| Page Range | 57693-58194 | |
| FR Document |
| Page and Subject | |
|---|---|
| 80 FR 57910 - Culturally Significant Objects Imported for Exhibition Determinations: “Delacroix's Influence: The Rise of Modern Art From Cézanne to van Gogh” Exhibition | |
| 80 FR 57882 - Sunshine Act; Notice of Agency Meeting | |
| 80 FR 57879 - Sunshine Act Meeting | |
| 80 FR 57741 - Changes to Requirements for Field Testing Regulated Genetically Engineered Wheat | |
| 80 FR 57808 - Environmental Modeling Public Meeting; Notice of Public Meeting | |
| 80 FR 57901 - Sunshine Act Meeting | |
| 80 FR 57906 - Kentucky Disaster #KY-00060 | |
| 80 FR 57907 - West Virginia Disaster Number WV-00041 | |
| 80 FR 57902 - Privacy Act; Computer Matching Agreement | |
| 80 FR 57816 - Farm Credit System Insurance Corporation Board; Regular Meeting | |
| 80 FR 57826 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 80 FR 57821 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 80 FR 57820 - Request for Nominations of Candidates To Serve as Members of the Community Preventive Services Task Force | |
| 80 FR 57817 - Formations of, Acquisitions by, and Mergers of Bank Holding Companies | |
| 80 FR 57910 - Culturally Significant Objects Imported for Exhibition Determinations: “Sōtatsu: Making Waves” Exhibition | |
| 80 FR 57910 - Culturally Significant Objects Imported for Exhibition Determinations: “Frank Stella: A Retrospective” Exhibition | |
| 80 FR 57809 - Recommendations for Specifications, Environmental Performance Standards, and Ecolabels for Federal Procurement | |
| 80 FR 57807 - Environmental Impact Statements; Notice of Availability | |
| 80 FR 57911 - PACCAR, Inc., Receipt of Petition for Decision of Inconsequential Noncompliance | |
| 80 FR 57785 - Foreign-Trade Zone (FTZ) 33-Pittsburgh, Pennsylvania, Notification of Proposed Production Activity, DNP Imagingcomm America Corporation, Subzone 33E, (Thermal Transfer Ribbon Master Rolls), Mount Pleasant, Pennsylvania | |
| 80 FR 57812 - Pesticide Registration Review; Draft Human Health and Ecological Risk Assessments for Sulfonylureas and Certain Other Pesticides; Notice of Availability and Request for Comment | |
| 80 FR 57785 - Foreign-Trade Zone (FTZ) 230-Piedmont Triad Area, North Carolina, Notification of Proposed Production Activity, Deere-Hitachi Construction Machinery Corporation, (Hydraulic Excavators), Kernersville, North Carolina | |
| 80 FR 57811 - Receipt of Test Data under the Toxic Substances Control Act | |
| 80 FR 57787 - Silicomanganese From Australia: Preliminary Affirmative Determination of Sales at Less Than Fair Value and Postponement of Final Determination | |
| 80 FR 57785 - Foreign-Trade Zone 122-Corpus Christi, Texas, Authorization of Production Activity, voestalpine Texas, LLC, Subzone 122T, (Hot Briquetted Iron), Portland, Texas | |
| 80 FR 57893 - Principal Exchange-Traded Funds, et al.; Notice of Application | |
| 80 FR 57891 - General Electric Company and GE Capital International Funding Company; Notice of Application | |
| 80 FR 57829 - Agency Information Collection Activities: Submission for OMB Review; Comment Request; OAA Title III-E Evaluation | |
| 80 FR 57738 - Fisheries Off West Coast States; Modifications of the West Coast Commercial and Recreational Salmon Fisheries; Inseason Actions #30 Through #36 | |
| 80 FR 57701 - Federal Contract Tower Safety Action Program (SAFER-FCT) and Air Traffic Safety Action Program for Engineers & Architects, Staff Support Specialists, Aviation Technical System Specialists (Series 2186) and Flight Procedures Team (ATSAP-X) | |
| 80 FR 57862 - Reopening of the Public Comment Period and Two Additional Public Meetings for the Draft Supplemental Environmental Impact Statement and Draft Plan Amendment, California Desert Conservation Area Plan, West Mojave Planning Area, Inyo, Kern, Los Angeles and San Bernardino Counties | |
| 80 FR 57790 - Western Pacific Fishery Management Council; Public Meeting | |
| 80 FR 57790 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council (SAFMC); Public Meeting | |
| 80 FR 57734 - Suspension of Community Eligibility | |
| 80 FR 57840 - Kentucky; Amendment No. 2 to Notice of a Major Disaster Declaration | |
| 80 FR 57848 - 60-Day Notice of Proposed Information Collection: Mark-to-Market Program: Requirements for Community-Based Non-Profit Organizations and Public Agencies | |
| 80 FR 57838 - Louisiana; Amendment No. 2 to Notice of a Major Disaster Declaration | |
| 80 FR 57874 - Webinar Meeting of the Federal Advisory Committee on Juvenile Justice | |
| 80 FR 57840 - Proposed Flood Hazard Determinations for Polk County, Minnesota and Incorporated Areas | |
| 80 FR 57887 - Submission for Review: Certification of Qualifying District of Columbia Service Under Section 1905 of Public Law 111-84, RI 20-126, 3206-XXXX | |
| 80 FR 57798 - Proposed Agency Information Collection | |
| 80 FR 57767 - Proposed Flood Elevation Determinations for Mercer County, New Jersey (All Jurisdictions) | |
| 80 FR 57886 - Submission for Review; Reinstatement of Disability Annuity Previously Terminated Because of Restoration to Earning Capacity, RI 30-9, 3206-0138 | |
| 80 FR 57888 - Submission for Review: Rollover Election (RI 38-117), Rollover Information (RI 38-118) and Special Tax Notice Regarding Rollovers (RI 37-22), 3206-0212 | |
| 80 FR 57767 - Proposed Flood Elevation Determinations for Butler County, Pennsylvania (All Jurisdictions) | |
| 80 FR 57797 - Agency Information Collection Extension | |
| 80 FR 57887 - Federal Salary Council; Meeting Notice | |
| 80 FR 57915 - Global Positioning System Adjacent Band Compatibility Assessment Workshop IV | |
| 80 FR 57877 - United States-Peru Trade Promotion Agreement; Notice of Determination Regarding Review of Submission #2015-01 | |
| 80 FR 57783 - Notice of Request for Renewal of a Currently Approved Information Collection | |
| 80 FR 57874 - Establishing a Minimum Wage for Contractors, Notice of Rate Change in Effect as of January 1, 2016; Correction | |
| 80 FR 57841 - Final Flood Hazard Determinations; Correction | |
| 80 FR 57838 - Washington; Amendment No. 1 to Notice of an Emergency Declaration | |
| 80 FR 57842 - Proposed Flood Hazard Determinations | |
| 80 FR 57837 - Proposed Flood Hazard Determinations | |
| 80 FR 57693 - Managing Senior Executive Performance | |
| 80 FR 57795 - Submission for OMB Review; Comment Request | |
| 80 FR 57839 - Proposed Flood Hazard Determinations | |
| 80 FR 57873 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act | |
| 80 FR 57791 - Limitations of Duty- and Quota-Free Imports of Apparel Articles Assembled in Beneficiary Sub-Saharan African Countries From Regional and Third-Country Fabric | |
| 80 FR 57831 - Bright Futures Pediatric Implementation Cooperative Agreement | |
| 80 FR 57783 - Notice of Request for Revision of Currently Approved Information Collection | |
| 80 FR 57830 - Bright Futures Pediatric Implementation Cooperative Agreement | |
| 80 FR 57862 - Atlantic Wind Lease Sale 5 (ATLW5) for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore New Jersey-Final Sale Notice | |
| 80 FR 57873 - Outer Continental Shelf, Alaska Region, Beaufort Sea Planning Area, Liberty Development and Production Plan, MMAA104000 | |
| 80 FR 57787 - Emerging Technology and Research Advisory Committee; Notice of Partially Closed Meeting | |
| 80 FR 57786 - Materials Processing Equipment Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 80 FR 57792 - Procurement List; Additions and Deletions | |
| 80 FR 57792 - Procurement List; Proposed Addition | |
| 80 FR 57784 - Yavapai Resource Advisory Committee | |
| 80 FR 57806 - Tennessee Gas Pipeline Company, LLC; Notice of Public Scoping Meeting for the Northeast Energy Direct Project, and Extension of Scoping Comment Period | |
| 80 FR 57805 - Cascade Clean Energy, Inc.; Kingdom Energy Products; Notice of Transfer of Exemption | |
| 80 FR 57803 - Alabama Power Company; Notice of Authorization for Continued Project Operation | |
| 80 FR 57800 - PacifiCorp; Notice of Scoping Meeting and Soliciting Scoping Comments for an Applicant Prepared Environmental Assessment Using the Alternative Licensing Process | |
| 80 FR 57807 - Meyersdale Storage, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 57801 - Green Mountain Storage, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request For Blanket Section 204 Authorization | |
| 80 FR 57799 - Carousel Wind Farm, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 80 FR 57801 - Notice of Effectiveness of Exempt Wholesale Generator Status | |
| 80 FR 57803 - Steve Patton; Notice of Declaration of Intention and Soliciting Comments, Protests, and Motions To Intervene | |
| 80 FR 57804 - City of Cheyenne, Wyoming; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene | |
| 80 FR 57805 - Records Governing Off-the-Record Communications; Public Notice | |
| 80 FR 57806 - ETP Crude LLC; Notice of Petition for Declaratory Order | |
| 80 FR 57799 - RC Cape May Holdings, LLC; Notice of Institution of Section 206 Proceeding and Refund Effective Date | |
| 80 FR 57804 - Combined Notice of Filings #2 | |
| 80 FR 57802 - Combined Notice of Filings #1 | |
| 80 FR 57817 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 80 FR 57906 - Revocation of License of Small Business Investment Company | |
| 80 FR 57906 - Surrender of License of Small Business Investment Company | |
| 80 FR 57906 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 80 FR 57786 - Information Systems Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 80 FR 57737 - Magnuson-Stevens Act Provisions; Fishery Management Council Freedom of Information Act Requests Regulations; Technical Amendments to Regulations | |
| 80 FR 57722 - Drawbridge Operation Regulation; Hood Canal, Port Gamble, WA | |
| 80 FR 57848 - Land Acquisitions; Mashpee Wampanoag Tribe | |
| 80 FR 57827 - Medicare Program; Medicare Appeals; Adjustment to the Amount in Controversy Threshold Amounts for Calendar Year 2016 | |
| 80 FR 57825 - Medicare and Medicaid Programs; Continued Approval of the American Diabetes Association as an Accrediting Organization for Diabetes Self-Management Training Programs | |
| 80 FR 57824 - Medicare and Medicaid Programs; Continued Approval of the American Association of Diabetes Educators as an Accrediting Organization for Diabetes Self-Management Training Programs | |
| 80 FR 57822 - Medicare and Medicaid Programs: Application From the American Association for Accreditation of Ambulatory Surgery Facilities for Continued Approval of Its Rural Health Accreditation Program | |
| 80 FR 57891 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 57890 - Product Change-Priority Mail Negotiated Service Agreement | |
| 80 FR 57891 - Product Change-Parcel Select Negotiated Service Agreement | |
| 80 FR 57818 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
| 80 FR 57816 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 80 FR 57709 - Reliance Standards for Making Good Faith Determinations | |
| 80 FR 57878 - The Lead in General Industry Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements | |
| 80 FR 57744 - Airworthiness Directives; The Boeing Company Airplanes | |
| 80 FR 57717 - Multiemployer Plans; Electronic Filing Requirements; Correction | |
| 80 FR 57793 - Agency Information Collection Activities: Comment Request | |
| 80 FR 57732 - Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Missouri; Control of Mercury Emissions From Electric Generating Units | |
| 80 FR 57835 - Letter of Recommendation for Washington State Ferries Liquefied Natural Gas Conversion; Seattle, WA | |
| 80 FR 57767 - Approval and Promulgation of State Plans for Designated Facilities and Pollutants; Missouri; Control of Mercury Emissions From Electric Generating Units | |
| 80 FR 57834 - Cook Inlet Regional Citizen's Advisory Council (CIRCAC) Charter Renewal | |
| 80 FR 57720 - Drawbridge Operation Regulation; Rancocas Creek, Centerton, NJ | |
| 80 FR 57832 - Prospective Grant of Start-Up Exclusive Evaluation Option License Agreement: Development of Diagnostic Tests and Kits for Detection of Pathological Angiogenesis in Cancer | |
| 80 FR 57789 - Certain Oil Country Tubular Goods From the People's Republic of China; Notice of Court Decision Not in Harmony With Final Results of Administrative Review and Notice of Amended Final Results of Administrative Review Pursuant to Court Decision | |
| 80 FR 57796 - Agency Information Collection Activities; Comment Request; TEACH Grant: Study of Institutional Practices and Grant Recipient Outcomes and Experiences | |
| 80 FR 57727 - Approval and Promulgation of Implementation Plans; Florida; Combs Oil Company Variance | |
| 80 FR 57730 - Approval and Promulgation of Implementation Plans; Mississippi: Miscellaneous Changes | |
| 80 FR 57717 - Special Local Regulations; Temporary Change for Recurring Marine Event in the Fifth Coast Guard District | |
| 80 FR 57832 - National Institute on Aging; Notice of Closed Meeting | |
| 80 FR 57834 - National Cancer Institute; Notice of Closed Meetings | |
| 80 FR 57833 - Center For Scientific Review; Notice of Closed Meetings | |
| 80 FR 57765 - Clarification of Employer's Continuing Obligation To Make and Maintain an Accurate Record of Each Recordable Injury and Illness; Extension of Comment Period | |
| 80 FR 57885 - Integrated Safety Analysis Standards for Acute Uranium Exposure of Workers | |
| 80 FR 57734 - Water Quality Standards Regulatory Revisions; Correction | |
| 80 FR 57756 - Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” | |
| 80 FR 57885 - Northern States Power Company-Minnesota; Prairie Island Nuclear Generating Plant, Units 1 and 2 | |
| 80 FR 57882 - Notice of Permit Modification Received Under the Antarctic Conservation Act of 1978 | |
| 80 FR 57883 - Chilled Water System | |
| 80 FR 57890 - New Postal Product | |
| 80 FR 57907 - Agency Information Collection Activities: Proposed Request and Comment Request | |
| 80 FR 57884 - Review and Submission of Updates to the Final Safety Analysis Reports, Emergency Preparedness Documents, and Fire Protection Documents | |
| 80 FR 57889 - New Postal Product | |
| 80 FR 57881 - NASA Advisory Council; Science Committee; Astrophysics Subcommittee; Meeting | |
| 80 FR 57888 - New Postal Product | |
| 80 FR 57828 - Proposed Information Collection Activity; Comment Request | |
| 80 FR 57704 - Disturbance Monitoring and Reporting Requirements Reliability Standard | |
| 80 FR 57795 - Availability of a Final Integrated Feasibility Report (Feasibility Study/Environmental Impact Statement/Environmental Impact Report), Los Angeles River Ecosystem Restoration Study, City of Los Angeles, Los Angeles County, CA | |
| 80 FR 57793 - Army Education Advisory Subcommittee Meeting Notice | |
| 80 FR 57794 - Notice of Intent To Grant Exclusive Patent License to Applied Materials; Austin, TX | |
| 80 FR 57742 - Airworthiness Directives Airbus Helicopters (Previously Eurocopter France) | |
| 80 FR 57698 - Sorghum Promotion, Research, and Information Program | |
| 80 FR 57843 - Federal Property Suitable as Facilities To Assist the Homeless | |
| 80 FR 58094 - Overtime Pay for Border Patrol Agents | |
| 80 FR 57729 - Air Plan Approval; GA; Removal of Stage II Gasoline Vapor Recovery Program | |
| 80 FR 58166 - Migratory Bird Hunting; Late Seasons and Bag and Possession Limits for Certain Migratory Game Birds | |
| 80 FR 58158 - Migratory Bird Hunting; Migratory Bird Hunting Regulations on Certain Federal Indian Reservations and Ceded Lands for the 2015-16 Late Season | |
| 80 FR 57755 - Proposed Establishment of Class E Airspace; International Falls, MN | |
| 80 FR 57700 - Establishment of Class E Airspace; Poplarville-Pearl River County Airport, MS | |
| 80 FR 57699 - Amendment of Class E Airspace; Mackall AAF, NC | |
| 80 FR 57753 - Airworthiness Directives; Alpha Aviation Concept Limited Airplanes | |
| 80 FR 57751 - Airworthiness Directives; Sikorsky Aircraft Corporation (Sikorsky) Helicopters | |
| 80 FR 57725 - Revisions to the California State Implementation Plan, Monterey Bay Unified Air Pollution Control District, Ventura County Air Pollution Control District | |
| 80 FR 57766 - Revisions to the California State Implementation Plan, Monterey Bay Unified Air Pollution Control District, Ventura County Air Pollution Control District | |
| 80 FR 58124 - Removal of Certain References to Credit Ratings and Amendment to the Issuer Diversification Requirement in the Money Market Fund Rule | |
| 80 FR 57768 - Technology Transitions, Policies and Rules Governing Retirement of Copper Loops by Incumbent Local Exchange Carriers and Special Access for Price Cap Local Exchange Carriers | |
| 80 FR 57912 - Administration Hazardous Materials: Actions on Special Permit Applications | |
| 80 FR 57913 - Hazardous Materials: Delayed Applications | |
| 80 FR 57914 - Hazardous Materials: Notice of Application for Modification of Special Permit | |
| 80 FR 57722 - Approval and Promulgation of Air Quality Implementation Plans; New Hampshire; Nonattainment New Source Review and Prevention of Significant Deterioration Program | |
| 80 FR 58014 - Management Standards for Hazardous Waste Pharmaceuticals | |
| 80 FR 57918 - Hazardous Waste Generator Improvements |
Agricultural Marketing Service
Animal and Plant Health Inspection Service
Commodity Credit Corporation
Federal Crop Insurance Corporation
Forest Service
Foreign-Trade Zones Board
Industry and Security Bureau
International Trade Administration
National Oceanic and Atmospheric Administration
Army Department
Engineers Corps
Energy Information Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Children and Families Administration
Community Living Administration
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Coast Guard
Federal Emergency Management Agency
Fish and Wildlife Service
Indian Affairs Bureau
Land Management Bureau
Ocean Energy Management Bureau
Justice Programs Office
Occupational Safety and Health Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Pipeline and Hazardous Materials Safety Administration
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.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Final rule.
The Office of Personnel Management (OPM) is amending subpart C of part 430 of title 5, Code of Federal Regulations, to help agencies design performance appraisal systems for senior executives that support a consistent approach for managing senior executive performance, incorporate current OPM policies, and reorganize information for ease of reading. We are also amending part 534 to make technical corrections to the regulation on pay for senior level and scientific and professional positions.
Effective October 26, 2015.
Nikki Johnson by telephone at (202) 606-8046 or by email at
The U.S. Office of Personnel Management (OPM) issued proposed regulations and requested comments on December 10, 2014 (79 FR 73239). OPM received comments from one Federal agency, a private association for career federal executives (“the Association”), and one individual. We reviewed the public comments, considered them, and decided upon any revisions we concluded were appropriate in light of that consideration. We have summarized the comments below and also indicate how we disposed of them in the final regulations.
In addition to specific substantive comments, we received general comments about the proposed regulations as well as information contained in the supplementary information. For example, the Association supports the concept of a consistent appraisal approach and recognizes the additional clarification provided for the definitions of performance standards and performance requirements as being particularly helpful.
Furthermore, the Association recommends ensuring a consistent framework to promote transparency for SES performance management by limiting agency flexibility. The Association suggests OPM direct agencies to leverage and tailor the critical elements, based on the executive core qualifications (ECQ), to secure the desired flexibility instead of permitting flexibility regarding the implementation of a Governmentwide system. In response, OPM notes that 5 U.S.C. 4312(a), one of the statutory provisions governing performance appraisals for the SES, specifically states: “Each agency shall, in accordance with standards established by OPM, develop one or more performance appraisal systems. . . .” Therefore, we are regulating concepts of good performance management by providing system standards for agencies to use in designing their SES performance management systems. In addition, the basic SES performance management system incorporates these system standards and is available for agencies to adopt and adapt, still allowing agencies limited flexibility in system design.
The Association also recommends OPM codify the SES and Performance Management Office to ensure that office can provide oversight and guidance on SES performance management, as well as serve as a resource for agencies. OPM already has sufficient statutory (5 U.S.C. 4312(c)(1) and (3) and 4315) and regulatory authority (5 CFR subpart C being finalized here and including § 430.314) to fulfill its obligations, with or without a separate office bearing this title, and OPM does not believe it is prudent to bind future directors to any particular organizational scheme. In addition, it is already clear that OPM is committed to providing agencies guidance and support in designing and implementing their performance management systems.
An agency has concerns that the use of the word “rare” in the example of a performance standard in the supplementary information describing Level 5 performance might be interpreted as imposing a quota or limitation on the number of executives who can receive a Level 5 rating. OPM did not intend “rare, high quality performance” to be a quantitative descriptor, as a quota would be proscribed under 5 U.S.C. 4312(b)(2). Nor did OPM intend to imply that Level 5 performance was merely “high level” as all standards for executives should anticipate high level work and be designed to encourage excellence in performance. Rather, OPM intended to convey that, qualitatively, the standards for a Level 5 (“An outstanding level”) rating should be clearly differentiated from and exceed the standards set for Level 4 performance (“An exceeds fully successful level”).
We received four comments on planning and appraising performance. First, the Association suggests the proposed regulations would be strengthened by a discussion of how Technical Qualifications (TQs) could be incorporated, when applicable, in appraising performance. OPM believes that the use of OPM-validated executive competencies can provide the proper balance between leadership qualifications and actual executive results, are the most appropriate basis for appraising executive performance, and would allow for incorporating TQs. We have removed specific reference to the ECQs, and clarified that standards for performance management systems should use critical elements based on OPM-validated executive competencies accordingly.
Also, the Association recommends the regulations establish appropriate timelines for communicating performance plans and ratings. It also recommends the communication of appraisals, including ratings that have been increased, sustained, or lowered, be provided in writing. OPM agrees with making this an explicit requirement and we have revised § 430.308 to ensure agencies establish timelines for communicating performance plans, conducting appraisals, and assigning and communicating annual summary ratings. In addition, we have revised § 430.306(b) regarding performance
In addition, the Association expresses concerns over the manner in which customer and employee perspectives will be collected and assessed and how those assessments will affect the performance appraisal of executives. The Association wants senior executives to be made aware of the assessment methods, and believes those methods must ensure a senior executive is assessed on things within the individual's control. OPM has included Governmentwide performance requirements for employee perspective into the Leading People critical element of the basic SES appraisal system executive performance plan template and for customer perspective in the Building Coalitions critical element. Beyond that, agencies are responsible for developing additional agency-specific requirements. In doing so, agencies should be clear on how the requirements will be measured and make executives aware of those assessment methods. They must make sure that such requirements are within the area of responsibility and control of the executive. We have clarified the language in several places in the regulation to include this concept.
Finally, an individual recommends OPM should consider providing a broader authority to develop alternative review procedures to cover other cases where it might be difficult or impossible to accommodate higher level review within the agency. For example, what would happen when the only person who can provide higher level review is also the final rater. The individual also questions the meaning of agency head in the proposed § 430.309(e)(2)(iii) and suggests OPM should provide a definition of agency for clarity and consistency. We have revised § 430.309(e)(2) to provide a broader authority for agencies to develop alternative review procedures when it is difficult or impossible to accommodate higher level review within the agency. We have also clarified that the review should be made by an official at a higher level who did not participate in determining the executive's initial summary rating. In other words, someone at a higher level who can provide an objective review who was not directly involved in the initial summary rating may serve as a higher-level official for this purpose. For example, a reviewing official may not provide a higher-level review because of their involvement in the process. It is not OPM's intention for agencies to exclude individuals with knowledge of the executive's performance from providing input. We also have revised § 430.303 to add a definition for agency.
Lastly, we received two comments on the oversight official. An agency suggests clarification of the responsibilities of the oversight official. It questions whether the responsibilities of the oversight official could be shared between two positions, such as one individual issuing performance appraisal guidelines and overseeing the performance management system and another individual issuing the organizational assessments. These regulations address the responsibilities of the oversight official with regard to providing oversight of the performance management system and issuing performance appraisal guidelines and do not make the oversight official responsible for organizational assessments. Therefore, it is up to the agency whether two separate positions have the responsibilities of these two functions.
The Association recommends the oversight official also oversee adherence to timelines for communicating performance plans and ratings, as well as ensure agency leaders and political appointees are meeting their responsibilities and obligations in support of implementation of the SES performance management system. We have revised § 430.308 to ensure agencies establish timelines for completing and communicating performance plans and ratings, and are continuing to provide agencies the flexibility to determine which official(s) will oversee adherence to these timelines and the proper exercise of upper management responsibilities regarding performance management.
In the interest of clarifying the regulatory content, OPM is making a few additional changes. Wherever we refer to written communications, we include the ability to accomplish these through the use of automated systems. In § 430.305(a)(7), we have revised the order of the wording to conform with the other entries in paragraph (a). In § 430.308(d)(3), we include language to clarify that guidelines must be issued before completion of the initial summary ratings. In § 430.310(b), we clarify that appraisal information from details and such must be provided to the executive.
On March 5, 2014, OPM published final regulations (79 FR 12353) on pay for senior level and scientific and professional positions to implement Section 2 of the Senior Professional Performance Act of 2008 (Pub. L. 110-372, October 8, 2008). We find that paragraphs (c)(1)(ii) and (c)(1)(iii) of 5 CFR 534.505 of these regulations contain erroneous cross-references that we are correcting. We also are revising the salary rates used in the example to reflect the most current rates at the time of publication of this correction.
I certify that these regulations will not have a significant economic impact on a substantial number of small entities, because they will apply only to Federal agencies and employees.
This rule has not been reviewed by the Office of Management and Budget in accordance with E.O. 12866.
Government employees.
Accordingly, OPM is amending 5 CFR parts 430 and 534 as follows:
5 U.S.C. chapter 43 and 5307(d).
(a)
(b)
(1) Encouraging excellence in senior executive performance;
(2) Aligning executive performance plans with the results-oriented goals required by the Government Performance and Results Act Modernization Act of 2010 (GPRAMA) or other strategic planning initiatives;
(3) Setting and communicating individual and organizational goals and expectations that clearly fall within the executive's area of responsibility and control;
(4) Reporting on the success of meeting organizational goals (including any factors that may have impacted success);
(5) Systematically appraising senior executive performance using measures that balance organizational results with customer and employee perspectives, and other perspectives as appropriate; and
(6) Using performance appraisals as a basis for pay, awards, development, retention, removal, and other personnel decisions.
(c)
This subpart applies to—
(a) All senior executives covered by subchapter II of chapter 31 of title 5, United States Code; and
(b) Agencies as defined in § 430.303.
In this subpart—
(a) To encourage excellence in senior executive performance, each agency must develop and administer one or more performance management systems for its senior executives in accordance with the system standards established in § 430.305.
(b) Performance management systems must provide for—
(1) Identifying executives covered by the system;
(2) Monitoring progress in accomplishing critical elements and performance requirements and conducting progress reviews at least once during the appraisal period, including informing executives on how well they are performing;
(3) Establishing an official performance appraisal period for which an annual summary rating must be prepared;
(4) Establishing a minimum appraisal period of at least 90 days;
(5) Ending the appraisal period at any time after the minimum appraisal
(6) Establishing criteria and procedures to address performance of senior executives who are on detail, temporarily reassigned, or transferred as described at § 430.312(c)(1), and for other special circumstances established by the agency.
(a) Each agency performance management system must incorporate the following system standards:
(1) Use critical elements based on OPM-validated executive competencies to evaluate executive leadership and results, including the quality of the executive's performance;
(2) Align performance requirements with agency mission and strategic planning initiatives;
(3) Define performance standards for each of the summary rating performance levels, which also may be used for the individual elements or performance requirements being appraised;
(4) Appraise each senior executive's performance at least annually against performance requirements based on established performance standards and other measures;
(5) Derive an annual summary rating through a mathematical method that ensures executives' performance aligns with level descriptors contained in performance standards that clearly differentiate levels above fully successful, while prohibiting a forced distribution of rating levels for senior executives;
(6) Establish five summary performance levels as follows:
(i) An outstanding level;
(ii) An exceeds fully successful level;
(iii) A fully successful level;
(iv) A minimally satisfactory level; and
(v) An unsatisfactory level;
(7) Include equivalency statements in the system description for agency-specific terms for the five summary performance levels aligning them with the five performance levels required in § 430.305(a)(6); and
(8) Use performance appraisals as a basis to adjust pay, reward, retain, and develop senior executives or make other personnel decisions, including removals as specified in § 430.312.
(b) An agency may develop its own performance management system for senior executives in accordance with the requirements of this section.
(c) OPM may establish, and refine as needed, a basic performance management system incorporating all requirements of this section, which agencies may adopt, with limited adaptation, for performance management of its senior executives.
(a) Each senior executive must have a performance plan that describes the individual and organizational expectations for the appraisal period that clearly fall within the senior executive's area of responsibility and control.
(b) Supervisors must develop performance plans in consultation with senior executives and communicate the plans to them in writing, including through the use of automated systems, on or before the beginning of the appraisal period.
(c) A senior executive performance plan must include—
(1)
(2)
(3)
(d) Agencies may require a review of senior executive performance plans at the beginning of the appraisal period to ensure consistency of agency-specific performance requirements. Such reviews may be performed by the Performance Review Board (PRB) or another body of the agency's choosing.
Supervisors must monitor each senior executive's performance throughout the appraisal period and hold at least one progress review. At a minimum, supervisors must inform senior executives during the progress review about how well they are performing with regard to their performance plan. Supervisors must provide advice and assistance to senior executives on how to improve their performance. Supervisors and senior executives may also discuss available development opportunities for the senior executive.
(a) Agencies must establish appropriate timelines for communicating performance plans, conducting appraisals, and assigning and communicating annual summary ratings.
(b) At least annually, agencies must appraise each senior executive's performance in writing, including through the use of automated systems, and assign an annual summary rating at the end of the appraisal period.
(c) Agencies must appraise a senior executive's performance on the critical elements and performance requirements in the senior executive's performance plan.
(d) Agencies must base appraisals of senior executive performance on both individual and organizational performance as it applies to the senior executive's area of responsibility and control, taking into account factors such as—
(1) Results achieved in accordance with agency mission and strategic planning initiatives;
(2) Overall quality of performance rendered by the executive,
(3) Performance appraisal guidelines that must be based upon assessments of the agency's performance and are provided by the oversight official to senior executives, rating and reviewing officials, PRB members, and appointing authorities at the conclusion of the appraisal period and before completion of the initial summary ratings;
(4) Customer perspectives;
(5) Employee perspectives;
(6) The effectiveness, productivity, and performance results of the employees for whom the senior executive is responsible;
(7) Leadership effectiveness in promoting diversity, inclusion and engagement as set forth, in part, under section 7201 of title 5, United States Code; and
(8) Compliance with the merit system principles set forth under section 2301 of title 5, United States Code.
(a) When rating senior executive performance, each agency must—
(1) Comply with the requirements of this section, and
(2) Establish a PRB as described at § 430.311.
(b) Each performance management system must provide that an appraisal and rating for a career appointee's performance may not be made within 120 days after the beginning of a new President's term.
(c) When an agency cannot prepare an annual summary rating at the end of the appraisal period because the senior executive has not completed the minimum appraisal period or for other reasons, the agency must extend the executive's appraisal period. Once the appropriate conditions are met, the agency will then prepare the annual summary rating.
(d) Senior executive performance appraisals and ratings are not appealable.
(e) Procedures for rating senior executives must provide for the following:
(1)
(2)
(i) A single review by an official at a higher level who did not participate in determining the executive's initial summary rating will satisfy this requirement. An official providing HLR may not change the initial summary rating but may recommend a different rating to the PRB. HLR may be provided by an official who is at a higher level in the agency than the appointing authority who will approve the final rating under paragraph (e)(4) of this section.
(ii) When an agency cannot provide review by a higher-level official for an executive who receives an initial summary rating from the agency head because no such official exists in the agency, the agency must offer an alternative review as it determines appropriate, except that the review may not be provided by a member of the PRB or an official who participated in determining the initial summary rating.
(iii) If a senior executive declines review by agency-designated higher-level officials, the agency may offer an alternative review but it not obligated to do so. The agency must document the executive's declination of the HLR opportunity provided by the agency before offering an alternative review.
(iv) Copies of findings and recommendations of the HLR official or the official performing an alternative review under paragraph (e)(2)(ii) through (iii) of this section must be given to the senior executive, the supervisor, and the PRB.
(3)
(4)
(5)
(a) When a senior executive is detailed or temporarily reassigned for 120 days or longer, the gaining organization must set performance goals and requirements for the detail or temporary assignment. The gaining organization must appraise the senior executive's performance in writing, including through the use of automated systems, and this appraisal must be considered when deriving the initial summary rating.
(b) When a senior executive is reassigned or transferred to another agency after completing the minimum appraisal period, the supervisor must appraise the executive's performance in writing, including through the use of automated systems, before the executive leaves and provide this information to the executive.
(c) The most recent annual summary rating and any subsequent appraisals must be transferred to the gaining agency or organization. The gaining supervisor must consider the rating and appraisals when deriving the initial summary rating at the end of the appraisal period.
Each agency must establish one or more PRBs to make recommendations to the appointing authority on the performance of its senior executives.
(a)
(2) PRB members must be appointed in a way that assures consistency, stability, and objectivity in SES performance appraisal.
(3) When appraising a career appointee's performance or recommending a career appointee for a performance-based pay adjustment or performance award, more than one-half of the PRB's members must be SES career appointees.
(4) The agency must publish notice of PRB appointments in the
(b)
(2) The PRB must make a written recommendation, including through the use of automated systems, to the appointing authority about each senior executive's annual summary rating, performance-based pay adjustment, and performance award.
(3) PRB members may not take part in any PRB deliberations involving their own appraisals, performance-based pay adjustments, and performance awards.
(a) Agencies must use performance appraisals as a basis for adjusting pay, granting awards, retaining senior executives, and making other personnel decisions. Performance appraisals also will be a factor in assessing a senior executive's continuing development needs.
(b) Agencies are required to provide appropriate incentives and recognition (including pay adjustments and performance awards under part 534, subpart D) for excellence in performance.
(c) A career executive may be removed from the SES for performance reasons, subject to the provisions of part 359, subpart E, as follows:
(1) An executive who receives an unsatisfactory annual summary rating must be reassigned or transferred within the SES, or removed from the SES;
(2) An executive who receives two unsatisfactory annual summary ratings in any 5-year period must be removed from the SES; and
(3) An executive who receives less than a fully successful annual summary rating twice in any 3-year period must be removed from the SES.
(a) To assure effective implementation of agency performance management systems, agencies must provide appropriate information and training to agency leadership, supervisors, and senior executives on performance management, including planning and appraising performance.
(b) Agencies must periodically evaluate the effectiveness of their performance management system(s) and implement improvements as needed. Evaluations must provide for both assessment of effectiveness and compliance with relevant laws, OPM regulations, and OPM performance management policy.
(c) Agencies must maintain all performance-related records for no fewer than 5 years from the date the annual summary rating is issued, as required in 5 CFR 293.404(b)(1).
(a) Agencies must submit proposed SES performance management systems to OPM for approval. Agency systems must address the system standards and requirements specified in this subpart.
(b) OPM will review agency systems for compliance with the requirements of law, OPM regulations, and OPM performance management policy, including the system standards specified at § 430.305.
(c) If OPM finds that an agency system does not meet the requirements and intent of subchapter II of chapter 43 of title 5, United States Code, or of this subpart, OPM will identify the requirements that were not met and direct the agency to take corrective action, and the agency must comply.
5 U.S.C. 1104, 3161(d), 5307, 5351, 5352, 5353, 5376, 5382, 5383, 5384, 5385, 5541, 5550a, sec. 1125 of the National Defense Authorization Act for FY 2004, Pub. L. 108-136, 117 Stat. 1638 (5 U.S.C. 5304, 5382, 5383, 7302; 18 U.S.C. 207); and sec. 2 of Pub. L. 110-372, 122 Stat. 4043 (5 U.S.C. 5304, 5307, 5376).
(c) * * *
(1) Any pay-setting action under § 534.506 or any pay increase under § 534.507 that results in a rate of basic pay that is within the highest 10 percent of the applicable rate range under § 534.504. A rate of basic pay equal to or above the amount derived using the following rules is considered to be within the highest 10 percent of the applicable pay range (in 2015, $177,166 or above if the applicable system is certified, or $164,026 or above if the applicable system is not certified or performance appraisal does not apply):
(i) Subtract the minimum rate of basic pay from the maximum rate of basic pay for the applicable rate range under § 534.504 (in 2015, $183,300−$121,956 = $61,344 if the applicable system is certified, or $168,700−$121,956 = $46,744 if the applicable system is not certified or performance appraisal does not apply);
(ii) Multiply the amount derived in paragraph (c)(1)(i) of this section by 0.10 (in 2015, $61,344 − 0.10 = $6,134 if the applicable system is certified, or $46,744 − 0.10 = $4,674 if the applicable system is not certified or performance appraisal does not apply); and
(iii) Subtract the amount derived in paragraph (c)(1)(ii) of this section from the maximum rate of basic pay applicable under § 534.504 (in 2015, $183,300−$6,134 = $177,166 if the applicable system is certified, or $168,700−$4,674 = $164,026 if the applicable system is not certified or performance appraisal does not apply);
Agricultural Marketing Service; USDA.
Announcement of the continuation of the sorghum promotion.
The Agricultural Marketing Service (AMS) is announcing that sorghum producers voting in a national referendum from March 23, 2015, through April 21, 2015, have approved the continuation of the Sorghum Promotion, Research, and Information Order (Order).
Effective September 25, 2015.
Kenneth R. Payne, Director, Research and Promotion Division; Livestock, Poultry, and Seed Program, AMS, USDA, Room 2608-S; 1400 Independence Avenue SW., Washington, DC 20250-0251; Telephone 202/720-5705; Fax 202/720-1125; or email to
Pursuant to the Commodity Promotion, Research, and Information Act of 1996 (Act)(7 U.S.C. 7411-7425), the Department of Agriculture conducted a referendum from March 23, 2015, through April 21, 2015, among eligible sorghum producers and importers to determine if the Order would continue to be effective. A final rule was published in the November 18, 2010,
Of the 1,202 valid ballots cast, 1,160 or 96.5 percent favored the program and 42 or 3.5 percent opposed continuing the program. For the program to continue, it must have been approved by at least a majority of those eligible persons voting for approval who were engaged in the production or importation of sorghum during the period January 1, 2011, through December 31, 2014.
Therefore, based on the referendum results, the Secretary of Agriculture has determined that the required majority of eligible voters who voted in the
In accordance with the Paperwork Reduction Act (44 U.S.C. Chapter 35), the information collection requirements have been approved under OMB number 0581-0093.
7 U.S.C. 7411-7425.
Federal Aviation Administration (FAA), DOT.
Final rule; technical amendment.
This action amends Class E Airspace at Mackall Army Airfield (AAF), NC, bringing current the regulatory text under the airspace designation for Mackall AAF, NC, by replacing the acronym “NCB” with “NDB”. This is an administrative change to coincide with the FAA's aeronautical database.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
The Order is also available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636, Atlanta, Georgia 30320; telephone (404) 305-6364.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends Class E airspace at Mackall AAF, NC.
In a review of the airspace, the FAA found the airspace description for Mackall AAF, NC, as published in FAA Order 7400.9Z, Airspace Designations and Reporting Points, does not match the FAA's charting information. This administrative change coincides with the FAA's aeronautical database for Class E Airspace Designated as an Extension to a Class D Surface Area.
Class E airspace designations are published in paragraphs 6004 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR part 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by replacing the acronym “NCB” with “NDB” in the regulatory text of the Class E airspace designated as an extension to Class D at Mackall AAF, NC. This is an administrative change merely amending the description for Mackall AAF, NC, to be in concert with the FAAs aeronautical database, and does not affect the boundaries, or operating requirements of the airspace, therefore, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it further clarifies the description of controlled airspace at Mackall AAF, NC.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface within 3 miles each side of the 295° bearing from the Mackall NDB, extending from the 4.2-mile radius of Mackall AAF to 7 miles northwest of the NDB. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action establishes Class E Airspace at Poplarville, MS. to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) serving Poplarville-Pearl River County Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. The FAA found that Class E airspace already exists for another airport in Poplarville, MS, and, therefore, is changing the title and airspace designation in this final rule to include the airport name. Also, a minor adjustment is made to the geographic coordinates of the airport.
Effective 0901 UTC, December 10, 2015. The Director of the Federal Register approves this incorporation by reference action under title 1, Code of Federal Regulations, part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
FAA Order 7400.9Z, Airspace Designations and Reporting Points, and subsequent amendments can be viewed on line at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and ATC Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 29591; telephone: 202-267-8783.
John Fornito, Operations Support Group, Eastern Service Center, Federal Aviation Administration, P.O. Box 20636,
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes Class E airspace at Poplarville-Pearl River County Airport, Poplarville, MS.
On June 22, 2015, the FAA published in the
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9Z dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
This document amends FAA Order 7400.9Z, Airspace Designations and Reporting Points, dated August 6, 2015, and effective September 15, 2015. FAA Order 7400.9Z is publicly available as listed in the
This amendment to Title 14, Code of Federal Regulations (14 CFR) part 71 establishes Class E airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Poplarville-Pearl River County Airport, Poplarville, MS, providing the controlled airspace required to support the new RNAV (GPS) standard instrument approach procedures for Poplarville-Pearl River County Airport. The title of this rule and the airspace designation is changed from Poplarville, MS, to Poplarville-Pearl River County Airport, MS, and the geographic coordinates of the airport are adjusted to be in concert with the FAAs aeronautical database.
Class E airspace designations are published in Paragraph 6005 of FAA Order 7400.9Z, dated August 6, 2015, and effective September 15, 2015, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in the Order.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current, is non-controversial and unlikely to result in adverse or negative comments. It, therefore, (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a Regulatory Evaluation as the anticipated impact is so minimal. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,” paragraph 311a. This airspace action is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 6.8-mile radius of Poplarville-Pearl River County Airport.
Federal Aviation Administration (FAA), DOT.
Notice of Order Designating Information as Protected from Disclosure; No comments received.
This action affirms the order published in the
Effective date: September 25, 2015.
For information on where to obtain copies of documents and other information related to this action, see “How to Obtain Additional Information” in the
For questions concerning this action, contact Ms. Coleen Hawrysko, Group Manager, Air Traffic Organization (ATO) Safety Programs, Federal Aviation Administration, 490 L'Enfant Plaza, Suite 7200, Washington, DC 20024; telephone (202) 267-8807, email:
Under Title 49 of the United States Code (49 U.S.C.), section 40123, certain voluntarily provided safety and security information is protected from disclosure in order to encourage persons to provide the information. In accordance with 14 CFR part 193, Protection of Voluntarily Submitted Information, the FAA must issue an Order that specifies why the agency finds that the information should be protected. If the Administrator issues an Order designating information as protected under 49 U.S.C. 40123, that information will not be disclosed under the Freedom of Information Act (Title 5 of the United States Code (5 U.S.C.), section 552) or other laws, except as provided in 49 U.S.C. 40123, 14 CFR part 193, and the Order designating the information as protected. This Order is issued under part 193; section 193.11, which sets out the notice procedure for designating information as protected.
On April 3, 2015, the FAA published a notice of proposed order designating information provided under the SAFER-FCT and ATSAP-X programs as protected from disclosure under 49 U.S.C. 40123 and 14 CFR part 193. 80 FR 18168. The FAA noted that the designation of protected information is intended to encourage persons to voluntarily provide information to the FAA under the SAFER-FCT and ATSAP-X, so the FAA can learn about and address aviation safety hazards of which it was unaware or more fully understand and implement corrective measures for events or safety issues known by it through other means. The FAA invited public comment. No comments were submitted to the docket.
The designation is applicable to any FAA office that receives information covered under this designation from SAFER-FCT and ATSAP-X, both of which will be incorporated in FAA Order JO 7200.20, Voluntary Safety Reporting Programs. Any other government agency that receives SAFER-FCT and ATSAP-X information covered under the designation from the FAA is subject to the requirements of 49 U.S.C. 40123 regarding nondisclosure of the information. Under § 193.7(e), each such agency must stipulate in writing, that it will abide by the requirements of section 40123, the provisions of part 193, and the Order designating SAFER-FCT and ATSAP-X as protected from public disclosure under 14 CFR part 193.
b. Voluntarily-provided Information Protected from Disclosure Under the Proposed Designation. Except for SAFER-FCT or ATSAP-X reports that involve possible criminal conduct, substance abuse, controlled substances, alcohol, or intentional falsification, the following information would be protected from disclosure:
(1) the content of any report concerning an aviation safety or security matter that is submitted by a qualified participant under the SAFER-FCT or ATSAP-X that is accepted into either program, including the SAFER-FCT or ATSAP-X report, and the name of the submitter of the report. Notwithstanding the foregoing, mandatory information about occurrences that are required to be reported under FAA Orders or ATO guidance is not protected under this designation, unless the same information has also been submitted or reported under other procedures prescribed by the Agency. The exclusion is necessary to assure that the information protected under this designation has been voluntarily submitted. It also permits changes to ATO Orders and guidance without requiring a change to this designation.
(2) Any evidence gathered by the Event Review Committee during its investigation of a safety- or security-related event reported under SAFER-FCT or ATSAP-X, including the SAFER-FCT or ATSAP-X investigative file.
The type of information or circumstances under which the information listed above would not be protected from disclosure is discussed in paragraph 3.b of this Order.
a.
b.
(1) The following types of reports are ordinarily submitted under the SAFER-FCT or ATSAP-X:
i.
ii.
(2) Region X employees support the design, delivery and efficiency of flight services throughout the National Airspace System (NAS) facilities, systems and equipment. Reports submitted by these employees under ATSAP-X ordinarily involve matters or observations occurring during the performance of their job responsibilities, and therefore the information submitted is inherently safety related. Vendor employees provide and support the provision of air traffic services at Federal Contract Tower facilities throughout the NAS. Reports submitted by these employees under SAFER-FCT ordinarily involve occurrences or problems identified or experienced during the performance of their job responsibilities which directly affect safety.
c.
The FAA finds that disclosure of the information would inhibit the voluntary provision of that type of information. Employees are unwilling to voluntarily provide detailed information about safety events and concerns, including those that might involve their own failures to follow Agency directives and policies, if such information could be released publicly. If information is publicly disclosed, there is a strong likelihood that the information could be misused for purposes other than to address and resolve the reported safety concern. Unless the FAA can provide assurance that safety-related reports will be withheld from public disclosure, employees will not participate in the programs.
d.
e.
(1) Withholding SAFER-FCT and ATSAP-X information from disclosure, as described in this designation, is consistent with the FAA's safety responsibilities. Without the Agency's ability to assure that the detailed information reported under these programs, which often explains why the event occurred or describes underlying problems, will not be disclosed, the information will not be provided to the FAA. Employees are concerned that public release of the information could result in potential misuses of the information that could affect them negatively. If the FAA does not receive the information, the FAA and the public will be deprived of the opportunity to make the safety improvements that receipt of the information otherwise enables. Corrective action under SAFER-FCT and ATSAP-X can be accomplished without disclosure of protected information. For example, for acceptance under both programs, the reporting employee must comply with ERC recommendations for corrective action, such as additional training for an employee. If the employee fails to complete corrective action in a manner satisfactory to all members of the ERC, the event may be referred to an appropriate office within the FAA for any additional investigation, reexamination, and/or action, as appropriate.
(2) The FAA may release SAFER-FCT or ATSAP-X information submitted to the agency, as specified in Part 193 and this Order. For example, to explain the need for changes in FAA policies, procedures, and regulations, the FAA may disclose de-identified, summarized information that has been derived from SAFER-FCT or ATSAP-X reports or extracted from the protected information listed under paragraph 5b. The FAA may disclose de-identified, summarized SAFER-FCT or ATSAP-X information that identifies a systemic problem in the NAS, when a party needs to be advised of the problem in order to take corrective action. Under the current version of FAA Order N JO 7200.20, reported events and possible violations may be subject to investigation, reexamination, and/or action. Although the report itself and the content of the report are not used as evidence, the FAA may use the knowledge of the event or possible violation to generate an investigation, and, in that regard, the information is not protected from disclosure. To withhold information from such limited release would be inconsistent with the FAA's safety responsibilities. In addition, reports that appear to involve possible criminal activity, substance abuse, controlled substances, alcohol, or intentional falsification will be referred to an appropriate FAA office for further handling. The FAA may use such reports for enforcement purposes, and will refer such reports to law enforcement agencies, if appropriate. To withhold information in these circumstances would be inconsistent with the agency's safety responsibilities because it could prevent, or at least diminish the FAA's ability to effectively address egregious misconduct.
f.
(1) All employee SAFER-FCT and ATSAP-X reports are clearly labeled as such. Each employee must submit their own report.
5.
Federal Energy Regulatory Commission, DOE.
Final rule.
The Federal Energy Regulatory Commission approves Reliability Standard PRC-002-2 (Disturbance Monitoring and Reporting Requirements) submitted by the North American Electric Reliability Corporation. The purpose of Reliability Standard PRC-002-2 is to have adequate data available to facilitate analysis of bulk electric system disturbances.
1. Pursuant to section 215 of the Federal Power Act (FPA), the Federal Energy Regulatory Commission (Commission) approves Reliability Standard PRC-002-2 (Disturbance Monitoring and Reporting Requirements).
2. Section 215 of the FPA requires a Commission-certified ERO to develop mandatory and enforceable Reliability Standards, subject to Commission review and approval.
3. On March 16, 2007, the Commission issued Order No. 693, approving 83 of the 107 Reliability Standards filed by NERC, including Reliability Standard PRC-018-1.
4. In Order No. 693, the Commission determined that proposed Reliability Standard PRC-002-1 was a “fill-in-the-blank” Reliability Standard because it required Regional Reliability Organizations to establish requirements for installation of disturbance monitoring equipment and report disturbance data to facilitate analyses of events and verify system models.
5. On December 15, 2014, NERC submitted a petition seeking Commission approval of proposed Reliability Standard PRC-002-2.
6. NERC stated that it is important to monitor and analyze disturbances to plan and operate the Bulk-Power System to avoid instability, separation and cascading failures.
7. NERC stated that, in the United States, Reliability Standard PRC-002-2 will apply to planning coordinators in the Eastern Interconnection, planning coordinators or the reliability coordinator in the Electric Reliability Council of Texas (ERCOT) Interconnection, and the reliability coordinator in the Western Interconnection, which are collectively referred to as “Responsible Entities.” Reliability Standard PRC-002-2 will also apply to transmission owners and generation owners.
8. NERC stated that Reliability Standard PRC-002-2 includes 12 requirements. Requirement R1 requires transmission owners: (1) To identify bulk electric system buses,
[Sequence of events recordings] and [fault recording] data is required at additional [bulk electric system] buses on the list determined in Step 6. The aggregate of the number of [bulk electric system] buses determined in Step 7 and this Step will be at least 20 percent of the [bulk electric system] buses determined in Step 6.
The additional [bulk electric system] buses are selected, at the [t]ransmission [o]wner's discretion, to provide maximum wide-area coverage for [Sequence of events recordings] and [fault recording] data. The following [bulk electric system] bus locations are recommended:
Electrically distant buses or electrically distant from other [disturbance monitoring equipment] devices.
Voltage sensitive areas.
Cohesive load and generation zones.
[Bulk electric system] buses with a relatively high number of incident [t]ransmission circuits.
[Bulk electric system] buses with reactive power devices.
Major [f]acilities interconnecting outside the [t]ransmission [o]wner's area.
9. NERC proposed an implementation plan that includes an effective date for Reliability Standard PRC-002-2 that is the first day of the first calendar quarter that is six months after the date that the Commission approves the Reliability Standard. Concurrent with the effective date, the implementation plan calls for the retirement of currently-effective Reliability Standard PRC-018-1 and “pending” Reliability Standard PRC-002-1.
10. On April 16, 2015, the Commission issued a Notice of Proposed Rulemaking proposing to approve Reliability Standard PRC-002-2.
11. In response to the NOPR, NERC filed initial comments in support of the NOPR. Bonneville Power Administration (Bonneville) and American Public Power Association (APPA) filed comments addressing aspects of Reliability Standard PRC-002-2 and the NOPR.
12. Pursuant to FPA section 215(d)(2), the Commission approves Reliability Standard PRC-001-2 as just, reasonable, not unduly discriminatory or preferential, and in the public interest. We also approve the associated violation risk factors, violation severity levels, implementation plan, and effective date proposed by NERC. In addition, we approve the retirement of Reliability Standard PRC-018-1 due to its consolidation with Reliability Standard PRC-002-2.
13. Reliability Standard PRC-002-2 enhances reliability by imposing mandatory requirements concerning the monitoring and reporting of disturbances. Reliability Standard PRC-002-2 provides greater continent-wide consistency regarding collection methods for data used in the analysis of disturbances on the Bulk-Power System. Specifically, Reliability Standard PRC-002-2 enhances reliability by consistently requiring covered entities to collect time-synchronized information and to report disturbances on the Bulk-Power System. Accordingly, we determine that Reliability Standard PRC-002-2 satisfies the relevant directive in Order No. 693.
14. We address below Bonneville's comments regarding the methodology used in Reliability Standard PRC-002-2 to identify bulk electric system buses that require data recording and, in Section V below, APPA's comments regarding the NOPR's Regulatory Flexibility Act certification.
15. The NOPR proposed to approve Reliability Standard PRC-002-2 because the Reliability Standard enhances reliability by imposing mandatory requirements concerning the monitoring and reporting of disturbances and provides greater continent-wide consistency regarding collection methods for data used in the analysis of disturbances on the Bulk-Power System. The NOPR did not raise concerns regarding the methodology used in Reliability Standard PRC-002-2 for identifying bulk electric system buses that require data recording.
16. Bonneville states that it supports using digital fault recorders for sequence of events recordings and fault recordings, but Bonneville does not support the methodology used to identify bulk electric system buses that require data recording.
17. Bonneville also contends that the methodology used in Reliability Standard PRC-002-2 does not allow for adequate consideration of the unique characteristics of an individual utility's
18. In its reply comments, NERC states that Reliability Standard PRC-002-2 provides a technically sound basis for identifying which buses require data collection.
19. NERC explains that it included Step 8 of the bus identification methodology in Reliability Standard PRC-002-2 to allow for the engineering judgment of a transmission owner to account for the unique characteristics of its system and to ensure adequate data capture for proper event analysis.
20. We are not persuaded by Bonneville's concerns regarding the methodology used to identify bulk electric system buses that require data recording. As described in NERC's reply comments, NERC has provided adequate technical justification, through the use of survey data and statistical analysis, for the 1,500 MVA threshold in Reliability Standard PRC-002-2. We also find that the methodology in Reliability Standard PRC-002-2 adequately addresses the unique characteristics of individual utility systems by allowing for the selection of additional buses in Step 8 and that the decisions to add buses under Step 8 are auditable.
21. The collection of information addressed in this final rule is subject to review by the Office of Management and Budget (OMB) under section 3507(d) of the Paperwork Reduction Act of 1995.
22.
23. Interested persons may obtain information on the reporting requirements by contacting the Federal Energy Regulatory Commission, Office of the Executive Director, 888 First Street, NE., Washington, DC 20426 [Attention: Ellen Brown, email:
24. Comments on the requirements of this rule may also be sent to the Office of Management and Budget, Office of Information and Regulatory Affairs [Attention: Desk Officer for the Federal Energy Regulatory Commission]. For security reasons, comments should be sent by email to OMB at the following email address:
25. The Commission is required to prepare an Environmental Assessment or an Environmental Impact Statement for any action that may have a significant adverse effect on the human environment.
26. The Regulatory Flexibility Act of 1980 (RFA)
27. The Commission proposed that, under SBA's new standards, some transmission owners and generation owners might fall under the following category and associated size threshold: electric bulk power transmission and control at 500 employees; hydroelectric power generation at 500 employees; fossil fuel electric power generation at 750 employees; nuclear electric power generation at 750 employees.
28. The Commission estimated that the number of applicable small entities will be minimal due to the gross MVA thresholds embedded into Reliability Standard PRC-002-2. The gross MVA thresholds focus information collection on bulk electric system facilities having Interconnection-wide impacts worthy of collecting. We estimated that Reliability Standard PRC-002-2 will apply to approximately 521 entities in the United States.
29. APPA contends that the NOPR understates the impact that Reliability Standard PRC-002-2 will have on small entities by underestimating the number or small entities affected and by not addressing the “discriminatory distribution of implementation costs” on small entities.
30. APPA also contends that Reliability Standard PRC-002-2 will place an undue burden on small entities because they do not currently have sequence of events recording or fault recording data recorders installed on their bulk electric system buses.
31. In its reply comments, NERC contends that Reliability Standard PRC-002-2 does not place an undue burden on small entities.
32. The RFA requires an analysis when a rule will have significant economic impact on a substantial number of small entities. The comments submitted by APPA do not justify altering the RFA certification proposed in the NOPR.
33. We are not persuaded by APPA's claims regarding the number of small entities likely to be affected by Reliability Standard PRC-002-2. APPA relied on an unverified report from a single unnamed entity to claim that eight small entities (rather than the two or three estimated in the NOPR) would be affected by Reliability Standard PRC-002-2. Even if we were to assume that APPA is correct regarding the eight small entities, we find that eight small entities out of 52 estimated small entities is not a substantial number of small entities. Further, aside from the number of small entities affected, APPA does not address the NOPR's estimate that Reliability Standard PRC-002-2 will not impose a significant economic impact on applicable small entities.
34. With respect to APPA's claim that Reliability Standard PRC-002-2 imposes “discriminatory distribution of implementation costs on small entities,”
35. Accordingly, we certify that Reliability Standard PRC-002-2 will not have a significant economic impact on a substantial number of small entities.
36. In addition to publishing the full text of this document in the
37. From the Commission's Home Page on the Internet, this information is available on eLibrary. The full text of this document is available on eLibrary in PDF and Microsoft Word format for viewing, printing, and/or downloading. To access this document in eLibrary, type the docket number excluding the last three digits of this document in the docket number field.
38. User assistance is available for eLibrary and the Commission's Web site during normal business hours from FERC Online Support at 202-502-6652 (toll free at 1-866-208-3676) or email at
39. The final rule is effective November 24, 2015. The Commission has determined, with the concurrence of the Administrator of the Office of Information and Regulatory Affairs of OMB, that this rule is not a “major rule” as defined in section 351 of the Small Business Regulatory Enforcement Fairness Act of 1996. This final rule is being submitted to the Senate, House, and Government Accountability Office.
By the Commission.
Issued: September 17, 2015.
Internal Revenue Service (IRS), Treasury.
Final regulations.
This document contains final regulations regarding the standards for making a good faith determination that a foreign organization is a charitable organization that is not a private foundation, so that grants made to that foreign organization may be qualifying distributions and not taxable expenditures. The regulations also make additional changes to conform the final regulations to statutory amendments made by the Deficit Reduction Act of 1984 and the Pension Protection Act of 2006. The regulations will affect private foundations seeking to make good faith determinations.
Ward L. Thomas, (202) 317-6173 (not a toll-free number).
The collection of information in these final regulations is the good faith determination set forth in §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5). The collection of information contained in these regulations is reflected in the collection of information for Form 990-PF, “Return of Private Foundation or Section 4947(a)(1) Trust Treated as Private Foundation,” that has been reviewed and approved by the Office of Management and Budget in accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3507(d)), under control number 1545-0052. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid control number assigned by the Office of Management and Budget. Books or records relating to a collection of information must be retained as long as their contents might become material in the administration of any internal revenue law.
This document contains amendments to 26 CFR part 53 under chapter 42, subtitle D of the Internal Revenue Code (Code). To avoid certain excise taxes under chapter 42, a private foundation (referred to in this preamble as a “foundation” or “grantor”)
Longstanding regulations under both sections 4942 and 4945 provide that a foundation will ordinarily be considered to have made a “good faith determination” if the determination is based on an affidavit of the grantee or on an opinion of counsel of either the grantor or the grantee. The affidavit or opinion must set forth sufficient facts concerning the operations and support of the grantee for the IRS to determine that the grantee would be likely to qualify as a public charity or an operating foundation. See §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5). In this preamble, we refer to this rule, which gives assurance to
Revenue Procedure 92-94, 1992-2 CB 507, provides further guidance by providing a “simplified procedure” that foundations may follow, both for making “good faith determinations” under §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5), and for making similar “reasonable judgments” under § 53.4945-6(c)(2)(ii) that a foreign organization is described in section 501(c)(3) (or in section 4947(a)(1), and thus treated under section 4947(a)(1) as described in section 501(c)(3) for purposes of chapter 42 of the Code). Under the revenue procedure, if the grantor's determination that a foreign organization is described in section 501(c)(3) or section 4947(a)(1) of the Code and is either a public charity or an operating foundation is based on a “currently qualified” affidavit prepared by the grantee containing the information specified in the revenue procedure, then the foundation will be deemed to have made a good faith determination (for purposes of §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5)) and a reasonable judgment (for purposes of § 53.4945-6(c)(2)(ii)). If a foundation possesses information that suggests the affidavit may not be reliable, it must consider that information in determining whether the affidavit is currently qualified.
Revenue Procedure 92-94 provides that an affidavit will be considered currently qualified if: (1) The facts it contains reflect the grantee organization's latest complete accounting year (or the affidavit is updated to reflect the grantee organization's current data) and (2) the relevant substantive requirements of sections 501(c)(3) and 4947(a)(1) and sections 509(a)(1), (2), or (3) or section 4942(j)(3) remain unchanged. If a grantee's status under the relevant Code sections does not depend on financial support, which can change from year to year, an affidavit need be updated only by asking the grantee to amend the description of any facts in the original affidavit that have changed. If the facts have not changed, an attested statement by the grantee to that effect is enough to update an affidavit. However, if a grantee's status as a public charity or operating foundation depends on financial support, the affidavit must be updated at least every other year by asking the grantee to provide an attested statement containing enough financial data to establish that it continues to meet the requirements of the applicable Code section.
On September 24, 2012, the Department of the Treasury (Treasury Department) and the IRS published a notice of proposed rulemaking (REG-134974-12) in the
The proposed revisions to the regulations were intended to facilitate grantmaking by foundations to foreign organizations by making it easier and less costly for foundations to obtain written advice from qualified tax practitioners to assure that a grant will ordinarily be considered a qualifying distribution (and not a taxable expenditure). The preamble to the proposed regulations explained that expanding the class of practitioners on whose written advice a foundation may base a good faith determination was expected to decrease the cost of seeking professional advice regarding these determinations, enabling foundations to engage in international philanthropy in a more cost-effective manner. At the same time, expressly allowing reliance for purposes of the special rule on a broader spectrum of professional tax advisors was expected to encourage more foundations to obtain written tax advice, thus promoting the quality of the determinations being made. To facilitate this, foundations were permitted to rely on the provisions of the proposed regulations for grants made on or after September 24, 2012.
The preamble to the proposed regulations specifically requested comments on three issues. First, comments were requested on whether a time limit for reliance on an affidavit or written advice would be appropriate, and if so, the proper length of such a time limit. Second, comments were sought on whether Rev. Proc. 92-94 should be modified to take into account changes to the public support test regulations for public charity qualification that were finalized in 2011 (TD 9549; 76 FR 55745). Third, although the proposed regulations did not change the ability of foundations to rely on grantee affidavits for purposes of the special rule, the Treasury Department and the IRS notified the public that they were considering whether it would be appropriate to remove reliance on affidavits for purposes of the special rule, or to restrict it (for example, by permitting use of affidavits only for grants below a certain dollar amount or by requiring supporting information), and requested comments.
No public hearing was requested or held; however, 11 comments from the public were received. All comments are available at
Commenters were generally supportive of the proposed regulations, with several expressing their hope or expectation that the proposed regulations would reduce barriers to, and streamline the process of, international grantmaking. Commenters noted that expanding the class of professionals upon whose written advice a foundation may base its good faith determination would reduce the costs of making equivalency determinations by enabling the sector to take advantage of economies of scale to increase the quality and efficiency of good faith determinations regarding foreign grantees. The majority of comments focused primarily on the three issues for which comments specifically were requested: (1) The circumstances under which it would be appropriate for foundations to rely on grantee affidavits in making equivalency determinations, (2) the permitted reliance period for an affidavit or advisor's written advice, and (3) modification of Rev. Proc. 92-94.
The final regulations balance two important considerations: (1) Removing barriers to international grantmaking by foundations (as well as by entities
The major areas of comment and the revisions are discussed in this preamble.
In accordance with the proposed regulations and public comments, the final regulations modify the special rule to expand the class of advisors providing written advice on which foundations may ordinarily rely to qualified tax practitioners, including CPAs and enrolled agents (as well as attorneys) who are subject to the standards of practice before the IRS set out in Circular 230. A qualified tax practitioner may include an attorney serving as a foundation's in-house counsel, as well as a foundation's outside counsel. Because Circular 230 requires that, to practice before the IRS, an attorney or CPA must be licensed in a state, territory, or possession of the U.S., and an enrolled agent must be enrolled by the IRS, the final regulations effectively require that the advisor be authorized to practice in a state, territory, or possession of the U.S. or as an enrolled agent. In addition, like the proposed regulations, the final regulations provide that a determination based on the written advice of a qualified tax practitioner ordinarily will be considered as made in good faith if the foundation's reliance meets the requirements of § 1.6664-4(c)(1). As noted in the preamble to the proposed regulations, § 1.6664-4(c)(1) provides that all pertinent facts and circumstances must be taken into account in determining whether a taxpayer has reasonably relied in good faith on written advice, but a foundation's reliance on written advice is not reasonable and in good faith if the foundation knows, or reasonably should have known, that a qualified tax practitioner lacks knowledge of the relevant aspects of U.S. tax law (which, in this context, would include the U.S. tax law of charities). Moreover, a foundation may not rely on written advice if it knows, or has reason to know, that relevant facts were not disclosed to the qualified tax practitioner or that the written advice is based on a representation or assumption that the foundation knows, or has reason to know, is unlikely to be true.
One commenter suggested that the final regulations clarify that foundations and qualified tax practitioners may obtain advice from foreign counsel on questions of foreign law when making good faith determinations. The final regulations, consistent with the proposed regulations, provide that, for purposes of the special rule, if a foundation's determination is based on the written advice of a qualified tax practitioner, the foundation will ordinarily be considered to have made a good faith determination. The Treasury Department and the IRS are concerned that, standing alone, an opinion of foreign counsel, who may or may not have expertise in U.S. tax law, may not ordinarily be a sufficient basis for a determination of a foreign organization's status. Thus, under the final regulations, foundations basing their determination on an opinion of counsel of the grantor or grantee will no longer come within the special rule unless the counsel is a qualified tax practitioner. However, neither the proposed regulations nor the final regulations proscribe the use of foreign counsel in otherwise seeking to make a good faith determination, including use of foreign counsel in gathering information relevant to the determination. The standards of practice before the IRS and requirements for written advice address reliance by qualified tax practitioners on foreign counsel for questions of foreign law. Sections 10.22(b), 10.35(a), and 10.37(b) of Circular 230 generally permit a practitioner to consult with and rely on other experts in appropriate circumstances. It follows, therefore, that a foundation may reasonably rely on written advice received from a qualified tax practitioner in accordance with § 1.6664-4(c)(1) that in turn reasonably relies on advice or assistance from foreign counsel as to questions of foreign law or other matters within such counsel's expertise.
The preamble to the proposed regulations requested comments on whether a foundation's ability to base a good faith determination on an affidavit should be removed, and if not, whether the use of such affidavits should be restricted. In the preamble, the Treasury Department and the IRS expressed their concern that, for purposes of the special rule, grantee affidavits, standing alone, are not always as reliable a basis for making good faith determinations as written advice from qualified tax practitioners and asked for comments. Several comments were received in response to this request.
Most commenters that addressed the issue recommended that foundations continue to be permitted to base a good faith determination on an affidavit of a foreign organization attested to by a principal officer of the foreign organization. These commenters noted that grantee affidavits are often a reliable means of collecting facts about the organization and operations of the foreign grantee, even if, as one commenter noted, on matters of U.S. tax law a grantmaker cannot ordinarily rely on a foreign organization's conclusion that the grantee has a particular tax status. Several commenters noted that the current procedures outlined in Rev. Proc. 92-94 require that affidavits include significant detail and specific accompanying information, which, in their experience, ensures that a foundation has a clear picture of the organization and operation of the foreign organization before making a determination based on the affidavit. However, these commenters also noted that, in their experience, it was often necessary for someone at the foundation (presumably with knowledge of U.S. tax law) to work closely with a foreign organization to ensure that the principal officer attesting to the affidavit understands exactly what is called for and that the affidavit is appropriately completed.
Many commenters stated that foundations should not be required to obtain professional tax advice and requested assurance that a foundation could continue to make good faith determinations without having to engage counsel or another qualified tax practitioner, especially if the foundation or the grant is small. One commenter noted that engaging a qualified tax practitioner may impose substantial costs on a foundation, particularly if the foundation makes repeated grants to the same organization. Another commenter stated that it would be excessive for the regulations to suggest that a grantmaker must ordinarily use professional advisors in order for a determination to be in good faith, but noted that if a grantmaker goes without professional advice, it is fair for the IRS to review its conclusions and its process for reaching
One commenter favored eliminating the grantee affidavit as a free-standing means for making equivalency determinations. In the commenter's experience, the staff and volunteers of most, but not all, foreign grantees have neither the training nor the experience with U.S. tax law needed to make determinations called for by Rev. Proc. 92-94. Therefore, the commenter believed it is important to eliminate reliance on the grantee affidavit.
The Treasury Department and the IRS agree that a grantee affidavit may be a reliable basis for forming a good faith determination in appropriate situations, for example, if the grantee has sufficient knowledge of U.S. tax law to ensure that the affidavit is appropriately completed and contains all relevant information. However, many foreign organizations may lack knowledge of U.S. tax law of charities, as noted by one commenter. In addition, although some foundations have knowledge of U.S. tax law sufficient to assess the reliability of grantee affidavits, to assist foreign grantees in completing the affidavits properly (if necessary), and to appropriately apply the law to the facts stated in the affidavit, the Treasury Department and IRS do not believe that such knowledge of U.S. tax law is universal. Accordingly, the Treasury Department and IRS do not think it is appropriate to ordinarily consider a good faith determination to have been made solely because it is based on a grantee affidavit. Therefore, under the final regulations, a grantee affidavit is not included in the special rule as a basis upon which a determination ordinarily will be considered a good faith determination.
The final regulations do not, however, foreclose the use of grantee affidavits as a source of information in otherwise making a good faith determination. Nor does elimination of the affidavit for purposes of the special rule mean that the foundation must obtain written advice from a qualified tax practitioner in order to make a good faith determination. For example, a foundation manager with understanding of U.S. charity tax law may under the general rule make a good faith determination that a foreign grantee is a qualifying public charity based on the information in an affidavit supplied by the grantee. Furthermore, foundation managers or their in-house counsel may themselves be qualified tax practitioners, whose written advice may be reasonably relied upon for determinations to come within the special rule.
One commenter suggested that to ensure that affidavits of foreign organizations provide a reliable basis for making a good faith determination, the IRS should further clarify what supporting documentation must be provided by a foreign organization and when private foundations may in good faith rely on the responses of foreign organizations. This commenter recommended that the IRS amplify Rev. Proc. 92-94 to state explicitly when the response of the foreign organization is sufficient and when additional supporting documentation (for example, a copy of the relevant law) should be requested from the organization. The Treasury Department and the IRS have concluded, however, that due to the many possible factual differences in foreign organizations' structures, governance, operations, financial support, and relevant local laws and practices, it would be difficult to provide specific guidance governing affidavits and supporting documentation in various situations.
Some commenters raised concerns that removing reliance on grantee affidavits for purposes of the special rule would increase costs for foundations and inhibit international grantmaking, particularly for those grantors making many small grants to foreign organizations. However, commenters generally agreed with the Treasury Department and IRS that the changes proposed in the regulations could lower the cost of obtaining professional advice on equivalency determinations by expanding the class of advisors who may provide written advice to foundation managers. Indeed, based on publicly available information, it appears that foundations relying on the proposed rules (as permitted) are now able to obtain professional advice from qualified tax practitioners to come within the special rule at a significantly reduced cost. Furthermore, under the final regulations, grantee affidavits remain a cost-effective way of obtaining information relevant to making good faith determinations and foundations may continue to rely on them when making determinations to the extent reliance is reasonable and appropriate under the facts and circumstances. Accordingly, the Treasury Department and IRS believe that the final regulations achieve the balance of facilitating international grantmaking while still ensuring that equivalency determinations are appropriately made.
To mitigate the effects of elimination of reliance on grantee affidavits for purposes of the special rule, the final regulations provide a 90-day transition period similar to that set forth in § 53.4945-5(f)(2) (dealing with the implementation of the expenditure responsibility rules). During this 90-day period, foundations may distribute grants in accordance with the former regulations regarding the use of grantee affidavits and opinions of counsel of the grantor or grantee. In addition, under the final regulations, if a grant is distributed pursuant to a written commitment made prior to the applicability date of the final regulations and the grantor made a determination in good faith based on the prior regulations, the distribution is treated as compliant as long as the grant is paid out to the grantee within five years.
The preamble to the proposed regulations requested comments on whether a time limit for reliance on written advice is appropriate, and if so, suggestions for the length of time that should be considered reasonable. Most commenters responded affirmatively to this request and favored guidance setting forth a definite period for reliance on written advice, with most suggesting a period of generally two years (starting from the date of the written advice or the time of the factual information on which the written advice is based).
More specifically, commenters recommended that foundations be able to rely on written advice that a foreign organization meets a public support test under § 1.170A-9(f)(4)(vii)(B) or § 1.509(a)-3(c)(1)(i) for periods similar to those in the rules applicable to publicly supported organizations that have been recognized by the IRS as exempt under section 501(c)(3) and described in section 170(b)(1)(A)(vi) or 509(a)(2).
Commenters also noted that Rev. Proc. 92-94, section 4.05, provides a general two-year period for reliance on an affidavit with regard to a foreign grantee's public support status, such that it is ordinarily necessary to obtain a full update of financial information to determine public support under sections 170(b)(1)(A)(vi) and 509(a)(2) only every other year. Citing these provisions, some commenters requested that the final regulations permit reliance for two tax years after the end of the foreign organization's last tax year of financial information used to determine the organization's public support. Thus, for example, commenters suggested that a 2012 equivalency determination based on financial information from 2007-2011 should be sufficient to demonstrate that the organization would be considered a public charity for both 2012 and 2013, resulting in a period of reliance of up to two years, depending on when in 2012 the determination was made. One commenter suggested that reliance should extend only until the 15th day of the fifth month after the end of the first year following the test period—in the example above, until May 15, 2013—and that a qualified tax practitioner should have to review the foreign grantee's sources of financial support for 2012 before issuing advice that the organization can be treated as publicly supported for the remainder of 2013.
For other qualifying public charities, which do not have a public support requirement, such as schools or hospitals, one commenter requested a reliance period of five years, with a requirement to get a certificate after three years that the relevant law and facts have not changed in any material respect. Another commenter suggested that a foundation be able to rely on advice if the information (other than that for the public support requirement) is current in the present or immediately preceding accounting period of the grantee.
The Treasury Department and the IRS agree with commenters that providing a specific timeframe for reliance on written advice for purposes of the special rule will provide clarity for foundations seeking to meet the requirements of the rule and will promote determinations that are consistently based on current information. Therefore, the final regulations provide that, for purposes of the special rule, written advice of a qualified tax practitioner serving as the basis for a good faith determination must be “current.” Written advice will be considered current if, as of the date of the distribution, the relevant law on which the advice was based has not changed since the date of the written advice and the factual information on which the advice was based is from the organization's current or prior year. However, consistent with rules for determinations of public support over a five-year test period for U.S. public charities, written advice that an organization satisfied the public support requirements under section 170(b)(1)(A)(vi) or section 509(a)(2) based on support over a test period of five years will be treated as current for the two years of the grantee immediately following the end of the five-year test period. For purposes of these rules, an organization's year refers to its taxable year for U.S. tax purposes, or its annual accounting period if it does not have a U.S. taxable year. Additional guidance and examples illustrating the application of these rules may be provided in the update to Rev. Proc. 92-94, discussed further in the next section of this preamble.
It should be noted that the rules regarding when written advice will be considered current apply only for purposes of the special rule. Although this standard reflects a belief that it will usually be reasonable to rely on written advice of a qualified tax practitioner if the advice and underlying facts are no more than two years old (provided the foundation does not know or have reason to know that such information is no longer accurate), it is possible that written advice that is not current for purposes of the special rule may, under some facts and circumstances, reasonably serve as the basis for a good faith determination under the general rule. The age of the facts underlying the written advice would be a consideration in determining whether a good faith determination has been made.
Qualified tax practitioners must, of course, satisfy all requirements for written advice under Circular 230 as of the date of issuance of the written advice (including requirements regarding the factual basis for the advice). The rules regarding when written advice will be considered current for purposes of making distributions to grantees do not alter the Circular 230 standards applicable to qualified tax practitioners, which provide that the practitioner must base the written advice on reasonable factual assumptions and reasonably consider all relevant facts and circumstances that the practitioner knows or reasonably should know. To avoid any implication that the reliance period under the special rule would permit written advice to be based on outdated factual information, the final regulation has been revised to clarify that the written advice must contain sufficient facts to permit the IRS to determine that the grantee would be likely to qualify as a public charity at the time the advice is written.
The preamble to the proposed regulations also requested comments on whether Rev. Proc. 92-94 should be modified to take into account changes in the public support test and whether additional guidelines regarding appropriate timeframes for gathering information should be provided. Most commenters recommended updating Rev. Proc. 92-94 and noted that it is frequently used by qualified tax practitioners for gathering factual information on which to base their written advice. Commenters also recommended that an updated revenue procedure address several key issues relating to foreign organizations, including foreign school compliance with Rev. Proc. 75-50, 1975-2 CB 587, the nature of support from foreign governments, and foreign hospital compliance with section 501(r) (subsequently addressed at § 1.501(r)-1(b)(17)).
The IRS intends to publish an updated revenue procedure, revised to reflect the changes implemented in these regulations as well as changes to the public support tests for section 170(b)(1)(A)(vi) and 509(a)(2) organizations set forth in final regulations implementing the redesign of Form 990, published in the
One commenter asked for confirmation that a foundation could share the written advice of its in-house counsel or other qualified tax practitioner with other foundations, and that the other foundations could make their determinations based on the shared advice, without incurring excise taxes.
Written advice relating to the grantee's status for purposes of an equivalency determination is based on the facts and circumstances of the grantee, and not on the facts and circumstances of the grantor foundation that received the advice. Therefore, it is possible that the conclusions reached in
Commenters suggested that the Treasury Department and the IRS clarify that sponsoring organizations of donor advised funds can use these final regulations to make equivalency determinations for purposes of distributions from donor advised funds to foreign organizations. Until further guidance is issued, sponsoring organizations of donor advised funds may use these regulations as guidance in making equivalency determinations (applying the definition of “disqualified supporting organization” under section 4966(d)(4) in lieu of section 4942(g)(4)(A)(i) or (ii)).
For purposes of the requirement that a distribution be “to” an organization described in section 170(b)(1)(A), in general, it is intended that rules similar to the rules of Treasury regulation § 53.4945-5(a)(5) apply. Under such regulations, for purposes of determining whether a grant by a private foundation is “to” an organization described in section 509(a)(1), (2), or (3) and so not a taxable expenditure under section 4945, a foreign organization that otherwise is not a section 509(a)(1), (2), or (3) organization is considered as such if the private foundation makes a good faith determination that the grantee is such an organization. Similarly, under the provision, if a sponsoring organization makes a good faith determination (under standards similar to those currently applicable for private foundations) that a distributee organization is an organization described in section 170(b)(1)(A) (other than a disqualified supporting organization), then a distribution to such organization is not considered a taxable distribution.
One commenter proposed that the final regulations also allow public charities to make equivalency determinations to avoid the requirements imposed on them by Rev. Rul. 68-489, 1968-2 CB 210, for grants to organizations not exempt under section 501(c)(3). That ruling permits a section 501(c)(3) organization to distribute funds to organizations not exempt under section 501(c)(3) if the grantor organization ensures use of the funds for section 501(c)(3) purposes by limiting distributions to specific projects in furtherance of its own exempt purposes, retains control and discretion as to the use of the funds, and maintains records establishing that the funds were used for section 501(c)(3) purposes. The commenter's proposal is outside the scope of this regulations project, but it may be considered in future guidance.
One commenter requested that the equivalency determination procedures be made expressly applicable to grantees in the U.S. as well as foreign grantees if the domestic grantee is not required to obtain a determination from the IRS or the determination is pending with the IRS. Another commenter requested clarification that a foundation could use the same procedures to determine the status of grantees that are foreign governments, agencies or instrumentalities of foreign governments, or international organizations (which are treated as section 509(a)(1) organizations under § 53.4945-5(a)(4)(iii), even if they are not described in section 501(c)(3), so long as the grant is made exclusively for charitable purposes). Both of these suggestions are beyond the scope of this regulations project but may be considered in future guidance.
Commenters suggested that the Treasury Department and the IRS make corresponding changes to other regulations that provide for determinations similar to equivalency determinations. Section 53.4945-6(c)(2) requires generally that a grant made to an organization not described in section 501(c)(3) be maintained in a separate charitable fund, unless made to a foreign organization that in the reasonable judgment of a foundation manager is described in section 501(c)(3) (other than section 509(a)(4)). Section 1.1441-9 sets forth exemptions from withholding of tax on exempt income of foreign tax-exempt organizations, and allows a withholding agent to accept an opinion from a U.S. counsel concluding that a foreign organization is described in section 501(c)(3) and is not a private foundation, supported by an affidavit of the organization. For more than 20 years, under Rev. Proc. 92-94, a foundation has been able to make the reasonable judgment required by § 53.4945-6(c)(2) by following the same procedure for making a good faith determination under §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5). The Treasury Department and the IRS anticipate that any revised version of that revenue procedure will continue to provide that foundations may meet the requirements of § 53.4945-6(c)(2) by meeting the requirements of §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5). The suggested changes to § 1.1441-9 are beyond the scope of this regulations project, but may be considered in future guidance.
The final regulations also include several amendments to conform the regulations to prior statutory changes. Specifically, changes were made to §§ 53.4942(a)-3(a)(2)(i), 53.4942(a)-3(a)(6)(i), 53.4945-5(a)(1), 53.4945-5(a)(5)(i), 53.4945-5(a)(6)(ii), and 53.4945-5(b)(5). Section 4945(d)(4) was amended in 1984 to treat exempt operating foundations under section 4940(d)(2) as organizations that may receive grants for which expenditure responsibility is not required. Sections 4942 and 4945(d)(4) were amended in
The final regulations apply generally to distributions made after the date of publication of this Treasury decision in the
For copies of recently issued revenue procedures, revenue rulings, notices and other guidance published in the Internal Revenue Bulletin, please visit the IRS Web site at
Certain IRS regulations, including these, are exempt from the requirements of Executive Order 12866, as supplemented and reaffirmed by Executive Order 13563. Therefore, a regulatory impact assessment is not required. It also has been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations.
It is hereby certified that the collection of information in these regulations will not have a significant economic impact on a substantial number of small entities. The collection of information is in §§ 53.4942(a)-3(a)(6) and 53.4945-5(a)(5) and is part of the collection of information for Form 990-PF. The equivalency determination process set forth in these regulations provides foundations with an optional procedure for determining that foreign organizations are qualifying public charities. The Treasury Department and the IRS believe that the economic impact of the proposed regulations on grantors making equivalency determinations has already been a reduction in cost of obtaining written tax advice, by expanding the class of practitioners whose written advice may form the basis of good faith determinations. The final regulations finalize this policy. The final regulations continue to permit grantee affidavits to be used in making good faith determinations under the general rule (although without the same level of reliance as under the special rule) and it is expected that affidavits will continue to be used for such purpose with small grants. Therefore, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required. Pursuant to section 7805(f) of the Internal Revenue Code, the notice of proposed rulemaking preceding these regulations was submitted to the Chief Counsel for Advocacy of the Small Business Administration for comment on its impact on small businesses, and no comment was received.
The principal author of these regulations is Ward L. Thomas of the Office of Associate Chief Counsel (Tax-Exempt and Government Entities). However, other personnel from the Treasury Department and the IRS participated in their development.
Excise taxes, Foundations.
Accordingly, 26 CFR part 53 is amended as follows:
26 U.S.C. 7805 * * *
The revisions and addition read as follows:
(a) * * *
(2)
(i) Any amount (including program related investments, as defined in section 4944(c), and reasonable and necessary administrative expenses) paid to accomplish one or more purposes described in section 170(c)(1) or (2)(B), other than any contribution to:
(
(
(
(6)
(ii)
(
(
(f)
The revisions and addition read as follows:
(a)
(5)
(ii)
(
(
(6) * * *
(ii)
(
(
(b) * * *
(5)
(f) * * *
(3)
Pension Benefit Guaranty Corporation.
Final rule; correction.
The Pension Benefit Guaranty Corporation (PBGC) published in the
Effective October 19, 2015.
Catherine B. Klion (
The following corrections are made to FR Doc. 2015-23361, published at page 55742 in the issue of September 17, 2015 (80 FR 55742):
(b) * * *
(4) When making filings to PBGC under parts 4041A, 4245, and 4281 of this chapter (except for notices of benefit reductions and notices of restoration of benefits under part 4281), you must submit the information required under these parts electronically in accordance with the instructions on the PBGC's Web site, except as otherwise provided by the PBGC.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is temporarily changing the enforcement periods of special local regulations for a recurring marine event in the Fifth Coast Guard District. These regulations apply to the Ocean City Maryland Offshore Grand Prix, a recurring marine event, which will take place this year on October 3-4, 2015. Special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in a portion of the North Atlantic Ocean near Ocean City, MD, during the event.
This rule is effective from October 3, 2015, to October 4, 2015.
Documents mentioned in this preamble are part of docket [USCG-2015-0400]. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Ronald Houck, U.S. Coast Guard Sector Baltimore, MD; telephone 410-576-2674, email
This marine event is regulated at 33 CFR 100.501. On July 16, 2015, we published a notice of proposed rulemaking (NPRM) entitled “Special Local Regulations; Temporary Change for Recurring Marine Event in the Fifth Coast Guard District” in the
Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making this rule effective less than 30 days after publication in the
The legal basis and authorities for this rulemaking establishing a special local regulation are found in 33 U.S.C. 1233, which authorize the Coast Guard to establish and define special local regulations. The Captain of the Port Baltimore is establishing a special local regulation for the waters of the North Atlantic Ocean, near Ocean City, MD, to protect event participants, spectators and transiting vessels during the Ocean City Maryland Offshore Grand Prix.
The Coast Guard received no comments in response to the NPRM. No public meeting was requested and none was held.
Through this regulation, the Coast Guard is temporarily changing the enforcement period of special local regulations for a recurring marine event in the Fifth Coast Guard District. This rule changes the enforcement periods for the “Ocean City Maryland Offshore Grand Prix” marine event that is listed at 33 CFR 100.501, Table to § 100.501. This regulation temporarily changes the enforcement periods for this marine event for 2015 only. The enforcement dates for 2015 are October 3rd and 4th, 2015.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes and executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Executive Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders.
The economic impact of this rule is not significant for the following reasons: The regulated area will be in effect from 10:30 a.m. to 5:30 p.m. on October 3, 2015 and from 10:30 a.m. to 5:30 p.m. on October 4, 2015, the regulated area has been narrowly tailored to impose the least impact on general navigation, yet provide the level of safety deemed necessary, and advance notifications will be made to the maritime community via marine information broadcasts and local notices to mariners, so mariners can adjust their plans accordingly. Additionally, this rulemaking does not change the permanent regulated areas that have been published in 33 CFR 100.501, Table to § 100.501. For the above reasons, the Coast Guard does not anticipate any significant economic impact.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received 0 comments from the Small Business Administration on this rule. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
This rule may affect the following entities, some of which may be small entities: The owners or operators of vessels intending to operate or transit through or within, or anchor in, the area where the marine event is being held.
This safety zone will not have a significant economic impact on a substantial number of small entities for the reasons stated under paragraph D.1., Regulatory Planning and Review.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to 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.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.
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.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
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 (NEPA) (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 implementation of regulations within 33 CFR part 100 applicable to organized marine events on the navigable waters of the United States that could negatively impact the safety of waterway users and shore side activities in the event area. The category of water activities includes but is not limited to sail boat regattas, boat parades, power boat racing, swimming events, crew racing, canoe and sail board racing. This rule is categorically excluded from further review under paragraph 34(h) 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
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.
Table to § 100.501
Coast Guard, DHS.
Final rule.
The Coast Guard is changing the regulation that governs the operation of the SR#38 Bridge in Centerton (Burlington County Route 635) over Rancocas Creek, mile 7.8, at Mt. Laurel, Westampton and Willingboro Townships in Burlington County, NJ. The new rule will change the current regulation and allow the bridge to remain in the closed position for the passage of vessels. There have been no requests for openings since the early 1990's. This rule also reflects a name change.
This rule is effective October 26, 2015.
Documents mentioned in this preamble are part of docket USCG-2015-0423. To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email Mr. Jim Rousseau, Fifth Coast Guard District Bridge Administration Division, Coast Guard; telephone 757-398-6557, email:
On July 6, 2015, we published a notice of proposed rulemaking (NPRM) entitled, “Drawbridge Operation Regulation; Rancocas Creek, Centerton, NJ” in the
The current operating schedule for the SR#38 bridge is set out in 33 CFR 117.745(b) which allows the SR#38 Bridge to operate as follows: From April 1 through October 31 open on signal from 7 a.m. to 11 p.m. From November 1 through March 31 from 7 a.m. to 11 p.m. open on signal if at least 24 hours notice is given. Year round from 11 p.m. to 7 a.m. need not open for the passage of vessels.
The bridge owner, County of Burlington, NJ requested a change in the operation regulation for the SR#38 Bridge, mile 7.8, across Rancocas Creek in Mt. Laurel, NJ and that its name is changed to what it is known locally. The County of Burlington provided information to the Coast Guard about the lack of any openings of the draw spans dating back to the early 1990's. The bridge is currently closed to navigation and vehicular traffic due to emergency repairs and emergency inspections since May 2015. The last requested opening was in the early 1990's as an emergency request. There have been monthly openings as per maintenance requirements. The Coast Guard will allow the above mentioned Bridge to remain in the closed to navigation position in accordance with 33 CFR 117.39. In the closed to navigation position, the bridge need not open for the passage of vessels.
In the closed-to-navigation position, the SR#38 Bridge has vertical clearances of six feet above mean high water. Vessels which can safely transit under the bridge in the closed to navigation position can do so at any time.
In order to align the operating schedule of the SR#38 bridge with observed marine traffic the proposed change amended the regulation by adding a paragraph (c) to state “that the bridge need not open.” The lack of requests for vessel openings of the drawbridge for over 20 years illustrates that the vessels that use this waterway can safely navigate while the bridge is in the closed-to-navigation position. The current regulation also incorrectly identifies the bridge as the SR#38 Bridge. The proposed change would change the name to the Centerton County Route 635 Bridge. All language in existing paragraph (b) would remain the same except for the removal of the SR#38 bridge reference.
While the proposed rule allowed the bridge to remain closed to navigation, it did not alleviate the bridge owner of his responsibility under 33 CFR 117.7.
The Coast Guard received no comments in response to the notice of proposed rulemaking. As a result, no changes have been made to this final rule.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on these statutes or executive orders.
This rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, as supplemented by Executive Order 13563, Improving Regulation and Regulatory Review, and does not require an assessment of potential costs and benefits under section 6(a)(3) of Order 12866 or under section 1 of Executive Order 13563. The Office of Management and Budget has not reviewed it under those Orders. Based on County of Burlington bridge tender logs, there will not be any vessels impacted by this proposed change. No bridge openings have been requested in over 20 years.
The Regulatory Flexibility Act of 1980 (RFA), 5 U.S.C. 601-612, as amended, requires federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard received no comments from the Small Business Administration on this rule. This rule would affect the following entities, some of which might be small entities: owners and operators of vessels intending to transit in that portion of Rancocas Creek that cannot transit under the Centerton Bridge during mean high water. Due to the fact that there have been no requests for openings in nearly 20 years, this final rule will not have a significant economic impact on a substantial number of small entities. The Coast
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 final rule. If the rule affects your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard. The Coast Guard will not retaliate against small entities that question or complain about this final rule or any policy or action of the Coast Guard.
This rule calls for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under 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 does not have implications for federalism.
The Coast Guard respects the First Amendment rights of protesters. Protesters are asked to 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.
This rule will not cause a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.
This rule meets applicable standards in sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.
We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that might disproportionately affect children.
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.
This action is not a “significant energy action” under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use.
This rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 (NEPA)(42 U.S.C. 4321-4370f), and have concluded 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 simply promulgates the operating regulations or procedures for drawbridges. This rule is categorically excluded, under figure 2-1, paragraph (32)(e), of the Instruction.
Under figure 2-1, paragraph (32)(e), of the Instruction, an environmental analysis checklist and a categorical exclusion determination are not required for this rule.
Bridges.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 117 as follows:
33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland Security Delegation No. 0170.1.
(b) The drawspan for the Riverside-Delanco/SR#543 Drawbridge, mile 1.3 at Riverside must operate as follows:
* * *
(c) The draw of the Centerton County Route 635 Bridge, mile 7.8, at Mt. Laurel, need not open for the passage of vessels.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation; extension and modification.
The Coast Guard has extended and modified a temporary deviation from the operating schedule that governs the Hood Canal Floating Drawbridge across Hood Canal (Admiralty Inlet), mile 5.0, near Port Gamble, WA. The temporary deviation is now effective until 7 p.m. on October 19, 2015 and allows the bridge to open the draw span half-way, 300 feet; as opposed to all the way, which is 600 feet, with at least one hour's notice and only at or near slack tide.
The temporary deviation published in the
The docket for this deviation, [USCG-2015-0767] is available at
If you have questions on this temporary deviation, call or email Mr. Steven Fischer, Bridge Administrator, Thirteenth Coast Guard District; telephone 206-220-7282, email
On August 21, 2015 the Coast Guard published a notice of temporary deviation at 80 FR 50768 from the operating schedule that governs the Hood Canal Floating Drawbridge across Hood Canal (Admiralty Inlet), mile 5.0, near Port Gamble, WA allowing the bridge to open the draw span half-way, 300 feet; as opposed to all the way, which is 600 feet. The Coast Guard is extending the end date of the previously published temporary deviation until 7 p.m. on October 19, 2015 as additional time is necessary for the Washington State Department of Transportation to complete the replacement of the bridge's draw span anchors. The temporary deviation is also modified to require opening with at least one hour's notice and only at or near slack tide. The former clarifies that the requirement for at least one hour's notice from the normal operating schedule is still in place during the temporary deviation and the latter is necessary to ensure the bridge does not move when opened during draw span anchor replacement. All other information provided in the temporary deviation published on August 21, 2015 at 80 FR 50768 continues to apply.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the State of New Hampshire on November 15, 2012. This revision amends New Hampshire's Prevention of Significant Deterioration (PSD) and Nonattainment New Source Review (NNSR) programs to make the programs consistent with the federal requirements. EPA is also conditionally approving a commitment from the state to submit revised regulations addressing three elements of EPA's PSD and NNSR programs that were not submitted with the November 15, 2012 submittal. EPA is also approving revisions to two definitions related to New Hampshire's permitting programs that were submitted on July 1, 2003. This action is being taken in accordance with the Clean Air Act.
This rule is effective on October 26, 2015.
EPA has established a docket for this action under Docket Identification No. EPA-R01-OAR-2014-0796 and EPA-R01-OAR-2014-0862. All documents in the docket are listed on the
Copies of the documents relevant to this action are also available for public inspection during normal business hours, by appointment at the Air Resources Division, Department of Environmental Services, 6 Hazen Drive, P.O. Box 95, Concord, NH 03302-0095.
Brendan McCahill, U.S. Environmental Protection Agency, EPA New England Regional Office, Office of Ecosystem Protection, Air Permits, Toxics, and Indoor Programs Unit, 5 Post Office Square—Suite 100, (mail code OEP05-2), Boston, MA 02109—3912, telephone number (617) 918-1652, Fax number (617) 918-0652, email
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
Organization of this document. The following outline is provided to aid in locating information in this preamble.
On January 21, 2015 (80 FR 2860), EPA published a Notice of Proposed Rulemaking (NPR) for the State of New
On April 24, 2015 EPA (80 FR 22956), EPA published a separate NPR for the state of New Hampshire. The NPR proposed to approve a separate portion of the November 15, 2012 SIP submittal revising the state's NNSR program under PART Env-A 618, “Nonattainment New Source Review” The NPR also reaffirmed EPA's January 21, 2015 proposed approval of the November 15, 2012 SIP submittal revising PART Env-A 619, “Prevention of Significant Deterioration” and the July 21, 2003 SIP submittal revising PART Env-A 101, “Definitions.”
In addition, the April 24, 2015 NPR proposed to conditionally approve the New Hampshire Department of Environmental Services' (NHDES) commitment to submit revised regulations addressing the following three provisions of the federal NNSR and PSD programs:
• Provisions at 40 CFR 51.165(a)(5)(i) that state approval to construct shall not relieve any owner or operator of the responsibility to comply fully with applicable provisions of the plan and any other requirements under local, State or Federal law;
• Provisions at 40 CFR 51.165(a)(6) and (a)(7) that meet the federal regulations applicable to projects at major stationary sources that are not major modifications based on the actual-to-projected actual test but have a “reasonable possibility” of resulting in a significant emission increase; and
• Provisions at 40 CFR 51.166(q)(2)(iv) requiring notice of a draft PSD permit to state air agencies whose lands may be affected by emissions from the permitted source.
The specific requirements for the two SIP submittals and the rationale for EPA's proposed actions are explained in the January 21, 2015 and April 24, 2015 NPRs and will not be restated here. EPA did not receive any public comments on the April 24, 2015 NPR.
EPA is approving and incorporating into the SIP, PART Env-A 618, “Nonattainment New Source Review” and PART Env-A 619, “Prevention of Significant Deterioration” that New Hampshire submitted on November 15, 2012. EPA is approving New Hampshire's definitions of “minor permit amendment,” and “state permit to operate” under PART Env-A 101, “Definitions” into the SIP.
Additionally, EPA is approving the commitment letter submitted by the NHDES on March 20, 2015, in which the NHDES committed to adopt revised NNSR and PSD regulations to address three provisions required by the federal NNSR and PSD program regulations. In that letter, NHDES committed to adopt these revisions no later than one year from the date of EPA's conditional approval, and to submit them to EPA for approval into the SIP.
EPA is approving New Hampshire's July 23, 2003 SIP submittal amending the definitions of “minor permit amendment,” and “state permit to operate” under PART Env-A 101, “Definitions.”
EPA is approving New Hampshire's November 15, 2012 SIP submittal amending PART Env-A 618, “Nonattainment New Source Review” and PART Env-A 619, “Prevention of Significant Deterioration.” With this action, PART Env-A 618 and PART Env-A 619 will supersede all other NNSR and PSD Program regulations currently approved in New Hampshire's SIP.
EPA is conditionally approving NHDES's commitment to adopt and submit to EPA by September 26, 2016 revised NNSR and PSD regulations which address the following provisions of the federal NNSR and PSD program regulations:
• Provisions at 40 CFR 51.165(a)(5)(i),
• Provisions at 40 CFR 51.165(a)(6) and (a)(7), and
• Provisions at 40 CFR 51.166(q)(2)(iv).
If the State fails to do so, the State's commitment to address these three provisions will become a disapproval on that date. EPA will notify the State by letter that this action has occurred. At that time, this commitment will no longer be a part of the approved New Hampshire SIP. EPA subsequently will publish a document in the
If the conditional approval is converted to a disapproval, such action will trigger EPA's authority to impose sanctions under section 110(m) of the CAA at the time EPA issues the final disapproval or on the date the State fails to meet its commitment. In the latter case, EPA will notify the State by letter that the conditional approval has been converted to a disapproval and that EPA's sanctions authority has been triggered. In addition, the final disapproval triggers the Federal implementation plan (FIP) requirement under section 110(c).
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of PART Env-A 618, “Nonattainment New Source Review;” PART Env-A 619, “Prevention of Significant Deterioration;” and PART Env-A 101, “Definitions” described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents generally available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Publ. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Part 52 of chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(a) * * *
(5) On November 15, 2012, the New Hampshire Department of Environmental Services (NHDES) submitted to a request to amend New Hampshire's Chapter Env-A 600 “Statewide Permit System” as a revision to New Hampshire's State Implementation Plan. The amendment included revisions to the state's Nonattainment New Source Review (NNSR) and the Prevention of Significant Deterioration (PSD) programs. On March 20, 2015, New Hampshire submitted a letter to EPA committing to adopt revised regulations which address the provisions at 40 CFR 51.165(a)(5)(i) and (a)(6) and (7) and 51.166(q)(2)(iv) required for EPA to fully approve New Hampshire's NNSR and PSD Programs.
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Monterey Bay Unified Air Pollution Control District (MBUAPCD) and the Ventura County Air Pollution Control District (VCAPCD) portions of the California State Implementation Plan (SIP). Under authority of the Clean Air Act (CAA or the Act), we are approving local rules that address volatile organic compound (VOC) emissions from the transfer of gasoline into vehicle fuel tanks, and from the transfer or dispensing of liquefied petroleum gas (LPG).
These rules are effective on November 24, 2015 without further notice, unless EPA receives adverse comments by October 26, 2015. If we receive such comments, we will publish a timely withdrawal in the
Submit comments, identified by docket number EPA-R09-OAR-2015-0369, by one of the following methods:
1.
2.
3.
James Shears, EPA Region IX, (213) 244-1810,
Throughout this document, “we,” “us” and “our” refer to EPA.
Table 1 lists the rules we are approving with the dates that they were adopted by the local air agencies and submitted by the California Air Resources Board.
On April 30, 2015, EPA determined that the submittals for MBUAPCD Rule 1002 and VCAPCD Rule 74.33 each met the completeness criteria in 40 CFR part 51 Appendix V, which must be met before formal EPA review.
We approved an earlier version of MBUAPCD Rule 1002 into the SIP on January 2, 2008 (73 FR 48). There is no previous version of VCAPCD Rule 74.33 in the SIP.
Section 110(a) of the CAA requires States to submit regulations that control VOCs, oxides of nitrogen, particulate matter, and other air pollutants which harm human health and the environment. VOC rules were developed as part of the local agencies' programs to control these pollutants. MBUAPCD Rule 1002 is designed to limit emissions of VOCs from the transfer of gasoline into vehicle fuel tanks. In order to simplify the source testing section of the SIP-approved rule, the Stage II vapor recovery compliance test procedures are removed from the rule language, and instead the rule requires owners and operators of gasoline dispensing facilities to adhere to the applicable California Air Resources Board (CARB) Executive Order for gasoline testing procedures. The corresponding testing cycles are included in the gasoline facility permits. VCAPCD Rule 74.33 is designed to limit fugitive VOC emissions from the transfer or dispensing of LPG. It describes related equipment and operation requirements, leak detection
These rules must be enforceable (see section 110(a) of the Act) and must not relax existing requirements (see sections 110(l) and 193). EPA policy that we use to evaluate enforceability requirements consistently includes the Bluebook (“Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations,” EPA, May 25, 1988), the Little Bluebook (“Guidance Document for Correcting Common VOC & Other Rule Deficiencies,” EPA Region 9, August 21, 2001), and “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 57 FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
We believe these rules are consistent with the relevant policy and guidance regarding enforceability and SIP relaxations. The TSDs have more information on our evaluation.
Our TSD for MBUAPCD describes additional rule revisions that we recommend for the next time the local agency modifies the rule. We have no recommendations for VCAPCD Rule 74.33 at this time.
As authorized in section 110(k)(3) of the Act, EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this
Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
In these rules, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR part 51.5, the EPA is finalizing the incorporation by reference of the MBUAPCD and VCAPCD rules described in the amendments to 40 CFR part 52 set forth below. The EPA made, and will continue to make, these documents available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the rules are not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rules do not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, Chapter I, Title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(461) New and amended regulations were submitted on April 7, 2015 by the Governor's designee.
(i) Incorporation by Reference.
(A) Monterey Bay Unified Air Pollution Control District.
(
(B) Ventura County Air Pollution Control District.
(
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a revision to the State Implementation Plan (SIP) submitted by the State of Florida through the Department of Environmental Protection (DEP) on July 31, 2009. The revision grants a variance to the Combs Oil Company, located in Naples, Florida. This source specific revision relieves the Combs Oil Company of the requirement to comply with the Florida rule governing installation and operation of vapor collection and control systems on loading racks at bulk gasoline plants. EPA is approving Florida's July 31, 2009, source specific SIP revision.
This rule will be effective October 26, 2015.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0133. All documents in the docket are listed on the
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 or via electronic mail at
The Florida Rule 62-296.418 requires bulk gasoline plants which began operation on or after August 1, 2007, to install and operate vapor collection and control systems on their loading racks. The rule became effective on May 9, 2007, and was submitted to EPA as a proposed SIP revision on May 31, 2007. EPA approved the SIP revision on June 1, 2009 (74 FR 26103).
On May 30, 2007, Combs Oil Company submitted a petition for variance from the requirements of Rule 62-296.418(2)(b)2, Florida Administrative Code (F.A.C.), for its new bulk gasoline plant. The company operates an existing bulk gasoline plant in Naples, Florida. The new plant would replace the existing plant and be constructed at a different site in the area.
Under Section 120.542 of the Florida Statutes, the DEP may grant a variance when the person subject to a rule demonstrates that the purpose of the underlying statute will be or has been achieved by other means, or when application of a rule would create a substantial hardship or violate principles of fairness. The DEP determined that Combs Oil Company had demonstrated that principles of fairness would be violated because the facility would have begun operations prior to August 1, 2007, but for delays in building and relocating to the new facility related to hurricanes, which were beyond the control of the company. Therefore, the DEP issued an Order Granting Variance to Combs Oil Company on August 20, 2008, relieving the company from the requirements of Rule 62-296.418(2)(b)2., F.A.C., for its proposed new facility.
In a notice of proposed rulemaking (NPR) published on July 20, 2015, EPA proposed to approve Florida's July 31, 2009, SIP revision granting a variance to the Combs Oil Company, located in Naples, Florida.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing incorporate by reference of “Combs Oil Company Source Specific Variance” order granting variance on August 20, 2008. EPA has made, and will continue to make, these documents generally available electronically through
EPA is approving a source specific SIP revision submitted by the Florida DEP on July 31, 2009. The revision grants a variance to the Combs Oil Company, located in Naples, Florida. This source specific revision relieves the Combs Oil Company of the requirement to comply with the Florida rule governing installation and operation of vapor collection and control systems on loading racks at bulk gasoline plants. It should be noted that approval of the variance for Combs Oil Company only relieves them from the requirements of Rule 62-296.418(2)(b)2 F.A.C., for its new bulk gasoline plant, it does not relieve them from any requirements established in 40 CFR parts 60 and 63.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Nitrogen dioxide, Particulate Matter, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42.U.S.C. 7401
(d) * * *
Environmental Protection Agency.
Final rule.
The Environmental Protection Agency (EPA) is approving changes to the Georgia State Implementation Plan (SIP) submitted by the State of Georgia, through the Georgia Environmental Protection Division, on January 22, 2015, to remove Stage II vapor control requirements for new and upgraded gasoline dispensing facilities in the State and to allow for the decommissioning of existing Stage II equipment.
This rule will be effective October 26, 2015.
EPA has established a docket for this action under Docket Identification No. EPA-R04-OAR-2015-0113. All documents in the docket are listed on the
Kelly Sheckler, Air Regulatory Management Section, Air Planning and Implementation Branch, Pesticides and Toxics Management Division, Region 4, U.S. Environmental Protection Agency, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Ms. Sheckler's telephone number is (404) 562-9222. She can also be reached via electronic mail at
On November 13, 1992, the State of Georgia submitted a SIP revision to address the Stage II requirements
EPA is taking final action to approve the January 22, 2015, SIP revision submitted by Georgia and remove Georgia Rule 391-3-1-.02(2)(zz) from the SIP. This action removes Stage II vapor control requirements for new and upgraded gasoline dispensing facilities and allows for the decommissioning of existing Stage II equipment. EPA has determined that Georgia's January 22, 2015, SIP revision related to the State's Stage II rules is consistent with the CAA and EPA's regulations and guidance.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving portions of a State Implementation Plan (SIP) revision submitted by the Mississippi Department of Environmental Quality (MDEQ), to EPA on July 25, 2010. The SIP revision includes multiple changes to Mississippi's SIP to add definitions in accordance with federal regulations and to implement clarifying language.
This rule will be effective October 26, 2015.
EPA has established a docket for this action under Docket Identification No.
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 or via electronic mail at
On June 25, 2010, MDEQ submitted a SIP revision to EPA for approval into the Mississippi SIP.
In a notice of proposed rulemaking (NPR) published on July 20, 2015, EPA proposed to approve the portions of Mississippi's June 25, 2010, SIP revision that modify Sections 2 and 3 of APC-S-1.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporate by reference of certain changes to Mississippi's air pollution control regulation APC-S-1, entitled “Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants.” Specifically, these changes include the amendments to Section 2—“Definitions” and Section 3—“Specific Criteria for Sources of Particulate Matter” which were State effective on February 9, 2009. EPA has made, and will continue to make, these documents generally available electronically through
EPA is approving the portions of Mississippi's July 25, 2010, SIP submission revising Sections 2 and 3 of Rule APC-S-1 to add and amend definitions in accordance with federal regulations and to implement clarifying language. EPA has preliminarily determined that these changes to the Mississippi SIP are in accordance with the Clean Air Act (CAA or Act) and EPA policy and regulations.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42. U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve a revision to the Missouri State Plan received May 7, 2013. This revision rescinds the state rule and associated state plan controlling mercury emissions from electric generating units. This rule is being rescinded because the Federal Clean Air Mercury Rule, which is the basis for this rule and associated plan, has been vacated and removed from the Code of Federal Regulations. This action will make Missouri's State Plan consistent with Federal regulations.
This direct final rule will be effective November 24, 2015, without further notice, unless EPA receives adverse comment by October 26, 2015.
If EPA receives adverse comment, we will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0427, by one of the following methods:
1.
2.
3.
Amy Bhesania, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at (913) 551-7147, or by email at
Throughout this document “we,” “us,” or “our” refer to EPA. This section provides additional information by addressing the following:
EPA is taking direct final action to approve a revision to the Missouri State Plan received May 7, 2013. This revision rescinds Missouri state rule 10 CSR 10-6.368,
The Missouri Air Conservation Commission adopted the rescission of 10 CSR 10-6.368 on February 5, 2013. No comments were received on this state action. The Missouri Air Conservation Commission has full legal authority to develop rules pursuant to section 643.050 of the Missouri Air Conservation Law. The State followed all applicable administrative procedures in proposing and adopting the rule actions. After publication by the Missouri Secretary of State in the Code of State Regulations, the rescission of the rule became effective May 30, 2013. The State of Missouri submitted the rule and rescission to us for approval pursuant to section 111(d). We have evaluated the state plan rescission against criteria in 40 CFR part 60, subpart B “Adoption and Submittal of State Plans for Designated Facilities.” The state plan rescission meets all of the applicable requirements.
EPA is taking direct final action to approve a revision to the Missouri State Plan to rescind Missouri state rule 10 CSR 10-6.368,
We are publishing this direct final rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. However, in the “Proposed Rules” section of this
If EPA receives adverse comment, we will publish a timely withdrawal in the
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 24, 2015. Filing a petition for reconsideration by the Administrator of this direct final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, EPA amends 40 CFR part 62 as set forth below:
42 U.S.C.
Environmental Protection Agency (EPA).
Final rule; correction.
EPA is removing a sentence regarding the effective date for judicial review purposes in the preamble to a final rule that appeared in the
This correction is effective as of August 21, 2015.
Janita Aguirre, Standards and Health Protection Division, Office of Science and Technology (4305T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington DC 20460; telephone number: (202) 566-1860; fax number: (202) 566-0409; email address:
In FR Doc. 2015-19821 appearing on page 51020 in the
On page 51022, in the second column, under the heading entitled
Environmental protection, Indians—lands, Intergovernmental relations, Reporting and recordkeeping requirements, Water pollution control.
Federal Emergency Management Agency, DHS.
Final rule.
This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the
The effective date of each community's scheduled suspension is the third date (“Susp.”) listed in the third column of the following tables.
If you want to determine whether a particular community was suspended on the suspension date or for further information, contact Bret Gates, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4133.
The NFIP enables property owners to purchase Federal flood insurance that is not otherwise generally available from private insurers. In return, communities agree to adopt and administer local floodplain management measures aimed at protecting lives and new construction from future flooding. Section 1315 of the National Flood Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale of NFIP flood insurance unless an appropriate public body adopts adequate floodplain management measures with effective enforcement measures. The communities listed in this document no longer meet that statutory requirement for compliance with program regulations, 44 CFR part 59. Accordingly, the communities will be suspended on the effective date in the third column. As of that date, flood insurance will no longer be available in the community. We recognize that some of these communities may adopt and submit the required documentation of legally enforceable floodplain management measures after this rule is published but prior to the actual suspension date. These communities will not be suspended and will continue to be eligible for the sale of NFIP flood insurance. A notice withdrawing the suspension of such communities will be published in the
In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that identifies the Special Flood Hazard Areas (SFHAs) in these communities. The date of the FIRM, if one has been published, is indicated in the fourth column of the table. No direct Federal financial assistance (except assistance pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act not in connection with a flood) may be provided for construction or acquisition of buildings in identified SFHAs for communities not participating in the NFIP and identified for more than a year on FEMA's initial FIRM for the community as having flood-prone areas (section 202(a) of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against certain types of Federal assistance becomes effective for the communities listed on the date shown in the last column. The Administrator finds that notice and
Each community receives 6-month, 90-day, and 30-day notification letters addressed to the Chief Executive Officer stating that the community will be suspended unless the required floodplain management measures are met prior to the effective suspension date. Since these notifications were made, this final rule may take effect within less than 30 days.
Flood insurance, Floodplains.
Accordingly, 44 CFR part 64 is amended as follows:
42 U.S.C. 4001
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule; technical amendments.
NMFS is hereby making technical amendments without altering the substance of the regulations governing the operation of Regional Fishery Management Councils (Councils) under the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The intent of this action is to update existing Council regulations to reflect the current procedure for processing Freedom of Information Act (FOIA) requests received by Councils. These changes will make our rules more internally consistent and easier to use.
This final rule is effective October 26, 2015.
1315 East West Highway, SSMC3, Room #10843, Silver Spring, MD 20910.
Steven Goodman at 301-427-8732,
Recently, the Department of Commerce (DOC) published a proposed rule and a final rule in the
NMFS has existing regulations for handling FOIA requests received by the Councils entitled “Freedom of Information Act (FOIA) requests.” 50 CFR 600.155. These regulations provide that the NOAA FOIA Officer will prepare a Form CD-244, “FOIA Request and Action Record,” for FOIA requests received by a Council.
NMFS is revising regulations at § 600.155(a) and (b) to reflect the use of FOIAonline. This action specifically amends the regulations to remove the requirement to prepare a Form CD-244 and to clarify that, after FOIA requests received by a Council are coordinated with the appropriate NMFS Regional Office (Region), the Region then forwards the request to the NOAA FOIA officer who enters the FOIA request into FOIAonline. No other changes are being considered or implemented.
The NMFS Assistant Administrator has determined that this rule is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.
This rule has been determined to be not significant for purposes of Executive Order 12866.
This rule pertains solely to agency procedure and corrects existing regulations to reflect the current practice for processing FOIA requests received by a Council. It makes no changes to the substantive legal rights, obligations, or interests of affected parties. This rule therefore is a “rule of agency organization, procedure or practice” and is therefore exempt from the notice-and-comment requirements of the Administrative Procedure Act at 5 U.S.C. 553(b)(A).
Administrative practice and procedure, Confidential business information, Fisheries, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, NMFS amends 50 CFR part 600 as follows:
5 U.S.C 561 and 16 U.S.C. 1801
(a) FOIA requests received by a Council should be coordinated promptly with the appropriate NMFS Regional Office. The Region will forward the request to the NOAA FOIA Officer to secure a FOIA number and log the request into FOIAonline. The Region will also obtain clearance from the NOAA General Counsel's Office concerning initial determination for denial of requested information.
(b) FOIA request processing will be controlled and documented in the Region. The requests should be forwarded to the NOAA FOIA Officer who will enter the request into FOIAonline. The request will be assigned an official FOIA number and due date. In the event the Region determines that the requested information is exempt from disclosure, in full or in part, under the FOIA, the denial letter prepared for the Assistant Administrator's signature, along with the “Foreseeable Harm” Memo and list of documents to be withheld, must be cleared through the NMFS FOIA Liaison. Upon completion, a copy of the signed letter transmitting the information to the requester should be posted to FOIAonline by NMFS.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Modification of fishing seasons; request for comments.
NMFS announces seven inseason actions in the ocean salmon fisheries. These inseason actions modified the commercial and recreational salmon fisheries in the area from the U.S./Canada border to Cape Falcon, OR.
The effective dates for the inseason actions are set out in this document under the heading Inseason Actions. Comments will be accepted through October 13, 2015.
You may submit comments, identified by NOAA-NMFS-2015-0001, by any one of the following methods:
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Peggy Mundy at 206-526-4323.
In the 2015 annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), NMFS announced the commercial and recreational fisheries in the area from the U.S./Canada border to the U.S./Mexico border, beginning May 1, 2015, and 2016 salmon fisheries opening earlier than May 1, 2016. NMFS is authorized to implement inseason management actions to modify fishing seasons and quotas as necessary to provide fishing opportunity while meeting management objectives for the affected species (50 CFR 660.409). Inseason actions in the salmon fishery may be taken directly by NMFS (50 CFR 660.409(a)—Fixed inseason management provisions) or upon consultation with the Pacific Fishery Management Council (Council) and the appropriate State Directors (50 CFR 660.409(b)—Flexible inseason management provisions). The state management agencies that participated in the consultations described in this document were: Oregon Department of Fish and Wildlife (ODFW) and Washington Department of Fish and Wildlife (WDFW).
Management of the salmon fisheries is generally divided into two geographic areas: north of Cape Falcon (U.S./Canada border to Cape Falcon, OR) and south of Cape Falcon (Cape Falcon, OR, to the U.S./Mexico border). The inseason actions reported in this document affect fisheries north of Cape Falcon. The north of Cape Falcon area is further subdivided into four management subareas: Neah Bay Subarea (U.S./Canada border to Cape Alava, WA), La Push Subarea (Cape Alava, WA, to Queets River, WA), Westport Subarea (Queets River, WA, to Leadbetter Point, WA), and Columbia River Subarea (Leadbetter Point, WA, to Cape Falcon, OR). All times mentioned refer to Pacific daylight time.
All other restrictions and regulations remain in effect as announced for the 2015 ocean salmon fisheries and 2016 salmon fisheries opening prior to May 1, 2016 (80 FR 25611, May 5, 2015) and as modified by prior inseason actions.
The RA determined that the best available information indicated that coho and Chinook salmon catch to date and fishery effort supported the above inseason actions recommended by the states of Washington and Oregon. The states manage the fisheries in state waters adjacent to the areas of the U.S. exclusive economic zone in accordance with these Federal actions. As provided by the inseason notice procedures of 50 CFR 660.411, actual notice of the described regulatory actions was given, prior to the time the action was effective, by telephone hotline numbers 206-526-6667 and 800-662-9825, and by U.S. Coast Guard Notice to Mariners broadcasts on Channel 16 VHF-FM and 2182 kHz.
The Assistant Administrator for Fisheries, NOAA (AA), finds that good cause exists for this notification to be issued without affording prior notice and opportunity for public comment under 5 U.S.C. 553(b)(B) because such notification would be impracticable. As previously noted, actual notice of the regulatory actions was provided to fishers through telephone hotline and radio notification. These actions comply with the requirements of the annual management measures for ocean salmon fisheries (80 FR 25611, May 5, 2015), the West Coast Salmon Fishery Management Plan (Salmon FMP), and regulations implementing the Salmon FMP, 50 CFR 660.409 and 660.411. Prior notice and opportunity for public comment was impracticable because NMFS and the state agencies had insufficient time to provide for prior notice and the opportunity for public comment between the time Chinook salmon catch and effort assessments and projections were developed and fisheries impacts were calculated, and the time the fishery modifications had to be implemented in order to ensure that fisheries are managed based on the best available scientific information, ensuring that conservation objectives and ESA consultation standards are not exceeded. The AA also finds good cause to waive the 30-day delay in effectiveness required under 5 U.S.C. 553(d)(3), as a delay in effectiveness of these actions would allow fishing at levels inconsistent with the goals of the Salmon FMP and the current management measures.
These actions are authorized by 50 CFR 660.409 and 660.411 and are exempt from review under Executive Order 12866.
16 U.S.C. 1801
Animal and Plant Health Inspection Service, USDA.
Notice of request for comments.
We are advising the public that the Animal and Plant Health Inspection Service is seeking public comment regarding plans to require the authorization of field testing of regulated genetically engineered (GE) wheat under permit. Currently, GE wheat field trials are authorized under notification. Authorizing GE wheat field trials under permit will help prevent future compliance issues, protect plant health and the environment, and allow for flexibility in the length of the volunteer monitoring period and the specific permit conditions to address how volunteers of GE wheat will be appropriately managed.
We will consider all comments that we receive on or before October 26, 2015.
You may submit comments by either of the following methods:
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Supporting documents and any comments we receive on this docket may be viewed at
Ms. Rachel Windsberg, Lead Management and Program Analyst, Regulatory Operations Programs, BRS, APHIS, 4700 River Road Unit 91, Riverdale, MD 20737; 301-851-3109.
The Animal and Plant Health Inspection Service (APHIS) administers regulations regarding genetically engineered (GE) organisms in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which are Plant Pests or Which There is Reason to Believe are Plant Pests” (referred to below as the regulations). The current regulations govern the introduction (importation, interstate movement, or release into the environment) of certain GE organisms termed “regulated articles.” Regulated articles are essentially GE organisms which might pose a risk as a plant pest. APHIS first promulgated these regulations in 1987 under the authority of the Federal Plant Pest Act and the Plant Quarantine Act, two acts that were subsumed into the Plant Protection Act (PPA, 7 U.S.C. 7701
Certain regulated articles may be introduced into the environment without a permit if developers follow the requirements for authorizations under notification in § 340.3. These requirements include, among other things, that, when the introduction of regulated articles is an environmental release, regulated articles must be planted in such a way that they are not inadvertently mixed with non-regulated plant materials of any species which are not part of the environmental release. In addition, the field trial must be conducted such that the regulated article will not persist in the environment, and no offspring can be produced that could persist in the environment.
In 2013 and 2014, APHIS responded to, and investigated, the detection of the unauthorized release of regulated GE wheat found growing in fields in Oregon and Montana, respectively. As part of its response to these incidents, APHIS has carefully assessed its regulatory requirements for field trials of GE wheat and determined that it is necessary to enhance those requirements. Therefore, we are advising the public that we have determined that field trials of GE wheat should be authorized only with a permit. This change will help prevent future compliance issues, protect plant health and the environment, and allow for flexibility in the length of the volunteer monitoring period and the specific permit conditions used to address how volunteers of GE wheat will be appropriately managed. Requiring authorization with a permit also allows APHIS to require the submission of volunteer monitoring reports on a regular basis.
Due to the change in authorization allowed for GE wheat trials, we are requesting public review and comment on this change. To better help us determine specific permit conditions and volunteer monitoring requirements, we are particularly interested in receiving comments regarding biological or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments. We also request that, when possible, commenters provide relevant information regarding specific localities or regions as wheat growth, crop management, and crop utilization may vary considerably by geographic region.
After the comment period closes, APHIS will review all written comments received during the comment period. APHIS will notify the public through an announcement on our Web site of the effective date of our decision whether to authorize GE wheat field trials only with a permit and any additional information regarding any change if APHIS decides to authorize wheat only under permits. APHIS will also announce on our Web site information regarding a stakeholder meeting to answer questions from developers on how to comply with this change.
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede airworthiness directive (AD) 2014-12-51 for Airbus Helicopters (previously Eurocopter France) Model EC130B4 and EC130T2 helicopters. AD 2014-12-51 currently requires repetitively inspecting the tailboom to Fenestron junction frame (junction frame) for a crack. This proposed AD would retain the requirements of AD 2014-12-51, change the applicability from helicopters with certain hours time-in-service (TIS) to junction frames with certain hours TIS, and add a compliance time for sling cycles to the junction frame inspection interval. These proposed actions are intended to detect a crack and to prevent failure of the junction frame, which could result in loss of the Fenestron and subsequent loss of control of the helicopter.
We must receive comments on this proposed AD by November 24, 2015.
You may send comments by any of the following methods:
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You may examine the AD docket on the Internet at
For service information identified in this proposed AD, contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
Robert Grant, Aviation Safety Engineer, Safety Management Group, FAA, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this proposal in light of the comments we receive.
On July 24, 2014, we issued AD 2014-12-51, Amendment 39-17921 (79 FR 45335, August 5, 2014), which was sent previously as an Emergency AD to all known U.S. owners and operators of Airbus Helicopters Model EC130B4 and EC130T2 helicopters. AD 2014-12-51 applies to helicopters with 690 or more hours TIS and requires, within 10 hours TIS, dye-penetrant inspecting certain areas of the junction frame for a crack. AD 2014-12-51 also requires, at intervals not exceeding 25 hours TIS, either repeating the dye-penetrant inspection or performing a borescope inspection of certain areas of the junction frame for a crack. If there is a crack, AD 2014-12-51 requires replacing the junction frame. Those actions are intended to detect a crack and to prevent failure of the junction frame, which could result in loss of the Fenestron and subsequent loss of control of the helicopter.
AD 2014-12-51 was prompted by AD No. 2014-0145-E, dated June 6, 2014, issued by EASA, which is the Technical Agent for the Member States of the European Union, to correct an unsafe condition on Airbus Helicopters Model EC130B4 and EC130T2 helicopters. EASA advises of two incidents of crack propagation through the junction frame that initiated in the lower right-hand side between the web and the flange where the lower spar of the tailboom is joined. EASA states the cracks were of a significant length and not visible from the outside of the helicopter. EASA advises that this condition, if not detected, could lead to structural failure, possibly resulting in Fenestron detachment and consequent loss of control of the helicopter. As a result, EASA AD No. 2014-0145-E required a one-time visual inspection of the junction frame for a crack and a repetitive borescope inspection of the junction frame for a crack.
EASA revised AD No. 2014-0145-E with AD No. 2014-0145R1, dated June 13, 2014. EASA AD No. 2014-0145R1 changes the compliance time by removing a calendar day requirement and by determining the time accumulated on the junction frame instead of on the helicopter. EASA AD No. 2014-0145R1 also allows the recurring inspection to be accomplished either by performing the borescope inspection or by repeating the visual inspection.
Since we issued AD 2014-12-51 (79 FR 45335, August 5, 2014), EASA issued AD No. 2015-0033-E dated February 24, 2015 (EAD 2015-0033-E), which supersedes AD No. 2014-0145-E and AD No. 2014-0145R1. EASA determined that an inspection interval defined in sling cycles is necessary in
This NPRM would retain the dye penetrant and borescope inspections in AD 2014-12-51 but would revise the compliance times. We have determined that applicable helicopters are those with 690 hours TIS accumulated on the junction frame instead of on the helicopter, and that it is necessary to include an inspection interval defined in sling cycles.
These helicopters have been approved by the aviation authority of France and are approved for operation in the United States. Pursuant to our bilateral agreement with France, EASA, its technical representative, has notified us of the unsafe condition described in its AD. We are proposing this AD because we evaluated all known relevant information and determined that an unsafe condition is likely to exist or develop on other helicopters of the same type design.
We reviewed Airbus Helicopters Emergency Alert Service Bulletin No. 05A017, Revision 2, dated February 20, 2015 (EASB 05A017), for Model EC130B4 and EC130T2 helicopters. EASB 05A017 describes alternate procedures for inspecting outside the tailboom for a crack at reduced inspection intervals in combination with the internal inspections at extended intervals. EASB 05A017 also specifies adding sling cycles to the existing flight hour inspection interval for helicopters that perform external load-carrying operations. EASA issued AD No. 2015-0033-E mandating the requirements in EASB 05A017 to ensure the continued airworthiness of these helicopters.
This service information is reasonably available because the interested parties have access to it through their normal course of business or by means identified in the Addresses Section of this proposed AD.
We have also reviewed Airbus Helicopters Service Bulletin No. EC130-53-029, Revision 0, dated February 20, 2015 (SB EC130-53-029), which contains procedures to cut out the skin and splice at the junction frame to facilitate the external inspection specified in EASB 05A017.
This proposed AD would require:
• Before the junction frame reaches 700 hours TIS or within 10 hours TIS, whichever comes later, removing the horizontal stabilizer, cleaning the junction frame, and dye-penetrant inspecting around the circumference of the junction frame for a crack, paying particular attention to the area around the 4 spars.
• Within 25 hours TIS or 390 sling cycles, whichever comes first, after the dye-penetrant inspection proposed by this AD, and thereafter at intervals not exceeding 25 hours TIS or 390 sling cycles, whichever comes first, either repeating the dye-penetrant inspection of this proposed AD or, if the area is clean, using a borescope, inspecting around the circumference of the junction frame for a crack.
The EASA AD includes alternate compliance instructions for helicopters modified with a cut-out in production by Airbus Helicopters Modification 350A087421 or in service by compliance with SB EC130-53-029. This proposed AD would not.
We consider this proposed AD to be an interim action. If final action is later identified, we might consider further rulemaking then.
We estimate that this proposed AD would affect 208 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. At an average labor rate of $85 per hour, dye-penetrant inspecting the junction frame would require 1 work-hour, for a cost per helicopter of $85, and a total cost of $17,680 for the fleet, per inspection cycle. Borescope inspecting the junction frame would require .5 work-hour, for a cost per helicopter of $43 and a total cost of $8,944 for the fleet, per inspection cycle.
If required, replacing the junction frame would require 50 work-hours, and required parts would cost $60,000, for a cost per helicopter of $64,250.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Airbus Helicopters Model EC130B4 and EC130T2 helicopters with a tailboom to fenestron junction frame (junction frame) that has 690 or more hours time-in-service (TIS), certificated in any category.
This AD defines the unsafe condition as a crack in the junction frame. This condition could result in failure of the junction frame, which could result in loss of the Fenestron and subsequent loss of control of the helicopter.
This AD supersedes AD 2014-12-51, Amendment 39-17921 (79 FR 45335, August 5, 2014).
We must receive comments by November 24, 2015.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
(1) Before the junction frame reaches 700 hours TIS or within 10 hours TIS, whichever occurs later, remove the horizontal stabilizer, clean the junction frame, and dye-penetrant inspect around the circumference of the junction frame for a crack in the areas shown in Figure 1 of Airbus Helicopters EC130 Emergency Alert Service Bulletin No. 05A017, Revision 2, dated February 20, 2015 (EASB 05A017). Pay particular attention to the area around the 4 spars (item b) of Figure 1 of EASB 05A017. An example of a crack is shown in Figure 3 of EASB 05A017.
(2) Within 25 hours TIS or 390 sling cycles, whichever occurs first after the inspection required by paragraph (f)(1) of this AD, and thereafter at intervals not exceeding 25 hours TIS or 390 sling cycles, whichever occurs first, either perform the actions of paragraph (f)(1) of this AD or, if the area is clean, using a borescope, inspect around the circumference of the junction frame for a crack in the areas shown in Figure 2 of EASB 05A017. Pay particular attention to the area around the 4 spars (item b) of Figure 2 of EASB 05A017. An example of a crack is shown in Figure 3 of EASB 05A017. For purposes of this AD, a sling cycle is defined as one landing with or without stopping the rotor or one external load-carrying operation; an external load-carrying operation occurs each time a helicopter picks up an external load and drops it off.
(3) If there is a crack, before further flight, replace the junction frame.
Special flight permits are prohibited.
(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: Robert Grant, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
(1) Airbus Helicopters Service Bulletin No. EC130-53-029, Revision 0, dated February 20, 2015, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Airbus Helicopters, Inc., 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(2) The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0033-E, dated February 24, 2015. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 5302: Rotorcraft Tailboom.
Federal Aviation Administration (FAA), DOT.
Supplemental notice of proposed rulemaking (SNPRM); reopening of comment period.
We are revising an earlier proposed airworthiness directive (AD) for The Boeing Company Model 777-200 and -300 series airplanes, equipped with Rolls-Royce Model RB211-Trent 800 engines. The notice of proposed rulemaking (NPRM) proposed to require repetitive inspections of the thrust reverser (T/R) structure and sealant, and related investigative and corrective actions if necessary. The NPRM was prompted by reports of T/R events related to thermal damage of the T/R inner wall. This action revises the NPRM by proposing to add different repetitive inspections requirements for T/R halves with a thermal protective system installed. This action also revises the NPRM by proposing to require installation of serviceable T/R halves, which would terminate the repetitive inspections in this SNPRM. This SNPRM also proposes to revise the inspection or maintenance program by incorporating new airworthiness limitations. We are proposing this SNPRM to detect and correct a degraded T/R inner wall panel, which could lead to failure of the T/R and adjacent components and their consequent separation from the airplane, and which could result in a rejected takeoff (RTO) and cause asymmetric thrust and consequent loss of control of the airplane during reverse thrust operation. If a T/R inner wall overheats, separated components could cause structural damage to the airplane, damage to other airplanes, or possible injury to people on the ground. Since these actions impose an additional burden over that proposed in the NPRM, we are reopening the comment period to allow the public the chance to comment on these proposed changes.
We must receive comments on this SNPRM by November 9, 2015.
You may send comments, using the procedures found in 14 CFR
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For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Kevin Nguyen, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-917-6501; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We issued an NPRM to amend 14 CFR part 39 by adding an AD that would apply to certain Model 777-200 and -300 series airplanes. The NPRM published in the
Since we issued the NPRM (76 FR 3561, January 20, 2011), we have received additional reports of thermal damage of the T/R inner wall on Rolls-Royce Model RB211-Trent 800 engines.
The preamble to the NPRM (76 FR 3561, January 20, 2011) specified that we considered those proposed requirements “interim action,” and that the manufacturer was developing a modification to address the unsafe condition. That NPRM explained that we might consider further rulemaking if a modification were developed, approved, and available. The manufacturer now has developed a thermal protection system (TPS) and inner wall. We have determined that further rulemaking is indeed necessary. This proposed AD also would require a revision to the maintenance or inspection program to incorporate new airworthiness limitations. We have determined the following actions are necessary to address the identified unsafe condition:
• For airplanes with pre-TPS insulation blankets, part number P/N 315W5113-(XX) and 315W5010-(XX): The interim actions and repetitive inspections are specified Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010.
• For airplanes with TPS insulation blankets, P/N 315W5115-(XX): The interim repetitive inspections (non-destructive test (NDT) and electronic engine control (EEC) repetitive inspections only) are specified in Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013.
• For all airplanes: The final terminating action, installing serviceable T/R halves, is specified in Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014.
• For all airplanes: New airworthiness limitations, Airworthiness Limitations 78-AWL-01 and 78-AWL-02, that need to be incorporated in the maintenance or inspection program are specified in Boeing 777 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, Revision dated October 2014.
We reviewed the following service information. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
• Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010. This service information describes procedures for a review of the airplane maintenance records to determine whether sealant was added to insulation blankets around compression pad fittings and powered door opening system (PDOS) fittings; inspections of the T/R structure; and related investigative and corrective actions.
• Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014. This service information describes procedures for installing serviceable T/R halves.
• Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013. This service information describes, among other actions, procedures for inspections of the T/R structure, and related investigative and corrective actions. Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, also describes, for airplanes on which the actions specified Boeing Special Attention Service Bulletin 777-78-0071, dated November 29, 2009, have been done, procedures for installation of
• Airworthiness Limitations 78-AWL-01, Thrust Reverser Thermal Protection System; and 78-AWL-02, Thrust Reverser Inner Wall; as specified in Boeing 777 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, Revision dated October 2014. Airworthiness Limitation 78-AWL-01 describes an inspection of the T/R TPS on both engines. Airworthiness Limitation 78-AWL-02 describes an inspection of the T/R inner wall.
We gave the public the opportunity to comment on the NPRM (76 FR 3561, January 20, 2011). The following presents the comments received on the NPRM and the FAA's response to each comment.
Boeing concurred with the contents of the NPRM (76 FR 3561, January 20, 2011).
American Airlines (AAL), Delta Air Lines, and Air New Zealand requested that we revise the NPRM (76 FR 3561, January 20, 2011) to allow installation of a TPS, which is described in Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013. The commenters proposed that the TPS installation terminate the proposed repetitive inspections of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, which are specified in the NPRM.
We partially agree with the request. We agree to provide a terminating action for the inspections specified in this proposed AD. However, we do not agree that installation of a TPS as described in Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, would provide an adequate level of safety to completely address the identified unsafe condition. Instead, we have determined that installing serviceable T/R halves as specified in Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014, is terminating action for the inspections specified in this proposed AD. We have also determined that installing serviceable T/R halves (see Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014, for definition of serviceable) and revising the maintenance or inspection program to incorporate new airworthiness limitations addresses the identified unsafe condition. We have added the proposed requirement to install serviceable T/R halves to paragraph (l) of this AD and we have added the proposed requirement to revise the maintenance or inspection program to paragraph (n) of this AD.
AAL requested that we revise paragraph (i) of the proposed AD, which incorrectly referred to the compliance time for Work Packages 2 and 5 “or Work Packages 2 and 6.” The correct reference is to the compliance time for Work Packages 2 and 5 “or Work Packages 5 and 6.”
We agree with this request, and have changed the references accordingly in paragraph (h)(2) in this proposed AD, which was paragraph (i) in the original proposed AD.
We also note a similar typographical error in the preamble of the NPRM (76 FR 3561, January 20, 2011), in the “Relevant Service Information” section, under the subsection titled “Work Package 6” for Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010. That subsection incorrectly specified that Work Package 6 may be done as an option to Work Package 2, if the shorter repetitive inspection intervals specified in “Work Package 2” are followed. The correct intervals are specified in “Work Package 6.” The “Relevant Service Information” section is not repeated in this proposed AD, however, so we have not changed this proposed AD regarding this issue. We have provided a general description of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010 in the “Related Service Information under 1 CFR part 51” section of this proposed AD.
AAL requested that we remove paragraph (k) from the proposed AD, which explained that where the Condition column in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, referred to “total flight cycles,” it means “total flight cycles as of the effective date of this AD.” AAL was concerned that total flight cycles are stated to be total flight cycles on the airplane rather than total flight cycles on the T/R half. AAL reported that it is not uncommon for the total flight cycles of the T/R half to differ from the total flight cycles of the airframe, because T/Rs are line-replacement units.
We partially agree. We agree that those compliance times, in terms of total flight cycles, should apply to each T/R half, although we had inadvertently specified total flight cycles on the airplane. We disagree, however, to remove paragraph (k) of the original proposed AD, which is paragraph (h)(4) in this proposed AD. The intent of paragraph (h)(4) of this proposed AD is to provide a relative starting date from which to establish the compliance time; no such starting point was provided in the service information. We have retained the exception in paragraph (h)(4) in this proposed AD, but changed “airplanes with the specified total flight cycles” to “each T/R half with the specified total flight cycles as of the effective date of this AD.”
AAL stated that Boeing intends to revise AMM 78-31-06, which is referenced in Work Package 1 of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010. AAL recommended that we revise paragraph (g)(1) of the proposed AD to allow the use of any revision of that AMM during the inspection specified in Work Package 1. AAL stated that the AD does not specify which revision levels of AMM 78-31-06 are acceptable for this inspection.
We disagree that it is necessary to revise the NPRM (76 FR 3561, January 20, 2011) in response to this request. Use of a specific revision level of an AMM is not required during the accomplishment of the actions specified in Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010. An operator can therefore use a new AMM revision during that inspection without requesting FAA approval of an alternative method of compliance (AMOC). We have not changed this proposed AD regarding this issue.
AAL was concerned about the effect on its operation of the proposed requirement for FAA approval of certain repairs. AAL recommended that we revise the NPRM (76 FR 3561, January 20, 2011) to provide Boeing repair approval authority. AAL added that Boeing's technical and engineering
We partially agree with the request. We agree to allow Boeing repair approval authority for structural aspects of the repair, but the FAA must approve non-structural aspects of any repair. We have added new paragraph (r)(3) in this proposed AD to delegate the authority to the Boeing Commercial Airplanes ODA to approve AMOCs for structural repairs that may be conditionally required by this AD.
AAL requested that we revise the NPRM (76 FR 3561, January 20, 2011) to allow airlines the flexibility to reorganize the proposed actions in such a way as to meet the work requirements and more easily fit the work into airline practices. AAL stated that forcing all airlines to do the actions strictly in alignment with the work package sequence in the service information could lead to confusion and the increased potential for noncompliance.
We agree with the intent of the request. Paragraph (g) of this proposed AD refers to Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, as the appropriate source of service information for doing the actions in that paragraph. Note 2 of paragraph 3.A., “General Information,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, states, “You can do each Work Package independently or at the same time. Refer to Service Bulletin Paragraph 1.E, Compliance, for when to do the work packages.” Therefore, for paragraph (g) of this proposed AD, operators are already allowed to combine work packages or otherwise adjust the procedure sequence as necessary to fit their work plan, provided the configuration meets the type design of the airplane before it is returned to service and the work package is done within the compliance time specified in Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010. We have not revised this proposed AD regarding this issue.
AAL reported that Boeing has agreed to develop alternative methods for sealant curing that would reduce the time to achieve an adequate cure. AAL therefore requested that we revise paragraph (g) of the proposed AD to allow use of this alternative sealant curing method.
We disagree with the request. While acceptable alternative cure methods might exist, the commenter did not supply sufficient information on the proposed cure process to allow the FAA to approve that process as part of the AD. Operators may propose alternative cure methods via the AMOC process as specified in paragraph (r) of this proposed AD. We have not changed this proposed AD regarding this issue.
We are proposing this SNPRM because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design. Certain changes described above expand the scope of the NPRM (76 FR 3561, January 20, 2011). As a result, we have determined that it is necessary to reopen the comment period to provide additional opportunity for the public to comment on this SNPRM.
This SNPRM would require accomplishing the actions specified in the service information described previously, except as discussed under “Difference Between this SNPRM and the Service Information.” Refer to Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010; Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014; Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013; for details on the procedures and compliance times.
The phrase “related investigative actions” is used in this SNPRM. “Related investigative actions” are follow-on actions that (1) are related to the primary action, and (2) further investigate the nature of any condition found. Related investigative actions in an AD could include, for example, inspections.
The phrase “corrective actions” is used in this SNPRM. “Corrective actions” are actions that correct or address any condition found. Corrective actions in an AD could include, for example, repairs.
Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, describe procedures for a general visual inspection of the perforated side of the T/R inner wall aft of the IP8 and the HP3 bleed port exits for color that is different than the normal T/R perforated wall color; a general visual inspection of the compression fitting for incorrect pin orientation; and a general visual inspection of the EEC wire bundles and clips for damage. However, this SNPRM would require detailed inspections instead of general visual inspections. Detailed inspections are necessary in order to adequately determine if the specified condition exists. This difference has been coordinated with Boeing.
Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014, specifies a compliance time of 5 years for doing the installation, but this SNPRM would require a compliance time of 48 months to ensure the safety of the fleet in light of the identified unsafe condition. This difference has been coordinated with Boeing.
Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, specifies a compliance time of 4 years for installation of click bond covers and bracket, and washer replacement; and for the general visual inspection of the compression fitting for incorrect pin orientation, a compliance time of 2,000 flight-cycles after accomplishing a certain work package (these actions are for airplanes on which the actions specified Boeing Special Attention Service Bulletin 777-78-0071, dated November 29, 2009, have been done). This SNPRM would require these actions to be done prior to or concurrently with the inspection specified in paragraph (i) of this SNPRM. These actions must be done first in order to accomplish the inspections specified in paragraph (i) of this SNPRM. We have coordinated this difference with Boeing.
Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010; Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013; Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014; specify contacting the manufacturer for instructions on how to repair certain conditions. Instead, this SNPRM would require repairing those conditions in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes ODA whom we have authorized to make those findings.
On March 31, 2005, we issued AD 2005-07-24, Amendment 39-14049 (70 FR 18285, April 11, 2005), for certain Boeing Model 777-200 and -300 series
This SNPRM would terminate the actions required by paragraphs (f), (g), and (h) of AD 2005-07-24, Amendment 39-14049 (70 FR 18285, April 11, 2005), by accomplishment of any of the following actions specified in this SNPRM:
• The actions specified in Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010 (paragraph (g) of this SNPRM).
• Certain inspections and actions specified in Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013 (paragraphs (i), (j), and (k) of this SNPRM).
• The installation specified in Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014 (paragraph (l) of this SNPRM).
We estimate that this proposed AD affects 55 of U.S. registry. We estimate the following costs to comply with this proposed AD:
We have received no definitive data that would enable us to provide cost estimates for the on-condition actions specified in this SNPRM.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by November 9, 2015.
This AD affects AD 2005-07-24, Amendment 39-14049 (70 FR 18285, April 11, 2005).
This AD applies to The Boeing Company Model 777-200 and -300 series airplanes, certificated in any category, equipped with Rolls-Royce Model RB211-Trent 800 engines.
Air Transport Association (ATA) of America Code 78, Engine exhaust.
This AD was prompted by reports of thrust reverser (T/R) events related to thermal damage of the T/R inner wall. We are issuing this AD to detect and correct a degraded T/R inner wall panel, which could lead to failure of the T/R and adjacent components and their consequent separation from the airplane, and which could result in a rejected takeoff (RTO) and cause asymmetric thrust and consequent loss of control of the airplane during reverse thrust operation. If a T/R inner wall overheats, separated components could cause structural damage to the airplane, damage to other airplanes, or possible injury to people on the ground.
Comply with this AD within the compliance times specified, unless already done.
For airplanes with pre-TPS insulation blankets, P/Ns 315W5113-(XX) and 315W5010-(XX): Except as required by paragraphs (h)(1), (h)(2), (h)(3), and (h)(4) of this AD, at the applicable time in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, review the airplane maintenance records to determine whether sealant was added to insulation blankets around the compression pad fittings and the powered door opening system (PDOS) fitting; do the applicable actions specified in paragraphs (g)(1), (g)(2), (g)(3), (g)(4), (g)(5), and (g)(6) of this AD; and do all applicable related investigative and corrective actions; in accordance with the applicable work packages of the Accomplishment Instructions of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, except as required by paragraph (h)(5) of this AD. Do all applicable related investigative and corrective actions before further flight. Repeat the applicable inspections, replacement, and installations required by paragraphs (g)(1), (g)(2), (g)(3), (g)(4), (g)(5), and (g)(6) of this AD thereafter at the applicable intervals specified in paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010.
(1) Do a detailed inspection of all T/R inner wall insulation blanket edges, grommet holes, penetrations, and seams for sealant that is cracked, has gaps, is loose, or is missing; do a general visual inspection of click bond studs, blanket studs, and temporary fasteners; and replace sealant as applicable.
(2) Do the actions specified by either paragraph (g)(2)(i) or (g)(2)(ii) of this AD.
(i) Do a full inner wall panel non-destructive test (NDT) inspection for delamination and disbonding of each T/R half, and do a general visual inspection for areas of thermal degradation.
(ii) Do a limited area NDT inspection of the inner wall panel of each T/R half for delamination and disbonding, and do a general visual inspection for areas of thermal degradation.
(3) Do a general visual inspection of theT/R perforated wall aft of the intermediate pressure compressor 8th stage (IP8) and the high pressure compressor 3rd stage (HP3) bleed port exits for a color that is different from that of the general area.
(4) Do a detailed inspection of the PDOS lug bushings on the upper number 1 compression pad fittings to detect hole elongation, deformation, and contact with the PDOS actuator; and install a PDOS actuator rod and sealant.
(5) Do an NDT inspection for unsatisfactory number 1 upper and numbers 1 and 2 lower compression pad fittings.
(6) Install and seal insulation blankets.
(1) Where paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, specifies a compliance time “after the date on the original issue of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD.
(2) Where table 2 of paragraph 1.E., “Compliance,” in Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, specifies a compliance time of “2,000 flight cycles after the date of the operator's own inspections,” for doing Work Packages 2 and 5, or Work Packages 5 and 6, this AD requires compliance within 2,000 flight cycles after the date of the operator's own inspections, or within 12 months after the effective date of this AD, whichever occurs later.
(3) Where the Condition column in table 2 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, refers to aT/R half that has or has not been inspected before “the date on this service bulletin,” this AD requires compliance for each corresponding T/R half that has or has not been inspected before the effective date of this AD.
(4) Where the Condition column in tables 2 and 3 of paragraph 1.E., “Compliance,” of Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, refers to “total flight cycles,” this AD applies to each T/R half with the specified total flight cycles as of the effective date of this AD.
(5) Where Boeing Alert Service Bulletin 777-78A0065, Revision 2, dated May 6, 2010, specifies to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (r) of this AD.
For airplanes with TPS insulation blankets, P/N 315W5115-(XX): Within 2,000 flight cycles after doing any NDT inspection specified in Boeing Special Attention Service Bulletin 777-78-0071; or within 2,000 flight cycles after doing any NDT inspection specified in Boeing Service Bulletin 777-78-0082; or within 30 days after the effective date of this AD; whichever occurs latest; do the inspections specified in paragraphs (i)(1) and (i)(2) of this AD, and do all applicable related investigative and corrective actions, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, or in accordance with the Accomplishment Instructions of Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015, as applicable; except as required by paragraph (m) of this AD. Do all applicable related investigative and corrective actions before further flight.
(1) Do an NDT inspection of the full T/R inner wall panel for delaminations and disbonds.
(2) Do a detailed inspection of the perforated side of the T/R inner wall aft of the IP8 and the HP3 bleed port exits for color that is different from the normal T/R perforated wall color.
For airplanes with TPS insulation blankets, part number P/N 315W5115-(XX) on which any action specified in Boeing Special Attention Service Bulletin 777-78-0071 have been done but the actions specified paragraphs (j)(1) and (j)(2) of this AD have not been done: Prior to or concurrently with doing the inspection required by paragraph (i) of this AD, do the actions specified in paragraphs (j)(1) and (j)(2) of this AD, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, except as required by paragraph (m) of this AD.
(1) Install click bond covers and bracket and replace the washers.
(2) Do a detailed inspection of the compression fitting for incorrect pin orientation, and do all applicable related investigative and corrective actions. Do all applicable related investigative and corrective actions before further flight.
For airplanes with TPS insulation blankets, part number P/N 315W5115-(XX): Do the inspections specified in paragraph (k)(1) or (k)(2) of this AD, as applicable.
(1) For airplanes on which any inspection specified in Boeing Special Attention Service Bulletin 777-78-0071 has been done: Within 2,000 flight hours after doing a detailed inspection of the EEC wire bundles and clips specified in Boeing Special Attention Service Bulletin 777-78-0071, or within 500 flight hours after the effective date of this AD, whichever occurs later; do a detailed inspection of the EEC wire bundles and clips for damage, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013, except as required by paragraph (m) of this AD. Do all applicable corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in table 5 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013.
(2) For airplanes on which any inspection specified in Boeing Service Bulletin 777-78-0082 has been done: Within 2,000 flight hours after doing a detailed inspection of the EEC wire bundles and clips specified in Boeing Special Attention Service Bulletin 777-78-0082, or within 500 flight hours after the effective date of this AD, whichever occurs later; do a detailed inspection for damage of the EEC wire bundles and clips, and do all applicable corrective actions, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015, except as required by paragraph (m) of this AD. Do all applicable corrective actions before further flight. Repeat the inspection thereafter at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015.
Within 48 months after the effective date of this AD: Install serviceable T/R halves, in accordance with the Accomplishment Instructions of Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014, except as required by paragraph (m) of this AD. The definition of a serviceable T/R half is specified in Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014. Accomplishing the installation specified in this paragraph and the revision to the maintenance or inspection program required by paragraph (n) of this AD terminates the actions required by paragraphs (g), (i), (j), and (k) of this AD.
Where Boeing Alert Service Bulletin 777-78A0094, dated July 29, 2014; Boeing Service Bulletin 777-78-0082, Revision 1, dated June 15, 2015; and Boeing Special Attention Service Bulletin 777-78-0071, Revision 2, dated July 23, 2013; specify to contact Boeing for appropriate action: Before further flight, repair using a method approved in accordance with the procedures specified in paragraph (r) of this AD.
Within 30 days after the effective date of this AD, revise the maintenance or inspection program, as applicable, to incorporate Airworthiness Limitations 78-AWL-01, Thrust Reverser Thermal Protection System; and 78-AWL-02, Thrust Reverser Inner Wall; as specified in Boeing 777 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, Revision dated October 2014.
(1) The initial compliance time for Airworthiness Limitation 78-AWL-01, Thrust Reverser Thermal Protection System, as specified in Boeing 777 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, Revision dated October 2014, is concurrent with the next inspection required by paragraph (i) of this AD, or within 30 days after the effective date of this AD, whichever occurs later.
(2) The initial compliance time for Airworthiness Limitation 78-AWL-02, Thrust Reverser Inner Wall, as specified in Boeing 777 Maintenance Planning Data (MPD) Document, Section 9, Airworthiness Limitations (AWLs) and Certification Maintenance Requirements (CMRs), D622W001-9, Revision dated October 2014, is at the applicable time specified in paragraph (n)(2)(i) or (n)(2)(ii) of this AD.
(i) For airplanes on which any inspections required by paragraph (i) of this AD are done: Concurrent with the next inspection required by paragraph (i) of this AD; or within 30 days after the effective date of this AD; whichever occurs later.
(ii) For airplanes on which the installation required by paragraph (l) of this AD is done: The later of the times specified in paragraph (n)(2)(ii)(A) and (n)(2)(ii)(B) of this AD.
(A) Within 1,125 days or 6,000 flight cycles, whichever occurs first after accomplishing the installation required by paragraph (l) of this AD.
(B) Within 30 days after the effective date of this AD.
After the the maintenance or inspection program, as applicable, has been revised as required by paragraph (n) of this AD, no alternative actions (
(1) This paragraph provides credit for the actions specified in paragraph (g) of this AD, if those actions were performed before the effective date of this AD using Boeing Alert Service Bulletin 777-78A0065, dated June 23, 2008; or Boeing Alert Service Bulletin 777-78A0065, Revision 1, dated January 29, 2009. This service information is not incorporated by reference in this AD.
(2) This paragraph provides credit for the actions specified in paragraph (i) of this AD, if those actions were performed before the effective date of this AD using any service information specified in paragraphs (p)(2)(i), (p)(2)(ii), and (p)(2)(iii) of this AD. This service information is not incorporated by reference in this AD.
(i) Boeing Service Bulletin 777-78-0082, dated November 9, 2011.
(ii) Boeing Special Attention Service Bulletin 777-78-0071, dated November 25, 2009.
(iii) Boeing Special Attention Service Bulletin 777-78-0071, Revision 1, dated September 8, 2010.
(3) This paragraph provides credit for the actions specified in paragraph (j) of this AD, if those actions were performed before the effective date of this AD using Boeing Special Attention Service Bulletin 777-78-0071, Revision 1, dated September 8, 2010. This service information is not incorporated by reference in this AD.
(4) This paragraph provides credit for the actions specified in paragraph (k)(2) of this AD, if those actions were performed before the effective date of this AD using Boeing
Accomplishing the actions specified in paragraph (q)(1), (q)(2), or (q)(3) of this AD terminates the actions required by paragraphs (f), (g), and (h) of AD 2005-07-24, Amendment 39-14049 (70 FR 18285, April 11, 2005).
(1) The actions required by paragraph (g) of this AD.
(2) The inspections required by paragraphs (i) and (k) of this AD, and, as applicable, the actions required by paragraph (j) of this AD.
(3) The installation specified in paragraph (l) of this AD.
(1) The Manager, Seattle Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (s)(1) of this AD. Information may be emailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any structural repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(1) For more information about this AD, contact Kevin Nguyen, Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, Washington 98057-3356; phone: 425-917-6501; fax: 425-917-6590; email:
(2) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede airworthiness directive (AD) 2014-07-04R1 for certain Sikorsky Model S-92A helicopters. AD 2014-07-04R1 currently requires repetitive inspections in the upper deck area for incorrectly installed clamps and chafing between the electrical wires and the hydraulic lines and replacing any unairworthy wires or hydraulic lines. Since we issued AD 2014-07-04R1, the manufacturer has developed an alteration that corrects the unsafe condition described in AD 2014-07-04R1. This proposed AD would require altering the wiring system in the upper deck area. These proposed actions are intended to prevent a fire in an area of the helicopter without extinguishing capability and subsequent loss of control of the helicopter.
We must receive comments on this proposed AD by November 24, 2015.
You may send comments by any of the following methods:
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You may examine the AD docket on the Internet at
For service information identified in this proposed AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
Ian Lucas, Aviation Safety Engineer, Boston Aircraft Certification Office, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7757; email
We invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that might result from adopting the proposals in this document. The most helpful comments reference a specific portion of the proposal, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit only one time.
We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this proposed rulemaking. Before acting on this proposal, we will consider all comments we receive on or before the closing date for comments. We will consider comments filed after the comment period has closed if it is possible to do so without incurring expense or delay. We may change this
On March 28, 2014, we issued AD 2014-07-04, Amendment 39-17818 (79 FR 21385, April 16, 2014), for certain serial-numbered Sikorsky Model S92A helicopters. AD 2014-07-04 required repetitively inspecting the upper deck area for incorrectly installed clamps and chafing between the electrical wires and the hydraulic lines, replacing any unairworthy wires or hydraulic lines, and correcting any clamps that were installed incorrectly. Due to typographical errors when the AD was published, an incorrect serial number and an incorrect reference to the service information appeared in the text of the rule. On August 21, 2014, we issued AD 2014-07-04R1, Amendment 39-17964 (79 FR 54893, September 15, 2014), to correct these errors.
Since we issued AD 2014-07-04R1 (79 FR 54893, September 15, 2014), Sikorsky has developed an alteration to correct the unsafe condition described in AD 2014-07-04R1. The alteration creates separate engine inlet and alternating current (AC) generator feeder lines, which were previously combined as an assembly. The new engine inlet feeder lines are rerouted through the cabin to the AC power distributors. The alteration also involves removing certain hydraulic to electrical clamps, which support the top deck main harnesses, and adding independent electrical brackets to create greater separation from the hydraulic lines. These proposed actions are intended to alter the wiring installation in the upper deck to prevent chafing between the electrical lines and hydraulic hoses. This condition, if not prevented, could result in a fire in an area of the helicopter without extinguishing capability and subsequent loss of control of the helicopter.
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of this same type design.
Sikorsky has issued Special Service Instructions SSI No. 92-070A, Revision A, dated April 25, 2014 (SSI 92-070A), which contains procedures to alter the wiring system in the upper deck area to prevent chafing. This service information is reasonably available because the interested parties have access to it through their normal course of business or by means identified in the Addresses Section of this proposed AD.
We also reviewed Alert Service Bulletin ASB 92-20-003, Basic Issue, dated May 5, 2014 (ASB 92-20-003). ASB 92-20-003 specifies a one-time modification of the upper deck wiring harnesses to prevent possible chafing by complying with SSI 92-070A.
This proposed AD would require altering the wiring system in the upper deck area.
The service information provides a compliance date of November 5, 2015; the proposed AD would require a compliance time of 150 hours TIS. Also, the service information requires submitting certain documentation to the manufacturer, and the proposed AD would not.
We estimate that this proposed AD would affect 20 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work hour. Rerouting the upper deck wiring system and replacing and installing new parts would take 58 work hours and $8,000 in required parts, for a total cost of $12,930 per helicopter and $258,600 for the fleet.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);
3. Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction; and
4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared an economic evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model S-92A helicopters, serial number 920006 through 920084, certificated in any category.
This AD defines the unsafe condition as an incorrectly installed clamp that does not
This AD supersedes AD 2014-07-04R1, Amendment 39-17964 (79 FR 54893, September 15, 2014).
We must receive comments by November 24, 2015.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Within 150 hours time-in-service, reroute the left hand and right hand upper deck wiring system by complying with the Instructions, paragraph B, of Sikorsky Aircraft Corporation Special Service Instructions SSI No. 92-070A, Revision A, dated April 25, 2014.
(1) The Manager, Boston Aircraft Certification Office, FAA, may approve AMOCs for this AD. Send your proposal to: Ian Lucas, Aviation Safety Engineer, Engine & Propeller Directorate, FAA, 12 New England Executive Park, Burlington, Massachusetts 01803; telephone (781) 238-7757; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office before operating any aircraft complying with this AD through an AMOC.
Sikorsky Aircraft Corporation Alert Service Bulletin ASB 92-20-003, Basic Issue, dated May 5, 2014, which is not incorporated by reference, contains additional information about the subject of this AD. For service information identified in this AD, contact Sikorsky Aircraft Corporation, Customer Service Engineering, 124 Quarry Road, Trumbull, CT 06611; telephone 1-800-Winged-S or 203-416-4299; email
You may review the service information at the FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, Texas 76177.
Joint Aircraft Service Component (JASC) Code: 2910 Main Hydraulic System.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain Alpha Aviation Concept Limited Model R2160 airplanes that would supersede AD 2008-09-01. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as a need to revise the maintenance program to include the revised airworthiness limitations for the internal wing structure and wing attachment inspections. We are issuing this proposed AD to require actions to address the unsafe condition on these products.
We must receive comments on this proposed AD by November 9, 2015.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Alpha Aviation Holdings Limited, Steele Road, RD 2 Hamilton Airport, Hamilton 3282, New Zealand, telephone: +64 7 843 9877; fax: +64 7 929 2878; Internet:
You may examine the AD docket on the Internet at
Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4123; fax: (816) 329-4090; email:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On April 11, 2008, we issued AD 2008-09-01, Amendment 39-15481 (73
Since we issued AD 2008-09-01, Alpha Aviation Concept Limited developed a longer life limit for the wing structure and wing attachments and transferred the life limit information from the related service information to the airplane maintenance manual. Subsequently, Alpha Aviation Concept Limited discovered that the analysis that allowed the life limit increase was incorrect and the previous life limit and inspection provisions of the related service bulletin should be retained.
The Civil Aviation Authority (CAA), which is the aviation authority for New Zealand, has issued AD DCA/R2000/43, dated August 7, 2015 (referred to after this as “the MCAI”), to correct an unsafe condition for the specified products. The MCAI states:
This AD introduces a change to the airworthiness limitations for the internal wing structure and wing attachment inspections. These inspection intervals were increased and added to Section 3.2—Airworthiness Limitations of the applicable Service Manual in January 2015. Section 3.2 of the respective Service Manuals has now been revised to revert to the original inspection intervals.
You may examine the MCAI on the Internet at
Alpha Aviation Concept Limited has issued Alpha Aviation APEX R2000 Service Manual, S/N 001 to 378, and Alpha Aviation R2000 Service Manual. These service manuals include a revision to Section 3: Airworthiness Limitations, Time Limits, & Maintenance Inspections, Issued August 2015. These revisions now include periodic internal wing structure and wing attachment inspections. A copy of these revisions to the Airworthiness Limitations section of the applicable service manuals are reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with this State of Design Authority, they have notified us of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all information and determined the unsafe condition exists and is likely to exist or develop on other products of the same type design.
We estimate that this proposed AD will affect 9 products of U.S. registry. We also estimate that it would take about 3 work-hours per product to comply with the basic requirements of this proposed AD. The average labor rate is $85 per work-hour.
Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $2,295, or $255 per product.
In addition, we estimate that any necessary follow-on actions would take about 12 work-hours and require parts costing $1,326, for a cost of $2,346 per product. We have no way of determining the number of products that may need these actions.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by November 9, 2015.
This AD supersedes AD 2008-09-01, Amendment 39-15481 (73 FR 21519; April 22, 2008) (“AD 2008-09-01”).
This AD applies to Alpha Aviation Concept Limited Model R2160 airplanes, serial numbers (S/Ns) 001 through 378, and 160A-06001 and subsequent, certificated in any category.
Air Transport Association of America (ATA) Code 5: Time Limits.
This AD was prompted by mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe
Unless already done, before further flight after the effective date of this AD, insert the following into the Airworthiness Limitations section of the FAA-approved maintenance program (
(1) For S/Ns 001 through 378: Insert paragraph 3.4.9, Wing 3500 hr Inspection, on pages 3-3 and 3-4, dated August 2015, of Section 3: Airworthiness Limitations, Time Limits, & Maintenance Inspections, dated August 2015, of the APEX R2000 Service Manual S/N 001 to 378, Alpha Aviation Ltd.
(2) For S/Ns 160A-06001 and subsequent: Insert paragraph 3.4.9, Wing 3500 hr Inspection, on pages 3-3 and 3-4, dated August 2015, of Section 3: Airworthiness Limitations, Time Limits, & Maintenance Inspections, all dated August 2015, of the R2000 Service Manual, Alpha Aviation Ltd.
The following provisions also apply to this AD:
(1) Alternative Methods of Compliance (AMOCs): The Manager, Standards Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Karl Schletzbaum, Aerospace Engineer, FAA, Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone: (816) 329-4146; fax: (816) 329-4090; email:
(2) Airworthy Product: For any requirement in this AD to obtain corrective actions from a manufacturer or other source, use these actions if they are FAA-approved. Corrective actions are considered FAA-approved if they are approved by the State of Design Authority (or their delegated agent). You are required to assure the product is airworthy before it is returned to service.
Refer to MCAI Civil Aviation Authority (CAA) AD DCA/R2000/43, dated August 7, 2015, for related information. You may examine the MCAI on the Internet at
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM), correction.
This action makes a correction to the NPRM published in the
Comments due date remains October 13, 2015.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001. You must identify the docket number FAA-2015-3084/Airspace Docket No. 15-AGL-13, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15.
Raul Garza, Jr., Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone: 817-868-2927.
History. A notice of proposed rulemaking was published in the
Accordingly, pursuant to the authority delegated to me, in the
That airspace extending upward from 1,200 feet above the surface within an area bounded by lat. 49°00′00″ N., long. 095°00′00″ W.; to lat. 49°00′00″ N., long. 093°30′00″ W.; to lat. 48°06′30″ N., long. 090°06′00″ W.; to lat. 47°53′00″ N., long. 090°55′00″ W.; to lat. 48°34′00″ N., long. 094°00′00″ W.; to lat. 48°40′00″ N., long. 095°00′00″ W., thence to the point of beginning, excluding that airspace within Federal airways and within Canadian airspace.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is intended to provide direction to regulated industry and to help avoid consumer confusion.
Submit either electronic or written comments on this proposed rule by November 24, 2015. See section IV.B of this document for the proposed effective date of a final rule based on this proposed rule.
You may submit comments, by any of the following methods:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
Submit written submissions in the following ways:
•
Bryant Godfrey or Darin Achilles, Office of Regulations, Center for Tobacco Products, Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD 20993-0002, 877-287-1373,
The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) amends the FD&C Act and provides FDA with the authority to regulate tobacco products. Section 201(rr) of the FD&C Act (21 U.S.C. 321(rr)), as amended by the Tobacco Control Act, defines the term “tobacco product” as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Excluded from the definition of a tobacco product is any article that is a drug, device, or combination product. Any article that is a drug, device, or combination product will be regulated as such rather than as a tobacco product.
Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, FDA is initiating this rulemaking to provide clarity regarding our interpretation of the drug and device definitions in the FD&C Act with respect to products made or derived from tobacco. This rulemaking will provide assistance for entities intending to market products made or derived from tobacco. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. The rulemaking will increase clarity regarding the types of claims and other evidence that make a product made or derived from tobacco subject to regulation as a drug, device or combination product, helping consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses.
In addition, FDA is taking the opportunity to propose corresponding changes to existing regulations at §§ 201.128 and 801.4 (21 CFR 201.128 and 801.4), and to conform them to how the Agency currently applies these regulations to drugs and devices generally.
Conceptually, the proposed rule follows the disease prong and the structure/function prong (with certain enumerated limitations) of the statutory definitions of “drug” and “device” (section 201(g) and (h) of the FD&C Act). Under the proposed rule, a product made or derived from tobacco and intended for human consumption would be regulated as a drug, device, or combination product in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000. The proposed rule also attempts to clarify remaining circumstances where a product would be or could be regulated as a tobacco product.
In addition, FDA is proposing to amend its existing intended use regulations for drugs and devices by inserting in §§ 201.128 and 801.4 a reference to the proposed rule to clarify the interplay between these regulations and this proposed rule, and to conform §§ 201.128 and 801.4 to reflect how the Agency currently applies them to drugs and devices.
The proposed rule would generate some benefit by reducing the ambiguity in the development and marketing of products made or derived from tobacco. The proposed rule is not expected to impose significant additional costs on manufacturers who make products made or derived from tobacco, or on drug and device manufacturers generally.
The Tobacco Control Act was enacted on June 22, 2009 (Pub. L. 111-31), amending the FD&C Act and providing FDA with the authority to regulate tobacco products. Section 101(a) of the Tobacco Control Act amends section 201 of the FD&C Act by adding paragraph (rr), which defines the term “tobacco product.” In general, a “tobacco product” is defined as any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product). Section 201(rr)(2) of the FD&C Act excludes from the definition of a tobacco product any article that is defined as a drug under section 201(g)(1), a device under section 201(h), or a combination product described in section 503(g) of the FD&C Act (21 U.S.C 353(g)). Section 201(rr)(3) of the FD&C Act explains that any article that is a drug, device, or combination product will be regulated under chapter V of the FD&C Act (the authorities for drugs and devices) rather than chapter IX (the authorities for tobacco products).
As noted in section I.A of this document, the definition of “tobacco product” excludes anything that is a “drug,” “device,” or “combination product” under the FD&C Act. The FD&C Act defines “drug” (in relevant part) as an article intended either: (1) For use in the diagnosis, cure, mitigation, treatment, or prevention of disease (referred to as the “disease prong” of the definition), or (2) to affect the structure or any function of the body (the “structure/function prong”) (section 201(g)(1) of the FD&C Act). The FD&C Act defines a “device” (in relevant part) as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, intended either: (1) For use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or (2) to affect the structure or any function of the body, and which does not achieve its primary intended purposes through chemical action within or on the body of man and which is not dependent on being metabolized for the achievement of its primary intended purposes (section 201(h) of the FD&C Act).
FDA has previously interpreted the exclusion in the tobacco product definition to mean that if a product made or derived from tobacco is determined to have a drug or device “intended use,” it will be regulated as a medical product, not as a tobacco product. As discussed in greater detail in this document, this interpretation was qualified in
In determining a product's intended use, the Agency may look to “any . . . relevant source,” including but not limited to the product's labeling, promotional claims, and advertising (see,
To establish a product's intended use, FDA is not bound by the manufacturer or distributor's subjective claims of intent, but rather can consider objective evidence, which may include a variety of direct and circumstantial evidence. Thus, FDA may also take into account any circumstances surrounding the distribution of the product or the context in which it is sold (
Thus, when a product made or derived from tobacco is marketed or distributed for an intended use that falls within the drug/device definitions, it would be regulated as a medical product, subject to the limitations discussed further in this document. Courts have recognized that products made or derived from tobacco marketed with “disease” claims and certain “structure/function” claims are drugs (
Although the courts have recognized that tobacco-derived products can be regulated as medical products under the FD&C Act in certain circumstances, courts have also held that there are limitations on how the drug and device definitions can be applied to products made or derived from tobacco. This section provides a summary of FDA regulatory action and related litigation relevant to those limitations.
In 1996, FDA issued a regulation restricting the sale and distribution of cigarettes and smokeless tobacco to children and adolescents (the 1996 rule) (61 FR 44396, August 28, 1996). This rule included FDA's determination that it had jurisdiction over cigarettes and smokeless tobacco under the FD&C Act. The basis for this determination was that cigarettes and smokeless tobacco were intended to affect the structure or function of the body, within the FD&C Act definitions of the terms “drug” and “device,” because nicotine has significant pharmacological effects. In
The Supreme Court struck down the 1996 rule in
In 2008 and early 2009, FDA detained multiple shipments of electronic cigarettes from overseas manufacturers and denied them entry into the United States on the ground that electronic cigarettes were unapproved drug-device combination products under the FD&C Act. In April 2009, plaintiffs sought a preliminary injunction to enjoin FDA from regulating electronic cigarettes as drug-device combination products and from denying entry of those products into the United States.
The Court in
Because some ambiguity surrounds the circumstances under which a product that is made or derived from tobacco would be regulated as a drug, device, or combination product, and the circumstances under which it would be regulated as a tobacco product, we are initiating this rulemaking to provide clarity regarding our interpretation of the drug/device definitions in the FD&C Act with respect to products made or derived from tobacco. We believe that this rulemaking will provide assistance for entities intending to market products made or derived from tobacco and for entities that plan to study these products. For example, the rule is expected to help sponsors determine which FDA Center should be consulted as they develop their products and make appropriate premarket submissions to bring new products to market. FDA expects the rule will also assist investigators planning to use products made or derived from tobacco for an investigational use in determining the investigational use requirements that apply to their proposed studies. In addition, we believe it is important to avoid consumer confusion about which products are intended for medical uses versus recreational or other uses. The rulemaking will increase clarity regarding the types of claims and other evidence that make a product made or derived from tobacco subject to regulation as a drug or device, which we expect will help consumers distinguish products made or derived from tobacco that are intended for medical use from products marketed for other uses. Finally, the rulemaking will provide clarity for drug and device manufacturers generally regarding FDA's interpretation and application of its existing intended use regulations.
In both the
As discussed in section I.B, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease are drugs, devices, or combination products under the FD&C Act. Products made or derived from tobacco have historically been regulated as medical products when they are marketed for intended uses that fall within the disease prong. For example, FDA has approved a number of drug products made or derived from tobacco as nicotine replacement therapies with indications to reduce withdrawal symptoms, including nicotine craving, associated with quitting smoking. Accordingly, FDA has long considered claims related to smoking cessation in the context of curing or treating nicotine addiction and its symptoms to be within FDA's “disease prong” jurisdiction.
FDA has also taken enforcement action against products made or derived from tobacco that were marketed with claims of therapeutic benefit but that did not have approved new drug applications. For example, FDA seized cigarettes on the grounds that they were misbranded drugs when the manufacturer represented that the cigarettes were effective in preventing respiratory diseases, common cold, influenza, pneumonia, and various other ailments. (
The “therapeutic benefit” language used by the
Given the availability of FDA-approved drugs for smoking cessation, FDA believes that consumers are particularly susceptible to confusion where products made or derived from tobacco that otherwise appear to be products intended for recreational use make claims related to quitting smoking. Therefore, FDA considers claims related to smoking cessation to require careful scrutiny. Where products making claims related to quitting smoking also attempt to disclaim that use in some way, FDA intends to view such disclaimers skeptically because of the likelihood of consumer confusion. In most cases, FDA does not believe that disclaimers will sufficiently mitigate consumer confusion related to the intended therapeutic use of the product.
FDA proposes to treat several other categories of claims for products made or derived from tobacco as falling within the disease prong of the drug/device definition. These categories of claims are discussed further in section IV (Description of Proposed Regulation). We note that sections 911(c) and 918 of the FD&C Act (21 U.S.C. 387k(c) and 387r), as amended by the Tobacco Control Act, contemplate that products intended for the treatment of tobacco dependence and for relapse prevention, among other things, may be subject to FDA's drug/device jurisdiction.
Through this rulemaking, FDA is also clarifying the relationship between FDA's regulation of a certain category of tobacco products—modified risk tobacco products (MRTPs)—and FDA's regulation of medical products that are intended to mitigate disease. MRTPs are tobacco products that are sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products (section 911(b)(1) of the FD&C Act). The phrase “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products” refers to a tobacco product:
1. That represents in its label, labeling, or advertising, either implicitly or explicitly, that:
• The tobacco product presents a lower risk of tobacco-related disease or is less harmful than one or more other commercially marketed tobacco products;
• the tobacco product or its smoke contains a reduced level of a substance or presents a reduced exposure to a substance; or
• the tobacco product or its smoke does not contain or is free of a substance;
2. That uses the descriptors “light,” “mild,” “low,” or similar descriptors in its label, labeling, or advertising;
3. For which the tobacco product manufacturer has taken any action directed to consumers through the media or otherwise, other than by means of the tobacco product's label, labeling, or advertising, after June 22, 2009, respecting the product that would be reasonably expected to result in consumers believing that the tobacco product or its smoke may present a lower risk of disease or is less harmful
See section 911(b)(2) of the FD&C Act.
Because MRTPs have the potential to be marketed as less harmful than other tobacco products, including as presenting a lower risk of tobacco-related disease than another tobacco product, FDA recognizes that there might be questions about how these products relate to FDA's medical product jurisdiction over products made or derived from tobacco that are intended for use in disease mitigation. MRTPs may have the ultimate effect of lowering disease risk for users who would otherwise use another, more harmful tobacco product. However, an important distinction between MRTPs and medical products is that, while medical products approved for disease mitigation act affirmatively to combat a disease or health condition, MRTPs present
For purposes of illustration, claims of modified risk might include claims like “contains less nicotine than [tobacco product X]”, “using [MRTP] reduces your risk of lung cancer compared to using [tobacco product X]”, and “lower level of nitrosamines than other smokeless tobacco products.” In contrast, a claim that a product “inhibits the progression of disease in adult patients with chronic obstructive pulmonary disease (COPD)” is not an appropriate modified risk claim, but would be appropriate for a medical product approved for such an indication.
As discussed in sections I.B and I.C of this document, the drug/device definitions in the FD&C Act include articles “intended to affect the structure or any function of the body,” and FDA's assertion of jurisdiction over cigarettes and smokeless tobacco in 1996 was predicated on the pharmacological effects of nicotine on the structure or function of the body. In addition, as explained previously, the Court in
Based on the
For example, claims related to satisfaction, pleasure, enjoyment, and refreshment have been recognized as euphemisms for the delivery of a pharmacologically active dose of nicotine. While these claims relate to effects on the structure or function of the body, FDA does not consider these tobacco satisfaction and enjoyment claims to fall within its drug and device regulatory authority. Similarly, FDA does not consider claims suggesting that a tobacco product provides an alternative way of obtaining the effects of nicotine, or that a tobacco product will provide the same effects as another tobacco product—such as “satisfying smoking alternative,” “provides all the pleasure of smoking,” “get your nicotine fix,” or “provides smokers the same delight, physical and emotional feelings”—to fall within its drug and device authority; however, we invite comment on this.
The
FDA believes that it is important to distinguish structure/function intended uses that were not commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to the decision in
FDA believes this proposed rule will provide clarity to manufacturers about how products made or derived from tobacco will be regulated if they are marketed or distributed for certain intended uses. This clarification will
In addition, we believe this proposed rule will help to avoid consumer confusion about which products made or derived from tobacco are intended for a medical use (
FDA is also proposing changes to §§ 201.128 and 801.4. First, the proposed rule would insert a reference to § 1100.5 to clarify the interplay between these regulations and the proposed rule. Second, as discussed previously, the Agency does not regard a firm as intending an unapproved new use for an approved or cleared medical product based solely on that firm's knowledge that such product was being prescribed or used by doctors for such use (see Ref. 5). Accordingly, FDA is taking this opportunity to amend §§ 201.128 and 801.4 to better reflect FDA's interpretation and application of these regulations. These changes would not reflect a change in FDA's approach regarding evidence of intended use for drugs and devices. These clarifying changes to the intended use regulations would apply to drugs and devices generally, and not just to products made or derived from tobacco and intended for human consumption.
Among the provisions of the FD&C Act that provide authority for this proposed rule are sections 201, 503(g), and 701(a) of the FD&C Act (21 U.S.C. 321, 353(g), 371(a)). Section 201 of the FD&C Act defines “drug,” “device,” and “tobacco product” (subsections (g)(1), (h), and (rr)(1)), and section 503(g) of the FD&C Act provides that combination products are those “that constitute a combination of a drug, device, or biological product.” Under section 701(a) of the FD&C Act, FDA has authority to issue regulations for the efficient enforcement of the FD&C Act.
FDA regulates the manufacture, sale, and distribution of drugs, devices, combination products, and tobacco products under the authority of the FD&C Act. Although the regulatory pathways for each product category differ, each product category is subject to similar types of regulatory requirements. For example, FDA's regulatory authority for drugs, devices, combination products, and tobacco products includes authority to review and authorize the marketing of new products as well as to oversee product labeling and advertising. Thus, whether a product meets the definition of a drug, device, or tobacco product under the FD&C Act and this proposed regulation, the manufacture, sale, and distribution of the product are subject to the applicable requirements of the FD&C Act.
As described in section II of this document, the goal of this proposed rule, when finalized, is to provide clarity regarding the types of intended uses of products made or derived from tobacco that may fall within the drug/device definitions and therefore cause those products to be regulated as medical products under the FD&C Act. In describing these intended uses, the proposed rule aims to assist regulated entities in the research and development of products made or derived from tobacco by clarifying which regulatory framework (
The proposed codified language states the circumstances in which a product made or derived from tobacco would be excluded from the definition of “tobacco product” and be subject to regulation as a drug, device, or combination product. Under the proposed rule, this exclusion could apply in two circumstances: (1) If the product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease; or (2) if the product is intended to affect the structure or any function of the body, in any way that is different from effects of nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
Conceptually, the proposed codified language follows the disease prong and the structure/function prong (with certain limitations) of the drug and device definitions.
Proposed § 1100.5(a) follows the disease prong. The proposed paragraph elaborates on the statutory language for the disease prong by describing several categories of intended uses that would cause a product made or derived from tobacco to be regulated as a medical product. The categories identified in proposed § 1100.5(a) are not intended to constitute an exhaustive list; nor are these categories necessarily mutually exclusive. In addition, these categories are intended to capture concepts, rather than to suggest that the use (or omission) of particular words is dispositive with respect to FDA's medical product jurisdiction. These categories are included as examples of types of intended uses that we believe are particularly relevant for products made or derived from tobacco and that fall within the disease prong.
Proposed § 1100.5(b) follows the structure/function prong, but with some changes to reflect the court decisions in
FDA believes that it is important to include a date limitation in proposed § 1100.5(b) to provide greater certainty about the universe of structure/function claims the Agency intends to consider when determining whether a product made or derived from tobacco is “customarily marketed.” This bright-line limitation also avoids creating a shifting standard that will cause confusion among consumers and regulated industry. FDA intends to look to the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000, to determine the types of structure/function claims that constitute customary tobacco product marketing. Examples of these types of claims include those related to satisfaction, pleasure, enjoyment, and refreshment (
As noted in section I.B.2 of this document, intended use may be determined from any relevant source and is not based solely on claims made in a product's labeling or advertising materials. For purposes of illustration, however, claims such as “treatment of tobacco dependence,” “wean yourself off of nicotine,” “for people who wish to quit smoking,” “stop smoking aid,” “prevent relapse,” or “stay quit” generally would fall within the intended uses described in proposed § 1100.5(a).
Claims such as “to reduce withdrawal symptoms,” “helps reduce symptoms including things like [list of withdrawal symptoms]” and “relieve withdrawal symptoms while you are on the plane” would be associated with an intended use for relief of nicotine withdrawal symptoms, and would also fall within the intended uses described in proposed § 1100.5(a). Withdrawal symptoms that are medically recognized as relevant to nicotine addiction may be determined by reference to standard classification and diagnostic tools such as the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and the tenth revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10).
Certain structure/function claims that were not commonly and legally made in the marketing of cigarettes and smokeless tobacco products before March 21, 2000, such as “promotes weight loss,” would fall within the intended uses described in proposed § 1100.5(b).
In contrast to the examples of medical product intended use claims given in the previous paragraphs, certain other claims made about products made or derived from tobacco would not on their own create an intended use that falls within the proposed codified language.
In addition, as discussed previously, a manufacturer's knowledge that an approved or cleared medical product is being used for an unapproved use, would not by itself establish a medical product intended use. To clarify FDA's policy on this point, as well as the interplay among §§ 201.128, 801.4, and proposed 1100.5, FDA is proposing revisions to §§ 201.128 and 801.4.
For products made or derived from tobacco that are intended for investigational use, FDA will consider whether the product is being used in a clinical investigation for an intended use that brings it within the proposed codified language. If it is, the product would meet the definition of “investigational new drug” in § 312.3 (21 CFR 312.3), and the clinical investigation would be subject to the applicable requirements in 21 CFR part 312.
The Agency proposes that any final rule based on this proposal will become effective 30 days after the date of publication of the final rule in the
FDA has analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the proposed rule, if finalized, would not contain policies that would have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, the Agency tentatively concludes that the proposed rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
FDA has determined under 21 CFR 25.30(h) and (k) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore,
FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. By clarifying when products made or derived from tobacco will be subject to regulation as medical products, the ambiguity that currently exists in the regulatory environment will be reduced. We cannot predict how many companies will revise labeling, advertising, or other marketing materials for their products following issuance of this rule. We note, however, that this regulation is intended to provide clarity regarding existing jurisdictional lines for products made or derived from tobacco and for drug and device manufacturers regarding FDA's interpretation and application of its existing intended use regulations; as such, any need to revise labeling, advertising, or other marketing materials or submit applications should have predated the regulation. Therefore, the Agency proposes to certify that the proposed rule will not have a significant economic burden on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $144 million (Ref. 1), using the most current (2014) Implicit Price Deflator for the Gross Domestic Product. FDA does not expect this proposed rule to result in any 1-year expenditure that would meet or exceed this amount.
The proposed rule would reduce the ambiguity in the market for products made or derived from tobacco and clarify FDA's interpretation and application of its existing intended use regulations. The rule clarifies the types of claims and other evidence that would result in these products being regulated as medical products rather than tobacco products. The reduction in ambiguity should increase appropriate market participation and thus increase welfare in the market, including greater clarity and less confusion for producers and consumers. While these clarifications would impact future marketing strategies, it is not expected to result in significant changes to current marketing costs.
Adopting the proposed rule would clarify the regulatory status of products made or derived from tobacco and how FDA interprets and applies its existing intended use regulations. This is expected to reduce the ambiguity associated with submitting a new product for approval or marketing authorization, or with initiating research of a new product. It is expected that industries are ambiguity averse.
Ambiguity aversion is preference of certainty over uncertainty (Ref. 2). It is assumed that industries developing and manufacturing products made or derived from tobacco prefer a regulatory environment with greater certainty than one with greater ambiguity. Previous research has shown that reduction in the uncertainty of financial markets increases participation by both traders and investors (Refs. 3 and 4). The proposed rule is expected to reduce ambiguity, and this reduction in ambiguity will encourage investment and innovation.
The proposed rule is not expected to impose significant additional costs on drugs, devices, or tobacco products. FDA's regulatory authority for drugs, devices, and tobacco products includes authority to review and authorize marketing of new products, as well as to oversee product labeling and advertising. Thus, whether a product meets the definition of a drug, device, or tobacco product under the FD&C Act and this proposed regulation, its manufacture, sale, and distribution is subject to the applicable requirements of the FD&C Act. Companies may revise marketing practices to conform to the rulemaking and to ensure they are incurring the appropriate costs for their product type. We do not have evidence that this will affect many currently marketed products and as such is unlikely to impose significant new costs.
The proposed rule does not extend FDA's authority to additional products and it does not impose any additional labeling requirements on currently regulated products. The proposed rule does not change the way FDA regulates medical products or tobacco products; it clarifies the applicable regulatory framework for products made or derived from tobacco and FDA's interpretation and application of its existing intended use regulations. This will reduce ambiguity for firms potentially seeking marketing authorization for a product as a drug, device, or tobacco product, will assist those seeking to study products made or derived from tobacco, and will help consumers differentiate between products that are intended for medical use and products marketed for other uses.
The proposed rule is expected to reduce regulatory ambiguity in the research, development and marketing of drugs, devices, and tobacco products, as well as consumer confusion in the marketplace. The reduction in ambiguity will encourage investment and innovation. The proposed rule may affect marketing strategies, but is only clarifying when products made or derived from tobacco will be regulated as drugs or devices and FDA's interpretation and application of its existing intended use regulations. Accordingly, any costs to revise marketing strategies predated the rule, and as such the rule itself is not expected to impose significant costs.
The Regulatory Flexibility Act requires Agencies to prepare a regulatory flexibility analysis if a proposed rule would have a significant effect on a substantial number of small businesses, non-profit organizations, local jurisdictions, or other entities. The proposed rule would reduce ambiguity in the regulatory environment for products made or derived from tobacco. We do not expect this clarification to significantly increase costs associated
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
Interested persons may submit either electronic comments regarding this document to
Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at
Please note that your name, contact information, and other information identifying you will be posted on
The following references have been placed on display in the Division of Dockets Management (see
Drugs, Labeling, Reporting and recordkeeping requirements.
Labeling, Medical devices, Reporting and recordkeeping requirements.
Combination products, Devices, Drugs, Smoking, Tobacco.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that 21 CFR chapter I be amended as follows:
21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360, 360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
The words
21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.
The words
21 U.S.C. 387a(b), 387f(d); Secs. 901(b) and 906(d), Pub. L. 111-31; 21 CFR 16.1 and 1107.1; 21 CFR 1.1, 1.20, 14.55, 17.1, and 17.2. Section 1100.5 is issued under 21 U.S.C. 321, 353(g), and 371(a); 21 CFR 1.1.
If a product made or derived from tobacco that is intended for human consumption is intended for use for any of the purposes described in paragraph (a) or (b) of this section, the product is not a tobacco product as defined in section 201(rr) of the Federal Food, Drug, and Cosmetic Act and will be subject to regulation as a drug, device, or combination product.
(a) The product is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease, including use in smoking cessation, the cure or treatment of nicotine addiction, relapse prevention, relief of nicotine withdrawal symptoms, or prevention or mitigation of disease;
(b) The product is intended to affect the structure or any function of the body in any way that is different from effects related to nicotine that were commonly and legally claimed in the marketing of cigarettes and smokeless tobacco products prior to March 21, 2000.
Occupational Safety and Health Administration (OSHA), Labor.
Notice of proposed rule; extension of comment period.
The Occupational Safety and Health Administration (OSHA) is extending the deadline for submitting comments on the proposed rule: Clarification of Employer's Continuing Obligation To Make and Maintain an Accurate Record of Each Recordable Injury and Illness.
The comment due date for the proposed rule published in the
Submit comments and additional material using any of the following methods:
Instructions for submitting comments: All submissions must include the Agency's name (OSHA), the title of the rulemaking (Clarification of Employer's Continuing Obligation to Make and Maintain an Accurate Record of Each Recordable Injury and Illness), and the docket number (OSHA-2015-0006). OSHA will place comments and other material, including any personal information you provide, in the public docket without revision, and the comments and other materials will be available online at
Docket: To read or download comments or other material in the docket, go to Docket Number OSHA-20015-0006 at
General information and press inquiries: Contact Frank Meilinger, Director, Office of Communications, Room N-3647, OSHA, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-1999; email
Copies of this
OSHA published a notice of proposed rulemaking on July 15, 2015, titled “Clarification of Employer's Continuing Obligation To Make and Maintain an Accurate Record of Each Recordable Injury and Illness.” The notice stated that comments were due by September 28, 2015. The National Association of Home Builders requested that the deadline for submitting comments be extended by 60 days to provide additional time for interested parties to engage in “legal analysis, as well as careful review and discussion” of the proposed rule. See Ex. OSHA-2015-006-0004. OSHA believes an extension of 30 days is reasonable. Therefore, to allow commenters adequate time to prepare complete and accurate comments on the proposed rule, OSHA is, with this notice, extending the deadline for submitting comments in response to the proposed rule to October 28, 2015.
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210, authorized the preparation of this notice pursuant to 29 U.S.C. 657, 673; 5 U.S.C. 553; and Secretary of Labor's Order No. 1-2012 (77 FR 3912; January 25, 2012), and 29 CFR 1911.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Monterey Bay Unified Air Pollution Control District (MBUAPCD) and the Ventura County Air Pollution Control District (VCAPCD) portions of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from the transfer of gasoline into vehicle fuel tanks, and from the transfer or dispensing of liquefied petroleum gas (LPG). We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act).
Any comments on this proposal must arrive by October 26, 2015.
Submit comments, identified by docket number EPA-R09-OAR-2015-0369, by one of the following methods:
1.
2.
3.
James Shears, EPA Region IX, (213) 244-1810,
This proposal addresses the following local rule(s): MBUAPCD Rule 1002 and VCAPCD Rule 74.33. In the Rules and Regulations section of this
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the Missouri State Plan received May 7, 2013. This revision rescinds the state rule and associated state plan controlling mercury emissions from electric generating units. This rule is being proposed for rescision because the Federal Clean Air Mercury Rule, which is the basis for this rule and associated plan, has been vacated and removed from the Code of Federal Regulations. This action will make Missouri's State Plan consistent with Federal regulations.
Comments on this proposed action must be received in writing by October 26, 2015.
Submit your comments, identified by Docket ID No. EPA-R07-OAR-2015-0427, by mail to Amy Bhesania, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the
Amy Bhesania, Environmental Protection Agency, Air Planning and Development Branch, 11201 Renner Boulevard, Lenexa, Kansas 66219 at 913-551-7147, or by email at
In the final rules section of this
Environmental protection, Air pollution control, Administrative practice and procedure, Intergovernmental relations, Reporting and recordkeeping requirements.
Federal Emergency Management Agency, DHS.
Proposed rule; withdrawal.
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Butler County, Pennsylvania (All Jurisdictions).
This withdrawal is effective on September 25, 2015.
You may submit comments, identified by Docket No. FEMA-B-1147, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
On October 5, 2010, FEMA published a proposed rule at 75 FR 61382, proposing flood elevation determinations along one or more flooding sources in Butler County, Pennsylvania (All Jurisdictions). FEMA is withdrawing the proposed rule.
42 U.S.C. 4104; 44 CFR 67.4.
Federal Emergency Management Agency, DHS.
Proposed rule; withdrawal.
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed rule concerning proposed flood elevation determinations for Mercer County, New Jersey (All Jurisdictions).
This withdrawal is effective on September 25, 2015.
You may submit comments, identified by Docket No. FEMA-B-1153 to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance
On November 9, 2010, FEMA published a proposed rule at 75 FR 68740-68741, proposing flood elevation determinations along one or more flooding sources in Mercer County, New Jersey. FEMA is withdrawing the proposed rule because FEMA has issued a Revised Preliminary Flood Insurance Rate Map and Flood Insurance Study report, featuring updated flood hazard information. A Notice of Proposed Flood Hazard Determinations was published in the
42 U.S.C. 4104; 44 CFR 67.4.
Federal Communications Commission.
Proposed rule.
In this document, the Commission takes further action on a rulemaking it initiated in January 6, 2015, to help guide and accelerate the technological revolutions that are underway involving the transitions from networks based on TDM circuit-switched voice services running on copper loops to all-IP multi-media networks using copper, co-axial cable, wireless, and fiber as physical infrastructure. This Further Notice of Proposed Rulemaking (FNPRM) is only one of a series of Commission actions to protect core values and ensure the success of these technology transitions. In this FNPRM, we take steps to ensure that competition continues to thrive and to protect consumers during transitions. These steps will help to ensure that the technology transitions continue to succeed.
Submit comments on or before October 26, 2015. Submit reply comments on or before November 24, 2015.
You may submit comments, identified by GN Docket No. 13-5, RM-11358, WC Docket No. 05-25, RM-10593, by any of the following methods:
• Federal Communications Commission's Web site:
• People with Disabilities: Contact the FCC to request reasonable accommodations (accessible format documents, sign language interpreters, CART, etc.) by email:
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
Michele Levy Berlove, Wireline Competition Bureau, Competition Policy Division, (202) 418-1477, or send an email to
This is a summary of the Commission's Further Notice of Proposed Rulemaking (FNPRM) in GN Docket No. 13-5, RM-11358, WC Docket No. 05-25, RM-10593, FCC 15-97, adopted August 6, 2015 and released August 7, 2015. The full text of this document is available for public inspection during regular business hours in the FCC Reference Information Center, Portals II, 445 12th Street SW., Room CY-A257, Washington, DC 20554. It is available on the Commission's Web site at
1. Communications networks are rapidly transitioning away from the historic provision of time-division multiplexed (TDM) services running on copper to new, all-Internet Protocol (IP) multimedia networks using copper, co-axial cable, wireless, and fiber as physical infrastructure. Our actions today further the technology transitions underway in our Nation's fixed communications networks that offer the prospect of innovative and improved services to consumers and businesses alike. The core goals of the January 2014
2. Industry is investing aggressively in modern telecommunications networks and services. Overall, according to data supplied by USTelecom and AT&T, capital expenditures by broadband providers topped $75 billion in 2013 and continue to increase. AT&T recently announced that by the year 2020, 75 percent of its network will be controlled by software. To do this, AT&T is undergoing a massive effort to train about 130,000 of its employees on software-defined networking architecture and protocols. AT&T has also expanded its wireline IP broadband network to 57 million customer locations, as well as extended fiber to 725,000 business locations. Moreover, Verizon passes more than 19.8 million premises with its all-fiber network—the largest such network in the country—and it projects that soon about 70 percent of the premises in its landline territory will have access to all-fiber facilities. Verizon too has announced an SDN-based strategy “to introduce new operational efficiencies and allow for the enablement of rapid and flexible service delivery to Verizon's customers.” And CenturyLink has announced the launch of 1 Gbps broadband service to 16 cities. According to recent reports, CenturyLink's national fiber network upgrade has expanded availability of CenturyLink's gigabit broadband services to nearly 490,000 business locations. These are just a few of many examples in which industry is investing heavily to bring the benefits of new networks and services to customers of all sizes.
3. We recognize that the success of the technology transitions is dependent, among other things, on clear and certain direction from the Commission that preserves the historic values that Congress has incorporated in the Communications Act of 1934, as amended (the Act). In the January 6, 2015 NPRM, 80 FR 450, we sought comment on limited oversight that
4.
5. We seek comment on specific proposals for possible criteria against which to measure “what would constitute an adequate substitute for retail services that a carrier seeks to discontinue, reduce, or impair in connection with a technology transition (
6. Our purpose is to adopt clear criteria that will eliminate uncertainty that could potentially impede the industry from actuating a rapid and prompt transition to IP and wireless technology. We recognize that our existing case-by-case approach may not provide sufficient guidance as to what constitutes an adequate substitute with regard to cutting-edge technology transitions, and we recognize that as a result carriers may be more inclined to pursue half-measures that merely “test the water.” Such outcomes reduce innovation and are inconsistent with our overarching goal of advancing the public interest and ensuring “that we protect consumers, competition, and public safety.”
7. The Commission always has applied certain criteria in evaluating the adequacy of alternative services in the context of section 214 discontinuance applications. The Commission has engaged in a highly fact-specific analysis based on the situation presented and has not codified any specific criteria by which it evaluates the adequacy of substitute services. The record we received in response to questions in the NPRM about adequate substitutes included a range of public interest organizations, state utility commissions, competitive LECs, telecommunications service consumers, and others advocating that we should define attributes of an adequate substitute, and other commenters, particularly larger incumbent LECs, urging us not to do so. Incumbent LECs believe that defining the attributes of an adequate substitute service would discourage carriers from innovating. A number of these commenters argue that the Commission should encourage the development of industry best practices.
8. Commenters have not swayed us from our belief that establishing criteria for evaluating the adequacy of replacement services will benefit industry and consumers alike by providing certainty. Indeed, we believe that by establishing and codifying such criteria, we provide transparency and certainty in an area that has been subject to case-by-case evaluation without formal rule-based guidance. We believe that it is important to ensure that key aspects of service such as connection persistence and quality, 9-1-1 service, and service for individuals with disabilities remain available. We agree with Public Knowledge that establishing clear principles that ensure the availability of key functions post-transition will likely increase public acceptance of alternative technologies, thus decreasing resistance to services based on next-generation technologies.
9. We agree with incumbent LECs that the Commission must evaluate the availability of alternative services from sources other than the carrier seeking section 214 discontinuance authority. Moreover, there seems to be a misplaced belief that the Commission will automatically categorize any change in underlying technology or facility as a discontinuance, reduction, or impairment of service for which a carrier must seek Commission authorization under section 214. It is important to note that the Commission must evaluate the adequacy of those alternative services using the same criteria as those applied to any replacement service offered by the discontinuing carrier. We also reiterate that the availability of adequate substitute services is just one of five factors the Commission looks at in evaluating section 214 discontinuance applications under existing precedent, to be balanced against the other factors in determining whether the public convenience and necessity will be adversely affected by discontinuance of the service at issue. In evaluating an application for discontinuance authority under section 214(a), the Commission considers five factors that are intended to balance the interests of the carrier seeking discontinuance authority and the affected user community: (1) The financial impact on the common carrier of continuing to provide the service; (2) the need for the service in general; (3) the need for the particular facilities in question; (4) the existence, availability, and adequacy of alternatives; and (5) increased charges for alternative services, although this factor may be outweighed by other considerations. The reasonably comparable wholesale
10. Consistent with the NPRM, we tentatively conclude that several of the criteria proposed by Public Knowledge, listed below, are the appropriate criteria for the Commission to consider in determining whether to authorize carriers to discontinue a legacy retail service in favor of a retail service based on a newer technology. These proposed criteria align the Commission's dual incentives of: (1) Meeting the statutory obligations to protect consumers, competition, and the public safety; and (2) resolving discontinuance applications as briskly as possible. As Public Knowledge et al. have noted, “[w]hen a new technology can be trusted to offer the same or better service than what customers had before (at the same or better price), customers will have no reason to object to the transition.” We find that having clear, established criteria is consistent with the Commission's obligations and also gives applicants the information they need to ultimately be more responsive to the Commission's concerns regarding adequate substitutes.
11. Specifically, we propose that a carrier seeking to discontinue an existing retail service in favor of a retail service based on a newer technology must demonstrate that any substitute service offered by the carrier or alternative services available from other providers in the affected service area meet the following criteria in order for the section 214 application to be eligible for an automatic grant pursuant to Section 63.71(d) of the Commission's rules: (1) Network capacity and reliability; (2) service quality; (3) device and service interoperability, including interoperability with vital third-party services (through existing or new devices); (4) service for individuals with disabilities, including compatibility with assistive technologies; (5) PSAP and 9-1-1 service; (6) cybersecurity; (7) service functionality; and (8) coverage. Certain commenters support the ten attributes proposed by Public Knowledge. One of those supporters suggests reworking and combining those criteria to focus on retail services, consistent with the Commission's stated emphasis in the NPRM, as follows: “(1) Reliable and accurate access to E911; (2) constant availability, including during storms and emergencies; (3) adequate call quality; (4) compatibility with health and safety services that use the network; (5) adequate data transmission capability; and (6) affordable to consumers.” We seek detailed comment on these and other possible criteria below. Although much of the discussion on the proposed criteria focuses on residential end users, we also recognize that the perspective of commercial stakeholders, including enterprise end users, is vitally important. We therefore seek comment from these stakeholders regarding how and to what extent the proposed criteria inform their decision-making process. Are their service concerns identical to those of residential consumers? If not, should different or additional service metrics be considered for their purposes?
12. As an initial matter, we seek comment on when any criteria that we adopt should apply. Should their application be dependent on the nature of the existing service and the newer service to which the carrier is transitioning? What should qualify as a “service based on a newer technology”? Rather than framing the draft rule in terms of discontinuance of an “existing” service in favor of a “service based on a newer technology,” should we instead frame it in terms of discontinuance of “legacy service,” and if so how should the term “legacy service” be defined? Should the criteria apply where the replacement service offered by the requesting carrier or the alternative services available from other providers in the relevant service area are IP-based or wireless? Should they apply where the replacement or alternative service is based on next-generation technologies? If so, how should we define next-generation technologies? For purposes of this FNPRM, we will simply refer to the relevant situations in which a carrier seeks to discontinue an existing retail service in favor of a next-generation service as “technology transitions,” but we do not intend to suggest that we have reached a conclusion on when any criteria that we have adopted will apply.
13. We further tentatively conclude that if a carrier certifies in its application that it satisfies all of these criteria, then the application will be eligible for automatic grant pursuant to section 63.71(d) of the Commission's rules as long as other already-adopted applicable requirements for automatic grant are satisfied. However, if the carrier discontinuing a service during a technology transition is unable to file such a certification, or if comments or objections call into question whether a substitute or alternative service satisfies all of the criteria we adopt, then we would not automatically grant the application. Instead, the carrier would be required to submit information demonstrating the degree to which it meets or does not meet each factor, and we would weigh this information in our evaluation of whether a replacement service offered by the applicant or an alternative service offered by another provider in the relevant service area qualifies as an adequate substitute for the existing service for which the carrier seeks discontinuance authorization. We propose that for applications not subject to automatic grant, the adequate substitute evaluation would retain its traditional role as a part of our multi-factor determination of whether to grant a discontinuance application. In other words, outside of the automatic grant context, we propose that we not alter the role that the existence, availability, and adequacy of alternatives plays in our analysis; rather, we propose to channel that analysis through the criteria that we will articulate. We seek comment on this proposed approach. We recognize that with respect to the question of whether automatic grant is available, this proposal affords the adequate substitute factor a new primacy in the section 214 analysis. However, we anticipate that this approach is necessary to ensure consumer protection as technologies transition by providing the Commission sufficient time to evaluate applications that may not provide a completely adequate substitute. Further, this approach permits industry to pursue transitions flexibly because it does not mandate that all criteria must be met and continues to evaluate the adequacy of substitutes as merely one factor in the overall discontinuance analysis.
14. To the extent commenters believe a different approach is preferable, they should describe with specificity the alternative and address how it would adequately protect consumers while providing sufficient industry flexibility. To the extent commenters argue that not all of the criteria should be considered mandatory in order for an application to qualify for automatic granting, they should identify which factors would not be mandatory. If we remove an application from automatic grant, we propose weighing compliance with the criteria as a part of our overall multi-factor analysis of whether to approve a
15. Where a carrier is seeking to establish the adequacy of alternative retail services in the context of a section 214 discontinuance application by certifying its compliance will all of the criteria such that its application may be eligible for automatic grant, we further tentatively conclude that the certification should be executed by an officer or other authorized representative of the company and be accompanied by a detailed statement explaining the basis for such certification. The certification would be subject to the requirements of section 1.16 of the Commission's rules and be subscribed to as true under penalty of perjury in substantially the form set forth in the rule. We seek comment on whether such an approach would be consistent with the objectives of the revised service discontinuance process, particularly in evaluating the adequacy of alternative services in the context of Section 214 discontinuance applications.
16. We tentatively conclude that in each case in which a carrier must demonstrate the existence of an adequate substitute service, the qualifying service can be a service the carrier offers, or can be an existing service offered by third parties. Under our proposal, references in this sub-section to “demonstrating” or otherwise showing that a criterion is met encompass demonstration via certification where the carrier is able to seek eligibility for automatic grant or, otherwise, demonstration via the submission of evidence and information. We also tentatively conclude that a showing as to a first-party or a third-party service will be treated equally,
17. We would prefer to adopt bright-line objective criteria that can be applied on a national basis instead of requiring localized testing of the service to be discontinued and/or the substitute service. We recognize that the criteria that we propose may not fully achieve this goal because of the lack of specific recommendations regarding objective metrics in the record. We further recognize that a localized testing-based approach may be incompatible with our proposal to allow parties to file a simple certification at the time of the application to allow potential automatic grant. We urge all interested parties to provide bright-line objective criteria to the maximum extent possible. For instance, what metrics or standards are incorporated into large commercial or governmental contracts regarding quality of service? However, we caution that we intend to adopt criteria and will adopt a localized testing-based regime if we deem it necessary in the absence of a workable national framework. We seek comment on the relative benefits of objective bright-line criteria and a localized testing approach in this context. If we do adopt a localized testing-based approach, how long a period of testing should we require for the discontinued and/or substitute service?
18. We also seek to further develop the record on whether the application of these criteria should be dependent on the nature of the legacy service and the newer service to which the carrier is transitioning, and specifically on what should qualify as a “newer” service. Should the criteria apply where the replacement service offered by the requesting carrier or the alternative services available from other providers in the relevant service area involve fixed, mobile wireless, or fixed wireless technologies that provide VoIP or other IP-based services? Should they apply where the replacement or alternative service is based on next-generation services?
19.
20. We seek comment on this tentative conclusion. Should network capacity and reliability be a part of our adequate substitute evaluation? For purposes of implementing the Connect America Fund Phase II model-based support to price cap carriers, the Wireline Competition Bureau adopted a 100 millisecond latency metric to judge whether a service offering meets the Commission's requirement that service enable the use of real time applications. The Wireline Competition Bureau selected the 100 millisecond standard based on the International Telecommunication Union (ITU) standards. We seek comment on whether to adopt that same metric to judge whether “noticeable latency” occurs here and seek comment on that proposal. In addition, we propose to adopt metrics for jitter, packet loss, and through-put to provide a more complete and robust performance measurement of the service being offered to evaluate
21.
22.
23. Certain commenters profess to be confused about what functionalities consumers consider to be essential components of their legacy service. However, the record is already replete with examples of such devices and services. Indeed, AT&T acknowledged in its Proposal for Wire Center Trials that a variety of such third-party devices and services are “vitally important to its customers.” And consumer response to Verizon's attempts to use its VoiceLink service as a replacement service for its damaged wireline service in the wake of Super Storm Sandy can leave no doubt regarding what consumers believe to be essential service features. Moreover, the CTC Report contains a discussion regarding the use of various technology standards to allow for ongoing interoperability. According to CTC Technology and Energy (CTC): “Despite this diversity, the majority of non-voice devices conform to a standard modem technology, such as v.32, v. 34, v.42bis, v.44, v.90, and v.92. Even where a truly proprietary device is used, the signaling and communications and protocol is similar enough to a standard modem that a test of a range of standards should be close enough to determine whether many devices will work on an IP-transitioned line.” CTC also notes that while older dial-up modems and fax machines fail to transmit properly over VoIP devices, this problem can be mitigated: “Technology complying with the ITU T.38 standard can mitigate this issue by allowing the VoIP ATA [analog telephone adapter] to decode or `read the fax or modem signal, transmit the contents to the VoIP device at the far end as IP packets, and re-encode it for the fax or modem at the receiving location.”
24. How should we measure the level of interoperability? Should we require that the service conform to standard modem technology and, if so, how should we define that phrase for
25.
26. We note that as TDM networks are discontinued in favor of IP-based networks, there is an opportunity to implement IP-based real time text to replace TTY text services, as the key functionalities of both services are similar. We seek comment on whether we should require the implementation of real time text over IP networks and whether we should set an end date for the termination of TTY text services. We also seek comment on the appropriate length of a transition period during which both TTY text services and IP-based real time text would be available. We ask commenters to describe what IP-based real time text service would look like, including applicable standards, and to explain how it will be implemented. In response to the -NPRM, some commenters assert that accessibility is currently the subject of an industry-wide proceeding and thus should not be addressed “ad hoc” in this proceeding. We tentatively conclude, however, that we should adopt a standard regarding compatibility with assistive technologies for purposes of evaluating discontinuance applications. We seek comment on this tentative conclusion. We also seek comment on the appropriate timelines for issuing notices that existing services will be discontinued, and that new services may not be compatible with certain equipment. We further seek comment on the means of issuing such notices to ensure effective communication to the full community of people with disabilities.
27. Although we acknowledge the possible impact that the transition to IP networks may have on people with disabilities, we also recognize an opportunity to implement high definition voice (HD voice) service over IP networks. HD voice would be especially beneficial for particular consumers who are hard of hearing to be able to better understand conversations over the telephone, thereby improving accessibility of the network to such consumers and potentially reducing their reliance on intermediary relay services such as captioned telephone service (CTS) and IP captioned telephone service (IP CTS) in favor of mainstream forms of communication. We therefore propose to require providers of IP networks to include HD voice as a feature for users with disabilities and seek comment on our proposal. We ask commenters to discuss timetables for the implementation of HD voice. Lastly, although speech recognition technologies that can accurately convert speech to text are still under development, we seek comment on the state of development of such technologies, which can also assist in the development of an all-inclusive network that will allow users to migrate away from the use of CTS and IP CTS in favor of mainstream forms of communication. In particular, we ask commenters to address the technical barriers to the development of accuracy for such technologies and the length of time that it is expected to take.
28.
29. Certain commenters expressed concern that questions regarding 9-1-1 service are being addressed in other proceedings and thus should not be addressed here. We note, however, that our
30.
31. Would it be sufficient for an applicant to demonstrate that the provider of the substitute service has engaged in implementation of the National Institute for Standards and Technology (NIST) Cybersecurity Framework (NSF) or an equivalent risk management construct? Should an applicant also address the provider's participation in the Communications Sector Coordinating Council or other public-private initiatives to promote more secure communications networks? Should an applicant provide more detailed information regarding the provider's cyber risk management practices in general, its implementation of relevant industry best practices, or its engagement with fellow providers to address shared risks? To what extent may the Commission reasonably expect that applicants to discontinue service are in a position to provide information about the network security risks of an unaffiliated provider of a substitute service? Should the degree of detail required from an applicant depend on whether the provider of a proposed substitute service is affiliated with the applicant? What additional information, if any, would assist the Commission in evaluating the security protections afforded by a proposed substitute service?
32.
33. How should “service functionality” be defined? We recognize that we need additional information on this issue. How can we ensure that it will be a technology neutral evaluation? Should we require that if, for instance, a voice service with caller ID is discontinued, a replacement service or alternative service offered by another provider in the relevant service area
34.
35. Public Knowledge suggests that we focus specifically on wireline coverage when evaluating the adequacy of the substitute service. We recognize that as illustrated by consumer response to Verizon's attempt to replace the wireline network destroyed by Super Storm Sandy with its wireless VoiceLink service, a significant portion of consumers view coverage equivalent to that traditionally found in wireline telephony as essential. And commenters noted the importance of the availability of wireline coverage to rural consumers, for whom there tend to be fewer available options. Should we look differently at technologies that offer the level of coverage traditionally afforded by wireline telephony from those that do not, and if so how?
36. As discussed in the
37.
38.
39.
40. In the -NPRM, the Commission sought comment on whether it should revise section 63.71 of its rules, which establishes the procedures that carriers must follow to obtain section 214(a)
41. We find we need a more complete record on this issue before determining whether to adopt any additional modifications to Section 63.71 of our rules. Accordingly, we seek further comment on whether we should update Section 63.71, including the costs and benefits of any changes. Section 63.71(b) states that a carrier shall file its 214 application “on or after the date on which notice has been given to all affected customers.” Section 63.71(d) provides that applications shall be automatically granted on the 31st day after filing an application for non-dominant carriers and the 60th day for dominant carriers, unless the Commission notifies the applicant that the grant will not be automatically effective. Should we update the earliest date by which the Commission may grant approval, either for dominant or non-dominant carriers or for both? We emphasize we wish to maintain a streamlined process for carriers that satisfy our existing criteria for such treatment and the adequate substitutes proposal discussed above if adopted. Should we require advance notice of discontinuance or are the existing procedures in section 63.71 sufficient? As noted above, parties recommend various revisions to the notice for discontinuance of TDM-based services used as wholesale inputs. While we seek comment on those proposals, we also seek comment on whether to align timing for notices of discontinuance with notices of copper retirement. In the
42. We also seek comment on whether we should revise our rules to explicitly allow email-based notice or other forms of electronic or other notice of discontinuance to customers. We recognize that email may be the preferred method of notice for both the carriers seeking discontinuance and consumers. We seek comment as to whether there are efficiencies of electronic distribution such that we should make a rule change to include it as a method of delivery. Would email or other electronic forms of notice harm or disadvantage any end users? Should alternative forms of notice be permissible only with customer consent, and if so what should be permissible methods to obtain consent? Are there factors the Commission should take into consideration for certain groups of customers, such as accessible formats? Are there any other issues we should consider to ensure all affected consumers receive adequate notice? For example, how should notice be provided when consumers lack access to broadband?
43. In the
44. In the Order above, we eliminate the objection procedures previously available to interconnecting carriers upon receipt of a copper retirement notice and instead adopt a requirement that incumbent LECs work with interconnecting entities in good faith to ensure that those entities have the information needed to allow them to accommodate the transition with no disruption of service to their end user customers. Should we provide specific objective criteria by which to evaluate this good faith requirement to ensure that all parties are aware of their respective rights and obligations? And
45. As discussed above, to support the current technology transitions, we seek to avoid delays due to diminished competition by imposing light-handed regulation through the interim reasonably comparable wholesale access condition. The Commission will have adopted and implemented the rules and policies that end the reasonably comparable wholesale access interim rule when: (1) It identifies a set of rules and/or policies that will ensure rates, terms, and conditions for special access services are just and reasonable; (2) it provides notice such rules are effective in the
46. We accordingly seek comment on how to facilitate continuation of commercial wholesale platform services, which we believe serve an important business need for enterprises that seek, among other things, “the ability to obtain service from a single supplier at their disparate retail locations nationwide.” Granite explains that it and other similarly-situated competitive carriers “serve multi-location business customers that have modest demands for voice services at each location by combining value-added services with underlying TDM-based telephone services purchased at wholesale from incumbent LECs.” Granite recently submitted a study prepared by Charles River Associates that finds, based on Granite's own estimate of the per-line added value that its service provides to customers, that loss of wholesale access to incumbents' voice services would result in customer harm of between $4.443 and 10.168 billion per year. We note that this study is additionally premised on the expectation that absent regulatory action by the Commission, wholesale arrangements between companies like Granite and incumbent providers will not occur. We seek comment on that underlying assumption and on the incentives of incumbents to enter into, or not enter into, IP-based wholesale arrangements for voice service. We recognize that incumbents are currently offering such commercial arrangements in TDM on a voluntary basis and we encourage such arrangements and hope they continue to be standard wholesale offerings, including in IP. Verizon, for example, points out that “[c]ommercial UNE-P replacement products are market-based responses to competitive pressures, and in the six wire centers that Verizon migrated to all-fiber facilities, Verizon provided Wholesale Advantage—[Verizon's] UNE-P commercial replacement product—onto the new fiber facilities with no change in rates, terms, or conditions.” We further recognize the benefits of agreements reached through market negotiations.
47. However, to the extent that the Commission finds that wholesale arrangements for voice service are unlikely to occur in the future on a marketplace basis, would it be appropriate for the Commission to require reasonably comparable wholesale access for commercial wholesale platform services for a further interim period beyond completion of the special access proceeding? If the Commission does extend this requirement, for how long should it be extended and should its substance be revised? Should the timeframe be connected to any pending Commission proceeding?
48. This proceeding shall continue to be treated as a “permit-but-disclose” proceeding in accordance with the Commission's
49. Pursuant to sections 1.415 and 1.419 of the Commission's rules, interested parties may file comments and reply comments on or before the dates indicated on the first page of this document. Comments may be filed by paper or by using the Commission's Electronic Comment Filing System (ECFS).
Electronic Filers: Comments may be filed electronically using the Internet by accessing the ECFS:
Paper Filers: Parties who choose to file by paper must file an original and one copy of each filing. Because more than one docket or rulemaking number appears in the caption of this proceeding, filers must submit two additional copies for each additional docket or rulemaking number. Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail. All filings must be addressed to the Commission's Secretary, Office of the Secretary, Federal Communications Commission.
All hand-delivered or messenger-delivered paper filings for the Commission's Secretary must be delivered to FCC Headquarters at 445 12th St. SW., Room TW-A325, Washington, DC 20554. The filing hours are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes
Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
U.S. Postal Service first-class, Express, and Priority mail must be addressed to 445 12th Street SW., Washington, DC 20554.
People with Disabilities: To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an email to
50. This document contains proposed new and modified information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document, as required by the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
51. As required by the Regulatory Flexibility Act (RFA), the Commission has prepared an Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities of the policies and rules proposed in the FNPRM contained herein. The analysis is found below. We request written public comment on the analysis. Comments must be filed in accordance with the same deadlines as comments filed in response to the FNPRM and must have a separate and distinct heading designating them as responses to the IRFA. The Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, will send a copy of this FNPRM, including the IRFA, to the Chief Counsel for Advocacy of the Small Business Administration.
52. Building on the record developed in response to the NPRM, in the FNPRM the Commission proposes specific criteria for the Commission to use in evaluating the adequacy of substitute services in connection with applications to discontinue retail services pursuant to section 214 of the Communications Act of 1934, as amended. The Commission believes all stakeholders will benefit from an additional round of comments focused on its specific proposals. Adopting specific criteria will enable the Commission to ensure that it can carry out its statutorily-mandated responsibilities in a technology-neutral manner and provide clear up-front guidance that will minimize complications when carriers seek approval for large-scale discontinuances. The Commission also seeks further comment on what constitutes a sufficient notice period for affected customers in connection with a section 214 discontinuance application and whether it should revise its rules to explicitly allow email-based notice or other forms of electronic or other notice of discontinuance to customers. And the Commission seeks comment on including notice to Tribal governments as part of the section 214 discontinuance application process. The Commission also seeks comment on defining what constitutes “good faith” in connection with the requirement adopted in the Order that incumbent LECs act in good faith to provide interconnecting entities with information needed in order to accommodate planned copper retirements. Finally, the Commission seeks comment on how to facilitate continuation of commercial wholesale platform services after technology transitions.
53. First, the FNPRM seeks additional comment on possible criteria against which to measure “what would constitute an adequate substitute for retail services that a carrier seeks to discontinue, reduce, or impair in connection with a technology transition (
54. Second, the FNPRM seeks additional comment on whether and how the Commission should adopt modifications to Section 63.71 of our rules, including the costs and benefits of any changes. In the NPRM, the Commission sought comment on whether it should revise section 63.71 of its rules, which establishes the procedures that carriers must follow to obtain section 214(a) approval for discontinuances, including notification to affected customers and the earliest dates by the Commission may grant approval of discontinuance applications. Although some entities filed comments, in the FNPRM the Commission determines that we need a more complete record on this issue. The FNPRM also seeks more general comment on whether it should revise its rules to explicitly allow email-based notice or other forms of electronic or other notice of discontinuance to customers and on whether there are factors the Commission should take into consideration for certain groups of customers, such as accessibility formats, or any other issues that the Commission should consider to ensure that all affected consumers receive adequate notice.
55. Third, the FNPRM tentatively concludes that the Commission should extend the notice requirements for discontinuances, reductions, or impairments of service to affected Tribal governments and seeks comment on including notice to Tribal governments as part of our section 214 discontinuance application process. Specifically, the FNPRM seeks comment on the tentative conclusion that the Commission should revise section 63.71(a) of its rules to include notice to Tribal governments in order to make its copper retirement and service discontinuance notice requirements consistent. The FNPRM tentatively concludes that the Commission should include any Tribal Nations in the state in which discontinuance, reduction, or
56. Fourth, the FNPRM notes that, in the attached Report and Order, the Commission eliminates the objection procedures previously available to interconnecting carriers upon receipt of a copper retirement notice and instead adopts a requirement that incumbent LECs work with interconnecting entities in good faith to ensure that those entities have the information needed to allow them to accommodate the transition with no disruption of service to their end user customers. The FNPRM seeks comment on whether the Commission should provide specific objective criteria by which to evaluate this good faith requirement to ensure that all parties are aware of their respective rights and obligations. The FNPRM also seeks comment on what recourse should be available to an interconnecting entity who believes that an incumbent LEC is not acting in good faith and whether there are limitations on how much and what types of information an incumbent LEC should be required to provide to an interconnecting entity.
57. Finally, the FNPRM notes that to support the current technology transitions, we seek to avoid delays due to diminished competition by imposing light-handed regulation through the interim reasonably comparable wholesale access condition. The FNPRM seeks comment on how to facilitate continuation of commercial wholesale platform services, which the Commission believes serve an important business need for enterprises that seek, among other things, “the ability to obtain service from a single supplier at their disparate retail locations nationwide.” The Commission seeks comment on whether to the extent that the Commission finds that wholesale arrangements for voice service are unlikely to occur in the future on a marketplace basis, it would be appropriate for the Commission to require reasonably comparable wholesale access for commercial wholesale platform services for a further interim period beyond completion of the special access proceeding and, if so, for how long.
58. The proposed action is authorized under Sections 1, 2, 4(i), 214, and 251 of the Communications Act of 1934, as amended; 47 U.S.C. 151, 152, 154(i), 214, and 251.
59. The RFA directs agencies to provide a description and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules, if adopted. The RFA generally defines the term “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” In addition, the term “small business” has the same meaning as the term “small-business concern” under the Small Business Act. A “small-business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the SBA.
60. The majority of our proposals in the FNPRM will affect obligations on incumbent LECs. Other entities, however, that choose to object to network change notification for copper retirement under our new proposed rules may be economically impacted by the proposals in this FNPRM.
61. A small business is an independent business having less than 500 employees. Nationwide, there are a total of approximately 28.2 million small businesses, according to the SBA. Affected small entities as defined by industry are as follows.
62.
63.
64.
65. We have included small incumbent LECs in this present RFA analysis. As noted above, a “small business” under the RFA is one that,
66.
67.
68.
69.
70.
71.
72.
73. The Census Bureau defines this industry as including “establishments primarily engaged in providing specialized telecommunications services, such as satellite tracking, communications telemetry, and radar station operation. This industry also includes establishments primarily engaged in providing satellite terminal stations and associated facilities connected with one or more terrestrial systems and capable of transmitting telecommunications to, and receiving telecommunications from, satellite systems. Establishments providing Internet services or Voice over Internet Protocol (VoIP) services via client-supplied telecommunications connections are also included in this industry.” The SBA has developed a small business size standard for this category; that size standard is $32.5 million or less in average annual receipts. According to Census Bureau data for 2007, there were 2,383 firms in this category that operated for the entire year. Of these, 2,346 firms had annual
74. The FNPRM proposes a number of rule changes that will affect reporting, recordkeeping, and other compliance requirements. Each of these changes is described below.
75. The FNPRM seeks comment on specific criteria for the Commission to use in evaluating the adequacy of substitute services in connection with applications to discontinue service pursuant to section 214, specifically seeking comment on possible criteria for evaluating the adequacy of replacement services. The FNPRM also seeks comment on effective ways to ensure compliance with the criteria and tentatively proposes requiring an officer or other authorized public representative to certify the accuracy of the statements in the application regarding the criteria. The FNPRM also seeks comment on whether and how the Commission should adopt modifications to section 63.71 of our rules, including notification to affected customers, and tentatively concludes that the Commission should extend the notice requirements for discontinuances, reductions, or impairments of service to affected Tribal entities. Further, the FNPRM seeks general comment on whether it should revise its rules to allow email-based notice or other forms of electronic or other notice of discontinuance to customers and on whether there are factors the Commission should take into consideration for certain groups of customers, such as accessibility formats, or any other issues that the Commission should consider to ensure that all affected consumers receive adequate notice. Additionally, the FNPRM eliminates the objection procedures previously available to interconnecting carriers upon receipt of a copper retirement notice and instead adopts a requirement that incumbent LECs work with interconnecting entities in good faith to ensure that those entities have the information needed to allow them to accommodate the transition with no disruption of service to their end user customers. The FNPRM seeks comment on what recourse should be available to an interconnecting entity who believes that an incumbent LEC is not acting in good faith and whether there are limitations on how much and what types of information an incumbent LEC should be required to provide to an interconnecting entity. Finally, the Commission seeks comment on how to facilitate continuation of commercial wholesale platform services after technology transitions.
76. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its proposed approach, which may include the following four alternatives (among others): (1) The establishment of differing compliance or reporting requirements or timetables that take into account the resources available to small entities; (2) the clarification, consolidation, or simplification of compliance or reporting requirements under the rule for small entities; (3) the use of performance, rather than design, standards; and (4) an exemption from coverage of the rule, or any part thereof, for small entities.
77. The FNPRM seeks comment on each of its proposed approaches and specifically seeks additional proposals of possible criteria for evaluating the adequacy of replacement services, input on effective ways to ensure compliance with proposed criteria, and comment on whether and how the Commission should adopt modifications to section 63.71 of our rules, including notification to affected customers. The FNPRM also seeks general comment on whether: (1) It should revise its rules to allow email-based notice or other forms of electronic or other notice of discontinuance to customers; (2) there are factors the Commission should take into consideration for certain groups of customers, such as accessibility formats; and (3) there are any other issues that the Commission should consider to ensure that all affected consumers receive adequate notice. And the FNPRM seeks comment on whether it should include Tribal governments in its notice requirements for section 214(a) discontinuance applications. The FNPRM also seeks comment on what recourse should be available to an interconnecting entity who believes that an incumbent LEC that is retiring copper is not acting in good faith to ensure that interconnecting carriers have the information they need, and whether there are limitations on how much and what types of information an incumbent LEC should be required to provide to an interconnecting entity. Finally, the Commission seeks comment on how to facilitate continuation of commercial wholesale platform services after technology transitions.
78. None.
79. Accordingly,
80.
Communications, Communications common carriers, Defense communications, Telecommunications, Telephone.
Cable television, Communications common carriers, Radio, Reporting and recordkeeping requirements, Telegraph, Telephone.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 63 as follows:
Sections 1, 4(i), 4(j), 10, 11, 201-205, 214, 218, 403 and 651 of the Communications Act of 1934, as amended, 47 U.S.C. 151, 154(i), 154(j), 160, 201-205, 214, 218, 403, and 571, unless otherwise noted.
(a) The carrier shall notify all affected customers of the planned discontinuance, reduction, or impairment of service and shall notify and submit a copy of its application to the public utility commission and to the Governor of the State in which the discontinuance, reduction, or impairment of service is proposed, to any federally recognized Tribal Nations with authority over the Tribal lands in which the discontinuance, reduction, or impairment of service is proposed, and also to the Secretary of Defense, Attn. Special Assistant for Telecommunications, Pentagon, Washington, DC 20301. Notice shall be in writing to each affected customer unless the Commission authorizes in advance, for good cause shown, another form of notice. Notice shall include the following:
(d) The application to discontinue, reduce
(1) The Commission has notified the applicant that the grant will not be automatically effective, or
(2) The applicant is subject to § 63.602 of this chapter and does not include with its application the certification specified in § 63.602(a) of this chapter. The application to discontinue, reduce or impair service, if filed by a domestic, dominant carrier, shall be automatically granted on the 60th day after its filing with the Commission without any Commission notification to the applicant unless either
(3) The Commission has notified the applicant that the grant will not be automatically effective, or
(4) The applicant is subject to § 63.602 of this chapter and does not include with its application the certification specified in § 63.602(a) of this chapter. For purposes of this section, an application will be deemed filed on the date the Commission releases public notice of the filing.
(a) In order to remain eligible for automatic grant, any domestic carrier that seeks to discontinue, reduce, or impair an existing retail service in favor of a retail service based on a newer technology shall include with its application, in addition to any other information required, a certification that there is an adequate substitute service available for the service to be discontinued, reduced, or impaired and that the substitute service provides adequate:
(1) Network capacity and reliability;
(2) Service quality;
(3) Device and service interoperability, including interoperability with vital third-party services and devices;
(4) Service for individuals with disabilities, including compatibility with assistive technologies;
(5) PSAP and 9-1-1 service;
(6) Cybersecurity;
(7) Service functionality; and
(8) Coverage.
(b) Any domestic carrier that seeks to discontinue, reduce, or impair an existing retail service in favor of a retail service based on a newer technology that does not file the certification described in paragraph (a) of this section shall include with its application, in addition to any other information required, supporting evidence regarding the degree to which there is an adequate substitute or substitutes available for the service to be discontinued, reduced, or impaired, and supporting evidence regarding the degree to which the substitute service(s) provide adequate:
(1) Network capacity and reliability;
(2) Service quality;
(3) Device and service interoperability, including interoperability with vital third-party services and devices;
(4) Service for individuals with disabilities, including compatibility with assistive technologies;
(5) PSAP and 9-1-1 service;
(6) Cybersecurity;
(7) Service functionality; and
(8) Coverage.
(c) A certification pursuant to paragraph (a) of this section must:
(1) -Set forth a detailed statement explaining the basis for such certification;
(2) Be executed by an officer or other authorized representative of the applicant; and
(3) Meet the requirements of § 1.16 of this chapter.
Commodity Credit Corporation, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, this notice announces the Commodity Credit Corporation's (CCC) intention to request a revision from the Office of Management and Budget (OMB) for a currently approved information collection process in support of the Foreign Market Development Cooperator (Cooperator) Program and the Market Access Program (MAP).
Comments on this notice must be received by November 24, 2015.
Prior to initiating program activities, each Cooperator or MAP participant must submit a detailed application to the Foreign Agricultural Service (FAS) which includes an assessment of overseas market potential; market or country strategies, constraints, goals, and benchmarks; proposed market development activities; estimated budgets; and performance measurements. Prior years' plans often dictate the content of current year plans because many activities are continuations of previous activities. Each Cooperator or MAP participant is also responsible for submitting: (1) Reimbursement claims for approved costs incurred in carrying out approved activities, (2) an end-of-year contribution report, (3) travel reports, and (4) progress reports/evaluation studies. Cooperators or MAP participants must maintain records on all information submitted to FAS. The information collected is used by FAS to manage, plan, evaluate, and account for Government resources. The reports and records are required to ensure the proper and judicious use of public funds. Because the number of Participants in MAP and FMD has decreased slightly since 2012, the Estimated Number of Respondents and Estimated Total Annual Burden on Respondents are decreasing.
Copies of this information collection can be obtained from Connie Ehrhart, the Agency Information Collection Coordinator, at (202) 690-1578.
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Federal Crop Insurance Corporation, USDA.
Renewal of approval of an information collection; comment request.
This notice announces a public comment period on the information collection requests (ICRs) associated with the Multiple Peril Crop Insurance.
Comments that we receive on this notice will be accepted until close of business November 24, 2015.
FCIC prefers that comments be submitted electronically through the Federal eRulemaking Portal. You may submit comments, identified by Docket ID No. FCIC-15-0006, by any of the following methods:
•
•
All comments received, including those received by mail, will be posted without change to
Director, Product Administration and Standards Division, Risk Management Agency, United States Department of Agriculture, Beacon Facility, Stop 0812, Room 421, P.O. Box 419205, Kansas City, MO 64141-6205, telephone (816) 926-7730.
FCIC is requesting the Office of Management and Budget (OMB) to renew the approval of this information collection for an additional 3 years.
The purpose of this notice is to solicit comments from the public concerning this information collection. These comments will help us:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information has practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other forms of information technology,
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
Forest Service, USDA.
Notice of meeting.
The Yavapai Resource Advisory Committee (RAC) will meet in Prescott, Arizona. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (Pub.L 110-343) (the Act) and operates in compliance with the Federal Advisory Committee Act. The purpose of the committee is to improve collaborative relationships and to provide advice and recommendations to the Forest Service concerning projects and funding consistent with the title II of the Act. The meeting is open to the public. The purpose of the meeting is to review and recommend projects.
The meeting will be held May 13, 2014 at 1:00 p.m.
All RAC meetings are subject to cancellation. For status of meeting prior to attendance, please contact the person listed under
The meeting will be held at the Prescott Fire Center, 2400 Melville Drive, Prescott, Arizona.
Written comments may be submitted as described under
Debbie Maneely, RAC Coordiantor, by phone at 928-443-8130 or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday. Please make requests in advance for sign language interpreting, assistive listening devices or other reasonable accommodation for access to the facility or procedings by contacting the person listed above.
Additional RAC information, including the meeting agenda and the meeting summary/minutes can be found at the following Web site:
The Piedmont Triad Partnership, grantee of FTZ 230, submitted a notification of proposed production activity to the FTZ Board on behalf of Deere-Hitachi Construction Machinery Corporation (Deere-Hitachi), located in Kernersville, North Carolina. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on September 8, 2015.
The Deere-Hitachi facility is located within Site 30 of FTZ 230. The facility is used for the production of hydraulic excavators. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Deere-Hitachi from customs duty payments on the foreign-status components used in export production. On its domestic sales, Deere-Hitachi would be able to choose the duty rate during customs entry procedures that applies to finished and unfinished hydraulic excavators (duty-free) for the foreign-status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The components and materials sourced from abroad include: Plastic hoses/o-rings/seals; decals; rubber hoses not reinforced or otherwise combined with other materials with fittings; rubber hoses reinforced or otherwise combined only with textile materials; rubber hoses reinforced or otherwise combined with other material; v-belts; rubber floor mats/o-rings/seals/fittings; steel bolts/screws/nuts/spring washers/other washers/cotters/cotter pins/pins/stoppers/springs/tracks; steel parts comprised of pipe clamps, hose clamps, clips, caps and plugs and similar fasteners; steel catches; steel locks; engines; hydraulic cylinders; hydraulic motors; parts for cylinders and motors; pumps; compressors; air conditioner parts; fuel/oil filters; receiver-dryers used in air conditioning systems; air filters; parts of filters; excavator parts comprised of covers, shoes, booms, cabs, counterweights, side frames, brackets, large pins, links, and pipes; control valves; other valves; parts of valves; bushings; pulleys; swing bearings; gaskets made of metal sheeting; horns; alarms; sensors; battery relays; electrical switches; sockets; controllers; wire harnesses; and lighters (duty rates range from duty-free to 5.7%).
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is November 4, 2015.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
Diane Finver at
On May 22, 2015, the Port of Corpus Christi Authority, grantee of FTZ 122, submitted a notification of proposed production activity to the Foreign-Trade Zones (FTZ) Board on behalf of voestalpine Texas, LLC, within Subzone 122T, in Portland, Texas.
The notification was processed in accordance with the regulations of the FTZ Board (15 CFR part 400), including notice in the
DNP Imagingcomm America Corporation (DNP), operator of Subzone 33E, submitted a notification of proposed production activity to the FTZ Board for its facility within Subzone 33E, located in Mount Pleasant, Pennsylvania. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on September 4, 2015.
DNP already has authority to produce thermal transfer ribbon (TTR) and monochrome TTR printer rolls using certain foreign-sourced components within Subzone 33E. The current request would add the production of TTR master rolls using foreign-sourced rolls of polyethylene terephthalate (PET)
Production under FTZ procedures could exempt DNP from customs duty payments on the foreign-status rolls of PET film (4.2% duty rate) used in export (an estimated 40 percent of shipments). On its domestic sales, DNP would be able to choose the duty rate during customs entry procedures that applies to TTR master rolls (duty rate 3.7%) for the foreign-status PET film. Customs duties also could possibly be deferred or reduced on foreign-status production equipment.
The request notes that DNP's proposed activity would involve PET film that is subject to antidumping/countervailing duty (AD/CVD) orders. The FTZ Board's regulations (15 CFR 400.14(e)) require that merchandise subject to AD/CVD orders be admitted to the zone in privileged foreign status (19 CFR 146.41). DNP's request indicates that any PET film subject to an AD/CVD order, proceeding, or suspension of liquidation under AD/CVD procedures would be used only in production for export (no TTR master rolls made from PET film subject to AD/CVD orders would be shipped for U.S. consumption).
Public comment is invited from interested parties. Submissions shall be addressed to the FTZ Board's Executive Secretary at the address below. The closing period for their receipt is November 4, 2015.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the FTZ Board's Web site, which is accessible via
Diane Finver at
The Materials Processing Equipment Technical Advisory Committee (MPETAC) will meet on October 27, 2015, 9:00 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration with respect to technical questions that affect the level of export controls applicable to materials processing equipment and related technology.
Open Session:
1. Opening remarks and introductions.
2. Presentation of papers and comments by the Public.
3. Discussions on results from last, and proposals from last Wassenaar meeting.
4. Report on proposed and recently issued changes to the Export Administration Regulations.
5. Selection of CY 2016 meeting dates.
6. Other business.
Closed Session:
7. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10 (a) (1) and 10 (a) (3).
The open session will be accessible via teleconference to 20 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on February 20, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 § 10(d)), that the portion of the meeting dealing with matters the premature disclosure of which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 §§ 10(a) (1) and 10(a) (3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
The Information Systems Technical Advisory Committee (ISTAC) will meet on October 28 and 29, 2015, 9:00 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on technical questions that affect the level of export controls applicable to information systems equipment and technology.
The open session will be accessible via teleconference to 20 participants on
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the Committee suggests that public presentation materials or comments be forwarded before the meeting to Ms. Springer.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on March 23, 2015, pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 (l0)(d))), that the portion of the meeting concerning trade secrets and commercial or financial information deemed privileged or confidential as described in 5 U.S.C. 552b(c)(4) and the portion of the meeting concerning matters the disclosure of which would be likely to frustrate significantly implementation of an agency action as described in 5 U.S.C. 552b(c)(9)(B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and l0(a)(3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
The Emerging Technology and Research Advisory Committee (ETRAC) will meet on October 15-16, 2015, 8:45 a.m., Room 3884, at the Herbert C. Hoover Building, 14th Street between Pennsylvania and Constitution Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on emerging technology and research activities, including those related to deemed exports.
1. Welcome and Introductions
2. Discussion and Reports—Wassenaar Arrangement 2013 Plenary Agreements Implementation: Intrusion and Surveillance items proposed technology control under ECCN 4E001.c
3. Background of the Proposed Rule
4. Review of Public Comments on the Proposed Rule
5. Presentations by industry and individuals on proposed ECCN 4E001.c entry to control “technology for the development of intrusion software”
6. Comments from the Public participating in person or by telephone
7. Presentation on CRISPR/Cas9 concept of editing genes
8. Continued discussions on ECCN 4E001.c
9. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)(1) and l0(a)(3).
The open sessions will be accessible via teleconference to 25 participants on a first come, first serve basis. To join the conference, submit inquiries to Ms. Yvette Springer at
A limited number of seats will be available for the public session. Reservations are not accepted. To the extent that time permits, members of the public may present oral statements to the Committee. The public may submit written statements at any time before or after the meeting. However, to facilitate the distribution of public presentation materials to the Committee members, the Committee suggests that presenters forward the public presentation materials prior to the meeting to Ms. Springer via email.
The Assistant Secretary for Administration, with the concurrence of the delegate of the General Counsel, formally determined on February 25, 2015, pursuant to section l0(d) of the Federal Advisory Committee Act, as amended, that the portion of the meeting dealing with matters the of which would be likely to frustrate significantly implementation of a proposed agency action as described in 5 U.S.C. 552b(c) (9) (B) shall be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 sections 10(a)1 and 10(a) (3). The remaining portions of the meeting will be open to the public.
For more information, call Yvette Springer at (202) 482-2813.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“Department”) preliminarily determines that silicomanganese from Australia is being, or is likely to be, sold in the United States at less than fair value (“LTFV”), as provided in section 733(b) of the Tariff Act of 1930, as amended (the “Act”). The period of investigation is January 1, 2014 through December 31, 2014. The estimated weighted-average dumping margins are shown in the “Preliminary Determination” section of this notice. Interested parties are invited to comment on this preliminary determination.
Magd Zalok or Robert Bolling, AD/CVD Operations, Office IV, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4162 or (202) 482-3434, respectively.
The Department published the notice of initiation of this investigation on March 17, 2015.
The scope of this investigation covers all forms, sizes and compositions of silicomanganese, except low-carbon silicomanganese, including silicomanganese briquettes, fines, and slag. Silicomanganese is properly classifiable under subheading 7202.30.0000 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Low-carbon silicomanganese is excluded from the scope of this investigation. Low-carbon silicomanganese is classifiable under HTSUS subheading 7202.30.0000. The HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope is dispositive. A full description of the scope of the investigation is contained in the Preliminary Decision Memorandum. The Preliminary Decision Memorandum is a public document and is made available to the public via Enforcement and Compliance's Antidumping and Countervailing Duty Centralized Electronic Service System (“ACCESS”). ACCESS is available to registered users at
The Department is conducting this investigation in accordance with section 731 of the Act. For a full description of the methodology underlying our conclusions,
Section 735(c)(5)(A) of the Act provides that the estimated “all others” rate shall be an amount equal to the weighted average of the estimated weighted-average dumping margins established for exporters and producers individually investigated, excluding any zero or
We based our calculation of the “All Others” rate on the margin calculated for Tasmanian Electro Metallurgical Company Pty Ltd. (“TEMCO”), the only mandatory respondent in this investigation.
The Department preliminarily determines that the following weighted-average dumping margins exist:
We will disclose the calculations performed within five days of any public announcement of this notice in accordance with 19 CFR 351.224(b). Case briefs or other written comments may be submitted to the Assistant Secretary for Enforcement and Compliance no later than seven days after the date on which the final verification report is issued in this proceeding. Rebuttal briefs, limited to issues raised in case briefs, may be submitted no later than five days after the deadline date for case briefs.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing must submit a written request to the Assistant Secretary for Enforcement and Compliance within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues parties intend to discuss. Issues raised in the hearing will be limited to those raised in the respective case and rebuttal briefs. If a request for a hearing is made, the Department intends to hold the hearing at the U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230, at a date and time to be determined.
We received a request from the mandatory respondent, TEMCO, that we postpone the final determination and extend the application of the provisional measures prescribed under section 733(d) of the Act and 19 CFR 351.210(e)(2), from a four-month period to a six-month period. Accordingly, we are postponing our final determination no later than 135 days after the date of publication of this preliminary determination, pursuant to section 735(a)(2) of the Act.
In accordance with section 733(d)(2) of the Act, we are directing U.S. Customs and Border Protection (“CBP”) to suspend liquidation of all entries of silicomanganese from Australia as described in the scope of the investigation section entered, or withdrawn from warehouse, for consumption on or after the date of publication of this notice in the
Pursuant to section 733(d)(1)(B) of the Act and 19 CFR 351.205(d), we will instruct CBP to require a cash deposit equal to the weighted-average amount by which the NV exceeds CEP as
In accordance with section 733(f) of the Act, we will notify the ITC of our preliminary affirmative determination of sales at LTFV. Because the preliminary determination in this proceeding is affirmative, section 735(b)(2) of the Act requires that the ITC make its final determination as to whether the domestic industry in the United States is materially injured, or threatened with material injury, by reason of imports of silicomanganese from Australia before the later of 120 days after the date of this preliminary determination or 45 days after our final determination. Because we are postponing the deadline for our final determination to 135 days from the date of publication of this preliminary determination, as discussed above, the ITC will make its final determination no later than 45 days after our final determination.
This determination is issued and published in accordance with sections 733(f) and 777(i)(1) of the Act and 19 CFR 351.205(c).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
On August 28, 2015, the United States Court of International Trade (“CIT”) issued its final judgment
Paul Stolz, Office III, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-4474.
Subsequent to the publication of the
On September 26, 2014, the CIT issued the Remand Order, instructing the Department to re-visit its decision to value most of Chengde's billet as alloy steel in the underlying review. Specifically with respect to Chengde's billets, the Court instructed the Department to: (1) Reevaluate the chemical composition of OCTG sold in certain contracts, (2) explain whether Chengde's mill test certificates prove the chemical properties of OCTG not specifically covered by those certificates, (3) assess whether Chengde's entry summary as provided in American Tubular Products, LLC's application to receive information under administrative protective order proves that the OCTG in one contract was comprised of carbon steel, and (4) recalculate the percentage of Chengde's steel billets that were alloy steel or carbon steel in accordance with this analysis.
On January 28, 2015, the Department issued its Remand Redetermination. Consistent with the CIT's instructions in the Remand Order, the Department recalculated the total quantity of carbon steel billets consumed by Chengde to produce subject merchandise during the period of review and explained why the surrogate value used for carbon steel billets in the
On August 28, 2015, the CIT issued its decision in
In its decision in
Because there is now a final court decision with respect to this case, the Department is amending the
Since the
This notice is issued and published in accordance with sections 516A(e), 751(a)(1), and 777(i)(1) of the Act.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The South Atlantic Fishery Management Council (Council) will hold a Visioning Workshop in Charleston, SC.
The Workshop will be held 8:30 a.m. to 5 p.m., Wednesday, October 14, 2015; and 8:30 a.m. to 5 p.m., Thursday, October 15, 2015. Public comment will be held at 4:30 p.m., Wednesday, October 14, 2015; and at 1:30 p.m., Thursday October 15, 2015.
Kim Iverson, Public Information Officer, 4055 Faber Place Drive, Suite 201, North Charleston, SC 29405; phone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email:
This workshop is being held for Council members to discuss the further development of a Vision Blueprint (long-term strategic plan) for the South Atlantic snapper grouper fishery. The outcome of the workshop will consist of a Vision Blueprint document outlining strategic goals, objectives, and strategies for managing the snapper grouper fishery going forward. The document will be provided to the Council at the December 2015 Council meeting and is scheduled for approval. Additionally, the Council will discuss an implementation and evaluation plan for periodic review of the Vision Blueprint. Topics of discussion include:
1. Final review and discussion of 2015 public input on the draft Vision Blueprint.
2. Breakout Group Discussion to prioritize short-, mid-, and long-term strategies to be considered under each of the four focus areas (Science, Management, Communication, and Governance) to include:
a. Sub-regional Management
b. Reporting/Data Collection
c. Reducing Discards
d. Access to the Fishery
e. Stakeholder Engagement
f. Habitat/Ecosystems
g. Allocation
3. Plenary session to summarize breakout group discussions, and
4. Facilitated discussion for developing an evaluation plan for periodic review of the Vision Blueprint.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SAFMC office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting and hearing.
The Western Pacific Fishery Management Council (Council) will hold a meeting of its Commonwealth of the Northern Mariana Islands (CNMI) Mariana Archipelago Fishery Ecosystem Plan (FEP) Advisory Panel (AP) and Hawaii Archipelago FEP AP to discuss and make recommendations on fishery
The CNMI Mariana Archipelago FEP AP will meet on Wednesday, October 14, 2015, between 6 p.m. and 8 p.m. and the Hawaii Archipelago FEP AP will meet on Thursday, October 15, 2015, between 9 a.m. and 11 a.m. All times listed are local island times. For specific times and agendas, see
The CNMI Mariana Archipelago FEP AP will meet at the Micronesian Environmental Services Office on Middle Road in Garapan, Saipan, CNMI. The Hawaii Archipelago FEP AP will meet at the Western Pacific Regional Fishery Management Council Office, 1164 Bishop St., Suite 1400, Honolulu, HI 96813 and by teleconference. The teleconference will be conducted by telephone and by Web. The teleconference numbers are: U.S. toll-free: 1-888-482-3560 or International Access: +1 647 723-3959, and Access Code: 5228220; The webconference can be accessed at
Kitty M. Simonds, Executive Director, Western Pacific Fishery Management Council; telephone: (808) 522-8220.
Public comment periods will be provided in the agenda. The order in which agenda items are addressed may change. The meetings will run as late as necessary to complete scheduled business.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Kitty M. Simonds, (808) 522-8220 (voice) or (808) 522-8226 (fax), at least 5 days prior to the meeting date.
16 U.S.C. 1801
Committee for the Implementation of Textile Agreements (CITA).
Publishing the New 12-Month Cap on Duty- and Quota-Free Benefits.
Don Niewiaroski, Jr., International Trade Specialist, Office of Textiles and Apparel, U.S. Department of Commerce, (202) 482-2496.
Title I, Section 112(b)(3) of the Trade and Development Act of 2000 (TDA 2000), Public Law (Pub. L.) 106-200, as amended by Division B, Title XXI, section 3108 of the Trade Act of 2002, Pub. L. 107-210; Section 7(b)(2) of the AGOA Acceleration Act of 2004, Pub. L. 108-274; Division D, Title VI, section 6002 of the Tax Relief and Health Care Act of 2006 (TRHCA 2006), Pub. L. 109-432, and section 1 of The African Growth and Opportunity Amendments (Pub. L. 112-163), August 10, 2012; Presidential Proclamation 7350 of October 2, 2000 (65 FR 59321); Presidential Proclamation 7626 of November 13, 2002 (67 FR 69459); and Title I, Section 103(b)(2) and (3) of the Trade Preferences Extension Act of 2015, Pub. L. 114-27, June 29, 2015.
Title I of TDA 2000 provides for duty- and quota-free treatment for certain textile and apparel articles imported from designated beneficiary sub-Saharan African countries. Section 112(b)(3) of TDA 2000 provides duty- and quota-free treatment for apparel articles wholly assembled in one or more beneficiary sub-Saharan African countries from fabric wholly formed in one or more beneficiary sub-Saharan African countries from yarn originating in the United States or one or more beneficiary sub-Saharan African countries. This preferential treatment is also available for apparel articles assembled in one or more lesser-developed beneficiary sub-Saharan African countries, regardless of the country of origin of the fabric used to make such articles, subject to quantitative limitation. Public Law 114-27 extended this special rule for lesser-developed countries through September 30, 2025.
The AGOA Acceleration Act of 2004 provides that the quantitative limitation for the twelve-month period beginning October 1, 2015 will be an amount not to exceed 7 percent of the aggregate square meter equivalents of all apparel articles imported into the United States in the preceding 12-month period for which data are available.
For the one-year period, beginning on October 1, 2015, and extending through September 30, 2016, the aggregate quantity of imports eligible for preferential treatment under these provisions is 1,935,096,830 square meters equivalent. Of this amount, 967,548,415 square meters equivalent is available to apparel articles imported under the special rule for lesser-developed countries. Apparel articles entered in excess of these quantities will be subject to otherwise applicable tariffs.
These quantities are calculated using the aggregate square meter equivalents of all apparel articles imported into the United States, derived from the set of Harmonized System lines listed in the Annex to the World Trade Organization Agreement on Textiles and Clothing (ATC), and the conversion factors for units of measure into square meter equivalents used by the United States in implementing the ATC.
Committee for Purchase From People Who Are Blind or Severely Disabled.
Proposed Addition to the Procurement List.
The Committee is proposing to add a service to the Procurement List that will be provided by a nonprofit agency employing persons who are blind or have other severe disabilities.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
This notice is published pursuant to 41 U.S.C. 8503(a)(2) and 41 CFR 51-2.3. Its purpose is to provide interested persons an opportunity to submit comments on the proposed actions.
If the Committee approves the proposed addition, the entities of the Federal Government identified in this notice will be required to procure the service listed below from the nonprofit agency employing persons who are blind or have other severe disabilities.
The following service is proposed for addition to the Procurement List for production by the nonprofit agency listed:
Committee for Purchase From People Who Are Blind or Severely Disabled.
Additions to and Deletion from the Procurement List.
This action adds products to the Procurement List that will be furnished by nonprofit agency employing persons who are blind or have other severe disabilities, and deletes a product from the Procurement List previously furnished by such agency.
Committee for Purchase From People Who Are Blind or Severely Disabled, 1401 S. Clark Street, Suite 715, Arlington, Virginia, 22202-4149.
Barry S. Lineback, Telephone: (703) 603-7740, Fax: (703) 603-0655, or email
On 6/19/2015 (80 FR 35320-35321), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed additions to the Procurement List.
After consideration of the material presented to it concerning capability of qualified nonprofit agency to provide the products and impact of the additions on the current or most recent contractors, the Committee has determined that the products listed below are suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in any additional reporting, recordkeeping or other compliance requirements for small entities other than the small organization that will furnish the products to the Government.
2. The action will result in authorizing small entity to furnish the products to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the products proposed for addition to the Procurement List.
Accordingly, the following products are added to the Procurement List:
On 8/21/2015 (80 FR 50825-50826), the Committee for Purchase From People Who Are Blind or Severely Disabled published notice of proposed deletions from the Procurement List.
After consideration of the relevant matter presented, the Committee has determined that the product listed below is no longer suitable for procurement by the Federal Government under 41 U.S.C. 8501-8506 and 41 CFR 51-2.4.
I certify that the following action will not have a significant impact on a substantial number of small entities. The major factors considered for this certification were:
1. The action will not result in additional reporting, recordkeeping or other compliance requirements for small entities.
2. The action may result in authorizing small entity to furnish the product to the Government.
3. There are no known regulatory alternatives which would accomplish the objectives of the Javits-Wagner-O'Day Act (41 U.S.C. 8501-8506) in connection with the product deleted from the Procurement List.
Accordingly, the following product is deleted from the Procurement List:
Bureau of Consumer Financial Protection.
Notice and request for comment.
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is requesting to renew the Office of Management and Budget (OMB) approval for renewal of an existing information collection titled, “Generic Information Collection Plan for the Development and/or Testing of Model Forms, Disclosures, Tools, and Other Similar Related Materials.”
Written comments are encouraged and must be received on or before November 24, 2015 to be assured of consideration.
You may submit comments, identified by the title of the information collection, OMB Control Number (see below), and docket number (see above), by any of the following methods:
• Electronic:
• Mail: Consumer Financial Protection Bureau (Attention: PRA Office), 1700 G Street NW., Washington, DC 20552.
• Hand Delivery/Courier: Consumer Financial Protection Bureau (Attention: PRA Office), 1275 First Street NE., Washington, DC 20002.
Documentation prepared in support of this information collection request is available at
Department of the Army, DoD.
Notice of open subcommittee meeting.
The Department of the Army is publishing this notice to announce the following Federal advisory committee meeting of the U.S. Army War College Board of Visitors, a subcommittee of the Army Education Advisory Committee. This meeting is open to the public.
The U.S. Army War College Board of Visitors Subcommittee will meet from 8:15 a.m. to 1:45 p.m. on November 6, 2015.
U.S. Army War College, 122 Forbes Avenue, Carlisle, PA, Command Conference Room, Root Hall, Carlisle Barracks, PA 17013.
Mr. Michael T. Martin, the Alternate Designated Federal Officer for the subcommittee, in writing at G3/Department of Academic Operations,
The subcommittee meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Department of the Army, DoD.
Notice of intent.
In compliance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i), the Department of the Army hereby gives notice of its intent to grant to Applied Materials; a corporation having its principle place of business at 10000 Spectrum Drive, Austin, TX 78717, exclusive license in the field of semiconductor technology applications relative to the following:
• U.S. Patent Number 8,866,367 entitled “Thermally oxidized seed layers for the production of {001} textured electrodes and PZT devices and method of making”, Inventors Fox et al, Issue date October 21, 2014.
• U.S. Patent Number 8,966,993 entitled “Three Dimensional Piezoelectric MEMS”, Inventors Pulskamp et al, Issue date March 3, 2015.
• U.S. Patent Application Number 14/0219,028 entitled “Stylo-Epitaxial Piezoelectric and Ferroelectric Devices and Method of Manufacturing”, Inventors Fox et al, Filing Date March 19, 2014.
The prospective exclusive license may be granted unless within fifteen (15) days from the date of this published notice, the U.S. Army Research Laboratory receives written objections including evidence and argument that establish that the grant of the license would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR 404.7. Competing applications completed and received by the U.S. Army Research Laboratory within fifteen (15) days from the date of this published notice will also be treated as objections to the grant of the contemplated exclusive license.
Objections submitted in response to this notice will not be made available to the public for inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Send written objections to U.S. Army Research Laboratory Technology Transfer Office, RDRL-DPP/Thomas Mulkern, Building 321 Room 110, Aberdeen Proving Ground, MD 21005-5425.
Thomas Mulkern, (410) 278-0889, email:
None.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by October 26, 2015.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
• Federal eRulemaking Portal:
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Notice.
The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.
Consideration will be given to all comments received by October 26, 2015.
Fred Licari, 571-372-0493.
Comments and recommendations on the proposed information collection should be emailed to Ms. Jasmeet Seehra, DoD Desk Officer, at
You may also submit comments and recommendations, identified by Docket ID number and title, by the following method:
•
Written requests for copies of the information collection proposal should be sent to Mr. Licari at WHS/ESD Directives Division, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350-3100.
Department of the Army, U.S. Army Corps of Engineers, DoD.
Notice of Availability.
The U.S. Army Corps of Engineers (Corps) in conjunction with
The Final IFR is available for a 30-day review period from September 25, 2015 through October 24, 2015 pursuant to the National Environmental Policy Act (NEPA) and California Environmental Quality Act (CEQA). Written comments pursuant to the NEPA will be accepted until the close of public review at close of business on October 24, 2015.
Questions or comments concerning the Final IFR may be directed to: Headquarters, U.S. Army Corps of Engineers, Attn: CECW-P (SA), 7701 Telegraph Road, Alexandria, VA 22315-3860.
Ms. Eileen Takata, U.S. Army Corps of Engineers, Los Angeles District,
The document is available for review at:
(1) Online:
(2) Arroyo Seco Regional Branch Library; 6145 N. Figueroa Street, Los Angeles, CA 90042; CD and Hard Copy.
(3) Los Angeles Central Library; 630 W 5th Street Los Angeles, CA 90071; CD and Hard Copy.
(4) Atwater Village Branch Library; 3379 Glendale Boulevard, Los Angeles, CA 90039; CD and Hard Copy.
(5) Cypress Park Branch Library; 1150 Cypress Avenue, Los Angeles CA 90065; CD.
(6) Lincoln Heights Branch Library; 2530 Workman Street, Los Angeles, CA 90031; CD.
(7) Chinatown Branch Library; 639 N. Hill Street, Los Angeles, CA 90012; CD.
(8) Little Tokyo Branch Library; 203 S. Los Angeles Street, Los Angeles CA 90012; CD.
(9) Benjamin Franklin Branch Library; 2200 E. First Street, Los Angeles, CA 90033; CD.
Office of Planning, Evaluation and Policy Development (OPEPD), Department of Education (ED) .
Notice.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 3501
Interested persons are invited to submit comments on or before November 24, 2015.
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 Brian Fu 202-260-1467 and Joanne Bogart 202-205-7855.
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 is described below. The Department of
U.S. Energy Information Administration (EIA), Department of Energy.
Notice and request for OMB review and comment.
The EIA has submitted an information collection request to the OMB for extension under the provisions of the Paperwork Reduction Act of 1995. The information collection requests a three-year extension, without change, of its Form EIA-886, Annual Survey of Alternative Fuel Vehicles, OMB Control Number 1905-0191. The proposed collection will gather information on the number and type of alternative fueled vehicles (AFVs) and other advanced technology vehicles that vehicle suppliers made available in the previous calendar year and plan to make available in the following calendar year; the number, type and geographic distribution of AFVs in use in the previous calendar year; and the amount and distribution of each type of alternative transportation fuel (ATF) consumed in the previous calendar year.
Comments regarding this proposed information collection must be received on or before October 26, 2015. 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, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202-395-4718.
Written comments should be sent to the DOE Desk Officer, Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10102, 735 17th Street NW., Washington, DC 20503.
And to Cynthia Amezcua, EI-22, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, Fax (202) 586-9753, Email
Requests for additional information or copies of the information collection instrument and instructions should be directed to Cynthia Amezcua, EI-22,
This information collection request contains: (1) OMB No. 1905-0191; (2) Information Collection Request Title: Annual Survey of Alternative Fueled Vehicles; (3) Type of Request: Extension, without change, of a currently approved collection; (4) Purpose: Form EIA-886 data are collected from suppliers and users of AFVs. EIA uses data from these groups as a basis for estimating total AFV and ATF use in the U.S. These data are needed by Federal and State agencies, fuel suppliers, transit agencies and other fleets to determine if sufficient quantities of AFVs are available for purchase and to provide Congress with a measure of the extent to which the objectives of the Energy Policy Act of 1992 are being achieved. These data serve as market analysis tools for Congress, Federal/State agencies, AFV suppliers, vehicle fleet managers, and other interested organizations and persons. These data are also needed to satisfy numerous public requests for detailed information on AFVs and ATFs (in particular, the number of AFVs distributed by State, as well as the amount and location of the ATFs being consumed).
EIA publishes summary information from the Form EIA-886 database in an annual report on EIA's Web site (
Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, (FEA Act), and codified at 15 U.S.C. 772(b), and section 503(b)(2) of the Energy Policy Act of 1992, Pub. L. 102-486 (EPACT92) codified at 42 U.S.C. 13253.
U.S. Energy Information Administration (EIA), Department of Energy.
Agency information collection activities: proposed extension with changes; notice and request for comments; correction.
EIA published a notice in the
EIA invites public comment on the proposed three-year extension of the following Oil and Gas Reserves System Survey Forms that EIA is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995: Revision of Form EIA-23L,
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, 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 information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments must be filed by November 24, 2015. If you anticipate difficulty in submitting comments within that period, contact the person listed in the below
Written comments may be sent to Mr. Steven Grape, EI-24, U.S. Department of Energy, 1000 Independence Avenue SW., Washington, DC 20585, by fax at (202) 586-4420, or by email at
Requests for additional information should be directed to Mr. Grape, as listed above. The information collection instruments and instructions are available on the EIA Web site at:
Comments and feedback are requested on the following topics directly related to the proposed changes to Form EIA-23L:
• Field versus County Level Data Detail—EIA currently collects data on a field level basis, but publishes reserves estimates on a State and State subdivision level. Reporting burden to respondents may be reduced, depending on existing record keeping practices, if operators report proved reserves and production data aggregated at a county level. EIA is able to make accurate State and State subdivision level reserves estimates if proved reserves are reported at a county level. Abandoning field-level detail will result in some loss of detail for reserve estimates; however, it will increase the utility of the data by facilitating the matching of other economic data that are only published at the county level.
• Well Counts (by County)—EIA does not currently collect the number of producing wells on Form EIA-23L. EIA proposes to collect well counts by county on Form EIA-23L to assist data quality validation of the production data reported on the form. Collecting well count data by county is consistent with commercially-available production data that is based on well-level reporting in many States and will facilitate data comparisons and data quality evaluations.
• Type Code—EIA is considering deleting the Type Code “CH” for Chalk from Schedule B. EIA has Type Codes for certain reservoir types: CV for Conventional, SH for Shale, CB for Coalbed, CH for Chalk, and LP for Other Low Permeability Reservoirs. CH is currently underutilized and EIA proposes to delete Chalk as a reservoir Type Code. The two codes SH and LP have been used interchangeably by operators for tight oil reserves estimates and may be combined for crude oil into a new reservoir Type Code title “Tight.” EIA requests comments on the proposal to delete Type Code “CH” for Chalk, and combine reservoir Type codes “SH” and “LP” into a single category “Tight” for crude oil only.
• Fuel Types—EIA tracks the proved reserves of four fuel types—two types of liquids; crude oil and lease condensate; and two types of natural gas proved reserves; nonassociated (aka gas well gas) and associated-dissolved (aka casinghead or oil well gas). EIA proposes to continue collecting proved reserves estimates by these four types, instead of combining them into Total Liquids and Total Natural Gas.
• Producing versus Nonproducing Reserves—Currently operators report both producing and nonproducing proved reserves by field on Form EIA-23L. EIA requests comments on the ability to report these data on a county level basis.
• Extensions, New Field Discoveries, and New Reservoir Discoveries in Old Fields—EIA requests comments on the utility of collecting and publishing these three components of Total Discoveries or whether it is more useful to report and publish these components under one data category such as “County level Discoveries.” EIA also requests comments on the burden of reporting these three components separately.
• Field Code Master List—EIA proposes to delete the EIA Field Code Master List that is currently used to report data at the field level. Changing the reporting on Form EIA-23L from Field to County level would eliminate the need to publish or maintain the EIA Field Code Master List.
All of the proposed changes that are described above are shaded the color yellow on the draft Form EIA-23L to illustrate and facilitate the review of the data elements that are affected by these proposed changes.
This information collection request contains:
(1)
(2)
(3)
(4)
The Government also uses the resulting information to develop national and regional estimates of proved reserves of domestic crude oil, natural gas, and natural gas liquids to facilitate national energy policy decisions. These estimates are essential to the development, implementation, and evaluation of energy policy and legislation. Data are used directly in EIA Web reports concerning U.S. crude oil, natural gas, and natural gas liquids reserves, and are incorporated into a number of other Web reports and analyses.
EIA proposes to make the following changes to Form EIA-23L,
• Change the title of Form EIA-23L to
• Change the title of Schedule A to Operated Proved Reserves, Production, and Related Data by County;
• Operators will be instructed to file their proved reserves by county rather than by field. Line Item 2.0 will be named “County Data (operated basis);”
• Line Item 2.1.4 “Field Code”, will be changed to “County Name;”
• Line Item 2.1.5 “MMS Code” will be changed to “Type Code;”
• Line Item 2.1.6. “Field Name” will be changed to “Field, Play, or Prospect Name (Optional);”
• Line Items 2.1.9 “water depth” and 2.1.10 “field discovery year” will be replaced with 2.1.9 “# of producing wells”, 2.1.10 “# of wells added [in survey year];” and
• Line Item 2.1.11, “Prospect Name (optional) will be replaced with “# of wells sold [in survey year].”
Comments and Feedback are requested on these proposed changes to Form EIA-23L.
Secondary reports that use the data include EIA's
(5)
Forms EIA-23L/23S/64A: 1,450.
(6)
Forms EIA-23L/23S/64A: 1,450.
(7)
Form EIA-23L
38 hours (420 intermediate-size operators); 110 hours (160 large operators); 15 hours (270 small operators): 37,610 hours.
Form EIA-23S
Form EIA-64A
(8)
Forms EIA-23L/23S/64A: EIA estimates that there are no capital and start-up costs associated with this data collection. The information is maintained in the normal course of business. The cost of burden hours to the respondents is estimated to be $2,965,884 (41,210 burden hours times $71.97 per hour). Therefore, other than the cost of burden hours, EIA estimates that there are no additional costs for generating, maintaining and providing the information.
Section 13(b) of the Federal Energy Administration Act of 1974, Pub. L. 93-275, codified at 15 U.S.C. 772(b).
On September 21, 2015, the Commission issued an order in Docket No. EL15-101-000, pursuant to section 206 of the Federal Power Act (FPA), 16 U.S.C. 824e (2012), instituting an investigation into the justness and reasonableness of RC Cape May Holdings, LLC's Reactive Power Schedule.
The refund effective date in Docket No. EL15-101-000, established pursuant to section 206(b) of the FPA, will be the date of publication of this notice in the
This is a supplemental notice in the above-referenced proceeding of Carousel Wind Farm, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 23, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
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The Commission strongly encourages electronic filing. Please file comments using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all interveners 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 intervener 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. The existing project consists of: (1) The Weber diversion dam with an overall length of 114 feet and crest elevation of 4,798 feet mean sea level (ms)l, consisting of a 27-foot-high, 79-foot-long concrete section, two radial gates approximately 29 feet long, and a 35-foot-long intake structure on the Weber River; (2) a 3-foot by 18-foot non-operative fish passage structure that is used to pass minimum flows through a calibrated slide gate opening; 3) an impoundment with surface area of 8.4 acres at elevation 4,798 msl and total storage of approximately 42 acre-feet; (4) a 9,107-foot-long, 5-foot to 6.3-foot diameter steel penstock partially encased in concrete beginning at the intake and terminating at the powerhouse on the Weber River; (5) a powerhouse with one 3,850 kW generating unit operating under a head of 185 feet and producing a 30-year average annual energy output of 16,932 MWh; (6) a discharging pipe returning turbine flows into the Weber River at the powerhouse; and (7) a 77-foot-long, 46-kV transmission line which connects to the Weber substation. PacifiCorp proposes to build a new fish passage structure at the edge of the existing diversion dam in an area that currently has graded, unvegetated soil.
PacifiCorp intends to utilize the Federal Energy Regulatory Commission's (Commission) alternative licensing process (ALP). Under the ALP, PacifiCorp will prepare an Applicant Prepared Environmental Assessment (APEA) and license application for the Weber Hydroelectric Project.
PacifiCorp expects to file with the Commission, the APEA and the license application for the Weber Hydroelectric Project by February 21, 2018. Although PacifCorp's intent is to prepare an EA, there is the possibility that an Environmental Impact Statement (EIS) will be required. Nevertheless, this meeting will satisfy the NEPA scoping requirements, irrespective of whether an EA or EIS is issued by the Commission.
The purpose of this notice is to inform you of the opportunity to participate in the upcoming scoping meetings identified below, and to solicit your scoping comments.
PacifiCorp and the Commission staff will hold two scoping meetings, one in the daytime and one in the evening, to help us identify the scope of issues to be addressed in the APEA.
The daytime scoping meeting will focus on resource agency concerns, while the evening scoping meeting is
To help focus discussions, Scoping Document 1 was mailed in September 2015, outlining the subject areas to be addressed in the APEA to the parties on the mailing list. Copies of the SD1 also will be available at the scoping meetings. SD1 is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
Based on all written comments received, a Scoping Document 2 (SD2) may be issued. SD2 will include a revised list of issues, based on the scoping sessions.
PacifiCorp and the Commission staff will conduct a project Environmental Site Review beginning at 9:00 a.m. (MDT) on Wednesday, October 7, 2015. All interested individuals, organizations, and agencies are invited to attend; however, anyone planning to attend should notify Miriam Hugentobler at
At the scoping meetings, the staff will: (1) Summarize the environmental issues tentatively identified for analysis in the APEA; (2) solicit from the meeting participants all available information, especially quantifiable data, on the resources at issue; (3) encourage statements from experts and the public on issues that should be analyzed in the APEA, including viewpoints in opposition to, or in support of, the staff's preliminary views; (4) determine the resource issues to be addressed in the APEA; and (5) identify those issues that require a detailed analysis, as well as those issues that do not require a detailed analysis.
The meetings will be recorded by a stenographer and will become part of the formal record of the Commission proceeding on the project.
Individuals, organizations, and agencies with environmental expertise and concerns are encouraged to attend the meetings and to assist PacifiCorp in defining and clarifying the issues to be addressed in the APEA.
This is a supplemental notice in the above-referenced proceeding of Green Mountain Storage, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure
(18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 23, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that during the month of August 2015, the status of the above-captioned entities as Exempt Wholesale Generators became effective by operation of the Commission's regulations. 18 CFR 366.7(a).
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On August 16, 2013, Alabama Power Company, licensee for the Holt Hydroelectric Project, filed an Application for a New License pursuant to the Federal Power Act (FPA) and the Commission's regulations thereunder. The Holt Hydroelectric Project is located on the Black Warrior River, in Tuscaloosa County, Alabama.
The license for Project No. 2203 was issued for a period ending August 31, 2015. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR.16.21(b), to continue project operations until the Commission issues someone else a license for the project or otherwise orders disposition of the project.
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 2203 is issued to the licensee for a period effective September 1, 2015 through August 31, 2016 or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first.
If issuance of a new license (or other disposition) does not take place on or before August 31, 2016, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise. If the project is not subject to section 15 of the FPA, notice is hereby given that the licensee, Alabama Power Company, is authorized to continue operation of the Holt Hydroelectric Project, until such time as the Commission acts on its application for a subsequent license.
Take notice that the following application has been filed with the Commission and is available for public inspection:
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j. Deadline for filing comments, protests, and motions to intervene is: 30 days from the issuance date of this notice by the Commission.
The Commission strongly encourages electronic filing. Please file comments, protests, and motions to intervene using the Commission's eFiling system at
k.
When a Declaration of Intention is filed with the Federal Energy Regulatory Commission, the Federal Power Act requires the Commission to investigate and determine if the project would affect the interests of interstate or foreign commerce. The Commission also determines whether or not the project: (1) Would be located on a navigable waterway; (2) would occupy public lands or reservations of the United States; (3) would utilize surplus water or water power from a government dam; or (4) would be located on a non-navigable stream over which Congress has Commerce Clause jurisdiction and would be constructed or enlarged after 1935.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
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p.
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
On August 26, 2015, the City of Cheyenne, Wyoming, by and through its Board of Public Utilities, filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Sherard Hydroelectric Generation Facility would have an installed capacity of 950 kilowatts (kW), and would be located along an existing 48-inch-diameter raw water pipeline within the city's water treatment plant. The project would be located near the City of Cheyenne, Wyoming.
The proposed project would have a total installed capacity of 950 kW.
A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.
Deadline for filing motions to intervene is 30 days from the issuance date of this notice.
Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.
The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at
1. By letter filed August 19, 2015, Neva Van Hook, d/b/a Kingdom Energy Products (KEP) informed the Commission that the exemption from licensing for the Sygitowicz Creek Power Project, FERC No. 5069, originally issued July 14, 1982,
2. Kingdom Energy Products is now the exemptee of the Sygitowicz Creek Power Project, FERC No. 5069. All correspondence should be forwarded to: Mr. Alan Van Hook, Kingdom Energy Products, Box 557, Klawock, AK 99925.
This constitutes notice, in accordance with 18 CFR 385.2201(b), of the receipt of prohibited and exempt off-the-record communications. Order No. 607 (64 FR 51222, September 22, 1999) requires Commission decisional employees, who make or receive a prohibited or exempt off-the-record communication relevant to the merits of a contested proceeding, to deliver to the Secretary of the Commission, a copy of the communication, if written, or a summary of the substance of any oral communication.
Prohibited communications are included in a public, non-decisional file
Exempt off-the-record communications are included in the decisional record of the proceeding, unless the communication was with a cooperating agency as described by 40 CFR 1501.6, made under 18 CFR 385.2201(e)(1)(v).
The following is a list of off-the-record communications recently received by the Secretary of the Commission. The communications listed are grouped by docket numbers in ascending order. These filings are available for electronic review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Take notice that on September 21, 2015, pursuant to Rule 207(a)(2) of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.207(a)(2) (2014), ETP Crude LLC filed a petition for a declaratory order seeking approval of the overall tariff and rate structure, proration procedure and the other matters set forth in Article III for a new crude oil pipeline that will have the capacity to accept approximately 120,000 barrels per day of crude oil from receipt points located in Reeves County, Texas and Lea County, New Mexico for transportation to delivery points in Loving County, Texas and Lea County, New Mexico, all as more fully explained in the petition.
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests will be considered by the Commission in determining the appropriate action to be taken, but will not serve to make protestants parties to the proceeding. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. Anyone filing a motion to intervene or protest must serve a copy of that document on the Petitioner.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The staff of the Federal Energy Regulatory Commission (Commission) will hold an additional public scoping meeting for the Northeast Energy Direct
The Commission's staff will begin the sign-up of speakers one hour before the meeting begins. The scoping meeting will begin with a brief description of our environmental review process by Commission staff, after which speakers will be called. The meeting will end once all speakers have provided their comments or 11:00 p.m., whichever comes first. A time limit may be implemented (typically no less than 3 minutes) for each commenter, to ensure all those wishing to comment have the opportunity to do so. Speakers should structure their oral comments accordingly. Time limits will be strictly enforced to ensure that as many individuals as possible are given an opportunity to comment. It is important to note that written comments provided to staff, or otherwise filed with FERC, hold the same weight as oral comments.
This is a supplemental notice in the above-referenced proceeding of Meyersdale Storage, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 23, 2015.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Amended Notices
Environmental Protection Agency (EPA).
Notice.
An Environmental Modeling Public Meeting (EMPM) will be held on October 26, 2015. This Notice announces the location and time for the meeting and provides a tentative list of topics to be covered in the meeting. The EMPM provides a public forum for EPA and its stakeholders to discuss current issues related to modeling pesticide fate, transport, and exposure for pesticide risk assessments in a regulatory context.
The meeting will be held on October 26, 2015 from 9:00 a.m. to 4:00 p.m.
Requests to participate in the meeting must be received on or before October 15, 2015.
To request accommodation of a disability, please contact the person listed under
The meeting will be held at the Environmental Protection Agency, Office of Pesticide Programs (OPP), One Potomac Yard (South Building), First Floor Conference Center (S-1204/6), 2777 S. Crystal Drive, Arlington, VA 22202.
Meridith Fry or R. David Jones, Environmental Fate and Effects Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone numbers: 703-347-0128 and 703-305-6725; fax number: 703-347-8011; email address:
You may be potentially affected by this action if you are required to conduct testing of chemical substances under the Toxic Substances Control Act (TSCA), the Federal Food, Drug, and Cosmetic Act (FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2009-0879, is available at
On a biannual interval, an Environmental Modeling Public Meeting (EMPM) is held for presentation and discussion of current issues related to modeling pesticide fate, transport, and exposure for risk assessment in a regulatory context. Meeting dates and abstract requests are announced through the “empmlist” forum on the LYRIS list server at
You may submit a request to participate in this meeting to the person listed under
7 U.S.C. 136
Environmental Protection Agency (EPA).
Notice.
This document describes EPA's approach for providing recommendations to federal agencies on specifications, environmental performance standards, and ecolabels for purchasing environmentally preferable products and services. The federal government is one of the world's largest purchasers. This action will help federal agencies purchase environmentally preferable products and services in accordance with Executive Order 13693 and reduce public health and environmental impacts associated with the federal government's extensive supply chain.
You may be potentially affected by this action if you are a federal purchaser or a vendor interested in selling to the federal government. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Food providers (NAICS code 722310),
Renovators (NAICS code 33333),
Commercial and Institutional Building Construction (NAICS code 236220),
Drywall and Insulation Contractors (NAICS code 238310),
Flooring Contractors (NAICS code 238330),
Janitorial Services (NAICS code 541620),
Electronic Computer Manufacturing (NAICS code 334111),
Computer Systems Design Services (NAICS code 541512),
Consumer Electronics Repair and Maintenance (NAICS code 811211),
Office Supplies and Stationary Stores (NAICS code 453210),
Packing and Crating (NAICS code 488991),
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPPT-20[XX]-[insert Docket ID no.], is available at
On March 19, 2015, the President issued Executive Order 13693, entitled “Planning for Federal Sustainability in the Next Decade” (80 FR 15871) (Ref. 1). Executive Order 13693 maintains federal leadership in sustainability and greenhouse gas emission reductions. Section 3(i) directs federal agencies to promote sustainable acquisition and procurement by ensuring that certain environmental performance and sustainability factors are included to the maximum extent practicable in the planning, award, and execution phases of agency acquisitions. Pursuant to Section 3(i)(iii)(A) of the Executive Order, one of the factors directs agencies to purchase environmentally preferable products or services that meet EPA recommendations for specifications, standards, and ecolabels for use in federal procurement. On June 10, 2015, the Office of Federal Sustainability in the White House Council on Environmental Quality (CEQ) issued Implementing Instructions for Executive Order 13693 (Ref. 2). The Implementing Instructions for Executive Order 13693 call on EPA, in consultation with the Office of Management and Budget (OMB) and CEQ, to provide guidance on recommendations for specifications, standards, and ecolabels for use in federal procurement within 90 days of the issuance of the Implementing Instructions.
In addition, the Pollution Prevention Act (PPA) (42 U.S.C.A. 13103(b)(11)) requires EPA to “Identify opportunities to use federal procurement to encourage source reduction” and section 12(d) of the National Technology Transfer and Advancement Act (NTTAA) (15 U.S.C. 272) requires federal agencies to “use technical standards that are developed or adopted by voluntary consensus standards bodies, using such technical standards as a means to carry out policy objectives or activities.”
This document describes EPA's approach for providing recommendations to federal purchasers on specifications, environmental performance standards, and ecolabels for environmentally preferable products and services. The federal government is one of the world's largest purchasers. This action will help federal agencies purchase environmentally preferable products and services and reduce public health and environmental impacts
Executive Order 13693 directs federal agencies to promote sustainable acquisition and procurement by ensuring that, to the maximum extent practicable, agencies purchase environmentally sustainable products and services by meeting statutory requirements that require a procurement preference for:
1. Recycled content products designated by the EPA;
2. Energy and water efficient products and services, such as ENERGY STAR® certified and Federal Energy Management Program (FEMP) designated products, identified by EPA and the Department of Energy (DOE); and
3. BioPreferred® and biobased products designated by the U.S. Department of Agriculture (USDA).
The Executive Order further instructs agencies to purchase sustainable products and services identified by EPA programs including:
1. Significant New Alternative Policy (SNAP) chemicals or other alternatives to ozone-depleting substances and high global warming potential hydrofluorocarbons, where feasible, as identified by SNAP;
2. WaterSense certified products and services (water efficient products);
3. Safer Choice certified products (chemically intensive products that contain safer ingredients); and
4. SmartWay Transport partners and SmartWay products (fuel efficient products and services).
Federal purchasers can also purchase environmentally preferable products or services that:
1. Meet or exceed specifications, standards, or labels recommended by EPA; or
2. Meet environmental performance criteria developed or adopted by voluntary consensus standards bodies consistent with the NTTAA section 12(d) and OMB Circular A-119.
In 2013, EPA sought comment on
On March 19, 2015, EPA announced the availability of revised Draft EPA Guidelines and the launch of a pilot to test the Draft EPA Guidelines in three building product categories: Furniture; flooring; and paints, coatings and paint removers (Ref. 4). It is expected that the pilot will inform refinements to the Draft EPA Guidelines, and help develop a process by which these Guidelines can be finalized and used to assess standards and ecolabels for use in federal procurement in a wide array of product and service categories.
The Implementing Instructions for the Executive Order direct EPA to prioritize application of the finalized Guidelines to product and service categories which “represent the largest share of procurement spending across Agencies and potential environmental impact” (Ref. 2, page 56).
Until the Draft EPA Guidelines are finalized and applied to key product and service categories, EPA is providing interim recommendations. Federal purchasers should utilize EPA's Interim Recommendations to select environmentally preferable products and services. EPA's Interim Recommendations are based on specifications, environmental performance standards, and ecolabels evaluated and currently utilized by federal agencies to assist in their procurement of environmentally preferable products and services. EPA will be initially using specifications, standards and labels information developed by other federal agencies to identify products that have verified sustainability attributes, are readily available in the market, and meet cost and performance needs. EPA's recommendations and further information about the evaluation processes used by these federal agencies will be available at
The Implementing Instructions state that “where there is no specification, standard, or label recommended by EPA, an agency may elect to use other open and voluntary standards . . .” to identify and procure environmentally preferable products and/or services, provided that they have conducted an assessment to ensure that the standard or ecolabel meets the requirements stipulated in the NTTAA, OMB Circular A-119 (Ref. 6), and Section II of the EPA Draft Guidelines or any subsequent revisions to those Guidelines (Ref. 2, page 56). The NTTAA requires that all agencies use standards developed by voluntary consensus standards bodies instead of government-unique standards unless inconsistent with applicable law or otherwise impractical. OMB Circular A-119 provides guidance on federal use of voluntary consensus standards and on conformity assessment. Because the NTTAA and OMB Circular A-119 do not address environmental performance, the Implementing Instructions point procurement officials to Section II of the EPA Draft Guidelines on Environmental Effectiveness and any subsequent revisions to those Guidelines (Ref. 2, pages 56-57). The Implementing Instructions direct agencies to consult with and share these assessments with EPA, and direct EPA to make these assessments available on its Web site.
Section 3(l)(i) of Executive Order 13693 includes requirements regarding procurement of environmentally sustainable electronic products. To meet the requirements of sections 3(i)(iii) and 3(l)(i) of the Executive Order, the Implementing Instructions state that agencies must acquire products that meet or exceed the specifications, standards, or labels recommended by EPA as posted on its Web site. As indicated in the Implementing Instructions, federal purchasers may continue to use the Electronic Product Environmental Assessment Tool (EPEAT)® product registry, or other methods to identify products that have been third-party verified as having met environmental performance criteria developed or adopted by voluntary consensus standards bodies consistent with section 12(d) of the NTTAA and OMB Circular A-119. However, the Implementing Instructions note that at this time CEQ is not aware of any product registries other than EPEAT for environmentally sustainable electronic products. It is possible that in the future other options may be developed that align with EPA Guidelines and support the electronic stewardship mandates of section 3(l) of Executive Order 13693. Any future tools will have to meet or exceed current levels of sustainable and environmental performance.
Once the
The following is a listing of the documents that are referenced in this document. The docket includes these documents and other information considered by EPA, even if the referenced document is not physically located in the docket. For assistance in locating these other documents, please consult the technical person listed under
42 U.S.C.A. 13103(b)(11), 15 U.S.C. 272 note, and Executive Order 13693 of March 19, 2015.
Environmental Protection Agency (EPA).
Notice.
EPA is announcing its receipt of test data submitted pursuant to an enforceable consent agreement (ECA)/Order issued by EPA under the Toxic Substances Control Act (TSCA). As required by TSCA, this document identifies each chemical substance and/or mixture for which test data have been received; the uses or intended uses of such chemical substance and/or mixture; and describes the nature of the test data received. Each chemical substance and/or mixture related to this announcement is identified in Unit I. under
Information about the following chemical substances and/or mixtures is provided in Unit IV.:
Section 4(d) of TSCA (15 U.S.C. 2603(d)) requires EPA to publish a notice in the
A docket, identified by the docket identification (ID) number EPA-HQ-OPPT-2003-0010, has been established for this
The docket for this
This unit contains the information required by TSCA section 4(d) for the test data received by EPA.
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15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice.
This notice announces the availability of and opens a public comment period on EPA's draft human health and ecological risk assessments for the registration review of a group of pesticides known collectively as sulfonylureas (SUs) that are identified individually in this document in Table 1 of Unit III, as well as additional chemicals identified in Table 2 of Unit III. This notice also announces both the opening of the registration review docket and the availability of the registration review human health and ecological risk assessments for antimycin A and imazosulfuron. Registration review is EPA's periodic review of pesticide registrations to ensure that each pesticide continues to satisfy the statutory standard for registration that is the pesticide can perform its intended function without unreasonable adverse effects on human health or the environment. As part of the registration review process, the Agency has completed a comprehensive preliminary human health and ecological risk assessment for the pesticide uses of the identified pesticides. After reviewing comments received during the public comment period, EPA may issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments and may request public input on risk mitigation before completing a proposed registration review decision for the identified pesticides. Through this program, EPA is ensuring that the registration of each pesticide is based on current scientific and other knowledge, including its effects on human health and the environment.
Comments must be received on or before November 24, 2015.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0386, by one of the following methods:
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Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker, and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the Chemical Review Manager listed in Table 1 and Table 2 of Unit III.
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EPA is conducting the registration review of the pesticides identified in this document pursuant to section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 136
As directed by FIFRA section 3(g), EPA is reviewing the registrations for the pesticides listed in Tables 1 and 2 to ensure that each pesticide on the list
A single, streamlined ecological risk assessment document covering the 22 sulfonylurea chemicals listed in Table 1, as well as 22 chemical-specific human health risk assessments separately addressing the same 22 active ingredients are being made available for public review and comment. The sulfonylureas (SUs) are an established and widely used class of agricultural pesticides in the United States. They are used to control broadleaf and grassy weeds and are registered for many agricultural and non-agricultural uses. The ecological risk assessment examines risks from the SUs simultaneously but not cumulatively. The streamlined assessment for SUs will focus on the risks to plants. This single document approach is intended to increase efficiency and consistency in assessing potential risks from this class of compounds. Separate human health risk assessment documents have been generated for each of the SUs because of differences in toxicity endpoints and points of departure.
Pursuant to 40 CFR 155.53(c), EPA is providing an opportunity, through this notice of availability, for interested parties to provide comments and input concerning the Agency's draft human health and ecological risk assessments for the pesticides identified in this document. Such comments and input could address, among other things, the Agency's risk assessment methodologies and assumptions, as applied to this draft risk assessment. The Agency will consider all comments received during the public comment period and make changes, as appropriate, to the draft human health and ecological risk assessment. EPA will then issue a revised risk assessment, explain any changes to the draft risk assessment, and respond to comments. In the
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• To ensure that EPA will consider data or information submitted, interested persons must submit the data or information during the comment period. The Agency may, at its discretion, consider data or information submitted at a later date.
• The data or information submitted must be presented in a legible and useable form. For example, an English translation must accompany any material that is not in English and a written transcript must accompany any information submitted as an audiographic or videographic record. Written material may be submitted in paper or electronic form.
• Submitters must clearly identify the source of any submitted data or information.
• Submitters may request the Agency to reconsider data or information that the Agency rejected in a previous review. However, submitters must explain why they believe the Agency should reconsider the data or information in the pesticide's registration review.
As provided in 40 CFR 155.58, the registration review docket for each pesticide case will remain publicly accessible through the duration of the registration review process; that is, until all actions required in the final decision on the registration review case have been completed.
7 U.S.C. 136
Farm Credit System Insurance Corporation Board.
Regular meeting notice.
Notice is hereby given of the regular meeting of the Farm Credit System Insurance Corporation Board (Board).
The meeting of the Board will be held at the offices of the Farm Credit Administration in McLean, Virginia, on October 1, 2015, from 9:30 a.m. until such time as the Board concludes its business.
Farm Credit System Insurance Corporation, 1501 Farm Credit Drive, McLean, Virginia 22102. Submit attendance requests via email to
Dale L. Aultman, Secretary to the Farm Credit System Insurance Corporation Board, (703) 883-4009, TTY (703) 883-4056.
Parts of this meeting of the Board will be open to the public (limited space available), and parts will be closed to the public. Please send an email to
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 November 24, 2015. If you anticipate that you will be
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
In November 2012, FCC modified this collection to include the voluntary requirements of the
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 October 23, 2015.
A. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
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The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than October 13, 2015.
A. Federal Reserve Bank of Cleveland (Nadine Wallman, Vice President) 1455 East Sixth Street, Cleveland, Ohio 44101-2566:
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B. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198-0001:
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Federal Trade Commission (“FTC” or “Commission”).
Notice.
The FTC intends to ask the Office of Management and Budget (“OMB”) to extend for an additional three years the current Paperwork Reduction Act (“PRA”) clearance for information collection requirements contained in the Children's Online Privacy Protection Act Rule (“COPPA Rule” or “Rule”), which will expire on February 29, 2016.
Comments must be filed by November 24, 2015.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Requests for additional information should be addressed to Miry Kim, Attorney, (202) 326-3622, Division of Privacy and Identity Protection, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., Washington, DC 20580.
The COPPA Rule, 16 CFR part 312, requires commercial Web sites to provide notice and obtain parents' consent before collecting, using, and/or disclosing personal information from children under age 13, with limited exceptions. The COPPA Rule contains certain statutorily-required notice requirements that apply to operators of any Web site or online service directed to children, and operators of any Web site or online service with actual knowledge of collecting personal information from children. Covered operators must: provide online notice and direct notice to parents of how they collect, use, and disclose children's personal information; obtain the prior consent of the child's parent in order to engage in such collection, use, and disclosure, with limited exceptions; provide reasonable means for the parent to obtain access to the information and to direct its deletion; and, establish procedures that protect the confidentiality, security, and integrity of personal information collected from children.
Based on public comments on the Commission's 2013 final amendments to the COPPA Rule,
Operators can comply with the COPPA Rule by meeting the terms of industry self-regulatory guidelines that the Commission approves after notice and comment.
Staff believes that most of the records submitted with a safe harbor request would be those that these entities have kept in the ordinary course of business, and that any incremental effort associated with maintaining the results of independent assessments or other records under section 312.11(d)(3) also would be in the normal course of business. Under 5 CFR 1320.3(b)(2), OMB excludes from the definition of PRA burden the time and financial resources needed to comply with agency-imposed recordkeeping, disclosure, or reporting requirements that customarily would be undertaken independently in the normal course of business.
The COPPA Rule requires safe harbor programs to audit their members at least annually and to submit annual reports to the Commission on the aggregate results of these member audits. The burden for conducting member audits and preparing these reports likely will vary for each safe harbor program depending on the number of members. Commission staff estimates that conducting audits and preparing reports will require approximately 100 hours per program per year. Aggregated for one new safe harbor (100 hours) and seven existing (700 hours) safe harbor programs, this amounts to an estimated cumulative reporting burden of 800 hours per year.
FTC staff believes that most of the records listed in the COPPA Rule's safe harbor recordkeeping provisions consist of documentation that such parties have kept in the ordinary course of business irrespective of the COPPA Rule. As noted above, OMB excludes from the definition of PRA burden, among other things, recordkeeping requirements that customarily would be undertaken independently in the normal course of business. In staff's view, any incremental burden, such as that for maintaining the results of independent assessments under section 312.11(d), would be marginal.
Based on its experience with previously approved safe harbor programs, FTC staff anticipates that in-house counsel (primarily senior) will perform the legal tasks associated with safe harbor applications. Conversely, based on the 2013 rulemaking record, staff assumes that outside counsel will perform legal services tied to Rule compliance by new entrant web operators.
For in-house legal costing, FTC staff applies to its analysis below an approximate mid-way between the mean hourly wage for lawyers ($64.17),
Regarding outside counsel costs, the
Labor costing for other assumed relevant categories (technical assistance, compliance officers) is detailed within the discussion below.
Consistent with its past estimates, FTC staff assumes that the time spent on compliance for new operators and existing operators covered by the COPPA Rule would be apportioned five to one between legal (lawyers or similar professionals) and technical (
Previously, industry sources have advised that all of the labor to comply with these requirements would be attributable to the efforts of lawyers. Accordingly, applying the estimated time stated above for these tasks (100 hours, annualized and rounded up) to the above-noted assumed hourly wage for in-house counsel ($185) yields $18,500 in labor cost per year.
Commission staff assumes that annual reports will be prepared by compliance officers, at a labor rate of $33.
For the reasons stated in 1.(d) above, associated labor costs, for PRA purposes, would be nil or marginal.
Because Web sites will already be equipped with the computer equipment and software necessary to comply with the Rule's notice requirements, the predominant costs incurred by the Web sites are the aforementioned estimated labor costs. Similarly, industry members should already have in place the means to retain and store the records that must be kept under the Rule's safe harbor recordkeeping provisions, because they are likely to have been keeping these records independent of the Rule. Capital and start-up costs associated with the Rule are minimal.
Under the PRA, 44 U.S.C. 3501-3521, federal agencies must obtain approval from OMB for each collection of information they conduct or sponsor. “Collection of information” means agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. 44 U.S.C. 3502(3), 5 CFR 1320.3(c). As required by section 3506(c)(2)(A) of the PRA, the FTC is providing this opportunity for public comment before requesting that OMB extend the existing paperwork clearance for the COPPA Rule. (OMB Control Number 3084-0117). Comments must be received on or before the deadline specified above in the
The FTC invites comments on: (1) Whether participation in the study is necessary, including whether the information will be practically useful; (2) the accuracy of our burden estimates, including whether the methodology and assumptions used are valid; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before November 24, 2015. Write “COPPA Rule: Paperwork Comment, FTC File No. 155408” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment doesn't include any sensitive health information, like medical records or other individually identifiable health information. In addition, don't include any “[t]rade secret or any commercial or financial information . . . which is privileged or confidential” as provided in section 6(f) of the FTC Act 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16CFR 4.10(a)(2). In particular, don't include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c)).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “COPPA Rule: Paperwork Comment, FTC File No. 155408” on your comment and on the envelope, and mail it to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex J), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before November 24, 2015. For information on the Commission's privacy policy, including routine uses permitted by the Privacy Act, see
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice.
The Centers for Disease Control and Prevention (CDC) within the Department of Health and Human Services (HHS) invites nominations of individuals qualified to serve as members of the Community Preventive Services Task Force (CPSTF).
Nomination packages must be received by November 9, 2015. Complete nomination packages must be submitted by the deadline in order to be considered.
Nomination packages should be submitted electronically to
Donyelle Russ, Center for Surveillance, Epidemiology, and Laboratory Services, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS E-69, Atlanta, Georgia, 30329, Phone: (404) 498-3971; email:
Nomination packages must be submitted electronically to the address above, and should include:
(1) The nominee's current curriculum vitae;
(2) A brief biographic sketch of the nominee;
(3) The nominee's contact information, including mailing address, email address, and telephone number; and
(4) A brief explanation of how the nominee meets the qualification requirements and how he/she would contribute to the CPSTF. The information provided should also attest to the nominee's willingness to serve as a member of the CPSTF.
HHS/CDC will later ask persons under serious consideration for CPSTF membership to provide detailed information that will permit evaluation of possible significant conflicts of interest.
To obtain diverse perspectives, HHS/CDC encourages nominations of women and members of minority populations. Interested individuals can self-nominate. Organizations and individuals may nominate one or more persons qualified for membership on the CPSTF. Federal employees are not eligible to be CPSTF members. Individuals nominated prior to this round, who continue to have interest in serving on the CPSTF, should be re-nominated.
To qualify for the CPSTF and support its mission, a nominee must, at a minimum, demonstrate knowledge, experience, and national leadership in the following areas:
• The critical evaluation of research or policy, and/or in the methods of evidence review; and
• Research, evaluation, or implementation of community and/or
Strongest consideration will be given to individuals with expertise and experience:
• That is applied, with practical applications for public health action;
• That addresses broad public health considerations, or is beyond one or two highly defined areas;
• In state and/or local health departments; and
• With policy.
In the current round of nominations, the strongest consideration will also be given to people with expertise and experience in systematic review methods, minority health, and aging. The CPSTF will also benefit from members with expertise and experience in the following areas: Youth populations; environmental health; injury (in particular substance abuse and violence prevention); media, communications, and marketing; public health nursing; and economic analysis.
Candidates with experience and skills in any of these areas should highlight them in their nomination materials.
All nominated individuals will be considered for CPSTF membership.
Applicants must have no substantial conflicts of interest, whether financial, professional, or intellectual, that would impair the scientific integrity of the work of the CPSTF and must be willing to complete regular conflict of interest disclosures.
Applicants must have the ability to work collaboratively with a team of diverse professionals who support the mission of the CPSTF. Applicants must have adequate time to contribute substantively to the work products of the CPSTF.
Appointments to the CPSTF will be made on the basis of qualifications as outlined above (see Qualification Requirements) and the current expertise needs of the CPSTF.
The CPSTF was established in 1996 by the Department of Health and Human Services (HHS) to identify population health interventions that are scientifically proven to save lives, increase lifespans, and improve quality of life. The CPSTF produces recommendations (and identifies evidence gaps) to help inform the decision making of federal, state, and local health departments, other government agencies, communities, healthcare providers and organizations, employers, schools and research organizations.
The CPSTF, is an independent, nonpartisan, nonfederal, unpaid panel of public health and prevention experts that is statutorily mandated to provide evidence-based findings and recommendations about community preventive services, programs, and policies to improve health (Public Health Service Act § 399U(a)). Its members represent a broad range of research, practice, and policy expertise in community preventive services, public health, health promotion, and disease prevention. The CPSTF members are appointed by the CDC Director and serve five year terms, with extensions possible in order to maintain a full scope of expertise, complete specific work, and ensure consistency of CPSTF methods and recommendations. HHS/CDC provides “ongoing administrative, research, and technical support for the operations of the Task Force” as directed by the Public Health Service Act § 399U(c).
The CPSTF bases its recommendations on rigorous, replicable systematic reviews of the scientific literature, which do all of the following:
• Evaluate the strength and limitations of published scientific studies about community-based health promotion and disease prevention programs, services, and policies;
• Assess whether the programs, services, and policies are effective in promoting health and preventing disease, injury, and disability;
• Examine the applicability of these programs, services, and policies to varied populations and settings; and
• Conduct economic analyses of recommended interventions.
These systematic reviews are conducted, with CPSTF oversight, by scientists and subject matter experts from HHS/CDC in collaboration with a wide range of government, academic, policy, and practice-based partners. CPSTF findings and recommendations, and the systematic reviews on which they are based are available at
The CPSTF conducts three, two-day meetings each year that are open to the public. In addition, a significant portion of the CPSTF's work occurs between meetings during conference calls and via email discussions. Member duties include overseeing the process of prioritizing Task Force work, participating in the development and refinement of systematic review methods, serving as members of individual review teams, and issuing recommendations and findings to help inform the decision making process about policy, practice, research, and research funding in a wide range of U.S. settings. The estimated workload for CPSTF members is approximately 168 hours a year in addition to the three in-person meetings. The members are all volunteers and do not receive any compensation beyond support for travel to in-person meetings.
Centers for Medicare & Medicaid Services, Department of Health and Human Services.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the
Comments on the collection(s) of information must be received by the OMB desk officer by October 26, 2015.
When commenting on the proposed information collections, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be received by the OMB desk officer via one of the following transmissions: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-5806 or Email:
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the
1.
(1) Mailout of a covering letter, the paper survey questionnaire, and a postage-paid return envelope.
(2) Mailout of a post card that thanks respondents and reminds the non-respondents to please return their survey.
(3) Mailout of a follow-up covering letter, the paper survey questionnaire, and a postage-paid return envelope.
Through the pilot test, we will determine the response rate that can be achieved using this approach. If it is deemed necessary, a prenotification letter, additional mailout reminders and a telephone non-response step can be added to the protocol to achieve desired response rate.
Centers for Medicare and Medicaid Services, HHS.
Proposed notice.
This proposed notice acknowledges the receipt of an application from the American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF) for continued recognition as a national accrediting organization for Rural Health Clinics (RHCs). The statute requires that within 60 days of receipt of an organization's complete application, the Centers for Medicare & Medicaid Services (CMS) publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period.
To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on October 26, 2015.
In commenting, please refer to file code CMS-3322-PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways:
1.
2.
Please allow sufficient time for mailed comments to be received before the close of the comment period.
3.
4.
a.
(Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, commenters are encouraged to leave their comments in the CMS drop slots located in the main lobby of the building. A stamp-in clock is available for persons wishing to retain a proof of filing by stamping in and retaining an extra copy of the comments being filed.)
Comments erroneously mailed to the addresses indicated as appropriate for hand or courier delivery may be delayed and received after the comment period.
b.
If you intend to deliver your comments to the Baltimore address, call telephone number (410) 786-9994 in advance to schedule your arrival with one of our staff members.
For information on viewing public comments, see the beginning of the
Cindy Melanson, (410) 786-0310; Patricia Chmielewski, (410) 786-6899.
Comments received timely will also be available for public inspection as they are received, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, Maryland 21244, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 1-800-743-3951.
Under the Medicare program, eligible beneficiaries may receive covered services from a Rural Health Clinic (RHC), provided certain requirements are met. Section 1861(aa) of the Social Security Act (the Act) establishes distinct criteria for facilities seeking designation as an RHC. Regulations concerning provider agreements are at 42 CFR part 489 and those pertaining to activities relating to the survey and certification of facilities are at 42 CFR part 488. The regulations at 42 CFR part 491, subpart A, specify the minimum conditions that an RHC must meet to participate in the Medicare program.
Generally, to enter into an agreement, an RHC must first be certified by a State survey agency as complying with the conditions or requirements set forth in part 491, subpart A of our Medicare regulations. Thereafter, the RHC is subject to regular surveys by a State survey agency to determine whether it continues to meet these requirements.
Section 1865(a)(1) of the Act provides that, if a provider entity demonstrates through accreditation by a Centers for Medicare & Medicaid Services (CMS) approved national accrediting organization that all applicable Medicare conditions are met or exceeded, we may deem those provider entities as having met the requirements. Accreditation by an accrediting organization is voluntary and is not required for Medicare participation.
If an accrediting organization is recognized by the Secretary of the Department of Health and Human Services (the Secretary) as having standards for accreditation that meet or exceed Medicare requirements, any provider entity accredited by the national accrediting body's approved program may be deemed to meet the Medicare conditions. A national accrediting organization applying for approval of its accreditation program under part 488, subpart A, must provide CMS with reasonable assurance that the accrediting organization requires the accredited provider entities to meet requirements that are at least as stringent as the Medicare conditions. Our regulations concerning the approval and re-approval of accrediting organizations are set forth at § 488.5. The regulations at § 488.5(i) require accrediting organizations to reapply for continued approval of its accreditation program every 6 years or sooner as determined by CMS.
American Association for Accreditation of Ambulatory Surgery Facilities (AAAASF's) current term of approval for their RHC accreditation program expires March 23, 2016.
Section 1865(a)(2) of the Act and our regulations at § 488.5 require that our findings concerning review and approval of a national accrediting organization's requirements consider, among other factors, the applying accrediting organization's requirements for accreditation; survey procedures; resources for conducting required surveys; capacity to furnish information for use in enforcement activities; monitoring procedures for provider entities found not in compliance with the conditions or requirements; and ability to provide CMS with the necessary data for validation.
Section 1865(a)(3)(A) of the Act further requires that we publish, within 60 days of receipt of an organization's complete application, a notice identifying the national accrediting body making the request, describing the nature of the request, and providing at least a 30-day public comment period. We have 210 days from the receipt of a complete application to publish notice of approval or denial of the application.
The purpose of this proposed notice is to inform the public of AAAASF's request for continued approval of its RHC accreditation program. This notice also solicits public comment on whether AAAASF's requirements meet or exceed the Medicare conditions for certification for RHCs.
AAAASF submitted all the necessary materials to enable us to make a determination concerning its request for continued approval of its RHC accreditation program. This application was determined to be complete on July 31, 2015. Under section 1865(a)(2) of the Act and our regulations at § 488.5 (Application and re-application procedures for national accrediting organizations), our review and evaluation of AAAASF will be conducted in accordance with, but not necessarily limited to, the following factors:
• The equivalency of AAAASF's standards for RHCs as compared with Medicare's RHC conditions for certification.
• AAAASF's survey process to determine the following:
++ The composition of the survey team, surveyor qualifications, and the ability of the organization to provide continuing surveyor training.
++ The comparability of AAAASF's processes to those of State agencies, including survey frequency, and the ability to investigate and respond appropriately to complaints against accredited facilities.
++ AAAASF's processes and procedures for monitoring a RHC found out of compliance with AAAASF's program requirements. These monitoring procedures are used only when AAAASF identifies noncompliance. If noncompliance is
++ AAAASF's capacity to report deficiencies to the surveyed facilities and respond to the facility's plan of correction in a timely manner.
++ AAAASF's capacity to provide CMS with electronic data and reports necessary for effective validation and assessment of the organization's survey process.
++ The adequacy of AAAASF's staff and other resources, and its financial viability.
++ AAAASF's capacity to adequately fund required surveys.
++ AAAASF's policies with respect to whether surveys are announced or unannounced, to assure that surveys are unannounced.
++ AAAASF's agreement to provide CMS with a copy of the most current accreditation survey together with any other information related to the survey as CMS may require (including corrective action plans).
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Because of the large number of public comments we normally receive on
Upon completion of our evaluation, including evaluation of comments received as a result of this notice, we will publish a final notice in the
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces our decision to approve the American Association of Diabetes Educators (AADE) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.
This final notice is effective September 25, 2015 through September 27, 2021.
Kristin Shifflett, (410) 786-4133; Jacqueline Leach, (410) 786-4282.
Under the Medicare program, eligible beneficiaries may receive outpatient diabetes self-management training (DSMT) when ordered by the physician (or qualified non-physician practitioner) treating the beneficiary's diabetes, provided certain requirements are met by the provider. Pursuant to our regulations at 42 CFR 410.141 (e)(3), we use national accrediting organizations (NAOs) to assess whether provider entities meet Medicare requirements when providing DSMT services for which Medicare payment is made. If a provider entity is accredited by an approved accrediting organization, it is “deemed” to meet applicable Medicare requirements.
A NAO must meet the standards and requirements specified by the Secretary of the Department of Health and Human Services in our regulations under part 410, subpart H, to qualify for deeming authority. The regulations pertaining to application procedures for NAOs for DSMT are specified at § 410.142 (CMS process for approving national accreditation organizations).
A NAO applying for deeming authority must provide us with reasonable assurance that the accrediting organization requires accredited entities to meet requirements that are at least as stringent as our requirements.
We may approve and recognize a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes to accredit entities to furnish DSMT. The accreditation organization, after being approved and recognized by CMS, may accredit an entity to meet one of the sets of quality standards in § 410.144 (Quality standards for deemed entities).
Section 1865(a)(2) of the Social Security Act (the Act) requires that we review the applying accreditation organization's requirements for accreditation, as follows:
• Survey procedures.
• Ability to provide adequate resources for conducting required surveys.
• Ability to supply information for use in enforcement activities.
• Monitoring procedures for providers found out of compliance with the conditions or requirements.
• Ability to provide CMS with necessary data for validation.
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the
On April 24, 2015, we published a proposed notice in the
In that notice, we detailed our evaluation criteria. Under section
The April 24, 2015 proposed notice also solicited public comments on the ability of AADE to continue to develop standards that meet or exceed the Medicare conditions for coverage and apply them to entities furnishing outpatient services. We received no public comments in response to our proposed notice.
AADE's application to continue as an accredited NAO to deem entities for the purposes of DSMT is approved for a period of 6 years. The accreditation is effective on September 25, 2015. This approval is subject to renewal subsequent to the receipt of an application from the AADE and subject to review, evaluation, and approval of its program.
Based on our review and observations described in section II of this final notice, we approve AADE as a national accreditation organization for entities furnishing DSMT that request participation in the Medicare program, effective September 25, 2015 through September 27, 2021.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare & Medicaid Services (CMS), HHS.
Final notice.
This final notice announces our decision to approve the American Diabetes Association (ADA) for continued recognition as a national accreditation program for accrediting entities that wish to furnish outpatient diabetes self-management training (DSMT) to Medicare beneficiaries.
This final notice is effective September 25, 2015 through September 27, 2021.
Kristin Shifflett, (410) 786-4133; Jacqueline Leach, (410) 786-4282.
Under the Medicare program, eligible beneficiaries may receive outpatient diabetes self-management training (DSMT) when ordered by the physician (or qualified non-physician practitioner) treating the beneficiary's diabetes, provided certain requirements are met by the provider. Pursuant to our regulations at 42 CFR 410.141(e)(3), we use national accrediting organizations (NAOs) to assess whether provider entities meet Medicare requirements when providing DSMT services for which Medicare payment is made. If a provider entity is accredited by an approved accrediting organization, it is “deemed” to meet applicable Medicare requirements.
A NAO must meet the standards and requirements specified by the Secretary of the Department of Health and Human Services in our regulations under part 410, subpart H, to qualify for deeming authority. The regulations pertaining to application procedures for NAOs for DSMT are specified at § 410.142 (CMS process for approving NAOs).
A NAO applying for deeming authority must provide us with reasonable assurance that the accrediting organization requires accredited entities to meet requirements that are at least as stringent as our requirements.
We may approve and recognize a nonprofit organization with demonstrated experience in representing the interests of individuals with diabetes to accredit entities to furnish DSMT. The accreditation organization, after being approved and recognized by CMS, may accredit an entity to meet one of the sets of quality standards in § 410.144 (Quality standards for deemed entities).
Section 1865(a)(2) of the Social Security Act (the Act) requires that we review the applying accreditation organization's requirements for accreditation, as follows:
• Survey procedures.
• Ability to provide adequate resources for conducting required surveys.
• Ability to supply information for use in enforcement activities.
• Monitoring procedures for providers found out of compliance with the conditions or requirements.
• Ability to provide CMS with necessary data for validation.
We then examine the NAO's accreditation requirements to determine if they meet or exceed the Medicare conditions as we would have applied them.
Section 1865(a)(3)(A) of the Act provides a statutory timetable to ensure that our review of applications for CMS-approval of an accreditation program is conducted in a timely manner. The Act provides us 210 days after the date of receipt of a complete application, with any documentation necessary to make the determination, to complete our survey activities and application process. Within 60 days after receiving a complete application, we must publish a notice in the
On April 30, 2015, we published a proposed notice in the
In that notice, we detailed our evaluation criteria. Under section 1865(a)(2) of the Act and our regulations at § 410.142 and § 410.143, we conducted a review of ADA's NAO based on the criteria set forth in § 410.142(b), which include, but are not limited to the following: (1) A review of the NAO's operations and office to verify information in the organization's application and assess the organization's compliance with its own policies and procedures; (2) evaluating accreditation results or the accreditation status decision making process; and (3) interviewing the organization's staff.
The April 30, 2015 proposed notice also solicited public comments on the ability of ADA to continue to develop standards that meet or exceed the Medicare conditions for coverage and apply them to accredit entities to furnish training. We received no public comments in response to our proposed notice.
ADA's application to continue as an accredited NAO to deem entities for the purposes of DSMT is approved for a period of 6 years. The accreditation is effective on September 25, 2015. This approval is subject to renewal subsequent to the receipt of an application from the ADA and subject to review, evaluation, and approval of its program.
Based on our review and observations described in section III of this final notice, we approve ADA as a NAO for entities furnishing DSMT that request participation in the Medicare program, effective September 25, 2015 through effective September 27, 2021.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the
Comments must be received by November 24, 2015.
When commenting, please reference the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in any one of the following ways:
1.
2.
To obtain copies of a supporting statement and any related forms for the proposed collection(s) summarized in this notice, you may make your request using one of following:
1. Access CMS' Web site address at
2. Email your request, including your address, phone number, OMB number, and CMS document identifier, to
3. Call the Reports Clearance Office at (410) 786-1326.
Reports Clearance Office at (410) 786-1326.
This notice sets out a summary of the use and burden associated with the following information collections. More detailed information can be found in each collection's supporting statement and associated materials (see
Under the PRA (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA requires federal agencies to publish a 60-day notice in the
1.
Data submission, processing, and reporting will be analyzed for potential errors, inconsistencies, and gaps that are related to data handling, program requirements, and clinical quality measure specifications of PQRS and eRx program. Surveys of Group Practices, Registries, and Data Submission Vendors (DSVs) will be conducted in order to evaluate the PQRS and eRx Incentive Program. Follow-up interviews will occur with a small number of respondents.
2.
To qualify for payment, providers must prescribe beta amyloid PET for beneficiaries with a set of clinical criteria specific to each cancer. Data elements will be transmitted to CMS for evaluation of the short and long-term benefits of beta amyloid PET to beneficiaries and for use in future clinical decision making.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice announces the annual adjustment in the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearings and judicial review under the Medicare appeals process. The adjustment to the AIC threshold amounts will be effective for requests for ALJ hearings and judicial review filed on or after January 1, 2016. The calendar year 2016 AIC threshold amounts are $150 for ALJ hearings and $1,500 for judicial review.
Liz Hosna (
Section 1869(b)(1)(E) of the Social Security Act (the Act), as amended by section 521 of the Medicare, Medicaid, and SCHIP Benefits Improvement and Protection Act of 2000 (BIPA), established the amount in controversy (AIC) threshold amounts for Administrative Law Judge (ALJ) hearing requests and judicial review at $100 and $1,000, respectively, for Medicare Part A and Part B appeals. Section 940 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), amended section 1869(b)(1)(E) of the Act to require the AIC threshold amounts for ALJ hearings and judicial review to be adjusted annually. The AIC threshold amounts are to be adjusted, as of January 2005, by the percentage increase in the medical care component of the consumer price index (CPI) for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10. Section 940(b)(2) of the MMA provided conforming amendments to apply the AIC adjustment requirement to Medicare Part C/Medicare Advantage (MA) appeals and certain health maintenance organization and competitive health plan appeals. Health care prepayment plans are also subject to MA appeals rules, including the AIC adjustment requirement. Section 101 of the MMA provides for the application of the AIC adjustment requirement to Medicare Part D appeals.
The statutory formula for the annual adjustment to the AIC threshold amounts for ALJ hearings and judicial review of Medicare Part A and Part B appeals, set forth at section 1869(b)(1)(E) of the Act, is included in the applicable implementing regulations, 42 CFR 405.1006(b) and (c). The regulations require the Secretary of the Department of Health and Human Services (the Secretary) to publish changes to the AIC threshold amounts in the
Section 940(b)(2) of the MMA applies the AIC adjustment requirement to Medicare Part C appeals by amending section 1852(g)(5) of the Act. The implementing regulations for Medicare Part C appeals are found at 42 CFR 422, subpart M. Specifically, §§ 422.600 and 422.612 discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 422.600 grants any party to the reconsideration, except the MA organization, who is dissatisfied with the reconsideration determination, a right to an ALJ hearing as long as the amount remaining in controversy after reconsideration meets the threshold requirement established annually by the Secretary. Section 422.612 states, in part, that any party, including the MA organization, may request judicial review if the AIC meets the threshold requirement established annually by the Secretary.
Section 1876(c)(5)(B) of the Act states that the annual adjustment to the AIC dollar amounts set forth in section 1869(b)(1)(E)(iii) of the Act applies to certain beneficiary appeals within the context of health maintenance organizations and competitive medical plans. The applicable implementing regulations for Medicare Part C appeals are set forth in 42 CFR 422, subpart M and apply to these appeals. The Medicare Part C appeals rules also apply to health care prepayment plan appeals.
The annually adjusted AIC threshold amounts for ALJ hearings and judicial review that apply to Medicare Parts A, B, and C appeals also apply to Medicare Part D appeals. Section 101 of the MMA added section 1860D-4(h)(1) of the Act regarding Part D appeals. This statutory provision requires a prescription drug plan sponsor to meet the requirements set forth in sections 1852(g)(4) and (g)(5) of the Act, in a similar manner as MA organizations. As noted previously, the annually adjusted AIC threshold requirement was added to section 1852(g)(5) of the Act by section 940(b)(2)(A) of the MMA. The implementing regulations for Medicare Part D appeals can be found at 42 CFR 423, subparts M and U. The regulations at § 423.562(c) prescribe that, unless the Part D appeals rules provide otherwise, the Part C appeals rules (including the annually adjusted AIC threshold amount) apply to Part D appeals to the extent they are appropriate. More specifically, §§ 423.1970 and 423.1976 of the Part D appeals rules discuss the AIC threshold amounts for ALJ hearings and judicial review. Section 423.1970(a) grants a Part D enrollee, who is dissatisfied with the independent review entity (IRE) reconsideration determination, a right to an ALJ hearing if the amount remaining in controversy after the IRE reconsideration meets the threshold amount established annually by the Secretary. Sections 423.1976(a) and (b) allow a Part D enrollee to request judicial review of an ALJ or Medicare Appeals Council (MAC) decision if, in part, the AIC meets the threshold amount established annually by the Secretary.
As previously noted, section 940 of the MMA requires that the AIC threshold amounts be adjusted annually, beginning in January 2005, by the percentage increase in the medical care component of the CPI for all urban consumers (U.S. city average) for July 2003 to July of the year preceding the year involved and rounded to the nearest multiple of $10.
The AIC threshold amount for ALJ hearing requests will remain at $150 and the AIC threshold amount for judicial review will rise to $1,500 for CY 2016. These amounts are based on the 50.125 percent increase in the medical care component of the CPI, which was at 297.600 in July 2003 and rose to 446.773 in July 2015. The AIC threshold amount for ALJ hearing requests changes to $150.125 based on the 50.125 percent increase over the initial threshold amount of $100 established in 2003. In accordance with section 1869(b)(1)(E)(iii) of the Act, the adjusted threshold amounts are rounded to the nearest multiple of $10. Therefore, the CY 2016 AIC threshold amount for ALJ hearings is $150.00. The AIC threshold amount for judicial review changes to $1,501.25 based on the 50.125 percent increase over the initial threshold amount of $1,000. This amount was rounded to the nearest multiple of $10, resulting in the CY 2016 AIC threshold amount of $1,500.00 for judicial review.
In the following table we list the CYs 2012 through 2016 threshold amounts.
This document does not impose information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements. Consequently, there is no need for review by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The Office of Head Start published a final rule on eligibility under the authority granted to the Secretary of Health and Human Services under the Head Start Act (Act) at sections 644(c), 645(a)(1)(A), and 645A(c). The final rule clarifies Head Start's eligibility procedures and enrollment requirements, and reinforces Head Start's overall mission to support low-income families and early learning. A program must maintain records as specified in sections 1305.4(d)(2), 1305.4(l), and 1305.4(h) through (j) of the final rule.
In compliance with the requirements of Section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email address:
The Department specifically requests comments on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Administration for Community Living, HHS.
Notice.
The Administration for Community Living (formerly the Administration on Aging (AoA)) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Submit written comments on the collection of information by October 26, 2015.
Submit written comments on the collection of information by fax 202.395.6974 to the OMB Desk Officer for ACL, Office of Information and Regulatory Affairs, OMB.
Alice-Lynn Ryssman, 202.357.3491
In compliance with PRA (44 U.S.C. 3501-3520), the Administration for Community Living (ACL, formerly the Administration for Aging) has submitted the following proposed collection of information to the Office of Management and Budget (OMB) for review and clearance. The outcome evaluation data collection associated with the Title III-E National Family Caregiver Support Program (NFCSP) is necessary to meet three broad objectives of ACL: (1) To provide information to support program planning, including an analysis of program processes, (2) to develop information about program efficiency and costs, and (3) gauge program effectiveness in assessing community and client needs, targeting and prioritizing, and providing services to family caregivers. The outcome evaluation will examine to what extent do the needs, services, and outcomes of NFCSP caregivers differ from non-NFCSP caregivers over a twelve-month period. As well, where feasible, the individuals supported by these two groups of caregivers will be asked seven short questions about their situation initially and at the end of twelve months, to take into account the care recipients' perceptions of their quality of life and the support for their caregivers.
In response to the 60-day
The outcome study will conduct telephone interviews with a randomly
The proposed data collection tools may be found on the ACL Web site at
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice of Single-Case Deviation from Competition Requirement for Program Expansion for the Bright Futures Pediatric Implementation Cooperative Agreement at the American Academy of Pediatrics, Grant Number U04MC07853.
HRSA announces the award of a program expansion supplement in the amount of $210,000 for the Bright Futures Pediatric Implementation (BFPI) cooperative agreement. The proposed program expansion supplement would provide funds to the American Academy of Pediatrics (AAP) to support the integration of genetics and genomic medicine into pediatric primary care by testing genomic resources and tools to ensure relevance to clinical practice and the practicality of implementing them in clinical practice and the eventual addition to the Bright Futures Tool and Resources Kit.
The BFPI is authorized by the Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended. The BFPI is a national resource to promote integration of the “Bright Futures Guidelines for Health Supervision of Infants, Children and Adolescents, Third Edition” and subsequent editions, through strengthening, aligning, and fostering partnerships among families, health professionals, public health, and the broader community to promote children's health.
Intended Recipient of the Award: The American Academy of Pediatrics
Amount of the Non-Competitive Award: $210,000.
CFDA Number: 93.110.
Current Project Period: 02/01/2007—01/31/2017.
Period of Supplemental Funding: 2/1/2015—1/31/2016.
Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended.
From June 1, 2011, to January 30, 2014, HRSA's Maternal and Child Health Bureau (MCHB) funded AAP to develop and implement the Genetics in Primary Care Institute (GPCI) program that provided models, best practices, and dissemination strategies for ensuring optimal integration of genetic medicine content and concepts into primary care practice.
The purpose of the BFPI cooperative agreement, as stated in the funding opportunity announcement, is to improve the quality of health promotion and preventive services for all infants, children, adolescents, and their families, including children with special health care needs, through the effective national implementation of
As part of the current award, BFPI would recommend updates to
AAP would partner with residency training programs, the Bright Futures Steering Committee, the Association of Pediatric Program Directors, and others, respectively, to ensure the development of a sound project implementation methodology consistent with the overall aims. Resources and tools would be
Lynn Van Pelt, DMD, Division of Child, Adolescent, and Family Health, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18W13B, Rockville, Maryland 20857;
Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS).
Notice of Single-Case Deviation from Competition Requirement for Program Expansion for the Bright Futures Pediatric Implementation Cooperative Agreement at the American Academy of Pediatrics, Grant Number U04MC07853.
HRSA announces its intent to award a program expansion supplement in the amount of $75,000 for the Bright Futures Pediatric Implementation (BFPI) cooperative agreement. The purpose of the BFPI cooperative agreement, as stated in the funding opportunity announcement, is to improve the quality of health promotion and preventive services for all infants, children, adolescents, and their families, including children with special health care needs, through the effective national implementation of
The BFPI is a national resource to promote integration of the
Intended Recipient of the Award: The American Academy of Pediatrics.
Amount of the Non-Competitive Award: $75,000.
CFDA Number: 93.110.
Current Project Period: 02/01/2007-01/31/2017.
Period of Supplemental Funding: 2/1/2015-1/31/2016.
Social Security Act, Title V, Sections 501(a)(2) (42 U.S.C. 701(a)(2)), as amended.
Home visiting within a strong early childhood system is a
The AAP collects data from pediatricians, the primary care medical providers most likely to encounter families with young children. AAP's Periodic Survey of Fellows is an established mechanism for surveying practice delivery among AAP's more than 60,000 pediatrician members, with response rates ranging from 50 to 55 percent, higher than many other national surveys of physicians. AAP conducts the survey every 2 years. The proposed program expansion supplement would fund AAP to collect additional complementary data from pediatricians and provide such data to MCHB.
The supplemental funds for survey questions would build on AAP's survey infrastructure to help MCHB understand the system, organization, and individual-level determinants and challenges that influence coordination between home visitors and pediatricians. AAP would add questions focusing on coordination between home visitors and pediatricians to the Fall 2015 Periodic Survey of Fellows that would be sent to a national random sample of approximately 1,600 non-retired United States members of the AAP. The survey would include specific questions about pediatricians' use of, and communication with, home visitors and perception of the role of the home visitor and the pediatrician in addressing several preventive care topics as part of routine well-child care and home visits. These topics include injury prevention, infant feeding practices, early reading/literacy development, developmental screening,
Lynn Van Pelt, DMD, Division of Child, Adolescent, and Family Health, Maternal and Child Health Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 18W13B, Rockville, Maryland 20857;
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
This is notice, in accordance with 35 U.S.C. 209 and 37 CFR part 404, that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of a Start-Up Exclusive Evaluation Option License Agreement to Angio360 Diagnostics, LLC, a company having a place of business in Wauwatosa, Wisconsin, to practice the inventions embodied in U.S. Provisional Patent Application No. 60/858,068, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed November 9, 2006 (HHS Ref. No.: E-285-2006/0-US-01); US Provisional Patent Application No. 60/879,457, entitled “Organ And Tumor Associated Endothelial Markers,” filed January 8, 2007 (HHS Ref. No. E-285-2006/1-US-01); PCT Application No. PCT/US2007/072395, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed June 8, 2007 (HHS Ref. No. E-285-2006/2-PCT-01); U.S. Patent Application No. 12/514,297, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed May 8, 2009 (HHS Ref No. E-285-2006/2-US-02); Australian Patent No. 2007-317753, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed June 28, 2007 (HHS Ref No. E-285-2006/2-AU-03); Canadian Patent Application No. 2,669,260, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed June 28, 2007 (HHS Ref. No. E-285-2006/2-CA-04); U.S. Patent No.: 8,440,411, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed March 21, 2011 (HHS Ref. No. E-285-2006/2-US-05); U.S. Patent Application No. 13/052,878, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed April 16, 2013 (HHS Ref. No.: E-285-2006/2-US-06); and Australian Application Patent No.: 2014-200453, entitled “Differential Gene Expression in Physiological and Pathological Angiogenesis,” filed January 28, 2014 (HHS Ref No. E-285-2006/2-AU-07). The patent rights in these inventions have been assigned to the Government of the United States of America. The territory of the prospective Start-Up Exclusive Evaluation Option License Agreement may be worldwide, and the field of use may be limited to “Development of diagnostic tests and kits to determine or monitor pathological angiogenesis related to cancer in animals or humans.”
Upon the expiration or termination of the Start-up Exclusive Evaluation Option License Agreement, Angio360 Diagnostics, LLC will have the exclusive right to execute a Start-Up Exclusive Patent License Agreement which will supersede and replace the Start-up Exclusive Evaluation Option License Agreement, with no greater field of use and territory than granted in the Start-up Exclusive Evaluation Option License Agreement.
Only written comments and/or applications for a license which are received by the NIH Office of Technology Transfer on or before October 13, 2015 will be considered.
Requests for copies of the patent application(s), inquiries, comments, and other materials relating to the contemplated Start-Up Exclusive Evaluation Option License Agreement should be directed to: Rose M. Freel, Licensing and Patenting Manager, Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-3804; Telephone: (301) 402-9521; Facsimile: (301) 402-0220; Email:
This technology describes a method of detecting pathological angiogenesis (formation of new blood vessels) using the expression levels of certain proteins for the diagnosis of cancer or monitoring response to cancer treatment.
The prospective Start-Up Exclusive Evaluation Option License Agreement is being considered under the small business initiative launched on October 1, 2011 and will comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR part 404. The prospective Start-Up Exclusive Evaluation Option License Agreement and a subsequent Start-Up Exclusive Patent License Agreement may be granted unless the NIH receives written evidence and argument, within fifteen (15) days from the date of this published notice, that establishes that the grant of the contemplated Start-Up Exclusive Evaluation Option License Agreement would not be consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use that are filed in response to this notice will be treated as objections to the grant of the contemplated Start-Up Exclusive Evaluation Option License Agreement. Comments and objections submitted to this notice will not be made available for public inspection and, to the extent permitted by law, will not be released under the Freedom of Information Act, 5 U.S.C. 552.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Coast Guard, DHS.
Notice of recertification.
The purpose of this notice is to inform the public that the Coast Guard has recertified the Cook Inlet Regional Citizen's Advisory Council (CIRCAC) as an alternative voluntary advisory group for Cook Inlet, Alaska. This certification allows the CIRCAC to monitor the activities of terminal facilities and crude oil tankers under the Cook Inlet Program established by statute.
This recertification is effective for the period from September 1, 2015 through August 31, 2016.
LTJG Katharine Martorelli, Seventeenth Coast Guard District (dpi), by phone at (907) 463-2809, email
As part of the Oil Pollution Act of 1990, Congress passed the Oil Terminal and Oil Tanker Environmental Oversight and Monitoring Act of 1990 (the Act), 33 U.S.C. 2732, to foster a long-term partnership among industry, government, and local communities in overseeing compliance with environmental concerns in the operation of crude oil terminals and oil tankers.
On October 18, 1991, the President delegated his authority under 33 U.S.C 2732 (o) to the Secretary of Transportation in Executive Order 12777, section 8(g) (see 56 FR 54757; October 22, 1991) for purposes of certifying advisory councils, or groups, subject to the Act. On March 3, 1992, the Secretary re-delegated that authority to the Commandant of the USCG (see 57 FR 8582; March 11, 1992). The Commandant re-delegated that authority to the Chief, Office of Marine Safety, Security and Environmental Protection (G-M) on March 19, 1992 (letter #5402).
On July 7, 1993, the USCG published a policy statement, 58 FR 36504, to clarify the factors that shall be considered in making the determination as to whether advisory councils, or groups, should be certified in accordance with the Act.
The Assistant Commandant for Marine Safety and Environmental Protection (G-M), re-delegated recertification authority for advisory councils, or groups, to the Commander, Seventeenth Coast Guard District on February 26, 1999 (letter #16450).
On September 16, 2002, the USCG published a policy statement, 67 FR 58440, that changed the recertification procedures such that applicants are required to provide the USCG with comprehensive information every three years (triennially). For each of the two years between the triennial application procedures, applicants submit a letter requesting recertification that includes a description of any substantive changes to the information provided at the previous triennial recertification. Further, public comment is not solicited prior to recertification during
On September 1, 2014, the Coast Guard recertified the Cook Inlet Regional Citizen's Advisory Council through August 31, 2015. Under the Oil Terminal and Oil Tanker Environmental Oversight Act of 1990 (33 U.S.C. 2732), the Coast Guard may certify, on an annual basis, an alternative voluntary advisory group for Cook Inlet, Alaska. This advisory group monitors the activities of terminal facilities and crude oil tankers under the Cook Inlet Program established by Congress, 33 U.S.C. 2732 (b).
By letter dated August 20, 2015, the Commander, Seventeenth Coast Guard certified that the CIRCAC qualifies as an alternative voluntary advisory group under 33 U.S.C. 2732(o). This recertification terminates on August 31, 2016.
Coast Guard, DHS.
Notice and response to comments
On June 27, 2014, Coast Guard Sector Puget Sound received a Letter of Intent (LOI) and Waterway Suitability Assessment (WSA) from Washington State Ferries (WSF) for a proposal to modify existing Washington State Ferry marine terminal operations to include the handling of Liquefied Natural Gas (LNG). The LNG would be transferred to and used as a marine fuel by six Issaquah Class Ferries converted to use LNG propulsion systems. In accordance with regulation and policy guidance, the Captain of the Port (COTP), Coast Guard Sector Puget Sound, in cooperation with key port stakeholders, will review and validate the information in the WSA. The COTP will then issue a Letter of Recommendation (LOR) to the State of Washington Department of Transportation that conveys the Coast Guard's recommendation on the suitability of the following waterways for LNG marine traffic as it relates to safety and security: Guemes Channel, Rosario Strait, Thatcher Pass, Harney Channel, Upright Channel, Wasp Channel, San Juan Channel, Spieden Channel, Haro Strait, Sidney Channel, Possession Sound, Admiralty Inlet, Puget Sound, Sinclair Inlet, Rich Passage, Elliot Bay, Admiralty Passage, North East Passage, and Colvos Passage.
As part of this validation process, the Coast Guard, on November 12, 2014, published a “Notice and Request for Comments” in the
For further information about this document call or email LT Sarah Rodiño, Coast Guard Sector Puget Sound; telephone 206-217-6623, email
In accordance with 33 CFR 127.007, the COTP, Coast Guard Sector Puget Sound, received an LOI and WSA from WSF on June 27, 2014 regarding WSF's proposal to modify existing Washington State Ferry marine terminal operations and add the handling of LNG. The LNG would be transferred to and used as a marine fuel by six Issaquah Class Ferries converted to use LNG propulsion systems. The LOI notes that if the conversion is completed, each vessel would require fueling by truck once every 7 to 10 days.
Pursuant to 33 CFR 127.009, and using the guidance set forth in reference to the Coast Guard's Navigation and Vessel Inspection Circular (NVIC) 01-2011, “Guidance Related to Waterfront Liquefied Natural Gas (LNG) Facilities,” the COTP is reviewing and validating WSF's WSA in cooperation with key port stakeholders. To assist the COTP, the Coast Guard on November 12, 2014 published a “Notice and Request for Comments” in the
Thirteen comments were received, including two outside the comment period. This document summarizes those comments, explains whether or not they are appropriate for consideration under 33 CFR 127.009, and provides additional information to help inform the public about the various issues raised in them. Comments that fell outside the scope of the WSA but are relevant to the vessel design modifications will be forwarded on to the Coast Guard Marine Safety Center (MSC) to be considered during the design review and approval process in accordance with 46 CFR 71.65-10.
WSF's LOI, WSA, and other supporting documentation can be viewed at:
The Coast Guard sincerely appreciates the comments received.
Multiple comments expressed concern that the proposed conversion is too expensive and that the funding that would pay for the conversion should be spent in a different manner. The COTP's role with regard to WSF's proposal is limited to issuing an LOR to the Washington State Department of Transportation regarding the suitability of the waterway for LNG marine traffic based on the criteria listed in 33 CFR 127.009. Cost of vessel conversion issues fall outside the scope of the LOR. As such, these comments will not be considered by the COTP in issuing the LOR.
Two comments expressed concern that LNG poses a pollution threat to the environment. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness, the Coast Guard will examine WSF's Emergency and Operations Manuals as required by 33 CFR 127.019 covering the transfer system and transfer procedures. These manuals include but are not limited to LNG release response procedures, local response organizations contact
Several comments expressed concern that exposed LNG tanks on the proposed converted ferries pose a security risk. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, the Coast Guard oversees a multilayered security framework under 33 CFR parts 101-105 to enhance maritime security throughout the Puget Sound region. If the WSF proposal is approved by the Washington State Department of Transportation, the marine terminal would be required to submit a facility security plan in accordance with 33 CFR part 105. Washington State Ferries is currently required to comply with 33 CFR part 104 which requires in-depth security assessments and Coast Guard-approved vessel security plans. WSF currently has Coast Guard-approved vessel security plans covering each of its vessels. These security plans would be reviewed and amended as necessary to reflect the conversion to LNG fuel.
Multiple comments expressed concern about the design of the proposed converted ferries and that the use of LNG poses an unnecessary risk to passengers. The COTP's role with regards to the subject proposal is limited to issuing an LOR to the Washington State Department of Transportation regarding the suitability of the waterway for LNG marine traffic based on the items listed in 33 CFR 127.009. This comment fell outside the scope of the Waterways Suitability Assessment but is relevant to the vessel design modification and will be forwarded on to the Coast Guard MSC to be considered during the design approval process in accordance with 46 CFR 71.65-10. At this time, final plans have not been submitted by WSF to MSC.
One comment stated that WSF should be required to update its Emergency Manual and include it as part of the docket. This comment fell outside the scope of the WSA but for the public's awareness, Operations and Emergency Manuals are required under 33 CFR 127.019. As such, the Coast Guard will examine Emergency and Operation Manuals for compliance with 33 CFR 127.305 and 33 CFR 127.307. WSF will be required to submit copies of these manuals to the COTP 30 days prior to transferring LNG. The COTP may also require WSF to update other required safety plans as necessary.
Two comments expressed concern that a seaplane or other aircraft could collide with an LNG tank onboard a converted ferry. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, historical data shows that instances of unintentional aircraft collisions with ferries are extremely low. Malicious or intentional collisions will be considered in the security threat mitigation strategies explained previously.
Two comments expressed concern that a large commercial vessel could collide with a converted ferry carrying LNG causing a tank rupture and explosion. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, the risk of collision between large commercial vessels is mitigated significantly through a number of systems, processes, and requirements already in place today including the Coast Guard's Vessel Traffic Service (VTS), Automated Identification System (AIS), and Automatic Radar Plotting Aids (ARPA) as well as established traffic separation schemes and the International Regulations for Preventing Collisions at Sea (COLREGS) Navigation Rules governing vessel navigation. In addition, Federal and state laws require large vessels transiting within Puget Sound, including WSF ferries, to be under the direction and control of a federally licensed pilot. A federally licensed pilot is an experienced navigator with expertise specific to Puget Sound who provides significant risk mitigation in regards to collisions. Of note, VTS Puget Sound closely monitors and, as necessary, directs all large commercial vessel traffic throughout the Puget Sound including the routes transited by the Issaquah class ferries. The Issaquah class ferry routes have remained unchanged for at least 55 years and there are no proposed changes to the routes.
One comment expressed the opinion that the Coast Guard should define strict criteria for conducting risk analysis and research. The Coast Guard in our role as stewards of safety and security in the maritime arena regularly integrate risk management into every aspect of our maritime governance and operations. 33 CFR part 127 and NVIC 01-2011 contain tailored requirements and guidance based on risk. In addition, the Coast Guard has commissioned studies from Sandia National Laboratories to examine the risks associated with potential LNG spills. These reports are titled “Guidance on Risk Analysis and Safety Implication of a Large Liquefied Natural Gas (LNG) Over Water” (2004) and “Breach and Safety Analysis of Spills over Water from Large Liquefied Natural Gas Carriers” (2008). These studies are available online at:
Further, NVIC 01-11 was written based on Risk Based Decision Making, COMDTINST M16010.3, which can be found at:
One comment expressed concern about WSF's plan to fuel the converted ferries by parking a tank truck on the terminal transfer span, placing the vehicle on an inclined plane. As an issue relevant under 33 CFR 127.009, the COTP will consider this comment in issuing the LOR. For the public's awareness, the Coast Guard will examine WSF's Operations Manual as required by 33 CFR 127.019 covering the transfer system and transfer procedures.
One comment expressed concern that currently there are no Federal regulations regarding LNG fueled passenger vessels. The commenter is correct that there are currently no Federal regulations in place that specifically govern the installation and use of LNG as a marine fuel. This concept is new in the United States, although it is more commonly used internationally. The Coast Guard has issued vessel design and LNG bunkering policy documents that provide guidelines for facility and vessel owner operators to use in consideration of facility operations and vessel design. Those documents can be found at:
One comment expressed concern that there is not explicit guidance regarding the criteria for developing or evaluating a WSA. The requirements and guidance are located in 33 CFR 127.007 and NVIC 01-11.
One comment expressed concern that the WSA referenced unverified probability calculations for tank collisions from SOLAS Chapter II-1. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, there is a lack
One comment stated that the SOLAS model used for collision damage in the WSA is meant to be used on vessels designed for an ocean route and the WSF ferries were constructed for lakes, bays and sounds route. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, DNV-GL determined that the use of this model was the best approach available because a probability model does not exist for a vessel of similar structure as the WSF ferries.
One commenter stated that DNV did not utilize the correct tank volume of fuel in the risk assessment models. The correct tank volume was incorporated in Revision 03 of the WSA.
One comment stated that DNV-GL used inappropriate ignition probability models when utilizing the International Association of Oil and Gas Producers (OGP) Scenario 24 Floating Production, Storage, and Offloading (FPSO) Vessels Gas model. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. For the public's awareness on this topic, no statistically significant data exists for ignition probability models for LNG as fuel onboard passenger ferries. The model used by DNV-GL is meant to model ignition probability onboard larger scale offshore vessels and was chosen because it represents a more conservative and representative model for application to the WSF vessel design.
One comment expressed concern that the societal risks identified in the WSA required that risks falling in the range between “broadly acceptable” and “maximum tolerable” be mitigated so that they are As Low As Reasonably Possible (ALARP) and that the WSA did not address mitigating factors to reach the ALARP mitigation. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. During the validation process, the COTP will determine if appropriate risk management strategies have been identified.
One comment expressed concern that the WSA was not completed objectively and appears to be incomplete. As an issue relevant under 33 CFR 127.009, the COTP will consider those comments in issuing the LOR. As part of the LOR process and in accordance with NVIC 01-2011, the COTP has been and will continue to review and validate the WSA in cooperation with key port stakeholders. This validation will determine if the WSA presents a realistic and credible analysis of the public safety and security implications of introducing LNG marine traffic into the port and waterway.
This response to comments is issued under authority of 33 CFR 127.009.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before December 24, 2015.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1530, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of an emergency declaration for the State of Washington (FEMA-3372-EM), dated August 21, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this emergency is closed effective September 10, 2015.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Louisiana (FEMA-4228-DR), dated July 13, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Louisiana is hereby amended to include the following area among those
West Feliciana Parish for Public Assistance.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before December 24, 2015.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1536, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Federal Emergency Management Agency, DHS.
Proposed notice; withdrawal.
The Federal Emergency Management Agency (FEMA) is withdrawing its proposed notice concerning proposed flood hazard determinations, which may include the addition or modification of any Base Flood Elevation, base flood depth, Special Flood Hazard Area boundary or zone designation, or regulatory floodway (herein after referred to as proposed flood hazard determinations) on the Flood Insurance Rate Maps and, where applicable, in the supporting Flood Insurance Study reports for Polk County, Minnesota and Incorporated Areas.
This withdrawal is effective September 25, 2015.
You may submit comments, identified by Docket No. FEMA-B-1452, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
On December 16, 2014, FEMA published a proposed notice at 79 FR 74758, proposing flood hazard determinations for Polk County, Minnesota and Incorporated Areas. FEMA is withdrawing the proposed notice.
42 U.S.C. 4104; 44 CFR 67.4.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the Commonwealth of Kentucky (FEMA-4239-DR), dated August 12, 2105, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the Commonwealth of Kentucky is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of August 12, 2015.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency; DHS.
Final notice; correction.
On August 19, 2015, FEMA published in the
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of September 30, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the table below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
In the final flood hazard determination notice published at 80 FR 50316 in the August 19, 2015, issue of the
Federal Emergency Management Agency, DHS.
Notice.
Comments are requested on proposed flood hazard determinations, which may include additions or modifications of any Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area (SFHA) boundary or zone designation, or regulatory floodway on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the preliminary FIRM, and where applicable, the FIS report that the Federal Emergency Management Agency (FEMA) has provided to the affected communities. The FIRM and FIS report are the basis of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report, once effective, will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents of those buildings.
Comments are to be submitted on or before December 24, 2015.
The Preliminary FIRM, and where applicable, the FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
You may submit comments, identified by Docket No. FEMA-B-1541, to Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
FEMA proposes to make flood hazard determinations for each community listed below, in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR 67.4(a).
These proposed flood hazard determinations, together with the floodplain management criteria required by 44 CFR 60.3, are the minimum that are required. They should not be construed to mean that the community must change any existing ordinances that are more stringent in their floodplain management requirements. The community may at any time enact stricter requirements of its own or pursuant to policies established by other Federal, State, or regional entities. These flood hazard determinations are used to meet the floodplain management requirements of the NFIP and also are used to calculate the appropriate flood insurance premium rates for new buildings built after the FIRM and FIS report become effective.
The communities affected by the flood hazard determinations are provided in the tables below. Any request for reconsideration of the revised flood hazard information shown on the Preliminary FIRM and FIS report that satisfies the data requirements outlined in 44 CFR 67.6(b) is considered an appeal. Comments unrelated to the flood hazard determinations also will be considered before the FIRM and FIS report become effective.
Use of a Scientific Resolution Panel (SRP) is available to communities in support of the appeal resolution process. SRPs are independent panels of experts in hydrology, hydraulics, and other pertinent sciences established to review conflicting scientific and technical data and provide recommendations for resolution. Use of the SRP only may be exercised after FEMA and local communities have been engaged in a collaborative consultation process for at least 60 days without a mutually acceptable resolution of an appeal. Additional information regarding the SRP process can be found online at
The watersheds and/or communities affected are listed in the tables below. The Preliminary FIRM, and where applicable, FIS report for each community are available for inspection at both the online location and the respective Community Map Repository address listed in the tables. For communities with multiple ongoing Preliminary studies, the studies can be identified by the unique project number and Preliminary FIRM date listed in the tables. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at
Office of the Assistant Secretary for Community Planning and Development, HUD.
Notice.
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Juanita Perry, Department of Housing and Urban Development, 451 Seventh Street SW., Room 7266, Washington, DC 20410; telephone (202) 402-3970; TTY number for the hearing- and speech-impaired (202) 708-2565 (these telephone numbers are not toll-free), or call the toll-free Title V information line at 800-927-7588.
In accordance with 24 CFR part 581 and section 501 of the Stewart B. McKinney Homeless Assistance Act (42 U.S.C. 11411), as amended, HUD is publishing this Notice to identify Federal buildings and other real property that HUD has reviewed for suitability for use to assist the homeless. The properties were reviewed using information provided to HUD by Federal landholding agencies regarding unutilized and underutilized buildings and real property controlled by such agencies or by GSA regarding its inventory of excess or surplus Federal property. This Notice is also published in order to comply with the December 12, 1988 Court Order in
Properties reviewed are listed in this Notice according to the following categories: Suitable/available, suitable/unavailable, and suitable/to be excess, and unsuitable. The properties listed in the three suitable categories have been reviewed by the landholding agencies, and each agency has transmitted to HUD: (1) Its intention to make the property available for use to assist the homeless, (2) its intention to declare the property excess to the agency's needs, or (3) a statement of the reasons that the property cannot be declared excess or made available for use as facilities to assist the homeless.
Properties listed as suitable/available will be available exclusively for homeless use for a period of 60 days from the date of this Notice. Where property is described as for “off-site use only” recipients of the property will be required to relocate the building to their own site at their own expense. Homeless assistance providers interested in any such property should send a written expression of interest to HHS, addressed to: Ms. Theresa M. Ritta, Chief Real Property Branch, the Department of Health and Human Services, Room 5B-17, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857, (301) 443-2265 (This is not a toll-free number.) HHS will mail to the interested provider an application packet, which will include instructions for completing the application. In order to maximize the opportunity to utilize a suitable property, providers should submit their written expressions of interest as soon as possible. For complete details concerning the processing of applications, the reader is encouraged to refer to the interim rule governing this program, 24 CFR part 581.
For properties listed as suitable/to be excess, that property may, if subsequently accepted as excess by GSA, be made available for use by the homeless in accordance with applicable law, subject to screening for other Federal use. At the appropriate time, HUD will publish the property in a Notice showing it as either suitable/available or suitable/unavailable.
For properties listed as suitable/unavailable, the landholding agency has decided that the property cannot be declared excess or made available for use to assist the homeless, and the property will not be available.
Properties listed as unsuitable will not be made available for any other purpose for 20 days from the date of this Notice. Homeless assistance providers interested in a review by HUD of the determination of unsuitability should call the toll free information line at1-800-927-7588 for detailed instructions or write a letter to Ann Marie Oliva at the address listed at the beginning of this Notice. Included in the request for review should be the property address (including zip code), the date of publication in the
For more information regarding particular properties identified in this Notice (
Comments: 30+ yrs. old; 600 sq. ft.; restroom; contact COE for more information.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice.
HUD is seeking approval from the Office of Management and Budget (OMB) for the information collection described below. In accordance with the Paperwork Reduction Act, HUD is requesting comment from all interested parties on the proposed collection of information. The purpose of this notice is to allow for 60 days of public comment.
Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB Control Number and should be sent to: Colette Pollard, Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 7th Street SW., Room 4176, Washington, DC 20410-5000; telephone 202-402-3400 (this is not a toll-free number) or email at
Claude Dickson, Acting Senior Advisor, Office of Recapitalization, Department of Housing and Urban Development, 451 7th Street SW., Washington, DC 20410; email:
This notice informs the public that HUD is seeking approval from OMB for the information collection described in section A.
This notice is soliciting comments from members of the public and affected parties concerning the collection of information described in section A on the following:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4) Ways to minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology,
HUD encourages interested parties to submit comment in response to these questions.
Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. chapter 35.
Bureau of Indian Affairs, Interior.
Notice of final agency determination.
The Assistant Secretary—Indian Affairs made a final determination to acquire approximately 321.35 acres of land, more or less, in Barnstable and Bristol Counties, Massachusetts, in trust for gaming and other purposes for the Mashpee Wampanoag Tribe on September 18, 2015.
Ms. Paula L. Hart, Director, Office of Indian Gaming, Bureau of Indian Affairs, MS-3657 MIB, 1849 C Street NW., Washington, DC 20240; Telephone (202) 219-4066.
This notice is published in the exercise of authority delegated by the Secretary of the Interior to the Assistant Secretary—Indian Affairs by 209 Departmental Manual 8.1, and is published to comply with the requirements of 25 CFR 151.12(c)(2)(ii) that notice of the decision to acquire land in trust be promptly provided in the
On September 18, 2015, the Assistant Secretary—Indian Affairs issued a decision to accept 321.35 acres, more or less, of land in trust for the Mashpee Wampanoag Tribe in the Town of Mashpee, Massachusetts (170 acres, more or less), and the City of Taunton, Massachusetts (151 acres, more or less), under the authority of Section 5 of the Indian Reorganization Act of 1934, 25 U.S.C. 465. The Assistant Secretary—Indian Affairs also determined that these lands meet the requirements of the Indian Gaming Regulatory Act's “initial reservation” exception, 25 U.S.C. 2719(b)(1)(B)(ii), to the general prohibition contained in 25 U.S.C.
The Assistant Secretary—Indian Affairs, on behalf of the Secretary of the Interior, will immediately acquire title in the name of the United States of America in trust for Mashpee Wampanoag Tribe. The 321.35 acres are located in Barnstable and Bristol Counties, Massachusetts, and are more particularly described as follows:
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the east side of Quippish Road, and the south side of Sampsons Mill Road more particularly shown as Lot 6 on a plan entitled “Plan of Land in Mashpee, Mass. Jill Slaymaker in Mashpee, Ma. Scale 1″ =100′, Date March 22, 1985” prepared by Edward E. Kelley Reg. Land Surveyor and recorded in Barnstable County Registry of Deeds, Plan Book 401 Page 97. Bounded and described as follows:
The above parcel contains 29.92 acres, more or less.
For Grantor's title see deed dated February 7, 2013 from Maushop L.L.C. and recorded in the Barnstable Registry of Deeds in Book 27116, Page 35.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee, on the east side of Mizzenmast more particularly shown as shown as Lot 80 Land Court Plan 35464-b (Sheet 7) filed in Land Registration Office, Barnstable County Registry of Deeds with a Certificate of Title Number 165381 bounded and described as follows:
The above described parcel contains 15,727± s.f. or 0.3610 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee, on the south side of Uncle Percy's Road more particularly shown as shown as Lot 15 (Block 10) Land Court Plan 11408-I filed in Land Registration Office, Barnstable County Registry of Deeds with a Certificate of Title Number 157612. Bounded and described as follows:
The above described parcel contains 6,500 s.f. or 0.1492 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the west side of Great Neck Road South more particularly shown on a plan entitled “Plan of Land in Mashpee, Mass. Prepared for Duck Pond Limited Partnership. Scale 1″=50′, dated February 13, 2007″ prepared by Holmes and McGrath, Inc. and recorded in Barnstable County Registry of Deeds, Plan Book 618 Page 13. Bounded and described as follows:
The above parcel contains 8.88 acres, more or less.
For Grantor's title see deed dated June 12, 2007 from Duck Pond Limited Partnership and recorded in the Barnstable Registry of Deeds in Book 22104, Page 110.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the west side of Great Neck Road South more particularly shown on a plan entitled “Plan of Land in Mashpee, Mass. Prepared for the Mashpee Wampanoag Indian Tribal Council, Inc. Scale 1″=100′, dated June 6/3/15″ prepared by Cape & Islands Engineering, Inc. To be recorded in Barnstable County Registry of Deeds; bounded and described as follows:
The above parcel contains 57.94 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the south side of Main Street more particularly shown as shown as parcel 35 30 0 on the Town of Mashpee Assessors Maps, and is shown as parcel labeled Town of Mashpee on a plan entitled “Plan of Land in Mashpee, Mass. As surveyed for Bonnie MacCarthy, Scale 1 in. = 40 ft., May 11, 1973, Nickerson & Berger, Inc. Engineers,” recorded with the Barnstable County Registry of Deeds at Plan Book 273, Page 2. Bounded and described as follows:
The above described parcel contains 29,708 ± s.f. or 0.6820 acres, more or less.
That certain parcel of land together with the buildings thereon located on the southerly side of Hollow Road in Mashpee, Barnstable County, Massachusetts, now known and numbered as 41 Hollow Road, described as follows:
Parcel 73A contains 10.81 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the east side of Meetinghouse Road more particularly shown as Parcel 58A on a plan entitled “Plan of Land Prepared for Old Indian Meeting House Authority, Inc. Scale 1″=10′, date March 29, 2007” prepared by Holmes and McGrath Inc. and recorded in Barnstable County Registry of Deeds, Plan Book 625 page 8. Bounded and described as follows:
The above parcel contains 6,447± s.f. or 0.1480 acres, more or less.
For grantor's title see deed dated April 28, 2008 from the Town of Mashpee, acting by and through its Board of Selectmen, and recorded in the Barnstable Registry of Deeds in Book 22867, Page 31.
Description of land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee on the west side of Falmouth Road, and the east side of Meetinghouse Road more particularly shown as Parcel 13B on a plan entitled “Plan of Land Prepared For Mashpee Wampanoag Tribe in Mashpee, MA. Scale 1″=80′, date May 16, 2008” prepared by Holmes and McGrath Inc. and recorded in Barnstable County Registry of Deeds, Plan Book 626 Page 4. Bounded and described as follows:
The above parcel contains 501,486± s.f. or 11.5125 acres, more or less.
For Grantor's title see deed dated May 19, 2008 from the Town of Mashpee, acting by and through its Board of Selectmen, and recorded in the Barnstable Registry of Deeds in Book 23010, Page 37.
Description of the land in the Commonwealth of Massachusetts, County of Barnstable, Town of Mashpee, on the northerly side of Main Street more particularly shown as parcel 27 42 0 on the Town of Mashpee Assessors Maps, bounded and described as follows:
Above described parcel contains 102,177 s.f. or 2.3456 acres, more or less.
For Grantor's title see deed dated April 28, 2008 from the Town of Mashpee, acting by and through its Board of Selectmen, and recorded in the Barnstable Registry of Deeds in Book 22867, Page 26.
That certain parcel of land together with the buildings thereon located on the easterly side of Meetinghouse Road in Mashpee, Barnstable County, Massachusetts, now known and numbered as #184 Meetinghouse Road, described as follows:
Parcel 75 contains 46.83 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the west side of O'Connell Way off of Stevens Street owned by the Taunton Development Corporation and shown as Assessor's Parcel 49 on Assessor's Map 118 and as Lot 9 on a plan by Field
The above described lot contains 2.726 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the west side of O'Connell Way off of Stevens Street owned by the Taunton Development Corporation and shown as Assessor's Parcel 27 on Assessor's Map 108 and as Lot 13 on a plan by Field Engineering Co., Inc. entitled “Definitive Subdivision Plan of Land, Liberty and Union Industrial Park—Phase II” and revised dated 3/08/2006, recorded in Plan Book 458, Page 21, bounded and described as follows: (For the purposes of these drawings, the portion of the property boundary defined by the centerline of the Cotley River has been approximated by line segments with bearings and distances).
The above described lot contains 22.238 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the west side of O'Connell Way off of Stevens Street owned by the Taunton Development Corporation and shown as Assessor's Parcel 26 on Assessor's Map 108 and as Lot 14 on a plan by Field Engineering Co., Inc. entitled “Definitive Subdivision Plan of Land, Liberty and Union Industrial Park—Phase II” and revised dated 3/08/2006, recorded in Plan Book 446, Pages 34-36, bounded and described as follows:
The above described lot contains 5.473 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the south side of Middleboro Avenue and west side of Stevens Street owned by the Taunton Development Corporation and shown as Assessor's Parcel 156 on Assessor's Map 94 and as shown on a plan by Tibbetts Engineering Corp. entitled “Plan of Land”, Prepared for Taunton Development Corporation (TDC) dated 4/25/2002, recorded in Plan Book 406, Pages 66-68, bounded and described as follows: (For the purposes of these drawings, the portion of the property boundary defined by the centerline of the Cotley River or the westerly edge of Barstow's Pond has been approximated by line segments with bearings and distances).
The above described lot contains 45.222 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the west side of Stevens Street owned by Taunton Development Corporation and shown as Assessor's Parcel 36 on Assessor's Map 95, bounded and described as follows:
The above described lot contains 1.293 acres, more or less.
The above described parcel has taken into consideration the roadway taking by the Commonwealth of Massachusetts, Department of Highways, for the relocation of Stevens Street, by taking dated September 8, 1993, recorded with Bristol County North District Registry of Deeds in Deed Book 5683, Page 12.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the west side of Stevens Street and the east side of O'Connell Way and more particularly shown as Lot 3A on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street, East Taunton, Massachusetts”, revised dated May 31, 2005 recorded in Plan Book 437, Page 30. Also a portion of said property is shown on a plan by Field Engineering Co. Inc., entitled “Definitive Subdivision Plan of Land, Liberty and Union Industrial Park—Phase II, Taunton Development Corporation”, revised dated March 8, 2006, recorded in Plan Book 446, Page 35 bounded and described as follows: Also see Tract 10 (Gap Parcel)
The above described parcel contains 3.895 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the west side of Stevens Street more particularly shown as Lot 2 on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street, County Street and Rte. 24 East Taunton, Massachusetts Prepared for Robert DiCroce”, dated March 23, 2005, recorded in Plan Book 436, Page 22, bounded and described as follows:
The above described parcel contains 6.875 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the west side of Stevens Street more particularly shown as Lot 2 on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street and O'Connell Way East Taunton, Massachusetts, prepared for One Stevens, LLC”, dated August 13, 2007, recorded in Plan Book 459, Page 72, bounded and described as follows:
The above described parcel contains 1.502 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the east side of O'Connell Way off Stevens Street, more particularly shown as Lot 11 on a plan by Cullinan Engineering Co. Inc., entitled “Definitive Subdivision Modification Plan of Land Liberty and Union Industrial Park—Phase II Taunton Development Corporation”, dated March 23, 2007, recorded in Plan Book 458, Page 21, bounded and described as follows:
The above described parcel contains 14.021 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the west side of Stevens Street and the west side on O'Connell Way more particularly shown as Lot 1A-R on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street and O'Connell Way East Taunton, Massachusetts prepared for One Stevens LLC”, dated August 13, 2007, recorded in Plan Book 459, Page 72, bounded and described as follows:
The above described parcel contains 9.146 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the west side of O'Connell Way off Stevens Street, more particularly shown as Lot 1B on plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street, County Street and Route 24 East Taunton, Massachusetts Prepared for the Maggiore Companies”, dated May 29, 2007, rev. June 13, 2007, recorded in Plan Book 458, Page 22, bounded and described as follows: (For the purposes of these drawings, the portion of the property boundary defined by the centerline of the Cotley River has been approximated by line segments with defined bearings and distances).
The above described parcel contains 26.249 acres, more or less.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on Stevens Street and Route 140, more particularly shown as Parcels A and B on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street, County Street and Rte. 24 East Taunton, Massachusetts, prepared for the Maggiore Companies”, dated May 29, 2007, recorded in Plan Book 458, Page 22 and as Parcel E on a plan by Cullinan Engineering Co. Inc., entitled “Plan of Land Stevens Street and O'Connell Way East Taunton, Massachusetts, Prepared for One Stevens LLC”, dated August 13, 2007, recorded in Plan Book 459, Page 72, bounded and described as follows:
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton on the west side of Stevens Street owned by the Taunton Development Corporation and shown as a proposed roadway layout on a plan by Field Engineering Co., Inc., entitled “Definitive Subdivision Plan of Land, Liberty and Union Industrial Park—Phase II” and revised dated 3/08/2006, recorded in Plan Book 446, Page 35, and a plan entitled, “Definitive Subdivision Modification Plan of Land, Liberty and Union Industrial Park—Phase II” and dated 3/23/2007, recorded in Plan Book 458, Page 21, bounded and described as follows:
The above described roadway parcel contains 3.442 +/− acres which, together with a 512 square foot easement on land now or formerly of Jamins LLC, constitute the O'Connell Way layout.
Said 512 square foot easement is on land now or formerly of Jamins LLC and is intended to be included with and for the use of O'Connell Way.
Description of land in the Commonwealth of Massachusetts, County of Bristol, City of Taunton, on the east side of O'Connell Way off Stevens Street being a land gap between the layout of O'Connell Way and Lot 10 in Plan Book 446, Page 35 and Parcel 2 described in a the deed from Taunton Development Corporation to Daniel G. DaRosa and Laurie B. DaRosa, dated July 18, 2005, recorded in Deed Book 15013, Page 42, bounded and described as follows:
The above described parcel contains 0.203 acres, more or less.
Description of parcel of land in Taunton, Massachusetts shown as Tax Parcel 119-2-0 on the City of Taunton Assessor's plans, bounded and described as follows:
The above described lot contains 0.699 acres, more or less.
Being the same premises conveyed to Kathleen Williams and Kenneth Williams by deed of Ernestina R. Torres and Nelson Henriquez, dated July 28, 2005 and recorded in Deed Book 15029, Page 189.
Description of parcel of land in Taunton, Massachusetts shown as tax parcel 119-3-0 on the City of Taunton Assessor's plans, bounded and described as follows:
The land in Taunton, on the northwesterly side of Stevens Street, being shown as Lot #9A on a plan entitled “Property of Richard C. Tilton et ux Taunton, Mass. Scale 1″ = 20′ July 8, 1964 John P. Gonzals, Surveyor”, which plan is recorded with Bristol County Northern District Registry of Deeds, Plan Book 94, Page 9 and being more particularly described as follows:
The above described lot contains 0.396 acres, more or less.
Being the same premises conveyed to John M. Allen by deed of John M. Allen and Betty Jean Allen dated June 4, 2011 and recorded in Deed Book 20376, page 275.
Description of parcel of land in Taunton, Massachusetts shown as Tax Parcel 109-17-0 on the City of Taunton Assessors' Plans and being more particularly described as follows:
The land located on the westerly side of Stevens Street, East Taunton, Bristol County, Massachusetts shown as Lot 3B on a plan entitled, “Plan of Land Stevens Street, East Taunton, Massachusetts, prepared for Taunton Development Corporation”, prepared by Cullinan Engineering, Scale 1″ = 30′ revised dated May 31, 2005 which plan is recorded with the Bristol County Northern District Registry of Deeds in Plan Book 437, Page 30, containing
The above described lot contains 0.416 acres more or less.
Being the same premises conveyed to Edward A. Haskins, Jr. and Sheri L. Haskins by deed of Jeffrey D. Smith dated December 30, 2005, recorded in Deed Book 15519, page 221.
Bureau of Land Management, Interior.
Notice.
On March 6, 2015, the Department of Interior, Bureau of Land Management (BLM), published in the
Written comments must be received on or before January 25, 2016. Two public meetings will be scheduled. Notice of the meetings will be provided on the BLM Web site (see
Submit your comments, identified by WMRNP in the subject line, by one of the following methods:
• Email:
• Web site:
• Fax: 951-697-5299.
• Mail: BLM California Desert District Office, 22835 Calle San Juan de Los Lagos, ATTN: West Mojave Route Network Project, Moreno Valley, CA 92553-9046.
Edythe Seehafer, telephone 760-252-6021; address: Bureau of Land Management, Barstow Field Office, 2601 Barstow Road, Barstow, CA 92311; email
Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1 (800)877-8339 to contact the above individual during normal business hours. The FIRS is available 24 hours a day, 7 days a week, to leave a message or question with the above individual. You will receive a reply during normal business hours.
On March 6, 2015, the BLM published in the
Concurrent with the WMRNP planning effort, the BLM is proposing CDCA LUPA alternatives in the DRECP that include, among other proposals, special area designations and associated management parameters, and which comprise new information that may be considered in the identification of alternatives and the analysis of impacts in the WMRNP. The BLM is considering whether to adjust or add additional alternatives to the WMRNP in response to the proposals in the DRECP. All previously submitted comments will be considered; comments submitted during the initial WMRNP comment period need not be resubmitted.
Information and environmental documents on the DRECP are available for review at
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.
40 CFR 1501.7, 40 CFR 1506.6, 40 CFR 1506.10, 43 CFR 1610.2
Bureau of Ocean Energy Management (BOEM or “the Bureau”), Interior.
Final Sale Notice for Commercial Leasing for Wind Power on the Outer Continental Shelf Offshore New Jersey.
This document is the Final Sale Notice (FSN) for the sale of two commercial wind energy leases on the Outer Continental Shelf (OCS) offshore
BOEM will hold a mock auction for the qualified bidders on November 4, 2015. The monetary auction will be held online and will begin at 9:00 a.m. Eastern Time (ET) on November 9, 2015. Additional details are provided in the section entitled “Deadlines and Milestones for Bidders.”
Will Waskes, BOEM Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia, 20166, (703) 787-1320 or
This FSN is published pursuant to subsection 8(p) of the OCS Lands Act (43 U.S.C. 1337(p)) (OCSLA), as amended by section 388 of the Energy Policy Act of 2005 (EPAct), and the implementing regulations at 30 CFR part 585, including 30 CFR 585.211 and 585.216.
The two LAs offered in this FSN are the same areas BOEM announced in the PSN on July 21, 2014 (79 FR 42361). BOEM received 24 comment submissions in response to the PSN, which are available in the
On February 3, 2012, BOEM published the Notice of Availability (NOA) (77 FR 5560) for the final Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for commercial wind lease issuance and site assessment activities on the Atlantic OCS offshore New Jersey, Delaware, Maryland, and Virginia, pursuant to the National Environmental Policy Act. Consultations ran concurrently with the preparation of the EA and included consultation under the Endangered Species Act (ESA), Magnuson-Stevens Fishery Conservation and Management Act (MSFCMA), section 106 of the National Historic Preservation Act (NHPA), and the Coastal Zone Management Act (CZMA). The proposed lease areas identified in this FSN have been reduced from the areas described in the Call and the New Jersey Wind Energy Area (WEA) described in the EA, but are the same as the areas described in the PSN (79 FR 42361). An explanation regarding the reduction in the area is provided in the section entitled “Area Offered for Leasing” of the New Jersey PSN published on July 21, 2014 (79 FR 42361). The
On October 19, 2012, BOEM initiated consultation with the National Marine Fisheries Service (NMFS) under the ESA for geological and geophysical (G&G) activities in support of renewable energy development offshore New Jersey, New York, Massachusetts, and Rhode Island. Formal consultation concluded on April 10, 2013, with receipt of a Biological Opinion that, along with the previous informal consultation, informed the development of the New Jersey commercial wind lease package. Additional environmental reviews will be prepared upon receipt of the lessees' proposed project plans, such as a Site Assessment Plan (SAP) or Construction and Operations Plan (COP).
Potential bidders should be aware of the following unsolicited request for a right-of-way (ROW) grant, and two limited leases issued by BOEM within the New Jersey WEA.
These leases did not confer a right to develop a commercial offshore wind project. Rather, the leases granted the exclusive right to conduct the activities described in each lease, which were limited to installing and operating facilities to characterize wind and environmental resources. These leases expired on November 1, 2014; BOEM requires all facilities to be removed by November 1, 2015. Electronic copies of the executed leases can be found at:
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Further information on non-monetary packages can be found in the section of this notice entitled “Credit Factor Definitions.” If BOEM does not receive a bidder's non-monetary package by October 20, 2015, BOEM will assume that the bidder is not seeking a non-monetary auction credit and the BOEM panel responsible for determining bidder eligibility for the credit will not consider that bidder for a non-monetary auction credit.
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A map of the North and South LAs, GIS spatial files, and a table of the boundary coordinates in X, Y (eastings, northings) UTM Zone 18, NAD83 Datum, and geographic X, Y (longitude, latitude), NAD83 Datum can be found on BOEM's Web site at:
A large scale map of these areas, showing boundaries of the area with numbered blocks, is available from BOEM upon request at the following address: Bureau of Ocean Energy Management, Office of Renewable Energy Programs, 45600 Woodland Road, VAM-OREP, Sterling, Virginia, 20166, Phone: (703) 787-1300, Fax: (703) 787-1708.
Prospective bidders should note that certain sub-blocks (or portions thereof) in the North and South LAs may not be available for future development (
First, at the New Jersey Intergovernmental Task Force meeting on December 18, 2012, the United States Coast Guard (USCG) presented an analysis of tug, towing and barge traffic that currently transits through the New Jersey WEA. USCG's presentation discussed potential safety implications and possible changes in traffic patterns to the extent that vessels reroute around the New Jersey WEA once development occurs. USCG identified the OCS Blocks listed in Table 1 as blocks of highest concern. These blocks represent 6.8% of the South LA.
Additionally, during the New Jersey PSN comment period, BOEM received comments from the American Waterways Operators (AWO) expressing concern that the western boundary of the New Jersey WEA does not allow for a sufficiently wide two-way near-shore corridor for tug and barge vessels to navigate safely. AWO has argued that tug and barge vessels would have a sufficiently wide near-shore corridor along the New Jersey coast if the OCS Blocks listed in Tables 2 and 3 were not developed. These blocks represent 6.6% of the North LA and 15.7% of the South LA, and there is some overlap with the OCS Blocks identified in Table 1 above.
Maps identifying these blocks and sub-blocks are available on BOEM's Web site at:
Potential bidders should note that certain sub-blocks (or portions thereof) in the North LA may not be available for future development (
The U.S. Department of State has identified four active subsea cables that are present in the North LA. BOEM has not determined the degree to which subsea cables will interfere with offshore wind facility operations or the associated infrastructure, but believes it is prudent to make potential lessees aware of potential conflicts and provide them with guidance on how such conflicts can be addressed. To this end, BOEM is presently revising its COP guidelines to include recommendations for engaging and coordinating with owners and operators of existing telecommunications cables. BOEM will determine at the COP stage if any site-specific mitigation is needed for the New Jersey LAs, once it has more detailed information.
Table 4 lists the sub-blocks where the active cables are present. These sub-blocks represent 6.41% of the North LA. Maps identifying these whole blocks and sub-blocks are available on BOEM's Web site at:
BOEM received comments in response to the PSN regarding potential conflicts with commercial fishing grounds in the proposed leasing areas. Although BOEM is retaining these fishing areas in the LAs, potential bidders should be aware that BOEM will be gathering additional data and may develop mitigation measures to minimize impacts. BOEM has completed preliminary work with NMFS Northeast Fisheries Science Center to characterize fishing activity in BOEM's wind energy areas. Results for the New Jersey LAs indicate the potential for economic impacts, particularly to those vessels conducting dredge activities for surf clams and ocean quahog. BOEM will encourage the sale winners to participate in discussions that the Bureau will hold with NMFS, the Mid-Atlantic Fisheries Management Council, the Mid-Atlantic Regional Council on the Ocean, and other interested stakeholders to further characterize fishing activity offshore New Jersey and develop site-specific best management practices as lease activities progress. These discussions may result in mitigation measures in key fishing grounds to offset impacts to fishermen using the area.
BOEM also received comments from the fishing industry in response to the PSN recommending that its New Jersey leases stipulate that lessees must hire a fisheries liaison to reduce potential multiple use conflicts. BOEM's 2007 Record of Decision (ROD) for the OCS Alternative Energy and Alternate Use Program adopted a series of best management practices (BMPs), one of which states that “lessees and grantees shall work cooperatively with commercial/recreational fishing entities and interests to ensure that the construction and operation of a project will minimize potential conflicts with commercial and recreational fishing interests.” The ROD also states that BOEM may choose to incorporate one or more of its identified BMPs into its leases as required stipulations.
Between 2012 and 2014, BOEM collaborated with numerous stakeholders in the fishing and offshore wind industries to develop additional BMPs in furtherance of its goal of eliminating/minimizing potential multiple use conflicts between offshore renewable energy developers and the fishing industry. As a result of this effort, BOEM concluded that it would be beneficial for a lessee to utilize both a fisheries liaison and fisheries representative during the lessee's plan development process. Therefore, BOEM recommends that lessees utilize a fisheries liaison and fisheries representative during the development of their plans to facilitate cooperation with the fishing industry. However, given the benefits of preserving lessee flexibility and the lack of project-specific information available at this juncture, BOEM is not including stipulations requiring the use of a
• Addendum “A” (Description of Leased Area and Lease Activities);
• Addendum “B” (Lease Term and Financial Schedule);
• Addendum “C” (Lease Specific Terms, Conditions, and Stipulations);
• Addendum “D” (Project Easement);
• Addendum “E” (Rent Schedule);
• Appendix A to Addendum C: (Incident Report: Protected Species Injury or Mortality); and
• Appendix B to Addendum C: (Required Data Elements for Protected Species Observer Reports).
The most recent version of BOEM's renewable energy commercial lease form (BOEM-0008) is available on BOEM's Web site at:
BOEM is aware that long-term electrical offtake mechanisms (
For example, for an 183,353 acre lease (the size of the entire North LA), the rent payment will be $550,059 per year if no portion of the leased area is authorized for commercial operations. If 300 megawatts (MW) of a project's nameplate capacity is operating (or authorized for operation), and its most recent approved COP specifies a maximum project size of 500 MW, the rent payment will be $220,024. This payment is based on the 200 MW of nameplate capacity BOEM has not yet authorized for commercial operations. For the above example, this would be calculated as follows: 200MW/500MW × ($3/acre × 183,353 acres) = $220,024.
If the lessee submits an application for relinquishment of a portion of its lease area within the first 45 calendar days following the date that the lease is received by the lessee for execution, and BOEM approves that application, no rent payment will be due on that relinquished portion of the LA. Later relinquishments of any LA will reduce the lessee's rent payments starting in the year following BOEM's approval of the relinquishment.
The lessee also must pay rent for any project easement associated with the lease, commencing on the date that BOEM approves the COP (or modification thereof) that describes the project easement. Annual rent for a project easement that is 200 feet wide and centered on the transmission cable is $70 per statute mile. For any additional acreage required, the lessee must also pay the greater of $5 per acre per year or $450 per year.
For purposes of calculating the initial annual operating fee payment and pursuant to 30 CFR 585.506, an operating fee rate is applied to a proxy for the wholesale market value of the electricity expected to be generated from the project during its first twelve months of operations. This initial payment will be prorated to reflect the period between the commencement of commercial operations and the Lease Anniversary. The initial annual operating fee payment is due within 45 days of the commencement of commercial operations. Thereafter, subsequent annual operating fee payments are due on or before each Lease Anniversary.
The subsequent annual operating fee payments are calculated by multiplying the operating fee rate by the imputed wholesale market value of the projected annual electric power production. For the purposes of this calculation, the imputed market value is the product of the project's annual nameplate capacity, the total number of hours in the year (8,760), the capacity factor, and the annual average price of electricity derived from a historical regional wholesale power price index. For example, the annual operating fee for a 100 MW wind facility operating at a 40% capacity (
The capacity factor is expressed as a decimal between zero and one, and represents the share of anticipated generation of the wind facility that is delivered to the interconnection grid (
Within 10 business days after receiving the lease copies and pursuant to 30 CFR 585.515-.516, the provisional winner must provide an initial lease-specific bond, or other approved means of meeting the lessor's initial financial assurance requirements. A provisional winning bidder may meet financial assurance requirements by posting a surety bond or by setting up an escrow account with a trust agreement giving BOEM the right to withdraw the money held in the account on demand. BOEM encourages provisionally winning bidders to discuss the financial assurance requirement with BOEM as soon as possible after the auction has concluded.
BOEM will base the amount of all SAP, COP, and decommissioning financial assurance requirements on cost estimates for meeting all accrued lease obligations at the respective stages of development. The required amount of supplemental and decommissioning financial assurance will be determined on a case-by-case basis.
The financial terms can be found in Addendum “B” of the proposed leases, which BOEM has made available with this notice on its Web site at:
Each bidder must fill out the Bidder's Financial Form referenced in this FSN. BOEM has also made a copy of the form available with this notice on its Web site at:
BOEM will not consider BFFs submitted by qualified bidders for previous lease sales to satisfy the requirements of this auction. BOEM will also only consider BFFs submitted after the deadline if BOEM determines that the failure to timely submit the BFF was caused by events beyond the bidder's control. BOEM will only accept an original, executed paper copy of the BFF. The BFF must be executed by an authorized representative who has been identified in the qualifications package on file with BOEM as authorized to bind the company.
Following the auction, bid deposits will be applied against bonus bids or other obligations owed to BOEM. If the bid deposit exceeds a bidder's total financial obligation, the balance of the bid deposit will be refunded to the bidder. BOEM will refund bid deposits to non-winners.
As authorized under 30 CFR 585.220(a)(4) and 585.221(a)(6), BOEM will conduct this lease sale under a multiple-factor auction format, with a multiple-factor bidding system. Under this system, BOEM may consider a combination of monetary and non-monetary factors, or “variables,” in determining the outcome of the auction. BOEM will appoint a panel of three BOEM employees to review the non-monetary packages and verify the results of the lease sale. BOEM reserves the right to change the composition of this panel prior to the date of the lease sale. The panel plans to meet to consider non-monetary packages on November 5, 2015. At this meeting, the panel will determine whether any bidder has earned a non-monetary credit (such as by submitting legal documentation that it holds a valid PPA or OREC) to be used during the auction and, if so, the value of that credit. The panel also will help determine the
As described below, BOEM has updated the auction details previously described in the PSN (79 FR 42361): A bidder can now bid on and win only one of the two LAs. This change was made following receipt and assessment of comments made on the PSN, as described in BOEM's
Only qualified bidders who submit the required bid deposit are authorized to bid in the sale. BOEM's asking prices in the opening round will be the minimum bids for each LA.
The auction will balance consideration of two variables: (1) A cash bid, and (2) a non-monetary credit. These two variables comprise the multi-factor bid (or “as-bid” auction price), as reflected either in a bidder submitting a “live” bid (
Bidding continues in successive rounds as long as at least one LA had two or more live bids in the previous round. The bidding ends at the round in which both LAs have one or zero live bids. This triggers the two-stage award part of the auction, as discussed below.
All of the live bids submitted in any round of the auction will be preserved and considered binding until determination of the winning bids is made. Therefore, the bidders are responsible for payment of each of the bids they submit.
BOEM has chosen to adopt a multi-round, multiple-factor auction format, pursuant to 30 CFR 585.220(a)(4). Under this format, BOEM may consider a combination of factors as part of each bid. The multiple-factor format provides BOEM flexibility in administering the auction. The regulations leave to BOEM the determination as to how to administer the multiple-factor auction format in order to “ensure a fair return to the United States” under OCSLA, 43 U.S.C 1337(p)(2)(A).
Under the format for this sale, a bidder may submit a bid proposal,
The auction continues for both LAs as long as there are two or more competing live bids for either or both LAs. At the end of each round, BOEM will share with the bidders the number of live bids associated with each LA and the asking prices in the next round.
This auction format enables both consideration of more than one bidding factor and enhanced competition among bidders for lease areas. The auction format also allows bidders to adjust their bidding strategies and bidding targets in real time as the auction proceeds through successive rounds of bidding. Accordingly, BOEM has concluded that this auction format will enhance competition and reduce bidder uncertainty more effectively than other available auction formats.
Prior to the auction, BOEM will convene a panel pursuant to 30 CFR 585.222(d) to evaluate bidders' non-monetary packages to determine whether and to what extent each bidder is eligible for a non-monetary credit. To qualify for the credit, bidders must submit non-monetary packages that meet the criteria outlined in the “Credit Factor Definitions” section below. The only non-monetary credits that BOEM will consider in this auction are a New Jersey OREC award and a PPA. In order to receive one of these credits, a bidder must be legally, technically, and financially qualified to acquire a commercial OCS wind lease, and must not be affiliated with another bidding entity seeking credit for the same PPA or qualified application for a New Jersey OREC. Any single PPA or OREC cannot be used by more than one bidder in the auction. The panel will review all non-monetary packages submitted and will determine whether bidders have established that they are qualified to receive a credit—and the percentage at which that credit will apply. The auction will proceed whether or not any bidders have qualified for a non-monetary factor.
A bidder will earn the full 25% credit if the BOEM panel determines the bidder has either a New Jersey OREC Order or a PPA totaling 250 MW or more. Smaller credit percentages may be earned for holding a valid PPA totaling less than 250 MW. BOEM will inform bidders by email before the monetary stage of the auction regarding the percentage credit that will be applied to their bid.
The bid credit will be bundled into each bid. In each round, the auction system will show each bidder how their as-bid auction price is affected by the credit imputed to its bid. For an intra-round bid (as defined below), the credit will be based on the previous round's asking price, not on the additional amount above the previous round's asking price that may be offered in an intra-round bid.
To be eligible to offer a bid on a LA at the start of the auction, BOEM must receive a bidder's bid deposit of $450,000 by October 20, 2015. A bidder's bid deposit will be used by BOEM as a down payment on the winning bid submitted by the bidder, should it be awarded a lease.
The auction will be conducted in a series of rounds. At the start of each round BOEM will state an asking price for the North LA and an asking price for the South LA. If a bidder is willing to meet the asking price for one of the LAs, it will indicate its intent by submitting a bid equal to the asking price. Any bid equal to the asking price is considered a “live bid.” If the bidder has earned a credit, it will meet the asking price by submitting a multiple-factor bid—that is, a live bid that consists of a monetary element and a non-monetary element, the sum of which equals the asking price.
To participate in the next round of the auction, a bidder must submit a live bid for one of the LAs in each previous round.
As long as there are two or more live bids for at least one LA, the auction moves to the next round. BOEM will raise the asking price for such LA by an increment determined by BOEM. Asking price increments will be determined based on a number of factors, including (but not necessarily limited to) the expected time needed to conduct the auction and the number of rounds that have already occurred. BOEM reserves the right to increase or decrease bidding increments if it determines that different increments of asking prices are warranted.
A bidder may switch its live bid from one LA to the other in the current round only if its bid from the previous round was contested—
A bidder remains eligible to participate in the auction if it has submitted a live bid in the prior round, or has its uncontested bid carried forward by BOEM to the current round.
Between rounds, BOEM will disclose to all bidders eligible to bid in the next round: (1) The number of live bids for each LA in the previous round of the auction (
A bidder may submit an intra-round bid that is higher than the previous round's asking price and less than the current round's asking price. An intra-round bid must consist of a single offer price for the same LA from the bidder's live bid in the previous round. An intra-round bid in this sale is equivalent to an exit bid, since it reduces the bidder's eligibility by one LA, and the bidder only has an eligibility of one LA at the start of the auction. During the auction, the intra-round bid will be seen only by BOEM and not by other bidders.
BOEM will not consider intra-round bids the same way as it does live bids for the purpose of determining whether to increase the asking price for a particular LA or to end the auction. A LA with only intra-round bids in a given round will not have its asking price raised in the next round. As long as both LAs have one or zero live bids, the auction is over, regardless of the number of intra-round bids on each area. For example, if each LA has one live bid and multiple intra-round bids, the auction will end. All intra-round bids submitted during the auction will be preserved, and the highest intra-round bid for a LA in this sale may be determined to be the provisionally winning bid for that LA under certain circumstances.
After the bidding ends, BOEM will determine the provisionally winning bids through a two-stage award process. During this process, BOEM and its panel will assess the two components of the multiple-factor bids, determine the provisional winners for each LA and identify the applicable bid prices to be paid by the winners for the LA they won. The panel will also validate the results of the auction in a timely manner. Provisional winners may be disqualified if they are subsequently found to have violated auction rules or otherwise engaged in conduct detrimental to the integrity of the competitive auction.
In Stage 1, BOEM will determine if either or both LAs have one live bid. BOEM will designate the provisional winner of a LA to be that bidder who offers the only live bid for that LA in the final round of the auction. As a result, this bidder is provisionally assured of winning the LA included in its final round bid, regardless of any other prior-to-final round live bids or intra-round bids in any round. If both LAs are awarded to bidders in Stage 1, BOEM need not proceed to Stage 2.
In Stage 2, BOEM will determine if the LA(s) not awarded in Stage 1 can be awarded based on intra-round bids and prior round live bids. In making this determination, BOEM will award leases to the bid(s) that maximize(s) the total as-bid prices, subject to the condition that a bidder can win at most one LA. If there is a provisional winning bidder for a LA in Stage 1, all bids by that bidder on the other LA will be excluded from consideration in selecting the provisional winning bidder in Stage 2.
The award procedures in Stage 2 could result in a tie if, for example, two bidders submit identical intra-round bids or prior round live bids for the same LA. In such cases, BOEM will resolve the tie by randomized means.
If a bidder submits a bid that BOEM and its panel determine to be a provisionally winning bid, the bidder will be expected to sign the applicable lease documents and submit the full cash payment due within 10 days pursuant to 30 CFR 585.224. BOEM reserves the right to not issue the lease to the provisionally winning bidder if that bidder fails to timely sign and pay for the lease or otherwise fails to comply with applicable regulations or terms of this FSN. In that case, that bidder will forfeit its bid deposit. BOEM may consider failure of a bidder to timely pay the full amount due an indication that the bidder is no longer financially qualified to participate in other lease sales under BOEM's regulations at 30 CFR 585.106 and 585.107.
The definitions below will apply to the factors for which bidders may earn a credit.
A
(i) A complete description of the proposed project;
(ii) Specification of the energy products to be supplied by the Generator;
(iii) Identification of both the electricity Generator and Buyer that will enter into a long term contract;
(iv) A timeline for permitting, licensing, and construction;
(v) Pricing projected under the long term contract being sought, including prices for all market products that would be sold under the proposed long term contract;
(vi) A schedule of quantities of each product to be delivered and projected electrical energy production profiles;
(vii) The term for the long term contract;
(viii) Details of the firm cost recovery mechanism approved by the State's public utility commission or other applicable authority used to recover expenditures incurred as a result of the PPA;
(ix) Citations to all filings related to the PPA that have been made with state and Federal agencies, and identification of all such filings that are necessary to be made; and
(x) Copies of or citations to interconnection filings related to the PPA.
If the panel determines a bidder has executed a PPA for at least 250 MW, it will be eligible for the entire 25% credit. If the panel determines a bidder has executed a PPA for an amount less than 250 MW, the bidder may still be eligible for a non-monetary credit proportional to the PPA's fraction of 250 MW. The smaller percentage for a partial credit will be calculated according to the following formula:
A
The NJ BPU defines a qualified offshore wind project as a wind turbine electric generation facility in the Atlantic Ocean and connected to the electrical transmission systems in New Jersey, including the associated transmission-related interconnection facilities and equipment.
If the panel determines a bidder has secured a New Jersey OREC order satisfying the criteria outlined in the New Jersey Offshore Wind Economic Development Act (
Prior to the auction, the Auction Manager will send several bidder authentication packages to the bidders shortly after BOEM has processed the BFFs. One package will contain digital authentication tokens for each authorized individual allowing access to the auction Web site. The tokens will be mailed to the Primary Point of Contact indicated on the BFF. This individual is responsible for distributing the tokens to the individuals authorized to bid for that company. Bidders are to ensure that each token is returned within three business days following the auction. An addressed, stamped envelope will be provided to facilitate this process. In the event that a bidder fails to submit a bid deposit or does not participate in the auction, BOEM will de-activate that bidder's token and login information, and the bidder will be asked to return its tokens.
The second package contains login credentials for authorized bidders. The login credentials will be mailed to the address provided in the BFF for each authorized individual. Bidders can confirm these addresses by calling 703-787-1320. This package will contain user login information and instructions for accessing the Auction System Technical Supplement and Alternative Bidding Form. The login information, along with the tokens, will be tested during the Mock Auction.
The auction will begin at 9:00 a.m. ET November 9, 2015. Bidders may log in as early as 8:00 a.m. on that day. We recommend that bidders log in no later than 8:30 a.m. to ensure that any login issues are resolved prior to the start of the auction. Once bidders have logged in, they should review the auction schedule, which lists the start times, end times, and recess times of each round in the auction. Each round is structured as follows:
• Round bidding begins;
• Bidders enter their bids;
• Round bidding ends and the recess begins;
• During the recess, previous round results and the next round's asking prices are posted;
• Bidders review the previous Round results and prepare their next Round bids;
• Next Round bidding begins.
The first round will last about 30 minutes, and subsequent rounds may be shorter. Recesses are anticipated to last approximately 10 minutes. The descriptions of the auction schedule and asking price increments included with this FSN are tentative. Bidders should consult the auction schedule on the bidding Web site just before and during the auction for updated times. Bidding may continue until about 6:00 p.m. for each day of the auction. BOEM anticipates the auction will last one or two business days, but bidders are advised to prepare to continue bidding for additional business days as necessary to resolve the auction.
BOEM and the auction contractors will use the auction platform messaging service to keep bidders informed on issues of interest during the auction. BOEM will use the messaging system for auction schedule changes and other updates during the auction.
Bidders may place bids at any time during the round. At the top of the bidding page, a countdown clock will show how much time remains in the round. Bidders have until the scheduled ending time to place bids. Bidders should bid according to the procedures described in both this notice and the Auction System Technical Supplement. No information about bidding during the round is available until the round has closed and results have been posted, so there is no tactical advantage to placing bids early or late in the round.
The timing of the auction will be elaborated on and clarified in the Auction System Technical Supplement available on BOEM's Web site at:
Alternate Bidding Procedures enable a bidder who is having difficulties accessing the Internet to submit its bid via fax using an Alternate Bidding Form available on BOEM's Web site at:
In order to be authorized to use an Alternative Bidding Form, a bidder must call the help desk number listed in the Auction Manual
Bidding behavior in this sale is subject to Federal antitrust laws. Accordingly, following the auction, but before the acceptance of bids and the issuance of leases, BOEM will “allow the Attorney General, in consultation with the Federal Trade Commission, 30 days to review the results of the lease sale.” 43 U.S.C. 1337(c). If a bidder is found to have engaged in anti-competitive behavior in connection with its participation in the competitive bidding process, BOEM may reject the provisionally winning bid. Compliance with BOEM's auction procedures and regulations is not an absolute defense to violations of antitrust laws.
Anti-competitive behavior determinations are fact specific. However, such behavior may manifest itself in several different ways, including, but not limited to:
• An express or tacit agreement among bidders to not bid in an auction, or to bid a particular price;
• An agreement among bidders not to bid for a particular LA;
• An agreement among bidders not to bid against each other; and
• Other agreements among bidders that have the potential to affect the final auction price.
BOEM will decline to award a lease if the Attorney General, in consultation with the Federal Trade Commission, determines that doing so would be inconsistent with the antitrust laws.
For more information on whether specific communications or agreements could constitute a violation of Federal antitrust law, please see:
1. Execute the lease on the bidder's behalf;
2. File financial assurance, as required under 30 CFR 585.515-537; and
3. Pay by electronic funds transfer (EFT) the balance (if any) of the bonus bid (winning bid less the bid deposit). BOEM requires bidders to use EFT procedures (not
BOEM will not execute a lease until the three requirements above have been satisfied, BOEM has accepted the provisionally winning bidder's financial assurance pursuant to 30 CFR 585.515, and BOEM has processed the provisional winning bidder's payment.
BOEM may extend the ten business day deadline for executing the lease on the bidder's behalf, filing the required financial assurance, and/or paying the balance of the bonus bid if it determines the delay was caused by events beyond the provisional winning bidder's control.
If the provisionally winning bidder does not meet these requirements or otherwise fails to comply with applicable regulations or the terms of the FSN, BOEM reserves the right to not issue the lease to that bidder. In such a case the winning bidder will forfeit its bid deposit.
In the event that a provisional winner does not execute and return its lease according to the instructions in this notice, BOEM reserves the right to reconvene the panel to determine whether it is possible and desirable to identify a new provisionally winning bidder.
Within 45 days of the date that the provisionally winning bidder receives copies of the lease, it must pay the first year's rent using the
(a) If BOEM rejects your bid, BOEM will provide a written statement of the reasons and refund any money deposited with your bid, without interest.
(b) You will then be able to ask the BOEM Director for reconsideration, in writing, within 15 business days of bid rejection, under 30 CFR 585.118(c)(1). We will send you a written response either affirming or reversing the rejection.
The procedures for appealing final decisions with respect to lease sales are described in 30 CFR 585.118(c).
BOEM will protect privileged or confidential information that you submit as required by the Freedom of Information Act (FOIA). Exemption 4 of FOIA applies to “trade secrets and commercial or financial information that you submit that is privileged or confidential.” 5 U.S.C. 552(b)(4). If you wish to protect the confidentiality of such information, clearly mark it “Contains Privileged or Confidential Information” and consider submitting such information as a separate attachment. BOEM will not disclose such information, except as required by FOIA. Information that is not labeled as privileged or confidential will be regarded by BOEM as suitable for public release.
BOEM will not treat as confidential aggregate summaries of otherwise confidential information or comments not containing such information. Additionally, BOEM will not treat as confidential the legal title of the commenting entity (
Bureau of Ocean Energy Management (BOEM), Interior.
Notice of Intent (NOI) to prepare an Environmental Impact Statement (EIS).
BOEM is announcing its intent to prepare an EIS for the Liberty Development and Production Plan (DPP) in the Beaufort Sea Planning Area. The DPP proposes several steps. A man-made gravel production island, known as the Liberty Drilling and Production Island (LDPI), would be established in Foggy Island Bay. Gravel for construction would come from a new mine west of the Kadleroshilik River. A pipeline would link the LDPI to the Badami Sales Oil Pipeline (Badami pipeline). The pipe-in-pipe pipeline would be buried along a route going south from the LPDI to the shoreline west of the Kadleroshilik River, transition to an above-ground pipeline, and continue south to tie into the existing Badami pipeline. Oil produced from the LDPI would be transported through the Badami pipeline to the existing common carrier pipeline system to the Trans-Alaska Pipeline System.
This NOI also serves to announce the beginning of the scoping process. The scope of an EIS refers to the range of issues, alternatives, and mitigation measures to be considered. Public scoping assists the agency in focusing on significant issues and alternatives and eliminating from detailed consideration those issues that are insignificant, irrelevant or have been fully and adequately considered in prior analyses. No alternatives, other than the no-action alternative, have yet been identified.
Through this notice, BOEM also invites public input regarding the identification of historic properties and potential effects from the proposed action to historic properties as defined by the National Historic Preservation Act (NHPA) (54 U.S.C. 306108), as provided for in 36 CFR 800.2(d)(3). Additional information related to the Liberty DPP, including the proposed plan itself, may be found at
Comments should be submitted no later than November 24, 2015.
For information on the Liberty DPP EIS, the submission of comments, or BOEM's policies associated with this notice, please contact Lauren Boldrick, Project Manager, BOEM, Alaska OCS Region, 3801 Centerpoint Drive, Suite 500, Anchorage, AK 99503, telephone (907) 334-5227.
BOEM invites qualified entities, such as other Federal agencies, state, tribal, and local governments, to consider becoming cooperating agencies for the preparation of this EIS. Following the guidelines at 40 CFR 1501.6 and 1508.5 from the Council on Environmental Quality (CEQ), qualified agencies and governments are those with “'jurisdiction by law or special expertise.” Potential cooperating agencies should consider their authority and capacity to assume the responsibilities of a cooperating agency and remember that an agency's role in the environmental analysis neither enlarges nor diminishes the final decisionmaking authority of any other agency involved in the National Environmental Policy Act (NEPA) process. Upon request, BOEM will provide potential cooperating agencies with a written summary of guidelines for cooperating agencies, including time schedules and critical action dates, milestones, responsibilities, scope and detail of cooperating agencies' contributions, and availability of pre-decisional information. BOEM anticipates this summary will form the basis for a Memorandum of Understanding between BOEM and any cooperating agency consistent with 43 CFR 46.226(d). BOEM, as the lead agency, will not provide financial assistance to cooperating agencies. In addition to becoming a cooperating agency, other opportunities will exist to provide information and comments to BOEM during the public comment period for the EIS.
Federal, state, tribal, and local governments and/or agencies and other interested parties may submit written comments on the scope of this EIS through the Federal eRulemaking Portal:
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 comments to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
Pursuant to the regulations implementing the procedural provisions of NEPA, BOEM will hold public scoping meetings. The purpose of these meetings is to solicit comments on the scope of the Liberty Development and Production Plan EIS. These meetings are scheduled as follows:
• November 2, 2015, Westmark Conference Center, Fairbanks, Alaska;
• November 3, 2015, Kaktovik Community Center, Kaktovik, Alaska;
• November 4, 2015, Kisik Community Center, Nuiqsut, Alaska;
• November 5, 2015, Inupiat Heritage Center, Barrow, Alaska; and
• November 9, 2015, Embassy Suites (Benson Boulevard), Anchorage, Alaska.
This NOI to prepare an EIS is in compliance with the National Environmental Policy Act of 1969, as amended (42 U.S.C. 4231
On September 21, 2015, the Department of Justice lodged a proposed consent decree with the United States District Court for the Southern District of West Virginia in the lawsuit entitled
The United States filed this lawsuit under the Clean Air Act. The United States' complaint alleges that Bayer CropScience violated section 112(r) of the Clean Air Act, 42 U.S.C. 7412(r), which addresses the prevention of accidental releases. The claims arise out of a 2008 explosion at the Methomyl production unit at Bayer CropScience's plant in Institute, West Virginia. The consent decree requires the defendant, Bayer CropScience LP, to pay a civil penalty of $975,000, to perform injunctive relief to reduce the likelihood of future accidents at the Institute Plant and several other chemical processing
The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $43.25 (25 cents per page reproduction cost) payable to the United States Treasury. For a paper copy without the exhibits and signature pages, the cost is $10.00.
Office of Juvenile Justice and Delinquency Prevention, DOJ.
Notice of meeting.
The Office of Juvenile Justice and Delinquency Prevention (OJJDP) has scheduled a meeting of the Federal Advisory Committee on Juvenile Justice (FACJJ).
Scott Pestridge, Acting Designated Federal Official, OJJDP,
The Federal Advisory Committee on Juvenile Justice (FACJJ), established pursuant to section 3(2)A of the Federal Advisory Committee Act (5 U.S.C. App. 2), will meet to carry out its advisory functions under section 223(f)(2)(C-E) of the Juvenile Justice and Delinquency Prevention Act of 2002. The FACJJ is composed of representatives from the states and territories. FACJJ member duties include: Reviewing Federal policies regarding juvenile justice and delinquency prevention; advising the OJJDP Administrator with respect to particular functions and aspects of OJJDP; and advising the President and Congress with regard to state perspectives on the operation of OJJDP and Federal legislation pertaining to juvenile justice and delinquency prevention. More information on the FACJJ may be found at
Wage and Hour Division, Department of Labor.
Notice; correction.
On September 16, 2015, the Department of Labor (the Department) published a notice to announce the applicable minimum wage rate to be paid to workers performing work on or in connection with Federal contracts covered by Executive Order 13658 (the Executive Order), beginning January 1, 2016.
Robert Waterman, Acting Director, Division of Regulations, Legislation, and Interpretation, Wage and Hour Division, U.S. Department of Labor, Room S-3502, 200 Constitution Avenue NW., Washington, DC 20210; telephone: (202) 693-0406 (this is not a toll-free number). Copies of this notice may be obtained in alternative formats (Large Print, Braille, Audio Tape, or Disc), upon request, by calling (202) 693-0023
On September 16, 2015, the Department published a notice to announce the applicable minimum wage rate to be paid to workers performing work on or in connection with Federal contracts covered by Executive Order 13658, beginning January 1, 2016.
Bureau of International Labor Affairs, U.S. Department of Labor.
Notice.
The Office of Trade and Labor Affairs (OTLA) gives notice that on September 21, 2015, Submission #2015-01 regarding Peru was accepted for review pursuant to Article 17.5.5 of the United States-Peru Trade Promotion Agreement (PTPA).
On July 23, 2015, the International Labor Rights Forum,
OTLA's decision to accept the submission for review is not intended to indicate any determination as to the validity or accuracy of the allegations contained in the submission. The objective of the review will be to gather information so that OTLA can better understand the allegations contained in the submission and publicly report on the issues raised therein in light of the GOP's obligations under the Labor Chapter of the PTPA. As set out in the Procedural Guidelines (published as 71 FR 76691, December 21, 2006), OTLA will complete the review and issue a public report to the Secretary of Labor within 180 days of this acceptance, unless circumstances, as determined by OTLA, require an extension of time.
Matthew Levin, Director, OTLA, U.S. Department of Labor, 200 Constitution Avenue NW., Room S-5303, Washington, DC 20210. Telephone: (202) 693-4900. (This is not a toll-free number.)
Article 17.5 of the Labor Chapter of the PTPA establishes that each Party's contact point shall provide for the submission, receipt, and consideration of communications (“submissions”) on matters related to the Labor Chapter and each Party shall review those submissions in accordance with domestic procedures. A
The Procedural Guidelines specify that OTLA shall consider six factors, to the extent that they are relevant, in determining whether to accept a submission for review:
1. Whether the submission raises issues relevant to any matter arising under a labor chapter;
2. Whether a review would further the objectives of a labor chapter;
3. Whether the submission clearly identifies the person filing the submission, is signed and dated, and is sufficiently specific to determine the nature of the request and permit an appropriate review;
4. Whether the statements contained in the submission, if substantiated, would constitute a failure of the other Party to comply with its obligations or commitments under a labor chapter;
5. Whether the statements contained in the submission or available information demonstrate that appropriate relief has been sought under the domestic laws of the other Party, or that the matter or a related matter is pending before an international body; and
6. Whether the submission is substantially similar to a recent submission and significant, new information has been furnished that would substantially differentiate the submission from the one previously filed.
U.S. Submission # 2015-01 alleges that, by permitting the unlimited consecutive renewal of short-term contracts under the Law Promoting Non-Traditional Exports (Law No. 22342) and Article 80 of the Law of Productivity and Labor Competitiveness (Law No. 728, Supreme Decree No. 003-97-TR), the GOP has failed to adopt and maintain, in its statutes and regulations, and practices thereunder, the right of freedom of association and the effective recognition of the right to collective bargaining. The submission also cites specific instances to support its allegation that the GOP, through its action or inaction, has failed to effectively enforce its labor laws in the non-traditional export and agricultural sectors with respect to freedom of association, the effective recognition of the right to collective bargaining, and acceptable conditions of work.
In determining whether to accept the submission, OTLA considered the statements in the submission in light of the relevant factors identified in the Procedural Guidelines. The submission raises issues relevant to the Labor Chapter of the PTPA because it cites alleged GOP failures to adopt and maintain in its statutes and regulations, and practices thereunder, freedom of association and the effective recognition of the right to collective bargaining, and alleged GOP failures to effectively enforce its labor laws with respect to freedom of association, collective bargaining, and acceptable conditions of work. It also clearly identifies the submitter and is sufficiently specific to determine the nature of the request and permit an appropriate review. The submission raises pertinent issues that could further the objectives of the Labor Chapter and that could, if substantiated, constitute a failure of the GOP to comply with its obligations under the Labor Chapter. The submitters provided information on specific cases of alleged labor violations and included citations to both Peruvian law and International Labor Organization (ILO) Conventions ratified by Peru that they believe were violated by the allegations in the submission. The submitters provided information on efforts to seek appropriate relief for these alleged violations under domestic laws and to raise the issues with GOP officials and with the ILO. The submission also notes that the issues raised in the submission have not been remedied to date. OTLA has not received similar submissions related to the PTPA obligations of the GOP. Accordingly, OTLA has accepted the submission for review.
OTLA's decision to accept the submission for review is not intended to indicate any determination as to the validity or accuracy of the allegations contained in the submission. The
Occupational Safety and Health Administration (OSHA), Labor.
Request for public comments.
OSHA solicits public comments concerning its proposal to extend the Office of Management and Budget's (OMB) approval of the information collection requirements contained in the Lead in General Industry Standard (29 CFR 1910.1025).
Comments must be submitted (postmarked, sent, or received) by November 24, 2015.
Theda Kenney or Todd Owen, Directorate of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609, 200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-2222.
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent (
The purpose of the Lead in General Industry Standard and its collection of information requirements is to reduce occupational lead exposure in general industry. Lead exposure can result in both acute and chronic effects and can be fatal in severe cases of lead toxicity. The standard contains the following collection of information requirements: Conducting worker exposure monitoring; notifying workers of their lead exposure levels; establishing, implementing and reviewing a written compliance program annually; labeling containers of contaminated protective clothing and equipment; providing medical surveillance to workers; providing examining physicians with specific information; notifying workers of their medical surveillance results (including medical examinations and biological monitoring) and of the option for multiple physician review; posting warning signs; establishing and maintaining exposure monitoring, medical surveillance, and medical removal records; and providing workers with access to these records. The records are used by employees, physicians, employers and OSHA to determine the effectiveness of the employer's compliance efforts.
OSHA has a particular interest in comments on the following issues:
• Whether the proposed collection of information requirements are necessary for the proper performance of the Agency's functions, including whether the information is useful;
• The accuracy of OSHA's estimate of the burden (time and costs) of the collection of information requirements, including the validity of the methodology and assumptions used;
• The quality, utility, and clarity of the information collected; and
• Ways to minimize the burden on employers who must comply; for example, by using automated or other technological information collection and transmission techniques.
The Agency is requesting an adjustment decrease of 75,092 burden hours (from 1,105,397 to 1,030,305 burden hours). The decrease in burden hours is due to an estimated overall decrease in the number of covered establishments, based on updated data and estimates. There is also an estimated decrease in operation and maintenance costs of $50,556,032, from $143,192,845 to $92,636,813. The decrease in operation and maintenance costs is due to an estimated decrease in the cost of biological medical surveillance, due to the Agency's identification of a new data source which indicates a lower cost for biological monitoring tests than previously assumed.
You may submit comments in response to this document as follows: (1) Electronically at
Because of security procedures, the use of regular mail may cause a significant delay in the receipt of comments. For information about security procedures concerning the delivery of materials by hand, express delivery, messenger, or courier service, please contact the OSHA Docket Office at (202) 693-2350, (TTY (877) 889-5627). Comments and submissions are posted without change at
David Michaels, Ph.D., MPH, Assistant Secretary of Labor for Occupational Safety and Health, directed the preparation of this notice. The authority for this notice is the Paperwork Reduction Act of 1995 (44 U.S.C. 3506
The Legal Services Corporation's Board of Directors and its six committees will meet October 4-6, 2015. On Sunday, October 4, the first meeting will commence at 1:00 p.m., Pacific Standard Time (PST), with the meeting thereafter commencing promptly upon adjournment of the immediately preceding meeting. On Monday, October 5, the first meeting will commence at 3:00 p.m., PST, with the next meeting commencing at 4:15 p.m., PST. On Tuesday, October 6, the first meeting will commence at 9:00 a.m., PST, it will be followed by the closed session meeting of the Board of Directors which will commence promptly upon adjournment of the prior meeting.
Hyatt Regency San Francisco, 5 Embarcadero Center, San Francisco, California 94111.
Unless otherwise noted herein, the Board and all committee meetings will be open to public observation. Members of the public who are unable to attend in person but wish to listen to the public proceedings may do so by following the telephone call-in directions provided below.
• Call toll-free number: 1-866-451-4981;
• When prompted, enter the following numeric pass code: 5907707348;
• When connected to the call, please immediately “MUTE” your telephone.
Members of the public are asked to keep their telephones muted to eliminate background noises. To avoid disrupting the meeting, please refrain from placing the call on hold if doing so will trigger recorded music or other sound. From time to time, the presiding Chair may solicit comments from the public.
* Please note that all times in this notice are in
Open, except as noted below.
Board of Directors—Open, except that, upon a vote of the Board of Directors, a portion of the meeting may be closed to the public to hear briefings by management and LSC's Inspector General, and to consider and act on the General Counsel's report on potential
** Any portion of the closed session consisting solely of briefings does not fall within the Sunshine Act's definition of the term “meeting” and, therefore, the requirements of the Sunshine Act do not apply to such portion of the closed session. 5 U.S.C. 552b(a)(2) and (b).
Institutional Advancement Committee—Open, except that, upon a vote of the Board of Directors, the meeting may be closed to the public to consider and act on recommendation of new prospective donors and to receive a briefing on the development report.**
Audit Committee—Open, except that the meeting may be closed to the public to hear a briefing on the Office of Compliance and Enforcement's active enforcement matters.**
A verbatim written transcript will be made of the closed session of the Board, Institutional Advancement Committee, and Audit Committee meetings. The transcript of any portions of the closed sessions falling within the relevant provisions of the Government in the Sunshine Act, 5 U.S.C. 552b(c)(6) and (10), will not be available for public inspection. A copy of the General Counsel's Certification that, in his opinion, the closing is authorized by law will be available upon request.
Katherine Ward, Executive Assistant to the Vice President & General Counsel, at (202) 295-1500. Questions may be sent by electronic mail to
Non-confidential meeting materials will be made available in electronic format at least 24 hours in advance of the meeting on the LSC Web site, at
LSC complies with the American's with Disabilities Act and Section 504 of the 1973 Rehabilitation Act. Upon request, meeting notices and materials will be made available in alternative formats to accommodate individuals with disabilities. Individuals who need other accommodations due to disability in order to attend the meeting in person or telephonically should contact Katherine Ward, at (202) 295-1500 or
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Astrophysics Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The meeting will be held for the purpose of soliciting, from the scientific community and other persons, scientific and technical information relevant to program planning.
Thursday, October 22, 2015, 9:00 a.m.-5:00 p.m., and Friday, October 23, 2015, 11:00 a.m.-5:00 p.m., Local Time.
NASA Goddard Space Flight Center, Building 34, Room W305, 8800 Greenbelt Road, Greenbelt, MD 20771.
Ms. Ann Delo, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0750, fax (202) 358-2779, or
The meeting will be open to the public up to the capacity of the room. This meeting will also be available telephonically and by WebEx. Any interested person may call the USA toll free conference call number 1-877-917-4912, or the toll number 1-312-470-0131 to participate in this meeting by telephone, passcode APSOctober. The telephone numbers and passcode will be used both days. The WebEx link is
The agenda for the meeting includes the following topics:
Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID to Security before access to the Goddard Space Flight Center. Due to the Real ID Act, Public Law 109-13, any attendees with driver's licenses issued from non-compliant states/territories must present a second form of identification: [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Arizona, Idaho, Louisiana, Maine, Minnesota, New Hampshire, and New York. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 working days prior to the meeting: Full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee; and home address to Ms. Briana E. Horton, via email at
6:00 p.m., Thursday, September 24, 2015.
Board Room, 7th Floor, Room 7047, 1775 Duke Street, Alexandria, VA 22314-3428.
Closed.
Pursuant to the provisions of the “Government in Sunshine Act,” notice is hereby given that the NCUA Board unanimously determined that agency business required holding a closed meeting with less than seven days' notice to the public, and that no earlier notice of the meeting was possible.
1. Consideration of Supervisory Action. Closed pursuant to Exemptions (8), (9) and (9)(ii).
Gerard Poliquin, Secretary of the Board, Telephone: 703-518-6304.
National Science Foundation.
Notice of Permit Modification Request Received under the Antarctic Conservation Act of 1978, Public Law 95-541.
The National Science Foundation (NSF) is required to publish a notice of requests to modify permits issued to conduct activities regulated under the Antarctic Conservation Act of 1978. NSF has published regulations under the Antarctic Conservation Act at title 45, part 670 of the Code of Federal Regulations. This is the required notice of a requested permit modification.
Interested parties are invited to submit written data, comments, or views with respect to this permit application by October 26, 2015. Permit applications may be inspected by interested parties at the Permit Office, address below.
Comments should be addressed to Permit Office, Room 755, Division of Polar Programs, National Science Foundation, 4201 Wilson Boulevard, Arlington, Virginia 22230.
Li Ling Hamady, ACA Permit Officer, at the above address or
The National Science Foundation, as directed by the Antarctic Conservation Act of 1978 (Pub. L. 95-541), as amended by the Antarctic Science, Tourism and Conservation Act of 1996, has developed regulations for the establishment of a permit system for various activities in Antarctica and designation of certain animals and certain geographic areas a requiring special protection. The regulations establish such a permit system to designate Antarctic Specially Protected Areas.
Now the applicant proposes a modification to the permit to extend the permit's duration, which had expired on June 30, 2015, and to include the use of Unmanned Aerial Systems (UASs) for photography, in order to make it consistent with and correspond to their Marine Mammal Protection Act permit (14097-06), which was recently extended and updated to include the aforementioned activity. The applicant would use utilize a remotely operated UAS (Unmanned Aerial System) equipped with a small high resolution camera to fly and take pictures at altitudes of 90-180 ft above the following species: killer whales (≤600 individuals), humpback whales (≤100 individuals), and Antarctic minke whales (≤100 individuals). The applicant wants to collect morphological data on the 4 types of killer whales to assist with taxonomic studies; identify prey species for small type B killer whales; and assess fitness in minke and humpback whales to provide baseline data for assessing the impact of krill fisheries on whale stocks in the Antarctic Peninsula area. The applicant has successfully deployed the equipment array over 200 times in various environments without wildlife disturbance.
Nuclear Regulatory Commission.
Standard review plan-final section; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final revision to Section 9.2.7, “Chilled Water System,” of NUREG-0800, “Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition.”
The effective date of this Standard Review Plan update is October 26, 2015.
Please refer to Docket ID NRC-2014-0184 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
• The NRC posts its issued staff guidance on the NRC's external Web page (
Mark Notich, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-6256, email:
On August 5, 2014 (79 FR 45498), the NRC published for public comment the proposed SRP Section 9.2.7, “Chilled Water,” in Chapter 9, “Auxiliary Systems,” of NUREG-0800. The NRC staff received comments on the draft section. After consideration of comments received on the proposed revision, the NRC staff reformatted guidance for the review of nonsafety-related structures, systems, and components (SSCs) into a tabular format, and separated it from the core review guidance used for review of safety-related SSCs. A summary of comments received and the staff's disposition of the comments are available in a separate document, “
The SRP Section 9.2.7, provides guidance to the staff for reviewing applications for a construction permit and an operating license under part 50 of Title 10 of the
Issuance of this SRP section revision does not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) nor is it inconsistent with the issue finality provisions in 10 CFR part 52. The NRC's position is based upon the following considerations:
1.
The SRP provides internal guidance to the NRC staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which either nuclear power plant applicants or licensees are protected under either the Backfit Rule or the issue finality provisions of 10 CFR part 52.
2.
The NRC staff does not intend to impose or apply the positions described in the SRP to existing licenses and regulatory approvals. Hence, the issuance of this SRP—even if considered guidance within the purview of the issue finality provisions in 10 CFR part 52—does not need to be evaluated as if it were a backfit or as being inconsistent with issue finality provisions. If, in the future, the NRC staff seeks to impose a position in the SRP on holders of already issued licenses in a manner that does not provide issue finality as described in the applicable issue finality provision, then the staff must make the showing as set forth in the Backfit Rule or address the criteria for avoiding issue finality as described in the applicable issue finality provision.
3.
Applicants and potential applicants are not, with certain exceptions, protected by either the Backfit Rule or any issue finality provisions under 10 CFR part 52. Neither the Backfit Rule nor the issue finality provisions under 10 CFR part 52—with certain exclusions—were intended to apply to every NRC action that substantially changes the expectations of current and future applicants.
The exceptions to the general principle are applicable whenever an applicant references a 10 CFR part 52 license (
This action is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
Nuclear Regulatory Commission.
Draft regulatory issue summary; request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is seeking public comment on a draft regulatory issue summary (RIS), RIS 2015-XX, “Review and Submission of Updates to the Final Safety Analysis Reports, Emergency Preparedness Documents, and Fire Protection Documents.” This RIS reminds addressees of the review and submission requirements regarding information to be withheld from public disclosure, and recommends a format for submission of updates to the Final Safety Analysis Reports (FSARs).
Submit comments by October 26, 2015. Comments received after this date will be considered if it is practical to do so, but the Commission is able to assure consideration only for comments received before this date.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Matthew Humberstone, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-1464; email:
Please refer to Docket ID NRC-2015-0226 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
Please include Docket ID NRC-2015-0226 in the subject line of your comment submission, in order to ensure that the NRC is able to make your comment submission available to the public in this docket.
The NRC cautions you not to include identifying or contact information in comment submisssions that you do not want to be publicly disclosed in your comment submission. The NRC will post all comment submissions at
If you are requesting or aggregating comments from other persons for submission to the NRC, then you should inform those persons not to include identifying or contact information that they do not want to be publicly disclosed in their comment submission. Your request should state that the NRC does not routinely edit comment submissions to remove such information before making the comment submissions available to the public or entering the comment submissions into ADAMS.
The NRC issues RISs to communicate with stakeholders on a broad range of regulatory matters. This may include communicating and restating staff technical positions on regulatory matters. The NRC staff has developed draft RIS 2015-XX to remind licensees of the review and submission requirements of section 2.390 of Title 10 of the
Specifically, the NRC is issuing this RIS for the following purposes:
• To remind licensees of the potential for physical protection information, which the NRC is required to protect in the same manner as commercial or financial information for the purposes of withholding from public disclosure pursuant to 10 CFR 2.390(d)(1), to be contained in documents that will be proactively released to the public in accordance with the Commission direction in Staff Requirements Memorandum (SRM)-SECY-15-0032 (ADAMS Accession No. ML15167A090). Specifically, the NRC reminds licensees of the potential for physical protection information to be contained in Preliminary Safety Analysis Reports,
• To recommend a format for submission of FSAR updates for nuclear power reactors. Research and test reactors and other non-power production and utilization facilities are not required to update their facility FSARs, unless applying for renewal of the facility license. Licensees have two submission format options regarding FSAR updates: (1) Electronically on a total FSAR replacement basis, as described in 10 CFR 50.4(b)(6), or (2) on a paper replacement page basis, as described in 10 CFR 50.71(e). Electronic submission of updates on a total FSAR replacement basis would save billable staff hours since time would not be taken to manually reconstruct sections of the FSAR for various staff reviews. Therefore, the NRC recommends that licensees voluntarily submit updates electronically (via CD or Electronic Information Exchange) on a total FSAR replacement basis. Submission of FSAR updates in this manner will also assist the NRC in its emergency response function by ensuring that recently-updated, total FSARs are available to NRC emergency response teams.
The NRC is requesting public comments on draft RIS 2015-XX. The NRC staff will make a final determination regarding issuance of the RIS after it considers any public comments received in response to this request.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
License amendment application; withdrawal by applicant.
The U.S. Nuclear Regulatory Commission (NRC) has granted the request of Northern States Power Company—Minnesota, doing business as Xcel Energy, to withdraw its application dated December 20, 2013, as supplemented by letters dated October 15, 2014, and May 28, 2015, for a proposed amendment to Renewed Facility Operating Licenses DPR-42 and DPR-60. The proposed amendment would have revised the Prairie Island Nuclear Generating Plant, Units 1 and 2, Emergency Plan to increase staff augmentation times for certain emergency response organization positions.
Please refer to Docket ID NRC-2014-0028 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Terry A. Beltz, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-3049, email:
The NRC has granted the request of Northern States Power Company—Minnesota (the licensee) to withdraw its application dated December 20, 2013 (ADAMS Accession No. ML13358A405), as supplemented by two letters dated October 15, 2014, and May 28, 2015 (ADAMS Accession Nos. ML14288A543 and ML15148A775, respectively) for a proposed amendment to Renewed Facility Operating Licenses DPR-42 and DPR-60 for the Prairie Island Nuclear Generating Plant, Units 1 and 2, located in Goodhue County, Minnesota.
The proposed amendment sought to revise the Emergency Plan for the Prairie Island Nuclear Generating Plant, Units 1 and 2, to increase the staff augmentation times for certain emergency response organization positions.
The NRC published a Biweekly Notice in the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Interim staff guidance; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing Interim Staff Guidance (ISG), FCSE ISG-14, “Acute Uranium Standards for Workers,” dated June 15, 2015. The ISG provides guidance to the NRC staff when reviewing licensee-proposed standards in the Integrated Safety Analysis Summary for determining worker uranium exposures that would result in high or intermediate consequences consistent with the general definition of these events in NRC regulations.
The ISG is available September 25, 2015.
Please refer to Docket ID NRC-2014-0173 when contacting the
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
James Hammelman, Office of Nuclear Material Safety and Safeguards, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-7526; email:
The purpose of this ISG (ADAMS Accession No. ML15147A682) is to identify acute uranium intake values that will be acceptable to the staff for classifying acute worker exposure events as high or intermediate consequence events consistent with the general definition of the terms presented in § 70.61 of Title 10 of the
In a
The NRC is issuing interim guidance for the NRC staff regarding acute uranium intake values for classifying acute worker exposure events. Issuance of the ISG does not constitute backfitting as defined in 10 CFR 70.76 (the Backfit Rule). The NRC's position is based upon the following considerations.
1.
The ISG provides interim guidance to the staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which applicants or licensees are protected under 10 CFR 70.76.
2.
Applicants and potential applicants are not, with certain exceptions, protected by the Backfit Rule. This is because the Backfit Rule was not intended to apply to every NRC action that substantially changes the expectations of current and future applicants.
This action is a rule as defined in the Congressional Review Act (5 U.S.C. 801-808). However, the Office of Management and Budget has not found it to be a major rule as defined in the Congressional Review Act.
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management.
60-Day Notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension without change of a currently approved information collection (ICR) 3206-0138, Reinstatement of Disability Annuity Previously Terminated Because of Restoration to Earning Capacity. As required by the Paperwork Reduction Act of 1995 (Public Law 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
Comments are encouraged and will be accepted until November 24, 2015. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to Retirement Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Alberta Butler, Room 2349, or sent via electronic mail to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW., Room 3316-AC, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
U.S. Office of Personnel Management.
Office of Personnel Management.
Notice of meeting.
The Federal Salary Council will meet on Friday, November 6, 2015, at the time and location shown below. The Council is an advisory body composed of representatives of Federal employee organizations and experts in the fields of labor relations and pay policy. The Council makes recommendations to the President's Pay Agent (the Secretary of Labor and the Directors of the Office of Management and Budget and the Office of Personnel Management) about the locality pay program for General Schedule employees under section 5304 of title 5, United States Code. The Council's recommendations cover the establishment or modification of locality pay areas, the coverage of salary surveys, the process of comparing Federal and non-Federal rates of pay, and the level of comparability payments that should be paid.
The Council will hear public testimony about the locality pay program, review the results of pay comparisons, and formulate its recommendations to the President's Pay Agent on pay comparison methods, locality pay rates, and locality pay areas and boundaries for 2017. The meeting is open to the public. Please contact the Office of Personnel Management at the address shown below if you wish to submit testimony or present material to the Council at the meeting.
Friday, November 6, 2015, at 10:00 a.m.
Office of Personnel Management, 1900 E Street NW., Pendleton Room 5th Floor, Washington, DC 20415.
Brenda L. Roberts, Deputy Associate Director, Pay and Leave, Office of Personnel Management, 1900 E Street NW., Room 7H31, Washington, DC 20415-8200. Phone (202) 606-2838; FAX (202) 606-0824; or email at
For the President's Pay Agent.
Office of Personnel Management.
30-Day notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a new information collection request (ICR) 3206-XXXX, Certification of Qualifying District of Columbia Service Under Section 1905 of Public Law (Pub. L.) 111-84. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the
Comments are encouraged and will be accepted until October 26, 2015. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of 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,
RI 20-126 is used to certify that an employee performed certain service with the District of Columbia (DC) that qualifies under section 1905 of Pub. L. 111-84 for determining retirement eligibility. However, this service cannot
U.S. Office of Personnel Management.
Office of Personnel Management.
30-Day Notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) 3206-0212, Rollover Election (RI 38-117), Rollover Information (RI 38-118), and Special Tax Notice Regarding Rollovers (RI 37-22). As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. This information collection was previously published in the
Comments are encouraged and will be accepted until October 26, 2015. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 144 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a
The Commission establishes Docket Nos. MC2015-84 and CP2015-140 to consider the Request pertaining to the proposed Priority Mail Contract 144 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 28, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Lyudmila Y. Bzhilyanskaya to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-84 and CP2015-140 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Lyudmila Y. Bzhilyanskaya is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than September 28, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Parcel Select Contract 10 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-85 and CP2015-141 to consider the Request pertaining to the proposed Parcel Select Contract 10 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 28, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Curtis E. Kidd to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-85 and CP2015-141 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Curtis E. Kidd is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than September 28, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 143 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-83 and CP2015-139 to consider the Request pertaining to the proposed Priority Mail Contract 143 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 28, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints Kenneth R. Moeller to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-83 and CP2015-139 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, Kenneth R. Moeller is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than September 28, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of Priority Mail Contract 142 negotiated service agreement to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
The Postal Service contemporaneously filed a redacted contract related to the proposed new product under 39 U.S.C. 3632(b)(3) and 39 CFR 3015.5. Request, Attachment B.
To support its Request, the Postal Service filed a copy of the contract, a copy of the Governors' Decision authorizing the product, proposed changes to the Mail Classification Schedule, a Statement of Supporting Justification, a certification of compliance with 39 U.S.C. 3633(a), and an application for non-public treatment of certain materials. It also filed supporting financial workpapers.
The Commission establishes Docket Nos. MC2015-82 and CP2015-138 to consider the Request pertaining to the proposed Priority Mail Contract 142 product and the related contract, respectively.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than September 28, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints JP Klingenberg to serve as Public Representative in these dockets.
1. The Commission establishes Docket Nos. MC2015-82 and CP2015-138 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, JP Klingenberg is appointed to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
3. Comments are due no later than September 28, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 18, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 18, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 18, 2015, it filed with the Postal Regulatory Commission a
Postal Service
Notice.
The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.
Elizabeth A. Reed, 202-268-3179.
The United States Postal Service® hereby gives notice that, pursuant to 39 U.S.C. 3642 and 3632(b)(3), on September 18, 2015, it filed with the Postal Regulatory Commission a
Securities and Exchange Commission (“Commission”).
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from all provisions of the Act.
Applicants request an order that would permit GE Capital International Funding Company (“FinCo”) to issue and sell commercial paper, preferred stock and other debt securities to finance the operations of subsidiaries of General Electric Company (“GE”). Applicants state that FinCo would qualify for the exemption provided by rule 3a-5 under the Act but for the fact that FinCo may finance GE subsidiaries that are not “companies controlled by” GE within the meaning of rule 3a-5 due to their reliance on sections 3(c)(5) or 3(c)(6) of the Act (collectively, the “Controlled Companies”).
GE and FinCo.
The application was filed on September 21, 2015.
An order granting the application 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 October 16, 2015, 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.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants, 299 Park Avenue, New York, NY 10171.
Steven I. Amchan, Senior Counsel, at (202) 551-6826, or Mary Kay Frech,
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. GE, a New York corporation, is one of the largest and most diversified infrastructure and financial services corporations in the world. Its products and services range from aircraft engines, power generation, oil and gas production equipment and household appliances to medical imaging, business and consumer financing and industrial products. Applicants state that GE is not an investment company as defined in section 3(a) of the Act.
2. General Electric Capital Corporation (“GE Capital”) is a Delaware corporation and a wholly-owned subsidiary of GE. GE Capital is a diversified financial services company that, directly or through its subsidiaries, engages in various forms of financing activity, including financing real estate, financing equipment and factoring. Applicants state that GE Capital is not an investment company pursuant to section 3(c)(6) of the Act. As described below, applicants expect GE Capital to be restructured and subsequently merged out of existence as part of a reorganization of GE's financial services businesses, with certain GE Capital businesses being transferred to other wholly-owned subsidiaries of GE as part of the restructuring.
3. On April 10, 2015, GE announced a plan to reduce the size of its financial services businesses through the sale of most of the assets of GE Capital over the next 24 months and to focus on continued investment and growth in GE's industrial businesses. In connection with this plan, GE Capital has formed FinCo, an Irish unlimited company and a wholly-owned subsidiary of GE Capital and of GE. FinCo's primary purpose is to finance the operations of GE's foreign subsidiaries and, initially, will do so by issuing new notes (“New Notes”) in exchange for old notes (“Old Notes”) previously issued by GE Capital (the “Exchange Offer”). Following the Exchange Offer, GE Capital's businesses will be reorganized into separate U.S. and non-U.S. holding companies, with GE Capital International Holdings Limited (“European Holdco”)
4. The New Notes that FinCo will issue in the Exchange Offer will include multiple classes with various maturity dates, interest rates and other terms. The New Notes will be offered for exchange only (i) to holders of Old Notes that are “qualified institutional buyers” as defined in rule 144A under the Securities Act of 1933 (the “Securities Act”) in a private transaction in reliance upon the exemption from the registration requirements of the Securities Act provided by section 4(a)(2) thereof and (ii) outside the United States, to non-U.S. holders of Old Notes in accordance with regulation S under the Securities Act. The New Notes will be guaranteed by GE and GE Capital, with European Holdco ultimately assuming GE Capital's guarantee obligation in connection with the Reorganization. In the future, FinCo may issue any manner of debt (including commercial paper exempt under section 3(a)(3) of the Securities Act) and preferred stock, in both public and private offerings in the United States or abroad, so long as such issuance is consistent with rule 3a-5 (together with the New Notes, “Securities”). Other than as noted in the application, FinCo will comply with the applicable requirements in rule 3a-5(a)(1) through (4) and with rule 3a-5(b)(1)(i) under the Act.
5. FinCo will utilize the proceeds from the issuance and sale of Securities to finance the operations of Controlled Companies and other “companies controlled by” GE within the meaning of rule 3a-5 under the Act.
6. Applicants state that in compliance with rule 3a-5(a)(5), FinCo will invest in or loan to Controlled Companies and other “companies controlled by” GE within the meaning of rule 3a-5 at least 85% of any cash or cash equivalents raised from the sale of Securities as soon as practicable, but in no event later than six months after the receipt of such cash or cash equivalents. In accordance with rule 3a-5(a)(6) under the Act, all investments by FinCo, including temporary investments, will be made in Government securities (as defined in the Act), securities of GE, Controlled Companies or other “companies controlled by” GE within the meaning of rule 3a-5, or debt securities that are exempted from the provisions of the Securities Act by section 3(a)(3) of the Securities Act.
1. Applicants request an order under section 6(c) of the Act exempting FinCo from all provisions of the Act. Rule 3a-5 under the Act provides an exemption from the Act for certain companies organized primarily to finance the business operations of their parent companies or companies controlled by their parent companies.
2. Rule 3a-5(b)(3)(i) under the Act, in relevant part, defines a “company controlled by the parent company” to mean any corporation, partnership, or joint venture that is not considered an investment company under section 3(a) of the Act, or that is excepted or exempted by order from the definition of investment company by section 3(b) or by the rules and regulations under section 3(a) of the Act. Applicants state that the Controlled Companies do not fit within the definition of “company controlled by the parent company” because they derive their non-
3. Section 6(c) of the Act, in pertinent part, provides that the Commission, by order upon application, may conditionally or unconditionally exempt any person, security or transaction, or any class or classes of persons, securities or transactions, from any provision or provisions of the Act 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. Applicants submit that its exemptive request meets the standards set out in section 6(c) of the Act.
Applicants agree that the order granting the requested relief will be subject to the following condition:
FinCo will comply with all of the provisions of rule 3a-5 under the Act, except FinCo will be permitted to (i) make loans to or make or hold investments in Controlled Companies that do not meet the portion of the definition of “company controlled by a parent company” in rule 3a-5(b)(3)(i) under the Act solely because they are excluded from the definition of investment company under sections 3(c)(5) or 3(c)(6) of the Act; (ii) have its securities owned by such Controlled Companies; and (iii) treat European Holdco as a “company controlled by the parent company” for purposes of rule 3a-5, if European Holdco is exempt from registration under the Act pursuant to an order issued by the Commission under section 6(c) of the Act.
For the Commission, by the Division of Investment Management, under 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.
Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090; Applicants: PMC and the Trust, 655 9th Street, Des Moines, IA 50392; PFD, 620 Coolidge Drive, Suite 300, Folsom, CA 95630.
Steven I. Amchan, Senior Counsel, at (202) 551-6826, or David P. Bartels, Branch Chief, at (202) 551-6821 (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 a Delaware statutory trust and is registered under the Act as an open-end management investment company with multiple series. Each series will operate as an exchange traded fund (“ETF”).
2. PMC, an Iowa corporation, will be the investment adviser to the new series of the Trust (“Initial Fund”). Each Adviser (as defined below) will be registered as an investment adviser under the Investment Advisers Act of 1940 (“Advisers Act”). The Adviser may enter into sub-advisory agreements with one or more investment advisers to act as sub-advisers to particular Funds (each, a “Sub-Adviser”). Any Sub-Adviser will either be registered under the Advisers Act or will not be required to register thereunder.
3. The Trust will enter into a distribution agreement with one or more distributors. Each distributor for a Fund will be a broker-dealer (“Broker”) registered under the Securities Exchange Act of 1934 (“Exchange Act”) and will act as distributor and principal underwriter (“Distributor”) for one or more of the Funds. No Distributor will be affiliated with any national securities exchange, as defined in Section 2(a)(26) of the Act (“Exchange”). The Distributor for each Fund will comply with the terms and conditions of the requested order. PFD, a Washington corporation and broker-dealer registered under the Exchange Act, will act as the initial Distributor of the Funds.
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” and together with the Initial Fund, “Funds”), each of which will operate as an ETF and will 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 PMC or an entity controlling, controlled by, or under common control with PMC (each, an “Adviser”) and (b) comply with the terms and conditions of the application.
5. Each 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. The Underlying Indexes 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”).
6. Applicants represent that each Fund will invest at least 80% of its assets (excluding securities lending collateral) in the component securities of its respective Underlying Index (“Component Securities”) and TBA Transactions,
7. Each Trust may issue Funds that 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 will establish (i) exposures equal to approximately 100% of the long positions specified by the Long/Short Index
8. A Fund will utilize either a replication or representative sampling strategy to track its Underlying Index. A Fund using a replication strategy will invest in the Component Securities of its Underlying Index in the same approximate proportions as in such Underlying Index. A Fund using a representative sampling strategy will hold some, but not necessarily all of the Component Securities of its Underlying Index. Applicants state that a Fund using a representative sampling strategy will not be expected to track the performance of its Underlying Index with the same degree of accuracy as would an investment vehicle that invested in every Component Security of the Underlying Index with the same weighting as the Underlying Index. Applicants expect that each Fund will have an annual tracking error relative to the performance of its Underlying Index of less than 5%.
9. Each 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 Adviser, which will have a licensing agreement with such Index Provider.
10. Applicants recognize that Self-Indexing Funds could raise concerns regarding the 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.
11. Applicants propose that each Self-Indexing Fund will post on its Web site, on each day the Fund is open, including any day when it satisfies redemption requests as required by Section 22(e) of the Act (a “Business Day”), before commencement of trading of Shares on 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 to maintain full portfolio transparency will also provide an additional mechanism for addressing any such potential conflicts of interest.
12. In addition, Applicants do not believe the potential for conflicts of interest raised by the Adviser's use of the Underlying Indexes in connection with the management of the Self Indexing 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.
13. 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 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, PMC will adopt 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 the ETS Securities or an associated person (“Inside Information Policy”). Any other Adviser or Sub-Adviser will be required to adopt and maintain a similar Inside Information Policy. In accordance with the Code of Ethics
14. To the extent the Self-Indexing Funds transact with an Affiliated Person of the 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, the Adviser, Affiliated Persons of the Adviser (“Adviser Affiliates”) and Affiliated Persons of any Sub-Adviser (“Sub-Adviser Affiliates”) may be authorized to provide custody, fund accounting and administration and transfer agency services to the Self-Indexing Funds. Any services provided by the Adviser, Adviser Affiliates, Sub-Adviser and Sub-Adviser Affiliates will be performed in accordance with the provisions of the Act, the rules under the Act and any relevant guidelines from the staff of the Commission. Applications for prior orders granted to Self-Indexing Funds have received relief to operate such funds on the basis discussed above.
15. 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”).
16. 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;
17. Creation Units will consist of specified large aggregations of Shares (
18. Each Business Day, before the open of trading on the Exchange on which Shares are primarily listed (“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 list. Each Listing Exchange will disseminate, every 15 seconds during regular Exchange trading hours, through the facilities of the Consolidated Tape Association, an amount for each Fund stated on a per individual Share basis representing the sum of (i) the estimated Cash Amount and (ii) the current value of the Deposit Instruments.
19. 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. In all cases, such Transaction Fees will be limited in accordance with requirements of the Commission applicable to management investment companies offering redeemable securities. Since the Transaction Fees are intended to defray the transaction expenses as well as to prevent possible shareholder dilution resulting from the purchase or redemption of Creation Units, the Transaction Fees will be borne only by such purchasers or redeemers.
20. 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
21. 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.
22. 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 through an Authorized Participant. A redeeming investor may pay a Transaction Fee, calculated in the same manner as a Transaction Fee payable in connection with purchases of Creation Units.
23. 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. Applicants state that investors may purchase Shares in Creation Units and redeem Creation Units from each Fund. Applicants further state that because Creation Units may always be purchased and redeemed at NAV, the price of Shares on the secondary market should not vary materially from NAV.
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
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 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 fourteen (14) calendar days. Accordingly, with respect to Foreign Funds only, applicants hereby request relief under section 6(c) from the requirement imposed by section 22(e) to allow Foreign Funds to pay redemption proceeds within fourteen calendar days following the tender of Creation Units for redemption.
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 fourteen calendar days would not be inconsistent with the spirit and intent of section 22(e). Applicants suggest that a redemption payment occurring within fourteen 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 Adviser, and 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
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 in which the Investing Management Company may invest. In addition, under condition B.5., 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 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 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 to purchase shares of other investment companies for short-term cash management purposes. 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 a 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. 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 the Adviser or an entity controlling, controlled by or under common control with the 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.
20. 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.”
21. 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.
22. 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.
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 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 Self-Indexing Fund) to acquire any Deposit Instrument for the Self-Indexing Fund through a transaction in which the Self-Indexing 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 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 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 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 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 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, 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 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; (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 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 under rule 12b-l under the Act) received from a 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
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 to purchase a security in any Affiliated Underwriting.
7. The Board of a Fund, including a majority of the non-interested Board members, will adopt procedures reasonably designed to monitor any purchases of securities by the 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; (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 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 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 applicable 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 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 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 the Fund acquires securities of another investment company pursuant to exemptive relief from the Commission permitting the Fund to acquire securities of one or more investment companies for short-term cash management purposes.
For the Commission, by the Division of Investment Management, under delegated authority.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a conference commemorating the 75th Anniversary of the Investment Company Act and the Investment Advisers Act on Tuesday, September 29, 2015 from 9:15 a.m. to 4:15 p.m., in the Auditorium, Room L-002.
The event will include remarks from SEC Chair Mary Jo White and fellow commissioners, as well as a series of panel discussions featuring industry pioneers, former SEC chairmen and division directors, academics and other distinguished leaders to discuss significant ideas and themes in the history of the asset management industry.
The conference will be held at SEC headquarters at 100 F Street NE. in Washington, DC. The roundtable will be webcast on the Commission's Web site at
For further information, please contact: The Office of the Secretary at (202) 551-5400.
The Small Business Administration (SBA) and the Department of Homeland Security, Federal Emergency Management Agency (DHS/FEMA) have entered into this Computer Matching Agreement (Agreement) pursuant to section (o) of the Privacy Act of 1974 (5 U.S.C. 552a), as amended by the Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), and as amended by the Computer Matching Privacy Protection Act Amendments of 1990 (Pub. L. 101-508, 5 U.S.C. 552a(p) (1990)). For purposes of this Agreement, both SBA and DHS/FEMA are the recipient agency and the source agency as defined in 5 U.S.C. 552a(a)(9) and (11). For this reason, the financial and administrative responsibilities will be evenly distributed between SBA and DHS/FEMA unless otherwise set forth in this agreement.
The purpose of this Agreement is to establish a framework and procedures governing the Computer Matching program between SBA and DHS/FEMA. The Computer Matching program seeks to ensure that applicants for SBA Disaster Loans and DHS/FEMA Individuals and Households Program, which provides Other Needs Assistance (ONA) and Housing Assistance (HA), do not receive a duplication of benefits for the same disaster. This will be accomplished by matching specific DHS/FEMA disaster applicant data with SBA disaster loan application and decision data for a declared disaster, as set forth in this Agreement.
SBA's legal authority for undertaking its disaster loan program without duplicating benefits is contained in section 7(b)(1) of the Small Business Act (15 U.S.C. 636 (b)(1). DHS/FEMA's legal authority contained at § 312(a) of the Robert T. Stafford Disaster Relief and Emergency Assistance Act (42 U.S.C. 5155), mandates DHS/FEMA not to duplicate assistance provided by another agency or similar source.
SBA is allowed to share information with DHS/FEMA pursuant to routine uses (f) and (g) of SBA-020 Disaster Loan Case Files system of records, 74 FR 14911 (April 1, 2009). DHS/FEMA is allowed to share information with SBA pursuant to routine uses H.1. and R. of DHS/FEMA-008 Disaster Recovery Assistance Files, 78 FR 25282 (April 30, 2013) (DHS/FEMA-008 SORN). The Computer Matching and Privacy Protection Act of 1988 (Pub. L. 100-503), as amended, (5 U.S.C. 552a(o)-(u)) establishes procedural requirements for agencies to follow when engaging in computer-matching activities.
As required by law, SBA and DHS/FEMA will not provide duplicative disaster assistance to individuals, and businesses including Private-Not-for Profits (PNPs) for the same disaster. To accomplish this, SBA and DHS/FEMA will participate in a computer-matching program to share data and financial/benefits award decisions of individuals, businesses and/or other entities to prevent duplicative aid from being provided in the same disaster declaration.
It is also recognized that the programs covered by this Agreement are part of a Government-wide initiative, Executive Order 13411—Improving Assistance for Disaster Victims (August 29, 2006). This order mandates DHS/FEMA to identify and prevent duplication of benefits received by individuals, businesses, or other entities for the same disaster. That initiative and this matching program are consistent with Office of Management and Budget (OMB) guidance on interpreting the provisions of the Computer Matching and Privacy Protection Act of 1988, 54 FR 25818 (June 19, 1989); and OMB Circular A-130, Appendix I, “Federal Agency Responsibilities for Maintaining Records about Individuals.”
The matching program is to ensure that benefits provided to disaster survivors by DHS/FEMA and SBA are not duplicated. By way of the DHS/FEMA disaster registration identification (ID) number, DHS/FEMA and SBA are able to identify the applications received from mutual DHS/FEMA and SBA disaster survivors. By the nature of the sequence of delivery as outlined in FEMA Regulation, 44 CFR 206.191, survivors that register with DHS/FEMA for possible grant assistance, and meet SBA's minimum income requirements, are automatically referred to SBA for possible loan assistance. For example, DHS/FEMA received 548,953 registrations in response to hurricane Sandy, and referred 241,282 of those registrations to SBA. More recently, in FY 2013 and 2014, DHS/FEMA received 775,089 registrations and referred 337,619 registrations to SBA. The computer match will also reveal instances where the same disaster survivor has submitted applications to both DHS/FEMA and SBA, which could result in a duplication of benefits. Since FY 2010,
DHS/FEMA accesses records from its Disaster Recovery Assistance Files system of records, as provided by the DHS/FEMA-008 SORN, through its National Emergency Management Information System-Individual Assistance (NEMIS-IA), and matches them to the records that SBA provides from its SBA-020 Disaster Loan Case Files, 74 FR 14911 (April 1, 2009) system of records. SBA uses its Disaster Credit Management System (DCMS) to access records from its Disaster Loan Case Files system of records, and match them to the records that DHS/FEMA provides from its Disaster Recovery Assistance Files system of records. Under this agreement, DHS/FEMA and SBA exchange data to: (1) Check for initial registrations, (2) check for the duplication of benefits, and (3) update the SBA Loan Status.
A definitive answer cannot be given as to how many records will be matched as it will depend on the number of individuals, businesses or other entities that suffer damage from a declared disaster and that ultimately apply for Federal disaster aid.
The three types of match processes, for initial registration, duplication of benefits, and status updates, are described below.
1. DHS/FEMA-SBA Automated Import/Export Process for Initial Registrations.
a. SBA is the recipient (
b. DHS/FEMA will provide SBA the data elements identified in the current NEMIS-IA Disaster Assistance Improvement Program (DAIP) Interface Control Document (ICD) (See Appendix A), which includes but is not limited to the following information: Applicant's FEMA Registration ID Number; applicant's personally identifiable information, which includes name, address, social security number, and date of birth; damaged property information; insurance policy data; property occupant data; vehicle registration data; and flood zone and flood insurance data.
c. SBA will conduct the match using the FEMA Disaster ID number, FEMA Registration ID number, Product (Home/Business) and Registration Occupant Social Security number (SSN) to create a New Pre-Application. The records SBA receives are of DHS/FEMA applicants who are referred to SBA for disaster loan assistance. Controls on the DHS/FEMA export of data are in place to ensure that SBA only receives unique and valid referral records.
d. When SBA matches its records to those provided by DHS/FEMA, two types of matches are possible: A full match and a partial match. A full match exists when an SBA record matches a DHS/FEMA record on each of the following data fields: FEMA Disaster ID number, FEMA Registration ID number, Product (Home/Business), and Registration Occupant Social Security Number (SSN). A partial match exists when an SBA record matches a DHS/FEMA record on one or more, but not all of the data fields listed above. If an exact (full) match is found among SBA records for the current imported record, the current record is automatically marked as a duplicate by the system with appropriate comments inserted to indicate the corresponding record that matched. If a partial match is found during the import process, the record is routed for manual examination, investigation, and resolution to determine whether it is truly a duplicate record.
2. DHS/FEMA-SBA Duplication of Benefits Automated Match Process:
a. Both DHS/FEMA and SBA will act as the recipient (
b. DHS/FEMA will return the following fields for the matching DHS/FEMA record, if any: FEMA Disaster Number; FEMA Registration ID number; applicant and if applicable, co-applicant name; damaged dwelling address, phone number, SSN, damaged property data, insurance policy information, contact address (if different from damaged dwelling address), flood zone and flood insurance data, FEMA Housing Assistance and Other Needs Assistance data, program, award level, eligibility, inspection data, verification of ownership and occupancy, and approval or rejection data. DHS/FEMA will return no result when the FEMA Registration ID number is not matched.
c. For each matching record received from DHS/FEMA, SBA determines whether DHS/FEMA assistance duplicates SBA loan assistance. If SBA loan officers determine that there is a duplication of benefits, the duplicated amount is deducted from the eligible SBA loan amount.
3. DHS/FEMA-SBA Status Update Automated Match Process:
a. DHS/FEMA will act as the recipient (
b. SBA will provide to DHS/FEMA information and data, including but not limited to the following: Personal information about SBA applicants, including name, damaged dwelling address, and SSN; application data; loss to personal property data; loss mitigation data; SBA loan data; and SBA event data. DHS/FEMA will conduct the match using FEMA Disaster Number and FEMA Registration ID number.
c. Loan data for matched records will be recorded and displayed in NEMIS-IA. Loan data will also be run through NEMIS-IA business rules; potentially duplicative categories of assistance are sent to FEMA's Program Review process for manual evaluation of any duplication of benefits. If FEMA review staff determines that there is a duplication of benefits, the duplicated amount is deducted from the eligible award. FEMA applicants receive a letter that indicates the amount of their eligible award and their ability to appeal.
This Agreement will take effect 40 days from the date copies of this signed Agreement are sent to both Houses of Congress or 30 days from the date the Computer Matching Notice is published in the
1. Transmit this Agreement to Congress.
2. Notify OMB.
3. Publish the Computer Matching Notice in the
4. Address public comments that may result from publication in the
Matches under this program will be conducted for every Presidential disaster declaration and will continue for as long as this agreement, including any renewals, remains in effect.
FEMA Form 009-0-1 “Application/Registration for Disaster Assistance,”
SBA Forms 5 “Disaster Business Loan Application,” 5C “Disaster Home Loan Application,” and the Electronic Loan Application (ELA) include a Privacy Act statement that provides notice that SBA may disclose personal information under a published “routine use,” as permitted by law. SBA's published system of records notice, identified in Section II. B), provides notice that a computer match may be performed to share information with another Federal agency in connection with the issuance of a grant, loan or other benefit. In addition, the Privacy Act requires that a copy of each CMA entered into with a recipient agency shall be available upon request to the public.
The matching program for the initial contact information for individuals and businesses will be accomplished by mapping applicant data for DHS/FEMA NEMIS-IA fields described earlier to the DCMS application data fields. During the automated import process, a computer match is performed against existing DCMS applications as described in Section IV.B.1.
If the applicant's data does not match an existing pre-application or application in the SBA's DCMS, then the applicant's data will be inserted into DCMS to create a new pre-Application. An SBA application for disaster assistance may be mailed to the registrant.
If the applicant's data does match an existing pre-application or application in SBA's DCMS, it indicates that there may be an existing pre-application/application for the applicant in the DCMS. If there is an exact match, the system will insert the record within the SBA's DCMS but will identify it as a duplicate with appropriate comments inserted to indicate the corresponding record that matched. If there is a partial match, the system will insert the record within the SBA's DCMS but will identify it as a potential duplicate. The record is then further reviewed by SBA employees to determine whether the data reported by the DHS/FEMA applicant is a duplicate of previously submitted registration data. Only one of the applications is kept for processing and the other duplicate pre-applications or applications will not be processed.
The matching program is to ensure that recipients of SBA disaster loans have not received duplicative benefits for the same disaster from DHS/FEMA. The matching process begins by matching the DHS/FEMA Registration ID number. If the data matches, specific to the application or approved loan, SBA will then proceed with its manual process to determine whether there is a duplication of benefits. Upon determining that there is duplication of benefits, the dollar values for the benefits issued by DHS/FEMA may reduce the eligible amount of the disaster loan or may cause SBA loan proceeds to be used to repay the grant program in the amount of the duplicated assistance.
DHS/FEMA and SBA are responsible for verifying the submissions of data used during each respective benefit process and for resolving any discrepancies or inconsistencies on an individual basis.
At SBA, the matching program for duplication of benefits will be executed as part of loan processing and prior to each disbursement of an approved SBA disaster loan. Any match indicating that there is a possible duplicate benefit will be further reviewed by an SBA employee to determine whether the DHS/FEMA grant monies reported by the applicant or borrower are correct and matches the data reported by DHS/FEMA. If there is a duplication of benefits, the amount of the SBA disaster loan will be reduced accordingly and the applicant will be provided written notice of the changes by processing a loan modification to reduce the loan amount or, where appropriate, to repay the DHS/FEMA grant program. The notice will provide the applicant with an opportunity to apply for reconsideration of the loan modification within six months of the date of the notice.
For informational purposes, SBA sends DHS/FEMA loan status updates as they occur and FEMA updates the loan records in NEMIS-IA based on the loan information received.
Authorized users of both DCMS and DHS/FEMA NEMIS-IA will not make a final decision to reduce or deny benefits of any financial assistance to an applicant or take other adverse final action against such applicant as the result of information produced by this matching program until an employee of the agency taking such action has independently verified such information and provided written notice to the applicant with a statement of the findings and informing the individual of the opportunity to respond or contest, along with the expiration of the time to respond or contest.
Pursuant to SBA document retention policy, SBA retains applicant records in DCMS loan files, including records for matched items. DHS/FEMA will retain records pursuant to the Retention and Disposal section of DHS/FEMA—008 Disaster Recovery Assistance Files, 78 FR 25282 (Apr. 30, 2013).
SBA and DHS/FEMA agree to the following information security procedures:
The privacy of the subject individuals will be protected by strict adherence to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a). SBA and DHS/FEMA agree that data exchange and any records created during the course of this matching program will be maintained and safeguarded by each agency in such a manner as to restrict access to only those individuals, including contractors, who have a legitimate need to see them in order to accomplish the matching program's purpose. Persons with authorized access to the information will be made aware of their responsibilities pursuant to this Agreement.
DHS/FEMA will transmit the data (specified in this Agreement) to SBA via the following process:
SBA will pull application data from DHS/FEMA Disaster Assistance Center (DAC) via a web services based Simple Object Access Protocol (SOAP), Extensible Markup Language (XML)/Hypertext Transfer Protocol Secure (HTTPS) request. The data will be used to create applications inside the Disaster Credit Management System. For each record, a National Information Exchange Model (NIEM)-compliant response will be sent back to FEMA DAC indicating success or failure for the transfer of data. The SBA/DCMS to DHS/FEMA DAC export of referral data (specified in this Agreement) will occur via a web services-based SOAP, XML/HTTPS request.
The DHS/FEMA Duplication of Benefits Interface will be initiated from the DCMS to the DHS/FEMA NEMIS-IA through a secured Virtual Private Network tunnel, open only to SBA domain Internet Protocol addresses. The results of the query are returned to the DCMS in real-time and populated in the DCMS for delegated SBA staff to use in the determination of duplication of benefits.
SBA and DHS/FEMA agree to maintain all automated matching records in a secured computer environment that includes the use of authorized access codes (passwords) to restrict access. Those records will be maintained under conditions that restrict access to persons who need them in connection with official duties related to the matching process and grant and loan making processes.
SBA and DHS/FEMA agree to the following restrictions on use, duplication, and disclosure of information furnished by the other agency.
A. Records obtained for this matching program or created by the match will not be disclosed outside the agency except as may be essential to conduct the matching program, or as may be required by law. Each agency will obtain the written permission of the other agency before making such disclosure.
B. Records obtained for this matching program or created by the match will not be disseminated within the agency except on a need-to-know basis, nor will they be used for any purpose other than that expressly described in this Agreement.
C. Data or information exchanged will not be duplicated unless essential to the conduct of the matching program. All stipulations in this Agreement will apply to any duplication.
D. If required to disclose these records to a state or local agency or to a government contractor in order to accomplish the matching program's purpose, each agency will obtain the written agreement of that entity to abide by the terms of this Agreement.
E. Each agency will keep an accounting of disclosure of an individual's record as required by the Privacy Act (5 U.S.C. 552a(c)) and will make the accounting available upon request by the individual or other agency.
DHS/FEMA and SBA attest that the quality of the specific records to be used in this matching program is assessed to be at least 99% accurate. The possibility of any erroneous match is extremely small.
In order to apply for DHS/FEMA assistance online via the DAC portal, an applicant's name, address, SSN, and date of birth are sent to a commercial database provider to perform identity verification. The identity verification ensures that a person exists with the provided credentials. In the rare instances where the applicant's identity is not verified online or the applicant chooses, the applicants must call one of the DHS/FEMA call centers to complete the registrations. The identity verification process is performed again.
In order to apply for SBA's Disaster Loan Assistance online via SBA's Electronic Loan Application (ELA) an applicant's name, address, SSN, and date of birth and other information is sent to a commercial database provider to perform identity verification. The identity verification confirms that a person exists with the provided credentials. In the rare instances where the online applicant's identity cannot be verified electronically or if the applicant chooses, the applicant must call SBA's Customer Service Center to complete the online application. Once an application (electronic or paper) is completed and submitted, the information is transmitted to the DCMS system, where it is reviewed and processed by loan officers, who also verify each applicant's identity.
The parties authorize the Comptroller General of the United States, upon request, to have access to all SBA and DHS/FEMA records necessary to monitor or verify compliance with this matching agreement. This matching agreement also authorizes the Comptroller General to inspect any records used in the matching process that are covered by this matching agreement pursuant to 31 U.S.C. 717 and 5 U.S.C. 552a(b)(10).
The Agreement may be renewed, terminated or modified as follows:
This Agreement will become effective in accordance with the terms set forth in Section IV.C and will remain in effect for 18 months from the commencement date. At the end of this period, this Agreement may be renewed for a period of up to one additional year if the Data Integrity Board of each agency determines within three months before the expiration date of this Agreement that the program has been conducted in accordance with this Agreement and will continue to be conducted without change. Either agency not wishing to renew this Agreement should notify the other in writing of its intention not to renew at least three months before the expiration date of this Agreement. Either agency wishing to terminate this Agreement before its expiration date should notify the other in writing of its wish to terminate and the desired date of termination.
This Agreement may be modified at any time in writing if the written modification conforms to the requirements of the Privacy Act and receives approval by the participant agency Data Integrity Boards.
SBA and DHS/FEMA will bear their own costs for this program.
SBA and DHS/FEMA's Data Integrity Boards will review and approve this Agreement prior to the implementation of this matching program. Disapproval by either Data Integrity Board may be appealed in accordance with the provisions of the Computer Matching and Privacy Protection Act of 1988, as amended. Further, the Data Integrity Boards will perform an annual review of this matching program. SBA and DHS/FEMA agree to notify the Chairs of each Data Integrity Board of any changes to or termination of this Agreement.
For general information, please contact: Eric M. Leckey (202-212-5100),
The authorizing officials whose signatures appear below have committed their respective agencies to the terms of this Agreement.
U.S. Small Business Administration.
Notice
This is a notice of an Administrative declaration of a disaster for the Commonwealth of KENTUCKY dated 09/21/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's disaster declaration, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14472 5 and for economic injury is 14473 0.
The State which received an EIDL Declaration # is Kentucky.
Pursuant to the authority granted to the United States Small Business Administration under the Small Business Investment Act of 1958, as amended, under Section 309 of the Act and Section 107.1900 of the Small Business Administration Rules and Regulations (13 CFR 107.1900) to function as a small business investment company under the Small Business Investment Company License No. 03/03-0246 issued to BIA Digital Partners SBIC II LP, said license is hereby declared null and void.
Pursuant to the authority granted to the United States Small Business Administration by the Windup Order of the United States District Court for the Southern District of Florida, entered July 1, 2015, the United States Small Business Administration hereby revokes the license of Crossbow Venture Partners, L.P., a Delaware Limited Partnership, to function as a small business investment company under the Small Business Investment Company License No. 04740281 issued to Crossbow Venture Partners, L.P., on June 29, 2000, and said license is hereby declared null and void as of July 1, 2015.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. Chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before October 26, 2015.
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
Boots to Business is an entrepreneurial education initiative offered by the U.S. Small Business Administration (SBA) as a career track within the Department of Defense's revised Training Assistance Program called Transition Goals, Plans, Success (Transition GPS). The curriculum provides valuable assistance to transitioning service members exploring self-employment opportunities by leading them through the key steps for evaluating business concepts and the foundational knowledge required for developing a business plan. Participants are also introduced to SBA resources available to help access startup capital and additional technical assistance.
The Boots to Business Post Course surveys will be online, voluntary surveys that enable the Boots to Business program office to capture data related but not limited to the effectiveness of all Boots to Business courses, quality of the instructors and materials, and number of small businesses created as a result of participating in Boots to Business. Boots to Business will send an initial survey via email to all course participants immediately following course completion to gain insight on the quality of the program. Every 6 months following course completion, a follow up survey will be sent to all participants to measure participant outcomes as we link course effectiveness to the creation of veteran owned small businesses. Participants will be surveyed twice a year for 5 years following course completion to allow time for business creation.
Comments may be submitted on (a) whether the collection of information is necessary for the agency to properly perform its functions; (b) whether the burden estimates are accurate; (c) whether there are ways to minimize the burden, including through the use of automated techniques or other forms of information technology; and (d) whether there are ways to enhance the quality, utility, and clarity of the information.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of West Virginia (FEMA-4236-DR), dated 08/07/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of WEST VIRGINIA, dated 08/07/2015, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
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 and extensions 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.
Office of Management and Budget, Attn: Desk Officer for SSA, Fax: 202-395-6974, Email address:
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 collections below are pending at SSA. SSA will submit them 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 November 24, 2015. Individuals can obtain copies of
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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 October 26, 2015. Individuals can obtain copies of the OMB clearance packages by writing to
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Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), Executive Order 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Receipt of petition.
PACCAR, Inc. (PACCAR), has determined that certain Peterbilt and Kenworth trucks do not fully comply with paragraph S9.3.2 of Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
The closing date for comments on the petition is October 26, 2015.
Interested persons are invited to submit written data, views, and arguments on this petition. Comments must refer to the docket and notice number cited at the beginning of this notice and submitted by any of the following methods:
• Mail: Send comments by mail addressed to: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Deliver: Deliver comments by hand to: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The Docket Section is open on weekdays from 10 a.m. to 5 p.m. except Federal Holidays.
• Electronically: Submit comments electronically by: Logging onto the Federal Docket Management System (FDMS) Web site at
Comments must be written in the English language, and be no greater than 15 pages in length, although there is no limit to the length of necessary attachments to the comments. If comments are submitted in hard copy form, please ensure that two copies are provided. If you wish to receive confirmation that your comments were received, please enclose a stamped, self-addressed postcard with the comments. Note that all comments received will be posted without change to
Documents submitted to a docket may be viewed by anyone at the address and times given above. The documents may also be viewed on the Internet at
The petition, supporting materials, and all comments received before the close of business on the closing date indicated above will be filed and will be considered. All comments and supporting materials received after the closing date will also be filed and will be considered to the extent possible. When the petition is granted or denied, notice of the decision will be published in the
This notice of receipt of PACCAR's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
S9.3.2 The indicator must consist of one or more lights flashing at the same frequency as the turn signal lamps.
PACCAR reviewed the agency's decisions on petitions for inconsequentiality in connection with various noncompliances with turn signal requirements. While PACCAR did not find any prior decisions that are similar to this noncompliance, PACCAR believes that NHTSA has granted previous petitions in connection with turn signal noncompliances that carried potentially greater safety risks.
PACCAR is not aware of any crashes or injuries associated with the noncompliance and it has not received any consumer complaints or warranty claims related to this issue.
PACCAR additionally informed NHTSA that after the noncompliance was discovered, all production of the noncompliant trucks in PACCAR's possession was put on hold until the software error can be corrected.
In summation, PACCAR believes that the described noncompliance of the subject trucks is inconsequential to motor vehicle safety, and that its petition, to exempt PACCAR from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, any decision on this petition only applies to the subject trucks that PACCAR no longer controlled at the time it determined that the noncompliance
(49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8).
Office of Hazardous Materials Safety, Pipeline And Hazardous Materials Safety Administration (PHMSA), DOT.
Notice of actions on special permit applications.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given of the actions on special permits applications in (October to October 2014). The mode of transportation involved are identified by a number in the “Nature of Application” portion of the table below as follows: 1—Motor vehicle, 2—Rail freight, 3—Cargo vessel, 4—Cargo aircraft only, 5—Passenger—carrying aircraft. Application numbers prefixed by the letters EE represent applications for Emergency Special Permits. It should be noted that some of the sections cited were those in effect at the time certain special permits were issued.
Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of applications delayed more than 180 days.
In accordance with the requirements of 49 U.S.C. 5117(c), PHMSA is publishing the following list of special permit applications that have been in process for 180 days or more. The reason(s) for delay and the expected completion date for action on each application is provided in association with each identified application.
Ryan Paquet, Director, Office of Hazardous Materials Special Permits and Approvals, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC 20590-0001, (202) 366-4535.
Office of Hazardous Materials Safety, Pipeline and Hazardous Materials Safety Administration (PHMSA), DOT.
List of application for modification of special permits.
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the applications described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier
Comments must be received on or before October 13, 2015.
Send comments to: Record Center, Pipeline and Hazardous Materials Safety Administration, U.S. Department of Transportation, Washington, DC 20590.
Comments should refer to the application number and be submitted in triplicate. If confirmation of receipt of comments is desired, include a self-addressed stamped postcard showing the special permit number.
Copies of the applications are available for inspection in the Records Center, East Building, PHH-30, 1200 New Jersey Avenue Southeast, Washington, DC or at
This notice of receipt of applications for modification of special permit is published in accordance with part 107 of the Federal hazardous materials transportation law (49 U.S.C. 5117(b); 49 CFR 1.53(b)).
Office of the Assistant Secretary for Research and Technology (OST-R), Department of Transportation.
Notice of meeting.
The purpose of this notice is to inform the public that the U.S. Department of Transportation will host a fourth workshop on the Global Positioning System (GPS) Adjacent Band Compatibility Assessment effort. Notice of the availability of the Draft Test Plan for the U.S. Department of Transportation GPS Adjacent Band Compatibility Assessment effort was issued in the
The purpose of this workshop is to provide an opportunity to discuss the draft test plan and to address questions prior to the close of the public comment period. Please note that we will not be accepting written comments at this meeting. If you would like to file a comment during the comment period, please follow the directions contained in the September 9th Notice.This workshop is open to the general public by registration only. For those who would like to attend the workshop, we request that you register no later than September 25, 2015. Please use the following link to register:
You must include:
The U.S. Department of Transportation is committed to providing equal access to this workshop for all participants. If you need alternative formats or services because of a disability, please contact Stephen Mackey (contact information listed below) with your request by close of business September 25, 2015.
Several days before the workshop, an email containing the agenda, dial-in, and WebEx information will be provided to registrants.
Stephen M. Mackey, U.S. Department of Transportation, John A. Volpe National Transportation Systems Center, V-345, 55 Broadway, Cambridge, MA 02142,
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA or the Agency) is proposing to revise the hazardous waste generator regulations under the Resource Conservation and Recovery Act (RCRA) to improve compliance and thereby enhance protection of human health and the environment. Specifically, EPA proposes to revise certain components of the hazardous waste generator regulatory program; address gaps in the regulations; provide greater flexibility for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner; reorganize the hazardous waste generator regulations to make them more user-friendly and thus improve their usability by the regulated community; and make technical corrections and conforming changes to address inadvertent errors, remove obsolete references to programs that no longer exist, and improve the readability of the regulations.
These proposed changes are both a result of EPA's experience in implementing and evaluating the hazardous waste generator program over the last 30 years, as well as a response to concerns and issues identified by the states and regulated community.
Comments must be received on or before November 24, 2015.
Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2012-0121, to the
Jim O'Leary, U.S. Environmental Protection Agency, Office of Resource Conservation and Recovery, (MC: 5304P), 1200 Pennsylvania Ave. NW., Washington, DC 20460, (703) 308-8827, (
Entities potentially affected by this action include between 353,000 and 543,000 industrial entities that generate hazardous waste regulated under the RCRA Subtitle C regulations. Of this universe, between 293,000 and 470,000 are conditionally exempt small quantity generators (CESQGs) that will only be affected if they choose to take advantage of two voluntary programs being proposed. Entities potentially affected by this proposed rule include practically every industrial sector, including printing, petroleum refining, chemical manufacturing, plastics and resin manufacturing, pharmaceutical manufacturing, paint and coatings, iron and steelmaking, secondary smelting and refining, metal manufacturing, electroplating, circuit board manufacturing, and automobile manufacturing, among other industries.
As discussed in section XVIII, the Regulatory Impact Analysis (RIA) for this action, available in the docket for this action, estimates the future annualized cost to industry to comply with the proposed requirements is between $6.2 and $17.4 million (at a 7% discount rate). The annualized benefits for entities opting to take advantage of two voluntary programs in the proposed rule (
The proposed Hazardous Waste Generator Improvements Rule is expected to yield a variety of benefits as generators change several of their waste management practices to comply with the proposed regulations. These benefits reflect the rule's focus on enhancing protection of human health and the environment while improving the efficiency of the RCRA hazardous waste generator standards. Ideally, the Agency would prefer to quantify and monetize the rule's total benefits. However, only some categories of benefits are quantifiable. For the majority of benefits, sufficient data are not available to support a detailed quantitative analysis. For example, the added flexibility from allowing a large quantity generator accumulating ignitable or reactive hazardous waste to obtain a waiver from the local fire department for 50-foot property line requirement at 40 CFR 265.176 (provided other safety requirements are met) is difficult to quantify. In addition, quantifying the benefits associated with emergency response due to changes in container labeling would require data on the annual number of emergencies at generator sites, the current risks associated with these incidents, the extent to which more detailed labeling would affect the procedures of emergency responders, and the reduction in risk associated with these changes. Detailed data on these items are not readily available. In this and in similar cases, the benefits are described qualitatively.
This action is not proposing to add any new IBR material, however, we are proposing to reorganize one of the existing requirements containing IBR material to make the regulation easier for the reader to follow. We are proposing to copy § 265.201(g)(2) to § 262.16(b)(3)(vii)(B). To accommodate this change, we are proposing to update § 260.11(d)(1), which is the IBR reference section for these regulations, by adding a reference to § 262.16. The materials for which we are seeking incorporation by reference are for the NFPA 30 standard, Flammable and Combustible Liquids Code, and are available for inspection at the ANSI Incorporation by Reference (IBR) Portal,
These regulations are proposed under the authority of sections 2002, 3001, 3002, 3003, 3004, 3007, and 3010 of the Solid Waste Disposal Act of 1965, as amended by the Resource Conservation and Recovery Act of 1976 (RCRA), as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924. This statute is commonly referred to as “RCRA.”
EPA is proposing to revise the hazardous waste generator regulations under RCRA to improve compliance by the regulated community and support the efficient implementation of the hazardous waste generator regulations by EPA and the states and, thereby enhance protection of human health and the environment. Specifically, EPA proposes to (1) revise certain components of the hazardous waste generator regulatory program, primarily at 40 CFR 261.5 and 40 CFR part 262; (2) address identified gaps in the regulations; (3) provide greater flexibility for hazardous waste generators to manage their hazardous waste in a cost-effective and protective manner; (4) reorganize the hazardous waste generator regulations to make them more user-friendly and thus improve their usability by the regulated community; and (5) make technical corrections and conforming changes to address inadvertent errors, remove obsolete programs, and improve the readability of the regulations.
These proposed changes are a result of EPA's experience in implementing and evaluating the hazardous waste generator program over the last 30 years, as well as a response to concerns and issues identified by the states and regulated community.
The hazardous waste generator regulatory program was originally promulgated in 1980. Over the course of the last 30 plus years, the Agency, through experience with implementing the program, and in various meetings, correspondence, and discussions with the states and the regulated community, has become aware of ambiguities, inconsistencies, gaps, and a lack of flexibility in the regulations, which, if revised, could result in a program that is more effective in protecting human health and the environment. Many of these problems were identified in a 2004 program evaluation of the hazardous waste generator program conducted by EPA.
Many of the changes in this proposal are revisions to existing rules designed to improve generator compliance without any increase in burden. For example, the Agency has inconsistently addressed the situation where a generator generates both acute and non-acute hazardous waste in a calendar month. This inconsistency has resulted in uncertainty for the generator regarding what generator category, and thus which regulatory provisions, would apply during that calendar month. This proposal addresses the problem. The Agency is also proposing to replace the phrase “conditionally exempt small quantity generator” (CESQG) with the phrase “very small quantity generator” (VSQG) so as to be consistent with the other two generator categories—large quantity generators (LQGs) and small quantity generators (SQGs).
Another area of the program that needs revision is the closure regulations for hazardous waste generators under § 262.34(a)(1). The regulations do not expressly specify whether closure provisions apply to generators accumulating hazardous waste in containment buildings only or also to hazardous waste accumulated in containers, tanks and on drip pads. This notice proposes to revise the closure provisions to address these and other concerns.
The Agency is also proposing changes to improve flexibility for generators of hazardous wastes. One example is the proposal to enhance flexibility by allowing conditionally exempt small quantity generators (CESQGs) to send hazardous waste to an LQG that is under the control of the same person, provided certain conditions are met. Numerous situations exist in industry, government, and academia where an organization with satellite locations that qualify as CESQGs could take advantage of this provision in order to consolidate and manage the hazardous waste in an environmentally sound manner. In addition, this proposal addresses the concern that some generators, such as generators located in urban environments, may find it difficult to meet the independent requirement that containers holding ignitable or reactive waste must be placed 15 meters (50 feet) from the site's property line. To build in flexibility, while maintaining protection of human health and the environment, we are proposing to allow generators to apply for a waiver from this requirement from their local fire department or emergency response organization, and if approved, maintain documentation of that agreement.
The Agency is also proposing to reorganize the hazardous waste generator regulations to make them more user-friendly for various stakeholders. For example, the current CESQG regulations are found at § 261.5, while the regulations for SQGs and LQGs are found in 40 CFR part 262. For convenience and ease of use, the Agency is proposing to move all the generator regulations into 40 CFR part 262. As a result of this reorganization, EPA is proposing to make a number of conforming changes to other parts of the regulations that cite particular sections of the part 262 regulations.
Lastly, the Agency is proposing to make several technical corrections that address inadvertent errors in the regulations, obsolete programs, and outdated citations.
EPA is proposing to revise the hazardous waste generator regulations, primarily at 40 CFR 261.5 and throughout 40 CFR part 262. The Agency is also proposing some changes to parts 260, 263, 264, 265, 268, 270, 273, and 279 mostly for the purposes of maintaining consistency with the proposed changes in part 262.
The preamble discussion of these proposed changes is organized by where the existing regulations currently appear in the Code of Federal Regulations (CFR). The preamble to this proposed rule first addresses changes to the substance of the existing generator provisions, as well as a number of related changes (sections VI through XII). These proposed revisions are discussed using existing regulatory citations to make the discussion easier to understand by those already familiar with the hazardous waste generator regulations. In the cases where the Agency is proposing to revise a regulation and is also proposing to move it as part of the reorganization, the new citation for the provision in the
Following those sections, a discussion of the proposed reorganization of the hazardous waste generator regulations is presented (section XIII), including where the existing regulatory sections would be located in the proposed reorganization. As part of this discussion, we have provided a crosswalk table that compares where a particular regulatory section is currently in the regulations and where it would appear under the proposed reorganization.
Finally, a number of technical corrections are discussed (section XIV).
EPA is proposing to revise the definition of “small quantity generator” and add definitions for the other two generator categories as well as a definition for “central accumulation area” in § 260.10. In addition, we propose to change the name of the “conditionally exempt small quantity generator” category to “very small quantity generator” or VSQG.
EPA is proposing four changes to the regulations currently in 40 CFR part 261. First, EPA is proposing to add a new provision that would explain what generator category would apply to a generator that generates both acute and non-acute hazardous waste in the same calendar month. Second, the Agency is proposing to revise the regulations at §§ 261.5(h) and (i) and 261.3 that address the mixing of a non-hazardous waste with a hazardous waste. Third, to make waste management more efficient in some cases and improve environmental protection, the Agency is proposing to amend § 261.5(f)(3) and (g)(3) to allow CESQGs to send their hazardous waste to LQGs that are operated under control of the same person. Under this proposal, a CESQG that wants to take advantage of this provision would need to comply with the proposed requirements. Finally, the Agency is proposing to amend § 261.6(c) to require biennial reporting for owners or operators of facilities that recycle but do not store hazardous waste before the recycling.
These proposed changes are discussed in section VII of this preamble.
EPA is proposing a number of changes to the regulations for generators of hazardous waste at 40 CFR part 262 to improve the understanding of the RCRA generator regulations in order to encourage increased compliance by the regulated community. These proposed changes include the following:
• Revising the scope and applicability section to distinguish between independent requirements and conditions for exemption for generators of hazardous waste.
• Revising the regulations for making hazardous waste determinations;
• Requiring re-notification by SQGs and LQGs;
• Revising the regulations for labeling and marking of containers, tanks, drip pads, and containment buildings when accumulating hazardous wastes;
• Revising the closure provisions for LQGs;
• Updating the preparedness, prevention, planning and emergency procedures provisions for SQGs and LQGs;
• Revising the provisions for satellite accumulation areas (SAA) for SQGs and LQGs;
• Revising the SQG regulations for accumulating hazardous waste on drip pads;
• Deleting obsolete regulations that refer to the Performance Track program;
• Revising the biennial reporting provisions for LQGs;
• Adding a provision that hazardous waste generators are prohibited from disposing liquid hazardous waste in landfills.
These proposed changes to the generator regulations in part 262 are discussed in section VIII of this preamble.
To provide greater program flexibility, EPA is proposing to allow a CESQG or an SQG to maintain its existing generator category in the event of either a planned or unplanned episodic event in which the CESQG or SQG generates a quantity of hazardous waste in a calendar month that would otherwise bump the CESQG or SQG into a more stringent generator regulatory category (
This proposed addition to the regulations is discussed in section IX of this preamble.
To improve environmental protection, EPA is proposing to revise the marking and labeling standards for transporters to be consistent with the proposed marking and labeling standards for containers for SQGs, LQGs, and satellite accumulation areas elsewhere in this proposal.
These proposed changes are discussed in section X of this preamble.
The Agency is proposing modifications to the biennial reporting provisions in 40 CFR parts 264 and 265 to specifically include facilities receiving hazardous wastes without a permit, such as reclaimers that do not store incoming materials and reclaimers operating under a variance. EPA is also proposing to modify the special conditions for ignitable and reactive wastes at § 265.176 to allow LQGs to apply for a waiver from their local fire departments if they are unable to meet the condition that hazardous waste be stored at least 15 meters (50 feet) from the site's boundary.
These proposed changes are discussed in section XI of this preamble.
EPA is proposing to revise the marking and labeling requirements at § 268.50 to be consistent with the proposed marking and labeling standards for containers at SQGs, LQGs, and satellite accumulation areas elsewhere in this proposal. These proposed changes are discussed in section XII of this preamble.
In addition to the proposed program changes outlined in this notice, EPA is proposing to reorganize the regulations for hazardous waste generators to consolidate most of the generator regulations into 40 CFR part 262 and reduce cross-referencing where possible. EPA believes this reorganization will assist CESQGs, SQGs, and LQGs in understanding their regulatory responsibilities.
The reorganization is discussed after completion of the other proposed changes in this proposal so that readers can more easily compare the existing regulatory framework with this proposal.
The reorganization is discussed in section XIII of this preamble.
The Agency is proposing a number of technical corrections and conforming changes to correct existing errors in the hazardous waste generator regulations, as well as in other areas of the hazardous waste regulations, such as typographical mistakes, incorrect or outdated citations, and omissions of text. In addition, EPA is proposing technical changes to address the impacts of reorganizing the hazardous waste regulations.
These changes are discussed in section XIV of this preamble.
As part of this proposed rule, the Agency is also exploring the feasibility of using electronic tools to streamline the hazardous waste recordkeeping and reporting requirements. EPA requests comment on the usefulness of such tools to help the regulated community comply with the recordkeeping and reporting requirements in the RCRA hazardous waste regulations.
This request for comment is discussed in section XV of this preamble.
As originally promulgated in 1980, the basic regulatory framework for hazardous waste generators consisted of two categories: Small quantity generators (SQGs) and large quantity generators (LQGs). Since then, there have been three major changes. First, as a result of the Hazardous and Solid Waste Amendments (HSWA) of 1984, a rule was promulgated that created a third generator category by splitting the SQG category in two and creating conditionally exempt small quantity generators (CESQGs). (51 FR 10146, March 24, 1986).
Second, also as a result of HSWA, the Land Disposal Restriction (LDRs) regulations required hazardous waste generators to ensure that their hazardous waste either met a specified treatment standard or performance standard, or, if not, was treated to specified concentrations or performance standards prior to land disposal.
Third, the Agency modified the Uniform Hazardous Waste Manifest regulations and associated manifest document used to track hazardous waste from a generator's site to its ultimate disposition (70 FR 10776, March 4, 2005; 70 FR 35034, June 16, 2005). The revisions to the Uniform Hazardous Waste Manifest standardized the content and appearance of the manifest form, made the forms available from a greater number of sources, and adopted new procedures for tracking certain types of hazardous waste shipments with the manifest. Otherwise, the changes that have occurred to the hazardous waste generator regulatory program have been, for the most part, relatively minor.
The hazardous waste generator regulatory program is structured around the quantity of hazardous waste a person (or generator) generates in a calendar month (by site). The quantity of hazardous waste generated determines a generator's category for the month, which in turn determines what requirements are applicable to the generator (including determining how the generator can qualify for an exemption from other regulations, such as having to get a storage permit).
The three generator categories—LQG, SQG, and CESQG—are based on the quantities of acute and non-acute hazardous waste generated by the generator.
For non-acute hazardous waste, the thresholds are as follows:
—LQGs generate 1,000 kilograms or greater of hazardous waste in a calendar month.
—SQGs generate greater than 100 kilograms but less than 1,000 kilograms of hazardous waste in a calendar month; and
—CESQGs generate no more than 100 kilograms of hazardous wastes in a calendar month.
For acute hazardous waste, the regulations at 40 CFR 261.5(e) state that if a generator generates acute hazardous waste in a calendar month in quantities greater than a total of one kilogram of acute hazardous waste listed in § 261.31 or 261.33(e) or a total of 100 kilograms of any residue or contaminated soil, waste, or other debris resulting from the cleanup of a spill of any acute hazardous waste listed in § 261.31 or 261.33(e), then all quantities of that acute hazardous waste are subject to the full set of LQG requirements.
In order to determine what requirements are applicable, a generator must first identify all the hazardous waste it generates subject to regulation using the four-step process below:
1. Determine whether the material is a solid waste subject to RCRA regulations at § 261.2;
2. If the material is a solid waste, then determine whether the solid waste is specifically excluded from regulation by examining the exclusions at § 261.4(a) and (b);
3. If not excluded, then determine whether the solid waste is a hazardous waste at § 262.11; and
4. If the material is a hazardous waste, then determine whether it is exempt from being counted towards its generator category by reviewing the exemptions at § 261.5(c) and (d).
Once that is completed, the generator must count the amount of regulated hazardous waste generated during the calendar month to determine its generator category.
Once a generator determines its generator category for the month, it then must manage the hazardous waste it generates and accumulates in a manner that complies with specified requirements, including requirements that qualify the generator for an exemption from having to obtain a permit.
When RCRA was enacted in 1976, the law did not explicitly address whether a permit would be required for generators accumulating hazardous wastes. However, it was clear in the legislative history of RCRA that Congress did not want to interfere with commerce and impose permitting requirements on every generator who accumulated hazardous wastes. Therefore, Congress deferred to EPA in how it would reconcile this issue. When EPA developed the regulations applicable to generators, it established two types of requirements for them: (1) Independent requirements that would apply to generators regardless of whether or not they choose to obtain an exemption from the permit requirement and from other applicable requirements (“independent requirements”); and (2) requirements to meet in order to achieve the specific purpose of obtaining such an exemption from permitting and from other applicable requirements (“conditions for exemption”).
An “independent requirement” in the context of the RCRA hazardous waste generator regulations is an unqualified standard. For example, the requirements of 40 CFR part 262 subpart D (Recordkeeping and Reporting), and the requirements in §§ 262.30 through 262.33, are among the independent requirements applicable to generators. If a generator violates an independent requirement, it may be subject to an enforcement action under section 3008 of RCRA. Unlike conditions for an exemption, independent requirements have no direct relationship to the option of obtaining or maintaining an exemption from certain RCRA regulations.
A “condition for exemption,” on the other hand, is a prerequisite that is necessary to occur or be met in order for something else to take legal effect. Thus, in the context of the RCRA hazardous waste generator regulations, a RCRA “condition for exemption” is a requirement that a generator must comply with in order to obtain or maintain an exemption from RCRA permitting requirements in part 270 and the requirements in part 264 or part 265. For example, a conditionally exempt small quantity generators (CESQGs) must meet a condition for exemption in order for its hazardous waste to be exempt from the requirements in parts 124, 262 through 266, 268, or 270, or from any requirement for notification under section 3010 of RCRA for its hazardous waste. A CESQG that fails to meet all of the conditions for an exemption for CESQGs in § 261.5 would now be subject to all these requirements.
The conditions for exemption available to large and small quantity generators are found in the current regulations at § 262.34.
As stated above, complying with the conditions for exemption is not required because it is not mandatory for a generator to obtain and maintain an exemption from RCRA permitting requirements. Instead, when a generator does not comply with a certain condition or conditions for exemption, the consequence is that the generator either fails to obtain—or loses—the exemption from the RCRA permitting requirements (unless it has complied with all of the conditions for a different applicable exemption from those requirements). This means that, because there is no exemption, permitting requirements become applicable to the generator for the same time period that the generator is out of compliance with the conditions for exemption.
The current RCRA regulations afford generators two types of conditional exemptions: (1) An exemption from most of the 40 CFR part 262 requirements, available to farmers and to CESQGs, and (2) an exemption from 40 CFR parts 124, 264 through 268, 270, and 279 requirements, and from the notification requirements of section 3010 of RCRA, available to SQGs and LQGs that accumulate hazardous waste.
The first conditional exemption is available only to farmers and CESQGs. With respect to farmers, this conditional exemption is found in part 262 subpart G and is limited to waste pesticides that are RCRA hazardous wastes that the farmer generates, provided the farmer triple rinses each emptied pesticide container in accordance with § 261.7(b)(3) and disposes of the pesticide residues on his own farm in a manner consistent with the disposal instructions on the pesticide label. This exemption from part 262 relieves farmers and CESQGs from the requirements related specifically to the generation, management, and transportation of hazardous wastes provided such waste meets certain conditions, including that the waste is treated or disposed of on site or is delivered to an off-site treatment, storage, or disposal facility which is located in the United States and is one of seven specified types of facilities. Provided the farmer and/or CESQG meets these conditions, they are not subject to the 40 CFR part 262, as well as other hazardous waste management requirements.
The second type of conditional exemption relieves generators that accumulate hazardous waste from the permitting and other requirements applicable to treatment, storage, and disposal facilities and makes temporary accumulation of hazardous waste possible for generators and is found in § 262.34. In EPA's experience, virtually every generator accumulates or stores its hazardous waste on site for some period before sending it to either an on-site or off-site permitted or interim status treatment storage or disposal facility (TSDF) or other RCRA-authorized disposal site. However, provided the generator meets the conditions in this exemption, they would not be subject to the permitting requirements and operations requirements applicable to a hazardous waste management facility for storage, or a “storage facility.”
The generator regulations in part 262, therefore, are made up of both independent requirements and conditions for exemptions. All generators are subject to at least one requirement in part 262 (
Of all the generators, LGQs are subject to the most independent requirements. The current regulations at § 262.34(a) are quite clear for LQGs where they state that a generator may accumulate hazardous waste on-site for 90 days or less without a permit or without having
SQGs have fewer independent requirements and conditions for exemption than LQGs. In particular, SQGs have longer accumulation time limits than LQGs (up to 180 days, or 270 days, if the hazardous waste is shipped greater than 200 miles) and have fewer regulations related to personnel training, contingency planning, and emergency response procedures. SQGs also do not have to submit biennial reports. However, like LQGs, SQGs must obtain an EPA ID number, meet the technical standards for containers and tanks, comply with manifesting regulations, and send their hazardous waste to a RCRA permitted hazardous waste TSDF. In addition, SQGs may not accumulate more than 6,000 kilograms of hazardous waste at any one time.
CESQGs have very few conditions. Specifically, in order for CESQGs to be excluded from 40 CFR parts 124, 262 through 266, 268, and 270 and the notification requirements of section 3010 of RCRA, they must (1) make correct hazardous waste determinations;
Table 1—Summary of Generator Regulations provides a summary of requirements that represent conditions for an exemption for CESQGs, SQGs and LQGs. As noted in the table, the category “Conditions for Exemption” applies to such requirements as the quantity generated and accumulated, accumulation time, the technical standards for containers, tanks, drip pads and containment buildings, marking and labeling, personnel training, contingency planning and emergency procedures. It is important to note that a waste determination is an independent requirement for SQGs and LQGs, whereas it is a condition for exemption for CESQGs as defined at § 261.5(f)(1) and (g)(1).
In 2011, 16,447 generators reported generating approximately 34.4 million tons of hazardous waste.
The fifty largest hazardous waste generators reported generating 28.7 million tons, or 83 percent of the total. Additionally, 3,148 generators, or approximately 19 percent of the total reporting universe, reported generating only one hazardous waste stream, while 8,435 generators, or 51 percent of the total reporting universe, reported generating between one and five hazardous waste streams.
Of the 34.4 million tons of hazardous waste generated in 2011, 30.5 million tons, or 89 percent, were generated in just five industrial sectors: Basic Chemical Manufacturing (which alone accounted for 55 percent of the hazardous waste generated); Petroleum and Coal Products Manufacturing, Waste Treatment and Disposal; Pesticide, Fertilizer, and Other Chemical Manufacturing; and Iron and Steel Mills and Ferroalloy Manufacturing.
Unlike LQGs, who must submit a biennial report every two years describing the types and quantities of hazardous waste generated and its subsequent disposition, SQGs are not required to provide such information to the Agency. Consequently, the Agency lacks the level of detail for SQGs that is available for LQGs. However, based on a review of biennial report data provided by treatment, storage, and disposal facilities (which must report waste received from all hazardous waste generators) and site identification data (from SQGs obtaining an EPA ID number), EPA estimates the number of SQGs to range from 45,762 to 59,702.
Because CESQGs are not required to obtain a RCRA ID, the information available to the Agency is limited to those states that require their CESQGs to obtain a RCRA ID. Therefore, in estimating the size of the CESQG universe, the Agency developed a methodology that extrapolated the size of the CESQG universes based on the data available in those states that require CESQGs to obtain a RCRA ID. We first established a ratio of SQGs to CESQGs in those states where information was available on the CESQG universe and then used that ratio to estimate the size of a state's CESQG universe where CESQG information was unavailable. Using this methodology, EPA currently estimates the size of the CESQG universe to range from 302,807 to 425,752.
On April 22, 2004, EPA published the “Hazardous Waste Generator Program Evaluation” Advanced Notice of Proposed Rulemaking (69 FR 21800). The purpose of the April 2004 notice was to seek information from stakeholders in order to evaluate the effectiveness of the RCRA hazardous waste generator program, as well as to identify areas for potential improvement.
Specifically, the April 2004 notice requested that stakeholders answer a series of questions in a number of areas of the hazardous waste generator regulatory program, including program effectiveness, improvements, redundancy, innovation, performance, burden reduction, pollution prevention and recycling, and priorities. Questions included whether the existing RCRA hazardous waste generator regulatory program is meeting its goal of protecting human health and the environment and whether the regulations are easy to understand, including questions asking which specific regulations are unclear or have been interpreted inconsistently.
EPA also included in the April 2004 notice a list of program areas that had previously been identified by stakeholders as needing improvement. These program areas included waste accumulation times, waste generation quantity thresholds and counting rules for LQGs, SQGs, and CESQGs, episodic generator provisions, waste sampling and testing, waste management standards, satellite accumulation, generator accumulation and treatment in containers or tanks, closure standards for generators, co-generator standards, RCRA identification numbers, waste minimization, and land disposal restriction requirements applicable to generators. During the comment period, EPA also held four public meetings in May 2004 in Boston, MA, Chicago, IL, Washington, DC, and Seattle, WA.
In response to the April 2004 notice and the May 2004 public meetings, EPA received over 500 comments from 55 organizations and individuals, including 9 states, 5 federal agencies, 2
Many commenters agreed that implementation of the generator regulations has made significant improvements in managing hazardous waste and has resulted in fewer releases of hazardous waste to the environment. However, many commenters identified several improvements they believed needed to be made to regulations. Specifically, they suggested the following:
• Simplify the regulations to make them more user-friendly and easy to understand, such as eliminating cross-referencing and codifying guidance into regulations, where applicable.
• Improve the efficiency of the program by clearing up ambiguities and removing potential redundancies, such as defining what constitutes a closed container and clarifying parts of the satellite accumulation regulations.
• Provide greater flexibility in the regulations, such as regulations that allow for episodic generation and that allow wastes to be shipped from remote locations to a centralized location to enable better waste management.
• Require re-notification to ensure better data quality to support compliance monitoring of SQG facilities (state commenters).
• Improve regulations on hazardous waste determinations, including when it is appropriate to use generator knowledge instead of analytical testing (Industry commenters).
In response to the comments on the April 2004 notice, EPA took several actions to help improve the hazardous waste generator program in order to foster better compliance. Actions included (1) improving EPA's Web site for the hazardous waste generator regulatory program,
EPA is proposing to codify definitions for the three categories of hazardous waste generators (CESQG, SQG and LQG). The term “small quantity generator” is codified in the regulations, but is outdated, whereas “conditionally exempt small quantity generator” and “large quantity generator” have been used within the RCRA hazardous waste community for several decades, but their exact definitions have not been codified. The regulations differentiate between the categories by stating the quantity of hazardous waste generated in a calendar month in each instance.
As the terms are most commonly used, CESQGs are generators that generate 100 kilograms or less of non-acute hazardous waste and 1 kilogram or less of acute hazardous waste in a calendar month; SQGs are generators that generate greater than 100 kilograms of non-acute hazardous waste but less than 1,000 kilograms of non-acute hazardous waste and 1 kilogram or less of acute hazardous waste in a calendar month; and LQGs are generators that generate 1,000 kilograms or greater of non-acute hazardous waste and/or greater than 1 kilogram of acute hazardous waste in a calendar month. However, generators often fail to consider residues from the cleanup of a spill of acute hazardous waste or do not count both the non-acute and acute hazardous waste they generate in a calendar month. The proposed definitions have been drafted to incorporate all the various categories of hazardous wastes—that is, acute hazardous waste, non-acute hazardous waste, and residues for the cleanup of a spill of acute hazardous wastes.
Considering the significance a generator's category has in determining the appropriate set of regulations that the generator must comply with, the Agency believes it is necessary to define the specific hazardous waste generator categories in the regulations.
The proposed generator category definitions are based solely on the amount of hazardous waste generated. While EPA acknowledges that accumulation limits may trigger different generator regulations, those accumulation limits do not affect a generator's generation category, which is based on how much hazardous waste is generated in a calendar month.
Therefore, EPA is proposing to add the following definitions to § 260.10:
EPA is also proposing to add definitions to § 260.10 for the terms “acute hazardous waste” and “non-acute hazardous waste,” which are both used in the above definitions for generator categories. The term acute hazardous waste is used for hazardous wastes that are particularly dangerous to human health and is defined as those hazardous wastes that meet the listing criteria in § 261.11(a)(2) and are therefore listed in § 261.31 and assigned the hazard code of (H) or are listed in § 261.33(e), also known as the RCRA P-list. In this proposal, any distinctions between acute and non-acute hazardous wastes are only being made in the context of determining generator category. Generally the term “hazardous waste” refers to both acute and non-acute hazardous waste.
As previously stated, the definitions of generator categories are based solely on the amount of hazardous waste generated in a calendar month and are generally consistent with how the regulated community understands the various categories based on EPA's references in existing publications to how much hazardous waste is generated in a calendar month. Additionally, these definitions reflect that a generator may only have one generator category in a calendar month even if the generator generates both acute hazardous waste and non-acute hazardous waste in the same calendar month, a topic discussed further in section VII.A.
In practice, five waste generation scenarios exist with different combinations of acute hazardous waste, non-acute hazardous waste, and residues from the cleanup of spills of acute hazardous waste generated in a calendar month. These scenarios are summarized in Table 2—Generator Categories Based on Quantity of Waste Generated.
Note: When calculating generator categories, the quantities of acute hazardous waste and non-acute hazardous waste are considered separately.
In three of the scenarios in Table 2—Generator Categories Based on Quantity of Waste Generated, the generator would be an LQG, in one scenario the generator would be an SQG, and in one scenario the generator would be a CESQG. In the first three scenarios, the generator is an LQG if it generates any of the following in a calendar month, regardless of the amounts of hazardous waste generated in the other categories: more than 1 kilogram of acute hazardous waste, 1,000 kilograms or more of non-acute hazardous waste, or more than 100 kilograms of residues from the cleanup of a spill of acute hazardous waste. This is made clear in the proposed regulatory definition of “LQG” by use of the word “any” and by the use of the word “or” between (1), (2), and (3). In these scenarios, the generator would need to comply with the independent requirements and conditions for the exemption for LQGs (specified in proposed § 262.17), as well as any applicable regulations for SAAs at § 262.15.
In the fourth scenario, the generator would be an SQG if, in a calendar month, it generates greater than 100 kilograms and less than 1,000 kilograms of non-acute hazardous waste and also 1 kilogram or less of acute hazardous waste and 100 kilograms or less of residues from the cleanup of a spill of acute hazardous waste.
Finally, in the fifth scenario, if a generator generates 1 kilogram or less of acute hazardous waste and 100 kilograms or less of non-acute hazardous waste and 100 kilograms or less of residue from the cleanup of a spill of acute hazardous waste, then the generator is a CESQG for that calendar month. The proposed regulatory text expresses this scenario by using the word “and” between (1), (2), and (3) in the definition. As a result, the generator would need to comply with the conditions for the exemption for CESQGs (specified in proposed § 262.14).
EPA requests comment on these proposed changes.
Currently only one of the three generator categories—CESQG—uses the words “conditionally exempt” in its title; however both SQGs and LQGs, which typically accumulate hazardous waste on site, are also conditionally exempt from obtaining a RCRA permit or complying with the interim status standards in 40 CFR parts 264 and 265, respectively, provided they meet certain conditions. In addition, while CESQGs are subject to few conditions for exemption, they are still considered hazardous waste generators, and must comply with the relevant regulations. If a CESQG does not comply, it would be out of compliance with the hazardous waste regulations and potentially subject to enforcement action. This inconsistency in terminology has caused some confusion throughout the regulated community. Therefore, EPA is proposing to change the name of the category from “conditionally exempt small quantity generator (CESQG)” to “very small quantity generator (VSQG).”
EPA requests comment on this proposed change.
The Agency is also proposing to define the term “central accumulation area” in § 260.10 to mean any on-site hazardous waste accumulation area with hazardous waste accumulating in units subject to either § 262.16 (for small quantity generators) or § 262.17 (for large quantity generators).
LQGs may accumulate hazardous waste on site without a permit or complying with the interim status standards for up to 90 days provided they comply with § 262.34(a) and SQGs may do the same for up to 180 days, provided they comply with § 262.34(d) though (f).
EPA emphasizes that we are proposing to define the term “central accumulation area” only as a matter of convenience. It is helpful for both the regulated community and the implementers to have a common term to use when referring to locations where generators accumulate hazardous waste other than satellite accumulation areas. Furthermore, the term is helpful for EPA to use when writing regulations, preamble, and guidance. The addition of the term does not establish any new regulatory standards or burden on generators. Generators may continue to have more than one central accumulation area on site; the use of the word “central” does not limit a generator to one area.
We have rephrased the proposed definition from how it currently appears in part 262 subpart K to make this clearer. The definition, as it appears in part 262 subpart K, currently states that a central accumulation area means an on-site hazardous waste accumulation area. We are proposing to revise the definition to say that a central accumulation area means
Because the proposed definition to be added to § 260.10 will now reference part 262 subpart K (the definition states that a central accumulation area at an eligible academic entity that chooses to be subject to part 262 subpart K must also comply with § 262.211 when accumulating unwanted material and/or hazardous waste), we are proposing to remove the definition of central accumulation area from part 262 subpart K.
EPA is proposing four changes to the regulations currently in 40 CFR part 261. First, the Agency is proposing to add a new provision that would explain what generator category would apply to a hazardous waste generator that generates both acute and non-acute hazardous waste in the same calendar month. Second, EPA is proposing to modify the regulations at §§ 261.5(h) and (i) and 261.3 that address the mixing of a non-hazardous waste with a hazardous waste. Third, the Agency is proposing to amend § 261.5(f)(3) and (g)(3) to allow a CESQG to send its hazardous waste to an LQG under control of the same person. Finally, the Agency is proposing to amend § 261.6(c) to require biennial reporting for owners or operators of facilities that recycle hazardous waste without storing them before they are recycled.
When a generator is determining what category it belongs in, it must consider three relevant categories of hazardous waste: hazardous waste (or non-acute hazardous waste, for purposes of this discussion), acute hazardous waste, and residues from the cleanup of a spill of acute hazardous waste. EPA is proposing regulations that make clear what a generator's category is for a calendar month when it generates any combination of non-acute hazardous waste, acute hazardous waste, and residues from the cleanup of a spill of acute hazardous waste in the same calendar month and which set of regulations apply. Currently, the RCRA hazardous waste regulations do not address situations involving combinations of wastes and Agency statements about this issue have been inconsistent.
According to the November 19,1980, FR notice discussing changes to § 261.5, “the regulation is revised to clarify that the lower exclusion levels for acutely hazardous waste apply only to generators who otherwise are deemed small quantity generators.
In other words, if a generator generates 1,000 kilograms or more of non-acute hazardous waste in a calendar month, it would be considered an LQG for that month and therefore should, for both practical and environmental reasons, manage the acute hazardous wastes under the same regulations as an LQG (even if the amount of acute hazardous waste generated in a calendar month is less than 1 kilogram). However, a provision regarding how to determine one's generator category when generating a combination of non-acute hazardous waste, acute hazardous waste, and residues from the cleanup of a spill of acute hazardous waste was not included in the regulatory language.
Conversely, in a September 2, 1987, letter concerning the accumulation time for acute hazardous waste and non-acute hazardous waste in the same month, the Agency stated, “Acute hazardous wastes are counted and managed separately from hazardous wastes (§ 261.5(e)). In the example given, the generator would have 90 days to send the acute hazardous waste off site, but would have 180 days for the non-acute hazardous waste.”
The Agency believes the more practical approach is for a generator to be in only one generator category in a calendar month, the approach outlined in the 1980
This is why EPA is proposing to expressly state in the definitions which generator category would apply to hazardous waste generators that generate a combination of non-acute hazardous waste, acute hazardous waste, and/or residues from the cleanup of spills of acute hazardous waste in a calendar month as discussed in section VI of this preamble. In conjunction with these changes, EPA is proposing a new section § 262.13 explaining how a generator determines which generator category applies to it. This topic is fully discussed in section VIII of this preamble. The Agency is soliciting comment on the proposal to revise the existing regulations to indicate that a generator can only have one generator category in a calendar month, according to the quantity of acute and non-acute hazardous waste it generates.
EPA is proposing to modify how mixtures of non-hazardous waste and hazardous waste would affect the generator categories of CESQGs and SQGs. Additionally, EPA is proposing to add a reference in 40 CFR part 262 that assists LQGs with finding the regulations applicable to mixing hazardous waste with non-hazardous waste.
With the partitioning of the original 1980 SQG regulations into two sets of regulations for CESQGs and SQGs in 1986, potential confusion surrounds the current reading and implementation of § 261.5(h) and (i). When the regulations at § 261.5(h) and (i) were promulgated on November 19, 1980 (45 FR 76623), the title of § 261.5 was “Special requirements for hazardous waste generated by small quantity generators.” At that time, there were only two hazardous waste generator categories: LQGs and SQGs. Prior to the promulgation of the new SQG regulations on March 24, 1986 (52 FR 10146), an SQG was a generator who generates less than 1,000 kilograms of hazardous waste in a calendar month; the regulations did not make a distinction between SQGs and CESQGs at that time. Prior to 1986, paragraphs (h) and (i) of section 261.5 read as follows:
“(h) Hazardous waste subject to the reduced requirements of this section may be mixed with non-hazardous waste and remain subject to these reduced requirements even though the resultant mixture exceeds the quantity limitations identified in this section, unless the mixture meets any of the characteristics of hazardous waste identified in subpart C.
(i) If a small quantity generator mixes a solid waste with a hazardous waste that exceeds a quantity exclusion level of this section, the mixture is subject to full regulation.”
With the promulgation of the SQG regulations in 1986, SQGs were broken into two classes of generators: (1) CESQGs (generators who generate up to 100 kilograms of hazardous waste in a calendar month) and (2) SQGs (generators who generate greater than 100 kilograms and less than 1,000 kilograms of hazardous waste in a calendar month). The regulations for CESQGs were established at § 261.5, while those for SQGs were moved to § 262.34 (d)-(f). Similarly the title of § 261.5 was changed to read, “Special requirements for hazardous waste generated by
EPA believes that the readability of these regulations could be improved, particularly for paragraph (i), to expressly state whether the regulation applies to situations where the hazardous waste being mixed exceeds the CESQG quantity exclusion level or to situations where the mixture exceeds the CESQG quantity exclusion level. Additionally, “full regulation,” could be interpreted as regulation commensurate with an LQG, even if the resultant mixture exceeds CESQG quantity levels, but not SQG quantity levels.
For these reasons, EPA is proposing to modify the language regarding mixing of non-hazardous waste with hazardous waste by CESQGs (which is currently
For example, if a CESQG mixed 50 kilograms of characteristic hazardous waste with 100 kilograms of non-hazardous waste and the resultant 150 kilograms mixture did not retain the characteristics of hazardous waste, then the generator could still comply with the CESQG conditions. However, if a CESQG mixed 50 kilograms of characteristic hazardous waste with 100 kilograms of non-hazardous waste and the resultant 150 kilograms mixture
EPA notes that the regulations covering mixing of hazardous and non-hazardous waste would apply regardless of when the initial wastes are generated. In other words, when a generator mixes a hazardous waste with a non-hazardous waste, the generator may have changed the properties of the hazardous waste and thus must make a hazardous waste determination on the resultant mixture. For example, if a CESQG mixed 50 kilograms of characteristic hazardous waste that it generated at different points over the last three months with 100 kilograms of non-hazardous waste and the resultant mixture
In modifying the language, the Agency is not changing the intent of the existing hazardous waste regulations, but is improving the readability of the regulatory text. Thus, this change in language does not impose any additional burden on CESQGs.
LQGs and SQGs are subject to the mixture rule in § 261.3. In short, the mixture rule has three parts: (1) If non-hazardous waste is mixed with listed hazardous waste, then the mixture is considered the listed hazardous waste (§§ 261.3(a)(2)(iv) and 261.3(b)(2)); (2) if non-hazardous waste is mixed with listed hazardous waste that is listed solely for exhibiting an ignitability, corrosivity, or reactivity characteristic in part 261 subpart C (such as F003 hazardous waste), then the mixture is considered hazardous waste only if it exhibits a characteristic (§ 261.3(g)(2)(i)); and (3) if non-hazardous waste is mixed with characteristic hazardous waste, then the mixture is considered hazardous waste only if the mixture exhibits a characteristic of hazardous waste (§ 261.3(b)(3)) (45 FR 33066, May 19, 1980; 66 FR 27266, May 16, 2001).
However, because the mixture rule appears in § 261.3 and the SQG and LQG regulations appear in 40 CFR part 262, the regulated community may not totally appreciate how the mixture rules apply to SQGs and LQGs. Therefore, EPA is proposing to include references in §§ 262.16(c) and 262.17(f) that assist SQGs and LQGs with finding the regulations applicable to the mixing of hazardous waste with non-hazardous waste. Additionally, EPA wants to modify the regulations to improve understanding of what circumstances an SQG may mix hazardous waste with non-hazardous waste and still remain subject to the SQG requirements.
Specifically, EPA is proposing to add a provision for SQGs that states that a small quantity generator may mix its hazardous waste with non-hazardous waste and remain eligible for the conditional exemption applicable to a small quantity generator under two circumstances: (1) The mixture is not a hazardous waste according to the mixture rules in §§ 261.3(a)(2)(iv), 261.3(b)(2), 261.3(b)(3), and 261.3(g)(2)(i); or (2) if the mixture is a hazardous waste, the mixture does not cause the generator to exceed the small quantity generator quantity limits for a calendar month, as identified in the definition of small quantity generator at § 260.10.
For example, if an SQG mixed 100 kilograms of listed hazardous waste (that was not listed solely for the ignitability, corrosivity and/or reactivity characteristic) with 1,000 kilograms of non-hazardous waste, then the resultant 1,100 kilogram mixture would be considered a listed hazardous waste and the generator would no longer be an SQG, but rather an LQG. The generator would then need to comply with all applicable regulations for an LQG for that month during which the SQG mixed the waste.
However, if an SQG mixed 100 kilograms of either characteristic hazardous waste or listed hazardous waste (that
EPA is also proposing to add a provision for LQGs that states that mixtures of hazardous waste with non-hazardous waste are subject to the mixture rule in § 261.3(a)(2)(iv), (b)(2) and (3), and (g)(2)(i).
In modifying the language, the Agency is not changing the existing hazardous waste regulations, but is improving the readability of the
The Agency requests comment on whether the proposed language for CESQGs and SQGs improves the understanding of the regulations regarding how mixtures of non-hazardous waste and hazardous waste would affect the generator category for CESQGs and SQGs. Additionally, EPA requests comment on whether the proposed language for LQGs assists LQGs in more easily finding the applicable mixture regulations.
EPA is proposing to allow CESQGs to send their hazardous waste to an LQG that is under the control of the same person, as defined at § 260.10, provided both the CESQG and LQG comply with specified conditions.
Under the existing regulations at § 261.5(f)(3) for acute hazardous waste, and § 261.5(g)(3) for non-acute hazardous waste, a CESQG may either treat or dispose of its hazardous waste on site or ensure delivery to an off-site treatment, storage, or disposal facility, which can include RCRA-permitted hazardous waste facilities, interim status hazardous waste facilities, municipal solid waste facilities, non-municipal non-hazardous waste facilities, recycling facilities, and universal waste handlers. The existing CESQG regulations do not allow a generator to send its hazardous waste off site to another generator, unless the receiving generator has a storage permit or is otherwise one of the types of facilities cited above. Thus, persons looking to reduce their overall environmental liability across multiple sites are prohibited from managing their CESQG hazardous waste at one or more of their LQG sites without first obtaining a permit or complying with the interim status standards, both of which would increase regulatory burden and costs.
EPA believes that allowing CESQGs to send their hazardous waste to an LQG that is under the control of the same person would provide an additional option for CESQGs to manage their hazardous waste. It may also improve the management of that hazardous waste for four main reasons.
First, LQGs are subject to more stringent management conditions, such as accumulation time, labeling, training, emergency planning, and containment standards, as compared to CESQGs. In addition, LQGs may only transport hazardous waste to a RCRA-permitted or interim status hazardous waste TSDF, which in turn, is subject to more stringent management standards than the municipal or non-municipal solid waste facilities that CESQGs are allowed to use. Therefore, allowing hazardous waste generated by a CESQG to be sent to an LQG under the control of the same person could improve overall oversight and management of the hazardous waste and enable more effective environmental protection. Furthermore, a company, because of economies of scale, may reduce its overall waste management costs, as well as its potential financial liabilities for hazardous waste it generates at CESQG facilities, as it would be handled under the more comprehensive LQG and TSDF regulatory programs.
Second, whereas LQGs have up to 90 days to accumulate hazardous waste in compliance with all the LQG conditions for exemption without having to obtain a RCRA storage permit or comply with all the other standards otherwise applicable, CESQGs may accumulate up to 1,000 kilograms of non-acute hazardous waste or up to 1 kilogram of acute hazardous waste or up to 100 kilograms of residues from the cleanup of a spill of acute hazardous waste without any time constraint. Even though the amount of hazardous waste allowed on site by CESQGs at any one time is limited, the longer that hazardous waste is accumulated on site the greater the risk of adverse impacts to human health and the environment. Allowing CESQGs to send their hazardous waste to an LQG under the control of the same person may reduce the overall time that the CESQG accumulates hazardous waste on site, which would further reduce the potential risk to human health and the environment.
Third, this proposed change would allow consolidation by an LQG of hazardous waste generated by several CESQGs under its control, which increases the potential opportunities for hazardous waste recycling by the LQG.
Fourth, this proposed change would give companies flexibility in allocating labor and resources required to manage the company's total quantity of hazardous waste generated, as the company would be allowed to consolidate its hazardous waste from CESQG facilities at its LQG sites.
EPA has received requests over the years from industry for the regulations to allow CESQGs to send their hazardous waste to LQGs for consolidation. EPA believes that such a change in the regulations would enable generators to employ greater control over the management of their hazardous waste, thereby resulting in improved efficiency and reduced liability for the generator. EPA believes numerous situations exist where CESQGs and LQGs under the same ownership could take advantage of this proposed change. For example, Army National Guard and Reserve units that may be CESQGs would have the opportunity to send their hazardous waste to an active Army base that is an LQG. The same situation applies to Air Force, Navy, and Marine Corps reserve units as well. Additionally, many universities have engineering, medical, and science laboratories located on campus, with each laboratory building possibly qualifying as a CESQG. Allowing different laboratory buildings within a university or industrial environment that are CESQGs to send their hazardous waste to another university or industrial entity that is an LQG would provide both economic and environmental benefits. Furthermore, utilities, retailers, and remote oil and gas production facilities also represent examples of industrial sectors that may realize benefits from the intra-company transfer of hazardous waste from CESQGs to LQGs.
As discussed above, EPA is proposing to amend the regulations under the existing regulatory framework at § 261.5(f)(3) and (g)(3) to allow CESQGs to send hazardous waste to an LQG under the control of the same person.
The Agency believes limiting transfers to facilities under control of the same person is appropriate because it ensures common control is maintained over both facilities and takes advantage of strong incentives to ensure the hazardous waste is safely managed. Additionally, if a CESQG sends hazardous waste to an LQG under the control of the same person, the LQG is likely to be familiar with the type of hazardous waste generated by the CESQG. Furthermore, questions regarding liability and responsibility for such hazardous waste are likely to be clearer than is the case with facilities from unrelated companies.
EPA is also proposing some labeling and marking standards for CESQG waste being transferred to LQGs under the control of the same person under this provision. Note that aside from these two conditions, the same standards for management of CESQG waste apply to materials going to an LQG under this provision as to other CESQG waste, including the exemption from the requirement to ship using a hazardous waste manifest. DOT shipping requirements do still apply.
As part of this provision, CESQGs would be required to meet the following conditions for exemption, proposed at § 262.14(a)(viii).
Because the hazardous waste generated and accumulated by a CESQG will be subsequently sent off site to an LQG under the same company in compliance with DOT hazardous material regulations, the CESQG may choose to use an appropriate DOT proper shipping name found in the 49 CFR 172.101 hazardous materials table to identify the contents of the container while hazardous waste is accumulating on site. That way, the generator will fulfill EPA and DOT requirements simultaneously; however, EPA is not proposing to require the use of the DOT shipping names while the hazardous waste is accumulating on site. We only suggest that the DOT shipping name may be one way that some generators may choose to identify the contents of the container.
EPA believes use of the DOT marking requirement should be sufficient in many situations involving DOT Class 9 hazardous materials that are also hazardous waste, with the DOT shipping name ending in N.O.S. (not otherwise specified). As noted at 49 CFR 172.301(b), generators using a DOT shipping name ending in N.O.S. must also provide the technical name of the hazardous material in association with the proper shipping name. However, the Agency is requesting comment on examples of when the DOT shipping name would not meet EPA's intent of “identifying the contents of the container” and suggestions for addressing this situation.
EPA believes that CESQGs should label and mark containers of hazardous waste sent to LQGs in order to communicate the contents of the containers to facility personnel that can then safely manage the hazardous waste in compliance with the LQG regulations. Since CESQGs already must make a hazardous waste determination to determine if and what types of hazardous waste they generate, the Agency does not believe this condition will pose an undue burden. In fact, if the CESQG was not required to provide this information, the burden to the LQG receiving the hazardous waste may increase because the LQG would then have to do so.
EPA is proposing that LQGs receiving hazardous waste from CESQGs under the control of the same person comply with the following conditions for exemption, all proposed at § 262.17(g).
Notification in this instance serves to inform the regulatory authorities of which LQGs are receiving hazardous waste from which CESQGs under control of the same person. The Agency believes notification is necessary in order to communicate to inspectors the origin of the hazardous waste received by the LQG and to ensure that the received shipment is managed in compliance with the conditions of the provision. EPA also believes that notification by the LQG, rather than notification by the CESQG, is more efficient and less burdensome, because LQGs are already required to submit
EPA has recently made available an electronic interface for states and the regulated community to use to submit Site ID forms electronically, which will further reduce burden on LQGs. Facilities should check with their states regarding whether their state will use EPA's electronic submittal process.
• The name, site address, and contact information for each CESQG; and
• A description of each waste shipment received from the CESQG, including the quantity, EPA hazardous waste number(s) of each waste received, and the date the hazardous waste was received.
EPA believes recordkeeping is necessary to ensure the requirement that the CESQG and LQG are under control of the same person is met, as well as to ensure that the hazardous waste from the CESQG is managed according to the other conditions for exemption of this provision, such as that LQGs are receiving shipments of hazardous waste from CESQGs in quantities commensurate with the CESQG's generator category. EPA believes this recordkeeping condition could be fulfilled through routine business records, such as a bill of lading, and would not present undue burden to the LQG. Additionally, the LQG could use this information in order to report the hazardous waste from the CESQG on its biennial report forms.
Because the LQG must manage the hazardous waste it receives from CESQGs according to the LQG regulations, EPA believes that the same labeling and marking regulations should apply to hazardous waste from a CESQG that is accumulated and managed by an LQG. EPA believes that it is important that employees, transporters, downstream handlers, emergency personnel, EPA, and the states know as much as possible about the potential hazards of the contents in containers that LQGs accumulate, transport, and manage.
An LQG would also be required to report the hazardous waste it receives from CESQGs on its biennial report, as required under § 262.41. EPA plans to include a new source code in the biennial report instructions (if this provision is made final) that LQGs would use to identify the hazardous waste as being received from a CESQG (to differentiate from hazardous waste the LQG generates on site). Generators would be required to report hazardous waste they receive from CESQGs by type of hazardous waste. In other words, if an LQG receives the same type of hazardous waste from multiple CESQGs, it would only need to report the total quantity of that hazardous waste received from all CESQGs. This provision is consistent with the existing provision that LQGs must report information on the quantities and types of hazardous waste they generate as part of the biennial reporting process. It will also enable states and EPA to better understand the additional volumes and types of hazardous wastes managed at an LQG, which will assist in prioritizing compliance assistance.
Because LQGs currently have no maximum limit on the amount of hazardous waste they can accumulate, and because the regulations that are applicable to LQGs are protective, the Agency believes there is no need to establish a maximum limit on the amount or types of hazardous waste that an LQG could receive from CESQGs. In fact, we believe the more hazardous waste that is shipped to LQGs, the greater potential for reduced risk, since these hazardous wastes would be managed under the more comprehensive hazardous waste regulations, as opposed to potentially being sent to non-hazardous waste disposal facilities.
EPA believes the proposed conditions to allow CESQGs to send their hazardous waste to an LQG under the control of the same person are necessary to ensure protection of human health and the environment. Failure to meet one or more of the conditions could lead to potential mismanagement of the hazardous waste, potentially resulting in a release of hazardous waste or hazardous waste constituents to the environment. Persons taking advantage of the proposed provision that fail to meet one or more of the conditions for exemption would be subject to an enforcement action under RCRA section 3008 for violations of applicable independent requirements in part 264, 265, 267, 268, and 270. EPA and authorized states would also have the authority to cease certain transfers of hazardous waste from CESQGs to an LQG in the context of an enforcement action. EPA also notes that failure on the part of the LQG to meet one of the conditions for exemption would not mean that the CESQG is subject to permitting or other standards in 264, 265, and 270, provided that the CESQG met its conditions for exemption and vice versa.
Under RCRA, authorized state programs may be more stringent than the federal program and thus states may choose not to adopt the proposed provision allowing CESQGs to send their hazardous waste to an LQG under the control of the same person. In the case of interstate shipments where a CESQG wants to transfer its waste to an LQG located in a different state than the CESQG, the CESQG must ensure that both states have adopted the provision in order to ship the hazardous waste to an LQG. Additionally, if a CESQG wants to transfer its waste through states that have not adopted the proposed provision, these transit states may also impose state requirements on the shipment while it is being transported through the state. Therefore, EPA recommends that generators contact any states through which the hazardous
EPA requests comment regarding its proposal to allow CESQGs to ship their hazardous waste to an LQG under the control of the same person.
EPA is also requesting comment on whether to establish a process that would allow an entity (whether CESQG or LQG) to request approval from its EPA Regional Administrator or the authorized state to transfer hazardous waste from CESQGs to LQGs that are not under the control of the same person. For example, such inter-company transfers could occur between high school laboratories and university laboratories or other waste management companies, such as those assisting with school chemical clean-outs. While the Agency believes that this should not be allowed as a general matter, we also recognize that there may be instances where such an arrangement may be appropriate, and thus, are taking comment on allowing such arrangements on a case-by-case basis. EPA is interested in whether such inter-company transfers would produce the same benefits as for intra-company transfers in enabling greater control over the management of CESQG hazardous waste, thereby resulting in improved efficiency and reduced liability for the generator.
The request for approval submitted to the state or Regional office would have to include the name, address, and contact information for each entity involved in the arrangement, how the entities will assign responsibility for the safe management of the hazardous waste during transport to and accumulation by the LQG, as well as a description of the actual practices that will be followed by the CESQG and LQG to ensure the safe management of the hazardous waste. EPA does not believe that these requests for approval would need publication in the
EPA is requesting comment on an additional variation for allowing LQGs to consolidate CESQG hazardous waste when the generators are not under the control of the same person with a self-implementing request for approval. Under this variation, the implementing agency would have sixty days from the date the request was sent to approve or deny it. After sixty days, the generator may start consolidating regardless of whether it has heard back from the implementing agency. This option provides the state or Regional office the ability to deny requests that pose a risk to human health or the environment or that come from entities that have a history of not managing waste responsibly, but puts a limit on how long a generator must wait for a response to its request for approval.
EPA is proposing to modify 40 CFR 261.6(c)(2) to require owners or operators of facilities that recycle hazardous waste without storing it prior to recycling to comply with the biennial reporting requirements at 40 CFR 265.75. Because these entities receive hazardous waste using a hazardous waste transporter and hazardous waste manifest, similar to a permitted TSDF or a facility with interim status, the Agency is proposing to amend its regulations and instructions to specify that such facilities must complete and submit a biennial report to EPA. Without this information, the Agency and states may have an incomplete picture of which facilities recycle hazardous waste and the quantities of regulated hazardous wastes that are recycled, impeding their ability to provide adequate oversight for those facilities.
The Agency believes that only a few recycling facilities will be affected by this change. Additionally, considering that most facilities already have sophisticated information systems to manage and track incoming shipments of hazardous waste, we believe the burden imposed on such facilities should be minimal.
The Agency requests comment on this proposed change. Additionally, the EPA is interested in information regarding whether these facilities already routinely submit biennial reports or are required by the states to submit biennial reports.
As previously discussed, one of the objectives of this proposal is to revise the hazardous waste generator regulations to make them more user-friendly and easily understood by both the regulated community and federal and state regulators. Currently, the hazardous waste generator regulations are located primarily in three different parts of the CFR (40 CFR parts 261, 262, and 265). In some cases, it is difficult to determine what components of the regulations apply to different categories of hazardous waste generators.
The proposed reorganization will address many of these problems by moving the regulations at § 261.5 and some of the technical standards of part 265 into part 262 and by organizing the regulations based on a generator's category so generators can more easily determine which regulations they are subject to. That is, EPA is proposing that § 262.14 contain conditions for exemption for conditionally exempt small quantity generators, that § 262.15 contain conditions for exemption for satellite accumulation areas, that § 262.16 contain conditions for exemption for small quantity generators, and that § 262.17 containing conditions for exemption for large quantity generators.
In concert with the reorganization of the generator conditions for exemption, EPA is proposing to add some regulatory language to more clearly explain how the regulations work for generators and to lay out which provisions the various categories of generators are responsible for complying with. The proposed addition of § 262.1 and the proposed revisions to § 262.10 are meant to achieve these goals.
One concern regarding the current generator regulations is that they are not sufficiently clear about the distinction between the two types of generator requirements: Those that a generator must meet because it is an entity that generates hazardous waste—independent requirements—and those that a generator must meet only if it
The difference between independent requirements and conditions for exemption, as discussed previously in this preamble, lies in the nature of each, and in the consequences that result when each is not met. An independent requirement is an unqualified or unconditional requirement imposed without reference or regard to obtaining an optional exemption from regulation. That is, independent requirements must be met whether or not the generator accumulates hazardous waste. An independent requirement is applicable and enforceable, independent of whether the generator is attempting to obtain an exemption.
A condition for exemption, on the other hand, is a requirement that is contingent in nature, in that it is only necessary to meet in order to obtain an optional exemption from other requirements. As an example, the regulations in § 262.34(a) introduce the conditions of the LQG exemption by stating that the LQG may accumulate hazardous waste on site for 90 days or less without a permit or without having interim status, provided that it meets the conditions listed in that paragraph.
This distinction is relevant because while an entity can “violate” and be penalized for violating an independent requirement, an entity cannot be penalized for not complying with a condition for an optional exemption. Instead, if the entity does not comply with the conditions of the exemption, that exemption no longer applies and the entity becomes subject to full regulation. Violation of an independent requirement, such as an SQG failing to obtain an EPA identification number, can result in a notice of violation and enforcement action for that particular provision. Noncompliance with a condition for exemption, such as an LQG accumulating hazardous waste for more than 90 days, however, can result in an entity losing its conditional status and becoming the operator of a non-exempt storage facility subject to the applicable requirements for storage facilities in parts 124, 264, 265, 267, 268 and 270, and for generators in part 262.
EPA is proposing to define an “independent requirement” as a requirement of any of part 262 that states an event, action, or standard that must occur or be met and that applies without relation to, or irrespective of, the purpose of obtaining a conditional exemption from a permit or having interim status under § 262.14, 262.15, 262.16, or 262.17.
EPA is proposing to define a “condition for exemption” as any requirement in § 262.14, 262.15, 262.16, or 262.17, that states an event, action, or standard that must occur or be met in order to obtain a conditional exemption from any requirement in parts 124, 262 through 268, or 270, or from any requirement for notification under section 3010 of RCRA.
We will be using these terms throughout this preamble to distinguish between these two types of provisions for generators.
EPA is requesting comment on this proposed change to the regulations, particularly whether it clarifies implementation of the generator regulations by industry and the regulating entities.
As part of the reorganization of the generator regulations, § 262.10(a), which addresses the purpose, scope, and applicability of the hazardous waste generator regulations, will list which generator provisions are independent requirements and which are conditions for a generator exemption from part 124, from the applicable standards of parts 264 through 268, from the permitting requirements of part 270, and from section 3010 of RCRA.
Specifically, EPA is proposing two changes to § 262.10(a): (1) Stating that a hazardous waste generator is subject to all the applicable independent requirements of part 262 and listing those independent requirements and (2) stating that a generator that accumulates hazardous waste on site is also considered to be a facility storing hazardous waste unless it meets the conditions for one of the generator exemptions in § 262.14, 262.15, 262.16, or 262.17.
a.
To be clear about the distinctions between these types of standards, EPA is proposing to state at § 262.10(a)(1) that a person who generates a hazardous waste as defined by 40 CFR part 261 is subject to all the applicable independent requirements in the subparts and sections listed, unless the person is a conditionally exempt small quantity generator (or “very small quantity generator,” in the terminology of the proposed rule) that meets the conditions for exemption in § 262.14. This new addition will reinforce to generators that they must meet these independent requirements whether or not they accumulate hazardous waste on site.
Therefore, EPA is proposing to state at § 262.10(a)(2) that a generator that accumulates hazardous waste on site is also considered a facility that stores hazardous waste, unless it is excluded because it meets the conditions of being a generator. The paragraph then lists the generator categories and where to find the relevant conditions for each, in § 262.14, 262.16, or 262.17.
These proposed changes to § 262.10 do not constitute substantive changes to the hazardous waste generator regulations. Rather, these changes simply reorganize the independent requirements and conditions for exemption applicable to all hazardous waste generators based on their generator category into one section of the regulations. EPA also believes these changes will reduce confusion for the regulated community in the context of enforcement actions. It has been the Agency's longstanding position that generators that do not comply with a condition of a generator exemption fail to qualify for the exemption and, if they have not qualified for any other exemption, they would be considered an operating TSDF without a permit and/or in violation of the storage facility operating standards in parts 264 or 265. The Agency believes this proposed reorganization will improve the use of and compliance with the regulations.
EPA is requesting comment on these proposed changes.
Section 262.10(c) of the hazardous waste regulations is a provision that describes the requirements for a generator who treats, stores, or disposes of hazardous waste on-site and includes
When § 262.10(c) was initially promulgated on February 26, 1980, the hazardous waste generator regulations distinguished between the generators that sent hazardous waste to be managed off site and those that managed their hazardous waste on site. Generators that sent hazardous waste off site could manage it for 90 days in an accumulation area, but generators that managed hazardous waste on site were expected to manage it under their permits or under interim status regulations. The purpose of § 262.10(c) was to provide the list of requirements that generators managing hazardous waste were required to follow in addition to those permits or interim status requirements.
This distinction meant that the two types of generators had very different standards for the areas where newly generated hazardous waste was managed. Significantly, generators sending hazardous waste off site could easily make physical changes to their accumulation areas, whereas a similar generator managing hazardous waste on site under a permit had to go through the permit modification process to make the same kind of changes. EPA effectively eliminated the distinctions by revising these regulations (45 FR 76624, November 19, 1980 and 47 FR 1248, January 11, 1982). The final rule promulgated in January 11, 1982, made a change to § 262.10(c) that added the generator accumulation provisions at § 262.34 to the list of things a generator who treats, stores, or disposes of hazardous waste on site must comply with. Currently, the Agency does not make this distinction between generators that send waste for treatment off site and those that manage waste on site. This revision is therefore outdated and not well understood and can be deleted and reserved without disruption to the generator hazardous waste regulations.
EPA seeks comment on whether anyone is using this provision or has objection to its removal and what the reasoning for that objection is.
The existing regulation at § 262.10(g) states that a generator is subject to the compliance requirements and penalties prescribed in section 3008 of [RCRA] if it does not comply with the requirements of that part. However, this paragraph does not expressly state that a generator that is not meeting the conditions of its exemption—and is, therefore, an illegal TSDF—is liable under section 3008 of RCRA for failing to meet the requirements for TSDFs in parts 124, 264 through 268, and 270.
Therefore, EPA is proposing to revise § 262.10(g) to state that a generator is subject to enforcement of the applicable requirements and penalties under section 3008 of RCRA if it fails to meet its applicable independent requirements under part 262: § 262.11 (Hazardous waste determinations and recordkeeping), § 262.12 (Obtaining an EPA identification number), part 262 subpart B (Manifest), §§ 262.30 through 260.33 (Pre-transport) and part 262 subpart D (Recordkeeping and reporting). The new language would further explain that a generator is subject to enforcement of the applicable requirements and penalties under section 3008 of RCRA if it fails to meet the applicable requirements of parts 124, 263 through 268, and 270, including such requirements made applicable when such person is not meeting the conditions of the generator exemption.
EPA is requesting comment on these proposed changes.
The Laboratory XL Project was created for Boston College, the University of Massachusetts, and the University of Vermont, and was finalized in the
EPA is requesting comment on this proposed change.
The Agency is proposing to add a new provision at § 262.10(a)(3) that would clearly and succinctly state that a generator cannot offer or otherwise cause its waste to be sent to a facility that is not authorized to accept it.
As the Agency has stated numerous times in the development and implementation of the RCRA hazardous waste program, a fundamental aspect of the program is the responsibility placed on the generator of hazardous waste to ensure its hazardous waste is properly managed from cradle to grave. Numerous existing regulatory provisions are designed to ensure that generators send their hazardous waste only to authorized TSDFs or other authorized facilities. See for example, §§ 262.12(c), 262.20(b), 262.40(a). However, from experience with the program, the Agency has found situations where a generator failed to send its hazardous waste to a facility authorized to receive that waste, thus creating both regulatory and potential hazardous waste mismanagement problems. The Agency believes this provision is necessary to ensure generators understand they have this obligation and, for that reason, is placing it in the initial provisions of the generator regulations.
This provision is being added to the regulatory framework and not replacing §§ 262.12(c), 262.20(b), 262.40(a), as those provisions are aimed at other aspects of the generator program (for example, ensuring manifests are properly completed).
The Agency requests comment on adding this new provision.
EPA is proposing to revise the hazardous waste determination regulations at § 262.11 in order to provide a more complete explanation of the regulation and improve compliance by hazardous waste generators. The proposed changes are intended to provide more information about when a waste determination must be made, as well as to better explain the methods and procedures for generators to determine whether they have a listed hazardous waste or a characteristic waste. The proposed changes also address some deficiencies in the current recordkeeping regulations.
Specifically, the proposed changes discussed in this section are the following: (1) Confirming that a generator's waste must be classified at its point of generation and, for wastes potentially exhibiting a hazardous characteristic, at any time during the course of its management when the properties of the wastes may change; (2) revising the language on making a determination for a listed hazardous waste in § 262.11 to explain more fully how generators can make this kind of determination, including use of acceptable kinds of generator knowledge; (3) explaining more completely in the regulations in § 262.11 how a generator should evaluate its waste for hazardous characteristics; (4) moving the independent recordkeeping and retention requirements for hazardous waste determinations currently found at § 262.40(c) into § 262.11 to integrate this provision more directly into the hazardous waste determination regulations; (5) revising the hazardous waste determination recordkeeping regulations to require that SQGs and LQGs maintain records of any test results, waste analyses, or other determinations made in accordance with § 262.11 for at least three years, including waste determinations where a solid waste (as defined in § 261.2) is found not to be a RCRA hazardous waste (as defined in § 261.3); (6) revising the hazardous waste determination regulations by copying § 262.40(d) into § 262.11 to address situations where an enforcement action has been initiated and the period of record retention (
In addition, EPA is asking for comment in this section on two additional potential changes regarding the accuracy of hazardous waste determinations and the length of time records must be maintained.
Finally, EPA discusses the potential development of an electronic decision making tool for hazardous waste determinations and takes comment on whether that would be a helpful tool to generators.
The revisions proposed at § 262.11 are designed to improve compliance by generators in making a hazardous waste determination for their solid wastes. To a great extent, the success of the RCRA hazardous waste regulatory program begins with and relies on generators making this determination. Failure to make an accurate hazardous waste determination may lead to mismanagement of the waste, with potential adverse consequences to human health and the environment. As described below, generators may have a difficult time making an accurate hazardous waste determination for a variety of reasons.
Many of the proposed changes at § 262.11 derive from policy statements and clarifications the Agency has made through the years in FR notices, guidance documents, and policy letters to help explain how hazardous waste determinations should be made. The proposed changes also derive from issues identified in EPA's 30 years of experience implementing the RCRA hazardous waste program.
The regulations at § 262.11 require generators of solid waste (as defined at § 261.2) to determine whether their waste is also a hazardous waste. Under RCRA, a solid waste may be hazardous if it is either listed as hazardous or exhibits a hazardous waste characteristic. Listed hazardous wastes are wastes that the Agency has specifically evaluated and determined may present a risk to human health and the environment, if improperly managed. Such wastes can be generated by specific processes of particular industries or by many different types of industry (
Once a generator has determined from § 261.2 that it has generated a solid waste, the regulations at § 262.11 currently provide the following method for a generator to determine if a waste is a hazardous waste:
(1) It should first determine if the waste is excluded from regulation under the exclusions found in 40 CFR 261.4.
(2) It must then determine if the waste is listed as a hazardous waste in subpart D of 40 CFR part 261. Note that even if the waste is listed, the generator still has an opportunity under 40 CFR 260.22 to demonstrate to the Administrator that the waste from his particular facility or operation is not a hazardous waste.
(3) For purposes of compliance with the land disposal restrictions in 40 CFR part 268, or if the waste is not listed in subpart D of 40 CFR part 261, the generator must then determine whether the waste is identified in subpart C of 40 CFR part 261 by either:
(A) Testing the waste according to the methods set forth in subpart C of 40 CFR part 261, or according to an equivalent method approved by the Administrator under 40 CFR 260.21; or
(B) Applying knowledge of the hazard characteristic of the waste in light of the materials or the processes used.
(4) Finally, if the waste is determined to be hazardous, the regulations state that the generator must refer to parts 261, 264, 265, 266, 267, 268, and 273 of this chapter for possible exclusions or restrictions pertaining to management of the specific waste.
A generator's responsibility begins with applying due diligence through knowledge of its processes, feedstocks, and wastes generated, and/or testing to make an accurate hazardous waste determination for the solid waste it has generated (see § 261.2). The Agency considers the application of the above information (
From experience with the waste determination program, the Agency has found that there are a number of situations in which generators may misclassify their wastes. In some cases, generators overlook certain wastes that are unrelated to their production processes, discarding them in the trash without realizing that they have discarded a hazardous waste. In other cases, generators may not understand how the hazardous waste characteristics or listings regulations may apply to the waste. There are also instances in which
States have also identified difficulties generators have in making hazardous waste determinations as a concern. A study conducted by the State of New Hampshire found that generators often overlooked hazardous wastes they had generated apart from their main production operations, for example, solvent-contaminated wipes and aerosol cans.
The Georgia Department of Natural Resources (GADNR) has also highlighted this problem in one of its publications, stating “Many solid waste streams at facilities tend to be overlooked as hazardous wastes because the solid waste usually does not resemble what one would think a hazardous waste looks like [
The importance of generators making an accurate hazardous waste determination cannot be over-emphasized. In 2013, a contractor for EPA completed a third-party program evaluation of the hazardous waste determination regulations to better understand the reasons generators may have difficulty making reliable hazardous waste determinations.
The evaluation reported the following findings. First, the average non-compliance rate with the RCRA hazardous waste determination regulations across the United States is approximately 34 percent. This figure is based on an analysis of hazardous waste determination violations during EPA compliance inspections recorded in EPA's RCRAInfo data system from 2001 to 2011.
Probably the most comprehensive analysis involved examining all compliance evaluation inspections of LQGs, SQGs, and CESQGs conducted by both the EPA Regions and the states for fiscal years 2008-2012.
The evaluation also discussed a number of implementation challenges that lead to non-compliance with the hazardous waste determination regulations. The evaluation identified 30 recurring themes that describe various obstacles, challenges, and factors that influence hazardous waste generators' compliance with the hazardous waste determination regulations. These 30 themes fall into three overarching categories: (1) Challenges related to the regulations; (2) challenges related to generators; and (3) challenges related to regulatory agencies.
The Agency is proposing changes intended to address the two challenges identified that are related to the regulations. These are (1) difficulty understanding the regulations as written and (2) difficulty interpreting and applying the regulations to specific circumstances. The proposed changes to § 262.11 are intended to elaborate on the meaning and intent of these regulations to make them easier for generators to understand. We believe the better understanding resulting from these changes will also make it easier to appropriately apply the requirements to a broader range of specific circumstances.
EPA's evaluation of the waste determination regulatory program noted that improving compliance in making accurate waste determinations is a multi-faceted problem. The Agency believes improving the clarity of the regulatory text is an important step because it represents the foundation from which all subsequent EPA and state outreach, technical assistance and enforcement efforts begin. In this regard, EPA identified several particular areas for possible improvements to the current regulations:
—Confusion about where and when to make a hazardous waste determination, particularly when further management of that material may result in a change in the hazardous waste determination.
—§ 262.11(b), which relates to whether or not a solid waste is a listed hazardous waste, does not describe how a generator should determine if the material in question is a listed hazardous waste.
—§ 262.11(c) states that a generator can either test its waste or use process knowledge or knowledge about its waste to determine whether a solid waste is a characteristic hazardous waste.
—The existing regulatory text notes that test methods are included in the hazardous characteristic definitions in subpart C of part 261,but does not note that tests are not provided for all aspects of the hazardous characteristics identified there.
The Agency has provided guidance on these issues over the past 30 years and through these proposed regulatory revisions intends to incorporate key aspects of that guidance into the regulatory language.
Finally, EPA is proposing to address deficiencies in the recordkeeping for hazardous waste determinations. These deficiencies include both a lack of specificity regarding what materials used in a hazardous waste determination must be maintained and lack of a specific statement that the independent requirement to maintain records is extended when there is an unresolved enforcement action. In addition, there are large number of hazardous waste determinations for which records are not being kept because the generator determines that the material in question is not a hazardous waste. Failure to maintain records in these cases makes it difficult for regulatory agencies to determine how a generator made the determination and to quickly assess whether the determination is accurate.
To respond to generator concerns about identifying the most appropriate point at which to make a hazardous waste determination, EPA is proposing to revise § 262.11 to add a paragraph (a), which would state that a hazardous waste determination must be made at the point of waste generation (
The 1980 preamble to the original hazardous waste regulations explicitly discussed this scenario, stating that a solid waste which is a hazardous waste because it is listed in part 261 subpart D must begin to be managed as a hazardous waste when it first meets the subpart D listing description. The preamble explains that most of the hazardous wastes listed in §§ 261.31 and 261.32 of subpart D (the F-list and the K-list) are process residues, emission control dusts, or wastewater treatment sludges and the point in time when they are created is generally well defined. For other hazardous wastes, such as spent solvents or those hazardous wastes listed in § 261.33, the point at which they meet the listing description is somewhat less well defined, but generally occurs when their intended use has ceased and they begin to be accumulated or stored for disposal, re-use, or reclamation. The preamble then goes on to provide several examples illustrating how this provision would operate in practice (45 FR 33095-96, May 19, 1980).
The 1980 regulatory preamble also addressed this issue for characteristic hazardous waste. In defining what waste is considered hazardous, § 261.3(b)(3) states that “a solid waste becomes a hazardous waste . . . when the waste exhibits any of the characteristics.” EPA elaborated on this regulatory definition in 1980 by noting that “paragraph (b) provides that a solid waste is a hazardous waste whenever it exhibits one or more of the characteristics. As a practical matter, this means that persons handling solid waste must determine whether they meet the characteristics whenever the management of the waste would be subject to EPA's part 262-265 regulations” (45 FR 33095, May 19, 1980).
This implies that a generator's waste characterization obligations may continue beyond the determination made at the initial point of generation. In the case of a non-hazardous waste that may, at some point in the course of its management, exhibit a hazardous waste characteristic, there is an ongoing responsibility to monitor and reassess its regulatory status if changes occur that may cause the waste to become hazardous. Thus, the generator must monitor the waste for potential changes if there is reason to believe that the waste may physically or chemically change during management in a way that might cause the waste, or a portion of the waste, to become hazardous.
The preamble to the final rule for the toxicity characteristic reiterated that the current rules require that the determination of whether a waste is hazardous is to be made at the point of its generation (
Thus, for determining whether a waste exhibits a hazardous characteristic, generators of solid waste are required to make a hazardous waste determination at the initial point of generation, in the form the waste is generated in (
As an example, in a letter regarding a waste consisting of solvents mixed with water that separates and becomes biphasic over time, the Agency stated that in this situation, the generator must make the hazardous waste determination not only at the initial point of generation, but also after the waste separates into phases. This letter went on to say that a generator's responsibility to make a hazardous waste determination may continue beyond the determination made at the initial point of generation. In the case of a nonhazardous waste that may, at some point in the future, exhibit a hazardous waste characteristic, there is an ongoing responsibility to monitor and reassess if changes occur that may cause the waste to become hazardous.
Again, if there is reason to believe that the waste may physically or chemically change during management in a way that might cause the waste, or portion of the waste, to become hazardous, the generator must monitor the waste for these changes. The generator should also notify any subsequent handlers of the waste so they are aware that they
Therefore, to clarify that hazardous waste determination must be made at the point of generation, the Agency is proposing to revise the regulations at 40 CFR 262.11 by adding a new paragraph (a) that would state that a hazardous waste determination for each solid waste must be made at the point of waste generation, before any dilution, mixing, or other alteration of the waste occurs, and at any time in the course of its management that it has, or may have, changed its properties as a result of exposure to the environment or other factors that may change the properties of the waste.
This addition of paragraph (a) would change current § 262.11(a) into § 262.11(b) and bump all subsequent paragraphs in that section.
EPA requests comments on the proposed changes to § 262.11 and in particular is soliciting comment on whether the proposed new language is sufficient to improve the existing regulatory text and better assist generators in making effective hazardous waste determinations. Additionally, EPA is interested in comments regarding improvements the Agency could make to the proposed regulatory text.
These three types of information can be considered as acceptable types of generator knowledge about a waste stream for making a hazardous waste determination. A November 20, 1997,
Other hazardous waste listings describe wastes generated from generic processes that are common to various industries and activities. They include, for example, waste solvents (
Note that these spent solvents are regulated as hazardous under RCRA, but only if the total of all the solvent constituents before use is greater than or equal to ten percent of the material's volume. This adds a layer of complexity to the hazardous waste determination and requires that the generator have knowledge of the composition of the unused solvent before the waste is generated.
Finally, the hazardous waste regulations include the “derived from” and “mixture” rules, which state that any solid waste derived from the treatment, storage, or disposal of a listed RCRA hazardous waste, or any solid waste mixed with a listed RCRA hazardous waste, respectively, is itself a listed RCRA hazardous waste until delisted (see § 261.3(a)(2)(iv) and § 261.3(c)(2)(i), respectively) (62 FR 62082, November 20, 1997). The exception to these rules is when the waste is listed solely because it exhibits a hazardous waste characteristic, but the particular waste in question no longer exhibits any hazardous characteristic (§ 261.3(g)).
The new § 262.11(c) would identify the types of acceptable information that the generator could consider in evaluating its waste against the hazardous waste listing descriptions and would assist them in determining if they have generated a listed hazardous waste. This proposed paragraph would state that if the waste is not excluded under 40 CFR 261.4, the person must then use knowledge of the waste to determine if the waste meets any of the listing descriptions under subpart D of 40 CFR part 261. Acceptable knowledge that may be used in making an accurate determination as to whether the waste is listed includes, but is not limited to, waste origin, composition, the process producing the waste, feedstock, and
EPA requests comments on these proposed modifications to § 262.11(c).
The RCRA hazardous waste regulations identify four characteristics that can result in a hazardous waste classification: ignitability, corrosivity, reactivity, and toxicity. Wastes exhibiting any of these characteristics have EPA hazardous waste numbers starting with the letter “D” and the regulations defining these characteristics are at §§ 261.20 through 261.24. The current § 262.11 regulations identify two methods for determining whether a solid waste is hazardous because it exhibits a hazardous characteristic: (1) Testing of the waste or (2) using knowledge of the hazard characteristic and the materials and processes used in generating the waste. Further, even if a waste is a listed hazardous waste, the regulations require the generator to determine whether it also exhibits a hazardous characteristic to ensure that all waste treatment obligations under part 268 are met. This ensures that the waste can be treated to mitigate hazards posed by chemicals or properties for which it was listed, and also any characteristic hazards, which may be different from hazards that are the basis for listing.
The proposed language associated with testing at § 262.11(d)(1) specifies that generators testing their waste must obtain a representative sample for testing, as defined at § 260.10 and as required by all of the hazardous characteristic regulations. For those characteristics that include a specific test as part of the regulation, the results of that test, when properly performed and compared with regulatory thresholds, are definitive for determining whether the waste is hazardous. The tests specified by the regulations are available in EPA's “Test Methods for Evaluation Solid Waste, Physical/Chemical Methods,” EPA Publication SW-846. This document which contains all of OSWER's analytical methods, is available on EPA's Web site at:
When evaluating a waste for one of the hazardous characteristics for which there is a regulatory test, generators are not required to use the test provided the generators' knowledge about the waste is adequate to make a reliable determination about the RCRA status of the waste, as discussed in the next section. However, if a disagreement arises between a generator and an inspector about whether a particular waste is hazardous, we would recommend that the generator use the regulatory test, since the results of the test, when properly performed, should resolve such a disagreement.
For those characteristics that do not include a specific test, but provide a narrative definition, the generator can use appropriate tests, such as those identified in SW-846 that identify hazardous properties as part of their knowledge about the waste to help determine whether the waste exhibits the hazardous waste characteristic. In addition, test methods used by DOT, the National Fire Protection Association, or other third-party testing organizations may be useful or relevant for evaluating a particular waste. However, the generator would need to show the relevance of the test to the waste evaluation.
The Agency has discussed the use or requirement of testing in various
Specifically, several FR notices discuss what constitutes “process knowledge” for making a hazardous waste determination and include the following potential sources: (1) Waste analysis data or studies on wastes generated from processes similar to that
Some states have also provided guidance to their generators on some of the challenges of only using process knowledge. For example, the Connecticut Department of Energy and Environmental Protection notes that although knowledge of process information can be very useful (especially in identifying hazardous constituents that are known to be present), it may not always be adequate to fully and properly characterize a waste. In particular, knowledge of the process may not account for factors such as trace contaminants that may not be listed on an MSDS (only chemicals present at concentrations greater than 1% are typically identified), contaminants introduced during use, and cross-contamination from other wastes. As a result, some sampling may be required by the state to properly characterize a waste.
Similarly, the Georgia DNR has highlighted some of the challenges of only using process knowledge. In particular, a GADNR publication states, “Using [process] knowledge alone to make a hazardous waste determination may not always be adequate due to the variability of the waste, or the lack of knowledge of chemical processes in generating the waste. In those cases where the waste generated is variable, generators may choose to make a determination that the waste is hazardous waste rather than testing the waste each time it is generated. In addition, in the case of a hazardous waste that is always hazardous, but is characteristic for certain constituents at times, but not at others, the generator may choose to be inclusive of all potential waste codes, rather than test the waste each time it is generated. If the generator with a variable waste chooses not to treat the waste as described above in this paragraph, the waste must be tested as generated.”
The Georgia DNR has also issued useful guidance for its generators regarding the testing and recordkeeping for waste, stating that, “If test methods are used to determine if the waste exhibits a characteristic, a description of how the waste was sampled to obtain a representative sample and copies of the analytical results for that sample should be included as documentation of the hazardous waste determination. The generator may apply knowledge of the waste and the generation process to determine which constituents/parameters to include in analyses, as well as where and when sampling is most appropriate. However, if the full suite of analyses is not applied, the generator must have sufficient documentation to demonstrate why only certain analyses were applied, and not all. Adequate documentation includes a list of constituents/chemicals that make up the waste, their physical and chemical properties, the effects of the process on the product/materials in the waste, and whether the product/material picks up additional hazardous constituents (contaminants) in the process; all of which provide knowledge as to what constituents should be included in the analyses.”
c.
A test other than a test method set forth in subpart C of 40 CFR part 261, or an equivalent method approved by the Administrator under 40 CFR 260.21, is also acceptable and may be used as part of a person's knowledge to determine whether a solid waste exhibits a characteristic of hazardous waste. However, such tests do not, by themselves, provide definitive results and the generator may need to identify why the test is relevant.
The Agency requests comments on the proposed changes associated with revising § 262.11(c) and moving it to
The Agency is proposing to make one organizational change and several revisions to the recordkeeping provisions associated with making a hazardous waste determination, a provision found currently at § 262.40(c). Section 262.40(c) currently states that a generator must keep records of any test results, waste analyses, or other determinations made in accordance with § 262.11 for at least three years from the date that the waste was last sent to on-site or off-site treatment, storage, or disposal. This independent recordkeeping requirement is applicable to SQGs and LQGs only. CESQGs are not affected by this section.
First, the Agency is proposing that this paragraph be moved to § 262.11(e) to integrate this provision with the hazardous waste determination regulations in that section. Additionally, EPA is proposing to revise the wording to better articulate the types of information acceptable to making an accurate hazardous waste determination that must be maintained and to emphasize the importance of this section.
These records must include, but are not limited to, the following types of information that have been used by the generator in making the waste determination: The results of any tests, sampling, or waste analyses; records documenting the tests, sampling, and analytical methods used and demonstrating the validity (or quality assurance/quality control) and relevance of such tests; records consulted in order to determine the process by which the waste was generated, information on the composition of the waste and the properties of the waste; and records which explain the basis for the generator's determination as described at § 262.11(d)(2).
Second, the Agency is also restating that these records must be maintained for at least three years from the date that the waste was last generated by the facility and also stating that should the generator be involved in any unresolved enforcement action regarding a waste determination, then the periods of record retention are extended automatically or if requested by the Administrator. An “unresolved enforcement action” means any formal administrative, civil or criminal enforcement action which has been filed or issued against a generator by EPA or authorized state pursuant to RCRA subchapter III or VII and for which all rights of appeal have not been exhausted.
Additionally, EPA is proposing to revise the wording of the section to better articulate the types of waste determination information that must be maintained and to emphasize the importance of this section. In an effort to improve compliance with the hazardous waste determination regulations, and therefore improve environmental protection, EPA is proposing to revise the recordkeeping regulations to require small and large quantity generators making a waste determination to document and maintain records of all their hazardous waste determinations, including determinations where a solid waste is found not to be a hazardous waste.
CESQGs would not be affected by this change. However, maintaining a copy of their hazardous waste determinations may be beneficial to a CESQG to support any questions posed during an inspection by EPA or state inspector, as well as to support their waste generator category. In analyzing Kansas and Iowa inspection data of CESQG facilities, instances were found where the generator failed to make an accurate hazardous waste determination resulting in the generator moving into a higher generator category and becoming subject to the regulations of either an SQG or LQG.
The hazardous waste determination process is the gateway to the hazardous waste generator regulatory program and, to a great extent, its ultimate success. If a generator can accurately identify the types of hazardous wastes it generates, it can then identify the applicable regulations it must comply with to ensure safe management of that waste. Conversely, if a generator fails to make an accurate hazardous waste determination, that failure can potentially lead to the mismanagement of hazardous waste and environmental damages. In addition, the generator could then be cited in an enforcement action not only for that violation, but also for failing to comply with other generator regulations, including operating without a RCRA permit (see § 262.34(a) and (d)).
The Agency made this point clear when it initially promulgated the hazardous waste generator rules in February 1980, where it stated, “The determination is the crucial, first step in the regulatory system, and the generator must undertake this responsibility seriously” (45 FR 12727, February 26, 1980). Unfortunately, as previously discussed, there is a high rate of noncompliance with the hazardous waste determination regulations.
Under the current regulations at § 262.40(c), a generator is required to document and maintain records of any test results, waste analyses, or other determinations made in accordance with § 262.11 for at least three years from the date that the waste was last sent to on-site or off-site treatment, storage, or disposal. When an inspector sees a container or other waste management unit, that inspector has the authority to ask the generator how it determined the regulatory status of the waste, and the generator should be able to articulate how that determination was made. In many instances, the inspector will also ask to see any documentation supporting a questionable determination that a material is not a hazardous waste in order to understand how the generator applied process knowledge or the results of testing the waste to support its non-hazardous waste determination.
The Agency strongly believes that documentation must be maintained for waste determinations, not only when a solid waste is a hazardous waste but also when a solid waste is determined by the generator to not be a hazardous
The requirement that a generator maintain records of determinations that a solid waste is not a hazardous waste was originally discussed in the preamble to the 1978 proposed rule for the hazardous waste regulatory program. In fact, the Agency proposed the following at 40 CFR 250.10(d)(1)(iii): “Generators who determine that their waste is not hazardous shall retain copies of the evaluation performed and shall repeat the necessary evaluation or testing when there is a significant change in their feed material or operations which may alter the test results.” (43 FR 58955, December 18, 1978). In the February 26, 1980, final rule for hazardous waste generators, however, the Agency did not make this requirement final. Rather, the Agency simply promulgated the provision stating that a generator must keep records of any test results, waste analyses, or other determinations made in accordance with § 262.11 for at least three years from the date the waste was last sent to on-site or off-site treatment, storage or disposal (45 FR 12734), which could be interpreted to mean either that a generator was required to keep records or that a generator was not required to keep records of solid wastes that were not hazardous wastes. (This provision is currently located at § 262.40.)
The Agency next discussed this issue in a March 29, 1990,
At the time the 1980 rules were finalized, the Agency had no experience with their implementation and whether documentation associated with determinations that a waste was not a hazardous waste was necessary. The Agency now believes that the original approach was insufficient. We now have 30 years of experience and compliance data to support an independent requirement that, as part of their obligation to determine whether a waste is hazardous under § 262.11, generators need to keep records and documentation of their waste determinations, including determinations that a solid waste is not a hazardous waste.
As an example, Georgia DNR requires that, in using generator knowledge, the determination must be valid, correct, and supported by documentation, especially when that determination is that the waste is not a hazardous waste or does not carry certain waste codes (contain certain contaminants).
The Agency does not believe requiring generators to retain documents used to make their non-hazardous waste determinations will pose an undue burden. In a review of 26 state waste determination regulations as well as discussions with several state agencies, the Agency found that 17 states already require documentation and recordkeeping of a solid waste that is not a hazardous waste.
An examination of biennial report data for a small sample of LQGs for both 2009 and 2011 reporting cycles demonstrated that the majority of generators generate the same hazardous waste streams from year to year. In other words, the Agency believes that, for the most part, SQGs and LQGs will make a hazardous waste determination once and will not need to make a new solid waste determination unless something changes in their process, thereby reducing the need to document waste determinations. This suggests that the burden of documenting a non-hazardous waste determination should be relatively minimal.
In light of the importance of making accurate hazardous waste determinations, and because of the high rates of non-compliance with § 262.11 among generators, the Agency is proposing to modify § 262.11 to specifically require that SQGs and LQGs document and maintain records of all determinations, including determinations that their solid waste is not a hazardous waste. Again, the Agency is not proposing to apply this independent requirement to CESQGs.
A key issue with this provision will be defining the scope of applicable entities for this requirement. First, documentation will not be required for entities that do not generate a solid waste, as defined by § 261.2, or that generate a solid waste that has been excluded or exempted from RCRA Subtitle C controls. However, all potential entities, with the exception of households, must determine whether they generate a solid waste as defined by § 261.2 for purposes of the existing RCRA hazardous waste regulations. Solid wastes under § 261.2 include spent materials, sludges, by-products, scrap metal, and commercial chemical products (CCPs) that are discarded. Specifically:
• Spent materials as defined in § 261.1(c)(1), include any material that has been used and as a result of contamination can no longer serve the purpose for which it was produced without processing.
• Sludge, as defined in § 260.10, means any solid, semi-solid, or liquid waste generated from a municipal, commercial, or industrial wastewater treatment plant, water supply treatment plant, or air pollution control facility.
• A by-product, as defined in § 261.1(c)(3), is a material that is not one of the primary products of a production process and is not solely or separately produced by the production process. Examples are process residues such as slags or distillation column bottoms. The term does not include a co-product that is produced for the general public's use and is ordinarily used in the form it is produced by the process.
• Scrap metal, as defined in § 261.1(c)(6), is bits and pieces of metal parts (
• CCPs are those materials listed in § 261.33 or those CCPs which exhibit one or more of the hazardous waste characteristics. The tern CCP includes those chemical substances which are manufactured or formulated for commercial or manufacturing use and consist of commercially pure grades of the chemical substance, any technical grades of the chemical substance that are produced or marketed, and all formulations in which the chemical substance is the sole active ingredient. CCPs do not include or refer to wastes, such as a manufacturing process residue, that contain any of the chemical substances.
Where there is a potential for a discarded material to be a hazardous waste listed under part 261 subpart D or when the material may contain hazardous constituents that would exhibit a characteristic of hazardous waste (
If an entity is generating a hazardous waste (and is, therefore, a hazardous waste generator) and if it is generating sufficient amounts of hazardous waste in a calendar month to be considered an SQG or an LQG, then these generators would be responsible for documenting determinations under this proposed revision.
We would note that the existing hazardous waste regulations already require every generator to make a waste determination and that the only additional provision that this proposal is addressing is that they document that waste determination, including for those wastes that are not hazardous waste. The focus of this provision is on solid wastes that have the potential to be hazardous wastes. Thus, for the purposes of this proposed provision, the Agency is not interested in entities that generate solid wastes that clearly have no potential to be hazardous, such as food waste, restroom waste, or paper products. There are literally hundreds of thousands of entities who generate such wastes. In addition, lawyers and accountants, business offices, religious organizations, governmental organizations, engineering and architectural firms, among other sectors, are not meant to be impacted by this provision for everyday municipal waste that does not have the potential to be hazardous. Most elementary schools also should not be affected by this provision unless they have laboratories that use large amounts of hazardous chemicals where greater than 100 kilograms of non-acute hazardous waste (or 1 kilogram of acute hazardous waste) is discarded monthly or another source of potentially hazardous waste.
In addition, as noted previously, for the purposes of this proposed provision, the Agency is not interested in entities that generate 100 kilograms or less of non-acute hazardous waste or 1 kilogram or less of acute hazardous waste in a calendar month (
The Agency does not believe the cost of documenting a waste determination, whether non-hazardous waste or hazardous waste, will be substantial. As previously discussed, generators may use either the results of testing their waste or process knowledge to make a hazardous waste determination. If a generator tests its waste or hires a third party to do so, then the written results of those tests will be the documentation. Similarly, if generator knowledge is used to make the waste determination, then a statement describing what the basis of that knowledge was (
In estimating the impact of requiring SQGs and LQGs to document their non-hazardous waste determinations, the Agency examined the relationship of the number of hazardous wastes generated per facility to non-hazardous waste generated per facility and established an approximate relationship of 60% to 40%. As part of this analysis, the Agency also found from examining the biennial report data that 50 percent of LQGs generate from one to five hazardous waste streams annually and that many of these generators continue to generate the same waste streams from year to year.
However, from examining biennial report data, the Agency is also aware of situations where a generator generates many different hazardous waste streams each year. Examples include academic and industrial laboratories, chemical manufacturers, and TSDFs. As an example, an analysis of the 2011 Biennial Report identified 843 LQGs reporting that they generated 41 or more hazardous waste streams. This analysis derived an average of 17 hazardous waste streams being generated by LQGs. EPA can infer that these entities also generate numerous types of solid, but not hazardous, waste streams.
Although TSDFs and chemical manufacturers may generate many different types of hazardous waste, many of them also have sophisticated protocols and testing procedures in place to make a hazardous waste determination. These processes should be sufficient to provide the proposed documentation to verify that the solid waste is or is not a hazardous waste. Other organizations may not and the Agency is interested in how best to address this important subject.
The Agency believes that requiring SQGs and LQGs to document their non-hazardous waste determinations is important to the success of RCRA hazardous waste program in protecting human health and the environment. Additionally, the Agency believes the proposed change will encourage generators to develop better internal processes and improve overall compliance with the RCRA hazardous waste regulations. At issue is how best to implement this provision in the most cost-effective manner possible. Therefore, the Agency seeks comment
The Agency seeks comment from those generators that generate many new wastes each year, on ways that could be used to reduce burden while maintaining sufficient protection. The Agency also seeks comment on whether there are particular industrial sectors where many, if not most, solid wastes generated could be clearly determined not to be hazardous wastes and whether there are families of solid wastes where it is clear that they will not be hazardous wastes and thus can be eliminated from this provision.
Generators have an obligation to apply due diligence in making an accurate hazardous waste determination by using either knowledge of their processes and waste and/or testing of their waste. As discussed above, RCRA inspectors often cite generators for “failing to make a waste determination” at § 262.11. By that we mean the generator failed to accurately identify a material that could be a solid waste, or failed to accurately make a hazardous waste determination. In both cases, the generator's failure to make accurate solid and hazardous waste determinations may result in adverse impacts to human health and the environment.
As previously stated, at the core of the RCRA hazardous waste program is the need for generators to make an accurate hazardous waste determination. Therefore, to emphasize this point the Agency is modifying the regulatory text at 40 CFR 262.11 to emphasize and make clear that a generator who generates a solid waste, as defined in 40 CFR 261.2, must accurately determine if that waste is a hazardous waste.
A 1993 FR notice states that in the case where a generator sends waste off site for treatment, storage, or disposal, the TSDF may rely on process knowledge supplied by the generator as a basis for the TSDF's waste characterization (40 CFR 264.13). The notice points out that while using process knowledge is “seemingly attractive because of the potential savings associated with using existing information (such as published data), the facility must ensure that this information accurately characterizes applicable wastes” (58 FR 48111, September 14, 1993).
Generators often rely on a third party, such as a TSDF, to help them make a hazardous waste determination. Whether the generator uses a third party or not, the generator is responsible for that determination. As such, the generator should still apply its due diligence to ensure a solid waste is not a hazardous waste, and if a hazardous waste, that it is characterized accurately.
Also with respect to characterizing a hazardous waste accurately, a generator identifying all possible RCRA waste numbers (or RCRA hazardous waste codes) on its manifest or container marking does not satisfy the requirement to make an accurate waste determination. First, the TSDF will not be able to treat the waste effectively or efficiently to comply with land disposal restriction requirements because it will not know precisely what waste it needs to treat. Second, the generator clearly did not apply its due diligence seriously.
The Agency also realizes that generators, whether inadvertently or intentionally, often make a hazardous waste determination when the material is actually a non-hazardous solid waste. The intent of this proposed change would not impact such determinations. The generator is always free to manage its solid waste as a hazardous waste if it so desires. However, the Agency is concerned about other related situations, such as when a generator applied due diligence but still made an incorrect hazardous waste determination potentially posing a risk to the environment, or where a generator intentionally tried to circumvent waste determination requirements.
EPA specifically requests comment on reasons why it may not be feasible to require a generator's solid and hazardous waste determinations to be accurate and how best the Agency can make clear that generators are responsible for making an accurate hazardous waste determination. EPA also requests comment regarding ways the proposed regulatory text could be improved to better assist generators in making more effective hazardous waste determinations.
EPA is also using this notice to take comment on an additional revision to the hazardous waste determination regulations at § 262.11, but is not proposing any regulatory text for this change. The Agency requests comment on requiring SQGs and LQGs to maintain records of their waste determinations until the generator closes its site, rather than for at least three years from the date that the waste was last sent to on-site or off-site treatment, storage and disposal. Because an inspector may not be able to inspect every SQG and LQG within three years from when the solid or hazardous waste was first generated, a generator may discard its waste determination records prematurely. For practical reasons, the Agency believes a generator will want to maintain records of its solid and hazardous waste determinations to support and respond to any questions an inspector may have about a particular waste determination—even if it is more than three years from when it was first generated. Similarly, the Agency believes generators that generate large numbers of solid and hazardous waste streams annually will computerize their records, making it easy to store and retrieve them when necessary. For these reasons, the Agency does not believe requiring SQGs and LQGs to maintain records of their active solid and hazardous waste streams should be overly burdensome.
Finally, while the Agency is not proposing that CESQGs maintain documentation of their non-hazardous waste determinations, the Agency does seek comment on the economic costs and environmental benefits of potentially requiring CESQGs to maintain documentation of their hazardous waste determinations, including their non-hazardous waste determinations. The Agency realizes that the total number of CESQGs is very large—ranging from an estimated 293,000 to 463,000; however, the Agency believes that based on the number of waste streams generated by SQGs and LQGs that such generators should only be generating a few solid waste streams and in many cases using their knowledge of the process and process materials in making hazardous waste determinations. In other words, the burden of documenting their hazardous waste determination should not be that costly for each CESQG.
Conversely, the costs of not making an accurate hazardous waste determination could be significant environmentally and financially to the CESQG. For
Building upon the above discussion and the importance of making accurate hazardous waste determinations, the Agency also seeks comment on the feasibility of developing a user-friendly electronic hazardous waste determination decision tool that generators could use to assist them in making a hazardous waste determination. This electronic tool would guide generators through a series of analytical decision-type (Yes or No) questions to assist them in determining whether the solid waste they have generated is also a hazardous waste subject to the applicable RCRA hazardous waste regulations. As part of this decision tool, generators would be able to document reasons why the solid waste is a hazardous waste, or conversely, why the solid waste is not a hazardous waste.
Given the large number and great variety of hazardous waste streams, a key challenge would be to determine how best to design this decision tool if the Agency went forward in developing it. Potential approaches include designing the tool conceptually around the following: (1) Industrial sectors; (2) families of industrial materials (
This decision tool could assist generators to make the following determinations under § 262.11:
• Whether the waste is excluded from regulation under § 261.4 [§ 262.11(a)]
• Whether the waste meets any of the hazardous waste listing descriptions in part 261 subpart D [§ 262.11(b)]
• Whether the waste exhibits one or more hazardous characteristics of hazardous waste, as identified in part 261 subpart C [§ 262.11(c)]
• What are all applicable EPA hazardous waste codes for wastes determined to be hazardous [§ 262.11(f)]
An electronic decision tool could also possibly provide a way for SQGs and LQGs to maintain records supporting their waste determinations [§ 262.11(e)].
Developing this decision tool would be a major investment on the part of the Agency and could take several years to fully develop, test, and make operational, with different components produced for use over time. However, even when completed (assuming it was a worthwhile Agency investment to pursue), this decision tool would never be able to account for all the industrial sector/family of industrial materials/type of hazardous secondary material possibilities that exist in industry. Therefore, scoping such a decision tool to capture as much of the most likely industrial sector/family of industrial materials/type of hazardous secondary material possibilities would be the Agency's goal.
Additionally, if such a decision tool were to be developed, the generator would still be ultimately responsible for making the hazardous waste determination, since no decision tool could ever account for its site-specific circumstances.
Hazardous waste determination software or tools could be web-based, off-the-shelf, or both. The software or tools could be developed by EPA, by authorized states and tribes, by private parties, or by public and private sector collaboration.
The Agency particularly requests comment on the feasibility of the private sector developing electronic application software (apps). An initial search for preexisting hazardous waste determination software identified no relevant, privately-developed, off-the-shelf software products to assist generators in making accurate waste determinations. However, EPA did identify a variety of state and academic internet-based hazardous waste determination tools and workbooks.
EPA is seeking comment on whether development of an electronic hazardous waste determination decision tool is feasible and by whom. The Agency requests comment on what circumstances would encourage the private sector to develop such a tool or app and on what generators would like to see in terms of components and organization that would facilitate a generator using it.
Under existing 40 CFR 262.12, SQGs and LQGs are required to notify EPA using EPA form 8700-12 (Site ID form) in order to obtain an EPA identification number (EPA ID). Without such identification, a generator cannot treat, store, dispose of, or transport, its hazardous waste. Once a generator applies for and receives an EPA ID, information provided by the generator (
Subsequent to obtaining an EPA ID, there is no federal regulation requiring LQGs or SQGs to re-notify EPA to update their site information or confirm the information remains accurate. However, LQGs do update their site information as part of the biennial report.
EPA believes that about half the states require annual reporting by LQGs and some require periodic reporting by SQGs in order to determine user fees based on the amount of hazardous waste they generate. However, the data from these annual reports may not always be submitted to EPA's national RCRA database. Additionally, although many LQGs currently submit a Site ID form as part of their biennial report, this
The lack of re-notification at the federal level greatly impairs EPA's and the states' ability to use the information for compliance monitoring and programmatic purposes. This is because a one-time notification provides no assurance that the information collected in EPA's and the states' databases over time will accurately reflect which facilities are generating hazardous waste. For example, a recent examination of EPA's data reveals that there are thousands of SQGs who last notified over 20 years ago.
Because of the lack of integrity in the data, the Agency and states must spend their limited resources to `clean up' the data every time regulatory authorities try to use it, for example, to estimate regulatory burden and benefits to the regulated community, offer compliance assistance, or produce public reports on hazardous waste generation. Furthermore, regulatory authorities may waste time and resources monitoring compliance at entities that no longer generate hazardous waste. This inefficient use of resources lowers the effectiveness of regulators to monitor compliance overall and could potentially increase the risk of environmental damage from mismanagement of hazardous waste. In summary, the Agency and many states have, for the most part, an outdated, incomplete, and inaccurate understanding of the LQG and SQG universe. Consequently, over time, this undermines the ability of EPA or the states to make effective programmatic decisions.
EPA is proposing to add an explicit independent requirement to the regulations that both LQGs and SQGs re-notify EPA using the Site ID form (EPA form 8700-12).
• Site name, address, contact information, and EPA ID number
• NAICS (North American Industry Classification System) code
• Information regarding the entity's legal owner and operator
• Type of regulated waste activity (
• Universal waste activities
• Used oil activities
• Notification for opting into or withdrawing from managing laboratory hazardous waste under 40 CFR part 262 subpart K
• Description of hazardous waste, including a list of applicable federal and state hazardous waste numbers
• Notification of hazardous secondary material activity managed under certain definition of solid waste exclusions.
• Certification signed by the entity's legal owner, operator, or authorized representative.
The specific information included in the notification will enable regulatory agencies to monitor compliance adequately and to ensure hazardous wastes are managed according to the appropriate RCRA hazardous waste regulations. The information can be used to assist RCRA inspectors in determining which facilities may warrant greater oversight and provides a basis for setting enforcement priorities. Notification information is collected in EPA's RCRAInfo database, which is the national repository of all RCRA Subtitle C site identification information, whether collected by a state authority or EPA. EPA provides public access to this information through EPA's public Web site at
Once an initial notification (to obtain an EPA ID number) is submitted, to re-notify, a generator need only review the previous notification and either make changes if necessary or confirm that the information remains accurate. Furthermore, EPA has recently made available an electronic system for the regulated community to use to submit Site ID forms electronically, which will further reduce burden on generators. Facilities should check with their states regarding whether their state will use EPA's electronic submittal process.
The proposed rule would require LQGs, having first obtained an EPA ID number, to re-notify EPA using the Site ID form prior to March 1 of each even-numbered year. This time frame is the same as that for the biennial reports in 40 CFR 262.41. Adding this provision to § 262.12 in the existing regulations (which is § 262.18 in the proposed reorganization in this proposed rule) reflects existing processes by which LQGs already submit Site ID forms as part of the biennial reporting process. EPA also believes that the requirement to re-notify is particularly important considering generators may change regulatory status from LQGs to SQGs and vice versa.
EPA is also proposing that SQGs, having first obtained an EPA ID number, must re-notify EPA using the Site ID form prior to February 1 of each even-numbered year. We propose the two-year time frame to mimic the current biennial reporting process for LQGs; however, we propose to require that SQG re-notifications (due by February 1 of each even-numbered year) to occur one month prior to the due date for LQG re-notifications (due by March 1 of each even-numbered year) to help reduce the burden on states that must process the re-notifications. We are also taking comment on whether re-notifying every four years would be appropriate for SQGs.
EPA also considered whether to require SQGs to re-notify on alternate years—that is, by March 1 of each odd-numbered year, from LQGs, in order to further reduce the burden on states. However, this may complicate the regulations because a generator can change its generator category year-to-year. For example, it is possible that a generator who is an LQG during the SQG-reporting year and an SQG during the LQG-reporting year would not have to submit any notification to EPA. Furthermore, requiring SQG and LQG re-notifications during the same year enables EPA to include information regarding SQGs in its National Biennial RCRA Hazardous Waste Report.
EPA believes that requiring a set due date (
Another alternative to requiring periodic notification (
• Re-notifying when a generator has a change of ownership is important so that EPA and the states understand who is legally responsible for managing the generated hazardous waste.
• Re-notifying due to a change in generator category provides EPA and the state with information regarding what regulations apply to the generator and thus assist with compliance assistance and monitoring activities.
EPA notes that, because an EPA ID number is specific to a site location, a change in site address for an entity already requires the entity to apply for a new EPA ID number using the Site ID form.
In this case, EPA would require re-notification within 30 days of when the change occurred. Re-notification in the event of change to these two items may further reduce burden on LQGs and SQGs, because EPA assumes that these changes would happen fairly infrequently. However, EPA also notes that although LQGs and SQGs would only have to re-notify in the event of a change in its ownership or generator category, re-notification would require a complete submittal of all information included in the Site ID form. EPA understands that this alternative may also increase the complexity of implementing the regulation because it would be difficult for regulatory authorities to ensure that re-notifications were received according to the regulations. For example, if a facility last notified ten years ago, it would be difficult for EPA and the states to ascertain whether the generator has failed to re-notify in compliance with the regulations or that the generator's information simply hasn't changed since its last notification. Additionally, EPA notes that re-notification based on a change does not result in data that is as reliable as data provided in periodic re-notifications because it provides no information on generators that have stopped operations.
EPA requests comment on its proposed change to require re-notification for SQGs and LQGs, including information regarding the benefits and burden of such a provision. EPA also requests comment on whether such re-notification should be every two years or one of the other alternatives discussed above. Finally, EPA requests comment on any other alternatives for an independent re-notification requirement, including suggestions that would reduce the burden on states that must process re-notifications.
EPA is proposing a new section § 262.13, which would describe how a generator determines which generator category it would be subject to. Proposed § 262.13 discusses the framework for making a generator determination in paragraph (a) and stresses that the calculation is made monthly and that the generator category can change from month to month. The proposed regulatory text would state that a generator's category is determined each month by the amount of hazardous waste it generates and may change from month to month. The regulation sets forth procedures to determine whether a generator is a very small quantity generator, a small quantity generator, or a large quantity generator for a particular month, as defined in § 260.10.
The discussion in § 262.13(a) is not a new requirement for generators, but these steps are not currently laid out in the regulations in as succinct a manner. EPA believes that the addition of the definitions of generator categories to § 260.10 and this paragraph on how to make a generator category determination should provide specific instructions on this matter for the regulated community and thereby improve compliance with the generator regulations.
Proposed paragraph (b) of § 262.13 would specifically address the situation in which a generator generates any combination of non-acute hazardous waste, acute hazardous waste, and the residues from the cleanup of a spill of acute hazardous waste. This paragraph presents a series of steps for a generator to follow when determining its generator category to ensure that it selects the appropriate category for the total amount and types of hazardous waste generated.
Proposed §§ 262.13(c) and (d) are existing provisions that we are proposing to move from §§ 261.5(c) and (d) of the existing regulations with a few small wording changes to reinforce that category determinations are made monthly and do not otherwise represent a change in the generator regulations.
EPA is requesting comment on the proposal to add this description of how a generator is to determine its generator category to the regulations.
The Agency is proposing to modify 40 CFR 262.32 to require SQGs and LQGs to mark their containers with the applicable EPA hazardous waste number (RCRA hazardous waste code) prior to transporting their hazardous waste off site to a designated RCRA facility for subsequent management. EPA is proposing this revision so that TSDFs can readily identify the contents of hazardous waste containers they are receiving from generators and effectively treat the wastes to meet land disposal restriction requirements (LDRs). As described elsewhere in this proposal, the Agency is proposing revisions to the marking and labeling of containers and other waste accumulation units in order for employees, inspectors, emergency responders, and waste handlers to better understand the potential hazards associated with the contents of hazardous waste contained in a unit.
This proposed provision should not increase burden on generators as it reaffirms commonly used waste management practices. Most generators, or their designated waste handlers, already mark their containers with the
The Agency requests comment on this proposed change.
The existing regulations for LQGs that address the conditions for exemption related to marking and labeling are at § 262.34(a)(2) and (3) for containers and at § 262.34(a)(3) for tanks. The marking and labeling condition for SQGs who accumulate hazardous waste in both tanks and containers are at § 262.34(d)(4), which references § 262.34 (a)(2) and (3). For practical reasons, there are no requirements to mark drip pads or containment buildings that accumulate hazardous waste other than requiring that documentation must exist that describes the procedures to ensure that each waste volume remains in the unit for no more than 90 days.
EPA is proposing to modify § 262.34(a)(2) to strengthen the marking and labeling conditions for exemption for containers and to modify § 262.34(a)(3) to strengthen and consolidate the marking and labeling conditions for exemption for hazardous waste tanks, drip pads, and containment buildings by LQGs. The Agency is also proposing to modify § 262.34(d) to strengthen the marking and labeling conditions of containers, tanks, drip pads, and containment buildings by SQGs.
The proposed changes are consistent with the applicable discussion of marking and labeling of containers in SAAs in section VIII.I. Where differences may occur is when the container may be shipped off-site as opposed to when the contents of the container are managed on-site, or temporarily managed on-site (
Currently, § 262.34(a)(3) requires each container and tank to be labeled or marked clearly with the words, “Hazardous Waste.” However, while the words “Hazardous Waste” on containers and tanks provide some measure of information regarding the contents of these units, this information fails to describe the specific hazards of the contents and what risk these wastes could pose to human health and the environment. EPA believes it is important that employees, transporters, downstream handlers, emergency personnel, and EPA and state inspectors know as much as possible about the potential hazards of the contents in containers being accumulated, transported, and managed, whether on-site and/or off-site, so that the hazardous wastes are managed in an environmentally sound manner.
The Agency is proposing two modifications that would strengthen the labeling and marking conditions for LQGs and SQGs accumulating hazardous waste in containers. These changes are similar to those proposed for containers stored in satellite accumulation areas (see section VIII.I.) First, the Agency is proposing that SQGs and LQGs accumulating hazardous waste in containers mark their containers with both the words “Hazardous Waste” and other words that identify the contents of the containers that a third party, such as an emergency responder, co-worker unfamiliar with the material, or even the general public may recognize. Although the words “Hazardous Waste” are important to convey that the container contains a waste, as opposed to a product, and that a hazardous waste determination has been made for the contents, it does not convey more practical information regarding the contents of the container. Examples of other words that identify the contents of the container may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents.” Another option for complying with this provision is to use the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D. The Agency does not consider chemical formulas, such as CH
If the hazardous waste will subsequently be sent off-site for treatment and disposal, an SQG or LQG may choose to use an appropriate DOT proper shipping name found on the hazardous materials table at 49 CFR 172.101 to identify the contents of the container while it is accumulating on-site. That way, the generator will fulfill EPA and DOT requirements simultaneously; however, EPA is not proposing to require the use of the DOT shipping names while the hazardous waste is accumulating on-site. We only suggest that the DOT shipping name may be one way that some generators may choose to identify the contents of the container.
EPA also believes use of the DOT marking requirement should be sufficient in many situations involving DOT Class 9 hazardous materials that are also hazardous waste, with the DOT shipping name ending in N.O.S. (not otherwise specified). As noted at 49 CFR 172.301 (b), generators using a DOT shipping name ending in N.O.S. must also provide the technical name of the hazardous material in association with the proper shipping name. However, the Agency is requesting comment on examples of when the DOT shipping name would not meet EPA's intent of “identifying the contents of the container” and suggestions for addressing this situation. EPA notes that additional pre-transport requirements, other than the DOT shipping name, apply when shipping hazardous waste off-site. We are not proposing to change EPA's existing requirements for pre-transport requirements that are currently found in §§ 262.30 through 262.33. Similarly, for packages subject to 49 CFR, the generator or shipper/carrier should be familiar with and aware of the marking requirements at 49 CFR 172.304 and prohibited labeling and label visibility requirements at 49 CFR 172.401 and 172.406, respectively.
The second modification we are proposing for labeling containers in central accumulation areas is to add a provision that SQGs and LQGs mark and label their containers with an indication of the hazards of the contents of the containers. SQGs and LQGs will have flexibility in how to comply with this new provision. That is, generators can indicate the hazards of the contents of the container using any of several established methods, including, but not limited to an EPA hazardous waste characteristic(s) (ignitable, corrosive, reactive or toxic); a hazard class label consistent with the DOT requirements at 49 CFR part 172 subpart E (labeling); a label consistent with the OSHA Hazard Communication Standard at 29 CFR 1920.1200; a chemical hazard label consistent with NFPA code 704; or a hazard pictogram consistent with the
EPA believes that placing both the appropriate label and marking on containers during hazardous waste accumulation will enable persons who may come in contact with it to be aware of the hazardous contents of the container with little or no additional cost to generators. In many instances, this proposed condition will already have been satisfied if the generator elects to move a container accumulating hazardous waste in a satellite accumulation area to a central accumulation area.
In summary, EPA is proposing to modify § 262.34(a)(3) and require LQGs and SQGs to mark containers with the following: (1) the words “Hazardous Waste,” (2) other words that identify the contents of the containers, and (3) an indication of the hazards of the container's contents. We are not proposing to change § 262.34(a)(2), which requires LQGs and SQGs to mark clearly and visibly the date accumulation began on each container and make that marking visible for inspection.
The Agency requests comment on the proposed changes for container marking and labeling for LQGs and SQGs.
The Agency is proposing to modify the regulations at § 262.34(a)(3) to require LQGs and SQGs to use inventory logs, monitoring equipment, or records indicating the date the hazardous waste first entered the tank in order to support a generator's determination that it has not exceeded its 90 day accumulation time limit, or in the case of an SQG, its 180-day time limitation. Exceeding the 90- or 180-day time limitation for LQGs and SQGs, respectively, would be a violation of a condition for an exemption from permitting requirements. Records from tank level sensors also may be used which could be either automatically logged from the sensors to a computer record, or recorded as part of a tank's operational daily inspection (see 40 CFR 265.195). Generators may also use any other methods that clearly demonstrate the date hazardous waste first entered the tank and show that the hazardous waste was subsequently emptied within 90 days of the date it first entered that tank, or 180 days in the case of an SQG (unless the hazardous waste must travel greater than 200 miles to a TSDF in which case 270 days is allowed). The generator must also use inventory logs to identify the hazardous waste contents and hazards of the tank.
With respect to the accumulation start date, in the preamble to the promulgation of the SQG regulations (51 FR 10160, March 24, 1986), EPA stated that § 262.34 contains the conditions for exemption for generators that accumulate hazardous waste on site. Under § 262.34(a), an LQG may accumulate hazardous waste on site in tanks or containers in any quantity for up to 90 days (and up to 180 days for a SQG unless the hazardous waste must travel greater than 200 miles to a TSDF in which case 270 days is allowed) without the need to have interim status or obtain a storage permit under RCRA, provided the generator complies with the conditions of § 262.34, which include marking the date upon which the period of accumulation begins. While the preamble mentions marking tanks and containers, the final regulation at § 262.34(a)(2) requires generators to mark the date upon which each period of accumulation begins only on containers.
As part of EPA's Hazardous Waste Technical Corrections and Clarifications Direct Final Rule (75 FR 12989, March 18, 2010), the Agency sought to correct this oversight by including what it thought to be the appropriate clarifying language. The proposed regulatory language required generators to mark the date upon which each period of accumulation begins on each container and tank, which would bring the regulation in line with the preamble to the 1986 rule. However, EPA received numerous adverse comments regarding this change and as a result withdrew that proposed change. The comments stated, among other things, that, unlike containers, the Agency failed to realize that generators do not actually mark their tanks with the date upon which each period of accumulation begins because the tank is often a fixture that is used and emptied repeatedly. Commenters argued that marking tanks would cause confusion since there would be numerous markings all over the tank making it difficult for the generator and inspector to identify when the last period of accumulation began or could cause an extra effort of removing the old marking before applying a new one.
At least one commenter also cited an EPA letter clarifying § 262.34(a)(l)(ii) in connection with the turnover of hazardous waste stored in generator accumulation tanks.
Later in this letter, EPA stated that LQGs accumulating hazardous wastes through a continuous flow process must “demonstrate that the hazardous waste has not been stored for more than 90 days . . . For example, a generator could confirm that the volume of a tank has been emptied every 90 days by recording the results of monitoring equipment both entering and leaving a tank. This recordkeeping, in conjunction with the tank volume, would enable inspectors, as well as [site] personnel, to demonstrate compliance with § 262.34(a)(l)(ii). Likewise, in marking the tank, a generator could mark both the tank volume and estimated daily throughput to allow inspectors to determine the number of days that hazardous wastes resides in a tank to determine compliance with § 262.34(a)(l)(ii). As noted above, there may be other methods to demonstrate that the tank has been emptied, but any method or demonstration to confirm compliance must be reasonable and easily discernible to EPA or an authorized state.”
Subsequent to withdrawing the provision at § 262.34(a)(2) as part of
Therefore, with respect to the accumulation start date for tanks, EPA is proposing that generators may use inventory logs, monitoring equipment or records indicating the date the hazardous waste first entered the tank, as long as this information is immediately accessible for inspection. Records from tank level sensors also may be used that are either automatically logged from the sensors to a computer record or recorded as part of a tank's operational daily inspection (required by 40 CFR 265.195). Generators may also use any other methods that clearly demonstrate the date hazardous waste first entered the tank and was subsequently emptied within 90 days of the date hazardous waste first entered that tank.
The same issue potentially applies to a generator physically marking and labeling the contents of the tank and its associated hazards. If the contents and associated hazards frequently change, then physically marking the tank could result in numerous markings and labels on the tank, making it difficult for employees and others to identify its contents. Therefore, following the same logic, the Agency is proposing that generators use inventory logs or records to identify the contents of the tank and its associated hazards. The Agency is also proposing that such tank logs be immediately accessible by the generator should the need arise.
The Agency requests comment on the feasibility and effectiveness of using inventory logs or records to identify the contents and hazards of a hazardous waste tank. The Agency also requests comment on alternative methods of identifying the contents and hazards of a hazardous waste tank in a more cost-effective manner.
Consistent with the existing regulations for tanks at § 262.34(a)(3), the Agency will continue to require that hazardous waste tanks be labeled with the words “Hazardous Waste.”
The existing regulations for drip pads at § 262.34(1)(iii)(A) and (B) require generators to produce a description of the procedures that will be followed to ensure that all wastes are removed from the drip pad and associated collection system at least every 90 days, and to produce documentation of each waste removal, including the quantity of waste removed from the drip pad and the sump or collection system and the date and time of removal. Likewise, the existing regulations for containment buildings at § 262.34(1)(iv)(A) and (B) require the generator to produce a written description of the procedures to ensure that each waste volume remains in the containment building for no more than 90 days, a written description of the waste generation and management practices for the facility showing that they are consistent with respect to the 90-day limit, and documentation that the procedures are complied with. However, in both instances, the existing regulation explicitly fails to account for when the hazardous waste is first placed in or on the unit, which raises questions as to how a generator documents that it has met the 90-day limit.
Therefore, to address this shortcoming, and because the risks for accumulating hazardous wastes on drip pads and containment buildings are similar to those accumulating in tanks, and for purposes of consistency and uniformity with the marking and labeling provisions for tanks, the Agency is proposing the same marking and labeling regulatory framework for hazardous wastes accumulated on drip pads and in containment buildings that it is proposing for tanks.
Specifically, the Agency is proposing that hazardous waste accumulated on drip pads and in containment buildings be labeled in a conspicuous place near these units with the words “Hazardous Waste.” The Agency is also proposing to revise the existing marking regulations and clarify that LQGs and SQGs document the date that the hazardous waste was first placed on the drip pad and the sump or collection system in order to verify that the removal or turnover of the hazardous wastes on the drip pad took place within 90 days or less in order to support a generator's determination that it has not exceeded its 90-day accumulation time limitation. Exceeding the 90-day time limitation for LQGs and SQGs, respectively would be a violation of a condition for an exemption from permitting requirements. Note that this is also important because, as described in section VIII.J below, SQGs may move their wastes from one type of unit to another (
Consistent with current drip pad regulations in 40 CFR 262.34(a)(1)(iii)(A) and (B), these provisions will continue to include a description of the procedures to be followed by both SQGs and LQGs to ensure that all wastes are removed from the drip pad and associated collection system at least once every 90 days as well as documentation of each waste removal.
Finally, the Agency is proposing that generators use inventory logs or records to identify the contents of the drip pad and its associated hazards and that such logs and records be immediately accessible. The Agency believes that these requirements are necessary to ensure that workers and emergency responders handling or coming in contact with the waste understand the hazards and dangers that they may be exposed to.
In addition, as with the proposed changes for hazardous wastes accumulated in tanks and on drip pads, the Agency is proposing to clarify that LQGs and SQGs may use inventory logs, monitoring equipment, or any other effective means to document the date the hazardous waste was first placed in the containment building and the date when the hazardous waste was removed to verify that the waste was accumulated no more than 90 days at any one time.
Consistent with the existing regulation at § 262.34(a)(1)(iv)(A) and (B) for containment buildings, the proposed regulation for both LQGs and SQGs will state that the generator must maintain the following records and that they can do so by using inventory logs, records from monitoring equipment, or any other effective means:
(1) A professional engineer certification that the building complies with the design standards specified in 40 CFR 265.1101 in the facility's operating record prior to operation of the unit; and
(2) A written description of procedures to ensure that each waste volume remains in the unit for no more
(3) Documentation that the unit is emptied at least once every 90 days.
Finally, the Agency is proposing that generators use inventory logs or records to identify the contents of the containment building and its associated hazards and that such logs and records be immediately accessible. As with the proposed changes to the marking and labeling of drip pads, the Agency believes that these requirements are necessary to ensure that workers and emergency responders handling or coming in contact with the waste understand the hazards and dangers that they may be exposed to.
As with the proposed changes to the tank marking and labeling regulations at § 262.34(a)(3), the Agency requests comment on the necessity and effectiveness of explicitly requiring generators to use inventory logs or records to identify the contents and hazards of hazardous waste accumulated on a drip pad or in a containment building. The Agency also requests comment on alternative methods of identifying the contents and hazards of a hazardous waste on a drip pad or in a containment building in a more cost-effective manner. Lastly, the Agency requests comment on how a generator can more effectively mark or label a drip pad or containment building with the words “Hazardous Waste.”
As part of the proposed reorganization to make the generator regulations more user-friendly, the Agency is proposing to incorporate parts of the existing regulatory text at § 265.174 (Container Inspections) into § 262.34 (§ 262.16(b)(2) for SQGs and § 262.17(a)(1) for LQGs under the proposed reorganization) and to revise these paragraphs to incorporate the existing regulatory text at § 265.171 for remedial action that is required if deterioration or leaks are detected.
The requirement for container inspections at § 265.174 states that the owner or operator must inspect areas where containers are stored at least weekly and that the owner or operator must look for leaking containers and for deterioration of containers caused by corrosion or other factors.
Currently, neither SQGs nor LQGs are required to record the results of their weekly inspections. As a result, EPA and some states have no reliable way to verify that such inspections took place unless, by the rare chance, an inspector is inspecting a generator site at the same time that the “at least weekly” inspection occurs or an inspector notices a release from a container during an inspection. This problem is compounded by the fact that generators accumulating hazardous wastes in containers are not required to have any type of secondary containment for their containers. Therefore, should a release occur, these problems could be compounded if the “at least weekly” inspection fails to occur.
A review of state programs found that many states already require generators accumulating hazardous waste in containers to maintain records of their weekly inspections. Many of these states provide templates for generators to use to assist them in recording the results of their inspections.
EPA does not believe the burden imposed upon generators to record the results of its weekly inspections would be significant, particularly if generators use a template of some type to document the results of inspections (see examples of templates provided by states to generators to assist them in recording the results of inspections in the docket to this proposal).
The Agency also believes that best management practices for generators would already include documenting the results of their weekly inspections to not only prevent any releases, but also identify situations, such as a damaged container, that could lead to a potential release to the environment. That is, the Agency believes that the incremental cost of documenting the results of weekly inspections would be less than the costs of having to clean up after a release.
The Agency is also seeking comment on modifying the generator accumulation conditions (the proposed language at §§ 262.16(b)(2)(iv) and 262.17(a)(1)(v) under the reorganization) to add a provision that generators document their weekly inspections of containers in central accumulation areas and keep the log of the inspections at the site for at least three years. The record of each inspection would document the following: the visual inspection of containers to identify any hazardous wastes accumulated in rusting, bulging, or leaking containers; a description of any discrepancies or problem areas encountered in the inspection and corrective actions taken; and the signature or initials of the inspector and the date of the inspection.
In requesting comment on documenting the results of “at least weekly” container inspections, the Agency is interested in the environmental and economic impacts of requiring all generators accumulating hazardous waste in containers to document weekly container inspection, as a condition for exemption. Additionally, the Agency requests comment on whether to require documentation of such inspections if the generator has a secondary containment system to control leaks in the event of a release of hazardous wastes or other such incidents. The Agency also requests comment on whether this documentation requirement should be limited to those generators that accumulate a certain amount of hazardous waste at any one time or generators that accumulate more than a certain number of containers in a central accumulation area at any one time. Lastly, the Agency also seeks comment from generators in states who already must maintain records of their container inspections on their experience with this provision and whether there are effective alternative options worth considering that achieve the same goals.
The regulations at § 265.201(c)(1) through (5) state that SQGs must inspect discharge equipment, data from monitoring equipment, and levels of waste in a tank daily, unless the tanks have secondary containment and leak detection equipment or procedures, in which case these can be inspected at least weekly. In addition, SQGs must inspect the construction of tanks and of discharge confinement structures like dikes and the areas immediately surrounding them at least weekly.
Section 265.201(d) also requires that SQGs with full tank secondary containment to document in the facility's operating record when an alternative inspection schedule is used. However, neither § 265.201(c) nor (d) contains a requirement to document the results of any inspection findings. Therefore, the Agency requests comment on adding a paragraph to § 262.16 that would require that generators record in a log the daily and weekly results of inspecting their tanks and maintain a record of those inspections on site for at least three years.
Similarly, the Agency requests comment on adding a similar provision to § 262.16 to address tanks with secondary containment and leak detection systems or practices to ensure that leaks that are identified, that the generator would be required to record in a log the results of inspecting these areas, including any leakage that may occur and maintain a record of those inspections on site for at least three years.
In commenting on this matter, please consider, in particular, whether it is environmentally and economically worthwhile to require SQGs accumulating hazardous waste in tanks to document the results of daily and weekly tank inspections. The Agency also requests comment on whether to require the documentation of such inspections if the SQG has a secondary containment system to control leaks in the event of the release of hazardous wastes. Additionally, the Agency requests comment on whether this documentation requirement should be limited to those generators that accumulate a certain amount of hazardous waste at any one time or generators that accumulate hazardous waste in more than a certain number of tanks in a central accumulation area. Lastly, the Agency also seeks comment from SQGs in states who already must maintain records of their tank inspections on their experience with this requirement and whether there are effective alternative options worth considering that achieve the same goal.
As with hazardous waste accumulated in containers by LQGs and SQGs and hazardous waste accumulated in tank systems by SQGs, there is no regulation requiring them to document the results of drip pad inspections. Therefore, the Agency requests comment on modifying the generator accumulation conditions (§§ 262.16(b)(4) and 262.17(a)(3) in the proposed reorganization) to add a condition that the generator record in a log the results of weekly inspections and inspections after storms and that the records address deterioration, malfunctions or improper operation of run-on and run-off control systems; the presence of leakage in and proper functioning of leakage detection systems; and deterioration or cracking of the drip pad surface. The generator would be required to keep a record of the inspections on site for at least three years from the date of the last inspection.
In commenting, please consider whether it is environmentally and economically worthwhile to require SQGs accumulating hazardous waste on drip pads to document the results of weekly drip pad inspections. Additionally, the Agency requests comment on whether this documentation requirement should be limited to those generators that accumulate a certain amount of hazardous waste at any one time. The Agency also seeks comment from SQGs and LQGs in states who already must maintain records of their drip pad inspections on their experience with this provision, including whether it makes environmental and economic sense to ensure releases do not occur and whether there are effective alternative options that achieve the same goals.
EPA is proposing three changes to the closure conditions for exemption from permitting for LQGs in § 262.34(a)(1)(iv)(B). First, EPA is proposing to consolidate the closure regulations for LQGs accumulating hazardous waste at § 262.17(a)(8). This consolidation would include both the general performance requirements found at §§ 265.111 and 265.114 for containers, tanks, drip pads, and containment buildings, and the unit specific requirements found at § 265.197 for tanks, § 265.445 for drip pads, and § 265.1102 for containment buildings.
Second, EPA is proposing to strengthen the closure regulations for LQGs accumulating hazardous waste in containers in central accumulation areas that plan to stop hazardous waste accumulation in those containers by requiring them to meet the same type of closure regulations that apply for tanks, drip pads and containment buildings, including in those situations where a generator is not able to demonstrate that its contaminated soils can be practicably removed or decontaminated.
Third, EPA is proposing to require an LQG to notify EPA or the authorized state using EPA form 8700-12 at least 30 days prior to closing the generator's site or when the generator closes a unit accumulating hazardous waste. Additionally, EPA is proposing that an LQG notify EPA or their authorized state within 90 days after closing the site or the unit accumulating the hazardous waste. This notification would state that the LQG has clean closed or failed to clean close and therefore must close as a landfill.
EPA is proposing to consolidate all of the closure regulations for LQGs accumulating hazardous waste in tanks, drip pads, and containment buildings in the generator accumulation conditions (§ 262.17(a)(8) under the proposed reorganization). EPA believes that the current structure of these regulations can be confusing and difficult to follow.
Currently, the closure regulations for LQGs are found at § 262.34(a)(1). These regulations refer to the general performance requirements for closure at §§ 265.111 and 265.114. Section 265.111 references the unit specific closure regulations found at subpart J of part 265 (for tanks), subpart W of part 265 (for drip pads) and subpart DD of part 265 (for containment buildings). The
However, while §§ 265.111 and 265.114 cite the specific closure regulations for different types of units, missing from § 265.111 is a reference to drip pads and missing from § 265.114 is a reference to both drip pads and containment buildings. The Agency believes these are inadvertent oversights where EPA failed to make the appropriate conforming changes when the regulations for drip pads and containment building were promulgated in 1990 and 1992, respectively.
Furthermore, as with other parts of the hazardous waste generator regulations, the accumulation regulations at § 262.34 often reference the detailed technical regulations of part 265 to reduce duplication. Part 265 describes the technical regulations for interim status TSDFs. Usually, the technical requirements in part 265 are clear in distinguishing the generator standards from standards for interim status TSDFs (
Finally, EPA believes the closure regulations are unnecessarily confusing. For example, the tank system regulations for LQGs at § 262.34(a)(1)(ii) make clear that the requirements of § 265.197(c) do not apply to LQGs. Yet, LQGs must comply with § 265.111, which in turn, at paragraph § 265.111(c) requires LQGs to comply with § 265.197, which includes paragraph (c). One commenter wrote about this confusion when the Agency proposed to clarify the closure regulations for LQGs as part its March 18, 2010, Hazardous Waste Technical Corrections and Clarifications Direct Final Rule (75 FR 12989).
Therefore, as a first step in improving the usefulness of the closure regulations for LQGs accumulating hazardous waste in containers, tanks, drip pads, and containment buildings, EPA is proposing to consolidate and integrate all relevant closure provisions for LQGs accumulating hazardous waste in tanks, drip pads, and containments buildings at § 262.17(a)(8). The closure regulations include the following: (1) the general closure performance standards found at § 265.111(a) and (b); (2) a modified version of the standards found at § 265.114 (Disposal or decontamination of contaminated equipment, structures, and soils) that incorporates regulatory language applicable to containers, tanks, drip pads, and containment buildings undergoing closure; (3) the unit-specific closure regulations relevant to tanks, drip pads, and containment buildings found at §§ 265.197(a) and (b), 265.445(a) and (b), and 265.1102(a) and (b), respectively;
(1) Minimizes the need for further maintenance by controlling, minimizing, or eliminating, to the extent necessary to protect human health and the environment, the post-closure escape of hazardous waste, hazardous constituents, leachate, contaminated run-off, or hazardous waste decomposition products to the ground or surface waters or to the atmosphere;
(2) Properly disposes of or decontaminates all contaminated equipment, structures and soil and any remaining hazardous waste residues from waste accumulation units including containment system components (pads, liners, etc.), contaminated soils and subsoils, bases, and structures and equipment contaminated with waste. Any hazardous waste residues remaining in the unit(s) being closed must be removed from the unit(s). Any leakage must also be decontaminated or removed and managed as a hazardous waste unless § 261.3(d) applies;
(3) Manages any hazardous waste generated in the process of closing either the generator's site or unit(s) accumulating hazardous waste in accordance with all applicable requirements of parts 260 through 270, including removing any hazardous waste contained in these units within 90 days of generating it and managing these wastes in a RCRA Subtitle C hazardous waste permitted or interim status treatment, storage and disposal facility or interim status facility; and
(4) Ensures that if the generator demonstrates that all contaminated soils cannot be practicably removed or decontaminated as required in this section, then the generator must close the waste accumulation unit(s) and perform post-closure care in accordance with the closure and post-closure care regulations that apply to landfills (§ 265.310). In addition, for the purposes of closure, post-closure, and financial responsibility, such a waste accumulation unit is then considered to be a landfill, and the generator must meet all of the standards for landfills specified in subparts G and H of part 265.
As an additional condition to qualify to accumulate hazardous waste without a permit or interim status, EPA is proposing to require LQGs accumulating hazardous wastes in containers in central accumulation areas that plan to stop hazardous waste accumulation in those containers to meet the same type of closure regulations discussed above—that is, the closure regulations for tanks, drip pads, and containment buildings. This includes situations where an LQG accumulating hazardous wastes in containers can demonstrate that any
Supporting these proposed regulations are damage cases by generators who accumulated hazardous wastes in containers. An examination of Superfund removal actions shows LQGs accumulating hazardous waste in containers have sometimes closed their doors or abandoned their sites, resulting in environmental problems.
For LQGs that accumulate hazardous waste in containers or container units, EPA is proposing closure regulations that replicate the regulations in paragraphs § 262.17(a)(8)(ii), mentioned above. The Agency believes the closure regulations are applicable to LQGs who have accumulated hazardous waste in containers as well as to LQGs who have accumulated hazardous waste in tanks, drip pads and containment buildings in order to prevent adverse impacts to human health and environment. Therefore, as with LQGs that accumulate hazardous wastes in tanks, drip pads, and containment buildings, should a generator decide to close a container or stop accumulating hazardous waste in containers at the site altogether, it would be responsible for complying with the regulations proposed at § 262.17(a)(8)(ii) and removing all relevant hazardous wastes accumulated within 90 days of generating it and any hazardous wastes that also may have been accumulated in SAAs. Otherwise, the generator would fail to meet the conditions for the exemption from permitting and would be subject to the requirements of 40 CFR parts 264, 265, 267 and the permit requirements of part 270.
EPA is also proposing that an LQG notify either EPA or its authorized state at least 30 days prior to closure of a hazardous waste accumulation unit, such as a container, tank, drip pad, or containment building, or closure of the site altogether. EPA is also proposing that such generators subsequently notify EPA or its authorized state no later than 90 days after closure of the site or a hazardous waste accumulation unit that they have either clean closed (
The hazardous waste regulatory program is a “cradle to grave” system in which any hazardous waste generated by an LQG (or SQG) must be subsequently managed, either on site or off site at an appropriate RCRA destination facility. Missing from the current regulatory framework is knowledge by the regulatory authority that the LQG, upon closing either a waste accumulation unit or closing the site altogether, properly closed the accumulation unit in compliance with the applicable closure regulations. Without this knowledge, regulatory authorities do not know whether generators have abandoned the site, leaving behind hazardous waste that could subsequently result in a release to the environment and adverse impacts to human health and the environment. Thus, these closure notifications are important to ensure that LQGs close their waste accumulation unit, or site, in compliance with the applicable closure regulations. Fail to properly close would be a violation of the waste accumulation exemption.
EPA requests comment regarding its proposal to consolidate the closure regulations for hazardous waste generated by LQGs in § 262.17(a)(8) and whether this approach would improve the readability/understandability of the rules, and thus, improve compliance. EPA also requests comment on whether parts of the proposed closure regulations at § 262.17(a)(8) should be modified.
EPA also requests comment regarding its proposal to strengthen the closure regulations for LQGs accumulating hazardous waste in containers.
In addition, EPA requests comment on whether it should require LQGs to notify EPA regarding closure both prior to closure (
Because there are no federal regulations for closure of a waste accumulation unit or site closure by SQGs, SQGs are not required to comply with the clean closure regulations, as well as notify when they close any or all waste accumulation units. Unlike LQGs, which have no waste accumulation limits as long as they remove any hazardous waste within 90 days of generating it, SQGs do have a waste accumulation quantity limitation of 6,000 kilograms. Given this waste accumulation quantity limitation, EPA sees no reason at this time to propose requiring SQGs to clean close or close as a landfill if they cannot clean close. However, EPA sees a potential benefit in having SQGs notify EPA when SQGs
EPA is proposing a number of modifications to the conditions for exemption for both SQGs and LQGs regarding preparedness, prevention and emergency procedures. The conditions for SQGs are found at §§ 262.34(d)(4) and (5) (which refer to the technical standards at 40 CFR part 265 subpart C) and the conditions for LQGs are found at § 262.34(a)(4) (which refers to the technical standards at part 265 subparts C and D).
The proposed revisions are organized in this section as follows: (1) Revising the scope of the contingency planning and emergency procedures regulations; (2) revising § 265.37(a) to state that when making arrangements with local authorities regarding emergency procedures, an SQG or LQG must first attempt to make emergency preparedness and procedures agreements with its Local Emergency Planning Committee (LEPC), and, if this attempt is not successful (or there is no LEPC in the area), the generator must make an arrangement with its local fire department and other emergency responders; (3) modifying the regulations for contingency plans for LQGs in §§ 265.52 and 265.53 to add an executive summary to the plan that a new LQG would submit to the LEPC and to adjust the content of an element of the required contingency plan; (4) making two revisions to the technical standards regarding required equipment that are part of the preparedness and prevention regulations in part 265 subpart C that are applicable to both SQGs and LQGs; (5) modifying the preparedness and prevention provisions for SQGs at § 262.34(d)(5) regarding posted emergency coordinator information and responsibility for cleaning up a spill; (6) modifying the personnel training provision for LQGs; (7) taking comment on what personnel should have mandated personnel training, and (8) taking comment on whether any of these proposed revisions would be appropriate for TSDFs in addition to generators.
Recent catastrophic chemical accidents in the United States, such as the 2013 West, Texas, fire and explosion that killed 15 people, the 2010 explosion and fire at Tesoro Refinery in Anacortes, Washington, that killed seven employees, and the 2012 Chevron Refinery hydrocarbon fire in Richmond, California, that affected 15,000 people in the surrounding area, highlight the need for continued improvement in a number of areas related to chemical facility safety. To address these concerns, the President issued Executive Order 13650—Improving Chemical Facility Safety and Security (EO) on August 1, 2013.
One of the key goals the EPA is addressing through this effort is enhancing and providing additional support to State Emergency Response Commissions (SERCs) and LEPCs to assist them in collecting and analyzing the chemical information they receive from local facilities and developing local emergency response plans to mitigate or prevent a devastating chemical disaster. Several of the proposed requirements are aligned with these EO efforts and will assist in furthering this goal and with those of the EO in general because they update the regulations to make them compatible with the current infrastructure of emergency planning and response by referencing LEPCs. Additionally, these revisions would provide a more usable contingency plan to emergency responders en route to a time-sensitive emergency at a generator of hazardous waste. Before finalizing these provisions, EPA will ensure that they are aligned with the efforts to improve chemical plant safety and security under the EO.
This preamble also discusses how EPA might incorporate modern technology into the emergency planning and procedures regulations for generators in order to provide information more quickly to emergency responders when faced with an event at a generator.
In addition to the changes listed above, as part of the reorganization of the preamble discussed in section XIII, EPA is proposing to copy the preparedness and prevention regulations for SQGs into § 262.16 and to create a new subpart in part 262—subpart M—that would contain the more extensive preparedness, prevention, and emergency procedures regulations for LQGs. Copying a version of these regulations into part 262 allows most of the preparedness, prevention, and emergency procedures regulations for generators to be easily found without accessing part 265 and with minimal cross-referencing.
As part of this reorganization, our proposed regulation has replaced the word “facility” in the regulations with “site” because “facility” is defined in § 260.10 as specific to TSDFs. Another small revision that we propose because of the reorganization of these regulations is folding the “comment” in § 265.55 into the body of the corresponding proposed regulation at § 262.264. We are proposing this because
The current preparedness and emergency procedures regulations do not clearly state whether they are applicable to the entire generator site or only to areas where hazardous waste is generated and accumulated on site (or where allowable treatment may occur in accumulation units) and when transported off site for subsequent treatment, storage, and disposal. EPA is proposing that the regulations for preparedness and prevention and for contingency planning and emergency procedures apply only to those areas of a generator's site where hazardous waste
The Agency is proposing to explicitly state that the RCRA preparedness and emergency procedures regulations are limited strictly to areas where hazardous waste is generated and accumulated.
The Agency has previously signaled that these requirements do not apply to the entire generator site. In a November 7, 2006, letter, EPA stated that the 40 CFR part 265 regulations for LQGs set forth in § 262.34(a)(4) apply to units accumulating hazardous wastes. The letter states that in order to comply with the part 265 requirements referenced in § 262.34(a)(4), LQGs only need to address those tanks, containers, drip pads, and containment buildings that accumulate hazardous wastes and are subject to the 90-day generator accumulation provision. As an example, the letter states that when developing a contingency plan, LQGs would only need to include those 90-day accumulation units involving the on-site management of hazardous waste.
It makes sense to limit the applicability of these regulations only to these areas because several other statutes already address the development and implementation of contingency plans associated with other areas of a generator site, such as the storage of chemical materials other than hazardous wastes. We also note that considerable overlap exists in the requirements in the various statutes and, since 1997, the federal government has encouraged facilities to develop integrated contingency plans and has provided guidance for doing so in the
The language EPA is proposing to change currently appears in §§ 265.30 and 265.50, though we are proposing to move it to a new part 262 subpart M to make it specific to generators. EPA proposes that subpart M apply only to those areas of a large quantity generator where hazardous waste is generated and accumulated on site in accordance with the conditions in § 262.17. This proposal includes a parallel change for the emergency procedures regulations for small quantity generators in § 262.16.
The Agency requests comment on making it explicit in the regulations that the preparedness, prevention, and emergency procedures regulations apply only to those areas of the generator's site where hazardous waste is generated and accumulated, and where applicable, those areas where allowable treatment may occur in accumulation units.
Sections 262.34(a)(4) and (d)(4) set forth conditions for LQGs and SQGs that accumulate without a permit. Both these paragraphs include references to part 265 subpart C, which contains a reference to § 265.37. Section 265.37(a) states that “The owner or operator must attempt to make the following arrangements, as appropriate for the type of waste handled at his facility and the potential need for the services of these organizations” and goes on to list the types of local emergency officials that should be informed about hazardous waste at a facility, such as fire departments and emergency response teams, and the information the generator should provide them.
The Agency is proposing to revise this provision for generators to state that SQGs and LQGs must first attempt to enter into agreements with their LEPC, but if there is no LEPC in the area or if the LEPC does not respond or is unwilling to enter an agreement, the generator must enter into an agreement(s) with the local fire department and other emergency responders. This proposed revision would add to the regulations both a reference to LEPCs and an explicit statement that generators must enter into an agreement with emergency planning officials, rather than just attempt to enter into an agreement.
The Superfund Amendments and Reauthorization Act (SARA) was enacted in 1986. Title III of SARA is also known as the Emergency Planning and Community Right-To-Know Act (EPCRA). EPCRA helps increase the public's knowledge and access to information regarding chemicals at individual facilities, their uses, and releases into the environment. States and communities, working with facilities, can use the information to improve chemical safety and protect public health and the environment. EPCRA requires both small and large entities to report chemical information to the SERC, the LEPC, the local fire department, and tribal nations.
EPCRA requires LEPCs to prepare a comprehensive plan for local communities designed to help them prepare for and respond to emergencies involving extremely hazardous substances (EHS). Facilities covered by EPCRA planning provisions are required to cooperate in emergency plan preparation and designate a facility emergency coordinator to participate in the planning process as well as notify their SERC and LEPC within 60 days of becoming subject to the emergency planning requirements (when an EHS is first present at the facility from a shipment or production). Additionally, as part of the community-right-to-know provisions of EPCRA, facilities that have hazardous chemicals for which they must have or prepare an MSDS or SDS and have at or above the threshold amount of those chemicals must also annually complete and submit an Emergency and Hazardous Chemical Inventory form (also known as a Tier II) to the LEPC, to the SERC, and to the local fire department by March 1. These facilities must send copies of their MSDS, SDS, or a list of hazardous chemicals to the LEPC, to the SERC, and to the fire department.
In turn, LEPCs must develop an emergency response plan, review it at least annually, and provide information about chemicals in the community to citizens. These plans are developed by LEPCs with stakeholder participation. There are more than 3,000 designated local emergency planning districts, although not all of these districts have functioning LEPCs. The LEPC membership must include (at a minimum) elected state and local officials; police, fire, civil defense, and public health professionals; environment, transportation, and hospital officials; facility representatives; and representatives from community groups and the media. Although in many areas the LEPCs are the main organizing entities for emergency response, the RCRA hazardous waste regulations do not
The proposed language directly references LEPCs, stating that the generator must make arrangements with the Local Emergency Planning Committee for the types and quantities of hazardous waste handled at the site.
Consistent with this proposed modification at § 265.37, the Agency is also proposing that when the language in current § 265.52(c) is copied into part 262, it state that the plan must describe arrangements agreed to with the Local Emergency Planning Committee. Should there be no Local Emergency Planning Committee, should it not respond, or should the Local Emergency Planning Committee determine that it is not the appropriate organization to make arrangements with, then the large quantity generator must make arrangements with its local fire department and other relevant emergency responders (
The Agency requests comment on this proposal to modify the language in §§ 265.37(a) and 265.52(c) when they are copied into part 262.
Section 265.37(a) states that the owner or operator must attempt to make arrangements with local fire and emergency organizations, as appropriate for the type of waste handled at the facility and the potential need for the services of these organizations. Paragraph (a)(1) makes clear that these arrangements involve familiarizing these organizations with the layout of the facility, properties of the hazardous waste handled at the facility and associated hazards, places where facility personnel would normally be working, entrances to roads inside the facility, and possible evacuation routes. Because an SQG is not required to submit a contingency plan, this language suggests that SQGs need only invite local officials to visit and familiarize themselves with the site as compared to LQGs, which are required to develop a written contingency plan and provide it to local officials.
Given the importance of emergency preparedness and planning, EPA is proposing to require that an SQG or an LQG must make direct arrangements with its LEPC as part of this condition. The Agency believes the LEPCs, in turn, will work with their local responders to integrate the activities of SQGs and LQGs into the overall emergency response plan.
Many SQGs and LQGs may already have arrangements with their LEPCs because most SQGs and LQGs either have EHSs that require reporting to the LEPC, which triggers EPCRA emergency planning requirements, or use chemicals that require an SDS, triggering the EPCRA community right-to-know requirement to report to LEPCs. However, in the case that a hazardous waste generator does not have a relationship with the LEPC, that LEPC may view working with non-EPCRA facilities as outside the scope of their authority. Alternatively, there may be a hazardous waste generator in a location where there is no organized LEPC. Therefore, as part of this regulation, EPA proposes to require that an SQG or LQG attempt to make formal arrangements with its LEPC unless there is no LEPC, the LEPC does not respond, or the LEPC determines that it is not the appropriate organization to make an arrangement with. In this case, the SQG or LQG would be required to make arrangements with its local fire department, as well as with other relevant emergency responders, such as the police department and local hospitals.
The proposed regulatory text for this condition would state that the generator must make arrangements with the Local Emergency Planning Committee for the types and quantities of hazardous waste handled at the site, as well as the potential need for the services of the local police department, other emergency response teams, emergency response contractors, equipment suppliers, and local hospitals.
EPA is also proposing regulatory text that describes procedures for how a facility that is not able to make arrangements with the LEPC would make such arrangements with the fire department and other local emergency services. Much of this language corresponds with the existing standards for making arrangements with emergency responders. These mandated steps are not necessary in the case of arrangements with the LEPC because that group is likely to have standardized procedures of its own to follow to make these arrangements with facilities.
The Agency requests comment on its proposal to require an SQG or an LQG to enter into arrangements with its LEPC unless there is no LEPC, the LEPC does not respond, or the LEPC determines that it is not the appropriate organization to make arrangements with, in which case the SQG or LQG would enter into an arrangement with its local emergency responders.
EPA is also proposing to add new language to supplement this condition because current § 265.37(a) does not specify the frequency that hazardous waste generators must make arrangements with local authorities. For example, should arrangements be updated according to a set schedule or only when modification is needed. Considering that some SQGs and LQGs may already coordinate with their LEPCs annually as part of their EPCRA requirements, the Agency is of the opinion that it is not necessary to include time frames for updating in this rule. The Agency requests comments on whether the regulations should mandate how frequently a generator must communicate with its LEPC or local fire department if it has not otherwise communicated with them.
One alternative suggested as part of the 2004 Program Evaluation of the hazardous waste generator regulatory program would be to require hazardous waste generators to list the emergency response agencies that have agreed to respond in the event of an emergency with some documentation confirming that the arrangements exist. In addition to helping generators prepare for emergencies, documentation of these arrangements would provide the necessary information for inspectors when determining compliance. The Agency believes this alternative may be the most effective approach to addressing the ambiguity that exists with the existing regulations at § 265.37(b).
The Agency seeks comment on this proposed change to documentation, in particular whether local ordinances already require generators to have documentation of arrangements with local emergency response organizations.
Under § 262.34(a)(4), LQGs are required to comply with 40 CFR part 265 subpart D, §§ 265.50-265.56, which describes the regulations on contingency planning and emergency procedures. These regulations address the purpose of the contingency plan, what it must contain, who receives copies, how to amend the contingency plan, and responsibilities of the facility's emergency coordinator and emergency procedures. One important thing to note is that the owner or operator of the facility can develop one contingency plan that meets all the regulatory standards for the various statutory and regulatory provisions for contingency planning:
• EPA's Oil Pollution Prevention Regulation (SPCC and Facility Response Plan Requirements) at 40 CFR 112.7(d), 112.20, and 112.21;
• EPA's Risk Management Programs Regulation at 40 CFR part 68;
• EPA's Resource Conservation and Recovery Act Contingency Planning Requirements at 40 CFR part 264 subpart D, 40 CFR part 265 subpart D, and 40 CFR 279.52;
• Department of Interior's Bureau of Safety and Environmental Enforcement (BSEE) Facility Response Plan Regulation at 30 CFR part 254;
• Pipeline and Hazardous Materials Safety Administration (PHMSA) Response Plans for Onshore Oil Pipelines at 49 CFR part 194;
• U.S. Coast Guard's (USCG) Facility Response Plan Regulation at 33 CFR part 154 subpart F;
• OSHA's Emergency Action Plan Regulation at 29 CFR 1910.38(a);
• OSHA's Process Safety Standard at 29 CFR 1910.119; and
• OSHA's HAZWOPER Regulation at 29 CFR 1910.120.
EPA recommends that generators base their contingency plan on the National Response Team's Integrated Contingency Plan Guidance (One Plan), discussed in the
In this action, EPA is proposing three modifications to the contingency planning regulations for generators: One is meant to improve the ability of emergency response teams to respond to an emergency at an LQG and the other two are technical changes to the content of the contingency plan.
The current regulations at § 265.53 state that a copy of the contingency plan must be submitted to all local police departments, fire departments, hospitals, and state and local emergency response teams that may be called upon to provide emergency services.
In discussions with EPA, emergency management professionals indicated that the length of the facility contingency plans prevents first responders from being able to fully review a facility's contingency plan when responding to an emergency.
A review of the information required as part of a RCRA contingency plan in § 265.52, as well as information required by the local fire department, identified certain components that would be useful in an executive summary and EPA used this information in developing this proposed regulation. Specifically, the Agency is proposing to require that the following information be included in an executive summary to assist emergency responders in the event of an incident: (1) The types/names of hazardous wastes in layman's terms and the associated hazard associated with each waste present at any one time (
EPA believes these are the appropriate elements for the executive summary but is taking comment on them. In addition, for identification of the hazardous waste under element (1), EPA is taking comment on whether providing the name of the waste in layman's terms is sufficient for ensuring that first responders will be able to identify the appropriate actions to take in response. A reference to the material in the North American Emergency Response Guide, where appropriate, would likely reduce the time it takes for first responders to get the necessary information for managing the situation. EPA is interested in whether this type of reference would be useful to first responders and whether generators can easily access this information to add to their contingency plans.
EPA is also taking comment on whether the executive summary should add to element (3) a requirement that the generator provide information on the medical information for exposure to those hazardous wastes that do require special treatment. EPA is specifically interested in whether this information is readily available to the generator to be included in the executive summary of the contingency plan and whether first responders would find this additional information useful for responses.
Under the proposed condition for contingency plans at LQGs, EPA is proposing that an LQG that becomes subject to this rule after the rule's effective date be required to develop and submit an executive summary of its contingency plan to the LEPC in addition to the full contingency plan. The Agency is not proposing to require that an LQG that has already developed and submitted a contingency plan to local emergency responders develop an executive summary because of the additional burden that would be imposed on existing LQGs to go back to their contingency plans and develop this summary. The Agency has determined that developing the executive summary during the initial writing of the contingency plan would not be a significant extra step. However, we recommend that an LQG that is not required to develop an executive summary of its contingency plan may want to do so and submit that executive summary to the LEPC when doing a periodic update on its contingency plan to ensure that the emergency responders have the appropriate information on hand in the event of an emergency.
EPA, therefore, is proposing to modify the condition regarding copies of the contingency plan to require that a copy of the contingency plan and all revisions to the plan must be maintained at the large quantity generator's site and the large quantity generator must submit a copy of the contingency plan to the Local Emergency Planning Committee. If there is no Local Emergency Planning Committee, if it does not respond, or if the Local Emergency Planning Committee determines that it is not the appropriate organization to make arrangements with, the facility must then submit the copy to the local emergency responders.
We are proposing to list in the regulations the eight elements described above as the most valuable items for emergency responders.
The Agency requests comment on this proposed revision. In addition, EPA requests comment on whether an existing LQG that has already provided its full contingency plan should also be required to submit an executive summary to the LEPC or, if appropriate, the fire department or other emergency responders.
The Agency also requests comment on whether an SQG should be required to develop an executive summary of a contingency plan. The major differences between the preparedness, prevention, and emergency procedures regulations applicable to SQGs and those applicable to LQGs are the development and implementation of a contingency plan and more rigorous responsibilities for the LQG emergency coordinator. Realizing that many SQGs may already have developed contingency plans to comply with other statutory and regulatory requirements, however, many of the elements of an executive summary may already be available and that the only addition would be summary information on the types and quantities of hazardous waste on site, their associated risks, and their location within the facility. Therefore, requiring SQGs to provide an executive summary of a contingency plan to first responders could provide information that is critical during emergencies with little extra effort by the SQGs.
Also as part of this revision, the Agency is proposing revisions to address situations where the facility has an emergency coordinator on duty 24 hours every day of the week. In those situations, the plan may list the staffed position (
The Agency requests comment on this proposed modification.
At issue is whether a contingency plan must contain information about alternative evacuation routes or whether a different approach for addressing alternative evacuation routes would be more effective. As part of the 2004 Program Evaluation of the hazardous waste generator regulatory program, the Agency received a comment stating that it does not make sense to include in the contingency plan the hundreds of possible evacuation routes that may be present at a facility depending on its configuration. The commenter argued that the regulation should be modified to require that evacuation routes be posted and drills be conducted but that the regulations should not require the routes to be in the contingency plan.
The Agency does not believe the current regulation requires all potential evacuation routes be identified and believes emergency responders may need this type of information in order to determine the most efficient and timely approach to reach the facility, which raises the question of whether the regulation should be modified in this way. However, the Agency seeks comment on whether the commenter's proposal to require the posting of evacuation routes and holding annual evacuation training and drills would be an effective substitute to maintaining alternative evacuation routes in the contingency plan. The Agency also seeks comment on whether this paragraph of the regulations should discuss shelter-in-place as part of contingency plans.
The Agency requests comment on whether contingency plans should be submitted electronically to emergency responders to enhance their ability to respond safely and effectively to an emergency at an LQG and what EPA's role should be in electronic submittals. Currently EPA makes numerous electronic databases and tools available for helping first responders with emergency management. These tools include CAMEO (Computer-Aided Management of Emergency Operations), which assists with data management requirements under EPCRA, such as the required annual submittal of an Emergency Hazardous Chemical Inventory Form to the LEPC. EPA is taking comment on whether an additional tool to manage contingency plans under RCRA would be a useful addition to this software suite and whether it would assist LEPCs by integrating the contingency plan with their existing data on facilities, making the information available to the first responders in the most usable way.
Specifically, we request comment on the feasibility and effectiveness of private sector parties or non-profit or governmental entities developing software that LQGs could use to provide important information to emergency responders in responding to an emergency. Building on the concept of a standard list of information to be included in a contingency plan executive summary that was discussed above, private sector or non-profit parties could design electronic software to identify the appropriate information emergency responders quickly need to assess an emergency. In turn, LQGs would then input that information into the application and provide that information to their local LEPC or emergency response organization for use should an emergency arise. The objective would be to allow emergency responders to more quickly and effectively analyze and respond to emergencies rather than having to review a lengthy document.
The Agency is proposing two additional clarifications and modifications to the existing preparedness, prevention, and emergency procedures regulations for SQGs and LQGs and is taking comment on one more.
The Agency is proposing revisions based on 30 years of experience with these rules, feedback from stakeholders as part of the Agency's 2004 Program Evaluation of the hazardous waste generator regulatory program and discussions and communication with stakeholders. EPA believes these clarifications will foster improved compliance without adversely affecting the protection of human health and the environment.
The Agency believes it may not always be appropriate or safe to have this equipment stored in the actual waste generation or accumulation area and instead, we are proposing that the regulation state that the hazardous waste generator should have this equipment located where it can be immediately accessed without jeopardizing a timely and effective response to any emergency. For example, the waste generation area may be in an enclosed room. Should a fire occur in the enclosed room, it might be more appropriate to exit the room and call the fire department rather than stay inside and be exposed to smoke inhalation and other risks. EPA believes
Therefore, EPA is proposing to modify the introductory paragraph to provide generators subject to subpart C of part 265 the flexibility to determine the most appropriate locations within the facility to locate equipment necessary to prepare for and respond to emergencies.
The proposed regulation would state that all areas where hazardous waste is either generated or accumulated must be equipped with the listed types of equipment (unless none of the hazards posed by waste handled at the site could require a particular kind of equipment or the actual waste generation or accumulation area does not lend itself for safety reasons to have a particular kind of equipment). It would also state that a generator may determine the most appropriate locations within its generator site to locate equipment necessary to prepare for and respond to emergencies.
The Agency requests comment on its proposal to modify § 265.32.
In the interest of clarity, the Agency is proposing to modify this language to read, “immediate access (
The Agency requests comment on the usefulness of modifying this language.
Current preparedness and prevention standards for SQGs are found at § 262.34(d)(5). SQGs must comply with the following:
• § 262.34(d)(5)(i)—have at least one employee either on the premises or on call with the responsibility for coordinating all emergency response measures (
• § 262.34(d)(5)(ii)—post specified information next to the telephone, including the name and telephone number of the emergency coordinator; the location of fire extinguishers and spill control material, and, if present, fire alarm; and the telephone number of the fire department, unless the facility has a direct alarm;
• § 262.34(d)(5)(iii)— ensure that all employees are thoroughly familiar with proper waste handling and emergency procedures, relevant to their responsibilities during normal facility operations and emergencies; and
• § 262.34(d)(5)(iv)— have the emergency coordinator or his designee follow the specified procedures in the event of a fire, spill, or explosion.
EPA is proposing changes to two of these provisions.
Stakeholders have recommended deletion of § 262.34(d)(5)(ii) because, in this age of near-universal 911 availability, they state it is simply not important from a regulatory point of view to have emergency telephone numbers posted. They argue that locations of fire extinguishers, spill control material, fire alarms, etc., should be conveyed to relevant employees and displayed in a worker break area rather than the facility office and that posting the name and telephone number of the emergency coordinator is also not necessary. For the majority of the SQG universe, the emergency coordinator is the owner or shop supervisor.
EPA disagrees with eliminating this provision because we believe that posting this information is important for workers and others to have readily available information so that they would know what to do and where to go in the case of an emergency. However, the Agency believes that the regulation should be modified to state clearly that the pertinent information should be posted where hazardous waste is generated and accumulated, since facility personnel can quickly seek assistance from it there.
Also unstated is whether the telephone number refers to the emergency coordinator's home phone or business phone. Over the years the Agency has received requests that we modify this provision to ensure that personal information not be used or distributed, particularly to individuals or organizations that could use such information to cause harm to the individual.
Therefore, EPA is proposing that § 262.34(d)(5)(ii) be modified to state that the small quantity generator must post the name and emergency telephone number of the emergency coordinator next to telephones or in areas directly involved in the generation and accumulation of hazardous waste. Section 262.34(d)(5)(ii)(B) and (C) are unchanged.
EPA requests comment on this proposed change.
Therefore, the Agency is proposing to modify § 262.34(d)(5)(iv)(B) and place the responsibility on the SQG to either perform the necessary cleanup of hazardous wastes or contract out the cleanup. The proposed language would state that in the event of a spill, the small quantity generator is responsible for containing the flow of hazardous waste to the extent possible, and as soon as is practicable, cleaning up the hazardous waste and any contaminated materials or soil. The proposal would allow such containment and cleanup to be conducted either by the small quantity generator or by a contractor on behalf of the small quantity generator.
The Agency requests comment on the proposed revision to § 262.34(d)(5)(iv)(B) and whether any unintended consequences arise from providing SQGs with this flexibility.
The Agency is proposing to modify the condition regarding personnel training for LQGs, currently found at § 262.34(a)(4), which refers to § 265.16. The proposed modification would allow a generator to use online computer training, in addition to classroom instruction and on-the-job training, to complete the personnel training requirements. Since the personnel training regulations were promulgated in the 1980s, use of computerized training has become a common practice for generators to teach their workers about the management of hazardous waste. In fact, many generators already use this method for training workers and this modification would simply bring the hazardous waste personnel training regulations up to date with existing industry practices.
The proposal would modify the first sentence of this provision by adding the words “online training” and would state that site personnel must successfully complete a program of classroom instruction, online training, or on-the-job training that teaches them to perform their duties in a way that ensures compliance with this part.
The Agency requests comment on the proposed modification.
The Agency seeks comment on clarifying what positions within an LQG must be responsible for receiving training associated with the management of hazardous waste, as well as identifying those positions for which a written job description is necessary. Under the current regulations, LQGs are responsible for complying with § 262.34(a)(4), which references, among other technical requirements, the personnel training provisions in § 265.16. Under the proposed reorganization discussed in section XIII, this condition for LQGs would move into 40 CFR 262.17.
The current regulations are not specific about which personnel at an LQG must complete the hazardous waste training. Other than stating that under § 265.16(a)(3) personnel must be able to respond effectively to emergencies by familiarizing them with emergency procedures, emergency equipment, and emergency systems, no other areas of hazardous waste management are cited.
At issue is the scope of these training standards and the applicability of the training provision to employees that are not assigned to work in the 90-day accumulation areas. The Agency is considering whether to require training and a written job description for specific types of employees working in areas of hazardous waste management related to 90-day accumulation areas. This clarification would have the benefit of assisting LQGs in determining more readily the scope of their hazardous waste training program.
The Agency, with the assistance of staff from the states of Vermont, Connecticut and New York,
The Agency seeks comment on whether the regulations should specifically identify positions at LQGs where hazardous waste training would be required and for which a written job description is necessary and what those areas should be. In addition, the Agency seeks comment on whether personnel involved in handling or managing hazardous wastes in SAAs should be required to undergo hazardous waste training. Current Agency guidance excludes staff working in satellite accumulation areas from the training requirements.
The proposed revisions discussed throughout this section of the preamble on the emergency planning and procedure regulations would only pertain to generators, as the proposed language would be found in the expanded generator regulations in part 262. However because many of the preparedness and emergency procedure provisions discussed in this section are taken from part 265 with only slight revisions, we are taking comment on whether these same proposed revisions should also be made in the applicable paragraphs of parts 264 and/or 265 as well to ensure consistency between the generator regulations and those for permitted facilities or facilities operating under interim status. The Agency requests comment on whether these revisions for consistency would be helpful and appropriate for facilities operating under part 264 or part 265 or whether the regulations should remain unchanged despite the result that generators and TSDFs would be left with some regulations that are very similar but not exactly the same.
The Agency is proposing a number of changes that would revise and strengthen the conditions for exemption for satellite accumulation areas (SAA) at § 262.34(c). These include (1) requiring SQGs and LQGs accumulating hazardous waste in SAAs to comply with the special requirements for incompatible wastes found at § 265.177; (2) providing limited exceptions to the regulation requiring generators to keep containers closed at all times; (3) strengthening the marking and labeling standards for SAAs (note these marking and labeling changes are the same as those proposed for containers in central accumulation areas); (4) confirming that three days means three consecutive calendar days, not business days; (5) providing a maximum weight for the accumulation of acute hazardous waste in SAAs in addition to a volume; (6) rewording the regulations for when the maximum volume or weight is exceeded in an SAA; (7) rescinding a guidance memo regarding the accumulation of reactive (D003) hazardous waste away from the point of generation; and (8) providing examples in the preamble to help generators better understand the term “under the control of the operator,” which is used in the SAA regulations.
In addition to these proposed changes, the SAA regulations would be moved as part of the proposed reorganization. These regulations would all be found together in § 262.15. The reorganization is discussed in section XIII of this preamble.
Using an SAA is not required of hazardous waste generators, but the regulations allowing them and setting the conditions for their use are designed to assist generators who generate and accumulate small amounts of hazardous waste in different parts of their facilities. SQGs and LQGs, however, may choose to accumulate hazardous waste only in central accumulation areas (CAAs) rather than SAAs or they may accumulate up to 55 gallons of non-acute hazardous waste and/or one quart of acute hazardous waste within each facility's SAAs and once that threshold has occurred, ship the hazardous waste to a designated facility. A generator may also accumulate hazardous waste within an SAA(s) and never move the waste to a CAA once the 55 gallons limit is reached, but instead, ship the waste directly to a RCRA designated facility.
Under the current regulations in § 262.34(c)(1)(i), generators accumulating hazardous waste in SAAs must meet the conditions for exemption, including complying with the container requirements at §§ 265.171, 265.172, and 265.173(a). These container requirements include accumulating hazardous waste in containers of good condition, ensuring the waste is compatible with, or will not react with, the contents of the container, and ensuring that the container accumulating hazardous waste is closed, except when it is necessary to add or remove waste. We are proposing to modify this part of the SAA container management standards by requiring that hazardous wastes not be mixed or be placed in the same container with other hazardous waste that are incompatible and could potentially result in fires, explosions, gaseous emissions, leaching, or other discharge of hazardous waste or hazardous waste constituents.
The Agency believes that in developing the regulations for SAAs, it inadvertently failed to account for the potential for accumulating incompatible wastes, especially since the current regulations already prohibit placing hazardous waste in containers that it may react with and that impair the containers ability to contain the hazardous waste. Therefore, the Agency is proposing that SQGs and LQGs accumulating hazardous waste in SAAs also comply with the part 265 subpart I container management standards for incompatible hazardous wastes at § 265.177. The Agency believes most generators already are aware of and comply with this best management practice at their SAAs since they must comply with this regulation when they move the SAA container(s) into a 90-day or 180-day central accumulation area.
The Agency requests comment on this proposed modification.
As noted in the previous section, the current regulation in § 262.34(c)(1)(i) for generators accumulating hazardous waste in SAAs requires containers accumulating hazardous waste to be kept closed, except when it is necessary to add or remove waste. The SAA regulations reference the requirement in § 265.173(a) that containers be closed while accumulating hazardous wastes at interim status treatment, storage and disposal facilities. We are proposing to modify this provision from § 262.34(c)(1)(i) in the new section for SAA conditions at § 262.15, but only as it pertains to SAAs; it will not affect the requirements for container management at interim status treatment, storage and disposal facilities. Because this modification is only meant to apply to containers accumulating hazardous waste in SAAs, and not to containers being stored at interim status treatment, storage, or disposal facilities, we are proposing to modify this requirement by eliminating the reference in the SAA regulations in part 262 to the container management standards for interim status treatment, storage or disposal facilities at § 265.173(a) and
Specifically, we are proposing to modify the standard in order to allow containers of hazardous waste in SAAs to remain open under limited circumstances. Specifically, we are proposing that containers of hazardous waste in SAAs may be open when it is necessary either for the operation of equipment to which the SAA container is attached or to prevent dangerous situations, such as the build-up of extreme pressure or heat because closing a container can be more dangerous than keeping it open temporarily in those situations. Stakeholders have identified situations where keeping SAA containers closed can interfere with the operation of equipment when the container is attached directly to the equipment via piping or tubing. Stakeholders have also identified situations in which closing a container can be more dangerous than keeping it open temporarily; for example, when the hazardous waste is very hot.
Therefore, EPA is proposing to modify the regulations to allow containers to be vented in such situations. However, we are also proposing that when the danger passes (
As noted above, the flexibility proposed for containers to remain open in specific situations applies only to containers in SAAs since that is where hazardous waste initially accumulates. The Agency does not anticipate that it is necessary to extend this flexibility to containers of hazardous waste in central accumulation areas.
The Agency requests comment on this proposed modification.
Currently, the regulations for SAAs in § 262.34(c)(1)(ii) require a generator to mark “his containers either with the words `Hazardous Waste'
Second, EPA is proposing that generators also indicate the hazards of the contents of the containers. EPA believes these proposed changes will alert workers, emergency responders, and others to the potential hazards posed by its contents. Identifying the hazard increases awareness to workers and others who might come into contact with the hazardous waste container and reduces potential risks to human health and the environment from container mismanagement. As discussed previously in section VIII.E, these changes are similar to those proposed for containers stored in central accumulation areas.
Specifically, EPA is proposing to modify the marking and labeling regulations for SAAs to require LQGs and SQGs to mark containers with the following: (1) The words “Hazardous Waste”; (2) other words that identify the contents of the containers. Examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride,” or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D; and (3) an indication of the hazards of the contents of the container. Examples of hazards include, but are not limited to, the applicable hazardous waste characteristic(s) (
The pre-transport requirements of part 262 subpart C already require hazardous waste generators to comply with the DOT labeling/marking requirements of 49 CFR part 172. By requiring generators to include other words that identify the contents of the containers, the Agency is proposing that generators perform a task that is already required when preparing the container prior to transporting the hazardous waste off site for subsequent waste management. In addition, the Agency is proposing to modify the marking and labeling of containers prior to shipping the hazardous waste. We are proposing that SQGs and LQGs can use the DOT hazard class labels to comply with the new labeling and marking regulation for containers in SAA. Alternatively, they may choose another method to indicate the hazards of the container that suits them better, as noted above.
The Agency requests comment on these proposed changes.
The current regulations at § 262.34(c)(2) state that a generator who accumulates either hazardous waste or acutely hazardous waste must, with respect to that amount of excess waste, comply “within three days” with paragraph (a) of that section or other applicable provisions of the chapter. The Agency is proposing to state in the regulations that the term “three days” means three consecutive calendar days, not three business days or three working days. The Agency has already clarified this term in a memo, which was based on preamble discussions from the proposed and final SAA regulations.
The Agency requests comment on this codification of an existing interpretation.
Currently, the regulations at § 262.34(c)(1) impose maximum volumes of hazardous waste that may be accumulated in an SAA without requiring a permit, complying with interim status standards, or complying with the generator accumulation standards. For non-acute hazardous waste, the maximum volume is 55 gallons. For acute hazardous waste, the maximum volume is 1 quart. When the SAA regulations were finalized, EPA explained that 55 gallons was selected for non-acute hazardous waste in part because it is the size of the most commonly used accumulation container.
We are not proposing to add a similar weight equivalent to the 55-gallon threshold for non-acute hazardous waste since stakeholders have not expressed a similar need. However, we request comment on whether it would be useful to have a maximum weight for the accumulation of non-acute hazardous waste in SAAs.
Currently, the regulation at § 262.34(c)(2) states that when the maximum volumes are exceeded in an SAA, a generator “must, with respect to that amount of excess waste, comply within three days with paragraph (a) of this section or other applicable provisions of this chapter.” The Agency is rewording this regulation in order to more clearly state the generator's options for managing the materials that exceed the limit. The proposed regulatory text states that a generator who accumulates either non-acute hazardous waste or acute hazardous waste listed in § 261.31 or § 261.33(e) in excess of the amounts listed in paragraph (a)(1) of this section at or near any point of generation must remove the excess from the satellite accumulation area within three calendar days either to a central accumulation area, an on-site interim status or permitted treatment, storage, or disposal facility, or an off-site designated facility. Similarly, during the three-calendar-day period the generator must continue to comply with paragraphs (a)(1)(i) through (iv) of this section and must mark the container(s) holding the excess accumulation of hazardous waste with the date the excess amount began accumulating.
The Agency does not view this as a substantive change to the SAA regulations. Nevertheless, the Agency solicits comments on this proposed change.
In a memo dated January 13, 1988, EPA wrote that a storage shed that is outside of a building where a reactive hazardous waste (D003) is initially generated, could be considered an SAA.
The Agency requests comment on proposing to revoke this interpretation of the SAA regulations.
The SAA regulation at § 262.34(c)(1) uses the term “under the control of the operator.” EPA has not defined this term in the regulations, nor have we discussed it in preamble or guidance letters. However, over the years, the Agency has received inquiries about what constitutes “under the control of the operator.” In an effort to assist generators to better understand this term and to foster improved compliance with the SAA provisions, the Agency is providing examples in this preamble of what constitutes “under the control of the operator.” For example, EPA would consider waste to be “under the control of the operator” if the operator controlled access to an area, building, or room that the SAA is in, such as with entry by access card, key or lock box. Another example would be if the operator accumulates waste in a locked cabinet and controlled access to the key, even if the cabinet is stored inside a room to which access is not controlled.
The Agency requests comment on additional practices that would constitute “under the control of the operator.”
EPA is proposing to modify the regulations at § 262.34(d) to require SQGs that accumulate hazardous waste for 90 days or less on drip pads without a permit or interim status to comply with the technical standards of 40 CFR part 265 subpart W and with all other conditions for an exemption associated with the accumulation of hazardous waste by an SQG.
Additionally, EPA is proposing to modify the conditions for an exemption currently at § 262.34(d) to require SQGs that accumulate hazardous waste for 90 days or less in a containment building
On December 30, 1988, EPA issued a proposed rule listing three additional hazardous wastes from wood preserving operations that use chlorophenolic, creosote, and/or inorganic (arsenic and chromium) preservatives, and listing one hazardous waste from surface protection processes that use chlorophenolics (53 FR 53282). As part of this rule, the Agency proposed additional standards “applicable to drip pads in treated wood storage yards and in kick back areas used in managing hazardous wastes at wood preserving and surface protection facilities. These standards are intended to provide for proper handling of treated wood drippage” (53 FR 53308).
In terms of the types of RCRA facilities this regulation would apply to, the proposed rule identified and discussed the regulatory requirements for two groups: Hazardous waste TSDFs subject to the part 264 permitting standards and LQGs subject to the part 265 interim status drip pad standards. More specifically, the preamble stated that “in the event that drippage is collected and is moved from the drip pad within 90 days following generation, generators may avail themselves of the 90-day accumulation standards of 40 CFR 262.34, and would not need Part B permits for their drip pads or tanks (consistent with § 264.1(g)(3), 265.1(c)(7), and 270.1(c)(2)(i)) provided that they comply with the Part 265 standards, as required by 40 CFR 262.34” (53 FR 53309).
When EPA promulgated the final rule for these hazardous wastes (55 FR 50450, December 6, 1990), the discussion addressed the same universe of facilities (
Pursuant to § 262.34(a), LQGs may accumulate the hazardous waste they generate without having to obtain a RCRA permit provided they comply with several specified conditions, including the technical standards for containers, tanks, drip pads, or containment buildings found at part 265 subparts I, J, W, and DD, respectively. Similarly, pursuant to § 262.34(d), SQGs may accumulate the hazardous waste they generate without having to obtain a permit, provided they comply with several specified conditions, including the technical standards for containers and tanks found at part 265 subparts I and J, respectively. Although there is no explicit condition for SQGs accumulating and managing their hazardous waste on drip pads, EPA intended SQGs accumulating hazardous wastes on drip pads either to comply with all of the conditions for exemption, as well as any associated independent requirements for LQGs at part 265 subpart W, or else obtain a Part B permit for their drip pads (consistent with §§ 264.1(g)(3), 265.1(c)(7), and 270.1(c)(2)(i)).
EPA has consistently interpreted this regulatory requirement to apply to SQGs. For example, as stated in the wood preserving technical guidance document issued by EPA in 1996, a copy of which is found in the docket, “this 90-day limit applies to both large quantity and small quantity generators. While small quantity generators may normally accumulate hazardous waste in accumulation units for up to 180 days, this is not the case for small quantity generators accumulating waste on Subpart W drip pads. Owners/operators of wood preserving facilities who generate between 100-1,000 kilograms of hazardous waste per calendar month and who accumulate the waste on drip pads are not eligible for the reduced standards normally provided for small quantity generators. Instead, these generators must comply with all the management conditions for large quantity generators accumulating hazardous waste on drip pads.”
Similarly, the RCRA training module for drip pads, a copy of which is found in the docket to this proposal, reinforced this principle by stating the following: “Under § 262.34(d), small quantity generators (SQGs) are subject to a reduced set of requirements when accumulating hazardous wastes in tanks or containers meeting the interim status unit standards. SQGs who accumulate wood-preserving wastes on drip pads do not qualify for this partial exemption. Consequently, all generators of more than 100 kilograms of waste per month who manage wood-preserving wastes on drip pads must comply with the requirements applicable to LQGs in § 262.34(a). As a result, the maximum generator accumulation time period on drip pads is 90 days.”
At the end of the same paragraph, the document states, “Generators using drip pads must also comply with the requirements that apply to large quantity generators for personnel training, development of a full contingency plan, and biennial reporting,” suggesting that SQGs accumulating hazardous waste on drip pads must comply with all of the conditions and independent requirements for LQGs, and not just the accumulation time limits.
Because of this statement, the Agency believes that confusion may potentially exist about the applicability of the regulations. As stated above, if an SQG accumulates hazardous waste in containers, it can comply with a reduced set of regulations, including accumulation of hazardous waste for up to 180 days, whereas if the SQG accumulates hazardous waste on drip pads, it must comply with the regulations for LQGs. The Agency believes a more effective and efficient approach is to require SQGs accumulating hazardous waste on drip pads to comply with the technical standards of part 265 subpart W, including compliance with the LQG 90-day accumulation limit (as opposed to the SQG 180-day accumulation limit), but to otherwise comply with less stringent conditions for SQGs found at 40 CFR 262.34(d). EPA notes that hazardous waste that is generated elsewhere at the wood preserving facility and accumulated in tanks or containers (
Because both the monthly generation quantities (
Situations may also occur where an SQG initially accumulates hazardous waste on a drip pad but subsequently transfers this waste to a container or tank for subsequent management. Similarly, the opposite situation may occur where hazardous wastes are generated and first accumulated by an SQG in a tank or in containers and then transferred to a drip pad. The Agency is proposing that the SQG have up to a total of 180 days to accumulate the hazardous wastes, which includes both the time the waste is on a drip pad and when it is in a tank or container, but that the total amount of time to accumulate the hazardous waste on the drip pad must not exceed 90 days. For example, if an SQG accumulates hazardous wastes on a drip pad for 80 days prior to transferring its waste to a tank, the SQG would be able to accumulate waste up to 100 days in the tank before it would be required to send it off-site for subsequent waste management, or conversely, treat and dispose of the waste on-site in compliance with all applicable RCRA regulations under parts 262 through 268 and 270.
In the case of an SQG first accumulating a hazardous waste in a tank or container and then transferring the waste to a drip pad, the generator would still have up to a total of 180 days, depending on the circumstances, to send the waste off-site for subsequent waste management, or conversely, treat and dispose of the waste on-site in compliance with all applicable RCRA regulations under parts 262 through 268 and 270. However, under the proposal, the amount of time allowed for the SQG to accumulate the hazardous waste on a drip pad may not exceed 90 days. For example, if an SQG first accumulated hazardous wastes in a tank or container for 100 days and then transferred the waste to a drip pad, the SQG would be able to accumulate up to 80 days more (for a total of 180 days) to accumulate the waste on the drip pad before the generator would be required to send the waste off-site for subsequent waste management, or conversely, treat and dispose of the waste on-site in compliance with all applicable RCRA regulations under parts 262 through 268 and 270.
However, if an SQG first accumulated hazardous wastes in a tank or container for 80 days and then transferred the waste to a drip pad, the SQG would only have 90 days more (or a total of 170 days) to accumulate the waste on the drip pad before the generator sent the waste off-site for subsequent waste management, or conversely, treat and dispose of the waste on-site in compliance with all applicable RCRA regulations under parts 262 through 268 and 270.
EPA solicits comments on these proposed revisions. In particular, EPA requests comment on whether SQGs accumulating hazardous waste on drip pads should be subject to the accumulation time limit of 180 days, similar to SQGs accumulating hazardous wastes in containers and tanks. Conversely, EPA is seeking comment on whether SQGs accumulating hazardous waste on drip pads should be subject to all applicable conditions and requirements for LQGs, and not just the 90-day accumulation time limit.
The Agency also requests comment on the procedures for documenting and ensuring hazardous wastes are removed from the sump or collection system 90 days or less from being first placed on the drip pad and also for situations where hazardous waste accumulation involves both drip pads and containers or tanks.
Consistent with the changes proposed for hazardous wastes accumulated on drip pads by SQGs, the Agency is also proposing that SQGs that accumulate hazardous waste in containment buildings for 90 days or less without a permit or interim status must comply with the technical standards of part 265 subpart DD and with all other conditions associated with the accumulation of hazardous waste by SQGs currently found at § 262.34(d).
Similar to the drip pad regulations, the containment building regulations promulgated in 1992 (August 18, 1992, 57 FR 37194) did not discuss the possibility of an SQG accumulating hazardous wastes in a containment building, but instead only discussed TSDFs and LQGs accumulating hazardous waste in containment buildings (57 FR 37212). Thus, under the current regulations, SQGs that choose to manage hazardous wastes in containment buildings can only do so if they comply with the LQG requirements or obtain a Part B permit for their containment building.
EPA is proposing to modify the regulations to allow SQGs to accumulate hazardous wastes in containment buildings for 90 days or less without a permit or without having interim status provided they comply with the technical standards of part 265 subpart DD and comply with all other conditions associated with the accumulation of hazardous waste by an SQG found at § 262.34(d). As with wastes accumulated by SQGs on drip pads, the Agency believes that SQGs complying with the less stringent conditions at § 262.34(d) (
As with drip pads, situations may potentially arise where hazardous wastes are first accumulated in a containment building and then transferred to containers for subsequent accumulation, or vice-versa. The Agency is proposing the same framework as described in the discussion on drip pads above for how long SQGs may accumulate hazardous wastes in a containment building to maintain their hazardous waste accumulation exemption.
EPA solicits comments on this proposed revision. In particular, EPA requests comment regarding whether SQGs accumulating hazardous waste in containment buildings should be subject to the accumulation time limit of 180 days, similar to SQGs accumulating hazardous wastes in containers and tanks or, conversely, whether SQGs accumulating hazardous waste in containment buildings should be subject to all applicable conditions for an exemption and independent requirements for LQGs, and not just the 90-day accumulation time limit. EPA also seeks comment on situations where hazardous waste accumulation involves both containment buildings and containers or tanks.
EPA launched The National Environmental Performance Track in 2000 to provide regulatory and administrative benefits to Performance Track members. Performance Track was a public-private partnership that encouraged continuous environmental improvement through use of environmental management systems, community outreach, and measurable results. In order to provide regulatory benefits to members, EPA made changes to the RCRA hazardous waste regulations, among others, that specifically referenced members of Performance Track.
EPA terminated the Performance Track program in 2009. Therefore, EPA is proposing to remove obsolete references to Performance Track in the RCRA hazardous waste regulations as a part of this rulemaking. In some cases, a whole paragraph of regulation will be removed and in other instances we will remove just the part of the paragraph that references Performance Track. The deleted paragraphs would then be reserved to reduce the possibility of confusion by replacing them with other regulations. The references that would be removed would be the following:
• § 260.10: Definition of Performance Track member facility;
• § 262.34(j), (k), and (l): Regulations for accumulation of hazardous waste by LQGs in Performance Track;
• § 262.211(c): Two parenthetical references to § 262.34 (j) and (k) in the regulations for academic labs in subpart K of part 262;
• §§ 264.15(b)(4) and 265.15(b)(4): References to the requirements for inspection of areas of the facility subject to spills in §§ 264.15(b)(5) and 265.15(b)(5), respectively;
• §§ 264.15(b)(5) and 265.15(b)(5): Requirements for Performance Track member facilities that reduce inspection frequency for areas subject to spills;
• §§ 264.174 and 265.174: References to Performance Track requirements for inspections of areas where containers are stored;
• §§ 264.195(e), 265.195(d), and 265.201(e): Requirements for Performance Track member facilities for inspections of tank systems;
• §§ 264.1101(c)(4) and 265.1101(c)(4): Requirements for Performance Track member facilities for reduced inspections of containment buildings;
• § 270.42(l): Procedures for permit modifications for Performance Track member facilities; and
• Appendix 1 to § 270.42—Classification of Permit Modification, Section O.1: Indication that a permit modification for reduced inspections for a Performance Track member facility is a Class 1 permit modification.
The provisions that EPA is proposing to remove were added to the regulations in the National Environmental Performance Track Program final rule, dated April 22, 2004 (69 FR 21737), the Resource Conservation and Recovery Act Burden Reduction Initiative final rule, dated April 4, 2006 (71 FR 16862), and the Academic Laboratories final rule, dated December 1, 2008 (73 FR 72912). The Agency is requesting comment on whether there are additional references to the Performance Track program in the RCRA hazardous waste regulations that should be removed as a part of this rulemaking.
EPA is proposing to modify the biennial reporting regulations for generators found at 40 CFR 262.41 in order to make the regulations consistent with Agency guidance, including its biennial report instructions and forms. More specifically, the Agency is proposing the following revisions: (1) Only LQGs need to submit biennial reports; (2) LQGs must report all of the hazardous waste they generate for the entire reporting year, not just the month(s) the generator was an LQG; (3) LQGs completing a biennial report must report all hazardous wastes they generated in the reporting year, regardless of whether they transferred the waste off site during the reporting year; and (4) a reference to the biennial report form (EPA form 8700-13) at § 262.41 rather than the list of specific data elements in currently at that citation.
Additionally, EPA is proposing to modify the title of subpart D from “Recordkeeping and Reporting” to “Recordkeeping and Reporting Applicable to Small and Large Quantity Generators” in order to highlight which entities need to comply with this subpart.
The first proposed change is to modify the biennial reporting regulations in § 262.41 to make these only applicable to LQGs (and thus not applicable to SQGs and CESQGs). Currently, the biennial report regulations at § 262.41(a) and (b) refer to “a generator” and “any generator,” but do not further specify which categories of generators must complete and submit a biennial report. However, current EPA guidance, as well as a 1986 FR notice, states that only LQGs must complete and submit a biennial report to EPA.
The second proposed change is to modify the biennial reporting regulations to require LQGs to report all of the hazardous waste they generate for the entire reporting year, not just the month(s) the generator was actually an LQG. (Additionally, if EPA were to make final the proposed provision allowing an LQG to receive hazardous waste from a CESQG under control of
Specifically, in a 1980
In the interest of national consistency, EPA proposes to modify the regulations at § 262.41 to require LQGs to report the total amount of hazardous waste generated during the entire reporting year. EPA believes that this change will ensure a more complete and reliable estimate on the total amount of hazardous waste generated in order to support various RCRA program development and implementation efforts by EPA and the states.
The Agency does not anticipate significant added burden from this provision. First, EPA knows of only two states (Idaho and Kentucky) that currently require generators to report only those hazardous wastes generated during the months the generator was an LQG. Thus, this modification will only affect a small percentage of the LQG universe that in certain months are not LQGs. Second, these LQGs are already completing a biennial report, so the change in burden will be in reporting the additional amounts of hazardous waste they generate for the remaining months of the reporting year that they were not an LQG. Third, generators are already required under § 261.5(c) and (d) to count the amount of hazardous waste they generate monthly to determine their regulatory status and thus would be counting hazardous waste during months they are not LQGs. Fourth, most generators transfer the hazardous waste they generate off site and, thus, should be able to use their hazardous wastes manifests to calculate the total amount of hazardous wastes they generate annually.
The third proposed change requires LQGs completing a biennial report to report all hazardous wastes they generated during the reporting year, regardless of when the hazardous waste was transported off site. Although the current biennial report instructions clearly state that LQGs should report the total quantity of hazardous waste that was generated during the reporting year, the regulations do not address cases in which the generator generates hazardous waste during the reporting year, but ships the waste off site during the next calendar year.
For purposes of completeness and to be consistent and avoid confusion with the current biennial report and its instructions, the Agency is proposing to state in § 262.41 that LQGs must report all hazardous wastes they generate in the reporting year, regardless of when the generated hazardous waste was transferred off site. The Agency believes that this change will not pose a significant burden since the information is already available; it is simply stating clearly in which year the data is reported.
EPA is proposing to modify the regulations at 40 CFR 262.41 to eliminate the specific list of data elements and to require the completion and submission of all data elements contained in the biennial report form (EPA form 8700-13).
Section 262.41(a) currently requires that the biennial report include a specific list of data elements, including the name, address, and EPA ID number of the generator and each transporter and TSDF, the EPA hazardous waste number for each hazardous waste shipped off site, and a signed certification, among other things.
In the nearly three decades since the biennial report regulations were first promulgated, EPA's biennial report form and instructions have evolved to enable better data analysis and to reduce burden, where possible. Thus, the regulations at § 262.41 no longer accurately reflect the data elements currently listed in EPA's biennial report instructions and forms. For example, current EPA guidance for biennial reporting requires generators to identify their hazardous wastes using not only the EPA hazardous waste number, but also using source, form, and management method codes. Additionally, EPA no longer requires the collection of the name and EPA identification number of each transporter in the biennial report. In order to maintain consistency between the regulations at § 262.41 and the EPA biennial report instructions and forms, EPA is proposing to remove the list of specific data elements currently in the regulations and to simply require completion and submission of all the data elements required in EPA form 8700-13. This change eliminates the need to update the list of data elements in the regulations, which would require periodic rulemakings, every time that changes were made to the information to be provided.
At least every three years, EPA's biennial report instructions and forms are reviewed and approved through the information collection request (ICR) process under the Paperwork Reduction Act (PRA). The PRA requires EPA to issue proposed and final notices in the
EPA does not believe this change in any way affects the enforceability of the biennial reporting regulations. Generators must complete and submit all information required by EPA form 8700-13. EPA also notes that this approach is similar to the current regulations at § 262.12, which require generators to obtain an EPA identification number using EPA form 8700-12 (Site ID form). Section 262.12 does not contain an itemized list of specific data elements contained in EPA form 8700-12. Instead, it requires the completion and submission of the specified form.
EPA also notes that some states develop their own biennial report forms, based on the federal forms. EPA does not believe this proposed change would impact the biennial reporting processes in these states. Authorized states that use a different form for collecting biennial report information would simply refer to their authorized state form in their state regulations.
The Agency requests comment on the proposed changes to § 262.41. EPA also specifically requests whether commenters believe the proposed change to eliminate the specific data elements in § 262.41 will ease compliance and understanding of the current biennial reporting procedures.
EPA is proposing to add a paragraph at § 262.14 (for CESQGs) and § 262.35 (for SQGs and LQGs) that hazardous waste generators are prohibited from disposing of liquid hazardous wastes in landfills. This is not a new requirement; it is a reflection of existing regulations found at § 258.28 for municipal solid waste landfills (MSWLFs), and §§ 264.314 and 265.314 for permitted and interim status hazardous waste landfills. The Agency believes it is important to emphasize that the responsibility for complying with this provision not only resides with municipal and hazardous waste haulers and landfill operators, but also with hazardous waste generators.
The restriction for disposal of liquid hazardous waste in MSWLFs has been in place since 1991 at § 258.28 and specifically restricts “bulk or noncontainerized liquid wastes, except (1) household wastes (other than septic wastes), and (2) leachate and gas condensate that is derived from the MSWLF unit where the unit is equipped with a composite liner and a leachate collection system. . . designed and constructed to maintain less than 30 centimeters of leachate over the liner” (56 FR 51055, October 9, 1991).
In the same preamble, EPA went on to state that liquids restrictions are necessary because the disposal of liquids into landfills can be a significant source of leachate generation and that restricting the introduction of liquids into landfills would minimize the leachate generation potential of landfills and reduce the risk of liner failure and subsequent contamination of the ground water.
Under current practices and operations, the primary onus for seeing that hazardous waste liquids are restricted from landfills generally resides with the hauler. Should a random inspection at a landfill of the hauler's waste find liquid hazardous waste, the landfill operator cannot accept the hauler's waste without violating its landfill permit. As a result, the hauler would be required to transport its waste back to the generator or to a RCRA-permitted treatment facility and pay the significantly higher tipping fees for any required treatment prior to disposal. While the waste management hauler or transporter can provide a measure of oversight, ultimately the hauler must rely on the due diligence and waste management practices of the hazardous waste generator to avoid such an outcome. In other words, the hazardous waste generator is responsible for ensuring that hazardous waste liquids are not disposed of in landfills.
Considering the importance of restricting liquid hazardous wastes in landfills, the Agency believes including a mirror provision in the 40 CFR part 262 hazardous waste generator regulations would increase awareness, and thus compliance, by generators with the liquids restriction that currently exists in §§ 258.28, 264.314(a) and 265.314(a) Therefore, the Agency is proposing to incorporate this provision into the generator regulations at part 262.
The Agency is proposing to extend the accumulation time for unwanted material by eligible academic entities with laboratories operating under 40 CFR part 262 subpart K from six months to one year.
Under 40 CFR part 262 subpart K eligible academic entities have the choice of operating their laboratories under the alternative subpart K standards instead of the satellite accumulation area regulations at 40 CFR 262.34(c). Currently, if the eligible academic entity chooses to operate its laboratories under subpart K, the entity must remove the unwanted material from each laboratory under the following two circumstances: (1) Every 6 months; or (2) within 10 days, if the laboratory accumulates more than 55 gallons of unwanted material or 1 quart of reactive acutely hazardous unwanted material.
Operating under the SAA regulations, an eligible academic entity has no time limit for accumulation. Therefore, for smaller eligible academic entities that do not accumulate 55 gallons in a laboratory, subpart K's six month accumulation time limit can mean a shorter, more stringent, accumulation time than they have under the satellite accumulation area regulations. Eligible academic entities have cited this shorter accumulation time as a disincentive for opting into the alternative standards in subpart K. The Agency therefore requests comment regarding its proposal to increase the accumulation time limit in an eligible academic entity's laboratory to 12 months.
Lengthening the time would yield a cost savings for those operating under subpart K compared to the costs they have now. The longer accumulation time would come with no increased risk because the volume limits—which are the same as the SAA volume limits—would continue to be in place for the rare cases where labs do accumulate 55 gallons of unwanted material or 1 quart of reactive acutely hazardous unwanted material.
The Agency requests comment on extending the accumulation time for
EPA is proposing to allow a CESQG or an SQG to maintain its existing generator category if, as a result of a planned or unplanned episodic event, the generator would generate a quantity of hazardous waste in a calendar month sufficient to bump the facility into a more stringent generator category (
Under the current RCRA regulatory framework for hazardous waste generators, a generator's category is determined by the quantity of hazardous waste it generates in a calendar month. For example, if a generator generates less than or equal to 100 kilograms of non-acute hazardous waste and 1 kilogram of acute hazardous waste in a calendar month, then it can comply with the regulations applicable to a CESQG.
At issue is when the generator generates an additional quantity of hazardous waste in a calendar month as a result of an episodic event—(planned or unplanned)—only to revert back to its normal waste generation quantities in the following month. For example, a CESQG plans a short-term demolition project that generates an additional 500 kilograms of hazardous waste in the calendar month, resulting in the CESQG becoming an SQG for that calendar month. However, once the demolition project has been completed, the generator's waste generation drops such that it again qualifies as a CESQG. Other examples of planned episodic events include tank cleanouts, short-term construction projects, site remediation, equipment maintenance during plant shut downs, and removal of excess chemical inventories.
Unplanned episodic events, which may be less frequent, include production process upsets, product recalls, excess inventory, accidental spills, or “acts of nature,” such as a tornado, hurricane, or flood. For example, an SQG suffers an unplanned disruption in production that results in the generation of 3,000 kilograms of an off-specification product that cannot be sold and must be discarded, therefore bumping the generator from an SQG to an LQG for that calendar month.
Currently, for the one month the hazardous waste generator was subject to more stringent regulations, the generator has two options: (1) Temporarily change its waste management practices to comply with those of the more stringent generator category for the duration of the event or (2) permanently adjust and manage all subsequent quantities it generates in the more stringent generator category (even though it is in a less stringent generator category in subsequent months). Generators that do not comply will be out of compliance with the applicable regulations.
Under the current regulatory framework, a CESQG must comply with minimal conditions for an exemption. For non-acute hazardous waste, these include the following: making a hazardous waste determination; counting the amount of hazardous waste it generates to ensure it is a CESQG (
Although EPA does not have specific information regarding the number of generators that may take advantage of its proposed alternative episodic standards, we can make certain estimates using data collected through the biennial report. EPA currently estimates that 1,270-2,550 generators could potentially take advantage of this provision if it is finalized.
On February 14, 2014, EPA published a Notice of Data Availability for the Retail Sector in which the Agency requested, among other topics, comments from retailers on issues they face in complying with the RCRA regulations. Some commenters mentioned the challenge posed by complying with the hazardous waste regulations when an irregular event causes them to exceed the threshold of their normal generator category for a single month. This provision would provide a way for retailers and others to manage that challenge.
Under the proposed framework, a CESQG or an SQG generating an increased quantity of hazardous waste because of an episodic event that resulted in a temporary change in a generator's category would be able to maintain its existing generator category provided specified conditions are met as the waste is accumulated. We believe these conditions will be sufficient to ensure these additional hazardous wastes are managed in an environmentally sound manner. Similar to the existing hazardous waste regulatory framework, should a CESQG fail to meet the specified conditions, it would immediately lose the CESQG accumulation exemption and be the operator of a non-exempt storage facility unless it also immediately complied with all of the conditions for exemption for an SQG or LQG. If an SQG failed to meet any specified condition for exemption, it would immediately lose its exemption and be the operator of a non-exempt storage facility unless it had immediately complied with all of the conditions for an exemption for an LQG.
For both CESQGs and SQGs taking advantage of this provision, the following conditions must be met:
(1) Episodic events are limited to one per calendar year;
(2) The generator must notify EPA at least 30 calendar days prior to initiating a planned episodic event or within 24 hours after an unplanned episodic event or as soon as possible; identify the start and end dates, which may be no more than 45 days apart, as well as other information about the event; and identify a facility contact and/or emergency coordinator with 24-hour telephone access to discuss notification submittal or respond to emergency;
(3) The generator must obtain an EPA ID number (CESQGs);
(4) The generator must comply with specified hazardous waste management conditions as the waste is accumulated on-site;
(5) The generator must use a hazardous waste manifest and hazardous waste transporter to ship the waste generated by the episodic event to a RCRA-designated facility within 45 calendar days from the start of the episodic event;
(6) The generator must complete and maintain specified records.
EPA is also proposing a petition process to allow hazardous waste generators to request from EPA one additional episodic event within the same calendar year and/or an extension of up to 30 calendar days to complete an episodic event and still be eligible to maintain its generator category. An example of how the implementation of these provisions would work in practice, particularly the start and end dates in conjunction with normal waste generation and accumulation operations, follows a discussion of these requirements.
The proposed regulations for episodic generators are located at a new part 262 subpart L, §§ 262.230-232.
The Agency is proposing that a CESQG or a SQG be allowed to exceed its generator category limits only once per calendar year without affecting its generator category.
A SQG or CESQG would have to notify EPA no later than 30 days prior to initiating a planned episodic event using EPA form 8700-12 (Site ID form). Should EPA finalize this provision, EPA will provide instructions in the Site ID form on how to report an episodic event (for example, using the notes section of the form). The hazardous waste generator would be required to identify the dates the episodic event will begin and end—a time frame not to exceed 45 calendar days—as well as describe the reason for the event and the types and estimated quantities of hazardous wastes that would be generated during the event. Should an unplanned event occur, the generator would be required to notify EPA as soon as possible via phone or email, but must submit EPA form 8700-12 (Site ID form) within 24 hours of the unplanned event, or as soon as possible depending upon the circumstances. Unless notified by EPA or an authorized state, a CESQG or SQG would be allowed to begin its episodic event on the date identified on its form 8700-12.
The date identified on the notification form as the start date for the episodic event is assumed to be the date the generator initiates physical action in generating and accumulating the hazardous waste. Whether such action actually occurs on that date or after by the generator will have no impact in changing the end date of the episodic event identified on the notification form.
No matter what, the end date must be no later than 45 calendar days from the date identified on the notification form as the start date of the episodic event. The end date will be the date on which all hazardous waste generated from the episodic event, and possibly other hazardous waste also generated during that time period as part of normal operations, will have had to be removed and sent to a RCRA designation facility as verified by the hazardous waste manifest. The Agency does not see any reason to preclude a generator taking advantage of this provision to also dispose of other hazardous wastes generated during the time of the episodic event.
As part of the notification form, a CESQG would have to notify its local fire department that it was taking advantage of an episodic event. The notice would need to include the start and end dates and identify the types and quantities of hazardous wastes that would be generated.
EPA believes notification is essential to inform regulatory authorities of the facility's activities in order to enable adequate compliance monitoring of the facility with the conditions of the alternative standards.
A CESQG generating and accumulating quantities of hazardous waste that would otherwise result in a higher generator category because of an episodic event (whether planned or unplanned) would be required, under the proposed regulations, to obtain an EPA ID number using EPA form 8700-12 if one had not previously been assigned. A generator cannot initiate a hazardous waste shipment to a RCRA-designated facility without an EPA ID number. (SQGs are already required to obtain an EPA ID number.)
When accumulating hazardous waste in containers, the CESQG would be required to mark its containers with the following: (1) The words “Episodic Hazardous Waste”; (2) other words that identify the contents of the containers—examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride,” or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D; and (3) an indication of the hazards of the contents of the container—examples of hazards include, but are not limited to, the applicable hazardous waste characteristic(s) (
These marking standards are the same as those for LQGs and SQGs accumulating hazardous wastes in containers in the course of normal business operations and are necessary to protect human health and the environment. In addition to these, the CESQG would be required to mark the date that the episodic event began clearly on each container.
For tanks, the CESQG would have to mark or label the tank containing hazardous waste accumulated during the event with the words “Episodic Hazardous Waste” and would be required to use inventory logs, monitoring equipment, or other records to identify the contents of the tank, the quantity accumulated as a result of the episodic event, and the associated hazards and to identify the date that the episodic event began. The records containing this information would have to be immediately accessible by the generator.
In addition, the generator would be required to manage the hazardous waste in a manner that minimizes the possibility of an accident or release. Management standards are critical to ensure the hazardous waste does not pose a risk to human health and the environment. A CESQG may use best management practices to comply with this condition. In practice, this includes managing the hazardous waste in containers that are in good condition and chemically compatible with any hazardous waste accumulated therein and keeping the containers closed except to add or remove waste. Complying with the standards in part 265 subpart I would satisfy this condition.
With respect to tanks, the following standards are proposed: (1) Having procedures in place to prevent overflow (
As mentioned above, an emergency coordinator (in compliance with proposed § 262.16(b)(9)(i)) must be identified for the duration of the episodic event on the notification form. A CESQG taking advantage of this provision would also need to notify the local fire department of who their emergency coordinator was if they had not done so already for other emergency preparedness and planning reasons. An emergency coordinator is needed because the CESQG will be generating greater amounts of hazardous waste than normal and, should an accident occur, the emergency coordinator would need to be prepared to handle the situation.
EPA believes these management standards are necessary to adequately protect human health and the environment because of the additional quantities of hazardous waste generated and accumulated as a result of an episodic event. The Agency, however, seeks comment on these proposed management standards. In particular, the Agency is aware of concerns expressed by generators in the past that the marking and labeling of tanks with the date the generator first began
Under the existing regulations, CESQGs may not treat hazardous waste generated on site in a manner equivalent to SQGs and LQGs under § 262.34, except in an on-site elementary neutralization unit. Elementary neutralization units, as defined in § 260.10, are exempt from RCRA treatment, storage, and disposal standards and permitting requirements. The elementary neutralization unit exclusion does not preclude a CESQG from treating waste in the exempt unit as long as the generator meets the criteria outlined in §§ 264.1(g)(6), 265.1(c)(10), and 270.1(c)(2)(v). Specifically, the elementary neutralization unit must meet the definition of a container, tank, tank system, transport vehicle, or vessel, and must be used for neutralizing wastes that are hazardous only because of the corrosivity characteristic.
Considering that CESQGs will be required to meet additional waste management requirements under this proposed rule for episodic generation, the Agency seeks comment on whether CESQGs taking advantage of this provision should be allowed to treat their episodic hazardous waste on site in a manner equivalent to SQGs and LQGs at § 262.34. In particular, the Agency seeks comment on whether the volume of hazardous waste generated from an episodic event exceeds the capacity and expertise of CESQGs, which are accustomed to managing smaller quantities of hazardous waste, and whether the Agency should identify a select list of allowable types of treatment that would not pose a risk to human health and the environment.
When accumulating hazardous waste generated as a result of an episodic event in containers, the SQG would be required to mark its containers with the following: (1) The words “Episodic Hazardous Waste”; (2) other words that identify the contents of the containers—examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride,” or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D; and (3) an indication of the hazards of the contents of the container—examples of hazards include, but are not limited to, the applicable hazardous waste characteristic(s) (
These standards are the same as those for SQGs accumulating hazardous wastes in containers in the course of normal business operations and are necessary to protect human health and the environment. In addition to these, the SQG would be required to mark the date that the episodic event began clearly on each container.
For tanks, the SQG would be required to mark or label the tank containing hazardous waste accumulated during the event with the words “Episodic Hazardous Waste” and would be required to use inventory logs, monitoring equipment, or other records to identify the contents of the tank and the associated hazards and to identify the date that the episodic event began and ended. The generator would need to have records containing this information immediately accessible.
In addition, the SQG would need to comply with all the conditions of the exemption in § 262.34 (d) through (f) with references to 40 CFR 265 subparts C, I, and J, part 268 land disposal restrictions (§ 262.16 under the proposed reorganization)—that is, the waste accumulation, waste management, employee training, and emergency preparedness and prevention conditions.
The Agency is proposing to allow SQGs and CESQGs 45 calendar days to initiate and complete an episodic event, which includes generation, accumulation and management (
Finally, generators would need to keep the following information in their records: (1) Beginning and end dates of the episodic event; (2) a description of the episodic event; (3) a description of the types and quantities of hazardous wastes generated during the episodic event; (4) a description of how the hazardous waste was managed as well as the name of the RCRA designated facility that received the hazardous waste; (5) name(s) of hazardous waste transporters, as appropriate; (6) an approval letter from EPA, if the generator successfully petitioned to conduct an additional episodic event during the calendar year; and (7) an approval letter from EPA, if the generator successfully petitioned for an additional 30 calendar day extension. These records would need to be maintained on site by the generator for three years from the completion date of each episodic event.
EPA believes the recordkeeping condition is critical to enable effective and credible oversight. We also believe that the information to be maintained is the minimum information necessary to determine that any hazardous waste generated during the episodic event is managed properly.
While the Agency believes that most generators will experience an episodic event infrequently, we also recognize that there may be situations, often unexpected, where a hazardous waste generator may have more than one episodic event within a calendar year, such as an unexpected product recall, a major spill, or an act of nature. Therefore, the Agency is proposing to allow CESQGs and SQGs to petition EPA (at least 30 days before initiating a planned episodic event and within 24 hours after an unplanned event) for permission to manage one additional episodic event without impacting the hazardous waste generator category. The petition must include (1) the reason why an additional episodic event is needed and the nature of the episodic event; (2) the estimated amount of hazardous waste to be managed from the event; (3) how the hazardous waste is to be managed; (4) the estimated length of time needed to complete management of the hazardous waste generated from the episodic event—not to exceed 45 days; and (5) information regarding previous episodic event(s) managed by the generator and whether it complied with the proposed conditions. EPA will then evaluate this and other site-specific information to determine whether a generator should be allowed to initiate a second episodic event under the proposed alternative standards. The petition by the generator may be made via fax, email, or letter. The generator may not manage hazardous waste for an additional episodic event until written approval by EPA (or the authorized state) has been received. The generator must retain written approval in its records for three years from the date the episodic event ended.
Events may arise, particularly unplanned events, such as an “act of nature,” where 45 days is insufficient to complete the event. The Agency is proposing to allow generators to petition EPA for an additional 30 days to complete the generation and removal of hazardous waste, if needed. The petition must include (1) the nature of the episodic event; (2) the estimated amount of hazardous waste to be managed from the event; and (3) and the generator's rationale for needing an extension for an additional 30 days beyond the 45-day limit to complete the episodic event. EPA will then evaluate the generator's request to determine whether it should be allowed up to an additional 30 days to complete the episodic event. For example, a situation may exist where a hazardous waste transporter cannot arrive and remove hazardous waste generated until the 46th day because of unforeseen problems with its truck or the generator did not foresee problems with completing a tank cleanout because cleanout equipment failed to operate. These are all site-specific situations that EPA or authorized state would evaluate when making its decision. The generator cannot go beyond the 45-day limit unless written approval by EPA has been received.
The generator would need to petition EPA for approval at least 15 days before the original end date of the episodic event. The petition by the generator may be made via fax, email, or letter. The generator must retain written approval in its records for three years from the date the episodic event ended.
Should the generator request an extension from the Agency or authorized state with less than 15 days remaining and be denied the extension, then the generator would have to remove all hazardous wastes generated as a result of the episodic event as of the specified end date in its notification or be in violation of its exemption.
Unlike rulemaking petitions in part 260 subpart C of the hazardous waste regulations, the Agency is not proposing to have a notice and comment period for granting an episodic event or an extension. The Agency believes a generator's actions and performance will dictate approval or disapproval of a generator's request. In addition, in some cases a timely response to these requests is critical, especially with requests for extension. Taking notice and comment would delay that response.
In practice, a generator taking advantage of this rule, in particular a CESQG or SQG, must track and monitor the start and end dates of the episodic event in conjunction with the date the
A CESQG could have a number of facility operations (
However, on or before September 2, the generator must remove and dispose of all the hazardous wastes it generated over the course of the last 45 days that represented the episodic event. Provided the generator meets that deadline, that waste would not count when determining the generator's status. In this example, the generator chooses to also dispose of waste generated from its normal operations by September 2. In this case, it would then not count that waste in determining its generator status for July, August, and September. The CESQG would then estimate the quantity of hazardous waste it generates and accumulates for the remainder of September (starting on September 3 until the end of the month) to determine its regulatory category.
If the generator decides to separate out normal production operations from episodic event operations, then the waste from normal operations is counted each month to determine the generator's status. For example, assume the generator at the beginning of the episodic event had accumulated 950 kg of hazardous waste and proceeds to accumulate another 75 kg over the course of the 45-day episodic event that is associated with normal operations.
There are numerous variations on the above example (
An episodic event may also involve overlapping two calendar years. The Agency is proposing that the generator count all the waste from the episodic event in the year with the most days involved in the episodic event. In other words, if the episodic event begins on December 16 of year 1 and ends on January 30 of year 2, the waste would count in year 2.
The Agency requests comment on its proposed approach for addressing hazardous waste generated during an episodic event. Specifically, the Agency requests comment on whether the overall approach proposed would assist generators and allow a CESQG or SQG to maintain its generator category and not be bumped up into a more stringent generator category temporarily.
EPA also requests comment on the number of episodic events that would be allowed under these proposed alternative regulations. As stated above, we are proposing to allow CESQGs and SQGs to take advantage of this alternative regulatory framework for one episodic event per calendar year, with the ability to petition EPA for one additional event per calendar year. EPA is interested in ideas on how best to structure this alternative framework in terms of identifying a reasonable number of episodic events allowed per year and identifying an appropriate time period allowed to conduct and manage the hazardous waste from an episodic event in a way that would be effective while still ensuring protection of human health and the environment.
Additionally, the Agency requests comment regarding its proposed conditions for CESQGs and SQGs managing hazardous waste generated from the episodic event, such as the proposed 45-day limit to generate and manage the waste and the ability for CESQGs and SQGs to petition the Agency for one additional episodic event per calendar year or an additional 30 days to complete an episodic event. The Agency also requests comment on whether the proposed conditions for CESQGs and SQGs are reasonable and sufficient to protect human health and the environment.
Finally, the Agency requests comment on whether to allow a CESQG or SQG to accumulate hazardous waste either on a drip pad or in a containment building in compliance with 40 CFR part 265 subparts W and DD, respectively, as a result of an episodic event. As proposed, the Agency has focused on hazardous wastes accumulated in containers or tanks as a result of an episodic event since almost all CESQGs and SQGs accumulate waste in containers with a small percentage accumulated in tanks. However, there may be circumstances that lend themselves to a CESQG or SQG accumulating hazardous wastes on a drip pad or in a containment building.
The current regulations at § 263.12 for transporters handling hazardous waste at a transfer facility for ten days or less state that the transporter is not subject to the storage regulations in 40 CFR parts 264, 265, 267, 268 and 270. In addition, the regulation stipulates that containers that hold hazardous waste must meet the provisions in § 262.30 that reference DOT's packaging regulations at 49 CFR parts 173, 178, and 179.
The Agency is proposing to change the marking and labeling requirements for transporters handling hazardous waste at transfer facilities, found at § 263.12, to be consistent with the proposed changes for marking and
Specifically, EPA is proposing that transporters storing hazardous wastes in containers at transfer facilities mark the containers with the following: (1) The words “Hazardous Waste”; (2) the applicable EPA hazardous waste number(s) (EPA hazardous waste codes) in subparts C and D of part 261; (3) other words that identify the contents of the containers—examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D; and (4) an indication of the hazards of the contents of the container—examples of which include, but are not limited to, the applicable hazardous waste characteristic(s) (
A transfer facility may choose to use an appropriate DOT proper shipping name found in the 49 CFR 172.101 hazardous materials table to identify the contents of the container. That way, the transfer facility will fulfill EPA and DOT requirements simultaneously; however, EPA is not proposing to require the use of the DOT shipping names while the hazardous waste is accumulating on-site. We only suggest that the DOT shipping name may be one way that some generators may choose to identify the contents of the container.
As previously discussed, the Agency believes providing this information on the container will alert workers and other handlers to the contents of the container and the potential hazards of the materials therein. This information increases the awareness of workers and others who might come into contact with the hazardous waste in the containers and reduces potential adverse impacts from container mismanagement. The Agency does not believe this proposed change will adversely impact transfer facility operations since similar marking and labeling standards are proposed for hazardous waste generators. One difference, however, is the inclusion of the EPA hazardous waste number in the list of labeling requirements. Although generators are not required to have the EPA hazardous waste number on the hazardous waste while accumulating it, we are proposing in this rulemaking that generators must include the EPA hazardous waste number on the label before transporting the hazardous waste off site, so when a container arrives at the transfer facility it should already have the EPA hazardous waste number on its label.
Given that containers received by the transfer facility will already be marked and labeled by the generator, the Agency believes the additional burden on the transfer facility will be minimal. However, there may be situations where the transporter would be required to mark and label a container. One example of when a transfer facility would be required to mark and label its containers would be when it consolidates two containers with the same hazardous waste into a new container or when it is able to combine and consolidate two different hazardous wastes that are compatible with each other and are able to be subsequently managed consistently in compliance with the applicable regulations in parts 264, 265, 267, 268 and 270 of this chapter.
The Agency requests comment on this proposed change, particularly the identification of any unintended problems from this requirement.
The Agency is proposing to modify the biennial report requirements for facilities subject to 40 CFR 264.75 and 40 CFR 265.75 and the special requirements for ignitable and reactive wastes at 40 CFR 265.176.
EPA is proposing to modify the regulations at §§ 264.75 and 265.75 to eliminate the list of specific data elements and to require the completion and submission of all data elements in the biennial report form (EPA form 8700-13).
Section 264.75 currently requires that the biennial report include a specific list of data elements, including the name, address, and EPA ID number of the generator and each transporter and TSDF, the EPA hazardous waste number for each hazardous waste shipped off site, and a signed certification, among other things.
Section 265.75 includes the above data elements as well as requiring monitoring data under § 265.94(a)(2)(ii) and (iii), and (b)(2), where required.
Similar to the approach EPA is proposing for the biennial reporting requirements for LQGs in § 262.41, EPA believes removing the specific data elements in the regulations and replacing it with a requirement to complete and submit all the data elements required in the biennial report form will ensure that the regulations and forms remain consistent. For example, the existing regulations require closure cost information and, at § 265.75(f), groundwater monitoring data under § 265.94(a)(2)(ii) and (iii), and (b)(2) to be submitted as part of the biennial report; however, these data elements are not collected on EPA's current biennial reporting form 8700-13.
EPA does not believe this change in any way affects the enforceability of the biennial report regulations. Owners and operators must complete and submit EPA form 8700-13.
EPA also notes that some states develop their own state biennial report forms. EPA does not believe this proposed change would impact a state's ability to use their own biennial report forms or to collect more information than is required by the federal forms. Authorized states that use a different form for collecting biennial report information would simply refer to their authorized state form in their state regulations. Additionally, EPA is aware that some states use their state biennial report form as a vehicle for collecting closure cost data, required to be submitted under § 264.142, and groundwater monitoring data, required to be submitted under § 264.97(j). Because the existing federal regulations already specify collection of this information, EPA would not consider states that continue collecting this data using their state authorized biennial report form to be more stringent than the federal program.
Additionally, as discussed in section VIII.L of this preamble, EPA is proposing to modify the phrase “prepare and submit,” which is the existing language in §§ 264.75 and 265.75, to “complete and submit” because the Agency believes that “complete and submit” more accurately reflects that facilities must complete all applicable elements of the biennial report forms.
The Agency requests comment on these proposed changes to §§ 264.75 and 265.75. EPA also specifically requests whether commenters believe the proposed change to eliminate the specific data elements in these regulations will ease compliance and understanding of the current biennial reporting procedures.
Sections 262.34(a)(1)(i) and 262.34(d)(2) contain conditions for exemptions for LQGs and SQGs that accumulate hazardous waste on site for up to 90 or 180 days without a permit. These regulations both reference part 265 subpart I, which contains regulations for owners and operators of interim status hazardous waste facilities that store hazardous waste in containers.
The LQG conditions in § 262.34(a)(1)(i) reference § 265.176. Section 265.176 states that containers holding ignitable or reactive waste must be located at least 15 meters (50 feet) from the facility's property line. SQGs are not required to comply with this provision.
In some cases, to comply with this standard for ignitable and reactive wastes, LQGs may modify their production feedstocks or production processes to generate a waste that is not an ignitable or reactive hazardous waste or reexamine the site's layout to identify alternative accumulation areas. However, there are some cases where it may not be physically possible to meet this standard, particularly if the width of the site is 100 feet or less or when the generator's operations have expanded such that it no longer has the ability to accumulate ignitable or reactive waste at least 15 meters (50 feet) from the site's property line. Insurance companies and local fire departments often assist hazardous waste generators in minimizing their environmental hazards and liabilities, but site dimensions may sometimes physically prevent a facility from complying with this condition.
Therefore, the Agency is proposing to modify the regulatory text for generators to allow LQGs to apply for a site-specific waiver from their local fire department if they are unable to meet the hazardous waste accumulation property line condition.
Because it is the local fire department that has the expertise to address this problem when it arises, EPA is relying on those local fire departments to work with the generators on any waivers that may be requested and on finding the most appropriate place on site to accumulate this hazardous waste.
Section 265.176 contains a comment that references § 265.17(a) and states that there are additional requirements in that section, which also contains provisions for ignitable, reactive, and incompatible wastes. The Agency is also proposing to incorporate the language from existing § 265.17(a) into § 262.17(a)(1)(vi)(B) of the generator regulations. EPA is proposing to replace the words “owner and operator” with “large quantity generator” as part of this revision. By eliminating the cross-references, generators should be able to more easily discern what provisions are applicable and therefore should be better able to properly manage any ignitable or reactive hazardous waste.
The Agency seeks comment on the proposed addition of this language to the generator conditions for exemption, as well as the change to allow LQGs to seek a waiver from the provision that containers holding hazardous waste must be located at least 15 meters (50 feet) from the property line. Specifically, EPA requests comment on whether this waiver option provides a sufficient level of protection for the facility and the surrounding community and whether generators would benefit from the increased flexibility. Additionally, EPA requests comment on whether it is appropriate to delegate the responsibility for issuing waivers in this case to the fire department and whether EPA should promulgate criteria that must be met as a condition of the waiver as part of this provision. For example, conditions may include a limit on the amount of ignitable or reactive hazardous waste that could be accumulated at any time or a requirement that the facility have certain technical controls, such as fire suppression devices or walls that meet a certain fire-resistance rating. Furthermore, EPA requests comment on whether the insertion of the language from § 265.17(a) in this section is helpful.
Finally, EPA requests comment on whether including a waiver to the provision for ignitable and reactive wastes would also be appropriate for interim status facilities or for permitted facilities in §§ 264.176 and 265.176.
The Agency is proposing to change the regulations on marking and labeling of containers by the owner/operator of a hazardous waste TSDF in § 268.50 to be consistent with the proposed marking and labeling changes for LQGs, for SQGs, for SAAs, and for transfer facilities.
Consistent with the other proposed changes that clarify the contents and hazards posed by the contents of hazardous waste in containers, the Agency is proposing to modify this language to state that each container must be clearly marked with (1) the words “Hazardous Waste”; (2) the applicable EPA hazardous waste number(s) (EPA hazardous waste codes) in subparts C and D of part 261; (3) other words that identify the contents of the containers—examples may include, but are not limited to the name of the chemical(s), such as, “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with DOT requirements at 49 CFR part 172 subpart D; (4) an indication of the hazards of the contents of the container (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
The Agency believes this proposed change will not adversely impact facility operations. In fact, because these are consistent with the requirements for marking and labeling that are proposed elsewhere in the regulations, we believe it will be easier for all those who manage the hazardous waste to know and comply with the consistent system of marking and labeling. In addition, a clear description of what material is in each container makes the facility safer for employees, first responders, and the public. The Agency requests comment on this proposed change.
EPA is proposing to reorganize the hazardous waste generator regulations to make them more user-friendly, which should facilitate better generator compliance. As part of the Agency's 2004 Program Evaluation of the hazardous waste generator program, the most frequent comment by stakeholders was to improve the user-friendliness of the regulations.
Although many existing generators are familiar with the current regulations, every year many generators either enter the hazardous waste generator program or switch their generator category and therefore need to become familiar with their obligations. Similarly, an existing generator may need to examine a particular regulatory citation to ensure it is complying with the regulations correctly. The Agency believes that providing these generators with a user-friendly regulatory framework is an effective way to make the regulations easier to understand for those who need to comply with them.
Therefore, in response to these concerns, EPA is proposing the following organizational changes:
(1) Integrate the generator regulations in § 261.5 into the generator regulations at part 262 by moving § 261.5 (which contains the regulations applicable to CESQGs, counting of hazardous waste, and mixing of hazardous wastes with non-hazardous wastes);
(2) Move the existing regulations at § 262.34 for SQGs and LQGs into three new sections:
(a) Satellite accumulation areas regulations for small and large quantity generators,
(b) Conditions for exemption for an SQG that accumulates hazardous waste; and
(c) Conditions for exemption for an LQG that accumulates hazardous waste;
(3) Use subtitles in these new sections; and
(4) Where reasonable, incorporate regulations that currently cross reference part 265 into these new sections.
Currently, certain hazardous waste generator regulations are located in a different part of the regulations (40 CFR 261.5) from the rest of the generator regulations (40 CFR part 262). Stakeholders have stated that this current organization is confusing and not user friendly and have asked EPA to move the CESQG regulations in § 261.5 into part 262 so that all the generator regulations are in the same place. The Agency believes this reorganization would alleviate much confusion in the regulated community and, in the process, would foster greater compliance with the regulations.
Specifically, EPA is proposing to move the definition of a CESQG that generates non-acute hazardous waste at § 261.5(a) into the CESQG definition at § 260.10, move § 261.5(c) through (e) to a new section at § 262.13 titled “Generator category determination” and move § 261.5(b) and (f) through (j) to a new section at § 262.14 titled “Conditions for exemption for a very small quantity generator.”
Currently § 261.5(a) sets forth the non-acute hazardous waste quantity limits for a CESQG and § 261.5(e) provides quantity limits for generating acute hazardous waste and any residue or contaminated soil, waste, or other debris resulting from the cleanup of a spill of
Section 261.5(c) and (d) set forth the provisions for a hazardous waste generator to use in making its generator category determination. Every hazardous waste generator must determine its generator category so it knows what regulations are applicable to it. Since these regulations are applicable to all hazardous waste generators, it makes sense to move them into 40 CFR part 262 along with the other hazardous waste generator regulations. To further aid in making the regulations more user friendly, the Agency is proposing to make a new section for generator category determination at § 262.13, titled “Generator category determination.” This new section is appropriate because, after a generator of a solid waste determines it has generated a hazardous waste (§ 262.11), the generator must then determine its hazardous waste generator category for the calendar month. Table 3—Crosswalk of Existing Citations to Proposed Citations for Determining Generator Category provides a summary of the crosswalk between the existing and proposed regulatory citations for determining a generator's category.
Sections 261.5(b) and (f) through (j) establish a CESQG's conditions for exemption from regulation as an SQG or LQG. More specifically, these conditions for exemption establish the regulations for accumulating acute and non-acute hazardous waste, where the acute and non-acute hazardous waste may be managed off-site, and what the implications are when hazardous waste is mixed with solid waste or used oil. Since these regulations set forth conditions for exemption for CESQGs, just as the regulations found in existing § 262.34 set forth conditions for exemption for SQGs and LQGs, EPA is proposing to move § 261.5(b) and (f) through (j) to the newly created § 262.14 titled, “Conditions for exemption for a very small quantity generator.” All these regulations would then be located parallel to one another in part 262. Section 262.14 would also include the CESQG landfill ban for liquids. In addition, CESQGs who episodically generate higher amounts of hazardous waste could follow the newly proposed standards for episodic generation in part 262 subpart L in order to maintain their CESQG status while managing these higher amounts of hazardous waste. Table 4—Crosswalk of Existing Citations to Proposed Citations for CESQGs provides a crosswalk between the existing and proposed CESQG conditions for exemption.
SQGs and LQGs may accumulate their hazardous waste on site without a permit or without having interim status provided they follow all of the conditions for exemption established in § 262.34. Section 262.34 can be difficult to navigate because the SQG and LQG conditions for exemption are intertwined and there are many references to sections in 40 CFR part 265. Therefore the Agency is proposing to break § 262.34 into three new sections at §§ 262.15, 262.16 and 262.17. Section 262.15 would establish the conditions for exemption for SQGs and LQGs who wish to operate an SAA, § 262.16 would establish conditions for exemption for SQGs, and § 262.17 would establish the conditions for exemption for LQGs.
Many generators use an SAA at their sites. These areas allow generators to accumulate hazardous waste near the point of generation, which provides for
Additionally, the Agency is proposing to duplicate §§ 265.171, 265.172 and 265.173(a) (which are currently referenced from § 262.34(c)(1)(i)) into § 262.15 in order to eliminate cross-referencing and improve the user friendliness of the regulations. Table 5—Crosswalk of Existing Citations to Proposed Citations for SAAs provides a summary of the crosswalk between existing and proposed regulations for SAAs.
As previously mentioned, the Agency is proposing to create 40 CFR 262.16 titled, “Conditions for exemption for a small quantity generator that accumulates hazardous waste.” This reorganization would move § 262.34(d) through (f) and (m) into § 262.16. Specifically, the Agency proposes to move the bulk of § 262.34(d) to § 262.16(b),
Table 6—Crosswalk of Existing Citations to Proposed Citations for SQGs provides a summary of changes between the existing and proposed citations for SQGs.
As previously mentioned the Agency is proposing to create 40 CFR 262.17 titled, “Conditions for exemption for a large quantity generator that accumulates hazardous waste.” The Agency is proposing to move § 262.34(a), (b), (g) through (i) and (m) into § 262.17. Specifically, the Agency is proposing to move § 262.34(a) to § 262.17(a), move § 262.34(b) to § 262.17(b), move § 262.34(g) to § 262.17(c), move § 262.34(h) to § 262.17(d), move § 262.34(i) to § 262.17(e), and move § 262.34(m) to § 262.16(g). EPA is additionally proposing to delete paragraphs (j) through (l), which deal with Performance Track, since the program is no longer in operation.
Section 262.35 would also include the landfill ban for liquids that applies to SQGs and LQGs. EPA requests comment on the proposed changes.
d.
Table 7—Crosswalk of Existing Citations to Proposed Citations for LQGs provides a summary of changes between the existing and proposed citations for LQGs.
EPA requests comment on the proposed reorganization to the hazardous waste generator regulations and, in particular, on whether the proposed changes would improve the user friendliness and utility of the regulations.
In the interest in keeping the generator regulations in a logical order, EPA is proposing to move existing § 262.12—EPA identification number—to § 262.18. Section 262.12 would then be reserved. EPA believes this will improve the flow of the hazardous waste generator regulations as it places the section addressing EPA identification number after § 262.13, which addresses how a generator determines its generator category. This proposed sequence is appropriate because a hazardous waste generator must first determine what generator category it belongs to in order to determine which regulations—including the requirement to obtain an EPA ID number—it must comply with. (For example, SQGs and LQGs must obtain an EPA identification number, but a CESQG does not).
EPA is requesting comment on these proposed changes.
The Agency is also proposing a number of technical corrections and conforming changes to the hazardous waste generator regulations. This proposed rule eliminates the regulatory text for discontinued programs, identifies areas where conforming changes are necessary, updates existing regulatory text to account for new programs, improves the readability of certain paragraphs, and corrects typographical errors. Specifically, the Agency is proposing the following changes, in order of the existing regulations:
(1) Revise § 260.3, which currently reads, “As used in parts 260 through 265 and 268 of this chapter.” This text fails to account for additional parts of the regulations that were promulgated after 1986, such as parts 266, 267, and 270 through 273. The Agency is proposing to revise this to read, “As used in parts 260 through 273 of this chapter.”
(2) Modify the definitions of “Treatability Study,” “Universal Waste Handler,” “Universal Waste Transporter” in § 260.10 to only capitalize the first word (
(3) Remove the closed parenthesis after “(
(4) Improve the readability of § 261.4(a)(7), which currently reads, “Spent sulfuric acid used to produce virgin sulfuric acid, unless it is accumulated speculatively as defined in § 261.1(c) of this chapter.” The Agency is proposing to revise the language to read “Spent sulfuric acid used to produce virgin sulfuric acid provided it is not accumulated speculatively as defined in § 261.1(c) of this chapter.”
(5) Make conforming changes to citations that reference § 261.5 to reflect EPA's proposal to move these regulations. The citations where references to § 261.5 are to be revised include all the following: §§ 262.10(b), 262.10(l)(2), 262.201(b), 262.204(a), 262.210(b)(3), 262.210(d)(2), 262.211(e)(3), 262.213(a)(2), 262.213(a)(3), 262.213(b)(2), 262.216(b), 264.1(g)(1), 268.1(e)(1), 270.1(c)(2)(iii), and 279.10(b)(3). In § 261.33(e) and (f), EPA is proposing to altogether remove the references to §§ 261.5(e) and 261.5(a) and (g), respectively, because the quantity limits for hazardous wastes are contained in EPA's proposed definitions for very small quantity generator, small quantity generator, and large quantity generator.
(6) Replace the word “waste” with “water” in § 261.5(e)(2), which reads, “A total of 100 kg of any residue or contaminated soil, waste, or other debris resulting from the clean-up of a spill, into or on any land or water. . . .” Prior to 1985, the word “waste” was “water” and the Agency is unable to determine why this change occurred. (In the proposed reorganization, this language is moved to § 260.10 and is contained in the definitions of large quantity generator, small quantity generator and very small quantity generator.)
(7) Revise § 261.420 to clarify that the requirement in § 261.411(c) that all employees be familiar with proper waste handling and emergency procedures relevant to their responsibilities applies to facilities that generate or accumulate more than 6,000 kg of hazardous materials as well as to facilities that generate or accumulate less than that amount.
(8) Remove Notes 1 and 2 from § 262.10. Note 1 states that the provisions of § 262.34 are applicable to the on-site accumulation of hazardous waste by generators. Therefore, the provisions of § 262.34 only apply to owners or operators who are shipping hazardous waste which they generated at that facility. Note 2 states that a generator who treats, stores, or disposes of hazardous waste on site must comply with the applicable standards and permit requirements set forth in 40 CFR parts 264, 265, 266, 268, and 270. These notes are no longer necessary should EPA finalize the changes in this proposed rule, which include replacing § 262.34 with a new reorganization of the regulations that address Note 1and proposing regulations in § 262.10 that address Note 2.
(9) Remove the extra period in the last line of the paragraph at § 262.10(l).
(10) Make conforming changes to sections that reference § 262.34 to reflect EPA's proposal to move these regulations. The citations where references to § 262.34 are to be revised include the following: §§ 262.10(l)(1), 262.201(a), 262.201(a), 262.216(a), 264.1(g)(3), 264.71(c), 264.1030(b)(2), 264.1050(b)(2), 265.1(c)(7), 265.71(c), 265.1030(b)(2) and (b)(3), 268.7(a)(5) and 270.1(c)(2)(i).
(11) Make conforming change to remove and reserve § 262.40(c) because this section (regarding records for waste determinations) is proposed to move to § 262.11.
(12) Correct the statutory citation at § 262.43 that currently refers to sections 2002(a) and 3002(6) of the Act. The reference to 3002(6) should be to 3002(a)(6). Additionally, the word “he” is removed in order to be gender neutral.
(13) Remove references to Project XL programs that have been discontinued. These include the New York State Public Utilities Project XL program at subpart I of 40 CFR part 262 and the University Laboratories Project XL program at subpart J of 40 CFR part 262. We have also removed and reserved the reference at § 262.10(j) to the University Laboratories Project XL.
(14) Make two conforming changes to the definition of “central accumulation area” in § 262.200 in subpart K. We are proposing to move this definition from this location to § 260.10 with the following revisions. First, because of the reorganization of the regulations in 40 CFR part 262, we are proposing to change the references to the applicable regulations for the central accumulation areas that are used in the definition of central accumulation area in § 262.200. For LQGs, we are proposing that the reference to § 262.34(a) be changed to § 262.17 and for SQGs, we are proposing that the reference to § 262.34(d) through (f) be changed to § 262.16. Second, we are proposing to remove the reference to Performance Track in the definition of “central accumulation area” in § 262.200 of subpart K because the Performance Track program has been terminated (74 FR 22741; May 14, 2009). Both of these conforming changes are reflected in the proposed definition of “central accumulation area” being added in § 260.10.
(15) Make conforming changes to citations that use the term “conditionally exempt small quantity generator” to reflect EPA's proposed change to the term “very small quantity generator.” The citations where “conditionally exempt small quantity generator” is to be replaced with “very small quantity generator” include: §§ 262.200, 262.201(b), 262.202(b), 262.203(a), 262.203(b)(2), 262.204(a), 262.209(b), 262.210(d)(2), 262.213(a)(3), 268.1(e)(1), 270.1(c)(2)(iii), 273.8, 273.8(a)(2), 273.81(b), 279.10(b)(3).
(16) Improve the readability of § 264.170, which currently reads, “The regulations in this subpart apply to owners and operators of all hazardous waste facilities that store containers of hazardous waste. . . .” The Agency is proposing to revise this language to read, “The regulations in this subpart apply to owners and operators of all hazardous waste facilities that store hazardous waste in containers. . . .”
(17) Improve the readability of the first sentence in § 264.191(a), which currently reads, “For each existing tank system. . . . the owner or operator must determine that the tank system is not leaking or is unfit for use.” The Agency is proposing to revise this language to read, “For each existing tank system . . . the owner or operator must determine that the tank system is not leaking or is fit for use.”
(18) Improve the readability of § 265.1(c)(7), which currently reads, “A generator accumulating waste on-site in compliance with § 262.34 of this chapter, except to the extent the requirements are included in § 262.34 of this chapter.” The Agency is proposing to revise the sentence to read, “A generator accumulating waste on site except to the extent the requirements are included in §§ 262.16, and 262.17 of this chapter.”
(19) Correct the list of
(20) Add to § 265.111(c) a missing regulatory citation to § 265.445 applicable to drip pads. Section 265.111(c) would then read, “Complies with the closure requirements of this subpart, including, but not limited to, the requirements of §§ 265.197, 265.228, 265.258, 265.280, 265.310, 265.351, 265.381, 265.404, 265.445, and 265.1102.”
(21) Add to § 265.114 a missing regulatory citation to § 265.445 applicable to drip pads and § 265.1102 applicable to containment buildings. Section 265.114 would then read, “During the partial and final closure periods, all contaminated equipment, structures and soil must be properly disposed of, or decontaminated unless specified otherwise in §§ 265.197, 265.228, 265.445, 265.258, 265.280, 265.310 or 265.1102. . . .”
(22) Make a conforming change to remove and reserve § 265.201 (Special requirements for generators of between 100 and 1,000 kg/mo that accumulate hazardous waste in tanks). EPA is proposing to move this section into proposed § 262.16.
(23) Add a missing reference to 40 CFR part 268 in § 270.1(a)(3), which currently reads, “The RCRA permit program. . . . in 40 CFR parts 264, 266, and 267.” Therefore, the Agency is revising this to read, “The RCRA permit program . . . in 40 CFR parts 264, 266, 267, and 268.”
As part of this proposed rule, the Agency is also exploring the feasibility of using electronic tools to streamline hazardous waste reporting and recordkeeping requirements. Two examples previously discussed include requesting comment on an electronic hazardous waste determination decision tool and development of an electronic application containing information from the executive summaries of contingency plans that emergency responders can use in responding to an emergency.
Information technology can be an important step toward improving RCRA implementation. Many aspects of our lives can currently be managed electronically. We bank from home, send pictures from phones, and track packages across the country from our desks. Yet, much of the information reported to EPA and states by generators is still submitted on paper, which requires government staff or contractors to manually enter the data into federal and state data systems. Delays in data processing can cause important information to go unnoticed. In addition, errors introduced through manual data entry can require aggravating and time-consuming correction processes by both regulated entities and the government.
Use of electronic tools can provide the regulated community, regulators, and the public with more accurate, complete, and timely information on regulated activities, pollution, and compliance. Software that allows for self-correction by flagging potential errors, as is done by EPA's Toxics Release Inventory—Made Easy web tool or the Greenhouse Gas Reporting system, can even help prevent mistakes before they happen, saving both regulated entities and regulators time and money. Electronic reporting also creates greater transparency as greater information accessibility can inspire better compliance by facilities.
Electronic reporting, in this context, is not simply emailing files to the government. Rather, it would be a system that begins with an electronic “smart” form or web tool to guide the regulated entity thru recordkeeping and reporting processes, such as waste determinations. The system would also include data standards, identity proofing, and a government database to receive data. Error prevention and compliance assistance could be integrated into the reporting tool. For example, forms can be configured to self-populate with data from prior forms (
The Agency believes electronic tools have the potential to greatly assist generators in complying with the existing and proposed hazardous waste regulations. For example, EPA believes that electronic tools could help generators make more accurate hazardous waste determinations. As previously discussed, an app could be used as a decision support tool to help guide generators through the hazardous waste determination process for each waste stream they generate. This tool could walk generators through a series of question and answer steps, identify relevant sources in making the determination, electronically generate and store all of the associated data and records that generators may be required to maintain, and provide assistance on proper management of the identified wastes.
Other examples include using electronic tools to file notifications required under the rule, such as notifications for episodic generators, for LQGs that desire to take advantage of consolidating waste from CESQGs that are within the same company, and for generators that close a unit that accumulated hazardous waste. In this case, the electronic tools could be useful in submitting required reports, and in electronically generating, storing, and filing all reports.
Other areas of the RCRA regulations where electronic tools may assist with compliance include the following:
EPA believes the use of electronic tools would help hazardous waste generators improve and maintain compliance with the RCRA regulations, thereby reducing violations and increasing environmental benefits. EPA also believes the costs of receiving and evaluating reports from generators could be greatly reduced for EPA and state/tribal agencies. For example, when the Toxics Release inventory switched from paper reporting to e-reporting, costs of managing the data went down by 99% and accuracy was increased.
EPA is not aware of any existing electronic tools that would specifically assist generators with meeting the RCRA regulatory requirements. However, EPA did identify a variety of state and academic internet-based hazardous waste determination tools and workbooks (as discussed in section VIII.B.8.).
EPA is considering a range of electronic reporting options. The Agency may explore developing certain tools for use by the regulated community or may invite third-party vendors to provide such tools. The latter option could be similar to the Internal Revenue Service (IRS) model for electronic tax preparation. The IRS model uses third-party software providers for tax data collection and transmission (
EPA welcomes public comment on specific reports and data types that could be reported electronically if the Agency were to move forward with exploring electronic reporting, including what the quality assurance and quality control procedures should be with respect to data timeliness, accuracy, completeness, and consistency. EPA also asks for comment on which reports commenters think should be highest priority for electronic reporting. EPA solicits comment on the option of allowing software vendors to offer their clients federal electronic reporting services compliant with the final rule and on potential methods for determining whether third-party software vendors meet the minimum federal electronic data requirements. EPA would need to certify or approve the methods used by the software to authenticate, encrypt, and possibly send compliance monitoring and other data. EPA would also like to hear from authorized RCRA programs that have experience in implementing electronic reporting, especially their experience with phasing in implementation. EPA also requests comment on whether electronic tools should be provided by EPA and/or states and tribes.
Persons that generate hazardous waste must comply with all the applicable independent requirements of the RCRA hazardous waste regulations, unless they obtain a conditional exemption from those requirements, provided by § 262.14 (formerly § 261.5), or by § 262.15, 262.16, or 262.17 (formerly all contained in § 262.34), or by § 262.70. If a person violates independent requirements or fails conditions for exemption, EPA may bring an enforcement action under section 3008 of RCRA for violations of the independent requirements. Where a generator does not comply with conditions for an exemption and is therefore no longer exempt, the enforcement action will allege violations of those independent requirements from which the generator was attempting to remain exempt. States may choose to enforce against violations of state hazardous waste requirements under state authorities.
As with any violation, EPA and authorized states have enforcement mechanisms available that range in severity. In addition, EPA and authorized states have flexibility in applying these mechanisms to the various responsible parties as appropriate to the specific circumstances. Some of the enforcement mechanisms include sending a notice of violation, ordering compliance, ordering that the operations cease, or assessing penalties as appropriate. Nothing in this proposal affects any of these enforcement mechanisms EPA or the states may utilize nor the manner in which enforcement cases will be initiated or pursued.
Under section 3006 of RCRA, EPA may authorize states to administer the
Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a state with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the federal program in that state. EPA did not issue permits for any facilities in that state, since the state was now authorized to issue RCRA permits. When new, more stringent federal requirements were promulgated, the state was obligated to enact equivalent authorities within specified time frames. However, the new requirements did not take effect in an authorized state until the state adopted the equivalent state requirements.
In contrast, under RCRA section 3006(g) (42 U.S.C. 6926(g)), which was added by HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized states at the same time that they take effect in unauthorized states. While states must still adopt HSWA related provisions as state law to retain authorization, EPA implements the HSWA provisions in authorized states, including the issuance of any permits pertaining to HSWA requirements, until the state is granted authorization to do so.
Authorized states are required to modify their programs only when EPA promulgates federal requirements that are more stringent or broader in scope than existing federal requirements.
This notice proposes regulations that amend certain sections of the hazardous waste generator regulations in 40 CFR parts 260 through 265, 268, 270, 273, and 279. These regulations were promulgated under the authority of sections 2002, 3001, 3002, 3003, 3004, 3007, and 3010 of RCRA). This notice proposes changes to the RCRA Subtitle C program under non-HSWA authority.
Thus, the standards, if finalized, would be applicable on the effective date only in those states that do not have final authorization of their base RCRA programs. Moreover, authorized states are required to modify their programs only when EPA promulgates federal regulations that are more stringent or broader in scope than the authorized state regulations. For those changes that are less stringent, states are not required to modify their programs. This is a result of section 3009 of RCRA, which allows states to impose more stringent regulations than the federal program.
Several of the revisions to the proposed hazardous waste generator regulations are more stringent than those promulgated in various rules that went into effect when the RCRA hazardous waste Regulations were first initiated (
On the other hand, three of the proposed revisions would be considered less stringent than the current hazardous waste regulations. These revisions include the following: (1) Allowing CESQGs to voluntarily send hazardous waste to LQGs under the control of the same person to facilitate the cost-effective management of hazardous wastes within the same company (section VII.C of this preamble); (2) allowing CESQGs and SQGs to voluntarily maintain their existing regulatory status if they have an episodic event that generates additional amounts of hazardous waste which would have resulted in them moving into a higher generator category for a short period of time, so long as they comply with specified conditions (section IX of this preamble); and (3) allowing LQGs to voluntarily apply for a waiver from their local fire department to accumulate ignitable and reactive wastes within the 50 foot facility boundary provision (section XI.B of this preamble). Thus, authorized states may, but would not be required to, adopt these changes.
This proposed rule also includes several revisions that are neither more nor less stringent, such as (1) mixing a non-hazardous waste with a hazardous waste (section VII.B of this preamble); (2) defining central accumulation area (section VI.C of this preamble); (3) prohibiting generators from sending hazardous liquids to landfills (section VIII.M of this preamble); (4) reorganizing the hazardous waste generator regulations to make them more user-friendly (section XIII of this preamble); (5) deleting the performance track regulations (section VIII.K of this preamble); (6) replacing the list of specific data elements with a requirement to complete and submit all data elements required in the biennial report form (section VIII.L of this preamble); and (7) technical corrections and conforming changes to various parts of the RCRA regulations (section XIV of this preamble). Thus, authorized states may, but would not be required to, adopt these changes.
Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is a “significant regulatory action” in that it may raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action.
In addition, EPA prepared an analysis of the potential costs and benefits associated with this action. This analysis is contained in EPA's Regulatory Impact Analysis (RIA) document titled “Assessment of the Potential Costs, Benefits, and other Impacts of the Improvements to the Hazardous Waste Generator Regulatory Program, As Proposed.” A copy of the analysis is available in the docket for this action and the analysis is briefly summarized here.
Based on the impact estimates presented in the RIA, EPA does not expect that this action will be “economically significant” because the estimated annualized cost for compliance with the proposed changes to the hazardous waste generator regulatory program is significantly less than the $100 million annual effect threshold of Section 3(f)(1) of Executive Order 12866. The RIA estimates the affected universe is between 353,000 and 543,000 entities. Of this universe, between 293,000 and 469,000 CESQGs will only be affected if they choose to take advantage of two voluntary programs being proposed.
EPA estimates the future annualized cost to industry to comply with the requirements of this proposed action at between $6.2 and $17.4 million (at 7% discount rate). Similarly, the annualized net cost savings or benefits for facilities opting to take advantage of two voluntary programs in the rule (
In addition to estimating the cost for this proposed rule, the RIA also provides both quantitative and qualitative (
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2513.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
This proposed rule is necessary for EPA and authorized states to oversee the generation and management of hazardous waste. EPA is proposing the establishment of these information collection requirements under the authority of RCRA Subtitle C. There are several provisions to this rule that will require respondents to either submit information to EPA or authorized state, or maintain records at their facility. For example, generators will have to notify EPA or their authorized state they plan to take advantage of two voluntary provisions that will provide greater flexibility in how they manage hazardous waste (
Similarly, SQGs will have to re-notify EPA or their authorized state every other year that they have not changed their regulatory category to support effective inspections and program management activities. In an effort to improve program compliance, both SQGs and LQGs will be required to maintain records supporting the basis for their non-hazardous waste determinations (
EPA and state agencies will use the collected information to ensure that hazardous wastes are managed in a cost-effective manner that minimizes risks to human health and the environment. Local emergency response organizations will also use the collected information to prepare contingency plans to reduce risks to emergency responders and bystanders. EPA does not expect confidentiality to be an issue in generators either providing information to EPA or an authorized state or in maintaining the necessary records supporting a non-hazardous waste determination. The statutory authority to collect the proposed information is found at RCRA 3002 (42 U.S.C. 6922) and RCRA 3003 (42 U.S.C. 6923).
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
Submit your comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden to the EPA using the docket identified at the beginning of this rule. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
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 directly regulated by this proposed rule include entities that generate hazardous waste across various industries, including, but not limited to, printing, petroleum refining, chemical manufacturing, plastics and resin manufacturing, pharmaceutical manufacturing, paint and coating, iron and steel mills, metal and metal product manufacturing, electroplating, printed circuit board manufacturing, semiconductor manufacturing, motor
Although this proposed rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. Many of the changes in this proposed rulemaking come from outreach efforts to generators of hazardous waste, including small entities, and are designed to make the generator regulations more accessible and user friendly. As part of the proposal, EPA is including several provisions that would provide increased flexibility for small entities in managing hazardous waste, such as the ability for hazardous waste generators to use the episodic generator provisions if they have a distinct event that would otherwise cause them to have to bump up to a higher generator category. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
This proposed rule does not contain an unfunded mandate of $100 million as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The RIA estimates that the state government share of future average annualized direct costs for the proposed rule requirements to range between $1.2 million and $2.3 million per year. Thus, this proposed rule is not subject to the requirements of sections 202 or 205 of UMRA.
This proposed rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. The rulemaking proposes clarifications and modifications to the hazardous waste generator regulations, which impacts only those entities that generate hazardous waste. Small governments would only be subject to the changes in the proposed rule if they generated hazardous waste subject to the RCRA hazardous waste requirements.
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, as specified in Executive Order 13132. The proposed rule simply proposes clarifications and modifications to the existing hazardous waste generator regulations. Thus, Executive Order 13132 does not apply to this action. Although section 6 of Executive Order 13132 does not apply to this action, EPA did consult with state officials in developing this action.
This action may have tribal implications. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt tribal law. Under the RCRA statute, the federal government implements hazardous waste regulations directly in Indian Country. Thus, the proposed changes to the hazardous waste regulations would not impose any direct costs on tribal governments.
The EPA consulted with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation is provided in the docket for this action.
As required by section 7(a), the EPA's Tribal Consultation Official has certified that the requirements of the executive order have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The Agency does not believe that this action presents risks to the public. In fact, there are several components to this proposed rule that modify the existing hazardous waste generator regulations to enhance environmental protection in the local community. Examples include (1) requiring LQGs and SQGs to document and maintain records of their waste determinations, including determinations that a solid waste is a non-hazardous waste; (2) requiring LQGs and SQGs to provide more detailed marking and labeling information for containers, tanks, drip pads, and containment buildings accumulating hazardous wastes; (3) requiring LQGs to notify EPA or an authorized state when they plan to close either a hazardous waste accumulation unit or their site; (4) requiring LQGs and SQGs to re-notify EPA or the authorized state on a periodic basis of their hazardous waste generator activities; and (5) improving emergency preparedness and response regulations on the part of SQGs and LQGs.
This action is not a “significant energy action” as defined in Executive Order 13211 (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy. This proposed rule does not involve the supply, distribution, or use of energy.
This rulemaking does not involve technical standards.
Executive Order 12898 (59 FR 7629 (February 16, 1994)) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States.
EPA has determined that this proposed rule increases the level of environmental protection for all affected populations and thus will not have disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. Specifically, there are several components to this proposed rule that modify the existing hazardous waste generator regulations to assist generators in understanding and facilitating improved compliance with the hazardous waste regulations. Examples include modifying regulations regarding mixing of non-hazardous waste with a hazardous waste by a
Still other components of this proposed rule enhance environmental protection in the local community, and therefore foster improved environmental protection, including for minority populations and low-income populations. They include, for example, (1) requiring LQGs and SQGs to document and maintain records of their waste determinations, including determinations that a solid waste is a non-hazardous waste; (2) requiring LQGs and SQGs to provide more detailed marking and labeling information for containers, tanks, drip pads, and containment buildings accumulating hazardous wastes; (3) requiring LQGs to notify EPA or an authorized state when they plan to close either a hazardous waste unit or their site; (4) requiring LQGs and SQGs to re-notify EPA or the authorized state on a periodic basis of their hazardous waste generator activities; and (5) improving emergency preparedness and response regulations on the part of SQGs and LQGs.
Furthermore, EPA is also proposing to allow CESQGs to ship their hazardous waste to an LQG under the control of the same person. As described in section VII.C of the preamble, this may increase environmental protection in the local community because hazardous waste generated by CESQGs would be subject to more stringent requirements upon receipt by the LQG, including ultimate management by a RCRA permitted TSDF (as opposed to being managed possibly in a municipal solid waste landfill). Although this proposed change could result in an increase in traffic for certain communities, EPA believes the increase would not be significant given that CESQGs currently may send their hazardous waste to a number of destinations, including municipal and non-municipal solid waste management facilities.
Lastly, EPA is proposing alternative standards for CESQGs and SQGs that would allow these entities to maintain their generator category if generating hazardous waste from an episodic event. Although these generators would be allowed to temporarily manage a greater amount of hazardous waste than their normal generator category allows, EPA is proposing conditions under which the hazardous waste generated from an episodic event must be managed in order to maintain protection of human health and the environment. Therefore, EPA does not anticipate disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations from these proposed alternative standards.
Environmental protection, Administrative practice and procedure, Confidential business information, Incorporation by reference, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Environmental protection, Exports, Hazardous materials transportation, Hazardous waste, Imports, Incorporation by reference, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Air pollution control, Hazardous waste, Insurance, Packaging and containers, Reporting and recordkeeping requirements, Security measures, Surety bonds.
Environmental protection, Air pollution control, Hazardous waste, Insurance, Packaging and containers, Reporting and recordkeeping requirements, Security measures, Surety bonds, Water supply.
Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous materials transportation, Hazardous waste, Reporting and recordkeeping requirements, Water pollution control, Water supply.
Environmental protection, Hazardous materials transportation, Hazardous waste.
Environmental protection, Petroleum, Recycling, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, title 40, chapter I of the Code of Federal Regulations is proposed to be amended as follows:
42 U.S.C. 6905, 6912(a), 6921-6927, 6930, 6934, 6935, 6937, 6938, 6939, and 6974.
As used in parts 260 through 273 of this chapter:
The revisions and additions read as follows:
(1) Greater than or equal to 1000 kilograms (2200 lbs) of non-acute hazardous waste;
(2) Greater than 1 kilogram (2.2 lbs) of acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter; or
(3) Greater than 100 kilograms (220 lbs) of any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter.
(1) Greater than 100 kilograms (220 lbs) but less than 1000 kilograms (2200 lbs) of non-acute hazardous waste;
(2) Less than or equal to 1 kilogram (2.2 lbs) of acute hazardous waste listed in §§ 261.31 or § 261.33(e) of this chapter; and
(3) Less than or equal to 100 kilograms (220 lbs) of any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter.
(1) 100 kilograms (220 lbs) of non-acute hazardous waste; and
(2) 1 kilogram (2.2 lbs) of acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter; and
(3) 100 kilograms (220 lbs) of any residue or contaminated soil, water, or other debris resulting from the cleanup of a spill, into or on any land or water, of any acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter.
(d) * * *
(1) “Flammable and Combustible Liquids Code” (1977 or 1981), IBR approved for §§ 262.16, 264.198, 265.198, 267.202(b).
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y), and 6938.
(a) * * *
(7) Spent sulfuric acid used to produce virgin sulfuric acid provided it is not accumulated speculatively as defined in § 261.1(c) of this chapter.
(c) * * *
(2) * * *
(iv) Section 265.75 of this chapter (biennial reporting requirements).
(e) The commercial chemical products, manufacturing chemical intermediates or off-specification commercial chemical products or manufacturing chemical intermediates referred to in paragraphs (a) through (d) of this section, are identified as acute hazardous wastes (H).
(f) The commercial chemical products, manufacturing chemical intermediates, or off-specification commercial chemical products referred to in paragraphs (a) through (d) of this section, are identified as toxic wastes (T).
(g)
42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.
As used in this part:
The revisions and additions read as follows:
(a) The regulations in this part establish standards for generators of hazardous waste as defined by 40 CFR 260.10.
(1) A person who generates a hazardous waste as defined by 40 CFR part 261 is subject to all the applicable independent requirements in the subparts and sections listed below, unless the person is a very small quantity generator that meets the conditions for exemption in § 262.14.
(i)
(B) Section 262.13 Generator category determination;
(C) Section 262.18 EPA identification numbers and re-notification for large quantity generators and small quantity generators;
(D) Part 262 subpart B—The manifest;
(E) Part 262 subpart C—Pre-transport requirements;
(F) Section 262.40 Recordkeeping;
(G) Section 262.44 Special independent requirements for small quantity generators;
(H) Part 262 subpart E-subpart F—Imports and exports of hazardous waste;
(I) Part 262 subpart G—Farmers; and
(J) Part 262 subpart H—Transfrontier shipments of hazardous waste for recovery within the OECD.
(ii)
(B) Section 262.13 Generator category determination;
(C) Section 262.18 EPA identification numbers and re-notification for large quantity generators and small quantity generators;
(D) Part 262 subpart B—The manifest;
(E) Part 262 subpart C—Pre-transport requirements;
(F) Part 262 subpart D—Recordkeeping and reporting, except § 262.44;
(G) Part 262 subpart E-subpart F— Imports and exports of hazardous waste;
(H) Part 262 subpart G—Farmers; and
(I) Part 262 subpart H—Transfrontier shipments of hazardous waste for recovery within the OECD.
(2) A generator that accumulates hazardous waste on site is a facility that stores hazardous waste and is subject to the applicable requirements of parts 124, 263 through 270, and section 3010 of RCRA, unless it is one of the following:
(i) A very small quantity generator that meets the conditions for exemption in § 262.14;
(ii) A small quantity generator that meets the conditions for exemption in §§ 262.15 and 262.16; or
(iii) A large quantity generator that meets the conditions for exemption in §§ 262.15 and 262.17.
(3) A generator shall not transport, offer its waste for transport, or otherwise cause its waste to be sent to a facility that is not a designated facility, as defined in § 260.10, or not otherwise authorized to receive the generator's waste.
(b)
(g)(1) A generator's violation of an applicable requirement in 40 CFR part 124, 262 through 268, or 270, or of applicable notification requirements of section 3010 of RCRA, is subject to penalty and injunctive relief under section 3008 of RCRA.
(2) A generator's noncompliance with a condition for exemption in this part is not subject to penalty or injunctive relief under section 3008 of RCRA as a violation of a 40 CFR part 262 condition for exemption. Noncompliance with a condition for exemption in this part results in failure to obtain, or to maintain, such exemption. Failure to obtain or maintain the exemption results in a violation of one or more applicable independent requirements in 40 CFR part 124, 262 through 268, or 270, or of the notification requirements of section 3010 of RCRA. A generator's violation of an independent requirement is subject to penalty and injunctive relief under section 3008 of RCRA.
(l) The laboratories owned by an eligible academic entity that chooses to be subject to the requirements of subpart K of this part are not subject to (for purposes of this paragraph, the terms “laboratory” and “eligible academic entity” shall have the meaning as defined in § 262.200 of subpart K of this part):
(1) The independent requirements of § 262.11 or the regulations in § 262.15 for large quantity generators and small quantity generators, except as provided in subpart K, and
(2) The conditions of § 262.14, for very small quantity generators, except as provided in subpart K.
A person who generates a solid waste, as defined in 40 CFR 261.2, must make an accurate determination of whether that waste is a hazardous waste using the following steps:
(a) A hazardous waste determination for each solid waste must be made at the point of waste generation, before any dilution, mixing, or other alteration of the waste occurs, and at any time in the course of its management that it has, or may have, changed its properties as a result of exposure to the environment or other factors that may change the properties of the waste.
(b) A person must determine if the solid waste is excluded from regulation under 40 CFR 261.4.
(c) If the waste is not excluded under 40 CFR 261.4, the person must then use knowledge of the waste to determine if the waste meets any of the listing descriptions under subpart D of 40 CFR part 261. Acceptable knowledge that may be used in making an accurate determination as to whether the waste is listed includes, but is not limited to, waste origin, composition, the process producing the waste, feedstock, and other relevant information. If the waste is listed, the person may file a delisting petition under 40 CFR 260.20 and 260.22 to demonstrate to the Administrator that the waste from this particular site or operation is not a hazardous waste.
(d) If the waste is not listed in subpart D of 40 CFR part 261 or if it is a listed waste, which must meet the land disposal restrictions under 40 CFR part 268, the person then must also determine whether the waste exhibits one or more hazardous characteristics as identified in subpart C of 40 CFR part 261 by following the procedures in either paragraph (d)(1) or (2) of this section.
(1) The person must test the waste according to the methods set forth in subpart C of 40 CFR part 261 or according to an equivalent method approved by the Administrator under 40 CFR 260.21 and in accordance with the following:
(i) Persons testing their waste must obtain a representative sample of the waste for the testing, as defined at 40 CFR 260.10.
(ii) Where a test method is specified in the regulation, the results of the regulatory test, when properly performed, are definitive for determining the regulatory status of the waste.
(2) The person must apply knowledge of the hazard characteristic of the waste in light of the materials or the processes
(e)
(f) If the waste is determined to be hazardous, all applicable EPA hazardous waste numbers (EPA hazardous waste codes) in subparts C and D of part 261 must be identified.
(g) If the waste is determined to be hazardous, the generator must refer to parts 261, 264, 265, 266, 267, 268, and 273 of this chapter for other possible exclusions or restrictions pertaining to management of the specific waste.
(a)
(b)
(1) Counting separately the total amount of acute hazardous waste and the total amount of non-acute hazardous waste generated in the calendar month;
(2) Subtracting from each total any amounts of waste exempt from counting as described in paragraphs (c) and (d) of this section;
(3) Determining separately the resulting generator categories for the quantities of acute and non-acute hazardous waste generated; and
(4) Comparing the resulting generator categories from paragraph (b)(3) of this section and applying the more stringent generator category to the accumulation and management of both non-acute hazardous waste and acute hazardous waste generated for that month.
(c) When making the monthly quantity-based determinations required by this part, the generator must include all hazardous waste that it generates, except hazardous waste that:
(1) Is exempt from regulation under 40 CFR 261.4(c) through (f), 261.6(a)(3), 261.7(a)(1), or 261.8;
(2) Is managed immediately upon generation only in on-site elementary neutralization units, wastewater treatment units, or totally enclosed treatment facilities as defined in 40 CFR 260.10;
(3) Is recycled, without prior storage or accumulation, only in an on-site process subject to regulation under 40 CFR 261.6(c)(2);
(4) Is used oil managed under the requirements of 40 CFR 261.6(a)(4) and 40 CFR part 279;
(5) Is spent lead-acid batteries managed under the requirements of 40 CFR part 266 subpart G;
(6) Is universal waste managed under 40 CFR 261.9 and 40 CFR part 273;
(7) Is a hazardous waste that is an unused commercial chemical product (listed in 40 CFR part 261 subpart D or exhibiting one or more characteristics in 40 CFR part 261 subpart C) that is generated solely as a result of a laboratory clean-out conducted at an eligible academic entity pursuant to § 262.213. For purposes of this provision, the term eligible academic entity shall have the meaning as defined in § 262.200; or
(8) Is managed under an episodic event in compliance with the conditions of subpart L of this part.
(d) In determining the quantity of hazardous waste generated in a calendar month, a generator need not include:
(1) Hazardous waste when it is removed from on-site accumulation; or
(2) Hazardous waste generated by on-site treatment (including reclamation) of the generator's hazardous waste, so long as the hazardous waste that is treated was previously counted once; or
(3) Spent materials that are generated, reclaimed, and subsequently reused on site, so long as such spent materials have been previously counted once.
(a) Hazardous waste generated by a very small quantity generator is not subject to the independent requirements of this part, except the paragraphs of § 262.11 specified below or the requirements of parts 124, 264 through 268, and 270 of this chapter, and the notification requirements of section 3010 of RCRA. A very small quantity generator may accumulate hazardous waste on site without a permit or interim status, and without complying with all the independent requirements of the above-mentioned parts and the notification requirements of section 3010, provided that it meets all the conditions for exemption listed in this section:
(1) In a calendar month the very small quantity generator generates less than or equal to the amounts specified in the definition of “very small quantity generator” in § 260.10 of this chapter;
(2) The very small quantity generator complies with § 262.11(a) through (d) of this chapter;
(3)
(ii)
(4) A very small quantity generator that accumulates hazardous waste within the limits in paragraphs (a)(3)(i) and (ii) of this section must either treat or dispose of its hazardous waste in an on-site facility or ensure delivery to an off-site treatment, storage, or disposal facility, either of which, if located in the U.S., is:
(i) Permitted under part 270 of this chapter;
(ii) In interim status under parts 270 and 265 of this chapter;
(iii) Authorized to manage hazardous waste by a State with a hazardous waste management program approved under part 271 of this chapter;
(iv) Permitted, licensed, or registered by a state to manage municipal solid waste and, if managed in a municipal solid waste landfill is subject to part 258 of this chapter;
(v) Permitted, licensed, or registered by a state to manage non-municipal non-hazardous waste and, if managed in a non-municipal non-hazardous waste disposal unit, is subject to the requirements in §§ 257.5 through 257.30 of this chapter;
(vi) A facility which:
(A) Beneficially uses or reuses, or legitimately recycles or reclaims its waste; or
(B) Treats its waste prior to beneficial use or reuse, or legitimate recycling or reclamation;
(vii) For universal waste managed under part 273 of this chapter, a universal waste handler or destination facility subject to the requirements of part 273 of this chapter;
(viii) A large quantity generator under the control of the same person as the very small quantity generator, provided the following conditions are met:
(A) The very small quantity generator and the large quantity generator are under the control of the same person as defined in § 260.10 of this chapter. “Control,” for the purposes of this section, means the power to direct the policies of the generator site, whether by the ownership of stock, voting rights, or otherwise, except that contractors who operate generator sites on behalf of a different person as defined in § 260.10 of this chapter shall not be deemed to “control” such generator sites.
(B) The very small quantity generator marks its container(s) of hazardous waste with:
(
(
(
(
(b)
(1) The mixture does not exhibit any of the characteristics of hazardous waste
(2) If the mixture does exhibit one or more characteristics of a hazardous waste identified in subpart C of part 261 of this chapter, the mixture does not cause the generator to exceed the very small quantity generator calendar month quantity limits identified in the definition of very small quantity generator at § 260.10 of this chapter. If the mixture does exceed the quantity limit for a very small quantity generator, the very small quantity generator, to remain exempt from the permitting and interim status standards, must meet the conditions for exemption applicable to either a small quantity generator or large quantity generator according to the quantity of the hazardous waste it generated in a calendar month, including the resultant mixture and the total quantity the very small quantity generator accumulated on site.
(c) If a very small quantity generator's wastes are mixed with used oil, the mixture is subject to 40 CFR part 279. Any material produced from such a mixture by processing, blending, or other treatment is also regulated under 40 CFR part 279.
(d) The placement of bulk or non-containerized liquid hazardous waste or hazardous waste containing free liquids (whether or not sorbents have been added) in any landfill is prohibited.
(e) A very small quantity generator experiencing an episodic event may accumulate hazardous waste in accordance with subpart L of this part in lieu of §§ 262.15, 262.16, and 262.17.
(a) A generator may accumulate as much as 55 gallons of non-acute hazardous waste and/or one quart or 1 kg (2.2 lbs) of acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter in containers at or near any point of generation where wastes initially accumulate which is under the control of the operator of the process generating the waste, without a permit or interim status and without complying with § 262.16(b) or § 262.17(a) provided the generator complies with the following conditions for exemption:
(1) If a container holding hazardous waste is not in good condition, or if it begins to leak, the generator must transfer the hazardous waste from this container to a container that is in good condition and does not leak, or transfer and manage the waste in a central accumulation area.
(2) The generator must use a container made of or lined with materials that will not react with, and are otherwise compatible with, the hazardous waste to be accumulated, so that the ability of the container to contain the waste is not impaired.
(3) Special standards for incompatible wastes.
(i) Incompatible wastes, or incompatible wastes and materials, (see appendix V of part 265 for examples) must not be placed in the same container, unless § 265.17(b) of this chapter is complied with.
(ii) Hazardous waste must not be placed in an unwashed container that previously held an incompatible waste or material (see appendix V of part 265 for examples), unless § 265.17(b) of this chapter is complied with.
(iii) A container holding a hazardous waste that is incompatible with any waste or other materials accumulated nearby in other containers, piles, open tanks, or surface impoundments must be separated from the other materials or protected from them by means of a dike, berm, wall, or other device.
(4) A container holding hazardous waste must be closed at all times during accumulation, except:
(i) When adding, removing, or consolidating waste, or
(ii) When venting of a container is necessary
(A) For the proper operation of equipment, or
(B) To prevent dangerous situations, such as build-up of extreme pressure.
(5) A generator must mark its container with the following:
(i) The words “Hazardous Waste,” and
(ii) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D); and
(iii) An indication of the hazards of the contents. (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(6) A generator who accumulates either non-acute hazardous waste or acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter in excess of the amounts listed in paragraph (a) of this section at or near any point of generation must do the following:
(i) Remove the excess from the satellite accumulation area within three calendar days to either
(A) A central accumulation area;
(B) An on-site interim status or permitted treatment, storage, or disposal facility, or
(C) An off-site designated facility.
(ii) During the three-calendar-day period the generator must continue to comply with paragraphs (a)(1) through (5) of this section. The generator must mark the container(s) holding the excess accumulation of hazardous waste with the date the excess amount began accumulating.
A small quantity generator may accumulate hazardous waste on-site without a permit or interim status, and without complying with the independent requirements of parts 124, 264 through 268, and 270 of this chapter, provided that all the conditions for exemption listed in this section are met:
(a)
(b)
(1)
(2)
(ii)
(iii)
(B) A container holding hazardous waste must not be opened, handled, or accumulated in a manner that may rupture the container or cause it to leak.
(iv)
(v)
(B) Hazardous waste must not be placed in an unwashed container that previously held an incompatible waste or material (see appendix V of part 265 for examples), unless § 265.17(b) of this chapter is complied with.
(C) A container accumulating hazardous waste that is incompatible with any waste or other materials accumulated or stored nearby in other containers, piles, open tanks, or surface impoundments must be separated from the other materials or protected from them by means of a dike, berm, wall, or other device.
(3)
(i) [Reserved]
(ii) A small quantity generator of hazardous waste must comply with the following general operating conditions:
(A) Treatment or accumulation of hazardous waste in tanks must comply with § 265.17(b) of this chapter.
(B) Hazardous wastes or treatment reagents must not be placed in a tank if they could cause the tank or its inner liner to rupture, leak, corrode, or otherwise fail before the end of its intended life.
(C) Uncovered tanks must be operated to ensure at least 60 centimeters (2 feet) of freeboard, unless the tank is equipped with a containment structure (
(D) Where hazardous waste is continuously fed into a tank, the tank must be equipped with a means to stop this inflow (
(iii) Except as noted in paragraph (a)(3)(iv) of this section, a small quantity generator that accumulates hazardous waste in tanks must inspect, where present:
(A) Discharge control equipment (
(B) Data gathered from monitoring equipment (
(C) The level of waste in the tank at least once each operating day to ensure compliance with paragraph (a)(3)(ii)(C) of this section;
(D) The construction materials of the tank at least weekly to detect corrosion or leaking of fixtures or seams; and
(E) The construction materials of, and the area immediately surrounding, discharge confinement structures (
(iv) A small quantity generator accumulating hazardous waste in tanks or tank systems that have full secondary containment and that either use leak detection equipment to alert personnel to leaks, or implement established workplace practices to ensure leaks are promptly identified, must inspect at least weekly, where applicable, the areas identified in paragraphs (a)(3)(iii)(A) through (E) of this section. Use of the alternate inspection schedule must be documented in the site's operating record. This documentation must include a description of the established workplace practices at the site.
(v) [Reserved.]
(vi) A small quantity generator accumulating hazardous waste in tanks must, upon closure of the site, remove all hazardous waste from tanks, discharge control equipment, and discharge confinement structures. At closure, as throughout the operating period, unless the small quantity generator can demonstrate, in accordance with § 261.3(c) or (d) of this chapter, that any solid waste removed from its tank is not a hazardous waste, then it must manage such waste in accordance with all applicable provisions of parts 262, 263, and 265 of this chapter.
(vii) A small quantity generator must comply with the following special conditions for accumulation of ignitable or reactive waste:
(A) Ignitable or reactive waste must not be placed in a tank, unless:
(
(
(
(B) A small quantity generator which treats or accumulates ignitable or reactive waste in covered tanks must comply with the buffer zone requirements for tanks contained in Tables 2-1 through 2-6 of the National Fire Protection Association's “Flammable and Combustible Liquids Code,” (1977 or 1981) (incorporated by reference, see § 260.11).
(C) A small quantity generator must comply with the following special conditions for incompatible wastes:
(
(
(4)
(i) A written description of procedures that will identify the date hazardous waste first entered the drip pad and ensure that all wastes are removed from the drip pad and associated collection system at least once every 90 days; and
(ii) Documentation of each waste removal, including the quantity of waste removed from the drip pad and the sump or collection system and the date and time of removal.
(5)
(i) The professional engineer certification that the building complies with the design standards specified in 40 CFR 265.1101. This certification must be in the facility's operating record prior to operation of the unit; and
(ii) A written description of procedures to ensure that each waste volume remains in the unit for no more than 90 days, a written description of the waste generation and management practices for the site showing that they are consistent with maintaining the 90 day limit, and documentation that the procedures are complied with; or
(iii) Documentation that the unit is emptied at least once every 90 days.
(6)
(A) The words “Hazardous Waste”;
(B) Other words that identify the contents of the containers (examples may include, but are not limited to, the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D);”
(C) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(D) The date upon which each period of accumulation begins clearly visible for inspection on each container.
(ii) A small quantity generator accumulating hazardous waste in tanks, drip pads and containment buildings must do the following:
(A) Mark or label its waste accumulation units with the words “Hazardous Wastes.” In the case of hazardous wastes accumulated in drip pads and containment buildings, generators must label their drip pads and containment buildings with the words “Hazardous Wastes” in a conspicuous place easily visible to employees, visitors, emergency responders, waste handlers, or other persons on site;
(B) Use inventory logs, monitoring equipment, or records to identify the contents of the tank, drip pad or containment building and its associated hazards;
(C) Use inventory logs, monitoring equipment or records to identify the date upon which each period of accumulation begins; and
(D) Keep inventory logs or records with the above information in close proximity to the tank, drip pad, or containment building.
(7)
(8)
(ii)
(A) An internal communications or alarm system capable of providing immediate emergency instruction (voice or signal) to site personnel;
(B) A device, such as a telephone (immediately available at the scene of operations) or a hand-held two-way radio, capable of summoning emergency assistance from local police departments, fire departments, or State or local emergency response teams;
(C) Portable fire extinguishers, fire control equipment (including special extinguishing equipment, such as that using foam, inert gas, or dry chemicals), spill control equipment, and decontamination equipment; and
(D) Water at adequate volume and pressure to supply water hose streams, or foam producing equipment, or automatic sprinklers, or water spray systems.
(iii)
(iv)
(B) In the event there is just one employee on the premises while the site is operating, the employee must have immediate access (
(v)
(vi)
(
(
(
(B) A small quantity generator shall maintain records documenting the arrangements with the Local Emergency Planning Committee, or if appropriate, with the local fire department as well as any other organization necessary to respond to an emergency. This documentation must include a certified letter or any other documentation that confirms such arrangements actively exist.
(9)
(i) At all times there must be at least one employee either on the premises or on call (
(ii) The small quantity generator must post the following information next to telephones or in areas directly involved in the generation and accumulation of hazardous waste:
(A) The name and emergency telephone number of the emergency coordinator;
(B) Location of fire extinguishers and spill control material, and, if present, fire alarm; and
(C) The telephone number of the fire department, unless the site has a direct alarm.
(iii) The small quantity generator must ensure that all employees are thoroughly familiar with proper waste handling and emergency procedures, relevant to their responsibilities during normal site operations and emergencies;
(iv) The emergency coordinator or his designee must respond to any emergencies that arise. The applicable responses are as follows:
(A) In the event of a fire, call the fire department or attempt to extinguish it using a fire extinguisher;
(B) In the event of a spill, the small quantity generator is responsible for containing the flow of hazardous waste to the extent possible, and as soon as is practicable, cleaning up the hazardous waste and any contaminated materials or soil. Such containment and cleanup can be conducted either by the small quantity generator or by a contractor on behalf of the small quantity generator;
(C) In the event of a fire, explosion, or other release that could threaten human health outside the site or when the small quantity generator has knowledge that a spill has reached surface water, the small quantity generator must immediately notify the National Response Center (using their 24-hour toll free number 800/424-8802). The report must include the following information:
(
(
(
(
(
(c)
(1) The mixture is not a hazardous waste according to the mixture rules in §§ 261.3(a)(2)(iv), (b)(2) and (3), and (g)(2)(i); or
(2) If the mixture is a hazardous waste, the mixture does not cause the generator to exceed the small quantity generator quantity limits for a calendar month, as identified in the definition of small quantity generator at § 260.10 of this chapter. If the mixture does exceed the small quantity generator quantity limits, a small quantity generator, to remain exempt from the permitting and interim status standards, must meet the conditions for exemption applicable to a large quantity generator.
(d)
(e)
(f)
(i) Sign Item 18c of the manifest, if the transporter returned the shipment using the original manifest; or
(ii) Sign Item 20 of the manifest, if the transporter returned the shipment using a new manifest.
(g) A small quantity generator experiencing an episodic event may accumulate hazardous waste in accordance with subpart L of this part in lieu of § 262.17.
A large quantity generator may accumulate hazardous waste on-site without a permit or interim status, and without complying with the independent requirements of parts 124, 264 through 268, and 270 of this chapter, provided that all of the conditions for exemption listed in this section are met:
(a)
(1)
(i)
(ii)
(iii)
(iv)
(B) A container holding hazardous waste must not be opened, handled, or stored in a manner that may rupture the container or cause it to leak.
(v)
(vi)
(B) The large quantity generator must take precautions to prevent accidental ignition or reaction of ignitable or reactive waste. This waste must be separated and protected from sources of ignition or reaction including but not limited to the following: open flames, smoking, cutting and welding, hot surfaces, frictional heat, sparks (static, electrical, or mechanical), spontaneous ignition (
(vii)
(B) Hazardous waste must not be placed in an unwashed container that previously held an incompatible waste or material (see appendix V of part 265 for examples), unless § 265.17(b) of this chapter is complied with.
(C) A container holding a hazardous waste that is incompatible with any waste or other materials accumulated or stored nearby in other containers, piles, open tanks, or surface impoundments must be separated from the other materials or protected from them by means of a dike, berm, wall, or other device.
(2)
(3)
(i) A written description of procedures that will identify the date hazardous waste first entered the drip pad and ensure that all wastes are removed from the drip pad and associated collection system at least once every 90 days; and
(ii) Documentation of each waste removal, including the quantity of waste removed from the drip pad and the sump or collection system and the date and time of removal.
(4)
(ii) The large quantity generator shall maintain the following records by use of inventory logs, monitoring equipment records, or any other effective means:
(A) A written description of procedures to ensure that each waste volume remains in the unit for no more than 90 days, a written description of the waste generation and management practices for the site showing that they are consistent with respecting the 90 day limit, and documentation that the procedures are complied with; or
(B) Documentation that the unit is emptied at least once every 90 days.
(5)
(A) The words “Hazardous Waste”;
(B) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D)”;
(C) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(D) The date upon which each period of accumulation begins clearly visible for inspection on each container.
(ii)
(A) Mark or label its waste accumulation units with the words “Hazardous Waste.” In the case of hazardous wastes accumulated in drip pads and containment buildings, generators must label their drip pads and containment buildings with the words “Hazardous Waste” in a conspicuous place easily visible to employees, visitors, emergency responders, waste handlers, etc.
(B) Use inventory logs, monitoring equipment, or records to identify the contents of the tank, drip pad or containment building and its associated hazards.
(C) Use inventory logs, monitoring equipment or records to identify the date upon which each period of accumulation begins; and
(D) Keep inventory logs or records with the above information in close proximity to the tank, drip pad, or containment building.
(6)
(7)
(B) This program must be directed by a person trained in hazardous waste management procedures, and must include instruction which teaches site personnel hazardous waste management procedures (including contingency plan implementation) relevant to the positions in which they are employed.
(C) At a minimum, the training program must be designed to ensure that site personnel are able to respond effectively to emergencies by familiarizing them with emergency procedures, emergency equipment, and emergency systems, including where applicable:
(
(
(
(
(
(
(D) For site employees that receive emergency response training pursuant to Occupational Safety and Health Administration regulations 29 CFR 1910.120(p)(8) and 1910.120(q), the large quantity generator is not required to provide separate emergency response training pursuant to this section, provided that the overall site training meets all the conditions of exemption in this section.
(ii) Site personnel must successfully complete the program required in paragraph (a)(7)(i) of this section within six months after the effective date of these regulations or six months after the date of their employment or assignment to the site, or to a new position at the site, whichever is later. Employees hired after the effective date of these regulations must not work in unsupervised positions until they have completed the training standards of paragraph (a)(7)(i) of this section.
(iii) Site personnel must take part in an annual review of the initial training required in paragraph (a)(7)(i) of this section.
(iv) The large quantity generator must maintain the following documents and records at the site:
(A) The job title for each position at the site related to hazardous waste management, and the name of the employee filling each job;
(B) A written job description for each position listed under paragraph (a)(7)(iv)(A) of this section. This description may be consistent in its degree of specificity with descriptions for other similar positions in the same company location or bargaining unit, but must include the requisite skill, education, or other qualifications, and duties of site personnel assigned to each position;
(C) A written description of the type and amount of both introductory and continuing training that will be given to each person filling a position listed under paragraph (a)(7)(iv)(A) of this section;
(D) Records that document that the training or job experience, required under paragraphs (a)(7)(i), (ii), and (iii) of this section, has been given to, and completed by, site personnel.
(v) Training records on current personnel must be kept until closure of the site. Training records on former employees must be kept for at least three years from the date the employee last worked at the site. Personnel training records may accompany personnel transferred within the same company.
(8)
(i)
(B) Notify EPA within 90 days after closure of a unit that accumulates hazardous waste at the site or prior to closing the site that it has either clean closed (
(ii)
(9)
(b)
(c)
(1) The large quantity generator has implemented pollution prevention practices that reduce the amount of any hazardous substances, pollutants, or contaminants entering F006 or otherwise released to the environment prior to its recycling;
(2) The F006 waste is legitimately recycled through metals recovery;
(3) No more than 20,000 kilograms of F006 waste is accumulated on site at any one time; and
(4) The F006 waste is managed in accordance with the following:
(i)(A) If the F006 waste is placed in containers, the large quantity generator must comply with the applicable conditions for exemption in § 262.17(a)(1); and/or
(B) If the F006 is placed in tanks, the large quantity generator must comply with the applicable conditions for exemption of § 262.17(a)(2); and/or
(C) If the F006 is placed in containment buildings, the large quantity generator must comply with subpart DD of 40 CFR part 265, and has placed its professional engineer certification that the building complies with the design standards specified in 40 CFR 265.1101 in the site's files prior to operation of the unit. The large quantity generator must maintain the following records:
(
(
(ii) The large quantity generator is exempt from all the requirements in subparts G and H of 40 CFR part 265, except for those referenced in § 262.17(a)(8).
(iii) The date upon which each period of accumulation begins is clearly marked and must be clearly visible for inspection on each container;
(iv) While being accumulated on site, each container and tank is labeled or marked clearly with:
(A) The words “Hazardous Waste”;
(B) Other words that identify the contents of the container or tank; and
(C) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(v) The large quantity generator complies with the requirements in §§ 262.17(a)(6) and (7).
(d)
(e)
(f)
(g)
(1) The large quantity generator notifies EPA thirty (30) days prior to receiving the first shipment from a very small quantity generator(s) using EPA form 8700-12; and
(i) Identifies on the form the name(s) and site address(es) for the very small quantity generator(s) as well as the name and business telephone number for a contact person for the very small quantity generator(s); and
(ii) Submits an updated Site ID form (EPA form 8700-12) within 30 days after a change in the name, site address, or contact information for the very small quantity generator.
(2) The large quantity generator maintains records of shipments for three years from the date the hazardous waste was received from the very small quantity generator. These records must identify the name, site address, and contact information for the very small quantity generator and include a description of the hazardous waste received, including the quantity, all applicable EPA hazardous waste number(s) (EPA hazardous waste codes) in subparts C and D of part 261 for the hazardous waste, and the date the waste was received.
(3) The large quantity generator manages all hazardous waste received from a very small quantity generator in compliance with the independent requirements in § 262.10(a)(1)(ii) and conditions for exemption in § 262.17 applicable to a large quantity generator. For purposes of the labeling and marking regulations in § 262.17(a)(5), the large quantity generator must label the container or unit with the date accumulation started (
(h)
(1) Sign Item 18c of the manifest, if the transporter returned the shipment using the original manifest; or
(2) Sign Item 20 of the manifest, if the transporter returned the shipment using a new manifest.
(a) A generator must not treat, store, dispose of, transport, or offer for transportation, hazardous waste without having received an EPA identification number from the Administrator.
(b) A generator who has not received an EPA identification number may obtain one by applying to the Administrator using EPA form 8700-12. Upon receiving the request the Administrator will assign an EPA identification number to the generator.
(c) A generator must not offer its hazardous waste to transporters or to treatment, storage, or disposal facilities that have not received an EPA identification number.
(d)
(ii) A large quantity generator must notify EPA by March 1 of each even-numbered year thereafter using EPA Form 8700-12. A large quantity generator may submit this re-notification as part of its biennial report required under § 262.41.
(c) Before transporting or offering hazardous waste for transportation off site, a generator must mark each container with the applicable EPA hazardous waste numbers (EPA hazardous waste codes) in subparts C and D of part 261 of this chapter.
The placement of bulk or non-containerized liquid hazardous waste or hazardous waste containing free liquids (whether or not sorbents have been added) in any landfill is prohibited.
(a) A generator who is a large quantity generator for at least one month of the reporting year must complete and submit EPA form 8700-13 to the Regional Administrator by March 1 of each even numbered year for all hazardous wastes generated during the previous calendar year. This requirement also applies to generators who treat, store, or dispose of hazardous waste on site in accordance with the provisions of 40 CFR parts 264, 265, 266, 267, and 270 and to large quantity generators that receive hazardous waste from very small quantity generators pursuant to § 262.17(g).
(b) Exports of hazardous waste to foreign countries are not required to be reported on the Biennial Report form. A separate annual report requirement is set forth at 40 CFR 262.56 for hazardous waste exporters.
The Administrator, as deemed necessary under sections 2002(a) and 3002(a)(6) of the Act, may require generators to furnish additional reports concerning the quantities and disposition of wastes identified or listed in 40 CFR part 261.
A small quantity generator is subject only to the following independent requirements in this subpart:
(a)
(b)
(a)
(b)
(a) An eligible academic entity must notify the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Identification Form (EPA Form 8700-12), that it is electing to be subject to the requirements of this subpart for all the laboratories owned by the eligible academic entity under the same EPA Identification Number. An eligible academic entity that is a very small quantity generator and does not have an EPA Identification Number must notify that it is electing to be subject to the requirements of this subpart for all the laboratories owned by the eligible academic entity that are on site, as defined by § 260.10. An eligible academic entity must submit a separate notification (Site Identification Form) for each EPA Identification Number (or site, for very small quantity generators) that is electing to be subject to the requirements of this subpart, and must submit the Site Identification Form before it begins operating under this subpart.
(b) * * *
(2) Site EPA Identification Number (except for very small quantity generators).
(a) An eligible academic entity must notify the appropriate EPA Regional Administrator in writing, using the RCRA Subtitle C Site Identification Form (EPA Form 8700-12), that it is electing to no longer be subject to the requirements of this subpart for all the laboratories owned by the eligible academic entity under the same EPA Identification Number and that it will comply with the requirements of §§ 262.11 and 262.15 for small quantity generators and large quantity generators. An eligible academic entity that is a very small quantity generator and does not have an EPA Identification Number must notify that it is withdrawing from the requirements of this subpart for all the laboratories owned by the eligible academic entity that are on site and that it will comply with the conditional exemption in § 262.14. An eligible academic entity must submit a separate notification (Site Identification Form) for each EPA Identification Number (or site, for very small quantity generators) that is withdrawing from the requirements of this subpart and must submit the Site Identification Form before it begins operating under the standards in §§ 262.11 and 262.15 for small quantity generators and large quantity generators or § 262.14 for very small quantity generators.
(d) * * *
(2) Make the hazardous waste determination, pursuant to § 262.11(a) through (d), for unwanted material.
(a) * * *
(1) Remove all containers of unwanted material from each laboratory on a regular interval, not to exceed 12 months; or
(2) Remove containers of unwanted material from each laboratory within 12 months of each container's accumulation start date.
(b)
(a) A trained professional must make the hazardous waste determination, pursuant to § 262.11(a) through (d), before the unwanted material is removed from the laboratory.
(b) * * *
(3) Count the hazardous waste toward the eligible academic entity's generator category, pursuant to § 262.13, in the calendar month that the hazardous waste determination was made.
(d) * * *
(2) Very small quantity generators must ensure it is taken directly from the laboratory(ies) to any of the types of facilities listed in § 262.14.
(c) The unwanted material becomes subject to the generator accumulation regulations of § 262.16 for small quantity generators or § 262.17 for large quantity generators as soon as it arrives in the central accumulation area, except for the “hazardous waste” labeling conditions of § 262.16(b)(6) and § 262.17(a)(5).
(d) A trained professional must determine, pursuant to § 262.11(a) through (d), if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials' arrival at the on-site central accumulation area.
(e) * * *
(3) Count the hazardous waste toward the eligible academic entity's generator category, pursuant to § 262.13 in the calendar month that the hazardous waste determination was made, and
(d) A trained professional must determine, pursuant to § 262.11(a) through (d), if the unwanted material is a hazardous waste within 4 calendar days of the unwanted materials' arrival at an on-site interim status or permitted treatment, storage, or disposal facility.
(a) * * *
(2) For the purposes of on-site accumulation, an eligible academic entity is not required to count a hazardous waste that is an unused commercial chemical product (listed in 40 CFR part 261, subpart D or exhibiting one or more characteristics in 40 CFR part 261, subpart C) generated solely during the laboratory clean-out toward its hazardous waste generator category, pursuant to § 262.13. An unwanted material that is generated prior to the beginning of the laboratory clean-out and is still in the laboratory at the time the laboratory clean-out commences must be counted toward hazardous waste generator category, pursuant to § 262.13, if it is determined to be hazardous waste; and
(3) For the purposes of off-site management, an eligible academic entity must count all its hazardous waste, regardless of whether the hazardous waste was counted toward generator category under paragraph (a)(2) of this section, and if it generates more than 1 kg/month of acute hazardous waste or more than 100 kg/month of non-acute hazardous waste (
(b) * * *
(2) The requirement to count all hazardous waste, including unused hazardous waste, generated during the laboratory clean-out toward its hazardous waste generator category, pursuant to § 262.13.
(b) * * *
(5) Describe its intended best practices for making hazardous waste determinations, including specifying the duties of the individuals involved in the process (see the required standards at § 262.11(a) through (d) and §§ 262.209 through 262.212).
(a) Remains subject to the generator requirements of §§ 262.11 and 262.15 for large quantity generators and small quantity generators (if the hazardous waste is managed in a satellite accumulation area), and all other applicable generator requirements of 40 CFR part 262, with respect to that hazardous waste; or
(b) Remains subject to the conditional exemption of § 262.14 for very small quantity generators, with respect to that hazardous waste.
This subpart is applicable to very small quantity generators and small quantity generators as defined in § 260.10.
An episodic event is an activity or activities, either planned or unplanned, that does not normally occur during generator operations, resulting in an increase in the generation of hazardous wastes that exceeds the calendar month quantity limits for the generator's usual category.
(a)
(1) The very small quantity generator is limited to one episodic event per calendar year unless a petition is granted under § 262.233;
(2) The very small quantity generator must notify EPA no later than thirty (30) calendar days prior to initiating a planned episodic event using EPA form 8700-12. In the event of an unplanned episodic event, the generator must notify EPA within 24 hours of the unplanned event or as soon as possible via phone or email and subsequently submit EPA form 8700-12. The generator shall include the start date of the episodic event, the reason(s) for the event, types and estimated quantities of hazardous waste expected to be generated as a result of the episodic event, and shall identify a facility contact and emergency coordinator with 24-hour telephone access to discuss the notification submittal or respond to an emergency;
(3) The very small quantity generator must have an EPA identification number or obtain an EPA identification number using EPA form 8700-12;
(4)
(i)
(A) The words “Episodic Hazardous Waste;”
(B) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D);
(C) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(D) The date upon which the episodic event began, clearly visible for inspection on each container.
(ii)
(A) Mark or label the tank with the words “Episodic Hazardous Waste;”
(B) Use inventory logs, monitoring equipment, or records to identify the contents of the tank and its associated hazards;
(C) Use inventory logs, monitoring equipment or records to identify the date upon which each episodic event begins; and
(D) Keep inventory logs or records with the above information in close proximity to the tank.
(iii) Hazardous waste must be managed in a manner that minimizes the possibility of a fire, explosion, or release of hazardous waste or hazardous waste constituents to the air, soil, or water;
(A) Containers must be in good condition and compatible with the hazardous waste being accumulated therein. Containers must be kept closed except to add or remove waste.
(B) Tanks must be in good condition and compatible with the hazardous waste accumulated therein. Tanks must have procedures in place to prevent the overflow (
(5) The very small quantity generator must comply with the hazardous waste manifest provisions of 40 CFR part 262 subpart B when it sends its episodic event hazardous waste off site to a RCRA-designated facility.
(6) The very small quantity generator has up to forty-five (45) calendar days from the start of the episodic event to manifest and send its hazardous waste generated from the episodic event to a RCRA-designated facility unless an extension is granted pursuant to § 262.233.
(7) Very small quantity generators must maintain the following records for three (3) years from the end date of the episodic event:
(i) Beginning and end dates of the episodic event;
(ii) A description of the episodic event;
(iii) A description of the types and quantities of hazardous wastes generated during the event;
(iv) A description of how the hazardous waste was managed as well as the name of the RCRA designated facility that received the hazardous waste;
(v) Name(s) of hazardous waste transporters;
(vi) An approval letter from EPA if the generator petitioned to conduct one additional episodic event per calendar year; and
(vii) An approval letter from EPA if the generator petitioned for an additional thirty (30) calendar day extension.
(b)
(1) The small generator is limited to one episodic event per calendar year unless a petition is granted under § 262.233;
(2) The small quantity generator must notify EPA no later than thirty (30) calendar days prior to initiating a planned episodic event using EPA form 8700-12. In the event of an unplanned episodic event, the small quantity generator must notify EPA within 24 hours of the unplanned event or as soon as possible via phone or email and subsequently submit EPA form 8700-12. The small quantity generator shall include the start date of the episodic event and the reason(s) for the event, types and estimated quantities of hazardous wastes expected to be generated as a result of the episodic event, and identify a facility contact and emergency coordinator with 24-hour telephone access to discuss the notification submittal or respond to emergency;.
(3) The small quantity generator must have an EPA identification number or obtain an EPA identification number using EPA form 8700-12.
(4)
(i)
(A) The words “Episodic Hazardous Waste”;
(B) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D);
(C) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(D) The date upon which the episodic event began, clearly visible for inspection on each container.
(ii)
(A) Mark or label its tank with the words “Episodic Hazardous Waste;”
(B) Use inventory logs, monitoring equipment, or records to identify the contents of the tank and its associated hazards;
(C) Use inventory logs, monitoring equipment or records to identify the date upon which each period of accumulation begins and ends; and
(D) Keep inventory logs or records with the above information immediately accessible.
(iii) Comply with the applicable conditions listed in § 262.16.
(5) The small quantity generator must treat hazardous waste generated from an episodic event on site or manifest and ship such hazardous waste off site to a RCRA-designated facility within forty-five (45) calendar days from the start of the episodic event, unless an extension is granted pursuant to § 262.233.
(6) The small quantity generator must maintain the following records for three (3) years from the end date of the episodic event:
(i) Beginning and end dates of the episodic event;
(ii) A description of the episodic event;
(iii) A description of the types and quantities of hazardous wastes generated during the event;
(iv) A description of how the hazardous waste was managed as well as the name of the RCRA designated facility that received the hazardous waste;
(v) Name(s) of hazardous waste transporters;
(vi) An approval letter from EPA if the generator petitioned to conduct one additional episodic event per calendar year; and
(vii) An approval letter from EPA if the generator petitioned for an additional thirty (30) calendar day extension.
(a) A very small quantity generator or a small quantity generator may petition EPA for one additional episodic event per calendar year without it impacting its generator category. The petition must include the following:
(1) The reason(s) why an additional episodic event is needed and the nature of the episodic event;
(2) The estimated amount of hazardous waste to be managed from the event;
(3) How the hazardous waste is to be managed;
(4) The estimated length of time needed to complete management of the hazardous waste generated from the episodic event—not to exceed 45 days; and
(5) Information regarding the previous episodic event managed by the generator, including the nature of the event and whether it was a planned or unplanned event.
(b) The petition must be made via fax, email, or letter.
(c) The generator cannot manage the hazardous waste generated from an additional episodic event under subpart L until written approval by EPA, including email, has been received.
(d) The generator must retain written approval in its records for three years from the date the episodic event ended.
(a) The very small quantity generator or a small quantity generator may petition EPA for a thirty (30) calendar day extension to complete the management of hazardous waste generated by an episodic event. The petition must include the following:
(1) The nature of the episodic event;
(2) The estimated amount of additional hazardous waste to be managed from the episodic event if the extension is granted; and
(3) The generator's rationale for needing an extension of an additional 30 days beyond the 45-day limit to complete management of the hazardous waste generated from the episodic event.
(b) The generator must petition EPA via fax, email, or letter within fifteen (15) calendar days of the event ending.
(c) The generator cannot go beyond the 45-day limit unless written approval from EPA has been received.
(d) The generator must retain written approval in its records for three years from the date the episodic event ended.
The regulations of this subpart apply to those areas of a large quantity generator where hazardous waste is generated or accumulated on site in
A large quantity generator must maintain and operate its site to minimize the possibility of a fire, explosion, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water which could threaten human health or the environment.
All areas where hazardous waste is being either generated or accumulated must be equipped with the items in paragraphs (a) through (d) of this section (unless none of the hazards posed by waste handled at the site could require a particular kind of equipment specified below or the actual waste generation or accumulation area does not lend itself for safety reasons to have a particular kind of equipment specified below). A large quantity generator may determine the most appropriate locations within its generator site to locate equipment necessary to prepare for and respond to emergencies:
(a) An internal communications or alarm system capable of providing immediate emergency instruction (voice or signal) to site personnel;
(b) A device, such as a telephone (immediately available at the scene of operations) or a hand-held two-way radio, capable of summoning emergency assistance from local police departments, fire departments, or state or local emergency response teams;
(c) Portable fire extinguishers, fire control equipment (including special extinguishing equipment, such as that using foam, inert gas, or dry chemicals), spill control equipment, and decontamination equipment; and
(d) Water at adequate volume and pressure to supply water hose streams, or foam producing equipment, or automatic sprinklers, or water spray systems.
All communications or alarm systems, fire protection equipment, spill control equipment, and decontamination equipment, where required, must be tested and maintained as necessary to assure its proper operation in time of emergency.
(a) Whenever hazardous waste is being poured, mixed, spread, or otherwise handled, all personnel involved in the operation must have immediate access (
(b) In the event there is just one employee on the premises while the site is operating, the employee must have immediate access (
The large quantity generator must maintain aisle space to allow the unobstructed movement of personnel, fire protection equipment, spill control equipment, and decontamination equipment to any area of site operation in an emergency, unless aisle space is not needed for any of these purposes.
(a) The large quantity generator must make arrangements with the Local Emergency Planning Committee for the types and quantities of hazardous waste handled at the site, as well as the potential need for the services of the local police department, other emergency response teams, emergency response contractors, equipment suppliers, and local hospitals. Should there be no Local Emergency Planning Committee, should it not respond, or should the Local Emergency Planning Committee determine that it is not the appropriate organization to make arrangements with, then the large quantity generator must make arrangements with the local fire department and other relevant emergency responders (
(1) A large quantity generator that must make arrangements with its local fire department must determine the potential need for the services of the local police department, other emergency response teams, emergency response contractors, equipment suppliers and local hospitals.
(2) As part of this coordination, the large quantity generator shall make arrangements, as necessary, to familiarize the above organizations with the layout of the site, the properties of the hazardous waste handled at the site and associated hazards, places where personnel would normally be working, entrances to roads inside the site, and possible evacuation routes as well as the types of injuries or illnesses which could result from fires, explosions, or releases at the site.
(3) Where more than one police or fire department might respond to an emergency, the large quantity generator shall enter into agreements designating primary emergency authority to a specific fire or police department, and agreements with any others to provide support to the primary emergency authority.
(b) The large quantity generator shall maintain records documenting the arrangements with the Local Emergency Planning Committee, or if appropriate, with the local fire department as well as any other organization necessary to respond to an emergency. This documentation must include a certified letter or any other documentation that confirms such arrangements actively exist.
(a) A large quantity generator must have a contingency plan for the site. The contingency plan must be designed to minimize hazards to human health or the environment from fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water.
(b) The provisions of the plan must be carried out immediately whenever there is a fire, explosion, or release of hazardous waste or hazardous waste constituents which could threaten human health or the environment.
(a) The contingency plan must describe the actions site personnel must take to comply with §§ 262.260 and 262.265 in response to fires, explosions, or any unplanned sudden or non-sudden release of hazardous waste or hazardous waste constituents to air, soil, or surface water at the site.
(b) If the generator has already prepared a Spill Prevention, Control, and Countermeasures (SPCC) Plan in accordance with part 112 of this chapter, or some other emergency or contingency plan, it need only amend that plan to incorporate hazardous waste management provisions that are sufficient to comply with the standards of this part. The generator may develop one contingency plan that meets all regulatory standards. EPA recommends that the plan be based on the National Response Team's Integrated Contingency Plan Guidance (“One Plan”).
(c) The plan must describe arrangements agreed to with the Local Emergency Planning Committee. Should there be no Local Emergency Planning Committee, should it not respond, or should the Local Emergency Planning Committee determine that it is not the appropriate organization to make arrangements with, then the plan must describe arrangements agreed to by local fire departments and other relevant emergency responders (
(d) The plan must list names and emergency telephone numbers of all persons qualified to act as emergency coordinator (see § 262.264), and this list must be kept up to date. Where more than one person is listed, one must be named as primary emergency coordinator and others must be listed in the order in which they will assume responsibility as alternates. In situations where the generator site has an emergency coordinator continuously on duty because it operates 24 hours per day, every day of the year, the plan may list the staffed position (
(e) The plan must include a list of all emergency equipment at the site (such as fire extinguishing systems, spill control equipment, communications and alarm systems (internal and external), and decontamination equipment), where this equipment is required. This list must be kept up to date. In addition, the plan must include the location and a physical description of each item on the list, and a brief outline of its capabilities.
(f) The plan must include an evacuation plan for generator personnel where there is a possibility that evacuation could be necessary. This plan must describe signal(s) to be used to begin evacuation, evacuation routes, and alternate evacuation routes (in cases where the primary routes could be blocked by releases of hazardous waste or fires).
A copy of the contingency plan and all revisions to the plan must be maintained at the large quantity generator's site and—
(a) The large quantity generator must submit a copy of the contingency plan to the Local Emergency Planning Committee. Should there be no Local Emergency Planning Committee, should it not respond, or should the Local Emergency Planning Committee determine that it is not the appropriate organization to make arrangements with, the large quantity generator must submit the copy to the local emergency responders.
(b) A generator that first becomes subject to these provisions after [date 6 months after the date of publication of the final rule in the
(1) The types/names of hazardous wastes in layman's terms and the associated hazard associated with each waste present at any one time (
(2) The estimated maximum amount of each hazardous waste that may be present at any one time;
(3) The identification of any hazardous wastes where exposure would require unique or special treatment by medical or hospital staff;
(4) A map of the site showing where hazardous wastes are generated and accumulated and routes for accessing these wastes;
(5) A street map of the site in relation to surrounding businesses, schools and residential areas to understand how best to get to the facility and also evacuate citizens and workers;
(6) The locations of water supply (
(7) The identification of on-site notification systems (
(8) The name of the emergency coordinator and 7/24-hour emergency telephone number.
The contingency plan must be reviewed, and immediately amended, if necessary, whenever:
(a) Applicable regulations are revised;
(b) The plan fails in an emergency;
(c) The generator site changes—in its design, construction, operation, maintenance, or other circumstances—in a way that materially increases the potential for fires, explosions, or releases of hazardous waste or hazardous waste constituents, or changes the response necessary in an emergency;
(d) The list of emergency coordinators changes; or
(e) The list of emergency equipment changes.
At all times, there must be at least one employee either on the generator's premises or on call (
(a) Whenever there is an imminent or actual emergency situation, the emergency coordinator (or his designee when the emergency coordinator is on call) must immediately:
(1) Activate internal site alarms or communication systems, where applicable, to notify all site personnel; and
(2) Notify appropriate state or local agencies with designated response roles if their help is needed.
(b) Whenever there is a release, fire, or explosion, the emergency coordinator must immediately identify the character, exact source, amount, and areal extent of any released materials. The emergency coordinator may do this by observation or review of the site records or manifests and, if necessary, by chemical analysis.
(c) Concurrently, the emergency coordinator must assess possible hazards to human health or the environment that may result from the release, fire, or explosion. This assessment must consider both direct and indirect effects of the release, fire, or explosion (
(d) If the emergency coordinator determines that the site has had a release, fire, or explosion which could threaten human health, or the environment, outside the facility, the emergency coordinator must report the findings as follows:
(1) If the assessment indicates that evacuation of local areas may be
(2) The emergency coordinator must immediately notify either the government official designated as the on-scene coordinator for that geographical area, or the National Response Center (using their 24-hour toll free number 800/424-8802). The report must include:
(i) Name and telephone number of reporter;
(ii) Name and address of the generator;
(iii) Time and type of incident (
(iv) Name and quantity of material(s) involved, to the extent known;
(v) The extent of injuries, if any; and
(vi) The possible hazards to human health, or the environment, outside the site.
(e) During an emergency, the emergency coordinator must take all reasonable measures necessary to ensure that fires, explosions, and releases do not occur, recur, or spread to other hazardous waste at the generator's site. These measures must include, where applicable, stopping processes and operations, collecting and containing released waste, and removing or isolating containers.
(f) If the generator's site stops operations in response to a fire, explosion or release, the emergency coordinator must monitor for leaks, pressure buildup, gas generation, or ruptures in valves, pipes, or other equipment, wherever this is appropriate.
(g) Immediately after an emergency, the emergency coordinator must provide for treating, storing, or disposing of recovered waste, contaminated soil or surface water, or any other material that results from a release, fire, or explosion at the facility. Unless the generator can demonstrate, in accordance with § 261.3(c) or (d) of this chapter, that the recovered material is not a hazardous waste, then it is a newly generated hazardous waste that must be managed in accordance with all the applicable independent requirements and conditions for exemption in parts 262, 263, and 265 of this chapter.
(h) The emergency coordinator must ensure that, in the affected area(s) of the site:
(1) No waste that may be incompatible with the released material is treated, stored, or disposed of until cleanup procedures are completed; and
(2) All emergency equipment listed in the contingency plan is cleaned and fit for its intended use before operations are resumed.
(i) The generator must note in the operating record the time, date, and details of any incident that requires implementing the contingency plan. Within 15 days after the incident, the generator must submit a written report on the incident to the Regional Administrator. The report must include:
(1) Name, address, and telephone number of the generator;
(2) Date, time, and type of incident (
(3) Name and quantity of material(s) involved;
(4) The extent of injuries, if any;
(5) An assessment of actual or potential hazards to human health or the environment, where this is applicable; and
(6) Estimated quantity and disposition of recovered material that resulted from the incident.
42 U.S.C. 6906, 6912, 6922-6925, 6937, and 6938.
(a) A transporter who stores manifested shipments of hazardous waste in containers meeting the independent requirements of § 262.30 of this chapter at a transfer facility for a period of ten days or less is not subject to regulation under parts 264, 265, 267, 268, and 270 of this chapter with respect to the storage of those wastes.
(b) The transporter must hold hazardous wastes that are stored at transfer facilities in containers marked with the following information:
(1) The words “Hazardous Waste;”
(2) The applicable EPA hazardous waste number(s) (EPA hazardous waste codes) in subparts C and D of part 261 of this chapter;
(3) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D); and
(4) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
42 U.S.C. 6905, 6912(a), 6924, and 6925.
(g) * * *
(1) The owner or operator of a facility permitted, licensed, or registered by a state to manage municipal or industrial solid waste, if the only hazardous waste the facility treats, stores, or disposes of is excluded from regulation under this part by § 262.14 of this chapter;
(3) A generator accumulating waste on site in compliance with § 262.14, 262.15, 262.16, or 262.17 of this chapter.
The revision reads as follows:
(b) * * *
(4) The frequency of inspection may vary for the items on the schedule. However, the frequency should be based on the rate of deterioration of the equipment and the probability of an environmental or human health incident if the deterioration, malfunction, or operator error goes undetected between inspections. Areas
The revision reads as follows:
(c) Whenever a shipment of hazardous waste is initiated from a facility, the owner or operator of that facility must comply with the requirements of part 262 of this chapter. The provisions of §§ 262.15, 262.16, and 262.17 of this chapter are applicable to the on-site accumulation of hazardous wastes by generators. Therefore, the provisions of §§ 262.15, 262.16, and 262.17 of this chapter only apply to owners or operators who are shipping hazardous waste which they generated at that facility.
The owner or operator must complete and submit EPA form 8700-13 to the Regional Administrator by March 1 of each even numbered year for facility activities during the previous calendar year.
The regulations in this subpart apply to owners and operators of all hazardous waste facilities that store hazardous waste in containers, except as § 264.1 provides otherwise.
At least weekly, the owner or operator must inspect areas where containers are stored. The owner or operator must look for leaking containers and for deterioration of containers and the containment system cause by corrosion or other factors. See §§ 264.15(c) and 264.171 for remedial action required if deterioration or leaks are detected.
(a) For each existing tank system that does not have secondary containment meeting the requirements of § 264.193, the owner or operator must determine that the tank system is not leaking or is fit for use. Except as provided in paragraph (c) of this section, the owner or operator must obtain and keep on file at the facility a written assessment reviewed and certified by a qualified Professional Engineer, in accordance with § 270.11(d) of this chapter, that attests to the tank system's integrity by January 12, 1988.
(b) * * *
(2) A unit (including a hazardous waste recycling unit) that is not exempt from permitting under the provisions of 40 CFR 262.17 (
(b) * * *
(3) A unit that is exempt from permitting under the provisions of 40 CFR 262.17 (
(c) * * *
(4) Inspect and record in the facility operating record, at least once every seven days, data gathered from monitoring and leak detection equipment as well as the containment building and the area immediately surrounding the containment building to detect signs of releases of hazardous waste.
42 U.S.C. 6905, 6906, 6912, 6922, 6923, 6924, 6925, 6935, 6936, and 6937.
(c) * * *
(5) The owner or operator of a facility permitted, licensed, or registered by a State to manage municipal or industrial solid waste, if the only hazardous waste the facility treats, stores, or disposes of is excluded from regulation under this part by § 262.14 of this chapter;
(7) A generator accumulating waste on site in compliance with §§ 262.15, 262.16, and 262.17 of this chapter, except to the extent the provisions are included in § 262.15, 262.16, or 262.17 of this chapter;
The revision reads as follows:
(b) * * *
(4) The frequency of inspection may vary for the items on the schedule. However, the frequency should be based on the rate of deterioration of the equipment and the probability of an environmental or human health incident if the deterioration, malfunction, or operator error goes undetected between inspections. Areas subject to spills, such as loading and unloading areas, must be inspected daily when in use. At a minimum, the inspection schedule must include the items and frequencies called for in §§ 265.174, 265.193, 265.195, 265.226, 265.260, 265.278, 265.304, 265.347, 265.377, 265.403, 265.1033, 265.1052,
(c) Whenever a shipment of hazardous waste is initiated from a facility, the owner or operator of that facility must comply with the requirements of part 262 of this chapter. The provisions of §§ 262.15, 262.16, and 262.17 of this chapter are applicable to the on-site accumulation of hazardous wastes by generators. Therefore, the provisions of §§ 262.15, 262.16, and 262.17 only apply to owners or operators who are shipping hazardous waste which they generated at that facility.
The owner or operator must complete and submit EPA form 8700-13 to the Regional Administrator by March 1 of each even numbered year for facility activities during the previous calendar year.
(c) Complies with the closure requirements of this subpart, including, but not limited to, the requirements of §§ 265.197, 265.228, 265.258, 265.280, 265.310, 265.351, 265.381, 265.404, 265.445, and 265.1102.
During the partial and final closure periods, all contaminated equipment, structures and soil must be properly disposed of, or decontaminated unless specified otherwise in § 265.197, 265.228, 265.445, 265.258, 265.280, 265.310, or 265.1102. By removing all hazardous wastes or hazardous constituents during partial and final closure, the owner or operator may become a generator of hazardous waste and must handle that hazardous waste in accordance with all applicable requirements of part 262 of this chapter.
At least weekly, the owner or operator must inspect areas where containers are stored. The owner or operator must look for leaking containers and for deterioration of containers caused by corrosion or other factors. See § 265.171 for remedial action required if deterioration or leaks are detected.
The revisions read as follows:
(b) * * *
(2) A unit (including a hazardous waste recycling unit) that is not exempt from permitting under the provisions of 40 CFR 262.17 (
(3) A unit that is exempt from permitting under the provisions of 40 CFR 262.17 (
(c) * * *
(4) Inspect and record in the facility's operating record at least once every seven days data gathered from monitoring and leak detection equipment as well as the containment building and the area immediately surrounding the containment building to detect signs of releases of hazardous waste.
42 U.S.C. 6905, 6912(a), 6921, and 6924.
(e) * * *
(1) Waste generated by very small quantity generators, as defined in § 260.10 of this chapter;
(a) * * *
(5) If a generator is managing and treating prohibited waste or contaminated soil in tanks, containers, or containment buildings regulated under 40 CFR 262.15, 262.16, and 262.17 to meet applicable LDR treatment standards found at § 268.40, the generator must develop and follow a written waste analysis plan which describes the procedures they will carry out to comply with the treatment standards. (Generators treating hazardous debris under the alternative treatment standards of Table 1 to § 268.45, however, are not subject to these waste analysis requirements.) The plan must be kept on site in the generator's records, and the following requirements must be met:
(a) * * *
(2) * * *
(i) Each container is clearly marked with:
(A) The words “Hazardous Waste;”
(B) The applicable EPA hazardous waste number(s) (EPA hazardous waste codes) in subparts C and D of part 261 of this chapter;
(C) Other words that identify the contents of the containers (examples may include, but are not limited to the name of the chemical(s), such as “acetone” or “methylene dichloride”; or the type or class of chemical, such as “organic solvents” or “halogenated organic solvents” or, as applicable, the proper shipping name and technical name markings used to comply with Department of Transportation requirements at 49 CFR part 172 subpart D); and
(D) An indication of the hazards of the contents (examples include, but are not limited to, the applicable hazardous waste characteristic(s) (
(E) The date each period of accumulation begins.
42 U.S.C. 6905, 6912, 6924, 6925, 6927, 6939, and 6974.
(a) * * *
(3)
(c) * * *
(2)
(i) Generators who accumulate hazardous waste on site in compliance with all of the conditions for exemption provided in 40 CFR 262.14, 262.15, 262.16, and 262.17.
(iii) Persons who own or operate facilities solely for the treatment, storage, or disposal of hazardous waste excluded from regulations under this part by 40 CFR 261.4.
42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.
(a) * * *
(2) Very small quantity generator wastes that are exempt under § 262.14 of this chapter and are also of the same type as the universal wastes defined at § 273.9.
(b) The waste or category of waste is not exclusive to a specific industry or group of industries, is commonly generated by a wide variety of types of establishments (including, for example, households, retail and commercial businesses, office complexes, very small quantity generators, small businesses, government organizations, as well as large industrial facilities);
Sections 1006, 2002(a), 3001 through 3007, 3010, 3014, and 7004 of the Solid Waste Disposal Act, as amended (42 U.S.C. 6905, 6912(a), 6921 through 6927, 6930, 6934, and 6974) ; and sections 101(37) and 144(c) of CERCLA (42 U.S.C. 9601(37) and 9614(c)).
(b) * * *
(3)
Environmental Protection Agency (EPA).
Proposed rule.
Some pharmaceuticals are regulated as hazardous waste under the Resource Conservation and Recovery Act (RCRA) when discarded. Healthcare facilities that generate hazardous waste pharmaceuticals as well as associated facilities have reported difficulties complying with the Subtitle C hazardous waste regulations for a number of reasons. First, healthcare workers, whose primary focus is to provide care for patients, are not knowledgeable about the RCRA hazardous waste regulations, but are often involved in the implementation of the regulations. Second, a healthcare facility can have thousands of items in its formulary, making it difficult to ascertain which ones are hazardous wastes when disposed. Third, some active pharmaceutical ingredients are listed as acute hazardous wastes, which are regulated in small amounts. To facilitate compliance and to respond to these concerns, the U.S. Environmental Protection Agency (EPA or the Agency) is proposing to revise the regulations to improve the management and disposal of hazardous waste pharmaceuticals and tailor them to address the specific issues that hospitals, pharmacies and other healthcare-related facilities face. The revisions are also intended to clarify the regulation of the reverse distribution mechanism used by healthcare facilities for the management of unused and/or expired pharmaceuticals.
Comments must be received on or before November 24, 2015.
Submit your comments, identified by Docket ID No. EPA-HQ-RCRA-2007-0932, to the
Kristin Fitzgerald, Office of Resource Conservation and Recovery (5304P), Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number: 703-308-8286; email address:
This is a proposed rule. If finalized, this rule would apply to healthcare facilities, pharmaceutical reverse distributors, and owners or operators of treatment, storage, and disposal facilities engaged in the management of hazardous waste pharmaceuticals. The list of NAICS codes for the potentially affected entities, other than RCRA treatment, storage and disposal facilities (TSDFs), are presented in Table 1. More detailed information on the potentially affected entities is presented in Section V.A and Section V.B.1 of this preamble.
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities potentially impacted by this action. This table lists examples of the types of entities of which EPA is aware that could potentially be affected by this action. Other types of entities not listed could also be affected. To determine whether your entity, company, business, organization, etc. is affected by this action, you should examine the applicability criteria in this rule. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding
These regulations are proposed under the authority of §§ 2002, 3001, 3002, and 3004 of the Solid Waste Disposal Act (SWDA) of 1970, as amended by the Resource Conservation and Recovery Act (RCRA) of 1976, as amended by the Hazardous and Solid Waste Amendments of 1984 (HSWA), 42 U.S.C. 6921, 6922, 6923, and 6924.
EPA is proposing to add a subpart P under 40 CFR part 266. Part 266 is entitled, “Standards for the Management of Specific Hazardous Wastes and Specific Types of Hazardous Waste Management Facilities.” This new subpart P is a tailored, sector-specific regulatory framework for managing hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors. If finalized, healthcare facilities that are currently small quantity generators (SQGs) or large quantity generators (LQGs) and all pharmaceutical reverse distributors, regardless of their RCRA generator category, will be required to manage their hazardous waste pharmaceuticals under subpart P of 40 CFR part 266, instead of 40 CFR part 262. That is, the proposed standards are not an optional alternative to managing hazardous waste pharmaceuticals under 40 CFR part 262; they are mandatory standards.
Briefly, healthcare facilities will have different management standards for their non-creditable and creditable hazardous waste pharmaceuticals. Non-creditable hazardous waste pharmaceuticals (
EPA is also proposing standards for the accumulation of the creditable hazardous waste pharmaceuticals at pharmaceutical reverse distributors. Like healthcare facilities, pharmaceutical reverse distributors will not be regulated under 40 CFR part 262 as hazardous waste generators, nor will they be regulated under 40 CFR parts 264, 265 and 270 as treatment, storage, and disposal facilities (TSDFs). Rather, the proposal establishes a new category of hazardous waste entity, called pharmaceutical reverse distributors. The proposed standards for pharmaceutical reverse distributors are, in many respects, similar to the LQGs standards, with supplementary standards added to respond to commenters' concerns.
For both healthcare facilities and reverse distributors, EPA is proposing to prohibit facilities from disposing of hazardous waste pharmaceuticals down the toilet or drain (
The Resource Conservation and Recovery Act governs the management and disposal of hazardous wastes.
Currently, there are no RCRA Subtitle C regulations that focus specifically on the management of hazardous wastes from hospitals, pharmacies, reverse distributors and other healthcare-related facilities. Rather, healthcare facilities are currently required to comply with the same RCRA hazardous waste regulations as many other industries that generate hazardous waste. While the RCRA Subtitle C program has requirements for all aspects of hazardous waste management, including those generating (referred to as “generators” by RCRA), transporting, storing, treating, and disposing of hazardous wastes, it is the generator requirements found under 40 CFR part 262 that will typically be most pertinent to healthcare-related facilities.
Under the federal RCRA regulations, the standards for hazardous waste generators are divided into three categories—LQGs, SQGs, and Conditionally Exempt Small Quantity Generators (CESQGs) depending upon the total amount of hazardous waste a facility generates per calendar month. It is the facility's generator category that determines the applicable RCRA hazardous waste management requirements with which the generator must comply.
A generator that generates a solid waste
• Facilities qualify as LQGs if in a calendar month they generate 1,000 kg or more of hazardous waste or more than 1 kg of acute hazardous waste (
• Facilities qualify as SQGs if in a calendar month they generate more than 100 kg but less than 1,000 kg of hazardous waste. SQGs are subject to fewer requirements than LQGs and are given additional flexibility. For example, SQGs have a longer on-site accumulation time limit (180 or 270 days vs. 90 days for LQGs), with fewer standards for the accumulation of hazardous waste, without having to obtain a RCRA permit or comply with the interim status standards, provided that they comply with the conditions set forth in § 262.34(d) (which have fewer personnel training and contingency planning obligations than in the conditions for exemption for LQGs); and do not need to complete a biennial report (BR).
• Facilities qualify as CESQGs if in a calendar month they generate less than or equal to 100 kg of hazardous waste, and less than or equal to 1 kg of acutely hazardous waste (
Finally, under the household hazardous waste exemption in § 261.4(b)(1), hazardous wastes generated by households are not subject to the RCRA hazardous waste regulations. This exemption from the Subtitle C requirements extends to any household wastes collected during community-oriented take-back programs or events, as long as these collected household hazardous wastes are managed separately from regulated hazardous wastes.
A portion of the pharmaceuticals currently on the market meets RCRA's definition of hazardous waste when discarded. As previously explained, it is the responsibility of the generator of a solid waste to determine if the waste is hazardous; this includes solid wastes that are pharmaceuticals. If the pharmaceutical waste meets RCRA's definition of hazardous waste, then the generator must manage it in accordance with all applicable federal, state, and/or local environmental regulations. A pharmaceutical is considered a hazardous waste under RCRA in one of two ways. First, a discarded pharmaceutical can be a listed hazardous waste if it is a commercial chemical product
Second, if the discarded pharmaceutical is not on the P- or U-list, then the pharmaceutical may be a hazardous waste if it exhibits one or more of the hazardous waste characteristics. Under the federal requirements (§ 261.21-24), a waste is a characteristic hazardous waste if it is ignitable (D001), corrosive (D002), reactive (D003) or toxic (D004-D043).
Since the hazardous waste rules were initially promulgated, EPA has issued several clarifications regarding the regulatory status of certain commercial chemical products on the P- and U-lists, and these clarifications have affected the regulatory status of some active pharmaceutical ingredients.
Finally, EPA has developed a “Hazardous Waste Pharmaceuticals Wiki” as a platform to facilitate the sharing of expertise among the healthcare industry and other stakeholders in order to help make accurate hazardous waste determinations for waste pharmaceuticals and increase compliance with the hazardous waste regulations. The Hazardous Waste Pharmaceuticals Wiki will also help users find guidance documents, state-specific information, and manufacturers' information. The Hazardous Waste Pharmaceuticals Wiki can be viewed at:
The impetus behind this proposal is to address the various concerns raised by stakeholders regarding the difficulty in implementing the Subtitle C hazardous waste regulations for the management of hazardous waste pharmaceuticals generated at healthcare facilities. EPA has met with various stakeholders to learn about compliance challenges, and it has received input from stakeholders through more formal mechanisms. For instance, when EPA solicited stakeholder input in response to Executive Order 13563 (Improving Regulation and Regulatory Review), retailers submitted comments detailing compliance challenges with hazardous waste pharmaceuticals in their stores.
First, in the healthcare setting, many hazardous waste pharmaceuticals are generated unpredictably and in relatively small quantities by a number of different employees across the facility. This situation differs from a manufacturing facility where fewer employees in a few locations generate comparatively much larger volumes of a smaller range of hazardous wastes.
Second, under the current hazardous waste regulatory scheme, healthcare workers, whose primary focus is to provide care for patients, are typically responsible for making hazardous waste determinations since they are at the point of generation (
Third, a healthcare facility can have thousands of items in its formulary at any one time and these may vary over time. In addition, pharmaceutical wastes come in many different forms, such as pills, patches, lozenges, gums, creams, and liquids, and are delivered by a variety of devices, such as nebulizers, intravenous (IV) tubing, syringes, etc. The combination of having thousands of different pharmaceutical products and little expertise in hazardous waste regulations makes it difficult for healthcare workers to make appropriate hazardous waste determinations when pharmaceuticals are disposed. This situation differs from manufacturing, where fewer, more predictable waste streams are generated.
Fourth, several of the hazardous waste pharmaceuticals that are generated by healthcare facilities are P-listed acute hazardous wastes (see § 261.33(e)), which are regulated at much smaller amounts. If a facility generates more than 1 kg of acute hazardous waste per calendar month or accumulates that amount at any time, it is regulated as an LQG. In addition to the pharmaceuticals, residues within pharmaceutical containers that contained P-listed commercial chemical products must be managed as acute hazardous waste even if the pharmaceutical was fully dispensed,
To facilitate compliance among healthcare facilities and to respond to these concerns, EPA is proposing a new set of sector-specific regulations to improve the management and disposal of hazardous waste pharmaceuticals at healthcare facilities. This proposed rule also intends to clarify the regulatory status of a major practice used by healthcare facilities for management of unused and/or expired pharmaceuticals, known as reverse distribution (see Sections V.D.1 and V.G).
In addition to improving compliance and responding to stakeholder concerns, the Agency has two additional goals for this proposal. The first is to reduce the amount of pharmaceuticals that are disposed of “down the drain.” This is presently an allowable and common disposal practice among healthcare facilities (as long as the pharmaceutical waste is not ignitable (see the Clean Water Act regulations of 40 CFR 403.5(b)(1)) and provided certain conditions are met (see the Clean Water Act regulations of 40 CFR 403.12(p)). Studies have found that many healthcare facilities, particularly long term-care facilities, are using drain disposal as a routine disposal method for pharmaceutical wastes. Although pharmaceuticals are also entering the environment through excretion, reducing sewer disposal is one mechanism to help reduce the environmental loading of pharmaceuticals into our Nation's waters. For more information about sewer disposal and pharmaceuticals in water, see Section V.E.1.
The second goal is to address the overlap between EPA's RCRA hazardous waste regulations and the controlled substances regulations of the Drug Enforcement Administration (DEA). Stakeholders have indicated that hazardous waste pharmaceuticals that are also controlled substances are stringently regulated and expensive to dispose of in accordance with both sets of requirements when sent for incineration. In addition, stakeholders have indicated that those regulated hazardous waste pharmaceuticals that are also controlled substances are most likely to be sewer disposed to avoid the costs of compliant incineration. EPA plans to address this overlap in this proposed rule, as this is an unnecessary burden for healthcare facilities and revised requirements will help to reduce sewer disposal.
On January 18, 2011, President Obama issued Executive Order 13563, which directed all federal agencies to perform periodic retrospective reviews of existing regulations to determine whether any should be modified,
EPA published a Notice of Data Availability (NODA) for the Retail Sector on February 14, 2014 (79 FR 8926), in which the Agency requested, among other things, comment on a series of topics related to retail operations in order to better understand the issues retail stores/establishments face in complying with RCRA regulations. Many retail commenters mentioned that because nicotine is an acute hazardous waste (P075), they are considered LQGs when they discard more than 1 kg per month of unused nicotine-containing products (
On December 2, 2008, EPA proposed to add hazardous waste pharmaceuticals to the existing federal universal waste program, which would have provided a streamlined approach to facilitate the proper management and disposal of hazardous waste pharmaceuticals generated at pharmacies, hospitals, reverse distributors, and other healthcare-related facilities. Specifically, under the universal waste program, handlers and transporters who generate or manage items designated as a universal waste
Transporters of universal waste are also subject to less stringent requirements than the full RCRA subtitle C hazardous waste transportation regulations. However, the primary difference between the universal waste transportation requirements and full RCRA subtitle C requirements is that no hazardous waste manifest is required for the transport of universal waste.
Destination facilities under the universal waste program are those facilities that treat, store, dispose of, or recycle universal wastes. Universal waste destination facilities are subject to all currently applicable requirements for hazardous waste treatment, storage, and disposal facilities (TSDFs), including the requirement to obtain a RCRA permit for such activities. (See 73 FR 73520, December 2, 2008, for a more detailed discussion of the proposed universal waste program for pharmaceutical wastes.)
EPA received approximately 100 public comments on the 2008 proposal to add hazardous waste pharmaceuticals to the universal waste program.
In addition to the public comments about the strengths and weaknesses of using the universal waste program to address the disposal of hazardous waste pharmaceuticals, EPA received other comments expressing concern with the proposal, including the following: The point of generation of hazardous waste pharmaceuticals as it pertains to reverse distribution; the management of
Based on the adverse comments received on the 2008 Pharmaceutical Universal Waste proposal regarding the lack of notification and tracking requirements for small quantity universal waste handlers, the reduced notification and tracking requirements for large quantity universal waste handlers, as well as the other issues raised in public comments, the Agency has decided to not finalize the proposal to add hazardous waste pharmaceuticals to the Universal Waste program. In fact, EPA has concluded that the universal waste program is not appropriate for managing hazardous waste pharmaceuticals because, among other things, we are unable to adequately address the notification and tracking concerns raised by the public comments within the Universal Waste program.
Under the Universal Waste regulations, there are eight factors to consider when determining whether it is appropriate to add a new hazardous waste or category of hazardous waste to the Universal Waste program (§ 273.81). A hazardous waste does not need to meet every factor in order to be added to the Universal Waste program. Rather, the Agency's decision is “based on the weight of evidence showing that regulation under part 273 is appropriate for the waste or category of waste, will improve management practices for the waste or category of waste, and will improve implementation of the hazardous waste program” (§ 273.80(c)).
The Agency has concluded based on the comments received that the weight of evidence does not show that regulation under the Universal Waste program is appropriate for hazardous waste pharmaceuticals. Specifically, we find the Universal Waste program to be lacking with regard to the factor in § 273.81(e), which states that the risk posed by the waste being considered for universal waste be relatively low compared to other hazardous wastes and that the management standards would be protective of human health and the environment during accumulation and transport. Although we continue to believe that potentially creditable pharmaceuticals en route to reverse distributors pose a low risk for leaks and other releases to the environment, commenters urged us to consider the unique risk posed by the accumulation and transport of hazardous waste pharmaceuticals: the risk of diversion. Although it is rare that a hazardous waste is so valuable that it is sought for abuse or sale on the black market, EPA believes that the diversion of hazardous waste pharmaceuticals for illicit use is a risk to human health.
The Universal Waste program does not include sufficient tracking requirements to address the potential for diversion. Under part 273, tracking is not required for shipments by small quantity handlers of universal waste; certain tracking of shipments is required only for large quantity handlers of universal waste and destination facilities. More importantly, these basic tracking requirements consist only of recordkeeping of shipments sent and received and no tracking is required to ensure delivery. Commenters noted that these tracking requirements are not sufficient given the high value of many of the unused pharmaceuticals en route to reverse distribution and the potential for diversion.
Accordingly, the Agency is proposing to amend § 273.80 to state that hazardous waste pharmaceuticals may not be added as a category of hazardous waste for management under the Universal Waste program. See Section IX State Authorization of the preamble for a discussion on the effect on the two states that have adopted pharmaceuticals under the Universal Waste program (Michigan and Florida).
By proposing a new set of management standards outside the confines of the Universal Waste program, it allows us greater flexibility in addressing the tracking of such shipments, as well as additional pharmaceutical waste management issues raised by stakeholders, such as drain disposal, container residues, pharmaceutical reverse distribution, and the overlap with DEA regulation. This new action will address the original stakeholder concerns that resulted in the 2008 Pharmaceutical Universal Waste proposal, as well as the comments received on that proposal.
To reiterate, EPA is not adding hazardous waste pharmaceuticals to the federal Universal Waste program. Rather, we are proposing sector-specific regulations for the management of hazardous waste pharmaceuticals by healthcare facilities and pharmaceutical reverse distributors. If finalized, these regulations will be codified in 40 CFR part 266, separate from both the generator regulations (40 CFR part 262) and the Universal Waste program (40 CFR part 273). This new proposed rulemaking will pertain to those waste pharmaceuticals that meet the current definition of a RCRA hazardous waste
On May 25, 2012, the EPA's Office of Inspector General (OIG) issued the report, “EPA Inaction in Identifying Hazardous Waste Pharmaceuticals May Result in Unsafe Disposal” (Report No. 12-P-0508).
(1) Identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste.
(2) Establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.
(3) Develop a nationally consistent outreach and compliance assistance plan to help states address challenges that healthcare facilities, and others as needed, have in complying with RCRA regulations for managing HWPs [hazardous waste pharmaceuticals] (Report No. 12-P-0508).
As detailed in OSWER's response to OIG, this proposal fulfills our obligation
EPA is proposing an entirely new set of regulations (40 CFR part 266, subpart P) for managing hazardous waste pharmaceuticals at both healthcare facilities and pharmaceutical reverse distributors. This section discusses in detail the major features of the proposal. The Agency also presents other options that it is considering or were considered in developing the proposed rule. EPA welcomes comments on all aspects of this proposed rule, and on options under consideration. Throughout this section, EPA requests comments on specific options and on specific issues, but comments are welcome on all provisions of this proposal.
All the definitions that appear in this proposal are for the purposes of 40 CFR part 266, subpart P only. Therefore, the definitions are relevant only to healthcare facilities and pharmaceutical reverse distributors that are subject to these proposed standards. For the purposes of this regulation, the Agency is proposing and soliciting public comment on the following terms and their definitions presented below: “evaluated hazardous waste pharmaceutical,” “hazardous waste pharmaceutical,” “healthcare facility,” “household waste pharmaceutical,” “long-term care facility,” “non-creditable hazardous waste pharmaceutical,” “non-hazardous waste pharmaceutical,” “non-pharmaceutical hazardous waste,” “pharmaceutical,” “pharmaceutical reverse distributor,” and “potentially creditable hazardous waste pharmaceutical.” Although the proposed definitions appear in alphabetical order in the regulations, we have chosen to discuss the proposed definitions in a different order in the preamble.
This proposed rule defines “pharmaceutical” as any chemical or biological product that is intended for use in the diagnosis, cure, mitigation, care, treatment, or prevention of disease or injury of a human or other animal; or any chemical or biological product that is intended to affect the structure or function of the body of a human or other animal. This definition includes, but is not limited to: dietary supplements as defined by the Federal Food, Drug and Cosmetic Act (FD&C Act), prescription drugs, over-the-counter drugs, residues of pharmaceuticals remaining in containers, personal protective equipment contaminated with residues of pharmaceuticals, and clean-up material from the spills of pharmaceuticals.
This proposed definition of “pharmaceutical” is intended to include all dose forms, including, but not limited to tablets, capsules, medicinal gums or lozenges, medicinal liquids, ointments and lotions, intravenous (IV) or other compounded solutions, chemotherapy pharmaceuticals, vaccines, allergenics, medicinal shampoos, antiseptics, and any delivery device, including medicinal dermal patches, with the primary purpose to deliver or dispense the pharmaceutical. As a rule of thumb, if an over-the-counter product is required by the FDA to include “Drug Facts” on the label, it would be considered a pharmaceutical for the purposes of this rule. EPA asks for comment to identify additional types or forms of pharmaceuticals that are not adequately captured by the definition.
EPA previously proposed to define the term “pharmaceutical” in the December 2008 Pharmaceutical Universal Waste proposal to mean “any chemical product, vaccine or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine or allergenic), not containing a radioactive component, that is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease or injury in man or other animals; or any chemical product, vaccine, or allergenic (including any product with the primary purpose to dispense or deliver a chemical product, vaccine, or allergenic), not containing a radioactive component, that is intended to affect the structure or function of the body in man or other animals. This definition includes products such as transdermal patches, and oral delivery devices such as gums or lozenges. This definition does not include sharps or other infectious or biohazard waste, dental amalgams, medical devices not used for delivery or dispensing purposes, equipment, contaminated personal protective equipment or contaminated cleaning materials.” This definition was adapted from FD&C Act's definition for “drug” 21 U.S.C. 321(g).
Based on the comments received in response to the Pharmaceutical Universal Waste proposal, the Agency is continuing to rely primarily on the FD&C Act's definition for “drug” for the definition of pharmaceutical in this proposal and has preserved most of the definition proposed in the previous proposal. However, EPA is proposing to expand on its previous proposed definition of pharmaceutical based on stakeholder input. In particular, stakeholders requested that the Agency take a broad view in delineating what items are included in the definition of pharmaceutical so that the proposed standards apply broadly. Stakeholders indicated a preference for managing more items under the new standards than trying to determine how to apply the existing RCRA framework to pharmaceutical related items. Thus, the proposed definition of pharmaceutical no longer excludes pharmaceuticals with a radioactive component and includes items not specifically recognized by the U.S. Food and Drug Administration (FDA) as drugs, such as dietary supplements and pharmaceutical residues in containers (including delivery devices), personal protective equipment contaminated with residues of pharmaceuticals, and clean-up material from spills of pharmaceuticals.
EPA's decision to include dietary supplements under this rulemaking's proposed definition of hazardous waste pharmaceutical reflects our interest in promoting a management scheme for all types of pharmaceuticals, and is based upon our understanding that dietary supplements are commonly found in various healthcare settings because they are recommended or prescribed by healthcare providers to patients.
When EPA uses the term “dietary supplements” in our proposed definition of “pharmaceutical,” EPA is referencing the definition for dietary supplement used by the FD&C Act, as amended by the Dietary Supplement Health and Education Act of 1994 (21 U.S.C. 321(ff)).
The Agency also is clarifying that its proposed definition includes any items containing pharmaceutical residuals, such as dispensing bottles, IV bags and tubing, vials, unit dose packages, and delivery devices, such as syringes and patches. In addition, EPA is proposing that items contaminated with or containing residual pharmaceuticals, such as personal protective equipment containing trace amounts of pharmaceuticals or related spill clean-up materials (including loose tablets accumulated during pharmacy floor sweepings) also meet this proposed definition of pharmaceutical. However, this proposed definitions does
The Agency solicits public comment on the proposed definition of “pharmaceutical” in its entirety, and particularly on EPA's decision to incorporate dietary supplements and items containing pharmaceutical residuals as part of the definition of pharmaceutical.
This proposed rule defines “hazardous waste pharmaceutical” as a pharmaceutical that is a solid waste, as defined in § 261.2, and is listed in part 261, subpart D, or exhibits one or more characteristics identified in part 261, subpart C. See Section IV.A.3. of this preamble for a discussion of pharmaceuticals that may be listed or characteristic hazardous wastes.
The Agency is proposing to define the term “hazardous waste pharmaceutical” in order to clarify its intent that only pharmaceuticals (as defined in this proposal) that meet the definition of hazardous waste when disposed or discarded need to be managed under these proposed management standards. This means that any pharmaceutical waste that meets the definition of hazardous waste is a hazardous waste pharmaceutical for the purposes of this rule. For example, the prescription pharmaceutical warfarin (brand name Coumadin) is a listed hazardous waste and when discarded meets the definition of a hazardous waste pharmaceutical. EPA requests public comment on the proposed definition for “hazardous waste pharmaceutical.” The Agency also solicits information on whether any dietary supplements currently on the market meet or potentially could meet RCRA's definition of a hazardous waste.
In order to distinguish hazardous waste pharmaceuticals that are transported to RCRA treatment, storage and disposal facilities (TSDFs) from those hazardous waste pharmaceuticals being returned by a healthcare facility to a pharmaceutical reverse distributor for a determination or verification of manufacturer's credit, the Agency is proposing a definition for “potentially creditable hazardous waste pharmaceutical.”
The proposed rule defines “potentially creditable hazardous waste pharmaceutical” to mean a hazardous waste pharmaceutical that has the potential to receive manufacturer's credit and is
(1) unused or un-administered; and
(2) unexpired or less than one year past expiration date.
The term does not include “evaluated hazardous waste pharmaceuticals,” residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals.
Whether a pharmaceutical is eligible for manufacturer's credit is determined solely by the manufacturer's return policy. Based on comments received for the 2008 Universal Waste proposed rule and through discussions with various stakeholders, the Agency understands that the return policies of manufacturers change regularly. As a result, pharmacies are not always aware if a particular pharmaceutical will be creditable at the time that it is pulled from the shelves. However, the Agency also understands that there are instances where it is well known that a pharmaceutical will not be creditable. Examples of these instances include the following: if the pharmaceutical has been removed from the original container and re-packaged for dispensing purposes; if an attempt was made to administer a pharmaceutical, but the patient refused to take it; if the hazardous waste pharmaceutical was generated during patient care; if the pharmacy receives a return of a dispensed pharmaceutical for which
Also, based on communication with stakeholders and the public comments received on the 2008 Universal Pharmaceutical Waste proposal, EPA understands that pharmaceutical manufacturers' policies often allow for credit to be received on the return of `partials.' Partials is a term used in the industry to refer to opened containers that have had some contents removed. Under the proposed definition, the Agency would consider partials to be potentially creditable hazardous waste pharmaceuticals.
The Agency is soliciting comment on the proposed definition of “potentially creditable hazardous waste pharmaceutical” and whether the definition is broad enough to encompass the various types of hazardous waste pharmaceuticals that are shipped to reverse distributors for manufacturer's credit, while also ensuring that non-creditable hazardous waste pharmaceuticals are not inappropriately shipped to reverse distributors solely for waste management purposes. Finally, the Agency is seeking comment on additional situations where it is well known that a returned pharmaceutical will or will not receive manufacturer's credit.
As discussed previously, there are instances when it is well known that credit will not be received for certain hazardous waste pharmaceuticals. In order to distinguish hazardous waste pharmaceuticals that have the potential for credit from those that have no expectation of receiving credit, the Agency is proposing to define the term “non-creditable hazardous waste pharmaceutical.” The proposed definition of a “non-creditable hazardous waste pharmaceutical” is a hazardous waste pharmaceutical that is not expected to be eligible for manufacturer's credit. Examples include, but are not limited to: if the pharmaceutical has been removed from the original container and re-packaged for dispensing purposes; if an attempt was made to administer a pharmaceutical, but the patient refused to take it; if the hazardous waste pharmaceutical was generated during patient care; if the pharmacy receives a return of a dispensed pharmaceutical for which they had already received compensation by a third-party payer (
After potentially creditable hazardous waste pharmaceuticals arrive at a pharmaceutical reverse distributor, they are evaluated to determine whether they are eligible for manufacturer's credit, or whether they need to be transferred to another pharmaceutical reverse distributor for additional verification of manufacturer's credit. Hazardous waste pharmaceuticals that need to be transferred to another pharmaceutical reverse distributor for additional verification of manufacturer's credit will continue to be considered potentially creditable hazardous waste pharmaceuticals. EPA is proposing that hazardous waste pharmaceuticals for which manufacturer's credit has been issued (and no further verification of credit is required), as well as those that have been deemed non-creditable, be referred to as “evaluated hazardous waste pharmaceuticals.” EPA is proposing to define “evaluated hazardous waste pharmaceutical” as a hazardous waste pharmaceutical that was a potentially creditable hazardous waste pharmaceutical but has been evaluated by a pharmaceutical reverse distributor to establish whether it is eligible for manufacturer's credit and will not be sent to another pharmaceutical reverse distributor for further evaluation or verification. It is important to define this term since the proposed management and shipping standards for potentially creditable hazardous waste pharmaceuticals differ from the proposed management and shipping standards for evaluated hazardous waste pharmaceuticals. For a discussion of the proposed management and shipping standards for potentially creditable hazardous waste pharmaceuticals, see Section V.F.2. For a discussion of the proposed management and shipping standards for evaluated hazardous waste pharmaceuticals, see Section V.F.1.b.
We are proposing to define the term “household waste pharmaceutical” as a solid waste, as defined in § 261.2, that also meets the definition of pharmaceutical, as defined in this proposed rule, but is not a hazardous waste because it is exempt from RCRA Subtitle C regulation by the household waste exclusion in § 261.4(b)(1). We are proposing this term to distinguish this type of waste pharmaceutical from the hazardous waste pharmaceuticals that are proposed to be regulated under this new subpart. This proposed rule does not apply to pharmaceutical waste that is exempt due to the household waste exclusion.
We are proposing to define the term “non-hazardous waste pharmaceutical.” While hazardous waste pharmaceuticals are proposed to be regulated under this new subpart, non-hazardous waste pharmaceuticals will not be regulated under this new subpart, nor the RCRA subtitle C hazardous waste regulations. The Agency is proposing to include this definition since we believe it important to delineate what is and is not regulated under this new subpart. We propose to define the term “non-hazardous waste pharmaceutical” to mean a pharmaceutical that is a solid waste, as defined in § 261.2, but that is not a listed hazardous waste and does not exhibit any characteristics of hazardous waste (
Like the previous definition, we are proposing a definition for non-pharmaceutical hazardous waste to help us delineate what is and what is not regulated under this new subpart. We are proposing to define the term “non-pharmaceutical hazardous waste” as a solid waste, as defined in § 261.2, that is either a listed hazardous waste or exhibits one or more characteristics of hazardous waste, but does not meet the definition of a pharmaceutical, as proposed under this new subpart. The management of non-pharmaceutical hazardous wastes is not regulated under this subpart; rather generators of non-
These proposed regulations differ from those in the Pharmaceutical Universal Waste proposal in that they apply based not only on the type of hazardous waste generated, but also on the sector generating the waste. Accordingly, EPA is proposing a definition for “healthcare facility” so that it is clear to whom these proposed regulations apply. This proposed definition is adapted from the definition of “health care” that the Department of Health and Human Services (DHHS) promulgated as a result of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (45 CFR part 160.103).
EPA proposes to include coroners in the definition of a healthcare facility despite the fact that the services coroners provide occur after life. Coroners will often inventory, and then dispose of, any pharmaceuticals that may be found at the scene of a death. A common method of disposal is sewering. In order to reduce the sewer disposal practices of coroners, and to provide the same management options that are available to other healthcare facilities, EPA has decided to include “coroners” within the definition of healthcare facility, although the Agency solicits comment on including coroners within the definition of healthcare facility.
Under the proposed definition, healthcare facilities include locations that sell pharmaceuticals over the internet, through the mail, or through other distribution mechanisms. A pharmacy does not necessarily have to have a “brick and mortar” or “store front” presence to be considered a healthcare facility for the purposes of this proposed rule. The proposed definition of a “healthcare facility” also applies to entities that engage in drug compounding. In general, compounding is a practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient. The proposed definition of “healthcare facility” applies to state-licensed pharmacies, Federal facilities, and licensed physicians that compound drugs in accordance with section 503A of the FD&C Act, and to outsourcing facilities that compound drugs in accordance with section 503B of the FD&C Act. The Agency is soliciting comment on the proposed definition of “healthcare facility,” including whether it is appropriate to consider these compounders as healthcare facilities within the scope of this proposed rule.
The proposed definition of “healthcare facility” does not apply to pharmaceutical manufacturers and their representatives, wholesalers, or any other entity that is involved in the manufacturing, processing or wholesale distribution of over-the-counter or prescription pharmaceuticals, unless they meet the definition of a “reverse distributor” as discussed in this section and in Section V.G. The purpose for these sector-based regulations is to address the various issues that healthcare facilities and reverse distributors face when managing hazardous waste pharmaceuticals. As noted previously, the Agency does not anticipate that manufacturing facilities, which predictably generate a known range of hazardous wastes, face the same issues as healthcare facilities.
The term “long-term care facility” does not have a standardized, industry definition. EPA is, therefore, proposing the following definition for “long-term care facility” (LTCF): a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, assisted living, hospices, nursing homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of continuing care retirement communities. Not included within the scope of this definition are group homes, independent living communities, and the independent living portions of continuing care retirement communities.
The included facilities are licensed care facilities that are more similar to hospitals than to standard residences. Although group homes may be licensed care facilities, they are typically very small (under 10 beds). Independent living communities are not licensed care facilities, but rather are residences made up of individual units such as townhomes or apartments. Finally, private residences with visiting nurses are not considered long-term care facilities. EPA requests public comment on the proposed definition of long-term care facility, and the inclusion of assisted living facilities, skilled nursing facilities and other LTCFs that administer their residents' pharmaceuticals as an integral part of their services within the definition of “healthcare facility.”
The DEA's definition of “long term care facility” is “a nursing home, retirement care, mental care or other facility or institution which provides extended health care to resident patients” (21 CFR 1300.01). EPA's definition is more descriptive, and includes a list—which is not
As more fully discussed in Section V.G.1 of this preamble, pharmaceutical manufacturers often offer credit to healthcare facilities on the return of unused and/or expired pharmaceuticals.
Some of the pharmaceuticals returned for credit will meet RCRA's definition of a hazardous waste. Due to the fact that the vast majority of pharmaceuticals that are returned for manufacturer's credit are disposed of once credit eligibility is determined, EPA is proposing new standards for shipment of potentially creditable hazardous waste pharmaceuticals (see Section V.F.2.) and the management of potentially creditable hazardous waste pharmaceuticals by reverse distributors (see Section V.G). Thus, EPA is proposing to define pharmaceutical reverse distributor to clearly delineate which types of facilities are subject to this proposed rule. In keeping with how the term is commonly used in the healthcare sector, EPA is proposing to define a “pharmaceutical reverse distributor” as any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer's credit. Any person, including forward distributors and pharmaceutical manufacturers, that processes pharmaceuticals for the facilitation or verification of manufacturer's credit is considered a pharmaceutical reverse distributor.
The Agency also needs to clarify the difference between what is defined as a pharmaceutical reverse distributor for the purpose of these proposed regulations and how DEA regulations define “reverse distribute.” The recently amended DEA regulatory definition of “reverse distribute” is to “acquire controlled substances from another registrant or law enforcement for the purposes of: (1) Return to the registered manufacturer or another registrant authorized by the manufacturer to accept returns on the manufacturer's behalf; or (2) Destruction (21 CFR 1300.01).
Under DEA's definition, a reverse distributor does not necessarily process pharmaceuticals for the purpose of determining manufacturer's credit; rather, their main function under DEA's definition is to destroy the controlled substances. Under EPA's proposed definition, however, a pharmaceutical reverse distributor is defined more broadly as a facility that can accept potentially creditable pharmaceuticals for the purposes of determining manufacturer's credit. These potentially creditable pharmaceuticals may or may not be identified as controlled substances by DEA.
In addition, the Department of Transportation's Pipeline and Hazardous Materials Safety Administration (PHMSA) has defined the closely related term, “reverse logistics,” in a recent proposed rulemaking.
The Agency solicits public comment on its proposed definition of a “pharmaceutical reverse distributor.” Specifically, EPA asks for comment on whether the definition of “pharmaceutical reverse distributor” captures the universe of facilities acting as reverse distributors for pharmaceuticals. In addition, the Agency asks for comment regarding the intersection of DEA and EPA's definitions.
The Agency is now providing notice that it intends to revise this interpretation. Specifically, hazardous waste (including pharmaceuticals) generated at long-term care facilities will no longer be considered exempt as household hazardous waste. It will be regulated as hazardous waste, subject to the appropriate RCRA Subtitle C management standards, including the standards being proposed. The Agency is revising its interpretation with regard to hazardous wastes generated at long-term care facilities based on a reevaluation of how such facilities operate. Specifically, in order for hazardous waste to qualify for the household hazardous waste exemption of § 261.4(b)(1), it must meet two criteria: (1) The hazardous waste must be generated by individuals on the premises of a household, and (2) the hazardous waste must be composed primarily of materials found in the wastes generated by consumers in their homes.
First, a long-term care facility is more akin to a hospital than it is a typical residence and EPA does not consider hospitals to be households. Long-term care facilities are licensed, residential care settings that offer their residents a wide range of services, many of which are centered on administering medications and providing healthcare by various professional healthcare providers, such as medical technicians, nurse's aides, nurses, and doctors. Other services provided involve assistance in performing activities of daily living, such as bathing, and eating. A 2012 American Association of Retired Person (AARP) Public Policy Institute report indicates that there is an average of 24 beds per licensed residential care facilities (excluding nursing homes).
Second, the hazardous wastes generated by long-term care facilities do not meet the second criteria for the waste to be considered household hazardous waste. This is primarily due to the quantity of pharmaceutical wastes that are often generated on the premises of long-term care facilities when compared to a typical residence. For example, the Colorado Department of Public Health and Environment estimates that a 100-bed nursing home might expect to generate approximately 120 to 336 pounds of pharmaceutical waste per year.
EPA is proposing one additional change for CESQGs in order to allow them to continue to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor. Currently, under § 261.5, CESQGs are limited in where they may send their hazardous waste for treatment and disposal (see § 261.5(f)(3)(i)-(vii) for acute hazardous waste and § 261.5(g)(3)(i)-(vii) for hazardous waste). However, in § 266.504(a) we are proposing to allow CESQGs to send their potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor. Without this change, CESQGs would be required to send all their hazardous waste pharmaceuticals, including those that are potentially creditable, to one of the types of facilities in § 261.5, which does not include a pharmaceutical reverse distributor. Although we are proposing to make this change within part 266, subpart P, we request comment on whether stakeholders would prefer this change to be made within § 261.5 instead. CESQGs will still be required to send their non-pharmaceutical hazardous waste and their non-creditable hazardous waste pharmaceuticals to one of the types of facilities listed in § 261.5.
In addition, it has been suggested that EPA seek comment on providing a rebuttable presumption that LTCFs with fewer than 10-beds are assumed to be CESQGs and thus would not be required to count the amount of hazardous waste generated each month. Under this presumption, they would be subject to all the requirements for CESQGs as described elsewhere in this proposal, including the requirement not to sewer hazardous waste pharmaceuticals. Therefore, EPA asks for comment on this rebuttable presumption and specifically whether the 10-bed cut off is appropriate or whether there are other criteria EPA should take into account. Further, EPA asks for commenters to submit data to support a 10-bed cut off to show that LTCFs with fewer than 10-beds are generally CESQGs. Alternatively, if comments wish to support a different cut-off for the rebuttable assumption, EPA also asks that the commenters submit information/data to support their suggested cut-off.
“EPA excluded household wastes because the legislative history of RCRA indicated an intent to exclude such wastes, though
The Agency recommends that, whenever possible, households utilize pharmaceutical collection and take-back events as the disposal option for their unwanted pharmaceuticals. For consumers without access to a pharmaceutical take-back event, FDA provides information on the disposal of unused pharmaceuticals and step-by-step guidance for disposing of pharmaceuticals in the household trash. For more information on the safe disposal of household pharmaceuticals, please see:
i.
ii.
iii.
As is discussed in the Joint NRC/EPA Guidance on Testing Requirements for Mixed Radioactive and Hazardous Waste (62 FR 62079, 62085; November 20, 1997), an inconsistency occurs when compliance with one statute or set of regulations would necessarily cause non-compliance with the other statute or set of regulations. Relief from the regulatory inconsistency would be provided by the AEA requirement overriding the specific RCRA requirement. It is important to note, however, that the determination of an inconsistency would relieve the healthcare facility only from compliance with the specific RCRA requirement(s) that is deemed inconsistent with the AEA requirement(s); it would still be required to comply with all of the other hazardous waste pharmaceutical management standards.
Wastes that are not included in the scope of this proposed rule include non-hazardous wastes or non-pharmaceutical hazardous wastes. Pharmaceutical wastes that are not listed or characteristic hazardous wastes under RCRA Subtitle C may nonetheless pose some risks to public health and the environment. These wastes are discussed further below.
If a healthcare facility decides to segregate its hazardous and non-hazardous pharmaceuticals, EPA recommends that healthcare facilities follow the best management practices (BMPs) outlined in the “Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States” (Practice Greenhealth, Revised August 2008)
i.
ii.
After a healthcare facility determines it is subject to this proposed rule and manages its hazardous waste pharmaceuticals under part 266, subpart P, it is no longer required to count the hazardous waste pharmaceuticals that it generates towards its generator category. As a result, the healthcare facility may experience a change in RCRA generator category for its non-pharmaceutical hazardous waste. For example, a healthcare facility may shift from being an LQG to a SQG or even CESQG by not counting its hazardous waste pharmaceuticals toward its generator category, especially when acute hazardous waste pharmaceuticals such as warfarin (brand name: Coumadin) no longer need to be counted. A shift in generator category, should it occur, would allow a healthcare facility to manage its non-pharmaceutical hazardous waste, such as hazardous waste from laboratories, according to the reduced generator requirements. It is important to note that only when a healthcare facility is managing its hazardous waste pharmaceuticals under the new proposed subpart does it have the benefit of not counting them towards its generator category (see Section VI.
This section discusses the proposed management standards for healthcare facilities (except CESQGs) that manage non-creditable hazardous waste pharmaceuticals, which include the following:
(1) Notification requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(2) personnel training requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(3) making a hazardous waste determination for non-creditable hazardous waste pharmaceuticals;
(4) elimination of central accumulation area and satellite accumulation area requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(5) container standards for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(6) labeling standards on containers for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(7) accumulation time limits for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(8) land disposal restrictions for non-creditable hazardous waste pharmaceuticals;
(9) procedures for shipping non-creditable hazardous waste pharmaceuticals off-site from healthcare facilities;
(10) procedures for managing rejected shipments of non-creditable hazardous waste pharmaceuticals from healthcare facilities;
(11) reporting requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(12) recordkeeping requirements for healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(13) procedures for responses to releases by healthcare facilities managing non-creditable hazardous waste pharmaceuticals;
(14) special requirements for long-term care facilities managing non-creditable hazardous waste pharmaceuticals;
(15) conditions for healthcare facilities that accept hazardous waste pharmaceuticals from off-site CESQGs; and
(16) a prohibition of sewering hazardous waste pharmaceuticals for all healthcare facilities; (see section V.E.1. of the preamble,
The proposed management standards discussed in this section only apply to hazardous waste pharmaceuticals that are non-creditable hazardous waste pharmaceuticals (
In order to address commenters' concerns from the 2008 Pharmaceutical Universal Waste proposal that regulatory agencies are unaware of hazardous waste pharmaceutical management activities, EPA is proposing to require that a healthcare facility that does not qualify as a CESQG to submit a one-time notification as a “healthcare facility” to the appropriate EPA Regional Administrator. Healthcare facilities subject to 40 CFR part 266, subpart P will have to submit notification even if the healthcare facility has previously obtained an EPA identification number. The required notification will enable EPA and state regulatory agencies to identify the universe of healthcare facilities managing hazardous waste pharmaceuticals subject to the 40 CFR part 266, subpart P requirements. In addition, having this information allows EPA and state environmental regulatory agencies to track healthcare facilities for enforcement and inspection purposes, ensuring the hazardous waste pharmaceuticals are managed in accordance with the regulations.
At any point a healthcare facility's hazardous waste pharmaceutical generation may change due to waste minimization efforts or other reasons, causing the facility to legitimately decrease its total monthly hazardous waste generation enough to qualify as a CESQG. In this case, if the healthcare facility plans to withdraw from the 40 CFR part 266, subpart P requirements due to qualifying as a CESQG, it will be required to re-notify EPA of its choice to withdraw.
Alternatively, if a healthcare facility determines that it is a CESQG,
The Agency is proposing that this notification occur via the RCRA Subtitle C Site Identification Form (EPA Form 8700-12; or Site Identification Form).
If this notification requirement is finalized, the Site Identification Form will be modified by EPA in a separate action.
The Agency does not anticipate that this proposed notification requirement will place any undue economic burden upon healthcare facilities or the environmental regulatory agencies that process these notifications (see the Regulatory Impact Analysis for the proposed rule in the rulemaking docket EPA-HQ-RCRA-2007-0932). In fact, under these proposed regulations, healthcare facilities would no longer need to count the hazardous waste pharmaceuticals managed under 40 CFR part 266, subpart P towards a healthcare facility's generator category. As a result, EPA anticipates that many healthcare facilities will change their generator category to either a SQG or CESQG for their other, non-pharmaceutical hazardous wastes. So while the notification requirement ensures that the environmental regulatory agencies are informed of all hazardous waste pharmaceutical management activities subject to the 40 CFR part 266, subpart P requirements in their jurisdictions, the fact that some healthcare facilities will no longer qualify as LQGs will reduce the number of healthcare facilities in the LQG universe. Because LQGs are inspected more frequently than SQGs or CESQGs, EPA expects this could result in an overall decrease in burden for both
The Agency is soliciting comment on the notification requirement for healthcare facilities, the method of notification via the Site Identification Form, and whether this notification requirement will result in any undue burden to either healthcare facilities or state environmental regulatory agencies.
Under the current RCRA Subtitle C regulations, an LQG healthcare facility must provide RCRA training to its healthcare workers involved in the generation and/or management of hazardous waste. Under § 262.34(a)(4), LQGs are required to comply with the personnel training requirements for interim status TSDFs (which are found in § 265.16). These personnel training requirements include either classroom instruction or on-the-job training in RCRA and state that the facility must maintain training documents and records for each trained staff person. On the other hand, under current regulation, healthcare facilities that are SQGs must meet a performance-based standard when training their healthcare workers. This entails ensuring “that all employees are thoroughly familiar with proper waste handling and emergency procedures relevant to their responsibilities during normal facility operations and emergencies” (§ 262.34(d)(5)(iii)). For comparative purposes, healthcare facilities that are considered CESQGs do not have any personnel training requirements under the current federal regulations. Similarly, generators, including healthcare facilities, are not required to provide RCRA training to personnel that only work in satellite accumulation areas regulated under § 262.34(c). However, healthcare personnel that are involved in the generation of pharmaceutical waste must be familiar enough with the pharmaceuticals with which they are working to know when they have generated a hazardous waste so that it will be managed in accordance with the RCRA regulations.
EPA believes that the LQG RCRA training requirement is excessive for healthcare workers who sporadically generate hazardous waste pharmaceuticals at healthcare facilities, but believe it is necessary to have some familiarity with the dangers that hazardous waste pharmaceuticals can pose. Therefore, the Agency is proposing healthcare facility-specific personnel training requirements that are akin to the training requirements for SQGs and small quantity universal waste handlers. Specifically, healthcare facilities managing their hazardous waste pharmaceuticals in accordance with the proposed healthcare facility standards must inform all employees that handle or have responsibility for generating and/or managing hazardous waste pharmaceuticals of the proper handling and emergency procedures appropriate to their responsibilities during normal facility operations and emergencies. This training information can be disseminated through verbal communication or through distribution of pamphlets or other documentation. However, a healthcare facility that is an LQG due to its non-pharmaceutical hazardous wastes may choose to continue to use its existing training program as an LQG so as not to have different training programs and that would be acceptable, as well.
The Agency solicits comments on the personnel training requirements proposed in this document for healthcare facilities managing hazardous waste pharmaceuticals. Specifically, the Agency is seeking comment regarding the appropriateness of these personnel training requirements and if these requirements will be sufficient for communicating key procedures to healthcare workers that generate and/or manage hazardous waste pharmaceuticals.
EPA is seeking comment on whether documentation of training is necessary in order to verify compliance with the training requirement. Based on the comments received, we may include a requirement in the final rule for documenting and retaining records of healthcare personnel training. Finally, the Agency wants to reiterate that these proposed personnel training requirements only apply to staff generating and/or managing hazardous waste pharmaceuticals. The training requirements of 40 CFR part 262 will continue to apply to staff generating and/or managing other types of hazardous wastes at the healthcare facility.
Similar to the current RCRA Subtitle C generator requirements, healthcare facilities will still be required to make a hazardous waste determination on pharmaceutical wastes prior to managing them under the proposed cradle-to-grave standards. Therefore, when a healthcare facility generates a solid waste pharmaceutical, the healthcare facility must determine if the pharmaceutical waste is listed in 40 CFR part 261, subpart D and if it exhibits one or more of the four characteristics of hazardous waste identified in 40 CFR part 261, subpart C. However, unlike the existing generator requirements, the healthcare facility does not need to identify the specific waste codes applying to the pharmaceutical wastes. If the pharmaceutical waste is determined to be a hazardous waste, then the healthcare facility must manage the hazardous waste pharmaceuticals in accordance with these proposed requirements instead of 40 CFR part 262. Pharmaceutical wastes not meeting the definition of a hazardous waste (
EPA understands that healthcare facilities utilize various approaches when making hazardous waste determinations. For example, healthcare facilities may hire contractors to review their formularies and identify those pharmaceuticals that are hazardous wastes when discarded. These facilities may then identify hazardous waste pharmaceuticals at the pharmacy level, marking these pharmaceuticals with a special label so that healthcare personnel know how to properly dispose of the pharmaceutical when it becomes a waste. Other healthcare facilities may instruct personnel to dispose of all pharmaceutical wastes into one RCRA hazardous waste collection container. These facilities may then choose to manage all of the contents of the container as hazardous waste or they may choose to sort the hazardous waste portion from the non-hazardous waste pharmaceutical portion in the central accumulation area. Due to the various ways that healthcare facilities make the hazardous waste determination, the Agency is not proposing that a specific approach be utilized when making the determination, only that the facility performs the waste determination. However, healthcare facilities may choose to manage all of their pharmaceutical wastes as hazardous, and thus, if a healthcare facility chooses this approach, they would not need to make individual hazardous waste determinations, but would have made a generic decision that all of their waste pharmaceuticals are hazardous and manage them as hazardous waste pharmaceuticals in accordance with the proposed requirements in 40 CFR part 266, subpart P.
Hazardous waste pharmaceuticals are generated at numerous locations across a healthcare facility. Under the current RCRA Subtitle C requirements, each location at the healthcare facility with a RCRA hazardous waste receptacle for the disposal of hazardous waste pharmaceuticals is considered a satellite accumulation area and is subject to volume accumulation limits and other requirements.
For the reasons articulated in the Pharmaceutical Universal Waste proposal, the Agency has decided that a healthcare facility accumulating hazardous waste pharmaceuticals will not be subject to the satellite accumulation area regulations or the central accumulation area regulations (also sometimes called less than 90- or 180-day areas), but rather to the proposed accumulation time limits and container standards.
A healthcare facility may choose to accumulate hazardous waste pharmaceuticals within its 90- or 180-day central accumulation area if it has one established for its other hazardous wastes as long as it maintains compliance with the proposed accumulation time limit and container requirements of 40 CFR part 266, subpart P. The Agency notes that even if the hazardous waste pharmaceuticals are accumulated in a 90- or 180-day central accumulation area, these hazardous waste pharmaceuticals are not subject to the 90- or 180-day requirements. EPA solicits public comment on its decision to not require hazardous waste pharmaceutical-specific central and satellite accumulation area requirements.
The container standards discussed in this section apply to those containers used by healthcare facilities to accumulate, store and transport non-creditable hazardous waste pharmaceuticals.
The Agency is proposing to require that healthcare facilities pack hazardous waste pharmaceuticals into containers that are structurally sound and that are compatible with the hazardous waste pharmaceuticals that will be contained within them. EPA intends this requirement to mean that containers used for holding hazardous waste pharmaceuticals must be in good condition, with no severe rusting, apparent structural defects, or deterioration. Containers also must not have any evidence of leakage, spillage or damage that could result in the release of waste under reasonably foreseeable circumstances. Furthermore, the Agency is proposing to require that incompatible wastes not be placed in the same container, unless the co-mingling of incompatible hazardous wastes is conducted in such a way that it does not have the potential to (1) generate extreme heat or pressure, fire or explosion, or violent reaction; (2) produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health; (3) produce uncontrollable flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions; (4) damage the structural integrity of the facility or container containing the hazardous waste pharmaceuticals; or (5) through other like means threaten human health or environment. For example, the majority of a healthcare facility's non-creditable hazardous waste pharmaceuticals are likely organic in nature, and thus, compatible with each other and can be accumulated together, especially since they will most likely be incinerated once they are transported to a TSDF. However, some non-creditable hazardous waste pharmaceuticals, such as metal bearing wastes not containing sufficient organics, are prohibited from being incinerated (
The Agency believes that these technical standards, like similar technical standards that EPA has promulgated in § 265.17 for interim status TSDFs, would ensure that hazardous waste pharmaceuticals are properly managed and would not be released into the environment, while at the same time providing flexibility to the healthcare facility in selecting those containers that are most appropriate for their situation.
In addition to the proposed container standards, the Agency is also proposing that accumulation containers for hazardous waste pharmaceuticals be secured in a manner that prevents unauthorized access to the contents in order to prevent the pilfering of hazardous waste pharmaceuticals or inadvertent exposures to them. As we have noted previously, hazardous waste pharmaceuticals still retain considerable value and can easily be diverted for illicit purposes. To ensure this does not occur, we believe it is important to propose a requirement that would prevent the unauthorized access to the contents of these containers. EPA intends this requirement to be performance-based and does not intend to propose prescriptive regulatory requirements for this standard. The Agency believes that healthcare facilities can choose to utilize containers that have built-in mechanisms to prevent access to their contents or can choose to store containers in locked storage lockers, closets or rooms where the public does not have access to the containers or their contents.
The Agency is seeking comment on the appropriateness of the proposed container management standards. In addition, the EPA is soliciting comment on the proposed requirement for ensuring that the hazardous waste pharmaceuticals contained in collection containers remain secure.
During the period of accumulation and storage, the Agency is proposing that containers of hazardous waste pharmaceuticals be marked with the words “Hazardous Waste Pharmaceuticals.” The Agency is not proposing to require that the hazardous waste numbers (often referred to as hazardous waste codes) of the container's contents be listed on the label. The personnel at healthcare facilities that typically generate the hazardous waste pharmaceuticals will be healthcare workers (
Several hazardous waste pharmaceuticals are P-listed, acute hazardous wastes (
Under the 2008 Pharmaceutical Universal Waste proposal, universal waste handlers would have had one year for accumulation of its hazardous waste pharmaceuticals in order to facilitate proper treatment and disposal. Commenters on the 2008 Universal Waste proposed rule indicated support for the one-year accumulation time limit. Thus, the Agency is proposing to allow healthcare facilities to accumulate hazardous waste pharmaceuticals for up to one year, without having interim status or a RCRA permit. As with Universal Waste, one year is an appropriate timeframe because it strikes a balance between allowing healthcare facilities enough time to accumulate amounts of hazardous waste pharmaceuticals to make it economically viable for transporting their hazardous waste pharmaceuticals off-site while ensuring that the hazardous wastes are not accumulated beyond the one year storage limit under the land disposal restrictions programs (see § 268.50).
Healthcare facilities will have various approaches to demonstrate the length of time that hazardous waste pharmaceuticals are accumulated on-site. For example, a healthcare facility can choose to mark the container label with the date that accumulation first began, maintain an inventory system that identifies dates when the hazardous waste pharmaceuticals were first accumulated, identify in the central accumulation area
Finally, the Agency reiterates that the one-year accumulation time limit only applies to a healthcare facility's non-creditable hazardous waste pharmaceuticals and does not apply to any other types of hazardous waste generated on-site or to potentially creditable hazardous waste pharmaceuticals. EPA solicits comment on the proposed accumulation time limit of one year in order to allow healthcare facilities to generate enough non-creditable hazardous waste pharmaceuticals for cost-effective shipment, and solicits comment on the proposed mechanism to request a time extension.
Similar to the current RCRA Subtitle C generator requirements, healthcare facilities must comply with the land disposal restrictions (LDR) prior to land disposal of the hazardous waste pharmaceuticals they generate. Since healthcare facilities are generators, even though they are not subject to the 40 CFR part 262 requirements for the management of hazardous waste pharmaceuticals, they must comply with the land disposal restrictions found at 40 CFR part 268. The land disposal restrictions are in place to ensure that toxic constituents present in hazardous waste are properly treated to reduce their mobility or toxicity before hazardous waste is placed into or onto the land (
In general, generators of hazardous waste assign the appropriate hazardous waste numbers codes to allow TSDFs to determine the specific treatment standard(s) for each prohibited waste. The Agency is proposing that healthcare facilities generating non-creditable hazardous waste pharmaceuticals do not have to assign hazardous waste codes to these wastes, but rather label them as “hazardous waste pharmaceuticals”. They do, however, need to be aware that
Tables 2 through 4 list the hazardous waste pharmaceuticals with their hazardous waste codes and their LDR treatment standards.
The organic hazardous waste pharmaceuticals (other than arsenic trioxide) may all be incinerated at RCRA permitted or interim status hazardous waste combustors. As noted in Tables 2-4, most of the organic wastes have a specified treatment standard of combustion (CMBST). The remaining seven organics (lindane, chloroform, m-cresol, dichlorodifluoro methane, trichloromonofluoromethane, phenacetin and phenol) have numerical treatment standards, such that no particular treatment technology is specified or required in order to achieve the numerical treatment standards. While these wastes may be incinerated, the incinerator residue (ash) must be analyzed for these seven organic constituents to demonstrate compliance with the LDR treatment standards before that ash can be disposed.
As mentioned earlier, because this proposed rule does not require that healthcare facilities label their waste with the hazardous waste codes, the TSDF must always analyze the incinerator ash for these seven constituents—lindane, chloroform, m-cresol, dichlorodifluoro methane, trichloromonofluoromethane, phenacetin, and phenol—according to their waste analysis plan, as they could possibly be present in any shipment of organic hazardous waste pharmaceuticals.
Emissions from combustion units that burn hazardous waste
To ensure continuous compliance with the emission limits, hazardous waste combustors are required to establish limits on (1) the feedrate of metals (including mercury), chlorine, and (for some types of hazardous waste combustors) ash; (2) combustor operating parameters such as minimum combustion chamber temperature; and (3) operating parameters of the air pollution control device. For mercury, continuous compliance requirements would generally include a limit on the total feedrate of mercury in all feedstreams to the combustion unit, limits on the operation of a wet scrubber (depending on the species of mercury in the combustion gases, wet scrubbers can be efficient at removing mercury), and operating limits on the activated carbon injection or carbon bed system, if such systems are used.
In addition, RCRA directs permitting authorities to impose additional terms and conditions on a site-specific basis as may be necessary to protect human health and the environment (see § 270.32(b)). Thus, if the mercury emission limits specified previously are not protective in an individual instance, the permit writer will establish permit limits that are protective.
Nevertheless, EPA is aware that some stakeholders are concerned about the risks associated with incinerating mercury-bearing hazardous wastes and we encourage healthcare facilities and pharmaceutical reverse distributors to consider the use of treatment technologies other than incineration for meeting the numeric treatment standards for mercury-bearing hazardous waste pharmaceuticals. Thimerosal-containing pharmaceuticals are expected to be non-wastewaters as defined by § 268.2, because they have more than 1% total organic carbon. For low mercury non-wastewaters, the numeric treatment standard can be achieved by stabilization/solidification, either with or without subsequent encapsulation.
The Agency is proposing to maintain the current RCRA Subtitle C tracking requirement by requiring that a hazardous waste manifest be prepared for each off-site shipment of non-creditable hazardous waste pharmaceuticals from healthcare facilities. Accordingly, each off-site shipment of hazardous waste pharmaceuticals must be transported to an interim status or permitted TSDF via a hazardous waste transporter. However, the Agency is proposing that for hazardous waste pharmaceuticals shipped by healthcare facilities, the RCRA hazardous waste codes do not need to be listed on the manifest. This is intended to accommodate the fact that healthcare providers generating the hazardous waste pharmaceuticals are generally unfamiliar with RCRA and are focused on providing healthcare to patients. One function of the hazardous waste codes is to determine the appropriate hazardous waste treatment standards under the land disposal restrictions (part 268). However, virtually all hazardous waste pharmaceuticals sent for off-site treatment are sent to hazardous waste incinerators, even when the treatment standard does not require incineration. The fact that EPA is proposing to not require hazardous waste codes for shipping hazardous waste pharmaceuticals is not intended to alter or impact any Department of Transportation (DOT) requirements for the shipment of these hazardous wastes. For a more detailed discussion of these proposed requirements, as well as the basis for these requirements, please see Section V.F.1 of this document.
In rare circumstances, a healthcare facility may send its non-creditable hazardous waste pharmaceuticals to a designated facility that is unable to manage the hazardous waste. For such situations, we are proposing that healthcare facilities follow the same procedures listed in 40 CFR part 262 (see § 262.23(f)). Specifically, if a designated facility is unable to accept the hazardous waste pharmaceuticals, and it returns the hazardous waste pharmaceuticals to the healthcare facility, the healthcare facility must sign the manifest that was used to return the shipment, provide the transporter a copy of the manifest, send a copy of the manifest within thirty days to the designated facility that returned the shipment and retain a copy of the manifest for three years from the date of delivery of the returned shipment. EPA believes that it is appropriate to continue current practices for rejected shipments that are part of the generator regulations of 40 CFR part 262 because rejected shipments are relatively rare and the procedures currently used for rejected shipments is relatively straightforward. In addition, healthcare facilities should be familiar with these procedures already.
The Agency is proposing that healthcare facilities managing non-creditable hazardous waste pharmaceuticals have reporting requirements similar to SQGs s regulated under 40 CFR part 262—that is, the exception reporting requirement under § 262.44(b) and the additional reporting requirement under § 262.44(c). In addition, we are proposing that healthcare facilities that are LQGs would no longer be required to include their hazardous waste pharmaceuticals on their biennial report (BR). Each of these reporting requirements for healthcare facilities is discussed below.
First, as part of the current RCRA Subtitle C generator requirements, healthcare facilities that are LQGs must submit a BR to the Regional Administrator by March 1st of every even numbered year (see § 262.41). Among other requirements, the BR must include a description (EPA hazardous waste number and DOT hazard class) and quantity of each hazardous waste shipped off-site to a TSDF during each odd numbered year. If a healthcare facility is an LQG due to its non-pharmaceutical hazardous waste, it will continue to be required to submit a BR. However, it need not include its hazardous waste pharmaceuticals in its BR. As discussed previously, the Agency is no longer requiring healthcare facilities to count hazardous waste pharmaceuticals when determining their generator category. Instead, all healthcare facilities, with the exception of CESQGs, will be subject to this proposed rule. The Agency has determined that it does not need the information to be included in the BR because this proposed rule will bring a consistent approach to managing pharmaceutical hazardous wastes. Nevertheless, the Agency is soliciting public comment on whether the Agency should require healthcare facilities—that is, all healthcare facilities subject to the 40 CFR part 266, subpart P requirements—to submit a BR, and if so, the type of information that should be included.
Second, the Agency is proposing that healthcare facilities follow the same reporting procedures for exception reporting that generators operating under the 40 CFR part 262 must follow. We are proposing to incorporate the generator exception reporting procedures in this new subpart. Specifically, if a healthcare facility does not receive a copy of the hazardous waste manifest from the designated facility within 60 days, the healthcare facility must submit to the EPA Regional Administrator a copy of the manifest with a statement that the healthcare facility did not receive confirmation of the hazardous waste pharmaceuticals' delivery along with an explanation of the efforts taken to locate the hazardous waste pharmaceuticals and the results of those efforts. Likewise, if a shipment of hazardous waste pharmaceuticals from a healthcare facility is rejected by the designated facility and it is shipped to an alternate facility and if the healthcare facility does not receive a signed copy of the hazardous waste manifest from the alternate facility within 60 days, it must submit to the EPA Regional Administrator a copy of the hazardous waste manifest with a statement that the healthcare facility did not receive confirmation of the hazardous waste pharmaceuticals' delivery along with an explanation of the efforts taken to locate the hazardous waste pharmaceuticals and the results of those efforts. Again, the Agency believes it is advantageous to use established procedures that should be familiar to healthcare facilities, especially given that rejected shipments are relatively rare.
Finally, the Agency proposes that the Administrator may require healthcare facilities to furnish additional reports concerning the quantities and disposition of hazardous waste pharmaceuticals. This is already the case for generators operating under the 40 CFR part 262 requirements. As with 40 CFR part 262, it is a codification of statutory authority under §§ 2002(a) and 3002(a)(6) that provides the Agency some flexibility in what reports may be required. The Agency solicits public comment on the proposed reporting requirements for healthcare facilities managing their hazardous waste pharmaceuticals in accordance with the standards proposed in this document.
The Agency is proposing that healthcare facilities managing non-creditable hazardous waste pharmaceuticals maintain records similar to the records that must be kept by generators regulated under 40 CFR part 262 (see § 262.40). Specifically, healthcare facilities must keep a signed copy of each hazardous waste manifest as a record for three years from the date that the non-creditable hazardous waste pharmaceutical was accepted by the initial hazardous waste transporter. If the healthcare facility is required to file an exception report because it does not receive a signed copy of the manifest from the designated facility within 60 days of the date that the hazardous waste pharmaceutical was accepted by the initial transporter, then the healthcare facility must keep a copy of the each exception report for a period of at least three years from the due date of the report.
The Agency is also proposing that any of the retention periods be extended during the course of enforcement actions against any activity associated with hazardous waste pharmaceutical management or as requested by the Administrator to ensure that the appropriate records are available and can be reviewed as part of any enforcement action. The Agency solicits public comment on the proposed recordkeeping requirements for healthcare facilities managing their non-creditable hazardous waste pharmaceuticals in accordance with the standards proposed in this document.
For hazardous waste pharmaceuticals generated and managed by healthcare facilities under the proposed standards, the Agency is proposing basic release responses, including the requirement that healthcare facilities immediately contain all releases of, and other residues from, hazardous waste pharmaceuticals. In addition, this proposal would require healthcare facilities to determine whether any material, residue, or debris resulting from the release is or contains a hazardous waste pharmaceutical and, if so, to manage it under the management standards for hazardous waste pharmaceuticals proposed in this document. These proposed release response procedures are the same as those under the Universal Waste program (see § 273.17 for small quantity universal waste handlers, and § 273.37 for large quantity universal waste handlers). Commenters to the 1993 proposed rule that established the Universal Waste program overwhelmingly supported the release response measures (60 FR 25528; May 11, 1995). Thus, we believe it is appropriate to include it again in this proposal.
Any releases of hazardous waste pharmaceuticals not cleaned up immediately would generally constitute illegal disposal, which may result in further action by EPA or an authorized state under RCRA. In addition, hazardous wastes under RCRA are included in the definition of hazardous substances for purposes of the Comprehensive Environmental Response Compensation, and Liability Act (CERCLA) (
The Agency solicits comment regarding the proposed standard for the response to releases of hazardous waste pharmaceuticals at healthcare facilities.
Long-term care facilities differ in one respect from other types of healthcare facilities subject to these proposed standards. Unlike hospitals, who own the pharmaceuticals they dispense to patients, many of the hazardous waste pharmaceuticals generated at long-term care facilities belong to the residents of the facility. That is, the pharmaceuticals are dispensed under the patient's name. However, as previously discussed in this preamble, EPA is proposing to no longer allow hazardous waste pharmaceuticals generated at long-term care facilities (as defined under this proposed regulation) to be eligible for the household hazardous waste exemption. As a result, long-term care facilities must manage all hazardous waste pharmaceuticals generated on-site, regardless of ownership, in accordance with these same proposed management standards for healthcare facilities. EPA understands that while long-term care facilities often maintain each individual's pharmaceuticals in a centralized location, such as a pharmaceutical cart, there are instances where some individuals may keep and self-administer their own pharmaceuticals. EPA is proposing that the long-term care facilities collect and manage all hazardous waste pharmaceuticals generated at their facilities in accordance with these proposed requirements. This requirement means that in addition to the hazardous waste pharmaceuticals kept in the centralized location, long-term care facilities will need to collect all other hazardous waste pharmaceuticals from individuals that self-administer these pharmaceuticals and manage them in accordance with these proposed standards, which, among other things, prohibits the sewering of hazardous waste pharmaceuticals. The Agency solicits comment on the extent to which long-term care facilities keep an inventory of the pharmaceuticals that individuals self-administer, as this would facilitate the collection of the hazardous waste pharmaceuticals for proper disposal.
Although long-term care facilities would not be required under this rule to collect non-hazardous waste pharmaceuticals, or hazardous waste pharmaceuticals from the independent living portion of a continuing care facility, EPA recommends that long-term care facilities collect all waste pharmaceuticals to ensure proper management, avoid flushing, and minimize the potential for accidental poisonings, misuse or abuse. As discussed later in this preamble, DEA regulations govern the management of controlled substances (see Section V.E.2.a of the preamble for a discussion of DEA's 2014 final rule for the disposal of controlled substances and the implications of that rule and this proposed rule for long-term care facilities.
The Agency solicits comment regarding this requirement, and specifically requests comment on the various approaches that long-term care facilities use, or could use in collecting hazardous waste pharmaceuticals from individuals that self-administer their pharmaceuticals.
Typically, hazardous waste pharmaceuticals from healthcare facilities are transported either to a reverse distributor, if it is potentially creditable,
EPA data indicates that the majority of long-term care facilities are CESQGs
EPA thinks it would be preferable to allow healthcare facilities that are CESQGs to send their hazardous waste pharmaceuticals to another healthcare facility rather than send it to a municipal or non-municipal non-hazardous solid waste landfill. Therefore, EPA is proposing to allow healthcare facilities that are CESQGs operating under this subpart to send their hazardous waste pharmaceuticals to an off-site healthcare facility, without a hazardous waste manifest, provided four conditions are met. First, the receiving healthcare facility must be contracted to supply pharmaceutical products to the CESQG long-term care facility, or the CESQG healthcare facility and the receiving healthcare facility must both be under the control
The Agency solicits comment on this new provision under this subpart, including whether any additional conditions should be imposed. In recommending any additional conditions, the Agency requests that commenters provide their rationale for the additional condition(s), as well as why such additional condition(s) would not pose an undue burden on healthcare facilities that are CESQGs. In addition, the Agency solicits comment on whether it might be appropriate to allow facilities, other than those meeting the proposed definition of a healthcare facility, to accept hazardous waste pharmaceuticals from an off-site CESQG (
One difference between this proposal and the 2008 Pharmaceutical Universal Waste proposal is the proposed interpretation of how RCRA applies to pharmaceuticals that are returned to reverse distributors to obtain manufacturers' credit. Two previous agency policy memos set out EPA's existing understanding of the status of these “creditable” pharmaceuticals. The
In this action, we are proposing to modify EPA's position regarding the waste status of creditable pharmaceuticals. Because we understand that many participants in this sector have relied on the interpretations in the two letters and the 2008 Pharmaceutical Universal Waste preamble, we are providing notice of a change in EPA's position and providing an opportunity for public comment. Until this rule is final and effective, however, EPA's previous interpretations will continue to be in effect.
In terms of the concept that returned pharmaceuticals have value and are not waste, EPA confirms the general rule under RCRA that materials that are discarded are solid wastes, regardless of the economics of the system in which those discarded materials are handled. Therefore, the fact that a material may have monetary value (
Commenters to the 2008 Pharmaceutical Universal Waste proposal, the 2014 Retail Notice of Data Availability (NODA), stakeholders, and pharmaceutical reverse distributors themselves have informed EPA that pharmaceuticals transported to reverse distributors to receive credit are rarely, if ever, repurposed, recycled, or reused. One commenter wrote, “. . . EPA's belief that reverse distributors first arrange to transport and receive the drugs, and then determine whether the drugs are useful products or wastes, is pure fiction.”
All donated drugs must not be expired and must have a verified future expiration date.
Controlled substances, defined by the federal Drug Enforcement Administration (DEA) usually be excluded and prohibited.
A state-licensed pharmacist or pharmacy to be part of the verification and distribution process.
Each patient who is to receive a drug must have a valid prescription form in his/her own name.”
Thus, in most, if not all cases, pharmaceuticals that are transported back to a reverse distributor for credit are discarded by the reverse distributor.
Therefore, EPA is proposing to reinterpret its position such that the decision to send a pharmaceutical to a reverse distributor is the point at which a decision has been made to discard the pharmaceutical. As a result, once the decision is made to send a hazardous waste pharmaceutical to a reverse distributor, it is a solid waste at the healthcare facility. In this document, EPA is proposing to define the term “potentially creditable hazardous waste pharmaceutical.” A portion of the potentially creditable pharmaceuticals at healthcare facilities that are transported to reverse distributors will likely meet the definition of hazardous waste. Of the set of pharmaceuticals that are hazardous wastes, only “potentially creditable” hazardous waste pharmaceuticals may be transported to a reverse distributor for manufacturer's credit (see definition Section V.A.3).
The Agency notes that the management standards discussed below pertain only to potentially creditable hazardous waste pharmaceuticals that are managed via reverse distribution and do not apply to the reverse distribution or reverse logistics systems that may exist for other consumer products. In addition to the standards discussed in this section, EPA is proposing standards for shipping potentially creditable hazardous waste pharmaceuticals to pharmaceutical reverse distributors as well as associated recordkeeping (see Section V.F.2. of the preamble).
As with non-creditable hazardous waste pharmaceuticals discussed
Typically, EPA requires specific management standards for containers that hold hazardous waste. However, potentially creditable hazardous waste pharmaceuticals appear to pose lower environmental risk of release than patient care hazardous waste pharmaceuticals or traditional industrial hazardous waste. The risk of release is lower for several reasons. First, potentially creditable hazardous waste pharmaceuticals that are prepared for shipment to a reverse distributor are usually in their original containers as well as outer packaging, providing two layers of protection from leaks or spills.
In the 2008 Pharmaceutical Universal Waste proposal, EPA specifically solicited comment on whether stakeholders have knowledge of problems with mixing incompatible pharmaceuticals during accumulation. In response, one commenter indicated that there were no issues encountered with the compatibility of pharmaceuticals during storage.
EPA also is proposing not to require specific labeling standards for containers holding potentially creditable hazardous waste pharmaceuticals, while they accumulate on-site. EPA does not want to deter the practice of co-mingling potentially creditable hazardous waste pharmaceuticals with potentially creditable non-hazardous waste pharmaceuticals since both are typically transported to a reverse distributor together.
In addition, due to concerns regarding diversion of pharmaceuticals, EPA believes that it is safer not to call attention to the fact that these containers hold pharmaceuticals. Unlike floor waste or patient care pharmaceutical waste, or most hazardous waste, the hazardous waste pharmaceuticals returned to a reverse distributor often have high street value that makes them susceptible to diversion. Thus, EPA is not proposing to require a label for potentially creditable hazardous waste pharmaceuticals during accumulation at a healthcare facility. The Agency seeks comment on its proposal not to require specific accumulation, container management or labeling standards for potentially creditable hazardous waste pharmaceuticals that will be transported to a reverse distributor, including no specific labeling standards for containers holding potentially creditable hazardous waste pharmaceuticals on-site prior to shipment off-site.
In 1984, Congress enacted the Hazardous and Solid Waste Amendments (HSWA) to the Solid Waste Disposal Act (SWDA), as amended by RCRA. HSWA included a new Section 3018, entitled Domestic Sewage. This section directed EPA to do two things with respect to the 261.4(a)(1)(ii) exclusion for mixtures of domestic sewage and other wastes: (1) Submit a Report to Congress (RTC) that describes the types, size and number of generators which dispose of such wastes in this manner, the types and quantities of wastes disposed of in this manner, and identify significant generators, wastes and waste constituents not regulated under existing Federal law or regulated in a manner sufficient to protect human health and the environment; and (2) based on the report, revise the existing regulations that are necessary to “ensure that substances . . . which pass through a sewer system to a publicly owned treatment works are adequately controlled to protect human health and the environment.”
EPA submitted its Report to Congress on February 7, 1986 (Domestic Sewage Study). Subsequent to the Report to Congress, EPA issued an advance notice of proposed rulemaking (ANPR) on August 22, 1986 (51 FR 30166); a response to comments on the ANPR on June 22, 1987 (52 FR 23477); a notice of proposed rulemaking (NPR) on November 23, 1988 (53 FR 47632); and a final rule on July 24, 1990 (55 FR 30082). That final rule prohibits the discharge of pollutants which create a fire or explosion hazard in the POTW, which includes, but is not limited to, wastestreams with a closed cup flashpoint of less than 140 degrees Fahrenheit or 60 degrees Celsius using the test methods specified in 40 CFR 261.21” (55 FR 30087). Although the exclusion for mixtures of domestic sewage and other wastes is found under the RCRA regulations in § 261.4(a)(1)(ii), the sewer ban of liquid ignitable hazardous wastes (
• A 2008 study of 59 long-term care facilities showed that 46 percent of the long-term care facilities dispose of their pharmaceuticals by dumping them down the drain.
• A 2003 King County, Washington survey of healthcare facilities showed that the vast majority of liquids, and nearly half of the pills, were disposed of down the drain.
• In a study by The Albany Medical Center, funded by an EPA Pollution Prevention Grant, the author states, “up to now, toilet wasting has been the common practice for drug wasting by patient care staff.”
• In a detailed study about the waste management practices within the healthcare industry, EPA's Office of Water also found that sewering of waste pharmaceuticals was common practice.
• EPA staff from the Office of Research and Development (ORD) have published numerous articles on the subject of active pharmaceutical ingredients (APIs) in the environment. One such paper states that “unit-packaged pills are probably not frequently disposed via toilets, whereas liquids are probably routinely poured down drains,” although the authors acknowledge that “gaining an understanding of the types and quantities of APIs introduced directly and purposefully to the environment by the disposal of unwanted, leftover drugs has been more problematic because of a dearth of comprehensive or reliable data.”
(1) Pharmaceuticals are intrinsically bioactive compounds; therefore, they are potentially able to impact living systems.
(2) There is a continuous and worldwide increase in their use and, thus, on their subsequent input into the environment.
(3) Many of the hundreds of frequently prescribed pharmaceuticals are known for targeted effects and adverse off-target side effects, a problem that can be exacerbated by interactive effects during therapy involving co-administration.
In addition, while healthcare facilities that are CESQGs are generally not subject to this proposed rule, EPA is proposing that the sewer ban of hazardous waste pharmaceuticals also apply to healthcare facilities that are CESQGs. The vast majority of healthcare facilities are CESQGs (84 percent). Some particular types of healthcare facilities have an even larger proportion of CESQGs: Over 94 percent of dental offices are CESQGs, and 94 percent of continuing care retirement communities are CESQGs (see the Regulatory Impact Analysis in the docket for this proposed rule EPA-HQ-RCRA-2007-0932.
EPA is concerned that these smaller healthcare facilities are more likely to dispose of their hazardous waste pharmaceuticals via the sewer. EPA estimates that there are more than 145,000 healthcare facilities that are CESQGs. Given this large number, the combined impact of sewer disposal by healthcare facilities that are CESQGs has an even greater potential to provide a substantial impact on the environment, as well as human health.
EPA solicits comment on EPA's proposal to ban the sewer disposal of hazardous waste pharmaceuticals at all healthcare facilities, including healthcare facilities that are CESQGs that generate such wastes. As part of its solicitation of comments, the Agency especially requests comment on the risk-risk tradeoffs inherent in prohibiting sewer disposal, which extends the life cycle of pharmaceutical waste, resulting in additional opportunities for diversion and increasing the possibility of inadvertent exposures for certain workers (and possibly even patients or visitors) as a tradeoff for a reduction in aquatic risks. EPA also solicits comment on whether the ban on sewer disposal should be limited to those healthcare facilities that are currently LQGs and SQGs, and not extended to CESQGs.
Under 40 CFR 403.12(p) of the CWA regulations, industrial users that discharge a substance to a POTW that, if otherwise disposed of, would be a hazardous waste, must notify in writing the POTW, the EPA Regional Waste Management Division Director and State hazardous waste authorities. POTWs should be made aware that under this proposal, if made final, the notifications they receive from healthcare facilities will no longer include hazardous waste pharmaceuticals since the healthcare facilities will be prohibited from sewering their hazardous waste pharmaceuticals.
We note that EPA's proposed ban on sewering hazardous waste pharmaceuticals is consistent with other federal and state actions. For example, the Drug Enforcement Administration (DEA) has finalized new regulations to implement the Secure and Responsible Drug Disposal Act of 2010 (September 9, 2014; 79 FR 53520). DEA's new regulations require a “non-retrievable” method of destruction of controlled substances. The preambles to DEA's proposed and final rules state that flushing does not meet the non-retrievable standard for destruction.
In addition, three states and the District of Columbia have taken action to limit the sewering of pharmaceuticals and a third has introduced a bill. In 2009, Illinois passed the Safe Pharmaceutical Disposal Act, which prohibits healthcare facilities from flushing any unused medication into public sewers or septic systems.
Finally, we would note that although the sewer ban is limited to pharmaceuticals that are RCRA hazardous wastes, EPA strongly recommends as a best management practice to not sewer any waste pharmaceutical (
For household pharmaceutical waste, we refer the public to the guidelines developed by the U.S. Office of National Drug Control Policy (ONDCP), the FDA, and EPA for the disposal of unwanted household pharmaceuticals. In summary, these guidelines are as follows:
(1) Use a drug take-back event or program, when available;
(2) Dispose in household trash, after mixing the unwanted medicines with an undesirable substance such as kitty litter or coffee grounds and placing in a sealed container; and
(3) Only if the drug label specifically instructs you to, flush the unwanted medicine down the toilet.
When a pharmaceutical that is discarded is both a hazardous waste and a controlled substance, its management and disposal is regulated under both the RCRA Subtitle C hazardous waste regulations, which is under EPA's or the authorized state's purview, and the Controlled Substances Act (CSA) and its implementing regulations, which is under DEA's purview. EPA understands that only a handful of pharmaceuticals are in common usage that are both hazardous waste and controlled substances and therefore subject to dual regulation by both EPA and the DEA. These are identified in Table 5:
Chloral hydrate, U034, is the only dually regulated hazardous waste/controlled substance that is a listed hazardous waste. It is listed for toxicity (note that EPA's U034 listing includes chloral hydrate, see memo dated April 6, 1998; Brandes to Knauss, RCRA Online #14175). On the other hand, the remaining four dually regulated hazardous wastes/controlled substances in common use are considered hazardous because they exhibit the characteristic of ignitibility (D001). However, the active ingredient is not ignitable, but these particular forms of the pharmaceuticals are ignitable because they are prepared in ignitable solutions, such as alcohol.
EPA is aware of three additional hazardous waste pharmaceuticals that are DEA controlled substances, but it is our understanding that they are no longer in common usage, although there may be legacy supplies remaining in healthcare facilities. See Table 6.
Similarly, as noted in Table 7, phentermine is a controlled substance, but the medical form is a phentermine salt, and the salts are no longer considered to be within the scope of the P046 listing (see memo dated February 17, 2012; from Devlin to RCRA Division Directors, RCRA Online #14831).
EPA requests comment on whether these are, indeed, the only pharmaceuticals in common usage that are regulated both as DEA controlled substances, and when discarded, RCRA hazardous waste.
Common practices that healthcare facilities have used in the past in order to comply with the DEA regulations for destroying controlled substances include sewering and incineration. However, DEA's new regulation requires that controlled substances must be destroyed, such that they are “non-retrievable.” As discussed previously, the preambles for DEA's proposed and final rules state that flushing will not meet their new non-retrievable standard, a position which EPA fully supports. However, EPA is concerned that flushing will continue to be used by healthcare facilities for eliminating their controlled substances. In part, this concern is due to a 2009 EPA report which concluded, “controlled substances are the pharmaceuticals most commonly poured down the drain, especially the partially-used IVs containing controlled substances.”
EPA wants to eliminate the flushing of pharmaceuticals in order to reduce potential environmental contamination. Sewering hazardous wastes that are ignitable (D001) is already banned and EPA is now proposing to eliminate the sewering of all other hazardous waste pharmaceuticals.
The first condition is to ensure that the controlled substances are destroyed in an environmentally protective manner by a high-temperature combustor, such as a large or small municipal waste combustor or a permitted or interim status hazardous waste combustor (incinerator or cement kiln). The majority of the hazardous wastes that are also controlled substances are hazardous because they exhibit the characteristic of ignitability. The best demonstrated available technology (BDAT) developed for ignitable hazardous waste under the LDRs includes combustion (see § 268.40). In addition, although chloral hydrate (U034) is listed because of its toxicity, its BDAT is also combustion. Therefore, in an effort to eliminate the sewering of these dually regulated hazardous wastes/controlled substances, and because combustion of these pharmaceuticals is a suitable technology for destruction, EPA is proposing to allow the few hazardous wastes pharmaceuticals that are also controlled substances to be combusted at municipal solid waste combustors, although as noted previously, a hazardous waste incinerator (permitted or interim status) would also be allowed.
We realize that DEA may allow a technology other than combustion to be used to destroy controlled substances. However, if the RCRA hazardous waste pharmaceuticals that are DEA controlled substances are exempt from RCRA, the other destruction technologies may lack environmental controls and permits. Therefore, combustion of the hazardous wastes/controlled substances, which requires permitting, operating and monitoring standards, is a condition of the exemption. EPA requests comment on whether there are additional technologies that would be appropriate to include for the destruction of hazardous waste pharmaceuticals that are also controlled substances. Under this proposal, if DEA allows a technology other than incineration for the destruction of controlled substances, it would be allowed only for DEA controlled substances, but not for those that are also RCRA hazardous wastes.
The second condition is to ensure that dually regulated hazardous wastes/controlled substances are managed under another rigorous regulatory program since they will not be managed in accordance with the RCRA Subtitle C regulations. Although developed for different reasons, both EPA's hazardous waste and DEA's controlled substance regulatory programs are designed to track the regulated material from cradle to grave. DEA regulations have requirements similar to EPA's hazardous waste manifest. In particular, in order to ship a schedule II controlled substance, a DEA registrant must submit a DEA Form 222 to the supplier of the schedule II controlled substance. The DEA Form 222 is a numerically controlled form issued by the DEA to authorized registrants, containing certain pre-printed information. The supplier must indicate on the DEA Form 222, the quantity of packages shipped and the date the packages were shipped. Like a hazardous waste manifest, a copy of Form 222 must accompany the shipment and it must be kept by both the supplier and purchaser for at least two years (copies of manifests must be kept for three years). Suppliers and distributors may utilize the electronic version of the DEA Form 222, which requires the same information and retention period. Similarly, DEA Schedule III, IV and V controlled substances must be accompanied by an invoice, which also must include a detailed inventory of the contents shipped. A copy of the invoice must also be retained by the supplier and purchaser of the controlled substances for a period of two years. EPA believes that the DEA tracking and shipping requirements are sufficient to act in lieu of the RCRA hazardous waste manifest and hazardous waste transporter requirements. EPA requests comment on this assessment.
DEA has previously stated that controlled substance “pharmaceutical wastage” may be disposed of in accordance with applicable federal, state, and local laws, regulations, and healthcare facility policies, to include sewering or putting down the drain.
DEA's new regulations to implement the Secure and Responsible Drug Disposal Act of 2010 are expected to help alleviate the problem that long-term care facilities face when discarding controlled substances. DEA's new regulations allow retail pharmacies and hospital/clinics with an on-site pharmacy that are DEA registrants to modify their registrations and become “collectors” to place collection receptacles at long-term care facilities (or at the retail pharmacy or hospital/clinic with an on-site pharmacy) for the collection of controlled substances from ultimate users (
Under the new DEA regulations, long-term care facilities have three options, two of which are new, for managing their patients' controlled substances. First, if a DEA registered retail pharmacy or hospital/clinic with an on-site pharmacy places a collection container at a long-term care facility, the staff from the long-term care facility may place the patients' controlled substances in the collection receptacles. Second, although long-term care facilities will not be able to conduct collection events for their patients' controlled substances for mail-back programs, they will be allowed to assist patients who choose to use a mail-back program for their own controlled substances, on an individual-by-individual basis. And third, law enforcement will continue to be allowed to pick up patients' controlled substances for disposal. With these changes to DEA's regulation, long-term care facilities can now dispose of patients' controlled substances in a more environmentally protective way. Because we are proposing that hazardous waste pharmaceuticals that are also controlled substances are conditionally exempt from RCRA, these wastestreams may also be managed in any of these three ways allowed by DEA, provided the waste is managed to meet the conditions of the RCRA conditional exemption.
The new DEA regulations do not mandate the placement of collection receptacles or patient participation in mail-back programs or take-back events. However, if long-term care facilities are prohibited from disposing of pharmaceuticals down the toilet or drain under RCRA (and as a method of destruction under DEA regulations), then the only way for patients at long-term care facilities to lawfully dispose of DEA controlled substances that are also RCRA hazardous wastes would be through participation in one of DEA's collection methods. Long-term care facilities are allowed to place patients' hazardous waste pharmaceuticals that are controlled substances in the DEA collection receptacles; the other hazardous waste pharmaceuticals generated by long-term care facilities must be managed under the proposed RCRA management standards for healthcare facilities. However, we note that if the long-term care facility is a CESQG, we are proposing as an acceptable method of disposal of the long-term care facility's hazardous waste pharmaceuticals would be to place them in a DEA collection receptacle, even if they are not controlled substances (see § 266.504(b)). DEA already allows controlled substances to be co-mingled with non-controlled substances. Therefore, EPA believes it is consistent to allow CESQG hazardous waste pharmaceuticals that are not controlled substances to be placed in DEA collection receptacles with controlled substances. EPA believes that management of CESQGs' hazardous wastes as DEA controlled substances is preferable to management as municipal solid waste because it provides greater protection to patients, visitors and workers at long-term care facilities to have the hazardous waste pharmaceuticals in DEA collection receptacles rather than in the regular trash. See Table 8 for a summary of the intersection of RCRA and DEA regulations for the disposal of hazardous waste pharmaceuticals at long-term care facilities:
Under this proposal, pharmaceuticals collected in DEA authorized collection receptacles will continue to be excluded from regulation as household hazardous waste, with some conditions. The Agency has a long-standing recommendation that household hazardous waste collection programs manage the collected waste as hazardous waste. We strongly believe that if a program goes to the expense of collecting the waste, including waste pharmaceuticals, it should manage the waste as hazardous waste, rather than manage it as municipal solid waste, which the household could do absent the collection program. However, the current household waste exemption does not
(1) Combusted at a municipal solid waste or hazardous waste combustor, and
(2) managed in accordance with all applicable DEA regulations (see § 266.506(a)(2)).The Agency solicits comments on all these provisions.
On a separate, but related matter, EPA has received a number of inquiries about the exemption in the Clean Air Act regulations for Other Solid Waste Incinerator (OSWI) “units that combust contraband or prohibited goods” (see the exemption at 40 CFR 60.2887(p) for new OSWIs and 40 CFR 60.2993(p) for existing OSWIs). As indicated in a previous guidance memo, EPA does not consider pharmaceuticals, voluntarily collected from ultimate users in a take-back program, to be contraband or prohibited goods.
The following materials or items are hazardous wastes if and when they are discarded or intended to be discarded . . .
(c) Any
According to § 261.7(b)(1), there are two ways a container that held a non-acute hazardous waste can be considered “empty”:
A container or an inner liner removed from a container that has held any hazardous waste, except a waste that is a compressed gas or that is identified as an acute hazardous waste listed in § 261.31 or § 261.33(e) of this chapter is empty if:
(i) All wastes have been removed that can be removed using the practices commonly employed to remove materials from that type of container,
(ii) No more than 2.5 centimeters (one inch) of residue remain on the bottom of the container or inner liner,
(iii)
(A) No more than 3 percent by weight of the total capacity of the container remains in the container or inner liner if the container is less than or equal to 119 gallons in size; or
(B) No more than 0.3 percent by weight of the total capacity of the container remains in the container or inner liner if the container is greater than 119 gallons in size.
Therefore, if the container that held the non-acute hazardous waste pharmaceutical does not have its contents removed by a commonly employed practice
Likewise, according to § 261.7(b)(3), there are three ways that a container that held an acute hazardous waste can be considered “empty”:
A container or an inner liner removed from a container that has held an acute hazardous waste listed in §§ 261.31 or 261.33(e) is “empty” if:
(i) The container or inner liner has been triple rinsed using a solvent capable of removing the commercial chemical product or manufacturing chemical intermediate;
(ii) The container or inner liner has been cleaned by another method that has been shown in the scientific literature, or by tests conducted by the generator, to achieve equivalent removal; or
(iii) In the case of a container, the inner liner that prevented contact of the commercial chemical product or manufacturing chemical intermediate with the container, has been removed.
Therefore, if the container that held the P-listed pharmaceutical is not triple rinsed, or cleaned by another method that has been demonstrated to achieve equivalent removal, or had the inner liner removed, the container is not considered “RCRA empty,” even though the pharmaceutical may have been fully dispensed. If the container is not “RCRA empty,” then the residues are regulated as acute hazardous waste.
In November 2011, EPA issued guidance about containers that once held P-listed pharmaceuticals
(1) Count only the weight of the residue toward generator category
(2) Demonstrate an equivalent removal method to render containers RCRA empty
(3) In the case of warfarin, show that the concentration in the residue is below the P-listed concentration.
This guidance was intended as a short-term solution that worked within the confines of the existing RCRA hazardous waste regulations and EPA indicated at the time that a more comprehensive solution would require notice and public comment that occurs during a rulemaking. We are proposing to amend the regulations that pertain to containers that once held pharmaceuticals that are RCRA hazardous wastes. We are proposing different regulatory solutions for different types of containers found in healthcare settings. Specifically, we address the following three types of containers: (1) Unit-dose containers (
We are proposing this conditional exemption for two reasons. First, we want to eliminate the sewering of pharmaceuticals. We are particularly concerned that in a healthcare setting, when containers are triple rinsed, the rinsate will be poured down the drain which is not a good environmental practice. We think it is important that the residues be managed in a more controlled manner—such as municipal solid waste management—rather than poured down the drain. Second, although the “empty container” regulations of § 261.7 apply to all sizes of containers, they were developed with larger, industrial-sized containers in mind. For the most part, the containers that hold pharmaceuticals range in size from a few milliliters (
EPA has received data from three stakeholders demonstrating that there is very little residue remaining in fully dispensed containers of pharmaceuticals. In addition, EPA's ORD conducted similar research. The results from each of the four sources are summarized below; the full results are included in the docket for this proposed rulemaking (EPA-HQ-RCRA-2007-0932).
i.
ii.
The results from each of the first two stakeholders reflect only the weight of the active pharmaceutical ingredient, not the full weight of the hazardous waste residues. Since it is the Agency's position that it is the full weight of the hazardous waste residues and not just the weight of the active pharmaceutical ingredients that must be counted in determining generator status, we have used the results to calculate the weight of the total residues. In the retailer's case, they have informed EPA that a typical pill with a 10 mg dose of Coumadin (brand name of warfarin) weighs 200 mg. The active ingredient represents 10 mg, or 5% of the weight of the pill, while 190 mg, or 95% of the weight of the pill, consists of ingredients other than the active ingredient. As indicated in Table 10, the average weight of warfarin residue remaining in a fully dispensed bottle of the high dose of warfarin (10 mg) is 1.196 mg. If we assume that the residue in the container has the same proportions of ingredients (
iii.
The intent of the study was to investigate the third regulatory approach suggested in the November 2011 memo discussed previously. That
The researchers collected a total of 59 samples containers, including 44 sample containers that had held warfarin pills but had been fully dispensed and another 15 sample containers from nicotine-containing products. The samples included warfarin and nicotine from several manufacturers, in a range of dose strengths and in various container types. The residues were solvent-extracted and then dried by rotary evaporation to determine the total weight of residues. Subsequently, the residues were re-dissolved in methanol and analyzed using HPLC to determine the concentration of the active pharmaceutical within the residues.
The majority of warfarin containers were plastic bottles, but some containers were blister packs and three samples were 30-pill blister packs, sometimes referred to as a “bingo card.” The results indicate that the concentration of the active pharmaceutical ingredient warfarin in the residues in plastic bottles was usually over the 0.3% concentration. However, the concentration of warfarin in the residues on blister packs, including the 30-pack blister pack, was consistently below 0.3%. Overall, in the majority of cases, the warfarin within the residues was present at a high enough concentration to be considered P001 (33 of 44 samples, 75 percent of the samples).
However, the results also confirm the results from the first two stakeholders. That is, the total weight of residues remaining in the containers after they were emptied of the warfarin pills is negligible. For the plastic bottles, the total weight of residue ranged from 4.3-82.3 mg. For the single-dose blister packs, the total weight of residue ranged from 3.5-7.6 mg. And for the 30-pack blister pack, the total weight ranged from 134.8-273 mg. Taking the smallest amount of residue of 3.5 mg, it would take close to 300,000 containers per month to exceed the 1 kg threshold to be an LQG. Even on the conservative side, taking the largest amount of residue of 273 mg, it would take close to 4000 containers per month to exceed the 1 kg threshold to be an LQG.
The results for nicotine residues were similar. For containers of gum and patches, the weight of total residues ranged from 9-111.2 mg, although the two containers of liquid nicotine solution contained more residues—1301 and 1616 mg. Although nicotine is not a concentration-based listing, it is worth noting that the active pharmaceutical ingredient of nicotine in the residues was below the quantifiable limit of 1.5 μg/ml in 8 of the 15 samples and for the other 7 samples, the concentration of nicotine ranged from 0.01-0.09%.
iv.
All combinations in Table 11 were analyzed in triplicate using the following three-step approach:
(1) After removing the tablets, gum, lozenges, etc from the containers, the amount of total residuals remaining in the container was determined using a sensitive balance to weigh the container before and after triple rinsing,
(2) The “maximum possible weight of residual drug/total residual/container” was calculated for each compound and packaging combination. This calculated result was used to infer a theoretical upper limit for the amount of active pharmaceutical compound in the total residue remaining in the container, and
(3) Thermal gravimetric analysis (TGA) was used to qualitatively evaluate the presence of active pharmaceutical ingredient in the residuals removed from the containers before and after triple-rinsing.
With respect to the weight of the remaining residuals in the containers, ORD's results are similar to the results
Unlike the quantitative results from the HPLC analyses from outside stakeholders, the results from the TGA are qualitative only. That is, the TGA was only intended to evaluate the presence of the API and compare the results from containers that had been triple rinsed with those that had not been triple rinsed. Using TGA, the API was not detected in the residuals, with one exception: The liquid nasal spray (note that TGA was not used on the nicotine inhaler residuals). In most cases, the TGA detected other, unspecified ingredients in the residuals, but not the active pharmaceutical ingredient on the P-list. The total weight of the residues was well under a gram and the active pharmaceutical ingredient is a small proportion of the total weight of the tablet, gum, etc. As a result, with the exception of the nicotine nasal spray, the TGA was not sensitive enough to detect the presence of the active pharmaceutical ingredient, regardless of whether the container had been triple rinsed or not.
EPA is aware that there are certain limitations with the data from the four sources. For instance, in the case of the consulting firm, no replicate samples were tested. In the case of the retailer, only warfarin residues were tested. However, given the size of the containers involved and the nominal quantities of residues involved, the Agency is proposing to allow the residues in single-unit dose containers/packaging and dispensing bottles, vials and ampules that once held pharmaceuticals to be managed as non-hazardous waste pharmaceuticals provided the pharmaceutical product has been fully dispensed (
Finally, we note that the Agency is concerned about the potential for diversion of the pharmaceutical containers that may occur when the pharmaceutical residues and containers are discarded in the municipal waste stream. In such instances, we are concerned that the containers could be diverted from the municipal waste stream and used for illicit purposes, such as packaging counterfeit pharmaceuticals. Therefore, EPA is proposing that “RCRA empty” pharmaceutical containers that are original pharmaceutical packages (and therefore are susceptible to diversion) should be destroyed prior to placing them in the trash. These types of containers would include dispensing bottles, vials or ampules typically used in pharmacies, but would not include paper or plastic cups, or blister packs used for dispensing singles doses to patients. The means of destruction could include crushing or shredding the container. We do not believe that simply defacing the label would be sufficient to avoid diversion, since labels could be replaced if the container is intact.
We request comment on these proposed provisions, including whether it is necessary to limit the size of the dispensing bottle to which this provision would apply. In our observation, EPA has rarely seen pharmaceutical dispensing bottles that are larger than 1000-count, which are approximately 1 liter in size. EPA requests comment on whether larger containers are used for dispensing pharmaceuticals and, if so, which pharmaceuticals they are used for and what RCRA hazardous waste codes apply. We also seek comment as to whether “RCRA empty” pharmaceutical containers that are the original pharmaceutical packages should be destroyed prior to placing them in the trash.
EPA issued guidance regarding the regulatory status of residues in syringes in December 1994
In the April 2008 memo, EPA clarified that the 1994 interpretation extends to other P- and U-listed pharmaceuticals that have been used to administer the pharmaceutical by syringe. This proposed conditional exemption for syringes, in large part, would maintain the existing interpretation. The primary difference is that under the proposed conditional exemption, healthcare facilities would not be required to determine if the residues in the syringes meet a listing description or exhibit a hazardous waste characteristic.
EPA believes this conditional exemption is important to minimize the potential for exposures to healthcare workers, which can happen if they are accidentally stuck with a needle. Typically, sharps containers are more readily available to a medical practitioner than a hazardous waste container. Therefore, the used syringe will be discarded more quickly into a sharps container and there will be less opportunity for accidental sticks to occur en route to disposing the sharp.
However, we also note that syringes in sharps containers are typically autoclaved prior to disposal. EPA is concerned that the residues remaining in the syringes could be aerosolized during autoclaving and inadvertently expose workers to the aerosolized hazardous waste residues, posing risks (via pulmonary exposure) to those present during venting of the autoclave. Research suggests that autoclaving may even increase the toxicity of certain drugs.
Typically, hazardous waste pharmaceuticals generated in a healthcare facility fall into two categories: (1) Non-creditable (
Generally, patient care/floor hazardous waste pharmaceuticals differ from potentially creditable hazardous waste pharmaceuticals in that they have been partially administered and often are not in their original packaging. In addition, patient care/floor hazardous waste pharmaceuticals cannot receive manufacturer's credit and therefore may not be shipped to a reverse distributor. EPA is proposing that patient care/floor hazardous waste pharmaceuticals generated at healthcare facilities, when shipped off-site, must be shipped to a designated facility (
For pharmaceutical reverse distributors, once potentially creditable hazardous waste pharmaceuticals have been deemed non-creditable or credit has been issued and they do not require any additional verification of credit, EPA is proposing that the hazardous waste pharmaceuticals be referred to as “evaluated hazardous waste pharmaceuticals.” As with shipping non-creditable hazardous waste pharmaceuticals, when evaluated hazardous waste pharmaceuticals are shipped off-site, EPA is proposing that they must be shipped in accordance
EPA is proposing that the pharmaceutical reverse distributor list the appropriate hazardous waste codes on the manifest (even though the healthcare facility is not required to provide such information to the reverse distributor). Hazardous waste pharmaceuticals received by pharmaceutical reverse distributors are in their original packaging with their label, so the information to determine the appropriate hazardous waste codes should be readily available. Also, reverse distributors are currently required to include hazardous waste codes on the manifest and it is expected that they have the necessary expertise in the management of these hazardous wastes that healthcare workers lack. As described in Section V.G.3 (pharmaceutical reverse distributor management standards), reverse distributors must keep copies of hazardous waste manifests for three years from the date of shipment.
EPA requests comment regarding the proposed manifest and transportation requirements for non-creditable hazardous waste pharmaceuticals from healthcare facilities and evaluated hazardous waste pharmaceuticals from pharmaceutical reverse distributors.
Under the existing regulations, a healthcare facility or pharmaceutical reverse distributor may not import hazardous waste pharmaceuticals unless it has a RCRA permit or interim status that allows it to accept hazardous waste from off-site and complies with the requirements for importing hazardous waste in 40 CFR part 262, subpart F. This proposal does not change the regulations as they apply to the import of non-creditable or evaluated hazardous waste pharmaceuticals. Likewise, under existing regulations, a healthcare facility or pharmaceutical reverse distributor may not export (non-creditable or evaluated) hazardous waste pharmaceuticals unless it complies with requirements for exporting hazardous waste in 40 CFR part 262, subpart E. This proposal also does not change the regulations as they apply to the export of (non-creditable or evaluated) hazardous waste pharmaceuticals.
EPA requests comment on the likelihood that non-creditable hazardous waste pharmaceuticals that are shipped from a healthcare facility to a domestic TSDF, would then be exported to a TSDF in a foreign country. In addition, EPA does not anticipate that hazardous waste pharmaceuticals would be destined for transboundary shipments for purposes of recovery operations and therefore potentially subject to 40 CFR part 262, subpart H; however, we also request comment on whether this is the case.
This section discusses the proposed requirements for shipping potentially creditable hazardous waste pharmaceuticals from healthcare facilities to pharmaceutical reverse distributors and between pharmaceutical reverse distributors. The return of potentially creditable pharmaceuticals (hazardous and non-hazardous) to reverse distributors can involve multiple shipping steps before the pharmaceuticals are transported for ultimate treatment and disposal. In comments on the 2008 Pharmaceutical Universal Waste proposal and in response to EPA's request for information,
As explained in Section V.D.1, EPA is proposing that pharmaceuticals transported to pharmaceutical reverse distributors for credit are solid wastes, some of which will also be considered hazardous wastes. Under the current RCRA Subtitle C regulations, hazardous waste, including hazardous waste pharmaceuticals must be manifested to a permitted or interim status TSDF and shipped using a hazardous waste transporter to ensure the cradle-to-grave system of RCRA is maintained. However, compared to other hazardous wastes, EPA believes that the risk of environmental release posed by most potentially creditable hazardous wastes pharmaceuticals during accumulation and transport are relatively low. The risk is low because of the form and packaging of most potentially creditable hazardous waste pharmaceuticals, which is typically in small, individually packaged doses (such as with many tablets and capsules) or small vials.
Due to the low risk of release to the environment described previously, EPA is proposing to allow potentially creditable hazardous waste pharmaceuticals to be shipped
In lieu of requiring a hazardous waste manifest and the use of hazardous waste transporters, EPA is proposing an alternate type of tracking for potentially creditable hazardous waste pharmaceuticals—with two requirements. First, for each shipment, healthcare facilities and pharmaceutical reverse distributors must provide in writing (via letter or electronic communication), advance notice of the shipment to the pharmaceutical reverse distributor. Second, for each shipment, the receiving pharmaceutical reverse distributors must provide confirmation to the healthcare facility or pharmaceutical reverse distributor that initiated the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived. One way to comply with this requirement would be for the receiving reverse distributor to require the healthcare facility or pharmaceutical reverse distributor that initiates the shipment of potentially creditable hazardous waste pharmaceuticals to utilize some form of “delivery confirmation” mechanism that is provided by the shipper that confirms that a shipment to a reverse distributor has reached its destination and is under the custody and control of the recipient (
Alternatively, EPA has learned that some stakeholders use bar-coding on the pharmaceuticals or on the boxes to track shipments. The barcodes contain detailed information, including the exact quantities and types of pharmaceuticals included in the shipment. Typically, when a reverse distributor receives a barcoded shipment, it will scan in the shipment and the sender will receive electronic notification that the shipment has arrived. This type of bar-code tracking would meet the delivery confirmation requirement of this proposed rule, but other mechanisms of “delivery confirmation” that are offered by common carriers, such as the U.S. Postal Service, FedEx or United Parcel Service (UPS), would also be acceptable.
Under this proposal, healthcare facilities and reverse distributors may use common carriers, such as the U.S. Postal Service, United Parcel Service, or FedEx
EPA notes that a pharmaceutical reverse distributor is not required to sort the potentially creditable hazardous waste pharmaceuticals from the potentially creditable non-hazardous waste pharmaceuticals when they are destined for another reverse distributor. However, if the potentially creditable pharmaceuticals are not sorted, the pharmaceutical reverse distributor must follow the tracking procedures in this proposal for the entire shipment. On the other hand, if a pharmaceutical reverse distributor chooses to sort the potentially creditable hazardous waste pharmaceuticals from the creditable non-hazardous waste pharmaceuticals prior to shipping to another reverse distributor, only the potentially creditable hazardous waste pharmaceutical portion would have to be shipped according to these proposed standards. EPA asks for comment on whether the proposed tracking system and controls are sufficient to protect human health and the environment.
If a healthcare facility or pharmaceutical reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a reverse distributor and does not receive delivery confirmation from the intended recipient within seven calendar days, EPA is proposing that the healthcare facility or pharmaceutical reverse
If a healthcare facility or pharmaceutical reverse distributor imports potentially creditable hazardous waste pharmaceuticals, then it must comply with the proposed requirements for the shipment of potentially creditable hazardous waste pharmaceuticals. The proposed requirements would be in lieu of those for manifested hazardous waste imports found at 40 CFR part 262, subpart F. EPA requests comment on whether potentially creditable hazardous waste pharmaceuticals are imported into the U.S. and, if so, how they are currently declared to customs when imported.
If a healthcare facility or pharmaceutical reverse distributor exports potentially creditable hazardous waste pharmaceuticals then it must generally comply with 40 CFR part 262, subpart E, except that it is not required to manifest the potentially creditable hazardous waste pharmaceuticals.
EPA is proposing to require healthcare facilities and reverse distributors to keep records of the shipments of potentially creditable hazardous waste pharmaceuticals to reverse distributors. Specifically, we are proposing that healthcare facilities and reverse distributors that initiate a shipment to another pharmaceutical reverse distributor keep (1) records of advance notification regarding shipments of potentially creditable hazardous waste pharmaceuticals, (2) shipping papers, and (3) confirmation of receipt of shipment for three years after the shipment was initiated. These records are necessary to ensure that potentially creditable hazardous waste pharmaceuticals are reaching their intended destination and not diverted. In most cases, retaining records for 3 years should be sufficient for inspection purposes; however, we are proposing that the periods of retention are automatically extended during unresolved enforcement activity, or at the request of the EPA Regional Administrator. The Agency seeks comment on whether additional recordkeeping is necessary to document the cases when the pharmaceutical reverse distributor does not receive a shipment of potentially creditable pharmaceuticals within 7 calendar days and the steps must be taken to locate the shipment.
Pharmaceutical reverse distributors act as intermediaries between healthcare facilities and pharmaceutical manufacturers. They receive shipments of potentially creditable hazardous waste pharmaceuticals from healthcare facilities and, on behalf of manufacturers, facilitate the process of crediting healthcare facilities for these pharmaceuticals. From stakeholder input and EPA site visits, EPA's understanding is that when a pharmaceutical reverse distributor receives a shipment of potentially creditable hazardous waste pharmaceuticals, the reverse distributor sorts through the shipment and often uses barcodes to scan items into its computer system. Based on manufacturers' return goods policies, the pharmaceutical reverse distributors determine which potentially creditable hazardous waste pharmaceuticals can be credited, as well as which must be sent on to another reverse distributor for completion of the crediting process.
In many cases, there is more than one reverse distributor involved in establishing and verifying manufacturer's credit for a particular potentially creditable hazardous waste pharmaceutical. For instance, reverse distributors may have contracts with specific pharmaceutical manufacturers such that only a specific pharmaceutical reverse distributor may facilitate credit for a particular manufacturer's pharmaceuticals. If the receiving reverse distributor has a contract with the healthcare facility, but not with the pharmaceutical manufacturer, then the receiving pharmaceutical reverse distributor sends the returned pharmaceutical on to the reverse distributor that has a contract with the pharmaceutical manufacturer in order to facilitate the credit process.
Because manufacturers' return goods policies change over time, sometimes a pharmaceutical reverse distributor receives a potentially creditable hazardous waste pharmaceutical that is not eligible for credit immediately, and the pharmaceutical reverse distributor retains the potentially creditable hazardous waste pharmaceutical on-site until it is credit eligible. EPA requests comment on how often this happens and how long the potentially creditable hazardous waste pharmaceuticals are kept on-site at reverse distributors to await changes in manufacturers' return goods policies.
In some cases, even after the pharmaceutical reverse distributor has awarded credit, a pharmaceutical manufacturer may request that the hazardous waste pharmaceuticals be transported back to the manufacturer to inventory and verify the amount of pharmaceuticals and credit. In developing this proposed rule, EPA considered all of the previous scenarios as part of the crediting process.
On the other hand, if the potentially creditable hazardous waste pharmaceuticals are not sent onward to another pharmaceutical reverse distributor, the pharmaceutical reverse distributor awards the manufacturer's credit to the healthcare facility and then manages the hazardous waste pharmaceuticals on-site until they are sent off-site for treatment and disposal. As discussed previously in this proposal, after a potentially creditable hazardous waste pharmaceutical has been evaluated and either credited or deemed non-creditable and no additional pharmaceutical reverse distributors will be involved in the crediting process, EPA proposes to use the term “evaluated hazardous waste pharmaceutical.” This is to distinguish between the potentially creditable hazardous waste pharmaceuticals awaiting determination within the reverse distribution system versus credited and non-creditable hazardous waste pharmaceuticals that have been through the reverse distributor process and are destined to be managed by a permitted or interim status TSDF. Both are considered hazardous waste pharmaceuticals, but they are managed differently under the proposed regulations.
EPA is not aware of any pharmaceutical reverse distributors that facilitate manufacturer's credit that also has interim status or a permit to treat or dispose of hazardous waste on-site. Therefore, EPA anticipates that pharmaceutical reverse distributors eventually send all evaluated hazardous waste pharmaceuticals off-site for
This proposed rule is establishing standards for the management of both potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals that pharmaceutical reverse distributors receive and manage. The Agency notes that the management standards discussed in this section apply only to reverse distributors of potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals and do not apply to reverse distribution or reverse logistics systems that may exist for other consumer products.
The current federal RCRA hazardous waste regulations at 40 CFR part 262 provide that only RCRA- permitted and interim status TSDFs may receive hazardous waste from off-site for treatment, storage, or disposal. However, the Agency does not believe it is necessary for pharmaceutical reverse distributors to obtain permits or have interim status to store hazardous waste pharmaceuticals in order to protect human health and the environment. Thus, EPA proposes a new category under RCRA called a “pharmaceutical reverse distributor,” which we proposed to define as any person that receives and accumulates potentially creditable hazardous waste pharmaceuticals for the purpose of facilitating or verifying manufacturer's credit. The definition specifies that any person, including forward distributors and pharmaceutical manufacturers, which processes pharmaceuticals for the facilitation or verification of manufacturer's credit is considered a pharmaceutical reverse distributor. EPA is proposing that pharmaceutical reverse distributors are not required to have interim status or a RCRA permit to accumulate hazardous waste pharmaceuticals and they may only accept potentially creditable hazardous waste pharmaceuticals from off-site provided they comply with the proposed standards in this rule. Pharmaceutical reverse distributors may not treat or dispose of hazardous waste on-site unless authorized to do so as a RCRA-permitted or interim status TSDF.
As discussed previously, EPA's existing interpretation allows pharmaceutical reverse distributors to be generators of hazardous waste pharmaceuticals after a decision is made about whether the pharmaceuticals will be repurposed. As a generator, a pharmaceutical reverse distributor currently must comply with the LQG, SQG, or CESQG generator requirements, depending on the total volume of hazardous waste generated in a calendar month. Some smaller pharmaceutical reverse distributors might stay under the hazardous waste quantity limits for CESQGs, which would mean that under the federal RCRA requirements, these CESQG pharmaceutical reverse distributors would not have to notify EPA as a generator and their hazardous waste pharmaceuticals could be disposed of with municipal and non-municipal solid waste (see § 261.5). However, the Agency has concerns with CESQG pharmaceutical reverse distributors not notifying EPA that they are managing hazardous waste. EPA is even more concerned about pharmaceutical reverse distributors that currently qualify as CESQGs placing the hazardous waste pharmaceuticals into the municipal and non-municipal solid waste stream and sending them to non-hazardous waste landfills. Some limited studies have shown active pharmaceutical ingredients present in landfill leachate that is collected in municipal solid waste landfill leachate systems.
EPA is proposing to revise its position regarding potentially creditable hazardous waste pharmaceuticals, such that they will be first considered discarded at the healthcare facilities, not at the reverse distributors. This revision is based on new information demonstrating to EPA that pharmaceuticals returned to a reverse distributor are rarely, if ever, recycled or reused, and therefore the decision to send a potentially creditable hazardous waste pharmaceutical to a pharmaceutical reverse distributor is a decision to discard the pharmaceutical (as discussed previously in Section V.D.1). Other comments on the December 2008 Pharmaceutical Universal Waste proposal indicated that notification to EPA by pharmaceutical reverse distributors and tracking of shipments of potentially creditable hazardous waste pharmaceuticals are critical and must be included in any regulatory scheme to ensure the safe management of potentially creditable hazardous waste pharmaceuticals.
As previously discussed, only between 2-6 percent of the potentially creditable hazardous wastes that are received by pharmaceutical reverse distributors are listed or characteristic hazardous wastes.
In addition, because the pharmaceuticals in the reverse distribution system are receiving credit, they are moved through the system efficiently. In fact, one national pharmacy retail chain informed EPA that the value of the credit they receive from manufacturers for returned pharmaceuticals is approximately $1 billion a year.
Furthermore, potentially creditable hazardous waste pharmaceuticals generally present a low risk of release to the environment as they typically are still in the manufacturer's packaging. Since there is a low human health and environmental risk of release associated with the low volumes of potentially creditable hazardous waste pharmaceuticals shipped to reverse distributors for crediting purposes, and because EPA is not aware of any incidents of mismanagement resulting
Thus, EPA is proposing to take a “middle-of-the-road” approach to regulating pharmaceutical reverse distributors by regarding them as a new type of RCRA hazardous waste entity—a pharmaceutical reverse distributor. This proposed approach addresses comments that EPA received on the December 2008 Pharmaceutical Universal Waste proposal and reflects EPA's proposed revised interpretation that the point of generation for potentially creditable hazardous waste pharmaceuticals is at the healthcare facility, not the reverse distributor.
EPA proposes to establish management standards for pharmaceutical reverse distributors in 40 CFR part 266, subpart P. These entities would not be subject to 40 CFR parts 262, 264, or 265. Generally, EPA is proposing that pharmaceutical reverse distributors comply with standards that are similar to the current federal LQG standards, in combination with certain requirements that permitted or interim status hazardous waste TSDFs must meet. We are establishing one set of requirements for all pharmaceutical reverse distributors, regardless of the amount of potentially creditable hazardous waste pharmaceuticals they receive. EPA believes this uniform set of standards will make it easier for pharmaceutical reverse distributors to comply with the new proposal, since the burden of having to count hazardous waste pharmaceuticals on a monthly basis, especially the 1 kg of acute hazardous waste pharmaceuticals, will be removed.
EPA proposes that a pharmaceutical reverse distributor will not be required to have a hazardous waste permit or interim status for on-site accumulation of creditable and evaluated hazardous waste pharmaceuticals provided it follows the proposed pharmaceutical reverse distributor standards. However, for activities such as treatment or disposal of hazardous waste pharmaceuticals or other hazardous waste, a pharmaceutical reverse distributor must either obtain a RCRA permit or have interim status. This proposal requires pharmaceutical reverse distributors to comply with standards that are similar to LQG standards for on-site accumulation of hazardous waste that are found in § 262.34(a) and (b). We are proposing these requirements because, as discussed prevoiusly, the value of the potentially creditable pharmaceuticals creates an incentive for proper management and the risk of release is low. Furthermore, many pharmaceutical reverse distributors are already LQGs and therefore this proposed rule should not represent a large shift in current practices or increased burden. However, once credit is provided, the value of the pharmaceuticals is eliminated and therefore the evaluated hazardous waste pharmaceuticals have a greater potential for mismanagement. As a result, we are proposing that pharmaceutical reverse distributors have additional standards for the management of evaluated hazardous waste pharmaceuticals. Note that while the LQG accumulation standards are found in §§ 262.34(a) and (b), these generator regulations reference many interim status TSDF standards in part 265. However, in the regulatory text and preamble for this rule, we reference the standards in part 265 directly for the applicable accumulation standards for pharmaceutical reverse distributors (rather than § 262.34(a) which would then simply refer the reader to part 265). However, the Agency requests comment as to whether we should include the regulatory standard directly in 40 CFR part 266, subpart P, instead of providing a cross-reference to the standard in 40 CFR part 265 in an effort to make the rules easier to follow and comply with.
The proposed standards for pharmaceutical reverse distributors are organized into three sections. The first section applies to the pharmaceutical reverse distributor for the management of all potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals. The second section includes additional standards that would apply to the management of the potentially creditable hazardous waste pharmaceuticals that will be sent to another pharmaceutical reverse distributor for further evaluation or verification of credit and therefore continue to be regulated as potentially creditable hazardous waste pharmaceuticals. The third section includes additional standards that apply to the management of the evaluated hazardous waste pharmaceuticals that will not be sent to another pharmaceutical reverse distributor, but instead will be sent to a permitted or interim status TSDF.
This portion of the preamble discusses the proposed standards that apply to pharmaceutical reverse distributors for the management of all hazardous waste pharmaceuticals on-site. Unlike the following two sections, the standards discussed in this section apply to all pharmaceutical reverse distributors, regardless of the subsequent destination of the hazardous waste pharmaceuticals. We note that a pharmaceutical reverse distributor must follow the proposed standards for the management of hazardous waste pharmaceuticals even if it generates other, non-pharmaceutical hazardous waste that is managed under 40 CFR part 262.
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Based on site visits, EPA recognizes that many pharmaceutical reverse distributors may already meet the proposed security standard through the use of key cards that allow only authorized personnel into specific areas of the pharmaceutical reverse distributor, camera surveillance systems, and cages for storing pharmaceuticals. Some pharmaceutical reverse distributors may use fences and signs. EPA is including several examples of acceptable security measures in the regulatory text, but pharmaceutical reverse distributors are not limited to the examples provided. Further, if a pharmaceutical reverse distributor already meets the performance-based security standard by complying with other regulations, such as DEA's regulations, then the pharmaceutical reverse distributor would not need to install additional security.
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EPA is proposing that, like LQGs, pharmaceutical reverse distributors may accumulate potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals on-site for up to 90 calendar days without having interim status or a permit. However, because of the value of the potentially creditable hazardous waste pharmaceuticals, and the low risk these materials present, the Agency has decided not to propose specific container management standards.
The 90-day time limit begins when the potentially creditable hazardous waste pharmaceuticals initially arrive at the pharmaceutical reverse distributor. The 90-day time limit follows the potentially creditable pharmaceutical, even after it becomes an evaluated hazardous waste pharmaceutical. That is, there is a single 90-day accumulation limit for the hazardous waste pharmaceutical at each pharmaceutical reverse distributor. However, some potentially creditable hazardous waste pharmaceuticals travel through more than one pharmaceutical reverse distributor to receive manufacturer's credit. In such cases, each pharmaceutical reverse distributor that receives the potentially creditable hazardous waste pharmaceuticals has a new 90-day accumulation limit. EPA requests comment on the 90-day timeframe and whether this timeframe is sufficient, or whether an alternative timeframe should be allowed.
As discussed previously, EPA is proposing that a pharmaceutical reverse distributor must inventory potentially creditable hazardous waste pharmaceuticals upon arrival. Many pharmaceutical reverse distributors utilize barcoding and scanners to log potentially creditable pharmaceuticals into a database upon arrival or soon after a shipment arrives. Current inventory systems may be adapted to provide verification of the time limits. For example, if a pharmaceutical reverse distributor includes the date of arrival in the inventory, then the pharmaceutical reverse distributor will be able to use the inventory to verify that potentially creditable hazardous waste pharmaceuticals and evaluated hazardous waste pharmaceuticals are not accumulated on-site for more than 90 calendar days. EPA is not proposing a specific method that pharmaceutical reverse distributors must use to document that accumulation does not exceed 90 calendar days. We anticipate that most pharmaceutical reverse distributors would use the inventory system to verify the 90-calendar day timeframe rather than using an additional requirement of labeling containers with dates for verification, but we request comment on this issue. We also request comment on whether EPA needs to specify a method of documenting that 90 calendar days is not exceeded.
Pharmaceutical reverse distributors have informed EPA that there are times when pharmaceutical returns may need to be consolidated for longer periods because they are subject to litigation and the pharmaceutical reverse distributor is not allowed to move them. Pharmaceutical reverse distributors may also need to handle large recalls of hazardous waste pharmaceuticals and might not be able to process all of the returned items within 90 calendar days. Therefore, EPA is proposing to allow a pharmaceutical reverse distributor to request from EPA an extension of the 90-day accumulation time limit for situations when the hazardous waste pharmaceuticals are involved in litigation, a recall, or in unforeseen circumstances beyond the control of the pharmaceutical reverse distributor. A pharmaceutical reverse distributor
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EPA is proposing that if a pharmaceutical reverse distributor receives a shipment from a healthcare facility that includes hazardous waste that it is not authorized to receive, such as non-creditable hazardous waste or hazardous waste that is not a pharmaceutical, the pharmaceutical reverse distributor must submit an unauthorized waste report to the EPA Regional Administrator within 15 days of receiving the hazardous waste. We have adapted the existing requirement for situations when permitted and interim status TSDFs receive unmanifested hazardous waste (§ 264.76 and § 265.76, respectively) to make it appropriate for pharmaceutical reverse distributors that receive unauthorized hazardous waste. However, we are also proposing two additional requirements for pharmaceutical reverse distributors that receive inappropriate hazardous waste. First, the pharmaceutical reverse distributor must send a copy of the unauthorized hazardous waste report to the healthcare facility that sent the unauthorized hazardous waste. This requirement is intended to alert the healthcare facility of its mistake in order to prevent further shipments of non-creditable hazardous waste or non-pharmaceutical hazardous waste. Second, the pharmaceutical reverse distributor must manage the unauthorized hazardous waste that it receives in accordance with all applicable regulations. The Agency expects that the pharmaceutical reverse distributor will likely pass these additional costs (
In order to prevent exposing employees to unnecessary risk, EPA recommends as a best management practice that pharmaceutical reverse distributors avoid sorting through shipments that contain non-creditable waste since the shipment may include hazardous waste, including infectious or radioactive healthcare waste. As a result, it is possible that a pharmaceutical reverse distributor receiving a shipment that includes non-creditable waste may be unsure whether the shipment includes hazardous waste. In such cases, EPA recommends that the pharmaceutical reverse distributor assume the shipment includes hazardous waste and submit an unauthorized waste report. Further, we recommend that pharmaceutical reverse distributors work with their clients to reduce the occurrence of inappropriate shipments.
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Note that additional recordkeeping requirements may also pertain to pharmaceutical reverse distributors. For example, a pharmaceutical reverse distributor that manifests its non-pharmaceutical hazardous waste is subject to the manifest recordkeeping requirements of § 262.40. Further, as discussed in subsequent sections, there are additional recordkeeping requirements that apply to pharmaceutical reverse distributors for the management of potentially creditable hazardous waste pharmaceuticals destined for another pharmaceutical reverse distributor and others that apply to pharmaceutical reverse distributors for the management of evaluated hazardous waste pharmaceuticals.
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EPA has chosen to propose 21 calendar days to ensure that the pharmaceutical reverse distributor has a long enough of time to make the evaluation, yet a short enough time to ensure that potentially creditable hazardous waste pharmaceuticals do not linger awaiting evaluation. The Agency requests comment on this timeframe and whether it should be shortened or lengthened. We also want to emphasize that the 21 calendar days for evaluating the potentially creditable hazardous pharmaceuticals counts as part of the total 90 calendar days that the hazardous waste pharmaceuticals are allowed to accumulate on-site.
Once an evaluation is made on the incoming potentially creditable hazardous waste pharmaceuticals, if they are destined for another pharmaceutical reverse distributor, they are still considered potentially creditable hazardous waste pharmaceuticals. There are additional regulations in this proposal at § 266.510(b) that pertain to these potentially creditable hazardous waste pharmaceuticals (discussed in Section V.G.3.b.). If, however, they are destined for an interim status or permitted TSDF, they are considered “evaluated hazardous waste pharmaceuticals.” There are additional regulations in this proposal at § 266.510(c) that pertain to these evaluated hazardous waste pharmaceuticals (discussed in Section V.G.3.c.).
This section discusses the additional standards that apply to a pharmaceutical reverse distributor for the management of potentially creditable hazardous waste pharmaceuticals that require further evaluation or verification of manufacturer's credit at another pharmaceutical reverse distributor. These hazardous waste pharmaceuticals continue to be considered potentially creditable hazardous waste pharmaceuticals. Until manufacturer's credit is finalized, the potentially creditable hazardous waste pharmaceuticals retain their value and there is greater incentive to manage them carefully in order to receive full manufacturer's credit. Therefore, EPA is proposing few regulatory standards for the management of the potentially creditable hazardous waste pharmaceuticals that are destined for another pharmaceutical reverse distributor.
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(1) a healthcare facility may send potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor, which may or may not be a manufacturer;
(2) the first pharmaceutical reverse distributor may send the potentially creditable hazardous waste to another pharmaceutical reverse distributor, which may or may not be a manufacturer
(3) the second pharmaceutical reverse distributor can only send the potentially creditable hazardous waste pharmaceuticals on to a pharmaceutical reverse distributor that is a manufacturer.
EPA anticipates that healthcare facilities that are CESQGs will send their potentially creditable hazardous waste pharmaceuticals directly to pharmaceutical reverse distributors, and that the accumulation mechanism that we are proposing will be used to send only non-creditable hazardous waste pharmaceuticals to off-site healthcare facilities (see Section V.C.15.). However, EPA requests comment on whether CESQG healthcare facilities would benefit from being able to consolidate potentially creditable hazardous waste pharmaceuticals off-site, as well. Depending on comments, EPA will consider allowing a fourth transfer (for this limited situation) when potentially creditable hazardous waste pharmaceuticals are sent from a CESQG healthcare facility to an off-site healthcare facility for accumulation, as would also be allowed by proposed § 266.504(a).
This chain of transfers ensures that the potentially creditable hazardous waste pharmaceuticals will be accumulated for no more than 270 days in total after leaving a healthcare facility and before being transported to a RCRA-permitted or interim status TSDF for treatment and disposal (assuming no accumulation time extensions are granted). EPA requests comment as to whether the three-transfer and 90-day limits are appropriate and whether more or fewer transfers are necessary for verification of manufacturer's credit.
Put another way, if a pharmaceutical reverse distributor receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility, the pharmaceutical reverse distributor must send those potentially creditable hazardous waste pharmaceuticals to another pharmaceutical reverse distributor (which may or may not be a manufacturer) or must manage them as evaluated hazardous waste pharmaceuticals under proposed § 266.510(c). However, a pharmaceutical reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another pharmaceutical reverse distributor is more limited in where it can send the potentially creditable hazardous waste pharmaceuticals. It can send potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor that is the manufacturer or else must manage them as evaluated hazardous waste pharmaceuticals under § 266.510(c).
Regardless of the destination, each pharmaceutical reverse distributor must make an evaluation of the hazardous waste pharmaceuticals within 21 calendar days and may only accumulate the hazardous waste pharmaceuticals on-site for a maximum of 90 calendar days, unless an extension is granted by the Regional Administrator before it ships them off-site to another pharmaceutical reverse distributor or a RCRA-permitted or interim status TSDF. In addition, all shipments of evaluated hazardous waste pharmaceuticals are subject to proposed § 266.508 and shipments of all potentially creditable hazardous waste pharmaceuticals are subject to proposed § 266.509.
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This section discusses the additional standards that apply to a pharmaceutical reverse distributor for the management of evaluated hazardous waste pharmaceuticals (
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In terms of container management standards, the Agency is proposing requirements that are similar to the container management standards for LQGs—that is, the standards in 40 CFR part 265, but the Agency is also proposing to include some additional management requirements specific to hazardous waste pharmaceuticals. Specifically, under 40 CFR 262.34(a)(1)(i), LQGs must comply with the container management standards in 40 CFR part 265, subpart I, which includes a requirement that containers of hazardous waste must be kept closed, except when adding or removing waste. In this document, EPA is proposing to require that only containers with hazardous waste pharmaceuticals that are liquids or gels be kept closed during accumulation due to the low potential for release for those hazardous waste pharmaceuticals that are in a solid form. However, because most potentially creditable hazardous waste pharmaceuticals are in their original packaging, if the original packaging for gels or liquids is intact and sealed or the pharmaceuticals have been repackaged (
EPA is also proposing that containers of hazardous waste pharmaceuticals must be maintained in good condition to prevent leaks and the container material must be compatible with the hazardous waste pharmaceuticals placed in the container. In addition, we are proposing to require that a pharmaceutical reverse distributor that manages ignitable or reactive evaluated hazardous waste pharmaceuticals or that mixes or comingles incompatible evaluated hazardous waste pharmaceuticals must manage the container to prevent dangerous situations, such as fire, explosion, or release of toxic fumes.
Similar to healthcare facilities that accumulate non-creditable hazardous waste pharmaceuticals, pharmaceutical reverse distributors that accumulate evaluated hazardous waste pharmaceuticals must segregate the pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of § 268.3(c) and accumulate them in separate containers from other evaluated hazardous waste pharmaceuticals.
There are also several existing LQG accumulation unit management standards in § 262.34(a) that EPA believes are not necessary to include for the management of evaluated hazardous waste pharmaceuticals. For instance, this proposal only sets standards for the accumulation of evaluated hazardous waste pharmaceuticals in containers. EPA does not think it is necessary to include accumulation units such as tanks, containment buildings, or drip pads because pharmaceutical reverse distributors do not currently use these types of accumulation units. However, if EPA is mistaken in this understanding and commenters indicate they would like to be able to use tanks, containment buildings, or drip pads, EPA would consider including in this proposal the LQG standards for accumulation in these units. The Agency solicits comment on this matter.
In addition, the Agency is not proposing to require pharmaceutical reverse distributors to meet the air emission standards found in 40 CFR part 265, subpart CC as required in § 262.34(a)(1)(i) because we anticipate that they will not be applicable. Specifically, § 265.1083(c) exempts tanks, surface impoundments, and containers from the organic air emission standards if the hazardous waste entering the accumulation unit has an average volatile organic concentration of less than 500 parts per million by weight, while § 265.1080(b)(2) exempts containers with a capacity of less than 0.1 m
Similarly, EPA does not anticipate that the 40 CFR part 265, subpart AA—air emissions standards for process vents—and subpart BB—air emission standards for equipment leaks—are applicable to the activities of a pharmaceutical reverse distributor and its management of hazardous waste pharmaceuticals. Therefore, like 40 CFR part 265, subpart CC discussed previously, EPA is not proposing to require that 40 CFR part 265, subparts AA and BB apply to pharmaceutical reverse distributors. EPA requests comments on whether its current understanding is correct and whether the 40 CFR part 265, subparts AA, BB, and CC RCRA air emission standards should be applied to pharmaceutical reverse distributors.
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EPA asks commenters to review the standards EPA is proposing for pharmaceutical reverse distributors and provide specific comment on whether the standards are appropriate and sufficient to protect human health and the environment.
EPA is proposing to not require that a pharmaceutical reverse distributor have a RCRA permit or interim status for accumulating potentially creditable and evaluated hazardous waste pharmaceuticals, provided that the pharmaceutical reverse distributor follows all the conditions of the permitting exemption in § 266.510. In other words, a pharmaceutical reverse distributor would be subject to regulation as a TSDF and require a RCRA permit (or interim status) if it does not meet the conditions of § 266.510. In addition, a pharmaceutical reverse distributor must have a RCRA permit (or interim status) if it treats or disposes of hazardous waste on-site or if it accepts manifested hazardous waste from off-site. A pharmaceutical reverse distributor is required to reject shipments of manifested hazardous waste that it may inadvertently receive from off-site because a pharmaceutical reverse distributor is not a designated facility and therefore is not eligible to receive hazardous waste via a manifest. EPA believes that this approach to regulation of pharmaceutical reverse distributors that accumulate hazardous waste pharmaceuticals strikes an appropriate balance because it recognizes that pharmaceutical reverse distributors are different from typical hazardous waste TSDFs for permitting purposes, while it still imposes certain conditions for exemption from permitting requirements that provide the necessary environmental protection.
EPA is proposing that healthcare facilities that are currently considered LQGs or SQGs are subject to the new 40 CFR part 266, subpart P requirements for the management of hazardous waste pharmaceuticals. Thus, a healthcare facility that generates (or accumulates)
To determine whether a healthcare facility is a subject to 40 CFR part 266, subpart P, or a CESQG regulated under § 261.5, a healthcare facility must count all the hazardous waste—pharmaceutical and non-pharmaceutical—it generates in a calendar month. In counting the amount of hazardous waste generated per calendar month, we note that EPA is proposing to change which pharmaceuticals will be considered hazardous wastes (
EPA is proposing that all healthcare facilities, with the exception of CESQGs, will be subject to the same regulations for the management of their hazardous waste pharmaceuticals, regardless of the quantity of hazardous waste pharmaceuticals generated. A healthcare facility that generates both pharmaceutical and non-pharmaceutical hazardous waste must manage the non-pharmaceutical hazardous waste pursuant to part 262, but need not count its hazardous waste pharmaceuticals toward the facility's monthly hazardous waste generator category. In addition, if a healthcare facility does not want to keep track of the amount of hazardous waste it generates to ensure it does not exceed the CESQG quantity limits, it could choose to operate under this proposed rule. If it chooses to operate under this proposed rule, however, a healthcare facility must comply with all the requirements of this subpart for the management of its hazardous waste pharmaceuticals.
One difference between this proposal and the 2008 Pharmaceutical Universal Waste proposal is how RCRA would apply to pharmaceuticals returned to pharmaceutical reverse distributors to obtain manufacturer's credit. EPA is proposing to change its existing position on this issue. If this rule is finalized, this change would mean that the decision by a healthcare facility to send a pharmaceutical to a pharmaceutical reverse distributor is the decision to discard the pharmaceutical. Therefore, under this proposed rule, once the healthcare facility makes the decision to send a pharmaceutical to a pharmaceutical reverse distributor for credit, it is a solid waste at the healthcare facility. It is likely that a portion of the potentially creditable solid waste pharmaceuticals at healthcare facilities that are destined for a pharmaceutical reverse distributor will also meet the definition of hazardous waste and as a result, these potentially creditable hazardous waste pharmaceuticals would need to be managed in accordance with the standards proposed in this document. However, until this rule is final and effective, EPA's current position will remain in effect.
In addition, the Agency notes that the proposed change in EPA's position concerning reverse distribution and the management standards discussed in this document pertain only to the reverse distribution of hazardous waste pharmaceuticals and does not apply to reverse distribution or reverse logistics systems that may exist for other consumer products. This limitation is because EPA has studied and collected data for reverse distribution systems for hazardous waste pharmaceuticals, and not all consumer products.
Under this proposal, all pharmaceutical reverse distributors are subject to 40 CFR part 266, subpart P and will be subject to the same standards with respect to their hazardous waste pharmaceuticals, regardless of the amount of hazardous waste pharmaceuticals they manage. Even pharmaceutical reverse distributors that are currently CESQGs will be regulated under 40 CFR part 266, subpart P for the management of their hazardous waste pharmaceuticals. Therefore, as with healthcare facilities, a pharmaceutical reverse distributor subject to 40 CFR part 266, subpart P will no longer have to keep track of the amount of hazardous waste pharmaceuticals that it generates on a monthly basis.
Most, if not all, healthcare facilities and pharmaceutical reverse distributors generate hazardous wastes other than pharmaceuticals. These, non-pharmaceutical hazardous wastes will continue to be regulated under 40 CFR part 262 (and other applicable Subtitle C regulations). However, because a healthcare facility or pharmaceutical reverse distributor operating under 40 CFR part 266, subpart P no longer has to count its hazardous waste pharmaceuticals, including acute hazardous waste pharmaceuticals such as warfarin, it could result in a change in the facility's overall generator category and thus change how its non-pharmaceutical hazardous waste must be managed. For example, the generator category for a healthcare facility or pharmaceutical reverse distributor may be reduced from an LQG to an SQG or even a CESQG, when it stops counting its hazardous waste pharmaceuticals, especially acute hazardous waste pharmaceuticals, toward its generator category.
If finalized, the standards established by this rulemaking apply only to the management of hazardous waste
States have taken a variety of approaches regarding pharmaceutical hazardous wastes. One major goal of this proposed rule is to provide clarity on this topic, and thereby promote national consistency, which, in turn, should promote better compliance among healthcare facilities, including pharmacies.
California has taken numerous enforcement actions against national retail chains with pharmacies for not complying with the RCRA hazardous waste regulations. In recent years, the state took enforcement actions and imposed fines on the following chains: Kmart (2009), Walmart (2010), Target (2011), CVS (2012), Costco (2012), Walgreens (2012) and Rite-Aid (2013). In at least two settlement agreements, California directed the defendants (CVS and Costco) to “initiate work with appropriate stakeholders from business and government, including the U.S. Environmental Protection Agency, the U.S. Food and Drug Administration, and the DTSC [Department of Toxic Substances Control], and thereafter either directly or through trade associations or informal coalitions of interested parties, undertake to promote federal regulatory reform regarding the proper management of nondispensable pharmaceuticals, including over-the-counter medications, through “reverse distribution.”
In 2012, Connecticut's Department of Energy and Environmental Protection (DEEP) took enforcement actions at seven CVS stores for violations of the RCRA hazardous waste regulations. Consent orders from Connecticut DEEP direct CVS stores in the state to follow a set of best management practices.
Aside from best management practices developed by Connecticut as part of a consent order, at least two other states have developed guidance documents that apply conditions to the management of hazardous wastes pharmaceuticals in exchange for enforcement discretion. In particular, in 2008, the Washington State Department of Ecology issued guidance titled, Interim Enforcement Policy: Pharmaceutical Waste in Healthcare.
In 2011, Minnesota's Pollution Control Agency (MPCA) issued a fact sheet titled Reverse Distribution of Pharmaceuticals: Guidance for Minnesota Healthcare Providers.
Some of the comments EPA received in response to the 2008 Universal Waste proposal recommended that EPA add additional pharmaceutical wastes to the P and U hazardous waste lists (see § 261.33). Some commenters suggested that EPA assess the hazards from all discarded pharmaceuticals (especially chemotherapy drugs) that have come into the market since the promulgation of the original P and U hazardous waste lists
Commenters specifically referred to EPA's P and U hazardous waste lists under the RCRA subtitle C regulations. Generally, in its hazardous waste determinations, EPA has evaluated both “production wastes” (from specific or non-specific sources; see §§ 261.31 and 261.32) and “commercial chemical products” that, when discarded, become wastes (§ 261.33). This latter category (commercial chemical products that are discarded) is the most relevant of the listed hazardous wastes to the pharmaceuticals wastes discussed elsewhere in this preamble, and to which commenters referred in the 2008 Universal Waste proposal. As discussed in Section IV.A.of this preamble, commercial chemical products listed in § 261.33 are (when discarded) defined as either P-listed “acute” hazardous wastes, or U-listed (non-acute) hazardous wastes. The criteria for listing a solid waste as hazardous under RCRA Subtitle C are described in § 261.11. A waste may be identified as a P-listed waste if it is shown to be fatal to humans or animals at low doses (see § 261.11(a)(2)). Thus, lethality data for any chemical is the principal factor for making a determination that a discarded commercial chemical product is a P-listed hazardous waste.
In contrast, a waste may be identified as a U-listed waste if it contains any of the toxic constituents listed in Appendix VIII of 40 CFR part 261, and if, after examining each of 10 factors in § 261.11(a)(3), it is determined that the waste is capable of posing a “substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed.”
In its September 2011 report, EPA found that 11 drugs on the NIOSH or OSHA lists of hazardous drugs meet the specific criteria for acute toxicity in § 261.11(a)(2) (identified as “Tier 1” drugs in the report). An additional 114 drugs on the NIOSH or OSHA lists did
In addition, as discussed in Section IV.D. of this preamble, the EPA's OIG has recommended that EPA identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous waste, and establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste. While EPA has an existing process generally for defining whether or not a solid waste is a listed hazardous
EPA is also exploring ways to identify new sources of information, along with alternative approaches that can most efficiently address these concerns. EPA is using the opportunity in this preamble to seek stakeholders' input on the best course of action concerning regulation of additional pharmaceuticals as hazardous wastes. It is also an opportunity for stakeholders to provide additional information that they may have about potentially hazardous pharmaceuticals. Thus, before deciding on a possible proposal to list additional pharmaceuticals as hazardous wastes, we request comment on the September 2011 final report, and solicit information regarding additional potentially hazardous pharmaceuticals. We request information on the sources and identity of additional potentially hazardous pharmaceuticals along with annual product generation data, annual waste generation data, use information, toxicity data, waste storage and handling information, and disposal information.
In addition, we request stakeholder input for alternative approaches to making hazardous waste listing determinations for pharmaceuticals that do not meet the acute hazardous criteria. Based on the existing listing determination process described previously for non-acute wastes, there is no single toxicity effect (
The Agency emphasizes that no regulatory action is being proposed with respect to expanding the number of pharmaceuticals that are considered hazardous waste. We will use the comments we receive to help inform how to proceed with evaluating discarded pharmaceuticals as listed or characteristic hazardous wastes. Any action taken would be part of a separate, proposed rulemaking in the future.
In 1980, as part of its final and interim final regulations implementing Section 3001 of RCRA, EPA promulgated the list of commercial chemical products or manufacturing chemical intermediates (40 CFR 261.33) that are hazardous wastes if they are discarded or intended to be discarded, which included nicotine and salts (45 FR 33124; May 19, 1980). The phrase “commercial chemical product or manufacturing chemical intermediate” refers to a “chemical substance which is manufactured or formulated for commercial or manufacturing use which consists of the commercially pure grade of the chemical, any technical grades of the chemical that are produced or marketed, and all formulations in which the chemical is the sole active ingredient” (see the
EPA listed nicotine and salts (referred to commonly as just nicotine) as acutely hazardous waste (P075) in § 261.33(e) based on an estimated oral LD50 toxicity to humans of 1 mg/kg and a dermal LD50 toxicity to rabbits of 50 mg/kg.
On February 14, 2014, EPA published a Notice of Data Availability (NODA) and Request for Comment (79 FR 8926) entitled “Hazardous Waste Management and the Retail Sector: Providing and Seeking Information on Practices to Enhance Effectiveness to the RCRA Program.” EPA received 44 comments in response to this NODA, many of which included comments related to pharmaceuticals, in particular comments concerning expired or returned low-concentration nicotine-containing smoking cessation products and e-cigarettes. The most detailed comments concerning the unsold low-concentration nicotine products were jointly submitted by the Retail Industry Leaders Association (RILA), the Food Marketing Institute (FMI), the National Association of Chain Drug Stores (NACDS), the National Retail Federation, and their members (referred to as the retail associations, retailers, or
The commenters, to support their request to EPA, state that EPA's listing for nicotine and salts warrants a reevaluation, because in more recent literature concerning nicotine toxicity, doubts have been expressed about the estimated oral LD50 toxicity to humans of 1 mg/kg, used as a key basis for the listing. According to information provided by commenters, the estimated oral LD50 toxicity to humans of 1 mg/kg was based on extrapolations from toxicological effects observed as result of “self-experiments” performed with nonfatal doses of nicotine. However, according to the commenters, there are doubts about the 1 mg/kg estimate because people have survived after ingesting much larger amounts of nicotine.
The commenters also state that in 1980, when EPA listed nicotine and salts as acute hazardous wastes, the nicotine products in the market contained a high concentration of the chemical (
While it may be reasonable for the commenters to conclude that toxicity is higher at higher concentrations of a chemical and lower at lower concentrations of a chemical, EPA currently lacks sufficient information to conclude that low-concentration nicotine-containing products are not acutely toxic as defined under 40 CFR 261.11(a)(2). In addition, except for warfarin and zinc phosphide, the listings for commercial chemical products under 40 CFR 261.33(e) are not concentration-based listings. The warfarin and zinc phosphide listings were changed to concentration-based listings because companies using products containing lower concentration formulations of warfarin and zinc phosphide petitioned EPA to amend the listings and provided LD50 data for animals for the lower concentration products to support their petition (see 49 FR 19922; May 10, 1984). The Agency does not think that linear extrapolations from toxicity levels determined using higher-concentration nicotine products can be used to characterize the acute toxicity of low-concentration nicotine-containing products. Furthermore, although nicotine pesticides are no longer available, high concentration nicotine products still exist. For example, manufacturers of nicotine-containing products, such as e-cigarettes, buy concentrated nicotine solutions and dilute them for consumer use.
In summary, nicotine and salts are P075 listed acute hazardous wastes if the waste arises from the discard of an unused commercial chemical product, manufacturing chemical intermediate, or off-specification material. Additionally, the P075 waste code applies only if the nicotine is present in pure or technical grade form, or is the sole active ingredient in the chemical formulation when discarded. As such, unused (unsold, expired, or returned) nicotine-containing products, including patches, gums, lozenges,
The over-the-counter (OTC) nicotine-containing smoking cessation products, referred to also as nicotine replacement therapy (NRT) products (
Since e-cigarettes have not been approved by the FDA as smoking cessation products, we do not anticipate being able to obtain animal or human toxicity data from the FDA on nicotine concentrations in e-cigarettes. To complicate matters, the concentration of nicotine in e-cigarettes is not limited by any regulation or approval process and is therefore unpredictable. As a result, this option would likely be limited to excluding FDA-approved over-the-counter nicotine-containing smoking cessation products from the P075 listing and would not include e-cigarettes.
The comments from the retail associations have stressed that the low
EPA invites comments on all possible approaches to amend the acute hazardous waste listing for nicotine and salts, including the two approaches discussed above in Section VIII.D. We also request toxicity information for low-concentration nicotine-containing products that could help determine whether or not these products meet the criteria for acute hazardous wastes under § 261.11(a)(2). The Agency emphasizes that no regulatory language is currently being proposed with respect to amending the P075 listing to exempt the low-concentration nicotine-containing products. However, depending on the information received during the comment period, EPA could finalize one of the approaches discussed previously without a separate proposed rulemaking in the future.
In addition, we request comments on whether we should exempt other low-concentration nicotine-containing smoking cessation products, such as inhalers and nasal sprays, from the P075 listing under approach 1, described in the Section VIII.D, above. These products are also FDA-approved, but require a prescription to purchase. The nicotine-containing patches, gums, and lozenges are sold over-the-counter, so they do not require a prescription for purchase. We are interested in finding out what the differences are between nicotine-containing smoking cessation products requiring a prescription and those products that do not require a prescription (
Finally, we request comment on whether we should include e-cigarettes and nicotine-containing e-liquids for the e-cigarettes within the scope of the definition of pharmaceutical. As described in this proposal, pharmaceutical hazardous wastes do not count toward generator category. Therefore, since e-cigarettes and nicotine-containing e-cigarette refill liquids (sometimes referred to as e-liquids or e-juice) are P075, if they are considered pharmaceuticals, they would not impact the hazardous waste generator category of the retailers. The retailers, however, would have to manage e-cigarettes and nicotine-containing liquids as hazardous waste pharmaceuticals under part 266, subpart P. We will use the comments we receive to help us decide whether and how to proceed with amending the scope of the definition of pharmaceutical to include e-cigarettes and nicotine-containing e-liquids.
Under Section 3006 of RCRA, EPA may authorize a qualified State to administer its own hazardous waste program within the State in lieu of the Federal program. Following authorization, EPA retains enforcement authority under Sections 3008, 3013, and 7003 of RCRA, although authorized States have primary enforcement responsibility. The standards and requirements for State authorization are found at 40 CFR part 271.
Prior to enactment of the Hazardous and Solid Waste Amendments of 1984 (HSWA), a State with final RCRA authorization administered its hazardous waste program entirely in lieu of EPA administering the Federal program in that State. The federal requirements no longer applied in the authorized State, and EPA could not issue permits for any facilities in that State, since only the State was authorized to issue RCRA permits. When new, more stringent federal requirements were promulgated, the State was obligated to enact equivalent authorities within specified time frames. However, the new federal requirements did not take effect in an authorized State until the State adopted the federal requirement as State law.
In contrast, under RCRA Section 3006(g) (42 U.S.C. 6926(g)), which was added by HSWA, new requirements and prohibitions imposed under HSWA authority take effect in authorized States at the same time that they take effect in unauthorized States. The statute directs EPA to implement these requirements and prohibitions in authorized States, including the issuance of permits, until the State is granted authorization to do so. While the State must still adopt HSWA related provisions as State law in order to retain final authorization, EPA implements the HSWA provisions in authorized States until the States do so.
Authorized States are required to modify their program only when EPA enacts federal requirements that are more stringent or broader in scope than the existing federal requirements. RCRA Section 3009 allows the States to impose standards more stringent than those in the federal program (see also § 271.1).
This action proposes to add a new subpart P to 40 CFR part 266, and it is being proposed in part under the authority of HSWA and in part under non-HSWA authority. The bulk of 40 CFR part 266, subpart P is being proposed under non-HSWA authority. Thus, when finalized, the amendments promulgated under non-HSWA authority would be applicable on the effective date only in those states that do not have final authorization of their base RCRA programs. However, the prohibition of sewering pharmaceutical hazardous wastes (§ 266.504) is being proposed under HSWA authority in section 3018 of RCRA. Thus, when finalized, the amendments promulgated under the authority of HSWA would be applicable on the effective date of the final rule in all states. Moreover, authorized states are required to modify
The Universal Waste program allows states to add wastestreams to their own state program, even when the waste stream has not been added to the federal Universal Waste program, provided the state has adopted and been authorized for the petition process in §§ 260.20 and 260.23. Two states have added hazardous waste pharmaceuticals to their Universal Waste programs: Florida and Michigan. Because this proposed rule is considered more stringent than either the “traditional RCRA” standards or the Universal Waste program, both Florida and Michigan will be required to modify their programs to adopt an approach at least as stringent as the amendments, if this rule is finalized. Furthermore, because the Agency has determined that it is not appropriate to add hazardous waste pharmaceuticals to the Universal Waste program, both Florida and Michigan must remove hazardous waste pharmaceuticals from their Universal Waste program when they adopt this new subpart, although they may continue to regulate non-hazardous waste pharmaceuticals under the Universal Waste program, to the extent allowed under state law. In addition, states may not add hazardous waste pharmaceuticals to their Universal Waste program in the future.
In addition to proposing new standards for the management of hazardous waste pharmaceuticals at healthcare facilities and pharmaceutical reverse distributors, EPA is proposing to add and reserve 40 CFR part 266, subpart O. Specifically, on May 22, 2001, EPA finalized a Project XL rule in 40 CFR part 266, subpart O (66 FR 28066) for US Filter Recovery Services. However, on July 2, 2008, EPA published a rule that withdrew 40 CFR part 266, subpart O (73 FR 37858). Generally, in order to avoid the potential for confusion that might be caused by reusing a subpart, EPA reserves a subpart that has already been used and removed. In 2008, when we removed 40 CFR part 266, subpart O, we neglected to reserve it. Consequently, we are proposing to add and reserve 40 CFR part 266, subpart O.
In order to meet the Office of Management and Budget (OMB) Circular A-4 requirement that EPA analyze the costs and benefits of regulations, we conducted an economic analysis of the proposed rule. The economic analysis follows OMB guidelines and estimates the costs and benefits of the rule. The economic analysis is titled “Regulatory Impact Analysis for EPA's Proposed Healthcare Facility-Specific Regulations for the Management of Hazardous Waste Pharmaceuticals” and is hereafter referred to as the Regulatory Impact Analysis (RIA). The RIA is summarized here while the full RIA can be found at regulations.gov under docket number EPA-HQ-RCRA-2007-0932.
This proposed rule may affect several different types of healthcare facilities, including hospitals, physicians' offices, dentists' offices, outpatient care centers, pharmacies, veterinary clinics, nursing care facilities, coroners' offices, other health practitioners, other ambulatory care services, and pharmaceutical reverse distributors. Based on data from the 2007 Economic Census and a limited number of states, the RIA estimates that the rule will affect approximately 174,000 facilities. Table 12 lists the number of facilities (by NAICS code) expected to be affected by the proposed rule. The vast majority of these (83.6%) are CESQGs, followed by SQGs (13.4%), and LQGs (3.0%).
We estimate that there is a total of approximately 139,000 tons of RCRA hazardous waste generated by healthcare facilities annually. Approximately 36,200 tons (26%) of this total are hazardous waste pharmaceuticals.
The estimated costs of the proposed rule are the incremental costs over and above the “baseline” (
The estimated cost of the proposed rule, including the proposed prohibition on sewering of hazardous waste pharmaceuticals is estimated at $37 million annually under the full compliance baseline. However, there are also significant cost savings under the proposed rule: $24.3 million annually under the full compliance baseline. Therefore the net cost of the rule is $13 million annually ($37million cost minus $24.3 million cost savings = $13 million net costs). Please see the RIA for more detailed analysis and results regarding the cost of the rule and the regulatory options analyzed.
The proposed rule for the management of hazardous waste pharmaceuticals is expected to yield a range of environmental benefits as hospitals, medical clinics, and other healthcare facilities divert hazardous waste pharmaceuticals currently disposed in sewers, municipal solid waste landfills (MSWLFs), municipal waste combustors (MWCs), and medical waste autoclaves and incinerators, to hazardous waste incinerators. The rule reduces the amount of hazardous waste pharmaceuticals sewered into waterways, provides regulatory clarity for industry and provides healthcare facilities and pharmaceutical reverse distributors with cost savings.
The largest quantified benefit is from avoided sewering of hazardous waste pharmaceuticals. Disposal of hazardous waste pharmaceuticals through sewering is believed to be a widespread practice of disposal. Sewering is believed to be one of the most deleterious disposal methods because active pharmaceutical ingredients (APIs) entering surface waters, often untreated by municipal wastewater treatment plants, pose the potential for adverse human health and environmental effects since they may be absorbed by humans and other organisms. Under the proposed rule, the Agency anticipates preventing approximately 6,400 tons of hazardous waste pharmaceuticals annually into waterways via a sewering ban. While the Agency was not able to quantify the human health and environmental benefits of reducing or eliminating the sewering of hazardous waste pharmaceuticals, EPA did estimate the cost savings of eliminating the wastewater treatment costs associated with sewering such pharmaceuticals. The estimated cost savings of eliminated wastewater treatment related to the prevented sewering of hazardous waste pharmaceuticals is estimated to be $4.3 million annually.
The proposed rule will yield other benefits beyond the reduction in sewering of hazardous waste pharmaceuticals. For example, under the proposed rule, healthcare facilities will no longer be required to count hazardous waste pharmaceuticals toward their RCRA generator category. This, in turn, will lead to changes in a healthcare facility's generator category,
Under Executive Order 12866 (58 FR 51735; October 4, 1993), this action is a “significant regulatory action” because it is likely to raise novel legal or policy issues under section 3(f)(4). Accordingly, EPA submitted this action to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821; January 21, 2011) and any changes made in response to OMB recommendations have been documented in the docket for this action (EPA-HQ-RCRA-2007-0932).
Findings for the RIA indicate that the rule, as proposed, is projected to result in an aggregate annual cost of approximately $37 million based on a discount rate of 7%. However, the proposed rule will also achieve an annual cost savings, which is estimated to be $24.3 million. Therefore, the net cost of the rule is estimated at $13 million annually. The costs, which represents annualized incremental costs relative to the full compliance baseline, is below the $100 million threshold established under part 3(f)(1) of the Order.
In addition to calling for an assessment of regulatory costs, Executive Order 12866 also requires Federal agencies to assess benefits and, “recognizing that some costs and benefits are difficult to quantify, propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs.” As discussed previously, the cost savings for the rule are estimated to be $24.3 million annually. These cost savings are considered benefits of the rule. Also, EPA estimates that the proposed rule will lead to the diversion of approximately 6,440 tons annually of hazardous waste pharmaceuticals from sewer disposal to alternate forms of disposal. This reduction in sewering will likely reduce the concentration of active pharmaceutical ingredients in the nation's waterways, potentially benefiting both ecosystems and human populations. Please see the RIA for more details on the benefits of the proposed rule.
The information collection activities in this proposed rule have been submitted for approval to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document that the EPA prepared has been assigned EPA ICR number 2486.01. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
EPA is proposing in this rule, under a new subpart P to 40 CFR part 266, new and revised reporting and recordkeeping requirements for healthcare facilities and pharmaceutical reverse distributors managing hazardous waste pharmaceuticals. These proposed requirements, which are also identified in the ICR supporting this action, will enable EPA and state regulatory agencies to identify the universe of healthcare facilities managing hazardous waste pharmaceuticals. The healthcare facilities must keep records of any test results, waste analyses or other determinations made on hazardous waste pharmaceuticals for three years from the date of analyses. In addition, the proposed requirements include provisions for improved tracking of hazardous waste pharmaceuticals that are routed through pharmaceutical reverse distributors.
EPA will use the collected information to ensure that hazardous waste pharmaceuticals are being managed in a protective manner. The tracking requirements ensure that these wastes arrive at their intended destinations rather than diverted for illicit purposes or managed at facilities not equipped to manage these wastes. These tracking requirements will also help facilities identify shipments that do not arrive at their destination as planned, allowing generators to take corrective action that will ensure that future shipments are transported to the appropriate location. In addition, during a facility inspection, information kept in facility records will help EPA and state environmental regulatory agencies determine whether or not regulatory requirements are being followed. Information marked on containers of hazardous waste pharmaceuticals will assist handlers and transporters in ensuring proper management during storage and shipment.
EPA has carefully considered the burden imposed upon the regulated community by the proposed regulations. EPA is confident that those activities required of respondents are necessary and, to the extent possible, has attempted to minimize the burden imposed. EPA believes strongly that if the minimum requirements specified under the proposed regulations are not met, neither the facilities nor EPA can ensure that hazardous waste pharmaceuticals are managed in a manner protective of human health and the environment.
EPA estimates that the total annual respondent burden for the new paperwork requirements in the proposed rule is approximately 54,857 hours, and the annual respondent cost for the new paperwork requirements in the rule is approximately $3,457,478. The estimated annual hourly burden ranges from 0.1 to 3.5 hours per response for the 28,637 respondents. However, in addition to estimating the annual respondent burden associated with new paperwork requirements in the proposed rule, the Agency also estimated the annual benefits (hours and cost savings) to respondents from the new paperwork requirements in comparison to complying with the existing RCRA hazardous waste information collection requirements for hazardous waste pharmaceuticals (
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for the EPA's regulations in 40 CFR are listed in 40 CFR part 9. Submit your comments on the Agency's need for this information, the accuracy of the
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 indicated in Table 13. The Agency has determined that costs of the regulation for a facility are less than 1 percent of annual revenue.
To assess the number of small entities in the regulated universe, EPA consulted NAICS-level data from the 2007 Economic Census and tallied the number of facilities, by NAICS code, owned by entities with revenues below SBA's threshold for consideration as small. Entities in revenue categories above the SBA threshold are
The percentage of facilities that qualify as small under SBA's thresholds were estimated for each industry affected by the proposed rule. These percentages were applied to the number of facilities in the regulatory universe, as presented in the RIA. After estimating the number of small entities by NAICS code, the average cost per small entity was estimated based on the model facility costs presented in the RIA. Next, the EPA determined whether the per
The proposed rule is expected to impact a total of 144,228 small entities (1,634 hospitals, 142,566 other healthcare facilities (
In the RIA, small entity impacts are presented incremental to the full compliance baseline. The annual per facility costs incremental to both baselines are estimated to be much less than 1% of average annual revenues. Since the incremental impact to the smallest healthcare facilities in terms of revenue is less than 1% of average annual revenues, the proposed rule is not expected to cause a significant impact to a substantial number of small businesses. Please see the RIA for a detailed analysis of cost impacts on small entities.
Although this proposed rule will not have a significant economic impact on a substantial number of small entities, EPA nonetheless has tried to reduce the impact of this rule on small entities. We continue to be interested in the potential impacts of the proposed rule on small entities and welcome comments on issues related to such impacts.
This rule does not contain an unfunded mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. As indicated previously, the annual net cost is estimated to be $13 million annually after cost savings ($37 million cost minus $24.3 million in cost savings). Thus, this proposed rule is not subject to the requirements of sections 202 or 205 of UMRA.
This proposed rule is also not subject to the requirements of section 203 of UMRA because it contains no regulatory requirements that might significantly or uniquely affect small governments. While some hospitals and coroners' offices are publicly owned, the requirements affecting those facilities are not unique in that they are the same as those affecting all facilities in the proposed rule. Also, using data on revenues of hospitals owned by state and local governments, EPA estimated that the costs of the rule borne by state and local governments represent less than 0.001% of their revenues. Therefore, the costs incurred by small governments are not expected to be significant.
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 relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action may have tribal implications. However, it will neither impose substantial direct compliance costs on tribal governments, nor preempt tribal law.
To assess the potential tribal implications of the proposed rule, EPA compiled data on the number of tribally run healthcare facilities in the U.S. and estimated the costs of the proposed rule for these facilities. Estimates of tribally run healthcare facilities were obtained from the U.S. Department of Health and Human Services' Indian Health Service (IHS), as summarized in Table 14.
The EPA consulted with tribal officials under the EPA Policy on Consultation and Coordination with Indian Tribes early in the process of developing this regulation to permit them to have meaningful and timely input into its development. A summary of that consultation is provided in the docket for this proposed rule (see EPA-HQ-RCRA-2007-0932).
As required by section 7(a), the EPA's Tribal Consultation Official has certified that the requirements of the executive order have been met in a meaningful and timely manner. A copy of the certification is included in the docket for this proposed rule (see EPA-HQ-RCRA-2007-0932).
This proposed rule is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the Agency does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children.
To examine whether the proposed rule has a disproportionate impact on children, the RIA uses a geographic analysis of demographics near wastewater treatment plants and hazardous waste combustion facilities. Table 15 summarizes the results of this analysis. As indicated in the table, this analysis finds that children (
These data suggest that the proposed rule will not result in a disproportionate adverse impact on children. Because the children's share of the population near hazardous waste combustion facilities is near the national average, any increase in the combustion of hazardous waste combustion that occurs as a result of the proposed rule is unlikely to have a significant disproportionate impact on children's health. The data in Table 15 also show that the number of children living in close proximity to wastewater treatment plants, in areas likely to benefit from the rule, far exceeds the number of children who live near hazardous waste combustion facilities. This suggests that the diversion of hazardous waste pharmaceuticals from wastewater treatment plants to combustion facilities will benefit a much greater number of children than it may put at greater risk of adverse health effects. See Table 15 for the demographics of children surrounding wastewater treatment plants and hazardous waste combustion facilities. Please see the RIA for a detailed methodology of the children's health analysis.
This action is not a “significant energy action” as defined in Executive Order 13211, (66 FR 28355 (May 22, 2001)), because it is not likely to have a significant adverse effect on the supply, distribution, or use of energy.
The proposed rule does not directly regulate energy production or consumption. Changes in the management of hazardous waste pharmaceuticals stipulated in the proposed rule are not expected to impact energy production or distribution. Similarly, the management requirements outlined in the proposed rule will have minimal impact on energy consumption (
This proposed rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects
To meet the requirements of Executive Order 12898, EPA analyzed potential environmental justice impacts associated with the diversion of hazardous waste pharmaceuticals from sewer disposal to hazardous waste combustion facilities. Populations living near and downstream from wastewater treatment plants may also benefit from the elimination of sewering of hazardous waste pharmaceuticals. To the extent that minority and/or low-income populations near or downstream from wastewater treatment plants make up a disproportionately high portion of the overall population, the proposed rule may result in positive environmental justice impacts. See Table 16 for the results of the Environmental Justice analysis.
Overall, EPA expects that the proposed rule may positively affect U.S. environmental justice populations, although the size of the impact will vary by wastewater treatment plant. As suggested by Table 16, the reduction in sewering expected under the proposed rule may benefit relatively large minority and low-income populations in close proximity to or downstream from wastewater treatment plants. The diversion of hazardous waste pharmaceuticals to combustion facilities, however, may increase the environmental burden borne by environmental justice populations near these combustion facilities. Although these effects offset each other to a certain degree, the number of minority and low-income individuals near wastewater treatment facilities greatly exceeds the number near hazardous waste combustion facilities. This suggests that, on the whole, the proposed rule may benefit environmental justice populations.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Environmental protection, Exports, Hazardous materials transportation, Hazardous waste, Imports, Labeling, Packaging and containers, Reporting and recordkeeping requirements.
Environmental protection, Energy, Hazardous Waste, Recycling, Reporting and recordkeeping requirements.
Environmental protection, Hazardous waste, Reporting and recordkeeping requirements.
Environmental protection, Hazardous materials transportation, Hazardous waste.
For the reasons stated in the preamble, Title 40, chapter I, of the Code of Federal Regulations is proposed to be amended as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, 6924(y) and 6938.
(c) * * *
(8) Is a hazardous waste pharmaceutical managed under 40 CFR part 266, subpart P.
(c) Healthcare facilities and pharmaceutical reverse distributors operating under 40 CFR part 266, subpart P are subject to § 266.507 for the management of hazardous waste pharmaceutical residues in containers, in lieu of this section.
42 U.S.C 6906, 6912, 6922-6925, 6937, and 6938.
(m) All pharmaceutical reverse distributors (as defined in § 266.500) are subject to 40 CFR part 266, subpart P for the management of hazardous waste pharmaceuticals in lieu of this part.
(n) Each healthcare facility (as defined in § 266.500) must determine whether it is subject to 40 CFR part 266, subpart P for the management of hazardous waste pharmaceuticals, based on the total hazardous waste it generates per calendar month (including pharmaceutical hazardous waste and non-pharmaceutical hazardous waste). Healthcare facilities that generate (or accumulate) more than 100 kg (220 pounds) of hazardous waste per calendar month, or more than 1 kg (2.2 pounds) of acute hazardous waste per calendar month, or more than 100 kg (220 pounds) per calendar month of any residue or contaminated soil, waste, or other debris, resulting from the clean-up of a spill, into or on any land or water, of any acute hazardous wastes listed in § 261.31 or § 261.33(e), are subject to 40 CFR part 266, subpart P for the management of hazardous waste pharmaceuticals in lieu of this part.
42 U.S.C. 1006, 2002(a), 3001-3009, 3014, 3017, 6905, 6906, 6912, 6921, 6922, 6924-6927, 6934, and 6937.
The following definitions apply to this subpart:
(1) Any person that:
(i) Provides preventative, diagnostic, therapeutic, rehabilitative, maintenance or palliative care, and counseling, service, assessment or procedure with respect to the physical or mental condition, or functional status, of a human or animal or that affects the structure or function of the human or animal body; or
(ii) Sells or dispenses over-the-counter or prescription pharmaceuticals.
(2) This definition includes, but is not limited to, hospitals, psychiatric hospitals, ambulatory surgical centers, health clinics, physicians' offices, optical and dental providers, chiropractors, long-term care facilities, ambulance services, coroners and medical examiners, pharmacies, long-term care pharmacies, mail-order pharmacies, retailers of over-the-counter medications; and veterinary clinics and hospitals.
(1) A hazardous waste pharmaceutical that has the potential to receive manufacturer's credit and is:
(i) Unused or un-administered; and
(ii) Unexpired or less than one year past expiration date.
(2) The term does not include “evaluated hazardous waste pharmaceuticals,” residues of pharmaceuticals remaining in containers, contaminated personal protective equipment, and clean-up material from the spills of pharmaceuticals.
(a) A healthcare facility that is a conditionally exempt small quantity generator remains subject to § 261.5 and is
(b) A healthcare facility that is a conditionally exempt small quantity generator has the option of complying with this subpart for the management of its hazardous waste pharmaceuticals, as an alternative to complying with the conditional exemption of § 261.5.
(c) A healthcare facility or pharmaceutical reverse distributor remains subject to all applicable hazardous waste regulations with respect to the management of its non-pharmaceutical hazardous waste.
(d) With the exception of healthcare facilities identified in subsection (a), a healthcare facility is subject to:
(1) Sections 266.502 and 266.504 through 266.508 of this subpart with respect to the management of:
(i) Non-creditable hazardous waste pharmaceuticals, and
(ii) Potentially creditable hazardous waste pharmaceuticals if they are not destined for a pharmaceutical reverse distributor.
(2) Sections 266.503 through 266.507 and 266.509 of this subpart with respect to the management of potentially creditable hazardous waste pharmaceuticals that are destined for a pharmaceutical reverse distributor.
(e) A pharmaceutical reverse distributor is subject to §§ 266.505 through 266.510 of this subpart with respect to the management of hazardous waste pharmaceuticals.
(f) This subpart does not apply to the management of hazardous waste pharmaceuticals that are generated or managed by entities other than healthcare facilities and pharmaceutical reverse distributors.
(a)
(i) A healthcare facility that already has an EPA identification number must re-notify the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a healthcare facility as part of its next Biennial Report, if it is required to submit one; or if not required to submit a Biennial Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(ii) A healthcare facility that does not have an EPA identification number must obtain one by notifying the EPA Regional Administrator, using the Site Identification form (EPA form 8700-12), that it is a healthcare facility as part of its next Biennial Report, if it is required to submit one; or if not required to submit a Biennial Report, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(iii) A healthcare facility must keep a copy of its notification on file for as long as the healthcare facility is subject to this subpart.
(2)
(i) A healthcare facility must submit the Site Identification Form notifying that it is withdrawing from this subpart before it begins operating under the conditional exemption of § 261.5(b).
(ii) A healthcare facility must keep a copy of its withdrawal on file for three years from the date of signature on the notification of its withdrawal.
(b)
(c)
(d)
(2) A healthcare facility that manages ignitable or reactive hazardous waste pharmaceuticals, or that mixes or commingles incompatible hazardous waste pharmaceuticals must manage the container so that it does not have the potential to:
(i) Generate extreme heat or pressure, fire or explosion, or violent reaction;
(ii) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;
(iii) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;
(iv) Damage the structural integrity of the container of hazardous waste pharmaceuticals; or
(v) Through other like means threaten human health or the environment.
(3) A healthcare facility must keep containers of non-creditable hazardous waste pharmaceuticals closed and secured in a manner that prevents unauthorized access to its contents.
(4) A healthcare facility may accumulate hazardous waste pharmaceuticals and non-hazardous pharmaceutical waste in the same container, except that hazardous waste pharmaceuticals prohibited from being combusted because of the dilution prohibition of § 268.3(c) must be accumulated in separate containers.
(e)
(f)
(2) A healthcare facility that accumulates non-creditable hazardous waste pharmaceuticals on-site must demonstrate the length of time that the hazardous waste pharmaceuticals have been accumulating, starting from the date it first becomes a waste. A healthcare facility may make this demonstration by any of the following methods:
(i) Marking or labeling the container of non-creditable hazardous waste pharmaceuticals with the date that hazardous waste pharmaceuticals became a waste;
(ii) Maintaining an inventory system that identifies the date the non-creditable hazardous waste pharmaceutical being accumulated first became a waste;
(iii) Placing the non-creditable hazardous waste pharmaceuticals in a specific area and identifying the earliest date that any of the non-creditable hazardous waste pharmaceuticals in the area became a waste; or
(iv) Any other method which clearly demonstrates the length of time that the non-creditable hazardous waste pharmaceuticals have been accumulating from the date it first became a waste.
(3) A healthcare facility may request from the EPA Regional Administrator an extension beyond the one year accumulation time limit for non-creditable hazardous waste pharmaceuticals involved in litigation, a recall, or unforeseen circumstances beyond the control of the healthcare facility.
(i) A request must be sent to the EPA Regional Administrator in writing (paper or electronic). The request for an extension must include an explanation of the reason an extension is requested, the approximate volume or weight of the hazardous waste pharmaceuticals that will be accumulated more than 90 days, and the amount of additional time requested.
(ii) The amount of time extension granted is at the discretion of the EPA Regional Administrator on a case-by-case basis.
(g)
(h)
(1) Sign either:
(i) Item 18c of the original manifest, if the original manifest was used for the returned shipment; or
(ii) Item 20 of the new manifest, if a new manifest was used for the returned shipment;
(2) Provide the transporter a copy of the manifest;
(3) Within 30 days of delivery of the rejected shipment, send a copy of the manifest to the designated facility that returned the shipment to the healthcare facility; and
(4) Transport or offer for transport the returned shipment in accordance with the shipping standards of § 266.508(a).
(i)
(2)
(A) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the EPA Regional Administrator for the Region in which the healthcare facility is located, and
(B) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
(ii) For shipments rejected by the designated facility and shipped to an alternate facility: If a healthcare facility does not receive a copy of the manifest for a rejected shipment of the non-creditable hazardous waste pharmaceuticals that is forwarded by the designated facility to an alternate facility (using appropriate manifest procedures), with the handwritten signature of the owner or operator of the alternate facility within 60 days of the date the waste was accepted by the initial transporter forwarding the shipment of non-creditable hazardous waste pharmaceuticals from the designated facility to the alternate facility, the healthcare facility must submit:
(A) A legible copy of the original manifest, indicating that the healthcare facility has not received confirmation of delivery, to the EPA Regional Administrator for the Region in which the healthcare facility is located, and
(B) A handwritten or typed note on the manifest itself, or on an attached sheet of paper, stating that the return copy was not received and explaining the efforts taken to locate the non-creditable hazardous waste pharmaceuticals and the results of those efforts.
(3)
(j)
(2) A healthcare facility must keep a copy of each exception report for a period of at least three years from the date of the report.
(3) A healthcare facility must keep records of any test results, waste analyses, or other determinations made to support its hazardous waste determination(s) for at least three years from the date of the test, analysis, or other determination.
(4) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the EPA Regional Administrator.
(k)
(2) A healthcare facility must determine whether any material resulting from the release is a non-creditable hazardous waste pharmaceutical, and if so, must manage the non-creditable hazardous waste pharmaceutical residues and spill clean-up materials in accordance with the requirements of this subpart.
(l)
(m)
(1) Is under the control of the same person, as defined in § 260.10, as the conditionally exempt small quantity generator healthcare facility that is sending the hazardous waste pharmaceuticals off-site or has a contractual relationship whereby the receiving healthcare facility supplies pharmaceuticals to the conditionally exempt small quantity generator healthcare facility,
(2) Is operating under this subpart for the management of its hazardous waste pharmaceuticals,
(3) Manages the non-creditable hazardous waste pharmaceuticals that it receives from off-site in compliance with this subpart, and
(4) Keeps records of the hazardous waste pharmaceuticals shipments it receives from off-site for 3 years from the date that the shipment is received.
(a)
(b) Healthcare facilities are prohibited from sending hazardous wastes other than potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor.
(c)
(d)
(i) A copy of the advance notification provided to the pharmaceutical reverse distributor;
(ii) The confirmation of delivery; and
(iii) The shipping papers or bill of lading.
(2) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the EPA Regional Administrator.
(a)
(b)
(c)
All healthcare facilities and pharmaceutical reverse distributors are prohibited from discharging hazardous waste pharmaceuticals to a sewer system that passes through to a publicly-owned treatment works. The exclusion in § 261.4(a)(1)(ii) for mixtures of domestic sewage and other wastes that pass through a sewer system to a publicly-owned treatment works does not apply to a hazardous waste pharmaceutical.
(a) The following are exempt from 40 CFR parts 260 through 273, provided the conditions of paragraph (b) of this section are met:
(1) A hazardous waste pharmaceutical that is also listed on a schedule of controlled substances by the Drug Enforcement Administration in 21 CFR part 1308, and
(2) An authorized collector (as defined by the Drug Enforcement Administration) registered with the Drug Enforcement Administration that collects controlled substances collected from an ultimate user (as defined by the Drug Enforcement Administration) and co-mingles them with hazardous waste pharmaceuticals that are exempt as a household waste under § 261.4(b)(1).
(b)
(1) A permitted large municipal waste combustor (LMWC), subject to 40 CFR part 62, subpart FFF for existing LMWCs, or 40 CFR part 60, subparts Ea and Eb for new LMWCs, or
(2) A permitted small municipal waste combustor (SMWC), subject to 40 CFR part 62, subpart JJJ for existing SMWCs, or 40 CFR part 60, subparts AAAA and BBBB for new SMWCs, or
(3) A unit that has a permit or interim status to burn hazardous waste and is covered by 40 CFR part 63, subpart EEE. A unit that is exempt from 40 CFR part 63, subpart EEE as specified in § 63.1200(b) of this chapter is not covered by subpart EEE.
(a)
(1) All pharmaceuticals have been removed from the dispensing bottle, vial or ampule; or the unit-dose container, (
(2) Any dispensing bottle or unit-dose container that is an original manufacturer's product package is destroyed prior to disposal in such a manner as would prevent further use of the container.
(b)
(1) The syringe has been used to administer the pharmaceutical to a patient, and
(2) The syringe is placed in a sharps container that is managed in accordance with all applicable federal, state, and local medical waste requirements.
(c)
(a) A healthcare facility or pharmaceutical reverse distributor that ships either non-creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals, respectively, off-site to a designated facility (such as a permitted or interim status treatment, storage, or disposal facility), must comply with:
(1) The following pre-transport requirements, before transporting or offering for transport off-site:
(i)
(ii)
(iii)
(B) Mark each container of 119 gallons or less used in such transportation with the following words and information in accordance with the requirements of 49 CFR 172.304:
HAZARDOUS WASTE—Federal Law Prohibits Improper Disposal. If found, contact the nearest police or public safety
Healthcare Facility's or Pharmaceutical Reverse Distributor's Name and Address__.
Healthcare Facility's or Pharmaceutical Reverse Distributor's EPA Identification Number__.
Manifest Tracking Number__.
(iv)
(v)
(2) The manifest requirements of 40 CFR part 262, subpart B, except that:
(i) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals is not required to list hazardous waste codes in box 13 of EPA Form 8700-22.
(ii) A healthcare facility shipping non-creditable hazardous waste pharmaceuticals must write the words “hazardous waste pharmaceuticals” in Box 14 (the special handling instructions and additional information) of EPA Form 8700-22.
(b)
(c)
(a) A healthcare facility or a pharmaceutical reverse distributor who transports or offers for transport potentially creditable hazardous waste pharmaceuticals off-site to a pharmaceutical reverse distributor must:
(1) Provide advance notice (paper or electronic) to the pharmaceutical reverse distributor of the intent to ship potentially creditable hazardous waste pharmaceuticals to the receiving pharmaceutical reverse distributor before each shipment of potentially creditable hazardous waste pharmaceuticals is sent, and
(2) Comply with the pre-transport requirements of § 266.508(a)(1)(i) through (v).
(b) Upon receipt of each shipment of potentially creditable hazardous waste pharmaceuticals, the receiving pharmaceutical reverse distributor must provide confirmation (paper or electronic) to the healthcare facility or pharmaceutical reverse distributor that initiated the shipment that the shipment of potentially creditable hazardous waste pharmaceuticals has arrived.
(c) If a healthcare facility or pharmaceutical reverse distributor initiates a shipment of potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor and does not receive delivery confirmation within seven calendar days from the date that the shipment of potentially creditable hazardous waste pharmaceuticals was sent, the healthcare facility or pharmaceutical reverse distributor that initiated the shipment must contact the shipper and the intended recipient (
(d)
(i) Comply with the requirements applicable to a primary exporter at 40 CFR 262.53, 262.56(a)(1) through (4), (a)(6), and (b) and 262.57;
(ii) Export such potentially creditable hazardous waste pharmaceuticals only upon consent of the receiving country and in conformance with the EPA Acknowledgement of Consent as defined in 40 CFR part 262, subpart E; and
(iii) Provide a copy of the EPA Acknowledgement of Consent for the shipment to the transporter transporting the shipment for export.
(2) A transporter of potentially creditable hazardous waste pharmaceuticals to a foreign destination other than those OECD countries specified 40 CFR 262.58(a)(1) (in which case the transporter is subject to the requirements of 40 CFR part 262, subpart H) may not accept a shipment if the transporter knows the shipment does not conform to the EPA Acknowledgment of Consent. In addition the transporter must ensure that:
(i) A copy of the EPA Acknowledgment of Consent accompanies the shipment; and
(ii) The shipment is delivered to the facility designated by the person initiating the shipment.
(e)
A pharmaceutical reverse distributor may accept potentially creditable hazardous waste pharmaceuticals from off-site and accumulate potentially creditable hazardous waste pharmaceuticals or evaluated hazardous waste pharmaceuticals on-site without a permit or without having interim status, provided that it complies with the following conditions:
(a)
(1)
(i) A pharmaceutical reverse distributor that already has an EPA identification number must re-notify the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(ii) A pharmaceutical reverse distributor that does not have an EPA identification number must obtain one by notifying the EPA Regional Administrator, using the Site Identification Form (EPA form 8700-12), that it is a pharmaceutical reverse distributor, as defined in § 266.500, within 60 days of the effective date of this subpart, or within 60 days of becoming subject to this subpart.
(2)
(i) A pharmaceutical reverse distributor must inventory each potentially creditable hazardous waste pharmaceutical upon arrival at the pharmaceutical reverse distributor.
(ii) The inventory must include the identity (
(3)
(i) Examples of methods that may be used to prevent unknowing entry and minimize unauthorized entry include, but are not limited to:
(A) 24-hour continuous monitoring surveillance system;
(B) An artificial barrier such as a fence; or
(C) Means to control entry, such as keycard access.
(ii) If the pharmaceutical reverse distributor already meets the security requirements of this paragraph because of other regulatory requirements, such as Drug Enforcement Administration regulations, the facility is not required to provide separate security measures pursuant to this section.
(4)
(5)
(i) A written request must be sent to the EPA Regional Administrator (paper or electronic). The request for an extension must include an explanation of the reason an extension is requested, the approximate volume or weight of the hazardous waste pharmaceuticals that will be accumulated more than 90 days, and the amount of additional time requested.
(ii) The amount of time granted for an extension is at the discretion of the EPA Regional Administrator on a case-by-case basis.
(6)
(7)
(8)
(A) The EPA identification number, name and address of the pharmaceutical reverse distributor;
(B) The date the pharmaceutical reverse distributor received the hazardous waste;
(C) The EPA identification number, name and address of the healthcare facility that shipped the hazardous waste, if available;
(D) A description and the quantity of each unauthorized hazardous waste the pharmaceutical reverse distributor received;
(E) The method of treatment, storage, or disposal for each unauthorized hazardous waste; and
(F) A brief explanation of why the waste was unauthorized, if known.
(ii)
(9)
(i) A copy of its notification on file for as long as the facility is subject to this subpart;
(ii) A copy of the advance notification, delivery confirmation, the shipping papers or bill of lading for each shipment of potentially creditable hazardous waste pharmaceuticals that it receives, and a copy of each unauthorized waste report, for at least three years from the date it receives the shipment;
(iii) A copy of its inventory for as long as the facility is subject to this subpart; and
(iv) The periods of retention referred to in this section are extended automatically during the course of any unresolved enforcement action regarding the regulated activity, or as requested by the EPA Regional Administrator.
(10) A pharmaceutical reverse distributor that is not a pharmaceutical manufacturer must evaluate a potentially creditable hazardous waste pharmaceutical within 21 calendar days of arriving at the pharmaceutical reverse distributor to establish whether it is destined for another pharmaceutical reverse distributor for further evaluation or verification of manufacturer's credit or for a permitted or interim status treatment, storage or disposal facility. This 21 calendar days is part of the 90 calendar days allowed for on-site accumulation.
(i) A potentially creditable hazardous waste pharmaceutical that is destined for another pharmaceutical reverse distributor is still considered a “potentially creditable hazardous waste pharmaceutical” and must be managed in accordance with paragraph (b) of this section.
(ii) A potentially creditable hazardous waste pharmaceuticals that is destined for a permitted or interim status treatment, storage or disposal facility is considered an “evaluated hazardous waste pharmaceutical” and must be managed in accordance with paragraph (c) of this section.
(11) A pharmaceutical reverse distributor that is a pharmaceutical manufacturer must evaluate a potentially creditable hazardous waste pharmaceutical to verify manufacturer's credit within 21 calendar days of arriving at the facility and must manage the evaluated hazardous waste pharmaceuticals in accordance with paragraph (c) of this section. This 21 calendar days is part of the 90 calendar days allowed for on-site accumulation.
(b)
(1) A pharmaceutical reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from a healthcare facility must send those potentially creditable hazardous waste pharmaceuticals to another pharmaceutical reverse distributor within 90 days from when the potentially creditable hazardous waste pharmaceuticals arrived or follow paragraph (c) of this section for evaluated hazardous waste pharmaceuticals.
(2) A pharmaceutical reverse distributor that receives potentially creditable hazardous waste pharmaceuticals from another pharmaceutical reverse distributor must send those potentially creditable hazardous waste pharmaceuticals to a pharmaceutical reverse distributor that is a pharmaceutical manufacturer within 90 days from when the potentially creditable hazardous waste pharmaceuticals arrived or follow paragraph (c) of this section for evaluated hazardous waste pharmaceuticals.
(3) A pharmaceutical reverse distributor must ship potentially creditable hazardous waste pharmaceuticals destined for another pharmaceutical reverse distributor in accordance with § 266.509.
(4)
(i) A copy of the advance notification provided to the pharmaceutical reverse distributor;
(ii) The confirmation of delivery; and
(iii) The shipping papers or bill of lading.
(c)
(1)
(2)
(3)
(4)
(i) Label the containers with the words, “hazardous waste pharmaceuticals”;
(ii) Ensure the containers are in good condition and managed to prevent leaks;
(iii) Use containers that are made of or lined with materials which will not react with, and are otherwise compatible with, the evaluated hazardous waste pharmaceuticals, so that the ability of the container to contain the waste is not impaired;
(iv) Keep containers closed, if holding liquid or gel evaluated hazardous waste pharmaceuticals. If the liquid or gel evaluated hazardous waste pharmaceuticals are in their original, intact, sealed packaging; or repackaged, intact, sealed packaging, they are considered to meet the closed container standard;
(v) A pharmaceutical reverse distributor that manages ignitable or reactive evaluated hazardous waste pharmaceuticals, or that mixes or commingles incompatible evaluated hazardous waste pharmaceuticals must manage the container so that it does not have the potential to:
(A) Generate extreme heat or pressure, fire or explosion, or violent reaction;
(B) Produce uncontrolled toxic mists, fumes, dusts, or gases in sufficient quantities to threaten human health;
(C) Produce uncontrolled flammable fumes or gases in sufficient quantities to pose a risk of fire or explosions;
(D) Damage the structural integrity of the container of hazardous waste pharmaceuticals; or
(E) Through other like means threaten human health or the environment; and
(vi) Accumulate evaluated hazardous waste pharmaceuticals that are prohibited from being combusted because of the dilution prohibition of § 268.3(c) (
(5)
(6)
(7)
(i) Sign either:
(A) Item 18c of the original manifest if the original manifest was used for the returned shipment; or
(B) Item 20 of the new manifest if a new manifest was used for the returned shipment;
(ii) Provide the transporter a copy of the manifest;
(iii) Within 30 days of delivery of the rejected shipment of the evaluated hazardous waste pharmaceuticals, send a copy of the manifest to the designated facility that returned the shipment to the pharmaceutical reverse distributor; and
(iv) Transport or offer for transport the returned shipment of evaluated hazardous waste pharmaceuticals in accordance with the shipping standards of § 266.508(b).
(8)
(9)
(ii)
(
(
(
(
(B) For shipments rejected by the designated facility and shipped to an alternate facility:
(
(
(
(
(10)
(ii) A pharmaceutical reverse distributor must keep a copy of each manifest signed in accordance with § 262.23(a) for three years or until it receives a signed copy from the designated facility which received the evaluated hazardous waste pharmaceutical. This signed copy must be retained as a record for at least three years from the date the evaluated hazardous waste pharmaceutical was accepted by the initial transporter.
(iii) A pharmaceutical reverse distributor must keep a copy of each biennial report for at least three years from the due date of the report.
(iv) A pharmaceutical reverse distributor must keep a copy of each exception report for at least three years from the submission of the report.
(v) A pharmaceutical reverse distributor must keep records to document personnel training, in accordance with § 265.16.
(d)
(1) Does not meet the conditions of this section;
(2) Accepts manifested hazardous waste from off-site; or
(3) Treats or disposes of hazardous waste on-site.
42 U.S.C. 6905, 6912(a), 6921, and 6924.
(a)
(a) * * *
(4) A healthcare facility accumulates such wastes in containers on-site solely for the purpose of the accumulation of such quantities of hazardous waste pharmaceuticals as necessary to facilitate proper recovery, treatment, or disposal and the healthcare facility complies with the requirements in § 266.502 of this chapter.
(5) A pharmaceutical reverse distributor accumulates such wastes in containers on-site solely for the purpose of the accumulation of such quantities of hazardous waste pharmaceuticals as necessary to facilitate proper recovery, treatment, or disposal and the pharmaceutical reverse distributor complies with § 266.510 of this chapter.
42 U.S.C. 6922, 6923, 6924, 6925, 6930, and 6937.
(a) Except as provided in paragraph (d), any person seeking to add a hazardous waste or category of hazardous waste to this part may petition for a regulatory amendment under this subpart and 40 CFR 260.20 and 260.23.
(d) Pharmaceutical hazardous waste is regulated by 40 CFR part 266, subpart P and may not be added as a category of hazardous waste for management under this part.
Office of Personnel Management.
Final rule.
The Office of Personnel Management is issuing final regulations to implement section 2 of the Border Patrol Agent Pay Reform Act of 2014, as amended, which established a new method of compensating Border Patrol agents for overtime work. Payments under this new provision will become payable beginning with the first pay period beginning in January 2016. These regulations affect only Border Patrol agents in the U.S. Customs and Border Protection component of the Department of Homeland Security.
Bryce Baker by telephone at (202) 606-2858 or by email at
On June 17, 2015, the Office of Personnel Management (OPM) published proposed regulations (80 FR 34540) to implement section 2 of the Border Patrol Agent Pay Reform Act of 2014 (Pub. L. 113-277, December 18, 2014, as amended by Pub. L. 114-13, May 19, 2015), hereafter referred to as “BPAPRA.” BPAPRA established a new method of compensating Border Patrol agents for overtime work. Most BPAPRA provisions are effective on the first day of the first pay period beginning on or after January 1, 2016.
The 30-day comment period for the proposed regulations ended on July 17, 2015. We received comments from 1 agency, 1 union, and 66 individuals. This
Under BPAPRA, a new form of overtime compensation will apply to Border Patrol agents employed by the U.S. Customs and Border Protection (CBP) component of the Department of Homeland Security (DHS). The key features of BPAPRA are summarized below:
BPAPRA was enacted on December 18, 2014 as Public Law 113-277. On May 19, 2015, BPAPRA was amended by Public Law 114-13 to clarify the
As required by these regulations, CBP must provide election information notices to Border Patrol agents no later than November 1 and agents must make elections for the upcoming annual period no later than December 1. Thus, BPAPRA provisions related to administering annual elections and advance assignments for the annual period beginning in January 2016 (§§ 550.1602-550.1605 and 550.1611-550.1615) must be effective as necessary before January 2016.
As provided by Public Law 114-13, regular tours of duty and any associated overtime supplements established under 5 U.S.C. 5550 (as added by section 2(b) of BPAPRA) will first take effect on the first day the first pay period beginning on or after January 1, 2016. That pay period begins on January 10, 2016. Other BPAPRA provisions that are effective on January 10, 2016 include (1) the amendments to 5 U.S.C. 5542 (dealing with overtime pay and compensatory time off) made by section 2(c) of BPAPRA, (2) the amendments to 5 U.S.C. 8331 (dealing with retirement-creditable basic pay) made by section 2(d) of BPAPRA, (3) the amendments to 5 U.S.C. 5547 (dealing with the premium pay cap) made by section 2(g)(1) of BPAPRA, and (4) the amendments to section 13(a) of the FLSA (dealing with FLSA exemptions) made by section 2(g)(2) of BPAPRA.
The “Applicability Dates” shown at the beginning of the Preamble reflect the statutory effective dates.
Below we will summarize and respond to comments on the proposed regulations, organized by the affected regulatory section number. We received 68 comments, including comments from CBP, the agency employing Border Patrol agents, and from the National Border Patrol Council (NBPC), a labor union that represents Border Patrol agents. Comments from CBP and NBPC are identified, while comments from individuals are not. Also, we address below certain clarifying changes we are making that are not a response to a specific comment but provide a general response to comments requesting greater clarity.
A number of commenters expressed general concerns and objections about the content of the BPAPRA statute. Some objected to the loss of entitlement to overtime pay under FLSA rules and the resulting loss in pay. Some objected to being paid the equivalent of a straight rate for within-tour overtime work through the Border Patrol overtime supplement. Some objected to the title 5 capped overtime hourly rate that would be applied to regularly scheduled overtime hours outside the agent's regular tour. Some objected to the use of compensatory time off to compensate agents for irregular overtime hours and to the statutory rules governing such compensatory time off. Some believed it was unfair that other categories of employees have more generous overtime pay entitlements—for example, Customs and Border Protection officers who receive a double overtime rate. Some stated they would prefer receiving law enforcement availability pay. Some objected to the fact that the Basic tour was the default tour for employees in headquarters and certain other positions, which penalizes them for providing critically important services to CBP. One commenter objected to changes in the pay rules being made in mid-career. Another objected to having three possible types of tours, stating that all agents should work the same hours. A couple of commenters objected to the general requirement that 90 percent of agents have a Level 1 tour (100 hours per pay period). One commenter objected to the requirement to make up for absences from within-tour obligated overtime hours. Some commenters acknowledged that their union supported the bill, but asserted that many agents opposed it. Several commenters stated their belief that the new overtime pay system would result in morale and staffing problems.
The above-described comments relate to provisions in the law itself. OPM regulations must implement those provisions and cannot make changes to address these comments.
NBPC commented that the definitions of
By law, agents are no longer subject to FLSA rules, including the suffered-or-permitted standard, but are instead under title 5 rules; therefore, we are applying the longstanding “ordered-or-approved” standard that applies to normal overtime (5 U.S.C. 5542(a)). Under the title 5 standard, overtime work is either ordered in advance or approved after the fact based on agency policies. CBP should clearly communicate to agents its policies regarding when an agent's activities will be retroactively approved as compensable hours of work. We note that agents were formerly covered by the administratively uncontrollable overtime (AUO) provision in 5 U.S.C. 5545(c)(2), which expressly recognizes that an employee is generally responsible for recognizing, without supervision, circumstances that require the employee to remain on duty. While the AUO provisions no longer apply, CBP may provide agents with similar discretion (subject to after-the-fact agency approval) under agency policies as necessary to support its mission. Some matters relating to overtime work, such as procedures and appropriate arrangements for adversely affected employees, may be subject to collective bargaining.
We are making a clarifying change to the definition of
CBP commented that the regulations should specifically reassert that nothing in the statute or regulations may be construed to affect the requirement that a Border Patrol agent must work overtime as assigned as a condition of employment. CBP was concerned that some may think that only overtime work within the regular tour of duty was required. CBP cited 5 U.S.C. 5550(g) and BPAPRA section 2(f) to show that agents are required to perform outside-tour overtime work in accordance with CBP needs.
We agree that CBP has clear authority to require agents to work outside-tour overtime based on CBP needs. In fact, the proposed regulations addressed this matter in § 550.1604, which explicitly cited 5 U.S.C. 5550(g) and BPAPRA section 2(f). This provision is unchanged in the final regulations. In general, OPM regulations do not address when a work requirement is a “condition of employment,” since that is a matter of agency policy under its broad management authority in 5 U.S.C. 301-302.
An individual commented that employees working at training centers have functions to perform that require overtime beyond the regular 8-hour basic workday.
We understand this comment to be directed at the fact that a Basic tour (40 hours a week) is the default tour assignment for an agent holding a training instructor position at a CBP training facility. This is a matter of law, but both the law and the regulations recognize the possibility of assigning training instructors a Level 1 or Level 2 tour based on a comprehensive staffing analysis under BPAPRA section 2(e). (See 5 U.S.C. 5550(b)(1)(D)(iv) and 5 CFR 550.1611(f)(3).) We note that CBP may assign scheduled and irregular overtime to training instructors as necessary to perform needed work beyond the assigned tour. (See BPAPRA sections 2(a) and 2(f)(1).)
One individual explained how it was unfair and harmful to CBP to deny headquarters and academy training staff the option of receiving an overtime supplement (Level 1 or 2). The individual observed that, faced with drastic pay reductions, agents would not seek promotions to headquarter/academy positions or would seek demotions to leave those positions. Another individual commented that some headquarters agents have duties that are more operational than administrative and that it is unfair to deny such agents a Level 1 or Level 2 tour.
The BPAPRA statute expressly provides that a Basic tour (40-hour week) is the default tour for agents in certain positions, including agents in a position at CBP headquarters, a position as a training instructor at a CBP training facility, an administrative position, or a position as a fitness instructor (5 U.S.C. 5550(b)(1)(D)(iv)). A headquarters position, regardless of whether it is considered primarily operational or administrative is covered by this provision. Congress determined that all headquarters positions should be treated the same in terms of the default tour. However, a Level 1 or Level 2 tour may be assigned to agents holding a headquarters position based on a comprehensive staffing analysis showing such tours are necessary to more adequately fulfill CBP operational requirements.
Two individuals commented that the term “administrative position” is vague and should be defined in regulation.
We considered whether we should attempt to define the term “administrative position” when we drafted the proposed regulations. We concluded then, and continue to believe now, that CBP is in the best position to determine whether a particular position is primarily administrative in nature. We have revised § 550.1611(f)(3) to clarify that CBP is responsible for making that determination.
CBP provided comments requesting clarification regarding how long an agent with an assigned Level 1 or Level 2 tour could be detailed to a position that is authorized only for a Basic tour, such as a headquarters position and a training academy position. CBP noted that the proposed regulations did not address this issue and recommended that, at a minimum, the time limit be 60 workdays.
We agree that the proposed regulations did not address the treatment of a temporary detail of an agent to a position that requires a Basic regular tour of duty under 5 U.S.C. 5550(b)(1)(D)(iv) and § 550.1611(f)(3). We do not believe that a short temporary detail should affect an agent's otherwise applicable assigned tour. Rather than establish a rule based on the number of workdays, we are establishing a rule based on the number of calendar days to simplify administration. We believe that it would be reasonable to establish 90 days as the calendar day limit. Ninety calendar days is roughly equivalent to the 60 workdays that CBP originally requested as a minimum. Accordingly, we are adding a new paragraph (g) in § 550.1611 to address temporary details that involve (
NBPC commented that § 550.1611(f)(2) is not clear. Consistent with law, that provision states that an agent who is “unable to perform overtime on a daily basis, as determined by CBP,” must be assigned a Basic tour. NBPC states that the regulation should be clarified to state that this provision is triggered only when an agent's law enforcement authority is revoked and asserts that this was always the intent.
The plain language of the law does not limit an “inability” finding to situations where an agent's law enforcement authority is revoked (
CBP also commented on § 550.1611(f)(2), requesting that OPM provide guidance on what constitutes being “unable to perform” the obligated overtime hours. CBP stated its belief that, at a minimum, the term included situations in which an agent's law enforcement authority is revoked. CBP also asked for clarification regarding situations where an agent is on light duty for physical or medical reasons (
Given the requests for clarification from both CBP and NBPC, we are making revisions in these final regulations. We are adding a new a paragraph (e) in § 550.1612 and amending paragraph (f)(2) in § 550.1611 to reference that new paragraph. Paragraph (e) addresses the bases on which CBP may make a determination regarding an employee's inability to perform overtime work and the effective date of such an inability determination. In paragraph (e)(1), we provide that an inability determination may be made (i) when an agent's law enforcement authority is revoked, (ii) when an agent's inability will last for an extended period due to physical or health reasons, or (iii) for any other appropriate reason, as determined by CBP, but excluding inability based on lack of work, rather than the employee's availability to work. The second condition parallels a similar provision that applies to recipients of law enforcement availability pay under 5 CFR 550.184(d). CBP will determine what constitutes an “extended period” under its policies. CBP would not be required to make an inability determination for a short-term medical condition. The third condition provides CBP with discretion, as intended by Congress, but clarifies that an inability determination cannot be based on lack of work (workload), but must be based solely on the employee's ability and availability to work. Workload management is the responsibility of CBP, which should adjust staffing levels and assignments as necessary to ensure that agents have sufficient work to fill agents' assigned regular tours of duty at any location. The third condition provides a broad, catch-all authority to cover any other appropriate situations where CBP determines that it is reasonable to find that an agent is unable to regularly perform overtime work. Some matters relating to overtime assignments, such as procedures and appropriate arrangements for adversely affected employees, may be subject to collective bargaining.
In paragraph (e)(2) of § 550.1612, we state a general rule that the change to a Basic tour takes effect on the agent's next workday; however, we provide for the possibility of exceptions. CBP may delay the effective date until the beginning of the next week or biweekly pay period (which simplifies administration). CBP may delay the effective date to allow an employee who is working during regular time to use up unused compensatory time off hours by applying those hours against the debt resulting from the agent's absences during obligated overtime hours. CBP may delay the effective date to allow an employee to use accrued paid leave or other paid time off if the agent will be performing no work during regular time for a continuous block of time. CBP may also delay the effective date during a continuous leave without pay period granted under the Family and Medical Leave Act. The above-described delays are approved at CBP's discretion; however, we provide that CBP must delay the effective date when the employee's inability to perform overtime work is based on a job-related injury covered by workers' compensation provisions.
CBP commented that the regulations should allow an agent to request, during an annual period, a change to a regular tour of duty with a lesser number of hours, notwithstanding the agent's election for that annual period. CBP noted that OPM regulations for the law enforcement availability pay (LEAP) program allows criminal investigators to request that LEAP be temporarily discontinued due to a personal or family hardship. (See 5 CFR 550.182(f), “Voluntary opt-out.”)
The BPAPRA law is very specific regarding the circumstances under which types of regular tours of duty are assigned. In particular, the BPAPRA specifically provides that tours are elected/assigned for a full annual period, with a limited set of superseding rules. Thus, the statutory framework differs from that found in the LEAP law. Fortunately, the concern CBP raises can largely be addressed within the BPAPRA statutory framework. Under 5 U.S.C. 5550(b)(1)(D)(iii), CBP may determine that an agent is “unable to perform overtime on a daily basis” and then assign a Basic tour. The law does not prescribe the specific reasons the agent is “unable” to perform overtime. As discussed above, we are adding a new paragraph (e) in § 550.1612, which provides additional parameters for this CBP authority. Paragraph (e)(1)(iii) allows CBP to base an inability determination on other appropriate reasons, as determined by CBP. This broad language would allow CBP to approve a requested mid-year change in an agent's tour based on personal or family hardship situation, if CBP determines that the hardship makes the agent unable to work the otherwise applicable tour.
CBP raised the idea that perhaps an agent's tour election or assignment could be changed pursuant to a directed assignment to another agent position in situations not covered by § 550.1612(d). CBP pointed out that OPM regulations allow elections to be made regarding the tour a new agent will have after completing basic training—even though the law is silent about such elections.
We don't believe a change in an agent's position provides any basis for changing the agent's tour election or assignment unless one of the superseding rules cited in § 550.1612(d) are applicable. Those superseding rules are found in § 550.1611(f) and § 550.1622 and are based on statutory provisions. (We have revised § 550.1612(d) to reference all of § 550.1622, rather than just paragraph (b), to avoid confusion. Paragraph (c) of § 550.1622 (dealing with canine handlers) is already implicated by paragraph (f)(1) of § 550.1611.) The BPAPRA law clearly anticipates that tour elections will be applicable for a full annual period absent a superseding tour assignment. If an agent changes positions, CBP is responsible for ensuring that the agent is assigned sufficient work in the new position to fill the agent's assigned tour.
In contrast, since the BPAPRA law did not address the assignment of tours to newly hired agents, there was a clear policy gap that OPM needed to fill by regulation. The law was focused on agents who were already on board as of November 1 and able to make elections for the next annual period. It did not address agents hired during the annual period. Also, the law addressed periods of “advanced training” but not periods
Based on comments received regarding § 550.1622(c) (dealing with canine handlers), we are making changes in § 550.1611(e) and § 550.1612(d). Those changes address the canine handler issues but also apply generally to other circumstances. (See section of this Supplementary Information dealing with comments on § 550.1622.)
Several commenters objected to the default 10 percent limit on the number of agents in any location who could have less than a Level 1 tour (
The BPAPRA law clearly provides that, as a default rule, not more than 10 percent of agents (
NBPC questioned the regulation at § 550.1614(d), which provides that assignments of tours to individual agents must be consistent with the pay assignment continuity requirement in § 550.1615, regardless of the percentage limits set under § 550.1614. NBPC commented that it was completely contrary to the express intent of Congress that the pay assignment continuity requirement trump the § 550.1614 percentage limits (
Section 550.1614(d) relies on express language in the law stating that, “notwithstanding any other provision of law,” CBP “may take such action as is necessary” to implement the pay assignment continuity plan, including the unilateral assignment of agents to any of three tours (5 U.S.C. 5550(b)(1)(G)(ii)). In addition, Congress granted OPM broad authority to regulate BPAPRA (section 2(h); see also 5 U.S.C. 5548). The “notwithstanding any other provision of law” language gives ample authority to trump the percentage limits established under 5 U.S.C. 5550(b)(1)(E). Any CBP selection plan under § 550.1613 must be “consistent with the requirements of this subpart,” and thus must incorporate the superseding rule in § 550.1614(d). If agents are in their “control period” (
We received general comments regarding § 550.1615 and retirement-related matters.
One commenter made general comments on the obvious administrative complexities of implementing and administering the pay assignment continuity provisions of BPAPRA.
Three commenters noted CBP's actions to decertify some positions from receiving AUO pay will create a “gap” in pay received by agents spanning the period when AUO ceased being paid and continuing through the implementation of BPAPRA, which lowers the amount of retirement-creditable basic pay that agents receive during this period of time compared to what they expected. A commenter noted that this could reduce an agent's high-3 average pay. Another commenter asked if “pay reform has included a gap measure” to make up for the loss of AUO pay and noted that AUO decertification would result in agents not reaching their “high 3 target.” This commenter suggested that any period when an agent's AUO pay was decertified should not be included in the calculation of the agent's high-3 average pay for retirement calculation purposes.
As noted in the Supplementary Information published with the proposed rule, various reviews indicated that AUO was being used improperly for some DHS employees, and DHS has taken actions to address the matter. The suggestions concerning ways to address the “gap” in retirement-creditable pay caused by the decertification of certain positions for AUO pay is beyond the scope of the regulations. There is no provision in BPAPRA to provide replacement retirement-creditable pay to agents occupying positions decertified from receiving AUO during the period covering the decertification until the implementation of BPAPRA. In addition, there is no legal authority to disregard a period of creditable service and retirement-creditable basic pay from consideration for the computation of the high-3 “average pay period” as if the period of service and the pay received during that service never existed. Under 5 U.S.C. 8331(4) and 8401(3), the high-3 “average pay period” is a period of 3 consecutive years of creditable service during which an employee has his or her highest rates of retirement-creditable basic pay. The high-3 average pay is used in computing an employee's retirement annuity. In effect, the commenter's suggested solution appears to be an attempt to avoid the word “consecutive” in the statutory definition of “average pay.” The calculation of the high-3 “average pay period” entails the consideration of all possible periods of 3 consecutive years of creditable service and retirement-creditable basic pay to determine which of the periods comprises the high-3 “average pay period.” If decertification of an agent's
One commenter posed a series of questions about the effects of the regulation. First, the commenter asked how the Border Patrol Interim Pay (which excludes AUO pay) affects the control period. Second, the commenter asked if § 550.1615 means that an agent cannot be promoted after age 50 or after 22 years of service because a promotion would also “inflate” the high-3 average pay via a pay increase that would not have been paid into the retirement system over the agent's career. Third, the commenter asked whether a change of duty stations with different locality pay would not be allowed because an agent would make more money not previously paid into the retirement system. Fourth, the commenter asked whether, under the 2.5 percent consistency standard stated in the proposed rule, an agent who worked 17 years with 25 percent AUO, and who elected 12.5 percent (Level 2 regular tour of duty) or 0 percent (Basic regular tour of duty) for a year just prior to his or her last year of service before retirement, would not be allowed to elect 25 percent (Level 1 regular tour of duty) during that last year.
In response to the first question, once the new overtime program for Border Patrol agents takes effect on January 10, 2016, CBP must control an agent's tour assignments (and associated overtime supplements) during the “control period” that begins when the agent is within 3 years of meeting age and service requirements for an immediate retirement annuity. During the control period, the CBP must ensure that an agent's average overtime supplement during any 3-year period is consistent with the agent's career-average overtime supplement percentage. Under the proposed rule, an agent's career average is based solely on periods of time during which an agent is covered by the new overtime program. (See proposed § 550.1615(a)(3). See also discussion of this in the Supplementary Information of the proposed rule, 80 FR 34544.) Thus, under the proposed rule, the interim period of time when agents are not receiving AUO pay but are, instead, receiving overtime pay under standard title 5 overtime provisions (May 17, 2015-January 9, 2016) would not have affected the career average used during the control period. However, we have made significant changes to § 550.1615(a), which are discussed below. The changes will not result in any agent's career average overtime supplement being less than it would have been under the proposed regulations, since we are providing for the use of the greater of two computations, one of which is the computation used in the proposed regulations. As explained below, the other computation will consider an agent's whole career prior to the beginning of the control period; thus, that computation would be affected by the loss of AUO pay during the interim period.
In response to the second question, § 550.1615 has no effect on promotions. Section 550.1615 deals with CBP controlling tour assignments and the resulting overtime supplement percentage during an agent's control period. It focuses on the career-average overtime supplement percentage, not the dollar amount of the supplement or the total rate. OPM actuarial calculations that determine the level of agency retirement contributions take into account average salary growth due to grade progression.
In response to the third question, § 550.1615 has no effect on the ability of agents to make geographic moves. Section 550.1615 deals with CBP controlling tour assignments and the resulting overtime supplement percentage during an agent's control period. It focuses on the career average overtime supplement percentage, not the dollar amount of the supplement or the total rate. OPM actuarial calculations that determine the level of agency retirement contributions take into account average locality pay that reflects geographic moves.
In response to the fourth question, during an agent's control period, the CBP must ensure that an agent's average overtime supplement percentage during any 3-year period is consistent with (within 2.5 percentage points of) the agent's career-average overtime supplement percentage. Under the proposed regulations, an agent's career average is based solely on periods of time during which an agent is covered by the new overtime program. (See proposed rule at § 550.1615(a)(3)). See also discussion of this in the Supplementary Information of the proposed rule, 80 FR 34544.) Thus, under the proposed rule, prior periods of time when an agent was receiving AUO pay would not have affected the career average used during the control period. However, we have made significant changes to § 550.1615(a) in the final rule, which are discussed below. The changes will not result in any agent's career average overtime supplement being less than it would have been under the proposed regulations, since we are providing for the use of the greater of two computations, one of which is the computation used in the proposed regulations. As explained below, the other computation will consider an agent's whole career prior to the beginning of the control period and would include an agent's AUO percentages in computing the career average overtime supplement.
The greater of the two computations will be used as the career average overtime supplement that will limit what tour and overtime supplement can be assigned to an agent during his or her control period. While an agent's retirement-creditable basic pay will be controlled during the control period, it is possible that some or all of an agent's high-3 average salary period will be outside that control period and could reach back to periods when an agent was receiving AUO pay, especially in the case of agents retiring in the next several years.
One commenter expressed the opinion that the regulations on pay assignment continuity are “particularly confusing and vague” and requested clarification. The commenter also stated that “controlling the work levels accessible to covered employees in the three-years before their retirement seem[s] discriminatory and arbitrary.”
BPAPRA places the responsibility for developing and implementing a plan to ensure, to the greatest extent practicable, pay assignment continuity with CBP, subject to consultation with OPM. OPM's regulations provide a basic framework, metrics, and a consistency standard for CBP to utilize in the design of its plan. The only means under BPAPRA to maintain pay continuity is through CBP's plan to concurrently control the assignment of agents to one of three types of “regular tour of duty” which provide one of three rates of pay (reflecting an overtime supplement of 25, 12.5, or 0 percent). Therefore, the law requires that pay continuity be maintained through assignments of agents to one of three types of fixed “regular tour of duty”; other means of
One commenter stated that “pay reform” is changing the “pension plan” and asked if there were “any plans to grandfather agents that have more than 10 years of service.” This commenter also asked where “the language that spells out and authorizes the drastic changes to the current retirement/pension plans for Border Patrol Agents” could be found in BPAPRA.
BPAPRA makes only one significant change to subchapter III of chapter 83 of title 5, United States Code, the provisions for the Civil Service Retirement System (CSRS), and chapter 84 of title 5, United States Code, the provisions for the Federal Employees' Retirement System (FERS). Section 2(d) of BPAPRA amends the definition of “basic pay” for CSRS and FERS retirement purposes to provide that a Border Patrol overtime supplement is basic pay for retirement purposes. (See also 5 U.S.C. 5550(d).) Section 2(b) of BPAPRA added a new section 5550 in title 5, which includes a pay assignment continuity provision in section 5550(b)(1)(G). That provision requires that an agent's average overtime supplement during the agent's control period be consistent with the agent's career average overtime supplement in order to protect the retirement fund and provide equitable treatment of agents. By design, BPAPRA has an effect on agents' retirement-creditable basic pay, which in turn affects the agents' high-3 average pay used to compute the agents' retirement annuity. BPAPRA included no grandfathering provision related to retirement matters.
Another commenter raised issues with the designation of certain Border Patrol positions as headquarters positions that are only entitled to the Basic border patrol rate of pay. This comment refers to determinations made by CBP that are beyond the scope of the regulations.
One commenter was concerned about the “cryptic, opaque language” describing the high-3 “average pay period” in the proposed rule, and in the Supplementary Information published with the proposed rule. This commenter asked for a clarification of the concept of the high-3 “average pay period.” Under 5 U.S.C. 8331(4) and 8401(3), the high-3 “average pay period” is a period of 3 consecutive years of creditable service during which an employee has his or her highest rates of retirement-creditable basic pay. Further explanation of the high-3 “average pay period” is provided in the context of our responses to other comments.
One commenter asserted, generally, that the pay assignment continuity provisions at § 550.1615 are unjust, unfair, and are “OPM's attempt to further harm the U.S. Border Patrol by implementing ideas and standards that are not in the law.” The pay assignment continuity provisions are an implementation of the statute at 5 U.S.C. 5550(b)(1)(G). Within the statutory framework provided by Congress, we have striven to implement the law in a reasonable and fair way, while also recognizing OPM's fiduciary responsibilities to protect the retirement fund.
One commenter asked, generally, how BPAPRA will affect retirement, specifically the high-3 “average pay period” used in retirement annuity calculations. How BPAPRA affects the computation of an agent's high-3 “average pay period” of an agent will depend on the particular work and pay history of the agent. In general, because of the statutory requirement that generally no more than 10 percent of agents at a location may have a Level 2 or Basic regular tour of duty, most agents should be consistently assigned to Level 1 regular tour of duty, and their high-3 average pay will reflect that. BPAPRA does require that an agent assigned to a headquarters, administrative, training instructor, or fitness instructor position be assigned a Basic regular tour of duty (with no overtime supplement), except as otherwise justified based on a CBP staffing analysis or the need to comply with the pay assignment continuity provision. This statutory requirement might affect the amount of retirement-creditable additional pay that the agent would otherwise receive.
We also received comments on specific sections of the proposed rule. Several commenters, including CBP, had concerns about proposed § 550.1615(a)(3), which provided, in part, that “[i]f an agent is in a control period . . . when the provisions of this subpart first become applicable to the agent, the agent's initially assigned overtime supplement percentage must be considered the agent's career average.” One commenter believed that proposed § 550.1615(a)(3) appears to artificially compute an agent's career average. Other commenters were concerned that this provision would harm agents who are in their control period when BPAPRA is implemented and who are assigned to positions at the Office of Border Patrol Headquarters, the CBP Border Patrol Academy, and other positions generally excluded from a Level 1 or Level 2 regular tour of duty. CBP and one commenter noted that it will be difficult to find agents willing to accept assignments to headquarters, and other positions limited to a 0 percent overtime supplement. A commenter also noted that these agents in headquarters, administrative, training instructor, or fitness instructor positions can only be assigned to a Basic regular tour of duty despite the fact that they have been working a large amount of overtime in the field for many years. Another commenter stated that agents working in a headquarters or academy position would be harmed by the implementation of the pay assignment continuity regulation. For example, some agents would have a career average overtime supplement “locked” at 0 percent because they will already be in their control period and have a Basic tour (due to holding a headquarters position) when BPAPRA takes effect, even if they later work another 5, 8 or 10 years out in the field. The commenter pointed out that these agents may have been working significant overtime (and receiving AUO pay) over most of their career and stated that all hours of overtime worked during the agents' career should be considered.
One of the most challenging implementation issues BPAPRA presents is the logical quandary of how to establish a
Another commenter proposed a second solution (hereafter “Option 2”) to address the problem of establishing a career average border patrol rate of pay for agents who are in their control period and who are assigned to a headquarters, administrative, training instructor, or fitness instructor position restricted to a Basic regular tour of duty. Option 2 would create a “waiver period” until the comprehensive staffing analysis CBP is required to complete under section 2(e) of BPAPRA is completed. During the proposed “waiver period” an agent's retirement high-3 average pay would be “based off
The proposed Option 1 solution is not consistent with the statutory framework because it would necessitate a determination, after the fact, regarding whether the agent artificially inflated his or her average pay for the purposes of increasing his or her annuity. BPAPRA does not provide OPM with authority to modify an employee's retirement-creditable basic pay or high-3 average pay. Limiting the creditability of the overtime supplement to an average amount over some period of years would conflict with 5 U.S.C. 5550(d), which provides that “[
The proposed Option 2 solution is also legally impermissible. The comprehensive staffing analysis CBP is required to complete under section 2(e) of BPAPRA might determine that certain headquarters, administrative, training instructor, or fitness instructor positions at certain duty stations require assignment to other than a Basic border patrol rate of pay. However, there is no assurance that this would be the result of the comprehensive staffing analysis for every affected position. If we attempted to set a waiver period of a fixed length, it would be viewed as arbitrary and would leave some agents just outside the period who are arguably just as deserving of the special treatment. Furthermore, one important implementation issue under BPAPRA regarding pay continuity is how to establish a career average border patrol rate of pay for agents who are immediately in their control period when BPAPRA is implemented when no agent has any history of having received pay under 5 U.S.C. 5550. A “waiver period” where the agent's retirement high-3 average pay would be based on whatever election they chose (with no relationship to what the agent actually receives as retirement-creditable pay) does not address the issue of how to establish the career average of an agent who is immediately in his or her control period, especially for those who are limited to the Basic border patrol pay rate when BPAPRA is implemented. Section 5550(b)(1)(G)(i) requires use of the average border patrol rate of pay level “to which the border patrol agent has been assigned”—not the level the employee elected, but was not actually assigned. Option 2 also conflicts with what is permitted by the statutory definitions of “basic pay” and “average pay.” “Basic pay” for retirement is pay actually received for which retirement deductions and agency contributions have been paid to the retirement fund. “Average pay” is the 3 consecutive years of creditable service during which an employee has his or her highest rates of retirement-creditable basic pay. These definitions do not permit basic pay to be deemed to have been received, and deeming basic pay, without employee retirement deductions or agency contributions, would itself produce an unfunded liability of the retirement fund.
Another commenter and CBP suggested that any period, of any length of time, when an agent cannot be assigned to a Level 1 or Level 2 regular tour of duty (and a 25 or 12.5 percent overtime supplement) should be excluded from calculation of the agent's career average overtime supplement. However, it is not possible to disregard periods of pay within an agent's career and still be consistent with the goals of pay assignment continuity provisions of BPAPRA.
CBP expressed concerns about § 550.1615 similar to those expressed by other commenters. CBP's comments on this aspect of the proposed rule focused on language of the pay assignment continuity provisions of BPAPRA which state the purpose of the provisions are to assure that an agent is “not able to artificially enhance his/her retirement annuity.” CBP argued that limiting consideration of the agent's career for pay assignment continuity
CBP also expressed concern that agents assigned to a position (such as headquarters, at training facilities, or in initial training) that is precluded, by statute or regulation, from receiving other than Basic border patrol rate of pay, or was similarly precluded from receiving AUO pay (available to other Border Patrol agents) that would have been included in their basic pay for retirement purposes, would experience a reduction of their career average because they will have the periods of 0 percent overtime supplement percentage factored into their career average calculation. CBP noted that this would discourage agents from accepting assignments to headquarters, administrative, training instructor, or fitness instructor positions.
CBP stated that “the stated statutory language [concerning pay assignment continuity] is too simplistic to comport with the clear statutory purpose [
CBP suggested several alternative changes to the regulations. First, CBP proposed that “[a]t a minimum, CBP believes it should be free to consider AUO pay at least since the start-up of DHS (when CBP has clear electronic pay records [
Alternatively, CBP suggested, “in light of Congressional intent that the agent not be able to `artificially enhance' their own retirement annuities,” that the rule should be changed to define career “to exclude periods when the agent, for the good of the agency (and
CBP suggested another alternative for employees who have more than 20 years of service as a Border Patrol agent. CBP suggested allowing consideration of only the 20 years that produced the employee's largest percentages of AUO pay and the Border Patrol overtime supplement in determining the career average.
We understand CBP's concerns; however, we emphasize that the underlying purpose of pay assignment continuity provisions of BPAPRA—the purpose behind the objective of ensuring that “agents are not able to artificially enhance their retirement annuities” (5 U.S.C. 5550(b)(1)(G)(iv))—is ultimately to protect the Civil Service Retirement and Disability Fund. To make this express, we have added the goal of protecting the retirement fund to § 550.1615(a)(1). We note that section 5550(b)(1)(G)(i) requires that tour assignments during an agent's control period be consistent with the “average border patrol rate of pay level to which the border patrol agent has been
After considering all of the comments on § 550.1615, we have decided to change § 550.1615 to establish a rule for computing the career average overtime supplement percentage that we believe is a reasonable interpretation of the statute and that is consistent with legislative intent. This rule will operate so as not to artificially inflate or deflate retirement calculations, while providing fair treatment of agents. In this final rule, § 550.1615(a)(2) has been changed so that the career average overtime supplement percentage of an agent is the greater of (1) the average overtime supplement percentages (25 percent, 12.5 percent, or 0 percent) assigned during service as an agent on or after January 10, 2016, that is prior to the beginning of the agent's control period; or (2) the average of the assigned overtime supplement percentages during all service as an agent that is prior to the beginning of the agent's control period, with assigned overtime supplement percentages (25, 12.5, or 0 percent) assigned during service on or after January 10, 2016, and with assigned percentages of AUO under 5 U.S.C. 5545(c)(2) treated as overtime supplement percentages for any period of service prior to January 10, 2016. This change addresses the concerns expressed by CBP and various individual commenters. The first method is the same that was included in the proposed regulations. Because of the “greater of” approach, no agent will be treated worse than he would have been treated under the proposed rule, and some agents will be treated better. For example, agents who have a Basic tour under the new overtime program established under BPAPRA, but who had years of service before January 2016 during which they received 25 percent AUO pay, will have their career average based on their total Border Patrol agent career prior to the beginning of their control period; thus, the career average will reflect the years when 25 percent AUO pay was received.
The second method is based on an interpretation of section 5550(b)(1)(G)(i) that gives weight to the language “course of the career” by reaching back to the portion of an agent's career before the BPAPRA overtime program takes effect on January 10, 2016. Since both AUO pay and the Border Patrol overtime supplement are retirement-creditable basic pay, inclusion of AUO pay is appropriate and fair and does not have a negative impact on the retirement fund. Given the extremely negative impact that considering only periods on or after January 1, 2016, in computing the career average would have had on certain agents and given the lack of any apparent Congressional intent to create such a negative impact, we concluded it would be reasonable to create a second method, while preserving the first method that relied on a narrower reading of the statutory language. The “greater of” approach ensures that no employee is disadvantaged.
The revised § 550.1615(a)(3) addresses a matter previously addressed in § 550.1615(a)(2) of the proposed regulations. Paragraph (a)(3) provides that, in applying 550.1615(a)(2), the assigned overtime supplement percentage is used regardless of whether or not the payable amount of the overtime supplement is limited by a premium pay cap. This protects an agent's career average from decreasing when a pay cap is imposed.
Section 550.1615(a)(4) has been added to provide that, in applying paragraph (a)(2) of this section, if an agent's control period begins on January 10, 2016, the agent's initially assigned overtime supplement percentage must be considered the agent's career average under § 550.1615(a)(2)(i). This provision is consistent with the second sentence in § 550.1615(a)(3) of the proposed rule.
A sentence has been added at the end of § 550.1615(b) to clarify that if, as of January 10, 2016, the date that is 3 years before the agent first met age and service requirements for an immediate retirement has already passed, then the agent's control period is considered to have begun on January 10, 2016.
In deciding on the revisions to § 550.1615 described above, we have necessarily had to reject the other alternative changes suggested by CBP and other commenters. We do not believe that it is reasonable to limit the definition of “career” for the purpose of the regulations as a period of at least 10 years under section 5550 or the AUO program simply because the electronic payroll records of DHS are conveniently available for this period. OPM has made its electronic retirement records available to DHS, which should allow CBP access to information more than 10 years old. As we explained in response to other commenters, the goals of pay assignment continuity do not allow periods of 0 percent overtime supplement to be disregarded for the calculation of an agent's career average overtime supplement or the high-3 average pay. We appreciate the difficulties presented by the statutory
One commenter expressed concern about the definition of
One commenter expressed concern that agents who consistently have a Level 1 tour and are promoted to grade GS-15 where they are reaching the premium pay cap will be unfairly forced to continue to work a Level 1 tour because they have a high career average overtime supplement percentage and must be consistent with that. The commenter pointed out that, because of the premium pay cap, the agent will still be depositing the same amount of money into the retirement account whether he/she is at the Level 1 or the Level 2. The commenter recommended that such agents be allowed to have a reduced tour.
This issue was already addressed in the proposed regulations. Under § 550.1615(c)(2)(i) (in both the proposed and final regulations), if an agent's overtime supplement is limited by the premium pay cap, the agent may elect a regular tour of duty with lesser hours providing an overtime supplement that is less than the agent's career average, as a permitted exception to the consistency requirement.
NBPC commented that the definition at § 550.1615(b) of “control period” would control an agent's overtime supplement assignments for many years. NBPC suggested that lengthy control periods could be instead addressed by “a process by which an Agent would acknowledge that he or she does not intend to retire at the first eligible date and instead state an anticipated retirement date.”
The supplementary information published with the proposed rule includes a lengthy explanation of our statutory interpretation for the definition of “control period” in the rule. (See 80 FR 34543-34544.) The regulations allow a 2.5 percent variation between an agent's career average overtime supplement and the agent's assigned overtime supplement to allow for a reasonable divergence between the two averages.
NBPC's proposed suggestion concerning the definition at § 550.1615(b) of “control period” is not a practical solution to the potential problem of agents “artificially enhance[ing] their retirement annuities.” An agent could, with the best of intentions, decide on an anticipated retirement date, only to see his or her personal circumstances change unexpectedly, necessitating a sudden change in his or her retirement date. An employee's decision to retire at a certain date can be revoked as late as the planned last day of service. This could result in the agent never being subject to pay assignment continuity before his or her retirement.
NBPC also commented on the relationship between § 550.1615 and § 550.1614(d), which addresses CBP's authority in connection with the pay assignment continuity requirement. Section 550.1614(d) provides that the pay assignment continuity requirement in § 550.1615 trumps that requirement in § 550.1614, which regulates the statutory requirement that, except when justified based on a CBP staffing analysis, no more than 10 percent of agents stationed at a location may be assigned a Level 2 or Basic regular tour of duty (
The purpose of the statutory provision at 5 U.S.C. 5550(b)(1)(E), the statutory requirement that, except when justified based on a CBP staffing analysis, no more than 10 percent of agents stationed at a location may be assigned a Level 2 or Basic regular tour of duty, is to “ensure that the Border Patrol has a stable floor of staffing, allowing managers with a steady annual base-line of hours to plan border security operations.” S. Rep. No. 113-248, at 9. In addition, the NBPC comment does not consider that the statutory provisions of pay assignment continuity include the provision at 5 U.S.C. 5550(b)(1)(G)(ii) of title 5, United States Code, which provides:
(ii) Implementation.—
As noted in the Supplementary Information for the proposed regulations, § 550.1615(d)(2) implements the provision in 5 U.S.C. 5550(b)(1)(G)(vi), which states that nothing in section 5550(b)(1)(G) may be construed to limit the ability of CBP to assign regular tours as necessary to meet operational requirements. Section 550.1604, reflects various provisions in BPAPRA (section 2(a) and 2(f)(1) of BPAPRA and 5 U.S.C. 5550(g)) that make clear that CBP has authority to assign unscheduled work as needed to meet mission needs and operational requirements, notwithstanding the regular tour assigned to agents. Thus, as a general matter, OPM does not consider the need to meet operational requirements as preventing CBP from also controlling agents' regular tour as necessary to comply with the pay assignment continuity requirement. As necessary to meet its operational requirements, CBP may assign outside-tour overtime work to an agent whose tour is limited due to the pay assignment continuity provision. Given the comments regarding the extent to which the pay assignment continuity takes precedence over other rules governing tour assignments, we are further clarifying in § 550.1615(d)(2) that, before exercising the authority in paragraph (d)(2) to allow assignment of a regular tour of duty that does not comply with the pay assignment continuity plan, CBP must first determine that it cannot adequately address the specific operational requirements in question by other means. For example, CBP could assign the affected agent outside-tour overtime work to address the specific operational requirements at issue. Also, CBP could possibly assign outside-tour overtime work to other agents to meet those work requirements. As part of the clarification of § 550.1615(d)(2), we have added language stating that, if the authority under paragraph (d)(2) is exercised, CBP must return the affected agent to a regular tour of duty that complies with pay assignment continuity plan as soon as possible.
CBP also noted the statutory primacy of pay assignment continuity requirements and asked if pay assignment continuity would take precedence over the statutory requirement that agents in certain positions (
The introductory phrase of § 5550(b)(1)(G)(ii)—“
NBPC also commented on § 550.1615(c), which provides that the average overtime supplement for all consecutive 3-year periods within the “control period” is considered to be “consistent” with the career average percentage of overtime supplement if the two averages are within 2.5 percentage points of each other. NBPC faults the regulations because “[n]owhere in the proposed regulations is there an explanation for how OPM determined this 2.5 [percent] metric. . . The NBPC believes that a more reasonable metric would be to use the level at which an agent spends half or more of his or her career.”
We do not view half of a career as a reasonable interpretation of the word “consistent” with the “average border patrol rate of pay level . . . assigned during the course of the career of the border patrol agent” (5 U.S.C. 5550(b)(1)(G)(i)). A simple example shows how the NBPC's proposed alternative would not produce consistency. In this example, an agent enters the control period after serving 20-years as an agent, where the agent was assigned a 25 percent overtime supplement for 10 years and a 0 percent overtime supplement for 10 years. Under the proposed rule, the career average would be 12.5 percent; however, NBPC's proposed alternative would allow the agent to have a 25 percent overtime supplement during the control period, which would not be consistent with the career average and would not protect the retirement fund.
OPM continues to believe that it is reasonable to allow an agent's average overtime supplement percentage during any 3-year period within the agent's control period to be considered “consistent” if it is within 2.5 percentage points of the agents' career average overtime supplement percentage. In our view, requiring a 0 percentage point difference would not be feasible given that the CBP can only affect the average during the control period by using combinations of 25, 12.5, and 0 percent overtime supplements. On the other side, we do not view a 5 percentage point difference as close enough to be considered consistent. However, the final rule provides that CBP must provide reports so that OPM can evaluate whether the CBP's pay assignment continuity plan and the 2.5 percent consistency requirement are adequately protecting the retirement fund.
NBPC requested clarification of § 550.1616, which addresses corrective actions in connection with tour assignments and allows retroactive corrections in cases of fraud or fault on the part of the agent. NBPC stated the proposed regulation should be changed to also allow for retroactive correction of tour assignments when (1) an agent worked the requisite hours but has not been paid properly (
We agree that clarification is needed. First, let us address the two scenarios raised by NBPC. First, NBPC described a scenario in which agents worked the “requisite hours” but did not receive pay for those hours, such as working Level 1 hours but getting Level 2. In fact, it is possible for an agent who elected Level 2 to be assigned outside-tour overtime hours that result in the agent having in some pay periods aggregate hours that may be equivalent to those of a Level 1 tour. However, that does not change the tour that the agent elected and that, by law, must be implemented. No retroactive correction would be appropriate. By law, if an agent works overtime hours beyond the assigned tour, the agent is entitled to overtime pay (for regularly scheduled overtime) or compensatory time off (for irregular overtime hours). Thus, the agent will receive compensation for
Second, NBPC described a scenario in which an agent elected to work a higher level tour but the agency erroneously did not assign it. We did not intend to bar retroactive correction in cases where CBP failed to implement an employee's valid tour election (when no superseding tour assignment applies under § 550.1611(f)). We would expect an employee to quickly identify such an error after receiving a Leave and Earnings Statement for an affected pay period. However, there could be a short period of time during which the payroll system improperly pays the employee before the error is corrected. In such a case, a retroactive correction should be made, since the employee made a valid election, which must be implemented (absent a superseding rule). If, as expected, the employee worked the correct tour despite the payroll system error, the retroactive correction will be simple.
Upon review of proposed § 550.1616, we believe that the bar on retroactive corrections is too broadly stated. We are revising § 550.1616 to specifically identity circumstances in which retroactive correction of a tour assignment may not be made. In other situations involving assignment of an incorrect tour (whether an error in terms of the actual scheduling of work or merely an error in payroll system), a retroactive correction will be required and appropriate adjustments in pay (including adjustments in retirement contributions) must be made. If the employee was underpaid, the normal principles governing back pay under 5 U.S.C. 5596 and 5 CFR part 550, subpart H will apply. If the employee was overpaid, the debt will be subject to collection under normal debt collection procedures (including 5 U.S.C. 5514 and 5 CFR part 550, subpart K).
We reviewed possible scenarios in which an agent might be assigned the incorrect tour, including failure to implement a valid election or to apply the superseding rules in § 550.1611(f) or § 550.1622(b). We determined that the bar on retroactive corrections of a tour assignment should be limited to two scenarios: (1) Misapplication of the consistency requirement under the pay assignment continuity provision and (2) misapplication of the 10 percent limit (or authorized alternative limit) on the number of agents at a location with a Basic or Level 2 tour. The bar on retroactive correction does not apply if the error is related to fraud or misrepresentation on the part of the affected agent. These scenarios are defined as involving a tour assignment error that is an error in the actual scheduling of work, not just a payroll system error. Both of these scenarios involve mathematical computations in determining the appropriate tour assignment. Mathematical errors could go undetected for a long period and it would be disruptive to retroactively change a tour assignment under these circumstances. An erroneous tour assignment in connection with the percentage limitation described in § 550.1614 could also be due to misapplication of selection procedures established under § 550.1613. Under § 550.1614, CBP could force one agent to have a Level 1 tour instead of a preferred shorter tour, while another agent would get a preferred shorter tour. If those tour assignments were incorrect due to a CBP error in applying selection procedures, the error would be corrected prospectively. However, CBP would not retroactively change the Level 1 tour assignment for the agent who worked that tour, nor would CBP retroactively change the other agent's preferred shorter tour to a Level 1 tour.
Retroactive tour assignment corrections would be possible with respect to determinations regarding whether an agent should or should not be categorized as (1) a canine handler under § 550.1611(f)(1), (2) unable to perform overtime on a daily basis under § 550.1611(f)(2), or (3) holding a headquarters or other position requiring a Basic tour under § 550.1611(f)(3). Making determinations under these provisions is more straightforward, and tour assignments should be consistent with the agent's actual status. The retroactive correction could result in an agent being assigned a longer or a shorter tour.
A few commenters were concerned that an agent with a Level 1 or 2 tour would accrue an overtime hours debt if the agent takes a full day of leave (
This concern is misplaced. The BPAPRA law and regulations provide that there is no accrual of an overtime hours debt on a day when an agent is on leave for the full 8-hour basic workday. By law, the obligation to work within-tour overtime on a regular workday (2 hours for Level 1, and 1 hour for level 2) applies only if the agent performs “work” during the 8 hours of regular time on that same day. (See § 550.1621(a)(3), (b)(3), and (e).)
Another commenter expressed concern that pay received during paid leave would not include overtime pay. This commenter understood that there was no obligation to work overtime during a full-day of leave; however, he thought that the exclusion of those hours would affect the pay received during paid leave.
This concern is also misplaced. An agent with a Level 1 or 2 tour will receive the applicable overtime supplement during periods of paid leave. An agent's overtime supplement (25 percent or 12.5 percent) is computed by multiplying the applicable percentage times the agent's hourly rate of basic pay and multiplying the result times the number of paid hours of regular time in the pay period (subject to the biweekly premium pay cap). (See § 550.1621(a)(4) and (b)(4).) Paid hours of regular time would include any paid hours of leave during that time. Thus, for example, if an agent with a Level 1 tour is on paid leave for the full 80 hours of a biweekly pay period, the overtime supplement will equal 25 percent of the agent's biweekly rate of basic pay (subject to the biweekly premium pay cap). The fact that the agent does not have any obligated overtime hours during full days of paid leave has no effect on the computation of the overtime supplement, since the overtime supplement is based on the number of paid regular time hours.
While a number of commenters were critical of the fact that BPAPRA provides the equivalent of “straight pay” (
CBP expressed concern that the substitution of overtime hours for absences during the regular tour of duty might be misconstrued as supplanting the normal management functions related to approval of absences. CBP recommended that OPM confirm in the regulations that absences during the regular tour of duty (in particular, during obligated overtime hours) are subject to approval by the employee's supervisor.
We do not believe we need to add anything to the regulations regarding the fact that absences during the basic workweek are subject to management approval under agency policies. (Management handling of absences is not specifically addressed in law or OPM regulations, but is left to agency policies established under the agency head's broad authority to manage agency employees under 5 U.S.C. 301-302.) The existence of a leave without pay substitution rule in 5 CFR 550.112(d) has never raised any issues regarding the need for management approval of absences during the basic workweek. However, we recognize that the concept of obligated overtime hours under the Border Patrol overtime program is new and unique. Therefore, to avoid any confusion, we are adding a paragraph (f) in § 550.1621, which expressly states that any absence during obligated overtime hours is subject to management approval under CBP policies. This is consistent with the treatment of absences during the basic workweek.
CBP expressed concern that, under the proposed regulations, an agent with a Level 1 or 2 tour could use 8 hours of compensatory time off during regular time and not have an overtime obligation on that same day, since an overtime obligation is triggered only when an agent performs “work” during regular time. CBP viewed this as essentially providing an agent with 10 hours of paid time off when the agent was charged for only 8 hours of compensatory time off. CBP offered the view that this outcome was contrary to BPAPRA section 2(f), which provides that nothing in the Act shall be “construed to require compensation of a border patrol agent for hours during which the border patrol agent is actually performing work or using approved paid leave or other paid time off”—since it believed the language in 5 U.S.C. 5542(g)(5)(C) could be interpreted to mean that compensatory time off is not “paid time off.” CBP also asserted that providing 10 hours of paid time off for 8 hours of compensatory time off was in conflict with 5 U.S.C. 5542(g)(5)(D), which precludes an agent from receiving “any cash value” for compensatory time off, and with 5 U.S.C. 5542(g)(1)(B)(ii) and (g)(2)(B)(ii), which provide that an agent receives compensatory time off for an equal amount of irregular overtime work. CBP recommended that OPM revise its regulations in § 550.1621 to provide that usage of compensatory time off constitutes “work” in applying § 550.1621(a)(3) and (b)(3) similar to the way that OPM provided that union “official time” is work for that purpose. (See § 550.1621(e).)
We do not agree with CBP's analysis or its recommendation. Use of compensatory time off excuses an agent from duty only during regular time (
Our regulations treat usage of compensatory time off in the same manner they treat annual leave or other paid time off. If an agent with a Level 1 tour has a full day (8 hours) of annual leave, the obligation to perform 2 hours of within-tour overtime does not accrue. We don't view this as giving the agent 10 hours of annual leave. Rather, we are just applying BPAPRA's rules regarding the overtime supplement and the associated hours obligations. Likewise, when an agent has 8 hours of holiday time off, we don't view the agent as receiving 10 hours of holiday time off merely because there are no obligated overtime hours on that day. The same logic applies to compensatory time off. We see no basis under the law for treating compensatory time off differently than other types of paid time off. (We understand CBP's policy perspective that it is inappropriate to allow agents to work irregular overtime hours and earn compensatory time off and then to bundle those compensatory time off hours in a way that reduces within-tour overtime obligations. However, we believe a law change would be needed to achieve CBP's desired policy. For example, Congress could revise BPAPRA to specifically provide that the normal overtime obligation will accrue on any day when an agent uses any amount of compensatory time off.)
Under 5 U.S.C. 5550(b)(2)(A)(ii) and (3)(A)(ii), the within-tour overtime hours obligation accrues only if the employee “performs work” during regular time on that day. In our view, the term “work” cannot reasonably be interpreted to include use of compensatory time off which allows an employee to be excused from duty. In contrast, union “official time” under 5 U.S.C. 7131 involves specific activities that Congress has deemed to support Government objectives. While using official time, an employee is in a special duty status and is accountable for the time, not excused from all duty. Thus, official time has always been treated as work time for various purposes, including the application of overtime thresholds.
We do not interpret 5 U.S.C. 5542(g)(5)(C) as meaning that compensatory time off is not paid time off. That provision states: “[the agent] shall be required to use 1 hour of compensatory time off for each hour of regular time not worked for which the border patrol agent is not on paid leave or other paid time off.” CBP believes that the word “other” implies that compensatory time off is not paid time off. We believe it is clear that this provision is simply stating that compensatory time off is used in place of time not worked when other paid time off is not being used.
We do not believe that 5 U.S.C. 5542(g)(5)(D) is in conflict with the proposed regulations. The language stating that an employee is not “entitled to any cash value” for compensatory time off clearly refers to
We do not view 5 U.S.C. 5542(g)(1)(B)(ii) and (g)(2)(B)(ii) as relevant. Those clauses provide that an agent receives compensatory time off for an equal amount of irregular overtime work. In other words, they deal with the
Two individual commenters questioned whether Border Patrol agents would receive 1 hour of regularly scheduled overtime work for providing canine care on a scheduled day off under proposed § 550.1622(c).
Under both the law and proposed § 550.1622(c), Border Patrol agents do not receive additional pay beyond the 25 percent overtime supplement for canine care duties performed on a scheduled day off. BPAPRA expressly addresses how Border Patrol agents are compensated for canine care duties. BPAPRA states that any canine care provided by an agent, without regard to the actual duration or “whether such care occurs on the regular workday,” is counted as 1 hour of scheduled overtime within the agent's regular tour of duty (5 U.S.C. 5550(b)(1)(F)(ii)). Thus, the canine care may actually be provided anytime, including on a non-workday. Regardless of the time or day the canine care is actually provided or how much time is actually spent providing canine care, an agent with canine care duties is automatically credited with 1 hour of scheduled overtime for canine care on each regular workday. Thus, these credited hours count toward the within-tour overtime obligation associated with a Level 1 tour and the corresponding 25 percent overtime supplement.
NBPC also commented on proposed § 550.1622(c). NBPC expressed concern that, if a Border Patrol agent is temporarily relieved of canine care duties, he or she could see a diminution in pay under proposed § 550.1622(c).
Based on NBPC's comment, we are revising proposed § 550.1611(e) and proposed § 550.1612(d) to clarify how a change in an agent's circumstances (in relation to § 550.1611(f) or § 550.1622)
Further, we are adding a paragraph (2) to § 550.1622(c) to make clear that when an agent is temporarily relieved of canine care duties for more than 2 full pay periods, the agent's tour of duty will automatically revert to his or her default election under § 550.1611(c) or (d). For example, consider a Border Patrol agent with canine care duties who had elected a Level 2 tour when making an annual election, but who now has a Level 1 tour based on application of § 550.1611(f)(1). If the agent is temporarily relieved of his or her canine care duties for more than 2 full pay periods during the annual period, the agent's tour of duty will revert to default election (Level 2 tour of duty) made under § 550.1611(c) or (d). The agent will return to a Level 1 tour under § 550.1611(f)(1) when resuming canine care responsibilities. Further, paragraph (2) of § 550.1622(c) states that, when an agent is temporarily relieved of canine care duties for a time period shorter than 2 full pay periods, he or she may either remain at the Level 1 tour with a 25 percent overtime or temporarily return to his or her default election for the annual period under § 550.1611(c) or (d). Note that, if an agent remains at the Level 1 tour while temporarily relieved of canine care duties, he or she does not receive the 1 hour of regularly scheduled overtime canine care credit and must work 2 hours of regularly scheduled overtime for each day on which the agent performs work during regular time.
NBPC further commented that OPM should add clarifying language in § 550.1622(c) to make clear that canine handlers will always be assigned to a Level 1 tour regardless of pay assignment continuity.
We disagree. As stated previously concerning NBPC's comment on proposed § 550.1614(d), OPM's regulations rely on express language in the BPAPRA stating that, “notwithstanding any other provision of law,” CBP “may take such action as is necessary” to implement the pay assignment continuity plan, including the unilateral assignment of agents to any of three tours (5 U.S.C. 5550(b)(1)(G)(ii)). Thus, in § 550.1611(f)(5), we provide that the pay assignment continuity provision will take precedence over tour assignments that would otherwise be made under paragraphs (f)(1)-(4) (where paragraph (f)(1) addresses canine handlers). The purpose of the pay assignment continuity provision is to protect the retirement fund. In order to provide that protection, an agent's tour assignments during his or her control period must be consistent with the agent's career average overtime supplement percentage. It would be detrimental to the retirement fund and to principles of equity if an agent could circumvent the career average consistency requirement by obtaining a canine handler position. Therefore, we are not revising proposed § 550.1622(c) or the related regulation at § 550.1611(f)(5).
Two individuals objected to the rules governing compensatory time off, including the biweekly 10-hour limit on earning compensatory time off and 26
The rules cited by the two individuals are statutory, and OPM has no authority to revise them by regulation. (See 5 U.S.C. 5542(g)(4) and (5).)
An individual commented that OPM regulations should require that compensatory time off be treated in the same manner as annual leave (
The exact timing regarding when compensatory time off is used is subject to management approval. The same rule applies to annual leave. Just as OPM has not issued specific regulations regarding when an agency may deny an employee's request to use annual leave at a particular time, we are not issuing specific regulations regarding when a Border Patrol agent's request to use compensatory time off at a particular time may be denied. We expect CBP will issue supplemental guidance to address such matters.
NBPC commented that, for the purpose of applying the premium pay cap, compensatory time off should be assigned a value based on the agent's hourly rate of basic pay. NBPC stated this would be more consistent with Congressional intent than the approach in the proposed regulations.
In the proposed regulations at § 550.1625(d), we provided that, for the purpose of applying the premium pay cap under 5 U.S.C. 5547, Border Patrol compensatory time off hours would be assigned a dollar value based on the overtime pay that would have been payable if the hours had been regularly scheduled outside the agent's tour. This is consistent with the treatment of compensatory time off earned under the title 5 provision (5 U.S.C. 5543) that applies to most Federal employees. The definition of “premium pay” in 5 CFR 550.103 states that it includes the dollar value of earned hours of compensatory time off, and that value is set in 5 CFR 550.114(g) as the amount of “overtime pay” the employee would have otherwise received. Thus, we have a long-established precedent for computing the value of compensatory time off at an overtime rate for the purpose of applying the premium pay cap. Congress reflected its knowledge of the existing OPM regulations when it specifically provided in BPAPRA that the value of Border Patrol compensatory time off must be counted in applying the premium pay cap (5 U.S.C. 5542(g)(5)(F); see also BPAPRA section 2(f)(3)). In exercising its broad regulatory authority under 5 U.S.C. 5548 and BPAPRA section 2(h), OPM has chosen to be consistent with its longstanding regulations and assign the value of Border Patrol compensatory time off based on an overtime rate. We decline to make the change recommended by NBPC.
Two commenters asked how long an agent has to repay an overtime hours debt resulting from absences during obligated overtime hours.
Our regulations do not mandate a specific time limit for repaying an overtime hours debt. However, the law and the regulations require that any unused compensatory time off and future outside-tour overtime work must be automatically applied against the debt. Since CBP has authority to assign outside-tour overtime work, it has the ability to ensure that an employee's debt is being eliminated over a reasonable period of time. The absence of a regulatory time limit does not preclude CBP from establishing a time limit by agency policy, but the enforcement mechanism would be for CBP to order the agent to perform outside-tour overtime work. Under the regulations, CBP does not have authority to require a monetary repayment until movement to a non-agent position or separation (including separation upon death). (See § 550.1626(d).)
An individual recommended revising § 550.1626(d) to allow an agent's positive balances of certain other types of paid time off (
As explained above, CBP has authority to assign outside-tour overtime work and thereby prevent an excessive debt of overtime hours. We are not inclined to take the step of requiring liquidation of the debt at the end of each year. This matter could be revisited after we have a chance to see how the program is working. However, we agree partially with the commenter's suggestion that an agent's positive balances of certain paid time off should be applied to offset any debt of overtime hours before converting the hours to a monetary debt. We are revising § 550.1626(d) to require that, at movement to a non-agent position or separation, any positive balance of annual leave, time-off awards, or compensatory time off for travel be applied to reduce the hours debt before it is converted to a monetary debt. We are including only types of accrued paid time off that can be used for
CBP commented that there should be a cap on the overtime hours debt such as 80 hours. CBP suggested that an agent who reached the debt limit would be automatically assigned a Basic tour based on a finding that the agent was unable to perform overtime on a daily basis (§ 550.1611(f)(2)).
We do not agree that a regulatory limit on the number of overtime debt hours should be established. As explained in our above responses to comments about the idea of time limits on eliminating an overtime hours debt, CBP has authority to assign outside-tour overtime work and thereby prevent an excessive debt of overtime hours. CBP also has authority to make a determination that an agent is unable to perform overtime on a daily basis, which would place the agent on a Basic tour with no within-tour overtime and prevent adding to an overtime hours debt going forward. Such a determination should be based on the agent's ability to work, not on a mathematical rule. CBP also has authority to disapprove an agent's request to be absent during obligated overtime hours and to take appropriate disciplinary action if an agent is absent without approval.
CBP commented that the regulations should not allow agents to receive compensation for hours substituted for periods of suspension or absence without leave approval (AWOL), since it would provide cash value for compensatory time off (earned by working irregular overtime hours). CBP cited 5 U.S.C. 5542(g)(5)(D), which provides that an agent “shall not be entitled to any cash value for compensatory time off earned under section 5550.”
We do not agree with CBP's position. The substitution of outside-tour overtime hours is merely a device to implement overtime hours thresholds. In other words, substitution recognizes that, due to a period of nonpay status, an outside-tour hour cannot be treated as an overtime hour for pay purposes, since the hours are below the overtime threshold. Under 5 U.S.C. 5550(f), substitution of outside-tour overtime hours for “leave without pay” is required, and the term “leave without pay” includes all periods of nonpay status. (See definition in § 550.1603, which is consistent with OPM's longstanding application of the leave without pay substitution rule in 5 CFR
Thus, section 5542(g)(5)(D) is not violated by the substitution of what would otherwise be an irregular overtime hour for leave without pay. If used in substitution, the irregularly scheduled outside-tour hour is not treated as an overtime hour and cannot be converted to a compensatory time off hour. Since it is never a compensatory time off hour, there is no violation of the rule that no cash value be provided for a compensatory time off hour. (In any event, as we have explained above, OPM interprets section 5542(g)(5)(D) as barring cash payments for
We understand CBP's concern to be that agents appear to be receiving compensation for suspension and AWOL through substitution of other hours of work. But, again substitution is merely a device to ensure that overtime thresholds are being applied and that overtime pay is not provided for hours below the overtime threshold. A suspension or AWOL hour (or any other type of leave without pay) is not actually generating any compensation. Compensation is generated by the hour that is being substituted for the nonpay status hour. The nonpay status still has the effect of reducing pay for the pay period.
If CBP's concern is that an employee who is suspended or placed in AWOL status may have an accrued balance of compensatory time off (based on irregular overtime hours worked in a previous pay period) and that such compensatory time off may be used during a period of suspension or AWOL, that concern is misplaced. There is no authority to use compensatory time off during a period of suspension or AWOL. The designation of a period of time as a period of suspension or AWOL precludes use of any other type of time off.
One commenter requested that OPM specifically detail when an agent would be eligible to earn hazardous duty pay.
As provided in § 550.1632, agents are eligible for hazardous duty pay, subject to the requirements of 5 U.S.C. 5545(d) and subpart I of this part. An agent is eligible for hazardous duty pay if he or she meets the statutory and regulatory requirements as applicable to a specific set of circumstances. We are not amending proposed § 550.1632, since hazardous duty pay is addressed in subpart I.
NBPC commented that OPM should clarify that the Level 1 or Level 2 overtime supplement is considered “premium pay” for workers' compensation purposes. NBPC noted the BPAPRA statute clearly addressed this.
We agree that the treatment of the overtime supplement for workers' compensation purposes is addressed in law at 5 U.S.C. 5550(d), where the workers' compensation provision in title 5 (section 8114(e)) is referenced. Section 5550(d) provides that the overtime supplement is “basic pay” (not premium pay) for purposes of applying the workers' compensation law. OPM regulations address this in § 550.1633(c). No further clarification is needed.
NBPC provided comments in opposition to proposed § 550.1635 prohibiting Border Patrol agents from having a flexible or compressed work schedule under 5 U.S.C. chapter 61, subchapter II. NBPC commented that both BPAPRA and the committee report were silent in regards to whether an employee could work an alternative work schedule and do not expressly exclude it. NBPC stated that OPM should not bar the ability of the NBPC to negotiate for alternative work schedules on behalf of its members. NBPC conceded that while BPAPRA does say that agents working the three types of regular tours of duty “shall have a regular tour of duty consisting of 5 workdays per week,” it also states that nothing shall “be construed to limit the right of U.S. Customs and Border Protection to assign both scheduled and unscheduled work to a border patrol agent based on the needs of U.S. Customs and Border Protection.” NBPC suggests that by limiting agents to 8 hour daily tours, § 550.1635 would limit the right of CBP to schedule work as needed. NBPC states that recent legal interpretations of the word “shall” have also shown that an employer is not required to follow a certain provision, but instead has a choice of whether or not to do so. NBPC suggests that the term “shall” in BPAPRA should be read in a similar manner. NBPC further commented that BPAPRA does not rescind the title 5 provisions in subchapter II or chapter 61 that permits compressed work schedules.
Several individuals also provided comments in opposition to the proposed § 550.1635. Several individual commenters specifically mentioned CBP's Overtime Transitional Plan which has allowed Border Patrol agents to work compressed work schedules. Other commenters stated that allowing agents to work a compressed work schedule would boost the morale of the agents. Several commenters suggested that a compressed work scheduled would allow better coverage of shifts by allowing supervisors to schedule all agents to work 10 hours. Both NBPC and several commenters suggest OPM's regulations permit alternative work schedules, particularly a compressed work schedule.
We disagree with the commenters and are making no changes to proposed § 550.1635. We believe the clear language of BPAPRA does not allow a Border Patrol agent to have a flexible or compressed work schedule under 5 U.S.C. chapter 61, subchapter II. BPAPRA states that all Border Patrol agents “shall” have a regular tour of duty consisting of 5 workdays per week with an 8 hour regular tour of duty and either zero, one, or two hours of regularly scheduled overtime per day depending upon the employee election. We believe that word “shall” in BPAPRA is both clear and unambiguous. We also do not believe that § 550.1635 limits the ability of CBP to assign work. CBP may still assign Border Patrol agents to perform work as necessary, including additional irregular and regularly scheduled overtime hours. The flexibility to assign scheduled tours of duty linked to the overtime supplement is limited to the options provided under the law. Further, while CBP's Overtime Transitional Plan may have allowed Border Patrol agents to work compressed work schedules, the clear language of BPAPRA does not permit agents to work compressed work schedules. Similarly, any potential improvement in employee morale via alternative work schedules cannot
NBPC's comments cite a court case,
We also note that the laws governing flexible and compressed work schedules include special rules related to overtime hours, compensatory time off, and night pay that are inconsistent with the BPAPRA rules, and Congress did not amend chapter 61 to address those inconsistencies, indicating that Congress did not intend for chapter 61 to be applicable. For example, section 6123(a)(1) provides that, for employees with a flexible work schedule, an agency head may grant compensatory time off for regularly scheduled overtime hours notwithstanding any other provision of law; however, section 5542(g) (as added by BPAPRA) provides that agents must be paid for regularly scheduled overtime and can receive compensatory time off only for irregular overtime hours.
Several commenters generally opposed Border Patrol agents being exempt from the minimum wage and overtime provisions of the Fair labor Standards Act (FLSA) under proposed § 550.1636. One individual stated that agents were being treated differently than other law enforcement officers and requested that agents be eligible for FLSA overtime pay. Another commenter suggested that exempting agents from the minimum wage and overtime provisions of the FLSA was contrary to labor laws of the United States. Another commenter stated the CBP officers receive better pay than Border Patrol agents and work shorter hours and questioned the fairness of Border Patrol agents being exempt under the FLSA. Several commenters requested that OPM's proposed regulations be amended to allow Border Patrol agents to remain eligible for the wage and overtime provisions of the FLSA.
We are not amending proposed § 550.1636. BPAPRA specifically provides that the minimum wage and overtime provisions of the FLSA are not applicable to Border Patrol agents.
One individual provided a comment in opposition to an agent's travel time not being considered hours of work and stated that agents, while traveling, continue to carry their firearm and are prepared to perform their law enforcement functions should the situation arise. The individual recommended that any travel time by an agent be considered hours of work.
We disagree. Certain travel time is considered hours of work under § 550.112(g). However, we do not agree that carrying a firearm and being prepared to perform law enforcement functions constitute the performance of actual work by an agent while traveling. We are not amending proposed § 550.1637.
NBPC commented that the requirement that agents serving as union representatives perform agency work during any period of regularly scheduled overtime is impractical and “makes little operational sense” because agents are normally deployed in the field “often more than an hour away from the station.” The union stated that it believes the regulations should be amended to make clear that scheduled overtime may be either official time or agency work in the field, or that the regulations should allow agents to work on average one day in the field per week to fulfill the overtime requirement.
We understand this comment to mean that, for example, an agent could request a weekly schedule consisting of four days with a 10-hour daily basic work requirement and a fifth day containing 10 within-tour overtime hours. However, such a schedule does not comply with any of the three schedules allowed under BPAPRA, since those schedules require an 8-hour basic workday with a fixed amount of within-tour overtime each workday (one within-tour overtime hour under Level 2 or two within-tour overtime hours under Level 1). (See the section of this Supplementary Information addressing § 550.1635, which further addresses issues related to alternative work schedules.)
A schedule of the type requested by the NBPC comment cannot be accommodated in these regulations and, further, it is required that agency work be conducted during periods of overtime. Nevertheless, we acknowledge the unique operational environment at CBP and balance it with these constraints. In response to the NBPC comment on this topic, along with its comments on § 550.1603 (which are further addressed in the section of the Supplementary Information addressing § 550.1603), we have made some clarifying modifications to § 550.1638. The final regulation provides additional clarification regarding the specific circumstances under which agents may engage in representational work while in an obligated overtime status. In addition, the final regulation makes clear that when CBP determines an agent's official time duties during the basic workday make it impracticable to perform agency work during scheduled obligated overtime hours, and CBP excuses the agent from working those hours as a result, the agent will accrue an overtime hours debt. CBP would then provide the agent with an opportunity to eliminate the resulting overtime hours debt by performing agency work outside the agent's regular tour of duty at another time. In addition to this opportunity, we note that an agent may opt to eliminate an overtime hours debt by substituting available compensatory time off that the agent has earned in the past.
The Office of Management and Budget has reviewed this rule in accordance with E.O. 13563 and E.O. 12866.
I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will apply only to Federal agencies and employees.
Education, Government employees.
Administrative practice and procedure, Claims, Government employees, Wages.
Government employees, Wages.
Administrative practice and procedure, Government employees, Hostages, Iraq, Kuwait, Lebanon, Life insurance, Retirement.
For the reasons stated in the preamble, OPM is amending parts 410, 550, 551, and 870 of title 5 of the Code of Federal Regulations as follows:
5 U.S.C. 1103(c), 2301, 2302, 4101,
(b) * * *
(8)
5 U.S.C. 5304 note, 5305 note, 5504(d), 5541(2)(iv), 5545a(h)(2)(B) and (i), 5547(b) and (c), 5548, and 6101(c); sections 407 and 2316, Pub. L. 105-277, 112 Stat. 2681-101 and 2681-828 (5 U.S.C. 5545a); section 2(h), Pub. L. 113-277, 128 Stat. 3005; E.O. 12748, 3 CFR, 1992 Comp., p. 316.
(1) 10-hour workdays (including 2 overtime hours each workday) in exchange for a 25-percent overtime supplement (Level 1); or
(2) 9-hour workdays (including 1 overtime hour each workday) in exchange for a 12.5-percent overtime supplement (Level 2).
The addition reads as follows:
(a) * * *
(5) An overtime supplement for regularly scheduled overtime hours within a Border Patrol agent's regular tour of duty under 5 U.S.C. 5550.
(j) For Border Patrol agents covered by 5 U.S.C. 5550 and subpart P of this part, overtime work means hours of work in excess of applicable thresholds, as specified in § 550.1623, excluding hours that are—
(1) Compensated by payment of an overtime supplement for regularly scheduled overtime within the agent's regular tour of duty under § 550.1621;
(2) Compensated by the earning of compensatory time off under § 550.1625; or
(3) Used in substitution or application under § 550.1626.
(e)
(d) For a Border Patrol agent covered by 5 U.S.C. 5550 and subpart P of this part, no holiday premium pay is payable for regularly scheduled overtime hours within the agent's regular tour of duty, as required by 5 U.S.C. 5550(b)(2)(C), (b)(3)(C), and (c)(1)(A). The overtime supplement payable for such scheduled overtime hours is not part of the agent's rate of basic pay used in computing the holiday premium pay for other hours that qualify for such premium pay.
(b) For a Border Patrol agent covered by 5 U.S.C. 5550 and subpart P of this part, no Sunday premium pay is payable for regularly scheduled overtime hours within the agent's regular tour of duty, as required by 5 U.S.C. 5550(b)(2)(C), (b)(3)(C), and (c)(1)(A). The overtime supplement payable for such scheduled overtime hours is not part of the agent's rate of basic pay used in computing the Sunday premium pay for other hours that qualify for such premium pay.
5 U.S.C. 5524a, 5527, 5545a(h)(2)(B), 5550(d)(1)(B); E.O. 12748, 3 CFR, 1992 comp., p. 316.
The additions reads as follows:
(5) An overtime supplement for regularly scheduled overtime within a Border Patrol agent's regular tour of duty under 5 U.S.C. 5550 (as allowed under 5 U.S.C. 5550(d)(1)(B)).
5 U.S.C. 5595; E.O. 11257, 3 CFR, 1964-1965 Comp., p. 357.
The addition reads as follows:
(5) An overtime supplement for regularly scheduled overtime within a Border Patrol agent's regular tour of duty under 5 U.S.C. 5550 (as required by 5 U.S.C. 5550(d)(1)(A)).
5 U.S.C. 5553, 6306, and 6311.
The addition reads as follows:
(b) * * *
(5) * * *
(iv) An overtime supplement for regularly scheduled overtime within a Border Patrol agent's regular tour of duty under 5 U.S.C. 5550, as in effect immediately prior to the date the agent became eligible for a lump-sum payment under § 550.1203. The agency must base the lump-sum payment on the agent's assigned overtime supplement percentage. The assigned percentage will be considered fixed for the duration of the lump-sum annual leave projection period described in § 550.1204, even if an annual period for elections under 5 U.S.C. 5550 begins during that projection period. In cases where the amount of the overtime supplement actually payable in a pay period was limited by a statutory cap, the agency must base the lump-sum payment on a reduced percentage rate that reflects the actual amount of the overtime supplement the agent could receive in a pay period.
5 U.S.C. 5548 and 5550(b)(1)(B) and (d)(1)(B); section 2(h), Pub. L. 113-277, 128 Stat. 3005.
This subpart contains OPM regulations to implement section 2 of the Border Patrol Agent Pay Reform Act of 2014 (Pub. L. 113-277), which added section 5550 in title 5, United States Code, and made related statutory amendments. The Act created a special overtime pay program for Border Patrol agents in the U.S. Customs and Border Protection component within the Department of Homeland Security. OPM has authority under 5 U.S.C. 5548(a) to regulate subchapter V (Premium Pay) of chapter 55 of title 5, United States Code, including section 5550 and the Act's amendments to sections 5542 and 5547. OPM was also granted broad authority to promulgate necessary regulations to carry out the Act and the amendments made by the Act under section 2(h) of the Act.
This subpart applies to an employee of the U.S. Customs and Border Protection component of the Department of Homeland Security (or any successor organization) who holds a position assigned to the Border Patrol Enforcement classification series 1896 or any successor series, consistent with classification standards established by OPM. Such an employee is referred to as a “Border Patrol agent” or “agent” in this subpart.
For the purpose of this subpart—
(1) An agent has one type of established regular tour of duty for one part of the pay period and another type of regular tour of duty for a different part of the pay period; or
(2) An individual is employed as an agent for only a portion of the pay period.
(1) 10-hour workdays (including 2 overtime hours each workday) in exchange for a 25 percent overtime supplement (Level 1); or
(2) 9-hour workdays (including 1 overtime hour each workday) in exchange for a 12.5 percent overtime supplement (Level 2).
Authorized management officials of U.S. Customs and Border Protection are responsible for determining the mission requirements and operational needs of the organization and have the right to assign scheduled and unscheduled work as necessary to meet those requirements and needs, regardless of an agent's officially established regular tour of duty. (See subsections (a) and (f)(1) of section 2 of Pub. L. 113-277 and 5 U.S.C. 5550(g).)
As required by section 2(f) of the Border Patrol Agent Pay Reform Act of 2014 (Public Law 113-277), nothing in section 2 of the Act or this subpart may be construed to require compensation of an agent other than for hours during which the agent is actually performing work or using approved paid leave or other paid time off. This section does not prevent CBP from granting paid excused absence from an agent's basic workweek under other authority.
(a)
(b)
(c)
(d)
(e)
(f)
(1) An agent who is assigned canine care duties must be assigned a Level 1 regular tour of duty, subject to § 550.1622(c);
(2) An agent who is unable to perform overtime on a daily basis, as determined by CBP, must be assigned a Basic regular tour of duty with no overtime supplement until such time as CBP determines the agent is able to perform the required overtime on a daily basis, subject to the rules in § 550.1612(e);
(3) An agent who holds a position at CBP headquarters, as a training instructor at a CBP training facility, or as a fitness instructor—or who holds another type of position that CBP has determined to be an administrative position— must be assigned a Basic regular tour of duty unless CBP determines a Level 1 or Level 2 regular tour of duty may be assigned to the agent based on a comprehensive staffing analysis conducted for the agent's duty station as required by section 2(e) of the Border Patrol Agent Pay Reform Act of 2014 (Public Law 113-277);
(4) CBP determines that an agent must be assigned to a Level 1 regular tour of duty to ensure that not more than 10 percent (or higher percentage established under § 550.1614(b)) of agents stationed at a location are assigned to a Level 2 regular tour of duty or a Basic regular tour of duty, as required by 5 U.S.C. 5550(b)(1)(E) and § 550.1614; or
(5) CBP determines that assignment of a different regular tour of duty is necessary to comply with the pay assignment continuity provisions in 5 U.S.C. 5550(b)(1)(G) and § 550.1615, notwithstanding any other provision of law or this subpart (including paragraphs (f)(1) through (4) of this section).
(g)
(a)
(b)
(1) The date the election was submitted; or
(2) The date the agent completed initial training.
(c)
(d)
(e)
(1) The inability determination may be made—
(i) When an agent's law enforcement authority is revoked (
(ii) When an agent is unable to perform overtime duties for an extended
(iii) For any other appropriate reason, as determined by CBP, but excluding inability based on lack of work (as opposed to inability based on the employee's availability).
(2) The change to a Basic regular tour of duty is effective on the next workday following a CBP inability determination, except that—
(i) CBP may delay the effective date to coincide with the beginning of a week or a biweekly pay period;
(ii) CBP may delay the effective date as necessary to allow an agent who is able to work during regular time to exhaust a positive balance of unused compensatory time off (by applying that balance against the newly accruing overtime hours debt resulting from work during regular time);
(iii) CBP may delay the effective date as necessary to allow an agent to use accrued paid leave or other paid time off if the agent will be performing no work during regular time for a continuous period;
(iv) CBP may delay the effective date during a continuous period of leave without pay granted under 5 U.S.C. chapter 63, subchapter V (dealing with family and medical leave); and
(v) CBP must delay the effective date during any period of paid leave, continuation of pay, or leave without pay granted in connection with application of 5 U.S.C. chapter 81 (dealing with workers' compensation due to a job-related injury).
If application of paragraphs (f)(3) and (4) of § 550.1611 (or application of those paragraphs through § 550.1612) requires CBP to select agents for assignment to a particular regular tour of duty out of a pool of agents who prefer a different assignment, CBP must make any such selection consistent with an established written plan that includes the criteria that will be considered and the priority of those criteria. Such plan must be consistent with the requirements of this subpart.
(a) CBP must take such action as is necessary, including unilateral assignment of agents to a Level 1 regular tour of duty, to ensure that not more than 10 percent of agents stationed at a location are assigned to a Level 2 regular tour of duty or a Basic regular tour of duty, as required by 5 U.S.C. 5550(b)(1)(E), notwithstanding any other provision of law or this subpart, except as provided by paragraphs (b), (c), and (d) of this section. For the purpose of this paragraph, the term “location” means a Border Patrol sector, which includes all subordinate organizational structures and related geographic areas within the sector (
(b) CBP may waive the 10 percent limit in paragraph (a) of this section and apply a higher percentage limit if CBP determines it is able to adequately fulfill its operational requirements under that higher limit based on a comprehensive staffing analysis conducted for the agent's duty station under section 2(e) of the Border Patrol Agent Pay Reform Act of 2014 (Pub. L. 113-277).
(c) The 10 percent limit in paragraph (a) does not apply to agents working at CBP headquarters or at a CBP training location.
(d) Regardless of the percentage limits set under this section, assignments of regular tours of duty to individual agents must be made consistent with the requirement to ensure pay assignment continuity under § 550.1615.
(a)
(2) In applying paragraph (a)(1) of this section, the career average overtime supplement percentage for an agent is the greater of—
(i) The average of overtime supplement percentages (25 percent, 12.5 percent, or 0 percent) assigned during service as an agent on or after January 10, 2016, that is prior to the beginning of the agent's control period (as specified in paragraph (b) of this section); or
(ii) The average of the overtime supplement percentages during all service as an agent that is prior to the beginning of the agent's control period (as specified in paragraph (b) of this section), with assigned overtime supplement percentages (25, 12.5, or 0 percent) assigned during service on or after January 10, 2016, and with assigned percentages of administratively uncontrollable overtime under 5 U.S.C. 5545(c)(2) treated as overtime supplement percentages for any period of service prior to January 10, 2016.
(3) In applying paragraph (a)(2) of this section, the assigned overtime supplement percentage is used regardless of whether or not the payable amount of the overtime supplement is limited by a premium pay cap.
(4) In applying paragraph (a)(2) of this section, if an agent's control period begins on January 10, 2016, as provided in paragraph (b), the agent's initially assigned overtime supplement percentage must be considered the agent's career average under paragraph (a)(2)(i).
(b)
(c)
(2) Notwithstanding the consistency requirement in paragraph (a) of this section, the CBP plan may allow an agent to be assigned a regular tour of duty that provides an overtime supplement percentage that is less than that necessary to produce an average percentage (during all consecutive 3-year periods within the control period specified in paragraph (b)) that is consistent with the agent's career average percentage if—
(i) The agent's overtime supplement is limited by the premium pay cap under §§ 550.105 and 550.107 and the agent voluntarily elects a regular tour of duty
(ii) CBP determines an agent is unable to perform overtime on a daily basis due to a physical or medical condition affecting the agent and assigns the agent a Basic regular tour of duty, as described in § 550.1611(f)(2), (but only if such assignment makes it impossible to satisfy the consistency requirement during any given consecutive 3-year period).
(d)
(2) Notwithstanding the requirements of 5 U.S.C. 5550(b)(1)(G) and this section, CBP is authorized to assign agents to regular tours of duty as necessary to meet operational requirements. Before exercising the authority to allow assignment of a regular tour of duty that does not comply with the plan described in paragraph (a) of this section, CBP must first determine that it cannot adequately address the specific operational requirements in question by other means, such as the assignment of overtime work outside the regular tour of duty to the affected agent or other agents. If this authority is exercised, CBP must return an affected agent to a regular tour of duty that complies with the plan described in paragraph (a) of this section as soon as possible.
(e)
(i) The date the agent became subject to controls on the assignment to a regular tour of duty;
(ii) The date the agent will become subject to mandatory separation under 5 U.S.C. 8335(b) or 5 U.S.C. 8425(b);
(iii) The service computation date based on eligibility under 5 U.S.C. 8336(c) or 5 U.S.C. 8412(d);
(iv) The average overtime supplement percentage during the course of the agent's career prior to the beginning of the control period specified in paragraph (b);
(v) The average overtime supplement percentage for the time period beginning with the date the agent became subject to controls on the assignment to a regular tour of duty and ending on the last day of the most recent annual period;
(vi) The average overtime supplement percentage for the last three annual periods (excluding any time that was not within a control period specified in paragraph (b) of this section);
(vii) The average overtime supplement percentage for the most recent annual period (excluding any time that was not within a control period specified in paragraph (b) of this section), and;
(viii) Any other information requested by OPM.
(2)
(i) The amount of earnings subject to retirement deductions, including overtime supplement payments, received during the most recent calendar year;
(ii) The amount of earnings subject to retirement deductions during the most recent calendar year minus the total amount of the overtime supplement payments during that year;
(iii) The service computation date computed as though law enforcement officer service is regular employee service (
(iv) The service computation date computed with credit for law enforcement officer service, and any other service creditable for eligibility under 5 U.S.C. 8336(c) or 5 U.S.C. 8412(d) (
(v) Date of birth;
(vi) Gender;
(vii) Retirement system (
(viii) Any other information requested by OPM.
(3)
(f)
(a) Except at provided in paragraph (b) of this section, an error made in connection with the assignment of an agent's regular tour of duty (including any associated overtime supplement) must be corrected as soon as possible.
(b) A retroactive correction of a tour assignment (
(1) Correction of an error in applying the consistency requirement described in §§ 550.1611(f)(5) and 550.1615; and
(2) Correction of an error that caused an employee to have a Level 1 regular tour of duty based solely on misapplication of the applicable percentage limitation described in §§ 550.1611(f)(4) and 550.1614.
(a)
(1) The agent has an officially established weekly regular tour of duty generally consisting of five 10-hour workdays (an 8-hour basic workday and 2 regularly scheduled overtime hours);
(2) The agent's 8-hour basic workday (regular time) may be interrupted by an unpaid off-duty meal break;
(3) The obligation to perform 2 hours of overtime work on a day including part of the agent's regular tour of duty does not apply if the agent performs no work during regular time on that day, subject to paragraph (e) of this section;
(4) As compensation for regularly scheduled overtime hours within the regular tour of duty, the agent is entitled to an overtime supplement equal to 25 percent of the agent's hourly rate of basic pay times the number of paid hours of regular time for the agent in the
(5) For any additional regularly scheduled overtime hours outside the regular tour of duty, the agent is entitled to overtime pay as provided in § 550.1624, except as otherwise provided by § 550.1626;
(6) For any irregular overtime hours, the agent is entitled to be credited with compensatory time off as provided in § 550.1625, except as otherwise provided by § 550.1626;
(7) The agent must be charged corresponding amounts of paid leave, compensatory time off, other paid time off, or time in nonpay status for each hour (or part thereof) the agent is absent from duty during regular time, as provided in § 550.1634, except as otherwise provided in § 550.1626(a); and
(8) If the agent is absent during regularly scheduled overtime hours within the agent's regular tour of duty that the agent is obligated to work, the agent accrues an obligation to perform other overtime work for each hour (or part thereof) the agent is absent, and such obligation must be satisfied as provided in § 550.1626.
(b)
(1) The agent has an officially established weekly regular tour of duty generally consisting of five 9-hour workdays (an 8-hour basic workday and 1 regularly scheduled overtime hour);
(2) The agent's 8-hour basic workday (regular time) may be interrupted by an unpaid off-duty meal break;
(3) The obligation to perform 1 hour of overtime work on a day including part of the agent's regular tour of duty does not apply if the agent performs no work during regular time on that day, subject to paragraph (e) of this section;
(4) As compensation for regularly scheduled overtime hours within the regular tour of duty, the agent receives an overtime supplement equal to 12.5 percent of the agent's hourly rate of basic pay times the number of paid hours of regular time for the agent in the pay period (subject to the premium cap in §§ 550.105 and 550.107 and the restriction in § 550.1626(a)(5)), and no additional compensation or compensatory time off may be provided for such overtime hours;
(5) For any additional regularly scheduled overtime hours outside the regular tour of duty, the agent is entitled to overtime pay as provided in § 550.1624, except as otherwise provided by § 550.1626;
(6) For any irregular overtime hours, the agent is entitled to be credited with compensatory time off as provided in § 550.1625, except as otherwise provided by § 550.1626;
(7) The agent must be charged corresponding amounts of paid leave, compensatory time off, other paid time off, or time in nonpay status for each hour (or part thereof) the agent is absent from duty during regular time, as provided in § 550.1634, except as otherwise provided in § 550.1626(a); and
(8) If the agent is absent during regularly scheduled overtime hours within the agent's regular tour of duty that the agent is obligated to work, the agent accrues an obligation to perform other overtime work for each hour (or part thereof) the agent is absent, and such obligation must be satisfied as provided in § 550.1626.
(c)
(1) The agent has an officially established weekly regular tour of duty generally consisting of five 8-hour basic workdays;
(2) The agent's 8-hour basic workday (regular time) may be interrupted by an unpaid off-duty meal break;
(3) For any regularly scheduled overtime hours, the agent is entitled to overtime pay as provided in § 550.1624, except as otherwise provided by § 550.1626;
(4) For any irregular overtime hours, the agent is entitled to be credited with compensatory time off as provided in § 550.1625, except as otherwise provided by § 550.1626; and
(5) The agent must be charged corresponding amounts of paid leave, compensatory time off, other paid time off, or time in nonpay status for each hour (or part thereof) the agent is absent from duty during regular time, as provided in § 550.1634, except as otherwise provided in § 550.1626(a).
(d)
(e)
(f)
(a)
(b)
(2) If an agent, during the period covered by paragraph (b)(1) of this section, performs creditable overtime work outside the agent's regular tour of duty on a day when the agent performed less than the required amount of obligated overtime work, the overtime work outside the regular tour of duty must be applied towards the obligated overtime hours, as provided in § 550.1626(b). After any such substitution, CBP must credit the agent with hours of work for any remaining nonwork time during obligated overtime hours on the same day for the purpose of determining the agent's total hours to be compared to the applicable overtime threshold. For example, if an agent performs 2 creditable hours of regularly scheduled overtime work outside the agent's Level 1 regular tour of duty on a training day when the agent performed half an hour of work during the 2 hours of obligated overtime, CBP would substitute 1.5 hours of regularly scheduled overtime outside the regular tour of duty for 1.5 hours of obligated overtime when no work was performed. CBP would not provide the agent with any credit for nonwork hours under paragraph (b)(1) of this section, since the 0.5 hours of actual work plus the 1.5 substituted hours account for the entire 2-hour period. The agent would be paid
(3) For days of advanced training in excess of 60 days in a calendar year, an agent must be assigned a Basic regular tour of duty and be treated accordingly. If this results in a hybrid pay period in which an agent has two types of regular tours of duty within the same biweekly pay period, CBP must determine the number of overtime hours outside the regular tour of duty as provided in § 550.1623(c). For an agent who is assigned a Basic regular tour of duty during advanced training under this paragraph, CBP must change the agent's regular tour of duty to the type in effect before the Basic tour was assigned when the agent is no longer participating in advanced training.
(4) Paragraphs (b)(1) through (3) of this section apply solely to advanced training that is provided in whole-workday increments (
(c)
(2) If an agent is generally assigned to provide care for a canine, but is temporarily relieved of that duty for any reason (
(a)
(2) An agent's total hours of work in a pay period for the purpose of applying applicable overtime thresholds is equal to the sum of:
(i) Time determined to be hours of work in duty status (regular time or overtime), subject to this subpart, 5 U.S.C. 4109 and 5 CFR 410.402 (related to training periods), and 5 U.S.C. 5542(b) and § 550.112 (establishing general rules), except that paragraphs (d) and (e) of § 550.112 are superseded by § 550.1626;
(ii) Paid leave or other paid time off during a period of nonduty status within an agent's regular time;
(iii) Obligated overtime hours during which no work is performed (creating a debt of hours) and for which no substitution is made under § 550.1626(b);
(iv) Nonwork hours deemed to be hours of work during obligated overtime hours on a day of advanced training under § 550.1622(b); and
(v) Overtime hours normally scheduled within an agent's regular tour of duty that an agent is not obligated to work because the agent performs no work during regular time on that day (as provided in paragraphs (a)(3) and (b)(3) of § 550.1621).
(b)
(i) 100 hours for a Level 1 regular tour of duty;
(ii) 90 hours for a Level 2 regular tour of duty; or
(iii) 80 hours for a Basic regular tour of duty.
(c)
(2) For a hybrid pay period in which an individual is employed as a Border Patrol agent for only part of the pay period, the threshold used to determine whether an agent has performed overtime work outside the regular tour of duty in a given pay period is equal to the sum of the paid regular time hours (paid or unpaid) and the number of normally scheduled overtime hours within a regular tour of duty (whether obligated or not and whether worked or not) during the portion of the pay period the individual was employed as an agent. For example, if an individual is employed as an agent only during the second week of a pay period and has a Level 1 regular tour of duty, the overtime threshold would be 50 hours (40 regular time hours plus 10 normally scheduled overtime hours) in determining whether the agent has overtime hours in that week that are compensable under §§ 550.1624, 550.1625, and 550.1626.
(a)
(b)
(c)
(2) Notwithstanding paragraph (c)(1) of this section, CBP may allow use of regularly scheduled overtime work outside an agent's regular tour of duty if an agent volunteers to perform such overtime (
(a)
(b)
(c)
(1) An agent is required perform such work on a day when the agent was not scheduled to work; or
(2) An agent is required to return to the agent's place of employment to perform such work.
(d)
(e)
(i) CBP, as it determines appropriate, approves in writing a waiver of the 10-hour limit; and
(ii) Such waiver approval is executed in advance of the performance of any work for which compensatory time off is earned.
(2) If a waiver of the 10-hour limit described in paragraph (e)(1) of this section is not granted, the agent involved may not be ordered to perform the associated overtime work.
(f)
(g)
(2) An agent's balance of unused compensatory time off is used to satisfy an overtime hours debt, as provided in § 550.1626(c)(1).
(h)
(a)
(2) Hours of work must be substituted for regular time work under paragraph (a)(1) of this section before being substituted for regularly scheduled overtime within the agent's regular tour of duty under paragraph (b) of this section.
(3) Hours used for substitution under paragraph (a)(1) of this section must be substituted in the following priority order: first, irregular overtime hours; second, regularly scheduled overtime hours outside the regular tour of duty; and third, regularly scheduled overtime hours within the regular tour of duty.
(4) The substitution of overtime hours for leave without pay is solely for pay computation purposes. The substitution does not change the hours of an agent's basic workweek or the fact that the agent was in a particular type of nonpay status during those hours. The hours that are substituted are considered to have been performed when they were worked, not during the leave without pay hours for which they are substituted. For example, if an agent performs 4 hours of overtime work outside the agent's regular tour of duty during the first week of a pay period and then is placed in leave without pay during the second week due to a shutdown furlough caused by a lapse in appropriations, the 4 hours must be substituted for furlough hours for the purpose of computing pay owed the agent for the week before the furlough began.
(5) If overtime hours are substituted for an absence without approval (AWOL) or a suspension, the basic pay for such substituted hours may not be used in computing an agent's overtime supplement.
(b)
(2) In substituting hours of work under paragraph (b)(1) of this section, work performed on the same day as the period of absence must be substituted first in circumstances described in § 550.1622(b)(2). Hours substituted under this paragraph must be substituted in the following priority order: first, irregular overtime hours; and second, regularly scheduled overtime hours outside the regular tour of duty.
(3) After substituting hours under paragraph (b)(2) of this section, any remaining hours used for substitution under paragraph (b)(1) of this section must be substituted in the following priority order: first, irregular overtime hours; and second, regularly scheduled overtime hours outside the regular tour of duty.
(4) The substitution of overtime hours outside the regular tour of duty for obligated overtime hours not worked is solely for pay computation purposes. The substitution does not change the hours of an agent's regular tour of duty. The hours that are substituted are considered to have been performed when they were worked, not during the obligated overtime hours for which they are substituted.
(c)
(2) If an agent has a remaining overtime hours debt after applying paragraphs (b) and (c)(1) of this section, any additional overtime work outside the agent's regular tour of duty in subsequent pay periods that would otherwise be credited under § 550.1624 or § 550.1625 must be applied towards the overtime hours debt until that debt is satisfied. The application of such hours must be done in the following priority order: first, irregular overtime hours; and second, regularly scheduled overtime hours outside the regular tour of duty. Any overtime hour applied under this paragraph (c)(2) may not be considered an overtime hour of work for any other purpose.
(d)
(2) Any unsatisfied overtime hours debt that exists at the time of movement to a non-agent position or separation from Federal service after applying paragraph (d)(1) of this section must be converted to a monetary debt equal to the result of multiplying the agent's hourly rate of basic pay at the time of movement to a non-agent position or separation by the number of hours in the overtime hours debt. CBP must follow standard debt collection procedures to recover any debt.
(a) An agent may not receive premium pay for night, Sunday, or holiday work for hours of regularly scheduled overtime work within the agent's regular tour of duty.
(b) An agent may receive premium pay for night, Sunday, or holiday work, as applicable, for hours not covered by paragraph (a) of this section, in accordance with 5 U.S.C. 5545(a) and (b) and section 5546 and corresponding regulations, except that section 5546(d) does not apply. (For an agent, pay for overtime work on a Sunday or holiday is determined under 5 U.S.C. 5542(g), not under section 5546(d).) The agent's rate of basic pay (without any overtime supplement) must be used in computing such premium payments.
(c) An agent may not be paid standby duty premium pay under 5 U.S.C. 5545(c)(1) or administratively uncontrollable overtime pay under 5 U.S.C. 5545(c)(2).
An agent is eligible for hazardous duty pay, subject to the requirements in 5 U.S.C. 5545(d) and subpart I of this part. The agent's rate of basic pay (without any overtime supplement) must be used in computing any hazardous duty pay.
Regularly scheduled overtime pay within an agent's regular tour of duty is treated as part of basic pay or basic salary only for the following purposes:
(a) 5 U.S.C. 5524a and 5 CFR part 550, subpart B, pertaining to advances in pay;
(b) 5 U.S.C. 5595(c) and 5 CFR part 550, subpart G, pertaining to severance pay;
(c) 5 U.S.C. 8114(e), pertaining to workers' compensation;
(d) 5 U.S.C. 8331(3) and 5 U.S.C. 8401(4) and related provisions that rely on the definition in those paragraphs, pertaining to retirement benefits;
(e) Subchapter III of chapter 84 of title 5, United States Code, pertaining to the Thrift Savings Plan;
(f) 5 U.S.C. 8704(c), pertaining to life insurance; and
(g) For any other purposes explicitly provided for by law or as the Office of
Personnel Management may prescribe by other regulation.
(a) An agent is subject to the rules governing leave accrual and usage under 5 U.S.C. chapter 63 on the same basis as other employees. The tour of duty for leave accrual and usage purposes is the basic workweek, which excludes regularly scheduled overtime hours within the regular tour of duty established under this subpart. The agent must be charged corresponding amounts of leave for each hour (or part thereof) the agent is absent from duty during regular time (except that full days off for military leave must be charged when required).
(b) An agent is subject to the normally applicable rules governing other types of paid time off (such as holiday time off under 5 U.S.C. chapter 61, compensatory time off for religious observances under subpart J of this part, or compensatory time off for travel under subpart N of this part) on the same basis as other covered employees. The tour of duty used in applying those rules is the basic workweek, which excludes regularly scheduled overtime hours within the regular tour of duty established under this subpart. The agent must be charged corresponding amounts of paid time off for each hour (or part thereof) the agent is absent from duty during regular time.
(c) In computing a lump-sum annual leave payment under 5 U.S.C. 5551-5552, an overtime supplement for an agent's regularly scheduled overtime hours within the agent's regular tour of duty is included, as provided in § 550.1205(b)(5)(iv).
An agent may not have a flexible or compressed work schedule under 5
The minimum wage and the hours of work and overtime pay provisions of the Fair Labor Standards Act do not apply to Border Patrol agents. (See also 5 CFR 551.217.)
(a) A Border Patrol agent's travel time to and from home and the agent's regular duty station (or to an alternative work location within the limits of the agent's official duty station, as defined in § 550.112(j)) may not be considered hours of work under any provision of law.
(b) Official travel time away from an agent's official duty station may be creditable hours of work as provided in § 550.112(g). When an agent travels directly between home and a temporary duty location outside the limits of the agent's official duty station (as defined in § 550.112(j)), the time the agent would have spent in normal home to work travel must be deducted from any creditable hours of work while traveling.
An agent who uses official time under 5 U.S.C. 7131 may be assigned to a Level 1 or Level 2 regular tour of duty, but is required to perform agency work during obligated overtime hours or to accrue an overtime hours debt. Official time may be used during overtime hours only when, while the agent is engaged in the performance of agency work, an event arises incident to representational functions that must be immediately addressed during the overtime hours. CBP may excuse the agent from duty during scheduled obligated overtime hours if it determines that an agent's official time duties during the basic workday make it impracticable to perform agency work during the scheduled obligated overtime hours on that day. The agent will accrue an overtime hours debt for that excused time. If CBP excuses the agent in this manner, then it must provide the agent with an opportunity to eliminate the resulting overtime hours debt by performing agency work outside the agent's regular tour of duty at another time. As provided in § 550.1621(e), official time during regular time is considered to be “work” when an agent otherwise would be in a duty status in applying paragraphs (a)(3) and (b)(3) of § 550.1621.
5 U.S.C. 5542(c); Sec. 4(f) of the Fair Labor Standards Act of 1938, as amended by Pub. L. 93-259, 88 Stat. 55 (29 U.S.C. 204f).
(c) * * *
(2) Employees whose primary duties involve patrol and control functions performed for the purpose of detecting and apprehending persons suspected of violating criminal laws;
A Border Patrol agent (as defined in 5 U.S.C. 5550(a)(2) and 5 CFR 550.1603) is exempt from the minimum wage and the hours of work and overtime pay provisions of the Act.
5 U.S.C. 8704(c), 8716; Subpart J also issued under section 599C of Pub. L. 101-513, 104 Stat. 2064, as amended; Sec. 870.302(a)(3)(ii) also issued under section 153 of Pub. L. 104-134, 110 Stat. 1321; Sec. 870.302(a)(3) also issued under sections 11202(f), 11232(e), and 11246(b) and (c) of Pub. L. 105-33, 111 Stat. 251, and section 7(e) of Pub. L. 105-274, 112 Stat. 2419; Sec. 870.302(a)(3) also issued under section 145 of Pub. L. 106-522, 114 Stat. 2472; Secs. 870.302(b)(8), 870.601(a), and 870.602(b) also issued under Pub. L. 110-279, 122 Stat. 2604; Sec. 870.510 also issued under Sec. 1622(b) of Public Law 104-106, 110 Stat. 515; Subpart E also issued under 5 U.S.C. 8702(c); Sec. 870.601(d)(3) also issued under 5 U.S.C. 8706(d); Sec. 870.703(e)(1) also issued under section 502 of Pub. L. 110-177, 121 Stat. 2542; Sec. 870.705 also issued under 5 U.S.C. 8714b(c) and 8714c(c); Public Law 104-106, 110 Stat. 521.
The addition reads as follows:
(a) * * *
(2) * * *
(xii) An overtime supplement for regularly scheduled overtime within a Border Patrol agent's regular tour of duty under 5 U.S.C. 5550 (as required by 5 U.S.C. 5550(d)).
Securities and Exchange Commission.
Final rule.
The Securities and Exchange Commission (“Commission”) is adopting certain amendments, initially proposed in March 2011 and re-proposed in July 2014, related to the removal of credit rating references in rule 2a-7, the principal rule that governs money market funds, and Form N-MFP, the form that money market funds use to report information to the Commission each month about their portfolio holdings, under the Investment Company Act of 1940 (“Investment Company Act” or “Act”). The amendments will implement provisions of the Dodd-Frank Wall Street Reform and Consumer Protection Act (“Dodd-Frank Act”). In addition, the Commission is adopting amendments to rule 2a-7's issuer diversification provisions to eliminate an exclusion from these provisions that is currently available for securities subject to a guarantee issued by a non-controlled person.
Effective Date: October 26, 2015; Compliance Date: October 14, 2016.
Adam Bolter, Senior Counsel; Erin C. Loomis, Senior Counsel; Amanda Hollander Wagner, Senior Counsel; Thoreau Bartmann, Branch Chief; or Sarah G. ten Siethoff, Assistant Director, Investment Company Rulemaking Office, at (202) 551-6792, Division of Investment Management, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-8549.
Section 939A of the Dodd-Frank Act requires each federal agency, including the Commission, to “review any regulation issued by such agency that requires the use of an assessment of the credit-worthiness of a security or money market instrument and any references to or requirements in such regulations regarding credit ratings.”
As a step toward implementing these mandates, and as a complement to similar initiatives by other federal agencies,
We received 16 comment letters on the 2014 proposal.
In adopting final amendments to rule 2a-7 and Form N-MFP to implement Section 939A of the Dodd-Frank Act, we have carefully considered the comments received, and the final amendments include certain modifications intended to respond to commenters' concerns. As proposed, we are adopting amendments to rule 2a-7 that would remove references to ratings and adopt a uniform standard to define an eligible security to be a security that has been determined to present minimal credit risks. However, we have eliminated the proposed “exceptionally strong capacity” standard from this determination, and as a substitute for this finding, the final rule amendments require that a minimal credit risk determination include, to the extent appropriate, an analysis of the guidance factors discussed in the preamble of the Proposing Release.
For these reasons, we are also adopting a similar approach for funds to determine whether a long-term security subject to a conditional demand feature is an eligible security.
Rule 2a-7's risk limiting conditions require a money market fund's portfolio to be diversified, both as to the issuers of the securities it acquires and providers of guarantees and demand features related to those securities.
We received 8 comment letters discussing the proposed issuer diversification amendment,
Under current rule 2a-7, money market funds must limit their portfolio investments to securities that are both “eligible securities” and have been determined by fund boards to pose minimal credit risks to the fund.
The proposal would have eliminated the rule's reference to NRSRO ratings in the eligible security definition, and consolidated the minimal credit risk standard into a single new standard under rule 2a-7's definition of eligible security.
Most of the commenters who discussed the proposed definition of “eligible security” generally supported it,
Some commenters who acknowledged that the removal of credit ratings from rule 2a-7 could create incentives for funds to invest in riskier securities also suggested that certain countervailing factors would alleviate this concern. These commenters stated that revising the definition of eligible security should mitigate concerns about increased credit risk and decreased uniformity by creating a single standard for identifying eligible securities, particularly when viewed in conjunction with the proposed Form N-MFP disclosure requirements and new disclosure requirements that were adopted as part of the 2014 money market fund reforms (which we expect would help to expose the increased volatility and other risks that could accompany greater investment in riskier portfolio holdings).
While generally supporting the overall approach of incorporating the eligible security definition into the general minimal credit risk determination, multiple commenters expressed concerns about the proposed secondary “exceptionally strong capacity” standard incorporated in the proposed definition of eligible security. They suggested that the Commission should reconsider or clarify this standard for a number of reasons. Several commenters argued that the word “exceptional” implies something unusual or extraordinary, which could be read as not including a large number of money market securities of very high credit quality that comprise a portion of money market fund portfolios today.
Some commenters also contended that the “exceptionally strong capacity” language adds an unnecessary standard to a money market fund's minimal credit risk analysis and imposes burdens on advisers without any corresponding benefit to investors.
Numerous commenters expressed support for the guidance factors included in the Proposing Release.
Commenters' opinions varied on whether the guidance factors should be codified. Multiple commenters expressed support for preserving the factors as guidance, rather than codifying them, in order to provide funds with flexibility and the ability to respond to changing market conditions, financing terms, laws, and regulations.
After review of comments received, we are today adopting a revised standard for eligible securities under rule 2a-7 that does not require an “exceptionally strong capacity” fund board finding, but instead requires a single uniform minimal credit risk finding, based on the capacity of the issuer or guarantor of a security to meet its financial obligations.
We have been persuaded by the commenters that suggested that the “exceptionally strong capacity” determination could create an unclear standard for determining eligible securities that might change the current credit quality profile of money market funds. Variations in how this language may be understood could lead to some funds only purchasing the lowest risk securities possible, creating a risk profile even more stringent than the
The requirement that a security present minimal credit risks to a money market fund has been part of rule 2a-7 since it was adopted in 1983.
[T]he mere fact that an instrument has or would receive a high quality rating may not be sufficient to ensure stability. The Commission believes that the instrument must be evaluated for the credit risk that it presents
Under this existing standard, a board (or its delegate) should determine that a security presents minimal credit risks not just in isolation, but also in the context of the fund as a whole. The 2014 Proposing Release made clear that the removal of NRSRO ratings is not intended to change the current risk profile of money market funds, or their evaluation of minimal credit risks.
Although we believe that the minimal credit risk standard should serve as an effective limitation on credit risk in money market fund portfolios even without the proposed secondary “exceptionally strong” finding, we appreciate commenters' concerns that eliminating the “floor” provided by NRSRO ratings in the rule without a replacement might lead to fund managers taking on additional credit risk if the rule does not provide objective and verifiable standards. As discussed above, several commenters suggested that codifying the general factors would enhance investor protections and promote uniform credit quality standards in the absence of specific NRSRO ratings requirements. We agree.
Accordingly, the final rule amendments now include, as part of the analysis of minimal credit risks, a requirement to consider, to the extent appropriate, the general credit analysis factors from the Proposing Release.
As discussed above, commenters disagreed over the proposed elimination of the first and second tier distinction,
Therefore, the final rule requires a money market fund's board (or its delegate) to consider, in making its minimal credit risk determinations, the capacity of each security's issuer, guarantor, or provider of a demand feature, to meet its financial obligations, and in doing so, consider, to the extent appropriate, the following factors: (1) Financial condition; (2) sources of liquidity; (3) ability to react to future market-wide and issuer- or guarantor-specific events, including ability to repay debt in a highly adverse situation; and (4) strength of the issuer or guarantor's industry within the economy and relative to economic trends, and issuer or guarantor's competitive position within its industry.
As discussed in the Proposing Release, the financial condition factor generally should include examination of recent financial statements, including consideration of trends relating to cash flow, revenue, expenses, profitability, short-term and total debt service coverage, and leverage (including financial and operating leverage). The second factor, sources of liquidity, generally should include consideration of bank lines of credit and alternative sources of liquidity. The third factor, involving market-wide events, generally should include analysis of risk from various scenarios, including changes to the yield curve or spreads, especially in a changing interest rate environment. The fourth factor, the competitive position of the firm and its industry, generally should include consideration of diversification of sources of revenue, if applicable.
The Commission is not codifying the asset-specific factors into the final rule text. As one commenter pointed out,
Accordingly, to the extent applicable, fund advisers may wish to consider the following asset-specific factors:
• For municipal securities: (i) Sources of repayment; (ii) issuer demographics (favorable or unfavorable);
• For conduit securities under rule 2a-7:
• For asset-backed securities, such as asset-backed commercial paper: (i) Analysis of the terms of any liquidity or other support provided; and (ii) legal and structural analyses to determine that the particular asset-backed security involves no more than minimal credit risks for the money market fund.
• For other structured securities, such as variable rate demand notes,
• For repurchase agreements under rule 2a-7: A financial analysis and assessment of the minimal credit risk of the counterparty, an assessment as to whether the haircut level is appropriate for the particular type of collateral based upon price volatility in the market for such collateral type, and a legal analysis of the protections for the money market fund provided by the terms of the repurchase agreements.
The list of factors in the rule and the additional factors discussed in this release as guidance are not meant to be exhaustive, and there may be additional factors that could be relevant depending on the type of security analyzed. We recognize that the range and type of specific factors appropriate for consideration could vary depending on the category of issuer and particular security or credit enhancement under consideration, and that the board (or its delegate) therefore may determine to include other factors in its credit assessment.
Rule 2a-7 limits money market funds to investing in securities with remaining maturities of no more than 397 days.
The Commission's proposal would have required a similar analysis, but consistent with Section 939A of the Dodd-Frank Act, it would have removed the requirement in the rule that the fund board (or its delegate) consider credit ratings of underlying securities.
The commenters who addressed this section generally opposed the proposed approach of requiring a different “very strong” standard for conditional demand features as compared to the proposed “exceptionally strong” standard for all other eligible securities. Instead, most commenters that addressed this issue suggested that the Commission adopt a single uniform standard for both eligible securities and conditional demand features as such a uniform standard would eliminate any potential inconsistences and confusion. We agree, and therefore the final amendments do not include the proposed “very strong” standard for conditional demand features, but instead apply the single uniform minimal credit risk standard (including an analysis of relevant factors) for all eligible security determinations, including conditional demand features.
Most commenters' discussion of the credit analysis of securities subject to conditional demand features focused on aligning the credit quality standard for these securities with the standard used to identify eligible securities generally.
We agree with these commenters' concerns and are adopting the rule amendments without the proposed “very strong capacity” standard.
As noted in the Proposing Release and reiterated here, we do not believe that securities that are rated by NRSROs in the third-highest category for long-term ratings (or comparable unrated securities) would satisfy the standard that underlying securities present minimal credit risks to the fund. We also note that funds currently can invest exclusively in underlying securities rated in the second-highest category if the instrument meets the other conditions for eligibility.
Currently, rule 2a-7 requires a money market fund board (or its delegate) to promptly reassess whether a security that has been downgraded by an NRSRO continues to present minimal credit risks, and to take such action as it determines is in the best interests of the
As discussed in the Proposing Release, such ongoing monitoring of minimal credit risks would include the determination of whether the issuer of the portfolio security, and the guarantor or provider of a demand feature, to the extent relied upon by the fund to determine portfolio quality, maturity or liquidity, continues to have the capacity to repay its financial obligations such that the security presents minimal credit risks. The review would typically update the information that was used to make the initial minimal credit risk determination and would have to be based on, among other things, financial data of the issuer or provider of the guarantee or demand feature.
All of the commenters who addressed the ongoing monitoring provision supported the proposed requirement.
Three commenters requested more specificity regarding the frequency of the monitoring requirement.
We are not specifying a periodic basis for the ongoing monitoring requirement adopted today. As a preliminary matter, doing so would conflict with the intent of an explicit ongoing monitoring requirement. Specifying a periodic frequency for monitoring might suggest that regular awareness of the credit profile of portfolio securities is not required, and might also interfere with the discretion of fund managers to react to changing market conditions. In addition, as discussed above, specifying the frequency of monitoring would be inconsistent with our understanding of how a majority of the industry currently evaluates minimal credit risk.
Although we are not codifying a specific frequency upon which monitoring must occur, we expect that for purposes of the rule, ongoing monitoring would mean that monitoring efforts should occur on a regular and frequent basis. We understand that many funds today engage in daily monitoring of changes in the markets or conditions relating to issuers that may affect their credit evaluation of portfolio holdings, and do so even on an hourly basis if there are rapidly changing events. We believe that this type of monitoring is consistent with the ongoing monitoring requirement adopted today.
One commenter who requested a specific periodic basis for minimal credit risk evaluations also suggested that the Commission require that the fund's board be notified when a portfolio security no longer meets the minimal credit risk standard (and thus, the definition of an eligible security).
Today, funds are required to retain a written record of the determination that a portfolio security is an eligible security, including the determination that it presents minimal credit risks. If the proposed requirement to conduct an ongoing review of the credit quality of a fund's portfolio securities were adopted, rule 2a-7's current recordkeeping requirement could have been understood to require the fund to provide for an ongoing documentation of the adviser's ongoing review, which could prove burdensome. Accordingly, we had proposed to make conforming amendments to the recordkeeping provision, requiring the fund to maintain and preserve a written record of the determination that a portfolio security presents minimal credit risks at
One commenter objected to the way the recordkeeping provision was phrased, stating that the rule was not clear as to the extent of the monitoring and whether and when recordkeeping was required.
Three commenters objected to the nature of the standard to be applied in determining minimal credit risks through ongoing monitoring.
The proposed amendments specified that government securities would not be subject to the initial minimal credit risk determination or the ongoing monitoring requirement. One commenter suggested that money market funds held in the fund's portfolio, which also would not be subject to the initial minimal credit risk determination, should be treated the same and carved out of the ongoing monitoring requirement as well.
We believe that explicitly requiring that funds perform ongoing monitoring of credit risks will help to ensure that funds are better positioned to quickly identify potential risks of credit events that could impact portfolio security prices and ultimately, for certain funds, the ability of the fund to maintain its stable net asset value.
Money market funds currently must adopt written procedures for stress testing their portfolios and perform stress tests according to these procedures on a periodic basis.
All commenters addressing the stress testing amendment supported it.
As part of the money market fund reforms adopted in 2010, money market funds must provide to the Commission a monthly electronic filing of portfolio holdings information on Form N-MFP.
Instead of disclosure of designated NRSRO ratings, the Commission's Proposing Release would have required that each money market fund disclose, for each portfolio security, (i) each rating assigned by any NRSRO if the fund or its adviser subscribes to that NRSRO's services, as well as the name of the agency providing the rating, and (ii) any other NRSRO rating that the fund's board of directors (or its delegate) considered in making its minimal credit risk determination, as well as the name of the agency providing the rating.
Most commenters addressing the proposed provision supported the Commission's proposal to require disclosure of NRSRO ratings, though many commenters suggested changes, in particular related to the subscription requirements, as discussed below.
Many commenters stated that requiring funds to disclose each rating assigned by any NRSRO that a fund or its adviser subscribes to would create unnecessary cost burdens for money market funds, as well as cause other problems.
After considering the comments received, we are persuaded by those commenters who argued, as discussed above, that requiring disclosure of each rating assigned by any NRSRO if the fund or its adviser subscribes to that NRSRO's services, as well as the name of the agency providing the rating, is unnecessary and potentially misleading. Except as discussed elsewhere in the section, these commenters did not oppose general disclosure of ratings information on Form N-MFP, provided the requirement is not based on subscribing to an NRSRO's service.
In regard to the comment that requiring disclosure might trigger the charging of publication fees by the NRSROs, numerous money market funds currently voluntarily report ratings on Form N-MFP, and we are not aware of the imposition of such fees on funds. In regard to the comment suggesting that requiring disclosure of ratings on Form N-MFP conflicts with Section 939A of the Dodd-Frank Act, we believe that requiring disclosure of the NRSRO ratings
Some commenters suggested that fund Web site disclosure of NRSRO ratings would be more useful and effective than disclosure on Form N-MFP.
One commenter suggested another approach that we did not propose, namely that the Commission require disclosure on Form N-MFP of the factors that a fund considers when determining whether a security presents minimal credit risks and the details of that determination.
Finally, one commenter stated that government money market funds should not have to disclose ratings information.
In addition to the substantive amendments to Form N-MFP, the Commission is also making a technical change to one of the definitions of “money market fund” on Form N-MFP.
We are amending the rule 2a-7 diversification provision as proposed.
Notwithstanding the 5 percent issuer diversification provision, rule 2a-7 currently does not require a money market fund to be diversified with respect to issuers of securities that are subject to a guarantee by a non-controlled person.
The diversification amendments that we adopt today will remove the current exclusion to the issuer diversification requirement for securities subject to a guarantee issued by a non-controlled person. That is, under this amendment, each money market fund that invests in securities subject to a guarantee (whether or not the guarantor is a non-controlled person) will have to comply with both the 10 percent diversification requirement for the guarantor as well as the 5 percent diversification requirement for the issuer.
One commenter supported the proposed issuer diversification amendment.
In cases where a money market fund invests in a security subject to a guarantee, the guarantor assumes the credit risks presented by a particular issuer by agreeing to provide principal and interest payments in the event the issuer of the underlying security is unable to do so. Accordingly, rule 2a-7 allows a money market fund to look to the credit quality of the guarantor as opposed to the issuer to meet rule 2a-7's portfolio quality provisions.
As we discussed in the Proposing Release, by permitting money market funds a higher 10 percent limit on their indirect exposures to a single provider of a guarantee than the 5 percent limit on direct investments in any one issuer, rule 2a-7 permits a money market fund to take on greater indirect exposures to providers of guarantees. As we previously discussed, and as acknowledged by commenters, a money market fund is permitted to take on greater indirect exposure because, rather than looking solely to the issuer, the money market fund would have two potential sources of repayment—the issuer whose securities are subject to the guarantees and the providers of those guarantees if the issuer defaults.
By diversifying solely against the guarantor, as is the case under the current issuer diversification exclusion, a fund could rely on the guarantors' credit quality or repayment ability, not the issuer's. Thus, in addition to looking to the credit quality of the guarantor as opposed to the issuer to meet rule 2a-7's portfolio quality provisions, the fund would also effectively substitute the credit of the guarantor for that of the issuer for diversification purposes, without imposing the tighter 5 percent requirement that rule 2a-7 generally applies for issuer diversification. This means that a fund could have a highly concentrated portfolio and could be subject to substantial risk if it has a significant investment in securities of a
In the Proposing Release, we requested comment as to whether commenters agreed with our proposed approach to treat securities subject to a guarantee by a non-controlled person similar to other securities with a guarantee under rule 2a-7, or whether we should instead require that a guarantor be treated as the issuer and subject to a 5 percent diversification requirement when a money market fund is relying exclusively on the credit quality of the guarantor or when the security need not meet the issuer diversification requirements. We also asked in the 2013 Money Market Fund Proposing Release more generally whether we should continue to distinguish between a fund's exposure to guarantors and issuers by providing different diversification requirements for these exposures.
As discussed further in the economic analysis section below, we believe that the potential costs of requiring both the guarantor and issuer to be subject to a 5 percent diversification requirement would likely be more significant than the costs of the amendment we are adopting today. As of the end of April 2015, we estimate that approximately 110 (of 214) prime money market funds had total exposure to a single entity (including directly issued, asset-backed commercial paper sponsorship, and provision of guarantees and demand features) in excess of 5 percent. If we adopted an amendment that both the guarantor and issuer are subject to a 5 percent diversification requirement, any fund that had exposure to an entity greater than 5 percent when those assets matured would have to reinvest the proceeds of the securities creating that exposure in different securities or securities with a different guarantor. Those changes may or may not require those funds to invest in alternative securities, and those securities might present greater risk if they offered lower yields, lower liquidity, or lower credit quality. In addition, we believe the approach we take today is preferable to making both the guarantor and issuer subject to a 5 percent diversification requirement because unlike a security that is not subject to a guarantee, a security that is subject to a guarantee would continue to have two sources of repayment.
Another commenter stated that the Commission has provided for the higher 10 percent limit on indirect exposure of money market funds to guarantors in part because of the “double-barreled” protection, as discussed above, and suggested that the same logic should apply in imposing an issuer diversification limit on guaranteed securities.
Several commenters argued that the proposed issuer diversification amendment should not be applied to tax-exempt money market funds in particular.
One commenter suggested that tax-exempt money market funds regularly rely on the exclusion for securities guaranteed by non-controlled persons to exceed the 5 percent diversification limit.
In order to obtain a greater sample, and in response to commenters, the staff supplemented its analysis using October 2014 and April 2015 Form N-MFP data to review the number of funds that exceeded the 5 percent issuer diversification limit, which would indicate that such funds were potentially relying on the 5 percent issuer diversification exclusion.
Based on their updated analysis, Commission staff believes that only tax-exempt money market funds appeared to be relying on the 5 percent issuer diversification exclusion. For October 2014, staff analysis shows that 16 national tax-exempt money market funds out of 72 total national tax-exempt money market funds were potentially relying on the 5 percent issuer diversification exclusion. In addition, staff analysis shows that as of October 2014, only 0.1 percent of national tax-exempt money market fund assets were above the 5 percent issuer diversification threshold.
One commenter argued that the proposed amendment would particularly affect single state money market funds.
These updated analyses confirm the Commission's initial assumption that overall, few money market funds would be affected by the issuer diversification amendment. As indicated by the staff's analysis above, and as discussed further in the economic analysis section below, we continue to believe a small number of all money market funds rely on the 5 percent issuer diversification exclusion and therefore believe the amendment's effect on funds, including the available supply of investable securities, would be minimal. We recognize that although overall few money market funds are relying on the 5 percent issuer exclusion, the amendment to remove such exclusion would disproportionately affect tax-exempt money market funds and single
We also note that money market funds will not be required to sell any of their portfolio securities as a result of our diversification amendment because rule 2a-7's diversification limits are measured at acquisition, and they may therefore retain these assets until they mature. Although we understand that national tax-exempt money market funds and single state money market funds may have made greater use of the 5 percent issuer exclusion in the past (and might do so in the future if we retained the 5 percent issuer diversification exclusion), we remain concerned that funds were previously exposed to concentrated risks inconsistent with the purposes of rule 2a-7's diversification requirements. As discussed above, we also continue to believe that restricting risk exposures to all issuers of securities subject to a guarantee or demand feature in the same way will appropriately limit the concentration of exposure that a money market fund could otherwise have to a particular issuer. Accordingly, we continue to believe that removing the exclusion to the 5 percent issuer diversification provision furthers our reform goal of limiting concentrated exposure of money market funds to particular economic enterprises.
The Commission is also making technical amendments to certain diversification provisions in rule2a-7.
Second, the Commission is clarifying the use of the three-day safe harbor as it pertains to issuer diversification. The current three-day safe harbor provides that a money market fund may invest up to 25 percent of its total assets in first tier securities of a single issuer for a period of three business days after the acquisition thereof.
Last, the Commission is amending rule 2a-7(d)(3)(i)(B)(
In the Proposing Release, we proposed a compliance date for the final amendments to rule 2a-7 and Form N-MFP that would coordinate compliance with the rule 2a-7 amendments relating to diversification, stress testing, and Form N-MFP, adopted in the 2014 Money Market Fund Adopting Release. We solicited comments on this compliance period in the Proposing Release, and one commenter addressed the issue, suggesting that the date be pushed back so that funds will have at least one full year to comply.
In response to this comment, we are now adopting October 14, 2016 as the compliance date for this final rule. This date will give funds more than a full year to comply, which we agree is appropriate, and will also coordinate with the floating net asset value, liquidity fee, and redemption gate
Certain provisions of this final rule contain “collections of information” within the meaning of the Paperwork Reduction Act of 1995 (“PRA”).
As discussed above, we are removing references to credit ratings in rule 2a-7, which affect five elements of the rule: (i) Determination of whether a security is an eligible security; (ii) determination of whether a security is a first tier security; (iii) credit quality standards for securities with a conditional demand feature; (iv) requirements for monitoring securities for ratings downgrades and other credit events; and (v) stress testing. These amendments involve collections of information, and the respondents to the collections of information are money market funds. This collection of information will be mandatory for money market funds that rely on rule 2a-7, and to the extent that the Commission receives confidential information pursuant to the collection of information, such information will be kept confidential, subject to the provisions of applicable law.
Rule 2a-7 limits a money market fund's portfolio investments to “eligible securities,” which are currently defined as securities that have received credit ratings from a requisite NRSRO in one of the two highest short-term rating categories, or comparable unrated securities.
Money market funds are required to have written policies and procedures regarding minimal credit risk determinations.
The Proposing Release provided the credit analysis factors as guidance, rather than in rule text, and required that the fund make a finding that the issuer of a security had an “exceptionally strong capacity” to meet its short-term financial obligations.
While we cannot predict with precision the extent to which funds may revise their policies and procedures for determining minimal credit risk, we estimate that each money market fund complex on average will incur a one-time burden of 9 hours,
Rule 2a-7 currently requires a money market fund board (or its delegate) to promptly reassess whether a security that has been downgraded by an NRSRO continues to present minimal credit risks.
We estimate that each money market fund complex on average would incur a one-time burden of 5 hours,
We estimate that the lower range of the one-time hour burden for a money market fund complex to adopt policies and procedures for ongoing review to determine whether a money market fund's portfolio securities continue to present minimal credit risks would be 3.5 hours (2 hours by a compliance manager and 1 hour by an attorney to develop and review policies and procedures (or transcribe and review pre-existing policies and procedures) + 0.5 hours for the fund's board to adopt the policies and procedures). We estimate that the upper range of the one-time hour burden for a money market fund complex to adopt such policies and procedures would be 6.5 hours (4 hours by a compliance manager and 2 hours by an attorney to develop and review policies and procedures (or transcribe and review pre-existing policies and procedures) + 0.5 hours for the fund's board to adopt the policies and procedures). The mid-point of the lower range estimate and the upper range estimate is 5 hours.
Rule 2a-7 currently requires money market funds to adopt written stress testing procedures and to perform stress tests according to these procedures on a periodic basis.
Rule 30b1-7 requires money market funds to file a monthly report electronically on Form N-MFP within five business days after the end of each month. The information required by the form must be data-tagged in XML format and filed through EDGAR. Preparing Form N-MFP is a collection of information under the PRA.
Money market funds are currently required to disclose on Form N-MFP, with respect to each portfolio security, whether the security is a first or second tier security or is unrated, as well as the “designated NRSROs” for each security (and for each demand feature, guarantee, or credit enhancement).
We estimate that each fund will incur a one-time burden of 3 hours,
We recognize that, in general, software service providers that modify their software may incur additional external costs, which they may pass on to money market funds in the form of higher annual licensing fees.
The current approved collection of information for Form N-MFP is 83,412 annual aggregate hours and $4,780,736 in external costs. The aggregate additional hours associated with the amendments to Form N-MFP increase the burden estimate to 83,949 hours annually for all funds.
As discussed above, we are adopting amendments to rule 2a-7 and Form N-MFP under the Investment Company Act to implement Section 939A of the Dodd-Frank Act, which requires the Commission, to “review any regulation issued by [the Commission] that requires the use of an assessment of the credit-worthiness of a security or money market instrument; and any references to or requirements in such regulations regarding credit ratings.”
We are also amending rule 2a-7 to eliminate the exclusion to the issuer diversification requirement for securities subject to a guarantee issued by a non-controlled person. As a result, most non-government securities subject to a guarantee (including an asset-backed security with a presumed sponsor guarantee) will have to comply with both the 5 percent diversification requirement for issuers (including SPE issuers) and the 10 percent diversification requirement for guarantors and providers of demand features.
The economic baseline for our economic analysis is the regulatory framework as it exists immediately before the adoption of these amendments, that is, the regulatory framework after the amendments to rule 2a-7 were adopted in the 2014 Money Market Fund Adopting Release. As discussed in more detail below, that release makes material changes to rule 2a-7 that we believe may result in material changes to the money market fund industry. Because there is an extended compliance period for those amendments, and we are not aware of any funds that are already complying with all of the amendments, we do not know how market participants, including money market fund managers selecting portfolio securities, may react as a result. Thus, we are not able to provide quantitative estimates for the incremental effects of this rule's amendments. For example, under the baseline, institutional prime money market funds have floating NAVs and maintain the distinction between first and second tier securities. We are unable to estimate how institutional prime funds will choose to allocate their portfolios among first and second tier securities under our amendments when they have floating NAVs and no commenters provided any estimates. We discuss potential economic effects of complying with the amendments to the rule, but without knowing how fund portfolio allocations may change we cannot quantify these potential effects. For the remainder of our economic analysis, we discuss separately the rule 2a-7 amendments to remove and replace ratings references, Form N-MFP amendments, and the amendments to rule 2a-7's issuer diversification provision.
The amendments to rule 2a-7 will affect five elements of the current rule. These are: (i) Determination of whether a security is an eligible security; (ii) determination of whether a security is a first tier security; (iii) credit quality standards for securities with a conditional demand feature; (iv) requirements for monitoring securities for ratings downgrades and other credit events; and (v) stress testing.
As discussed above, the current credit risk limitations in rule 2a-7 require that money market funds undertake a two-step analysis before acquiring a portfolio security.
Based on Form N-MFP filings from April 30, 2015, the Commission estimates that 98.26 percent of aggregate money market fund assets are in first tier securities, 0.14 percent of aggregate money market fund assets are in second tier securities, and 1.6 percent of aggregate money market fund assets are in unrated securities. Among the 537 funds that filed Form N-MFP that month, 412 funds reported that they held only first tier securities, 477 funds reported that they held no second tier securities, and 447 funds reported that they held no unrated securities. In addition, less than 4 percent of all money market funds held the maximum amount of second tier securities permitted under current rule 2a-7. Using additional data from the Federal Reserve Board, we estimate that money market fund holdings of second tier commercial paper represent 0.9 percent of the outstanding issues of second tier commercial paper.
Securities subject to a conditional demand feature are typically variable rate demand notes issued by municipalities that have a conditional demand feature issued by a bank. Based on Form N-MFP filings as of April 30, 2015, the Commission estimates that 9.3 percent of money market fund assets are invested in securities with a demand feature. We estimate further that securities with conditional demand features represent 3.9 percent of securities with demand features and 0.4 percent of all securities held by money market funds. We further estimate that 77 percent of those underlying securities (or their issuers or guarantors) have received an NRSRO rating in the second-highest long-term rating category, while 23 percent have received an NRSRO rating in the highest long-term category.
Rule 2a-7 currently requires a money market fund board (or its delegate) to promptly reassess whether a security that has been downgraded by an NRSRO continues to present minimal credit risks.
Finally, rule 2a-7 currently requires money market funds to stress test their portfolios.
The amendments to rule 2a-7 will assist in further implementing Section 939A of the Dodd-Frank Act. They are designed to establish credit quality standards similar to those currently in the rule. By replacing references to credit ratings, the amendments will, particularly when considered together with other amendments the Commission has adopted that remove credit ratings references in other rules and forms under the federal securities laws, contribute to the Dodd-Frank Act goals of reducing perceived government endorsement of NRSROs and over-reliance on credit ratings by market participants.
Under the final rule, a money market fund board (or its delegate) will be required to determine minimal credit risk by applying certain credit quality factors. Because the application of these factors may differ among fund boards and their advisers, the possible range of securities available for investment may differ from that under the current rule. However, inclusion of the credit analysis factors in the rule, as opposed to the more subjective standard in the proposed rule, should limit this range by helping to make compliance more uniform across money market funds. The final rule also clarifies that, when making minimal credit risk determinations, the fund's board (or its delegate) should consider the contribution of the security to aggregate credit risks and not just evaluate the security in isolation. In particular, a potential addition to the portfolio that has low risk by itself might increase portfolio risk to unacceptable levels if it is sufficiently correlated with the overall portfolio. For example, a security that has a very low probability of default might be inappropriate for the fund if that security is likely to default at the same time as other securities in the fund's portfolio.
In addition, we believe that fund managers are generally unlikely to increase exposure of their funds to riskier second tier securities in light of both current market practices and amendments to rule 2a-7 adopted in the 2014 Money Market Fund Adopting Release.
Second, as discussed above, the 2014 amendments to rule 2a-7 should reduce the potential that funds will invest in riskier securities. Under the 2014 reforms, money market funds other than government money market funds are allowed to impose fees and gates, while institutional prime money market funds will be required to transact at a floating NAV.
Third, under the final rule funds are permitted to refer to credit ratings while making their minimal credit risk determinations. A credit rating in the top short-term credit quality category by an NRSRO might help support the fund's determination that the security is an eligible security, while a credit rating in a lower category might not support the same determination. Thus, fund managers may have to perform additional credit research and analysis on the issuers of second tier securities in order to determine whether the investment is permitted under the adopted amendments. We believe that many fund managers may not wish to invest in the additional resources necessary to make this assessment with respect to second tier securities unless the fund believes that the expected risk-adjusted return of doing so would be greater than the expected costs. Thus, the demand for securities rated second tier will likely be lower.
The final rule would eliminate the current limitations on fund investments in second tier securities.
If we were to assume that money market funds increase their relative holdings of second tier securities with the adoption of the amendments, the effects on competition and capital formation would depend, in part, on whether the increased demand for second tier investments comes from new assets that investors bring to money market funds, which are then disproportionately invested in second tier securities, or whether the increased second tier investments would come from a shift of existing money market fund assets from first tier securities to second tier securities. If the former, the effects on competition between issuers of first and second tier securities might be small, and capital formation might improve in the second tier market as the size of the new investment increases. If the latter, an increase in capital formation from issuers of second tier securities may result in a corresponding decrease in capital formation from issuers of first tier securities, which, in turn, may lead to increased competition between issuers of first and second tier securities. We are unable to estimate these effects because we do not know how shareholders and funds will respond to the elimination of the current limitation on fund investments in second tier securities and no commenters provided any estimates.
The amendments to Form N-MFP, which are discussed in more detail below, may make it easier for fund shareholders and other third parties to
As discussed above, the vast majority of money market funds held no second tier securities on April 30, 2015, and few funds held the maximum permissible 3 percent. We therefore believe that a reduction or even elimination of second tier securities from the money market fund industry's aggregate portfolio will not likely have a material effect on issuers of either first or second tier securities. However, removing second tier securities from the portfolios of individual money market funds may negatively affect yields in certain funds, especially during periods when second tier securities offer substantially higher yields than the yields offered by first tier securities.
We believe that most money market funds are not likely to change their current investment policies in response to the adopted amendments. Nevertheless, we recognize that some fund boards might choose not to consider NRSRO ratings in their credit assessments or as noted above, fewer securities may be rated. If, as a result, the demand for NRSRO ratings were significantly reduced, NRSROs might invest less in producing quality ratings. The importance attached to NRSRO ratings currently as a result of the history of their use in regulatory requirements may impart franchise value to the NRSRO rating business. By eliminating references to NRSRO ratings in federal regulations, Section 939A of the Dodd-Frank Act could reduce these franchise values and reduce NRSROs' incentives to produce credible and reliable ratings. If the quality and accuracy of NRSRO ratings were adversely affected, yet the ratings continued to be used by enough other parties, the capital allocation process and economic efficiency might be impaired as investors make investment decisions using lower-quality information.
Conversely, the removal of ratings requirements in Commission rules may enhance incentives for NRSROs to produce credible and reliable ratings, in order to remain competitive, maintain revenue, and protect franchise value. In addition, certain industry commenters on the 2014 Proposing Release expressed support for the continued use of ratings as a tool in determining creditworthiness.
The Proposing Release provided the credit analysis factors as guidance, rather than in rule text, and required that the fund make a finding that the issuer of a security had an “exceptionally strong capacity” to meet its short-term financial obligations.
Finally, we note that Commission staff engages in ongoing monitoring of money market fund risks and operations, through review of Form N-MFP filings, examinations, and other outreach efforts, and provides regular updates to the Commission about relevant issues. As part of these ongoing monitoring efforts, the staff also will undertake to study and report to the Commission no later than 3 years following the adoption of these amendments to rule 2a-7 and Form N-MFP the impact of these amendments on capital formation and investor protection. The study will include, but not be limited to, a review of any changes in the risk profile of money market fund portfolio security investments during the period studied and whether any additional measures, including further investor protections, may be necessary.
The final rule provides the same credit quality standard for securities with a conditional demand feature as for other portfolio securities. The fund's board (or its delegate) must determine that a security with a conditional demand feature presents minimal credit risks to the fund. We do not believe that fund managers will likely interpret this standard in a manner that results in funds increasing the risk profiles of their underlying securities. First, as discussed above, we do not believe that securities that are rated by NRSROs in the third-highest category for long-term ratings (or comparable unrated securities) would satisfy the standard that underlying securities present minimal credit risks to the fund. We also note that funds currently can invest exclusively in underlying securities rated in the second-highest category if the instrument meets the other
For the reasons explained above, and because the minimal credit risk standard is largely the same as what we understand that many funds apply now, and also the same as will be required for all eligible portfolio securities, we believe that our rule will result in only small changes to the practices of funds with respect to investments in securities with conditional demand features. In addition, the elimination of the “very strong capacity” standard presented in the proposal should result in little or no change to this analysis, as discussed above.
As discussed above, we believe that the amendments to rule 2a-7 will cause money market fund complexes to incur certain costs in reviewing and updating their policies and procedures. Specifically, each complex is likely to review the amendments to the credit quality standards in rule 2a-7 and, as it determines appropriate in light of the amendments, revise its policies and procedures to incorporate the amended credit quality evaluation method to be used in determining the eligibility of a money market fund's portfolio securities, including securities that are subject to a conditional demand feature.
The Commission is adopting the ongoing monitoring provision as proposed. As discussed above, we believe that the requirement that each money market fund adopt written policies and procedures for ongoing monitoring of minimal credit risks for each portfolio security essentially codifies the current practices of fund managers.
The Commission is adopting the stress testing provision as proposed. As discussed above, the amendments are designed to retain similar standards for stress testing as under current rule 2a-7. Specifically, the amendments will remove the current reference to ratings downgrades in the rule 2a-7 stress testing requirement, and instead require funds to test for an event indicating or evidencing credit deterioration of particular portfolio security positions, with a downgrade or default provided as examples of such an event. Consequently, we recognize that a money market fund could use its current policies and procedures for stress testing, including testing for a downgrade, to comply with the amendments. We believe that funds will do so because a downgrade by a relevant NRSRO may impact the price of a portfolio security.
As discussed above, money market funds have written policies and procedures for complying with rule 2a-7, including policies and procedures for determining and reassessing minimal credit risk and for stress testing the portfolio.
As noted above, we believe that while funds currently monitor for minimal credit risks on an ongoing basis, we assume that funds do not have written policies and procedures to address monitoring.
The Commission chose not to adopt certain credit quality standards and requirements from the Proposing Release. First, the proposed rule would have required that a portfolio security not only present minimal credit risks, but also that its issuer has an “exceptionally strong capacity” to meet its short-term financial obligations.
The Proposing Release provided two lists of credit analysis factors for use in determining whether a security presented only minimal credit risks to a fund.
In addition to the changes to the primary risk standard, the final rule also changed the risk standard for securities with conditional demand features.
In developing this final rule, we also considered changes consistent with the amendments we proposed in 2011. The 2011 proposal would have required fund boards first to determine whether securities are eligible securities based on minimal credit risks, and second to distinguish between first and second tier securities based on subjective standards similar to those the ratings agencies have developed to describe their ratings. However, we were persuaded by the concerns some commenters expressed on the 2011 proposal,
The two industry commenters on the 2014 proposal who discussed the elimination of the first and second tier distinction supported it.
The two-tier approach discussed above could have had different effects on competition and capital formation than the effects on competition and capital formation stemming from the adopted approach, as a result of ensuing increased or decreased investments in second tier securities. However, we are unable to estimate the relative effects on competition or capital formation because we do not know how shareholders and funds would respond to this approach as compared to the final rule, and no commenters provided any estimates.
With respect to replacing the reference to ratings in determining the eligibility of underlying securities (
In choosing to eliminate the current reference to ratings downgrades in the monitoring standard of rule 2a-7, we considered the rule 2a-7 amendments that we proposed in 2011.
Finally, we also considered removing the current reference to ratings downgrades in the stress testing provisions of rule 2a-7 and replacing this reference with the requirement that money market funds stress test their portfolios for an adverse change in the ability of a portfolio security issuer to meet its short-term credit obligations. We had proposed this alternative in 2011, and commenters on the 2011 proposal who addressed this issue uniformly advocated against removing the reference to a downgrade in the stress testing conditions.
The final rule's amendments to Form N-MFP will require money market funds to disclose NRSRO ratings that they use in their evaluations of portfolio securities. Specifically, a fund will have to disclose for each portfolio security any NRSRO rating that the fund's board of directors (or its delegate) considered in making its minimal credit risk determination, as well as the name of the agency providing the rating. NRSRO ratings provide one indicator of credit risk of a fund's portfolio securities and, as discussed above, we anticipate that they will continue to be considered by many money market fund managers in performing credit quality assessments. We believe this ratings information will be useful to the Commission, to investors, and to various third parties as they monitor and evaluate the risks that fund managers take in both stable-NAV and institutional prime funds.
Under the economic baseline outlined above, money market funds are required to disclose in Form N-MFP the credit ratings for each portfolio security.
As noted above, based on Form N-MFP filings from April 30, 2015, the Commission estimates that 98.26 percent of aggregate money market fund assets are invested in first tier securities, 0.14 percent of aggregate money market fund assets are invested in second tier securities, and 1.6 percent of aggregate money market fund assets are invested in unrated securities. Among the 537 funds that filed that month, 412 funds reported that they held only first tier securities, 477 funds reported that they held no second tier securities, and 447 funds reported that they held no unrated securities.
We anticipate that our amendments are likely to have two primary benefits. First, they should reduce perceived government endorsement of NRSROs, particularly when considered together with other amendments the Commission has adopted that remove credit ratings references in this rule and other rules and forms under the federal securities laws. Second, they will provide transparency on whether or not specific funds use credit ratings when making investment decisions, and might make it easier, if ratings are used, for shareholders and other interested parties to also use those ratings as part of their own risk assessments.
We anticipate that our amendments are likely to have two primary costs. First, they may impose administrative costs on funds that need to re-program their Form N-MFP filing software.
The net effect of the amendments to Form N-MFP is that funds will not be required or permitted to disclose credit ratings if credit ratings are not considered in determining whether a security is eligible for the portfolio. However, as discussed above, we believe that our amendments will not result in any material changes for the majority of funds because they will, we believe, continue to refer to credit ratings. We believe, therefore, that the amendments' effects on efficiency, competition, and capital formation will likely be negligible. To the extent that money market funds continue to consider NRSRO ratings in making their minimal credit risk determinations, the amendments to Form N-MFP may reduce the potential that fund managers will increase significantly fund investments in riskier second tier securities; a fund will be required to disclose ratings considered in those credit determinations, and the ratings will reflect that increased risk. As a result, the disclosure to investors of these risk indicators may have the effect of penalizing funds that assume more risk.
Although this final rule reflects a change from the proposal by not requiring disclosure of every rating that a fund subscribes to, we believe that it will have a negligible impact on the overall costs and benefits of these amendments to Form N-MFP. Just as in the proposed rule, funds will still have to report the ratings they considered, and adjust their compliance programs to ensure such reporting. The extra reporting that would have been required under the proposed rule would likely only have caused a very small burden on funds because funds would incur the same reprogramming costs under either approach.
In the 2014 Proposing Release, the Commission presented an alternative to the now adopted amendments to Form N-MFP that would have required greater disclosure of credit ratings. Specifically, a fund would have had to disclose not only the ratings that it considered in evaluating a security and the name of the NRSRO providing the rating, but also each rating assigned by any NRSRO if the fund or its adviser subscribed to that NRSRO's services, and the name of that NRSRO. Several commenters on the proposed rule objected strongly to this requirement, stating that it would be costly, onerous and that mere subscription to an NRSRO's services was not a good indication that a particular rating was part of the evaluation of a particular security.
In developing this final rule, we also considered the 2011 proposal to completely eliminate the following two form items: the item that requires a fund to identify whether a portfolio security is a first tier security, a second tier security, or an unrated security; and the item that requires the fund to identify the “requisite NRSROs” for each security (and for each demand feature, guarantee, or other credit enhancement). Although we have eliminated the terminology “requisite NRSRO”, we did not adopt this alternative because we now believe that completely eliminating such disclosure requirements masks not only the credit ratings but also information on whether or not the fund uses credit ratings when making its investment decisions.
We also considered not removing the current disclosure requirement as recommended by several commenters to the 2011 Proposing Release.
As discussed above, most money market fund portfolio securities that are subject to a guarantee by a non-controlled person are currently subject to a 10 percent diversification requirement on guarantors but no diversification requirement on issuers, while non-government securities with guarantors that do not qualify as non-controlled persons are generally subject to both a 5 percent diversification requirement with respect to issuers and a 10 percent diversification requirement with respect to guarantors.
We believe that a small number of money market funds rely on the issuer diversification exclusion for securities subject to a guarantee by a non-controlled person. In the Proposing Release, staff's analysis of February 2014 Form N-MFP data showed that only 8 out of 559 money market funds held securities with a guarantee by a non-controlled person that exceeded the 5 percent diversification requirement for issuers. We stated in the Proposing Release that we believed that these funds in February 2014 relied on the exclusion from the 5 percent issuer diversification requirement with respect to issuers of securities that are subject to a guarantee issued by a non-controlled person.
In response to commenters, staff supplemented its analysis using October 2014 and April 2015 Form N-MFP data to review the number of funds that exceeded the 5 percent diversification limit.
Commission staff also separately analyzed the number of single state money market funds that appear to be relying on the issuer diversification exclusion.
We recognize that changes in fund assets could mask which funds rely on the issuer diversification exclusion at acquisition: A fund might be above the 5 percent limit today solely due to a decline in fund assets after acquisition, and a fund might be below the 5 percent limit today solely due to an increase in fund assets after acquisition.
In response to commenters' suggestion that the Commission consider a broader sample of data, as discussed above, and to assess the amendment's effect on yield, our staff examined whether the 7-day gross yields of funds that use the 5 percent issuer diversification exclusion were higher than the 7-day gross yields for funds that do not. Our staff found: (i) For national tax-exempt money market funds in October 2014, the average yield for funds using the 5 percent issuer diversification exclusion was 0.10 percent as compared to the average yield for funds that did not use the 5 percent issuer diversification exclusion of 0.08 percent; (ii) for national tax-exempt money market funds in April 2015, the average yield for funds using the 5 percent issuer diversification exclusion was 0.12 percent as compared to the average yield for funds that did not use the 5 percent issuer exclusion of 0.11 percent; (iii) for single state money market funds in October 2014, the average yield for funds using the 5 percent issuer diversification exclusion was 0.10 percent as compared to the average yield for funds that did not use the 5 percent issuer exclusion of 0.08 percent; and (iv) for single state money market funds in April 2015, the average yield for funds using the 5 percent issuer diversification exclusion was 0.12 percent as compared to the average yield for funds that did not use the 5 percent issuer exclusion of 0.07 percent. Although we do not believe the above differences in yield are material, we do recognize that funds that appear to be relying on the exclusion have, on average, a higher yield than money market funds that do not rely on the exclusion. In addition, we acknowledge that the current low-interest rate environment may cause the yield spread in each comparison above to be less than if we were measuring the yield spreads in a higher interest rate environment.
It appears that the elimination of the exclusion would affect the 63 money market funds out of a total of 542 money market funds (or approximately 11.6 percent of all money market funds) that exceeded the 5 percent issuer diversification limit as of April 2015, and would affect the 0.0624 percent of total money market fund assets that were above the 5 percent issuer diversification threshold, such that
A couple commenters expressed concern regarding the amendment's impact on the supply of available securities for all money market funds.
We recognize that the removal of the issuer diversification exclusion and tightening of issuer diversification requirements for securities subject to a guarantee by a non-controlled person may impact issuers of these securities and the fund's risk profile. We also recognize that the amendment may occasionally prevent some issuers from selling securities to a money market fund that would otherwise invest in the issuer's securities above the 5 percent diversification requirement, but we believe, as discussed below, that the effect on such issuers would be negligible. In addition, while we recognize that removing the exclusion may cause some money market funds to invest in securities with higher credit risk, we note that a money market fund's portfolio securities must meet certain credit quality requirements, such as posing minimal credit risks, as discussed above.
Our diversification amendment offers two primary benefits. First, by requiring greater issuer diversification for those funds that rely on the exclusion, the amendment will reduce concentration risk in those funds and may make it easier for funds to maintain or generate liquidity during periods when they impose fees and/or gates. Second, the amendment simplifies rule 2a-7's diversification requirements by eliminating the exclusion for securities with a guarantee issued by a non-controlled person, which should lower certain compliance and operational costs to the extent that funds no longer have to keep track of the securities that have such guarantees and would be eligible for the exclusion.
Because we believe that the universe of affected funds and issuers is small, we continue to believe that our amendment will have only negligible effects on efficiency, competition, and capital formation. Although we recognize that this amendment may constrain more funds (and issuers) in the future that otherwise would have less issuer diversification, we estimate, based on our staff's analysis of data from April 2015, that it will affect 63 funds, or approximately 11.6 percent of all money market funds today. Based on our staff's analysis we also estimate that, as of April 2015, our amendment will affect the 0.0624 percent of total money market fund assets that were above the 5 percent issuer diversification threshold. Based on staff analysis of Form N-MFP data and the amount of high quality securities available to tax-exempt money market funds, we continue to believe that the affected funds will find comparable alternative securities for the amount that exceeds 5 percent, and we believe that the affected issuers, to the extent applicable, will find other investors willing to buy the amount that exceeds the 5 percent for a comparable price.
As an alternative to eliminating the exclusion from issuer diversification for securities with a guarantee issued by a non-controlled person, at the proposal stage we considered requiring money market funds to be more diversified by lowering a fund's permitted exposure to any guarantor or provider of a demand feature from 10 percent to 5 percent of total assets. We discussed potential benefits and costs of this alternative approach, and we requested comment on it in the 2013 Money Market Fund Proposing Release.
As discussed above, we are making technical amendments to certain diversification provisions in rule 2a-7. Due to the nature of these amendments, we believe that the amendments will have no effect on efficiency, competition, or capital formation.
The Commission certified, pursuant to section 605(b) of the Regulatory Flexibility Act of 1980
The Commission is adopting amendments to rule 2a-7 under the authority set forth in sections 6(c) and 38(a) of the Investment Company Act [15 U.S.C. 80a-6(c), 80a-37(a)] and Section 939A of the Dodd-Frank Act. The Commission is adopting amendments to Form N-MFP under the authority set forth in sections 8(b), 30(b), 31(a) and 38(a) of the Investment Company Act [15 U.S.C. 80a-8(b), 80a-29(b), 80a-30(a) and 80a-37(a)] and Section 939A of the Dodd-Frank Act.
Investment companies, Reporting and recordkeeping requirements, Securities.
In accordance with the foregoing, title 17, chapter II of the Code of Federal Regulations is amended as follows:
15 U.S.C. 80a-1
The revisions read as follows:
(a) * * *
(11)
(i) With a remaining maturity of 397 calendar days or less that the fund's board of directors determines presents minimal credit risks to the fund, which determination must include an analysis of the capacity of the security's issuer or guarantor (including for this paragraph (a)(11)(i) the provider of a conditional demand feature, when applicable) to meet its financial obligations, and such analysis must include, to the extent appropriate, consideration of the following factors with respect to the security's issuer or guarantor:
(A) Financial condition;
(B) Sources of liquidity;
(C) Ability to react to future market-wide and issuer- or guarantor-specific events, including ability to repay debt in a highly adverse situation; and
(D) Strength of the issuer or guarantor's industry within the
(ii) That is issued by a registered investment company that is a money market fund; or
(iii) That is a government security.
For a discussion of additional factors that may be relevant in evaluating certain specific asset types see Investment Company Act Release No. IC-31828 (9/16/15).
(d) * * *
(2)
(ii)
(iii)
(A) The conditional demand feature is an eligible security;
(B) The underlying security or any guarantee of such security is an eligible security, except that the underlying security or guarantee may have a remaining maturity of more than 397 calendar days.
(C) At the time of the acquisition of the underlying security, the money market fund's board of directors has determined that there is minimal risk that the circumstances that would result in the conditional demand feature not being exercisable will occur; and
(
(
(D) The issuer of the conditional demand feature, or another institution, has undertaken to promptly notify the holder of the security in the event the conditional demand feature is substituted with another conditional demand feature (if such substitution is permissible under the terms of the conditional demand feature).
(3) * * *
(i)
(A)
(
(
(B)
(
(
(f)
(i) The default with respect to a portfolio security (other than an immaterial default unrelated to the financial condition of the issuer);
(ii) A portfolio security ceases to be an eligible security (
(iii) An event of insolvency occurs with respect to the issuer of a portfolio security or the provider of any demand feature or guarantee.
(2)
(3)
(i) In the case of an instrument subject to a demand feature, the demand feature has been exercised and the fund has recovered either the principal amount or the amortized cost of the instrument, plus accrued interest;
(ii) The provider of the guarantee is continuing, without protest, to make payments as due on the instrument; or
(iii) The provider of a guarantee with respect to an asset-backed security pursuant to paragraph (a)(16)(ii) of this section is continuing, without protest, to provide credit, liquidity or other support as necessary to permit the asset-backed security to make payments as due.
(g) * * *
(3)
(i) Include an assessment of each security's credit quality, including the capacity of the issuer or guarantor (including conditional demand feature provider, when applicable) to meet its financial obligations; and
(ii) Be based on, among other things, financial data of the issuer of the portfolio security or provider of the
(h) * * *
(3)
(j)
(1)
(2)
15 U.S.C. 77f, 77g, 77h, 77j, 77s, 78c(b), 78l, 78m, 78n, 78o(d), 80a-8, 80a-24, 80a-26, 80a-29, and Pub. L. 111-203, sec. 939A, 124 Stat. 1376 (2010), unless otherwise noted.
The text of Form N-1A does not, and this amendment will not, appear in the Code of Federal Regulations.
“Money Market Fund” means a registered open-end management investment company, or series thereof, that is regulated as a money market fund pursuant to rule 2a-7 (17 CFR 270.2a-7) under the Investment Company Act of 1940.
The additions and revisions read as follows:
The text of Form N-MFP does not, and this amendment will not, appear in the Code of Federal Regulations.
Item C.9 Is the security an Eligible Security? [Y/N]
Item C.10 Security rating(s) considered. Provide each rating assigned by any NRSRO that the fund's board of directors (or its delegate) considered in determining that the security presents minimal credit risks (together with the name of the assigning NRSRO). If none, leave blank.
Item C.14 * * *
e. Rating(s) considered. Provide each rating assigned to the demand feature(s) or demand feature provider(s) by any NRSRO that the board of directors (or its delegate) considered in evaluating the quality, maturity or liquidity of the security (together with the name of the assigning NRSRO). If none, leave blank.
Item C.15 * * *
c. Rating(s) considered. Provide each rating assigned to the guarantee(s) or guarantor(s) by any NRSRO that the board of directors (or its delegate) considered in evaluating the quality, maturity or liquidity of the security (together with the name of the assigning NRSRO). If none, leave blank.
Item C.16 * * *
d. Rating(s) considered. Provide each rating assigned to the enhancement(s) or enhancement provider(s) by any NRSRO that the board of directors (or its delegate) considered in evaluating the quality, maturity or liquidity of the security (together with the name of the assigning NRSRO). If none, leave blank.
E. Definitions * * *
“Money Market Fund” means a registered open-end management investment company, or series thereof, that is regulated as a money market fund pursuant to rule 2a-7 (17 CFR 270.2a-7) under the Investment Company Act of 1940.
By the Commission.
Fish and Wildlife Service, Interior.
Final rule.
This rule prescribes special late-season migratory bird hunting regulations for certain tribes on Federal Indian reservations, off-reservation trust lands, and ceded lands. This rule responds to tribal requests for U.S. Fish and Wildlife Service (hereinafter Service or we) recognition of their authority to regulate hunting under established guidelines. This rule allows the establishment of season bag limits and, thus, harvest at levels compatible with populations and habitat conditions.
This rule takes effect on September 26, 2015.
You may inspect comments received on the special hunting regulations and Tribal proposals during normal business hours at U.S. Fish and Wildlife Headquarters, 5275 Leesburg Pike, Falls Church, VA 22041-3803, or at
Ron W. Kokel, U.S. Fish and Wildlife Service, Department of the Interior, MS: MB, 5275 Leesburg Pike, Falls Church, VA 22041-3803; (703) 358-1967.
The Migratory Bird Treaty Act of July 3, 1918 (16 U.S.C. 703
In the August 4, 2015,
(1) On-reservation hunting by both tribal members and nonmembers, with hunting by nontribal members on some reservations to take place within Federal frameworks but on dates different from those selected by the surrounding State(s);
(2) On-reservation hunting by tribal members only, outside of usual Federal frameworks for season dates and length, and for daily bag and possession limits; and
(3) Off-reservation hunting by tribal members on ceded lands, outside of usual framework dates and season length, with some added flexibility in daily bag and possession limits.
In all cases, the regulations established under the guidelines must be consistent with the March 10-September 1 closed season mandated by the 1916 Migratory Bird Treaty with Canada.
In the April 13, 2015,
(1) Harvest anticipated under the requested regulations;
(2) Methods that would be employed to measure or monitor harvest (such as bag checks, mail questionnaires, etc.);
(3) Steps that would be taken to limit level of harvest, where it could be shown that failure to limit such harvest would adversely impact the migratory bird resource; and
(4) Tribal capabilities to establish and enforce migratory bird hunting regulations.
No action is required if a tribe wishes to observe the hunting regulations established by the State(s) in which an Indian reservation is located. We have successfully used the guidelines since the 1985-86 hunting season. We finalized the guidelines beginning with the 1988-89 hunting season (August 18, 1988,
Although the August 4 proposed rule included generalized regulations for both early- and late-season hunting, this rulemaking addresses only the late-season proposals. Early-season proposals were addressed in a final rule published in the September 1, 2015,
Information on the status of waterfowl and information on the status and harvest of migratory shore and upland game birds, including detailed information on methodologies and results, is available at the address indicated under
For the 2015-16 migratory bird hunting season, we proposed regulations for 31 tribes or Indian groups that followed the 1985 guidelines and were considered appropriate for final rulemaking. Some of the proposals submitted by the tribes had both early- and late-season elements. However, as noted earlier, only those with late-season proposals are included in this final rulemaking; 10 tribes have proposals with late seasons. We also noted in the August 4 proposed rule (80 FR 46218) that we were proposing seasons for seven Tribes who have submitted proposals in past years but from whom we had not yet received proposals this year. We did not receive proposals from five of those Tribes and, therefore, have not included them in this final rule.
The comment period for the August 4 proposed rule closed on August 14, 2015. We received three comments on our August 4 proposed rule, which announced proposed seasons for migratory bird hunting by American Indian Tribes. We responded to all three comments in the September 1, 2015, final rule.
The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” filed with the Environmental Protection
Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has reviewed this rule and has determined that this rule is significant because it would have an annual effect of $100 million or more on the economy.
Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
An updated economic analysis was prepared for the 2013-14 season. This analysis was based on data from the newly released 2011 National Hunting and Fishing Survey, the most recent year for which data are available (see discussion in Regulatory Flexibility Act section, below). This analysis estimated consumer surplus for three alternatives for duck hunting (estimates for other species are not quantified due to lack of data). The alternatives were: (1) Issue restrictive regulations allowing fewer days than those issued during the 2012-13 season, (2) issue moderate regulations allowing more days than those in alternative 1, and (3) issue liberal regulations identical to the regulations in the 2012-13 season. For the 2013-14 season, we chose Alternative 3, with an estimated consumer surplus across all flyways of $317.8-$416.8 million. For the 2015-16 season, we have also chosen alternative 3. We also chose alternative 3 for the 2009-10, the 2010-11, the 2011-12, the 2012-13, and the 2014-15 seasons. The 2013-14 analysis is part of the record for this rule and is available at
The annual migratory bird hunting regulations have a significant economic impact on substantial numbers of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. For the reasons outlined above, this rule will have an annual effect on the economy of $100 million or more. However, because this rule establishes hunting seasons, we are not deferring the effective date under the exemption contained in 5 U.S.C. 808(1).
This final rule does not contain any new information collection requirements that require approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• 1018-0019—North American Woodcock Singing Ground Survey (expires 5/31/2018).
• 1018-0023—Migratory Bird Surveys (expires 6/30/2017). Includes Migratory Bird Harvest Information Program, Migratory Bird Hunter Surveys, Sandhill Crane Survey, and Parts Collection Survey.
We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Department, in promulgating this rule, has determined that this rule will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.
In accordance with Executive Order 12630, this rule, authorized by the Migratory Bird Treaty Act (16 U.S.C. 703-711), does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this rule allows hunters to exercise otherwise unavailable privileges and, therefore, reduces restrictions on the use of private and public property.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. While this rule is a significant regulatory action under Executive Order 12866, it is not expected to adversely affect energy supplies, distribution, or use. Therefore, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally recognized Indian tribes and have determined that there are no effects on Indian trust resources. However, in the April 13, 2015,
Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the Migratory Bird Treaty Act. We annually prescribe frameworks from which the States make selections regarding the hunting of migratory birds, and we employ guidelines to establish special regulations on Federal Indian reservations and ceded lands. This process preserves the ability of the States and tribes to determine which seasons meet their individual needs. Any State or Indian tribe may be more restrictive than the Federal frameworks at any time. The frameworks are developed in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of frameworks from which they will make selections, thereby having an influence on their own regulations. These rules do not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. Therefore, in accordance with Executive Order 13132, these regulations do not have significant federalism effects and do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
The rulemaking process for migratory game bird hunting must, by its nature, operate under severe time constraints. However, we intend that the public be given the greatest possible opportunity to comment. Thus, when the preliminary proposed rulemaking was published, we established what we believed were the longest periods possible for public comment. In doing this, we recognized that when the comment period closed, time would be of the essence. That is, if there were a delay in the effective date of these regulations after this final rulemaking, Tribes would have insufficient time to publicize the necessary regulations and procedures to their hunters. We therefore find that “good cause” exists, within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, and this rule will, therefore, take effect less than 30 days after the date of publication.
Accordingly, with each participating Tribe having had an opportunity to participate in selecting the hunting seasons desired for its reservation or ceded territory on those species of migratory birds for which open seasons are now prescribed, and consideration having been given to all other relevant matters presented, certain sections of title 50, chapter I, subchapter B, part 20, subpart K, are hereby amended as set forth below.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
Accordingly, part 20, subchapter B, chapter I of title 50 of the Code of Federal Regulations is amended as follows:
Migratory Bird Treaty Act, 40 Stat. 755, 16 U.S.C. 703-712; Fish and Wildlife Act of 1956, 16 U.S.C. 742a-j; Public Law 106-108, 113 Stat. 1491, Note Following 16 U.S.C. 703.
(
(a)
Season Dates: Open September 1 through 15, 2015; then open November 7 through December 20, 2015.
Daily Bag and Possession Limits: For the early season, daily bag limit is 10 mourning or white-winged doves, singly, or in the aggregate. For the late season, the daily bag limit is 15 mourning doves. Possession limits are twice the daily bag limits after the first day of the season.
Season Dates: Open October 17, 2015, through January 25, 2016.
Daily Bag and Possession Limits: Seven ducks, including two hen mallards, two redheads, two Mexican ducks, two goldeneye, two cinnamon teal, three scaup, one canvasback, and
Season Dates: Same as ducks.
Daily Bag and Possession Limits: 25 coots and common moorhens, singly or in the aggregate. The possession limit is twice the daily bag limit.
Season Dates: Open October 18, 2015, through January 19, 2016.
Daily Bag and Possession Limits: Three dark (Canada and white-fronted) geese and three white (snow, blue, Ross's) geese. The possession limit is six dark geese and six white geese.
General Conditions: All persons 14 years and older must be in possession of a valid Colorado River Indian Reservation hunting permit before taking any wildlife on tribal lands. Any person transporting game birds off the Colorado River Indian Reservation must have a valid transport declaration form. Other tribal regulations apply, and may be obtained at the Fish and Game Office in Parker, Arizona. The early season will be open from one-half hour before sunrise until noon. For the late season, shooting hours are from one-half hour before sunrise to sunset.
(b)
Season Dates: Open September 2, 2015, through March 9, 2016.
Daily Bag and Possession Limits: The Tribe does not have specific bag and possession restrictions for Tribal members. The season on harlequin duck is closed.
Season Dates: Same as ducks.
Daily Bag and Possession Limits: Same as ducks.
Season Dates: Same as ducks.
Daily Bag and Possession Limits: Same as ducks.
Season Dates: Open September 26, 2015, through January 10, 2016.
Season Dates: September 26, 2015, through December 20, 2015.
Daily Bag and Possession Limits: Seven ducks, including no more than two hen mallards, two pintail, three scaup (when open), two canvasback, and two redheads. The possession limit is three times the daily bag limit.
Season Dates: Same as ducks.
Daily Bag and Possession Limits: 25 and 75, respectively.
Season Dates: Open September 26, 2015, through January 10, 2016.
Daily Bag and Possession Limits: 4 and 12 geese, respectively.
Season Dates: Open September 26, 2015, through January 10, 2016.
Daily Bag and Possession Limits: 20 and 60 geese, respectively.
General Conditions: Tribal and nontribal hunters must comply with all basic Federal migratory bird hunting regulations contained in 50 CFR part 20 regarding manner of taking. In addition, shooting hours are one-half hour before sunrise to one-half hour after sunset, and each waterfowl hunter 16 years of age or older must carry on his/her person a valid Migratory Bird Hunting and Conservation Stamp (Duck Stamp) signed in ink across the stamp face. Special regulations established by the Confederated Salish and Kootenai Tribes also apply on the reservation.
(f)
Season Dates: Open October 10 through November 30, 2015.
Daily Bag and Possession Limits: The daily bag limit is seven, including no more than two hen mallards, two pintail, two redheads, two canvasback, and three scaup. The possession limit is three times the daily bag limit.
Season Dates: Open October 10 through November 30, 2015.
Daily Bag and Possession Limits: Two and six, respectively.
General Conditions: Tribal and nontribal hunters must comply with all basic Federal migratory bird hunting regulations in 50 CFR part 20 regarding shooting hours and manner of taking. In addition, each waterfowl hunter 16 years of age or older must carry on his/her person a valid Migratory Bird Hunting and Conservation Stamp (Duck Stamp) signed in ink across the stamp face. Special regulations established by the Jicarilla Tribe also apply on the reservation.
(l)
Season Dates: Open September 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: Six ducks, including no more five mallards (only two of which may be hens), three scaup, one mottled duck, two redheads, three wood ducks, two canvasback, and two pintail. Coot daily bag limit is 15. Merganser daily bag limit is five, including no more than two hooded mergansers. The possession limit is three times the daily bag limit.
Season Dates: Open September 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: 6 and 18, respectively.
Season Dates: Open September 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: Two and six, respectively.
Season Dates: Open September 1, 2015, through March 10, 2016.
Daily Bag Limit: 20.
Season Dates: Open October 10, 2015, through January 14, 2016.
Daily Bag and Possession Limits: Six ducks, including five mallards (no more of which can be two hen mallard), three scaup, two canvasback, two redheads, three wood ducks, one mottled duck, and two pintail. Coot daily bag limit is 15. Merganser daily bag limit is five, including no more than two hooded mergansers. The possession limit is three times the daily bag limit.
Season Dates: Open October 31, 2015, through February 14, 2016.
Daily Bag and Possession Limits: 6 and 18, respectively.
Season Dates: Open October 31, 2015, through January 26, 2016.
Daily Bag and Possession Limits: Two and six, respectively.
Season Dates: Open October 31, 2015, through February 14, 2016.
Daily Bag and Possession Limits: 50 and no possession limit.
General Conditions: All hunters must comply with the basic Federal migratory bird hunting regulations in 50 CFR part 20, including the use of steel shot and shooting hours. Nontribal hunters must possess a validated Migratory Bird Hunting and Conservation Stamp. The Lower Brule Sioux Tribe has an official Conservation Code that hunters must adhere to when hunting in areas subject to control by the Tribe.
(o)
Season Dates: Open September 1 through 30, 2015.
Daily Bag and Possession Limits: 5 and 10 pigeons, respectively.
Season Dates: Open September 1 through 30, 2015.
Daily Bag and Possession Limits: 10 and 20 doves, respectively.
Season Dates: Open September 27, 2015, through January 10, 2016.
Season Dates: Open September 27 through December 20, 2015.
Daily Bag and Possession Limits: Seven ducks, including no more than two hen mallards, one mottled duck, two canvasback, three scaup (when open), two redheads, and two pintail. Coot daily bag limit is 25. Merganser daily bag limit is seven. The possession limit is three times the daily bag limit.
Season Dates: Open September 27, 2015, through January 10, 2016.
Daily Bag and Possession Limits: 4 and 12, respectively.
General Conditions: Tribal and nontribal hunters will comply with all basic Federal migratory bird hunting regulations in 50 CFR part 20, regarding shooting hours and manner of taking. In addition, each waterfowl hunter 16 years of age or over must carry on his/her person a valid Migratory Bird Hunting and Conservation Stamp (Duck Stamp) signed in ink across the face. Special regulations established by the Navajo Nation also apply on the reservation.
(t)
Duck Season Dates: Open October 3, 2015, through January 19, 2016.
Scaup Season Dates: Open October 3, 2015, through December 27, 2015.
Daily Bag and Possession Limits: Seven ducks and mergansers, including no more than two hen mallards, two pintail, three scaup, two canvasback, and two redheads. The possession limit is three times the daily bag limit.
Season Dates: Same as ducks.
Daily Bag and Possession Limits: 25 coots. The possession limit is three times the daily bag limit.
Season Dates: Same as ducks.
Daily Bag and Possession Limits: 8 and 24 snipe, respectively.
Season Dates: Open October 3, 2015, through January 19, 2016.
Daily Bag and Possession Limits: 4 and 12, respectively.
Season Dates: Open October 3, 2015, through January 19, 2016.
Daily Bag and Possession Limits: 10 and 30, respectively.
Season Dates: Open October 3, 2015, through January 19, 2016.
Daily Bag and Possession Limits: 20 and 60, respectively
General Conditions: Nontribal hunters must comply with all basic Federal migratory bird hunting regulations in 50 CFR part 20 regarding shooting hours and manner of taking. In addition, each waterfowl hunter 16 years of age or older must possess a valid Migratory Bird Hunting and Conservation Stamp (Duck Stamp) signed in ink across the stamp face. Other regulations established by the Shoshone-Bannock Tribes also apply on the reservation.
(x)
Season Dates: Open October 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: 10 and 30, respectively.
Season Dates: Open October 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: 10 ducks. The possession limit is three times the daily bag limit.
Season Dates: Open October 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: 25 coots. The possession limit is three times the daily bag limit.
Season Dates: Open October 1, 2015, through March 10, 2016.
Daily Bag and Possession Limits: 6 and 18, respectively. The season on brant is closed.
Tribal members hunting on lands will observe all basic Federal migratory bird hunting regulations found in 50 CFR part 20, which will be enforced by the Stillaguamish Tribal Law Enforcement. Tribal members are required to use steel shot or a nontoxic shot as required by Federal regulations.
(y)
Season Dates: Open September 26, 2015, through March 1, 2016.
Daily Bag and Possession Limits: Fourteen ducks and mergansers, including no more than four hen mallards, four pintail, six scaup, four canvasback, one harlequin per season, and four redheads. Possession limit is three times the daily bag limit (except for harlequin).
Season Dates: Open September 26, 2015, through March 1, 2016.
Daily Bag and Possession Limits: 8 and 24 geese, respectively.
Season Dates: Open September 26, 2015, through February 23, 2016.
Daily Bag and Possession Limits: 4 and 12 brant, respectively.
Season Dates: Open September 21, 2015, through February 26, 2016.
Daily Bag and Possession Limits: 50 and 150 coots, respectively.
Season Dates: Open September 26, 2015, through March 9, 2016.
Daily Bag and Possession Limits: Fourteen ducks and mergansers, including no more than four hen mallards, four pintail, six scaup, four canvasback, one harlequin per season,
Season Dates: Open September 26, 2015, through March 9, 2016.
Daily Bag and Possession Limits: Eight geese. Possession limit is three times the daily bag limit.
Season Dates: Open September 26, 2015, through March 9, 2016.
Daily Bag and Possession Limits: 4 and 12 brant, respectively.
Season Dates: Open September 26, 2015, through March 9, 2016.
Daily Bag and Possession Limits: 50 and 150 coots, respectively.
(aa)
Season Dates: Open September 1 through December 31, 2015.
Daily Bag and Possession Limits: 12 and 15 mourning doves, respectively.
Season Dates: Open October 1, 2015, through February 28, 2016.
Daily Bag and Possession Limits: 15 and 20, respectively.
Season Dates: Open October 1, 2015, through February 15, 2016.
Daily Bag and Possession Limits: 20 and 30, respectively.
Season Dates: Open October 1, 2015, through February 28, 2016.
Daily Bag and Possession Limits: 7 and 10 geese, respectively.
Season Dates: Open November 1 through 10, 2015.
Daily Bag and Possession Limits: Two and two, respectively.
General Conditions: Tribal members must have the tribal identification and harvest report card on their person to hunt. Tribal members hunting on the Reservation will observe all basic Federal migratory bird hunting regulations found in 50 CFR part 20, except shooting hours would be 15 minutes before official sunrise to 15 minutes after official sunset.
(dd)
Season Dates: Open September 1 through 15, 2015.
Daily Bag and Possession Limits: Three and six pigeons, respectively.
Season Dates: Open September 1 through 15, 2015.
Daily Bag and Possession Limits: 10 and 20 doves, respectively.
Season Dates: Open October 17, 2015, through January 24, 2016.
Daily Bag Limits: Seven, including no more than two female mallards and two redhead. The season on scaup is closed.
Possession Limits: Twice the daily bag limit.
Season Dates: Open October 17 through November 29, 2015.
Daily Bag Limits: Two pintail and one canvasback.
Possession Limits: Twice the daily bag limit.
Season Dates: Open October 17, 2015, through January 24, 2016.
Daily Bag and Possession Limits: 25 and 50, respectively.
Season Dates: Open October 18, 2015, through January 24, 2016.
Daily Bag and Possession Limits: Three and six Canada geese, respectively.
General Conditions: All nontribal hunters hunting band-tailed pigeons and mourning doves on Reservation lands shall have in their possession a valid White Mountain Apache Daily or Yearly Small Game Permit. In addition to a small game permit, all nontribal hunters hunting band-tailed pigeons must have in their possession a White Mountain Special Band-tailed Pigeon Permit. Other special regulations established by the White Mountain Apache Tribe apply on the reservation. Tribal and nontribal hunters will comply with all basic Federal migratory bird hunting regulations in 50 CFR part 20 regarding shooting hours and manner of taking.
Fish and Wildlife Service, Interior.
Final rule.
This rule prescribes the hunting seasons, hours, areas, and daily bag and possession limits for general waterfowl seasons and those early seasons for which States previously deferred selection. Taking of migratory birds is prohibited unless specifically provided for by annual regulations. This rule permits the taking of designated species during the 2015-16 season.
This rule is effective on September 26, 2015.
You may inspect comments received on the migratory bird hunting regulations during normal business hours at the Service's office at 5275 Leesburg Pike, Falls Church, Virginia. You may obtain copies of referenced reports from the street address above, or from the Division of Migratory Bird Management's Web site at
Ron W. Kokel, Division of Migratory Bird Management, U.S. Fish and Wildlife Service, (703) 358-1714.
On April 13, 2015, we published in the
On June 11, 2015, we published in the
On June 24-25, 2015, we held open meetings with the Flyway Council Consultants, at which the participants reviewed information on the current status of migratory shore and upland game birds and developed recommendations for the 2015-16 regulations for these species plus regulations for migratory game birds in Alaska, Puerto Rico, and the Virgin Islands; special September waterfowl seasons in designated States; special sea duck seasons in the Atlantic Flyway; and extended falconry seasons. In addition, we reviewed and discussed preliminary information on the status of waterfowl as it relates to the development and selection of the regulatory packages for the 2015-16 regular waterfowl seasons. On July 21, 2015, we published in the
On July 29-30, 2015, we held open meetings with the Flyway Council Consultants, at which the participants reviewed the status of waterfowl and developed recommendations for the 2015-16 regulations for these species.
On August 21, 2015, we published in the
On August 25, 2015, we published in the
The final rule described here is the final in the series of proposed, supplemental, and final rulemaking documents for migratory game bird hunting regulations for 2015-16 and deals specifically with amending subpart K of 50 CFR part 20. It sets hunting seasons, hours, areas, and limits for species subject to late-season regulations and those for early seasons that States previously deferred.
This final rule is the culmination of the rulemaking process for the migratory game bird hunting seasons, which started with the April 13 proposed rule. As discussed elsewhere in this document, we supplemented that proposal on June 11 and August 25, and published final late season frameworks in a late September
The programmatic document, “Second Final Supplemental Environmental Impact Statement: Issuance of Annual Regulations Permitting the Sport Hunting of Migratory Birds (EIS 20130139),” filed with the Environmental Protection Agency (EPA) on May 24, 2013, addresses NEPA compliance by the Service for issuance of the annual framework regulations for hunting of migratory game bird species. We published a notice of availability in the
Section 7 of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
Executive Order 12866 provides that the Office of Information and Regulatory Affairs (OIRA) will review all significant rules. OIRA has reviewed this rule and has determined that this rule is significant because it would have an annual effect of $100 million or more on the economy. Executive Order 13563 reaffirms the principles of E.O. 12866 while calling for improvements in the nation's regulatory system to promote predictability, to reduce uncertainty, and to use the best, most innovative, and least burdensome tools for achieving regulatory ends. The executive order directs agencies to consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public where these approaches are relevant, feasible, and consistent with regulatory objectives. E.O. 13563 emphasizes further that regulations must be based on the best available science and that the rulemaking process must allow for public participation and an open exchange of ideas. We have developed this rule in a manner consistent with these requirements.
An updated economic analysis was prepared for the 2013-14 season. This analysis was based on data from the newly released 2011 National Hunting and Fishing Survey, the most recent year for which data are available (see discussion in Regulatory Flexibility Act section below). This analysis estimated consumer surplus for three alternatives for duck hunting (estimates for other species are not quantified due to lack of data). The alternatives were: (1) Issue restrictive regulations allowing fewer days than those issued during the 2012-13 season, (2) issue moderate regulations allowing more days than those in alternative 1, and (3) issue liberal regulations identical to the regulations in the 2012-13 season. For the 2013-14 season, we chose Alternative 3, with an estimated consumer surplus across all flyways of $317.8-$416.8 million. For the 2015-16 season, we have also chosen alternative 3. We also chose alternative 3 for the 2009-10, the 2010-11, the 2011-12, the 2012-13, and the 2014-15 seasons. The 2013-14 analysis is part of the record for this rule and is available at
The annual migratory bird hunting regulations have a significant economic impact on substantial numbers of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
This rule is a major rule under 5 U.S.C. 804(2), the Small Business Regulatory Enforcement Fairness Act. For the reasons outlined above, this rule will have an annual effect on the economy of $100 million or more. However, because this rule establishes hunting seasons, we are not deferring the effective date under the exemption contained in 5 U.S.C. 808(1).
This final rule does not contain any new information collection that requires approval under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
• 1018-0019—North American Woodcock Singing Ground Survey (expires 5/31/2018).
• 1018-0023—Migratory Bird Surveys (expires 6/30/2017). Includes Migratory Bird Harvest Information Program, Migratory Bird Hunter Surveys, Sandhill Crane Survey, and Parts Collection Survey.
We have determined and certify, in compliance with the requirements of the Unfunded Mandates Reform Act, 2 U.S.C. 1502
The Department, in promulgating this rule, has determined that this rule will not unduly burden the judicial system and that it meets the requirements of sections 3(a) and 3(b)(2) of Executive Order 12988.
In accordance with Executive Order 12630, this rule, authorized by the Migratory Bird Treaty Act (16 U.S.C. 703-711), does not have significant takings implications and does not affect any constitutionally protected property rights. This rule will not result in the physical occupancy of property, the physical invasion of property, or the regulatory taking of any property. In fact, this rule allows hunters to exercise otherwise unavailable privileges and, therefore, reduces restrictions on the use of private and public property.
Executive Order 13211 requires agencies to prepare Statements of Energy Effects when undertaking certain actions. While this rule is a significant regulatory action under Executive Order 12866, it is not expected to adversely affect energy supplies, distribution, or use. Thus, this action is not a significant energy action and no Statement of Energy Effects is required.
In accordance with the President's memorandum of April 29, 1994, “Government-to-Government Relations with Native American Tribal Governments” (59 FR 22951), Executive Order 13175, and 512 DM 2, we have evaluated possible effects on Federally-recognized Indian tribes and have determined that there are no effects on Indian trust resources. However, in the April 13
Due to the migratory nature of certain species of birds, the Federal Government has been given responsibility over these species by the Migratory Bird Treaty Act. We annually prescribe frameworks from which the States make selections regarding the hunting of migratory birds, and we employ guidelines to establish special regulations on Federal Indian reservations and ceded lands. This process preserves the ability of the States and tribes to determine which seasons meet their individual needs. Any State or Indian tribe may be more restrictive than the Federal frameworks at any time. The frameworks are developed in a cooperative process with the States and the Flyway Councils. This process allows States to participate in the development of frameworks from which they will make selections, thereby having an influence on their own regulations. These rules do not have a substantial direct effect on fiscal capacity, change the roles or responsibilities of Federal or State governments, or intrude on State policy or administration. Therefore, in accordance with Executive Order 13132, these regulations do not have significant federalism effects and do not have sufficient federalism implications to warrant the preparation of a federalism summary impact statement.
The preliminary proposed rulemaking (April 13
The rulemaking process for migratory game bird hunting must, by its nature, operate under severe time constraints. However, we intend that the public be given the greatest possible opportunity to comment. Thus, when the preliminary proposed rulemaking was published, we established what we believed were the longest periods possible for public comment. In doing this, we recognized that, when the comment period closed, time would be of the essence. That is, if there were a delay in the effective date of these regulations after this final rulemaking, States would have insufficient time to select season dates and limits; to communicate those selections to us; and to establish and publicize the necessary regulations and procedures to implement their decisions. We find that “good cause” exists, within the terms of 5 U.S.C. 553(d)(3) of the Administrative Procedure Act, and therefore, under authority of the Migratory Bird Treaty Act (July 3, 1918), as amended (16 U.S.C. 703-711), these regulations will take effect less than 30 days after publication. Accordingly, with each conservation agency having had an opportunity to participate in selecting the hunting seasons desired for its State or Territory on those species of migratory birds for which open seasons are now prescribed, and consideration having been given to all other relevant matters presented, certain sections of title 50, chapter I, subchapter B, part 20, subpart K, are hereby amended as set forth below.
Exports, Hunting, Imports, Reporting and recordkeeping requirements, Transportation, Wildlife.
For the reasons set out in the preamble, title 50, chapter I, subchapter B, part 20, subpart K of the Code of Federal Regulations is amended as follows:
Migratory Bird Treaty Act, 40 Stat. 755, 16 U.S.C. 703-712; Fish and Wildlife Act of 1956, 16 U.S.C. 742a-j; Public Law 106-108, 113 Stat. 1491, Note Following 16 U.S.C. 703.
The following annual regulations provided for by §§ 20.104, 20.105, 20.106, 20.107, and 20.109 of 50 CFR part 20 will not appear in the Code of Federal Regulations because of their seasonal nature.
The revisions and additions read as follows:
Subject to the applicable provisions of the preceding sections of this part, areas open to hunting, respective open seasons (dates inclusive), shooting and hawking hours, and daily bag and possession limits for the species designated in this section are prescribed as follows:
Shooting and hawking hours are one-half hour before sunrise until sunset, except as otherwise restricted by State regulations. Area descriptions were published in the August 21, 2015 (80 FR 51090) and August 25, 2015 (80 FR 51658),
The following seasons are in addition to the seasons published previously in the September 1, 2015,
The revisions and additions read as follows:
Subject to the applicable provisions of the preceding sections of this part, areas open to hunting, respective open seasons (dates inclusive), shooting and hawking hours, and daily bag and possession limits for the species designated in this section are prescribed as follows:
Shooting and hawking hours are one-half hour before sunrise until sunset, except as otherwise restricted by State regulations.
Area descriptions were published in the August 21, 2015 (80 FR 51090) and August 25, 2015 (80 FR 51658),
(a)
The following seasons are in addition to the seasons published previously in the September 1, 2015,
(2) In
(b)
The following seasons are in addition to the seasons published previously in the September 1, 2015,
Within the special sea duck areas, the daily bag limit is 7 scoter, eider, and long-tailed ducks of which no more than
Notwithstanding the provisions of this Part 20, the shooting of crippled waterfowl from a motorboat under power will be permitted in
(4) In
(5) In
(e)
Merganser Limits: The daily bag limit is 5 mergansers and may include no more than 2 hooded mergansers. In States that include mergansers in the duck bag limit, the daily limit is the same as the duck bag limit, of which only 2 may be hooded mergansers. The possession limit is three times the daily bag limit.
Duck and Merganser Limits: The daily bag limit of 7 ducks (including mergansers) may include no more than 2 female mallards, 2 pintails, 2 redheads, 3 scaup, and 2 canvasbacks. The possession limit is three times the daily bag limit.
Coot and Common Moorhen Limits: Daily bag and possession limits are in the aggregate for the two species.
(f)
The following seasons are open only to youth hunters. Youth hunters must be accompanied into the field by an adult at least 18 years of age. This adult cannot duck hunt but may participate in other open seasons.
The following seasons are in addition to the seasons published previously in the September 1, 2015,
The revisions and additions read as follows:
Subject to the applicable provisions of the preceding sections of this part, areas open to hunting, respective open seasons (dates inclusive), shooting and hawking hours, and daily bag and possession limits on the species designated in this section are as follows:
Shooting and hawking hours are one-half hour before sunrise until sunset, except as otherwise restricted by State regulations. Area descriptions were published in the August 28, 2014,
Federally authorized, State-issued permits are issued to individuals, and only the individual whose name and address appears on the permit at the time of issuance is authorized to take sandhill cranes at the level allowed by the permit, in accordance with provisions of both Federal and State regulations governing the hunting season. The permit must be carried by the permittee when exercising its provisions and must be presented to any law enforcement officer upon request. The permit is not transferable or assignable to another individual, and may not be sold, bartered, traded, or otherwise provided to another person. If the permit is altered or defaced in any way, the permit becomes invalid.
CHECK STATE REGULATIONS FOR ADDITIONAL RESTRICTIONS AND DELINEATIONS OF GEOGRAPHICAL AREAS. SPECIAL RESTRICTIONS MAY APPLY ON FEDERAL AND STATE PUBLIC HUNTING AREAS AND FEDERAL INDIAN RESERVATIONS.
The following seasons are in addition to the seasons published previously in the September 1, 2015,
Subject to the applicable provisions of the preceding sections of this part, areas open to hunting, respective open seasons (dates inclusive), shooting and hawking hours, and daily bag and possession limits on the species designated in this section are as follows:
Shooting hours are one-half hour before sunrise until sunset, except as otherwise restricted by State regulations. Hunting is by State permit only.
Federally authorized, State-issued permits are issued to individuals, and only the individual whose name and address appears on the permit at the time of issuance is authorized to take swans at the level allowed by the permit, in accordance with provisions of both Federal and State regulations governing the hunting season. The permit must be carried by the permittee when exercising its provisions and must be presented to any law enforcement officer upon request. The permit is not transferable or assignable to another individual, and may not be sold, bartered, traded, or otherwise provided to another person. If the permit is altered or defaced in any way, the permit becomes invalid.
CHECK STATE REGULATIONS FOR ADDITIONAL RESTRICTIONS AND DELINEATIONS OF GEOGRAPHICAL AREAS. SPECIAL RESTRICTIONS MAY APPLY ON FEDERAL AND STATE PUBLIC HUNTING AREAS AND FEDERAL INDIAN RESERVATIONS.
Successful permittees must immediately validate their harvest by that method required in State regulations.
The revisions and additions read as follows:
Subject to the applicable provisions of the preceding sections of this part, areas open to hunting, respective open seasons (dates inclusive), hawking hours, and daily bag and possession limits for the species designated in this section are prescribed as follows:
Hawking hours are one-half hour before sunrise until sunset except as otherwise restricted by State regulations.
Area descriptions were published in the August 21, 2015 (80 FR 51090) and August 25, 2015 (80 FR 51658)
CHECK STATE REGULATIONS FOR ADDITIONAL RESTRICTIONS AND DELINEATIONS OF GEOGRAPHICAL AREAS. SPECIAL RESTRICTIONS MAY APPLY ON FEDERAL AND STATE PUBLIC HUNTING AREAS AND FEDERAL INDIAN RESERVATIONS.
Limits: The daily bag limit may include no more than 3 migratory game birds, singly or in the aggregate. The possession limit is three times the daily bag limit. These limits apply to falconry during both regular hunting seasons and extended falconry seasons, unless further restricted by State regulations. The falconry bag and possession limits are not in addition to regular season limits. Unless otherwise specified, extended falconry for ducks does not include sea ducks within the special sea duck areas.
Although many States permit falconry during the gun seasons, only extended falconry seasons are shown below. Please consult State regulations for details.
The following seasons are in addition to the seasons published previously in the September 1, 2015,
| 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 |