standards, and state and local building codes. To the extent that release during maintaining, repairing, servicing, or disposing of appliances is controlled by regulations and standards of other authorities, these practices and controls for the use of propane are sufficiently protective. These practices and controls mitigate the risk to the environment that may be posed by the venting, release, or disposal of propane during the maintaining, servicing, repairing, or disposing of appliances.
EPA is aware of equipment that can be used to recover HC refrigerants. While there are no relevant U.S. standards for such recovery equipment currently, to the extent that propane is recovered rather than vented in specific end-uses and equipment, EPA recommends the use of recovery equipment designed specifically for flammable refrigerants in accordance with applicable safe handling practices. See section VI.A.1.d above, “What recommendations does EPA have for the safe use of propane?”
Consistent with the proposed listing under SNAP in this action, EPA proposes that venting, releasing or disposing of propane in water coolers, self-contained commercial ice machines, and very low temperature refrigeration equipment is not expected to pose a threat to the environment. As discussed more fully above, we propose this on the basis of the inherent characteristics of this substance, the limited quantities used in the relevant end-uses, and the limits and controls under other authorities, regulations, or practices that adequately control the release of and exposure to propane and mitigate risks from any possible release. Accordingly, EPA is proposing to revise the regulations at § 82.154(a)(1) to add propane in these end-uses to the list of substitute refrigerants that are exempt from the venting prohibition. We also note that EPA has recently proposed to revise the format of the text of this section to include separate paragraphs for each substitute refrigerant, rather than grouping refrigerants in an end-use (80 FR 69457; November 9, 2015). Thus, the final text of § 82.154(a)(1) may reflect revised language related to both the November 2015 proposal and to this proposal.
We are proposing that propane would be exempt from the venting prohibition as of 30 days after the publication of a final rule in the
If this proposed exemption were to become final as proposed, it would not mean that propane could be vented in all situations. Propane and other HCs being recovered, vented, released, or otherwise disposed of from commercial and industrial appliances are likely to be hazardous waste under RCRA (see 40 CFR parts 261 through 270). As discussed in the final rules addressing the venting of ethane, isobutane, propane, and R-441A as refrigerant substitutes in certain end-uses, incidental releases may occur during the maintenance, service, and repair of appliances subject to CAA section 608 (79 FR 29682, May 23, 2014; 80 FR 19454, April 10, 2015). Such incidental releases would not be subject to RCRA requirements for the disposal of hazardous waste, as such releases would not constitute disposal of the refrigerant charge as a solid waste,
EPA requests comment on all aspects of our proposal to exempt from CAA section 608's venting prohibition the venting or release of propane used as a refrigerant substitute in water coolers, self-contained commercial ice machines, and very low temperature refrigeration equipment, as well as seeking comment on the proposed exemption language at 40 CFR 82.154(a)(1).
EPA is proposing to list the following flammable refrigerants as unacceptable for use in existing unitary split AC and heat pumps for residential and light commercial AC and heat pumps because they pose significantly more risk to human health or the environment than other available alternatives:
• All refrigerants identified as flammability Class 3 in ANSI/ASHRAE Standard 34-2013.
• All refrigerants meeting the criteria for flammability Class 3 in ANSI/
Existing unitary split AC systems and heat pumps were not designed to use a flammable refrigerant. We are aware of instances in which people or property have been harmed by retrofit or so-called `drop-in' use of certain of the specified flammable refrigerants in equipment designed to use HCFC-22. For new equipment, we have listed certain flammable refrigerants as acceptable on the basis that flammability risks can be addressed in designing the equipment and mitigated through use conditions. In contrast, existing equipment has not been designed for flammable refrigerants and we have not identified appropriate use conditions that can manage the flammability risk for retrofits such that these flammable refrigerants would pose similar or lower risk than other available refrigerants in this end-use.
The residential and light commercial AC and heat pumps end-use includes equipment for cooling air in individual rooms, in single-family homes, and sometimes in small commercial buildings. This end-use differs from commercial comfort AC, which uses chillers that cool water that is then used to cool air throughout a large commercial building, such as an office building or hotel. This proposal specifically concerns unitary split systems and heat pumps, commonly called central AC. These systems include an outdoor unit with a condenser and a compressor, refrigerant lines, an indoor unit with an evaporator, and ducts to carry cooled air throughout a building. Central heat pumps are similar but offer the choice to either heat or cool the indoor space. We are proposing that certain flammable refrigerants would be listed as unacceptable for retrofit use in this type of equipment.
We are not currently proposing that the unacceptability determination for certain flammable refrigerants applies to other types of residential AC and heat pump equipment, but we may do so in the future. The presence of a proposal for a single type of equipment within this end-use or listings finding certain substitutes acceptable, subject to use conditions, in a specific type of equipment does not imply that other uses are acceptable (
• Multi-split air conditioners and heat pumps. These systems include one or more outdoor unit(s) with a condenser and a compressor and multiple indoor units, each of which is connected to the outdoor unit by refrigerant lines. For ductless multi-split systems, the cooled air exits directly from the indoor unit rather than being carried through ducts.
• Mini-split air conditioners and heat pumps. These systems include an outdoor unit with a condenser and a compressor and a single indoor unit that is connected to the outdoor unit by refrigerant lines. Cooled air exits directly from the indoor unit rather than being carried through ducts.
• Packaged outdoor air conditioners and heat pumps. These systems include an outdoor unit with a condenser and a compressor and a heating assembly, often used on top of the roof of a building such as a commercial office building or apartment building. These units carry cool air to the inside of the building through ducts, so they are not completely self-contained units; however, the refrigerant remains within the packaged unit, thus reducing the chance of leaks from refrigerant lines.
• Window air conditioners and heat pumps. These are self-contained units that fit in a window with the condenser extending outside the window.
• Packaged terminal air conditioners (PTACs) and packaged terminal heat pumps (PTHP). These are self-contained units that consist of a separate, un-encased combination of heating and cooling assemblies mounted through a wall.
• Portable room air conditioners and heat pumps. These are self-contained, factory-sealed, single package units that are designed to be moved easily from room to room and are intended to provide supplemental cooling within a room. These units typically have wheels or casters for portability and have a fan which operates continuously when the unit is on. Portable room air conditioners and heat pumps may contain an exhaust hose that can be placed through a window or door to eject heat to the outside.
Compared to self-contained AC equipment such as window air conditioners, PTAC, PTHP, and portable room air conditioners, unitary split AC systems and heat pumps are much more likely to have a refrigerant release due to having larger charge sizes, more locations that are prone to leak, and because they are more likely to require servicing by a technician. A higher risk of refrigerant releases and a potential for larger releases and higher concentration releases results in higher risk that flammable refrigerant could be ignited from unitary split AC systems and heat pumps compared to self-contained equipment.
EPA is aware of a number of situations where companies have sold highly flammable refrigerants for use in residential AC that have not been submitted to SNAP for review. EPA has conducted enforcement actions against companies that have sold such substitutes in violation of EPA's regulations.
EPA is proposing that the following flammable refrigerants be listed as unacceptable for retrofits in unitary split AC systems and heat pumps:
• All refrigerants identified as flammability Class 3 in ANSI/ASHRAE Standard 34-2013.
• All refrigerants meeting the criteria for flammability Class 3 in ANSI/ASHRAE Standard 34-2013. These include, but are not limited to, refrigerant products sold under the names R-22a, 22a, Blue Sky 22a refrigerant, Coolant Express 22a, DURACOOL-22a, EC-22, Ecofreeeze 22a, EF-22a, Envirosafe 22a, ES-22a, Frost 22a, HC-22a, Maxi-Fridge, MX-22a, Oz-Chill 22a, Priority Cool, and RED TEK 22a.
ANSI/ASHRAE Standard 34-2013 assigns a safety group classification for each refrigerant which consists of two
The flammability classification “1” is given to refrigerants that, when tested, show no flame propagation. The flammability classification “2” is given to refrigerants that, when tested, exhibit flame propagation, have a heat of combustion less than 19,000 kJ/kg (8,174 British thermal units (BTU)/lb), and have a LFL greater than 0.10 kg/m
Refrigerants with a flammability classification of 3 identified by ASHRAE in ASHRAE 34-2013 include the HCs R-1150 (ethylene), R-170 (ethane), R-1270 (propylene), R-290 (propane), R-50 (
In addition to refrigerants specifically identified in the ASHRAE 34-2013 standard as having a flammability classification of 3, EPA is proposing that refrigerants meeting the criteria of that standard are unacceptable. In other words, refrigerants are unacceptable if they exhibit flame propagation and either have a heat of combustion of 19,000 kJ/kg (8,174 BTU/lb) or greater or an LFL of 0.10 kg/m
We request comment on whether we should list as unacceptable both any refrigerant that meets the criteria in ASHRAE 34-2013 for a flammability
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks (
EPA has listed a number of alternatives as acceptable for retrofit usage in unitary split AC systems and heat pumps. All of the listed alternatives are HFC blends, with some containing small percentages (approximately five percent or less) of HCs. Specific blends include: R-125/134a/600a (28.1/70/1.9), R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-407F, R-417A, R-417C, R-421A, R-422B, R-422C, R-422D, R-424A, R-427A, R-434A, R-438A, R-507A, and RS-44 (2003 composition). These blends are all non-ozone-depleting. As shown in Table 3, they have GWPs ranging from approximately 1,770 for R-407C to 3,990 for R-507A. Knowingly venting or releasing these refrigerants is limited by the venting prohibition under section 608(c)(2) of the CAA, codified at 40 CFR 82.154(a)(1). The HFC components of these refrigerant blends are excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS, while the HC components are VOC.
Both the currently acceptable refrigerants and those proposed to be unacceptable are non-ozone depleting. The refrigerants proposed to be unacceptable would result in higher VOC emissions than the acceptable refrigerants, with the saturated HCs (
All refrigerants currently listed as acceptable in this end-use are nonflammable, resulting in no risk of fire or explosion from flammability of the refrigerant. In comparison, ASHRAE Class 3 refrigerants are highly flammable. As discussed further below in section VI.A.3.b.iii.(b), EPA analyzed the flammability impacts of one ASHRAE Class 3 refrigerant, R-443A, and found that a release of the entire refrigerant charge inside a building from a unitary split AC system or heat pump could result in surpassing the LFL.
The HFC components of acceptable substitutes in this end-use, as well as the HFC components of the unacceptable refrigerant blends have exposure limits, such as WEELs from the AIHA or manufacturer acceptable exposure limits, of 1,000 ppm on an 8-hr TWA and the HC components of both the acceptable refrigerants and those proposed unacceptable have exposure limits ranging from 500 to 1,000 ppm (8-hr TWA for TLVs from ACGIH and 10-hr TWA for recommended exposure limits (RELs) from NIOSH). Both the acceptable refrigerants and the proposed unacceptable refrigerants are able to be used be used in this end-use in accordance with their respective 8-hr or 10-hr workplace exposure limits. Acute exposure may also be of concern during use in unitary split AC systems and heat pumps because of possible exposure to consumers in the event of a sudden release. The currently acceptable refrigerants typically have high acute exposure limits for their components based upon cardiotoxic effects of halocarbons over 10,000 ppm (
At this time, the potential reduced climate risks from using a highly flammable refrigerant with lower GWP does not outweigh the flammability risks of using these refrigerants in existing equipment that was designed for nonflammable refrigerants. In addition to flammability risk, in at least some cases, acute exposure limits of the proposed unacceptable refrigerants may be more difficult to attain than those for acceptable refrigerants in this end-use. Therefore, EPA proposes that the highly flammable refrigerants proposed to be unacceptable pose greater overall risk to human health and the environment than other substitutes for retrofit in the residential and light commercial AC and heat pumps end-use. However, the Agency may look back at these end-uses for other reasons if we receive information on how risks from the refrigerants proposed for listing as unacceptable can be sufficiently mitigated, we may reconsider any final action listing these refrigerants as unacceptable in this end use.
EPA proposes that these listings would apply 30 days after the date of publication of a final rule. To date, only one of these substitutes have been submitted to EPA for this end-use and this submission is currently incomplete. Thus, under 40 CFR 82.174, manufacturers are prohibited from introducing them into interstate commerce for this end-use. Thus, manufacturers and service technicians should not be currently using these substitutes in the manner that would be prohibited by this proposed listing decision. Further, a date or 30 days after the date of publication of a final rule, the same as the proposed effective date of this regulation, would protect technicians and consumers from the risks of these substitutes at the earliest opportunity.
EPA is not aware of other federal rules that would apply to the use of these flammable refrigerants for retrofits in existing unitary split AC systems and heat pumps.
EPA requests comment on all aspects of this proposal. In particular, we request comment on our proposal to list as unacceptable for retrofit use in existing unitary split AC systems and heat pumps all refrigerants identified as flammability Class 3 in ANSI/ASHRAE Standard 34-2013 and all refrigerants meeting the criteria for flammability Class 3 in ANSI/ASHRAE Standard 34-2013, including, but not limited to, refrigerant products sold under the names R-22a, 22a, Blue Sky 22a refrigerant, Coolant Express 22a, DURACOOL-22a, EC-22, Ecofreeeze 22a, EF-22a, Envirosafe 22a, ES-22a, Frost 22a, HC-22a, Maxi-Fridge, MX-22a, Oz-Chill 22a, Priority Cool, and RED TEK 22a. The agency also requests comment on the proposed decision to list these substitutes as unacceptable 30 days after the date of publication of a final rule, and any additional technical information on how risks from the refrigerants proposed for listing as unacceptable can be sufficiently mitigated.
EPA is proposing to list the refrigerants propylene (R-1270) and R-443A as unacceptable in new equipment in residential and light commercial AC and heat pumps, cold storage warehouses, and centrifugal and positive displacement chillers for commercial comfort AC.
The refrigeration and AC end-uses addressed in this action include:
○ Centrifugal and positive displacement chillers;
○ residential and light commercial AC and heat pumps, including both self-contained units (
○ cold storage warehouses.
EPA has received a submission for R-443A in new residential and light commercial AC and heat pumps and for new window air conditioners, a subset of that end-use. We have also received a submission for propylene for use in new chillers for commercial comfort AC (centrifugal and positive displacement chillers) and for cold storage warehouses. Because the two refrigerants, R-443A and propylene, have similar properties and risk profiles, we reviewed both refrigerants for all four end-uses.
Propylene, also known as propene or R-1270, is a HC with three carbons, the chemical formula C
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks (
Propylene and R-443A have an ODP of zero. Many acceptable substitutes in the refrigeration and AC end-uses addressed in this proposed rule also have an ODP of zero (
Propylene and the components of R-443A have relatively low GWPs of less than ten. As shown in Table 4, GWPs of acceptable refrigerants in these end-uses range from zero to 3,990, depending on the specific end-use. (Elsewhere in this proposal, we propose to find unacceptable a number of higher GWP blends for use in new chillers and new cold storage warehouses; if that portion of this proposed rule was finalized as proposed, the highest GWP for any acceptable refrigerant in new chillers would be 630 and in new cold storage warehouses would be approximately 1,830.) The GWPs of propylene and R-443A are comparable to or higher than those of CO
In addition to global impacts on the atmosphere, EPA evaluated potential impacts of propylene and the components of R-443A on local air quality. Propylene and the three components of R-443A, propylene, propane and isobutane are not excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. However, there is a significant difference in the photochemical reactivity between propylene and the other two HCs. Propylene, because it has an unsaturated double bond between two carbons, is significantly more reactive in the atmosphere than propane, the saturated HC with the same number of carbon atoms, and isobutane. For example, the Maximum Incremental Reactivity (MIR) of propylene, in gram ozone per gram of the substance, is 11.57 while the MIR of propane is 0.56 g O
Based on analyses described below, EPA estimates that potential emissions of saturated HCs if used as refrigerant substitutes in all end-uses in the refrigeration and AC sector would have little impact on local air quality, while emissions of propylene, including propylene from R-443A, could have a significant negative impact.
EPA analyzed a number of scenarios to consider the potential impacts on local air quality if HC refrigerants were used widely. We used EPA's Vintaging Model to estimate the HC emissions from these scenarios and EPA's Community Multiscale Air Quality (CMAQ) model to assess their potential incremental contributions to ground-level ozone concentrations.
EPA also performed less conservative analyses that considered the end-uses where these refrigerants would more likely be used, based upon submissions received and upon end-uses where there are industry standards addressing the use of flammable refrigerants. Propylene was previously listed as an acceptable substitute in industrial process refrigeration. EPA has received submissions for use of R-443A in residential and light commercial AC and heat pumps and window air conditioners. We have received a SNAP submission for use of propylene in cold storage warehouses and in commercial comfort AC in chillers, and have received inquiries about using propylene in retail food refrigeration. In addition, EPA is aware that UL has developed standards addressing use of flammable refrigerants in stand-alone retail food refrigeration equipment and coolers; vending machines; water coolers; commercial ice machines; household refrigerators and freezers; and room air conditioners; and is currently developing revisions to UL 1995 for residential AC equipment. Thus, we considered scenarios where propylene would be used and emitted (1) in all stationary AC and refrigeration end-uses, but excluding MVAC, (2) in all refrigeration end-uses and all AC end-uses except for MVAC and chillers for commercial comfort AC. For further details on the scenarios and end-uses in the analysis, see the docket for this rulemaking.
Based on this still conservative assessment of refrigerant use, we found that if all the refrigerant in appliances in the end-uses analyzed were to be emitted, there would be a worst-case impact of 4.47 ppb ozone in the Los Angeles area. In the other cities examined in the analysis, Houston and Atlanta, which have also had historically high levels of ambient ozone, impacts were smaller (as much as 0.67 and 0.39 ppb, respectively).
A more recent analysis specifically examining use of R-443A and propylene in residential and light commercial AC and heat pumps, cold storage warehouses, and commercial comfort AC (centrifugal and positive displacement chillers) found noticeable impacts from these end-uses. If propylene were the only refrigerant in these end-uses and it was emitted from residential and light commercial AC and heat pumps and cold storage warehouses,
Propylene and R-443A in the proposed end-uses would be subject to the CAA section 608 venting prohibition unless EPA were to issue a final rule specifically exempting them; EPA is not proposing such an exemption in this rulemaking. While potential air quality impacts of propylene and R-443A would likely be reduced through the CAA section 608 venting prohibition, we do not consider this sufficient to mitigate the risks of these refrigerants in the proposed end-uses, particularly in light of their photochemical reactivity and toxicity. EPA is not aware of commercially available recovery equipment for flammable refrigerants (
Ecosystem effects, primarily effects on aquatic life, of the substitutes are expected to be small as are the effects of other acceptable substitutes. Propylene, propane and isobutane are all highly volatile and would evaporate or partition to air, rather than contaminate surface waters. Neither propylene nor R-443A pose a greater risk of aquatic or ecosystem effects than those of other substitutes for these uses.
Propylene and R-443A are both designated as A3 refrigerants according to ASHRAE 34-2013 and subsequent addenda. Thus, their flammability is comparable to that of ethane, propane, isobutane, and R-441A, other refrigerants that EPA has listed as acceptable, subject to use conditions, in a number of end-uses (76 FR 78832, December 20, 2011; 80 FR 19454, April 10, 2015).
Due to their flammable nature, propylene and R-443A could pose a significant safety concern for workers and consumers if they are not properly handled. In the presence of an ignition source (
To determine whether flammability would be a concern for manufacturing and service personnel or for consumers, EPA analyzed a plausible worst-case scenario to model a catastrophic release of the refrigerants. The worst-case scenario analysis for each refrigerant revealed that even if the full charge of a window AC unit is emitted within one minute, neither of these refrigerants reached their respective LFLs. However, for larger residential AC systems, such as for a unitary split AC system, charges are significantly higher, and a catastrophic leak of refrigerant inside a building could result in surpassing the LFL.
EPA also reviewed the submitters' detailed assessments of the probability of events that might create a fire and engineering risk and approaches to avoid sparking from the refrigeration equipment. Further information on these analyses and EPA's risk assessments are available in public docket EPA-HQ-OAR-2015-0663. Manufacturing and service personnel or consumers may not be familiar with refrigeration or AC equipment containing a flammable refrigerant. Thus, additional risk mitigation would be appropriate. Use conditions such as those recently finalized for ethane, isobutane, propane, and R-441A could potentially be adopted by regulation as use conditions to mitigate flammability concerns from propylene and R-443A in end-uses for self-contained refrigeration and AC equipment such as stand-alone retail food refrigeration units, household refrigerators and freezers, vending machines, and room air conditioners for residential and light commercial AC and heat pumps. We further note that refrigerant handling equipment designed to be used safely with flammable refrigerants are not commercially available in the United States nor are standards to test and certify such equipment in place. Assuming these substitutes would not be exempted from the venting prohibition under CAA section 608 due to potential local air quality impacts, the lack of such equipment and standards for refrigerant recovery calls into
In evaluating potential toxicity impacts of propylene and R-443A on human health, EPA considered both occupational risk, and for end-uses in the household or in retail establishments, also consumer risks. EPA investigated the risk of asphyxiation and of exposure to toxic levels of refrigerant for a plausible worst-case scenario and a typical use scenario for each refrigerant. In the worst-case scenario of a catastrophic leak, we modeled release of the unit's full charge within one minute into a confined space to estimate concentrations that might result. We considered a conservatively small space appropriate to each end-use, such as a small utility room of 18 m
To evaluate toxicity of both refrigerants, EPA estimated the maximum TWA exposure both for a short-term exposure scenario, with a 30-minute TWA exposure, and for an 8-hour TWA that would be more typical of occupational exposure for a technician servicing the equipment. We compared these short-term and long-term exposure values to relevant industry and government workplace exposure limits for propylene and the components of R-443A (including potential impurities). The modeling results indicate that both the short-term (30-minute) and long-term (8-hour) worker exposure concentrations would be below the relevant workplace exposure limits, such as the OSHA PEL, the NIOSH REL, or the ACGIH's TLV in cold storage warehouses, commercial comfort AC equipment, and residential and light commercial AC and heat pumps.
• Isobutane: 800 ppm REL on 10-hr TWA; 6,900 ppm over 30 minutes
• Propane: 1,000 ppm PEL/TLV on 8-hr TWA; 6,900 ppm AEGL-1 over 30 minutes
• Propylene: 500 ppm TLV on 8-hr TWA; 1,500 ppm excursion limit over 30 minutes
In comparison, HFCs and the HFC components of acceptable substitutes in these end-uses, have exposure limits, such as WEELs from the AIHA or manufacturer acceptable exposure limits, of 1,000 ppm on an 8-hr TWA and the HC components of both the acceptable refrigerants and those proposed unacceptable have exposure limits ranging from 500 to 1,000 ppm (8-hr TWA for TLVs from ACGIH and 10-hr TWA for recommended exposure limits (RELs) from NIOSH). HFOs acceptable in centrifugal and positive displacement chillers have WEELs of 800 ppm. Both the acceptable refrigerants and the proposed unacceptable refrigerants are able to be used in these end-uses in accordance with their respective workplace exposure limits.
For equipment with which consumers might come into contact, such as residential air conditioners and heat pumps, EPA also performed a consumer exposure analysis. In this analysis, we examined potential catastrophic release of the entire charge of the substitute in one minute under a worst-case scenario. We did not examine exposure to consumers in cold storage warehouses and commercial comfort AC (chillers), since such equipment is typically used in workplaces where access is controlled and not in homes or public spaces. The analysis was undertaken to determine the 30-minute TWA exposure levels for the substitute, which were then compared to the toxicity limits to assess the risk to consumers.
EPA considered toxicity limits for consumer exposure that reflect a short-term exposure such as might occur at home or in a store or other public setting where a member of the general public could be exposed and could then escape. Specific toxicity limits that we used in our analysis of consumer exposure include:
The analysis of consumer exposure assumed that 100 percent of the unit's charge would be released over one minute, at which time the concentration of refrigerant would peak in an enclosed space, and then steadily decline. Refrigerant concentrations were modeled under two air change scenarios, believed to represent the baseline of potential flow rates for a home or other public space, assuming flow rates of 0.11 and 0.67 ACH.
In comparison, the currently acceptable refrigerants typically have high acute exposure limits for their components based upon cardiotoxic effects of halocarbons over 10,000 ppm (
In summary, EPA's concerns about propylene and R-443A encompass both toxicity and exposure and impacts of these refrigerants on local air quality.
EPA proposes that this listing would apply 30 days after the date of publication of a final rule. To our knowledge, manufacturers and service technicians are not currently using these substitutes in the proposed end-uses. We note that EPA has only recently found submissions complete for these substitutes, and under the SNAP program regulations, a substitute may not be introduced into interstate commerce prior to 90 days after EPA receives a complete submission. Further, a date of 30 days after the date of publication of a final rule, the same as the proposed effective date of this regulation, would protect against the risks of these substitutes at the earliest opportunity.
DOE has indicated its intent to issue a proposed energy conservation standard for portable air conditioners, a subset of the residential and light commercial air conditioning and heat pumps end-use. For information on DOE's 2015 Fall Regulatory Agenda, see
EPA requests comment on all aspects of this proposal. In particular, we request comment on our proposal to list the refrigerants propylene (R-1270) and R-443A as unacceptable in new equipment in residential and light commercial AC and heat pumps, cold storage warehouses, and centrifugal and positive displacement chillers for commercial comfort AC. EPA specifically requests comment on the proposed decision to list these refrigerants as unacceptable 30 days after the date of publication of a final rule, and the end-uses proposed here.
As provided in the following table, EPA is proposing to change the status of numerous refrigerants from acceptable to unacceptable for new centrifugal chillers:
In the initial rule establishing the SNAP program (59 FR 13044; March 18, 1994), EPA included within the refrigeration and AC sector the end-use “commercial comfort air conditioning” and then elaborated on that end-use saying that “CFCs are used in several different types of mechanical commercial comfort AC systems, known as chillers.” EPA indicated “that over time, existing cooling capacity [from chillers] will be either retrofitted or replaced by systems using non-CFC refrigerants in a vapor compression cycle or by alternative technologies.”
Centrifugal chillers are equipment that utilize a centrifugal compressor in a vapor-compression refrigeration cycle. Centrifugal chillers are typically used for commercial comfort AC although other uses do exist. Centrifugal chillers can be found in office buildings, hotels, arenas, convention halls, airport terminals and other buildings. Centrifugal chillers tend to be used in larger buildings.
For commercial comfort and some other applications, centrifugal chillers typically cool water that is then pumped to fan coil units or other air handlers to cool the air that is supplied to the occupied spaces transferring the heat to the water. The heat absorbed by the water can then be used for heating purposes, and/or can be transferred directly to the air (“air-cooled”), to a cooling tower or body of water (“water-cooled”) or through evaporative coolers (“evaporative-cooled”). A centrifugal chiller or a group of centrifugal chillers could similarly be used for district cooling where the chiller plant cools water or another fluid that is then pumped to multiple locations being served such as several different buildings within the same complex. All such centrifugal chillers are covered by this section of the proposed rule.
Centrifugal chillers are used for other applications besides commercial comfort AC and are covered under this section of the proposed rule. For instance, centrifugal chillers used to cool equipment, such as in data centers, are covered under this section of the proposed rule.
Other equipment including packaged rooftop units and split system air conditioners, both of which fall under the SNAP end-use “household and light commercial air conditioning,” can also be used for commercial comfort AC, typically for smaller capacity needs. These equipment types are not centrifugal chillers and hence are not covered under this section of the proposed rule.
Centrifugal chillers historically employed either CFC-11 (called “low pressure chillers”) or CFC-12 (“high pressure chillers”), although other CFCs have been used, including CFC-114 and R-500 (a blend of CFC-12 and HFC-152a). When the production and consumption of CFCs were phased out in the United States in the 1990s, centrifugal chillers was one of the first end-uses to be redesigned for alternative refrigerants and HCFC-123 and HFC-134a became the primary refrigerants used in centrifugal chillers. HCFC-123 was used in low pressure chillers while HFC-134a was used in high pressure chillers. Both of these alternatives continue to be used today. HCFC-22 was also used in some centrifugal chillers, primarily only in equipment produced before approximately the year 2000. HFC-245fa was also identified as a possible refrigerant for low pressure centrifugal chillers, but has found only limited use.
More recently, centrifugal chillers that use alternatives listed as acceptable have been demonstrated or announced. For instance, one manufacturer has introduced centrifugal chillers using
For new centrifugal chillers, EPA is proposing to change the status of the following refrigerants from acceptable to unacceptable: FOR12A, FOR12B, HFC-134a, HFC-227ea, HFC-236fa, HFC-245fa, R-125/134a/600a (28.1/70/1.9), R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-423A, R-424A, R-434A, R-438A, R-507A, RS-44 (2003 composition), and THR-03.
For new centrifugal chillers, acceptable refrigerants for which we are not proposing a change of status in this end-use include: HFO-1234ze(E), IKON A, IKON B, R-450A, R-513A, R-717 (ammonia), THR-02, and trans-1-chloro-3,3,3-trifluoroprop-1-ene.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
The refrigerants for which we are proposing a change of status have an ODP of zero. Other alternatives also with an ODP of zero that we are not proposing a change of status for new centrifugal chillers include HFO-1234ze(E), IKON A, IKON B, R-450A, R-513A, R-717, and THR-02. Also, the alternative refrigerant
One of the refrigerant blends not subject to the proposed status change (THR-02), as well as several of the substitutes subject to the proposed status change, include small amounts of R-290 (propane), R-600 (butane) or other substances that are VOCs. These amounts are small and for this end-use are not expected to contribute significantly to ground level ozone formation.
The refrigerants not subject to the proposed status change are highly volatile and typically evaporate or partition to air, rather than contaminating surface waters. Their effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other refrigerants that are subject to the proposed status change for this end-use.
For the centrifugal chillers end-use, with the exceptions of HFO-1234ze(E) and R-717, all other refrigerants listed as acceptable, including those for which we are proposing to change the status to unacceptable, are not flammable. HFO-1234ze(E) is non-flammable at standard temperature and pressure using the standard test method ASTM E681; however, at higher temperatures it is mildly flammable. It is classified as a Class 2L (lower flammability, low burning velocity) refrigerant under the standard ASHRAE 34 (2013). Our assessment and listing decision (77 FR 47768; August 10, 2012) found that the overall risk, including the risk due to this mild flammability at elevated temperature, is not significantly greater than for other refrigerants or for the refrigerants we are proposing to list as unacceptable.
R-717 is slightly flammable with a low flame speed; it is classified as a 2L refrigerant under ASHRAE 34 (2013). R-717 has a long history of use in cold storage warehouses and other applications, but it is not believed to be used extensively in centrifugal chillers. In the original SNAP rule, EPA noted “[a]mmonia has been used as a medium to low temperature refrigerant in vapor compression cycles for more than 100 years. Ammonia has excellent refrigerant properties, a characteristic pungent odor, no long-term atmospheric risks, and low cost. It is, however, slightly flammable and toxic, although it is not a cumulative poison. OSHA standards specify a 15 minute short-term exposure limit of 35 ppm for ammonia.” (53 FR 13072; March 18, 1994). We further noted its use in various food and beverage processing and storage applications as well as other industrial applications. In that rule, we found R-717 acceptable for use in new centrifugal chillers, concluding that its overall risk to human health and the environment was not significantly greater than the other alternatives found acceptable. This conclusion was based on the assumption that the regulated community adheres to OSHA regulations on such use as well as standard refrigeration practices, such as the adherence to ASHRAE Standard 15, which is often utilized by local authorities when setting their own building and safety requirements.
For further information, including EPA's risk screens and risk assessments as well as information from the submitters of the substitutes, see docket EPA-HQ-OAR-2015-0663.
The toxicity of the refrigerants we are proposing to list as unacceptable is comparable to that of other alternatives that are acceptable in this end-use, with the exception of R-717. R-717, for which we are not proposing a change of status, is of a higher toxicity than some other refrigerants and is classified as a B refrigerant under ASHRAE 34 (2013). See section VI.A.4.a.iii.(b) for a discussion on the long history of use of R-717 and our original decision finding it acceptable in new centrifugal chillers. The other acceptable alternatives listed above that are included in ASHRAE 34 (2013) are classified as A (lower toxicity) refrigerants.
For all refrigerants, the relatively large charge sizes employed in centrifugal chillers, and the fact that some such chillers are placed in an enclosed mechanical room, raise a concern regarding oxygen displacement. This concern has been addressed over the long history of the use of centrifugal chillers, including the use of HCFC-123, another B refrigerant as classified by ASHRAE 34 (2013), by providing adequate ventilation, reducing leaks to small levels, and other techniques such as employing refrigerant sensors and automatic air movement. Commonly followed standards and practices have reduced toxicity concerns equally for historically used ODS, the alternatives for which we are proposing a status
EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the refrigerants whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the alternatives than for the refrigerants we are proposing to list as unacceptable, and the GWPs for the refrigerants we are proposing to list as unacceptable are significantly higher and thus pose significantly greater risk.
EPA is proposing a narrowed use limit that would allow continued use of HFC-134a in centrifugal compressor chillers for military marine vessels after the change of status date where reasonable efforts have been made to ascertain that other alternatives are not technically feasible due to performance or safety requirements. Under the narrowed use limit, the end user for this military application would need to ascertain that other alternatives are not technically feasible and document the results of their analysis. See 40 CFR 82.180(b)(3). For the military, there are several unique performance requirements related to marine vessel air conditioning systems that require extensive testing prior to qualifying alternatives for HFC-134a. The lower-GWP alternatives available or potentially available for use in commercial chillers either do not meet the military-unique requirements or will require longer testing, based on available program funding for testing, for military suitability. It will also then take additional time to redesign, qualify, and procure new chillers for military shipbuilding programs.
We anticipate that most centrifugal compressor chillers in military applications will be able to transition to acceptable alternatives by the proposed January 1, 2024 date. However, HFC-134a chillers are mission-critical equipment on ships and submarines, primarily in cooling of electronics, sensors, and weapon systems, but also cooling of ship spaces for personnel. Failure of the chillers would disable the ship. The equipment is not the same as commercial equipment and it is located in confined engineering spaces near other critical equipment, including conventional and nuclear propulsion plants. All major components are designed, tested and certified for military use (including the compressor, motor, evaporator, condenser, and electronic controls) and must meet military-unique requirements: Weapons effect shock resistance, stringent electromagnetic interference resistance, ship vibration resistance, all weather pitch and roll operation, low acoustic signature, arctic to tropical operations (at temperatures from 28 °F to 105 °F), compact to fit in confined warship spaces, 40 to 50 year service life, and very high reliability due to extended at-sea missions. Further challenges include installation on submarines with the inherent risk of refrigerant leakage and need for the refrigerant to be compatible with the submarine life support systems. Production for these equipment for naval ships and submarines is low volume with only one certified manufacturer, limited test facilities, and prototype hardware and designs shared among platforms for affordability and commonality. Another significant challenge lies in the fact that the testing program for the use of alternatives for ships has not yet been funded. Once funding is in place, the completion timeline to fund, test, qualify, and begin procurement on all Navy-unique surface ship chiller designs is estimated to be about ten years. Due to the unique challenges associated with submarines, including potential refrigerant incompatibility with life support systems, it may not be feasible to implement currently available alternatives being evaluated for surface ships. Given the limited population of submarine chillers, the resulting greenhouse gas emissions from refrigerant leakage in this application is not expected to be significant.
EPA is proposing a narrowed use limit that would allow continued use of HFC-134a and R-404A in centrifugal compressor chillers for human-rated spacecraft and related support equipment applications after the change of status date where reasonable efforts have been made to ascertain that other alternatives are not technically feasible due to performance or safety requirements. Under the narrowed use limit, the end user for this human-rated spacecraft and related support equipment application would need to ascertain that other alternatives are not technically feasible and document the results of their analysis. See 40 CFR 82.180(b)(3). HFC-134a and R-404A chillers are used to provide cooling to human-rated spacecraft and related support equipment during ground-based assembly, integration and test operations, and launch. The cooling of sensitive human-rated electrical equipment is critical to the spacecraft technical performance and crew safety. EPA understands that such programs use specialized ground coolant systems to provide heat transfer during certain ground operations. These coolant circulation systems use HFC-134a and R-404A chillers to meet the program's stringent performance and material compatibility requirements. Other alternatives currently listed as acceptable under the SNAP program have not yet been proven to provide appropriate heat transfer, material compatibility, stability in the test environment, and other critical properties necessary for use in human-rated spacecraft and related support equipment applications. Considering that identification, testing, and implementation of materials to be used in human-rated-spacecraft programs routinely take several years due to the challenging operational environment, lengthy qualification process associated with human rating, and the federal budgetary cycle, it may not be feasible to deploy centrifugal chillers using other alternatives in the proposed timeframe. Given the limited population of chillers used in human-rated spacecraft and related support equipment applications, the resulting greenhouse gas emissions from refrigerant leakage in this application is not expected to be significant.
Users of a restricted agent within the narrowed use limits category must make a reasonable effort to ascertain that other substitutes or alternatives are not technically feasible. Users are expected to undertake a thorough technical investigation of alternatives to the otherwise restricted substitute. Although users are not required to report the results of their investigations to EPA, users must document these results, and retain them in their files for the purpose of demonstrating compliance. This information includes descriptions of:
• Process or product in which the substitute is needed;
• Substitutes examined and rejected;
• Reason for rejection of other alternatives,
• Anticipated date other substitutes will be available and projected time for switching.
The Agency understands that relevant building standards and codes are likely to change in 2021. These include ASHRAE 15, UL 1995, UL 60335-2-40, and the International Building Code. The Agency believes some amount of
In addition, EPA has received communication from representatives of AHRI and NRDC requesting a change of status date of January 1, 2025, for HFC-134a, R-407C and R-410A, in all types of chillers.
DOE has established efficiency requirements, based on ANSI/ASHRAE/IES Standard 90.1-2010, for chillers used in federal buildings.
EPA requests comment on all aspects of this proposal. In particular, we request comment on a range of dates from January 1, 2022, through January 1, 2025, for the change of status of the identified substitutes. EPA requests comment and information on any potential environmental or other impacts of EPA adopting a date other than January 1, 2024, which is our lead option. In particular, EPA requests comment on whether other alternatives that reduce overall risk would be available prior to January 1, 2024 and for comment on any technical or other reasons that NRDC and AHRI proposed January 1, 2025 in their joint letter. EPA requests comment on the specific steps that must be undertaken to commercialize centrifugal chillers with alternative refrigerants, including the time each such step would take, which steps must occur in sequence, and which steps could occur in parallel. EPA requests comments on if and how this timing might vary based on the characteristics of the chiller, such as but not limited to, compressor type, capacity range, evaporator design, condenser design (
EPA requests comment on the current use of four refrigerants not subject to the proposed change of status,
Additionally, EPA requests comment on any energy efficiency performance impacts of using the refrigerants not subject to the change of status proposed today that could affect the ability of manufacturers to meet current energy efficiency requirements or standards for centrifugal chillers in the United States. Also, EPA requests comment on the ability of centrifugal chillers using refrigerants other than those for which we are proposing a status change to meet those energy efficiency requirements or standards. In particular, we request comment on the specific steps and timing of such steps required to design and develop centrifugal chillers to meet applicable federal energy efficiency requirements.
EPA is also requesting comment on the proposed narrowed use limitation for chillers on military marine vessels and human-rated spacecraft and related support equipment where the unique requirements would limit the availability and feasible use of alternatives not subject to the proposed status change.
As provided in the following table, EPA is proposing to change the status of numerous refrigerants from acceptable to unacceptable for new positive displacement chillers:
As discussed in section VI.A.4.a.i, vapor compression cycle chillers are divided into centrifugal chillers and positive displacement chillers. This section deals with positive displacement chillers, which are those that utilize positive displacement compressors such as reciprocating, screw, scroll or rotary types. Positive displacement chillers are applied in similar situations as centrifugal chillers, again primarily for commercial comfort AC, except that positive displacement chillers tend to be used for smaller capacity needs such as in mid- and low-rise buildings.
For commercial comfort and some other applications, positive displacement chillers typically cool water that is then pumped to fan coil units or other air handlers to cool the air that is supplied to the occupied spaces transferring the heat to the water. The heat absorbed by the water can then be used for heating purposes, and/or can be transferred directly to the air (“air-cooled”), to a cooling tower or body of water (“water-cooled”) or through evaporative coolers (“evaporative-cooled”).
Positive displacement chillers are used for other applications besides commercial comfort AC and are covered under this section of the proposed rule. For instance, positive displacement chillers used to cool equipment, such as in data centers, are covered under this section of the proposed rule.
Other equipment including packaged rooftop units and split system air conditioners, both of which fall under the SNAP end-use “household and light commercial air conditioning,” can also be used for commercial comfort AC, typically for even smaller capacity needs than positive displacement chillers. These equipment types are not positive displacement chillers and hence are not covered under this section of the proposed rule.
Positive displacement chillers historically used CFC-12, although HCFC-22 was also used and became more common after the production and consumption of CFC-12 were phased out. In accordance with CAA 605(a) and the implementing regulations codified at 40 CFR part 82, subpart A, in the United States, the use of newly manufactured HCFC-22 for new positive displacement chillers (and other new equipment) ceased as of January 1, 2010. Both R-407C and to a larger extent R-410A are used in new positive displacement chillers primarily in lower capacity ranges previously served by HCFC-22 chillers. HFC-134a is also used for new positive-displacement chillers, including some mid-level capacity water-cooled screw chillers.
More recently, positive displacement chillers that use alternatives listed as acceptable including HFO-1234ze(E) and R-513A (a blend of HFC-134a and HFO-1234yf) have been demonstrated or announced. EPA is aware of air-cooled rotary chillers in the 115 to 500 refrigeration ton (400 to 1,750 kW) range using R-513A.
For new positive displacement chillers, EPA is proposing to change the status of the following refrigerants from acceptable to unacceptable: FOR12A, FOR12B, HFC-134a, HFC-227ea, KDD6, R-125/134a/600a (28.1/70/1.9), R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-424A, R-434A, R-437A, R-438A, R-507A, RS-44 (2003 composition), SP34E, and THR-03.
For new positive displacement chillers, acceptable refrigerants for which we are not proposing a change of status in this end-use include: HFO-1234ze(E), IKON B, R-450A, R-513A, R-717, and THR-02.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
The refrigerants for which we are proposing to change the status to unacceptable have zero ODP and GWPs ranging from about 920 to 3,990. As shown in Table 8, other alternatives for which we are not proposing a change of status in this end-use have GWPs ranging from zero to 630.
One of the refrigerant blends not subject to the proposed status change (THR-02), as well as several of the substitutes subject to the proposed status change, include small amounts of R-290 (propane), R-600 (butane), or other substances that are VOCs. These amounts are small and for this end-use are not expected to contribute significantly to ground level ozone formation.
The refrigerants not subject to the proposed status change are highly volatile and typically evaporate or partition to air, rather than contaminating surface waters. Their effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other refrigerants that are subject to the proposed status change for this end-use.
For the positive displacement chillers end-use, with the exception of HFO-1234ze(E) and R-717, all other refrigerants listed as acceptable, including those for which we are proposing to change the status to unacceptable, are not flammable. HFO-1234ze(E) is non-flammable at standard temperature and pressure using the standard test method ASTM E681; however, at higher temperatures it is mildly flammable. It is classified as a Class 2L (lower flammability, low burning velocity) refrigerant under the standard ASHRAE 34 (2013). Our assessment and listing decision (77 FR 47768; August 10, 2012) found that the overall risk, including the risk due to this mild flammability at elevated temperature, is not significantly greater than for other refrigerants or for the refrigerants we are proposing to list as unacceptable. As noted above, a positive displacement chiller using this refrigerant has already been installed.
R-717 is slightly flammable with a low flame speed; it is classified as a 2L refrigerant under ASHRAE 34 (2013). R-717 has a long history of use as a refrigerant in positive displacement chillers, especially in water-cooled screw chillers, and other applications. In our evaluation finding R-717 acceptable in this end-use, EPA noted “Ammonia has been used as a medium to low temperature refrigerant in vapor compression cycles for more than 100 years. Ammonia has excellent refrigerant properties, a characteristic pungent odor, no long-term atmospheric risks, and low cost. It is, however, slightly flammable and toxic, although it is not a cumulative poison. Ammonia may be used safely if existing OSHA and ASHRAE standards are followed” (61 FR 47015).
With the exception of R-717, the toxicity of the refrigerants we are proposing to list as unacceptable is comparable to that of other alternatives that are acceptable in this end-use. R-717, for which we are not proposing a change of status, is of a higher toxicity than some other refrigerants and is classified as a B refrigerant under ASHRAE 34 (2013). See section VI.A.4.b.iii.(b) for a discussion on the long history of use of R-717 and our original decision finding it acceptable in new positive displacement chillers.
For all refrigerants, the possible relatively large charge sizes of some positive displacement chillers, and the fact that some such chillers are place in an enclosed mechanical room, raise a concern regarding oxygen displacement. This concern has been addressed over the long history of the use of positive displacement chillers by providing adequate ventilation, reducing leaks to small levels, and other techniques such as employing refrigerant sensors and automatic air movement. Commonly followed standards and practices have reduced toxicity concerns equally for historically used ODS, the alternatives subject to the proposed status change, and the alternatives not subject to the proposed status change.
EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the refrigerants whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the
EPA is proposing a narrowed use limit that would allow continued use of HFC-134a in positive displacement compressor chillers for military marine vessels after the change of status date where reasonable efforts have been made to ascertain that other alternatives are not technically feasible due to performance or safety requirements. Under the narrowed use limit, the end user for this military application would need to ascertain that other alternatives are not technically feasible and document the results of their analysis. See 40 CFR 82.180(b)(3). For the military, there are several unique performance requirements related to marine vessel air conditioning systems that require extensive testing prior to qualifying alternatives for HFC-134a. The lower-GWP alternatives available or potentially available for use in commercial chillers either do not meet the military-unique requirements or will require longer timeframes to test, based on available program funding for testing, for military suitability. It will also then take additional time to redesign, qualify, and procure new chillers for military shipbuilding programs. See additional information in section VI.A.4.a.iv above on centrifugal chillers.
EPA is proposing a narrowed use limit that would allow continued use of HFC-134a and R-404A in positive displacement compressor chillers for human-rated spacecraft and related support equipment applications after the change of status date where reasonable efforts have been made to ascertain that other alternatives are not technically feasible due to performance or safety requirements. Under the narrowed use limit, the end user for this human-rated spacecraft and related support equipment application would need to ascertain that other alternatives are not technically feasible and document the results of their analysis. See 40 CFR 82.180(b)(3). HFC-134a and R-404A chillers are used to provide cooling to human-rated spacecraft and related support equipment during ground-based assembly, integration and test operations, and launch. The cooling of sensitive human-rated electrical equipment is critical to the spacecraft technical performance and crew safety. EPA understands that such programs use specialized ground coolant systems to provide heat transfer during certain ground operations. These coolant circulation systems use HFC-134a and R-404A chillers to meet the program's stringent performance and material compatibility requirements. Other alternatives currently listed as acceptable under the SNAP program have not yet been proven to provide appropriate heat transfer, material compatibility, stability in the test environment, and other critical properties necessary for use in human-rated spacecraft and related support equipment applications. Considering that identification, testing, and implementation of materials to be used in human-rated spacecraft programs routinely take several years due to the challenging operational environment, lengthy qualification process associated with human rating, and the federal budgetary cycle, it may not be feasible to deploy positive displacement chillers using other alternatives in the proposed timeframe. Given the limited population of chillers used in human-rated spacecraft and related support equipment applications, the resulting greenhouse gas emissions from refrigerant leakage in this application is not expected to be significant.
Users of a restricted agent within the narrowed use limits category must make a reasonable effort to ascertain that other substitutes or alternatives are not technically feasible. Users are expected to undertake a thorough technical investigation of alternatives to the otherwise restricted substitute. Although users are not required to report the results of their investigations to EPA, users must document these results, and retain them in their files for the purpose of demonstrating compliance. This information includes descriptions of:
• Process or product in which the substitute is needed;
• Substitutes examined and rejected;
• Reason for rejection of other alternatives,
• Anticipated date other substitutes will be available and projected time for switching.
The Agency understands that relevant building standards and codes are likely to change in 2021. These include ASHRAE 15, UL 1995, UL 60335-2-40, and the International Building Code. The Agency believes some amount of time will be needed to meet the technical challenges for a safe and smooth transition to alternatives particularly considering the complexity of chiller designs and the need to ensure energy efficiency levels are met. EPA is considering a range of dates from January 1, 2022, through January 1, 2025, as the change of status date for new positive displacement chillers. Our lead proposal is a status change date of January 1, 2024, which we believe would allow development of designs of new positive displacement chillers using an acceptable alternative. We are aware that some equipment has been introduced with acceptable alternatives and that additional research and development is underway with these and other possible alternatives.
In addition, EPA has received communication from representatives of AHRI and NRDC requesting a change of status date of January 1, 2025, for HFC-134a, R-407C and R-410A, in all types of chillers. See section VI.A.4.a.v.
DOE has established efficiency requirements, based on ANSI/ASHRAE/IES Standard 90.1-2010, for chillers used in federal buildings.
EPA requests comment on all aspects of this proposal. In particular, we request comment on a range of dates from January 1, 2022, through January 1, 2025, for the change of status of the identified substitutes. EPA requests comment and information on any potential environmental or other impacts of EPA adopting a date other than January 1, 2024, which is our lead option. In particular, EPA requests comment on whether other alternatives that reduce overall risk would be available prior to January 1, 2024 and for comment on any technical or other reasons that NRDC and AHRI proposed January 1, 2025 in their joint letter. EPA requests comment on the specific steps that must be undertaken to commercialize positive displacement chillers with alternative refrigerants, including the time each such step would take, which steps must occur in sequence, and which steps could occur in parallel. EPA requests comments on if and how this timing might vary based on the characteristics of the chiller, such as but not limited to, compressor type,
Additionally, EPA requests comment on any energy efficiency performance impacts of using the refrigerants not subject to the change of status proposed today that could affect the ability of manufacturers to meet current energy efficiency requirements or standards for positive displacement chillers in the United States. Also, EPA requests comment on the ability of positive displacement chillers using refrigerants other than those for which we are proposing a status change to meet those energy efficiency requirements or standards. In particular, we request comment on the specific steps and timing of such steps required to design and develop positive displacement chillers to meet federal energy efficiency requirements.
EPA is also requesting comment on the proposed narrowed use limitation for chillers on military marine vessels and human-rated spacecraft and related support equipment where the unique requirements would limit the availability and feasible use of alternatives not subject to the proposed status change.
As provided in the following table, EPA is proposing to change the status of numerous refrigerants from acceptable to unacceptable for new cold storage warehouses.
Cold storage warehouses are temperature-controlled facilities used to store meat, produce, dairy and other products that are delivered to other locations for sale to the ultimate consumer. This end-use within the SNAP program describes an application of refrigeration equipment for an intended purpose, and hence the listings of acceptable and unacceptable refrigerants for this end-use apply regardless of the type of refrigeration system used. In addition to traditional vapor-compression cycle systems, EPA has found several not-in-kind systems acceptable for this end-use, including ammonia absorption, evaporative cooling, desiccant cooling, and Stirling cycle systems, which are not subject to the proposed status change.
Cold storage warehouses are usually deemed “private” or “public,” describing the relationship between the owner or operator of the cold storage warehouse and the owner of the products stored within. Private cold storage warehouses are ones owned by a company for the purpose of storing its products; for instance, a food producer, processor or shipper may own and operate a facility as a distribution point for its products. Likewise, a supermarket chain may own and operate a facility to control the distribution of a variety of products to multiple stores in a given region. A public cold storage warehouse provides storage for lease and hence may receive and hold products from multiple producers and for multiple supermarkets or other vendors. Some cold storage warehouses may be both public and private, with one part dedicated to the owner's products and another part available for lease. All such types of cold storage warehouses are included within the SNAP end-use.
Cold storage warehouses are also often divided into two general uses: Those storing products at temperatures above 32 °F (0 °C) and those storing products below this temperature. The former is referred to as a “cooler” while the term “freezer” is used for the latter. The 2014 ASHRAE Handbook of Refrigeration provides an additional cooler application called “controlled atmosphere for long-term fruit and vegetable storage” and three subdivisions of freezers: “high-temperature freezers” storing goods at 27 to 28 °F (−2.8 to −2.2 °C), “low-temperature storage rooms for general frozen products, usually maintained at −5 to −20 °F” (−21 to −29 °C), and low-temperature storage at the same temperature range as before but “with a surplus of refrigeration for freezing products received at above 0 °F” (−18 °C).
Several other end-uses under the SNAP program cover other parts of the food (and product) cold chain, and are distinct from the cold storage warehouse end-use. These are discussed here as examples of what EPA considers to be part of or separate from the “cold storage warehouse” end-use for which we are proposing changes of status.
Many food products require refrigeration during the production process. The application of refrigerating equipment used during the production of food and beverages falls within the SNAP end-use “industrial process refrigeration.” The industrial process refrigeration end-use would include all equipment and operations (that use a refrigerant) used to make and prepare food that is not immediately available for sale to the ultimate consumer and would require shipping it, possibly through intermediate points, to the point where such sale would occur. The industrial process refrigeration end-use could be applied at facilities where food is processed and packaged by the food producer. An example could be a meat processor that prepares and packages individual cuts of meat within a single facility or building while maintaining the required temperatures within that facility or building. Although such facilities may be designed in a fashion similar to a cold storage warehouse, the fact that items are being processed by the food producer indicates that the application falls in the industrial process refrigeration end-use. However, if a food producer operates a refrigerated storage area solely for the holding of already packaged products, and possibly packing such products in larger containers or bundles for shipment, that application would fall under the cold-storage warehouse end-use. In the
Another example of an industrial process refrigeration system is a “blast cooler” or “blast freezer.” As described previously in a separate SNAP rulemaking “[a] `blast chiller' or `blast freezer' is a type of equipment in which cold air is supplied and circulated rapidly to a food product, generally to quickly cool or freeze a product before damage or spoilage can occur.” (80 FR 42901; July 20, 2015). Such devices might be used as part of a food production line in an industrial setting. They also can be placed separately at public facilities including hospitals, schools, restaurants and supermarkets. These public facilities might use the blast chiller on products that they will store for later use after they receive products from a vendor or that they cook or prepare as part of their operations. Such units might also be placed near entranceways to cold storage warehouses, for instance to receive food shipped refrigerated at one temperature and bring it down to a lower temperature for storage. EPA does not consider a separate blast chiller or blast freezer (
As discussed in section VI.A.4.d, because products from refrigerated food processing and dispensing equipment are generally available for sale to the ultimate consumer, that end-use category, part of the retail food refrigeration end-use, is distinct from industrial process refrigeration.
Another application in the food cold chain is the use of a “cold room” at a retail facility where refrigerated food is kept generally for short periods of time. In the July 20, 2015, final rule (80 FR 42870), EPA changed the status of certain refrigerants used in “remote condensing units” and “stand-alone systems,” two categories within the “retail food refrigeration” end-use that include equipment that can be used for such cold rooms. Remote condensing units may include a dedicated one- or two-compressor system with condensers located on a roof or the side of a building providing cooling through unit coolers to an insulated room, for instance in a restaurant or supermarket, that are built and charged with refrigerant at the site. Also, some cold rooms are stand-alone systems that are pre-charged at the factory and ready to use once placed at the retailer's facility and provided with electrical and possibly plumbing connections, and are accessed via a door to store refrigerated products. In general, both types of applications are often called “walk-in coolers” or “walk-in freezers,” depending on the design temperature.
Such cold rooms are used to store products at required temperatures until sale to the ultimate consumer, such as a shopper in a supermarket or a diner in a restaurant. In some cases, one side of the room is fitted with glass doors and racks where the owner stacks products on the racks and the consumer obtains the product from the rack. In other cases, the cold room is only accessible by employees of the retail food establishment. For these applications, even if this equipment is not accessible to the public—for instance, it is in the back of a supermarket and holds products that are later brought to display cases from which customers obtain the products; or in the back of a restaurant where a cook takes and prepares the food that is brought to the diner by a waiter—it is considered part of the retail establishment and hence is part of the “retail food refrigeration” end-use and is not included in the “cold storage warehouse” end-use. The changes of status proposed in this action would not apply to such “cold rooms,” “walk-in coolers,” or “walk-in freezers;” however, EPA refers the reader to a previous rulemaking that does apply (80 FR 42870; July 20, 2015).
R-717 is believed to be the most common refrigerant used in cold storage warehouses. While R-717 is not used extensively in many other types of refrigeration and air-conditioning equipment, certain characteristics of cold storage warehouses have facilitated the widespread use of that refrigerant in this end-use. For example, because cold storage warehouses are often large in size for economies of scale reason and require a large amount of land use—as opposed to other systems that might be located on a building roof or a small slab next to the building—they are typically located away from population centers where land costs and taxes may be higher. Also, because they often service multiple retail locations and may receive goods from multiple producers, cold storage warehouses are often sited where major transportation services (
Limitations on the use of R-717 do exist. For example, it is reported that charge sizes exceeding 10,000 pounds of R-717 “may require government-mandated process safety management (PSM) and [a] risk management plan (RMP)”.
Some of the limitations on the use of R-717 in cold storage warehouses may be overcome with system designs that have been introduced or have been more fully explored recently. These include low charge packaged R-717 systems, R-717/R-744 cascade systems, and indirect secondary-loop systems using R-717 as the primary refrigerant in a machine room separated from the cooled interior. These systems are described in market characterizations found in the docket to
Where R-717 was not used, cold storage warehouses traditionally used CFC-12, R-502 and HCFC-22. With the 1996 CFC phaseout, and the restriction on the use of newly manufactured HCFC-22 in new equipment that took effect January 1, 2010, R-404A or R-507A are generally used when R-717 is not chosen. Two nonflammable HFC/HFO blends, R-448A and R-449A, are designed to perform similarly to R-404A and R-507A and are under investigation for this use. EPA also notes that a major retailer recently announced progress on implementing HFC-free food distribution centers.
For new cold storage warehouses, EPA is proposing to change the status of the following refrigerants from acceptable to unacceptable: HFC-227ea, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-423A, R-424A, R-428A, R-434A, R-438A, R-507A, and RS-44 (2003 composition).
EPA understands that existing cold storage warehouses may undergo expansion to handle needs such as increased production, consolidation of distribution points, or increased population or other reasons for increased demands of the products stored. Such expansions could include a physical expansion of the storage space or using racking techniques to increase the amount of product within a given facility. The owner of cold storage warehouses undergoing such expansions (or the owner's designer) may determine that a new system needs to be added. That new system could be a complete newly manufactured system separate from the existing system, or it could be equipment and refrigerant added to the existing system increasing the capacity of the existing system. In both cases, EPA considers these actions as the manufacturing of a new system and hence that equipment could be affected by the proposed changes of status, as explained further below.
EPA addressed the difference between a “new” and “retrofit” system as used in the SNAP program in a previous rule (80 FR 42902-42903; July 20, 2015). As used in the SNAP program, “new” refers to the manufacture and often installation of a refrigeration system, which may occur on a newly manufactured or an existing cold storage warehouse. This proposed action would apply to expansion of the refrigeration system in an existing cold storage warehouse as being designated a “new” system if the capacity of that existing refrigeration system is increased to handle the expansion. On the other hand, if an existing refrigeration system is extended (for instance, by adding additional refrigerant lines and evaporators to a newly manufactured or newly commissioned building, to a portion of the existing facility previously not used for cold storage, or to an extension of the previous building), without requiring an increase in capacity, the system is not considered “new” and hence may continue its operations with the existing refrigerant. Likewise, a facility may increase the amount of products it handles while at the same time providing better sealing around infiltration points and/or increasing the insulation on walls and roofs, and thereby avoid the need to increase the refrigeration capacity of the equipment serving the cold storage warehouse. EPA requests comment on the definition of “new” and how it applies to cold storage warehouses. In particular, EPA requests comments on the likelihood and frequency that existing cold storage warehouses are expanded and whether it is typical to utilize or expand the existing refrigeration system to address the increased load from the facility expansion or whether it is typical to install a new system specifically to handle that expansion.
For new cold storage warehouses, acceptable refrigerants for which we are not proposing a change of status in this end-use include: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-407C, R-407F, R-437A, R-450A, R-513A, R-717, R-744, RS-24 (2002 composition), SP34E, THR-02, and THR-03.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
The refrigerants we are proposing to find unacceptable through this action have zero ODPs, but they have GWPs ranging from 2,090 to 3,990. As shown in Table 10, acceptable alternatives have GWPs ranging from zero to 1,820.
Some of the refrigerant blends not subject to the proposed status change, as well as several of the substitutes subject to the proposed status change, include small amounts of R-290, R-600, or other substances that are VOCs. These amounts are small and for this end-use, are not expected to contribute significantly to ground level ozone formation.
The refrigerants not subject to the proposed status change are highly volatile and typically evaporate or partition to air, rather than contaminating surface waters. Their effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other refrigerants that are subject to the proposed status change for this end-use.
For the cold storage warehouse end-use, with the exception of R-717, the acceptable refrigerants not subject to proposed changes of status, as well as those that are subject to proposed changes of status, are not flammable. R-717 is slightly flammable with a low flame speed; it is classified as a 2L refrigerant under ASHRAE 34 (2013). R-717 has a long history of use as a refrigerant in cold storage warehouses and other applications. In the original SNAP rule, EPA noted “[a]mmonia has been used as a medium to low temperature refrigerant in vapor compression cycles for more than 100 years. Ammonia has excellent refrigerant properties, a characteristic pungent odor, no long-term atmospheric risks, and low cost. It is, however, slightly flammable and toxic, although it is not a cumulative poison. OSHA standards specify a 15 minute short-term exposure limit of 35 ppm for ammonia.” (53 FR 13072; March 18, 1994). We further noted its use in various food and beverage processing and storage applications as well as other industrial applications. In that rule, we found R-717 acceptable for use in new cold storage warehouses, concluding that its overall risk to human health and the environment was not significantly greater than the other alternatives found acceptable. This conclusion was based on the assumption that the regulated community adheres to OSHA regulations on such use as well as standard refrigeration practices, such as the adherence to ASHRAE Standard 15, which is often utilized by local authorities when setting their own building and safety requirements.
For the cold storage warehouse end-use, with the exception of R-717, the acceptable refrigerants not subject to the proposed status change, as well as those that are subject to the proposed status change, are of low toxicity (
EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the refrigerants whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the alternatives than for the refrigerants we are proposing to list as unacceptable, and the GWPs for the refrigerants we are proposing to list as unacceptable are significantly higher and thus pose significantly greater risk.
EPA is proposing a change of status date for new cold storage warehouses of January 1, 2023, which the Agency believes is the earliest date by which the technical challenges can be met for a safe and smooth transition to alternatives, particularly considering the various equipment types that could be employed to provide the cooling necessary for new cold storage warehouses and the requirement for many of these equipment types to meet energy conservation standards while undergoing such a transition. Given the widespread use of other acceptable alternatives, particularly R-717, EPA expects that only a limited number of new cold storage warehouses, including expansions at existing facilities, would otherwise have been designed to use one of the alternatives for which we are proposing a change of status. Nonetheless, because of the restrictions that may apply on the use of ammonia at the local level, and the variety of equipment that could be applied at a cold storage warehouse, EPA expects that this period of time is necessary until acceptable alternatives will become available for cold storage warehouses. HFC blends, primarily R-404A and R-507A, like CFCs and HCFCs in the past, may have been used where R-717 was deemed by the owner as impractical, costly, onerous and/or too risky to use, given the restrictions that might exist in certain locations or for certain applications. For such locations and applications, the cold storage warehouse industry may need the time proposed to develop equipment with other alternative refrigerants or address the issues that exist with R-717 and the other alternatives that are not subject to the proposed change in status. As explained below, certain types of equipment potentially applied in cold storage warehouses are subject to energy conservation standards, and hence time will be required to design, test and certify equipment for those standards, while at the same time using acceptable alternatives.
EPA is not aware of other federal rules applying to efficiency of cold storage warehouses (
DOE recently issued a pre-publication version of a direct final rule affecting CUACs and CUHPs (see docket numbers EERE-2013-BT-STD-0007 and EERE-2013-BT-STD-0021). DOE's standards require that minimum energy efficiency levels be met by January 1, 2018 and that a second phase of minimum energy efficiency levels be met by January 1, 2023. The 2023 date was chosen by the Appliance Standards and Rulemaking Federal Advisory Committee Working Group as a time when alternative refrigerants could be adopted during design modifications for the second phase of DOE's minimum energy efficiency levels. In adopting a 2023 date, DOE stated “In recognition of the issues related to alternative refrigerants, members of the Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC) Working Group agreed as part of the Term Sheet to delay implementation of the second phase of increased energy conservation standard levels until January 1, 2023, in part to align dates with potential refrigerant phase-outs and to provide sufficient development lead time after safety requirements for acceptable alternatives have been established.” (
DOE issued a final rulemaking on June 3, 2014 (79 FR 32049) that set nineteen energy conservation standards for walk-in coolers and walk-in freezers with a compliance date of June 5, 2017. Due to litigation regarding this rulemaking, DOE vacated six of those standards for refrigeration systems and is currently engaged in a negotiated rulemaking to address the standards as referenced in the agency's technical amendments final rulemaking (80 FR 69837, November 12, 2015). For purposes of the DOE regulations, the Energy Conservation Act 42 U.S.C. 6311(20) defines walk-in coolers and walk-in freezers as having a total chilled storage area of less than 3,000 square feet. EPA considers the vast majority of such equipment to fit within the retail food refrigeration end-use, rather than the cold storage warehouse end-use. As described in the July 20, 2015 SNAP final rule, walk-in coolers and walk-in freezers as pertaining to DOE regulations could fall in the SNAP retail food refrigeration end-use category “supermarket system” (
EPA requests comment on all aspects of this proposal. In particular, we request comment on the types and subdivisions of cold storage warehouses explained here and whether other subdivisions of the end-use should be considered for this action. In particular, EPA requests comments on whether different alternatives are used or are otherwise available for different types of cold storage warehouses, why such differences exist, and whether the proposed change of status decisions, including the date such changes occur, might be affected considering such differences.
EPA requests comment on the proposed decision to change the status of the identified substitutes to unacceptable on January 1, 2023, and on the specific steps that must be undertaken to commercialize cold storage warehouse refrigeration equipment with alternative refrigerants, including the time each such step would take, which steps must occur in sequence, and which steps could occur in parallel. EPA requests comments on if and how this timing might vary based on the characteristics of the cold storage warehouse and application of the equipment. Such characteristics could include but are not limited to the equipment and system design (
Additionally, EPA requests comment on any energy efficiency performance impacts of using the refrigerants not subject to the change of status proposed today that could affect the ability of manufacturers to meet current energy efficiency requirements or standards for cold storage warehouses in the United States. Also, EPA requests comment on the ability of cold storage warehouses using refrigerants other than those for which we are proposing a status change to meet those energy efficiency requirements or standards. In particular, we request comment on the specific steps and timing of such steps required to design and develop cold storage warehouses to meet applicable federal energy efficiency requirements.
EPA requests comment on the distinctions made here between cold storage warehouses and other SNAP end-uses. In particular, EPA requests comments on whether such distinctions are clear and if not, comments on how to make such distinctions clear so that they are understood by the regulated community.
EPA requests comment on the definition of “new” and how it applies to cold storage warehouses. In particular, EPA requests comments on the likelihood and frequency that existing cold storage warehouses are expanded and whether it is typical to utilize or expand the existing refrigeration system to address the increased load from the facility expansion or whether it is typical to install a new system specifically to handle that expansion.
EPA also requests comment on the current and expected use of refrigerants in cold storage warehouses. In particular, we request comment on the continued use of ODS and on the use of the HFCs for which we propose a change of status. We request comment on the factors that led to the decision to use those refrigerants as opposed to other refrigerants for which we are not proposing a change of status, including especially R-717, which as explained above has been used widely in this end-use. We request comment on the use of other alternatives, including the ones for which we are not proposing a change of status and others that may be in development, and the expected availability and penetration into the cold storage warehouse market for such alternatives. Two nonflammable HFC/HFO blends, R-448A and R-449A, are designed to perform similarly to R-404A and R-507A and are under investigation for this use. EPA requests comment on the status of such investigations and results seen to date.
We request comment on our interpretation that there may be some overlap between EPA's proposed status change in cold storage warehouses and DOE's regulatory activity on walk-in coolers and walk-in freezers, as discussed in section VI.A.4.c.v above.
As provided in the following table, EPA is proposing to change the status of numerous refrigerants from acceptable to unacceptable for new retail food refrigeration (refrigerated food processing and dispensing equipment):
In the SNAP July 20, 2015, final rule (80 FR 42870), EPA clarified in the response to comments that “equipment designed to make or process cold food and beverages that are dispensed via a nozzle, including soft-serve ice cream machines, ‘slushy’ iced beverage dispensers, and soft-drink dispensers” was not included as part of the retail food refrigeration end-use categories specifically identified in that final rule. In the July 20, 2015, final rule, EPA clarified that this equipment is part of a separate end-use category within the retail food refrigeration end-use—“refrigerated food processing and dispensing equipment.” A variety of food and beverage products are dispensed and often processed by equipment within this end-use category, including but not limited to: Chilled and frozen beverages (carbonated and uncarbonated, alcoholic and nonalcoholic); frozen custards, gelato, ice cream, Italian ice, sorbets and yogurts; milkshakes, “slushies” and smoothies, and whipped cream. For instance, some such equipment will process the product by combining ingredients, mixing and preparing it at the proper temperature, while others function mainly as a holding tank to deliver the product at the desired temperature or to deliver chilled ingredients for the processing, mixing and preparation. Some may use a refrigerant in a heat pump, or utilize waste heat from the cooling system, to provide hot beverages. Some may also provide heating functions to melt or dislodge ice or for sanitation purposes.
We noted in the July 20, 2015, final rule that refrigerated food processing and dispensing equipment “can be self-contained or can be connected via piping to a dedicated condensing unit located elsewhere” (80 FR 42902) and clarify here that both types fall within this end-use category. The equipment can be air-cooled although in some cases where multiple units are together and/or other space constraints exist (and hence air movement to the condenser would be compromised), a separate water line could be used to remove heat.
This end-use category does not include certain types of refrigeration equipment. For example, units designed solely to cool and dispense water, including those that feature detachable containers of water as well as those that are supplied directly from a shared water supply, fall under the separate “Water Coolers” end-use within the SNAP program. In addition, this end-use category does not include the preparation of chilled products in factory situations; such equipment falls under the SNAP end-use “Industrial Process Refrigeration” and are characterized as being those that do not provide products to the ultimate consumer for immediate or near-immediate consumption. Also included in the industrial process refrigeration end-use are blast chillers and freezers, including those that may be used at consumer settings such as schools, hotels, supermarkets, hospitals, restaurants, etc. Further, this end-use category does not include the equipment used to transport food products between distinct points of production and storage, such as refrigerated trucks that may transport products from a factory to a cold storage warehouse or from that warehouse to a supermarket or restaurant. That type of equipment falls under the SNAP end-use “Refrigerated Transport.”
As part of the retail food refrigeration end-use, any alternative that has been listed broadly acceptable for the retail food refrigeration end-use, as opposed to being listed for only an individual end-use category within the retail food end-use, is likewise acceptable for this end-use category. For example, because R-744 was found acceptable for the retail food refrigeration end-use (74 FR 50129; September 30, 2009), it is acceptable for the refrigerated food processing and dispensing equipment category within the retail food refrigeration end-use. Those alternatives that have been found broadly
For new refrigerated food processing and dispensing equipment, EPA is proposing to change the status of the following refrigerants from acceptable to unacceptable: HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-44 (2003 formulation).
For new retail food refrigeration (refrigerated food processing and dispensing equipment), acceptable refrigerants for which we are not proposing a change of status in this end-use category include: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, R-426A, RS-24 (2002 formulation), R-450A, R-744, SP34E, THR-02 and THR-03.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
The refrigerants for which we are proposing a change of status through this action have zero ODP, but they have GWPs ranging from 1,770 to 3,990. As shown in Table 12, acceptable alternatives have GWPs ranging from one to 1,510.
Some of the refrigerant blends not subject to the proposed status change, as well as several of the substitutes subject to the proposed status change, include small amounts of VOC such as R-290 (propane) and R-600 (butane). These amounts are small, and for this end-use are not expected to contribute significantly to ground level ozone formation.
The refrigerants not subject to the proposed status change are highly volatile and typically evaporate or partition to air, rather than contaminating surface waters. Their effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other refrigerants that are subject to the proposed status change for this end-use.
For the retail food refrigeration (refrigerated food processing and dispensing equipment) end-use category, all other refrigerants, including those for which we are proposing to change the status to unacceptable, are not flammable (
Toxicity is not a significant concern for the refrigerants we are proposing to list as unacceptable. Their toxicity is comparable to that of other alternatives that are acceptable in this end-use. For the retail food refrigeration (refrigerated food processing and dispensing equipment) end-use category, all other refrigerants, including those for which we are proposing to change the status to unacceptable, are of lower toxicity (
EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the refrigerants whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the alternatives than for the refrigerants we are proposing to list as unacceptable, and the GWPs for the refrigerants we are proposing to list as unacceptable are significantly higher and thus pose significantly greater risk.
EPA is proposing a change of status date for new retail food refrigeration (refrigerated food processing and dispensing equipment) of January 1, 2021, which the Agency believes is the earliest date by which the technical challenges can be met for a safe and smooth transition to alternatives particularly considering the need for equipment to comply with any sanitation, safety and energy conservation standards while continuing to maintain the properties, characteristics and quality of the food or beverage provided by the equipment. EPA recognizes that some manufacturers will need time to test alternative refrigerants and develop equipment to use them while meeting other standards that may apply. We find however that components for some refrigerants, such as HFC-134a, are in wide supply. Further, as noted in our July 2015 rule, at least one major beverage retailer has chosen R-744 as its alternative refrigerant for stand-alone equipment and vending machines. Given the change of status dates established for such products in that rule (from January 1, 2018 to January 1, 2020) precede the change of status date we are proposing here, we expect an increasing supply of R-744 components that could be utilized in refrigerated food processing and dispensing equipment. We note that two substitutes are currently awaiting SNAP review for this end-use. These two substitutes, R-448A and R-449A, are designed to mimic R-404A and could be readily adapted to those refrigerants if they are listed as acceptable in the future. As discussed below, there are other relevant requirements that mean that newly designed equipment will need to be certified as complying with sanitation and safety standards, and some may be required to meet energy conservation standards issued by DOE. These standards apply to similar equipment that falls within other end-use categories of the retail food refrigeration end-use, and changes of status for those end-use categories take effect January 1, 2020, or before. Those requirements will provide additional incentive for refrigerant producers to increase low-GWP refrigerant supply, for component manufacturers to test and qualify components for such low-GWP refrigerants, and for manufacturers to gain the technical knowledge necessary to successfully implement those refrigerants. Hence, we foresee that additional equipment using similar low-GWP refrigerants, and using components that are expected to become available, could be similarly transitioned in a similar amount of time as finalized for those other end-use categories.
EPA is not aware of any energy conservation standards issued by DOE that apply to refrigerated food processing and dispensing equipment. EPA also understands that food safety and sanitation standards, such as those from the U.S. Food and Drug Administration and the National Sanitation Foundation (NSF), as well as product safety standards, such as those from UL, apply.
EPA requests comment on all aspects of this proposal. In particular, we request comment on the refrigerant(s) used for equipment in this end-use category, and detailed descriptions of the functions and why a particular refrigerant is used. We also seek comment on the applicability, technical feasibility, research, development and use of HCs, HFC/HFO blends, R-744 or other low-GWP alternatives for equipment within this end-use category. Additionally, we request comment on applicable standards for equipment used in the United States as well as those that apply to products that are pre-charged with refrigerant and exported to other countries and specifically request comment on how those standards may affect when equipment can be transitioned away from the alternatives we are proposing to list as unacceptable. Likewise, we request comment on DOE energy conservation standards and other federal requirements that apply to this equipment.
Additionally, EPA requests comment on any energy efficiency performance impacts of using the refrigerants not subject to the change of status proposed today that could affect the ability of manufacturers to meet current energy efficiency requirements or standards for refrigerated food processing and dispensing equipment in the United States. Also, EPA requests comment on the ability of refrigerated food processing and dispensing equipment using refrigerants other than those for which we are proposing a status change to meet those energy efficiency requirements or standards. In particular, we request comment on the specific steps and timing of such steps required to design and develop refrigerated food processing and dispensing equipment to meet applicable federal energy efficiency requirements.
EPA requests detailed comment on the proposed decision to change the status of the identified substitutes to unacceptable on January 1, 2021, and on the specific steps that must be undertaken for refrigerated food processing and dispensing equipment with alternative refrigerants to be available, including the time each such step would take, which steps must occur in sequence, and which steps could occur in parallel. EPA requests comments on if and how this timing might vary based on the characteristics of the equipment. Such characteristics could include, but are not limited to, compressor type, condenser design (
Additionally, EPA requests comment on our description of this end-use category to ensure it is sufficiently understood particularly by those in the equipment manufacturing and equipment servicing industry. For example, are there other technical factors that should be used to describe this end-use category? In particular, do such factors describe equipment types that are sufficiently distinct such that they are better described as two separate end-use categories (
As provided in the following table, EPA is proposing to change the status of numerous refrigerants from acceptable to unacceptable for new household refrigerators and freezers:
Household refrigerators, freezers and combination refrigerator/freezers are intended primarily for residential use, although they may be used outside the home. The designs and refrigeration capacities of equipment vary widely. Household refrigerators and freezers are composed of three main categories of equipment. Household freezers only offer storage space at freezing temperatures, while household refrigerators only offer storage space at non-freezing temperatures. Products with both a refrigerator and freezer in a single unit are most common. In addition to the most common types, other small refrigerated household appliances exist (
The 2014 ASHRAE Handbook of Refrigeration provides an overview of food preservation in regards to household refrigerators and freezers. Generally, a storage temperature between 32 and 39 °F (0 to 3.9 °C) is desirable for preserving fresh food. Humidity and higher or lower temperatures are more suitable for certain foods and beverages. Wine chillers, for example, are frequently used for storing wine, and have slightly higher optimal temperatures from 45 to 65 °F (7.2 to 18.3 °C). Freezers and combination refrigerator-freezers that are designed to store food for long durations have temperatures below 8 °F (−13.3 °C) and are designed to hold temperatures near 0 to 5 °F (−17.7 to −15 °C). In single-door refrigerators, the optimum conditions for food preservation are typically warmer than this due to the fact that food storage is not intended for long-term storage.
The following alternatives are currently acceptable for new household refrigerators and freezers: FOR12A, FOR12B, HFC-134a, HFC-152a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-290, R-404A, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-427A, R-428A, R-434A, R-437A, R-438A, R-441A, R-450A, R-513A, R-507A, R-600a, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02 and THR-03. Of those, R-290, R-441A and R-600a are acceptable subject to use conditions.
Currently, the most commonly used refrigerant in the United States for household refrigerators and freezers is R-134a, a HFC with a GWP of 1,430. However, throughout many parts of the world, R-600a with a GWP of 8 is the most commonly used refrigerant and there are ongoing efforts to help facilitate the adoption and continued use of R-600a in this industry.
EPA previously found a number of flammable HC refrigerants including R-290, R-441A and R-600a as acceptable, subject to use conditions in household refrigerators and freezers (76 FR 78832, December 20, 2011; 80 FR 19454, April 10, 2015). Hydrocarbon refrigerants have been in use for over 20 years in countries such as Germany, the United Kingdom, Australia, and Japan.
For new household refrigerators and freezers, EPA is proposing to change the status of the following refrigerants from acceptable to unacceptable: FOR12A, FOR12B, HFC-134a, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, and THR-03.
For new household refrigerators and freezers, acceptable refrigerants for which we are not proposing a change of status in this end-use include: HFC-152a, IKON A, IKON B, and THR-02; two HFC/HFO blends R-513A and R-450A; and HC refrigerants R-290, R-441A and R-600a.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
The refrigerants we are finding unacceptable through this action also have zero ODP, but they have GWPs ranging from 920 to 3,990. As shown in Table 14, other alternatives, some of which are acceptable subject to use conditions, have GWP ranging from three to 630.
Three substitutes that remain acceptable subject to use conditions, R-290, R-600a, and R-441A, are or are composed primarily of VOC. EPA's analysis indicates that their use as refrigerants in this end-use are not expected to contribute significantly to ground level ozone formation.
The refrigerants not subject to the proposed status change are highly volatile and typically evaporate or partition to air, rather than contaminating surface waters. Their effects on aquatic life are expected to be small and pose no greater risk of aquatic or ecosystem effects than those of other refrigerants that are subject to the proposed status change for this end-use.
For household refrigerators and freezers, with the exception of HFC-152a, R-290, R-600a and R-441A, all other refrigerants listed as acceptable, including those for which we are proposing to change the status to unacceptable, are not flammable. The HCs R-290 and R-600a are classified as Class A3 (lower toxicity, higher flammability) refrigerants under the standard ASHRAE 34 (2013) while HFC-152a is classified as Class A2 (lower toxicity, lower flammability). To address flammability, EPA listed these HCs as acceptable, subject to use conditions. The use conditions include conditions consistent with industry standards, limits on charge size, and requirements for warnings and markings on equipment to inform consumers and technicians of potential flammability hazards. Our assessment and listing decisions (76 FR 78832; December 20, 2011 and FR 80 1954; April 10, 2015) found that the overall risk, including the risk due to flammability with the use conditions, is not significantly greater than for other refrigerants at that time and likewise are not significantly greater than for the refrigerants we are proposing to list as unacceptable. EPA found HFC-152a acceptable for new household refrigerators and freezers in the original SNAP rule indicating “[a]lthough HFC-152a is flammable, a risk assessment demonstrated it could be used safely in this end-use” (59 FR 13081; March 18, 1994).
Toxicity is not a significant concern for the refrigerants we are proposing to list as unacceptable. Their toxicity is comparable to that of other alternatives that are acceptable in this end-use. The refrigerants subject to the proposed status change and the refrigerants not subject to the proposed status change, if listed under ASHRAE 34 (2013), are classified as A refrigerants (lower toxicity).
EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the refrigerants whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the alternatives than for the refrigerants we
EPA is proposing a change of status date for new household refrigerators and freezers of January 1, 2021, by this date the Agency believes the technical challenges can be met for a safe and smooth transition to alternatives, particularly considering the likely use of alternatives that are acceptable subject to use conditions such as isobutane or propane. As noted above, most experts, including the TEAP, anticipate the majority of the household refrigeration market will use HC refrigerants globally and EPA does not have information suggesting anything different for the United States. Although some models may be able to transition in compliance with use conditions required for alternatives earlier, the Agency believes that most can transition by 2021.
EPA recognizes that manufacturers will need time to continue product design work for alternative refrigerants, drawing from current models used both in the United States and elsewhere. Household refrigerators are subject to DOE energy conservation standards and will need to be tested to demonstrate compliance with those standards. We understand that there may be limitations with regards to the availability of testing facilities. If the proposed change of status date was exceedingly ahead of the next anticipated DOE energy conservation standard date, it could affect the availability of testing facilities. DOE's previous energy conservation rulemaking for this end-use was finalized in 2011 with a compliance date of September 15, 2014 (76 FR 57516; September 15, 2011). EPA anticipates that any amended standard set by DOE for these products in an upcoming rulemaking will, consistent with prior rulemakings, have a compliance date several years following issuance of the standard and thus we expect that the compliance date would be no earlier than 2020. As a result, EPA's proposed change of status in 2021 likely would occur at approximately the same time as a compliance date for the next future DOE energy conservation standard for these products.
DOE energy conservation standards apply to household refrigerators and freezers, as discussed in section VI.A.4.e.iv.
EPA requests comment on all aspects of this proposal. In particular, we request comment on the proposed change of status date of January 1, 2021. In particular, EPA requests comments on the specific steps that must be undertaken to commercialize household refrigerators and freezers with alternative refrigerants in the United States, including the time each step would take, which steps must occur in sequence, and which steps could occur in parallel. EPA requests comments on how and if this timing might vary based on the characteristics of the household refrigerator and freezer. Such characteristics could include, but are not limited to, capacity range, internal volume, design (
EPA is proposing to list HFO-1234yf as acceptable, subject to use conditions, in MVAC systems for newly manufactured MDPVs, HD pickup trucks, and complete HD vans. EPA is proposing to list HFO-1234yf as acceptable, subject to use conditions, for use in complete HD vans; we also are requesting comment and information on listing HFO-1234yf as acceptable subject, to use conditions for some incomplete HD vans. At this time, our proposal only includes complete HD vans because we do not have sufficient information on the potential for modifications to OEM-installed MVAC systems of incomplete HD vans by secondary and tertiary manufacturers and the impact of those modifications on safe use of HFO-1234yf. The use conditions are detailed below in section V.B.1.c, “What are the proposed use conditions?”
The vehicle types within the MVAC end-use that are addressed in today's proposal include limited types of heavy-duty (HD) vehicles, specifically, MDPVs,
HD vehicles are often subdivided by vehicle weight classifications, as defined by the vehicle's gross vehicle weight rating (GVWR), which is a measure of the combined curb (empty) weight and cargo carrying capacity of the truck. HD vehicles have GVWRs above 8,500. Table 15 outlines the HD vehicle weight classifications commonly used. MDPVs,
The types of HD vehicles for which EPA is proposing to list HFO-1234yf as acceptable, subject to use conditions, are in many ways more similar to LD vehicles, for which HFO-1234yf has already been approved under SNAP,
All types of HD vehicles can be sold as “complete” or “incomplete” vehicles (76 FR 57259-60; September 15, 2011). Complete vehicles are sold by vehicle manufacturers to end-users with no secondary manufacturer making substantial modifications prior to registration and use. Incomplete vehicles are sold by vehicle manufacturers to secondary manufacturers without the primary load-carrying device or container attached. With regard to HD pickup trucks and vans, 90 percent are sold as complete vehicles while only 10 percent are sold as incomplete (80 FR 40331; July 13, 2015). Of the 10 percent of HD pickups and vans that are sold as incomplete vehicles to secondary manufacturers, about half are HD pickup trucks and half are HD vans.
Examples of modifications by secondary manufacturers to HD pickup trucks are installing a flatbed platform or tool storage bins. EPA is not aware of any equipment added by a secondary manufacturer to an incomplete HD pickup truck that would result in a secondary manufacturer modifying or adjusting the already installed MVAC system to provide cooling capacity.
Incomplete vans are typically sold with no enclosed cabin area behind the driver's seat, and secondary manufacturer modifications could include applications such as conversion to ambulances, shuttle vans, and motor homes. Incomplete vans may include OEM MVAC systems that are identical to those installed in the complete van on which the incomplete model is based. In some cases these systems are designed solely for cooling the front driver area, while other systems are manufactured by the OEM with additional capability to provide cooling behind the driver area to the cabin. Some, but not all, secondary manufacturers use the OEM MVAC system with no modification to the contained refrigerant system (hoses, connections, heat exchangers, compressor, etc.).
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
Available refrigerants in the end-uses subject to this proposal include HFC-134a, HFC-152a,
As explained more fully below, to evaluate environmental, flammability, and toxicity risks resulting from the use of HFO-1234yf in new MDPVs, HD pickup trucks, and complete HD vans, the Agency is relying on EPA's analysis conducted in support of the 2011 listing decision for HFO-1234yf for LD
EPA is able to rely on the 2011 analysis of HFO-1234yf in LD vehicles in support of this proposal because the MVAC systems, vehicle designs, and the potential for exposure for the HD vehicle types for which EPA is proposing to list HFO-1234yf as acceptable, subject to use conditions, in today's action are identical or very similar to those of LD vehicles. As discussed in more detail below, EPA has determined that the analyses conducted on HFO-1234yf in LD vehicles are sufficiently conservative to support today's proposal, and, in turn, that the use of HFO-1234yf in the MVAC systems of MDPVs, HD pickup trucks, and complete HD vans does not pose greater risk to human health or the environment than other alternatives, when used in accordance with use conditions.
HFO-1234yf has a GWP of one to four. HFO-1234yf has a GWP similar to or lower than the GWP of other alternatives for the HD vehicle types addressed in today's proposal. For example, its GWP is significantly lower than that of HFC-134a, the refrigerant most widely used in these vehicles today, which has a GWP of 1,430. As shown in Table 16, two other alternatives, HFC-152a,
HFO-1234yf does not deplete the ozone layer. Like HFO-1234yf, HFC-134a, HFC-152a, CO
HFO-1234yf, HFC-134a, HFC-152a, and CO
Another potential environmental impact of HFO-1234yf is its atmospheric decomposition to trifluoroacetic acid (TFA, CF
In support of the 2011 listing decision for HFO-1234yf in LD vehicles, EPA analyzed potential TFA concentrations from a full transition to HFO-1234yf in all MVAC applications, not limited to LD vehicles.
Since the 2011 final rule listing HFO-1234yf as acceptable for LD vehicles, additional research on TFA has been conducted. The UNEP Ozone Secretariat provided a summary of key information pertaining to TFA based on the 2014 Assessment Reports of the Environmental Effects Assessment Panel (EEAP) and the Scientific Assessment Panel (SAP) of the Montreal Protocol. The brief states, “While it is well established that TFA is a ubiquitous natural component in rivers, lakes, and other surface water bodies, uncertainties remain regarding anthropogenic sources, long-term fate and abundances as these are linked to current and future use and emissions of HFCs, HCFCs, and HFOs. Based on estimates to 2040, increases are predicted to remain relatively low and are therefore not expected to be a significant risk to human health or detrimental to the environment. Projected future increased loadings of TFA to playas, land-locked lakes, and the oceans due to continued use of HCFCs, HFCs, and replacement products such as HFOs are still judged to present negligible risks for aquatic organisms and humans.” The UNEP background document also states that TFA and its salts “do not bioconcentrate in aquatic organisms, and do not biomagnify in the food chain. Thus they present negligible risk to organisms higher on the food chain, including humans.”
A 2014 study by Kazil,
Taking into consideration the analysis conducted in support of the 2011 listing decision, which was based on conservative emissions assumptions and a transition from HFC-134a to HFO-1234yf for all MVAC systems (not limited to LD vehicles), and the research that has been conducted since, EPA concludes that the use of HFO-1234yf in the HD vehicle types addressed in this action will not pose a significant risk to the environment from atmospheric decomposition to TFA.
Based on the consideration of all of these environmental impacts, EPA concludes that HFO-1234yf does not pose significantly greater risk to the environment than the other alternatives for use in newly manufactured MDPVs, HD pickup trucks, and complete HD vans, and it poses significantly less risk than several of the alternatives with high-GWPs and ODPs.
HFO-1234yf is a flammable refrigerant classified as A2L under ASHRAE 34-2013. HFC-134a and CO
To evaluate human health and safety impacts, including flammability risks, of the use of HFO-1234yf in MDPVs, HD pickup trucks, and complete HD vans, the Agency is relying on EPA's analysis conducted in support of the 2011 listing decision for HFO-1234yf for LD vehicles and information submitted during the public comment period of the proposal for the 2011 final decision (October 19, 2009; 74 FR 53445), including the SAE CRP risk assessments. With regards to occupational exposure, EPA's risk screen on the use of HFO-1234yf in LD vehicles evaluated flammability risks (
The SAE CRP's risk assessments also evaluated flammability risks to technicians. The SAE CRP conducted Computational Fluid Dynamics (CFD) modeling of exposure levels in case of a leak in a system in a service shop. The SAE CRP found that a leaked concentration of HFO-1234yf could exceed the LFL of 6.2%, but only within ten centimeters or less of the leak. The SAE CRP risk assessment concluded that the risk of this occupational exposure scenario is “inconsequential” because ignition sources would not be located within ten centimeters of the MVAC system given technicians' familiarity with precautions necessary to avoid flammability risks due to the presence of other flammable materials in the engine compartment.
Regarding the flammability risks of HF-1234yf to passengers inside a LD vehicle, in support of the 2011 listing decision, EPA determined the following (76 FR 17490; March 29, 2011):
Depending on the charge size of an HFO-1234yf MVAC system, which may range from as little as 400 grams to as much as 1600 grams,
Since that time additional analysis has been conducted under more recent SAE CRPs.
The fourth and most recent SAE CRP, SAE CRP1234-4, was established in October 2012 in response to a press release issued by the German OEM Daimler “suggesting that new testing conducted by the company had shown R-1234yf to pose greater risk of vehicle fire than was estimated by the prior CRP1234 analysis.” The final report for SAE CRP1234-4 was released on July 24, 2013, and concluded that the “refrigerant release testing completed by Daimler was unrealistic.” And, “their testing created extreme conditions that favored ignition while ignoring many mitigating factors that would be present in an actual real-world collision.”
To fully assess the newly raised concerns, CRP1234-4 completed two new fault tree scenarios as refinements to the original fault tree analysis (FTA). “The two new fault tree scenarios consider the possibility of an individual being unable to exit the vehicle due to a collision or a non-collision event that involves a refrigerant/oil release, the refrigerant/oil being ignited and the fire propagating. The FTA examined average risks across the entire global fleet of light-duty vehicles and used a number of conservative assumptions to ensure that the final risk estimate would be more likely to overestimate rather than underestimate actual risks.” SAE CRP1234-4 concluded that:
Based on the updated analysis, the estimated overall risk of vehicle fire exposure attributed to use of R-1234yf is conservatively estimated at 3 × 10
The findings of CRP1234-4 provide additional support for the conclusions of prior CRPs, and the EPA's analysis for its 2011 rule listing HFO-1234yf as acceptable, subject to use conditions, for use in LD vehicles. These findings in conjunction with EPA's earlier evaluation for LD vehicles support this proposal to list HFO-1234yf as acceptable, subject to use conditions, for the identified HD vehicle types.
To determine the appropriateness of relying on the conclusions of the extensive risk assessments conducted on flammability risks to passengers from HFO-1234yf in LD vehicles to support today's proposed SNAP listing of the same alternative in MDPVs, HD pickup trucks, and complete HD vans, we conducted an analysis of refrigerant charge size as compared to vehicle cabin size.
EPA considered the results of our examination of the ratio of charge size to compartment area and our understanding of these vehicle types and their MVAC systems being very similar to LD vehicles in determining it was appropriate to rely on the currently available analyses on light-duty vehicles. In addition, EPA has considered the characteristics of MDPVs, HD pickup trucks, and HD vans that could be different from LD vehicles, such as differences in the engine compartment size, passenger cabins, and operating conditions, and how those might impact EPA's reliance on the LD analyses. CRP1234-4 considered the temperature and condition of a hot surface that would be necessary to ignite HFO-1234yf released into the engine compartment as part of the FTA. The risk assessment conservatively analyzed a refrigerant and oil mixture contacting a hot surface, at or above 700 degrees Fahrenheit, in a stagnant zone condition such as might occur if the hot surface were covered with a heat shield with limited ventilation. EPA considered whether the engine temperatures and configurations of MDPVs, and HD pickup trucks and vans would reach higher temperatures (above 700 degrees) more regularly due to workload and towing capabilities, and if this would increase the likelihood of a fire under the hood of the vehicle. EPA does not believe this is the case. Despite their use as occupational vehicles and their towing capabilities, EPA does not expect any engine compartment surfaces to reach temperatures above those conservatively assumed for LD vehicles. The engine materials in these vehicles are the same as their LD counterparts, or in some cases a different material may be used to ensure consistent operating conditions. Also, in many cases the engine compartments for these vehicle types are larger than a LD engine compartment, allowing for additional space between hot parts and refrigeration lines, as well as increased airflow in the engine, decreasing the likelihood that refrigerant would be released onto a hot surface and that
EPA also considered whether the MVAC systems in diesel vehicles require additional analysis, since only gasoline vehicles have been used in the existing risk assessments. Unlike the LD fleet, where few vehicles have diesel engines, about half of HD pickup trucks and vans use diesel engines (July 13, 2015; 80 FR 40137). Based on EPA's understanding that MVAC systems and passenger compartments will be the same in gasoline and diesel engines, and surface temperatures within a diesel engine are typically lower than those in a gasoline vehicle because of the lean combustion and more complete utilization of thermal energy inherent to diesel engines, EPA has determined that additional analysis on vehicles with diesel engines is not necessary.
For these reasons, EPA concludes that the currently available assessments on the use of HFO-1234yf in LD vehicles are sufficiently conservative to account for all possible flammability risks from the use of HFO-1234yf in MDPVs, HD pickup trucks, and complete HD vans. Relying on the same analysis considered in support of the 2011 SNAP listing of HFO-1234yf as acceptable, subject to use conditions, for MVAC in new LD vehicles, verifying that more recent information is consistent with that analysis, and considering unique factors for these vehicle types, EPA concludes that the use of HFO-1234yf in new MVAC systems for MDPVs, HD pickup trucks, and complete HD vans does not pose greater flammability risk than the other alternatives when used in accordance with the proposed use conditions.
To evaluate human health and safety impacts, including toxicity risks, from the use of HFO-1234yf in MDPVs, HD pickup trucks, and complete HD vans, the Agency is relying on EPA's analysis conducted in support of the 2011 listing decision for HFO-1234yf for LD vehicles and information submitted during the public comment period of the proposal (October 19, 2009; 74 FR 53445) for the 2011 final decision, including the SAE CRP risk assessments.
In our analysis supporting the 2011 final decision, EPA compared worker exposures to a workplace exposure limit of 250 ppm
Concerning workplace exposure, we expect that professional technicians have proper training and certification and have the proper equipment and knowledge to minimize their risks due to exposure to refrigerant from an MVAC system. Thus, worker exposure to HFO-1234yf is expected to be low. If workers service MVAC systems using certified refrigerant recovery equipment after receiving training and testing, exposure levels to HFO-1234yf are estimated to be on the order of 4 to 8.5 ppm on an 8-hour time-weighted average (as compared with a 250 ppm workplace exposure limit)
EPA's review of consumer risks from toxicity of HFO-1234yf indicated that
In addition to analyzing exposure to the refrigerant, EPA and the SAE CRPs have also considered risks of generating hydrogen fluoride (HF) from combustion of HFO-1234yf. With regards to consumer risks from the use of HFO-1234yf in MVAC systems, we have considered information concerning consumer exposure to HF from thermal decomposition or combustion of HFO-1234yf. The 2009 CRP risk assessments analyzed potential concentrations of HFO-1234yf, from a leak inside the passenger compartment, and HF, from thermal decomposition or ignition, in the passenger compartment. SAE CRP members conducted testing to measure HF concentrations and to identify factors that were most likely to lead to HF formation.
The SAE CRP selected an Acute Exposure Guideline Limit (AEGL)-2 of 95 ppm over 10 minutes as its criterion for determining toxicity risk from HF.
SAE CRP1234-4 considered the need to reevaluate HF exposure due to decomposition or ignition of HFO-1234yf and determined it was unnecessary. This decision considered that: The risks of HF evaluated in the earlier CRP were not significantly different from the risks of HF generation during use of HFC-134a; a presentation from the German automobile manufacturing industry group VDA found that thermal decomposition would not lead to significant amounts of HF and confirmed that there is not expected to be additional risk due to HF from HFO-1234yf compared to HFC-134a. In addition, the CRP1234-4 considered new scenarios where an individual might not be able to leave a car; however, it is expected that because HF is irritating, individuals will leave the area unless they are unable to do so. The CRP1234-4 also considered that mitigating factors specific to HF, such as convection of HF away from the vehicle due to the heat of a fire, mean that the factors already analyzed were likely to be very conservative. Finally, the CRP1234-4 was aware of studies conducted by the CRP for a refrigerant blend, referred to as “CRP MRB,” that found HF from HFO-1234yf along the side of a vehicle never exceeded the health-based HF limit of 95 ppm, even in the case of fire. This additional information confirms that the consumer risks from generation of HF are no greater than in EPA's 2011 evaluation. Further, risks of generation of HF are comparable to those from HFC-134a, and likely also from HFC-152a. CO
EPA did not analyze toxicity concerns from the generation of HF in the workplace. In its December 17, 2009,
All MVAC refrigerants listed as acceptable are subject to use conditions requiring labeling and the use of unique fittings. HFC-152a and CO
EPA is proposing to list HFO-1234yf acceptable, subject to use conditions, because the use conditions are necessary to ensure that use of HFO-1234yf will not have a significantly greater overall impact on human health and the environment than other alternatives for use in MDPVs, HD pickup trucks, and complete HD vans. EPA is proposing to require the same use conditions for HFO-1234yf in the HD vehicle types included in today's proposal that are currently required for the use of HFO-1234yf in newly manufactured LD vehicles. Because of the similarities in the MVAC systems used for these vehicles, these use conditions will be sufficiently protective to ensure use of HFO-1234yf
The first use condition requires that MVAC systems designed to use HFO-1234yf must meet the requirements of SAE J639, “Safety Standards for Motor Vehicle Refrigerant Vapor Compression Systems.” This standard sets safety standards that include unique fittings; a warning label indicating the refrigerant's identity and that it is a flammable refrigerant; and requirements for engineering design strategies that include a high-pressure compressor cutoff switch and pressure relief devices. This use condition also requires that for connections with refrigerant containers for use in professional servicing, use fittings must be consistent with SAE J2844 (revised October 2011). SAE J639 (2011 version) which specifies quick-connect fittings that are different from those for any other refrigerant. The low-side service port and connections will have an outside diameter of 14 mm (0.551 inches) and the high-side service port will have an outside diameter of 17 mm (0.669 inches), both accurate to within 2 mm. Under SAE J2844 (revised October 2011), containers of HFO-1234yf for use in professional servicing of MVAC systems must have a left-handed screw valve with a diameter of 0.5 inches and Acme (trapezoidal) thread with 16 threads per inch. The SAE standards do not include and EPA has not received a submission for unique fittings for small containers of HFO-1234yf refrigerant.
Consistent with the conclusion EPA drew at the time of the EPA's listing decision for HFO-1234yf in LD vehicles relied, EPA believes that the safety requirements that are included in SAE J639 sufficiently mitigate risks of both HF generation and refrigerant ignition (March 29, 2011; 76 FR 17488) for MDPVs, HD pickup trucks, and complete HD vans subject to this proposed action. HFO-1234yf is mildly flammable (2L classification) and, like other fluorinated refrigerants, can decompose to form the toxic compound HF when exposed to flame or to sufficient heat. The SAE J639 standard can also address flammability and HF risks of HFO-1234yf for MDPVs, HD pickup trucks, and complete HD vans. For example, SAE J639 provides for a pressure relief device designed to minimize direct impingement of the refrigerant and oil on hot surfaces and for design of the refrigerant circuit and connections to avoid refrigerant entering the passenger cabin. The pressure release device ensures that pressure in the system will not reach an unsafe level that might cause an uncontrolled leak of refrigerant, such as if the AC system is overcharged. The pressure release device will reduce the likelihood that refrigerant leaks would reach hot surfaces that might lead to either ignition or formation of HF. Designing the refrigerant circuit and connections to avoid refrigerant entering the passenger cabin ensures that if there is a leak, the refrigerant is unlikely to enter the passenger cabin. Keeping refrigerant out of the passenger cabin minimizes the possibility that there would be sufficient levels of refrigerant to reach flammable concentrations or that HF would be formed and transported where passengers might be exposed.
The second use condition requires the manufacturer of MVAC systems and vehicles to conduct Failure Mode and Effects Analysis (FMEA) as provided in SAE J1739 (adopted 2009) and keep records of the FMEA on file for three years from the date of creation. SAE J1739 (adopted 2009) describes a FMEA as “a systematic group of activities intended to: (a) Recognize and evaluate the potential failure of a product/process and the effects and causes of that failure, (b) identify actions that could eliminate or reduce the change of the potential failure occurring, and (c) document the process.” Through the FMEA, OEMs determine the appropriate protective strategies necessary to ensure the safe use of HFO-1234yf across their vehicle fleet. It is standard industry practice to perform the FMEA and to keep it on file while the vehicle is in production and for several years afterwards. As with the previous use condition, this use condition is intended to ensure that new MDPVs, HD pickup trucks, and complete HD vans manufactured with HFO-1234yf MVAC systems are specifically designed to minimize release of the refrigerant into the passenger cabin or onto hot surfaces that might result in ignition or in generation of HF.
EPA proposes that this listing would apply 30 days after the date of publication of a final rule. This date, the same as the proposed effective date of this regulation, allows for the safe use of this substitute at the earliest opportunity.
CAA section 609 establishes standards and requirements regarding servicing of MVAC systems. Under section 609, no person repairing or servicing motor vehicles for consideration
Section 608 of the CAA prohibits the intentional release (venting) of all refrigerants except those specifically exempted; because HFO-1234yf is not exempt, intentional release from MVAC systems of MDVPs, HD pickup trucks, and HD vans addressed in this action would be prohibited if the decision to list HFO-1234yf as acceptable subject to use conditions is finalized. MVAC end-of-life disposal and recycling specifications are also covered under section 608 of the CAA and our regulations issued under that section of the Act, which are codified at subpart F of 40 CFR part 82.
Today's proposal to list HFO-1234yf as acceptable, subject to use conditions, if finalized, will have no direct effect on the MY 2017-2025 light-duty vehicle GHG standards since today's proposed action applies to HD vehicles, not light duty. We raise the issue here, however, because today's proposed action would apply to MPDVs. As noted above in section V.B.1.a., although MDPVs are classified as HD vehicles based on their GVWR, due to their similarities to LD vehicles, GHG emissions from MDPVs are regulated under the LD GHG and fuel economy standards, and they are excluded from the HD GHG and fuel economy standards.
Nonetheless, this proposed action would have no direct effect on the regulations on MDPVs established under the LD GHG standards. Those standards are established by rule and EPA is not reopening that rule in this action. We do note, however, that today's proposal is relevant to one of the compliance flexibilities in that rule. As part of the MY 2017-2025 LD GHG rule,
The Phase 1 HD GHG rules divided the industry into three discrete categories—combination tractors, heavy-duty pickups and vans, and vocational vehicles. The Phase 1 rules also set separate standards for engines that power vocational vehicles and combination tractors—based on the relative degree of homogeneity among vehicles within each category (76 FR 57106; September 15, 2011). On July 13, 2015, EPA and the National Highway Traffic Safety Administration (NHTSA) proposed Phase 2 HD GHG standards that would build on existing Phase 1 HD GHG standards, and also proposed GHG standards for certain trailers used in combination with HD tractors (80 FR 40137; July 12, 2015). Today's proposal, should EPA adopt it, will have no direct effect on the HD GHG standards, either for Phase 1 or the proposed Phase 2.
As part of today's action, EPA is proposing to list HFO-1234yf as acceptable, subject to use conditions, for MDPVs, HD pickup trucks, and complete HD vans. HD pickup trucks and vans are one of the categories of HD vehicles regulated under the Phase 1 HD GHG standards, and proposed to be further regulated under the Phase 2 program. As part of the Phase 1 HD GHG standards, EPA finalized a low leakage requirement of 1.50 percent leakage per year for AC systems installed in HD trucks and vans and combination tractors for model years 2014 and later. EPA finalized a standard of 1.50 percent leakage per year for heavy-duty pickup trucks and vans and combination tractors. See section II.E.5 of Phase 1 HD GHG standard preamble (76 FR 57194-57195) for further discussion of the MVAC leakage standard.
As part of the NPRM for Phase 2 of the HD GHG standards (80 FR 40343; July 12, 2015), EPA proposed regulatory provisions that would be in place if and when lower-GWP alternative refrigerants are approved and adopted by manufacturers of HD vehicles. EPA proposed to adopt the same MVAC leakage standard for vocational vehicles as apply for pickups and vans, and for combination tractors. If adopted, these provisions would have the effect of easing the burden associated with complying with the lower-leakage requirements when a lower-GWP refrigerant is used instead of HFC-134a. These provisions would recognize that leakage of refrigerants would be relatively less damaging from a climate perspective if one of the lower-GWP alternatives is used. Specifically, EPA proposed to allow a manufacturer to be “deemed to comply” with the leakage standard set through the Phase 1 regulations by using a lower-GWP alternative refrigerant. EPA proposed that in order to be “deemed to comply” the vehicle manufacturer would need to use a refrigerant other than HFC-134a that is listed as an acceptable alternative refrigerant for heavy-duty MVAC systems under SNAP, and defined under the LD GHG regulations at 40 CFR 86.1867-12(e) (80 FR 40343-44; July 12, 2015). The lower-GWP refrigerants currently defined at 40 CFR 86.1867-12(e) are HFC-152a, HFO-1234yf, and CO
If HFO-1234yf is listed as acceptable under SNAP for use in HD pickup trucks and complete HD vans, as proposed, and if the incentive proposed in the Phase 2 HD NPRM is finalized, these types of HD vehicles manufactured with HFO-1234yf MVAC systems will be “deemed to comply” with the low leakage standard.
EPA requests comment on all aspects of this proposed action. EPA is particularly interested in any additional exposure scenarios or unique characteristics of the types of HD vehicles included in today's action as compared to LD vehicles where HFO-1234yf has previously been listed as acceptable. In addition, EPA also specifically requests comment on whether the proposed use conditions are adequately protective for MDPVs, HD pickup truck, and complete HD vans, or whether more protective use conditions are necessary. If a commenter believes more protective use conditions are necessary, the commenter should identify what additional, more protective use conditions could be implemented.
With regard to incomplete HD pickup trucks and vans, EPA requests information on any modifications to incomplete HD pickup trucks by secondary manufacturers that could result in modifying the OEM-installed MVAC system. Concerning incomplete HD vans, at this time, EPA does not have information on all potential vehicle conversions that could be made by secondary manufacturers or the impact those conversions may have with regard to the SNAP criteria. Due to lack of information on potential vehicle conversions, EPA cannot assess whether or not the same risk analysis used for complete HD vans would be applicable to all incomplete HD vans. However, EPA is aware that for some incomplete HD vans, secondary manufacturers do not modify the MVAC systems. An example of an incomplete HD van that is manufactured by the OEM with cabin cooling that is not altered by the secondary manufacturer might be a HD van customized by a secondary manufacturer for transportation of persons with disabilities. In this situation, the secondary manufacturer would install wheelchair ramps, lifts, and other equipment to meet the needs of their customer in an incomplete HD van from the OEM without making any modifications to the OEM-installed MVAC system. However, some secondary manufacturers may alter the OEM MVAC system design based on their needs (
Additional risk analysis would be necessary prior to considering a listing decision for HFO-1234yf in all incomplete HD vans, especially on those for which the OEM-installed MVAC system may be altered. EPA requests comment on secondary manufacturer modifications that are likely for HD vans and, we welcome information on the types of modifications that could result in altering the MVAC system installed by the OEMs and the procedures for those modifications. EPA requests information on potential exposure scenarios, and is especially interested in information relevant to risk assessment such as charge sizes, the ratio of charge size to cabin size, exposure levels, potential for leaks and for ignition events, and means of mitigating risks during system modifications by the secondary manufacturer, and subsequently during the useful life of the vehicle. This information may be used to inform a future listing.
Additionally, EPA requests information on development of HFO-1234yf MVAC systems for other HD vehicle types or off-road vehicles, or plans to develop these systems in the future. This information may be used to inform a future listing.
As provided in the following table, for rigid PU spray foam, EPA is proposing to list as acceptable, subject to narrowed use limits, numerous foam blowing agents for military or space- and aeronautics-related applications, and change the status from acceptable to unacceptable for all other uses:
EPA is proposing to change the listings from acceptable to unacceptable, for HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa; commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and the HFC blend Formacel TI for use in rigid PU spray foam, with the exception of certain narrowed use limits for military, space, and aeronautics uses. See section VI.C.3 for how these proposed changes would apply to imported foam products.
In the NPRM published on August 6, 2014, EPA proposed to change the listings from acceptable to unacceptable for HFC-134a and blends thereof, and the HFC blend Formacel TI for spray foam as of January 1, 2017 (79 FR 46149). In that proposal, EPA stated that a number of nonflammable HFCs and HFC blends, such as HFC-245fa, blends of HFC-365mfc with at least four percent HFC-245fa by weight, and commercial blends of HFC-365mfc and HFC-227ea, with seven to 13 percent HFC-227ea and the remainder HFC-365mfc, were available and posed significantly less risk in the spray foam end-uses. We noted that these available HFC foam blowing agents provide a non-flammable alternative where there are flammability concerns associated with
In the past, EPA combined spray foam, commercial refrigeration foam, sandwich panels, and marine flotation foam within a single end-use: rigid PU spray foam. However, because of differences in the exposure and fire safety characteristics of these uses as well as the fact that different alternatives are generally used for each of these applications, EPA more recently created separate end-use listings for each of these applications. See 80 FR 42870; July 20, 2015. Commercial refrigeration and sandwich panels include insulation for walls, pipes (including “pipe-in-pipe”), metal doors, vending machines, refrigerated and unrefrigerated coolers, refrigerated transport vehicles, and other laboratory and commercial refrigeration equipment, as well as foam for taxidermy. These foams may be injected or applied using “pour-in-place” equipment, depending on the agent used and on whether the formulation is pressurized. Marine flotation foam includes buoyancy or flotation foam used in construction of boats and ships. These foams typically are injected into a cavity in the boat wall from a two-canister (A- and B-side) system under lower pressures and they provide structure as well as buoyancy. Rigid PU
High-pressure two-component spray foam products are pressurized 800-1600 psi during manufacture, are sold in pressurized containers as two parts (
Low-pressure two-component spray foam products are pressurized to less than 250 psi during manufacture, are sold in pressurized containers as two parts (
One-component foam sealants are packaged in aerosol cans and are applied
EPA is proposing to change the status of the following HFCs and HFC blends that are currently listed as acceptable foam blowing agents for use in spray foam: HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa; commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and Formacel TI.
HFCs have been widely used as blowing agents in spray foam in the United States since the phaseout of ODS blowing agents such as HCFC-141b, particularly where insulation value and flammability have been of greater concern. Over the past ten years, the number of available alternatives has increased and the variety of uses for acceptable blowing agents has also expanded. A number of new foam blowing agents with low GWPs, both fluorinated and non-fluorinated, have been introduced during the past several years. Many end users have indicated interest in these newer alternatives, often to improve energy efficiency of the foam products manufactured with the foam blowing agent. Production volumes for some of these newer substitutes are expanding rapidly to keep pace with growing demand.
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks (
The HFCs that we are proposing to find unacceptable have GWPs ranging from 1,030 for HFC-245fa to 1,430 for HFC-134a. The HFC blends that we are proposing to find unacceptable have GWPs that vary depending on the specific composition; the range of GWPs for blends is 740 to 1,030 for blends of HFC-365mfc with at least four percent HFC-245fa, 900 to 1,100 for commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc, and 1,330 to approximately 1,500 for Formacel TI.
Alternatives for all three spray foam applications include CO
All of the HFCs and HFC blends for which we are proposing a change of status to unacceptable consist of compounds that are non-ozone-depleting. Of all of the alternatives in the three applications affected by the proposed change of status listed above, only
All of the HFCs and HFC blends for which we are proposing a change of status to unacceptable consist of compounds that are excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. With the exception of light saturated HCs (for one-component foam sealants only), Exxsol blowing agents (for all spray foam applications) and HFO-1336mzz(Z) (for high-pressure two-component spray foam only), the other alternatives contain compounds that are not VOC (
All of the HFCs and HFC blends for which we are proposing a change of status are nonflammable. There has been use of blends of HFC-134a and HFC-152a, composition unspecified, in the past; those blends may be flammable depending on the exact composition.
HFO-1234ze(E), HFO-1336mzz(Z), and
Use of flammable blowing agents in spray foam can be an issue. Spray foam is frequently used in situ in commercial and residential buildings and it is not practical to make all electrical fixtures explosion proof or to add engineered ventilation when applying spray foam in place in many circumstances. As mentioned above, flammability is a major issue for high-pressure and low-pressure two-component spray foam. Thus, all acceptable substitutes in these applications either are nonflammable or else are flammable but information in EPA's possession indicates there are measures available to mitigate flammability risk.
Both the HFC substitutes for which we are proposing a change of status and other alternatives have workplace exposure limits, either as regulatory requirements (
EPA is proposing to find HFC-134a, HFC-245fa, and blends thereof; commercial blends of HFC-365mfc and HFC-227ea, containing seven to 13 percent HFC-227ea and the remainder HFC-365mfc; blends of HFC-365mfc and at least four percent HFC-245fa; and Formacel TI unacceptable in spray foam because there are other available or potentially available alternatives that reduce risk overall compared to these foam blowing agents. EPA has listed as acceptable several alternatives that pose lower overall risk to human health and the environment than the blowing agents whose status we are proposing to change to unacceptable. The risks other than GWP are not significantly different for the alternatives than for the blowing agents we are proposing to list as unacceptable, and the GWPs for the blowing agents we are proposing to list as unacceptable are significantly higher and thus pose significantly greater risk.
EPA is proposing an time-limited exception to the proposed unacceptability determination for HFC and HFC blend foam blowing agents for military or space- and aeronautics-related applications when used in low pressure two-component and high pressure two-component spray foam. Specifically, EPA is proposing a narrowed use limit that would expire on January 1, 2025. As provided in section e below, the vast majority of applications for spray foams are anticipated to be able to transition to acceptable alternatives by January 1, 2020, for high-pressure two-component spray foam and as of January 1, 2021, for low-pressure two-component spray foam. However, for the military, there are several unique performance requirements related to weapon systems that require extensive testing and qualification prior to qualifying alternatives for HFC-containing foams. In addition, some of the lower-GWP alternatives may not be available by 2020 or 2021in certain specialty applications with unique military requirements such as undersea; aerospace; and chemical, biological, and radiological warfare systems. In the case of space- and aeronautics- related applications, past experience indicates that transitions away from the foam blowing agents in current use took several years due to the challenging operational environment and the lengthy requalification process associated with human-rated space flight systems.
Users of a restricted agent within the narrowed use limits category must make a reasonable effort to ascertain that other substitutes or alternatives are not technically feasible. Users are expected to undertake a thorough technical investigation of alternatives to the otherwise restricted substitute. Although users are not required to report the results of their investigations to EPA, users must document these results, and retain them in their files for the purpose of demonstrating compliance.
Users should include the following additional documentation to demonstrate compliance with the narrowed use applications. This information includes descriptions of:
• Process or product in which the substitute is needed;
• Substitutes examined and rejected;
• Reason for rejection of other alternatives,
• Anticipated date other substitutes will be available and projected time for switching.
Except for the proposed narrow use limits addressed above, EPA is proposing to change the listings from acceptable to unacceptable (1) in high-pressure two-component spray foam and in one-component foam sealants as of January 1, 2020, and (2) in low-pressure two-component spray foam as of January 1, 2021. The change of status would apply to the following blowing agents: HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa, and commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc and Formacel TI. The Agency is aware of several companies transitioning between now and 2017.
For high-pressure two-component and low-pressure two-component spray foam a certain insulation value may be required to meet building code requirements. Some studies have indicated that CO
January 1, 2020, is the earliest date by which there will be sufficient supply of alternatives for high-pressure two-component spray foam. Although alternatives are commercially available for this end-use (
For one-component foam sealants, we expect that the transition process for manufacturers of these products should be quicker than for manufacturers of low-pressure two-component spray foam because testing is required only for a final formulation in an aerosol can for one-component foam sealants, rather than testing both the formulation in separate containers (A- and B-side) and ensuring the long-term stability of the final blown foam once the two parts are mixed to blow the foam. Also, no certification testing would be required for the one-component foam sealant, unlike for high-pressure two-component foam. In Europe, one-component foam sealants have already converted away from using HFCs and predominantly use HCs or HFO-1234ze(E), which are available substitutes for this end-use under SNAP. Allowing for one year for reformulation and one to two years for testing of products and to allow existing stock of one-component foams to be purchased and used, we are proposing a change of status date of January 1, 2020, after which date, no more one-component foam sealants (cans) could be manufactured using the specified HFC blowing agents, but the end user could continue to use cans that had already been manufactured. In the July 20, 2015, final rule, EPA took such an approach for aerosol propellants, which are used in similar packages for consumer use as well as for manufacturing use, and similarly, may be in distribution for a year or more before they are purchased and eventually used by the end user. Under the proposed approach, we would limit the applicability of the use prohibition on closed cell foam products (discussed in section VI.C.3), so that it would not apply to closed cell foam products produced through the use of a one-component spray foam manufactured prior to the status change date.
For low-pressure two-component spray foam, commenters on the August 6, 2014, proposal with a change of status date of January 1, 2017, expressed concern about the feasibility of alternatives by that date. Specifically, two manufacturers mentioned the heightened challenges of shelf-life and stability for a product using HFO-1234ze(E), and suggested change of status dates of January 1, 2020 or 2021.
Over the past several years, to address potential exposure to workers and consumers, the Federal Partnership and each of its member agencies, including EPA, CPSC, OSHA, and NIOSH have worked to reduce exposure to various chemicals emitted from spray foam. For example, EPA and its federal partners have continued to work with industry to develop best practices for application of spray foam, and EPA's Office of Research and Development has been developing methods to measure emissions of chemicals from spray foam as part of the ASTM Indoor Air Subcommittee D.22.05 on Spray Polyurethane Foam Insulation. The list of proposed and final standards represents the issues raised by the committee and the range of compounds of interest includes isocyanates, blowing agents, amine catalysts, flame retardants, and aldehydes.
EPA requests comments on all aspects of this proposed decision to change the listings of certain foam blowing agents in the three for spray foam end-uses. In particular, EPA requests comment on the proposed decision to change the status of the identified substitutes to unacceptable (1) in high-pressure two-component spray foam and in one-component foam sealants on January 1, 2020, and (2) in low-pressure two-component spray foam on January 1, 2021. EPA is interested in comment on whether there are specific applications for one-component spray foam sealants, low-pressure two-component, and high-pressure two-component spray foam for which there are no alternatives available with lower overall risks to human health and the environment than the substitutes for which we are proposing a change of status: HFC-134a, HFC-245fa, and blends thereof; blends of HFC-365mfc with at least four percent HFC-245fa, and commercial blends of HFC-365mfc with seven to 13 percent HFC-227ea and the remainder HFC-365mfc; and Formacel TI, for reasons of fire safety or technical feasibility. EPA requests comment on whether the proposed change of status dates for one-component spray foam sealants, low pressure two-component, and high pressure two-component spray foam are appropriate in light of technical challenges and the supply of other alternatives. Where commenters indicate more time is needed due to supply or technical challenges, EPA is interested in information concerning what is limiting supply of substitutes and on the specific technical steps and time needed for each step in order to transition to alternatives. Additionally, EPA requests comment on whether the change of status date for one component foam sealants and low-pressure two-component spray foam should be based upon the date the product may no longer be used or whether it should be based upon a date of manufacture of the product with no restriction on the use of products sold prior to the change of status date.
EPA is proposing to change the date upon which certain HFCs and HFC blend foam blowing agents for space- and aeronautics-related applications change status from acceptable, subject to narrowed use limits, to unacceptable. EPA is proposing to revise this change of status date to January 1, 2025. EPA is proposing to revise the change of status date only for space- and aeronautics-related applications and not for military uses.
Table 19 summarizes the end-uses and blowing agents that in the July 20, 2015, final rule were listed as unacceptable for military and space- and aeronautics-related applications as of January 1, 2022 and for which we are proposing to revise the change of status date to January 1, 2025.
This proposal would apply specifically to space- and aeronautics-related applications in the same end-uses that are regulated in appendix U to subpart G of 40 CFR part 82, as listed above in Table 19. This proposal to revise the changes of status date does not apply to the narrowed use limit for military uses for which the change of status date is January 1, 2022.
This proposal applies to the HFC and HFC blend foam blowing agents that are regulated in appendix U to subpart G of 40 CFR part 82, as listed above in Table 19. This proposal does not affect any HCFC foam blowing agents.
We are proposing to revise the status change date for certain HFC and HFC blend foam blowing agents for space and aeronautics-related foam applications from acceptable, subject to narrowed use limits to unacceptable as of January 1, 2025—three years later than the current status change date of January 1, 2022. Based on recent discussions with other government agencies, EPA is aware that some space flight hardware used in the United States is being developed in the European Union. Under E.U. regulations, certain types of HFC foams may be blown and used after January 1, 2022, but by the mid-2020s those regulations will no longer allow the use of the HFC blowing agents restricted under EPA's SNAP regulations. Further, the most recent U.S. space flight program is still being developed, and it now appears that it may not be possible to qualify all foams needed with alternative foam blowing agents by the current January 1, 2022, date in order to ensure the safety of space vehicles. Thus, we are proposing to extend the period during which the narrowed use limits apply for space and aeronautics related applications from January 1, 2022, to January 1, 2025.
EPA is not aware of any other relevant federal rules that would be affected by this proposed revision to the change in status date for certain HFC and HFC blend foam blowing agents for space and aeronautics-related foam applications.
EPA requests comment on the revised date of January 1, 2025, for the change of status for certain HFC and HFC blend foam blowing agents space and aeronautics-related foam applications from acceptable, subject to narrowed use limits, to unacceptable.
As provided in the following table, EPA is proposing to change the status methylene chloride from acceptable to unacceptable for multiple foam blowing end-uses.
EPA is proposing to change the status of methylene chloride from acceptable to unacceptable when used as a blowing agent in the production of flexible PU foam, integral skin PU foam, and polyolefin foam. Flexible PU includes foam in furniture, bedding, chair cushions, and shoe soles. Integral skin PU includes car steering wheels, dashboards, and shoe soles. Polyolefin includes foam sheets and tubes.
Methylene chloride, also known as dichloromethane, has the chemical formula CH
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks (
Methylene chloride contains chlorine and thus could have an ODP. We are unaware of a calculated ODP for methylene chloride in the peer-reviewed literature, but it has historically been considered negligibly small.
Methylene chloride has a GWP of approximately nine. As shown in Table 21, other acceptable alternatives have GWPs that are comparable or lower than methylene chloride's GWP of nine except for HFC-152a, which has a GWP of 124.
Methylene chloride is excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. With the exception of HCs, Exxsol blowing agents, HFO-1336mzz(Z), and methylal, the other alternatives contain compounds that are excluded from the definition of VOC. The manufacturer of HFO-1336mzz(Z) has petitioned EPA to exempt HFO-1336mzz(Z) from the definition of VOC under those regulations. As provided in our decisions listing these substitutes as acceptable, we determined that emissions of these alternatives in this end use would not pose a significantly greater risk than that posed by foam blowing agents that are not VOCs.
Methylene chloride exhibits no flash point under standard testing conditions and thus is considered nonflammable, although it does exhibit lower and upper flammability limits of 13 percent and 23 percent, respectively. Of the various alternatives, ecomate
Health effects of concern with methylene chloride include cancer, liver, and kidney effects (longer-term exposure) and neurotoxic effects (acute exposure), in addition to irritation to the skin, eyes, and respiratory tract. Other alternatives for this end-use have potential health effects such as impacts on body weight, mononuclear infiltration of heart tissue, neurotoxic effects, and irritation to the skin, eyes, and respiratory tract; no other alternatives in this end-use have evidence of cancer as a health effect. Toxicity is not a significant concern in the workplace for methylene chloride or for the other available alternatives because they may be used for blowing flexible PU foam consistent with required or recommended workplace exposure limits. Workplace exposure limits for the other available alternatives range from 100 ppm to 5,000 ppm. Methylene chloride's workplace exposure limits include a PEL of 25 p.m. (8-hr TWA) and 125 ppm over a 15-minute period. Methylene chloride is regulated for its toxicity as a hazardous air pollutant under the CAA and potentially as a U-listed hazardous waste under RCRA (40 CFR 261.33). None of the other alternative blowing agents are regulated as hazardous air pollutants or as U-listed hazardous wastes.
In the initial SNAP rulemaking, EPA listed methylene chloride as acceptable in this end-use, citing the presence of the OSHA regulations as sufficient to address workplace risk. Information regarding general population risk was not available for methylene chloride or for any of the other alternatives at the time EPA listed them as acceptable for this end use.
Since EPA's initial listing decision for methylene chloride in flexible PU foam, the Agency has separately issued a health-based residual risk standard under section 112 of the CAA for flexible PU foam production. (
Methylene chloride contains chlorine and thus could have an ODP. We are unaware of a calculated ODP for methylene chloride in the peer-reviewed literature, but it has historically been considered negligibly small.
Methylene chloride has a GWP of approximately nine. As shown in Table 21, other acceptable alternatives have GWPs that are comparable or lower than methylene chloride's GWP of nine except for HFC-152a, which has a GWP of 124.
Methylene chloride is excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. With the exception of HCs, Exxsol blowing agents, formic acid, HFO-1336mzz(Z), and methylal, the other alternatives contain compounds that are exempt from the definition of VOC. The manufacturer of HFO-1336mzz(Z) has petitioned EPA to exempt HFO-1336mzz(Z) from the definition of VOC under those regulations. As provided in our decisions listing these alternatives as acceptable, we determined that emissions of these alternatives in this end-use would not pose a significantly greater risk than that posed by foam blowing agents that are not VOCs.
Methylene chloride exhibits no flash point under standard testing conditions and thus is considered nonflammable, although it does exhibit lower and upper flammability limits of 13 percent and 23 percent, respectively. Of the
Health effects of concern with methylene chloride include cancer, liver, and kidney effects (longer-term exposure) and neurotoxic effects (acute exposure), in addition to irritation to the skin, eyes, and respiratory tract. Other alternatives for this end-use have potential health effects such as impacts on body weight, mononuclear infiltration of heart tissue, neurotoxic effects, and irritation to the skin, eyes, and respiratory tract; no other alternatives in this end-use have evidence of cancer as a health effect. Toxicity is not a significant concern in the workplace for methylene chloride or for the other available alternatives because they may be used for blowing integral skin PU consistent with required or recommended workplace exposure limits. Workplace exposure limits for the other available alternatives range from 100 ppm to 5,000 ppm. Methylene chloride's workplace exposure limits include a PEL of 25 p.m. (8-hr TWA) and 125 ppm over a 15-minute period. Methylene chloride is regulated for its toxicity as a hazardous air pollutant under the CAA and potentially as a U-listed hazardous waste under RCRA (40 CFR 261.33). None of the other alternative blowing agents are regulated as hazardous air pollutants or as U-listed hazardous wastes.
Methylene chloride is the only acceptable alternative in this end-use that is a carcinogen. On this basis, we are proposing that methylene chloride poses significantly greater toxicity risks than the other alternatives available for this end use. The risk posed by methylene chloride and the other alternatives based on the other SNAP review criteria are not significantly different. Because of the significantly greater toxicity risk posed by methylene chloride, we believe it poses significantly greater overall risk than other available substitutes and we are proposing to change the status to unacceptable.
Methylene chloride contains chlorine and thus could have an ODP. We are unaware of a calculated ODP for methylene chloride in the peer-reviewed literature, but it has historically been considered negligibly small.
Methylene chloride has a GWP of approximately nine. As shown in Table 21, the other acceptable substitutes have GWPs that are comparable or lower than methylene chloride's GWP of nine except for HFC-152a, which has a GWP of 124.
Methylene chloride is excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS. With the exception of HCs, HC blends, and Exxsol blowing agents, the other alternatives contain compounds that are exempted from the definition of VOC. The manufacturer of HFO-1336mzz(Z) has petitioned EPA to exempt HFO-1336mzz(Z) from the definition of VOC under those regulations. As provided in our decisions listing these alternatives as acceptable, we determined that emissions of these alternatives in this end-use would not pose a significantly greater risk than that posed by foam blowing agents that are not VOCs.
Methylene chloride exhibits no flash point under standard testing conditions and thus is considered nonflammable, although it does exhibit lower and upper flammability limits of 13 percent and 23 percent, respectively. Of the various alternatives, blends of HFC-152a and HCs, ecomate
Health effects of concern with methylene chloride include cancer, liver, and kidney effects (longer-term exposure) and neurotoxic effects (acute exposure), in addition to irritation to the skin, eyes, and respiratory tract. Other alternatives for this end-use have potential health effects such as impacts on body weight, mononuclear infiltration of heart tissue, neurotoxic effects, and irritation to the skin, eyes, and respiratory tract; no other alternatives in this end-use have evidence of cancer as a health effect. Toxicity is not a significant concern in the workplace for methylene chloride or for the other available alternatives because they may be used for blowing polyolefin foam consistent with required or recommended workplace exposure limits. Workplace exposure limits for the other available alternatives range from 100 ppm to 5,000 ppm. Methylene chloride's workplace exposure limits include a PEL of 25 p.m. (8-hr TWA) and 125 ppm over a 15-minute period. Methylene chloride is regulated for its toxicity as a hazardous air pollutant under the CAA and potentially as a U-listed hazardous waste under RCRA (40 CFR 261.33). None of the other alternative blowing agents are regulated as hazardous air pollutants or as U-listed hazardous wastes.
Methylene chloride is the only acceptable alternative in this end-use
EPA proposes to change the status of methylene chloride in flexible PU foam as of 30 days after a final rule is published in the
For integral skin PU foam and polyolefin, we propose the respective change of status dates to be January 1, 2017, and January 1, 2020. These dates are consistent with the change of status dates we previously established for certain HFCs in these end-uses (80 FR 42870; July 20, 2015). These dates were established considering factors such as the supply of alternatives, time required for testing of alternatives, and time required to prepare facilities for use of flammable foam blowing agents. By proposing to change the status of methylene chloride from acceptable to unacceptable, we expect that end-users will consider blowing agents other than methylene chloride as they plan their transition away from HFCs in these end-uses.
In a recent rulemaking,
EPA requests comment on all aspects of this proposal. In particular, we request comment on the proposed dates for a change of status for methylene chloride (30 days after publication of a final rule for flexible PU foam, January 1, 2017, for integral skin PU foam, and January 1, 2020, for polyolefin foam). We request comments on, the extent to which methylene chloride is currently being used in these end-uses in integral skin PU, in polyolefin, or by area sources that manufacture flexible PU foam and the technical challenges that exist for transitioning from methylene chloride to other available alternatives.
EPA is proposing to apply the unacceptability determinations in this action for foam blowing agents to closed cell foam products and products containing closed cell foam. In addition, EPA is proposing to apply all listings for foam blowing agents codified in the appendices to 40 CFR part 82 subpart G to such products. This would mean that closed cell foam products and products containing closed cell foams manufactured abroad and imported could not be used in the United States if the foam blowing agent was listed as unacceptable.
The foam sector includes both closed cell and open cell foams. Closed cell foams are specifically designed to retain the foam blowing agent in the cells; in insulation foam products, the foam blowing agent continues to perform a function in providing thermal insulation, once the foam has already been blown. With open cell foams, the foam blowing agent completes its function once the foam is blown; almost all of the foam blowing agent escapes from the open cells prior to import, and any vestigial amounts remaining do not perform a function.
Foam blowing end-uses that contain closed-cell foams include rigid PU spray foam (all three applications described in section VI.C.1); rigid PU commercial refrigeration and sandwich panels; rigid PU marine flotation foam; rigid PU appliance foam; rigid PU slabstock and other; rigid PU and polyisocyanurate laminated boardstock; polystyrene: Extruded boardstock and billet; polystyrene: Extruded sheet; polyolefin; and phenolic insulation board and bunstock. Foam blowing end-uses containing open cell foams include flexible PU and integral skin PU. Open cell phenolic, and some other open cell foams also exist within the SNAP foam blowing end-uses that include closed cell foams. Integral skin foam may include a rigid surface with an interior flexible core.
Currently, an unacceptable foam blowing agent may not be used to manufacture products in the United States, whether for domestic use or for export. However, products made abroad with unacceptable foam blowing agents may be imported and used in the United States. This is because EPA has historically interpreted the use prohibitions for this sector to apply to blowing foam with the foam blowing agent and not to the use of products made with foam. For example, commercial refrigerators containing appliance foam blown with an unacceptable blowing agent may be imported into and used in the United States, though commercial refrigerators manufactured in the United States may not be manufactured with foam blown with that same agent.
If this proposal were to be finalized as proposed, use of closed cell foam products (
Several provisions of CAA Title VI and EPA's implementing regulations are relevant to HCFC foam products. Under regulations implementing CAA section 611, EPA requires labeling of products that contain an ODS and those that are manufactured with an ODS. EPA determined that open cell foams blown with an ODS must be labeled as a
Section 610 restricts sale and distribution and offers of sale and distribution of certain products containing or manufactured with CFCs and HCFCs.
• Closed cell rigid polyurethane foam;
• Closed cell rigid polystyrene boardstock foam;
• Closed cell rigid phenolic foam; and
• Closed cell rigid polyethylene foam when such foam is suitable in shape, thickness and design to be used as a product that provides thermal insulation around pipes used in heating, plumbing, refrigeration, or industrial process systems.
CAA section 605(a) prohibits the introduction into interstate commerce or use of any class II substance effective January 1, 2015, unless such substance: (1) Has been used, recovered, and recycled; (2) is used and entirely consumed (except for trace quantities) in the production of other chemicals; (3) is used as a refrigerant in appliances manufactured prior to January 1, 2020; or (4) is listed as acceptable for use as a fire suppression agent for nonresidential applications in accordance with section 612(c).
The section 605(a) implementing regulations codified at 40 CFR part 82, subpart A restrict the use of virgin HCFCs to air conditioning, refrigeration, and fire suppression applications, with minor exceptions. Thus, while the Nonessential Products Ban does not apply to HCFC insulating foams, section 605(a) and its implementing regulations prohibit the use of HCFCs for blowing foam in the United States. The combined effect of the Nonessential Products Ban and the section 605(a) implementing regulations is that HCFC foam insulation products may be imported, sold, and distributed in the United States but cannot be manufactured in the United States.
In the preamble to a July 11, 2000, SNAP proposed rule, EPA reviewed its authority under CAA section 610 and noted that HCFC insulating foams were exempt from regulation under that section of the statute. EPA stated that “Title VI of the Act thus does not provide EPA with the authority to prevent imports of products containing those foams” (65 FR 42653, 42656). EPA did not, however, base this statement on a full examination of the various authorities under Title VI. In taking final action on that proposal, EPA noted that while under section 610 it could not ban the
In the August 6, 2014, NPRM (79 FR 46126; 46154), EPA proposed to consider use of a foam blowing agent to include use of closed cell foam products or products containing closed cell foam. In response to that proposal, some commenters supported applying the unacceptability determinations to the use of closed cell foam products or products containing closed cell foam with unacceptable foam blowing agents, on the basis that it would maintain a “level playing field” for domestically manufactured products made with lower-GWP foam blowing agents that were going to compete with imported products. Some commenters also supported extending such a prohibition to open cell foams, stating that there was still some foam blowing agent left in the foam and citing the negative impacts of allowing cheaper imported products containing unacceptable foam blowing agents.
Other commenters opposed applying unacceptability determinations to anything other than the act of blowing foam in the United States. These commenters stated that this would be a significant departure from the Agency's previous interpretation and suggested that EPA needed to explain the basis for such a change. For example, one commenter stated that “without any legal rationale, EPA has proposed to reverse its long-standing interpretation of the Clean Air Act with respect to the import of products containing HCFC-141b as a foam-blowing agent.” In addition, some commenters pointed out that the proposal only allowed 60 days before this change in interpretation would apply to HCFC-141b, which they viewed as insufficient time to adjust. EPA did not take final action in the July 20, 2015, final rule (80 FR 42870) but instead elected to continue assessing the merits of the change.
In this action, EPA is again proposing to apply listings and prohibitions for foam blowing agents to use of closed cell foam products and products containing closed cell foam. To the extent EPA's earlier statements regarding Title VI reflect an interpretation that the agency could not address imported closed cell foam products or products containing closed cell foam under any provision of Title VI, EPA is proposing to change that interpretation.
Section 612 requires EPA to promulgate regulations prohibiting the replacement of ODS with certain substitutes and to publish lists of the substitutes prohibited for specific uses as well as those found acceptable for those uses. EPA's implementing regulations at 40 CFR 82.174 state, in part: “No person may use a substitute after the effective date of any rulemaking adding such substitute to the list of unacceptable substitutes” (40 CFR 82.174(d)). The SNAP regulations define “use” of a substitute as including, but not being limited to, “use in a manufacturing process or product, in consumption by the end-user, or in intermediate uses, such as formulation or packaging for other subsequent uses.” (§ 82.172)
EPA currently treats use of foam blowing agents in the manufacture of a foam product as covered by the use prohibition. In this action, EPA is proposing to apply the use prohibition more broadly in the case of closed cell foam products. With respect to other sectors, EPA has treated use of a product manufactured with or containing a substance as constituting use of the substance where the product holds some amount of the substance, the substance continues to perform its intended function, and the substance is likely to be emitted in the United States either during use of the product or at the time of its disposal. For example, an
EPA does not propose to treat use of an open cell foam product as constituting use of the foam blowing agent. The foam blowing agent in an open cell foam product does not continue to perform its intended function during the lifetime of the product. Except for insignificant amounts remaining in the cells, emissions of the foam blowing agent would occur at the time and place of manufacture. Therefore, we are proposing to differentiate between closed cell and open cell foam products for this purpose. This would be consistent with the different treatment of closed and open cell foam products under the section 611 labeling regulations.
For changes of status proposed in this rulemaking (section VI.C.1 and VI.C.2), we are proposing that the unacceptability determination would apply to use of closed cell foam products and products that contain closed cell foam where the products are manufactured on or after the change of status date. As noted in the July 15, 2015 SNAP rule with respect to MVAC and stand-alone refrigeration equipment (80 FR 42884), it is reasonable to allow use of products manufactured before the change of status date to avoid market disruption, creation of stranded inventory, and perverse incentives for releasing these substances to the environment.
For alternatives that have already been listed as unacceptable with a change of status date of January 1, 2017,
EPA requests comment on all aspects of this proposal. In particular, we request comment on our proposal to revise our previous interpretation and to consider use of the foam blowing agent to include use of closed cell foam products and products containing closed cell foam. We are also taking comment on whether use of an open cell foam product should constitute use of the foam blowing agent. Finally, we request comment on the amount of time provided after which closed cell foam products and products containing closed cell foams manufactured on or after the specified dates would be subject to the use prohibitions.
EPA is proposing to list 2-bromo-3,3,3-trifluoropropene (hereinafter referred to as 2-BTP) as acceptable, subject to use conditions, for use in engine nacelles and APUs on aircraft in total flooding fire suppression systems. In addition, EPA proposes to list 2-BTP as acceptable, subject to use conditions, for use in aircraft as a streaming agent. EPA is reviewing additional potential fire suppression applications for 2-BTP but is not taking action on those other uses in this proposed rule.
The fire suppression and explosion protection end-uses addressed in this action are total flooding and streaming. Total flooding systems, which historically employed halon 1301 as a fire suppression agent, are used in both normally occupied and unoccupied areas. In the United States, approximately 90 percent of installed total flooding systems protect anticipated hazards from ordinary combustibles (
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
In addition to halon 1301, the current market for total flooding systems also includes HCFCs, HFCs, inert gases, and a variety of NIK extinguishing agents (
In addition
2-BTP is nonflammable, as are all other available total flooding agents.
When identifying potential alternatives, toxicity is an important characteristic to consider for manufacturing personnel, service technicians, and end users. Typical concerns include residual oxygen concentration in the protected space
EPA has evaluated the risks associated with potential exposures to 2-BTP during production operations and the filling of fire extinguishers as well as in the case of an inadvertent discharge of the system during maintenance activities on the fire extinguishing system. EPA's review of the human health impacts of 2-BTP, including the summary of available toxicity studies, and EPA's review of the human health impacts of 2-BTP is in the docket for this rulemaking (EPA-HQ-OAR-2015-0663).
According to the MSDS, exposure to 2-BTP through ocular or dermal absorption, inhalation, or ingestion is unlikely to be harmful. However, the most likely pathway of exposure is through inhalation, which may cause central nervous system effects, such as dizziness, confusion, physical incoordination, drowsiness, anesthesia, or unconsciousness. EPA uses the NOAEL value as the basis to ensure protection to the worker population. The cardiotoxic Lowest-Observed-Adverse-Effect-Level (LOAEL) for this agent is 1.0 percent (10,000 ppm), at which level exposure may cause increased sensitivity of the heart to adrenaline, which might cause irregular heartbeats and possibly ventricular fibrillation or death; the cardiotoxic NOAEL for this agent is 0.5 percent (5,000 ppm).
2-BTP vapors are heavier than air and may reduce oxygen available for breathing, causing asphyxiation in high concentrations. Such vapors pose a potential hazard if large volumes are trapped in enclosed or low places. In addition, as noted above, if person(s) are exposed to high concentrations, the person(s) may experience central nervous system effects, such as drowsiness and dizziness, which may result in the person(s) not realizing that he/she is suffocating. These health effects after exposure are similar for other common fire suppressants.
Employees responsible for manufacturing the systems should wear the appropriate PPE, such as protective gloves, tightly sealed goggles, protective work clothing, and suitable respiratory protection in case of accidental release or insufficient ventilation. Use of respirators is recommended during activities in which exposure to the proposed substitute cannot be controlled through other means. When handling a leak in a storage container, protective clothing is recommended as well as vapor-in air detection systems. Gloves (
For operations requiring regular handling of 2-BTP, engineering controls should include adequate ventilation systems and enclosed or confined operations to ensure exposure levels to the proposed substitute are below the occupational AEL. 2-BTP is not expected to pose a risk to workers when the engineering controls and PPE recommendations referenced in the MSDS for this proposed substitute are followed.
Exposure to 2-BTP is not likely during installation or servicing of 2-BTP total flooding systems for engines and APUs on aircraft. These are both considered to be unoccupiable areas, meaning personnel cannot physically occupy these spaces, thus reducing the risk from exposure to an inadvertent discharge. The risk of accidental activation of the fire extinguishing system while personnel are present near the protected space is highly unlikely if proper procedures, including those of the 2-BTP system manufacturer as well as the aircraft manufacturer, are followed. Instructions on system installation and servicing included in manuals for the 2-BTP systems should be adhered to. In the case of an inadvertent discharge of the system during maintenance activities on the fire extinguishing system or surrounding equipment, the cowl doors that would be open to allow access to the area will allow personnel to immediately egress and avoid exposure. Protective gloves and tightly sealed goggles should be worn for installation and servicing activities, to protect workers in any event of potential discharge of the proposed substitute, accidental or otherwise. Filling or servicing operations should be performed in well-ventilated areas.
2-BTP is not expected to cause a significant risk to human health in the general population when used as a total flooding fire extinguishing agent. Disposal of 2-BTP total flooding systems is subject to local, state, and federal regulations, which ensure that 2-BTP and water contaminated with 2-BTP are not be dumped into sewers, on the ground, or into any body of water, but rather taken to a wastewater treatment facility or disposed of properly. 2-BTP is not considered to be hazardous waste under EPA regulations implementing RCRA.
EPA's evaluation indicates that the use of 2-BTP is not expected to pose a significant toxicity risk to personnel or the general population. 2-BTP is not expected to cause a significant risk to human health in the general population when used as a total flooding fire extinguishing agent in systems designed specifically for engines and APUs on aircraft. Exposure to 2-BTP is not likely for technicians during installation or servicing of 2-BTP total flooding systems for engines and APUs. As indicated by the submitter, the risk of accidental activation of the fire extinguishing system while personnel are present near the protected space is highly unlikely if proper procedures are followed. Proper instructions on system installation and servicing included in manuals for the 2-BTP systems should be adhered to. The locations of the 2-BTP bottles in the engine and APU compartments will vary by airplane model. The engine bottles could be installed inside or outside the pressurized volume, but they are connected through piping to the engines. APU bottles are typically installed forward of the APU firewall, outside of the pressurized volume of the plane. The bottles are hermetically sealed and the piping system is pressure tested, mitigating the potential for any leak of 2-BTP from the system. According to the submitter, in the case of an inadvertent discharge of the system during maintenance activities on the fire extinguishing system or surrounding equipment, the cowl doors that would be open to allow access to the area will allow service personnel to immediately egress and avoid exposure. Furthermore, aircraft maintenance procedures provide specific instruction to prevent accidental discharge of 2-BTP systems. It is expected that procedures identified in the MSDS for 2-BTP and good manufacturing practices will be adhered to, and that the appropriate safety and PPE (
The toxicity risks can be minimized through the use conditions specified in section VI.D.c below. The risks after exposure are common to many total
In addition to halon 1211, the current market for streaming applications also includes HCFCs, HFCs, and a variety of other agents (
Regarding local air quality impacts, EPA compared the annual VOC emissions from the use of 2-BTP as a streaming agent to other anthropogenic sources of VOC emissions considering both worst case and more realistic scenarios. Under either scenario, emissions are a small fraction of a percentage (7.4 × 10
2-BTP is nonflammable, as are all other available streaming agents.
EPA evaluated occupational and general population exposure at manufacture and at end-use to ensure that the use of 2-BTP as a streaming agent will not pose unacceptable risks to workers or the general public. EPA has evaluated the risks associated with potential exposures to 2-BTP during production operations and the filling of fire extinguishers as well as in the case of an inadvertent discharge of the fire extinguisher during maintenance activities.
2-BTP is not expected to pose a risk to workers during manufacture when the engineering controls and PPE requirements as also referenced in the MSDS for this proposed substitute are followed as described below in section VI.D.1.c.i. The combination of appropriate engineering controls and the use of PPE will ensure exposure levels to the proposed substitute are below the occupational AEL. Exposure to 2-BTP is not likely during installation or servicing of 2-BTP fire extinguishers. As indicated by the submitter, the risk of accidental activation of the fire extinguisher while personnel are present in the protected space is highly unlikely if proper procedures are followed. Proper instructions on system installation and servicing included in manuals for the 2-BTP systems should be adhered to.
EPA also assessed potential end-use exposure scenario, 15-minute and 30-minute TWA exposures for 2-BTP following potential release of agent from the handheld extinguisher on-board aircraft. These exposures were then compared to the cardiotoxic LOAEL for 2-BTP. The modeled 15-minute and 30-minute exposures for varying ventilation rates were significantly lower than the LOAEL of 10,000 ppm for 2-BTP, as well as below the NOAEL of 5,000 ppm. 2-BTP handheld extinguishers must follow required minimum room volumes established by UL 2129, Halocarbon Clean Agent Fire Extinguishers,
There are various precautions described above, but the actual use conditions are described below. The general population risks during release or disposal of the agent are described in section VI.D.1.b above. The risks after exposure are common to many streaming agents, including those already listed as acceptable under SNAP for this same end-use, such as C6-perfluoroketone. EPA is proposing to find 2-BTP acceptable, subject to use conditions, as a streaming agent on aircraft because the overall environmental and human health risk posed by the substitute is lower than or comparable to the overall risk posed by other alternatives listed as acceptable in the same end-use.
EPA is proposing to add 2-BTP to the list of acceptable total flooding substitutes, subject to use conditions. For the total flooding end-use, the proposed use conditions would require that 2-BTP be used only for engine nacelles and APU on aircraft.
For the streaming end-use, the use condition would require that 2-BTP be used only for handheld extinguishers in aircraft.
In the “Further Information” column of the regulatory listing, EPA is providing the following additional information for establishments manufacturing, installing and maintaining total flooding systems using this agent:
• This agent should be used in accordance with the safety guidelines in the latest edition of the National Fire Protection Association (NFPA) 2001 Standard for Clean Agent Fire Extinguishing Systems;
• In the case that 2-BTP is inhaled, person(s) should be immediately removed and exposed to fresh air; if breathing is difficult, person(s) should seek medical attention;
• In case of ocular exposure, person(s) should immediately flush the eyes, including under the eyelids, with
• Eye wash and quick drench facilities should be available. In case of ocular exposure, person(s) should immediately flush the eyes, including under the eyelids, with fresh water and move to a non-contaminated area; Exposed persons should remove all contaminated clothing and footwear to avoid irritation; and medical attention should be sought if irritation develops or persists;
• Although unlikely, in case of ingestion of 2-BTP, the person(s) should consult a physician immediately;
• Manufacturing space should be equipped with specialized engineering controls and well ventilated with a local exhaust system and low-lying source ventilation to effectively mitigate potential occupational exposure; regular testing and monitoring of the workplace atmosphere should be conducted;
• Employees responsible for chemical processing should wear the appropriate PPE, such as protective gloves, tightly sealed goggles, protective work clothing, and suitable respiratory protection in case of accidental release or insufficient ventilation;
• All spills should be cleaned up immediately in accordance with good industrial hygiene practices; and
• Training for safe handling procedures should be provided to all employees that would be likely to handle containers of the agent or extinguishing units filled with the agent.
• Safety features that are typical of total flooding systems such as pre-discharge alarms, time delays, and system abort switches should be provided, as directed by applicable OSHA regulations and NFPA standards. Use of this agent should also conform to relevant OSHA requirements, including 29 CFR 1910, subpart L, sections 1910.160 and 1910.162.
In the “Further Information” column of the regulatory listing, EPA is providing the following additional information for establishments manufacturing, installing and maintaining streaming agents:
• This agent should be used in accordance with the latest edition of NFPA Standard 10 for Portable Fire Extinguishers;
• In the case that 2-BTP is inhaled, person(s) should be immediately removed and exposed to fresh air; if breathing is difficult, person(s) should seek medical attention;
• Eye wash and quick drench facilities should be available. In case of ocular exposure, person(s) should immediately flush the eyes, including under the eyelids, with fresh water and move to a non-contaminated area. Exposed person(s) should remove all contaminated clothing and footwear to avoid irritation, and medical attention should be sought if irritation develops or persists;
• Although unlikely, in case of ingestion of 2-BTP, the person(s) should consult a physician immediately;
• Manufacturing space should be equipped with specialized engineering controls and well ventilated with a local exhaust system and low-lying source ventilation to effectively mitigate potential occupational exposure; regular testing and monitoring of the workplace atmosphere should be conducted;
• Employees responsible for chemical processing should wear the appropriate PPE, such as protective gloves, tightly sealed goggles, protective work clothing, and suitable respiratory protection in case of accidental release or insufficient ventilation;
• All spills should be cleaned up immediately in accordance with good industrial hygiene practices;
• Training for safe handling procedures should be provided to all employees that would be likely to handle containers of the agent or extinguishing units filled with the agent;
• 2-BTP use as a streaming fire extinguishing agent in handheld extinguishers on aircraft should be in accordance with UL 711,
EPA proposes that this listing would apply 30 days after the date of publication of a final rule. This date, the same as the proposed effective date of this regulation, allows for the safe use of this substitute at the earliest opportunity.
As required for a new chemical, the manufacturer of this agent submitted a Toxic Substance Control Act (TSCA) Premanufacture Notice (PMN) for review by EPA. The PMN, designated as P-14-260, has completed EPA review and the manufacturer is presently subject to requirements contained in a TSCA section 5(e) Consent Order. Other future manufacturers and processors will be subject to a TSCA section 5(a)(2) Significant New Use Rule (SNUR) that is expected to be promulgated in 2016. The requirements of the consent order and SNUR would apply to all commercial manufacturing, processing, distribution in commerce, use and disposal of 2-BTP, unless exempted. Consistent with today's proposed listing, the consent order and SNUR will require use of 2-BTP for aircraft either (1) as a total flooding agent in engine nacelles and APUs on aircraft or (2) as a streaming agent in handheld extinguishers in aircraft. As noted above in section VI.D.1.d, FAA has issued guidance on the use of hand-held fire extinguishers on aircraft that is relevant to the streaming uses proposed in this rule.
EPA is requesting comment on all aspects of the proposed listing decision, including the proposed use conditions.
As described in Table 23, EPA is proposing to change the listings from acceptable to unacceptable for C
The fire suppression and explosion protection end-uses addressed in this action is total flooding. The fire suppression industry has historically used halons, a class of halogenated chemicals containing bromine, as clean extinguishing agents (
Halons have a unique combination of characteristics including being electrically non-conductive, dissipating rapidly without residue (
Halons have very high ODPs because they contain bromine, which has a higher reactivity with ozone than chlorine. Specifically, the ODP of halon 1301 is 15.9.
In response to the early 1994 phaseout of halon production, industry took early actions to find alternatives including less ozone-depleting HCFCs, non-ozone-depleting HFCs, as well as a variety of lower-GWP or no-GWP alternatives (
EPA is proposing to list C
The SNAP program considers a number of environmental criteria when evaluating substitutes: ODP; climate effects, primarily based on GWP; local air quality impacts, particularly potential impacts on smog formation from emissions of VOC; and ecosystem effects, particularly from negative impacts on aquatic life. These and other environmental and health risks are discussed below. In addition, a technical support document
PFCs are fully fluorinated compounds, unlike CFCs, HCFCs, or HFCs. These chemicals have an ODP of zero, are excluded from the definition of VOC under CAA regulations (see 40 CFR 51.100(s)) addressing the development of SIPs to attain and maintain the NAAQS, and have high GWPs (5,000-10,000 times greater than CO
As shown in Table 24, C
C
In evaluating the toxicity concerns with fire suppression agents, we evaluate consumer and worker exposures to discharges of substitutes during fire emergencies and accidental discharges. In these acute, episodic exposures to the substitutes, cardiac sensitization is of particular interest. The term cardiac sensitization refers to an increased susceptibility of the heart to adrenaline (or other catecholamines) which may result in potentially fatal heart arrhythmias. Human heart arrhythmias and sudden deaths resulting from overexposure to CFCs, halons, and other halogenated hydrocarbons have been documented in workplace settings.
The determination of the toxicity risk to either workers or the general population from an accidental discharge of either a flooding or streaming agent substitute is also dependent on a number of other related factors. For total flood systems, the magnitude of exposure will depend on the design concentration of the flooding agent (as determined by the substitute's extinguishing concentration plus a safety factor, as specified by NFPA guidelines) and the length of time it takes a person to evacuate the area in which the agent is released. Because total flood systems are designed to achieve a uniform concentration of agent within a space, the magnitude of exposure is independent of the size of space, size of fire, or proximity of person to the fire. In assessing exposure the design concentration of a total flood substitute is compared to its cardiotoxic NOAEL and LOAEL levels. Generally, for occupied areas, if the design concentration is higher than the agent's NOAEL level, conditions are placed on the use of the agent to ensure human safety (
Compared to other substitutes in the same total flooding end-use, these PFCs have lower toxicity profiles. The cardiotoxic NOAEL for C
In comparing the environmental and health risks of C
EPA has listed as acceptable several substitutes that pose lower overall risk to human health and the environment than the two fire suppression alternatives, C
Today, the demand in the fire suppression total flooding end-use is being met through the availability of clean agents and not-in-kind (NIK) substitutes (
Considering the above, and the current suite of other available substitutes in the fire suppression total flooding end uses EPA is proposing to change the listings from acceptable to unacceptable for C
EPA is not aware of other federal rules applying to these two fire suppression agents in the total flooding end-use.
EPA requests comments on all aspects of these proposed changes. EPA specifically requests comment on the proposed decision to change the status of C
EPA requests comment and updated information on whether there is current or continuing use of SF
HFC-23 is listed as acceptable as a total flooding substitute. In the SNAP final rule of March 18, 1994 (59 FR 13044), EPA decided not to adopt the proposed narrowed use limits on HFC-23 in response to comments that its cardiotoxicity profile was favorable compared to its design or inerting concentration and in some cases it was the only acceptable alternative in particular applications such as: (1) Where temperatures are likely to go below zero degrees, (2) where pre-inerting is required for occupied areas, and (3) where occupied areas can suffer considerable variation in fire volume. HFC-23 is used as a total flooding agent in occupied areas because of its favorable cardiotoxicity profile with values of 30 percent for the NOAEL and 50 percent for the LOAEL, compared to a design concentration of 14.4 percent, based on cup burner tests in heptane. Compared to an inerting concentration in methane of 20.5 percent and an inerting design concentration of 22.6 percent in methane, the agent made for an excellent candidate for use in explosion inertion. Nevertheless, it is also a potent greenhouse gas with a GWP of 14,800.
In its 2014 Assessment, the UNEP TEAP HTOC reported on the status of the use of halons and alternatives in the various sector of use including in pipelines and the oil and gas industry.
With significant progress made by the U.S. total flooding systems industry in adopting a variety of suppression agent alternatives, EPA understands that, as a result, a mix of agents are in use today with high-GWP HFCs occupying a substantial portion of the products on the market. Currently, HFCs account for approximately 23 percent of the alternatives used to replace halon 1301, while HFC-227ea constitutes a majority of that total, with some use of other HFCs such as HFC-23 and HFC-125.
Powdered Aerosol D is a pyrotechnic particulate aerosol and explosion suppressant that also is marketed under the trade names of Aero-K® and Stat-X®. This fire suppressant is supplied to users as a solid housed in a double-walled hermetically-sealed steel container. When the unit is triggered by heat (300 °C), the product is pyrotechnically activated to produce gases and aerosol particles from a mixture of chemicals. EPA listed Powdered Aerosol D as acceptable subject to use conditions as a total flooding agent (71 FR 56359; September 7, 2006). The use conditions required that Powdered Aerosol D be used only in areas that are not normally occupied, because the Agency did not have sufficient information at that time supporting its safe use in areas that are normally occupied. Based on a review of additional information from the submitter to support the safe use of Powdered Aerosol D in normally occupied spaces, EPA subsequently determined that Powdered Aerosol D is also acceptable for use in total flooding systems for normally occupied spaces (79 FR 62863; October 21, 2014). The listing provides that Powdered Aerosol D is acceptable for total flooding uses, which includes both unoccupied and occupied spaces. In the October 2014 listing action, EPA noted that in a subsequent rulemaking, the Agency would remove the previous listing of acceptable subject to use conditions. Today, EPA is proposing to remove this listing for Powdered Aerosol D.
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. It raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Any changes made in response to OMB recommendations have been documented in the docket. EPA prepared an analysis of the potential costs and benefits associated with this action. These are available in docket EPA-HQ-OAR-2015-0663 under the titles, “Climate Benefits of the Proposed SNAP Program Status Change Rule” and “Preliminary Cost Analysis for Regulatory Changes to the Listing Status of High-GWP Alternatives used in Refrigeration and Air Conditioning, Foams, and Fire Suppression.”
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection requirements contained in the existing regulations and has assigned OMB control number 2060-0226. This proposed rule contains no new requirements for reporting or recordkeeping.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. The small entities subject to the requirements of this action are small businesses. For purposes of assessing the impacts of this proposed rule on small entities, EPA evaluated small businesses as defined by the Small Business Administration's (SBA) regulations at 13 CFR 121.201. The Agency has determined that about 90 small businesses could be subject to the rulemaking, and roughly 76 percent of the small businesses subject to this proposed rulemaking would be expected to experience compliance costs of less than one percent of annual sales revenue. Details of this analysis are presented in the document entitled, “Economic Impact Screening Analysis for Regulatory Changes to the Listing Status of High-GWP Alternatives used in Refrigeration and Air Conditioning, Motor Vehicle Air Conditioners, Foams, and Fire Suppression.” EPA evaluated the potential costs to small businesses associated with the proposed rule. EPA estimates that the total annualized compliance costs for all small businesses would be approximately $11.8 to $14.4 million at a seven percent discount rate, or $11.5 to $14.0 million at a three percent discount rate.
The requirements of this proposed rule with respect to HFCs, if finalized as proposed, would impact small businesses that manufacture food processing and dispensing equipment, household refrigerators and freezers, cold storage refrigeration systems, and polyurethane foams; operators of cold storage refrigeration systems, including refrigerated warehouses, wholesalers, and food manufacturers; and manufacture and use cold storage warehouses, and small businesses that import products containing closed cell phenolic, polyisocyanurate, polyolefin, PU, and polystyrene foams manufactured with HFC or HCFC foam blowing agents. The proposal to prohibit use of methylene chloride as a foam blowing agent is not anticipated to impact small businesses because this substance is not expected to be used currently as a blowing agent. This rule's provisions do not create enforceable requirements for refrigeration and AC technicians, but they would indirectly affect technicians servicing motor vehicle AC systems, certain types of retail food refrigeration equipment, cold storage warehouses, and commercial AC equipment where the technician, rather than the refrigeration or AC equipment owner, purchases servicing equipment for different refrigerants. EPA expects these indirect impacts on technicians are minimal, because the transitions to different refrigerants required by this proposed rule are already occurring due to corporate social responsibility initiatives (
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 action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government. EPA is aware that the California Air Resources Board is considering regulation of a number of the substitutes and end-uses in this proposed rule. EPA specifically solicits comment on whether any state agencies have existing environmental requirements affecting the substitutes and the end-uses in this proposed rule.
This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action. EPA specifically solicits additional comment on this proposed action from tribal officials.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. This proposed rule restricts the use of certain substitutes that have greater overall risks for human health and the environment, primarily due to their high global warming potential. The reduction in GHG emissions would provide climate benefits for all people, including benefits for children and future generations. The public is invited to submit comments or identify peer-reviewed studies and data that assess effects of early life exposure to the alternatives addressed in the comparisons of toxicity for the various substitutes, as well as risk screens for the substitutes that are proposed to be listed as acceptable, subject to use conditions, or are newly listed as unacceptable.
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. For the end-uses that are related to energy effects such as refrigeration and AC, a number of alternatives are available to replace those refrigerants that are proposed as unacceptable in this action; many of the alternatives are as energy efficient or more energy efficient than the substitutes being
This action involves technical standards. EPA proposes to use standards from UL in the use conditions for propane. These use conditions would ensure that these new substitutes for very low temperature refrigeration equipment, commercial ice machines, and water coolers, do not present significantly greater risk to human health or the environment than other alternatives.
EPA is proposing to incorporate by reference portions of current editions of the UL Standard 399, “Standard for Drinking-Water Coolers”; UL Standard 471, “Standard for Commercial Refrigerators and Freezers”; and UL Standard 563, “Standard for Ice Makers”, which includes requirements for the safe use of refrigerants . Specifically, these standards are:
1. Supplement SB to UL Standard 399: Requirements for Drinking Water Coolers Employing A Flammable Refrigerant in the Refrigerating System (7th Edition, August 22, 2008). This document establishes requirements for self-contained drinking water coolers, including those supplying cold and/or hot water and those employing flammable refrigerants. The standard is available at
2. Supplement SB to UL Standard 471: Requirements for Refrigerators and Freezers Employing A Flammable Refrigerant in the Refrigerating System (10th Edition, November 24, 2010). This document establishes requirements for commercial refrigerators and freezers that employ a refrigerant that has been identified as having flammable characteristics. The standard is available at
3. Supplement SA to UL Standard 563: Requirements for Ice Makers Employing a Flammable Refrigerant in the Refrigeration System (8th Edition, July 31, 2009). This document establishes requirements for automatic ice makers, including unitary and remote ice makers. The standard is available at
In addition, EPA is proposing to incorporate by reference the list of refrigerants that ASHRAE designates as flammability Class 3 according to ASHRAE Standard 34-2013,
The human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. This action's health and risk assessments are contained in the comparisons of toxicity for the various substitutes, as well as risk screens for the substitutes that are proposed to be listed as acceptable, subject to use conditions, or are newly listed as unacceptable.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Recycling, Reporting and recordkeeping requirements, Stratospheric ozone layer.
For the reasons set forth in the preamble, EPA proposes to amend 40 CFR part 82 as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
(a) * * *
(1) * * *
(iv) Effective [DATE 30 DAYS AFTER PUBLICATION OF THE FINAL RULE], propane (R-290) in self-contained commercial ice machines, very low temperature refrigeration equipment, and water coolers.
| 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 |