| Page Range | 57743-58380 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 57743 - National Employer Support of the Guard and Reserve Week, 2016 | |
| 81 FR 57801 - Safety Zone; Nahant Bay, Marblehead, MA | |
| 81 FR 57995 - Southeastern Land, LLC-Acquisition and Operation Exemption-Vaughan Railroad Company | |
| 81 FR 57910 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
| 81 FR 57994 - Culturally Significant Objects Imported for Exhibition Determinations: “Yves Saint Laurent: The Perfection of Style” Exhibition | |
| 81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Fragonard: Drawing Triumphant-Works from New York Collections” Exhibition | |
| 81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Beckmann in New York” Exhibition | |
| 81 FR 57994 - Culturally Significant Objects Imported for Exhibition Determinations: “Drawings for Paintings in the Age of Rembrandt” Exhibition | |
| 81 FR 57993 - Culturally Significant Objects Imported for Exhibition Determinations: “Degas: A New Vision” Exhibition | |
| 81 FR 57887 - Regulations and Procedures Technical Advisory Committee; Notice of Meeting | |
| 81 FR 57888 - Materials Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 57854 - Protective Regulations for Hawaiian Spinner Dolphins Under the Marine Mammal Protection Act | |
| 81 FR 57907 - Issuance of National Pollutant Discharge Elimination System (NPDES) General Permit (GP) for Idaho Drinking Water Treatment Facilities | |
| 81 FR 57914 - Submission for OMB Review; Nondiscrimination in Federal Financial Assistance Programs, GSA Form 3702 | |
| 81 FR 57806 - Fisheries of the Exclusive Economic Zone Off Alaska; Atka Mackerel in the Bering Sea and Aleutian Islands Management Area | |
| 81 FR 57911 - Information Collection; Alliant2 Greenhouse Gas Disclosure | |
| 81 FR 57846 - Significant New Use Rule on Certain Chemical Substances | |
| 81 FR 57807 - Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Ocean Perch in the Bering Sea and Aleutian Islands Management Area | |
| 81 FR 57891 - Defense Advisory Committee on Women in the Services; Notice of Federal Advisory Committee Meeting | |
| 81 FR 57902 - Public Meeting; Data That Support the Registration of Plant-Incorporated Protectants (PIPs) | |
| 81 FR 57903 - Certain New Chemicals; Receipt and Status Information for July 2016 | |
| 81 FR 57761 - IFR Altitudes; Miscellaneous Amendments | |
| 81 FR 57998 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel NISSI; Invitation for Public Comments | |
| 81 FR 57890 - Agency Information Collection Activities Under OMB Review | |
| 81 FR 57901 - Combined Notice of Filings | |
| 81 FR 57896 - Combined Notice of Filings | |
| 81 FR 57897 - Combined Notice of Filings | |
| 81 FR 57901 - Pacific Gas & Electric Company; Notice of Intent To File License Application, Filing of Pre-Application Document, Approving Use of the Traditional Licensing Process | |
| 81 FR 57896 - Boyce Hydro Power, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 57899 - Duke Energy Carolinas, LLC; Notice of Application Accepted for Filing and Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 57902 - EnLink Crude Pipeline, LLC; Notice of Petition for Declaratory Order | |
| 81 FR 57896 - Combined Notice of Filings #1 | |
| 81 FR 57898 - Notice of Commission Staff Attendance | |
| 81 FR 57900 - Huskilson, Christopher G.; Blunden, Gregory W.; Notice of Filing | |
| 81 FR 57899 - California Independent System, Operator Corporation; Supplemental Notice of Agenda and Discussion Topics for Staff Technical Conference | |
| 81 FR 57900 - National Fuel Gas Supply Corporation; Notice of Request Under Blanket Authorization | |
| 81 FR 57898 - Combined Notice of Filings #1 | |
| 81 FR 57936 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act | |
| 81 FR 57810 - Special Conditions: Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 Airplanes, Lithium Batteries | |
| 81 FR 57942 - Pacific Gas and Electric Company; Diablo Canyon Power Plant, Units 1 and 2; Annual Updates to License Renewal Application | |
| 81 FR 57995 - BNSF Railway Company-Discontinuance of Trackage Rights Exemption-in Big Stone, Swift, Chippewa, Yellow Medicine, and Renville Counties, Minn. | |
| 81 FR 57942 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on T-H Phenomena; Notice of Meeting | |
| 81 FR 57945 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Planning and Procedures; Notice of Meeting | |
| 81 FR 57893 - Reopening the Fiscal Year 2016 Competition for Certain Eligible Applicants; Investing in Innovation Fund-Development Grants Full Application | |
| 81 FR 57887 - Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed Meeting | |
| 81 FR 57941 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Reliability and PRA; Notice of Meeting | |
| 81 FR 57801 - Drawbridge Operation Regulation; Upper Mississippi River, Rock Island, IL | |
| 81 FR 57807 - Fisheries of the Economic Exclusive Zone Off Alaska; Deep-Water Species Fishery by Vessels Using Trawl Gear in the Gulf of Alaska | |
| 81 FR 57893 - Agency Information Collection Activities; Comment Request; 2012/17 Beginning Postsecondary Students Longitudinal Study: (BPS:12/17) | |
| 81 FR 57937 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Claim for Compensation by a Dependent Information Reports | |
| 81 FR 57944 - Advisory Committee on Reactor Safeguards (ACRS) Meeting of the ACRS Subcommittee on Digital I&C Systems; Notice of Meeting | |
| 81 FR 57945 - Advisory Committee on Reactor Safeguards (ACRS); Meeting of the ACRS Subcommittee on Metallurgy & Reactor Fuels; Notice of Meeting | |
| 81 FR 57915 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 81 FR 57985 - Proposed Collection; Comment Request | |
| 81 FR 57946 - Submission for OMB Review; Comment Request | |
| 81 FR 57963 - Proposed Collection; Comment Request | |
| 81 FR 57937 - Meeting of the Federal Advisory Committee on Juvenile Justice | |
| 81 FR 57877 - United States Standards for Grades of Carcass Beef | |
| 81 FR 57889 - Proposed Information Collection; Comment Request; Green Sturgeon ESA 4(d) Rule Take Exceptions and Exemptions | |
| 81 FR 57888 - Takes of Marine Mammals Incidental to Specified Activities; Taking Marine Mammals Incidental to BlueCrest Alaska Operating LLC Drilling Activities at Cosmopolitan State Unit, Alaska, 2016 | |
| 81 FR 58001 - BMW of North America, LLC, Denial of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 57895 - Agency Information Collection Activities; Comment Request; EDFacts Data Collection School Years 2016-17, 2017-18, and 2018-19 | |
| 81 FR 58003 - Request for Applications; Tribal Issues Advisory Group | |
| 81 FR 57881 - Yavapai Resource Advisory Committee | |
| 81 FR 58004 - Final Priorities for Amendment Cycle | |
| 81 FR 57908 - Agency Information Collection Activities: Information Collection Revision; Comment Request (3064-0200) | |
| 81 FR 57880 - Assessment of Fees for Dairy Import Licenses for the 2017 Tariff-Rate Import Quota Year | |
| 81 FR 57940 - Notice of Intent to Prepare a Comprehensive Environmental Evaluation Under the Antarctic Conservation Act of 1978, as amended | |
| 81 FR 57932 - Bulk Manufacturer of Controlled Substances Application: Chattem Chemicals | |
| 81 FR 58002 - Proposed Renewal Without Change; Comment Request; Imposition of Special Measure Against Commercial Bank of Syria, Including Its Subsidiary Syrian Lebanese Commercial Bank, as a Financial Institution of Primary Money Laundering Concern | |
| 81 FR 57927 - Agency Information Collection Activities: Proposed Collection; Comment Request | |
| 81 FR 57932 - Importer of Controlled Substances Application: Noramco, Inc. | |
| 81 FR 57933 - Importer of Controlled Substances Application: Cerilliant Corporation | |
| 81 FR 57935 - Importer of Controlled Substances Application: Akorn, Inc. | |
| 81 FR 57936 - Bulk Manufacturer of Controlled Substances Application: Noramco, Inc. | |
| 81 FR 57997 - Buy America Waiver Notification | |
| 81 FR 57996 - Emergency Route Working Group (ERWG)-Federal Advisory Committee | |
| 81 FR 57800 - Drawbridge Operation Regulation; Trent River, New Bern, NC | |
| 81 FR 57891 - Notice of Intent To Prepare a Supplemental Environmental Impact Statement (EIS) to the Land Acquisition and Airspace Establishment Final EIS at the Marine Corps Air Ground Combat Center, Twentynine Palms, California | |
| 81 FR 57996 - Buy America Waiver Notification | |
| 81 FR 57930 - Notice of Public Meeting, Idaho Falls District Resource Advisory Council Meeting | |
| 81 FR 57879 - Statements That Bioengineered or Genetically Modified (GM) Ingredients or Animal Feed Were Not Used in the Production of Meat, Poultry, or Egg Products | |
| 81 FR 57999 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel KIA ORA; Invitation for Public Comments | |
| 81 FR 58000 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel OCEANFLYER; Invitation for Public Comments | |
| 81 FR 57998 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel JULIA; Invitation for Public Comments | |
| 81 FR 57999 - Requested Administrative Waiver of the Coastwise Trade Laws: Vessel ANGARI; Invitation for Public Comments | |
| 81 FR 57919 - Patient Preference Information-Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling; Guidance for Industry, Food and Drug Administration Staff and Other Stakeholders; Availability | |
| 81 FR 57908 - Petition of APL Co. PTE Ltd; for An Exemption From Commission Regulations; Notice of Filing and Request for Comments | |
| 81 FR 58005 - Privacy Act of 1974; System of Records | |
| 81 FR 57916 - Agency Information Collection Activities: Submission for OMB Review; Comment Request | |
| 81 FR 57977 - Self-Regulatory Organizations; BOX Options Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend the Fee Schedule on the BOX Market LLC (“BOX”) Options Facility | |
| 81 FR 57948 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Order Approving Rule Change as Modified by Amendment Nos. 1 and 2 To Adopt FINRA Capital Acquisition Broker Rules | |
| 81 FR 57968 - Self-Regulatory Organizations; The Nasdaq Stock Market LLC; Notice of Filing of Proposed Rule Change To Amend Nasdaq Rule 5735 To Adopt Generic Listing Standards for Managed Fund Shares | |
| 81 FR 57986 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Amend NYSE Arca Equities Rules 7.35P, 7.34P, 7.18P and 7.31P Regarding Order Processing Following an Auction or When Transitioning From One Trading Session to Another | |
| 81 FR 57981 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Instituting Proceedings To Determine Whether To Approve or Disapprove Proposed Rule Change, as Modified by Amendment Nos. 1 and 2, To List and Trade Shares of the AdvisorShares KIM Korea Equity ETF | |
| 81 FR 57967 - Self-Regulatory Organizations; Bats BZX Exchange, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the JPMorgan Global Bond Opportunities ETF | |
| 81 FR 57984 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rules 803 and 1308 | |
| 81 FR 57960 - Self-Regulatory Organizations; Municipal Securities Rulemaking Board; Notice of Filing of Amendment No. 1 and Order Granting Accelerated Approval of a Proposed Rule Change, as Modified by Amendment No. 1, Consisting of Proposed Amendments to Rule G-12, on Uniform Practice, Regarding Close-Out Procedures for Municipal Securities | |
| 81 FR 57960 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Designation of a Longer Period for Commission Action on a Proposed Rule Change To List and Trade Shares of the JPMorgan Diversified Event Driven ETF Under NYSE Arca Equities Rule 8.600 | |
| 81 FR 57964 - Self-Regulatory Organizations; Financial Industry Regulatory Authority, Inc.; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change Relating to Use of the Alternative Display Facility for Trade Reporting Purpose Only | |
| 81 FR 57909 - Formations of, Acquisitions by, and Mergers of Savings and Loan Holding Companies | |
| 81 FR 57909 - Change in Bank Control Notices; Acquisitions of Shares of a Bank or Bank Holding Company | |
| 81 FR 57931 - Certain Inflatable Products With Tensioning Structures and Processes for Making the Same; Commission Determination Not To Review an Initial Determination Terminating the Investigation Based on a Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the Investigation | |
| 81 FR 57931 - Certain Nanopores and Products Containing Same Commission Determination Not To Review an Initial Determination Terminating the Investigation Based Upon Consent Order Stipulation and Proposed Consent Order; Issuance of Consent Order; Termination of the Investigation | |
| 81 FR 57922 - Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting | |
| 81 FR 57992 - Louisiana Disaster Number LA-00066 | |
| 81 FR 57993 - Louisiana Disaster Number LA-00065 | |
| 81 FR 57992 - West Virginia Disaster Number WV-00043 | |
| 81 FR 57992 - LOUISIANA Disaster #LA-00065 | |
| 81 FR 57912 - Privacy Act of 1974; Notice of an Updated System of Records of Records | |
| 81 FR 57946 - Revision of Information Collection: Combined Federal Campaign Applications | |
| 81 FR 57923 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request | |
| 81 FR 57917 - Health Insurance MarketplaceSM | |
| 81 FR 57881 - Lyon-Mineral Resource Advisory Committee | |
| 81 FR 57928 - Agency Information Collection Activities: Application To Use the Automated Commercial Environment (ACE) | |
| 81 FR 57994 - SJI Board of Directors Meeting, Notice | |
| 81 FR 57809 - Prevailing Rate Systems; Definition of Kent County, Michigan, and Cameron County, Texas, to Nonappropriated Fund Federal Wage System Wage Areas | |
| 81 FR 57882 - Opportunity for Designation in Amarillo, TX Area; Request for Comments on the Official Agency Servicing This Area | |
| 81 FR 57816 - Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability | |
| 81 FR 57784 - The Food and Drug Administration Food Safety Modernization Act; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules | |
| 81 FR 57939 - Notice of Intent To Grant an Exclusive License | |
| 81 FR 57886 - Notice of Intent To Certify Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin); Request for Comments | |
| 81 FR 57745 - Prevailing Rate Systems; Redefinition of the Asheville, NC, and Charlotte, NC, Appropriated Fund Federal Wage System Wage Areas | |
| 81 FR 57884 - Designation for the Cedar Rapids, IA; Fremont, NE; State of Maryland; and West Lafayette, IN Areas | |
| 81 FR 57884 - Opportunity for Designation in Cairo, IL Area; Request for Comments on the Official Agency Servicing This Area. | |
| 81 FR 57889 - State Alternative Plan Program (SAPP) and the First Responder Network Authority Nationwide Public Safety Broadband Network | |
| 81 FR 57885 - Opportunity for Designation in North Carolina Area; Request for Comments on the Official Agency Servicing This Area. | |
| 81 FR 57882 - Opportunity for Designation in Louisiana Area; Request for Comments on the Official Agency Servicing This Area | |
| 81 FR 57883 - Designation for the Fargo, ND; Urbana, IL; Sandusky, MI; Davenport, IA; Enid, OK; Keokuk, IA; Marshall, MI; and Omaha, NE Areas | |
| 81 FR 57894 - Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Evaluation of the ESSA Title I, Part D, Neglected or Delinquent Programs | |
| 81 FR 57927 - Government-Owned Inventions; Availability for Licensing | |
| 81 FR 57925 - Government-Owned Inventions; Availability for Licensing | |
| 81 FR 57926 - Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2014-2015; Availability of Report | |
| 81 FR 57924 - Agency Information Collection Activities; Proposed Collection; Public Comment Request | |
| 81 FR 57803 - Atlantic Highly Migratory Species (HMS); Porbeagle Shark Management Measures | |
| 81 FR 57886 - Advisory Committee on Supply Chain Competitiveness: Notice of Public Meeting | |
| 81 FR 57925 - Center For Scientific Review; Notice of Closed Meetings | |
| 81 FR 57925 - Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meeting | |
| 81 FR 57818 - New Animal Drugs for Use in Animal Feed; Category Definitions | |
| 81 FR 57796 - New Animal Drugs for Use in Animal Feed; Category Definitions | |
| 81 FR 58003 - Proposed Collection Of Information: CMIA Annual Report and Direct Cost Claims | |
| 81 FR 57921 - Bioequivalence Recommendations for Fidaxomicin; Draft Guidance for Industry; Availability | |
| 81 FR 57922 - Agency Information Collection Activities; Proposed Collection; Public Comment Request | |
| 81 FR 57822 - Revisions to the Petition Provisions of the Title V Permitting Program | |
| 81 FR 57758 - Special Conditions: The Boeing Company, Boeing Model 767-2C Airplane; Non-Rechargeable Lithium Battery Installations | |
| 81 FR 57745 - Energy Conservation Program: Notice of Partial Grant and Partial Denial of Petitions To Amend the Error Correction Rule | |
| 81 FR 57929 - Agency Information Collection Activities: Request for Comments on the Assessing Public Views of Waterfowl-Related Topics To Inform the North American Waterfowl Management Plan | |
| 81 FR 57812 - Disqualification of a Clinical Investigator | |
| 81 FR 58341 - Good Laboratory Practice for Nonclinical Laboratory Studies | |
| 81 FR 57851 - Structure and Practices of the Video Relay Service Program | |
| 81 FR 58269 - Use of Spectrum Bands Above 24 GHz for Mobile Radio Services | |
| 81 FR 58309 - Amendments Relating to Disclosure of Records and Information | |
| 81 FR 58163 - Energy Conservation Program: Test Procedures for Central Air Conditioners and Heat Pumps | |
| 81 FR 58009 - Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements | |
| 81 FR 57938 - Agency Information Collection Activities; Submission for OMB Review; Comment Request; Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed | |
| 81 FR 57764 - Federal-State Unemployment Compensation Program; Implementing the Total Unemployment Rate as an Extended Benefits Indicator and Amending for Technical Corrections; Final Rule |
Agricultural Marketing Service
Food Safety and Inspection Service
Foreign Agricultural Service
Forest Service
Grain Inspection, Packers and Stockyards Administration
Industry and Security Bureau
National Oceanic and Atmospheric Administration
National Telecommunications and Information Administration
Navy Department
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Health Resources and Services Administration
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
U.S. Customs and Border Protection
Geological Survey
Land Management Bureau
Drug Enforcement Administration
Justice Programs Office
Employment and Training Administration
Federal Aviation Administration
Federal Highway Administration
Maritime Administration
National Highway Traffic Safety Administration
Financial Crimes Enforcement Network
Fiscal Service
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
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U.S. Office of Personnel Management.
Final rule.
The U.S. Office of Personnel Management (OPM) is issuing a proposed rule to redefine the geographic boundaries of the Asheville, NC, and Charlotte, NC, appropriated fund Federal Wage System (FWS) wage areas. The final rule will redefine Alexander and Catawba Counties, NC, from the Charlotte wage area to the Asheville wage area. These changes are based on a consensus recommendation of the Federal Prevailing Rate Advisory Committee (FPRAC) to best match the counties proposed for redefinition to a nearby FWS survey area.
Madeline Gonzalez, by telephone at (202) 606-2858 or by email at
On April 27, 2016, OPM issued a proposed rule (81 FR 24737) to redefine Alexander and Catawba Counties, NC, from the Charlotte, NC, wage area to the Asheville, NC, wage area. FPRAC, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, reviewed and recommended these changes by consensus. There are no FWS employees stationed in Alexander or Catawba Counties.
The proposed rule had a 30-day comment period, during which OPM received no comments.
I certify that these regulations will not have a significant economic impact on a substantial number of small entities because they will affect only Federal agencies and employees.
Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.
Accordingly, OPM amends 5 CFR part 532 as follows:
5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Final rule; partial grant and partial denial of petitions.
The U.S. Department of Energy (“DOE”) is granting in part and denying in part a series of petitions to amend a recently published rule that established a procedure through which a party can, within a prescribed period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before the rule is published in the
This partial grant and partial denial is effective September 23, 2016.
All petitions and comments filed in accordance with the timelines set forth in the prior
Mr. John Cymbalsky, U.S. Department of Energy, Office of Energy Efficiency and Renewable Energy, Building Technologies Program, EE-5B, 1000 Independence Avenue SW., Washington, DC 20585-0121. Telephone: (202) 287-1692 or
The Department of Energy (“DOE” or the “Department”) recently published a final rule establishing a procedure through which an interested party can, within a 30-day period after DOE posts a rule establishing or amending an energy conservation standard, identify a possible error in such a rule and request that DOE correct the error before its publication in the
DOE received four petitions to amend the rule and several comments responding to those petitions. The submitters of these documents, along with their affiliations, are identified in Table 1.
At the outset, DOE notes that the petitioners agreed with the fundamental underpinnings supporting the basis for the error correction rule. First, the petitioners—AHRI, Hussmann, the Joint Advocates, and Lennox—all agreed with the stated purpose of the error correction rule—that is, to prevent errors from affecting energy conservation standards applicable to consumer products or commercial equipment. AHRI Petition to Amend, EERE-2016-BT-PET-0016-0005, at 1-2; Hussmann Petition to Amend, EERE-2016-BT-PET-0016-0003, at 1; Joint Advocates Petition to Amend, EERE-2016-BT-PET-0016-0006, at 1; and Lennox Petition to Amend, EERE-2016-BT-PET-0016-0004, at 1. They also generally agreed that errors in need of correction are not common,
While the petitioners agreed with the need and rationale for the error correction rule, they also suggested several changes to the rule. These suggestions are discussed in the following sections.
The error correction rule requires that a party must submit a request for correction “within 30 calendar days of the posting of the rule.” 10 CFR 430.5(d)(1). The timelines also prescribe a period within which DOE will submit any corrected rule for publication in the
First, with respect to potential modifications to the rule, each of the industry petitioners asked that DOE consider providing a longer period of time than the 30 days prescribed by the rule within which to submit an error correction request.
Second, the Joint Advocates argued in favor of an exception to the error correction rule when following the rule's timing provisions for review would conflict with statutorily mandated rulemaking deadlines. In their view, case law suggests that there are only limited circumstances when federal agencies can extend statutory deadlines, none of which apply in the case of an error correction rule. In the event it is needed to avoid potential timing conflicts with statutory deadlines, the Joint Advocates suggested that DOE publicly post a draft of a standards final rule once it is transmitted to the Office of Management and Budget for pre-posting review, in order to provide more lead-time for parties to check for errors. Joint Advocates Petition, No. 0006, at 1-2.
Others disagreed with the Joint Advocates' suggestion.
After further consideration, DOE is extending the amount of time for the submission of error correction requests by 15 additional days—for a total of 45 days after the posting of a final rule. Providing this additional time will better ensure that any potential errors are addressed and corrected prior to the publication of a standards final rule, which will reduce the possibility of promulgating an incorrect energy conservation standard. By taking this step, DOE seeks to increase the likelihood that the public will identify any errors of the types addressed by the error correction rule. Correction of these errors will be beneficial for the reasons discussed in the Final Rule. With respect to providing a longer period of time, such as the 60 days suggested by industry petitioners, in DOE's view, offering a 60-day period as a matter of routine practice for identifying the types of errors addressed by this rule is unnecessary, as these kinds of errors typically can be readily identified well within the time period provided in this rule. DOE also notes that, contrary to AHRI's contention, its approach is consistent with the provision in EPCA that provides entities with 60 days from the date a rule is published in the
AHRI also suggested that DOE extend the period for submitting error correction requests until the effective date of a rule. This suggestion misapprehends the purpose and operation of the error correction rule. AHRI's request, by its nature, would permit error correction requests to be submitted after publication of a rule in the
DOE believes that the pre-publication error correction process set forth in the amended rule is superior to an error correction process permitting the submission of error correction requests during the existing 30-day pre-publication period through the effective date of a rule, which post-dates the publication of a rule in the
DOE need not, however, decide in this rulemaking whether the Joint Advocates are correct because, even if EPCA and the APA granted DOE the authority to grant any error correction request submitted after the publication of a standards rule in the
DOE is also declining to adopt the approach suggested by the Joint Advocates. In DOE's view, ensuring that its energy conservation standards published in the
While providing a pre-publication error correction process may require the expenditure of a modest amount of additional time, in DOE's view, weighing the potential energy savings losses of this relatively small delay against the benefits of correcting errors, given that errors, on occasion, can occur, cuts in favor of providing potential error correction requesters with the additional time provided by the error correction rule to review and identify errors to the Secretary.
The error correction rule defined a number of terms related to the error correction process. Among these terms were definitions for “Error,” “Party,” and “Rule.” The rule defined “Error” as “an aspect of the regulatory text of a rule that is inconsistent with what the Secretary intended regarding the rule at the time of posting.” 10 CFR 430.5(b). That definition also provided three examples of possible mistakes that could give rise to “Errors”—typographical mistakes, calculation mistakes, and numbering mistakes.
Industry petitioners viewed these definitions as overly narrow. First, in their view, the definition for “Error” should be broadened to include not only the regulatory text of a final rule but errors contained within the accompanying Technical Support Document (“TSD”) and the final rule's preamble discussion. With respect to TSD-related errors, the petitioners noted that the analysis within the TSD may be needed to help identify potential errors, which would necessitate including these TSD-related errors as part of the error correction rule. Additionally, they noted that new information presented in the preamble should be subject to comment since that information is often intertwined with the regulatory text itself. Lennox argued that errors in the preamble should be included because stakeholders will not have had a prior opportunity to comment on new information presented in the preamble discussion of a final rule. AHRI argued that the definition should be amended to make it objective, not subjective, and that stakeholders cannot guess the “intent” of the Secretary. Furthermore, AHRI expressed concern that a subjective definition could give rise to unfairness if DOE makes “post hoc assertions” about the Secretary's intent that did not in fact exist at the time of the posting of a final rule.
Second, some industry petitioners suggested that the rule's definition of the term “Party” was too narrow.
Finally, the industry petitioners viewed the definition of “Rule” as too narrow. In their view, this term should include rules besides energy conservation standard rulemakings. The petitioners asserted that this term should include test procedure rulemakings in addition to energy conservation standard rulemakings. According to Lennox, test procedure rules are complex and can have an impact on efficiency ratings when intertwined with energy conservation standards. Lennox Petition, No. 0004, at 2-3. In AHRI's view, adding test procedure rules to the definition would promote transparency. It asserted that test procedure rulemakings are intertwined with efficiency standards and contain voluminous, technical data; are often not issued until after, or simultaneously with, efficiency standards; and have the same “real-world effect” as do energy conservation standards. AHRI Petition, No. 0005, at 4-5 n.2 & 7; Lennox Petition, No. 0004, at 2-3. Hussmann suggested that “all rule types” should be included as part of this definition. Hussmann Petition, No. 0003, at 1-2.
Commenters responding to these points largely agreed with the industry petitioners. Most commenters generally agreed with AHRI's criticisms of the definition for “Error.” Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1. Most commenters also agreed that the definition of “Party” is too narrow. Zero Zone, No. 0007, at 1; Lennox, No. 0009, at 2; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1; AHRI-AHAM, No. 0012, at 2. Zero Zone stated that someone seeing the information for the first time might catch errors that someone familiar with the subject might miss. Zero Zone, No. 0007, at 1. Lennox agreed with Hussmann's petition, stating that the definition should be eliminated entirely because the goal of error correction is to detect errors. Lennox, No. 0009, at 2. AHRI and AHAM added that the source reporting an error is irrelevant because the purpose of error correction is to identify errors. AHRI-AHAM, No. 0012, at 2. Most commenters also agreed that the definition of “Rule” is too narrow. Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009 at 1; AGA-APGA, No. 0010, at 2; Traulsen-Kairak, No. 0011, at 1. Zero Zone commented that expanding the definition to include “[a]ll rules and test procedures” would ensure accurate federal documents. Zero Zone, No. 0007, at 1. AHAM echoed AHRI's petition, commenting that the error correction process will be more transparent if the definition is broadened. AHAM, No. 0008, at 2.
DOE is declining to adopt any of the suggested changes to the definitions of “Error” and “Rule,” but it is amending the rule in accordance with the suggested changes regarding the rule's definition of “Party.” With respect to the definition of “Error,” DOE disagrees that the error correction process should be available to correct mistakes that are not in the regulatory text itself. The purpose of the error correction rule is to prevent an erroneous energy conservation standards regulation from being published because after the compliance date, products (or equipment) subject to a standard may not be sold in the United States unless they meet the standard. As a result, errors in the standards adopted in an energy conservation standards rulemaking can have large economic consequences. By contrast, preambles and technical support documents are generally not legally binding in the same way. An error in one of those documents would not have the consequences that an error in the regulatory text might.
DOE does not rule out the possibility that a mistake contained in a preamble, TSD, or other supporting material might lead the resulting regulatory text to be inconsistent with DOE's determinations in the rulemaking. In such a case, a person might properly file an error correction request that pointed out the mistake in the supporting material in the course of identifying the error in the regulatory text. But accepting input, during the brief error correction window, on mistakes in a preamble, TSD, or other supporting document that did not result in errors in the regulatory text would either be pointless (because the error was harmless) or would essentially mean being open to revisiting the entirety of the rulemaking. DOE declines to establish a general procedure, applicable to every standards rulemaking, requiring it to reconsider every aspect of the rulemaking documents. As discussed in this preamble, having such a general reconsideration procedure would create substantially more delay than the error correction rule; and the delay would not be warranted, because DOE would generally adhere to the policy decisions it has already made.
Because the regulatory text forms the basis of what a regulated entity is legally obligated to perform, this aspect of the final rule should, in DOE's view, remain the focus of the error correction process. While DOE acknowledges that there may be potential value in addressing issues that may arise in the context of the preamble discussion or TSD (and related supporting documents), these documents, by themselves, do not impose any legal requirements on the affected regulated entities. And, to the extent that certain information in these documents creates a question regarding the validity of a particular rule, individuals are free to exercise their options under 42 U.S.C. 6306 to seek a remedy to address any applicable issues that would fall outside of the ambit of the error correction rule.
While DOE appreciates the value of ensuring that the preamble discussion and other supporting documents are free from potential errors, DOE emphasizes that, because regulated entities are held accountable for the provisions contained within the regulatory text, it is vital that this aspect of a standards final rule be correct. To the extent that a given preamble discussion warrants further clarification, DOE is willing—and has—provided supplemental guidance regarding its views. As for corrections to erroneous items within a given TSD or related DOE supporting document, DOE may address these types of issues on a case-by-case basis to eliminate any potential confusion that may arise from conflicts between those supporting documents and the final rule's regulatory text.
AHRI also criticized the definition of “Error” as involving an assessment of DOE's “intent” regarding a rule. AHRI urged DOE to adopt a definition of “Error” that is objective. Although AHRI did not suggest an alternative definition, AHRI contends that without some different definition DOE will be encouraged to provide
Moreover, DOE does not agree that because the definition of “Error” refers to what DOE “intended,” the concept of “Error” is inherently subjective. Objective conceptions of intent are common in the law. For example, in interpreting a contract, objective manifestations of intent ordinarily prevail over any contrary claims about what one or the other party actually subjectively intended. With respect to the error correction process, the rule states that a claim of error must be based on evidence in the rulemaking record. Thus, the objective evidence in the rulemaking record will ordinarily illustrate whether the regulatory text contained an Error.
Finally, AHRI noted that in some circumstances a person may conclude that a regulation contains an Error but may not be able to determine what the correct version of the regulation should be. DOE acknowledges that such a situation is in principle possible, and the Department's being notified of the potential Error would be valuable even if the submitter could not state what the correction version of the rule should be. Accordingly, DOE is amending paragraph (d)(2)(i) to permit a person to submit an error correction request without stating the correct substitute text, so long as the person states that it is unable to determine the correct text and explains why.
With respect to the definition of “Party,” which delineates who can file an error correction request, DOE is adopting the suggestion that the rule should not restrict to commenters alone the opportunity to submit such requests. As the error correction rule explained, DOE believes that individuals who have availed themselves of the opportunity to comment on DOE's standards rulemakings, at public meetings or via written comments, are in the best position to identify potential errors with a given final rule. Those participating individuals who have provided comments to assist the agency in crafting the final rule's standards have demonstrated both the interest and requisite familiarity with the relevant rulemaking and its underlying analyses and data to help DOE in readily identifying errors that may appear in the final rule's regulatory text. However, DOE recognizes that other persons may, on occasion, be able to identify errors. DOE's original decision to define “Party” based on prior participation was based on a desire to avoid the burden of responding to voluminous input from persons who, generally lacking familiarity with a rulemaking, might submit suggestions that were really revisiting the substantive decisions behind the rule rather than error correction requests. In light of the petitions and comments, DOE has become convinced that such improper submissions would probably not be as common as it had thought. A person will likely not undertake the effort to prepare and submit a request during the error correction period without making some assessment that the submission will probably be proper. Improper submissions might occur, of course, but because they would represent unfruitful effort, DOE expects that submitters will try to avoid them. In light of this revised balancing of the considerations related to the term “Party,” DOE is dropping the definition and modifying its regulations to reflect that any person may submit an error correction request.
Finally, with respect to which rules would be subject to the error correction rule's provisions, DOE is declining to extend the rule's application beyond rulemakings that establish or amend energy conservation standards. While it is also important to ensure that other rules such as those for test procedures are error-free, DOE has more flexibility to address errors in such rulemakings because there is no question that test procedures can be modified without regard to whether they have already been published or become effective. Accordingly, in DOE's view, while test procedure rulemakings can be complex, potential problems that are discovered in a test procedure's regulatory text can be addressed more readily than with standards rules. DOE also notes that the complexity of test procedure rules, which stems in large part from the very detailed and comprehensive text of the test procedure itself—along with related industry-based testing protocols that are often incorporated by reference—weighs in favor of not including test procedure rulemakings as part of the error correction process. While DOE believes that errors contained in the regulatory text of a standards final rule can be identified within the window prescribed in this rule, the variations in both length and complexity of the regulatory text of test procedures makes the application of this process less workable for these rulemakings. And if a person believed that DOE needed to correct an error discovered in the test procedure, it would be free to file a petition for rulemaking asking DOE to initiate a rulemaking to correct that rule.
The error correction rule prescribes a timeline under which DOE will submit a rule to the Office of the Federal Register for publication. If the Secretary determines that a correction is necessary after receipt of a properly filed request, the Secretary will submit a corrected rule for publication in the
The Joint Advocates objected to the quoted language and argued that the error correction rule should contain a more definitive statement regarding when the corrected rule will be submitted for publication in the
Lennox indicated in its comments that DOE cannot foresee every possible error and that the complexity of past DOE rulemaking analyses suggests that more than 30 days may sometimes be needed to resolve a given error correction request. In its view, devoting an additional amount of time in favor of ensuring that a standard is correct is preferable to the alternative of having a permanently flawed standard. Lennox, No. 0009, at 3.
DOE is declining to make any change in response to this part of the Joint Advocates' petition. The language in 10 CFR 430.5(f)(3) was crafted to ensure that DOE could adjust to potential situations where additional time beyond the 30-day period for submitting a corrected rule to the
The error correction rule uses the term “posting” to refer to the Secretary's action causing a rule under the Act to be posted on a publicly-accessible Web site.
The Joint Advocates stated that, based on this definition, DOE should replace “issuance” with “posting” in these two instances in the error correction rule, namely, at 10 CFR 430.5(d)(3) (which describes the point by which evidence supporting an error correction request must be entered into the rulemaking record) and 10 CFR 430.5(f)(3) (which describes the point by which DOE must receive a properly filed error correction request). The Joint Advocates asserted that the term “issuance” means publication in the
Zero Zone commented that it generally disagreed with the Joint Advocates' Petition. Zero Zone, No. 0007, at 1. AHRI and AHAM commented that they agreed with the Joint Advocates that “issuance” of a final rule does not occur until publication in the
In response to the petition and comments, DOE is amending its error correction rule to clarify the point by which evidence supporting an error correction request must be in the rulemaking record (10 CFR 430.5(d)(3)) and the point after which a properly filed error correction request is submitted to DOE (10 CFR 430.5(f)(3)). DOE is clarifying that these points are denoted by the posting date of the final rule. Making this change will help ensure that there is no confusion as to when the supporting evidence must be in the rulemaking record and after which a properly filed request is submitted. DOE notes that it is also clarifying 10 CFR 430.5(c)(3) to more clearly indicate that errors must be identified as provided in 10 CFR 430.5 and that DOE may make any necessary corrections in the regulatory text submitted to the Office of the
The error correction rule states that to substantiate an error correction request, the evidence relied upon must be evidence that is “in the record of the rulemaking at the time of the rule's issuance, which may include the preamble accompanying the rule. The Secretary will not consider new evidence submitted in connection with the request.” 10 CFR 430.5(d)(3). AHRI petitioned to broaden the scope of evidence that the Secretary could consider to include any new evidence. AHRI Petition, No. 0005, at 6. According to AHRI, there is no precedent for excluding “new evidence.”
In addition, the preamble to the error correction rule stated that DOE “consider[ed] the record with respect to a rule subject to the error correction process [to be] closed upon the posting of the rule.” 81 FR at 26999. AHRI construed this sentence to mean that, in the event of a court challenge to a standards rule, no documents postdating the posting of a rule would be included in the administrative record filed in a court of appeals. AHRI Petition, No. 0005, at 9-10. AHRI argued that exclusion of such documents from an administrative record filed in court would be contrary to the Administrative Procedure Act.
Industry commenters agreed with AHRI's suggested approach. Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 1; Traulsen-Kairak, No. 0011, at 1. AHRI also commented that the Joint Advocates indirectly supported AHRI's Petition. According to AHRI, when the Joint Advocates stated that a final rule is not “issued” until it is published in the
With respect to AHRI's distinct concern about the scope of the administrative record that would be filed in a court of appeals in the event of a challenge to a final standards rule published in the
In DOE's view, the posting of an energy conservation standards rule signals the end of DOE's substantive analysis and decision-making regarding the applicable standards. The purpose of the error correction rule is to ensure that the legal requirements that regulated entities will need to meet—as detailed in the regulatory text of a given standards rule—accurately reflect that completed substantive analysis and decision-making. It is not possible for a regulation to be in error, as defined for purposes of the error correction rule, based on evidence first introduced after the substantive decision has been made. Accordingly, such a consideration would be beyond the scope of the error correction process that DOE has developed. It would, essentially, be akin to a request for reconsideration; the submitter would be arguing that, in light of additional evidence, DOE should alter its decision. For the reasons discussed elsewhere in this preamble, DOE declines to expand the scope of the error correction process to encompass requests for reconsideration of its standards rules on any ground.
The error correction rule describes three potential options that could occur after the period for submitting error correction requests expires.
Several petitioners stated that DOE should provide a public response to requests for correction, regardless of whether the Secretary deems that any correction is merited. Hussmann Petition, No. 0003, at 1; Lennox Petition, No. 0004, at 4; AHRI Petition, No. 0005, at 10. Hussmann stated that DOE should do so, either before or at the time of publication of a final rule in the
Related to the Secretary's options under 10 CFR 430.5(f), petitioners made reference to a statement in the preamble to the error correction rule under the “Publication in the
Most commenters generally agreed with the petitioners who urged DOE to provide a public response to requests for error correction, including when DOE deems an error to be “insignificant.” Zero Zone, No. 0007, at 1; AHAM, No. 0008, at 2; Lennox, No. 0009, at 1; AGA-APGA, No. 0010, at 2; Traulsen-Kairak, No. 0011, at 1.
After giving careful consideration to this issue, DOE has decided to make public brief written indications of its handling of all properly-filed error correction requests. DOE will ordinarily summarize these indications in a single document. In DOE's view, the vast majority of cases in which it grants an error correction request are likely to involve a request that DOE correct a typographical error that appears in a posted, pre-publication version of a rule. In such cases, DOE's written indication addressing the request may note only that DOE made the requested change because the reason for the change may be readily apparent to the public. When requesters have sought to identify a potential error in a posted standards rule and DOE has decided not to make the requested change, an explanation as to why that correction request has not been adopted will usually be helpful in assisting the public with understanding DOE's reasoning, and DOE will provide a brief explanation in those circumstances. Accordingly, DOE is modifying the regulatory text under 10 CFR 430.5(f) to include a provision indicating that DOE will make available a brief written statement indicating the agency's treatment of the error correction requests it received. DOE expects to make such a statement available at around the same time it publishes the rule.
In a separately filed comment, AHAM asked that the error correction final rule be treated as a proposed rule. It further asked that, upon granting the petition from AHRI, DOE seek stakeholder input in order to ensure that the next version of the error correction process does not suffer from the same deficiencies as the first version. AHAM Comments, No. 0008, at 2.
As an initial matter, DOE notes that the error correction rule was published as a final rule and has already taken effect. Moreover, DOE is not required to provide the public with an opportunity to comment on the error correction rule or any amendments to that rule because it is a rule of agency procedure and practice.
AHRI's principal request is for DOE to replace the error correction rule with a process that “provide[s] for the posting of a pre-publication version of final rules under 42 U.S.C. 6293 and 6295 (and the corresponding provisions applicable to commercial equipment, sections 6313 and 6314) for a period of 60 days and allow[s] petitions for reconsideration under the APA during that prepublication period.” AHRI Petition, No. 0005, at 2-3. Embedded in this request, it appears, are the following five suggested changes to the current error correction rule, all of which AHRI also separately requests, in the alternative, in the event that DOE denies its principal request: (1) Broaden the types of arguments that may be asserted in error correction requests to encompass any grounds for changing a rule, not just arguments identifying an “error” as defined in the current rule,
DOE has explained above why it is rejecting (in part) AHRI's second through fifth requests embedded in its principal suggestion. For the reasons explained below, DOE also rejects AHRI's first request embedded in its principal suggestion (and offered as a standalone request)—that DOE expand the error correction process to encompass requests alleging any grounds for changing a rule.
DOE understands that the “full” reconsideration procedure that AHRI describes in its principal request, as well as in item 1 under its alternative request, would encompass the full range of issues germane to a given rulemaking. DOE has considered whether to adopt a reconsideration procedure along the lines suggested by AHRI. Given the practical implications of crafting an error correction process that would allow for full reconsideration of any factual or legal issue implicated by the rulemaking, as discussed in this preamble, DOE declines to broaden the error correction rule to permit petitions asserting any ground for changing a rule.
As AHRI acknowledges, energy conservation rulemakings are an “enormous undertaking . . . in terms of time, effort and cost, both on the part of stakeholders and DOE.” AHRI Petition, No. 0005, at 2. In addition, these rulemakings tend to involve an extensive opportunity for comment, both through written submissions in response to notices of proposed rulemaking and notices releasing additional technical information, as well as through oral participation at public meetings held by DOE. Adding a full reconsideration process, in which the Department would specifically review a further round of comment on any matter, would substantially increase the cost of energy conservation rulemakings and the length of time they take.
By contrast, DOE developed the error correction rule to invite public input on a narrow but challenging category of problems, namely errors that may occur in formulating the text of regulations and that, if left uncorrected, could result in standards that would be binding on regulated parties but would not accurately reflect DOE's judgment about the appropriate standard level. Obtaining public input on “errors” as defined by the rule is particularly valuable because, by their nature, such errors are inadvertent, and thus DOE is unaware of them. In addition, the narrow error correction rule helps avoid the possibility that DOE might inadvertently adopt an energy conservation without having determined that it meets the statutory standards. That is so because many “errors” (as defined by the error correction rule) may, if uncorrected, result in the promulgation of standards that DOE did not intend to adopt. For example, if DOE's calculations in the preamble to a final rule suggested that the standard for a given product should be set at one level, but a more stringent standard was inadvertently presented in the regulatory text, that standard would not have been the one DOE intended to adopt as being technologically feasible and economically justified. By contrast, a request to change a rule on a ground other than the identification of an “error” (as defined by the error correction rule) does not raise the possibility that DOE adopted a standard in the regulatory text without determining that it was technologically feasible and economically justified. Moreover, reviewing and responding to requests to correct errors as defined in the error correction rule should not be too burdensome because DOE will need to review only a limited scope of materials for each submission. Thus, the error correction rule is specifically tailored to address what the agency views as a critical class of inadvertent errors warranting the creation of an additional limited administrative process apart from the procedures already afforded by EPCA and the APA.
In contrast, the full reconsideration process that AHRI suggests is not closely tailored to address this key problem and would represent a commitment by DOE to revisiting the entire rulemaking record in order to assess the particulars of any issue a person might raise in a reconsideration request. Because of the open-ended nature of such a process, DOE would need to provide interested persons with a period of time to submit reconsideration petitions that is longer than the 45-day period established by the error correction rule (as amended in this document). In addition, it would take DOE significantly more time to consider such petitions and to determine whether to change the rule in response to the petitions. Furthermore, DOE's preparation and issuance of a written response to any such reconsideration requests, as suggested by industry petitioners, would extend the process further.
DOE declines to extend its rulemaking procedures in that fashion. Many standards-setting rules are subject to a statutory deadline.
DOE also finds unpersuasive AHRI's argument that DOE must entertain pre-publication petitions for reconsideration alleging any grounds for changing a rule because “5 U.S.C. 553(e) does not limit the grounds on which reconsideration can be pursued.” AHRI Petition, No. 0005, at 5. Reliance on section 553(e) is inapposite here because DOE is not establishing the error correction process under this section. Through the error correction rule, DOE established a new procedure in addition to and independent of any statutory rights to petition for rulemaking afforded to persons under the APA and EPCA.
In its petition to amend the error correction rule, AHRI refers back to certain arguments raised in its brief to the Fifth Circuit in
AHRI argued in its Fifth Circuit brief in
However, because DOE has established a pre-publication error correction procedure, DOE can leave for another day the questions AHRI has raised about DOE's authority to reconsider rules that have already been published in the
Similarly, AHRI's Fifth Circuit brief in
That conclusion follows from the text of section 6295(n). DOE has, for the most part, already published the “last final rule[s] required” by subsections (b) through (i) of section 6295. Thus, for nearly all new standards rules for consumer products and for any standards applicable to commercial equipment, a petition under section 6295(n) would be submitted under the second clause of that subsection, applicable to “published” rules. Regardless which clause of 6295(n) may be the basis for a rule (
For similar reasons, DOE rejects AHRI's suggestion that it must substantively resolve the argument AHRI advanced in its
As explained in this preamble, DOE has fully considered but is declining to adopt the full reconsideration procedure that AHRI suggests—irrespective of what DOE's legal authority to accept a post-publication petition would be. Because resolution of those legal arguments is not determinative of DOE's basis for rejecting a full reconsideration procedure in the matter at hand, DOE declines to definitively resolve the questions AHRI raises about the Department's authority to reconsider rules that have already been published in the
It is DOE's position that a process to correct errors such as typographical mistakes or calculation errors can be resolved at the administrative level without causing an undue burden on agency resources or the agency's ability to comply with statutory deadlines. The error correction rule, as amended, reflects DOE's balancing between the resource-intensive rulemaking process and its ability to offer an additional administrative process to stakeholders that will reduce the need to pursue judicial review in instances where it is clear that the relevant standard in the posted rule is not the standard the agency had intended to select.
DOE has carefully considered petitioners' request for a full reconsideration procedure but concludes that agency and stakeholder interests will be best served by a streamlined process for correcting the errors described in the amended error correction rule.
This rule of agency procedure and practice is not subject the requirement to provide prior notice and an opportunity for public comment pursuant to authority at 5 U.S.C. 553(b)(A). The Administrative Procedure Act's exception to the notice-and-comment rulemaking requirement for rules of agency procedure and practice reflects Congress's judgment that such rules typically do not significantly benefit from notice-and-comment procedures, and that judgment is particularly applicable here, where the agency perceives no specific need for notice and comment. In addition, DOE has concluded that seeking further input on this rule—beyond that which has already been provided through the submitted petitions to amend and comments responding to them—would inappropriately divert valuable agency resources from other rulemakings that Congress has directed DOE to complete according to certain statutory timelines.
This rule is also not a substantive rule subject to a 30-day delay in effective date pursuant to 5 U.S.C. 553(d).
This regulatory action is not a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, this action was not subject to review under that Executive Order by the Office of Information and Regulatory Affairs (“OIRA”) of the Office of Management and Budget (“OMB”). DOE has also reviewed this regulation pursuant to Executive Order 13563, issued on January 18, 2011. 76 FR 3281 (January 21, 2011). EO 13563 is supplemental to and explicitly reaffirms the principles, structures, and definitions governing regulatory review established in Executive Order 12866. As a result, EO 13563 also does not apply to this rule.
The Regulatory Flexibility Act (5 U.S.C. 601,
This rule does not contain a collection of information for purposes of the Paperwork Reduction Act.
DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Executive Order 13132, “Federalism,” 64 FR 43255 (August 10, 1999), imposes certain requirements on Federal agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE examined this final rule and determined that it will not have a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the equipment that are the subject of this final rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.
With respect to the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; and (3) provide a clear legal standard for affected conduct rather than a general standard and promote simplification and burden reduction. 61 FR 4729 (February 7, 1996). Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in section 3(a) and section 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, this rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (“UMRA”) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a regulatory action resulting in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and requires an agency plan for giving notice and opportunity for timely input to potentially affected small governments before establishing any requirements that might significantly or uniquely affect small governments. On March 18, 1997, DOE published a statement of policy on its process for intergovernmental consultation under UMRA. 62 FR 12820; also available at
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule will not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights,” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516, note) provides for Federal agencies to review most disseminations of information to the public under guidelines established
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OIRA at OMB, a Statement of Energy Effects for any significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use if the regulation is implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
This final rule is not a significant energy action because the ability to correct regulations will not, in itself, have a significant adverse effect on the supply, distribution, or use of energy. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
As required by 5 U.S.C. 801, DOE will report to Congress on the promulgation of this rule before its effective date. The report will state that it has been determined that the rule is not a “major rule” as defined by 5 U.S.C. 804(2).
Administrative practice and procedure, Energy conservation test procedures, Household appliances.
Administrative practice and procedure, Energy conservation test procedures, Commercial and industrial equipment.
For the reasons set forth in the preamble, DOE amends parts 430 and 431 of chapter II of title 10 of the Code of Federal Regulations as set forth below:
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(a)
(b)
(i) A typographical mistake that causes the regulatory text to differ from how the preamble to the rule describes the rule;
(ii) A calculation mistake that causes the numerical value of an energy conservation standard to differ from what technical support documents would justify; or
(iii) A numbering mistake that causes a cross-reference to lead to the wrong text.
(c)
(2) The Secretary will not submit a rule for publication in the
(3) Each rule posted pursuant to paragraph (c)(1) of this section shall bear the following disclaimer:
(d)
(2)(i) A request under this section must identify an Error with particularity. The request must state what text is claimed to be erroneous. The request must also provide text that the requester argues would be a correct substitute. If a requester is unable to identify a correct substitute, the requester may submit a request that states that the requester is unable to determine what text would be correct and explains why the requester is unable to do so. The request must also substantiate the claimed Error by citing evidence from the existing record of the rulemaking that the text of the rule as issued is inconsistent with what the Secretary intended the text to be.
(ii) A person's disagreement with a policy choice that the Secretary has made will not, on its own, constitute a valid basis for a request under this section.
(3) The evidence to substantiate a request (or evidence of the Error itself) must be in the record of the rulemaking
(4) A request under this section must be filed in electronic format by email to the address that the rule designates for correction requests. Should filing by email not be feasible, the requester should contact the program point of contact designated in the rule regarding an appropriate alternative means of filing a request.
(5) A request that does not comply with the requirements of this section will not be considered.
(e)
(f)
(2) If the Secretary receives no properly filed requests after posting a rule and identifies no Errors on the Secretary's own initiative, the Secretary will in due course submit the rule, as it was posted pursuant to paragraph (c)(1) of this section, to the Office of the Federal Register for publication. This will occur after the period prescribed by paragraph (c)(2) of this section has elapsed.
(3) If the Secretary receives a properly filed request after posting a rule pursuant to (c)(1) and determines that a correction is necessary, the Secretary will, absent extenuating circumstances, submit a corrected rule for publication in the
(4) Consistent with the Act, compliance with an energy conservation standard will be required upon the specified compliance date as published in the relevant rule in the
(5) Consistent with the Administrative Procedure Act, and other applicable law, the Secretary will ordinarily designate an effective date for a rule under this section that is no less than 30 days after the publication of the rule in the
(6) When the Secretary submits a rule for publication, the Secretary will make publicly available a written statement indicating how any properly filed requests for correction were handled.
(g)
(h)
42 U.S.C. 6291-6317.
Requests for error corrections pertaining to an energy conservation standard rule for commercial or industrial equipment shall follow those procedures and provisions detailed in 10 CFR 430.5 of this chapter.
Federal Aviation Administration (FAA), DOT.
Final special conditions.
These special conditions are issued for the Boeing Model 767-2C airplane. This airplane will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport-category airplanes. This design feature is associated with non-rechargeable lithium battery installations. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Effective April 22, 2017.
Nazih Khaouly, Airplane and Flight Crew Interface Branch, ANM-111, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone 425-227-2432; facsimile 425-227-1149.
The FAA anticipates that non-rechargeable lithium batteries will be installed in other makes and models of airplanes. We have determined to require special conditions for all applications requesting non-rechargeable lithium battery installations, except the installations excluded in the Applicability section, until the airworthiness requirements can be revised to address this issue. Applying special conditions to these installations across the range of all transport-airplane makes and models ensures regulatory consistency among applicants.
The FAA issued special conditions no. 25-612-SC to Gulfstream Aerospace Corporation for their GVI airplane. Those are the first special conditions the FAA issued for non-rechargeable lithium battery installations. We explained in that document our determination to make those special conditions effective one year after publication of those special conditions in the
On January 18, 2010, The Boeing Company (Boeing) applied for an amendment to type certificate no. A1NM to include a new Model 767-2C airplane. The Model 767-2C airplane is a twin-engine, transport-category freighter derivative of the Model 767-200 airplane currently approved under type certificate no. A1NM. This freighter has a maximum takeoff weight of 415,000 pounds and can be configured to carry up to 11 supernumeraries.
The Model 767-2C airplane incorporates provisions to support subsequent supplemental type
Under the provisions of Title 14, Code of Federal Regulations, (14 CFR) 21.101, Boeing must show that the Model 767-2C airplane meets the applicable provisions of the regulations listed in type certificate no. A1NM or the applicable regulations in effect on the date of application for the change, except for earlier amendments as agreed upon by the FAA. The regulations listed in the type certificate are commonly referred to as the “original type certification basis.” The regulations listed in type certificate no. A1NM are 14 CFR part 25, effective February 1, 1965, including Amendments 25-1 through 25-37, with exceptions listed in the type certificate. In addition, the certification basis includes other regulations, special conditions, and exemptions that are not relevant to these special conditions. Type certificate no. A1NM will be updated to include a complete description of the certification basis for this airplane model.
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the airplane model for which they are issued. Should the type certificate for that model be amended later to include any other model that incorporates the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Model 767-2C airplane must comply with the fuel-vent and exhaust-emission requirements of 14 CFR part 34, and the noise-certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.
The Boeing Model 767-2C airplane will incorporate non-rechargeable lithium batteries.
A battery system consists of the battery and any protective, monitoring, and alerting circuitry or hardware inside or outside of the battery. It also includes vents (where necessary) and packaging. For the purpose of these special conditions, a “battery” and “battery system” are referred to as a battery.
The FAA derived the current regulations governing installation of batteries in transport-category airplanes from Civil Air Regulations (CAR) 4b.625(d) as part of the re-codification of CAR 4b that established 14 CFR part 25 in February 1965. We basically reworded the battery requirements, which are currently in § 25.1353(b)(1) through (b)(4), from the CAR requirements. Non-rechargeable lithium batteries are novel and unusual with respect to the state of technology considered when these requirements were codified. These batteries introduce higher energy levels into airplane systems through new chemical compositions in various battery-cell sizes and construction. Interconnection of these cells in battery packs introduces failure modes that require unique design considerations, such as provisions for thermal management.
Recent events involving rechargeable and non-rechargeable lithium batteries prompted the FAA to initiate a broad evaluation of these energy-storage technologies. In January 2013, two independent events involving rechargeable lithium-ion batteries demonstrated unanticipated failure modes. A National Transportation Safety Board (NTSB) letter to the FAA, dated May 22, 2014, which is available at
On July 12, 2013, an event involving a non-rechargeable lithium battery in an emergency-locator-transmitter installation demonstrated unanticipated failure modes. The United Kingdom's Air Accidents Investigation Branch Bulletin S5/2013 describes this event.
Some known uses of rechargeable and non-rechargeable lithium batteries on airplanes include:
• Flight deck and avionics systems such as displays, global positioning systems, cockpit voice recorders, flight data recorders, underwater locator beacons, navigation computers, integrated avionics computers, satellite network and communication systems, communication-management units, and remote-monitor electronic line-replaceable units;
• Cabin safety, entertainment, and communications equipment, including emergency-locator transmitters, life rafts, escape slides, seatbelt air bags, cabin management systems, Ethernet switches, routers and media servers, wireless systems, internet and in-flight entertainment systems, satellite televisions, remotes, and handsets;
• Systems in cargo areas including door controls, sensors, video surveillance equipment, and security systems.
Some known potential hazards and failure modes associated with non-rechargeable lithium batteries are:
•
•
•
Special condition no. 1 requires that each individual cell within a non-rechargeable lithium battery be designed to maintain safe temperatures and pressures. Special condition no. 2 addresses these same issues but for the entire battery. Special condition no. 2 requires that the battery be designed to prevent propagation of a thermal event, such as self-sustained, uncontrolled increases in temperature or pressure from one cell to adjacent cells.
Special condition nos. 1 and 2 are intended to ensure that the non-rechargeable lithium battery and its cells are designed to eliminate the potential for uncontrolled failures. However, a certain number of failures will occur due to various factors beyond the control of the designer. Therefore, other special conditions are intended to protect the airplane and its occupants if failure occurs.
Special condition nos. 3, 7, and 8 are self-explanatory, and the FAA does not provide further explanation for them at this time.
Special condition no. 4 makes it clear that the flammable-fluid fire-protection requirements of § 25.863 apply to non-rechargeable lithium battery installations. Section 25.863 is applicable to areas of the airplane that could be exposed to flammable fluid leakage from airplane systems. Non-rechargeable lithium batteries contain electrolyte that is a flammable fluid.
Special condition no. 5 requires each non-rechargeable lithium battery installation to not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape. Special condition no. 6 requires each non-rechargeable lithium battery installation to have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells. The means of meeting these special conditions may be the same, but they are independent requirements addressing different hazards. Special condition no. 5 addresses corrosive fluids and gases, whereas special condition no. 6 addresses heat.
These special conditions will apply to all non-rechargeable lithium battery installations in lieu of § 25.1353(b)(1) through (b)(4) at Amendment 25-123. Sections 25.1353(b)(1) through (b)(4) at Amendment 25-123 will remain in effect for other battery installations.
These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Notice of proposed special conditions no. 25-16-01-SC, for the Boeing 767-2C airplane, was published in the
The Aerospace Industries Association (AIA) provided several comments that were identical to their comments for special conditions no. 25-612-SC, which we issued to Gulfstream Aerospace Corporation for non-rechargeable lithium battery installations on Gulfstream GVI airplanes. The FAA responded to each of these comments in that final special conditions document. We incorporated the same revisions into these Boeing 767-2C special conditions that we incorporated into the Gulfstream GVI special conditions as a result of AIA's comments.
Boeing commented that they fully support AIA's comments.
Boeing requested that the FAA provide adequate time before non-rechargeable lithium battery special conditions become effective to support validation activities by foreign civil airworthiness authorities (FCAA) and to not adversely impact future airplane deliveries by all applicants. The FAA considered this same comment from Boeing for special conditions no. 25-612-SC and provided a detailed response in that document. We determined the effective date for these Boeing 767-2C special conditions based on Boeing's comment and other factors stated in special conditions no. 25-612-SC.
Boeing commented that the FAA needs to clearly define the applicability of these special conditions. Boeing's comment is similar to their comment on special conditions no. 25-612-SC. We provided a detailed response in special conditions no. 25-612-SC and have clearly defined the applicability for these Boeing 767-2C special conditions. One aspect of Boeing's comment that we did not address in special conditions no. 25-612-SC is that some design changes may not change a lithium battery installation but affect it, which results in these special conditions being applicable. For example, adding a heat source next to a lithium battery can increase its possibility of entering into thermal runaway. Lithium battery installations affected by design changes must meet these special conditions. Some examples of changes that affect lithium battery installations are those that:
• Increase the temperatures or pressures in a battery,
• Increase the electrical load on a battery,
• Increase potential for imbalance between battery cells,
• Modify protective circuitry for a lithium battery,
• Increase the airplane level risk due to the location of an existing lithium battery. An example is installation of a new oxygen line next to an existing part that has a lithium battery. The airplane level risk may increase due to the potential hazard of a lithium battery fire in the proximity of oxygen.
Gulfstream Aerospace Corporation commented that they agree with Boeing's comments and requested that the FAA consider incorporating their proposed changes into this document.
AmSafe recommended that the FAA state in the preamble that design mitigation or analysis at the airplane level may be applied to show that designs meet these special conditions. The FAA has determined that these special conditions are to require the battery to be designed to minimize the potential of uncontrollable failure, and to not only rely on mitigation of a battery failure at the airplane level. Therefore, we have not incorporated the proposed revision into the preamble of these special conditions.
AmSafe commented that they concur with proposed special condition no. 1 with an understanding that “foreseeable operating conditions” equates to the full normal operating envelope of the airplane. However, this is not a correct understanding of proposed special condition no. 1. The FAA intends for the term “foreseeable operating conditions,” in these special conditions, to apply at the cell level and not only at the airplane level. In addition, “foreseeable” includes anticipated abnormal operating conditions.
AmSafe recommended revising proposed special condition no. 2 to read, “Battery installation and/or equipment containing any non-rechargeable lithium battery must preclude the occurrence of, or mitigate the effect of self-sustaining, uncontrolled increases in temperature or pressure.” Amsafe's rationale was based on their recommendation that design mitigation or analysis at the airplane level be acceptable. As explained above, the FAA has determined that these special conditions are to require the battery to be designed to minimize the potential of uncontrollable failure, and to not only rely on mitigation of a battery failure at the airplane level. The FAA has not incorporated the proposed revision into special condition no. 2.
AmSafe recommended adding the phrase “. . . failure
AmSafe recommended deleting § 25.863(c)(d) from proposed special condition no 4. The FAA does not concur. Section 25.863 already applies to non-rechargeable lithium batteries since they contain electrolyte that is a flammable fluid. Since § 25.863 has historically been applied to flammable fluids related to propulsion and hydraulic systems, the FAA is including special condition no. 4 to ensure that
AmSafe recommended revising proposed special condition no. 5 to prohibit damage to surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape “in such a way as to cause a hazardous or catastrophic failure condition.” AIA also recommended this revision. The FAA intends for special condition no. 5 to be consistent with § 25.1309. So, we added the words “. . . in such a way as to cause a major or more-severe failure condition.” The revised special condition now reads, “. . . each non-rechargeable lithium battery installation must not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.” The FAA does not concur with excluding major failure conditions.
AmSafe concurred with proposed special condition no. 6.
AmSafe concurred with proposed special condition no. 7 and recommended revising proposed special condition no. 8. However, the FAA deleted these proposed special conditions as explained in our response to AIA's comments in special conditions no. 25-612-SC.
AmSafe recommended revising “safe operation of the airplane” in proposed special condition nos. 9 and 10 to “
The FAA has determined that “uncontrolled” in special condition no. 2 should be “uncontrollable” to more accurately describe the concern. This revision does not change the intended meaning of this special condition.
Except as discussed above, the special conditions are adopted as proposed.
As discussed above, these special conditions are applicable to the Model 767-2C airplane. Should the applicant apply at a later date for a change to the type certificate to include another model incorporating the same novel or unusual design feature, or should any other model already included on the same type certificate be modified to incorporate the same novel or unusual design feature, these special conditions would apply to that model as well.
These special conditions are only applicable to design changes applied for after their effective date. The existing airplane fleet and follow-on deliveries of airplanes with previously certified non-rechargeable lithium battery installations are not affected.
These special conditions are not applicable to previously certified non-rechargeable lithium battery installations where the only change is either cosmetic or relocating the installation to improve the safety of the airplane and occupants. The FAA determined that this exclusion is in the public interest because the need to meet all of the special conditions might otherwise deter such design changes that involve relocating batteries. A cosmetic change is a change in appearance only, and does not change any function or safety characteristic of the battery installation.
This action affects only certain novel or unusual design features on one model of airplane. It is not a rule of general applicability.
Aircraft, Aviation safety, Reporting and record keeping requirements.
The authority citation for these special conditions is as follows:
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
Accordingly, the following special conditions are part of the type certification basis for the Boeing Model 767-2C airplane.
In lieu of § 25.1353(b)(1) through (b)(4) at Amendment 25-123, each non-rechargeable lithium battery installation must:
1. Maintain safe cell temperatures and pressures under all foreseeable operating conditions to prevent fire and explosion.
2. Prevent the occurrence of self-sustaining, uncontrollable increases in temperature or pressure.
3. Not emit explosive or toxic gases, either in normal operation or as a result of its failure, that may accumulate in hazardous quantities within the airplane.
4. Meet the requirements of § 25.863.
5. Not damage surrounding structure or adjacent systems, equipment, or electrical wiring from corrosive fluids or gases that may escape in such a way as to cause a major or more-severe failure condition.
6. Have provisions to prevent any hazardous effect on airplane structure or systems caused by the maximum amount of heat it can generate due to any failure of it or its individual cells.
7. Have a failure sensing and warning system to alert the flightcrew if its failure affects safe operation of the airplane.
8. Have a means for the flightcrew or maintenance personnel to determine the battery charge state if the battery's function is required for safe operation of the airplane.
Federal Aviation Administration (FAA), DOT.
Final rule
This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.
Richard A. Dunham, Flight Procedure Standards Branch (AMCAFS-420), Flight Technologies and Programs Division, Flight Standards Service,
This amendment to part 95 of the Federal Aviation Regulations (14 CFR part 95) amends, suspends, or revokes IFR altitudes governing the operation of all aircraft in flight over a specified route or any portion of that route, as well as the changeover points (COPs) for Federal airways, jet routes, or direct routes as prescribed in part 95.
The specified IFR altitudes, when used in conjunction with the prescribed changeover points for those routes, ensure navigation aid coverage that is adequate for safe flight operations and free of frequency interference. The reasons and circumstances that create the need for this amendment involve matters of flight safety and operational efficiency in the National Airspace System, are related to published aeronautical charts that are essential to the user, and provide for the safe and efficient use of the navigable airspace. In addition, those various reasons or circumstances require making this amendment effective before the next scheduled charting and publication date of the flight information to assure its timely availability to the user. The effective date of this amendment reflects those considerations. In view of the close and immediate relationship between these regulatory changes and safety in air commerce, I find that notice and public procedure before adopting this amendment are impracticable and contrary to the public interest and that good cause exists for making the amendment effective in less than 30 days.
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. 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. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Airspace, Navigation (air).
Accordingly, pursuant to the authority delegated to me by the Administrator, part 95 of the Federal Aviation Regulations (14 CFR part 95) is amended as follows effective at 0901 UTC, July 21, 2016.
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44719, 44721.
Employment and Training Administration, Labor.
Final rule.
The Employment and Training Administration (ETA) of the U.S. Department of Labor (Department) issues this final rule to implement statutory amendments to the Extended Benefits (EB) program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the Total Unemployment Rate (TUR) indicator which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.
This rule is effective October 24, 2016.
Gay Gilbert, Administrator, Office of Unemployment Insurance, Employment and Training Administration, (202) 693- 3029 (this is not a toll-free number) or 1-877-889-5627 (TTY). Individuals with hearing or speech impairments may access the telephone number above via TTY by calling the toll-free Federal Information Relay Service at (800) 877- 8339.
a. ETA issues this final rule to implement statutory amendments to the EB program, which pays extra weeks of unemployment compensation during periods of high unemployment in a State. Specifically, this final rule codifies a methodology for computing the TUR indicator, which is an optional indicator used to measure unemployment in a State. Also, the final rule makes technical corrections to the current regulations and corrects minor mistakes.
b. The Unemployment Compensation Amendments of 1992, Public Law 102-318, added Section 203(f), EUCA, to provide for an optional alternative indicator that States may use to trigger “on” EB based on the TUR. That indicator requires that, for the most recent 3 months for which data for all States is published, the average TUR in the State (seasonally adjusted) for the most recent 3-month period equals or exceeds 6.5 percent and the average TUR in the State (seasonally adjusted) equals or exceeds 110 percent of the average TUR for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The 1992 amendments also provided for a calculation of a “high unemployment period” when the TUR in a State equals or exceeds 8 percent and meets the 110-percent look-back described above, permitting the payment of additional weeks of EB. Section 203(f)(3), EUCA, provides that “determinations of the rate of total unemployment in any State for any period . . . shall be made by the Secretary.” An EB period ends when the State no longer meets any of the “on” triggers provided for in State law.
To conform the regulations to current practice, the Department is issuing this final rule to describe how the TUR indicators are computed for purposes of determining whether a State meets the 110 percent look-back requirements. The final rule regulations at 20 CFR 615 implement the provisions of EUCA relating to the insured unemployment rate (IUR) indicators, including how they will be computed. The regulation, at 20 CFR 615.12, explains the IUR triggers and how the rates are computed. Until this final rule, the regulation did not address the TUR indicator although the Department issued UIPLs No. 45-92 and No. 16-11, respectively, addressing the TUR indicator and its computation.
Because of these differences in the calculation of the insured and total unemployment rates, the appropriate methodology for computing the look-back percentage for the TUR indicator is to switch from truncation at the second decimal place, which is used for calculating the IUR indicator, to rounding to the second decimal place.
This rule has not been designated an economically significant rule under section 3(f) of Executive Order 12866. However, the Department provides an analysis of the impact of the final rule, including a costs and benefits analysis under Executive Order 13563, in the Administrative Section of this final rule. This costs and benefits analysis was conducted for the proposed rule. Since the Department made no changes in the final rule, a new analysis was not conducted.
The Preamble to this final rule is organized as follows:
An understanding of the basic elements that comprise the mechanisms used to determine if EB is payable in a State is necessary to appreciate the dynamics of the EB program. EB programs can be triggered by two different measures for unemployment: The IUR and TUR. The table below compares the characteristics of each.
EB is payable in a State only during an EB period of unusually high unemployment in the State. Section 203 of the Federal-State Extended Unemployment Compensation Act of 1970 (EUCA), Public Law 91-373, provides methods for determining whether a State's current unemployment situation qualifies as an EB period. EB periods are determined by “on” and “off” indicators (commonly referred to as triggers) in the State. Section 203(d), EUCA, provides for an “on” indicator based on the IUR. The IUR is computed weekly by the States using administrative data on State unemployment compensation claims filed and the total population of employed individuals covered by unemployment insurance. States trigger “on” EB if the IUR trigger value for the most recent 13-week period equals or exceeds 5 percent and equals or exceeds 120 percent of the average of such trigger values for the corresponding 13-week period ending in each of the preceding 2 calendar years. The calculation of the relationship between the current rate and prior 2 years' rates is commonly referred to as the “look-back.”
The Unemployment Compensation Amendments of 1992, Public Law 102-318, added Section 203(f), EUCA, to provide for an optional alternative indicator that States may use to trigger “on” EB based on the TUR. That indicator requires that, for the most recent 3 months for which data for all States is published, the average TUR in the State (seasonally adjusted) for the most recent 3-month period equals or exceeds 6.5 percent and the average TUR in the State (seasonally adjusted) equals or exceeds 110 percent of the average TUR for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The 1992 amendments also provided for a calculation of a “high unemployment period” when the TUR in a State equals or exceeds 8 percent and meets the 110 percent look-back described above, permitting the payment of additional weeks of EB. Section 203(f)(3), EUCA, provides that “determinations of the rate of total unemployment in any State for any period . . . shall be made by the Secretary.” An EB period ends when the State no longer meets any of the “on” triggers provided for in State law.
Regulations at 20 CFR part 615 implement the provisions of EUCA relating to the IUR indicators, including how they will be computed. The regulation at 20 CFR 615.12 explains the IUR triggers and how the rates are computed. The regulation does not address the TUR indicator although the Department issued UIPLs No. 45-92 and No. 16-11, respectively, addressing the TUR indicator and its computation. To conform the regulations to current practice, the Department is issuing this final rule to describe how the TUR indicators are computed for purposes of determining whether a State meets the 110 percent look-back requirements.
In the absence of explicit guidance and regulation, the Department previously adapted a portion of the existing guidance for the IUR look-back as a basis for calculating the TUR look-back. Specifically, in computing the look-back percentage for the TUR trigger the procedure for determining the number of significant digits from the resulting fraction followed 20 CFR 615.12(c)(3).
The TUR indicator uses total unemployment rates determined by the Bureau of Labor Statistics (BLS). These rates are measured using sampled data and therefore are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth, or second decimal place. Additionally, rounding, rather than truncating, is consistent with BLS practices in treating the TUR data. UIPL No. 16-11, dated May 20, 2011,
Section 3304(a)(11) of the Federal Unemployment Tax Act (26 U.S.C. 3301
There were two “on” and “off” indicators in existence before the enactment of the UC Amendments. These indicators were based on the IUR. The IUR indicator's trigger value is, under section 203(e) of EUCA, the ratio of the average number of unemployment claims filed in a State during the most recent 13 weeks to the average monthly number of employed individuals covered by UC in that State during the first four of the last six completed calendar quarters. The first indicator has two conditions which must be met and is required to be in State law. Under section 203(d) of EUCA, the EB Program is activated if a State's IUR trigger value (first condition) is at least 5 percent (referred to as the regular IUR trigger threshold with “look-back”), and is at least 120 percent of the average of the trigger values in the prior 2 years for the corresponding 13-week calendar periods (second condition). The second condition—that the most recent 13-week period must be at least 120 percent of the average of the corresponding periods in the last 2 years—is commonly referred to as the “look-back” provision. (The Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312, allowed States to temporarily modify provisions in their EB laws to use the prior 3 years in applying the look-back.) The look-back provision supports activation of a State's EB Program only when the current unemployment rate is both high and increasing, which indicates that the State's labor market is worsening and additional compensation is warranted. Under the second indicator, which is an option for a State, section 203(d) of EUCA provides the EB Program may be triggered “on” with an IUR trigger value of at least 6 percent regardless of its relation to the IUR trigger values in the preceding 2 years. The 6 percent value is referred to as the regular IUR trigger threshold without look-back.
Because the IUR indicator failed to trigger many States “on” to the EB Program during the recession of the early 1990s, the UC Amendments amended the EUCA to permit States to adopt an alternative, more labor market sensitive, indicator based on the TUR to trigger “on” and “off” the EB Program. Specifically, paragraph (f) of section 203 of EUCA provides for a TUR indicator comprised of a Trigger Value and look-back provision. The Trigger Value for this indicator is the 3-month average of seasonally adjusted TURs for the most recent 3 months for which data for all States is published. The regular TUR trigger threshold is 6.5 percent. The look-back provision requires that the Trigger Value equals or exceeds 110 percent of the TUR Trigger Values for either or both of the corresponding 3-month periods in the 2 preceding calendar years. The TUR Trigger Value is determined by the Department based on data from BLS.
As with the IUR indicator, the look-back provision ensures that the State's TUR Trigger Value is both high and increasing, indicating that the State's labor market is worsening and additional compensation is warranted. A State will trigger “off” its EB Program when either the TUR Trigger Value falls below 6.5 percent, or the requirements pertaining to the look-back provision are not satisfied.
Regardless of whether a State's EB Program is triggered “on” based on the IUR or TUR indicators, sections 203(d)(2) and 203(f)(1)(B) of EUCA provide that the EB period is triggered “off' when the conditions supporting the activation of the EB Program are no longer satisfied. Additionally, when the program triggers “on” or “off” EB payments, it must remain in the new status (“on” or “off” EB payments) for a minimum of 13 weeks regardless of changes in future trigger values.
The Department implemented EUCA's provisions on the IUR indicator at 20 CFR part 615, published in 53 FR 27928, Jul. 25, 1988. The Department implemented the alternative TUR indicator provided by the UC Amendments through guidance on August 31, 1993 (UIPL No. 45-92). The Department now incorporates the TUR indicator into regulations.
The UC Amendments provided that States electing to use the new TUR indicator must also provide for the payment of additional weeks of EB during a “high unemployment period” that occurs during an EB period. These additional weeks of EB are available if State law provides for the use of the alternative TUR indicator.
Consistent with EUCA § 203(b)(1), no EB period or high unemployment period may begin in any State by reason of a State “on” indicator before the 13-week minimum status period expires after the ending of a prior EB period with respect to such State. Conversely, no EB period or high unemployment period may end in any State by reason of a State “off” indicator before the 13-week minimum status period expires after the beginning of an EB period with respect to such State.
EUCA originally provided for the establishment of an EB account, and the amount in the account is the least of one of three amounts which is payable for regular extended compensation. The UC amendments added a new paragraph to section 202(b) of EUCA that increases the amount in these accounts during a high unemployment period. The amount payable in a high unemployment period is equal to whichever of the following is the least and is referred to as “high unemployment extended compensation”:
The term “high unemployment period” is defined in Section 202(b)(3)(B), EUCA, as any period during which an EB Program would be in effect if the TUR indicator equaled or exceeded 8 percent and the TUR indicator equals or exceeds 110 percent of the TUR indicators for either or both the corresponding 3-month periods in the 2 previous calendar years.
Whether a high unemployment period exists in a State for a particular week is determined in accordance with provisions of State law implementing sections 202(b)(3) and 203(f) of EUCA
Before April 16, 2011, in absence of explicit statutory guidance and regulation, the Department adapted a portion of the requirement (in 20 CFR 615.12) for calculating the look-back percentage for the IUR indicator as a basis for determining the significant number of digits from the look-back percentage for the TUR indicator. Specifically, the quotient is computed to two decimal places and multiplied by 100 with all numbers to the right of the decimal point being dropped (known as “truncation”). The result is expressed as a percentage.
The UC Amendments provide for a State to trigger “on” EB using the TURs determined by BLS. As discussed above, because the TUR indicator uses unemployment rates determined by BLS using sampled data, the rates are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth. In contrast, the IUR indicator values are computed from administrative data and thus represent the full universe. Because of these differences in the calculation of the insured and total unemployment rates, on May 20, 2011 the Department announced, in UIPL No. 16-11, that an appropriate methodology for computing the look-back percentage for the TUR indicator is to switch from truncation at the second decimal place to rounding to the second decimal place.
UIPL No. 16-11 informed States of the new rounding methodology the Department now employs when computing the current trigger rate as a percent of the comparable trigger rates in prior years for the TUR indicator. Since TURs have been rounded, an expression of a ratio of two TURs must also be rounded.
On a monthly basis, the 3-month average of the seasonally adjusted TUR is divided by the same measure for the corresponding 3 months in each of the applicable 2 prior years. The resulting decimal fraction is then rounded to the hundredths place (the second digit to the right of the decimal place). The resulting number is multiplied by 100, reported as an integer, and compared to the statutory threshold to determine if the State triggers “on” EB. UIPL No. 16-11 informed the SWAs that the full effect of this new rounding procedure was implemented retroactive to April 16, 2011.
The Department published the Notice of Proposed Rulemaking (NPRM) on the subject of this final rule in the
At the close of the 60-day public comment period at midnight on December 26, 2014, the Department had received one public comment. After a careful analysis of the comment, which was posted on
Therefore, because the Department did not receive any comments that required a response on the NPRM, this final rule adopts the regulation as proposed, with minor technical corrections explained below.
The final rule updates 20 CFR part 615 so that it includes the TUR indicator. In addition, the final rule updates Part 615 to incorporate the rounding method adopted for the look-back. Also, the final rule makes technical amendments to this part to update its provisions since the last regulatory revision and to correct minor errors in the text of the existing regulations.
However, since the NPRM publication, the Department discovered that minor technical corrections were needed. A non-substantive technical addition of a phrase was made in the definition of “Department” in § 615.2 to acknowledge that a Secretary's Order delegating authority to ETA can be superseded. A non-substantive technical addition was made in the definition of “Extended compensation” in § 615.2 to clarify that “extended benefits” can be used interchangeably with “extended compensation.” Non-substantive deletions were made, in the definition of “Extended unemployment compensation” in § 615.2, of paragraphs (3) and (4). Paragraph (3) of § 615.2 in the NPRM was deleted because it redundantly repeats the substance in paragraph (1) of that section. Paragraph (4) of § 615.2 was deleted because it was placed in this location of the NPRM erroneously, simply as a typographical error.
For ease of reading § 615.2, the definitions in this section have been printed in their entirety. The following definitions are unchanged with the exception of changing Act to EUCA where appropriate: Additional compensation; And; Applicable State; Applicable State law; Average weekly benefit amount; Base period; Benefit structure; Benefit year; Claim filed in any State under the interstate benefit payment plan; Compensation and unemployment compensation; Date; Employed; Gross average weekly remuneration; Hospitalized for treatment of an emergency or life-threatening condition; Individual's capabilities; Jury duty; Reasonably short period; Regular compensation; Secretary; State; State agency; State law; systematic and sustained effort; Tangible evidence; and Week of unemployment. Also, an “s” was removed from the word “mean” in the definition of “Employed,” and since the paragraph designations were removed in order to reorder the definitions alphabetically, the phrase “(n)(2) of this section” was replaced with “(2) of this definition” in paragraph (1), and the phrase “(n)(1) of this section” was replaced with “(1) of this definition” in paragraph (2) in the definition of “Week of unemployment.”
Paragraph (a) of § 615.7 in the NPRM was revised in the final rule to delete the following language—
Removing the term “Extended Benefits” wherever it appears and replacing it with the term “Extended compensation” throughout.
Non-substantive deletions were made in paragraph (d) of § 615.11, which discusses the limitations in an extended
Three technical corrections were made in § 615.12. First, “our concurrence” was replaced with “the concurrence of the Department” in paragraph (d)(1). Second, in paragraph (d)(2), “Bureau of Labor Statistics” was spelled out since it is the first use in the rule text, and the paragraph was slightly revised to clarify that unemployment data released by BLS for each month have an initial release and then regular revisions. Third, an identical sentence in paragraphs (e)(1)(ii) and (e)(2)(ii) referencing the Tax Relief, Unemployment Insurance Reauthorization, and Job Creation Act of 2010, Public Law 111-312, was deleted from both paragraphs because it describes a temporary provision of law that no longer applies. Several non-substantive additions and deletions were made in § 615.13. The first was to clarify that paragraphs (a) and (b) were revised by adding paragraphs (a)(1), (a)(2), (b)(1), (b)(2), and (b)(3). Second, the phrase “the Department determines” was added after the word “which” in paragraph (a)(1). Third, the phrase “or high unemployment period” was added in paragraphs (a)(1) and (a)(2). Fourth, “a result of our determination” was replaced with “determined by the Department to be” in paragraph (a)(1).
Finally, typographical errors were corrected in §§ 615.2, 615.12, 615.13, 615.14, and 615.15. In § 615.2, a comma was added after the word “published” in the definition of “High unemployment period,” and “is” was replaced with “as” before the word “described” in the definition of “Trigger Value.” In § 615.12, an “s” was added to the word “State” in paragraph (e)(2)(i), and “However” was deleted and the “t” in the word “the” was capitalized to begin the sentence in paragraph (f). In paragraph (a)(1) of § 615.13, “the” was replaced with “a” before the word “notice”; “to us” located after the word “acceptable” was deleted; “we” was replaced with “the Department”; “will” was added before the phrase “publish in the
The final rule, as explained also in the discussion of Paperwork Reduction Act requirements below, retains proposed revisions in the NPRM to regulatory requirements at § 615.15, pertaining to records and reports State agencies must submit. Paragraphs (a) and (b) are revised for clarity by deleting unnecessary language regarding the Secretary's authority to request Extended Benefit Program reports and to appoint audit officials for those reports. Furthermore, the final rule deletes paragraphs (c) and (d). In reference to reporting guidelines discussed in the Paperwork Reduction Act, the ET Handbook is a more effective way to communicate reporting requirements, because codifying the reporting requirements in paragraphs (c) and (d) of § 615.15 prevents the Department from adapting reporting instructions to changing conditions or needs. The ET Handbook requires the weekly submission of Forms ETA-538 and ETA-539. These forms have been computerized and contain information on initial Unemployment Insurance claims and continued weeks claimed. These figures are important economic indicators. Form ETA-538 provides information allowing release of advance unemployment claims information to the public five days after the close of the reference period. Form ETA-539 contains more detailed weekly claims information and the State's 13-week IUR that is used to determine eligibility for the Extended Benefits program. The reporting requirements in paragraphs (c) and (d) of the old regulation are included in the ET Handbook, and elimination of the requirements in regulation allow for ease in making future modifications by simply updating the ET Handbook.
Furthermore, paragraph (d) existed during the implementation phase of the IUR indicator and required States to submit the method used to identify and select the weeks used for EB trigger purposes to ensure that States were consistent and comparable in their methods. With 30 years of experience, as well as numerous data validation and data quality programs in effect, the Department has determined it is unnecessary to compel State administrators to provide this information. Current reporting guidelines contained in the ET Handbook are clear enough that States continue to have clear standards about which claims are used for constructing totals used to compute trigger values, thus permitting the deletion of this paragraph. The NPRM did not change the existing reporting requirements for Forms ETA-538 or ETA-539, and the Department received no substantive comments on the NPRM during the public comment period.
Executive Orders (E.O.) 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects; distributive impacts; and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, reducing costs, harmonizing rules, and promoting flexibility.
Section 3(f) of E.O. 12866 defines a “significant regulatory action” as an action that is likely to result in a rule that: (1) Has an annual effect on the economy of $100 million or more or adversely and materially affects a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or Tribal governments or communities (also referred to as “economically significant”); (2) creates serious inconsistency or otherwise interferes with an action taken or planned by another agency; (3) materially alters the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raises novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866. Regarding item (4), any novel legal or policy issues raised by this rule do not arise from legal mandates, Presidential priorities, or the principles set forth in E.O. 12866.
For a “significant regulatory action,” E.O. 12866 asks agencies to describe the need for the regulatory action and explain how the regulatory action will meet that need, as well as assess the
EUCA, as amended by the UC Amendments, requires two conditions be met for a TUR-based “on” indicator to occur in a State: (1) For the most recent 3 months for which data for all States is published, the 3-month average seasonally adjusted TUR in the State equals or exceeds 6.5 percent, and (2) that the Trigger Value equals or exceeds 110 percent of the Trigger Values for either or both of the corresponding 3-month periods in the 2 preceding calendar years (look-back). The UC Amendments also provide for a “high unemployment period” when the TUR Trigger Value in a State equals or exceeds 8 percent and meets the 110 percent look-back described above, permitting the payment of additional weeks of compensation.
Under the original methodology by which the Department determined the look-back criterion for the optional TUR indicator, the indicator's Trigger Value was divided by the indicator's Trigger Value for the comparable period in the preceding year and 2nd preceding year. Digits beyond the hundredths place (the second digit to the right of the decimal place) in the resultant decimal fractions were truncated and the results multiplied by 100 to determine the percent the current indicator Trigger Value was of the indicator Trigger Value in the comparable periods in the prior years. If the result was greater than or equal to 110 for one of the fractions, the look-back criterion was met. This approach paralleled the method used for the IUR look-back computation established in regulations at 20 CFR 615.12(c)(3); however, neither the law nor regulations specify the method for computing the TUR indicator look-back.
The Department is changing the method for computing the TUR look-back by rounding to the hundredths place, rather than truncating. The TUR indicator uses total unemployment rates determined by BLS. These rates are measured using sampled data and therefore are imprecise due to sampling error. In order to ensure that the TUR indicator is measured with more consistency to similar measures, and to the extent possible, a more accurate measure, the Department has determined that an appropriate methodology for computing the look-back on the TUR indicator is to switch from truncation to rounding to the nearest hundredth, or second decimal place. In contrast, IUR indicators are computed from administrative data and thus represent the full universe. Because of these differences in the computation of the insured and total unemployment rates, the Department has determined that an appropriate methodology for computing the look-back for the TUR indicator is to switch from truncation at the second decimal place, to rounding to the second decimal place. Rounding, rather than truncating, is consistent with BLS practices for TUR data. UIPL No. 16-11, dated May 20, 2011, informed the SWAs that the full effect of this new rounding procedure was implemented retroactive to April 16, 2011.
Changing the look-back computational method will have a marginal economic impact because of the new rounding method and no increased operational burden because it would result in no change in claimant behavior or in procedure from the existing process.
The UI program is a transfer payment program. For the purposes of a cost-benefit analysis under E.O.s 13563 and 12866, transfer payments are not considered a cost. Therefore, the analysis will be on the possible redistribution of wealth that may take place, as opposed to any impact on aggregate social welfare.
The actual future impacts of changing the look-back calculation on the flow of UI benefits and taxes are dependent upon the unemployment rate in relation to the TUR trigger threshold and the number of States that have actually implemented the optional TUR indicator. Historically, the proportion of months that the EB Program has been in effect was extremely low, due primarily to a relatively high threshold in relation to the level of unemployment, unwillingness by States to adopt the optional indicators, and Federal emergency benefit programs that at times can and have supplanted the EB Program. For example, on average for the 1991 and 2001 high unemployment periods, State indicators were “on” in roughly 3 percent of the State trigger months.
Only seven States adopted the optional TUR indicator upon its introduction in 1993. Then from 1994 through 2008, only four more States added the TUR indicator to their State law, bringing the number to 11 at the start of 2009 (see Table 2). The number of States implementing the optional TUR indicator and how often the EB Program is actually activated are critical pieces of information for estimating the impacts of the look-back rounding methodology change. In 2009, as part of the American Recovery and Reinvestment Act (Recovery Act), the Federal government began paying 100 percent of extended compensation and high unemployment extended compensation, so the number of States that adopted the optional TUR indicator went up to 38 in 2009, then 39 in 2011.
ETA used two distinct methodologies, a time-series simulation and a Monte Carlo-type simulation analysis (each explained more fully below), to provide quantitative impact estimates for the change in the level and timing of the UI benefits paid and taxes collected as a result of the change in formulation of the TUR indicator. The specific goal of these two analyses is to provide a quantitative measure for: (1) The increased probability of a State turning “on” the EB Program under the new rounding rules, and (2) the likely change in the aggregate level of UI benefits and taxes with each instance of additional EB benefits paid. The results of these measures will allow a determination of the economic impact of that occurrence of additional EB benefits paid on the overall economy and on any subgroups.
The time-series simulation estimates are developed using a historical simulation methodology: By first applying the existing TUR indicator computation, and then applying the new rounding rules to data from a specified period of time and measuring the difference in outcomes. To examine the impact on outcomes, the data used is from the introduction of the optional TUR indicator in 1993 through September 2011 when this analysis was completed. This period encompasses two recessions of varying severity, two complete economic cycles, and a large number of States turning “on” the EB Program. This period also includes the temporary period of 100 percent Federal reimbursement of EB benefit payments when a majority of States, 39, adopted the TUR indicator.
The baseline case is considered to be the simulated outcomes under the current TUR look-back computation for the States that had adopted the optional TUR indicator. For each month during this historical period (January 1993 through September 2011), the actual seasonally adjusted 3-month average TUR
The seven instances included six different States. In four of the instances, the State was triggering “on” because of the 8.0 percent high unemployment period. In none of the instances were there two consecutive months in which a State had a different EB triggering outcome under the new rounding methodology compared to the truncation method. Two of the instances when States triggered “on” EB due to the rounding calculation occurred following the 1991 recession, one occurred following the 2001 recession, and four occurred following the 2007 recession when 39 States had adopted the optional TUR indicator (see Table 4). In six of the seven occurrences, the difference in the look-back calculation occurred in the 2nd prior year look-back calculation.
The 0.6 percent increase in the EB Program's being “on” in this simulation represents the percentage likelihood change in the number of times that the EB Program would trigger “on” due solely to the change in formulation of the look-back mechanism for, on average, 13 States having the TUR indicator in place. Therefore, the likelihood of a State turning “on” the EB Program with the new rounding formulation may be represented by .05 percent (.6/13).
The time series estimates used the actual State unemployment rates as they occurred from 1993 through September 2011 and include only the States which had adopted the optional TUR indicator. To provide further support for the estimate of the difference in the number of times the EB Program may trigger “on” due to rounding in the look-back calculation during a recession, an additional analysis was employed based on a Monte Carlo-type methodology. The Monte-Carlo methodology allows the simulation of thousands of possible State TUR values rather than just the historical values used in the time series analysis. Thirteen States—the seven original States that adopted the optional TUR indicator and six additional randomly selected States—were chosen,
Across the States this represents, on average, a 1.7 percent (81/4822) increase in the likelihood of turning “on” the EB Program under the new rounding rules (see Table 6). This also represents the cumulative difference of the 13 States, meaning that each State in this simulation could be considered to have added a 0.13 percent increase of an added instance of turning “on” the EB Program (1.7/13). This value will be used as the per-State increase in the likelihood of turning “on” the EB Program under the new rounding rules in this simulation.
The revision to the TUR indicator computation methodology will result in increased benefits payments during a recession, which provide temporary income support and greater economic stimulus than would otherwise exist during that economic time period. This increased economic stimulus will prevent greater economic distress during a recession. This impact is not a true benefit of the rule because, as explained above, the TUR indicator formulation would redistribute existing transfer payments only over time. That is, a change to increase extended benefits during recessions will ultimately increase the counter-cyclical nature of the program by increasing stimulus during recessions while doing the opposite during expansions.
Total Wkly Extended Compensation EB Benefits = Σ (Reg. Program Wkly Exhaustions
Applying this computation to the seven State periods that turned “on” the EB Program under the rounding formulation in the time series simulation, it was estimated that in total
Again, dividing these results into the per State added percentage point increase for each instance of triggering “on” the EB Program means there would be a 0.17 percent increase in extended compensation paid
In terms of how the increased extended compensation paid would be distributed among subgroups of EB recipients, attempting to disaggregate this level of benefits into numerically small select subgroups of claimants such as low-wage workers, or minority claimants, would mean working with monetary flows of very little statistical consequence. Therefore, the Department has determined that no distributional analysis is necessary.
The revision to the TUR indicator computation methodology will result in increased economic stimulus during recessions. However, a significant increase in extended compensation may result in a State UI tax increase on employers. An increased UI tax on employers might result in dampened overall economic activity as employers postpone equipment purchases or hiring. This impact does not represent a true cost of the changes made in this rule because it is associated with a corresponding transfer of payments to EB recipients during recessions. That is, the regulation would result in redistribution of wealth over time (based on the counter-cyclical nature of the EB Program), rather than have a net social welfare impact.
The Federal monies for extended compensation flow from EUCA, which is also used to fund additional Federal emergency benefit programs. Historically, the balance of this account has been sufficient to pay the level of extended compensation during a recession and would therefore be much greater than the estimated amounts that may result from the change in the look-back mechanism.
On the State side, every State has a tax structure that responds with higher taxes when the amount of reserves in its UTF account declines.
Using the estimated increase of extended compensation paid (due to the TUR indicator rounding computation) from the time-series simulation, $294 million, an estimate was derived for the amount of potential State tax increases by assuming the increase in extended compensation was divided among the average number of States that experienced an increase in extended EB compensation paid over a 10-year period. To arrive at an estimate for the expected increase in State unemployment compensation taxes due to a change in the rounding rule for the look-back feature of the TUR indicator, 50 percent of the total extended compensation, $147 million, is assumed to be financed by seven States for an average of $21 million per State. The amount is assumed to be financed by increased State taxes over a 10-year period for an average of $2.1 million per year. This amount represents an estimated increase of 0.14 percent
In terms of specific distribution of these impacts, disaggregating the tax increases into subgroups of employers such as small businesses would mean working with monetary flows of very little consequence. Therefore, the Department has determined that no distributional analysis is necessary.
OMB Circular No. A-4 requires the identification of any non-quantifiable benefits and costs that cannot be reasonably measured.
Regarding the secondary impacts from increased temporary income during recessions and increased employer taxes during expansions, the Department has determined that the estimates of extended compensation and UI tax increases are too small to meaningfully model their impact on the macro economy. With a likely impact of increasing the number of instances the EB Program triggers “on” by two during an average recession and nine instances during a severe recession (as computed in detail in the scenarios below), these impact numbers are too small to model any stimulus impact during a recession or a dampening effect of the tax increases during expansions. Not only are the impacts on extended compensation and taxes small compared to the U.S. economy (
By increasing the overall level of benefits paid by States during recessionary periods, the change in TUR indicator computation methodology would aid in the counter-cyclical nature of the Unemployment Compensation program by increasing the economic stimulus during recessions and possibly dampening overall activity with possible higher taxes. The estimates for the increased probability of States triggering “on” the EB Program, increased benefits, higher first payments, and potential changes to UI taxes, can provide estimates for the change in flows of the Unemployment Compensation program that this proposal may cause under various future recessionary scenarios.
The preceding impact analysis focused on changing the computational methodology of the TUR look-back provision. Since the Department is not considering the removal of the optional TUR indicator, the analysis does not measure the impact of the original adoption of the TUR indicator in 1992. However, it should be noted that a review of the most evident differences caused by the implementation of this option shows a rather small impact.
From 1993 to 2006, for the 11 States that adopted the TUR indicator by 2006 (Table 2), EB costs are totaled for each period when one of these States triggered on to the EB Program with the TUR option but would not have turned on extended compensation under the IUR option.
This is a relatively small number of States and amount spent, on average approximately $22 million per year, and in no year did the amount spent on extended compensation from States that triggered on using the TUR option ever exceed $100 million. Indeed, measuring the change in cyclical financial flows of the UI program does not seem necessary under these aggregates.
Placing the optional TUR indicator in regulations does not impose any additional change in burden, since no change in the operational procedure will occur. In addition, it incorporates in regulations the computational methodology previously communicated in UIPL No. 16-11 for the TUR's look-back.
Changing the look-back computation does have an impact, although it is estimated to be small. For each State that adopted the optional TUR indicator, it was found that the new rounding rule would likely add a 0.13 percentage point increase in the likelihood of a single State triggering “on” the EB Program during a recession. For each State that triggered “on” the EB Program, it would likely add a 0.17 percent increase in the level of extended compensation paid, a 0.22 percent increase in people receiving extended compensation, and a per State increase in unemployment compensation taxes of 0.14 percent per year. These numbers indicate a negligible impact on the redistribution of the flows (unemployment compensation and taxes) in the Unemployment Compensation program. These impacts are so small that any stimulative or distributional effects would be considered of little consequence. Indeed, the probable economic impact encompasses the likely possibility (depending on the future level of the TUR) that there would be no measurable impact from a change in the derivation of the TUR indicator due to rounding the look-back proportion as opposed to truncating that value.
The purposes of the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501
A Federal agency may not conduct or sponsor a collection of information unless it is approved by OMB under the PRA, and displays a currently valid OMB control number, and the public is not required to respond to a collection of information unless it displays a currently valid OMB control number. Also, notwithstanding any other provisions of law, no person shall be subject to penalty for failing to comply with a collection of information if the collection of information does not display a currently valid OMB control number (44 U.S.C. 3512).
The Department published an NPRM on October 27, 2014, in the
The preamble to the NPRM stated that the Department had determined the proposed rule did not contain new information collections. However, to ensure transparency and full opportunities for public participation under all appropriate authorities, the Department is submitting an Information Collection Request (ICR) to the Office of Management and Budget (OMB) to revise the PRA approval for the information collections to reflect this rulemaking. See 44 U.S.C. 3506(c)(2)(B); 5 CFR 1320.11. As part of that process, the Department sought public comments on the removal of specific information collection requirements in the NPRM and on the general Extended Benefit reporting requirements in Handbook 401 and Forms ETA 538 and 539 in light of specific areas of interest to minimize so-called “paperwork” burdens on the public. The Department published a notice in the
Concurrent with the publication of this final rule, the Department is submitting an ICR to OMB for approval. The Department will publish a
Section 6 of Executive Order 13132 requires Federal agencies to consult with State entities when a regulation or policy may have a substantial direct effect on the States or the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of government, within the meaning of the Executive Order. Section 3(b) of the Executive Order further provides that Federal agencies must implement regulations that have a substantial direct effect only if statutory authority permits the regulation and it is of national significance.
This final rule does not have a substantial direct effect on the States or the relationship between the National Government and the States, or the distribution of power and responsibilities among the various levels of Government, within the meaning of the Executive Order 13132. Any action taken by a State as a result of the final rule would be at its own discretion as the rule imposes no requirements.
This regulatory action has been reviewed in accordance with the Unfunded Mandates Reform Act of 1995 (Reform Act). Under the Reform Act, a Federal agency must determine whether a regulation proposes a Federal mandate that would result in the increased expenditures by State, local, or tribal governments, in the aggregate, or by the private sector, of $100 million or more in any single year. The Department has determined this final rule does not include any Federal mandate that may result in increased expenditure by State, local, and Tribal governments in the aggregate of more than $100 million, or increased expenditures by the private sector of more than $100 million.
Accordingly, it is unnecessary for the Department to prepare a budgetary impact statement. Further, as noted above in the conclusion of the economic impact analysis, the impact is positive for State UTF accounts.
The Department certifies that this final rule has been assessed according to section 654 of the Treasury and General Government Appropriations Act, enacted as part of the Omnibus Consolidated and Emergency Supplemental Appropriations Act of 1999 (Pub. L. 105-277, 112 Stat. 2681), for its effect on family well-being. It will not adversely affect the well-being of the nation's families. Therefore, the Department certifies that this final rule does not adversely impact family well-being.
The Regulatory Flexibility Act (RFA) at 5 U.S.C. 603(a) requires agencies to prepare and make available for public comment an initial regulatory flexibility analysis which will describe the impact of the final rule on small entities. Section 605 of the RFA allows an agency to certify a rule, in lieu of preparing an analysis, if the final rulemaking is not expected to have a significant economic impact on a substantial number of small entities. Furthermore, under the Small Business Regulatory Enforcement Fairness Act of 1996, 5 U.S.C. 801 (SBREFA), an agency is required to produce compliance guidance for small entities if the rule has a significant economic impact on a substantial number of small entities.
The RFA defines small entities as small business concerns, small not-for-profit enterprises, or small governmental jurisdictions. The final rule does not regulate small entities. As a result, any indirect impact on small entities would be from a tax increase resulting from a State triggering “on” because of the new computation method for the look-back. Therefore, the Department certifies that the final rule will not have a significant economic impact on a substantial number of these small entities.
The Department drafted this final rule in plain language.
Grant programs-labor; Reporting and recordkeeping requirements; Unemployment compensation.
For the reasons discussed in the preamble, ETA amends 20 CFR part 615 as follows:
26 U.S.C. 7805; 26 U.S.C. 1102; Secretary's Order No. 6-10.
This part implements the “Federal-State Extended Unemployment Compensation Act of 1970” (EUCA). Under the Federal Unemployment Tax Act, 26 U.S.C. 3304(a)(11), an approved State law must provide for the payment of extended compensation to eligible individuals who have exhausted all rights to regular compensation during specified periods of unemployment, as prescribed in EUCA and this part.
For the purposes of the EUCA and this part—
(1) Amounts of regular weekly benefit payments,
(2) Amounts of additional and extended weekly benefit payments,
(3) The State maximum or minimum weekly benefit,
(4) Partial and part-total benefit payments,
(5) Amounts payable after deduction for pensions, and
(6) Amounts payable after any other deduction required by State law.
(1) Any interstate claim for a week of unemployment filed pursuant to the Interstate Benefit Payment Plan, but does not include—
(i) A claim filed in Canada,
(ii) A visiting claim filed by an individual who has received permission from his/her regular reporting office to report temporarily to a local office in another State and who has been furnished intrastate claim forms on which to file claims, or
(iii) A transient claim filed by an individual who is moving from place to place searching for work, or an intrastate claim for Extended Benefits filed by an individual who does not reside in a State that is in an Extended Benefit Period,
(2)
(1) The weeks in the individual's applicable benefit year which begin in an extended benefit period or high unemployment period, or for a single benefit year, the weeks in the benefit year which begin in more than one extended benefit period or high unemployment period, and
(2) If the applicable benefit year ends within an extended benefit period or high unemployment period, any weeks thereafter which begin in such extended benefit period or high unemployment period,
(3) An individual may not have more than one eligibility period for any one exhaustion of regular benefits, or carry over from one eligibility period to another any entitlement to extended compensation.
(1) Regular extended compensation paid to an eligible individual under those provisions of a State law which are consistent with EUCA and this part, and that does not exceed the smallest of the following:
(i) 50 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or
(ii) 13 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or
(iii) 39 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year; or
(2) High unemployment extended compensation paid to an eligible individual under an optional TUR indicator enacted under State law when the State is in a high unemployment period, in accordance with § 615.11(e) of this part, and that does not exceed the smallest of the following:
(i) 80 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or
(ii) 20 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or
(iii) 46 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.
(1) Extended compensation paid to an eligible individual under those provisions of a State law which are consistent with EUCA and this part, and that does not exceed the smallest of the following:
(i) 50 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or
(ii) 13 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or
(iii) 39 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.
(2) Extended compensation paid to an eligible individual under an optional TUR indicator enacted under State law when the State is in a high unemployment period, in accordance with § 615.12(f) of this part, and that does not exceed the smallest of the following:
(i) 80 percent of the total amount of regular compensation payable to the individual during the applicable benefit year; or
(ii) 20 times the individual's weekly amount of extended compensation payable for a week of total unemployment, as determined under § 615.6(a); or
(iii) 46 times the individual's weekly benefit amount, referred to in paragraph (1)(ii) of this definition, reduced by the regular compensation paid (or deemed paid) to the individual during the applicable benefit year.
(3) Regular compensation paid to an eligible individual for weeks of unemployment in the individual's eligibility period, but only to the extent that the sum of such compensation, plus the regular compensation paid (or deemed paid) to the individual for prior weeks of unemployment in the applicable benefit year, exceeds 26 times and does not exceed 39 times the average weekly benefit amount (including allowances for dependents) for weeks of total unemployment payable to the individual under the State law in such benefit year: Provided, that such regular compensation is paid under provisions of a State law which are consistent with EUCA and this part.
(4) Notwithstanding the preceding provisions of this paragraph, sharable compensation does not include any regular or extended compensation for which a State is not entitled to a payment under section 202(a)(6) or 204 of EUCA or § 615.14 of this part.
A
(i) A high level of job search activity throughout the given week, compatible with the number of employers and employment opportunities in the labor market reasonably applicable to the individual,
(ii) A plan of search for work involving independent efforts on the part of each individual which results in contacts with persons who have the authority to hire or which follows whatever hiring procedure is required by a prospective employer in addition to any search offered by organized public and private agencies such as the State employment service or union or private placement offices or hiring halls,
(iii) Actions by the individual comparable to those actions by which jobs are being found by people in the community and labor market, but not restricted to a single manner of search for work such as registering with and reporting to the State employment service and union or private placement offices or hiring halls, in the same manner that such work is found by people in the community,
(iv) A search not limited to classes of work or rates of pay to which the individual is accustomed or which represent the individual's higher skills, and which includes all types of work within the individual's physical and mental capabilities, except that the individual, while classified by the State agency as provided in § 615.8(d) as having “good” job prospects, shall search for work that is suitable work under State law provisions which apply to claimants for regular compensation (which is not sharable),
(v) A search by every claimant, without exception for individuals or classes of individuals other than those in approved training, as required under section 3304(a)(8) of the Internal Revenue Code of 1986 or section 236(e) of the Trade Act of 1974,
(vi) A search suspended only when severe weather conditions or other calamity forces suspension of such activities by most members of the community, except that
(vii) The individual, while classified by the State agency as provided in § 615.8(d) as having “good” job prospects, if such individual normally obtains customary work through a hiring hall, shall search for work that is suitable work under State law provisions which apply to claimants for regular compensation (which is not sharable).
(1) For purposes of eligibility for and payment of extended compensation, a week as defined in the applicable State law.
(2) For purposes of computation of extended compensation “on” and “off” and “no change” indicators and insured unemployment rates and the beginning and ending of an EB Period or a HUP, a calendar week.
(1) A week of total, part-total, or partial unemployment as defined in the applicable State law, which shall be applied in the same manner and to the same extent to the Extended Benefit Program as if the individual filing a claim for Extended Benefits were filing a claim for regular compensation, except as provided in paragraph (2) of this definition.
(2)
* * * Conformity with EUCA and this part in the payment of regular compensation, regular extended compensation, and high unemployment extended compensation (if State law so provides) to any individual is a continuing requirement, applicable to every week as a condition of a State's entitlement to payment for any compensation as provided in EUCA and this part.
(b) * * *
(3) If State law provides, in accordance with § 615.12(e), for a high unemployment period for weeks of unemployment beginning after March 6, 1993, the provisions of paragraph (b)(1) of this section are applied by substituting:
(i) 80 percent for 50 percent in (b)(1)(i),
(ii) 20 for 13 in (b)(1)(ii), and
(iii) 46 for 39 in (b)(1)(iii).
(d)
(e) * * *
(5) * * *
(iii) The work pays less than the higher of the minimum wage set in section 6(a)(1) of the Fair Labor Standards Act of 1938, or any applicable State or local minimum wage, without regard to any exemption elsewhere in those laws, or
(f) * * *
(2) * * *
(i) The gross average weekly remuneration for the work for any week does not exceed the sum of the individual's weekly benefit amount plus any supplemental unemployment compensation benefits (as defined in section 501(c)(17)(D) of the Internal Revenue Code of 1986) payable to the individual,
(iii) The work pays less than the higher of the minimum wage set in section 6(a)(1) of the Fair Labor Standards Act of 1938, or any applicable State or local minimum wage, without regard to any exemption elsewhere in those laws, or
(h) * * *
(3) What kind of jobs he/she must be actively engaged in seeking each week depending on the classification of his/her job prospects, and what tangible evidence of such search must be furnished to the State agency with each claim for benefits. In addition, the State must inform the claimant that he/she is required to apply for and accept suitable work, and
(4) The resulting disqualification if he/she fails to apply for work to which referred, or fails to accept work offered, or fails to actively engage in seeking work or to furnish tangible evidence of such search for each week for which extended compensation or sharable regular benefits is claimed, beginning with the week following the week in which such information shall be furnished in writing to the individual.
(a)
(b)
(c)
(d)
(e)
(2) If a State concludes a 13-week mandatory “on” period by virtue of the TUR indicator which, at the end of the 13-week period no longer satisfies the requirements for a State to be “on,” the extended benefit period continues if the IUR indicator is “on” during the 11th week of the 13-week mandatory “on” period.
(f)
The additions and revisions read as follows:
(d) * * *
(1) Any determination by the head of a State agency of an “on” or “off” or “no change” IUR indicator may not be corrected more than three weeks after the close of the week to which it applies. If any figure used in the computation of a rate of insured unemployment is later found to be wrong, the correct figure must be used to redetermine the rate of insured unemployment and the 120 percent factor for that week and all later weeks, but no determination of previous “on” or “off” or “no change” indicator shall be affected unless the redetermination is made within the time the indicator may be corrected under the first sentence of this paragraph (d)(1). Any change is subject to the concurrence of the Department as provided in paragraph (e) of this section.
(2) The initial release of the TUR by the Bureau of Labor Statistics (BLS) is subject to revision. However, once a State's TUR indicator is determined using the initial release of the TUR data, it is not subject to revision even if the BLS TUR for that period of time is revised.
(3) The “on” period under a State's optional IUR or TUR indicator may not begin before the later of the date of the State's adoption of the optional insured unemployment rate or total unemployment rate indicator, or the effective date of that enactment. The “off” period under a State's optional insured unemployment rate or total unemployment rate indicator may not occur until after the effective date of the repeal of the optional insured unemployment rate or total unemployment rate indicator from State law.
(e)
(i) The Trigger Value in such State computed using the most recent 3 months for which data for all States are published before the close of such week equals or exceeds 6.5 percent; and
(ii) The Trigger Value computed using data from the 3-month period referred to in paragraph (e)(1)(i) of this section equals or exceeds 110 percent of the Trigger Value for either (or both) of the corresponding 3-month periods ending in the 2 preceding calendar years. This “look-back” is computed by dividing the Trigger Value by the same measure for the corresponding 3 months in each of the applicable prior years, and the resulting decimal fraction is rounded to the hundredths place, multiplied by 100 and reported as an integer and compared to the statutory threshold to help determine the State's EB Program status; and
(iii) There is a State “off” indicator for a week if either the requirements of paragraph (e)(1)(i) or (ii) of this section are not satisfied.
(2) Where a State adopts the optional indicator under paragraph (e)(1) of this section, there is a State “on” indicator for a high unemployment period (as defined in § 615.2) under State law if—
(i) The Trigger Value in the State computed using the most recent 3 months for which data for all States are published before the close of such week equals or exceeds 8.0 percent, and
(ii) The Trigger Value in the State computed using data from the 3-month period referred to in paragraph (e)(2)(i) of this section equals or exceeds 110 percent of the Trigger Value for either (or both) of the corresponding 3-month periods ending in the 2 preceding calendar years. This “look-back” is computed by dividing the Trigger Value by the same measure for the corresponding 3 months in each of the applicable prior years, and the resulting decimal fraction is rounded to the hundredths place, multiplied by 100 and reported as an integer and compared to the statutory threshold to help determine the State's EB Program status; and
(iii) There is a State “off” indicator for high unemployment period for a week if either the requirements of paragraph (e)(2)(i) or (ii) of this section are not satisfied.
(3)
(4)
(f)
(a)
(2)
(b)
(2) Whenever the head of a State agency receives notification from the Department in accordance with § 615.12(f) that there is an “on” indicator by reason of which an extended benefit period or high unemployment period (based on the total unemployment rate in the State) will begin in the State, or an “off” indicator by reason of which a regular extended benefit period or high unemployment period (based on the total unemployment rate) will end, the head of the State agency must promptly announce the determination through the appropriate news media in the State.
(3) Announcements made in accordance with paragraphs (b)(1) or (b)(2) of this section must include the beginning or ending date of the extended benefit period or high unemployment period, whichever is appropriate. In the case of a regular EB period or high unemployment period that is about to begin, the announcement must describe clearly the unemployed individuals who may be eligible for extended compensation or high extended compensation during the period, and in the case of a regular EB period or high unemployment period that is about to end, the announcement must also describe clearly the individuals whose entitlement to extended compensation or high extended compensation will be terminated. If a high unemployment period is ending, but an extended benefit period will remain “on,” the announcement must clearly state that fact and the effect on entitlement to extended compensation.
(c)
(2) The State agency must provide the notice promptly to each individual who begins to claim sharable regular benefits or who exhausts all rights under the State law to regular compensation during a regular extended benefit period or high unemployment period, including exhaustion by reason of the expiration of the individual's benefit year.
(3) The notices required by paragraphs (c)(1) and (2) of this section must describe the actions required of claimants for sharable regular compensation and extended compensation and those disqualifications which apply to the benefits which are different from those applicable to other claimants for regular compensation which is not sharable.
(4) Whenever there is a determination that a regular extended benefit period or high unemployment period will end in a State, the State agency must provide prompt written notice to each individual who is currently filing claims for extended compensation of the forthcoming end of the regular extended benefit period or high unemployment period and its effect on the individual's right to extended compensation.
(c) * * *
(4) As provided in section 204(a)(2)(C) of EUCA, for any week in which extended compensation is not payable because of the payment of trade readjustment allowances, as provided in section 233(c) of the Trade Act of 1974, and § 615.7(d).
(a)
(b)
Food and Drug Administration, HHS.
Final rule; extension and clarification of compliance dates for certain provisions.
The Food and Drug Administration (FDA or we) is extending the dates for compliance with certain provisions in four final rules. We are extending the compliance dates to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. In addition, we are clarifying certain compliance dates in the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption rule.
This final rule is effective August 24, 2016. See sections III.C, IV.A.2, IV.B, and V through VIII for the extended compliance dates.
This extension and clarification of compliance dates concerns four of the seven foundational rules that we have established in Title 21 of the Code of Federal Regulations (21 CFR) as part of our implementation of the FDA Food Safety Modernization Act (FSMA; Pub. L. 111-353). The four final rules are entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (published in the
In part 117 (21 CFR part 117), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (80 FR 55908, September 17, 2015). Among other things, the rulemaking to establish part 117 amended our current good manufacturing practice (CGMP) regulation for manufacturing, packing, or holding human food to modernize it and establish it in new part 117, subparts A, B, and F. Part 117 also includes new requirements for domestic and foreign facilities that are required to register under section 415 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350d) in subparts A, C, D, E, F, and G to establish and implement hazard analysis and risk-based preventive controls for human food (the human food preventive controls requirements). In the preamble of the final rule establishing part 117, we stated that the rule is effective November 16, 2015, and provided for compliance dates of 1 to 3 years from the date of publication in most cases (see table 53 in the preamble of the final rule establishing part 117, 80 FR 55908 at 56128). In the rulemaking to establish part 117, we also amended the “farm” definition in our regulations implementing section 415 of the FD&C Act (the section 415 registration regulation; 21 CFR part 1, subpart H) to clarify the scope of the exemption from registration requirements provided for “farms” and, in so doing, to clarify which human food establishments are subject to the human food preventive controls requirements, and which human food establishments are exempt from those requirements because they are “farms.”
In part 507 (21 CFR part 507), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals” (80 FR 56170, September 17, 2015). Among other things, the rulemaking to establish part 507 established new requirements for CGMPs in subparts A, B, and F (CGMP requirements) and also established requirements for hazard analysis and risk-based preventive controls for food for animals in subparts A, C, D, E, and F (the animal food preventive controls requirements). The part 507 requirements apply to domestic and foreign facilities that are required to register under the section 415 registration regulation and, thus, the “farm” definition that we amended as part of the rulemaking to establish part 117 also clarifies which animal food establishments are subject to the part 507 requirements, and which animal food establishments are exempt from those requirements because they are “farms.” In the preamble of the final rule establishing part 507, we stated that the rule is effective November 16, 2015 (80 FR 56170). We provided for compliance dates of 1 to 3 years from the date of publication in most cases for compliance with the CGMP requirements, with an additional year beyond that for compliance with the animal food preventive controls
In part 1, subpart L (21 CFR part 1, subpart L), we have established our regulation entitled “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” (the FSVP regulation; 80 FR 74226, November 27, 2015). The FSVP regulation requires importers to establish foreign supplier verification programs to verify that their foreign suppliers are using processes and procedures that provide the same level of public health protection as those required under the provisions on hazard analysis and risk-based preventive controls and standards for produce safety in the FD&C Act, that the imported food is not adulterated, and that food is not misbranded with respect to food allergen labeling. In the preamble of the final rule establishing the FSVP regulation, we stated that the rule is effective January 26, 2016, and provided for varying compliance dates based in part on the size of the foreign supplier, the nature of the importer, and whether the foreign supplier is subject to certain other FSMA regulations (80 FR 74226 at 74332 to 74333, as corrected in a technical amendment (81 FR 25326, April 28, 2016)).
In part 112 (21 CFR part 112), we have established our regulation entitled “Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” (the produce safety regulation; 80 FR 74354, November 27, 2015). Among other things, the rulemaking to establish the produce safety regulation set forth in a new part 112 procedures, processes, and practices that minimize the risk of serious adverse health consequences or death, including those reasonably necessary to prevent the introduction of known or reasonably foreseeable biological hazards into or onto produce and to provide reasonable assurances that the produce is not adulterated on account of such hazards. The produce safety regulation applies to certain produce farms, and does not apply to activities of facilities that are subject to part 117 (as established in part 117). In the preamble of the final rule establishing the produce safety regulation, we stated that the produce safety regulation is effective January 26, 2016, and provided for compliance dates of 1 to 6 years from the effective date depending on the commodity and the provision(s) (see table 30 in the preamble of the final rule establishing the produce safety regulation, 80 FR 74354 at 74527, as corrected in a technical amendment at 81 FR 26466, May 3, 2016). (Some of the compliance dates identified in the technical amendment fall on weekends (
We are extending the dates for compliance with certain provisions in four final rules to address concerns about the practicality of compliance with certain provisions, consider changes to the regulatory text, and better align compliance dates across the rules. First, we are extending the compliance dates for certain related provisions concerning customer assurances when controls are applied downstream in the distribution chain in all four rules. Second, we are extending the compliance dates for part 117 and part 507 for facilities solely engaged in packing and/or holding activities conducted on raw agricultural commodities (RACs) that are produce and/or nut hulls and shells and for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. Third, we are extending the compliance dates for part 117 for certain facilities that color RACs. Fourth, we are extending the compliance dates for part 507 for facilities solely engaged in the ginning of cotton. Fifth, we are extending the compliance dates for the FSVP regulation for importation of food contact substances. Sixth, we are extending the date for certain facilities producing Grade “A” milk and milk products covered by the National Conference on Interstate Milk Shipments (NCIMS) under the Pasteurized Milk Ordinance (PMO) to comply with the CGMP requirements of part 117.
Finally, we are clarifying how we interpret the compliance dates for certain provisions related to agricultural water testing in the produce safety regulation.
In a supplemental notice of proposed rulemaking for part 117 (79 FR 58524, September 29, 2014), we proposed several exceptions to the requirement for a manufacturer/processor to establish and implement a supply-chain program. Under one proposed exception, a receiving facility would not have been required to have a supply-chain program if it relied on its customer to control the hazard and annually obtained from its customer written assurance that the customer had established and was following procedures (identified in the written assurance) that would significantly minimize or prevent the hazard (see the discussion in the preamble of the final rule at 80 FR 55908 at 56036; see the proposed regulatory text at 79 FR 58524 at 58565).
After considering comments, we replaced this proposed provision with several provisions (§§ 117.136(a)(2) through (4) and 117.137) (referred to collectively as “customer provisions”) that apply when a manufacturer/processor identifies a hazard requiring a preventive control (“identified hazard”), does not control the identified hazard, and relies on an entity in its distribution chain to address the hazard (80 FR 55908 at 56037 to 56039). (In these provisions, “customer” means a commercial customer, not a consumer.) A manufacturer/processor that complies with the customer provisions is not required to implement a preventive control for the identified hazard. The combination of three requirements in the customer provisions is intended to provide assurance that the food will be processed to control the identified hazard before it reaches consumers:
• Documentation provided by the manufacturer/processor to its direct customer that the food is “not processed to control [identified hazard]” (the disclosure statement provisions; § 117.136(a)(2)(i), (3)(i), and (4)(i));
• Written assurance provided by the customer to the manufacturer/processor that the customer is manufacturing, processing, or preparing the food in accordance with applicable food safety requirements (the written assurance provisions; § 117.136(a)(2)(ii), (3)(ii), and (4)(ii)); and
• Provisions relating to accountability for written assurances (the accountability provision; § 117.137).
We established similar requirements in three other FSMA rules (“related rules”): Part 507 (§§ 507.36 (a)(2) through (4) and 507.37); the FSVP regulation (§§ 1.507(a)(2) through (4), and 1.507(c)); and the produce safety regulation (§ 112.2(b)(2) through (4), and (6)).
On March 23, 2016, FDA met with the Grocery Manufacturers Association (GMA) at their request to listen to concerns regarding the customer
After considering the information presented by GMA, FDA believes that the requirement for written assurance in the customer provisions of part 117 significantly exceeds the current practices of even the largest facilities; compliance by those facilities by September 19, 2016, may not be feasible; and it is appropriate to extend the compliance dates for 2 years for the written assurance requirements for part 117 and the related rules while FDA considers the best approach to address feasibility concerns.
We believe it continues to be appropriate to provide for an entity earlier in the distribution chain to disclose that a hazard has not been controlled and rely on a subsequent entity to control a hazard in human or animal food. For example, it would not make sense to require a facility that chops nuts to have a preventive control for
Table 1 provides a summary of the revised compliance dates.
We are extending the compliance date by 2 years for the written assurance requirement in the customer provisions in part 117. With the extension, facilities that are small businesses must comply with § 117.136(a)(2)(ii), (3)(ii), and (4)(ii) by September 18, 2019, and other facilities subject to the requirements must comply with those provisions by September 19, 2018. As a result of the extension, the compliance date for certain associated requirements that are contingent on the specified delayed provisions are also delayed (
We are also extending the compliance date by 2 years for the written assurance requirement in the customer provisions in part 507. With the extension, facilities that are small businesses must comply with § 507.36(a)(2)(ii), (3)(ii), and (4)(ii) by September 17, 2020, and other facilities subject to the requirements must comply with those provisions by September 18, 2019. As a result of the extension, the compliance dates for certain associated requirements that are contingent on the specified delayed provisions are also delayed (
In addition, we are extending the compliance date under the FSVP regulation for complying with the written assurance requirements in § 1.507(a)(2)(ii), (3)(ii), and (4)(ii) by 2 years beyond the dates established in the final rule (as corrected in the technical amendment). In the preamble of the final rule, as corrected by the technical amendment, we stated that importers would need to comply with the FSVP regulation by the latest of the following:
• 18 months after the publication of the final rule;
• For importers of food from a foreign supplier that is subject to part 117, the CGMP requirements or the preventive controls requirements for animal food in part 507, or the produce safety regulation, 6 months after the supplier was required to comply with the relevant regulations; or
• For an importer subject to the supply-chain program provisions of the human or animal food preventive controls regulations, the date the importer, as a receiving facility, was required to comply with the supply-chain program provisions of the relevant regulation.
As a result of this extension, the earliest that an importer would be required to comply with the written assurance requirements in the customer provisions in § 1.507 would be May 28, 2019. When an importer's compliance date is determined by when the foreign supplier must comply with the preventive controls regulation for human food, the preventive controls or CGMP requirements in part 507, or the produce safety regulation (
Finally, we are extending by 2 years the compliance dates for the written assurance requirements in the customer provisions of the produce safety regulation in § 112.2(b)(3). With the extension, sprout operations wishing to rely on the exemption in § 112.2(b) with respect to sprouts that would otherwise be subject to subpart M of part 112 must comply with the written assurances provisions in § 112.2(b)(3) by January 26, 2021 (very small businesses); January 27, 2020 (small businesses); and January 28, 2019 (all other businesses). With the extension, operations wishing
Some facilities that are subject to part 117 are solely engaged in packing and/or holding RACs that are produce (“produce RACs”). These activities are similar to packing and holding activities commonly conducted on produce RACs by farms subject to the produce safety regulation. Examples of such facilities are produce packinghouses, warehouses that hold produce RACs, and facilities that hull, shell, pack and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). (We note that FDA will soon be making available for public comment a draft guidance on classification of activities as harvesting, packing, holding, or manufacturing/processing for farms and facilities). During the rulemaking to establish part 117, we received comments asking us to revise the regulatory text to ensure that similar activities would be treated similarly under either the produce safety regulation or part 117. (See Comment 25, 80 FR 55908 at 55927 to 55928.)
We received comments that expressed concern about how the requirements in part 117 for environmental monitoring and product testing would apply to off-farm facilities that pack or hold produce RACs. (See Comment 524, 80 FR 55908 at 56062.) In responding to those comments, we stated that we were considering developing a separate guidance on packing and holding operations for produce RACs in light of the questions we have received regarding similarities and differences for off-farm packing and holding compared to on-farm packing and holding. In a letter to us dated April 19, 2016, the United Fresh Produce Association and 21 other organizations (UFPA et al.) noted that such guidance has not been issued, and the September 19, 2016, compliance date for part 117 is approaching (Ref. 2).
In the preamble of the final rule establishing part 117, we described several changes to the regulatory text in response to comments asking us to consider revisions to ensure that similar activities would be treated the same way under either the produce safety regulation or part 117. (See Response 25, 80 FR 55908 at 55928 to 5929.) For example, we revised the “farm” definition to provide for two types of farms: (1) A primary production farm and (2) a secondary activities farm (see §§ 1.227 and 117.3). With the added definition of “secondary activities farm,” some packinghouses that are managed by a business entity (such as a cooperative) that is different from the business entity growing crops (such as individual farms) can be within the “farm” definition and, thus, not be subject to the human food preventive controls requirements. We also established a new provision to allow off-farm establishments that package, pack, and hold produce RACs to comply with the CGMPs in part 117 by complying with the relevant requirements for packing and holding in the final produce safety regulation (see § 117.8).
In responding to these comments, we noted that the revised “farm” definition did not, as requested, provide for all off-farm operations such as certain packinghouses and hulling/shelling operations to be subject to the produce safety regulation rather than part 117. We explained that the statutory framework does not provide for entities such as packinghouses and hulling/shelling operations that do not have a sufficient connection to a farm to be subject to the requirements of the produce safety regulation. However, we stated that we continued to believe that an off-farm packinghouse that is subject to the human food preventive controls requirements in part 117 will be able to draw from the provisions of the produce safety regulation in developing its food safety plan and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. For example, we stated our expectation that the food safety plan for an off-farm packinghouse would focus on a few key preventive controls, including some that would have counterparts in the produce safety regulation, such as maintaining and monitoring the temperature of water used during packing (which would have counterparts under § 112.48(c) in the produce safety regulation). We also expected that an off-farm packinghouse would establish sanitation controls to address the cleanliness of food-contact surfaces (including food-contact surfaces of utensils and equipment) and the prevention of cross-contamination from insanitary objects and from personnel to food, food-packaging material, and other food-contact surfaces. On-farm packinghouses would be subject to similar, but not identical, requirements (see,
We agree that certain activities conducted on produce RACs are similar regardless of where they happen. Therefore, facilities for which the packing and/or holding of produce RACs is subject to the human food preventive controls requirements may nonetheless still be able to draw from the provisions of the produce safety regulation in developing their food safety plans and establishing preventive control management components that are appropriate in light of the nature of the preventive controls and their role in the facility's food safety system. We acknowledge that we have not yet issued guidance with specific recommendations for how packinghouses subject to the human food preventive controls requirements could comply with those requirements.
Table 2 provides a summary of the revised compliance dates.
We published the final rule establishing part 117 more than 2 months before we published the final rule establishing the produce safety regulation and, thus, the compliance dates for the produce safety regulation had not yet been established. To provide facilities that are solely engaged in packing and/or holding activities on produce RACs the same time to understand the applicable provisions of the produce safety regulation as farms that conduct similar packing and holding activities, and to enable such facilities to develop a food safety plan that builds on the requirements of the produce safety regulation, where applicable, we are extending the date for facilities that are solely engaged in packing and/or holding activities on produce RACs to comply with part 117 by approximately 16 months to make the compliance dates the same as for businesses in the same size categories in the produce safety regulation. For example, the new compliance date for a facility that is a small business under part 117 is the compliance date for a small business under the produce safety regulation, regardless of whether the facility subject to part 117 would be considered a small business under the produce safety regulation. (Note that the produce safety regulation has different compliance dates associated with sprouts but for the purposes of this extension we are not establishing different dates for sprouts.) This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document.
With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018. We are extending compliance dates for very small businesses because, although they are not required to comply with subparts C and G (
To maintain the intended alignment between part 117 and part 507, we also are making a parallel extension to the dates for facilities that are solely engaged in packing and/or holding activities on produce RACs that are used as animal food to comply with part 507 requirements. While there may be limited facilities that pack and hold produce RACs exclusively for animal food, the by-products, such as culls, from packing and holding of produce RACs for human food are often used as animal food. The rulemaking to establish part 507 included a provision for certain human food by-products used as animal food (§ 507.12). To qualify for § 507.12, the human food facility whose packing or holding of produce results in by-products for use as animal food must be in compliance with the part 117 CGMPs or in compliance with the applicable requirements for packing and holding in part 112. The extension of compliance dates allows for facilities that are providing by-products for use as animal food time to implement the applicable part 117 or part 112 requirements. The parallel 16 month compliance date extension for part 507 is staggered to allow time for such operations to first comply with the part 507 CGMP requirements, including the related requirement in § 507.12. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of
In addition, nut hulls and shells are used for animal food and result from some activities performed by those facilities that are receiving an extension to comply with part 117. Therefore, we are extending the compliance dates for animal food preventive controls requirements for facilities solely engaged in packing and/or holding activities conducted on nut hulls and shells. Facilities that are solely engaged in hulling, shelling, drying, packing, and/or holding of nuts and hulls are exempt from the part 507 CGMP requirements (§ 507.5(h)(2)) and will continue to remain exempt. With the extension, eligible facilities that are very small businesses must comply with animal food preventive controls requirements by January 26, 2021; eligible facilities that are small businesses must comply by January 27, 2020, and all other eligible facilities must comply by January 28, 2019.
The extended compliance dates do not apply to facilities that manufacture/process produce RACs or nut hulls and shells in addition to packing and/or holding produce RACs or nut hulls and shells, because such facilities must come into compliance with part 117 and part 507 with respect to their manufacturing/processing as well as their packing and holding. Examples of facilities to which the extended compliance dates apply are packinghouses that solely pack and/or hold produce RACs; and facilities that solely hull, shell, pack, and/or hold nuts (nuts are produce RACs and hulling and shelling may be considered “packing” when done for safe or effective packing). Examples of manufacturing/processing facilities to which the extended compliance dates do not apply are a “fresh-cut” processing facility, such as a facility that produces bagged salad mixes or packages of sliced fruit, and a facility that grinds nut shells to make an animal food ingredient.
Table 3 provides a summary of the revised compliance dates.
The rulemaking to establish part 117 created a “secondary activities farm” definition within the “farm” definition to cover certain operations that are not located on a primary production farm but are sufficiently related to a primary production farm so that it is appropriate to consider the operations to be farms (§ 1.227). A secondary activities farm is devoted to harvesting (such as hulling or shelling), packing, and/or holding of RACs (such as produce, grains, and eggs). Further, a majority interest in a secondary activities farm must be majority-owned (singly or jointly) by the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested packed, and/or held by the secondary activities farm (§ 1.227).
We have received questions via our Technical Assistance Network regarding whether certain operations qualify as secondary activities farms under part 117 and part 507. These questions describe a variety of business structures that may satisfy our intention to require a close relationship regarding ownership of the primary and secondary activities farms but the business structures do not meet the ownership requirement as codified in the “farm” definition. For example, some operations that might otherwise qualify as secondary activities farms own the primary production farm, rather than being owned by the primary production farm as currently required. Other operations that might otherwise qualify as a secondary activities farm are operations that are not owned by (and do not own) the primary production farm but are majority owned by the same entity as the primary production farm. For example, Farm A is a primary
We are extending the compliance dates for certain operations that would be secondary activities farms except that they do not meet the ownership criterion in the definition. The extension is applicable only to an operation satisfying all of the following requirements: (1) The operation is not located on a primary production farm; (2) the operation is devoted to harvesting, packing, and/or holding of RACs (including operations that hull, shell, and/or dry nuts without additional manufacturing); and (3) the operation is under common ownership with the primary production farm(s) that grows, harvests, and/or raises the majority of the RACs harvested, packed, and/or held by the operation. Examples of common ownership include an operation that is owned by (or that owns) one or more primary production farms (
We are extending the compliance dates for part 117 for operations satisfying all of the requirements by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation (note that the produce safety regulation has different compliance dates associated with sprouts but for purposes of this extension we are not establishing different dates for sprouts). This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document. With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018.
The parallel 16 month compliance date extension for part 507 is staggered to allow time for operations satisfying all of the requirements to first comply with the CGMP requirements. With the extension, eligible facilities that are very small businesses must comply with the CGMP requirements of part 507 by January 27, 2020, and with the preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the CGMP requirements of part 507 by January 28, 2019, and with the preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply by with the CGMP requirements of part 507 by January 26, 2018, and with the preventive controls requirements of part 507 by January 28, 2019.
Table 4 provides a summary of the revised compliance dates.
The definition of RAC in section 201(r) of the FD&C Act includes “fruits that are . . . colored . . . in their unpeeled natural form prior to marketing.” (21 U.S.C. 321(r)). As we noted in the proposed rule to establish part 117 (78 FR 3646 at 3678 to 3679, January 16, 2013), FDA does not consider the activity of coloring a RAC to result in the transformation of the RAC into a processed food. However, this does not mean that coloring a RAC is not manufacturing/processing. The activity classification “manufacturing/processing” is broader than just activities that transform a RAC into a processed food. It includes most food-handling activities because it is satisfied by any degree of “making food from one or more ingredients, or synthesizing, preparing, treating, modifying or manipulating food” (§ 1.227). In contrast, transforming a RAC into a processed food generally requires meeting a threshold of altering the general state of the commodity. In the proposed rule, coloring was provided as an example of an activity that is manufacturing/processing but does not transform a RAC into a processed food (78 FR 3646 at 3678 to 3679).
An establishment that conducts manufacturing/processing activities other than those specified as being within the “farm” definition generally is a facility that is required to register and is subject to the human food preventive controls requirements in part 117. The “farm” definition provides for farms to do several manufacturing/processing activities, including treating RACs to manipulate ripening and packaging and labeling RACs. These are all manufacturing/processing activities that do not transform a RAC into a processed food. However, FDA did not include coloring, another manufacturing/processing activity that does not transform a RAC into a processed food, within the “farm” definition. Therefore, currently coloring triggers the
Therefore, we are extending the compliance dates for facilities that would qualify as farms if they did not color RACs. We are extending the compliance dates for such operations by approximately 16 months to match the compliance dates for businesses in the same size categories in the produce safety regulation. (Note that the produce safety regulation has different compliance dates associated with sprouts but for purposes of this extension, we are not establishing different dates for sprouts.) This will match the other extended compliance dates that relate to the “farm” definition or the produce safety regulation in this document. With the extension, eligible facilities that are very small businesses must comply with part 117 by January 27, 2020; eligible facilities that are small businesses must comply by January 28, 2019, and all other eligible facilities must comply by January 26, 2018. We are not extending the compliance dates for facilities that engage in additional manufacturing/processing activities currently outside of the “farm” definition because we expect such facilities to come into compliance with part 117 as a result of those other activities.
Table 5—provides a summary of the revised compliance dates.
Cotton ginning is considered part of harvesting and thus within the “farm” definition when done on a farm (and when done for safe or effective packing, it may also be considered a packing activity on a farm). When done off-farm, cotton ginning is either a packing activity (if done for safe or effective packing), or a manufacturing/processing activity, depending on the circumstances. Ginning cotton does not transform a RAC into a processed food but results in component RACs, some of which (
Therefore, we are extending the compliance dates for animal food preventive controls requirements for facilities subject to part 507 that solely engage in the ginning of cotton. We are extending the compliance dates for such operations by approximately 16 months to match the other extension dates that relate to the “farm” definition. With the extension, eligible facilities that are very small businesses must comply with the animal food preventive controls requirements of part 507 by January 26, 2021; eligible facilities that are small businesses must comply with the animal food preventive controls requirements of part 507 by January 27, 2020, and all other eligible facilities must comply with the animal food preventive controls requirements of part 507 by January 28, 2019. We are not extending the compliance dates for facilities that engage in additional animal food manufacturing/processing activities of cotton currently outside of the “farm” definition (
In addition, some cotton ginners may be operations that would be secondary activities farms except that they do not meet the ownership criterion in the current “farm” definition. For further discussion of the compliance date extension for these types of operations see section IV.B. Certain Facilities That Would Qualify as Secondary Activities Farms Except for the Ownership of the Facility.
Table 6 provides a summary of the revised compliance dates.
In the preamble of the final rule establishing the FSVP regulation, we stated that the definition of “food” for purposes of FSVP (§ 1.500) includes food contact substances that are considered “food” in section 201(f) of the FD&C Act. A food contact substance is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if such use of the substance is not intended to have any technical effect in such food (21 CFR 170.3(e)(3)). The term “food” is defined in section 201(f)(3) of the FD&C Act to include articles used as components of food. Therefore, we concluded that importers must have an FSVP for a food contact substance that they import that meets the definition of “food” in section 201(f) of the FD&C Act (80 FR 74226 at 74233).
Since we published the final rule establishing the FSVP regulation, our Technical Assistance Network has received inquiries regarding the applicability of the FSVP regulation to food contact substances. In addition, on June 16, 2016, FDA met with representatives of the food packaging manufacturing industry at their request to listen to concerns regarding the applicability of the FSVP regulation to the importation of food contact substances (Ref. 4). The industry representatives stated that the supply chain associated with imported substances used to manufacture food contact substances is highly complex and very different from other foods subject to the FSVP regulation. The industry representatives also asserted that the hazards associated with food contact substances are already adequately addressed through the food additive petition and food contact substance notification processes under section 409 of the FD&C Act (21 U.S.C. 348).
After considering the information presented by the industry representatives, FDA believes that compliance with the requirement to conduct verification activities under the FSVP regulation for food contact substances by May 30, 2017, might not be feasible. Accordingly, we are extending the compliance date for the importation of food contact substances by 2 years so that we can consider how best to address the feasibility concerns. We note the relatively rare occurrence of significant safety concerns associated with the manufacture of food contact substances and FDA's extensive premarket approval and review processes for these substances under section 409 of the FD&C Act provide some assurances regarding safety during this time. As a result of this extension, the earliest that an importer would be required to comply with FSVP for the importation of food contact substances would be May 28, 2019.
In the preamble of the final rule establishing part 117, we established a compliance date of September 17, 2018, for “PMO facilities” (see Response 214, 80 FR 55908 at 55987 to 55988). As we discussed in Response 214, we agreed that we should make use of the existing system of State regulatory oversight for Grade “A” milk and milk products provided through the NCIMS and the food safety requirements of the PMO. We described our reasons for deciding to extend the compliance date for “PMO-regulated facilities” to comply with the human food preventive controls requirements to September 17, 2018. Those reasons related to the current provisions of the PMO, the work already begun by NCIMS to modify the PMO to include all of the human food preventive controls requirements established in part 117, and complex implementation issues concerning the interstate movement of milk and milk products and imported milk.
In the
We have not established compliance dates for the modernized CGMPs that are different from the general compliance dates for the preventive controls requirements in part 117 with one exception related to “PMO facilities” (see table 53 in the preamble of the final rule establishing part 117, 80 FR 55908 at 56128). Specifically, we provided that the extension of the compliance date for “PMO facilities” until September 17, 2018, applied only to “subparts C and G” (the principal provisions of the human preventive controls requirements) (see Response 214, 80 FR 55908 at 55987 to 55988). In this document, we are extending the date for compliance with the modernized CGMPs by “PMO facilities” until September 17, 2018. We will continue to work with the NCIMS to modify the PMO to reflect the modernized CGMPs and the preventive control requirements. The extension will create a single compliance date for the Grade “A” milk and milk products covered by the PMO. Note that this extension applies only to Grade “A” milk and milk products covered by NCIMS under the PMO, and not to the manufacturing, processing, packing, or holding of other food produced in such facilities.
In this final rule, we are also clarifying our intent regarding the meaning of the compliance dates with respect to certain testing requirements related to agricultural water in the produce safety regulation.
Specifically, in the preamble of the final rule establishing the produce safety regulation (at 80 FR 74354 at 74453 to 74454) we explained that we excluded § 112.46(b)(1), with respect to untreated surface water only, from the 2-year extended compliance period provided for the remainder of § 112.46 because, in order to comply with the microbial quality criteria in § 112.44(b), farms must have developed a microbial water quality profile (MWQP) based on
We want to clarify and correct these earlier statements. We note that § 112.46(b)(1)(i)(A) allows covered farms discretion as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples; and (2) the time period over which such samples are taken, provided that the period must be at least 2 years and no more than 4 years. For each business size category, the compliance date for § 112.46(b)(1) with respect to untreated surface water testing is 2 years before the compliance date for the § 112.44(b) microbial quality criteria for such water. This does not mean that covered farms have only 2 years in which to conduct their initial surveys for untreated surface water under § 112.46(b)(1) if they begin testing on the compliance date for that provision. Covered farms have 2 to 4 years in which to fulfill that requirement, per § 112.46(b)(1)(i)(A). This means that, for example, a farm that is not small or very small must begin sampling and testing untreated surface water in accordance with § 112.46(b)(1)(i)(A), as applicable, no later than January 26, 2018. The relevant compliance date for the related microbial quality criteria is 2 years later, on January 27, 2020. However, the farm has discretion under § 112.46(b)(1)(i)(A) as to both (1) the number of samples they include in their initial survey, provided that the total must be 20 or more samples; and (2) the time period over which such samples are taken, provided that the period must be at least 2 years and no more than 4 years. Therefore, to provide a few examples, all of the following possible approaches are acceptable for farms that are not small or very small:
• Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 2 years (10 in 2018 and 10 in 2019) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (
• Beginning in 2018, conducting an initial survey consisting of taking 5 samples per year over 4 years (5 in 2018, 5 in 2019, 5 in 2020, and 5 in 2021) for a total of 20 samples; calculating the MWQP for the first time upon completing the 20-sample data set (
• Beginning in 2018, conducting an initial survey consisting of taking 10 samples per year over 4 years (10 in 2018, 10 in 2019, 10 in 2020, and 10 in 2021) for a total of 40 samples; calculating the MWQP for the first time upon completing the 40-sample data set (
For small and very small farms, the same approaches are acceptable, and the relevant dates are 1 and 2 years later, respectively.
In the final regulatory impact analysis (FRIA) for part 117, we concluded that extension of the compliance dates would be unlikely to significantly affect the cost estimates made (Ref. 5). In the FRIA for the produce safety regulation, we noted that extended compliance dates would result in a decrease in costs as smaller operations would have additional time to fully and correctly implement the rule's requirements (Ref. 6). We did not quantify the potential impact of extended compliance periods on the costs of part 507 or the FSVP regulation but expect the impacts would be similar to those of part 117 or the produce safety regulation.
We are extending the compliance dates by 2 years for the written assurances in the customer provisions in part 117 and part 507, the produce safety regulation, and the FSVP regulation. Although none of the FRIAs provided a separate cost analysis for the written assurance provisions, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with the written assurances during the compliance delay period, we believe that a 2-year delay in the compliance dates for the written assurances in the customer provisions for these rules is unlikely to significantly affect the costs of the rules.
We are extending the compliance dates in part 117 and part 507 for facilities that are solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells. The new compliance dates for part 117 are the same as the compliance dates under the produce safety regulation for the same size categories: January 27, 2020 (very small businesses), January 28, 2019 (small businesses), and January 26, 2018 (other businesses). The new compliance dates for part 507 are staggered to allow for compliance with CGMP requirements first followed by the animal food preventive controls requirements 1 year later. The part 507 CGMP compliance dates for these facilities are the same as the compliance dates under the produce safety regulation for the same size categories: January 27, 2020 (very small businesses), January 28, 2019 (small businesses), and January 26, 2018 (other businesses). The part 507 animal food preventive controls requirements for the same size categories are: January 26, 2021 (very small businesses), January 27, 2020 (small businesses), and January 28, 2019 (other businesses). Although the FRIAs for part 117 and part 507 did not provide a separate compliance cost analysis for facilities solely engaged in packing and/or holding activities on produce RACs and/or nut hulls and shells, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rules.
We are similarly extending the compliance dates in part 117 and part 507 for certain facilities that would qualify as secondary activities farms except for the ownership of the facility. Although the FRIAs for part 117 and part 507 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending
We are similarly extending the compliance dates in part 117 for certain facilities that color RACs. Although the FRIA for part 117 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rule.
We are similarly extending the compliance dates in part 507 for facilities that are solely engaged in the ginning of cotton. Although the FRIA for part 507 did not provide a separate compliance cost analysis for these facilities, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the cost of the rule.
We are extending the compliance date for the importation of food contact substances by 2 years, such that the earliest that an importer would be required to comply with the FSVP regulation for the importation of food contact substances would be May 28, 2019. Although the FRIA for the FSVP regulation did not provide a separate compliance cost analysis for importers of food contact substances, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the cost of the rule.
We are extending the compliance date for the CGMP Requirements of part 117 for facilities producing Grade “A” milk and milk products covered by NCIMS under the PMO. Although the FRIA for part 117 did not provide a separate compliance cost analysis for these facilities to comply with subpart B of part 117, based on our general conclusions about the costs of extending compliance dates and because the affected businesses will not be incurring the costs associated with compliance during the delay period, we believe that the delay in the compliance dates for these facilities is unlikely to significantly affect the costs of the rule.
We have examined the impacts of the final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). Executive Order 13563 states the importance of quantifying costs and benefits, reducing costs and burdens, and harmonizing rules. We believe this final rule will not increase compliance costs and will serve an important purpose of providing us an opportunity to consider how to reduce burdens on the public and maintain or improve coordination among the four rules affected. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this final rule only extends various compliance dates for certain provisions and/or certain entities with respect to the four rules discussed here, we have determined that the final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This final rule would not result in an expenditure in any year that meets or exceeds this amount.
We have determined under 21 CFR 25.30(j) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. FDA has determined that the rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required.
We have analyzed this rule in accordance with the principles set forth in Executive Order 13175. We have determined that the rule does not contain policies that have substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. Accordingly, we conclude that the rule does not contain policies that have tribal implications as defined in the Executive order and, consequently, a tribal summary impact statement is not required.
The following references are on display in the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they are also available electronically at
Food and Drug Administration, HHS.
Direct final rule.
The Food and Drug Administration (FDA, the Agency, we) is amending the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
This rule is effective December 1, 2016. Submit either electronic or written comments by November 7, 2016. See Section IV for further discussion of the effective date.
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David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205,
FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in
The category in which a new animal drug used in medicated feeds is placed is based on their likelihood of producing unsafe residues in the edible products of treated animals. Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.
New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.
Certain Category I Type A medicated articles would be recategorized to Category II when a production indication is voluntarily withdrawn by a sponsor as part of the judicious use initiative that is currently underway, based on the next lowest use level that remains once the production use is withdrawn having a withdrawal period such that the drug would then meet the definition for Category II. For Category I Type A medicated articles that include indications for minor species, FDA is concerned that if such a Type A medicated article is recategorized to Category II based on a withdrawal period for an approved therapeutic use in a minor species, sponsors may opt to request withdrawal of approval of these minor species indications in order to ensure the Type A medicated article can remain in Category I. Sponsors may also decline to pursue development of additional therapies for minor species if these uses would require a withdrawal period that would trigger a recategorization to Category II.
This direct final rule revises the category definitions such that they will be based only on whether a withdrawal period is required for a major species.
The purpose of this revision is to preserve the present availability of medicated feeds intended for therapeutic uses in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe this revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.
FDA is amending 21 CFR 558.3
FDA is issuing these regulations based on its authority under the new animal drug provisions in sections 512 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b) and under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
The revisions made by this direct final rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.
FDA is issuing this direct final rule to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the
New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.
This action is being taken to address a potential consequence of animal drug
These changes, which are described in Guidance for Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013 (
Under GFI #213, sponsors of medically important antimicrobial new animal drugs approved for over-the-counter use in the feed or water of food-producing animals were asked to change the marketing status of their products to veterinary prescription (Rx) marketing status in the case of new animal drugs administered in water, or to veterinary feed directive (VFD) marketing status for drugs administered in or on animal feed. New animal drugs with Rx or VFD marketing status can legally only be used with a veterinarian's oversight. Prescription animal drugs require a veterinarian's prescription, while use of VFD drugs requires a VFD; both types of orders must be issued by a licensed veterinarian in the course of the veterinarian's professional practice.
In addition, under GFI #213 sponsors of medically important new animal drugs used in animal feed or water that have production indications were requested to voluntarily withdraw these indications; approved therapeutic indications for use of these drugs would remain.
In some instances, once a sponsor withdraws the production indication from a drug approved for use in animal feed (which is generally the lowest use level of the drug), the remaining lowest therapeutic use level will require a withdrawal period. Based on the existing definitions of the feed drug categories, this results in a Category I new animal drug being recategorized as a Category II drug, the more restrictive of the two possible categories of drugs used in medicated feed. Category II drugs require that the manufacture of Type B and Type C medicated feeds from Type A medicated articles be done in facilities possessing a medicated feed mill license, which number roughly 900 in the United States. In contrast, there are tens of thousands of unlicensed feed mills in this country. Such a recategorization to Category II, thereby limiting the use of the Type A medicated article to a much smaller subset of feed mills, may disrupt the existing movement of these medicated feeds through distribution channels.
FDA believes that sponsors may request voluntary withdrawal of those specific therapeutic indications as a way to keep their products in the less restrictive Category I when the recategorization of a drug to Category II is triggered by a therapeutic indication for a minor species. For certain drug products, the only therapeutic indications requiring a withdrawal period that would remain following the voluntary withdrawal of approval of production uses are those for minor species. The loss of therapeutic indications for minor species would adversely affect the availability of therapeutic medicated feeds necessary for the health of minor species, which is a matter of significant concern for the Agency.
This foreseeable adverse effect on the health of minor species would directly undermine the intent of Congress in passing the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as well as to our intent in establishing the implementing regulations under that statute. The Category I drugs likely to be affected have been safely used in this category for decades, and we have no reason to believe they would not continue to be safely used in this category moving forward.
Under the current category definitions in § 558.3 for feed use drugs, a drug will be included in Category II if the lowest use level of the drug in any approved species requires a withdrawal period. This approach equates the existence of a withdrawal period for a particular use with the potential risk that edible tissues from animals administered a medicated feed might contain a residue of concern.
However, the toxicological analysis of animal drugs used to calculate a withdrawal period is based on lifetime exposure by humans to potential drug residues. This assessment of lifetime exposure does not consider the lower risk to the public health from the use of these same new animal drugs in food-producing minor species attributable to the lower human consumption over time of edible tissues from food-producing minor species (Refs. 1 and 2). For this reason, FDA does not at this time believe this revision of the category definitions presents a risk to the public health.
In a manner similar to its effect on drug indications that are already approved, CVM believes the existing categorization scheme would pose a significant disincentive for future development of additional minor species therapies for existing Category I drugs if those new uses would require a withdrawal period and thus trigger a change to Category II for that drug.
Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 are being revised to base category assignment only on uses in major species. This revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.
We are amending paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (
FDA has determined that the subject of this rulemaking is suitable for a direct final rule. FDA is amending § 558.3(b)(1) by revising the definitions of Category I and Category II new animal drugs administered in or on medicated feed. This rule is intended to make noncontroversial changes to existing regulations. The Agency does not anticipate receiving any significant adverse comments on this rule.
Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the
FDA is providing a comment period for the direct final rule of 75 days after the date of publication in the
Comments that are frivolous, insubstantial, or outside the scope of this direct final rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, FDA may adopt as final those provisions of the rule that are not the subject of a significant adverse comment.
If FDA withdraws the direct final rule, all comments received will be considered under the companion proposed rule in developing a final rule under the usual notice-and-comment procedures under the APA (5 U.S.C. 552
A full description of FDA's policy on direct final rule procedures may be found in a guidance document announced in the
We are issuing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
We have examined the impacts of the direct final rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this direct final 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. Because this direct final rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we certify that this direct final rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount.
This direct final rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.
Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that will be recategorized from Category II to Category I as a result of this direct final rule. No compliance costs will be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This direct final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
We have analyzed this direct final rule in accordance with the principles set forth in Executive Order 13132. We have determined that this direct final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded that this direct final rule does not contain policies that have federalism implications as defined in the Executive Order and, consequently, a federalism summary impact statement is not required.
The following references are on display in the Division of Dockets Management (see
Animal drugs, animal feeds.
Therefore, under the Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, 21 CFR part 558 is amended as follows:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
(b) * * *
(1) * * *
(i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.
(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.
(13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.
(14) “Minor species” means animals, other than humans, that are not major species.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the U.S. 70/Alfred A. Cunningham Bridge across the Trent River, mile 0.0, at New Bern, NC. The deviation is necessary to facilitate safe participation in the Multiple Sclerosis Society's Historic New Bern Bike Ride. This deviation allows the bridge to remain in the closed-to-navigation position.
The deviation is effective from 8 a.m. on Saturday, September 10, 2016, to 9:30 a.m. Sunday, September 11, 2016.
The docket for this deviation, [USCG-2016-0814] is available at
If you have questions on this temporary deviation, call or email Mr. Michael Thorogood, Bridge Administration Branch Fifth District, Coast Guard, telephone 757-398-6557, email
The North Carolina Department of Transportation, who owns and operates the U.S. 70/Alfred A. Cunningham Bridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.843(a), to ensure the safety of the cyclists and spectators that are associated with the Multiple Sclerosis Society's Historic New Bern Bike Ride.
Under this temporary deviation, the bridge will be maintained in the closed position from 8 a.m. to 9:30 a.m. on Saturday, September 10, 2016, and from 8 a.m. to 9:30 a.m. on Sunday, September 11, 2016. The bridge is a double bascule drawbridge and has a vertical clearance in the closed position of 14 feet above mean high water.
The Trent River is used by small commercial vessels and recreational vessels. The Coast Guard has carefully considered the nature and volume of vessel traffic in publishing this temporary deviation.
Vessels able to pass through the bridge in the closed position may do so at any time. The bridge will be able to open in case of emergencies, there is no immediate alternative route for vessels to pass. The Coast Guard will also inform the users of the waterway through our Local and Broadcast Notice to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Rock Island Railroad and Highway Drawbridge across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois. The deviation is necessary to facilitate a charity marathon race. This deviation allows the bridge to be maintained in the closed-to-navigation position for four and a half hours.
This deviation is effective from 7 a.m. to 11:30 a.m., September 25, 2016.
The docket for this deviation, (USCG-2016-0707) is available at
If you have questions on this temporary deviation, call or email Eric A. Washburn, Bridge Administrator, Western Rivers, Coast Guard; telephone 314-269-2378, email
The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, across the Upper Mississippi River, mile 482.9, at Rock Island, Illinois to remain in the closed-to-navigation position for four and a half hours from 7 a.m. to 11:30 a.m., September 25, 2016 to facilitate the Quad City Marathon.
The Rock Island Railroad and Highway Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that the drawbridge shall open on signal. There are no alternate routes for vessels transiting this section of the Upper Mississippi River. The bridge cannot open in case of emergency.
The Rock Island Railroad and Highway Drawbridge provides a vertical clearance of 23.8 feet above normal pool in the closed-to-navigation position. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessel operators can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Temporary final rule.
The Coast Guard is establishing a temporary safety zone on the navigable waters of the Captain of the Port (COTP) Boston Zone within a 2,500-yard radius around a position approximately 6nm Northeast of Nahant Bay, MA, for a Department of Defense (DOD) Training Exercise. The safety zone is needed to protect Navy personnel, support vessels, and the maritime public from the hazards associated with this training exercise. Entering into, transiting through, mooring, or anchoring within this safety zone during periods of enforcement is prohibited unless authorized by the Coast Guard Sector Boston COTP or the COTP's designated representative.
This rule is effective on August 24, 2016 from 7:00 p.m. through 10:00 p.m.
To view documents mentioned in this preamble as being available in the docket, go to
If you have questions on this rule, call or email, Mark Cutter, Sector Boston Waterways Management Division, U.S. Coast Guard; telephone 617-223-4000, email
The Coast Guard is issuing this temporary rule without prior notice and opportunity to comment pursuant to authority under section 4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision authorizes an agency to issue a rule without prior notice and opportunity to comment when the agency for good cause finds that those procedures are “impracticable, unnecessary, or contrary to the public interest.” Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good cause exists for not publishing a NPRM with respect to this rule because publishing a NPRM would be impracticable. DOD Training Exercise will take place on August 24, 2016. The DOD Exercise will consist of High-altitude military parachuting freefall insertion approximately 6nm Northeast of Nahant, MA, in position 42° 27.000′ N., 070° 50.000′ W. This exercise will present safety hazards and risks to Navy personnel, support vessels, and the maritime public during the exercise. It would be impracticable to delay promulgating this rule, as it would not be possible to conduct notice and comment rulemaking before the date of the exercise. For this reason, the Coast Guard finds it impracticable to delay this regulation.
We are issuing this rule, and under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause exists for making it effective less than 30 days after publication in the
The Coast Guard is issuing this rule under authority in 33 U.S.C. 1231. The
This rule establishes a safety zone from 7:00 p.m. until 10:00 p.m. on August 24, 2016. The safety zone will cover all navigable waters within a 2,500-yard radius of position 42° 27.000′ N., 070° 50.000′ W. The duration of the zone is intended to protect Navy personnel, vessels, and normal marine traffic in these navigable waters during the DOD training exercise. No vessel or person will be permitted to enter the safety zone without obtaining permission from the COTP or a designated representative.
We developed this rule after considering numerous statutes and executive orders related to rulemaking. Below we summarize our analyses based on a number of these statutes and executive orders, and we discuss First Amendment rights of protestors.
Executive Orders 12866 and 13563 direct agencies to assess the costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits. Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has not been designated a “significant regulatory action,” under Executive Order 12866. Accordingly, it has not been reviewed by the Office of Management and Budget.
This regulatory action determination is based on the size, location, and duration of the safety zone. The implementation of this temporary safety zone is necessary for the protection of all waterway users. The size of the zone is the minimum necessary to provide adequate protection for the waterway users, adjoining areas, and the public. Vessel traffic will be able to safely transit around this safety zone. Any hardships experienced by persons or vessels are considered minimal compared to the interest in protecting the public.
The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as amended, requires Federal agencies to consider the potential impact of regulations on small entities during rulemaking. The term “small entities” comprises small businesses, not-for-profit organizations that are independently owned and operated and are not dominant in their fields, and governmental jurisdictions with populations of less than 50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will not have a significant economic impact on a substantial number of small entities.
While some owners or operators of vessels intending to transit the safety zone may be small entities, for the reasons stated in section V.A above, this rule will not have a significant economic impact on any vessel owner or operator.
Under section 213(a) of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121), we want to assist small entities in understanding this rule. If the rule would affect your small business, organization, or governmental jurisdiction and you have questions concerning its provisions or options for compliance, please contact the person listed in the
Small businesses may send comments on the actions of Federal employees who enforce, or otherwise determine compliance with, Federal regulations to the Small Business and Agriculture Regulatory Enforcement Ombudsman and the Regional Small Business Regulatory Fairness Boards. The Ombudsman evaluates these actions annually and rates each agency's responsiveness to small business. If you wish to comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR (1-888-734-3247). The Coast Guard will not retaliate against small entities that question or complain about this rule or any policy or action of the Coast Guard.
This rule will not call for a new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. We have analyzed this rule under that Order and have determined that it is consistent with the fundamental federalism principles and preemption requirements described in Executive Order 13132.
Also, this rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes. If you believe this rule has implications for federalism or Indian tribes, please contact the person listed in the
The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $100,000,000 (adjusted for inflation) or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.
We have analyzed this rule under Department of Homeland Security Management Directive 023-01 and Commandant Instruction M16475.lD, which guide the Coast Guard in complying with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that this action is one of a category of actions that do not individually or cumulatively have a significant effect on the human environment. This rule involves a safety zone that will prohibit entry within 2,500 yards of position 42° 27.000′ N., 070° 50.000′ W. during the DOD training exercise. It is categorically excluded from further review under paragraph 34(g) of Figure 2-1 of the Commandant Instruction. An environmental analysis checklist supporting this determination and a Categorical Exclusion Determination will be available in the docket where indicated under
The Coast Guard respects the First Amendment Rights of protesters. Protesters are asked to contact the person listed in the
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:
33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Department of Homeland Security Delegation No. 0170.1.
(a)
(b)
(1) Under the general safety zone regulations in subpart B of this part, you may not enter the safety zone described in paragraph (a) of this section unless authorized by the COTP or a COTP designated representative.
(2) To seek permission to enter, contact the COTP or the COTP's representative by VHF-FM channel 16 or by phone at (617) 223-5757 (Sector Boston Command Center). Those in the safety zone must comply with all lawful orders or directions given to them by the COTP or a COTP designated representative.
(c)
(d)
(e)
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final rule implements the International Commission for the Conservation of Atlantic Tunas (ICCAT) Recommendation 15-06 regarding porbeagle sharks (
Effective on September 23, 2016.
Larry Redd, Carrie Soltanoff, or Karyl Brewster-Geisz by phone at 301-427-8503.
Atlantic HMS are managed under the 2006 Consolidated HMS Fishery Management Plan (FMP). Implementing regulations at 50 CFR part 635 are issued under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), 16 U.S.C. 1801
At its 24th Annual Meeting in 2015, ICCAT adopted Recommendation 15-06 on “Porbeagle [Sharks] Caught in Association with ICCAT Fisheries.” Recommendation 15-06 requires, among other things, fishing vessels “. . . to promptly release unharmed, to the extent practicable, porbeagle sharks caught in association with ICCAT fisheries when brought alive alongside for taking on board the vessel.” Recommendation 15-06 notes that, according to the ICCAT Standing Committee for Research and Statistics (SCRS), biomass of northwest Atlantic and northeast Atlantic porbeagle sharks is depleted to well below the biomass at maximum sustainable yield, but recent fishing mortality is below the fishing mortality at maximum sustainable yield (
Domestically, porbeagle sharks are managed pursuant to a rebuilding plan established in Amendment 2 to the 2006 Consolidated HMS FMP (73 FR 35788, June 24, 2008 as corrected at 73 FR 40658, July 15, 2008). Under current regulations, commercial and
During the proposed rule stage, NMFS received 28 written comments. The comments received on the proposed rule during the public comment period can be found at
Regarding handling and release practices, U.S. fishermen who interact with porbeagle sharks have historically followed safe handling and release practices. This regulation requires U.S. fishermen to release live porbeagle sharks in a manner that is largely consistent with the safe handling and release practices that most fishermen employ. NMFS believes and expects that fishermen will continue to follow these safe handling and release practices after implementation of the ICCAT Recommendation 15-06. NMFS will continue to monitor potential violations of Atlantic HMS regulations to ensure that both commercial and recreational fishermen maintain proper catch and release practices.
NMFS made one change to the proposed regulations. At § 635.22 (a)(3), NMFS has added text specifying that the permit holders subject to the applicable requirements of this rulemaking include fishermen who hold a Swordfish General Commercial permit when they are participating in an HMS registered tournament. The proposed rule clearly stated that recreational fishing for porbeagle sharks would be affected when swordfish, tuna, or billfish are retained or possessed on board, or offloaded from, the vessel on a trip. We inadvertently did not list the Swordfish General Commercial permit, even though participation in an HMS registered recreational tournament with such a permit is clearly recreational fishing, and such permit holders had notice of the proposed rule's effect on recreational fishing both through the
It is generally understood that the Swordfish General Commercial permit is similar to the HMS General Category commercial permit in that the permit is considered recreational when the vessel owner or operator is using that vessel in an HMS registered tournament and landings of HMS are allowed, consistent with the regulations. While the regulatory language in the proposed rule did not specifically include this category of permit when listing the permit titles, the rule did repeatedly refer to recreational fisheries, and permit holders could reasonably have anticipated that the prohibition would apply to them given the rule's overall context and content and thus had sufficient notice. The underlying NEPA analysis associated with this rulemaking is not affected by this correction. These fishermen are considered recreational when fishing during a registered HMS tournament, and all such fishing in tournaments was within the scope of what was analyzed; any harvest of porbeagle sharks by these fishermen was analyzed at the proposed rule stage as recreational data. The Regulatory Flexibility Act (RFA) certification is similarly unaffected by this correction. It was based on the recreational information about porbeagle sharks received through the Large Pelagics Survey, which does not distinguish among permit types. Therefore, any recreational harvest of porbeagle sharks by Swordfish General Category permit holders was considered at the proposed rule stage. Furthermore, recreationally-caught porbeagle sharks cannot be sold, limiting the effects analyzed under the RFA.
The NMFS Assistant Administrator has determined that the final rule is consistent with the 2006 Consolidated HMS FMP and its amendments, the Magnuson-Stevens Act, ATCA, and other applicable law.
This final action has been determined to be not significant for the purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration during the proposed rule stage that this action would not have a significant economic impact on a substantial number of small entities. The factual basis for the certification was published in the proposed rule and is not repeated here. No comments were received regarding this certification. As a result, a regulatory flexibility analysis was not required and none was prepared.
On December 29, 2015, NMFS issued a final rule establishing a small business size standard of $11 million in annual gross receipts for all businesses primarily engaged in the commercial fishing industry (NAICS 11411) for Regulatory Flexibility Act (RFA) compliance purposes only (80 FR 81194, December 29, 2015). The $11 million standard became effective on July 1, 2016, and is to be used in place of the U.S. Small Business Administration's (SBA) current standards of $20.5 million, $5.5 million, and $7.5 million for the finfish (NAICS 114111), shellfish (NAICS 114112), and other marine fishing (NAICS 114119) sectors of the U.S. commercial fishing industry in all NMFS rules subject to the RFA after July 1, 2016. Id. at 81194.
Pursuant to the Regulatory Flexibility Act, and prior to July 1, 2016, a certification was developed for this regulatory action using SBA's former size standards. NMFS has reviewed the analyses prepared for this regulatory action in light of the new size standard. All of the entities directly regulated by this regulatory action are commercial finfish fishing businesses. The new standard could result in fewer commercial finfish businesses being considered small. However, NMFS has determined that the new size standard does not affect its decision to certify this regulatory action. NMFS considers all HMS longline permit holders to be small entities because these vessels have reported annual gross receipts of less than $11 million for commercial fishing. The average annual gross revenue per active pelagic longline vessel was estimated to be $187,000 based on the 170 active vessels between 2006 and 2012 that produced an estimated $31.8 million in revenue annually. The maximum annual revenue for any pelagic longline vessel between 2006 and 2015 was $1.9 million, well below the NMFS small business size threshold of $11 million in gross receipts for commercial fishing. Therefore, NMFS considers all Atlantic Tunas Longline category permit holders to be small entities. Since the annual revenue for Atlantic Tunas Longline category permit holders is well below both the former and new SBA size standard, there continues to be no significant economic impact on a substantial number of small entities.
Fisheries, Fishing, Fishing vessels, Foreign relations, Imports, Penalties, Reporting and recordkeeping requirements, Treaties.
For the reasons set out in the preamble, 50 CFR part 635 is amended as follows:
16 U.S.C. 971
(c) * * *
(1) * * *
(iii) Has pelagic longline gear on board, persons aboard that vessel are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback.
(a) * * *
(3) Vessels issued an HMS General Category permit under § 635.4(d) that are participating in an HMS registered tournament, vessels issued a Swordfish General commercial permit under § 635.4(f) that are participating in an HMS registered tournament, vessels issued a HMS Angling category permit under § 635.4(c), or vessels issued a HMS Charter/Headboat permit under § 635.4(b) are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback if swordfish, tuna, or billfish are retained or possessed on board, or offloaded from, the vessel during that trip.
(a) * * *
(10) Notwithstanding other provisions in this paragraph (a), vessels issued a permit under this part that have pelagic longline gear on board or on vessels issued both an HMS Charter/Headboat permit and a commercial shark permit when tuna, swordfish, or billfish are on board the vessel, offloaded from the vessel, or being offloaded from the vessel, are required to release unharmed, to the extent practicable, porbeagle sharks that are alive at the time of haulback.
(d) * * *
(20) Retain, possess, or land porbeagle sharks that were alive at the time of haulback as specified in §§ 635.21(c)(1)(iii), 635.22(a)(3), and 635.24 (a)(10).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian district (CAI) of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2016 total allowable catch (TAC) of Atka mackerel in this area allocated to vessels participating in the BSAI trawl limited access fishery.
Effective 1200 hrs, Alaska local time (A.l.t.), August 19, 2016, through 2400 hrs, A.l.t., December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 TAC of Atka mackerel, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 1,421 metric tons by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Atka mackerel in the CAI by vessels participating in the BSAI trawl limited access fishery.
After the effective dates of this closure, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the Atka mackerel directed fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for Pacific ocean perch in the Central Aleutian district (CAI) of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the BSAI trawl limited access fishery. This action is necessary to prevent exceeding the 2016 total allowable catch (TAC) of Pacific ocean perch in the CAI allocated to vessels participating in the BSAI trawl limited access fishery.
Effective 1200 hrs, Alaska local time (A.l.t.), August 19, 2016, through 2400 hrs, A.l.t., December 31, 2016.
Steve Whitney, 907-586-7228.
NMFS manages the groundfish fishery in the BSAI exclusive economic zone according to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2016 TAC of Pacific ocean perch, in the CAI, allocated to vessels participating in the BSAI trawl limited access fishery was established as a directed fishing allowance of 618 metric tons by the final 2016 and 2017 harvest specifications for groundfish in the BSAI (81 FR 14773, March 18, 2016).
In accordance with § 679.20(d)(1)(iii), the Regional Administrator finds that this directed fishing allowance has been reached. Consequently, NMFS is prohibiting directed fishing for Pacific ocean perch in the CAI by vessels participating in the BSAI trawl limited access fishery.
After the effective dates of this closure, the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA) finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such a requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the Pacific ocean perch directed fishery in the CAI for vessels participating in the BSAI trawl limited access fishery. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016. The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.20 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; closure.
NMFS is prohibiting directed fishing for species that comprise the deep-water species fishery by vessels using trawl gear in the Gulf of Alaska (GOA). This action is necessary because the third seasonal apportionment of the Pacific halibut bycatch allowance specified for the trawl deep-water species fishery in the GOA has been reached.
Effective 1200 hours, Alaska local time (A.l.t.), August 20, 2016, through 1200 hours, A.l.t., September 1, 2016.
Josh Keaton, 907-586-7228.
NMFS manages the groundfish fishery in the GOA exclusive economic zone according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The third seasonal apportionment of the Pacific halibut bycatch allowance specified for the deep-water species in the GOA by vessels not participating in the cooperative fishery in the Rockfish Program of the Central GOA, is 159 metric tons (mt). This apportionment was established by the final 2016 and 2017 harvest specifications for groundfish of the GOA (81 FR 14740, March 18, 2016) and reapportionment (81 FR 45423, July 14, 2016), for the period 1200 hours, A.l.t., July 1, 2016, through 1200 hours, A.l.t., September 1, 2016.
In accordance with § 679.21(d)(6)(i), the Administrator, Alaska Region, NMFS, has determined that the third seasonal apportionment of Pacific halibut bycatch allowance specified for deep-water species by vessels using trawl gear in the GOA has been reached. Consequently, NMFS is prohibiting directed fishing for the deep-water species by vessels using trawl gear in the GOA. The species and species groups that comprise the deep-water species fishery include sablefish, rockfish, deep-water flatfish, rex sole, and arrowtooth flounder. This closure does not apply to fishing by vessels participating in the cooperative fishery in the Rockfish Program for the Central GOA.
After the effective date of this closure the maximum retainable amounts at § 679.20(e) and (f) apply at any time during a trip.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the closure of the deep-water species fishery by vessels using trawl gear in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of August 18, 2016.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
This action is required by § 679.21 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
U. S. Office of Personnel Management.
Proposed rule with request for comments.
The U.S. Office of Personnel Management (OPM) is issuing a proposed rule that would define Kent County, Michigan, as an area of application county to the Macomb, MI, nonappropriated fund (NAF) Federal Wage System (FWS) wage area and Cameron County, Texas, as an area of application county to the Nueces, TX, NAF FWS wage area. These changes are necessary because there are NAF FWS employees working in Kent and Cameron Counties, and the counties are not currently defined to NAF wage areas.
We must receive comments on or before September 23, 2016.
You may submit comments, identified by “RIN 3206-AN40,” using any of the following methods:
Madeline Gonzalez, by telephone at (202) 606-2838 or by email at
OPM is issuing a proposed rule that would define Kent County, MI, as an area of application county to the Macomb, MI, NAF FWS wage area and Cameron County, TX, as an area of application county to the Nueces, TX, NAF FWS wage area. The Veterans Canteen Service (VCS) now employs one NAF FWS employee at VCS #315 in the Wyoming Health Care Center in Kent County and two NAF FWS employees at VCS #740 in the Veterans Affairs Health Care Center at Harlingen in Cameron County.
Under § 532.219 of title 5, Code of Federal Regulations, each NAF wage area “shall consist of one or more survey areas, along with nonsurvey areas, if any, having nonappropriated fund employees.” Kent and Cameron Counties do not meet the regulatory criteria under 5 CFR 532.219 to be established as separate NAF wage areas; however, nonsurvey counties may be combined with a survey area to form a wage area. Section 532.219 lists the regulatory criteria that OPM considers when defining FWS wage area boundaries.
OPM recently completed reviews of the definitions of Kent and Cameron Counties and is proposing the changes described below. The Federal Prevailing Rate Advisory Committee, the national labor-management committee responsible for advising OPM on matters concerning the pay of FWS employees, recommended these changes by consensus. These changes would apply on the first day of the first applicable pay period beginning on or after 30 days following publication of the final regulations.
Kent County would be defined as an area of application county to the Macomb, MI, NAF FWS wage area. The closest NAF wage area to Kent County is the Macomb wage area. There are no other NAF wage areas in the immediate vicinity of Kent County. VCS #315 is located approximately 175 miles from Selfridge Air National Guard Base, the Macomb wage area's host activity.
With the definition of Kent County to the Macomb NAF wage area, the Macomb wage area would consist of 1 survey county, Macomb County, MI, and 13 area of application counties: Alpena, Calhoun, Crawford, Grand Traverse, Huron, Iosco, Kent, Leelanau, Ottawa, Saginaw, Washtenaw, and Wayne Counties, MI; and Ottawa County, OH.
Cameron County would be defined as an area of application county to the Nueces, TX, NAF FWS wage area. The closest NAF wage area to Cameron County is the Nueces wage area. There are no other NAF wage areas in the immediate vicinity of Cameron County. VCS #740 is located approximately 148 miles from Naval Air Station Corpus Christi, the Nueces wage area's host activity.
With the definition of Cameron County to the Nueces NAF wage area, the Nueces wage area would consist of one survey county, Nueces County, TX, and six area of application counties: Bee, Calhoun, Cameron, Kleberg, San Patricio, and Webb Counties, TX.
I certify that these regulations would not have a significant economic impact on a substantial number of small entities because they would affect only Federal agencies and employees.
Administrative practice and procedure, Freedom of information, Government employees, Reporting and recordkeeping requirements, Wages.
Accordingly, OPM is proposing to amend 5 CFR part 532 as follows:
5 U.S.C. 5343, 5346; § 532.707 also issued under 5 U.S.C. 552.
Federal Aviation Administration (FAA), DOT.
Notice of proposed special conditions.
This action proposes special conditions for the Pilatus Aircraft, Ltd., Model PC-12, PC-12/45, and PC-12/47 airplanes. This airplane as modified by Finnoff Aviation will have a novel or unusual design feature associated with the installation of a rechargeable lithium battery. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Send your comments on or before October 11, 2016.
Send comments identified by docket number FAA-2016-9001 using any of the following methods:
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Ruth Hirt, Federal Aviation Administration, Programs and Procedures, ACE-114, Small Airplane Directorate, Aircraft Certification Service, 901 Locust; Kansas City, Missouri 64106; telephone (816) 329-4108; facsimile (816) 329-4090.
We invite interested people to take part in this rulemaking by sending written comments, data, or views. The most helpful comments reference a specific portion of the special conditions, explain the reason for any recommended change, and include supporting data. We ask that you send us two copies of written comments.
We will consider all comments we receive on or before the closing date for comments. We will consider comments filed late if it is possible to do so without incurring expense or delay. We may change these special conditions based on the comments we receive.
On September 28, 2015, Finnoff Aviation applied for a supplemental type certificate for installation of a rechargeable lithium battery in the Model PC-12, PC-12/45, PC-12/47 airplanes. The Model PC-12, PC-12/45, PC-12/47 airplanes are single-engine turboprop-powered business aircraft that can accommodate up to nine passengers with a take-off weight up to 10,450 lbs.
The current regulatory requirements for part 23 airplanes do not contain adequate requirements for the application of rechargeable lithium batteries in airborne applications. This type of battery possesses certain failure and operational characteristics with maintenance requirements that differ significantly from that of the nickel-cadmium (Ni-Cd) and lead-acid rechargeable batteries currently approved in other normal, utility, acrobatic, and commuter category airplanes. Therefore, the FAA is proposing this special condition to address (1) all characteristics of the rechargeable lithium batteries and their installation that could affect safe operation of the modified Model PC-12, PC-12/45, and PC-12/47 airplanes, and (2) appropriate Instructions for Continued Airworthiness (ICAW) that include maintenance requirements to ensure the availability of electrical power from the batteries when needed.
Under the provisions of § 21.101, Finnoff Aviation must show that the Model PC-12, PC-12/45, and PC-12/47, as changed, continue to meet the applicable provisions of the regulations incorporated by reference in Type Certificate No. A78EU
If the Administrator finds that the applicable airworthiness regulations (
Special conditions are initially applicable to the model for which they are issued. Should the applicant apply for a supplemental type certificate to modify any other model included on the same type certificate to incorporate the same or similar novel or unusual design feature, the special conditions would also apply to the other model under § 21.101.
In addition to the applicable airworthiness regulations and special conditions, the Model PC-12, PC-12/45, and PC-12/47 airplanes must comply with the fuel vent and exhaust emission requirements of 14 CFR part 34 and the noise certification requirements of 14 CFR part 36.
The FAA issues special conditions, as defined in 14 CFR 11.19, in accordance with § 11.38, and they become part of the type-certification basis under § 21.101.
The Model PC-12, PC-12/45, and PC-12/47 airplanes will incorporate the following novel or unusual design feature: Installation of a rechargeable lithium battery as the main or engine start aircraft battery.
Presently, there is limited experience with use of rechargeable lithium batteries and rechargeable lithium battery systems in applications involving commercial aviation. However, other users of this technology, ranging from personal computers, wireless telephone manufacturers to the electric vehicle industry, have noted safety problems with lithium batteries. These problems include overcharging, over-discharging, flammability of cell components, and cell internal defects described in the following paragraphs:
1. Overcharging: In general, lithium batteries are significantly more susceptible to internal failures that can result in self-sustaining increases in temperature and pressure (
2. Over-discharging: Discharge of some types of lithium battery cells beyond a certain voltage (typically 2.4 volts) can cause corrosion of the electrodes of the cell, resulting in loss of battery capacity that cannot be reversed by recharging. This loss of capacity may not be detected by the simple voltage measurements commonly available to flight crews as a means of checking battery status, which is a problem shared with Ni-Cd batteries.
3. Flammability of Cell Components: Unlike Ni-Cd and lead-acid batteries, some types of lithium batteries use liquid electrolytes that are flammable. The electrolyte may serve as a source of fuel for an external fire, if there is a breach of the battery container.
4. Cell Internal Defects: The rechargeable lithium batteries and rechargeable battery systems have a history of undetected cell internal defects. These defects may or may not be detected during normal operational evaluation, test, and validation. This may lead to unsafe conditions when operating in service.
These problems experienced by users of lithium batteries raise concern about the use of these batteries in commercial aviation. The intent of the special condition is to establish appropriate airworthiness standards for lithium battery installations in the Model PC-12, PC-12/45, and PC-12/47 airplanes and to ensure, as required by §§ 23.1309 and 23.601, that these battery installations are neither hazardous nor unreliable.
In summary, the lithium battery installation will consider the following items:
(a) The flammable fluid fire protection requirement is § 23.863. In the past, this rule was not applied to batteries of normal, utility, acrobatic, and commuter category airplanes since the electrolytes utilized in Ni-Cd and lead-acid batteries are not flammable.
(b) New Instructions for Continuous Airworthiness that include maintenance requirements to ensure that batteries used as spares have been maintained in an appropriate state of charge and installed lithium batteries have been sufficiently charged at appropriate intervals. These instructions must also describe proper repairs, if allowed, and battery part number configuration control.
(c) The applicant must conduct a system safety assessment for the failure condition classification of a failure of the battery charging and monitoring functionality (per Advisory Circular AC 23.1309-1E
(d) New requirements, in the proposed special conditions section, address the hazards of overcharging and over-discharging that are unique to lithium batteries, which should be applied to all rechargeable lithium battery and battery installations on the Model PC-12, PC-12/45, and PC-12/47 airplanes in lieu of the requirements of § 23.1353(a)(b)(c)(d)(e), amendment 23-49.
These special conditions are not intended to replace § 23.1353(a)(b)(c)(d)(e) at amendment 23-49 in the certification basis of Model PC-12, PC-12/45, and PC-12/47 airplanes. These special conditions apply only to rechargeable lithium batteries and lithium battery systems and their installations. The requirements of § 25.1353 at amendment 23-49 remains in effect for batteries and battery installations on Model PC-12, PC-12/45, and PC-12/47 airplanes that do not use rechargeable lithium batteries.
As discussed above, these special conditions are applicable to the Model PC-12, PC-12/45, and PC-12/47 airplanes. Should Finnoff Aviation apply at a later date for a supplemental type certificate to modify any other model included on Type Certificate No. A78EU
This action affects only certain novel or unusual design features on one model series of airplanes. It is not a rule of general applicability and it affects only the applicant who applied to the FAA for approval of these features on the airplane.
Aircraft, Aviation safety, Signs and symbols.
49 U.S.C. 106(g), 40113, 44701, 44702, 44704.
1. Installation of Lithium Batteries must show compliance to the following requirements:
(1) Safe cell temperatures and pressures must be maintained during—
i. Normal operations;
ii. Any probable failure conditions of charging or discharging or battery monitoring system;
iii. Any failure of the charging or battery monitoring system not shown to be extremely remote.
(2) The rechargeable lithium battery installation must be designed to preclude explosion or fire in the event of (1)(ii) and (1)(iii) failures.
(3) Design of the rechargeable lithium batteries must preclude the occurrence of self-sustaining, uncontrolled increases in temperature or pressure.
(4) No explosive or toxic gasses emitted by any rechargeable lithium battery in normal operation or as the result of any failure of the battery charging system, monitoring system, or battery installation which is not shown to be extremely remote, may accumulate in hazardous quantities within the airplane.
(5) Installations of rechargeable lithium batteries must meet the requirements of § 23.863(a) through (d) at amendment 23-34.
(6) No corrosive fluids or gases that may escape from any rechargeable lithium battery may damage surrounding structure or any adjacent systems, equipment, electrical wiring, or the airplane in such a way as to cause a major or more severe failure condition, in accordance with § 23.1309(c) at amendment 23-62 and applicable regulatory guidance.
(7) Each rechargeable lithium battery installation must have provisions to prevent any hazardous effect on structure or essential systems that may be caused by the maximum amount of heat the battery can generate during a short circuit of the battery or of its individual cells.
(8) Rechargeable lithium battery installations must have—
i. A system to automatically control the charging rate of the battery to prevent battery overheating and overcharging, or;
ii. A battery temperature sensing and over-temperature warning system with a means for automatically disconnecting the battery from its charging source in the event of an over-temperature condition, or;
iii. A battery failure sensing and warning system with a means for automatically disconnecting the battery from its charging source in the event of battery failure.
(9) Any rechargeable lithium battery installation functionally required for safe operation of the airplane must incorporate a monitoring and warning feature that will provide an indication to the appropriate flight crewmembers whenever the State of Charge (SOC) of the batteries has fallen below levels considered acceptable for dispatch of the airplane.
(10) The Instructions for Continued Airworthiness required by § 23.1529 at amendment 23-26 must contain maintenance requirements to assure that the battery has been sufficiently charged at appropriate intervals specified by the battery manufacturer and the equipment manufacturer that contain the rechargeable lithium battery or rechargeable lithium battery system. This is required to ensure that lithium rechargeable batteries and lithium rechargeable battery systems will not degrade below specified ampere-hour levels sufficient to power the aircraft system. The Instructions for Continued Airworthiness must also contain procedures for the maintenance of replacement batteries in spares storage to prevent the installation of batteries that have degraded charge retention ability or other damage due to prolonged storage at a low state of charge. Replacement batteries must be of the same manufacturer and part number as approved by the FAA.
The term “sufficiently charged” means that the battery will retain enough of a charge, expressed in ampere-hours, to ensure that the battery cells will not be damaged. A battery cell may be damaged by lowering the charge below a point where there is a reduction in the ability to charge and retain a full charge. This reduction would be greater than the reduction that may result from normal operational degradation.
(11) In showing compliance with the proposed special conditions herein, paragraphs (1) through (8), and the RTCA document, Minimum Operational Performance Standards for Rechargeable Lithium Battery Systems, DO-311, may be used. The list of planned DO-311 tests should be documented in the certification or compliance plan and agreed to by the Denver ACO. Alternate methods of compliance other than DO-311 tests must be coordinated with the directorate and Denver ACO.
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the regulations for new animal drugs for investigational use to expand the scope of clinical investigator disqualification to include ineligibility to conduct nonclinical laboratory studies. Currently, when the Commissioner of Food and Drugs (the Commissioner) determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also is ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. Under this proposal, when the Commissioner determines that an investigator is ineligible to receive a new animal drug for investigational use, the investigator also will be ineligible to conduct any nonclinical study intended to support an application for a research or marketing permit for a new animal drug. This proposal is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA.
Submit either electronic or written comments on the proposed rule by November 22, 2016. See section VII of this document for the proposed effective date of a final rule based on this document.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
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Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Vernon Toelle, Center for Veterinary Medicine (HFV-230), 7519 Standish Pl., Rockville, MD 20855, 240-402-5637.
The current regulations in part 511 (21 CFR part 511) prohibit a disqualified clinical investigator from conducting any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA. We propose to expand the current clinical investigator disqualification regulations in part 511 by providing that a disqualified investigator also is ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. In this document, consistent with our proposal in part 58 (21 CFR part 58) published elsewhere in this issue of the
Under current § 511.1(c) (21 CFR 511.1(c)), a clinical investigator disqualified by the Commissioner is ineligible to receive the test article regulated in part 511 (
In order to conclude that a clinical investigator is no longer eligible to receive new animal drugs for investigational use, the Commissioner must find that the investigator repeatedly or deliberately failed to comply with the conditions of the exempting regulations or repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report (§ 511.1(c)(2)). When a clinical investigator is disqualified under part 511, the basis for disqualification typically is the repeated or deliberate submission of false information to FDA or a sponsor in a required report. For new animal drugs, the same clinical investigator could conduct both nonclinical laboratory studies and clinical investigations.
In the new animal drug approval process, nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. Therefore, this proposal to expand § 511.1(c) to include nonclinical laboratory studies is intended to help ensure adequate protection of animal research subjects and the quality and integrity of data submitted to FDA for the approval of a new animal drug.
Consistent with the proposed changes to the provisions in part 511, we propose amending the list of regulatory provisions under which a part 16 (21 CFR part 16) informal regulatory hearing is available. In part 16, we propose changing the scope of the relevant provision for part 511 to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.”
Concurrent with this proposal, FDA is publishing elsewhere in this issue of the
FDA may consider disqualification of a clinical investigator when FDA has information that an investigator has repeatedly or deliberately failed to comply with applicable requirements for the conduct of clinical investigations, or has repeatedly or deliberately submitted to FDA or to the sponsor false information in any required report. Disqualification of an investigator is initiated by the appropriate FDA Center depending upon the particular type of test article (
The regulations provide the investigator, who is subject to disqualification, an opportunity to be heard and explain the matter complained of,
Because CVM regulates drugs for animal use, the study subjects are animals in both nonclinical laboratory studies and clinical investigations intended to support the approval of a new animal drug. Nonclinical laboratory studies such as those for target animal safety and human food safety may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. For animal drug products regulated by CVM, the same investigator may conduct both nonclinical laboratory studies and clinical investigations. For example, CVM's two most recent clinical investigator disqualification matters involved investigators who were also study directors on nonclinical laboratory studies submitted to CVM in support of applications for a new animal drug. In addition, CVM is aware of multiple persons that conduct both clinical investigations and nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Therefore, it is critical for CVM to have the authority to disqualify an investigator from conducting nonclinical laboratory studies when that same investigator is disqualified from conducting clinical investigations, particularly when the basis for disqualification is the repeated or deliberate submission of false information to FDA or the sponsor in a required report.
This proposal to amend part 511 to expand a disqualified investigator's ineligibility to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug would help to ensure adequate protection of animal research subjects and data integrity. This action also may lead to improved public confidence in the nonclinical and clinical data supporting FDA decisions for new animal drug approvals.
We therefore propose that when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511 and is therefore ineligible to conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, the investigator also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.
To effect this change, FDA proposes to amend the current regulations in § 511.1(c).
Proposed Revisions to § 511.1(c)(1): We propose to change the scope of the question addressed during a part 16 hearing, should the investigator request and be granted an informal hearing, also to include whether the investigator is eligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.
Proposed Revisions to § 511.1(c)(2): We propose that an investigator disqualified by a Commissioner's decision also will be ineligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit for a new animal drug.
Therefore, as proposed, an investigator determined to be ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. This proposal expands the scope of the current regulations in § 511.1(c)(2) which states that a disqualified clinical investigator is ineligible to conduct any
FDA proposes amending § 511.1(c)(6) for consistency with our proposal to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to the part 511 investigator disqualification regulations. Therefore, for consistency with the proposed changes in § 511.1(c)(2), we propose adding in § 511.1(c)(6) that the investigator has presented adequate assurances that the investigator will conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug solely in compliance with the applicable provisions of chapter I.
We propose to revise § 16.1(b)(2) to amend the entry for § 511.1(c)(1) to add “any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug” to be consistent with the other proposed amendments in this rulemaking.
We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is authorized to issue regulations for the efficient enforcement of the FD&C Act. Section 512(j) of the FD&C Act (21 U.S.C. 355(j)) authorizes FDA to issue regulations for exempting from the operation of section 512 of the FD&C Act new animal drugs intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of animal drugs. An investigator who repeatedly or deliberately violates the regulations or who repeatedly or deliberately submits to FDA or the sponsor false information in a required report would not be considered a qualified expert with the experience required to conduct nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. This proposed rulemaking would disqualify a clinical investigator from conducting nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug when the Commissioner determines that a clinical investigator is ineligible to receive the test article under the disqualification regulations in part 511. FDA's legal authority to promulgate this proposal regarding clinical investigators exists under sections 512(j) and 701(a) of the FD&C Act, as essential to protection of the public health and safety and to enforcement of the Agency's responsibilities under sections 201, 501, 502, 503, 512, and 701 of the FD&C Act (21 U.S.C. 321, 351, 352, 353, 360b, and 371).
FDA proposes that any final rule that may issue based on this proposal become effective 30 days after the date of publication of the final rule in the
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. Because this proposed rule does not impose new requirements on any entity and therefore has no associated compliance costs, the Agency proposes to certify that the final rule will not have a significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 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, 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.
This proposed rule seeks to expand the scope in part 511 of disqualification of a clinical investigator to include ineligibility to conduct nonclinical laboratory studies. A final rule (77 FR 25353), published on April 30, 2012, prevents a disqualified investigator from conducting any clinical investigation, and therefore applies explicitly to clinical investigations. However, the rule is silent on nonclinical laboratory studies. Thus, under the current regulation in part 511, a disqualified investigator could conduct a nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. Because the reason typically for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is essential to adequate protection of animal research subjects and data integrity.
The Agency would not incur additional costs by expanding the scope in part 511 for disqualification of a clinical investigator. Similarly, we do not expect that industry would incur additional costs because the proposed rule would not require sponsors to perform additional tasks. For instance, upon disqualification, the respective investigator's name is posted on FDA's Web page, and this helps mitigate the employment of the investigator for clinical investigations or nonclinical laboratory studies intended to support an application for a research or marketing permit for a new animal drug. Because the typical reason for disqualification in part 511 is the repeated or deliberate submission of false information to FDA or a sponsor in a required report, the benefit of preventing a disqualified clinical investigator from performing both nonclinical laboratory studies and clinical investigations is enhanced protection of animal research subjects and data integrity.
FDA tentatively concludes that this proposed rule contains no collection of information. Therefore, clearance by OMB under the Paperwork Reduction Act of 1995 is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that 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.
Administrative practice and procedure.
Animal drugs, Medical research, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, it is proposed that parts 16 and 511 be amended as follows:
15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
(b) * * *
(2) * * *
§ 511.1(c)(1), relating to whether an investigator is eligible to receive test articles under part 511 and eligible to conduct:
(i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products; and
(ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.
21 U.S.C. 321, 351, 352, 353, 360b, 371.
(c) * * *
(1) * * * If an explanation is offered but not accepted by the Center for Veterinary Medicine, the investigator will be given an opportunity for a regulatory hearing under part 16 of this chapter on the question of whether the investigator is eligible to receive test articles under this part and eligible to conduct:
(i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA; and
(ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.
(2) * * * The notification also will explain that an investigator determined to be ineligible to receive a test article under this part will be ineligible to conduct
(i) Any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA, including drugs, biologics, devices, new animal drugs, foods, including dietary supplements, that bear a nutrient content claim or a health claim, infant formulas, food and color additives, and tobacco products, and
(ii) Any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug.
(6) An investigator who has been determined to be ineligible under paragraph (c)(2) of this section may be reinstated as eligible when the Commissioner determines that the investigator has presented adequate assurances that the investigator will employ all test articles, and will conduct any clinical investigation that supports an application for a research or marketing permit for products regulated by FDA and any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug, solely in compliance with the applicable provisions of this chapter.
Food and Drug Administration, HHS.
Notification of availability.
The Food and Drug Administration (FDA, we, or Agency) is announcing the availability of a draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food: Guidance for Industry.” This draft guidance document includes several chapters of a multi-chapter guidance intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under our rule entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.”
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that we consider your comment on this draft guidance before we issue the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
Submit written requests for single copies of the draft guidance to Office of Food Safety, Center for Food Safety and Applied Nutrition, Food and Drug Administration (HFS-300), 5001 Campus Dr., College Park, MD 20740. Send two self-addressed adhesive labels to assist that office in processing your request. See the
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-2166.
The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353) enables FDA to better protect public health by helping to ensure the safety and security of the food supply. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to problems after they occur. FSMA recognizes the important role industry plays in ensuring the safety of the food supply, including the adoption of modern systems of preventive controls in food production.
Section 103 of FSMA amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act), in section 418 of the FD&C Act (21 U.S.C. 350g), by adding requirements for hazard analysis and risk-based preventive controls for establishments that are required to register as food facilities under our regulations, in 21 CFR part 1, subpart H, in accordance with section 415 of the FD&C Act (21 U.S.C. 350d). We have established regulations to implement these requirements within part 117 (21 CFR part 117).
We are announcing the availability of several chapters of a multi-chapter draft guidance for industry entitled “Hazard Analysis and Risk-Based Preventive Controls for Human Food.” We are issuing the draft guidance consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternate approach if it satisfies the requirements of the applicable statutes and regulations.
The multi-chapter draft guidance for industry is intended to explain our current thinking on how to comply with the requirements for hazard analysis and risk-based preventive controls under part 117, principally in subparts C and G. The chapters that we are announcing in this document are as follows:
We intend to announce the availability for public comment of additional chapters of the draft guidance as we complete them.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under
Persons with access to the Internet may obtain the draft guidance at either
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA, the Agency, we) proposes to amend the animal drug regulations by revising the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. The proposed revision will preserve the availability of medicated feeds intended for therapeutic use in minor animal species and prevent a significant disincentive for future development of additional minor species therapies.
Submit either electronic or written comments by November 7, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
•
David Edwards, Center for Veterinary Medicine (HFV-220), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-6205, email:
FDA proposes to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. This revision is being proposed to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by the FDA Center for Veterinary Medicine (CVM) to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobial drugs in animal agriculture. Under this program, sponsors of antimicrobial new animal
The category in which a new animal drug used in medicated feeds is placed is based on their likelihood of producing unsafe residues in the edible products of treated animals. Category I consists of those drugs that require no withdrawal period at the lowest use level in each species for which they are approved. Category II consists of those drugs that require a withdrawal period at the lowest use level for at least one species for which they are approved, or that are regulated on a “no-residue” basis or with a zero tolerance because of a carcinogenic concern, regardless of whether a withdrawal period is required.
New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.
Certain Category I Type A medicated articles would be recategorized to Category II when a production indication is voluntarily withdrawn by a sponsor as part of the judicious use initiative that is currently underway, based on the next lowest use level that remains once the production use is withdrawn having a withdrawal period such that the drug would then meet the definition for Category II. For Category I Type A medicated articles that include indications for minor species, FDA is concerned that if such a Type A medicated article is recategorized to Category II based on a withdrawal period for an approved therapeutic use in a minor species, sponsors may opt to request withdrawal of approval of these minor species indications in order to ensure the Type A medicated article can remain in Category I. Sponsors may also decline to pursue development of additional therapies for minor species if these uses would require a withdrawal period that would trigger a recategorization to Category II.
The proposed revisions would revise the category definitions such that they would be based only on whether a withdrawal period is required for a major species.
The purpose of the proposed revision is to preserve the present availability of medicated feeds intended for therapeutic use in minor species and to prevent a significant disincentive for future development of additional therapies for minor species. We believe the proposed revision will not compromise public health due to the comparatively lower exposure by humans to potential drug residues in edible tissues of food-producing minor species inherent in their less frequent consumption.
FDA proposes to amend 21 CFR 558.3
We are proposing these regulations based on our authority under the new animal drug provisions in section 512 (21 U.S.C. 360b) and section 701 (21 U.S.C. 371) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which gives the Agency general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
The revisions made by this proposed rule are intended to preserve the availability of medicated feeds intended for therapeutic use in minor animal species. In addition, these proposed revisions will prevent a significant disincentive for future development of additional therapies for minor species. No additional costs or benefits will accrue from this rulemaking.
FDA is proposing to revise the definitions of the two categories of new animal drugs used in medicated feeds to base category assignment only on approved uses in major animal species. To strengthen the Agency's medicated feed program, FDA issued a final rule in the
New animal drugs approved for use in medicated feeds are approved as Type A medicated articles, the most concentrated form of the drug product for use by feed mills. Category I Type A medicated articles can be handled by both licensed and unlicensed feed mills, whereas Category II Type A medicated articles can be handled only by licensed feed mills.
This action is being taken to address a potential consequence of animal drug sponsor cooperation in implementing a strategy initiated by CVM to address antimicrobial resistance by taking measures to ensure the judicious use of antimicrobials of importance to human medicine (
These changes, which are described in Guidance for Industry (GFI) #213, “New Animal Drugs and New Animal Drug Combination Products Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209,” published December 2013 (
Under GFI #213, sponsors of medically important antimicrobial new animal drugs approved for over-the-counter use in the feed or water of food-producing animals were asked to change the marketing status of their products to veterinary prescription (Rx) marketing status in the case of new animal drugs administered in water, or to veterinary feed directive (VFD) marketing status for drugs administered in or on animal feed. New animal drugs with Rx or VFD marketing status can legally only be used with a veterinarian's oversight. Prescription animal drugs require a veterinarian's prescription, while use of VFD drugs requires a VFD; both types of orders must be issued by a licensed veterinarian in the course of the veterinarian's professional practice.
In addition, under GFI #213 sponsors of medically important new animal drugs used in animal feed or water that have production indications were requested to voluntarily withdraw these indications; approved therapeutic indications for use of these drugs would remain.
In some instances, once a sponsor withdraws the production indication from a drug approved for use in animal feed (which is generally the lowest use level of the drug), the remaining lowest therapeutic use level will require a withdrawal period. Based on the existing definitions of the feed drug categories, this results in a Category I new animal drug being recategorized as a Category II drug, the more restrictive of the two possible categories of drugs used in medicated feed. Category II drugs require that the manufacture of Type B and Type C medicated feeds from Type A medicated articles be done in facilities possessing a medicated feed mill license, which number roughly 900 in the United States. In contrast, there are tens of thousands of unlicensed feed mills in this country. Such a recategorization to Category II, thereby limiting the use of the Type A medicated article to a much smaller subset of feed mills, may disrupt the existing movement of these medicated feeds through distribution channels.
FDA believes that sponsors may request voluntary withdrawal of those specific therapeutic indications as a way to keep their products in the less restrictive Category I when the recategorization of a drug to Category II is triggered by a therapeutic indication for a minor species. For certain drug products, the only therapeutic indications requiring a withdrawal period that would remain following the voluntary withdrawal of approval of production uses are those for minor species. The loss of therapeutic indications for minor species would adversely affect the availability of therapeutic medicated feeds necessary for the health of minor species, which is a matter of significant concern for the Agency.
This foreseeable adverse effect on the health of minor species would directly undermine the intent of Congress in passing the Minor Use and Minor Species Animal Health Act of 2004 (Pub. L. 108-282) as well as to our intent in establishing the implementing regulations under that statute. The Category I drugs likely to be affected have been safely used in this category for decades, and we have no reason to believe they would not continue to be safely used in this category moving forward.
Under the current category definitions in § 558.3 for feed use drugs, a drug will be included in Category II if the lowest use level of the drug in any approved species requires a withdrawal period. This approach equates the existence of a withdrawal period for a particular use with the potential risk that edible tissues from animals administered a medicated feed might contain a residue of concern.
However, the toxicological analysis of animal drugs used to calculate a withdrawal period is based on lifetime exposure by humans to potential drug residues. This assessment of lifetime exposure does not consider the lower risk to the public health from the use of these same new animal drugs in food-producing minor species attributable to the lower human consumption over time of edible tissues from food-producing minor species (Refs. 1 and 2). For this reason, FDA does not at this time believe this revision of the category definitions presents a risk to the public health.
In a manner similar to its effect on drug indications that are already approved, CVM believes the existing categorization scheme would pose a significant disincentive for future development of additional minor species therapies for existing Category I drugs if those new uses would require a withdrawal period and thus trigger a change to Category II for that drug.
Given the potential for implementation of GFI #213 to result in the foreseeable consequence of the withdrawal of approval of needed therapeutic indications for minor species, we propose to revise the definitions of the two categories of new animal drugs used in medicated feeds in § 558.3 to base category assignment only on uses in major species. This proposed revision is expected to preserve the availability of drugs intended for therapeutic use in minor species and also prevent a significant disincentive for future development of additional therapies for minor species without compromising public health.
FDA proposes to amend paragraphs (b)(1)(i) and (ii) of this Agency's regulations at § 558.3 (
This proposed rule is a companion to the direct final rule published elsewhere in this issue of the
Consistent with FDA's procedures on direct final rulemaking, we are publishing elsewhere in this issue of the
FDA is providing a comment period for the proposed rule of 75 days after the date of publication in the
Comments that are frivolous, insubstantial, or outside the scope of the proposed rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to those in the proposed rule would not be considered a significant adverse comment unless the comment states why the proposed rule would be ineffective without the additional change.
If FDA does not receive significant adverse comment in response to the companion direct final rule, the Agency will publish, within 30 days after the comment period ends, a document in the
A full description of FDA's policy on direct final rule procedures may be found in a guidance document announced in the
We are proposing these regulations under the legal authority provided by section 512 of the FD&C Act relating to new animal drugs and section 701(a) of the FD&C Act. Section 512 gives FDA the authority to approve new animal drug applications (NADAs). Such approval establishes conditions of use under which the drug can be used in a safe and effective manner. Categorization of new animal drugs used in medicated feeds is one such condition of use. In addition, section 701(a) of the FD&C Act gives FDA general rulemaking authority to issue regulations for the efficient enforcement of the FD&C Act.
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). We believe that this proposed rule is not a significant regulatory action as defined by Executive Order 12866.
The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because this proposed rule would not impose any compliance costs on the sponsors of animal drug products that are currently marketed or in development, we propose to certify that this proposed rule will not have a significant economic impact on a substantial number of small entities.
The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing “any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year.” The current threshold after adjustment for inflation is $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
This proposed rule allows certain new animal drugs approved for use in animal feed that would otherwise be recategorized as Category II drugs under the current definitions in § 558.3 following withdrawal of approval of production indications during GFI #213 implementation to remain in Category I if the change to Category II would have been triggered by a minor species indication.
Based on the revised definitions of the two feed drug categories, there is one drug, sulfamerazine for control of furunculosis in trout (21 CFR 558.582), that would be recategorized from Category II to Category I as a result of this proposed rule, if finalized. No compliance costs would be incurred due to this recategorization because no changes to the approved application are required for continued marketing of the drug.
We have determined under 21 CFR 25.30(h) that this action is of a type that will not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
This proposed rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520) is not required.
We have analyzed this proposed rule in accordance with the principles set forth in Executive Order 13132. We have determined that the proposed rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we have concluded 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.
The following references are on display in the Division of Dockets Management (see
1. U.S. Department of Agriculture, “Livestock & Meat Domestic Data,”
2. “Food Fish Production and Sales by Species, by Size Category, by State and United States: 2005,”
Animal drugs, animal feeds.
Therefore, under the Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs and redelegated to the Center for Veterinary Medicine, it is proposed that part 558 be amended as follows:
21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.
(b) * * *
(1) * * *
(i) Category I—These drugs require no withdrawal period at the lowest use level in each major species for which they are approved or are approved for use only in minor species.
(ii) Category II—These drugs require a withdrawal period at the lowest use level for at least one major species for which they are approved, or are regulated on a “no-residue” basis or with a zero tolerance because of carcinogenic concern regardless of whether a withdrawal period is required in any species.
(13) “Major species” means cattle, horses, swine, chickens, turkeys, dogs, and cats.
(14) “Minor species” means animals, other than humans, that are not major species.
Environmental Protection Agency (EPA).
Proposed rule.
The U.S. Environmental Protection Agency (EPA) proposes to revise its regulations to streamline and clarify processes related to submission and review of title V petitions. This notice covers five key areas, each of which should increase stakeholder access to and understanding of the petition process and aid the EPA's review of petitions. First, the EPA is proposing regulatory provisions that provide direction as to how petitions should be submitted to the agency. Second, the EPA is proposing regulatory provisions that describe the expected format and minimum required content for title V petitions. Third, the proposal clarifies that permitting authorities are required to respond to significant comments received during the public comment period for draft title V permits, and to provide that response with the proposed title V permit to the EPA for the agency's 45-day review period. Fourth, guidance is provided in the form of “recommended practices” for various stakeholders to help ensure title V permits have complete administrative records and comport with the requirements of the Clean Air Act (CAA or Act). Fifth, to increase familiarity with the post-petition process, this notice presents information on the agency's interpretation of certain title V provisions of the CAA and its implementing regulations regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2016-0194, to the
Questions concerning these proposed rule revisions should be addressed to Ms. Carrie Wheeler, U.S. Environmental Protection Agency, Office of Air Quality Planning and Standards, Air Quality Planning Division, (C504-05), Research Triangle Park, NC 27711, telephone number (919) 541-9771, email at
The information presented in this document is organized as follows:
Entities potentially affected directly by the proposed revisions to the EPA's regulations include anyone who intends to submit a title V petition on a proposed title V permit prepared by a state, local or tribal title V permitting authority pursuant to its EPA-approved title V permitting program. Entities also potentially affected by this rule include state, local and tribal permitting authorities responsible for implementing the title V permitting program. Entities not directly affected by this proposed rule include owners and operators of major stationary sources or other sources that are subject to title V permit requirements, as well as the general public who would have an interest in knowing about title V permitting actions and associated public hearings but do not intend to submit a petition.
2.
To request a public hearing or information pertaining to a public hearing, contact Ms. Pamela Long, Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, by phone at (919) 541-0641 or by email at
In addition to being available in the docket, an electronic copy of this
Title V of the CAA establishes an operating permit program. Section 505 of the CAA requires permitting authorities to submit a proposed title V permit to the EPA Administrator for review for a 45-day review period before issuing the permit as final. The Administrator shall object to issuance of the permit within that 45-day review period if the Administrator determines that the permit contains provisions that are not in compliance with the applicable requirements under the CAA. If the Administrator does not object to the permit during the 45-day EPA review period, any person may petition the Administrator within 60 days after the expiration of the 45-day review period to take such action (hereinafter “title V petition” or “petition”). The title V petition provisions of the current implementing regulations found at 40 CFR part 70 largely mirror the CAA, and have not been revised since original promulgation in 1992. With 20 years of experience with title V petitions as well as feedback from various stakeholders, the agency is now proposing changes to 40 CFR part 70 intended to provide clarity and transparency to the petition process, and to improve the efficiency of that process.
The changes proposed and the information provided in the preamble to the proposal are intended to benefit permitting authorities, permitted sources, and potential petitioners, as well as the EPA. Permitting authorities and permitted sources are expected to benefit by early consultation with the appropriate EPA Regional Office when the permitting authority is preparing a permit to ensure it includes conditions that assure compliance with applicable requirements under the CAA and part 70). These early actions should minimize potential permit deficiencies and reduce the associated likelihood that a petition will be submitted on that title V permit.
Potential petitioners are expected to benefit by having better notification of permits and review deadlines (
The EPA is expected to benefit by improving the agency's ability to meet its statutory obligations to review proposed permits, respond to title V petitions and provide more transparency in the title V petition process. These were concerns expressed by a Clean Air Act Advisory Committee task force in recommendations provided to the agency in 2006.
The proposed regulatory revisions described in Section IV of this notice would, among other things: (1) Provide direction as to how title V petitions should be submitted to the agency, including encouraging the use of an electronic submittal system as the preferred (but not exclusive) method to submit title V petitions; (2) describe mandatory content and format for title V petitions, which is intended to clarify the process for petitioners and improve the EPA's ability to review and act on petitions efficiently; and (3) require permitting authorities to respond in writing to significant comments received during the public comment period on a draft title V permit and to provide that written response to the EPA along with the proposed title V permit at the start of the EPA's 45-day review period. This proposal also requests comment on the proposed revisions to the regulations governing the CAA title V petition process, as well as comment on questions related to potentially establishing page limits on title V petitions. The proposed revisions to the 40 CFR part 70 regulations are described more fully in Section IV of this notice.
Separate from the regulatory revisions proposed in Section IV, Section V.A of this notice provides guidance on “recommended practices” for permit development for various stakeholders that, when followed, helps to ensure permits have complete administrative records and comport with the requirements of the CAA. Lastly, to increase stakeholder familiarity with the post-petition process, Section V.B. provides information concerning the agency's interpretation of certain provisions of title V of the CAA and the implementing regulations at part 70 regarding the steps following an EPA objection in response to a title V petition, as previously discussed in specific title V orders. The following paragraphs briefly provide additional information on each area.
First, in order to reduce confusion with and add clarity to the process of submitting title V petitions, the EPA has developed a centralized point of entry for all title V petitions using an electronic submittal system. As described in Section IV.A of this notice, the EPA encourages petitioners to use this electronic system when submitting title V petitions, which will improve customer service by allowing for better access to and tracking of petitions. This is the preferred method identified in the proposed regulatory revisions that would be acceptable to use to submit a title V petition to the agency. Alternative methods for submittal are also identified in this notice.
Second, with regard to petition content, the EPA is proposing regulatory revisions that would specify requirements for mandatory petition content and standard formatting for all petitions. This is expected to benefit potential petitioners by ensuring completeness while promoting streamlining and improving the EPA's ability to review and act on petitions efficiently. In its orders responding to title V petitions, the EPA has already identified key elements that are critical for demonstrating that a title V permit does not assure compliance with applicable requirements under the CAA or under the part 70 regulations, and has explained their relevance to its determinations. In this proposal, the EPA is proposing new regulatory language to codify what has already been discussed in prior orders. If finalized, petitioners would be expected to follow these requirements and include this content following a standard format. As described later in this notice and in the proposed regulatory text, this content includes identifying where the issue being raised in the title V petition was raised during the public comment period on the draft title V permit and addressing the permitting authority's response to the comment in the petition in order to demonstrate that an objection is warranted.
Along with the proposed changes and requests for comment regarding petition content and format in Section IV.B of this notice, the EPA proposes to add new regulatory language to 40 CFR 70.8 that would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions implementing this requirement of section 505(b)(2) of the Act. Therefore, this rule proposes to insert a requirement into the part 70 rules mirroring the Act's requirement in order to ensure consistency with this provision of the statute.
Third, Section IV.C of this notice contains requirements for certain procedures related to responding to significant public comments on the draft title V permit, as well as the administrative record for and submittal of proposed title V permits to the EPA by permitting authorities. The changes being proposed now would require that all permitting authorities respond to significant comments received on draft permits. The EPA is also proposing that the 45-day review period under section 505(b)(1) would not begin until the permitting authority forwards the proposed permit, the written response to comments (RTC) or statement that no public comments were received, and the statement of basis document, to the EPA for its review. These changes are expected to benefit permitting authorities and permitted sources by resulting in a more complete permit record and greater clarity for all stakeholders. If finalized, these changes may result in a need to revise at least some state, local and tribal part 70 programs.
In addition to these three areas, as part of the agency's effort to share information with stakeholders about the title V petition process, this notice includes guidance to help ensure permits have complete administrative records and comport with the requirements of the CAA. Presented in the form of “recommended practices” for stakeholders, this guidance is shared in the spirit of providing information and context to give a more comprehensive view of the title V
All four of the previously mentioned areas should help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions. The proposed revisions to the part 70 regulations associated with the first three key areas are anticipated to increase transparency and add clarity to the title V petition submittal, review, and response processes. Codifying existing practices into title V regulations of the CAA is also expected to make the EPA petition review process more efficient. In addition, providing “recommended practices” for stakeholders, including some related to permit issuance, also increases transparency and clarity to further improve the stakeholder experience and understanding surrounding title V petitions.
Section V.B of this notice discusses steps following the EPA's issuance of an objection in response to a title V petition, particularly where the state, local, or tribal permitting authority subsequently amends the permit terms and conditions and/or the permit record in response to the EPA's objection. This process is often referred to as the post-petition process. The information provided in Section V.B reflects interpretations of certain statutory and regulatory provisions related to this aspect of the title V petition process that have previously been discussed by the EPA, including in title V petition orders. This information is repeated as a convenience to stakeholders and the general public: The agency is not proposing to alter its interpretation of that process in this notice and the regulatory revisions proposed in this notice do not relate to or modify this interpretation. The agency is not soliciting comment on this interpretation or otherwise reopening or revising the already-issued title V petition orders or other EPA documents in which it has previously been discussed. Rather, this discussion is included to provide additional transparency and clarity.
Finally, as a convenience to stakeholders and the general public, and to provide context and background that informs how the EPA determines whether to grant an objection and to promote awareness of the EPA's existing interpretation of key provisions of section 505(b)(2) of the Act, Section III.D of this notice includes a summary of some past orders responding to title V petitions and court decisions addressing the burden on a title V petitioner to demonstrate that an objection is warranted.
Congress amended the CAA in 1990 to add title V, now found at 42 U.S.C. 7661-7661f, to assist in compliance and enforcement of air pollution controls. CAA Amendments of 1990, Public Law 101-549, sections 501-507, 104 Stat. 2399, 2635-48 (1990). Before this, the CAA pollution control requirements that might apply to a particular source could be found in many different provisions of the Act and its numerous regulations. As one court opinion has described it: “Before 1990, regulators and industry were left to wander through this regulatory maze in search of the emission limits and monitoring requirements that might apply to a particular source. Congress addressed this confusion in the 1990 Amendments by adding title V of the Act, which created a national permit program that requires many stationary sources of air pollution to obtain permits that include relevant emission limits and monitoring requirements.”
Accordingly, title V of the Act establishes an operating permits program for major sources of air pollutants, as well as certain other sources. CAA section 502(a). Under title V of the CAA, states were required to develop and submit to EPA for approval title V permitting programs consistent with program requirements promulgated by the EPA. Those requirements are now found in 40 CFR part 70. Most states, certain local agencies, and one tribe have approved part 70 programs.
Prior to the title V program, CAA requirements for major sources of air pollutants were implemented in multiple and various ways. As a lawmaker involved in the 1990 CAA Amendments explained:
Title V creates, for the first time, a unifying permit program for facilities subject to the [A]ct's various control requirements. In the past, some provisions of the Clean Air Act—for example, the nonattainment and PSD new source requirements—were, and will continue to be, implemented through preconstruction permits. Other control requirements were effected without Federal, or in some cases, State permits—for example, NESHAPS and NSPS—although States often incorporated these requirements into their own permit programs.
More specifically, a title V permit must contain enforceable emission limits and standards, including operational requirements and limitations, and such other conditions as necessary to assure compliance with all applicable requirements that apply to the source at the time of permit issuance, as well as the monitoring, recordkeeping, and reporting requirements to assure compliance. In sum, the title V permit program is a vehicle for ensuring that air quality control requirements are appropriately applied to a source's emission units and for assuring compliance with such requirements.
For the most part, title V of the CAA does not impose new pollution control requirements on sources. The definition of “applicable requirements” in the part 70 regulations includes many standards and requirements that are established through other CAA programs, such as standards and requirements under sections 111 and 112 of the Act, and terms and conditions of preconstruction permits issued under the New Source Review programs. 40 CFR 70.2. Once those air quality control requirements are established in those other programs, they are incorporated into a source's title V permits as appropriate. Hence, a title V permit is a comprehensive document that identifies all the specific CAA requirements that must be met by a source in order to operate. Developing
The creation of the new permit program in title V provides an opportunity and an obligation for EPA to harmonize the substantive provisions of the other titles in this complex legislation. Many of the same sources and pollutants will be controlled under multiple titles—the same facilities and pollutants will often be controlled under the hazardous air pollutant, nonattainment, and acid rain programs. EPA must make every effort to harmonize and prevent unproductive duplication among those titles. The permit provisions of title V provide a focus for this harmonization, although title V does not change, and gives EPA no authority to modify, the substantive provisions of these other titles.
As this language suggests, in providing an opportunity for harmonization through title V of the CAA, Congress did not replace or remove the procedures and requirements for establishing substantive requirements that exist in other provisions of the CAA. Nor did Congress alter or supplant the opportunities for public participation and administrative and judicial review that are found in other CAA programs, such as those for public participation and judicial review of certain final agency actions under section 307 of the Act. In addition, the Act requires that title V permitting programs provide opportunities for public participation in title V permitting processes and an opportunity for judicial review in state court. CAA section 502(b)(6);
Although title V of the CAA does not generally impose new pollution control requirements on sources, it does require that certain procedural measures be followed especially with respect to assuring compliance with underlying applicable requirements, and it also requires sources to pay certain fees. For example, title V of the CAA requires permits to contain adequate monitoring, recordkeeping, and reporting provisions to assure sources' compliance with permit terms and conditions.
In general terms, as noted above, the title V permit program was a significant development that established new procedural requirements for permitting authorities and sources. In crafting the program, Congress balanced the benefit of a single document that contains all applicable requirements of the Act with the need to process these complex documents in an efficient manner. As part of the effort to promote efficient implementation of the operating permits program, the provisions relating to title V objections establish an orderly process with specific deadlines, which give the EPA an opportunity to raise objections to a title V permit before it is issued and which give any person the opportunity to timely raise specific issues to the EPA through a title V petition. In light of the complexities of implementing a program of title V's scope, a statement of one lawmaker in the legislative history indicates that the opportunity to “challenge EPA's failure to object” through the petition process was “designed to avoid delays” while preserving the discretion of both the EPA and the states.
More specifically, under CAA section 505(a), and the current implementing regulations found at 40 CFR 70.8(a), permitting authorities are required to submit each proposed title V permit to the EPA for review.
As the EPA explained when proposing the initial title V regulations in 1991, the Act limits the EPA's opportunity for its initial review and an objection based on that review to 45 days in order to minimize delays. 56 FR 21749 (May 10, 1991). If the Administrator objects under CAA 505(b)(1), he/she must provide a statement of the reasons for the objection, providing a copy of both the objection and the statement to the permit applicant. CAA 505(b)(1);
If the Administrator does not object during the 45-day review period, consistent with section 505(b)(2) of the CAA and 40 CFR 70.8(d), any person may petition the Administrator within 60 days after the expiration of the EPA's 45-day review period to object to the permit. The Administrator shall grant or deny such a petition within 60 days after it is filed. CAA section 505(b)(2) establishes several requirements related to such petitions. Among other things, it provides that such a petition shall be based only on objections to the permit that were raised with reasonable specificity during the public comment period, unless the petitioner demonstrates that it was impracticable to raise objections during that period or the grounds for objection arose after completion of the public comment period. It also provides that the Administrator shall issue an objection if the petitioner demonstrates that the permit is not in compliance with the requirements of the CAA, including the requirements of the applicable implementation plan.
The implementing regulations are found in 40 CFR 70.8(d) and largely mirror this provision. As the EPA explained in proposing the initial title V regulations, the title V petition opportunity serves an important purpose because title V permits are frequently complex documents, and given the brevity of the agency review period there may be occasions when the EPA does not recognize that certain permit provisions are not in compliance with applicable requirements of the Act. 56 FR 21751 (May 10, 1991). CAA section 505(b)(2) states that the Administrator “shall” object if the petitioner makes the required demonstration. If the Administrator denies a petition for an objection, CAA 505(b)(2) provides that denial is subject to judicial review under CAA section 307; however, under CAA section 505(c), no objection is subject to judicial review until the Administrator has taken final action to issue or deny the permit. Further, the requirements under CAA section 505(b)(2) may not be delegated by the Administrator.
In addition to the provisions of title V, the rulemaking of provisions under CAA section 307(d) are relevant to this notice. The Administrator is applying the rulemaking provisions of CAA section 307(d) to the rulemaking discussed in this notice, pursuant to
After 20 years of experience in implementing the title V petition process, the EPA has identified some general trends in petition content and aspects of the petition review process that pose challenges for potential petitioners in preparing petitions and for the EPA in providing an efficient response to petitions. These are described in this section of the notice to provide additional context for this proposal. This proposed rulemaking is aimed in part at increasing stakeholder access to and understanding of the petition process and increasing the efficiency of the agency's response to petitions received and at mitigating some of the factors that contribute to poorly prepared or incomplete petitions, misunderstanding of applicable permit and CAA requirements, and longer response times. These factors include: (1) The lack of administrative requirements around petition submittals, which results in a variety of inconsistent methods used by petitioners; (2) the lack of specific rules regarding petition content, which results in considerable inconsistency in the format and content of petitions; and (3) the need to often deal with numerous and highly complex issues that arise in title V petitions given that title V permits must address many applicable requirements. These include issues relating to compliance with the requirements of the prevention of significant deterioration (PSD) permitting program, the hazardous air pollutant program (
Over time, petitions have raised increasingly more complex policy, legal, and technical matters. Through the review of such extensive and complicated petitions, the petition review process has evolved into a resource-intensive effort by the EPA. To increase stakeholder understanding of the title V petition process, help ensure consistent presentation of critical information in such petitions, and facilitate more efficient review of them, the EPA is proposing to revise its regulations to establish procedural parameters which, if finalized, would govern the title V petition process moving forward. As described in more detail in Section IV of this notice, this proposal includes proposed requirements for petition submittal, petition content and format, and certain administrative record requirements. As mentioned previously, one of the primary goals of the proposed changes is to improve stakeholder access to and understanding of the petition process and improve the agency's ability to meet its statutory obligations to review proposed permits and respond to title V petitions, in light of the overall structure of the CAA.
Yet another overarching factor that hampers the current petition review process is the confusion or lack of familiarity with the process itself. In the 2006 Title V Task Force Final Report noted earlier, for example, the CAAAC task force expressed a concern with the lack of transparency in the title V petition process. This concern has been echoed in the years since the 2006 report through feedback the agency has received from various stakeholders. In response, the EPA has tried to provide more explanation and insight into the title V petition process in the administrative orders it issues in responding to petitions. Some of these issues have also been discussed in the opinions courts have issued in reviewing such EPA orders. However, the EPA expects that not all stakeholders, including the public, may have read these response orders or related court decisions.
Therefore, the next section of this notice seeks to provide additional transparency concerning the petition process by repeating some of the relevant interpretations of statutory and regulatory provisions that the EPA has previously explained in title V petition orders, as well as interpretations of certain provisions related to the title V petition process provided in judicial opinions. Reiterating these prior statements concerning the EPA's application and interpretation of the statute to reviewing title V petitions may also provide useful context for the proposed changes to 40 CFR part 70, which are discussed in Section IV of this notice.
This section includes a discussion of certain aspects of the statutory elements of CAA section 505(b)(2) as well as the implementing regulations that have previously been interpreted by the EPA and/or courts. The discussion that follows serves to inform the public, stakeholders, permitting authorities, and other interested parties of these interpretations. Although the matters discussed in this section are available to the public,
Certain of the requirements under CAA section 505(b)(2) related to petitions are sometimes referred to as “threshold” requirements, which provide some procedural requirements and some limitations on the scope of title V petitions. These include, for example, that the petition be filed within 60 days following the agency's 45-day review period. Another example is the requirement that the petition be based only on objections to the permit
Generally speaking, the first step in the petition response process is for the agency to ascertain if the petition was timely filed pursuant to CAA section 505(b)(2). The Act and implementing regulations at 40 CFR 70.8(d) provide for a 60-day window in which to file a title V petition, which runs from the expiration of the EPA's 45-day review period. A petition received after the 60-day petition deadline is not timely. The agency is aware that because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. The agency currently encourages permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example making that information available either online, such as Region 4 has done on the EPA Web site, “Region 4 Proposed Title V Permits and State Contacts,”
The second “threshold” requirement described in the statute regards the content of a petition. CAA section 505(b)(2) requires that, unless one of the enumerated exceptions applies, the petition must be based only on objections to the permit that were raised with reasonable specificity during the public comment period provided by the permitting agency. Subject to the exceptions contained in the provision, the EPA understands this statutory language to require that the issues presented in a petition be raised during the public comment process with reasonable specificity. Such issues could, however, be raised in comments filed by a commenter other than the petitioner.
The EPA continues to believe that, as stated in the preamble to the 1991 part 70 proposal, Congress did not intend for petitioners to create an entirely new record before the EPA that the permitting authority had no opportunity to address. The requirement to raise issues “with reasonable specificity” places the burden on the petitioner. Unless there are unusual circumstances, the Petitioner needs to provide evidence that would support a finding of noncompliance with the Act to the permitting authority before it is raised in a petition.
Where an issue is raised to the EPA in a title V petition without first raising it with reasonable specificity to the permitting authority to give it the opportunity to address the issue, the Administrator has generally denied such claims consistent with the statutory requirements. The EPA has specifically addressed the reasonable specificity threshold requirement in a number of title V petition orders. Some key highlights are summarized next.
In 2013 in the
As noted above, the Act contains two enumerated exceptions to the “reasonable specificity” requirement. Namely, issues that were not raised with reasonable specificity during the public comment period can be raised in a petition if the petitioner demonstrates that it was impracticable to raise such objections within such period or unless the grounds for such objection arose after such period. CAA section 505(b)(2). For an issue to fit within one of these exceptions, the petitioner would have to demonstrate the impracticality, or show that the grounds arose after the comment period. The EPA has also addressed this issue in petition orders.
One example is in the 2012
Petitions may be submitted on several types of proposed title V permits, such as proposed initial permits, permit renewals, or permit revisions, which may include minor or significant modifications to the title V permit. Some stakeholders have indicated there may be confusion on the matter of petition opportunities, particularly for minor modification actions. In cases where the permitting authority has not provided for a prior public comment period on a minor permit modification, petitioners can still submit a petition to the Administrator. 57 FR 32283;
Under CAA section 505(b)(2), a petition pertains to a particular permit. Thus, the EPA must be able to discern from the petition what permit action the petition is based on in order to review and respond to it. The EPA has interpreted the potential scope of the petition as related to the scope of the permit action that is the basis of the petition. In the 1992 preamble to the final part 70 rule, the EPA explained that public objections to an initial permit, permit revision, or permit renewal must be germane to the applicable requirements implicated by the permitting action in question. For example, objections raised on a portion of an existing permit that would not in any way be affected by a proposed permit revision would not be germane. 57 FR 32250, 32290/3 (July 21, 1992). Consistent with CAA section 505(b)(2), the EPA has considered the scope of the permit proceeding in reviewing petitions and denied petitions that concern issues that are outside the scope of the permit proceeding.
One such denial can be found in the 2007
EPA interprets its title V regulations at 40 CFR part 70 to require different opportunities for citizens to petition on initial permit issuance, permit modifications, and renewals. The regulations state that a permit, permit modification, or renewal may be issued if specified conditions are met, 40 CFR 70.7(a)(1), including a requirement that `[t]he permitting authority shall provide a statement that sets forth the legal and factual basis for the draft permit conditions.' 40 CFR 70(a)(1)(ii) and 70.7(a)(5) (emphasis added). Further, 40 CFR 70.7(h), in requiring the permitting authority to provide adequate procedures for public notice and comment for permit proceedings that qualify as significant modifications, provides that the notice shall identify `the activity or activities involved in the permit action; the emissions change involved in any permit modification; . . . and all other materials available to the permitting authority that are relevant to the permit decision . . .' 40 CFR 70.7(h)(2) (emphasis added). We interpret these provisions to limit petitions on significant modifications to issues directly related to those modifications.
The
In addition to the threshold requirements, the statute identifies another general guideline for the EPA's consideration. Specifically, to compel an objection by the EPA, CAA section 505(b)(2) requires the petitioner to demonstrate that a permit is not in compliance with requirements of the Act, including the requirements of the applicable implementation plan. The EPA has interpreted the demonstration burden under CAA section 505(b)(2) in numerous title V petition orders and court opinions have also interpreted it. What follows is a brief restatement of interpretations previously articulated in some of those orders and opinions.
In the 2013
The petitioner demonstration burden is a critical component of CAA section 505(b)(2). As courts have recognized, CAA section 505(b)(2) contains a “discretionary component” that requires the exercise of the EPA's judgment to determine whether a petition demonstrates noncompliance with the Act, as well as a nondiscretionary duty to object where such a demonstration is made.
The EPA highlighted in the
After discussing the relatively short time frames for the EPA to review as the first point, the
Second, the Act is structured so that the EPA's evaluation of a petition under CAA section 505(b)(2) follows and is distinct from its review of a proposed permit under section 505(b)(1), which requires the Administrator to object on his own accord if he determines the permit is not in compliance with the Act. By contrast, under section 505(b)(2), the Administrator is compelled to object only if the necessary demonstration has been made.
Third, the EPA is also sensitive to the fact that its response to title V petitions often comes late in the title V permitting process and often after the title V permit has been issued.
Fourth, and consistent with its importance in CAA section 505(b)(2), the petitioner demonstration requirement helps to ensure the equity, procedural certainty, efficiency, and viability of the title V petition process for petitioners, state and local permitting authorities, the EPA and source owner/operators. This petitioner demonstration requirement helps to ensure that each and every petitioner is treated equitably in the petition process because the same standard for demonstration applies to each petitioner. Where petitioners meet their burden, the EPA will grant the petition. Where they do not, the EPA will not grant the petition. In this way, the EPA gives equal consideration to the petitioner's arguments, as appropriate.
In addition, the petitioner burden requirement also helps to ensure that the title V petition process is consistent with the division of responsibilities and co-regulator relationship between the EPA and state or local permitting authorities established in the CAA. When carrying out our title V review responsibilities under the CAA, it is our practice, consistent with that relationship, to defer to permitting decisions of state and local agencies with approved title V programs where such decisions are not inconsistent with the requirements under the CAA. The EPA does not seek to substitute its judgment for the state or local agency. As we discuss above in this section, sections 505(b)(1) and (2) of the Act, require the EPA to object to the issuance of a title V permit if it determines that the title V permit contains provisions that are not in compliance with applicable requirements of the Act, including the requirements of the applicable SIP. State and local agencies must ensure that the title V permit includes all applicable requirements under the CAA for that source, and provide an adequate rationale for the permit requirements in the public record, including the response to comment. When the EPA grants a particular title V petition under CAA section 505(b)(2), the EPA directs the state or local agency regarding actions necessary to ensure that the title V permit meets the applicable requirements with regard to the particular issue(s) that was raised, including appropriate and necessary changes to the permit.
The petitioner burden requirement assures that petitioners have clearly and sufficiently articulated the basis for an objection before a title V petition is granted. Thus, state and local agencies have certainty regarding the standard against which petitions on their title V permits and permit records will be assessed. The petitioner burden requirement also helps to ensure that the EPA does not have to spend significant time and resources responding to ungrounded claims regarding the title V permit or permit record. For example, petitioners might include claims in petitions unrelated to applicable requirements for the title V permit at issue or that do not provide sufficient information for the EPA to analyze the claim. Without the petitioner demonstration burden, the EPA could be required to investigate and respond to claims that ultimately prove to be ungrounded or frivolous. This would increase the complexity and uncertainty of the title V permit process, and would be burdensome and unproductive for the EPA, as well as for state and local agencies. The petitioner burden standard also helps to ensure certainty of the permitting process for source owner/operators, because it provides a consistent standard against which petitions on their title V permits will be assessed.
In light of the EPA's interpretation of the demonstration requirement and its importance to the implementation of the statutory structure that Congress created for addressing objections to title V permits, the EPA has discussed and applied its interpretation of the demonstration burden in numerous title V orders. Examples of the EPA's application of this standard can be found in:
The interpretation quoted from the
Several federal courts of appeal have agreed with the EPA's position that the term “demonstrates” in CAA section 505(b)(2) is ambiguous.
This recognition of the ambiguity in CAA section 505(b)(2) leads to the conclusion that “the statute's silence on these important issues means Congress has delegated to the EPA some discretion in determining whether, in its expert opinion, a petitioner has presented sufficient evidence to prove a permit violates clean air requirements.”
In the context of reviewing particular applications of the demonstration burden in title V petition orders, courts have also deferred to the agency's interpretation as to whether or not a petition had adequately demonstrated that an objection was warranted. For example, in
As noted earlier, many petitions raise numerous and highly complex issues around PSD permitting, a separate permitting program under the CAA. Because of the frequency with which title V petitions raise PSD claims, statements in prior petition orders regarding such claims is worth a separate mention here. In the
Where a petitioner's request that the Administrator object to the issuance of a title V permit is based in whole, or in part, on a permitting authority's alleged failure to comply with the requirements of its approved PSD program (as with other allegations of noncompliance with the Act), the burden is on the petitioner to demonstrate to the Administrator that the permitting decision was not in compliance with the requirements of the Act, including the requirements of the SIP. CAA section 505(b)(2). . . . Such requirements, as the EPA has explained in describing its authority to oversee the implementation of the PSD program in states with approved programs, include the permitting authority: (1) following the required procedures in the SIP; (2) making PSD determinations on reasonable grounds properly supported on the record; and (3) describing the determinations in enforceable terms.
Many petitions also raise issues surrounding emissions monitoring, recordkeeping and reporting in title V permits. Title V of the CAA requires permits to contain adequate emissions monitoring, recordkeeping, and reporting to assure sources' compliance with applicable requirements. 57 FR 32250, 32251 (July 1, 1992). Because of
As a general matter, permitting authorities must take three steps to satisfy the monitoring requirements in the EPA's part 70 regulations. First, a permitting authority must ensure that monitoring requirements contained in applicable requirements are properly incorporated into the title V permit. 40 CFR 70.6(a)(3)(i)(A). Second, if the applicable requirements contain no periodic monitoring, permitting authorities must add monitoring “sufficient to yield reliable data from the relevant time period that are representative of the source's compliance with the permit.” 40 CFR 70.6(a)(3)(i)(B). Third, if the applicable requirement has associated periodic monitoring but the monitoring is not sufficient to assure compliance with permit terms and conditions, a permitting authority must supplement monitoring to assure compliance.
The EPA has previously noted that as part of the CAA section 505(b)(2) demonstration requirement, the petitioner is expected to address the permitting authority's final decision, and the permitting authority's final reasoning (including the RTC), where these documents were available during the timeframe for filing the petition. Where a permitting authority has articulated its rationale for the permit terms and conditions concerning an applicable requirement in its record (RTC and statement of basis) and the petitioner did not adequately address that rationale in its petition, the EPA has often denied the petition, at least in part, on that basis.
This notice proposes several changes to part 70. Many of the proposed revisions fall within three key areas. First, regulatory language is proposed that encourages the use of the agency's electronic submittal system for title V petitions. Alternative methods for submittal are also identified in this notice. Petitioners who experience technical difficulty when attempting to submit a petition through the electronic submittal system may send it to the designated email address, while those without access to the Internet or unable to access email for other reasons may send a paper copy to the specific physical address identified in this proposal.
Second, this rule proposes mandatory petition content requirements and standard formatting for title V petitions. The EPA has identified key pieces of information that are critical when assessing claims and potential flaws in a title V permit or permit process, and these pieces are now proposed as required content for petitions and would be a new provision, 40 CFR 70.12. Under the proposed revisions, in order to demonstrate a flaw in the permit, permit record, or permit process that warrants an objection under CAA section 505(b)(2), the petition would present the required content in the same manner and order as contained in the new section of the title V regulations, 40 CFR 70.12.
A related change is proposed that would add new regulatory language to 40 CFR 70.8, which would require a petitioner to send a copy of the petition to both the permitting authority and the permit applicant. The current title V regulations do not have provisions effectuating this requirement of section 505(b)(2) of the Act. Therefore, this proposal would insert a requirement into the regulation identical to the one in the Act in order to ensure consistency with this provision of the statute.
Third, the agency proposes to require that permitting authorities respond in writing to significant comments received during the public comment period on a draft title V permit. Further, the EPA proposes regulatory language stating that this response to significant comments, often referred to as the RTC, must be sent with the proposed permit and statement of basis for the 45-day EPA review period of the proposed permit.
These proposed revisions to part 70 provide increased transparency and clarity to the title V petition preparation, submittal, review, and response processes. Improved interactions with stakeholders that participate in the title V process and more accurate tracking of petitions may also result from the establishment of the preferred petition submittal method. If finalized, the proposed rule revisions would help facilitate a more effective process for the development of title V petitions and a more efficient process for the review and response to title V petitions. Overall, the EPA is intending that these rule revisions along with other shared information will help to improve title V permits issued by permitting authorities, promote access to and provide better understanding of the title V petition process for potential petitioners, and reduce delays in decisions and support the agency's efforts to meet its obligations in responding to title V petitions.
For each of the three key areas, the agency describes the proposed regulatory changes, rationale for proposing the changes, and request for comment in the sections that follow. Before discussing each of the three key areas of this proposal, however, this notice provides some additional legal background related to these proposals.
To provide context for the statutory and regulatory interpretations discussed below, the EPA first discusses some additional legal background, including principles generally applied by courts in reviewing agency interpretations.
The Supreme Court decision,
Similarly, courts accord deference to an administrative agency's interpretations of its own regulations under principles enunciated in
Finally, the EPA notes that administrative agencies have broad discretion to adopt procedures to discharge their obligations under the statutes they implement. In the words of the U.S. Supreme Court: “[T]he formulation of procedures [is] basically to be left within the discretion of the agencies to which Congress [has] confided the responsibility for substantive judgments.”
In this notice, the EPA is proposing to revise part 70 to add a new provision that would require petitions to be submitted using one of three identified methods. Among those three methods, the agency encourages petitioners to submit title V petitions through the electronic submittal system, the agency's preferred method. The EPA has developed a title V petitions submittal system through the Central Data Exchange (CDX) and information on how to access and use the system is available at the title V petitions Web site:
If a petitioner experiences technical difficulties when trying to submit a petition through the electronic submittal system identified on the title V petitions Web site, the petition may also be submitted to the agency through the following email address:
Although regulatory changes are being proposed to integrate these methods of submission into the part 70 rules, all three of these methods are currently available for petition submission, and petitioners may elect to use any one of them now. Furthermore, although the proposed changes to the regulatory provisions identify three possible means to submit petitions, for any particular petition, once a petition and any attachments have been successfully submitted using one method, there is no need to submit a duplicate copy via another method. The EPA requests that petitioners only submit a petition using one method, which will expedite the administrative process and improve the EPA's efficiency in reviewing petitions. Finally, if these regulatory revisions are finalized, the agency would not be obligated to consider petitions submitted through any means other than the three identified in the rule.
Section 505(b)(2) of the Act requires that the petitioner provide copies of its petition to the permitting authority and the permit applicant. This requirement does not currently appear in the part 70 rules. The EPA is proposing to revise the part 70 regulations in order to fill this gap in the regulations. Specifically, in this notice, the EPA proposes to add language to 40 CFR 70.8(d) that is identical to the statutory language.
In general, feedback from stakeholders, as well as the EPA's experience in receiving petitions, indicate there is confusion at present as to where a petition should be submitted. While section 505(b)(2) of the CAA and 40 CFR 70.8(d) provide that any person may petition the Administrator to object within 60 days after the expiration of the EPA's 45-day review period for the proposed permit, both the statute and the regulations are currently silent as to how a petition should be submitted to
One goal of this proposal is to clarify where and how title V petitions should be submitted. Another goal of this proposal is to announce the establishment of an electronic submittal system and promote its use as the preferred method for the submittal of petitions to the EPA. These proposed changes are expected to allow for more accurate tracking of petitions and to increase the agency's efficiency and effectiveness in responding to petitions by ensuring the timely receipt of petitions and any attachments in a central location.
The EPA has identified several benefits of establishing the electronic submittal system as the preferred submittal method for receiving title V petitions. For petitioners, the electronic submittal system will provide immediate confirmation to the petitioner that the petition was received by the agency. In contrast to the size limitations that can be experienced when sending title V petitions through email, petitioners will be able to see that all intended supporting materials are attached to the petition and are submitted in one entry. Thus, submitting a petition and attachments via the electronic submittal system would avoid the need to send multiple emails to transmit the entire petition package. Sending petitions through the electronic submittal system also eliminates timeliness issues from potential mishandling due to courier issues.
For the agency, there is a time savings as petitions and any attachments submitted through the electronic submittal system will be immediately and directly available to the agency. This saves administrative time otherwise spent processing the incoming petition and any attachments, especially those submitted separately from the petition. Thus, the EPA anticipates that using this system will facilitate more efficient processing for incoming petitions. Further, the electronic submittal system in its current form identifies the number of attachments a petitioner intends to submit, which can alert the EPA to any missing attachments.
More information about the electronic submittal system, including information about security concerns regarding providing personal information, uploading and/or downloading files, personally identifiable information (PII), and CBI is available at the CDX Web site:
These proposed rule revisions to identify specific methods for petition submittal fall within the EPA's inherent discretion to formulate procedures to meet its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. In addition, the Act is silent as to the methods that should be used for title V petition submittal but imposes a 60-day deadline for granting or denying such petitions. Accordingly, these proposed changes to improve the efficiency of the EPA's initial processing of petitions and to support the agency's efforts to satisfy that obligation are based on a reasonable interpretation of CAA section 505(b)(2), including the relatively short timeframe for the EPA to grant or deny a petition.
Comments are requested on all aspects of these proposed revisions. The EPA is also specifically soliciting comment on our proposal to add language to part 70 that identifies the electronic submittal of petitions through the agency's identified electronic submittal system as the preferred primary method for submitting a title V petition, as well as identifying two alternative methods that could be used in case of technical difficulties or by a petitioner without Internet access. Commenters are encouraged to address in their comments whether additional specification or direction is needed to ensure all stakeholders are aware and have a better understanding of the preferred electronic submittal process. The EPA is expressly requesting comment on whether the proposed regulatory revisions are necessary, or whether the same effect could be achieved through the direction provided in this preamble and through the title V petitions Web site. Further, the EPA is requesting comment on what, if any, outreach methods or training materials (
The following proposed regulatory changes are designed to assist the public with preparing their petitions, as well as to assist the EPA in its review of petitions. In this notice, the agency proposes to establish in the part 70 regulations key mandatory content requirements for title V petitions. These proposed requirements are based on statutory requirements under CAA section 505(b)(2) and aspects of the demonstration standard interpreted by the EPA in numerous title V petition orders and restated in Section III.D of this notice. By proposing to codify what has already been discussed in prior orders, the EPA aims to help all stakeholders understand the criteria that the EPA applies in reviewing a title V petition. The EPA also proposes to establish requirements to encourage similar formats for all petitions to further assist the agency in its review process.
The EPA is proposing to revise part 70 to require standard content that must be included in a title V petition, laying out the agency's expectations with more specificity to assist petitioners in understanding how to make their petitions complete and to enhance the EPA's ability to review and respond to them promptly. Under this proposal, a new section of the title V regulations, 40 CFR 70.12, would add the following list of required elements:
• Identification of the proposed permit on which the petition is based. The proposed permit is the version of the permit the permitting authority forwards to the EPA for the agency's 45-day review under CAA section 505(b)(1).
• Sufficient information to show that the petition was timely filed. A petition must be filed within 60 days after the expiration of the Administrator's 45-day review period, as required by section 505(b)(2) of the Act. Timeliness may be demonstrated by the electronic receipt date generated upon submittal of the petition through the agency's electronic submittal system, the date and time the emailed petition was received, or the postmark date generated for a paper copy mailed to the agency's designated physical address. It is helpful if the petition provides key dates, such as the end of the public comment period provided under 40 CFR 70.7(h), (or parallel regulations in an EPA-approved state, local or tribal title V permitting program), or the conclusion of the EPA 45-day review period for the proposed permit.
• Identification of Petition Claims. Any issue raised in the petition as grounds for an objection must be based on a claim that the permit, permit record, or permit process is not in compliance with the applicable requirements under the Act or requirements under part 70. All pertinent information in support of each issue raised as a petition claim must be included within the body of the petition. In determining whether to object, the Administrator would not consider information incorporated into the petition by reference (for example, comments offered during the public comment period on the draft permit that are incorporated by reference into the petition on the proposed permit, or, as another example, claims raised in one title V petition that are incorporated by reference into a different title V petition). However, petitions may and should still provide citations to support each petition claim (
○ The specific grounds for an objection, citing to a specific permit term or condition where applicable.
○ The applicable requirement under the CAA or requirement under part 70 that is not met. Note that the term “applicable requirement” refers to Clean Air Act requirements only, and does not include other requirements (
○ An explanation of how the term or condition in the proposed permit, or relevant portion of the permit record or permit process, is not adequate to comply with the corresponding applicable requirement under the CAA or requirement under part 70.
○ If the petition claims that the permitting authority did not provide for the public participation procedures required under 40 CFR 70.7(h), the petition must identify specifically the required public participation procedure that was not provided.
○ Identification of where the issue in the claim was raised with reasonable specificity during the public comment period provided for in 40 CFR 70.7(h), citing to any relevant page numbers in the public comment as submitted and attaching the submitted public comment to the petition. If the grounds for the objection were not raised during the public comment period, the petitioner must demonstrate that it was impracticable to raise such objections within the period or that they arose after such a period, as required by section 505(b)(2) of the Act and 40 CFR 70.8(d).
○ Unless the exception under CAA section 505(b)(2) and 40 CFR 70.8(d) discussed in the immediately preceding bullet applies, the petition must identify where the permitting authority responded to the public comment, including the specific page number(s) in the document where the response appears, and explain how the permitting authority's response to the comment is inadequate to address the claimed deficiency. If the written RTC does not address the public comment at all or if there is no RTC, the petition should state that.
In addition to including all specified content, it is important that the information provided or any analysis completed by the petitioner must also be accurate. However, including this content would not necessarily result in the Administrator granting an objection on any particular claim raised in a petition. For example, a petitioner could include all this information but not demonstrate noncompliance, or the petition might point to a specific permit term as not being adequate to comply with an air emission limit, but may not have identified the appropriate applicable requirement.
One impediment to the EPA's review process is the use of incorporation by reference of other documents, in whole or in part, into petitions. As noted earlier in this section, under “identification of petition issues” in the new proposed mandatory content requirements, the EPA would require all pertinent information in support of each issue raised as a petition claim to be included in the body of a petition. Incorporating information into a petition by reference is inconsistent with the demonstration obligations in the statute and would extend the petition review time as the agency spends time searching for and then attempting to decipher the petitioner's intended claim. In practice, the EPA often finds that where claims have been incorporated by reference it is not clear that the specific grounds for objection have been raised by the petitioner, which could lead to the EPA denying for failure to meet the demonstration burden. Relatedly, petitioners have sometimes used incorporation by reference to include comments from a comment letter, but a comment letter alone would typically not address a state's response to the comment.
For further transparency and clarity, the EPA in this notice gives examples of types of information that are not necessary to include when preparing an effective petition. In doing so, the EPA hopes to ease the effort associated with preparing a petition while promoting succinctness. For example, while a petitioner needs to cite to the legal authority supporting its specific claim, a petition does not need to include pages of background or history on
Even with all necessary information provided, a petition may still require substantial time to review because of how it is organized. Therefore, the EPA is also proposing and taking comment on format requirements. If information is presented in the same format, including the same order, in all petitions, the EPA anticipates this standard organization could reduce review time as the general location of specific details would be the same in every petition received. These proposed format requirements could also help petitioners better understand what is, and what isn't, necessary in an effective title V petition. To that end, the EPA proposes the use of a standard format following the same order as previously identified in the list of required petition content. Regulatory language to this effect is included in the proposed new provision, 40 CFR 70.12. If finalized, templates and/or guidance are planned for development for inclusion on the title V petitions Web site.
Further, the EPA is requesting input from the public on several specific questions related to potentially establishing page limits for title V petitions, as explained further in Section IV.C.4 of this notice. While the EPA has received petitions ranging from approximately 3 to 82 pages (excluding attachments), the length for most petitions is in the range of 20 to 30. The amount of detail required to successfully raise a claim and meet the demonstration standard may depend on the complexity of the issue. However, we expect that most claims could be written effectively and succinctly, as demonstrated in the example claim that follows.
The following paragraphs contain an example of a concise and effective presentation of a hypothetical single claim that would be part of a larger petition—one that includes all pieces of required content for a claim proposed in this rule. Because this is only a sample claim, not a sample petition, it does not include some of the required content that relates to the petition as a whole (such as identifying information for the proposed permit). This example is organized following the order presented in the proposed required content changes identified previously, which is also the proposed standard format. The bullets highlight each element of the proposed content requirements.
Although EPA is providing this sample claim to illustrate how the material that would be required under the proposed regulatory revisions could be presented succinctly and effectively, the information that is needed to satisfy the demonstration burden for any given petition claim will vary depending on the specifics of the claim, the applicable requirements, and the underlying permit terms and record. The following hypothetical claim is provided solely for purposes of illustration:
Facility X's title V permit lacks monitoring sufficient to assure compliance with the 4.5 pound per hour (lb/hr) nitrogen dioxide (NO
CAA section 504(c), and the implementing regulations in 40 CFR 70.6(c)(1) and 70.6(a)(3)(i)(B), requires all title V permits to contain monitoring requirements to assure compliance with permit terms and conditions.
The SIP-approved NO
This petition does not claim that any public participation procedures were not provided.
Public Group Y (Petitioners) raised this issue on page 5 of the July 31, 2015 comment letter it submitted on Facility X's July 1, 2015 draft title V permit. (
In responding to Petitioners' comment stating that the frequency of the permit's compliance monitoring for the compressor engines' 4.5 lb/hour NO
As explained, state agency is relying on the portable analyzer test results as a snapshot sampling of emissions to confirm annually whether the units continue to meet their 4.5 lb/hour NO
The CAA and part 70 regulations currently provide little information on what a title V petition must or should contain. In fact, the primary requirement in CAA section 505(b)(2) is that a petition (with a few identified exceptions) must be based on objections that were raised with reasonable specificity during the public comment period for the permit, and that is the only specific requirement for petition content in the relevant regulation.
One of the EPA's desired outcomes for this proposed rule is to provide direction to petitioners that will assist them with preparing petitions. The agency anticipates receiving petitions that are both more concise and clear and that contain all the key relevant material, so that the EPA does not have to search for fundamental information or attempt to decipher the petitioner's intent. These proposed revisions are intended to facilitate a more effective petition development process and a more efficient petition review and response process, which are critical in this context because CAA section 505(b)(2) requires the agency to grant or deny a petition within 60 days. Similarly, this tight timeframe makes it imperative that a petitioner make a clear and concise demonstration that can be efficiently evaluated. By proposing to create obligations related to the content and structure of a petition, the EPA anticipates receiving petitions that more clearly articulate the petition claim and the basis for it, focusing on key information, including the alleged deficiency in the permit or permit process; the applicable requirements under the CAA or requirements under part 70 that are in question; and where the issue was raised during the public comment period (or a demonstration as to why it was impracticable to do so or that the grounds for the objection arose after the public comment period closed), how the state responded, and why that response did not adequately address the issue.
These proposed rules are consistent with statements and conclusions that the EPA has made in previous orders responding to title V petitions. The EPA has identified and emphasized the importance of such key pieces of information in assessing petitioners' claims that a title V permit or permit process does not assure compliance with applicable requirements under the CAA or under part 70. For context, examples of some of these orders were discussed in Section III.D of this notice. The EPA is proposing to add petition content requirements that would make certain information mandatory in petitions. These requirements would help clarify for petitioners specific information that is useful or necessary to evaluate a petition claim. The EPA anticipates that these mandatory petition content requirements and standard formatting would help petitioners to succinctly focus their claims and present them effectively. The EPA anticipates that these proposed changes could also decrease the instances in which the Administrator denies a petition because the petitioner did not provide an adequate demonstration. The agency believes these changes would help petitioners to hone their claims to include the appropriate information and to realize when a claim does not meet the mandatory requirements and should not be included in the petition (
The EPA expects the proposed revisions to require mandatory content to improve the efficiency of the agency's review process for title V petitions, as the key information would be presented in a clear and succinct fashion. Similarly, the agency expects that the proposed revisions to require similar organization for all petitions could reduce agency review time as a result of having the specific information in the same format in every petition received. Increasing the efficiency of the review process, and more specifically reducing the time it takes to review petitions, are consistent with Congress's intent that the petition process proceed in a timely and expeditious fashion, as indicated by the 60-day time frame for the Administrator to grant or deny petitions provided in CAA section 505(b)(2).
Moreover, as discussed in more detail in Section III.D of this notice, the EPA has explained in previous title V orders the importance of the demonstration burden in determining whether or not to grant an objection in response to a petition.
Furthermore, these proposed revisions to the part 70 rules related to mandatory petition content and format fall within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA section 505(b)(2), as discussed in Section IV.A of this notice. Similar procedural requirements have been established for other EPA programs and processes, including the procedures for appeals filed with the Environmental Appeals Board (EAB).
Comments are requested on all aspects of these proposed revisions. The EPA is proposing changes to part 70 to include mandatory petition content and format to facilitate the efficient review of issues raised in petitions. The EPA requests comment on all aspects of the required petition content in the proposed 40 CFR 70.12, including the requirement to provide all key information, arguments, or analysis in the petition, rather than incorporating it by reference. The agency also requests comments on the proposed requirement that the petition format follow the same order as the proposed list of required content, as well as the proposed revision to the regulatory language in 40 CFR 70.8(d) that requires that copies of the petition be provided to the permitting authority and the applicant.
The EPA is also requesting comment on whether or not page limits should be established for title V petitions, as a means of promoting concise petitions and to further facilitate efficient and expeditious review of petitions by the EPA. Procedural requirements specifying the maximum length of submissions have been instituted for processes such as the EAB appeal process, where petitions and response briefs may not exceed an identified word or page limit.
The EPA proposes to revise 40 CFR 70.7 to require a permitting authority to respond in writing to significant comments received during the public participation process for a draft permit. The agency is proposing a regulatory revision to 40 CFR 70.8 that would require a written response to all significant comments (RTC) and the statement of basis document to be included as part of the proposed permit record that is sent to the EPA for its review under CAA section 505(b)(1).
Under the existing 40 CFR 70.7(h)(5), a permitting authority is required to keep a record of the commenters and also of the issues raised during the public participation process so that the Administrator may fulfill the obligation under CAA section 505(b)(2) of the Act to determine whether a title V petition may be granted. This provision also requires that such records shall be available to the public. The EPA is proposing regulatory language to revise 40 CFR 70.7 to add a new requirement that a permitting authority respond in writing to significant comments from the public participation process for a draft title V permit.
The statement of basis document, which provides the legal and factual basis for the permit terms or conditions, is a necessary component for an effective permit review. Under the current regulations, permitting authorities are required to send this “statement of basis” to the EPA and “to any other person who requests it.” 40 CFR 70.7(a)(5). The EPA recently compiled best practices for developing and preparing statement of basis documents in the April 2014 guidance document,
To address any occasions where it may be absent during the permit issuance process, the EPA now proposes to add language to the part 70 regulations that would reaffirm its importance and require its inclusion at all points in the permit review process for every permit. To that end, we are proposing that 40 CFR 70.4(b), 70.7(h) and 70.8(a) would be revised to specifically identify the statement of basis document as a required document.
The EPA proposes one additional change to 40 CFR 70.4(b) to amend an incorrect reference. Specifically, the language in 40 CFR 70.4(b)(3)(viii) currently reads: “[t]he contents of a part 70 permit shall not be entitled to protection under section 115(c) of the Act.” However, section 115(c) of the Act pertains to reciprocity related to statutory provisions addressing endangerment of public health or welfare in foreign countries from air pollution emitted in the United States.
Therefore, the EPA proposes to revise the citation in 40 CFR 70.4(b)(3)(viii) to section 114(c) of the Act, which pertains to the availability of records, reports, and information to the public. This change ensures the regulations comport with the parallel provision in the section 503(e) of the CAA, which states
The agency considers both the statement of basis and the written RTC to be integral components of the permit record. Having access to these documents during the agency's 45-day review period could improve the efficiency of the review, and also ensures that the agency has these critical parts of the record before it in reviewing a proposed permit under CAA section 505(b)(1). Further, it ensures that these documents are completed and available during the petition period under CAA section 505(b)(2). The EPA is proposing revisions to part 70 to require that any proposed permit that is transmitted to the agency must include both the statement of basis and written RTC among the necessary information as described in 40 CFR 70.8. The agency is proposing that the 45-day review period would not begin until all the supporting information listed in the proposed revisions to 40 CFR 70.8(a)(1)(i) has been received by the EPA. This includes the proposed permit, statement of basis, and the written RTC (or when no significant comments are received during the public comment period a statement to that effect). Finally, the EPA proposes to revise 40 CFR 70.7(h)(7) to require that within 30 days of sending the proposed permit to the EPA, that permitting authorities must provide notification that the proposed permit and the response to significant public comments are available to the public. Such notice must explain how these materials may be accessed.
The EPA recognizes that some permitting authorities run the 30-day public comment period and 45-day EPA review period concurrently, as long as no significant comments are received. Under this proposal such a practice could continue, but if a significant public comment is received, the Administrator would no longer consider the submitted permit as a proposed permit. In such instances, the permitting authority must make any necessary revisions to the permit or permit record, and per the regulations proposed in this notice, resubmit the proposed permit to EPA with the RTC and statement of basis, and any other required supporting information, with any revisions that were made to address the public comments, to re-start the EPA's 45-day review period. This reflects the EPA's understanding of how such concurrent permitting programs currently operate.
Because the petition period runs from the end of the EPA's 45-day review period, and the date a proposed permit is received by the EPA is not always apparent, the petition deadline is not always readily apparent. To date, the agency has encouraged permitting authorities to provide notifications to the public or interested stakeholders regarding the timing of proposal of permits to the EPA, for example by making that information available either online or in the publication in which public notice of the draft permit was given. At this time, the agency is considering and requests comment on the best method for the public to be made aware of the date that a proposed permit is received by the EPA, as well as the deadline to submit a petition on a particular proposed permit. The EPA proposes to post when a proposed permit is received and the corresponding 60-day deadline for submitting a petition on the EPA Regional Office Web sites.
Section 505(a)(1)(B) of the CAA requires in relevant part that permitting authorities transmit to the Administrator each proposed permit. The current regulations contain the same requirement in 40 CFR 70.8(a)(1). Failure to submit any information necessary for the adequate review of the proposed permit is grounds for an objection.
As a general matter, initial and renewed title V permits are developed by a permitting authority and then go through a public notice and comment period. The draft permit may undergo some revisions based on the public comment period and this updated version of the permit, referred to as the proposed permit, is sent to the EPA for a 45-day review period per CAA section 505(b)(1). Many permitting authorities already send a written RTC and a statement of basis along with the proposed permit for the EPA 45-day review. However, there are other permitting authorities that do not; instead this information may be provided by these permitting authorities at some point later in the permitting process. When these documents, and the RTC document in particular, are unavailable for the EPA review period, the EPA cannot provide a fully effective review. Moreover, when these documents are unavailable to the public following the EPA's review, potential petitioners may be missing necessary information to determine whether to submit a petition or to provide a full argument in support of any issues they may raise in a petition.
Notably, the EPA's 45-day review period under the current rules begins when the EPA has received the proposed permit and “all necessary information” from the permitting authority. 40 CFR 70.8(c). With regard to the availability of necessary information for the agency's 45-day review of a proposed permit, the EPA stated in the proposal to the original title V regulations that the agency believes it can object to the issuance of permit where the materials submitted by the permitting authority do not provide enough information to allow a meaningful EPA review of whether the proposed permit is in compliance with requirements of the Act (including the SIP). If the agency was not able to object under these circumstances, the EPA's oversight rule could be severely hampered. 56 FR 21750 (1991). The EPA continues to interpret the Act in this way and provides part of the rationale for these proposed revisions to the regulations.
In reviewing title V petitions, the EPA generally pays careful attention to the permitting authority's RTC. The EPA also explained the benefits of making the written RTC available during its 45-day review period in 2014 in the
[P]roviding the entire record for a Proposed Permit at the beginning of the EPA's 45-day review period serves to enhance the EPA's review of the Proposed Permit by providing a fuller understanding of the permitting history and the state's rationale for its permitting decisions. Where the entire record is available at the beginning of the 45-day review period, the EPA has the benefit of understanding the permitting history and the state's rationale for its permitting decisions. Likewise, where the entire record is available at the beginning of the public's 60-day window to submit petitions to the Administrator, the public has the benefit of understanding the permitting history and the state's rationale for its permitting decisions. Providing the entire record before the start of the public's 60-day petition period would allow the public to better assess any issues with the permit that they may have identified.
As noted in Section III.D.5 of this notice under general principles of
While many permitting authorities submit the RTC and statement of basis with a title V proposed permit, these proposed revisions, if finalized, would promote national consistency and the availability of the RTC document during the EPA 45-day review and the 60-day window in which a petition may be submitted on the proposed permit. This proposed requirement would allow a petitioner to better determine whether flaws in the permit, permit record, or public participation procedures raised during the public comment period had been adequately addressed. In turn, this would enhance a petitioner's confidence in its judgment whether a title V petition is warranted, because it would have the benefit of the permitting authority's rationale for permit terms and permit actions. Thus, it could facilitate resolution of issues earlier in the permitting process and may reduce the number of petitions or petition claims filed. Further, when properly implemented by permitting authorities, the agency anticipates that this proposed requirement would likely reduce the number of EPA determinations to grant a petition because a permitting authority's rationale is inadequate. The EPA is proposing this regulatory change to ensure that petitioners have the opportunity to address the permitting authority's response to comment in order to meet their demonstration burden. As such, these proposed revisions are supported by and would help implement the EPA's interpretation in this context of the ambiguous term “demonstrate” under CAA section 505(b)(2).
These proposed changes are responsive to recommendations from the CAAAC Title V Task Force Final Report. The 2006 report included a number of recommendations for implementation improvements, including specific recommendations regarding public notification and public participation in the title V process. The majority of Task Force members agreed that if a permitting authority receives comments on a draft permit, it is essential that the permitting authority prepare a written response to comments.
While the Act does not expressly require the submission of the RTC and statement of basis together with the proposed permit, it also does not preclude such a requirement or prescribe the specific materials that are needed to review a proposed permit. In light of the focus of CAA section 505(b)(2) on issues raised with reasonable specificity during the comment period, it is reasonable to interpret the Act to include a requirement that would allow the EPA and the public access to materials such as the RTC and statement of basis that would allow them to evaluate the issues raised with reasonable specificity during the comment period and the permitting authority's response.
The agency believes these proposed revisions to the part 70 rules are within the EPA's inherent discretion to formulate procedures to discharge its obligations under CAA sections 505(b)(1) and 505(b)(2), as discussed in Section IV.A of this notice. If finalized, it would help the EPA more efficiently review both proposed permits and title V petitions.
Comments are requested on all aspects of these proposed revisions. Comments are specifically requested on the proposed regulatory language requiring the preparation of a written RTC. Additionally, the EPA requests comment on all aspects of the proposal to require both the written RTC and statement of basis be included in the record that is sent with the proposed title V permit for the EPA's 45-day review. The EPA is expressly taking comment on the best method(s) for proposed permits to be made available so that the public is aware when a proposed permit is received by the EPA for its 45-day review. States are also encouraged to provide information on whether any changes to state rules and programs would be necessary if this proposed revision to part 70 were finalized. The EPA is also expressly taking comment on the practices of permitting authorities that conduct concurrent review and is particularly interested in what processes or steps should be followed to allow for concurrent review, even if the permitting authority is not aware of whether or not it will receive comment on the title V permit when that permit is initially submitted to EPA. Finally, the EPA solicits comments on the proposed regulatory language in 40 CFR 70.4, 70.7, and 70.8 requiring the
In this section of the notice, the EPA is providing information on certain steps in the title V petition process, namely the permit issuance process that occurs before a petition is submitted, and the post-petition process, which occurs after the EPA grants an objection on at least one issue in a petition. The EPA anticipates this information will help stakeholders gain a better understanding of the role a petition might play in the development of a permit that assures compliance with applicable requirements under the CAA and part 70. Most of what follows has been addressed publicly in various formats, but the EPA believes that repeating this information here for the public's convenience will provide stakeholders with a comprehensive look at the petition opportunity in CAA section 505(b)(2) and 40 CFR 70.
The proposed changes in Section IV.D of this notice are intended to increase the effectiveness of the EPA 45-day review as well as ensure that the full permit record is before petitioners during the 60-day petition period. Making these documents available also provides an opportunity for a permitting authority to ensure that they have fully responded to comments when preparing the proposed permit. Permitting authorities have at least three opportunities to provide the permit record and ensure that it comports with the CAA: the draft, proposed, and final permit.
While the EPA is not requiring the following actions, the agency is recommending practices for permitting authorities when preparing title V permits. In the agency's experience, these practices can minimize the likelihood that a petition will be submitted on a title V permit. Many involve taking action at an appropriate time to ensure that the permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In addition, many focus on consulting with the appropriate EPA Regional Office early when preparing and issuing permits. These “recommended practices” include:
○ Consulting with the appropriate EPA Regional Office as needed on key aspects of the permit before the draft permit stage, especially if the permit is expected to be highly visible or contested.
○ On a case-by-case basis, considering whether a particular draft permit warrants outreach to the community.
○ On a case-by-case basis, considering whether it is appropriate to provide for a public participation opportunity on a revised draft permit.
○ Fully addressing significant comments on draft permits and ensuring the permit or permit record includes adequate rationale for the decisions made. For example, permitting authorities should provide sufficient rationale for selected monitoring to assure compliance. The EPA's objections based on an inadequate record most often occur when the EPA finds that a permitting authority did not sufficiently explain why the monitoring was sufficient to assure compliance with a particular limit.
○ Consulting with the appropriate EPA Regional Office as needed to resolve issues related to comments on draft permits and incorporating those resolutions into the proposed permits.
○ Consulting with the appropriate EPA Regional Offices as needed to resolve issues related to the EPA objections or comments on proposed permits and incorporating those resolutions into the final permits.
○ For petitions on which the EPA grants an objection on a claim because the record is inadequate, revising the record and permit as necessary and in a timely manner to resolve the objection.
○ Reviewing permits that are the subject of a petition and revising or reopening for cause to address any issues raised by the petition that have not been resolved.
○ Posting the proposed permit and RTC online where possible.
The EPA is providing the following recommended practices for a source to consider to help ensure that its permit includes the conditions to assure compliance with applicable requirements under the CAA and part 70. In some cases, this may minimize the likelihood that a petition will be submitted on its title V permit. These “recommended practices” include:
○ Submitting permit applications that include all information required under the approved title V permit program.
○ Consulting with the permitting authority when any discrepancy or inaccuracy is identified in the permit, at any stage of the permitting process.
○ Promptly providing any updates to the permit application to the permitting authority.
○ If public comments identify an issue in the draft permit, contacting the permitting authority to make revisions to address the concern before the permit is proposed to the EPA.
○ Timely responding to inquiries from the permitting authority at each stage in the permitting process, including the draft, proposed, and final stages.
The following discussion provides information about the activities that occur, or may occur, after the EPA responds to a title V petition. Various stakeholders have indicated there can be confusion around the appropriate steps following an EPA petition order, particularly when the Administrator granted the petition in whole or in part. The summary below describes EPA's interpretation of key provisions of the CAA and implementing regulations. This interpretation has already been shared publicly in title V orders responding to petitions.
When the EPA objects to a proposed permit under CAA section 505(b), section 505(b)(3) instructs that a permitting authority “may not issue the permit unless it is revised and issued” in accordance with section 505(c) of the Act. If the permit has already been issued by the permitting authority before it receives the objection, then the EPA “shall modify, terminate, or revoke” the permit, and the permitting authority may then only issue a revised permit in accordance with section 505(c) of the Act.
Under CAA section 505(c), if the permitting authority fails to submit a permit revised to meet the Administrator's objection within 90 days after the objection, the Administrator must issue or deny the
Neither CAA section 505(b)(3) nor section 505(c) provide express direction as to the specific procedures and steps the EPA must use to “modify, terminate, or revoke” or “issue or deny” the permit, though section 505(c) points generally to the requirements under title V. Although the Act is ambiguous, the implementing regulations shed some light on the process. Those regulations provide a state with 90 days to resolve the EPA's objection and terminate, modify, or revoke and reissue the permit, before the EPA would need to begin to act on the permit. 40 CFR 70.8(d), 70.7(g)(4)-(5);
As described in previous title V orders, such as the 2013
[T]he EPA viewed the revised permit as providing the EPA an opportunity to object to the permit under CAA section 505(b)(l) and 40 CFR 70.8(c), and, when the EPA did not object, an opportunity for a citizen to petition the EPA to object under CAA section 505(b)(2) and 40 CFR 70.8(d). The EPA has also treated state responses to EPA objections that revised the permit record to provide further support for its decision as constituting new proposed permits subject to review by the EPA under CAA section 505(b)(1) and 40 CFR 70.8(c), and, absent an EPA objection, citizen petition under CAA section 505(b)(2) and 40 CFR 70.8(d).
The EPA's interpretation that a state's response to an EPA objection generally triggers a new EPA review and petition opportunity is consistent with, and a reasonable interpretation of, the statutory and regulatory process for addressing objections by the EPA, as explained previously. Accordingly, at the end of the 45-day review period, if the EPA does not object, there is a 60-day window in which there is an opportunity for a second petition. If a second petition is received, the EPA must respond to the petition within 60 days under CAA section 505(b)(2).
Costs associated with this proposed rule are expected to be minimal. Much of the focus in this proposal is to codify the established practice that has been publicly discussed and evolved over time. If finalized, the revisions should impose no costs on petitioners, and may reduce confusion over and the time necessary for preparing a title V petition. The agency anticipates that a small number of permitting authorities may need to amend their rules regarding permit issuance to require responses to significant comments and the submittal of those responses with the proposed permit that is sent to the EPA for review.
The existing part 70 regulations provide for state program revisions if part 70 is revised and the EPA determines such conforming changes are necessary. 40 CFR 70.4(a) and 70.4(i). The EPA is soliciting comment as to whether revisions to any approved state programs would be necessary if the revisions to part 70 regulations proposed in this notice are finalized. States are expressly encouraged to provide information on any changes to state rules and programs that may be necessary if the proposed revisions to 40 CFR 70.7(h) and 70.8 are finalized to require permitting authorities to respond in writing to all significant comments raised during the public participation process and to provide that response to the EPA for the agency's 45-day review period.
Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of nationally applicable regulations promulgated, or final actions taken, by the Administrator; or (ii) when such action is locally or regionally applicable, if the action is determined to be of nationwide scope or effect and the Administrator publishes such a determination. The EPA proposes to find and publish that this rule is based on a determination of nationwide scope and effect. This proposed rule concerns revisions to the EPA's regulations in part 70 for operating permit programs, and these regulations apply to permitting programs across the country. Accordingly, we propose to determine that this is a rulemaking of nationwide scope or effect such that any petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit.
This action proposes certain revisions to part 70 regulations to improve the title V petition submittal, review and response processes. The proposed revisions and guidance provided in this rule should increase the transparency and clarity of the petition process for all stakeholders. First, the establishment of centralized petition submittal is expected to reduce or eliminate
In preparation for this proposal, the agency participated in community calls where the EPA presented a brief overview and announcement of the rulemaking effort. The EPA provided additional details about a planned webinar that will describe the title V petition process, the content of this proposal, and when and how to submit comments.
This action is not a significant action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action would not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0243 for the title V part 70 program. To the extent that a SIP revision or a title V program revision is necessary to effect the changes being proposed, we believe that the burden is already accounted for under the approved information collection requests noted earlier.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This proposed action would not impose any requirements directly on small entities. Entities potentially affected directly by this proposal include anyone that chooses to submit a title V petition on a proposed title V permit prepared by an EPA-approved state, local or tribal title V permitting authority. Other entities directly affected may include state, local, and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this action.
This action does not contain any unfunded federal mandate of $100 million or more as described in UMRA, 2 U.S.C. 1531-1538, and would not significantly or uniquely affect small governments. This proposed action imposes no enforceable duty on any state, local or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct 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.
This action has tribal implications. However, it will neither impose substantial direct compliance costs on federally recognized tribal governments, nor preempt tribal law. The Southern Ute Indian Tribe has an EPA-approved operating permit program under 40 CFR part 70 and could be impacted. The EPA conducted outreach to the tribes through a call with the National Tribal Air Association. Further, the agency plans to offer consultation to all tribal governments, and will specifically offer to consult with the Southern Ute Indian tribe. The EPA solicits comment from affected tribal governments on the implications of this proposed rulemaking.
The EPA interprets Executive Order 13045 as applying to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This proposed action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes the human health and environmental risk addressed by this proposed action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income or indigenous populations. The results of this evaluation are contained in Section
Section 307(d)(1)(V) of the CAA provides that the provisions of CAA section 307(d) apply to “such other actions as the administrator may determine.” Pursuant to CAA section 307(d)(1)(V), the Administrator determines that this proposed action is subject to the provisions of CAA section 307(d).
The statutory authority for this proposed action is provided by 42 U.S.C. 7401
Environmental protection, Administrative practice and procedure, Air pollution control, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, Chapter I of the Code of Federal Regulations is proposed to be amended as set forth below.
42 U.S.C. 7401,
(b) * * *
(3) * * *
(viii) Make available to the public any permit application, statement of basis, compliance plan, permit, and monitoring and compliance certification report pursuant to section 503(e) of the Act, except for information entitled to confidential treatment pursuant to section 114(c) of the Act. The contents of a part 70 permit itself shall not be entitled to protection under section 114(c) of the Act.
The revisions and additions read as follows:
(h) * * *
(2) The notice shall identify the affected facility; the name and address of the permittee; the name and address of the permitting authority processing the permit; the activity or activities involved in the permit action; the emissions change involved in any permit modification; the name, address, and telephone number of a person from whom interested persons may obtain additional information, including copies of the draft permit, statement of basis for the draft permit, the application, all relevant supporting materials, including those set forth in § 70.4(b)(3)(viii), and all other materials available to the permitting authority that are relevant to the permit decision; a brief description of the comment procedures required by this part; and the time and place of any hearing that may be held, including a statement of procedures to request a hearing (unless a hearing has already been scheduled);
(5) The permitting authority shall keep a record of the commenters and of the issues raised during the public participation process, as well as records of the written comments submitted during that process, so that the Administrator may fulfill his obligation under section 505(b)(2) of the Act to determine whether a citizen petition may be granted, and such records shall be available to the public.
(6) The permitting authority shall respond in writing to all significant comments raised during the public participation process, including any such written comments submitted during the public comment period and any such comments raised during any public hearing on the permit. If no significant comments are raised during the public participation process, the permitting authority shall prepare a written statement to that effect.
(7) The permitting authority shall give notice within 30 days of transmitting the proposed permit to the Administrator, consistent with the procedures under paragraph (h)(1) of this section, that the proposed permit in accordance with § 70.8(a)(1) and responses to public comments in accordance with paragraph (h)(6) of this section have been transmitted to the EPA, the date of the transmission, and that these documents are available to the public. Such notice shall explain how the public may access the proposed permit and responses to comments. When possible, such notice shall include notification in the same manner used to announce the availability of the draft permit for public comment.
(a)
(ii) In instances where the Administrator has received a proposed permit from a permitting authority before the public participation process on the draft permit has been completed, and the permitting authority receives a significant comment on the draft permit after the submission of the proposed permit to the Administrator, the Administrator will no longer consider the submitted proposed permit as a permit proposed to be issued under section 505 of the Act. In such instances, the permitting authority must make any revisions to the permit or permit record necessary to address the public comments, including preparation or revision of the response to comment document, and must re-submit the
(c) * * *
(1) The Administrator will object to the issuance of any proposed permit determined by the Administrator not to be in compliance with applicable requirements or requirements under this part. No permit for which an application must be transmitted to the Administrator under paragraph (a) of this section shall be issued if the Administrator objects to its issuance in writing within 45 days of receipt of the proposed permit and all necessary supporting information required under paragraph (a)(1) of this section.
(d)
(a)
(b) Sufficient information to show that the petition was timely filed.
(c)
(1) The specific grounds for an objection, citing to a specific permit term or condition where applicable.
(2) The applicable requirement as defined in § 70.2, or requirement under part 70, that is not met.
(3) An explanation of how the term or condition in the permit, or relevant portion of the permit record or permit process, is not adequate to comply with the corresponding applicable requirement or requirement under part 70.
(4) If the petition claims that the permitting authority did not provide for a public participation procedure required under § 70.7(h), the petition must identify specifically the required public participation procedure that was not provided.
(5) Identification of where the issue was raised with reasonable specificity during the public comment period provided for in § 70.7(h), citing to any relevant page numbers in the public comment submitted to the permitting authority and attaching this public comment to the petition. If the grounds for the objection were not raised with reasonable specificity during the public comment period, the petitioner must demonstrate that such grounds arose after that period, or that it was impracticable to raise such objections within that period, as required under § 70.8(d).
(6) Unless the grounds for the objection arose after the public comment period or it was impracticable to raise the objection within that period such that the exception under § 70.8(d) applies, the petition must identify where the permitting authority responded to the public comment, including page number(s) in the publicly available written response to comment, and explain how the permitting authority's response to the comment is inadequate to address the issue raised in the public comment. If the response to comment document does not address the public comment at all, the petition shall state that.
The information that the Administrator considers in making a determination whether to grant or deny a petition submitted under § 70.8(d) on a proposed permit generally includes, but is not limited to, the Administrative Record for the proposed permit and the petition, including attachments to the Petition. For purposes of this paragraph, the Administrative Record for a particular proposed permit includes the draft and proposed permits; any permit applications that relate to the draft or proposed permits; the statement of bases for the draft and proposed permits; the permitting authority's written responses to comments, including responses to all significant comments raised during the public participation process on the draft permit; relevant supporting materials made available to the public according to § 70.7(h)(2); and all other materials available to the permitting authority that are relevant to the permitting decision and that the permitting authority made available to the public according to § 70.7(h)(2). If a final permit and a statement of basis for the final permit are available during the agency's review of a petition on a proposed permit, those documents may also be considered as part of making a determination whether to grant or deny the petition.
Any petition to the Administrator shall be submitted through the Operating Permits Group in the Air Quality Policy Division in the Office of Air Quality Planning and Standards, using one of the three following methods identified at the Title V Petitions Web site: An electronic submission through the EPA's designated submission system (the agency's preferred method); an electronic submission through the EPA's designated email address listed on that Web site; or a paper submission to the EPA's designated physical address listed on that Web site. Any necessary attachments shall be submitted together with the petition, using the same method as for the petition. Once a petition has been successfully submitted using one of these three methods, the petitioner should not submit additional copies of the petition using another method. The Administrator is not obligated to consider petitions submitted to the agency using any method other than the three identified in this paragraph.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing significant new use rules (SNURs) under the Toxic Substances Control Act (TSCA) for two chemical substances which were the subject of premanufacture notices (PMNs). This action would require persons who intend to manufacture (defined by statute to include import) or process any of the chemical substances for an activity that is designated as a significant new use by this proposed rule to notify EPA at least 90 days before commencing that activity. The required notification initiates EPA's evaluation of the intended use within the applicable review period. Manufacture and processing for the significant new use is unable to commence until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination.
Comments must be received on or before September 23, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-0491, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
You may be potentially affected by this action if you manufacture, process, or use the chemical substances contained in this proposed rule. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
Manufacturers (including importers) or processors of one or more subject chemical substances (NAICS codes 325 and 324110),
This action may also affect certain entities through pre-existing import certification and export notification rules under TSCA. Chemical importers are subject to the TSCA section 13 (15 U.S.C. 2612) import certification requirements promulgated at 19 CFR 12.118 through 12.127 and 19 CFR 127.28. Chemical importers must certify that the shipment of the chemical substance complies with all applicable rules and orders under TSCA. Importers of chemicals subject to these SNURs must certify their compliance with the SNUR requirements. The EPA policy in support of import certification appears at 40 CFR part 707, subpart B. In addition, any persons who export or intend to export a chemical substance that is the subject of this proposed rule on or after September 23, 2016 are subject to the export notification provisions of TSCA section 12(b) (15 U.S.C. 2611(b)) (see § 721.20), and must comply with the export notification requirements in 40 CFR part 707, subpart D.
1.
2.
EPA is proposing these SNURs under TSCA section 5(a)(2) for two chemical substances which were the subject of PMNs P-14-321 and P-14-323. These SNURs would require persons who intend to manufacture or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity.
Section 5(a)(2) of TSCA (15 U.S.C. 2604(a)(2)) authorizes EPA to determine that a use of a chemical substance is a “significant new use.” EPA must make this determination by rule after considering all relevant factors, including the four bulleted TSCA section 5(a)(2) factors listed in Unit III. Once EPA determines that a use of a chemical substance is a significant new use, TSCA section 5(a)(1)(B) requires persons to submit a significant new use notice (SNUN) to EPA at least 90 days before they manufacture or process the chemical substance for that use (15 U.S.C. 2604(a)(1)(B)(i)). TSCA furthermore prohibits such manufacturing or processing from commencing until EPA has conducted a review of the notice, made an appropriate determination on the notice, and taken such actions as are required in association with that determination (15 U.S.C. 2604(a)(1)(B)(ii)). As described in Unit V., the general SNUR provisions are found at 40 CFR part 721, subpart A.
General provisions for SNURs appear in 40 CFR part 721, subpart A. These provisions describe persons subject to the rule, recordkeeping requirements, exemptions to reporting requirements, and applicability of the rule to uses occurring before the effective date of the final rule. Provisions relating to user fees appear at 40 CFR part 700. According to § 721.1(c), persons subject to these SNURs must comply with the same SNUN requirements and EPA regulatory procedures as submitters of PMNs under TSCA section 5(a)(1)(A). In particular, these requirements include the information submission requirements of TSCA section 5(b) and 5(d)(1), the exemptions authorized by TSCA section 5(h)(1), (h)(2), (h)(3), and (h)(5), and the regulations at 40 CFR part 720. Once EPA receives a SNUN, EPA must either determine that the significant new use is not likely to present an unreasonable risk of injury or take such regulatory action as is associated with an alternative determination before the manufacture or processing for the significant new use can commence. If EPA determines that the significant new use is not likely to present an unreasonable risk, EPA is required under TSCA section 5(g) to make public, and submit for publication in the
Section 5(a)(2) of TSCA states that EPA's determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
• The projected volume of manufacturing and processing of a chemical substance.
• The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance.
• The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance.
• The reasonably anticipated manner and methods of manufacturing, processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors enumerated in TSCA section 5(a)(2), the statute authorized EPA to consider any other relevant factors.
To determine what would constitute a significant new use for the chemical substances that are the subject of these SNURs, EPA considered relevant information about the toxicity of the chemical substances, likely human exposures and environmental releases associated with possible uses, and the four bulleted TSCA section 5(a)(2) factors listed in this unit.
EPA is proposing significant new use and recordkeeping requirements for two chemical substances in 40 CFR part 721, subpart E. In this unit, EPA provides the following information for each chemical substance:
• PMN number.
• Chemical name (generic name, if the specific name is claimed as CBI).
• Chemical Abstracts Service (CAS) Registry number (assigned for non-confidential chemical identities).
• Tests recommended by EPA to provide sufficient information to evaluate the chemical substance (see Unit VII. for more information).
• CFR citation assigned in the regulatory text section of this proposed rule.
The regulatory text section of this proposed rule specifies the activities designated as significant new uses. Certain new uses, including production volume limits (
1. Submission of certain toxicity testing on the PMN substances prior to exceeding the time trigger specified in the consent order of the PMN substances.
2. Use of impervious gloves and protective clothing where dermal exposure is reasonably likely for workers.
3. Use of respirators with an APF of 1000, in conjunction with a minimum set of engineering controls to prevent inhalation exposure for workers, or, as an alternative to using respirators, maintain workplace airborne concentrations of the PMN substances at or below a specified New Chemical Exposure Limit (NCEL) of 130 parts per million (ppm) for P-14-321 and 33 parts per billion (ppb) for P-14-323 as an 8-hour time-weighted average, where inhalation exposure is reasonably likely for workers.
4. Use of engineering controls to limit worker exposure and air release of the PMN substances to the environment.
5. Label containers of the PMN substances and provide Safety Data Sheets and worker training.
6. Manufacture, process and use the PMN substances only in an enclosed process.
7. Use of the PMN substances only as chemical intermediates.
8. No predictable or purposeful release of the PMN substances from manufacturing, processing or use into the waters of the United States that result in surface water concentrations exceeding 8 ppb.
9. Prohibition on the distribution of the PMN substances.
The SNUR designates as a “significant new use” the absence of these protective measures.
During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160 (see Unit VI.).
EPA is proposing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this proposed rule:
• EPA would receive notice of any person's intent to manufacture or process a listed chemical substance for the described significant new use before that activity begins.
• EPA would have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing or processing a listed chemical substance for the described significant new use.
• EPA would be able to either determine that the prospective manufacture or processing is not likely to present an unreasonable risk, or to take necessary regulatory action associated with any other determination, before the described significant new use of the chemical substance occurs.
Issuance of a SNUR for a chemical substance does not signify that the chemical substance is listed on the TSCA Chemical Substance Inventory (TSCA Inventory). Guidance on how to determine if a chemical substance is on the TSCA Inventory is available on the Internet at
To establish a significant new use, EPA must determine that the use is not ongoing. The chemical substances subject to this proposed rule have undergone premanufacture review. In cases where EPA has not received a notice of commencement (NOC) and the chemical substance has not been added to the TSCA Inventory, no person may commence such activities without first submitting a PMN. Therefore, for chemical substances for which an NOC has not been submitted EPA concludes that the designated significant new uses are not ongoing.
When chemical substances identified in this proposed rule are added to the TSCA Inventory, EPA recognizes that, before the rule is effective, other persons might engage in a use that has been identified as a significant new use. The identities of the two chemical substances subject to this proposed rule have been claimed as confidential and EPA has received no post-PMN
Therefore, EPA designates August 15, 2016 (the date of public release/web posting of this proposal) as the cutoff date for determining whether the new use is ongoing. This designation varies slightly from EPA's past practice of designating the date of
Persons who begin commercial manufacture or processing of the chemical substances for a significant new use identified as of August 15, 2016 would have to cease any such activity upon the effective date of the final rule. To resume their activities, these persons would have to first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacture or processing have been satisfied. If such a person met the conditions of advance compliance under § 721.45(h), the person would be considered exempt from the requirements of the SNUR. Consult the
EPA recognizes that TSCA section 5 does not require developing new information (
1. Development of test data is required where the chemical substance subject to the SNUR is also subject to a test rule, order, or consent agreement under TSCA section 4 (see TSCA section 5(b)(1)).
2. Development of test data may be necessary where the chemical substance has been listed under TSCA section 5(b)(4) (see TSCA section 5(b)(2)).
In the absence of a test rule, order, or consent agreement under TSCA section 4 covering the chemical substance, persons are required only to submit information in their possession or control and to describe any other information known to or reasonably ascertainable by them (see 40 CFR 720.50). However, upon review of PMNs and SNUNs, the Agency has the authority to require appropriate testing. Descriptions of tests are provided for informational purposes. EPA strongly encourages persons, before performing any testing, to consult with the Agency pertaining to protocol selection. To access the OCSPP test guidelines referenced in this document electronically, please go to
The recommended tests specified in Unit IV. may not be the only means of addressing the potential risks of the chemical substance. However, submitting a SNUN that does not itself include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available to the Agency is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant
SNUN submitters should be aware that EPA will be better able to evaluate SNUNs and define the terms of any potentially necessary controls if the submitter provides detailed information on:
• Human exposure and environmental release that may result from the significant new use of the chemical substances.
• Potential benefits of the chemical substances.
• Information on risks posed by the chemical substances compared to risks posed by potential substitutes.
EPA recommends that submitters consult with the Agency prior to submitting a SNUN to discuss what information may be useful in evaluating a significant new use. Discussions with the Agency prior to submission can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance. According to § 721.1(c), persons submitting a SNUN must comply with the same notification requirements and EPA regulatory procedures as persons submitting a PMN, including submission of test data on health and environmental effects as described in 40 CFR 720.50. SNUNs must be submitted on EPA Form No. 7710-25, generated using e-PMN software, and submitted to the Agency in accordance with the procedures set forth in 40 CFR 720.40 and 721.25. E-PMN software is available electronically at
EPA has used scientific information, technical procedures, measures, methods, protocols, methodologies, and models consistent with the risk assessment documents included in the public docket.
The clarity and completeness of the data, assumptions, methods, quality assurance, and analyses employed in EPA's decision are documented, as applicable and to the extent necessary for purposes of this proposed significant new use rule, in Unit II and in the documents noted above. EPA recognizes, based on the available information, that there is variability and uncertainty in whether any particular significant new use would actually present an unreasonable risk. For precisely this reason, it is appropriate to secure a future notice and review process for these uses, at such time as they are known more definitely. The extent to which the various information, procedures, measures, methods, protocols, methodologies or models used in EPA's decision have been subject to independent verification or peer review is adequate to justify their use, collectively, in the record for a significant new use rule.
EPA has evaluated the potential costs of establishing SNUN requirements for potential manufacturers and processors of the chemical substances subject to this proposed rule, during the development of the direct final rule. EPA's complete economic analysis is available in the docket under docket ID number EPA-HQ-OPPT-2016-0491.
This proposed rule would establish SNURs for two chemical substances that were the subject of PMNs. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitled
According to PRA (44 U.S.C. 3501
The information collection requirements related to this proposed rule have already been approved by OMB pursuant to PRA under OMB control number 2070-0012 (EPA ICR No. 574). This proposed rule would not impose any burden requiring additional OMB approval. If an entity were to submit a SNUN to the Agency, the annual burden is estimated to average between 30 and 170 hours per response. This burden estimate includes the time needed to review instructions, search existing data sources, gather and maintain the data needed, and complete, review, and submit the required SNUN.
Send any comments about the accuracy of the burden estimate, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques, to the Director, Collection Strategies Division, Office of Environmental Information (2822T), Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. Please remember to include the OMB control number in any correspondence, but do not submit any completed forms to this address.
On February 18, 2012, EPA certified pursuant to RFA section 605(b) (5 U.S.C. 601
1. A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
2. The SNUR submitted by any small entity would not cost significantly more than $8,300.
A copy of that certification is available in the docket for this proposed rule.
This proposed rule is within the scope of the February 18, 2012 certification. Based on the Economic Analysis discussed in Unit IX. and EPA's experience promulgating SNURs (discussed in the certification), EPA believes that the following are true:
• A significant number of SNUNs would not be submitted by small entities in response to the SNUR.
• Submission of the SNUN would not cost any small entity significantly more than $8,300.
Therefore, the promulgation of the SNUR would not have a significant economic impact on a substantial number of small entities.
Based on EPA's experience with proposing and finalizing SNURs, State, local, and Tribal governments have not been impacted by these rulemakings, and EPA does not have any reasons to believe that any State, local, or Tribal government would be impacted by this proposed rule. As such, EPA has determined that this proposed rule would not impose any enforceable duty, contain any unfunded mandate, or otherwise have any effect on small governments subject to the requirements of UMRA sections 202, 203, 204, or 205 (2 U.S.C. 1501
This proposed rule would not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999).
This proposed rule would not have Tribal implications because it is not expected to have substantial direct effects on Indian Tribes. This proposed rule would not significantly nor uniquely affect the communities of Indian Tribal governments, nor would it involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (65 FR 67249, November 9, 2000), do not apply to this proposed rule.
This proposed rule is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because this is not an economically significant regulatory action as defined by Executive Order 12866, and this proposed rule does not address environmental health or safety risks disproportionately affecting children.
This proposed rule is not subject to Executive Order 13211, entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001), because this proposed rule is not expected to affect energy supply, distribution, or use and because this proposed rule is not a significant regulatory action under Executive Order 12866.
In addition, since this proposed rule would not involve any technical standards, NTTAA section 12(d) (15 U.S.C. 272 note), would not apply to this proposed rule.
This proposed rule does not entail special considerations of environmental justice related issues as delineated by Executive Order 12898, entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Environmental protection, Chemicals, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, it is proposed that 40 CFR chapter I be amended as follows:
15 U.S.C. 2604, 2607, and 2625(c).
(a)
(2) The significant new uses are:
(i)
(A) Any NIOSH-certified powered air purifying full facepiece respirator equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges.
(B) Any NIOSH-certified powered air-purifying respirator equipped with a hood or helmet and appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges with evidence demonstrating protection level of 1,000 or greater. (Note: OSHA has assigned APFs of 1000 for certain types of hoods and helmets with powered air purifying respirators (PAPRs) or supplied air respirators (SARs) where the manufacturer can demonstrate adequate air flows to maintain positive pressure inside the hood or helmet in normal working conditions. However, the employer must have evidence provided by the respirator manufacturer that the testing of these respirators demonstrates performance at a level of protection of 1,000 or greater to receive an APF of 1,000. This level of performance can best be demonstrated by performing a Workplace Protection Factor (WPF) or Simulated Workplace Protection Factor (SWPF) study or equivalent testing. Without testing data that demonstrates a level of protection of 1,000 or greater, all PAPRs and SARs with helmets/hoods are to be treated as loose-fitting facepiece respirators, and receive an APF of 25.)
(C) Any NIOSH-certified continuous flow supplied-air respirator equipped with a full facepiece.
(D) Any NIOSH-certified continuous flow supplied-air respirator equipped with a hood or helmet with evidence demonstrating protection level of 1,000 or greater. (See Note under (II), above)
(E) Any NIOSH-certified pressure-demand or other positive pressure mode supplied-air respirator equipped with a full facepiece.
(1) As an alternative to the respiratory requirements listed here, a manufacturer or processor may choose to follow the New Chemical Exposure Limit (NCEL) provisions listed in the TSCA section 5(e) consent order for this substance. The NCEL is 130 parts per million for P-14-321 and 33 parts per billion for P-14-323 as an 8-hour time weighted average (TWA) verified by actual monitoring data.
(ii)
(ii)
(iii)
(b)
(1)
(2)
Federal Communications Commission.
Proposed rule.
In this document, the Consumer and Governmental Affairs Bureau (CGB or Bureau) of the Federal Communications Commission (FCC or Commission), pursuant to a delegation of authority, proposes to incorporate into the Commission's rules the Video Relay Service (VRS) interoperability and portability standards developed by the VRS Task Group of the Session Initiation Protocol (SIP) Forum and a successor group, the Relay User Equipment (RUE) Forum.
Comments are due on or before September 14, 2016.
You may submit comments, identified by CG Docket Nos. 10-51 and 03-123, by any of the following methods:
•
•
• 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 8:00 a.m. to 7:00 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes and boxes must be disposed of
• 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.
Eliot Greenwald, Consumer and Governmental Affairs Bureau, at phone: (202) 418-2235 or email:
This is a summary of the Commission's Further Notice of Proposed Rulemaking (
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to
The Further Notice does not contain proposed information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any proposed information collection burden for small business concerns with fewer than 25 employees, pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
1. In 2013, the Commission amended its rules to improve the effectiveness of its interoperability and portability rules for video relay service (VRS), in order to improve functional equivalence and VRS availability for consumers, ease of compliance by providers, and overall efficiency in the operation of the
2. The Further Notice, issued by CGB pursuant to a delegation of authority in the
3. Since 2006, the Commission has required VRS providers to (i) allow VRS users to make and receive calls through any VRS provider, and to choose a different default provider, without changing the VRS access technology they use to place calls, and (ii) ensure that VRS users can make point-to-point calls to all other VRS users, irrespective of the default provider of the calling and called party. Providers also must ensure that videophone equipment that they distribute retains certain features when a user ports his or her ten-digit VRS number to a new default provider. 47 CFR 64.611(e);
4. In order to improve the effectiveness of these interoperability and portability requirements, the Commission delegated “to the Chief of CGB, after consultation with the CTO [Chief Technology Officer] and the Chief of OET [Office of Engineering and Technology], the authority to conduct rulemaking proceedings to incorporate into the Commission's rules by reference any interoperability and portability standards developed under the auspices of the SIP Forum, now or in future, or such other voluntary, consensus standard organization as may be formed to address these issues.”
5. In August 2015, the SIP Forum published the Video Relay Service (VRS) Provider Interoperability Profile (VRS Provider Interoperability Profile), a consensus document developed by the SIP Forum's VRS Task Group. The VRS Provider Interoperability Profile provides technical specifications for the interface between VRS providers and the interface between a VRS provider and the TRS Numbering Directory. In July 2016, the Relay User Equipment Forum (RUE Forum) published a second consensus document, the Interoperability Profile for Relay User Equipment (RUE Profile) on the Internet Engineering Task Force (IETF) Web site. The RUE Profile provides technical specifications that define a standard interface between a relay user's equipment and the services offered by relay service providers.
6. The Bureau tentatively concludes that the VRS Provider Interoperability Profile and the RUE Profile will effectively meet the Commission's goals of ensuring interoperability and portability, as required by the
7. The Bureau also proposes to follow, in the future, a procedure that permits amendments or changes to the standards to be incorporated into the Commission's rules in a timely and efficient manner. The Bureau believes that a voluntary, consensus standards process that results in amendments or changes to the standards will, as is the case for the standards proposed for incorporation herein, allow for widespread participation by the affected parties, and in particular VRS providers. In the event of such amendments or changes, the Bureau will issue a public notice seeking comment on such modifications, followed by an order incorporating into the VRS rules amendments or changes by reference if justified based on the resulting record. When such revised standards are completed and accepted by the Bureau, a second public notice will be issued containing information on how to access the modified standards and establishing an implementation schedule. To facilitate ready access to such standards, the Bureau further proposes that the Commission make them available to the public online. The Bureau believes that this process will allow interested parties to have the opportunity to participate in the standards-setting process, comment on the inclusion of such standards in the Commission's rules, and receive notice about the implementation of any amendments or changes to the standards. The Bureau seeks comment
8. As to the timing of the implementation of the recently developed standards, the Bureau believes that insofar as all current VRS providers participated in developing these standards and had an opportunity to debate the various technical issues over a period of several years, as a practical matter, all providers have become familiar with the content of the standards, have had ample opportunity to incorporate the standards into their software development processes, and have had sufficient opportunity to familiarize their suppliers with any necessary design changes. The Bureau therefore proposes that the rule amendment incorporating the standards into 47 CFR 64.621 shall become effective 60 days after publication in the
9. As the Commission contemplated in the
10. The Office of Federal Register (OFR) recently revised its regulations to require that agencies must discuss in the preamble of a proposed rule ways that the materials the agency proposes to incorporate by reference are reasonably available to interested parties or how it worked to make those materials reasonably available to interested parties. In addition, the preamble of the proposed rule must summarize the material. 1 CFR 51.5(a). In accordance with OFR's requirements, the discussion in the following two paragraphs summarizes and indicates the availability of the VRS Provider Interoperability Profile and the RUE Profile.
11. The U.S. Video Relay Service (VRS) Provider Interoperability Profile, Version 15, SIP Forum Document Number: VRS U.S. Providers Profile TWG-6-0.15 (Sept. 23, 2015) (VRS Provider Interoperability Profile), is available from SIP Forum LLC, 733 Turnpike Street, Suite 192, North Andover, MA 01845 USA, (203) 829-6307, at
12. The Interoperability Profile for Relay User Equipment, draft-vrs-rue-dispatch-00 (July 20, 2016) (RUE Profile), is available from IETF Secretariat, 5177 Brandin Court, Fremont, CA 94538, 510-492-4080, at
13. As required by the Regulatory Flexibility Act (RFA), the Bureau has prepared this Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on small entities by the policies and rules proposed in the Further Notice. Written public comments are requested on this IRFA. Comments must be identified as responses to the IRFA and must be filed by the deadlines for comments specified in the Further Notice.
14.
15.
16.
17.
18.
19.
Telecommunications relay services, Individuals with disabilities.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR part 64 as follows:
47 U.S.C. 154, 254(k); 403(b)(2)(B), (c), Public Law 104-104, 110 Stat. 56. Interpret or apply 47 U.S.C. 201, 218, 222, 225, 226, 227, 228, 254(k), 616, and 620, and the Middle Class Tax Relief and Job Creation Act of 2012, Public Law 112-96, unless otherwise noted.
(b)
(1) VRS providers shall ensure that their provision of VRS and video communications, including their access technology, meets the requirements of the U.S. Video Relay Service (VRS) Provider Interoperability Profile Version 15, SIP Forum Document Number: VRS U.S. Providers Profile TWG-6-0.15 (Sept. 23, 2015) (VRS Provider Interoperability Profile),
(2) This incorporation by reference of the VRS Provider Interoperability Profile and the RUE Profile was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of the VRS Provider Interoperability Profile may be obtained from SIP Forum LLC, 733 Turnpike Street, Suite 192, North Andover, MA 01845 U.S.A., (203) 829-6307, at
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce.
Proposed rule; request for comments.
We, the National Marine Fisheries Service (NMFS), propose regulations under the Marine Mammal Protection Act (MMPA) to prohibit swimming with and approaching a Hawaiian spinner dolphin within 50 yards (45.7 m) (for persons, vessels, and objects), including approach by interception. These proposed regulatory measures are intended to prevent take of Hawaiian spinner dolphins from occurring in marine areas where viewing pressures are most prevalent; prohibitions would apply in waters within 2 nautical miles (nm; 3.7 km) of the Hawaiian Islands and in the waters between the islands of Lanai, Maui, and Kahoolawe. This proposed rule to establish 50-yard swim-with and approach regulations would help ensure public compliance by providing clear notice of prohibited conduct that results in take, including harassment and disturbance.
Although unauthorized take of marine mammals, including harassment of spinner dolphins, already is and continues to be prohibited under the MMPA throughout their range, the purpose of this regulation is to identify and prohibit specific human activities that result in take (including harassment) of spinner dolphins, and thus reduce disturbance and disruption of important Hawaiian spinner dolphin behaviors in areas where human-dolphin interactions are most likely to occur. These proposed regulations would reduce take of Hawaiian spinner dolphins and the impact of human viewing and interaction on these animals in the Main Hawaiian Islands (MHI). We developed this proposed rule after considering comments submitted in response to an Advance Notice of Proposed Rulemaking (ANPR), as well as information received during the public scoping period for the Draft Environmental Impact Statement (DEIS), from community meetings, and from a dedicated scientific research project.
Although not currently part of this proposal, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats that are regularly targeted by humans for dolphin-directed activities. Accordingly, we are soliciting public comment on the proposed swim-with and approach regulations, as well as alternative management options discussed in this rule and in detail in the DEIS.
Comments must be received no later than 5 p.m. on October 23, 2016.
Public meetings will provide the public with an opportunity to provide comments on any portion of the proposed rule or DEIS. These meetings are scheduled for:
September 7, 2016, 5:30-9:30 p.m. at Konawaena High School Cafeteria, 81-1043 Konawaena School Rd., Kealakekua, HI 96750;
September 8, 2016, 5:30-9:30 p.m. at Kealakehe High School Cafeteria, 74-5000 Puohulihuli St., Kailua Kona, HI 96740;
September 21, 2016, 5:30-9:00 p.m. at Kauai High School Cafeteria, 3577 Lala Rd., Lihue, HI 96766;
September 22, 2016, 5:30-9:00 p.m. at the Hawaiian Islands Humpback Whale National Marine Sanctuary Visitor Center, 726 South Kihei Rd., Kihei, HI 96753;
September 27, 2016, 5:30-9:30 p.m. at Roosevelt High School Dining Hall, 1120 Nehoa Street, Honolulu, HI 96822; and
September 28, 2016, 5:30-9:30 p.m. at Waianae High School Cafeteria, 85-251 Farrington Hwy., Waianae, HI 96792.
You may submit comments, information, or data on this document, identified by NOAA-2005-0226, and on the DEIS by either of the following methods:
The Draft Environmental Impact Statement (DEIS) and references can be found online at
Hilo Library, 300 Waianuenue Ave., Hilo, HI 96720;
Kailua-Kona Library, 75-138 Hualalai Rd., Kailua Kona, HI 96740;
Kealakekua Library, 81-6619 Mamalahoa Hwy., Kealakekua, HI 96750;
Pahoa Library, 15-3070 Pahoa-Kalapana Rd., Pahoa, HI 96778;
Kihei Library, 35 Waimahaihai St., Kihei, HI 96753;
Lahaina Library, 680 Wharf St., Lahaina, HI 96761;
Lanai Library, 555 Fraser Ave., Lanai City, HI 96763;
Hawaii State Library, 478 S. King St., Honolulu, HI 96813;
Molokai Public Library, 15 Ala Malama, Kaunakakai, HI 96748;
Waianae Library, 85-625 Farrington Hwy., Waianae, HI 96792; and
Lihue Library, 4344 Hardy St., Lihue, HI 96766; or upon request from the Conservation Planning and Rulemaking Branch Chief (see
Susan Pultz, NMFS, Pacific Islands Region, Chief, Conservation Planning and Rulemaking Branch, 808-725-5150; or Trevor Spradlin, NMFS, Office of Protected Resources, Acting Chief, Marine Mammal and Sea Turtle Conservation Division, 301-427-8402.
Viewing wild marine mammals in Hawaii has been a popular recreational activity for both tourists and residents over the past several decades. Historically, most marine mammal viewing focused on humpback whales (
The number of commercial operators engaged in wild dolphin viewing has grown dramatically in Hawaii in recent years (O'Connor 2009), putting new pressures on easily accessible groups of resting Hawaiian spinner dolphins. In addition, a number of residents and visitors venture on their own, independent of commercial operators, to view and interact with spinner dolphins. The expectation for close interactions with wild dolphins has been encouraged by some operators and various media outlets, which routinely contradict established wildlife viewing guidelines by promoting close vessel or in-water encounters with the dolphins.
We have received many complaints that spinner dolphins are being routinely disturbed by people attempting to closely approach and interact with the dolphins by boat or other watercraft (
In 2010, we recognized five island-associated stocks and one pelagic stock of Hawaiian spinner dolphins in our annual Stock Assessment Report, identifying genetic distinctions and site fidelity differences as reasons to separately manage stocks found in waters surrounding the Hawaiian Islands (Carretta
Island-associated spinner dolphins, such as those found in the MHI, have complex social structures and behavioral patterns linked to specific habitats that support their high energetic demands. The rigid, cyclical, and patterned behavior of a Hawaiian spinner dolphin's day is well documented from decades of scientific research on spinner dolphins off the Kona coast on the island of Hawaii (Norris and Dohl 1980, Norris
During the day, spinner dolphins return in smaller groups to areas closer to shore to socialize, nurture their young, and rest in preparation for nightly foraging (Norris
Essential daytime habitats have been targeted by commercial operators and individuals interested in viewing or interacting with Hawaiian spinner dolphins because encounters with dolphins in these areas are virtually guaranteed. At some locations, up to 13 tour boats have been observed jockeying for position on a single dolphin group, with up to 60 snorkelers in the water (Heenehan
There is a growing body of scientific evidence documenting the effects of dolphin-directed activities on spinner dolphins, especially activities that involve close approaches by humans. Peer-reviewed scientific literature documents disturbance of individual spinner dolphins as well as changes to spinner dolphin group behavioral patterns. Individual dolphin responses to these activities vary, and in some cases may not be apparent to an observer (
Effects have been documented in the form of changes over time to spinner dolphins' behavioral patterns in essential daytime habitats, where spinner dolphins' behavioral patterns are easily observed. Courbis and Timmel (2008) reported differences in peak aerial activity throughout the day in comparison with earlier studies (Forrest 2001) and noted that dolphins may have reduced aerial behavior when entering and exiting bays to avoid human notice and approaches. Timmel
Hawaiian spinner dolphin studies off the island of Oahu also demonstrate the effects of swimmers on dolphins' daily resting behavioral patterns. As the number of swimmers increased in an essential daytime habitat off the west coast of Oahu, the dolphins departed the area at earlier times during the day, possibly indicating reduced rest periods in response to swimmer presence (Danil
When marine mammals respond to disturbance events, they incur a cost in the form of the energy expended to respond as well as the lost opportunity to engage in natural fitness-enhancing behavior. For example, spinner dolphins disturbed during rest may engage in avoidance or distress behaviors, which require energy, and disturbance detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. In this example, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young.
The predictable patterns of MHI resident spinner dolphins' nearshore distribution and daytime behaviors result in concentrated daily viewing and interaction pressure on individual dolphins and groups over extended periods of time. In other small cetacean populations, chronic disturbance to natural behavioral patterns has been linked to biologically significant impacts such as habitat abandonment and reduced female reproductive success (Bejder 2005; Bejder
Disturbances to dolphins' daily behavioral patterns may result in “take,” as defined and prohibited under the MMPA and its implementing regulations, and the chronic nature of these problems in Hawaii and observed changes to spinner dolphin behavioral patterns over time are a cause for concern.
Under section 102 of the MMPA, 16 U.S.C. 1361
In addition, NMFS' regulations implementing the MMPA further define the term “take” to include “the negligent or intentional operation of an aircraft or vessel, or the doing of any other negligent or intentional act which results in disturbing or molesting a marine mammal; and feeding or attempting to feed a marine mammal in the wild” (50 CFR 216.3).
Section 112 of the MMPA authorizes NOAA to implement regulations that are “necessary and appropriate to carry out the purpose” of the MMPA (16 U.S.C. 1382).
To date, NMFS has developed specific approach distance regulations for certain species of marine mammals listed under the Endangered Species Act (ESA) (16 U.S.C. 1531
In addition to the specific ESA regulations mentioned above, NMFS has developed guidelines for conducting responsible marine wildlife viewing to help the public avoid causing any take (harassment or disturbance) of protected wildlife species (
In addition to the national guidelines, each of the five NMFS Regions has developed recommended viewing guidelines relevant to protected species within their region to assist the general public with information on how to responsibly view and act around these animals in the wild. The guidelines are aimed at assisting the public in meeting their obligations under the MMPA and ESA. Although some guidelines address activities that are prohibited under law, others address activities that are not expressly prohibited.
The NMFS Pacific Islands Regional Office's viewing guidelines for Hawaii recommend that people view wild dolphins from a safe distance of at least 50 yards (45.7 m) and advise against trying to chase, closely approach, surround, swim with, or touch the animals. To support the guidelines in Hawaii, NMFS has partnered with the State of Hawaii and the Hawaiian Islands Humpback Whale National Marine Sanctuary over the past several years to promote safe and responsible wildlife viewing practices through the development of outreach materials, training workshops, signage, and public service announcements. NMFS' education and outreach efforts have also been supported by a partnership with the Watchable Wildlife program, a consortium of Federal and State wildlife agencies and wildlife interest groups that encourages passive viewing of wildlife from a distance for the safety and well-being of both animals and people (Duda 1995, Oberbillig 2000, Clark 2006). In addition to the guidance provided to the general public on protected wildlife viewing, several tour industry-specific programs have been initiated in various NMFS regions to further support protection of marine mammals targeted for wildlife viewing. In Hawaii this includes administration of the voluntary Dolphin SMART program for commercial operators who pledge to comply with safe and responsible wildlife viewing practices.
Dolphin SMART is a model wildlife viewing stewardship program developed by NMFS and NOAA's Office of National Marine Sanctuaries in partnership with Whale and Dolphin Conservation, the Dolphin Ecology Project, local businesses, and members of the public, who have teamed up to support responsible viewing of wild dolphins. The program was launched in 2007 in Key West, Florida, was subsequently expanded to the Central and Southwest Florida coast, and established in Hawaii in 2011.
The NMFS Pacific Islands Regional Office developed the Dolphin SMART program in Hawaii to aid education and outreach efforts for Hawaiian spinner dolphin conservation and management. Three businesses on Oahu, one on Kauai, and two on Maui are currently recognized as Dolphin SMART participants.
The Dolphin SMART program goals are to minimize the potential of wild dolphin harassment caused by commercial viewing activities, reduce expectations of close interaction with wild dolphins in a manner that may cause harassment, address advertising that creates expectations of engaging in activities that may cause harassment, and promote responsible stewardship of dolphins in local coastal waterways. The “SMART” acronym stands for:
More information on the Dolphin SMART program can be found at the following Web sites:
Despite the prohibitions, guidelines, outreach, and stewardship efforts currently in place, close interactions between humans and spinner dolphins continue to occur in Hawaii's waters and are especially prevalent in essential daytime habitats (see Background). In April 2000, the MMC released a literature review of scientific publications that evaluated the impacts of swimming with wild dolphins worldwide (Samuels
The concerns about disturbance to spinner dolphins by boaters and swimmers prompted NMFS to raise the topic of enhancing protections for these animals in an Advanced Notice of Proposed Rulemaking (ANPR) (70 FR 73426, December 12, 2005). Public comments received in 2005 reiterated and reinforced the concerns expressed by the MMC. In the years since the 2000 Samuels
Based on extensive review and analysis through internal scoping, external scoping via the ANPR, public scoping for the DEIS, and the best available scientific information, we have determined that the existing prohibitions, regulations, and guidelines need to be strengthened to protect Hawaiian spinner dolphins from various forms of take from human activities that cause harassment or disturbance. Dolphins' response to disturbance varies among individuals, but in most cases it includes a departure from natural behavioral patterns that support the animal's health and fitness, and chronic disturbance may result in negative impacts to the fitness of individuals and/or populations. We therefore deem it necessary and appropriate to adopt additional regulations to clarify human activities that result in take of Hawaiian spinner dolphins, including harassment or other forms of disturbance as currently defined by statute and regulation.
Although unauthorized take of dolphins continues to be illegal wherever it occurs, we are focusing these regulations in nearshore areas, out 2 nm (3.7 km) from shore of the MHI and including designated waters between Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e) and
In 2005, NMFS convened a Spinner Dolphin Working Group with representatives from the MMC, State and Federal agencies, and scientific researchers who work on spinner dolphin conservation concerns. The group evaluated the best available information at the time to understand the scope of the tourist and recreational activities targeting spinner dolphins. As noted above (Need for Additional Action section), in December 2005, we published an ANPR in the
During the ANPR and the NOI comment periods, five public scoping meetings were held on the islands of Kauai, Oahu, Maui, and Hawaii, and oral statements were taken at each meeting. NMFS received a total of 4,641 public comments in response to the ANPR and the NOI (this includes all emails, letters, and public testimonies). Comments were submitted by concerned citizens, tour operators, scientific researchers, conservation and education groups, and Federal, State, and other government entities.
Comments received through both of the public comment periods varied widely and recommended numerous actions to consider, ranging from no regulations to permanent closure of areas used by the dolphins for rest and shelter. Additionally, public comments raised concerns about various topics that should be addressed in the EIS or proposed action. These concerns are grouped into various topics in the final scoping report, and include the following topics: Hawaiian spinner dolphin biology and behavior; cultural issues; cumulative effects; data/data gaps; direct and indirect effects; education/outreach; enforcement; the ESA; guidelines/solutions for other species or from other countries; human-dolphin interaction, medical benefits from swimming with dolphins; MMPA; monitoring; the NEPA; public and stakeholder involvement; regulatory regime; social and economic issues; spiritual and religious issues; take and harassment, traditional Hawaiian knowledge; and welfare of the dolphins. Although comments varied greatly, a consistent theme that stood out under several topics was the need for effective and enforceable regulations.
As a result of stakeholder concerns expressed through these public comments, and for the preparation of this rule and associated DEIS, we made multiple site visits to areas where concerns have been raised regarding Hawaiian spinner dolphin disturbance in the MHI. During these visits, we met with concerned members of the public to gather information relevant to this analysis. Additionally, we coordinated with State and Federal agencies, and used the public comments generated from the ANPR and NOI to develop a range of actions and mitigation measures that are reflected in numerous alternatives under consideration for the proposed action.
Presentations made at the public scoping meetings, the April 2007 EIS public scoping summary report, a list of the attendees, the ANPR, public comments, and background materials are provided at
We relied on the public comments on the ANPR and the NOI, and on new scientific information to develop a range of regulatory and non-regulatory alternatives, including the alternative of not adopting regulations. We analyzed the environmental effects of these alternatives and considered options for mitigating effects. After a preliminary analysis of alternatives, we developed and analyzed the effects of the swim-with and 50-yard (45.7 m) approach regulations, which we chose as our preferred alternative, which includes no interception (
Although not currently proposed, we are considering whether other management measures also may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. Accordingly, we have also analyzed the effects of the alternative management measures of promulgating swim-with and approach regulations, while additionally creating either mandatory (see DEIS Alternative 4) or voluntary (see DEIS Alternative 5) time-area closures in five essential daytime habitats. The results of our analyses are contained in a DEIS. The DEIS is available for review and comment in association with this rulemaking (see
During the initial scoping period for the Spinner Dolphin Human Interaction EIS, we received comments that recommended gathering additional information on Hawaiian spinner dolphins, including monitoring local populations to determine impacts to numbers and overall health of the MHI resident spinner dolphins. In response to this recommendation and to inform this rulemaking effort, NMFS internal grant funding was awarded to the “Spinner Dolphin Acoustics, Population Parameters, and Human Impact Research” (SAPPHIRE) program, conducted jointly by Duke University and Murdoch University. The SAPPHIRE project's objective was to provide baseline data on the local abundance, distribution, and behavior of spinner dolphins in Kealakekua Bay, Honaunau Bay, Kauhako Bay, and Makako Bay off of the island of Hawaii, as well as in nearshore, shallow-water environments near these resting bays. This intensive study integrated a suite of visual and acoustic sampling techniques, using boat-based and land-based surveys, as well as acoustic recording devices, to assess the following: Spinner dolphin daytime habitat use and resting behavior in study areas and surrounding waters; residency and fidelity patterns of spinner dolphins during the day in nearshore habitats in both the study areas and surrounding waters; spinner dolphin exposure to human activities within the studied resting bays and surrounding waters; and spinner dolphin demographic response to human activities within resting bays and surrounding waters.
Research in the four bays and nearshore waters of the island of Hawaii began in August 2010 and was completed in May 2013. Results from this study provided robust population estimates for the Hawaii Island stock (see Background), as well as additional information about spinner dolphin habitat use and the pressure that this resident stock faces from dolphin-directed human activities. Many of these studies have been published in scientific literature and scientific reports and were used to inform this rulemaking process (Thorne
Early researchers (Norris and Dohl 1980, Norris
Tyne
Johnson
Tyne (2015) similarly noted that spinner dolphins off the west coast of the island of Hawaii are exposed to a high rate of human activities and that this rate of exposure may obscure researchers' ability to distinguish disturbance effects associated with intense viewing pressures. In his evaluations, Tyne (2015) found that spinner dolphins were exposed to human activities within 100 m over 80 percent of the time that the dolphins were using essential daytime habitat. Evaluations between control conditions,
The swim-with and approach prohibitions described in this proposed rule are designed to protect spinner dolphins from take, including harassment and disturbance, caused by dolphin-directed activities that are concentrated in coastal waters (within 2 nm (3.7 km) of shore and in designated waters between Lanai, Maui, and Kahoolawe) and reduce the impact of increased viewing and interaction pressures. Although we stress that unauthorized take of spinner dolphins or any marine mammals already is and continues to be prohibited by the MMPA in any location, we believe that specific regulations aimed at identified human activities that result in take of Hawaiian spinner dolphins is warranted because of the chronic disturbance that is currently taking place in nearshore waters. NMFS is proposing these regulations pursuant to its rulemaking authority under MMPA sections 112(a) (16 U.S.C. 1382(a)) and 102 (16 U.S.C. 1372).
Although not included in this proposed rule, we are also considering whether additional management measures may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. The
The proposed rule's swim-with and approach prohibitions would apply to all Hawaiian spinner dolphins found in the action area (see
The action area for this rule is limited to waters within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe (see Figures 1 and 2 in section 216.20(e)). The latter designated waters include all water areas enclosed by three line segments that connect points at the 2-nm boundary between the islands as follows: The rhumb line between (A1) 20°32′51″ N./156°43′50″ W. and (A2) 20°42′4″ N./156°55′34″ W. between Kahoolawe and Lanai; the rhumb line between (B1) 20°51′1″ N./156°54′0″ W. and (B2) 20°59′48″ N./156°42′28″ W. between Lanai and Maui; and the rhumb line between (C1) 20°33′55″ N./156°26′43″ W. and (C2) 20°32′15″ N./156°29′51″ W. between Maui and Kahoolawe. Throughout this rule, all coordinates are referenced to the World Geodetic System of 1984 (WGS84).
This is inclusive of the majority of the nearshore habitats where MHI resident stocks of spinner dolphins engage in daytime behaviors and where dolphin-directed human activities that may result in take are known to occur (see Rationale section below).
The regulations apply to all forms of swim-with and approach activities in water and air. Forms of approaching spinner dolphins include, but are not limited to, operating a manned or unmanned motorized, non-motorized, self-propelled, human-powered, or submersible vessel; operating an unmanned aircraft system (UAS) or drone; and swimming at the water surface or underwater (
The proposed rule would prohibit people from engaging in the following activities around Hawaiian spinner dolphins:
(1) Approaching or remaining within 50 yards (45.7 m);
(2) Swimming or attempting to swim within 50 yards;
(3) Causing a vessel, person, or object to approach or remain within 50 yards; and
(4) Intercepting, or placing a vessel, person, or other object on a path of a spinner dolphin so that the dolphin approaches within 50 yards of the vessel, person, or object.
NMFS considered specific categories that should be exempt from the regulations, which are proposed below:
(1) Any person who inadvertently comes within 50 yards (45.7 m) of a Hawaiian spinner dolphin or is approached by a spinner dolphin, provided the person makes no effort to engage or pursue the animal and takes immediate steps to move away from the animal;
(2) Any vessel that is underway and is approached by a spinner dolphin, provided the vessel continues normal navigation and makes no effort to engage or pursue the animal;
(3) Any vessel transiting to or from a port, harbor, or in a restricted channel when a 50-yard distance will not allow the vessel to maintain safe navigation;
(4) Vessel operations necessary to avoid an imminent and serious threat to a person or vessel;
(5) Activities authorized through a permit or authorization issued by the NMFS to take spinner dolphins; and
(6) Federal, State, or local government vessels, aircraft, personnel, and assets when necessary in the course of performing official duties.
The exception for vessels transiting to or from ports, harbors, or restricted channels is necessary to allow
Hawaiian spinner dolphins resident to the MHI are made up of small, genetically isolated stocks that exhibit a specialized behavioral ecology that makes them easy to access in coastal environments during their daytime resting hours. This leaves these resident stocks vulnerable to human-caused disturbance and its effects such as habitat abandonment or declines in reproductive success (Norris
Observed individual dolphin responses to disturbance events when closely approached by people and vessels include charging or threat displays, aerial displays, and avoidance behaviors such as moving around and away from people and vessels, or leaving the bay in response to human pursuit (Norris
Chronic disturbance can disrupt natural behavioral patterns associated with feeding, resting, nurturing, and socializing, and diminish the animals' ability to utilize the benefits of important habitat, ultimately resulting in negative impacts to the fitness of individuals and resident populations. For example, disturbance while spinner dolphins are resting detracts from the dolphins' abilities to recuperate from energetically demanding behaviors such as foraging, transiting to and from offshore foraging grounds, and nurturing their young. If these disturbances happen chronically, the lack of consistent, undisturbed resting periods can reduce the amount of energy available to forage and care for young. In other small cetacean populations, chronic human disturbances have been linked to biologically significant impacts such as reduced female reproductive success (Bejder 2005, Lusseau and Bejder 2007).
In other locations globally, intense dolphin-directed human activities have resulted in changes to targeted dolphin populations' habitat use and even caused habitat abandonment (Bejder
Chronic disturbance of spinner dolphins in the MHI could negatively affect the habitat use or health of resident populations. Additionally, disturbance effects may be amplified in the MHI's resident stocks, which exhibit high site fidelity and restricted gene flow, because the impacts to multiple individuals' health and fitness are quickly reflected in the overall fitness of these small populations (Bejder 2005).
The 50-yard (45.7 m) approach regulation, including prohibiting swimming with dolphins, is intended to reduce the degree of behavioral disruption from close approaches by vessels and swimmers, while allowing for meaningful dolphin watching opportunities. Research indicates that spinner dolphins exhibit changes and disruptions to natural behaviors from close approach by swimmers (Danil
We have considered multiple distances that may provide protections for spinner dolphins from human activities that result in take (such as swimming with and approaching dolphins), including 50 yards, 100 yards (91.4 m), or even greater distances. NMFS believes that 50 yards is the minimum distance that will prevent most forms of take, while also providing the public with sufficient opportunity to tailor their conduct to avoid disruptive encounters with spinner dolphins. We already recommend this distance (50 yards) in our wildlife viewing guidelines and request that people do not swim-with wild dolphins to reduce the risk of behavioral disruption from close encounters. These guidelines are recognized by tour operators and are used by some (
A 100-yard approach restriction exists for humpback whales and this distance was also considered for reducing take of spinner dolphins. Spinner dolphins are fast-moving, small cetaceans and groups of dolphins may move through areas changing directions throughout the day. A distance restriction of 100 yards provides more space for these animals to move back and forth, and helps ensure that people and vessels have sufficient opportunity to maintain an appropriate distance to avoid take. A 100-yard approach restriction might also be easier for vessel operators to recognize and achieve, as this distance applies to humpback whales. However, approach regulations at a distance greater than 50 yards may be difficult for recreational swimmers to recognize and achieve in the water. Based on the best scientific information available, it is difficult to determine a precise distance beyond which human activity does not have the potential to cause disturbance by disrupting natural behaviors. However, we recognize that not all approaches within 100 yards result in take, and we are concerned that such a prohibition may unnecessarily burden the public, without necessarily achieving the purposes of this rulemaking. Further, this greater distance may diminish both the experience of dolphin watching and opportunities to participate in dolphin watching, because these animals are small and may be difficult to spot at a distance. NMFS recognizes that the dolphin watching industry is important to Hawaii's economy, and that these tours have the ability to inform the public about dolphins and to foster stewardship. To reduce the threat of take occurring (including harassment and disturbance) when swimmers and vessels closely approach dolphins, to remain consistent with the current recommended approach guideline for the region, and to allow for continued dolphin watching opportunities at safe distances, NMFS is proposing a distance of 50 yards for swim-with and approach restrictions.
The proposed swim-with and approach regulations prevent a range of human activities that occur in close proximity to Hawaiian spinner dolphins. This includes swimming-with spinner dolphins, touching or attempting to touch spinner dolphins; corralling or herding spinner dolphins into small areas; and leap-frogging, all of which have the potential to disturb the dolphins and result in take. Implementation of these prohibitions would include enforcement by NMFS and DLNR Division of Conservation and Resource Enforcement (DOCARE) personnel, and outreach by NMFS staff and volunteers who would assist with an informational campaign about the new regulation and the scientific information on which it is based. This proposed rule provides new tools for enforcement that are measurable, easy to understand, and based on the best available science regarding human impacts on spinner dolphins. To limit some potential impacts to the public from these regulations, we propose exceptions that are designed to allow for transit into and out of ports, harbors, and restricted channels; public safety measures; avoidance of penalties when the animal has closely approached a boat or person; and continuation of essential government and permitted activities (see
The costs of implementing human and vessel regulations to protect the dolphins are expected to be low. Some will be borne by the commercial dolphin watch and dolphin swim industry, dolphin-associated spiritual retreats, and other generalized nature tours (see the DEIS and the
The reduction in disturbance to Hawaiian spinner dolphins, as addressed through each element of the rule as described above, provides a benefit to the dolphins as well as to members of the public who value the dolphins. Reducing threats to the dolphins also supports the long-term sustainability of the responsible dolphin watching industry.
The proposed regulations are designed to address dolphin-directed activities that are resulting in various forms of take of Hawaiian spinner dolphins. NMFS selected 2 nm (3.7 km) from shore around the MHI as well as designated waters between the islands of Lanai, Maui, and Kahoolawe as the boundary for the proposed prohibitions because this range encompasses the areas where current and best available information indicates that most dolphin-directed activities are likely to be concentrated. NMFS gathered information from scientific literature about Hawaiian spinner dolphin daytime habitat preferences and information from over 400 sightings of spinner dolphins collected around the MHI since 1992 from various members of the Pacific Islands Photo Identification Network (PIPIN) to determine where resident spinner dolphins are likely to occur during the day. Dolphin-directed activities in Hawaii are concentrated in the nearshore portion of the island-associated Hawaiian spinner dolphin stocks' ranges because these stocks are easily accessed in coastal waters during the day when most people seek out marine recreational activities.
Daytime habitat for Hawaiian spinner dolphins varies across the MHI, because the bathymetry, or depths and shapes of underwater terrain, is different for each island, and spinner dolphins seek out areas with physical and biological characteristics that support their ecological needs (see Background section). On Hawaii Island, Norris
In reviewing this information, we determined that selecting a boundary based on depth in any particular area may be difficult for people to identify without having access to proper instrumentation (which would be especially difficult for kayakers, standup paddleboarders, and swimmers), and that the distance from shore may provide a more easily discerned boundary. In addition, although spinner dolphin daytime habitat may be located at different distances from the shoreline of different islands, establishing different prohibitions based on the location of these daytime habitats (
We reviewed the habitat preferences and sighting information as it relates to distance from shore to identify a boundary that would be easy for people to recognize and would incorporate the best available information about spinner dolphin habitat preferences and sighting information. Along the west coast of Hawaii Island, habitats that are 50 m or less in depth and where dolphin-directed activities are prevalent, are encompassed within 1-1.5 nm (1.9-2.8 km) from shore. Habitats within 100 m depth fall almost entirely within 2 nm of shore, and at 3 nm (5.6 km) these areas are entirely included. Off the west coast of Oahu, where most dolphin-directed activities on this island occur, the 10-fathom (18.3 m) isobath is largely captured within 1 nm of shore, while 17 fathoms (31.1 m) is largely captured within 1.5 nm. Habitats of these depths extend out farther on the south shore where spinner dolphins are also known to rest; these habitats are largely captured within 1.5 and 2 nm from shore respectively. The 100-fathom (182.9 m) contour is largely captured within 1.5 nm on the west side of the island, but extends out past 3 nm on the south shore. Little information is available from the other MHIs regarding specific depth preferences, although there are areas where the 50- and 100-m depth contours extend past 4 nm (7.4 km). Off most of the MHI, a large majority of the PIPIN sighting information is captured within 2 nm from shore.
A key area for spinner dolphin sightings during the day, where the depth contour extends out past 4 nm, is between the islands of Lanai, Maui, and Kahoolawe. This area is traversed by many recreational and commercial tour vessels in search of marine mammal viewing opportunities throughout the day. Consequently, spinner dolphins also require protections in this area. To ensure that dolphins are protected throughout the day where they may transit between islands and encounter dolphin-directed activities, we delineated an area around all three islands that includes the 2-nm buffer around the outside of each island and the channels and waters between these islands. This delineated area includes 96 percent of all PIPIN sighting information across the MHI.
We are proposing this action to reduce the threat of take of Hawaiian spinner dolphins (including harassment and disturbance) caused by dolphin-directed activities that are concentrated in coastal waters of the MHI and to reduce the impact of increased viewing and interactions pressures on MHI resident stocks. We do not expect that these same pressures are prevalent in the outer portions of the MHI stocks' ranges, because these spinner dolphins are not easily accessed when they are offshore. Therefore, the proposed rule applies to an area within 2 nm of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe. This area encompasses the majority of the resident stocks' daytime habitat, thereby incorporating the area where spinner dolphins are easily accessed and where take of Hawaiian spinner dolphins is most likely to occur.
Although not currently proposed, we are also considering and seeking public comment on whether additional management measures (beyond swim-with and approach regulations) may be necessary and appropriate to protect Hawaiian spinner dolphins from take, especially in essential daytime habitats targeted by humans for dolphin-directed activities. At this time, we believe that the swim-with and approach regulations alone will provide sufficient protection to Hawaiian spinner dolphins, by reducing close encounters between spinner dolphins and humans that result in take. We also expect that the swim-with and approach regulations will reduce the intensity of activities within essential daytime habitats that are targeted by people for dolphin-directed activities to some degree. However, NMFS recognizes that the intensity of activity in some of these areas is high and that additional measures could be necessary.
Area closures have been shown to be an effective management tool for addressing the intensity of wildlife viewing and interaction in other areas globally (Notarbartolo-di-Sciara
Two possible management options evaluated in the DEIS would create either mandatory (see Alternative 4 in the DEIS) or voluntary (see Alternative
As noted in the SAPPHIRE Project section above, essential daytime habitats are particularly important to island-associated spinner dolphins because the habitats provide environmental characteristics that support the dolphins' ability to minimize travel to offshore food sources and to detect predators (Norris and Dohl 1980, Norris
For time-area closures we are considering a closure time of 6 a.m. to 3 p.m. This time-period would allow spinner dolphins to enter essential daytime habitats without disturbance and remain in these areas undisturbed during peak resting hours, while allowing for human activities to occur (at a distance greater than 50 yards (45.7 m) in accordance with the approach regulations) after 3 p.m. Historic spinner dolphin resting times (before human interactions were likely a major factor in the dolphins' resting patterns) were observed to occur between dawn and dusk (Norris and Dohl 1980), and research indicates that Hawaiian spinner dolphin resting behavior still occurs throughout daytime hours (generally 6 a.m. to 6 p.m.) with the highest resting activity occurring between 10 a.m. and 2 p.m. (Tyne
For either mandatory or voluntary closure options, the closure areas would be marked using buoys, sight-line markers, and landmarks from shore, and explanations of the closure's purpose and effective hours would be provided by signs on land and through other public outreach efforts. The intent of both mandatory and voluntary closures would be to prevent take by eliminating the intense human activity within essential daytime habitats during important resting times. These closures would allow for increased opportunities for spinner dolphins to engage in fitness-enhancing behaviors in the absence of vessels and people.
The bays identified for the mandatory and voluntary time-area closure options are (1) Makako Bay, (2) Kealakekua Bay, (3) Honaunau Bay, and (4) Kauhako Bay on the island of Hawaii, and (5) La Perouse Bay on the island of Maui. Below we describe the areas delineated for the time-area closures; these areas are also depicted in Figures 1-5 of this preamble.
No public access point from shore is identified by the County of Hawaii for Makako Bay. The closest access points are identified south at Wawaloli Beach, with another access point identified North at Keahole Point.
The County of Hawaii identifies two public access points on Boulder Beach and Napoopoo Landing at Kealakekua Bay; both points would remain open for access. Additionally, the route used by kayakers to access the Captain Cook Monument at Kaawaloa from Napoopoo Pier is located outside of the closure
The County of Hawaii identifies Honaunau Bay boat ramp as a public access area for this bay. The boat ramp and the popular access point for swimming and snorkeling known as Two-Step are located outside of the closure area, and would remain open for everyday use.
The County of Hawaii identifies Hookena Beach Park as a public access point for this area. The nearshore area located inshore of the line between points A and B would be open for everyday use, including swimming, snorkeling, and freediving.
Maui County identifies La Perouse as a public access point for this area (coordinates: 20°36′09.66″ N., 156°25′22.48″ W.). The area inshore of the line between A and B, which includes this access point, would remain open for everyday uses such as surfing, snorkeling, and freediving.
Activities occurring in the intertidal zone (the area that is above water at low tide and under water at high tide), such as shore-based fishing and subsistence gathering, would be able to continue during any time of day in either type of closure.
Although not currently proposed, if we were to implement mandatory time-area closures in addition to promulgating swim-with and approach regulations (described under Alternative 4 in the DEIS), we would create the time-area closures (depicted in Figures 1-5 above) and promulgate regulations that prohibit use of waters within the five delineated areas from 6 a.m. to 3 p.m.. All
(1) Vessels that transit the time-area closure for the sole purpose of ingress and egress to privately-owned shoreline residential property located immediately adjacent to the time-area closure;
(2) Vessels participating in organized community-based outrigger canoe races that transit straight through a time-area closure; and
(3) Vessels that transit straight through the time-area closure for the purpose of traditional subsistence fishing where harvested resources are intended for personal, family, or community consumption or traditional use and not for commercial market sale.
Entering mandatory time-area closures during closed periods would result in a violation unless an exception to the rule applies.
Mandatory time-area closures would prevent take within these important areas and ensure that spinner dolphins are provided space to achieve deep rest during the day. Additionally, regulations to impose these closures would provide a strong tool for enforcement that is measurable and easy to understand, promoting both enforcement and compliance. Under this management option, swim-with and approach regulations would reduce disturbance to Hawaiian spinner dolphins from close approach activities throughout nearshore areas, and mandatory time-area closures would provide additional protection by reducing the intensity of viewing pressure in five essential daytime habitats.
Although not currently proposed, if we were to implement voluntary time-area closures in addition to promulgating swim-with and approach regulations (Alternative 5 in the DEIS), we would demarcate the same five areas for voluntary time-area closures as are described for the mandatory closures (see
Success with voluntary measures requires strong community engagement and support. Ideally, conservation benefits for Hawaiian spinner dolphins would be the same for mandatory and voluntary closures because both management measures demarcate space
NMFS did not propose some of the regulatory options suggested in the ANPR and in public comments for several reasons, including the measures' inability to meet the purpose and need for this rulemaking (see the DEIS for more detail), difficulties in enforcing them, changes to infrastructure needed to implement them, lack of effectiveness of the measures, lack of resources available to institute them, and the complexity associated with complying with the measures. For example, a permit certification program for all marine operators that engage in some form of dolphin viewing would be inappropriate for addressing chronic and concentrated viewing practices, would require a large processing infrastructure to implement throughout the Hawaiian Islands, and would not address disturbance caused by vessels that are not conducting dolphin tours (
We are soliciting comments on any aspect of these proposed swim-with and 50-yard (45.7 m) approach regulations. As explained above, NMFS does not propose to implement mandatory or voluntary time-area closures as part of this rulemaking. At this time, NMFS believes that the proposed swim-with and approach regulations will provide adequate protection to spinner dolphins against take, including harassment and disturbances. Should NMFS determine that swim-with and approach regulations provide insufficient protection for Hawaiian spinner dolphins using essential daytime habitats, we would consider additional conservation and management measures, including time-area closures to reduce take in high intensity areas, in a separate rulemaking.
We are particularly interested in comments concerning the following: (1) Effects of the increasing number of human interactions with Hawaiian spinner dolphins; (2) proposed prohibited and exempted activities; (3) whether 50 yards is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (4) whether 100 yards (91.4 m) or another distance is the most appropriate distance for swim-with and approach restrictions to reduce take of spinner dolphins; (5) research recommendations and priorities for better understanding how human disturbance affects Hawaiian spinner dolphins; (6) information on responsible viewing of marine mammals; (7) additional information on spinner dolphin behaviors; (8) other human activities affected by the proposed rule that were not discussed; (9) the temporal and geographic scope (
Please be aware that all comments received are a part of the public record and will generally be posted for public viewing on
A complete list of all references cited in this proposed rule can be found on our Web site at:
NMFS has prepared a DEIS and an RIR pursuant to NEPA (42 U.S.C. 4321
Under the Regulatory Flexibility Act (RFA) (5 U.S.C. 601
Pursuant to the RFA, NMFS prepared the following Initial Regulatory Flexibility Analysis (IRFA). A description of the action, why it is being considered, and the legal basis for this action are contained in the preamble to this proposed rule. This proposed rule does not duplicate, overlap, or conflict with other Federal rules. The analysis contains a description of and, where feasible, an estimate of the number of, small entities to which the proposed rule will apply. The Small Business Administration (SBA) establishes criteria for defining a “small entity” for purposes of the RFA. This IRFA analyzes the proposed alternatives and other alternatives described in the preamble to the rule, and does not
There are several types of industries directly affected by this proposed rulemaking: Swim-with-wild-dolphins tour operators; dolphin watch tour operators; non-motorized vessel ocean wildlife viewing tour operators; and generalized commercial boat tour operators. This analysis uses size standards prescribed by the SBA. Specifically, for scenic and sightseeing water transportation operators (North American Industry Classification System Code 487210), the SBA size standard for a small business is average annual receipts of $7.5 million or less. Much of the background information for potentially affected entities is based on a 2007 report that summarized surveys and other information collected in 2006 with regard to participants within these industries that potentially interact with Hawaiian spinner dolphins to varying degrees in the MHI (Impact Assessment 2007). The report provides information that suggests that all businesses operating in the swim-with-wild-dolphins tour and the kayak tour industries operating in 2006 could be considered small entities, and all but one of the generalized commercial boat tour operators were assumed to be small entities (Impact Assessment 2007). This is the most recent information available to NMFS regarding revenue information, but NMFS notes that the composition of these vessel-based tour industries, including the number which can be considered small entities and the total number, may have changed since the report was written.
Swim-with-wild-dolphins tour operators are those that bring clientele into close proximity with spinner dolphins. This includes health and/or spiritual retreat operations as well as dolphin-oriented swim tours. Health and spiritually-linked businesses provide opportunities for persons wishing to interact with spinner dolphins for perceived physical, mental, and/or spiritual well-being enhancement. Spiritually-linked tour operations may charter vessels through other established dolphin-swim companies to transport customers as part of an overall per-person package consisting of lodging, swimming with dolphins, and other activities. For spiritual retreats that offer dolphin swims, the number of businesses is estimated to be as follows: Hawaii (22), Maui (7), Oahu (1), and Kauai (2+).
Dolphin-oriented swim tours operate by transporting passengers by boat or having them swim from shore to areas in which dolphins are known to be present during daytime hours. Customers may also be provided with facemasks, fins, floatation devices, and snorkels to enhance viewing. Recent information compiled by NMFS suggests that the number of swim-with-dolphins tour companies is as follows: Hawaii (22), Maui (2), Oahu (10), and Kauai (1). All are believed to be small entities.
Dolphin-watch tour operators involve taking clients out specifically to view wild dolphins. These companies tend to operate smaller boats than the more generalized commercial boat tours described below, and are more likely to view dolphins at a closer range. Revenue information for this specific business category is not available. NMFS estimates the number of dolphin watch tour businesses to be as follows: Hawaii (3), Maui (21), Oahu (3), and Kauai (11).
More generalized commercial boat tours offer a range of ocean activities, which may include sightseeing, snorkeling, diving, viewing various forms of sea life from a vantage point in and/or above the water, or just generally spending time on the ocean. The majority of the general tour boats derive revenue from whale watching and sightseeing operations, while a number of the dive/snorkel vessels offer snorkeling or diving trips. Based on recent information collected by NMFS, the estimated number of generalized commercial boat tour businesses reportedly involving indirect dolphin interaction is estimated as follows: Hawaii (10), Maui (19), Oahu (36), and Kauai (12). NMFS believes that most, but not all, would be considered small entities.
Non-motorized vessel ocean wildlife viewing tour operators, specifically kayak tour businesses around the MHI, provide a general wildlife viewing experience, with a very small number of operators advertising direct or intentional interactions with dolphins. The number of kayak tour operators who advertise the opportunity to directly interact with wild dolphins is not available. NMFS estimates the numbers of companies that either operate kayak tours or rent out kayaks to be as follows: Hawaii (6), Maui (9), Oahu (6), and Kauai (13).
The estimated numbers of small entities directly affected by the proposed rulemaking, by industry, on the MHI are as follows: 67 swim-with-wild-dolphins tour operators (including health and/or spiritual retreats enabling opportunities to swim with wild dolphins), 77 generalized commercial boat tour operators (one or more of which are likely to be considered large entities), and 34 kayak tour and rental companies.
The preferred alternative would restrict all activities associated with close approach to Hawaiian spinner dolphins, including swimming with dolphins and close approach by vessel. These prohibitions would be applicable within 2 nm (3.7 km) of each of the MHI and in designated waters between the islands of Lanai, Maui, and Kahoolawe.
The proposed action to ban swimming and approaching within 50 yards (45.7 m) of Hawaiian spinner dolphins, has the potential to eliminate all commercial activities that result in take of spinner dolphins (
Commercial wildlife boat tour operators, including generalized commercial boat tour operators, dolphin
NMFS concludes that there would be disproportionate impacts to the swim-with-wild-dolphin tour operators from implementation of this preferred alternative relative to all other general wildlife viewing tour operators. Similarly, because of the focus of activities, it is also likely that the dolphin watch tour industry will face greater impacts than the generalized wildlife tour companies. As a result, dolphin-watch tour entities may face disproportionate impacts relative to the generalized commercial boat tour companies, which are likely to incur few direct economic impacts from the proposed action. We note that dolphin watch tour entities are all believed to be small entities, and most of the generalized commercial boat tour companies are as well, although a few might be considered large entities with revenues exceeding $7.5 million.
NMFS considered other alternatives in addition to the swim-with and 50-yard approach regulations in this proposed rule (
No additional reporting, record keeping, and other compliance requirements are anticipated for small businesses. NMFS has identified no Federal rules that may duplicate, overlap, or conflict with the action alternatives.
This proposed rule was determined to be not significant for purposes of E.O. 12866.
The purpose of the Paperwork Reduction Act is to minimize the paperwork burden for individuals, small businesses, educational and nonprofit institutions, and other persons resulting from the collection of information by or for the Federal government. The preferred alternative includes no new collection of information, so further analysis is not required.
The goal of the National Historical Preservation Act (NHPA; 16 U.S.C. 470
Under the NHPA, an “effect” means an alteration to the characteristics of a historic property qualifying it for inclusion or eligibility for the National Register. The proposed swim-with and approach regulations for Hawaiian spinner dolphins, if finalized, would not have the potential to cause effects on or alterations to the characteristics of historic properties. Therefore, section 106 consultation is not required.
Section 307(c)(1) of the Federal Coastal Zone Management Act of 1972 requires that all Federal activities that affect any land or water use or natural resource of the coastal zone be consistent with approved state coastal zone management programs to the maximum extent practicable. We have determined that these proposed swim-with and approach regulations are consistent to the maximum extent practicable with the enforceable policies of the approved Coastal Zone Management Program of Hawaii. This determination, a copy of this document, and the DEIS will be submitted for review by the Hawaii Coastal Zone Management Program.
E.O. 13132 requires agencies to take into account any federalism impacts of regulations under development. It includes specific consultation directives for situations in which a regulation may preempt state law or impose substantial direct compliance costs on state and local governments (unless required by statute). NMFS has determined that the proposed swim-with and approach regulations do not have federalism implications.
Pursuant to Section 515 of Public Law 106-554 (the Information Quality Act), this information product has undergone a pre-dissemination review by NMFS. The signed Pre-dissemination Review and Documentation Form is on file with the NMFS Pacific Islands Regional
Administrative practice and procedure, Marine mammals.
For the reasons set out in the preamble, 50 CFR part 216 is proposed to be amended as follows:
16 U.S.C. 1361
(a)
(1) In all waters within 2 nautical miles of the main Hawaiian Islands, and
(2) In all waters located between the islands of Lanai, Maui, and Kahoolawe enclosed by three line segments that connect points on the 2-nautical mile boundary between the islands as follows: the straight line between 20°32′51″ N./156°43′50″ W. and 20°42′4″ N./156°55′34″ W. between Kahoolawe and Lanai, the straight line between 20°51′1″ N./156°54′0″ W. and 20°59′48″ N./156°42′28″ W. between Lanai and Maui, and the straight line between 20°33′55″ N./156°26′43″ W. and 20°32′15″ N./156°29′51″ W. between Maui and Kahoolawe (all coordinates referenced to The World Geodetic System of 1984 (WGS 84)).
(b)
(1) Approach or remain within 50 yards of a Hawaiian spinner dolphin by any means;
(2) Swim within 50 yards of a Hawaiian spinner dolphin;
(3) Cause a vessel, person, or other object to approach or remain within 50 yards of a Hawaiian spinner dolphin; or
(4) Intercept or place a vessel, person, or other object on the path of a Hawaiian spinner dolphin so that the dolphin approaches within 50 yards of the vessel, person, or object.
(c)
(1) Any person who inadvertently comes within 50 yards of a Hawaiian spinner dolphin or is approached by a spinner dolphin, provided the person makes no effort to engage or pursue the animal and takes immediate steps to move away from the animal;
(2) Any vessel that is underway and is approached by a Hawaiian spinner dolphin, provided the vessel continues normal navigation and makes no effort to engage or pursue the animal;
(3) Any vessel transiting to or from a port, harbor, or in a restricted channel when a 50-yard distance will not allow the vessel to maintain safe navigation;
(4) Vessel operations necessary to avoid an imminent and serious threat to a person or vessel;
(5) Activities authorized through a permit or authorization issued by the National Marine Fisheries Service to take Hawaiian spinner dolphins; and
(6) Federal, State, or local government vessels, aircraft, personnel, and assets when necessary in the course of performing official duties.
(d)
(e)
Agricultural Marketing Service, USDA.
Notice, request for comments.
The Agricultural Marketing Service (AMS) of the Department of Agriculture (USDA) is seeking public comments on a petition requesting revision to the United States Standards for Grades of Carcass Beef. Specifically, AMS is requesting comments concerning a petition that requests that the beef standards be amended to include dentition and documentation of actual age as an additional determination of maturity grouping for official quality grading. Currently, the standards only include skeletal and muscular evidence as a determination of maturity grouping for the purposes of official quality grading. Official quality grading is used as an indication of meat palatability and is a major determining factor in live cattle and beef value.
Submit comments on or before October 24, 2016.
Comments should be sent to Beef Carcass Revisions, Standardization Branch, Quality Assessment Division; Livestock Poultry and Seed Program, Agricultural Marketing Service, U.S. Department of Agriculture, 1400 Independence Ave. SW., Room 3932-S, STOP 0258, Washington, DC 20250-0258. Comments may also be sent by fax to (202) 690-2746 or by email to
For additional information, please contact Bucky Gwartney, International Marketing Specialist, Quality Assessment Division, at
Section 203(c) of the Agricultural Marketing Act of 1946, as amended, directs and authorizes the Secretary of Agriculture “to develop and improve standards of quality, condition, quantity, grade, and packaging and recommend and demonstrate such standards in order to encourage uniformity and consistency in commercial practices.” AMS is committed to carrying out this authority in a manner that facilitates the marketing of agricultural commodities and makes copies of official standards available upon request. The United States Standards for Grades of Carcass Beef do not appear in the Code of Federal Regulations but are maintained by USDA. These standards are located on USDA's Web site at:
The Federal beef grade standards and associated voluntary, fee-for-service beef grading service program are authorized under the Agricultural Marketing Act of 1946, as amended (7 U.S.C. 1621
The quality grades are intended to identify differences in the palatability or eating satisfaction of cooked beef principally through the characteristics of marbling and physiological maturity groupings. As noted in the standards referenced above, the principal official USDA quality grades for young (maturity groups “A” and “B”) cattle and carcasses are Prime, Choice, and Select, in descending order in terms of historic market value. USDA recognizes that the beef standards must be relevant to be of greatest value to stakeholders and, therefore, recommendations for changes in the standards may be initiated by USDA or by interested parties at any time to achieve that goal.
For beef, USDA quality grades provide a simple, effective means of describing product that is easily understood by both buyers and sellers. By identifying separate and distinct segments of beef, grades enable buyers to obtain that particular kind of beef that meets their individual needs. For example, certain restaurants may choose to only sell officially graded USDA Prime beef so as to provide their customers with a product that meets a very consistent level of overall palatability. At the same time, grades are important in transmitting information to cattlemen to help ensure informed decisions are made. For example, the market preference and price paid for a particular grade of beef is communicated to cattle producers so they can adjust their production accordingly. In such a case, if the price premium being paid for a grade such as USDA Prime beef merits producers making the investments required in cattle genetics and feeding to produce more USDA Prime beef, such marketing decisions can be made with justification.
The current beef standards do not utilize dentition or age verification as methods to determine maturity groupings and instead rely solely on skeletal and lean (physiological) maturity. Although never intended to be a definitive method to determine the age of cattle at the time of slaughter and instead utilized to predict beef palatability, the maturity groupings have historically been roughly correlated to different age categories. Maturity grouping A was correlated with beef from cattle between 9 and 30 months of age at time of slaughter, maturity grouping B was correlated with beef from cattle between 30 and 42 months of age at time of slaughter, maturity grouping C was correlated with beef from cattle between 42 and 72 months of age at time of slaughter, maturity grouping D was correlated with
The current use of dentition to determine animal age at time of slaughter is done on all slaughtered cattle in order to determine whether their age is less than or greater than 30 MOA due to food safety requirements. Cattle older than 30 MOA must have specific risk materials (
The official standards have had past revisions made to the maturity grouping requirements, and these revisions resulted in classifications that were designed to reduce the variability of eating quality within the grades. The most recent such change occurred in 1997 when certain carcasses from the B maturity grouping were no longer eligible for the USDA Choice or Select quality grades. However, the official standards have never relied upon any other indicator besides physiological maturity to determine maturity grouping or the resulting USDA quality grade. This was primarily because the use of physiological maturity wasn't intended to be used to predict the age of an animal at time of slaughter but, instead, the resulting palatability of the meat. Many years of research have demonstrated a strong correlation between physiological maturity and beef palatability.
However, current research has indicated that carcasses from grain-fed steers and heifers that are deemed less than 30 MOA, based on dentition, are similar in palatability to A maturity carcasses determined via physiological maturity and thus could be classified “A” maturity for grading purposes even though the physiological maturity characteristics of “B” or older maturity groupings may be present. Utilizing the recommendations of dentition and age verification would allow for an alternate method of classifying beef carcasses into maturity groupings and thus allow additional carcasses to qualify for the higher USDA grades of Prime, Choice and Select without a significant reduction in the consistency of those grades in predicting palatability.
AMS was provided a large data set from a recent study of beef packing plant slaughter and has performed a statistical and economic analysis on this data in order to determine the possible impact should the proposed change to the Standards be adopted. That report can be found here:
Extrapolating the study data across the total population of cattle graded each year by AMS—approximately 21 million—results in the following:
• Seventy-two percent were slaughtered in facilities participating in the study,
• Ninety-seven percent were found to be less than 30 MOA using dentition,
• Less than 3 percent (2.8) were found to be equal to or greater than 30 MOA,
• Less than 2 percent (1.68) were deemed to be age-discounted when using skeletal ossification as the measure of maturity grouping, and
• Less than one-half of 1 percent of the total cattle graded were age-verified.
According to the study, had there been an allowance to use dentition as a means to override physiological characteristics of advanced maturity grouping, as is proposed, an additional 1.3 percent of those cattle would have been eligible for grading. Of these cattle, 4.5 percent would have been graded Prime, 63.6 percent Choice, and 31.9 percent Select. Within the Choice category, 24.4 percent of all newly graded carcasses, would have been placed in the top two-thirds Choice category (branded Choice programs), and 39.2 percent of all added carcasses would have been placed in the bottom of the Choice category. Currently, many private companies or organizations have established carcass schedules whereby AMS graders evaluate individual carcasses for conformance with those established requirements—things such as breed or breed influence, age, ribeye size, carcass weight. Most of those carcass programs (
The grade composition of the carcasses being added by using dentition as a measure of age was not much different than the grade composition of carcasses graded using physiological maturity, and overall, these data show an increase of 1.05 percent for Prime beef, 0.91 percent for Choice
According to projections provided by the National Cattlemen's Beef Association (NCBA), producers would yield approximately $59 million in added revenue from removal of discounts for cattle identified as greater than A maturity grouping that dentition would allow to be classified as such. AMS found a net gain to producers of nearly $55 million, primarily due to reduced hard bone discounts for quality grade maturity grouping done by the current physiological maturity approach alone.
A petition has been submitted by NCBA, the National Association State Departments of Agriculture, the U.S. Meat Export Federation, and the American Farm Bureau Federation and can be found here:
The petitioners cite several research papers, as listed in the reference section at the above link, to support their request. Two of the summary papers that outline the relevant studies can be found here:
In addition, a recent analysis located at:
AMS is soliciting comments from stakeholders about whether changes in the methodology for determining maturity grouping assessment for the purposes of official USDA quality grading should be made. This change would have no effect on the role that maturity groupings have upon USDA quality grade determination, simply how carcasses are placed into those maturity groupings. AMS also invites comments about how those changes would be implemented in the current beef grading system. If, after analyzing the comments, AMS determines that changes are warranted, a notice will be published in the
Food Safety and Inspection Service, USDA.
Notice of availability and opportunity for comment.
The Food Safety and Inspection Service (FSIS) is announcing the availability of the Agency's compliance guidance on how companies can make label or labeling claims concerning the fact that bioengineered or genetically modified (GM) ingredients or animal feed were not used in the production of meat, poultry, or egg products. For purposes of this guidance document, these claims will be referred to as “negative claims.”
Comments must be received by October 24, 2016.
A downloadable version of the compliance guidance is available to view and print at
FSIS invites interested persons to submit comments on this notice. Comments may be submitted by one of the following methods:
For additional information about FSIS labeling policies and programs, including Generic Label Approval, please review the FSIS Web site at:
Dr. Daniel L. Engeljohn, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.
FSIS is the public health regulatory agency in the USDA that is responsible for ensuring that the nation's commercial supply of meat, poultry, and egg products is safe, wholesome, and accurately labeled and packaged. FSIS develops and implements regulations and policies to ensure that meat, poultry, and egg product labeling is not false or misleading. Under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601-695, at 607), the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451-470, at 457), and the Egg Products Inspection Act (21 U.S.C. 1031-1056, at 1036) the labels of meat, poultry, and egg products must be approved by the Secretary of Agriculture, who has delegated this authority to FSIS, before these products can enter commerce.
FSIS is announcing that it has developed a compliance guide for companies that seek to make label or labeling claims concerning the fact that bioengineered or GM ingredients were not used in a meat, poultry or egg product. This guidance also provides information on how companies can make label or labeling claims that a product was produced from livestock or poultry that were not fed bioengineered or GM feed. For purposes of this guidance document, these claims will be referred to as “negative claims.”
FSIS has approved negative claims through its prior label approval process. Because FSIS does not have the ability to independently verify negative claims for ingredients or feed, FSIS has required establishments that make these claims to comply with standards established by a third-party certifying organization. FSIS currently requires that the third-party certifying organization's standards be publicly available on a Web site and the label or labeling disclose the Web site address of the third-party certifying organization. FSIS currently requires that the establishment demonstrate that its
As a policy matter, prior to issuing this guidance document, FSIS has not allowed the use of the terms “genetically modified organism” or “GMO” in negative claims. FSIS has allowed the use of the terms “genetically modified organism” or “GMO” on product labels or labeling only if the name of the third-party certifying organization contains these terms (
Effective immediately, FSIS will begin approving negative claims for meat, poultry and egg products that do not contain bioengineered ingredients or that are derived from livestock that do not consume bioengineered feed and that contain the terms “genetically modified organism” or “GMO”. In evaluating such claims, FSIS will utilize the definition of “bioengineering” in Public Law 114-216. In that law, the term “bioengineering” refers to a food that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (DNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.
Consistent with past practice, FSIS will continue to allow the use of synonymous terms such as “genetically engineered.” If FSIS has approved an organic claim on the product label, establishments may add an applicable negative claim of the kind discussed in the guidance.
FSIS encourages companies to follow this guidance. This guidance represents FSIS's current thinking, and FSIS welcomes comment on this compliance guidance and will update it as necessary to reflect comments received and any additional information that becomes available.
No agency, officer, or employee of the USDA shall, on the grounds of race, color, national origin, religion, sex, gender identity, sexual orientation, disability, age, marital status, family/parental status, income derived from a public assistance program, or political beliefs, exclude from participation in, deny the benefits of, or subject to discrimination, any person in the United States under any program or activity conducted by the USDA.
To file a complaint of discrimination, complete the USDA Program Discrimination Complaint Form, which may be accessed online at:
Send your completed complaint form or letter to USDA by mail, fax, or email:
Persons with disabilities who require alternative means for communication (Braille, large print, audiotape, etc.) should contact USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at
Foreign Agricultural Service, USDA.
Notice.
This notice announces a fee of $250 to be charged for the 2017 tariff-rate quota (TRQ) year for each license issued to a person or firm by the Department of Agriculture authorizing the importation of certain dairy articles, which are subject to tariff-rate quotas set forth in the Harmonized Tariff Schedule (HTS) of the United States.
August 24, 2016.
Abdelsalam El-Farra, Dairy Import Licensing Program, Import Policies and Export Reporting Division, STOP 1021, U.S. Department of Agriculture, 1400 Independence Avenue SW., Washington, DC 20250-1021 or telephone at (202) 720-9439 or email at
The Dairy Tariff-Rate Import Quota Licensing Regulation promulgated by the Department of Agriculture and codified at 7 CFR 6.20-6.36 provides for the issuance of licenses to import certain dairy articles that are subject to TRQs set forth in the HTS. Those dairy articles may only be entered into the United States at the in-quota TRQ tariff-rates by or for the account of a person or firm to whom such licenses have been issued and only in accordance with the terms and conditions of the regulation.
Licenses are issued on a calendar year basis, and each license authorizes the license holder to import a specified quantity and type of dairy article from a specified country of origin. The use of
The regulation at 7 CFR 6.33(a) provides that a fee will be charged for each license issued to a person or firm by the Licensing Authority in order to defray the Department of Agriculture's costs of administering the licensing system under this regulation.
The regulation at 7 CFR 6.33(a) also provides that the Licensing Authority will announce the annual fee for each license and that such fee will be set out in a notice to be published in the
Notice: The total cost to the Department of Agriculture of administering the licensing system for 2017 has been estimated to be $624,300.00 and the estimated number of licenses expected to be issued is 2,500. Of the total cost, $479,200.00 represents staff and supervisory costs directly related to administering the licensing system, and $145,100.00 represents other miscellaneous costs, including travel, postage, publications, forms, and ADP system support.
Accordingly, notice is hereby given that the fee for each license issued to a person or firm for the 2017 calendar year, in accordance with 7 CFR 6.33, will be $250 per license.
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 (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 Title II of the Act. RAC information can be found at the following Web site:
The meeting will be held on September 27, 2016, at 11:00 a.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 Coordinator, 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.
The purpose of the meeting is to:
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 1, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time to make oral comments must be sent to Debbie Maneely, RAC Coordinator, 344 South Cortez, Prescott, Arizona 86301; or by email to
Forest Service, USDA.
Notice of meeting.
The Lyon-Mineral Resource Advisory Committee (RAC) will meet in Yerington, Nevada. The committee is authorized under the Secure Rural Schools and Community Self-Determination Act (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 Title II of the Act. RAC information can be found at the following Web site:
The meeting will be held October 4, 2016, at 1:00 p.m.
All RAC meetings are subject to cancellation. For status of the meeting prior to attendance, please contact the person listed under
The meeting will be held at the Lyon County Administration Complex, Commissioners Meeting Room, 27 South Main Street, Yerington, Nevada.
Written comments may be submitted as described under
Jeremy Marshall, Designated Federal Officer by phone at 760-932-5801, or via email at
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8:00 a.m. and 8:00 p.m., Eastern Standard Time, Monday through Friday.
The purpose of the meeting is to:
1. Discuss new project proposals; and
2. Receive an update on current and completed projects.
The meeting is open to the public. The agenda will include time for people to make oral statements of three minutes or less. Individuals wishing to make an oral statement should request in writing by September 20, 2016, to be scheduled on the agenda. Anyone who would like to bring related matters to the attention of the committee may file written statements with the committee staff before or after the meeting. Written comments and requests for time for oral comments must be sent to Jeremy Marshall, Designated Federal Officer, Bridgeport Ranger District, HC 62, Box 1000, Bridgeport, California 93517; or by email to
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Louisiana Department of Agriculture and Forestry (Louisiana).
Applications and comments must be received by September 23, 2016.
Submit applications and comments concerning this Notice using any of the following methods:
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Jorge Vazquez, 816-866-2224 or
Section 79(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.
Pursuant to Section 79(f)(2) of the United States Grain Standards Act, the following geographic area in the State of Louisiana is assigned to this official agency.
The entire State, except those export port locations within the State, which are serviced by GIPSA.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 79(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic areas in Louisiana is for the period beginning October 1, 2016, to September 30, 2021. To apply for designation or to request more information, contact Jorge Vazquez at the address listed above.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the Louisiana official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Submit all comments to Jorge Vazquez at the above address or at
We consider applications, comments, and other available information when determining which applicants will be designated.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated
Applications and comments must be received by September 23, 2016.
Submit applications and comments concerning this Notice using any of the following methods:
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Sharon Lathrop, 816-891-0415 or
Section 79(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.
Pursuant to Section 79(f)(2) of the United States Grain Standards Act, the following geographic area, in the States of Texas and Oklahoma, is assigned to this official agency.
Armstrong (north of Prairie Dog Town Fork of the Red River), Carson, Childress, Collingsworth, Dallam, Deaf Smith (east of U.S. Route 385), Donley, Gray, Hansford, Hall (east of U.S. Route 287), Harley, Hemphill, Hutchinson, Lipscomb, Moore, Ochiltree, Oldham, Potter, Randall (north of Prairie Dog Town Fork of the Red River, State Route 217 and FM 1062), Roberts, Sherman, and Wheeler Counties.
Beaver, Cimarron, and Texas Counties.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 79(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic area, in the States of Texas and Oklahoma, is for the period beginning October 1, 2016, to September 30, 2021. To apply for designation or to request more information, contact Sharon Lathrop at the address listed above.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the Amarillo official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Submit all comments to Sharon Lathrop at the above address or at
We consider applications, comments, and other available information when determining which applicants will be designated.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designations of North Dakota Grain Inspection, Inc. (North Dakota); Champaign Danville Grain Inspection Departments, Inc. (Champaign); Detroit Grain Inspection Service, Inc. (Detroit); Eastern Iowa Grain Inspection and Weighing Service, Inc. (Eastern Iowa); Enid Grain Inspection Company, Inc. (Enid); Keokuk Grain Inspection Service (Keokuk); Michigan Grain Inspection Services, Inc. (Michigan); and Omaha Grain Inspection Service, Inc. (Omaha) to provide official services under the United States Grain Standards Act (USGSA), as amended.
Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.
Sharon Lathrop, 816-891-0415,
All applications and comments are available for public inspection at the office above during regular business hours (7 CFR 1.27(c)).
In the March 29, 2016,
The current official agencies: North Dakota, Champaign, Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha were the only applicants for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.
GIPSA evaluated the designation criteria in section 79(f) of the USGSA (7 U.S.C. 79(f)) and determined that North Dakota, Champaign, Detroit, Eastern Iowa, Enid, Keokuk, Michigan, and Omaha are qualified to provide official services in the geographic areas specified in the
Interested persons may obtain official services by contacting these agencies at the following telephone numbers:
Section 79(f) of the USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)).
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
GIPSA is announcing the designations of Mid-Iowa Grain Inspection, Inc. (Mid-Iowa); Fremont Grain Inspection Department, Inc. (Fremont); Maryland Department of Agriculture (Maryland); and Titus Grain Inspection, Inc. (Titus) to provide official services under the United States Grain Standards Act (USGSA), as amended.
Sharon Lathrop, Compliance Officer, USDA, GIPSA, FGIS, QACD, 10383 North Ambassador Drive, Kansas City, MO 64153.
Sharon Lathrop, 816-891-0415,
In the March 29, 2016,
The current official agencies: Mid-Iowa, Fremont, Maryland, and Titus were the only applicants for designation to provide official services in these areas. As a result, GIPSA did not ask for additional comments.
GIPSA evaluated the designation criteria in section 79(f) of the USGSA (7 U.S.C. 79(f)) and determined that Mid-Iowa, Fremont, Maryland, and Titus are qualified to provide official services in the geographic areas specified in the
Interested persons may obtain official services by contacting these agencies at the following telephone numbers:
Section 79(f) of the USGSA authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79 (f)).
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: Cairo Grain Inspection Agency, Inc. (Cairo).
Applications and comments must be received by September 23, 2016.
Submit applications and comments concerning this Notice using any of the following methods:
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Mark Wooden, 816-659-8413 or
Section 79(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.
Pursuant to Section 79(f)(2) of the United States Grain Standards Act, the following geographic areas, in the States of Illinois, Kentucky, and Tennessee, are assigned to this official agency.
Alexander, Jackson County (south of State Route 3, State Route 149, and State Route 13; west of U.S. Route 51), Johnson, Hardin, Massac, Pope, Pulaski, Randolph County (south of State Route 150 and south of State Route 3), and Union Counties.
Ballard, Calloway, Carlisle, Fulton, Graves, Hickman, Livingston, Lyon, Marshall, McCracken, and Trigg Counties.
Benton, Dickson, Henry, Houston, Humphreys, Lake, Montgomery, Obion, Stewart, and Weakley Counties.
The following grain elevator is not part of this geographic area assignment and is assigned to Midsouth Grain Inspection Service: Cargill, Inc., Tiptonville, Lake County, Tennessee.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 79(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic areas in the States of Illinois, Kentucky, and Tennessee is for the period beginning October 1, 2016, to September 30, 2021. To apply for designation or to request more information, contact Mark Wooden at the address listed above.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the Cairo official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Submit all comments to Mark Wooden at the above address or at
We consider applications, comments, and other available information when determining which applicants will be designated.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
The designation of the official agency listed below will end on September 30, 2016. We are asking persons or governmental agencies interested in providing official services in the areas presently served by this agency to submit an application for designation. In addition, we are asking for comments on the quality of services provided by the following designated agency: North Carolina Department of Agriculture (North Carolina).
Applications and comments must be received by September 23, 2016.
Submit applications and comments concerning this Notice using any of the following methods:
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Jacob Thein, 816-866-2223 or
Section 79(f) of the United States Grain Standards Act (USGSA) authorizes the Secretary to designate a qualified applicant to provide official services in a specified area after determining that the applicant is better able than any other applicant to provide such official services (7 U.S.C. 79(f)). Under section 79(g) of the USGSA, designations of official agencies are effective for no longer than five years, unless terminated by the Secretary, and may be renewed according to the criteria and procedures prescribed in section 79(f) of the USGSA.
Pursuant to Section 79(f)(2) of the United States Grain Standards Act, the following geographic area in the State of North Carolina is assigned to this official agency.
The entire State, except those export port locations within the State, which are serviced by GIPSA.
Interested persons or governmental agencies may apply for designation to provide official services in the geographic areas specified above under the provisions of section 79(f) of the USGSA and 7 CFR 800.196. Designation in the specified geographic areas in North Carolina is for the period beginning October 1, 2016, to September 30, 2021. To apply for designation or to request more information, contact Jacob Thein at the address listed above.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the North Carolina official agency. In the designation process, we are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the designation of the applicant. Submit all comments to Jacob Thein at the above address or at
We consider applications, comments, and other available information when determining which applicants will be designated.
7 U.S.C. 71-87k.
Grain Inspection, Packers and Stockyards Administration, USDA.
Notice.
We are asking for comments on the quality of services provided by this Delegated State: Wisconsin Department of Agriculture, Trade and Consumer Protection (Wisconsin).
Comments must be received by September 23, 2016.
Submit comments concerning this Notice using any of the following methods:
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Jacob Thein, 816-866-2223,
Section 79(e)(2)(A) of the United States Grain Standards Act (USGSA) designates that if the Secretary determines, pursuant to paragraph (3) of Section 79(e), that a State agency is qualified to perform official inspection, meets the criteria in subsection (f)(1)(A) of Section 79, and (i) was performing official inspection at an export port location under this chapter on July 1, 1976, or (ii)(I) performed official inspection at an export port location at any time prior to July 1, 1976, (II) was designated under subsection (f) of Section 79 on December 22, 1982, to perform official inspections at locations other than export port locations, and (III) operates in a State from which total annual exports do not exceed, as determined by the Secretary, five per centum of the total amount of grain exported from the United States annually, the Secretary may delegate authority to the State agency to perform all or specified functions involving official inspection (other than appeal inspection) at export port locations within the State, including export port locations which may in the future be established, subject to such rules, regulations, instructions, and oversight as the Secretary may prescribe, and any such official inspection shall continue to be the direct responsibility of the Secretary. Any such delegation may be revoked by the Secretary, at the discretion of the Secretary, at any time upon notice to the State agency without opportunity for a hearing. Under Section 79(e) of the USGSA, every five years, the Secretary shall certify that each State agency with a delegation of authority is meeting the criteria described in subsection (f)(1)(A). Delegations shall be renewed according to the criteria and procedures set forth in Section 79(e)(2)(B) of the USGSA.
Pursuant to Section 79(e)(2) of the USGSA, the following export port locations, in the State of Wisconsin is assigned to this State agency.
All export port locations in the State of Wisconsin, except those export port locations within the State, which are serviced by GIPSA (Milwaukee).
The export port location of Duluth, Minnesota.
We are publishing this Notice to provide interested persons the opportunity to comment on the quality of services provided by the State of Wisconsin. We are particularly interested in receiving comments citing reasons and pertinent data supporting or objecting to the delegation of the applicant. Submit all comments to Jacob Thein at the above address or at
We consider comments and other available information when determining certification.
7 U.S.C. 71-87k.
International Trade Administration, U.S. Department of Commerce.
Notice of open meeting.
This notice sets forth the schedule and proposed topics of discussion for a public meeting of the Advisory Committee on Supply Chain Competitiveness (Committee).
This conference call meeting will be held on Wednesday, September 7, 2016, from 4 p.m. to 5:30 p.m. Eastern Daylight Time. The deadline for members of the public to register to participate in or listen to the meeting is 5 p.m., Thursday, September 1, 2016.
The meeting will be held by conference call with webinar capabilities. The Web site, call-in number and passcode will be provided by email to registrants. Requests to register and any written comments should be submitted to: Richard Boll, Office of Supply Chain, Professional & Business Services, International Trade
Richard Boll, Office of Supply Chain, Professional & Business Services, International Trade Administration. (Phone: (202) 482-1135 or Email:
The Committee was established under the discretionary authority of the Secretary of Commerce and in accordance with the Federal Advisory Committee Act (5 U.S.C. App. 2). It provides advice to the Secretary of Commerce on the necessary elements of a comprehensive policy approach to supply chain competitiveness designed to support U.S. export growth and national economic competitiveness, encourage innovation, facilitate the movement of goods, and improve the competitiveness of U.S. supply chains for goods and services in the domestic and global economy; and provides advice to the Secretary on regulatory policies and programs and investment priorities that affect the competitiveness of U.S. supply chains. For more information about the Committee visit:
• Improve coordination, cooperation, and information-sharing among U.S. supply chains and port stakeholders;
• improve supply chain and cargo logistics, planning, and management;
• ensure the availability of sufficient container movement equipment and workforce; and
• improve the efficiency and flow of cargo and trade throughout U.S. supply chains.
The Committee will also discuss how these elements could be used in possible technology solutions that would facilitate element sharing among cargo owners, seaports, and supply chain stakeholders.
The Office of Supply Chain, Professional & Business Services will post the draft recommendations and the final agenda on the Committee Web site at least one week prior to the meeting. Please provide any comments on the draft recommendations to Richard Boll, Office of Supply Chain, Professional & Business Services, International Trade Administration. (Phone: (202) 482-1135 or Email:
The Transportation and Related Equipment Technical Advisory Committee will meet on September 7, 2016, 9:30 a.m., in the Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania 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 transportation and related equipment or technology.
1. Welcome and Introductions.
2. Status reports by working group chairs.
3. Public comments and Proposals.
4. 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 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 during the public session of the meeting. 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 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 November 5, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section (10)(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and U.S. export control policies 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.
The Regulations and Procedures Technical Advisory Committee (RPTAC) will meet September 13, 2016, 9:00 a.m., Room 3884, in the Herbert C. Hoover Building, 14th Street between Constitution and Pennsylvania Avenues NW., Washington, DC. The Committee advises the Office of the Assistant Secretary for Export Administration on implementation of the Export Administration Regulations (EAR) and provides for continuing review to update the EAR as needed.
1. Opening remarks by the Chairman.
2. Opening remarks by Bureau of Industry and Security.
3. Presentation of papers or comments by the Public.
4. Export Enforcement update.
5. Regulations update.
6. Working group reports.
7. Automated Export System (AES) update.
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.
For more information, call Yvette Springer at (202) 482-2813.
The Materials Technical Advisory Committee will meet on September 8, 2016, 10 a.m., Herbert C. Hoover Building, Room 3884, 14th Street between Constitution & Pennsylvania 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 and related technology.
1. Opening remarks and Introductions.
2. Remarks from the Bureau of Industry and Security senior management.
3. Report by regime representatives.
4. Report by working groups (Composite Working Group, Biological Working Group, Pump and Valves Working Group, and the Chemicals Working Group).
5. Public Comments and New Business.
6. Discussion of matters determined to be exempt from the provisions relating to public meetings found in 5 U.S.C. app. 2 section 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 during the public session of the meeting. Reservations are not accepted. To the extent time permits, members of the public may present oral statements to the Committee. Written statements may be submitted at any time before or after the meeting. However, to facilitate distribution of public presentation materials to Committee members, the materials should be forwarded 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 November 5, 2015, pursuant to Section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. app. 2 section 10(d)), that the portion of the meeting dealing with pre-decisional changes to the Commerce Control List and the U.S. export control policies 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.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; withdrawal of an Incidental Harassment Authorization (IHA) application.
Notice is hereby given that BlueCrest Alaska Operating, LLC (BlueCrest) has withdrawn its application for an IHA to take marine mammals, by harassment, incidental to conducting an oil and gas production drilling program in lower Cook Inlet, AK, on State of Alaska Oil and Gas Lease 384403 under the program name of Cosmopolitan State during the 2016 open water season. Accordingly, NMFS has withdrawn its related proposed IHA.
An electronic copy of the application, proposed IHA
Dale Youngkin, Office of Protected Resources, NMFS, (301) 427-8401.
On September 28, 2015 NMFS received an IHA application from BlueCrest for the taking of marine mammals incidental to an oil and gas production drilling program in lower Cook Inlet, AK, during the 2016 open water season. NMFS determined that the application was adequate and complete on April 12, 2016. The requested IHA would authorize take, by Level B harassment only, of nine marine mammal species as a result from the specified activity. NMFS published a notice of the proposed IHA in the
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before October 24, 2016.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Melissa Neuman, NMFS West Coast Region Protected Resources Division, 501 West Ocean Boulevard, Suite 4200, Long Beach, CA 90802, (562) 980-4115, or
This request is for an extension, without change, of a currently approved information collection.
The Southern Distinct Population Segment of North American green sturgeon (Acipenser medirostris; hereafter, “Southern DPS”) was listed as a threatened species in April 2006. Protective regulations under section 4(d) of the ESA were promulgated for the species on June 2, 2010 (75 FR 30714) (the final ESA 4(d) Rule). To comply with the ESA and the protective regulations, entities must obtain take authorization prior to engaging in activities involving take of Southern DPS fish unless the activity is covered by an exception or exemption. Certain activities described in the “exceptions” provision of 50 CFR 223.210(b) are not subject to the take prohibitions if they adhere to specific criteria and reporting requirements. Under the “exemption” provision of 50 CFR 223.210(c), the take prohibitions do not apply to scientific research, scientific monitoring, and fisheries activities conducted under an approved 4(d) program or plan; similarly, take prohibitions do not apply to tribal resource management activities conducted under a Tribal Plan for which the requisite determinations described in 50 CFR 223.102(c)(3) have been made.
To ensure that activities qualify under exceptions to or exemptions from the take prohibitions, local, state, and federal agencies, non-governmental organizations, academic researchers, and private organizations are asked to voluntarily submit detailed information regarding their activity on a schedule to be determined by National Marine Fisheries Service (NMFS) staff. This information is used by NMFS to (1) track the number of Southern DPS fish taken as a result of each action; (2) understand and evaluate the cumulative effects of each action on the Southern DPS; and (3) determine whether additional protections are needed for the species, or whether additional exceptions may be warranted. NMFS designed the criteria to ensure that plans meeting the criteria would adequately limit impacts on threatened Southern DPS fish, such that additional protections in the form of a federal take prohibition would not be necessary and advisable.
Respondents have a choice of either electronic or paper forms. Methods of submittal include email of electronic forms, and mail and facsimile transmission of paper forms.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
National Telecommunications and Information Administration, U.S. Department of Commerce.
Notice; reopening of comment period.
On July 19, 2016, the National Telecommunications and Information Administration (NTIA) issued a notice and request for public comments on NTIA's preliminary guidance concerning how a qualified state may apply to NTIA for required authority to enter into a spectrum capacity lease with the First Responder Network Authority (FirstNet) and optional grant funds to assist in the construction of its radio access network (RAN) should it opt to do so as allowed under the Middle Class Tax Relief and Job
Comments are due no later than 5:00 p.m. Eastern Daylight Time on September 7, 2016.
The public may submit written comments on issues addressed in this Notice. Written comments may be submitted electronically via email to:
Carolyn Dunn, Office of Public Safety Communications, National Telecommunications and Information Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW., Room 4078, Washington, DC 20230;
The original notice provided NTIA's preliminary guidance concerning how a qualified state may apply to NTIA for authority to enter into a spectrum capacity lease with FirstNet and receive a grant to construct its RAN should it opt to do so as allowed under the Act.
Commodity Futures Trading Commission.
Notice.
In compliance with the Paperwork Reduction Act of 1995 (PRA), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collection and its expected costs and burden.
Comments must be submitted on or before September 23, 2016.
Comments regarding the burden estimated or any other aspect of the information collection, including suggestions for reducing the burden, may be submitted directly to the Office of Information and Regulatory Affairs (OIRA) in OMB, within 30 days of the notice's publication, by email at
Comments may also be mailed to: Christopher J. Kirkpatrick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street NW., Washington, DC 20581 or by Hand Deliver/Courier at the same address.
A copy of the supporting statements for the collection of information discussed above may be obtained by visiting
Roger Smith, Special Counsel, Division of Market Oversight, Commodity Futures Trading Commission, (202) 418-5344; email:
The Commission did not receive any relevant comments on the 60-day
44 U.S.C. 3501
Department of Defense.
Federal Advisory Committee meeting notice.
The Department of Defense is publishing this notice to announce that the following Federal Advisory Committee meeting of the Defense Advisory Committee on Women in the Services (DACOWITS) will take place. This meeting is open to the public.
Tuesday, September 13, 2016, from 8:30 a.m. to 2:15 p.m.; Wednesday, September 14, 2016, from 8:30 a.m. to 12 p.m.
Hilton Alexandria—Mark Center, 5000 Seminary Road, Alexandria, VA 22311.
Mr. Robert Bowling or DACOWITS Staff at 4800 Mark Center Drive, Suite 04J25-01, Alexandria, Virginia 22350-9000;
Pursuant to 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), and section 10(a), Public Law 92-463, as amended, notice is hereby given of a forthcoming meeting of the DACOWITS.
The purpose of the meeting is for the Committee to receive briefings and updates relating to their current work. The Committee will start the meeting with the Designated Federal Officer (DFO) giving a status update on the Committee's requests for information. There will then be a panel discussion with the U.S. Army and U.S. Marine Corps to discuss the Curriculum Standards for Infantry Officer School. This will be followed by a panel discussion with the Military Services on their Gender Neutral Occupational Standards. This will be followed with a public comment period. Day one will end with a panel discussion with the Military Services on their Maternity Uniforms. On the second day the Committee will receive a briefing from the Joint Advertising Market Research & Studies (JAMRS) Office on the Nation's Recruitable Population, which will then be followed by a panel discussion with the Military Services on the same topic. Lastly, the Committee will propose and vote on their 2016 Recommendations to the Secretary of Defense.
Pursuant to 41 CFR 102-3.140, and section 10(a)(3) of the Federal Advisory Committee Act of 1972, interested persons may submit a written statement for consideration by the DACOWITS. Individuals submitting a written statement must submit their statement to the point of contact listed at the address in
Pursuant to 5 U.S.C. 552b and 41 CFR 102-3.140 through 102-3.165, this meeting is open to the public, subject to the availability of space.
Department of the Navy, DoD.
Notice.
Pursuant to Section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations (40 CFR parts 1500-1508), the Department of the Navy (DON) announces its intent to prepare a Supplemental Environmental Impact Statement (EIS) to evaluate the potential environmental impacts that may result from implementing alternative desert tortoise translocation plans at the Marine Corps Air Ground Combat Center, Twentynine Palms (hereinafter “the Combat Center”). The Supplemental EIS is a supplement to the Final EIS for “Land Acquisition and Airspace Establishment to Support Large-Scale Marine Air Ground Task Force Live Fire and Maneuver Training” dated July 2012 (hereinafter “2012 Final EIS”) (77 FR 44234).
Pursuant to 40 CFR 1502.9(c), a Supplemental EIS is being prepared to evaluate new information relevant to environmental concerns associated with translocation of tortoises from specific training areas on newly acquired lands. Translocation was deemed necessary to mitigate the moderate to high levels of impact on the tortoise population from the Marine Expeditionary Brigade training activities assessed in the 2012 Final EIS. Since the 2012 Final EIS, the Marine Corps has conducted additional detailed studies and worked cooperatively with the United States Fish and Wildlife Service (USFWS), the California Department of Fish and Wildlife, and the Bureau of Land Management (BLM) on alternative translocation plans for the desert tortoise, as required in a 2012 Biological Opinion (BO) issued by the USFWS. In light of new information gained from these efforts, the DON has elected to prepare a Supplemental EIS focusing on the evaluation of potential impacts from alternative tortoise translocation plans.
The purpose of the proposed action evaluated in the Supplemental EIS is to study alternative translocation plans in support of the project that was described in the 2012 Final EIS, selected in the 2013 Record of Decision (ROD) (78 FR 11632), and authorized by the National Defense Authorization Act for Fiscal Year 2014.
The Marine Corps needs to implement the proposed action to satisfy requirements identified in the 2012 Final EIS and associated 2012 BO. The 2012 BO concluded that the implementation of the Preferred Alternative from the 2012 Final EIS would likely result in the “take” of desert tortoises associated with military training, tortoise translocation efforts, and authorized and unauthorized Off-Highway Vehicle (OHV) use by recreationists displaced from former areas of the Johnson Valley OHV Area.
The 2013 ROD and associated BO committed the Marine Corps to undertake measures to minimize the “take” of desert tortoises including:
• Establishment of new Special Use Areas (tortoises habitat areas where military training and Off-Highway Vehicle use will be prohibited;
• Translocation Program;
• Desert Tortoise Headstarting and Population Augmentation; and
• Monitoring.
While the 2012 Final EIS and associated BO analyzed a particular translocation program, additional detailed studies and cooperative work on alternative translocation plans for the desert tortoise revealed other possible methods of meeting these requirements. In light of the purpose and need for the proposed action, the DON has identified two potential action alternatives and a No-Action Alternative for the translocation of desert tortoise from training impact areas.
Each alternative will identify recipient sites (to which tortoises would be translocated), and control sites (where the resident tortoise populations will be studied to provide comparative data on survival, threats to survival, habitat stability and changes, and health and disease relative to the translocated tortoise populations at the recipient sites). Each alternative will also include details of the proposed tortoise translocation, including specific handling procedures, fencing, clearance surveys, 30 years of post-translocation monitoring, and other research activities.
The Combat Center identified and applied screening criteria from the 2011 USFWS revised recovery plan for the Mojave population of the desert tortoise and the 2011 USFWS guidance for translocation of desert tortoises to evaluate and select the proposed recipient sites/areas under each alternative. These criteria relate to land use, habitat quality, population levels, disease prevalence, and distance from collection. The Combat Center also screened for research and monitoring feasibility.
Under the No-Action Alternative, the Marine Corps would conduct translocation of desert tortoises in accordance with the General Translocation Plan (GTP) described in the 2012 BO. Alternatives 1 and 2 primarily differ from the No Action Alternative in the selection of proposed recipient and control areas and in the distribution of desert tortoises at each release site. Compared to the No Action Alternative, Alternatives 1 and 2 would also include additional research studies and reflect updated information obtained from the 3-year program of surveys conducted since the 2012 Final EIS. Alternative 2 differs from Alternative 1 in that: (1) One less recipient site would be used; (2) the pairing of control sites to recipient sites would be different; (3) the Bullion control site would be located on the Combat Center instead of within the Cleghorn Lakes Wilderness Area; and (4) translocation densities would be different.
The Supplemental EIS will analyze environmental effects associated primarily with biological resources, land use, air quality, and cultural resources. The Supplemental EIS analysis will evaluate direct, indirect, short-term and long-term impacts, as well as cumulative impacts from other relevant activities. Additionally, the DON will undertake any consultations required by all applicable laws or regulations.
BLM has been invited to be a Cooperating Agency on the preparation of the Supplemental EIS since many of the lands to which tortoises would be relocated are managed by BLM.
Pursuant to 40 CFR 1502.9(c)(4), the DON will prepare, circulate, and file the Supplemental EIS in the same fashion (exclusive of scoping) as it did the draft and 2012 Final EIS. This will include providing a Draft Supplemental EIS for a 45-day public review period in October 2016, during which three (3) public information meetings will be held in the communities of Joshua Tree, Palm Springs, and Barstow. A Notice of Availability of the Draft Supplemental EIS and Notice of Public Meetings will be published in the
The mailing list for the Supplemental EIS is based on the 2012 Final EIS. Those on this list will receive notices and documents related to Supplemental EIS preparation. This list includes local, state, and federal agencies with jurisdiction or other interests in the alternatives. In addition, the mailing list includes adjacent property owners, affected municipalities, and other interested parties such as conservation
No decision will be made to implement any alternative until the Supplemental EIS process is completed and a ROD is signed by the Assistant Secretary of the Navy (Energy, Installations and Environment) or designee.
NEPA Program Manager (Attn: Mr. Scott Kerr), Bldg. 1418, MAGTFTC/MCAGCC, Twentynine Palms, CA 92278-8104; phone: 760-830-8190; email:
National Center for Education Statistics (NCES), 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 October 24, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
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 Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Office of Innovation and Improvement, Department of Education.
Notice.
On April 25, 2016, we published in the
On April 25, 2016, we published in the
Under section 14007(a)(1) of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5), an eligible applicant for the Investing in Innovation Fund is (a) a local educational agency (LEA) or (b) a partnership between a nonprofit organization and (1) one or more LEAs or (2) a consortium of schools. An eligible applicant that is a partnership may apply under this reopened competition if any of the entities required to be part of the partnership (
An eligible applicant must provide a certification in its application that it meets the criteria for submitting an application as part of the reopened competition and be prepared to provide appropriate supporting documentation, if requested. If such an eligible applicant is submitting its application electronically, the submission of the application serves as the eligible applicant's attestation that it meets the criteria for submitting an application as part of this reopened competition.
We are not reopening the application period for any other applicants. Thus, applications from applicants not affected by the severe storms and flooding that were not timely submitted may not be submitted as part of this reopened competition.
All information in the NIA for this competition remains the same, except for the deadline date for certain eligible applicants and the deadline for intergovernmental review.
ARRA, Division A, Section 14007, Pub. L. 111-5.
Kelly Terpak, U.S. Department of Education, 400 Maryland Avenue SW., Room 4W312, Washington, DC 20202. Telephone: (202) 245-7122. Email address:
If you use a telecommunications device for the deaf or a text telephone, call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
You may also access documents of the Department published in the
Department of Education (ED), Office of Planning, Evaluation and Policy Development (OPEPD).
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 September 23, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact Michael Fong, 202-401-7462.
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 Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
National Center for Education Statistics (NCES), 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 October 24, 2016.
To access and review all the documents related to the information collection listed in this notice, please use
For specific questions related to collection activities, please contact NCES Information Collections at
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 Education is especially interested in public comment addressing the following issues: (1) is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology. Please note that written comments received in response to this notice will be considered public records.
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file comments, motions to intervene, and protests using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
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.
o.
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. Protests may be considered, but intervention is necessary to become a party to the proceeding.
Any person desiring to protest in any of the above proceedings must file in accordance with Rule 211 of the Commission's Regulations (18 CFR 385.211) on or before 5 p.m. Eastern time on the specified comment date.
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Energy Regulatory Commission (Commission) hereby gives notice that members of the Commission's staff will attend the following meeting related to the Midcontinent Independent System Operator, Inc. (MISO)—PJM Interconnection, L.L.C. (PJM) Joint and Common Market Initiative (Docket No. AD14-3-000):
MISO/PJM Joint Stakeholder Meeting—August 23, 2016.
The above-referenced meeting will be held at: PJM Conference & Training Center, 2750 Monroe Boulevard, Audubon, PA 19403.
The above-referenced meeting is open to the public.
Further information may be found at
The discussions at the meeting described above may address matters at issue in the following proceedings:
For more information, contact Bahaa Seireg, Office of Energy Policy and Innovation, Federal Energy Regulatory Commission at (202) 502-8739 or
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 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.
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
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.
o.
This notice establishes the agenda and topics for discussion at the technical conference to be held on September 16, 2016 to discuss issues related to the measures implemented by the California Independent System Operator Corporation (CAISO) to address the limited availability of the Aliso Canyon natural gas storage facility.
The purpose of the technical conference is to provide Commission staff and interested parties an opportunity to discuss lessons learned regarding the efficacy of and the need for retention of any of the instant tariff revisions accepted by the Commission in the June 1 Order as well as potential longer-term solutions to address any ongoing limitations at the Aliso Canyon facility. The topics and related questions to be discussed during this conference are attached. No formal presentations will be made other than an opening presentation by CAISO and its Department of Market Monitoring; however, attendees will be encouraged to participate in the discussion along with Commission staff, time permitting. Attendees may also submit questions or potential discussion topics in the docket prior to the technical conference. Any such submissions should be made no later than one week prior to the conference and will be for discussion purposes only, time permitting.
This conference will be transcribed and webcast. Transcripts will be available immediately for a fee from Ace Reporting Company ((202) 347-3700). A link to the webcast of this event will be available in the Commission Calendar of Events at
FERC conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations please send an email to
For more information on this conference, please contact Virginia Castro at (202) 502-8491,
Take notice that on August 18, 2016, Christopher G. Huskilson and Gregory W. Blunden submitted for filing, an application for authority to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d(b) and section 45.8 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR part 45.8.
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. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that on August 11, 2016, National Fuel Gas Supply Corporation (National Fuel), 6363 Main Street, Williamsville, New York 14221 filed in Docket No. CP16-491-000, filed a prior notice request pursuant to sections 157.205 and 157.216 of the Federal Energy Regulatory Commission's regulations under the Natural Gas Act (NGA) and National Fuel's blanket authorizations issued in Docket Nos. CP83-4-000. National Fuel seeks authorization to abandon on injection/withdraw storage well and abandon in place the associated well line, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing may also be viewed on the web at
National Fuel proposes to abandon facilities in its Henderson Storage Field, located in Mercer County, Pennsylvania. National Fuel proposes to plug and abandon one injection/withdrawal storage well, Well 622, and abandon in place the associated well line NW-622H. National Fuel states that based on the excessive cost to rehabilitate this well, it claims that the most prudent course of action is to plug and abandon it and that the proposed abandonment will not result in a material decrease in service to customers.
Any questions regarding this Application should be directed to Kenneth E. Webster, Attorney for National Fuel, 6363 Main Street, Williamsville, New York 14221, by phone (716) 857-7067, by fax (716) 857-
Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
Pursuant to Section 157.9 of the Commission's rules, 18 CFR 157.9, within 90 days of this Notice the Commission staff will either: Complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding, or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commenters will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commenters will not be required to serve copies of filed documents on all other parties. However, the non-party commenters will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the internet in lieu of paper. See 18 CFR 385.2001(a) (1) (iii) and the instructions on the Commission's Web site (
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified date(s). 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:
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j. PG&E filed its request to use the Traditional Licensing Process on June 30, 2016. PG&E provided public notice of its request on June 9 and June 10, 2016. In a letter dated August 18, 2016, the Director of the Division of Hydropower Licensing approved PG&E's request to use the Traditional Licensing Process.
k. With this notice, we are initiating informal consultation with the U.S. Fish and Wildlife Service and NOAA Fisheries under section 7 of the
l. With this notice, we are designating PG&E as the Commission's non-federal representative for carrying out informal consultation pursuant to section 7 of the Endangered Species Act and section 305(b) of the Magnuson-Stevens Fishery Conservation and Management Act; and consultation pursuant to section 106 of the National Historic Preservation Act.
m. PG&E filed a Pre-Application Document (PAD; including a proposed process plan and schedule) with the Commission, pursuant to 18 CFR 5.6 of the Commission's regulations.
n. A copy of the PAD is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site (
o. The licensee states its unequivocal intent to submit an application for a new license for Project No. 10821-004. Pursuant to 18 CFR 16.8, 16.9, and 16.10 each application for a new license and any competing license applications must be filed with the Commission at least 24 months prior to the expiration of the existing license. All applications for licensing this project must be filed by June 30, 2019.
p. Register online at
Take notice that on August 16, 2016, 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) (2015), EnLink Crude Pipeline, LLC (“EnLink”), filed a petition for a declaratory order approving the overall tariff and rate structure for EnLink's new pipeline system in the Midland Basin in Texas that will gather and transport crude oil from origin points located in Upton County, Texas and Midland County, Texas to the SunVit Midland Terminal and the Enterprise Midland Terminal, both in Midland County, Texas, 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
Environmental Protection Agency (EPA).
Notice.
The Environmental Protection Agency (EPA) will hold a one-day public symposium on the types of data that support the registration of plant-incorporated protectants (PIPs). The symposium is open to the public and can be attended in person and online.
The meeting will be held on September 29, 2016, from approximately 9:00 a.m. to 5:00 p.m. Sign-in begins at 8:30 a.m.
If you wish to participate in person, we encourage registration on or before September 26, 2016.
If you wish to attend in person and would like to request accommodation for a disability, please follow the registration link under III. How Can I Request to Participate in this Meeting? and follow the prompts for in-person attendance. In order to give EPA as much time as possible to process your request, we encourage participants to request accommodations at least 10 days prior to the meeting.
The meeting will be held at the Environmental Protection Agency, Conference Center Room S1204/06, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
Wiebke Tapken, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of pesticidal
The docket for this action, identified by docket identification (ID) number EPA-HQ-OPP-2016-0427, is available at
The purpose of the symposium is to provide a forum for biotechnology developers, the agricultural sector, researchers, and the public, to receive first-hand information on the scope of the scientific pesticide application review process that determines the safety of PIPs, including the type of data EPA typically needs to make a regulatory decision. We anticipate that this symposium and the information being presented will promote transparency, clarity, and consistency for EPA's regulation of PIPs. The symposium will provide opportunities for the audience to ask questions on each of the topics covered. EPA is not requesting public comment or advice on the materials being presented during the symposium. Following the meeting, the materials that will be presented will be made available in docket ID No. EPA-HQ-OPP-2016-0427.
No fees are associated with the attendance of the symposium. You may request to participate online and in-person by referring to this link and following the prompts:
7 U.S.C. 136.
Environmental Protection Agency (EPA).
Notice.
EPA is required under the Toxic Substances Control Act (TSCA) to publish in the
Comments identified by the specific case number provided in this document, must be received on or before September 23, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2016-2016-0481, and the specific PMN number or TME number for the chemical related to your comment, 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. As such, the Agency has not attempted to describe the specific entities that this action may apply to. Although others may be affected, this action applies directly to the submitters of the actions addressed in this document.
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This document provides receipt and status reports, which cover the period from July 1, 2016 to July 29, 2016, and consists of the PMNs and TMEs both pending and/or expired, and the NOCs to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.
Under TSCA, 15 U.S.C. 2601
Anyone who plans to manufacture or import a new chemical substance for a non-exempt commercial purpose is required by TSCA section 5 to provide EPA with a PMN, before initiating the activity. Section 5(h)(1) of TSCA authorizes EPA to allow persons, upon application, to manufacture (includes import) or process a new chemical substance, or a chemical substance subject to a significant new use rule (SNUR) issued under TSCA section 5(a), for “test marketing” purposes, which is referred to as a test marketing exemption, or TME. For more information about the requirements applicable to a new chemical go to:
Under TSCA sections 5(d)(2) and 5(d)(3), EPA is required to publish in the
As used in each of the tables in this unit, (S) indicates that the information in the table is the specific information provided by the submitter, and (G) indicates that the information in the table is generic information because the specific information provided by the submitter was claimed as CBI.
For the 58 PMNs received by EPA during this period, Table 1 provides the following information (to the extent that such information is not claimed as CBI): The EPA case number assigned to the PMN; the date the PMN was received by EPA; the projected end date for EPA's review of the PMN; the submitting manufacturer/importer; the potential uses identified by the manufacturer/importer in the PMN; and the chemical identity.
For the 20 NOCs received by EPA during this period, Table 2 provides the following information (to the extent that such information is not claimed as CBI): The EPA case number assigned to the NOC; the date the NOC was received by EPA; the projected date of commencement provided by the submitter in the NOC; and the chemical identity.
15 U.S.C. 2601
Environmental Protection Agency (EPA).
Notice of availability.
The Director, Office of Water and Watersheds, Environmental Protection Agency (EPA) is publishing notice of availability of the final NPDES GP (IDG380000) to drinking water treatment facilities in Idaho. The GP authorizes discharges of treated wastewater from water treatment filtration processes and their delivery systems to waters of the United States within the State of Idaho. On April 25, 2016, EPA proposed the GP and there was a 30 day comment period. During the comment period, EPA received comments on the draft permit but no changes to the permit were necessary based on the comments received.
The issuance date of the GP is the date of publication of this notice. The GP will be effective on November 1, 2016.
The GP, Fact Sheet and Response to Comments may be found on the Region 10 Web site at
Electronic requests may be emailed to:
Kai Shum at (206) 553-0060,
EPA requested final certification under the Clean Water Act § 401 from the State of Idaho and Tribal governments. EPA received certification from the Idaho Department of Environmental Quality in a letter dated July 28, 2016, that the subject discharges comply with the applicable provisions of Sections 301, 302, 303, 306 and 307 of the Clean Water Act, the Idaho Water Quality Standards (WQS) (IDAPA 58.01.02), and other appropriate water quality requirements of state law.
Federal Deposit Insurance Corporation (FDIC).
Notice and request for comment.
The FDIC, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the revision of an existing information collection, as required by the Paperwork Reduction Act of 1995. The FDIC is soliciting comment on the revision of the existing information collection entitled “Joint Standards for Assessing Diversity Policies and Practices” by adding a form to the information collection entitled “Diversity Self-Assessment Template for Entities Regulated by the FDIC.”
Comments must be submitted on or before October 24, 2016.
Interested parties are invited to submit written comments to the FDIC by any of the following methods:
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All comments should refer to the relevant OMB control number. A copy of the comments may also be submitted to the OMB desk officer for the FDIC: Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Washington, DC 20503.
Manny Cabeza, at the FDIC address above.
Under the PRA (44 U.S.C. 3501-3520), certain Federal agencies must obtain approval from OMB for each collection of information that they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) (and 5 CFR 1320.3(c) of the PRA implementing regulations) to include agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. The PRA (44 U.S.C. 3506(c)(2)(A)) directs these Federal agencies to provide a 60-day notice in the
The FDIC may use the information submitted by the entities it regulates to monitor progress and trends in the financial services industry with regard to diversity and inclusion in employment and contracting activities and to identify and highlight those policies and practices that have been successful. The FDIC will continue to reach out to the regulated entities and other interested parties to discuss diversity and inclusion in the financial services industry and share leading practices. The FDIC may also publish information disclosed by the entity, such as any identified leading practices, in any form that does not identify a particular institution or individual or disclose confidential business information.
This is to provide notice of filing and to invite comments on or before September 1, 2016, regarding the Petition described below.
APL Co. Pte Ltd on behalf of itself and American President Lines, Ltd. (Petitioner), has petitioned the Commission pursuant to 46 CFR 502.76 of the Commission's Rules of Practice
Petitioner requests that in lieu of publishing amendments to each of approximately 600 service contracts effected by the transfer of ANL's transpacific business, “the Commission permit APL to send a universal notice to the Commission and to each of the service contract parties.” In addition, because existing ANL tariffs “will be taken over by APL and will be renumbered and republished under APL's organization number,” Petitioners also seek a waiver to permit insertion of notices in existing ANL and new APL tariffs.
The Petition in its entirety is posted on the Commission's Web site at
In order for the Commission to make a thorough evaluation of the Petition, interested persons are requested to submit comments in reply to the Petition no later than September 1, 2016. Commenters must send an original and 5 copies to the Secretary, Federal Maritime Commission, 800 North Capitol Street NW., Washington, DC 20573-0001, and be served on Eric R. Swett, VP & General Counsel, Americas, APL Limited, 16220 N. Scottsdale Rd., Scottsdale, AZ 85254-1781. A text-searchable PDF copy of the comment must also be sent as an email attachment to
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 September 6, 2016.
A. Federal Reserve Bank of San Francisco (Gerald C. Tsai, Director, Applications and Enforcement) 101 Market Street, San Francisco, California 94105-1579:
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B. Federal Reserve Bank of Chicago (Colette A. Fried, Assistant Vice President) 230 South LaSalle Street, Chicago, Illinois 60690-1414:
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The companies listed in this notice have applied to the Board for approval, pursuant to the Home Owners' Loan Act (12 U.S.C. 1461
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 application also will 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 HOLA (12 U.S.C. 1467a(e)). 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 10(c)(4)(B) of the HOLA (12 U.S.C. 1467a(c)(4)(B)). 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 September 18, 2016.
A. Federal Reserve Bank of Atlanta (Chapelle Davis, Assistant Vice President) 1000 Peachtree Street NE., Atlanta, Georgia 30309. Comments can also be sent electronically to
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Federal Trade Commission (FTC or Commission).
Notice.
The information collection requirements described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act (PRA). The FTC seeks public comments on its proposal to extend, for three years, the current PRA clearance for information collection requirements contained in its Consumer Product Warranty Rule. That clearance expires on December 31, 2016.
Comments must be received on or before October 24, 2016.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comments part of the
Requests for copies of the collection of information and supporting documentation should be addressed to Gary Ivens, Attorney, Division of Marketing Practices, Bureau of Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue NW., CC-8528, Washington, DC 20580, (202) 326-2330.
Under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501-3520, federal agencies must get OMB approval for each collection of information they conduct, sponsor, or require. “Collection of information” means agency requests or requirements to 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 PRA clearance for the information collection requirements associated with the Commission's Rule Concerning Disclosure of Written Consumer Product Warranty Terms and Conditions (the Consumer Product Warranty Rule or Warranty Rule), 16 CFR part 701 (OMB Control Number 3084-0111).
The FTC invites comments on: (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, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond. All comments must be received on or before October 24, 2016.
The Warranty Rule is one of three rules
In its 2013 submission to OMB, the FTC estimated that the information collection burden of including the disclosures required by the Warranty Rule was 116,128 hours per year. Although the Rule's information collection requirements have not changed, this estimate slightly increases the number of manufacturers subject to the Rule based on recent Census data. Further, because most warrantors would continue to disclose this information even if there were no statute or rule requiring them to do so, staff's estimates likely overstate the PRA-related burden attributable to the Rule. Moreover, the Warranty Rule has been in effect since 1976, and warrantors have long since modified their warranties to include the information the Rule requires.
Based on conversations with various warrantors' representatives over the years, staff has concluded that eight hours per year is a reasonable estimate of warrantors' PRA-related burden attributable to the Warranty Rule.
Labor costs are derived by applying appropriate hourly cost figures to the burden hours described above. The work required to comply with the Warranty Rule—ensuring that new warranties and changes to existing warranties comply with the Rule—requires a mix of legal analysis (50%), legal support (paralegals) (25%) and clerical help (25%). Staff estimates that half of the total burden hours (70,140 hours) requires legal analysis at an average hourly wage of $250 for legal professionals,
The Rule imposes no appreciable current capital or start-up costs. As stated above, warrantors have already modified their warranties to include the information the Rule requires. Rule compliance does not require the use of any capital goods, other than ordinary office equipment, which providers would already have available for general business use.
You can file a comment online or on paper. Write “Warranty Rules: Paperwork Comment, FTC File No. P044403” 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 does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is . . . privileged or confidential,” as discussed in section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not 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), 16 CFR 4.9(c). Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest.
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, the Commission encourages 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 “Warranty Rules: Paperwork Comment, FTC File No. P044403” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex J), 600 Pennsylvania Avenue NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
Federal Acquisition Service (FAS), General Services Administration (GSA).
Notice of request for comments regarding a new request for an OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding OMB Control No: 3090-00XX; Alliant2 Greenhouse Gas Disclosure.
Submit comments on or before October 24, 2016.
Submit comments identified by Information Collection 3090-00xx; Alliant2 Greenhouse Gas Disclosure by any of the following methods:
• Regulations.gov:
• Mail: General Services Administration, U.S. General Services
Dana Arnold, Director, Federal Acquisition Service Office of Acquisition Management, Special Programs Branch at telephone 703-605-0534 or via email to
President Obama has made Greenhouse Gas (GHG) emissions reduction nationwide and in the Federal community a priority. The President's Executive Order 13693,
GSA has selected the Alliant2 Government-wide Acquisition Contract (GWAC) acquisition for inclusion of contractor GHG emissions disclosure requirements. Alliant, GSA's premier enterprise GWAC, provides flexible access to customized IT solutions from a large, diverse pool of industry partners. Alliant2 offers both large and small contractors. It is GSA's intent to require the large (unrestricted) Alliant2 contractors to inventory and publicly disclose their operational GHG emissions, set targets for reducing those emissions, and disclose progress toward meeting their targets. Of the current Alliant2 contractors, approximately 40 percent already publicly disclose their GHG emissions in response to requests from their non-government customers, investors, insurers, and corporate sustainability policies.
Public disclosure of GHG emissions and GHG reduction goals or targets has become standard practice in many industries, and companies are increasingly asking their own suppliers about their GHG management practices. More than 4,000 companies provided public disclosure through third-party organization CDP (formerly the Carbon Disclosure Project) in 2015. Performing a GHG inventory provides insight into operations and opportunities for energy and operational savings that can result in both environmental and financial benefits.
The Allliant2 GHG disclosure requirement will require the unrestricted (large and medium-sized) Alliant2 contractors to inventory, and publicly disclose their operational GHG emissions, set targets for reducing those emissions, and report progress toward meeting their targets. This will be an annual requirement.
Public comments are particularly invited on: Whether this collection of information is necessary, whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405, telephone 202-501-4755. Please cite OMB Control No. 3090-00XX, Alliant2 Greenhouse Gas Disclosure, in all correspondence.
General Services Administration (GSA).
Notice; New system.
GSA proposes a new system of records subject to the Privacy Act of 1974, as amended, 5 U.S.C. 552a.
GSA Privacy Act Officer (ISP), General Services Administration, 1800 F Street NW., Washington, DC 20405.
Call or email the GSA Privacy Act Officer: Telephone 571-388-6570; email
GSA proposes to establish a new system of records subject to the Privacy Act of 1974, 5 U.S.C. 552a. The system is a citizen-centric platform for delivering government services through a centralized single sign-on platform. The platform will leverage personal information to provide identity proofing to partner agencies, as well as data and resources associated with the user's account. Based on a successful user login and identity proofing, the partner agency will grant access to the user.
In order to facilitate access, information must be collected to authenticate an individual's identity at the requisite level of assurance for the purpose of obtaining a credential or electronically authorizing access to an agency application or service. Identity proofing is the process by which an identity service provider collects and verifies personally identifiable information (PII) about an individual for the purpose of issuing credentials to that individual.
Third-party identity service providers used by
For access to services or records that require LOA3, the user will be asked for PII that will be used for identity proofing, and then maintained in the system. Attributes requested for the proofing process are full name, date of birth, address, phone number, and social security number (SSN). The identity proofer will also ask the user credit and financial related questions.
Once proofed, the attribute bundle will be given a meaningless, but unique identifier number (MBUN) to identify the user in the system. The MBUN and attribute bundle will be asserted to the partner agency. The partner agency is granted access to user information only when the user logs in or specifically gives permission to transmit their information. The information in the system is contributed voluntarily by the user and cannot be accessed by the government without explicit consent of the user, except as provided in this notice.
Information is not shared between government agencies, except when the user gives explicit consent to share his or her information, except as provided in this notice.
The system is maintained for GSA under contract. Contact the System Manager for additional information.
Anyone is able to create an account.
Records may include, but are not limited to: Biographical data such as name, address, email, password, phone number, birth date, social security number. Use of the system, and contribution of personal information, is completely voluntary.
E-Government Act of 2002 (P.L. 107-347, 44 U.S.C. 3501 note)
To enable users to control how government interacts with them and their personal information, and to aid and assist users in interacting with the government. Users interacting with local, state, or federal agency developed applications may be asked to authorize the application to access system resources, such as their personal profile information. If a user authorizes use of his or her information, the agency application will be given programmatic access to the user's account resources. Profile, usage, and system information may be accessed by system managers, technical support and designated analysts in the course of their official duties.
Information from this system also may be disclosed as a routine use:
a. In any legal proceeding, where pertinent, to which GSA, a GSA employee, or the United States is a party before a court or administrative body.
b. To a Federal, State, local, or foreign agency responsible for investigating, prosecuting, enforcing, or carrying out a statute, rule, regulation, or order when GSA becomes aware of a violation or potential violation of civil or criminal law or regulation.
c. To a Member of Congress or his or her staff on behalf of and at the request of the individual who is the subject of the record.
d. To the Office of Personnel Management (OPM), the Office of Management and Budget (OMB), and the Government Accountability Office (GAO) in accordance their responsibilities for evaluating Federal programs.
e. To an expert, consultant, or contractor of GSA in the performance of a Federal duty to which the information is relevant.
f. To the National Archives and Records Administration (NARA) for records management purposes.
g. To a Federal agency in connection with the hiring or retention of an employee; the issuance of a security clearance; the reporting of an investigation; the letting of a contract; or the issuance of a grant, license, or other benefit to the extent that the information is relevant and necessary to a decision.
h. To appropriate agencies, entities, and persons when (1) the Agency suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (2) The Agency has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by GSA or another agency or entity) that rely upon the compromised information; and (3) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with GSA's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
i. To federal, state, or local government agencies or entities for purposes of complying with any legally authorized order or request of such an entity that is made in carrying out the entity's official responsibilities.
All records are stored electronically in a database. Personally Identifiable Information (PII) is encrypted.
Records are retrieved using an authorization protocol. A user of the system grants explicit authorization to an application or government agency to access his or her profile.
Access to the database is maintained behind a firewall certified in accordance with National Institute of Standards and Technology standards and information in the database is encrypted.
Records access is limited to authorized individuals and protected with two-factor authentication, and databases are behind a firewall. PII is encrypted at rest, and all transmissions of any information over external networks are encrypted. All passwords, encryption algorithms and firewalls are compliant with National Institute of Standards and Technology standards.
System records are retained and disposed of according to GSA records maintenance and disposition schedules and the requirements of the National Archives and Records Administration. The initial implementation of this has a limited scope of users. The option for users to delete their own information will be functional in a future version of the application. Physical records are disposed of by cross-cut shredding or burning as scheduled in the handbook, GSA Records Maintenance and Disposition System (CIO P. 1820.1).
Director,
Individuals or users maintain their own information. Inquires can be made via the Web site at
Individuals or users wishing to access their own records may do so by password or by contacting the system administrator at the above address.
Individuals or users of the system may amend their own records online.
The sources for information in the system are the individuals (or system users) for whom the records are maintained, and third-party applications which the user has authorized to contribute information to his or her account.
Office of Civil Rights, General Services Administration (GSA).
Notice of request for comments regarding a new request for an OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve a new information collection requirement regarding OMB Control No: 3090-XXXX; Nondiscrimination in Federal Financial Assistance Programs, GSA 3702. This information is needed to facilitate nondiscrimination in GSA's Federal Financial Assistance Programs, consistent with Federal civil rights laws and regulations that apply to recipients of Federal financial assistance. A notice was published in the
Submit comments on or before: September 23, 2016.
Evelyn Britton, Director, External Programs Division, Office of Civil Rights, at telephone 202-603-1645 or via email to
Submit comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to: Office of Information and Regulatory Affairs of OMB, Attention: Desk Officer for GSA, Room 10236, NEOB, Washington, DC 20503. Additionally submit a copy to GSA by any of the following methods:
•
•
GSA has mission responsibilities related to monitoring and enforcing compliance with Federal civil rights laws and regulations that apply to Federal financial assistance programs administered by GSA. Specifically, those laws provide that no person on the ground of race, color, national origin, disability, sex or age shall be excluded from participation in, be denied the benefits of, or be otherwise subjected to discrimination under any program in connection with which Federal financial assistance is extended under laws administered in whole, or in part, by GSA.
These mission responsibilities generate the requirement to request and obtain certain data from recipients of Federal surplus property for the purpose of determining compliance, such as the number of individuals, based on race and ethnic origin, of the recipient's eligible and actual serviced population; race and national origin of those denied participation in the recipient's program(s); non-English languages encountered by the recipient's program(s) and how the recipient is addressing meaningful access for individuals that are Limited English Proficient; whether there has been complaints or lawsuits filed against the recipient based on prohibited discrimination and whether there has been any findings; and whether the recipient's facilities are accessible to qualified individuals with disabilities.
Public comments are particularly invited on: Whether this collection of information will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
Resources and Services Database of the CDC National Prevention Information Network (NPIN)(OMB Control No. 0920-0255 exp. 12/31/2016)—Extension—National Center for HIV/AIDS, Viral Hepatitis, Sexually Transmitted Diseases, and Tuberculosis Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
NCHHSTP has the primary responsibility within the CDC and the U.S. Public Health Service for the prevention and control of HIV infection, viral hepatitis, sexually transmitted diseases (STDs), and tuberculosis (TB), as well as for community-based HIV prevention activities, syphilis, and TB elimination programs. NPIN serves as the U.S. reference, referral, and distribution service for information on HIV/AIDS, viral hepatitis, STDs, and TB, supporting NCHHSTP's mission to link Americans to prevention, education, and care services. NPIN is a critical member of the network of government agencies, community organizations, businesses, health professionals, educators, and human services providers that educate the American public about the grave threat to public health posed by HIV/AIDS, viral hepatitis, STDs, and TB, and provides services for persons infected with human immunodeficiency virus (HIV). NPIN services are designed to facilitate program collaboration in sharing information, resources, published materials, research, and trends among the four diseases.
The NPIN Resources and Services Database contains entries on approximately 9,000 organizations and is the most comprehensive listing of HIV/AIDS, viral hepatitis, STD, and TB resources and services available throughout the country. The American public can also access the NPIN Resources and Services database through the NPIN Web site. More than 1,000,000 unique visitors and more than 3,000,000 page views are recorded annually.
To accomplish CDC's goal of continuing efforts to maintain an up-to-date, comprehensive database, NPIN plans each year to add up to 400 newly identified organizations and to verify those organizations currently described in the NPIN Resources and Services Database each year. Organizations with access to the Internet will be given the option to complete and submit an electronic version of the questionnaire by visiting the NPIN Web site. Methods to be used to collect the information include online, telephone and email survey questionnaires to collect information from representatives of the organizations that provide covered services.
The respondent population includes Registered Nurses, Social and Community Service Managers, Health Educators, Social and Human Service Assistants working within NPIN member organizations that provide HIV/AIDS, viral hepatitis, STD, and TB prevention, education, testing, and healthcare services. This data collection uses no inferential statistical methods. The data collected is in textual or anecdotal format and will be used for information purposes.
There is a total of 1,717 burden hours involved in this collection. There are no costs to respondents other than their time.
Centers for Medicare & Medicaid Services, HHS.
Notice.
The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (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
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:
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.
The regulation that was published on May, 16, 2012 (77 FR 29034) included a reduction in the reporting requirement related to hospital deaths associated with the use of restraint or seclusion, § 482.13(g). Hospitals are no longer required to report to CMS those deaths where there was no use of seclusion and the only restraint was 2-point soft wrist restraints. It is estimated that this will reduce the volume of reports that must be submitted by 90 percent for hospitals. In addition, the final rule replaced the previous requirement for reporting via telephone to CMS, which proved to be cumbersome for both CMS and hospitals, with a requirement that allows submission of reports via telephone, facsimile or electronically, as determined by CMS. Finally, the amount of information that CMS needs for each death report in order for CMS to determine whether further on-site investigation is needed has been reduced.
The Child Health Act (CHA) of 2000 established in Title V, Part H, Section 591 of the Public Health Service Act (PHSA) minimum requirements concerning the use of restraints and seclusion in facilities that receive support with funds appropriated to any Federal department or agency. In addition, the CHA enacted Section 592 of the PHSA, which establishes minimum mandatory reporting requirements for deaths in such facilities associated with use of restraint or seclusion. Provisions implementing this statutory reporting requirement for hospitals participating in Medicare are found at 42 CFR 482.13(g), as revised in the final rule that published on May 16, 2012 (77 FR 29034).
2.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice of meeting.
This notice announces the new meeting of the Advisory Panel on Outreach and Education (APOE) (the Panel) in accordance with the Federal Advisory Committee Act. The Panel advises and makes recommendations to the Secretary of the U.S. Department of Health and Human Services (HHS) and the Administrator of the Centers for Medicare & Medicaid Services (CMS) on opportunities to enhance the effectiveness of Health Insurance Marketplace
Registration: The meeting is open to the public, but attendance is limited to the space available. Persons wishing to attend this meeting must register at the Web site
Abigail Huffman, Designated Federal Official, Office of Communications, CMS, 7500 Security Boulevard, Mail Stop S1-05-06, Baltimore, MD 21244, 410-786-0897, email
The Advisory Panel for Outreach and Education (APOE) (the Panel) is governed by the provisions of Federal Advisory Committee Act (FACA) (Pub. L. 92-463), as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of federal advisory committees. The Panel is authorized by section 1114(f) of the Social Security Act (42 U.S.C. 1314(f)) and section 222 of the Public Health Service Act (42 U.S.C. 217a).
The Secretary of the U.S. Department of Health and Human Services (HHS) (the Secretary) signed the charter establishing the Citizen's Advisory Panel on Medicare Education
The Medicare Modernization Act of 2003 (MMA) (Pub. L. 108-173) expanded the existing health plan options and benefits available under the M+C program and renamed it the Medicare Advantage (MA) program. We have had substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options available and better tools to evaluate these options. The successful MA program implementation required CMS to consider the views and policy input from a variety of private sector constituents and to develop a broad range of public-private partnerships.
In addition, Title I of the MMA authorized the Secretary and the Administrator of CMS (by delegation) to establish the Medicare prescription drug benefit. The drug benefit allows beneficiaries to obtain qualified prescription drug coverage. In order to effectively administer the MA program and the Medicare prescription drug benefit, we have substantial responsibilities to provide information to Medicare beneficiaries about the range of health plan options and benefits available, and to develop better tools to evaluate these plans and benefits.
The Affordable Care Act (Patient Protection and Affordable Care Act, Public Law 111-148, and Health Care and Education Reconciliation Act of 2010, Public Law 111-152) expanded the availability of other options for health care coverage and enacted a number of changes to Medicare as well as to Medicaid and the Children's Health Insurance Program (CHIP). Qualified individuals and qualified employers are now able to purchase private health insurance coverage through competitive marketplaces, called Affordable Insurance Exchanges (we also call an Exchange a Health
The scope of this panel also includes advising on issues pertaining to the education of providers and stakeholders with respect to the Affordable Care Act and certain provisions of the Health Information Technology for Economic and Clinical Health (HITECH) Act enacted as part of the American Recovery and Reinvestment Act of 2009 (ARRA).
On January 21, 2011, the Panel's charter was renewed and the Panel was renamed the Advisory Panel for Outreach and Education. The Panel's charter was most recently renewed on January 21, 2015, and will terminate on January 21, 2017 unless renewed by appropriate action.
Under the current charter, the APOE will advise the Secretary and the Administrator on optimal strategies for the following:
• Developing and implementing education and outreach programs for individuals enrolled in, or eligible for, Medicare, Medicaid, and CHIP or coverage available through the Health Insurance Marketplace
• Enhancing the federal government's effectiveness in informing Health Insurance Marketplace
• Expanding outreach to vulnerable and underserved communities, including racial and ethnic minorities, in the context of Health Insurance Marketplace
• Assembling and sharing an information base of “best practices” for helping consumers evaluate health coverage options.
• Building and leveraging existing community infrastructures for information, counseling, and assistance.
• Drawing the program link between outreach and education, promoting consumer understanding of health care coverage choices, and facilitating consumer selection/enrollment, which in turn support the overarching goal of improved access to quality care, including prevention services, envisioned under the Affordable Care Act.
The current members of the Panel are: Kellan Baker, Associate Director, Center for American Progress; Robert Blancato, President, Matz, Blancato & Associates; Dale Blasier, Professor of Orthopaedic Surgery, Department of Orthopaedics, Arkansas Children's Hospital; Deborah Britt, Executive Director of Community & Public Relations, Piedmont Fayette Hospital; Deena Chisolm, Associate Professor of Pediatrics & Public Health, The Ohio State University, Nationwide Children's Hospital; Josephine DeLeon, Director, Anti-Poverty Initiatives, Catholic Charities of California; Robert Espinoza, Vice President of Policy, Paraprofessional Healthcare Institute; Jennifer Gross, Manager of Political Field Operations, Planned Parenthood of Montana; Louise Scherer Knight, Director, The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Roanne Osborne-Gaskin, M.D., Senior Medical Director, MDWise, Inc.; Cathy Phan, Outreach and Education Coordinator, Asian American Health Coalition DBA HOPE Clinic; Kamilah Pickett, Litigation Support, Independent Contractor; Brendan Riley, Outreach and Enrollment Coordinator, NC Community Health Center Association; Alvia Siddiqi, Medical Director, Advocate Physician Partners; Carla Smith, Executive Vice President, Healthcare Information and Management Systems Society (HIMSS); Tobin Van Ostern, Vice President and Co-Founder, Young Invincibles Advisors; and Paula Villescaz, Senior Consultant, Assembly Health Committee, California State Legislature.
In accordance with section 10(a) of the FACA, this notice announces a meeting of the APOE. The agenda for the September 21, 2016 meeting will include the following:
Individuals or organizations that wish to make a 5-minute oral presentation on an agenda topic should submit a written copy of the oral presentation to the DFO at the address listed in the
This meeting will be held in a federal government building; therefore, federal security measures are applicable. The Real ID Act, enacted in 2005, establishes minimum standards for the issuance of state-issued driver's licenses and identification (ID) cards. It prohibits federal agencies from accepting an official driver's license or ID card from a state unless the Department of Homeland Security determines that the state meets these standards. Beginning October 2015, photo IDs (such as a valid driver's license) issued by a state or territory not in compliance with the Real ID Act will not be accepted as identification to enter federal buildings. Visitors from these states/territories will need to provide alternative proof of identification (such as a valid passport) to gain entrance into CMS buildings. The current list of states from which a federal agency may accept driver's licenses for an official purpose is found at
• Presentation of government issued photographic identification to the Federal Protective Service or Guard Service personnel.
• Inspection of vehicle's interior and exterior (this includes engine and trunk inspection) at the entrance to the grounds. Parking permits and instructions will be issued after the vehicle inspection.
• Inspection, via metal detector or other applicable means, of all persons entering the building. We note that all items brought into CMS, whether personal or for the purpose of
Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 45 minutes prior to the convening of the meeting.
All visitors must be escorted in areas other than the lower and first floor levels in the Central Building.
Sec. 222 of the Public Health Service Act (42 U.S.C. 217a) and sec. 10(a) of Pub. L. 92-463 (5 U.S.C. App. 2, sec. 10(a) and 41 CFR 102-3).
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled “Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of the guidance document is available for download from the Internet. See the
Anindita Saha, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5414, Silver Spring, MD 20993-0002, 301-796-2537,
FDA is announcing the availability of a guidance entitled “Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and
This document explains the principal concepts that sponsors and other stakeholders should consider when choosing to collect PPI, which may inform FDA's benefit-risk determinations in the premarket review of PMAs, HDE applications, and
The objectives of this guidance are: (1) To encourage submission of PPI, if available, by sponsors or other stakeholders to FDA and to aid in FDA decisionmaking; (2) to outline recommended qualities of patient preference studies, which may result in valid scientific evidence; (3) to provide recommendations for collecting and submitting PPI to FDA; and (4) to discuss FDA's inclusion of PPI in its decision summaries and provide recommendations for the inclusion of such information in device labeling, where appropriate. The guidance also includes hypothetical examples that illustrate how PPI may inform FDA's decisionmaking. The guidance applies to both diagnostic and therapeutic devices that are subject to these review processes. Additionally, this guidance may be information to other stakeholders such as patient groups and academia who may wish to conduct patient preference studies.
In the
FDA is also issuing a Level 2 update to the guidance document entitled “Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on “Patient Preference Information—Voluntary Submission, Review in PMAs, HDE Applications, and
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to currently approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 812.25(c) have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, subparts B and E have been approved under OMB control number 0910-0231; the collections of information in 21 CFR part 814, subpart H have been approved under OMB control number 0910-0332; the collections of information in 21 CFR part 822 have been approved under OMB control number 0910-0449; the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485; and the collections of information in the guidance document “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff” have been approved under OMB control number 0910-0756.
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry on generic fidaxomicin tablets entitled “Draft Guidance on Fidaxomicin.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for fidaxomicin tablets.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 24, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the
Xiaoqiu Tang, Center for Drug Evaluation and Research (HFD-600), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4730, Silver Spring, MD 20993-0002, 301-796-5850.
In the
As described in that guidance, FDA adopted this process to develop and disseminate product-specific BE recommendations and to provide a meaningful opportunity for the public to consider and comment on those recommendations. This notice announces the availability of draft BE recommendations for generic fidaxomicin tablets.
FDA initially approved new drug application (NDA) 201699 for DIFICID (fidaxomicin) in May 2011. Currently, there are no approved ANDAs for this product. We are now issuing a draft guidance for industry on BE recommendations for generic fidaxomicin tablets (“Draft Guidance on Fidaxomicin”).
On May 6, 2015, Cubist Pharmaceuticals, Inc. submitted a
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on the design of BE studies to support ANDAs for fidaxomicin tablets. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons with access to the Internet may obtain the draft guidance at either
In accordance with section 10(a)(2) of the Federal Advisory Committee Act, notice is hereby given of the following meeting of the Advisory Council on Blood Stem Cell Transplantation (ACBSCT).
Crystal Gateway Marriott, 1700 Jefferson Davis Highway, Arlington, VA 22202.
Robert Walsh, Executive Secretary, Division of Transplantation, Healthcare Systems Bureau, Health Resources and Services Administration, 5600 Fishers Lane, Room 8W60, Rockville, MD 20857; telephone (301) 443-6839.
After Council discussions, members of the public will have an opportunity to provide comment. Because of the Council's full agenda and timeframe in which to cover the agenda topics, public comment will be limited. All public comments will be included in the record of the ACBSCT meeting.
The draft meeting agenda will be posted on
Participants can also join this meeting via teleconference by:
1. (Audio Portion) Calling the Conference Phone Number (1-800-832-0736) and providing the Participant Passcode (1337210); and
2. (Visual Portion) Connecting to the ACBSCT Adobe Connect Pro Meeting using the following URL
The allocation of time may be adjusted to accommodate the level of expressed interest. Persons who do not file an advance request for a presentation, but desire to make an oral statement, may request it during the public comment period. Public participation and ability to comment will be limited as time permits.
Office of the Assistant Secretary for Health, Office of Adolescent Health, HHS.
Notice.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit a Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting that ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on the ICR must be received on or before September 23, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the document identifier OMB # 0990-0424-30D for reference.
The total annual burden hours estimated for this ICR are summarized in the table below.
OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Office of the Secretary, HHS.
Notice.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Comments on the ICR must be received on or before September 23, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the Information Collection Request Title and document identifier HHS-OS-0990-New-30D for reference.
Office of the Secretary, HHS.
Notice.
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). The ICR is for extension of the approved information collection assigned OMB control number OS-0990-0323, which expires on January 31, 2017. Prior to submitting the ICR to OMB, OS seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Comments on the ICR must be received on or before October 24, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the document identifier HHS-OS-0990-0323-60D for reference.
OS specifically requests comments on (1) the necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 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.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
National Institutes of Health, HHS.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702.
Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email
Technology description follows.
• Large-scale manufacturing for producing highly purified, live virus.
• Improved viral purification process that:
○ Increases the yield and/or purity of the resulting product, while decreasing the purification time;
○ is generally applicable to purification of any nucleic acid molecule-containing composition, such as virus-based composition, and can be used for the purification of live native or recombinant viruses necessary for clinical applications.
• Improved process for generating viral template plasmid (such as one that includes a DNA template for an RNA virus), which addresses the problem of genetic instability of the plasmids containing the viral genome (
• Cost- and time-effective means of producing highly purified virus-based GMP products, such as oncolytic viruses, for regulatory approval.
HHS Ref. No. E-267-2014/0-PCT-02, corresponding to International Patent App. No. PCT/US2016/036888, filed June 10, 2016, entitled “Processes for Production and Purification of Nucleic Acid Containing Compositions”.
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2014-2015. This report, prepared in accordance with requirements of the ICCVAM Authorization Act of 2000 (42 U.S.C. 285
The report is available at
Dr. Warren Casey, Director, NICEATM; email:
Background: The ICCVAM Authorization Act of 2000 established ICCVAM as a permanent interagency committee of the National Institute of Environmental Health Sciences (NIEHS) under NICEATM. ICCVAM's mission is to facilitate development, validation, and regulatory acceptance of new and revised regulatory test methods that reduce, refine, or replace the use of animals in testing while maintaining and promoting scientific quality and the protection of human health, animal health, and the environment.
A provision of the ICCVAM Authorization Act states that ICCVAM shall prepare “reports to be made available to the public on its progress under this Act.” The eighth ICCVAM progress report is now available, which describes ICCVAM activities and accomplishments from January 2014 through December 2015.
Summary of Report Contents: Key ICCVAM, ICCVAM agency, and NICEATM accomplishments summarized in the report include:
Availability of Report: The report is available at
Background Information on ICCVAM and NICEATM: ICCVAM is an interagency committee composed of representatives from 15 federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods and integrated testing strategies with regulatory applicability and promotes the scientific validation and regulatory acceptance of testing methods that more accurately assess the safety and hazards of chemicals and products and replace, reduce, or refine (enhance animal well-being and lessen or avoid pain and distress) animal use.
The ICCVAM Authorization Act of 2000 (42 U.S.C. 285
NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts and publishes analyses and evaluations of data from new, revised, and alternative testing approaches. NICEATM and ICCVAM work collaboratively to evaluate new and improved testing approaches applicable to the needs of U.S. federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative testing approaches for validation studies and technical evaluations. Additional information about NICEATM can be found at
National Institutes of Health, HHS.
Notice.
The invention listed below is owned by an agency of the U.S. Government and is available for licensing and/or co-development in the U.S. in accordance with 35 U.S.C. 209 and 37 CFR part 404 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing and/or co-development.
Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702.
Information on licensing and co-development research collaborations, and copies of the U.S. patent applications listed below may be obtained by contacting: Attn. Invention Development and Marketing Unit, Technology Transfer Center, National Cancer Institute, 9609 Medical Center Drive, Mail Stop 9702, Rockville, MD 20850-9702, Tel. 240-276-5515 or email
Technology description follows.
• Improved methods for detecting mutations in GMP-manufactured virus-derived therapeutics, including viruses, viral template plasmids, or vaccines;
• The method allows for at least two different virus-derived therapeutics to be assayed simultaneously.
• Provides a cost- and time-effective means of assaying a virus-derived therapeutic, such as oncolytic viruses, for viral sequence variants, for regulatory approval;
• RNA virus preparation steps increase the amount of viral RNA obtained;
• Demonstrated superiority of massively parallel sequencing (“MPS”) over mutant analysis by PCR and restriction enzyme cleavage (“MAPREC”) analysis.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Executive Order 12862 directs agencies that “provide significant services directly to the public” to “survey customers to determine the kind and quality of services they want and their level of satisfaction with existing services.” SAMHSA provides significant services directly to the public, including treatment providers and State substance abuse and mental health agencies, through a range of mechanisms, including publications, training, meetings, technical assistance and Web sites. Many of these services are focused on information dissemination activities. The purpose of this submission is to extend the existing generic approval for such surveys.
The primary use for information gathered is to identify strengths and weaknesses in current service provisions by SAMHSA and to make improvements that are practical and feasible. Several of the customer satisfaction surveys expected to be implemented under this approval will provide data for measurement of program effectiveness under the Government Performance and Results Act (GPRA). Information from these customer surveys will be used to plan and redirect resources and efforts to improve or maintain a high quality of service to health care providers and members of the public. Focus groups may be used to develop the survey questionnaire in some instances.
The estimated annual hour burden is as follows:
Send comments to Summer King, SAMHSA Reports Clearance Officer, 5600 Fishers Lane, Room 15E57-B, Rockville, Maryland 20857,
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Extension and revision of an existing collection of information.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Application to Use the Automated Commercial Environment (ACE). CBP is proposing that this information collection be extended with a change to the burden hours resulting from the addition of a new application for brokers, importers, sureties, attorneys and other parties to establish an ACE Portal account to file protests. There are no proposed changes to the existing ACE Portal application for imported merchandise. This document is published to obtain comments from the public and affected agencies.
Written comments should be received on or before September 23, 2016 to be assured of consideration.
Interested persons are invited to submit written comments on this proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
Requests for additional information should be directed to Paperwork Reduction Act Officer, U.S. Customs and Border Protection, Regulations and Rulings, Office of Trade, 90 K Street NE., 10th Floor, Washington, DC 20229-1177, or via email (
This proposed information collection was previously published in the
In order to establish an ACE Portal account, participants submit information such as their name, their employer identification number (EIN) or social security number, and if applicable, a statement certifying their capability to connect to the Internet. This information is submitted through the ACE Secure Data Portal which is accessible at:
CBP is proposing to add the capability of electronically filing protests to ACE. A protest is a procedure whereby a private party may administratively challenge a CBP decision regarding imported merchandise and certain other CBP decisions. Trade members wishing to establish a protest filer account will need to submit the following data elements:
U.S. Geological Survey (USGS), Interior.
Notice of a new information collection, Assessing Public Views of Waterfowl-Related Topics to Inform the North American Waterfowl Management Plan.
We (the U.S. Geological Survey) are notifying the public that we have submitted to the Office of Management and Budget (OMB) the information collection request (ICR) described below. To comply with the Paperwork Reduction Act of 1995 (PRA) and as part of our continuing efforts to reduce paperwork and respondent burden, we invite the general public and other Federal agencies to take this opportunity to comment on this ICR.
To ensure that your comments on this ICR are considered, OMB must receive them on or before September 23, 2016.
Please submit written comments on this information collection directly to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs, Attention: Desk Officer for the Department of the Interior, via email: (
Holly Miller, Fort Collins Science Center, U.S. Geological Survey, 2150 Centre Ave., Bldg. C, Fort Collins, CO 80526 (mail); 970-226-9133 (phone); or
I. Abstract
The North American Waterfowl Management Plan (NAWMP) is an international agreement signed by the United States Secretary of the Interior, the Canadian Minister of the Environment, and the Mexican Secretary of the Environment and Natural Resources. NAWMP lays out a strategy to restore waterfowl populations in North America through habitat protection, restoration, and enhancement. The 2012 revised goals of
To meet the goals set forth in the 2012 NAWMP revision, the NAWMP Human Dimensions Working Group has asked the USGS to conduct a mail survey to assess the general public's awareness and perceptions of waterfowl and wetlands, as well as measure participation in recreational activities, conservation behaviors, how people obtain information on nature-related issues, and demographics. Demographics voluntarily collected on the survey will include gender, education, income, and race/ethnicity. Additionally, a representative sample of names and mailing addresses from the general public will be purchased from a survey sampling company which uses publically available information to construct sample lists. To protect the confidentiality and privacy of survey respondents, the demographic information from the survey will not be associated with any respondent's name or mailing address at any time and will only be analyzed and reported in aggregate.
Demographic information collected on the survey will be used to understand if any segments of the American public hold differing views on waterfowl and waterfowl-related topics. For example, there may be differences in awareness and perceptions of waterfowl and wetlands or in participation in recreational activities between men and women. This will enable waterfowl managers and policymakers to better understand and be more responsive to the varied stakeholders they are serving. The data from the survey will be aggregated and statistically analyzed and the results will be published in publically available USGS reports.
The USGS Ecosystems Mission Area is conducting this effort as it aligns with their mission to “work with others to provide the scientific understanding and technologies needed to support the sound management and conservation of our Nation's biological resources.” Specifically, the Ecosystems Mission Area “enters into partnerships with scientific collaborators to produce high-quality scientific information and partnerships with the users of scientific information to ensure this information's relevance and application to real problems.”
We again invite comments concerning this ICR as to: (a) Whether the proposed collection of information is necessary for the agency to perform its duties, including whether the information is useful; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) how to enhance the quality, usefulness, and clarity of the information to be collected; and (d) how to minimize the burden on the respondents, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this notice are a matter of public record. Before including your personal mailing address, phone number, email address, or other personally identifiable information in your comment, you should be aware that your entire comment, including your personally identifiable information, may be made publicly available at any time. While you can ask the OMB in your comment to withhold your personal identifying information from public review, we cannot guarantee that it will be done.
Bureau of Land Management, Interior.
Notice of public meetings.
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Idaho Falls District Resource Advisory Council (RAC), will meet as indicated below.
The Idaho Falls District RAC will meet in Salmon, Idaho, September 20-21, 2016 for a two-day meeting. The first day will begin at 10:30 a.m. at the Public Lands Center, 1206 South Challis, Salmon, Idaho 83401. The second day will begin at same location starting at 8:00 a.m. adjourning at 1:30 p.m. Members of the public are invited to attend. All meetings are open to the public.
The first day will be held at the office beginning at 10:30 a.m. The agenda includes the following topics: a resource management plan (RMP) update and discussion on public collaboration in that process; discussion on the Western States Wolverine Conservation Project; the Salmon/Challis Vegetation Environmental Assessment Process; Sage-grouse Updates; Wilderness Planning Updates and; Pocatello Field Office's request for assistance as they
On Wednesday, the group will depart the office at 8:00 a.m. to view Land and Water Conservation Fund (LWCF) parcels. Following that stop the group will head to Lemhi Pass/Agency Creek area where they will look at the site location for a possible new cabin along the Continental Divide Trail. While on the Pass, local archaeologist will provide background on the Lemhi Pass National Historic Landmark. The group will have lunch in the field before departing for home around 1:30 p.m.
The 15-member Council advises the Secretary of the Interior, through the Bureau of Land Management, on a variety of planning and management issues associated with public land management in the BLM Idaho Falls District (IFD), which covers eastern Idaho.
All meetings are open to the public. The public may present written comments to the Council. Each formal Council meeting will also have time allocated for hearing public comments. Depending on the number of persons wishing to comment and time available, the time for individual oral comments may be limited. The IFD RAC will hear public comment from 10:30-11:00 a.m. on September 20. Individuals who plan to attend and need special assistance, such as sign language interpretation, tour transportation or other reasonable accommodations, should contact the BLM as provided below.
Sarah Wheeler, RAC Coordinator, Idaho Falls District, 1405 Hollipark Dr., Idaho Falls, ID 83401. Telephone: (208) 524-7550. Email:
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 13) granting a joint motion to terminate the investigation based upon a consent order stipulation and proposed consent order. The Commission has issued the consent order. The investigation is terminated.
Lucy Grace D. Noyola, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-3438. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on March 31, 2016, based on a complaint filed by Illumina, Inc. of San Diego, California; University of Washington of Seattle, Washington; and UAB Research Foundation of Birmingham, Alabama (collectively, “Complainants”). 81 FR 18648 (Mar. 31, 2016). The complaint, as supplemented, alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain nanopores and products containing same by reason of infringement of certain claims of U.S. Patent Nos. 8,673,550 and 9,170,230.
On July 5, 2016, Complainants and Respondents filed a joint motion to terminate the investigation based upon a consent order stipulation and proposed consent order. On July 12, 2016, OUII filed a response, supporting the motion.
On July 26, 2016, the presiding administrative law judge (“ALJ”) issued an ID (Order No. 13) granting the motion. The ALJ found that the consent order stipulation and proposed consent order contain the statements required by 19 CFR 210.21(c). The ALJ also found that termination of the investigation was in the public interest. No petitions for review of the ID were filed.
The Commission has determined not to review the subject ID and has issued the consent order. The investigation is terminated.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review an initial determination (“ID”) (Order No. 6) of the presiding administrative law judge (“ALJ”) terminating the above-captioned investigation based upon a consent order stipulation and proposed consent order. The Commission has also determined to issue a consent order.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this
The Commission instituted this investigation on June 24, 2016, based on a complaint filed by Intex Recreation Corp. of Long Beach, California; and Intex Marketing Ltd. of Tortola, British Virgin Islands (together, “Intex”). 81
On July 14, 2016, Bestway filed a motion to terminate the investigation based upon a consent order stipulation and proposed consent order. That same day, OUII filed a response arguing that the motion should be granted because it complies with the Commission Rules for consent orders and termination serves the public interest. Intex did not respond to the motion.
On July 25, 2016, the ALJ granted the motion in the subject ID. She found that the motion for termination by consent order stipulation complies with the requirements of Commission Rule 210.21(c) and is in the public interest. No petitions for review of the ID were received.
The Commission has determined not to review the subject ID and to issue a consent order. The investigation is terminated in its entirety.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before October 24, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on July 27, 2016, Chattem Chemicals, 3801 St. Elmo Avenue, Chattanooga, Tennessee 37409 applied to be registered as a bulk manufacturer of the following basic classes of controlled substances:
The company plans to manufacture the listed controlled substances in bulk for distribution and sale to its customers.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 23, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 23, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 12, 2016, Noramco, Inc., 500 Swedes Landing Road, Wilmington, Delaware 19801-4417 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import phenylacetone (8501), opium, raw (9600), and poppy straw concentrate (9670) to bulk manufacture other controlled substances for distribution to its customers. The company plans to import an intermediate form of tapentadol (9780) to bulk manufacture tapentadol (9780) for distribution to its customers
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.34(a) on or before September 23, 2016. Such persons may also file a written request for a hearing on the application pursuant to 21 CFR 1301.43 on or before September 23, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing must be sent to: Drug Enforcement Administration, Attn: Administrator, 8701 Morrissette Drive, Springfield, Virginia 22152. All requests for hearing should also be sent to: (1) Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 Morrissette Drive, Springfield, Virginia 22152; and (2) Drug Enforcement Administration, Attn: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152. Comments and requests for hearing on applications to import narcotic raw material are not appropriate. 72 FR 3417, (January 25, 2007).
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on July 7, 2016, Cerilliant Corporation, 811 Paloma Drive, Suite A, Round Rock, Texas 78665-2402 applied to be registered as an importer of the following basic classes of controlled substances:
The company plans to import small quantities of the listed controlled substances for the manufacture of analytical reference standards and distribution to their research and forensic customers. Placement of these drug codes onto the company's registration does not translate into automatic approval of subsequent permit applications to import controlled substances.
In reference to drug code 7360 (Marihuana) the company plans to import a synthetic cannabidiol. No other activity for this drug code is authorized for this registration.
Notice of application.
Registered bulk manufacturers of the affected basic class, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.34(a), this is notice that on June 3, 2016, Akorn, Inc., 1222 W. Grand Avenue, Decatur, Illinois 62522 applied to be registered as an importer of remifentanil (9739), a basic class of controlled substances listed in schedule II.
The company plans to import remifentanil in dosage form for distribution.
Notice of application.
Registered bulk manufacturers of the affected basic classes, and applicants therefore, may file written comments on or objections to the issuance of the proposed registration in accordance with 21 CFR 1301.33(a) on or before October 24, 2016.
Written comments should be sent to: Drug Enforcement Administration, Attention: DEA Federal Register Representative/ODW, 8701 Morrissette Drive, Springfield, Virginia 22152.
The Attorney General has delegated her authority under the Controlled Substances Act to the Administrator of the Drug Enforcement Administration (DEA), 28 CFR 0.100(b). Authority to exercise all necessary functions with respect to the promulgation and implementation of 21 CFR part 1301, incident to the registration of manufacturers, distributors, dispensers, importers, and exporters of controlled substances (other than final orders in connection with suspension, denial, or revocation of registration) has been redelegated to the Deputy Assistant Administrator of the DEA Office of Diversion Control (“Deputy Assistant Administrator”) pursuant to section 7 of 28 CFR part 0, appendix to subpart R.
In accordance with 21 CFR 1301.33(a), this is notice that on July 20, 2016, Noramco, Inc., 1440 Olympic Drive, Athens, Georgia 30601 applied to be registered as a bulk manufacturer the following basic classes of controlled substances:
The company plans to manufacture bulk active pharmaceutical ingredients (APIs) and reference standards for distribution to their customers.
In reference to drug codes 7360 (marihuana) and 7370 (tetrahydrocannabinols), the company plans to bulk manufacturer these drugs as synthetic. No other activities for these drug codes are authorized for this registration.
On August 18, 2016, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the District of Columbia in the lawsuit entitled
The United States' Complaint alleges that Harley-Davidson, Inc. (and three related companies) manufactured and sold over 339,392 after-market devices (known as “Super Tuners” and used with Harley-Davidson motorcycles) in violation of the Clean Air Act prohibition on the manufacture or sale of devices that defeat the functioning of the motorcycle's certified emissions control system. The Complaint also alleges, relatedly, that Defendants violated the provision of the Act that prohibits any person from removing or rendering inoperative a motor vehicle's certified emissions control system and from causing such “tampering.” Finally, the Complaint alleges that Defendants manufactured and sold more than 12,000 motorcycles from model years 2006, 2007 and 2008 that were not certified by EPA as required by the Clean Air Act.
The Consent Decree requires Defendants to stop selling the illegal tuners in the United States by August 23, 2016. Defendants will also offer to buy back all such tuners in stock at Harley-Davidson dealerships across the country and destroy them. The Decree requires Defendants to obtain an Executive order from the California Air Resources Board (CARB) for any tuners it sells in the United States in the future. These Executive orders (E.O.s) will demonstrate that the CARB-certified tuners do not cause Defendants' motorcycles to exceed the EPA-certified emissions limits. Defendants must also conduct tests on motorcycles that have been tuned with the E.O.-certified tuners and provide the results to EPA to ensure that their motorcycles remain in compliance with EPA emissions requirements. In addition, for any uncertified Super Tuners that Defendants sell outside the United
Under the Consent Decree, Defendants must also ensure that all of their future motorcycle models intended for sale in the United States are certified by EPA.
Finally, Defendants will pay a civil penalty of $12 million and spend $3 million implementing a project to mitigate excess hydrocarbon emissions by replacing conventional woodstoves with cleaner-burning stoves.
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 $9.50 (25 cents per page reproduction cost) payable to the United States Treasury.
Office of Juvenile Justice and Delinquency Prevention, Justice.
Notice of annual in-person meeting.
The Office of Juvenile Justice and Delinquency Prevention (OJJDP) has scheduled an Annual Meeting of the Federal Advisory Committee on Juvenile Justice (FACJJ).
The Annual Meeting will take place on Thursday, September 29, 2016, at 8:30 a.m.-5 p.m. ET and Friday, September 30, 2016, at 8:30 a.m.-12:30 p.m. ET.
The meeting will take place in the third floor main conference room at the U.S. Department of Justice, Office of Justice Programs, 810 7th St. NW., Washington, DC 20531.
Visit the Web site
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
To view the webcast meeting, the public must pre-register online at
Notice.
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) revision titled, “Claim for Compensation by a Dependent Information Reports,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork
The OMB will consider all written comments that agency receives on or before September 23, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the RegInfo.gov Web site at
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-OWCP, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
44 U.S.C. 3507(a)(1)(D).
This ICR seeks approval under the PRA for revisions to the Claim for Compensation by a Dependent Information Reports information collection. This ICR covers forms a dependent of a deceased Federal employee, whose death is work-related, uses to prove continued eligibility for benefits, to show entitlement to remaining compensation payments of the deceased employee, and to show dependency. Specifically, this ICR covers Forms CA-5 (Claim for Compensation by Widow, Widower, and/or Children), CA-5b (Claim for Compensation by Parents, Brothers, Sisters, Grandparents, or Grandchildren), CA-1031 (Claimant Support of Dependent), and CA-1074 (Request for Clarification of CA-5b), as well as related form letters used to obtain follow-up information commonly needed to clarify an initial benefit claim. This information collection is considered a revision, because several clarifying changes were made to the forms and letters; however, the changes do not affect the estimated burden. Federal Employee Compensation Act as amended sections 28 and 32 authorize this information collection.
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Notice.
The Department of Labor (DOL) is submitting the Employment and Training Administration (ETA) sponsored information collection request (ICR) revision titled, “Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed,” to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act (PRA) of 1995. Public comments on the ICR are invited.
The OMB will consider all written comments that agency receives on or before September 23, 2016.
A copy of this ICR with applicable supporting documentation; including a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained free of charge from the
Submit comments about this request by mail or courier to the Office of Information and Regulatory Affairs, Attn: OMB Desk Officer for DOL-ETA, Office of Management and Budget, Room 10235, 725 17th Street NW., Washington, DC 20503; by Fax: 202-395-5806 (this is not a toll-free number); or by email:
Contact Michel Smyth by telephone at 202-693-4129, TTY 202-693-8064, (these are not toll-free numbers) or sending an email to
This ICR seeks approval under the PRA for revisions to the Weekly Claims and Extended Benefits Data and Weekly Initial and Continued Weeks Claimed information collection requirements. This data collection is necessary for the determination of the beginning, continuance, or termination of an Extended Benefit (EB) period in any State that determines the EB trigger rate. In addition, data on initial and continued claims are used to help determine economic indicators. The revisions are related to the Final Rule titled, “Federal-State Unemployment Compensation Program; Implementing the Total Unemployment Rate as an Extended Benefits Indicator and Amending for Technical Corrections,” that appears elsewhere today in the
This information collection is subject to the PRA. A Federal agency generally cannot conduct or sponsor a collection of information, and the public is generally not required to respond to an information collection, unless it is approved by the OMB under the PRA and displays a currently valid OMB Control Number. In addition, notwithstanding any other provisions of law, no person shall generally be subject to penalty for failing to comply with a collection of information that does not display a valid Control Number.
Interested parties are encouraged to send comments to the OMB, Office of Information and Regulatory Affairs at the address shown in the
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• 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,
44 U.S.C. 3507(a)(1)(D).
National Aeronautics and Space Administration.
Notice of intent to grant exclusive license.
This notice is issued in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i). The National Aeronautics and Space Administration (NASA) hereby gives notice of its intent to grant an exclusive license in the United States to practice the inventions described and claimed in U.S. Patent Number 8,401,217, titled “Extreme Low Frequency Acoustic Measurement System,” NASA Case Number LAR-17317-1, and U.S. Patent Application Serial Number 13/771,735, titled “Extreme Low Frequency Acoustic Measurement System,” NASA Case Number LAR-17317-2, to Infrasonix Inc., having its principal place of business in Lawrenceville, GA. The fields of use may be limited to, but not necessarily limited to, human and/or animal healthcare. Certain patent rights in these inventions have been assigned to the United States of America as represented by the Administrator of the National Aeronautics and Space Administration. The prospective
The prospective exclusive license may be granted unless, within fifteen (15) days from the date of this published notice, NASA 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 NASA within fifteen (15) days of the date of this published notice will also be treated as objections to the grant of the contemplated partially 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.
Objections relating to the prospective license may be submitted to Patent Counsel, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, VA 23681; (757) 864-3221 (phone), (757) 864-9190 (fax).
Andrea Z. Warmbier, Patent Attorney, Office of Chief Counsel, NASA Langley Research Center, MS 30, Hampton, VA 23681; (757) 864-7686; Fax: (757) 864-9190. Information about other NASA inventions available for licensing can be found online at
National Science Foundation
Notice of Intent to Prepare a Comprehensive Environmental Evaluation (hereinafter CEE) for Continuation of United States Antarctic Program (USAP) Activities
The National Science Foundation (NSF) announces its intent to prepare a CEE pursuant to the Antarctic Conservation Act, 16 U.S.C. 2401,
This notice initiates the public scoping process for the CEE. Scoping comments on issues may be submitted in writing until October 15, 2016. To be eligible for inclusion in the Draft CEE, all comments must be received prior to the close of the scoping period. NSF will provide additional opportunities for public participation upon publication of the Draft CEE.
Written comments should be addressed to Dr. Polly A. Penhale, Environmental Officer, Room 755, Division of Polar Programs, National Science Foundation, 4201 Wilson Boulevard, Arlington, Virginia 22230 or by email at
For further information regarding the CEE process, please contact: Dr. Polly A. Penhale, Environmental Officer, at
The United States has been active in Antarctica since its discovery and exploration in the 1800's and has played a crucial role in building the international cooperation necessary for establishing a peaceful human presence on the Earth's last undeveloped continent. Through the Antarctic Treaty, which went into effect with 12 original member nations in 1961, the United States and 52 other nations have agreed to avoid militarization or conflict over territorial claims in the Antarctic Treaty Area, the area of the earth from the South Pole to 60 degrees south latitude. Treaty nations are dedicated to international cooperation, scientific study, and the protection of Antarctica's distinctive environment.
Since 1956 and without interruption, Americans have been conducting science and education programs in Antarctica. The 2,500 or so American scientists, administrators, and supporting personnel involved in these activities make up USAP. Three year-round research stations are maintained by the USAP: McMurdo, Amundsen-Scott South Pole, and Palmer. From October through February, field research camps are established for research. McMurdo Station, the largest station in Antarctica is USAP's logistics hub and a center for scientific studies. The Amundsen-Scott South Pole Station supports astronomy, upper atmosphere science, meteorology, glaciology, and earth sciences studies. Palmer Station, on Anvers Island just west of the Antarctic Peninsula, is primarily a marine biology center and also supports upper atmospheric sciences and other studies.
USAP transportation infrastructure includes vessels, aircraft, and tractor-based traverse capabilities. USAP operates two research vessels (the Laurence M. Gould and the Nathaniel B. Palmer) and deploys a fuel tanker, resupply vessel, and a United States Coast Guard ice breaker once annually. The United States Air National Guard and Air Force operate LC-130 and C-17 aircraft supporting intracontinental and intercontinental transport of equipment, material, and people. In addition, DeHavilland Twin Otter and Basler BT-67 aircraft, plus helicopters transport research teams to remote research locations. Traverses are a critical method to transport fuel and material to South Pole Station, Black Island, and Marble Point from McMurdo Station. Similarly, traverse capabilities are in used to support major deep field science projects.
The NSF has overall management responsibility for USAP and U.S. activities in Antarctica. However, several federal agencies have important roles in the U.S. presence in Antarctica. The Department of Defense assists in planning and provides logistical support to USAP. The Department of Homeland Security's United States Coast Guard provides icebreaker services and other assistance, as required. Further, the United States has strong diplomatic interests in Antarctica and the Department of State coordinates U.S. policy on Antarctica.
USAP activities have increased in complexity and locations over the years.
In addition to supporting increasingly complex science and education programs in Antarctica, a safety, environment, and health program has enabled USAP to reduce the health and safety risks to participants and improve environmental protection. USAP has made significant progress in the remediation of old waste disposal sites and in the removal of wastes from Antarctica.
Because the science and education programs supported by USAP are increasing in size and complexity, improved equipment, more specialized facilities, additional electrical power, and improved logistical support are required. USAP has met many of these emerging needs, including construction and operation of the Crary Science and Engineering Center and the Science Support Center at McMurdo Station.
However, approximately 60 years after USAP began much of the infrastructure at each of the three year-round USAP Stations has exceeded its intended life expectancy. USAP stations were originally built to serve the newly developing Antarctic science and education programs of the 1950s and 1960s. With few people or facilities in Antarctica, there was an expeditionary approach to infrastructure development. Energy efficiency and environmental protection were not high priorities. Today, much of the USAP infrastructure cannot meet modern practices without replacement, significant repair, or substantial restrictions in use. Reconstruction of the Amundsen-Scott South Pole Station was completed in 2010; however, the Station and outlying facilities require repairs and ongoing maintenance in order to support current and future science and education programs.
In 2011, a Blue Ribbon Panel was established by the Directors of the Office of Science and Technology Policy and of the NSF to assess the current USAP operations, logistics and management and make recommendations on a long-term strategy to deliver an efficient and effective national research program. The 2012 report “More and Better Science in Antarctica through Increased Logistical Effectiveness” provided a basis for discussions among USAP participants, managers, scientists, educators, and NSF leadership. From these discussions and others, the following USAP needs have been identified:
These needs are important considerations in meeting USAP's long-term goals and may generate conflicts in the use of available resources. To more fully respond to these needs, NSF has been preparing Master Plans for McMurdo and Palmer stations. In addition, NSF has been expanding planning efforts to address the needs of other USAP components including South Pole Station, field camps, vessels, and traverse capabilities. To address the issues and fulfill the purpose and need of the proposed action, two alternatives have been identified for evaluation in the CEE:
Alternative A—Implement the McMurdo Station Master Plan, Palmer Station Master Plan, South Pole Station renovation and maintenance plan; and maintain and improve traverse, field camp, and marine capabilities (Proposed Action). This alternative would include the modernization of McMurdo Station and Palmer Station through reconstruction, consolidation, and renovation of facilities. Critical maintenance as well as facility and infrastructure improvements would be made at the Amundsen-Scott South Pole Station. Traverse, field camp, and marine operations and capabilities would be maintained and enhanced to meet evolving science requirements, improve efficiencies, and continue to protect health, safety, and the environment.
Alternative B—Maintain facilities and capabilities at the current level of performance. This alternative maintains the “status quo” of USAP facilities and capabilities across the program, including at all three stations, camps, traverse, and vessels. This alternative represents the `No action' alternative. The improvement or replacement of facilities to prevent major structural failures, and mitigate risks to health and safety, would be conducted on a modest, long-term implementation schedule.
The purpose of the public scoping process is to determine relevant issues that will influence the scope of the environmental analysis, including identification of viable alternatives, and guide the process for developing the CEE. At present, NSF has identified the following preliminary resource areas for analysis of potential impacts: Air quality, climate, marine and terrestrial biological resources, geological resources, glacial resources, water quality, groundwater resources, aesthetics, wilderness values, solid waste generation, and health and safety. Federal, state, and local agencies, along with other stakeholders that may be interested or affected by NSF's decision on this proposal are invited to participate in the scoping process.
The ACRS Subcommittee on Reliability and PRA will hold a meeting on September 7, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will be briefed on the activities of Risk-Informed Steering Committee from both the staff and the industry. The Subcommittee will hear presentations by and hold discussions with the NRC staff, the industry, and
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), John Lai (Telephone 301-415-5197 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North Building, 11555 Rockville Pike, Rockville, Maryland. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittees on T-H Phenomenon and Metallurgy & Reactor Fuels will hold a meeting on September 19, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance with the exception of portions that may be closed to protect information that is proprietary pursuant to 5 U.S.C. 552b(c)(4). The agenda for the subject meeting shall be as follows:
The Subcommittee will review the fidelity of methods and codes for operation at AREVA's Extended Flow Window (plant-specific Monticello). The Subcommittee will hear presentations by and hold discussions with the NRC staff regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Zena Abdullahi (Telephone 301-415-8716 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
Nuclear Regulatory Commission.
Exemption; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing an exemption in response to an August 1, 2016, request from Pacific Gas and Electric Company (PG&E), which requested an exemption from the requirement to submit annual updates to its license renewal application (LRA) for Diablo Canyon Power Plant (DCPP), Units 1 and 2. The NRC staff reviewed this request and determined that it is appropriate to grant the exemption while the review of the LRA remains suspended.
The exemption is effective on August 24, 2016.
Please refer to Docket ID NRC-2009-0552 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.
Michael J. Wentzel, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington DC 20555-0001; telephone: 301-415-6459; email:
By letter dated November 23, 2009 (ADAMS Package No. ML093340125), PG&E submitted an application pursuant to part 54 of title 10 of the
Pursuant to 10 CFR 54.15, “Specific exemptions,” which references 10 CFR 50.12, PG&E's letter dated August 1, 2016 (ADAMS Accession No. ML16214A369), requested an exemption from the requirements of 10 CFR 54.21, “Contents of application—technical information,” paragraph (b), related to the schedule for submitting periodic updates to the DCPP LRA, while the NRC staff's review of the DCPP LRA is suspended. Given PG&E's request for approval from the California Public Utilities Commission to not proceed with license renewal for DCPP, PG&E is requesting exemption from the requirements in 10 CFR 54.21(b). Should the California Public Utilities Commission deny PG&E's request and direct PG&E to pursue license renewal, PG&E would provide an amendment to the DCPP LRA that identifies changes to the CLB of the facility that materially affect the contents of the LRA by a date agreed upon between PG&E and the NRC.
Pursuant to 10 CFR 54.15, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of the regulations of 10 CFR part 54, in accordance with 10 CFR 50.12, when (1) the exemptions are authorized by law, will not present an undue risk to the public health and safety, and are consistent with the common defense and security; and (2) special circumstances are present. As applicable to the requested exemption, special circumstances exist when application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule (10 CFR 50.12(a)(2)(ii)).
The purpose of 10 CFR 54.21(b) is to ensure that the effect of changes to a renewal applicant's existing licensing basis is evaluated during the review of a renewal application (56 FR 64954). As referenced above, the NRC staff has suspended its review of the DCPP LRA in response to PG&E's June 21, 2016, request. As such, the NRC staff would not review an update to the DCPP LRA, should it be provided; therefore, updating the LRA while the review is suspended is unnecessary to achieve the underlying purpose of the rule. Should PG&E resume the license renewal process for DCPP, the NRC will require it to provide an amendment to the DCPP LRA that identifies applicable changes to the CLB of the facility since the period of time covered in PG&E's December 21, 2015, update (ADAMS Accession No. ML16004A149) by a date agreed upon between PG&E and the NRC.
Pursuant to 10 CFR 54.15, and in accordance with 10 CFR 50.12, the NRC may grant an exemption from the requirements of 10 CFR part 54, if the exemption is authorized by law. The exemption is authorized by law in that no other prohibition of law exists to preclude the activities which would be authorized by the exemption. Granting this exemption will provide PG&E with relief from the requirements of 10 CFR 54.21(b) while review of the DCPP LRA is suspended and will not result in a violation of the Atomic Energy Act of 1954, as amended, or the NRC's regulations. Therefore, this exemption request is authorized by law.
The underlying purpose of 10 CFR 54.21(b) is to ensure that changes made to the CLB of a facility that materially affect an LRA are reflected in a timely manner over the course of the NRC staff's review. The requested exemption is administrative in nature, in that it pertains to the schedule for submitting periodic updates of an application for renewal under 10 CFR part 54. Based on the nature of the requested exemption as described above, no new accident precursors are created by the exemption. As a result, neither the probability, nor the consequences, of postulated accidents are increased. Therefore, the requested exemption does not result in any undue risk to public health and safety.
The requested exemption would exempt PG&E from providing updates to the DCPP LRA while review of the LRA is suspended. This proposed change has no relation to security issues. Therefore, the common defense and security is not impacted by the exemption.
Special circumstances, in accordance with 10 CFR 50.12(a)(2), are present whenever application of the regulation in the particular circumstances would not serve the underlying purpose of the rule or is not necessary to achieve the underlying purpose of the rule (10 CFR 50.12(a)(2)(ii)).
As discussed above, the requested exemption will exempt PG&E from submitting LRA updates while the NRC's review of the application is suspended. Because the NRC staff would not review an update to the DCPP LRA, should it be provided, application of 10 CFR 54.21(b) is not necessary to achieve the underlying purpose of the rule. Therefore, special circumstances exist under 10 CFR 50.12(a)(2)(ii).
With respect to the exemption's impact on the quality of the human environment, the NRC has determined that this specific exemption request is eligible for categorical exclusion as identified in 10 CFR 51.22(c)(25). Under 10 CFR 51.22(c)(25), granting of an exemption from the requirements of any regulation of 10 CFR chapter 1 (which includes 10 CFR 54.21(b)) is an action that is a categorical exclusion, provided that it meets the requirements of 10 CFR 51.22(c)(25)(i) through (vi). The NRC staff's determination that each of the applicable criteria for this categorical exclusion is met as follows:
I. 10 CFR 51.22(c)(25)(i): There is no significant hazards consideration.
(1) Involve a significant increase in the probability or consequences of an accident previously evaluated; or
(2) Create the possibility of a new or different kind of accident from any accident previously evaluated; or
(3) Involve a significant reduction in a margin of safety.
II. 10 CFR 51.22(c)(25)(ii): There is no significant change in the types or significant increase in the amounts of any effluents that may be released offsite.
III. 10 CFR 51.22(c)(25)(iii): There is no significant increase in individual or cumulative public or occupational radiation exposure.
IV. 10 CFR 51.22(c)(25)(iv): There is no significant construction impact.
V. 10 CFR 51.22(c)(25)(v): There is no significant increase in the potential for or consequences from radiological accidents.
VI. 10 CFR 51.22(c)(25)(vi): The requirements from which this exemption is sought involve 10 CFR 51.22(c)(25)(vi)(B) (reporting requirements) and 10 CFR 51.22(c)(25)(vi)(G) (scheduling requirements).
The NRC has determined that, pursuant to 10 CFR 54.15, and in accordance with 10 CFR 50.12, the exemption is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, special circumstances exist under 10 CFR 50.12(a)(2)(ii). Therefore, the NRC hereby grants PG&E this exemption from the requirements of 10 CFR 54.21(b) to allow PG&E to dispense with the submission of updates to the DCPP LRA while the NRC's review of the LRA is suspended. Should PG&E resume the license renewal process for DCPP, the NRC will require it to provide an amendment to the DCPP LRA that identifies applicable changes to the CLB of the facility since the period of time covered in PG&E's December 21, 2015, update by a date agreed upon between PG&E and the NRC.
Additionally, pursuant to 10 CFR 51.22, the Commission has determined that the exemption request meets the applicable categorical exclusion criteria set forth in 10 CFR 51.22(c)(25), and the granting of this exemption will not have a significant effect on the quality of the human environment.
For the Nuclear Regulatory Commission.
The ACRS Subcommittee on Digital I&C Systems will hold a meeting on September 7, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will review the Methods for Assuring Safety and Dependability when Applying Digital Instrumentation and Control Systems. The Subcommittee will hear presentations by and hold discussions with the NRC staff, representatives from EPRI, and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christina Antonescu (Telephone 301-415-6792 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North Building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittee on Metallurgy & Reactor Fuels will hold a meeting on September 20, 2016, Room T-2B1, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss the draft Managing Aging Processes in Storage (MAPS) Report. The Subcommittee will hear presentations by and hold discussions with the NRC staff and other interested persons regarding this matter. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Christopher Brown (Telephone 301-415-7111 or Email:
Detailed meeting agendas and meeting transcripts are available on the NRC Web site at
If attending this meeting, please enter through the One White Flint North building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (Telephone 240-888-9835) to be escorted to the meeting room.
The ACRS Subcommittee on Planning and Procedures will hold a meeting on September 8, 2016, Room T-2B3, 11545 Rockville Pike, Rockville, Maryland.
The meeting will be open to public attendance with the exception of a portion that may be closed pursuant to 5 U.S.C. 552b(c)(2) and (6) to discuss organizational and personnel matters that relate solely to the internal personnel rules and practices of the ACRS, and information the release of which would constitute a clearly unwarranted invasion of personal privacy.
The agenda for the subject meeting shall be as follows:
The Subcommittee will discuss proposed ACRS activities and related matters. The Subcommittee will gather information, analyze relevant issues and facts, and formulate proposed positions and actions, as appropriate, for deliberation by the Full Committee.
Members of the public desiring to provide oral statements and/or written comments should notify the Designated Federal Official (DFO), Quynh Nguyen (Telephone 301-415-5844 or Email:
Information regarding changes to the agenda, whether the meeting has been canceled or rescheduled, and the time allotted to present oral statements can be obtained by contacting the identified DFO. Moreover, in view of the possibility that the schedule for ACRS meetings may be adjusted by the
If attending this meeting, please enter through the One White Flint North Building, 11555 Rockville Pike, Rockville, MD. After registering with security, please contact Mr. Theron Brown (240-888-9835) to be escorted to the meeting room.
U.S. Office of Personnel Management.
30-Day notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13, May 22, 1995), this notice announces that the Office of Personnel Management intends to submit to the Office of Management and Budget (OMB) a request for clearance to revise an information collection. Combined Federal Campaign Applications, OMB Control No. 3206-0131, which include OPM Forms 1647-A, -B, and -E, are used to review the eligibility of national, international, and local charitable organizations and Department of Defense morale, welfare, and recreation (MWR)/Family Support and Youth Activities/Programs (FSYA/FSYP) organizations that wish to participate in the Combined Federal Campaign. The proposed revisions reflect changes in eligibility guidance from the Office of Personnel Management. On March 10, 2016, we published a 60-day notice and request for comments. We received two comments recommending the addition of a “thank you statement” field that would facilitate immediate acknowledgement of electronic pledges. This recommended revision is included below.
We estimate 20,500 responses to this information collection annually. Each form takes approximately three hours to complete. The annual estimated burden is 40,500 hours.
Comments are encouraged and will be accepted until September 23, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management 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 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,
The Combined Federal Campaign (CFC) is the world's largest and most successful annual workplace philanthropic giving campaign, with 127 CFC campaigns throughout the country and overseas raising millions of dollars each year. The mission of the CFC is to promote and support philanthropy through a program that is employee focused, cost-efficient, and effective in providing all federal employees the opportunity to improve the quality of life for all.
The CFC charity applications collect information from about 20,500 national, international, and local charities for inclusion on the CFC charity list. This ICR is being revised to accommodate presentation in an online CFC charity application format. Revisions include:
1. The addition of name and email fields for CFC application system account creation;
2. the inclusion of electronic fund transfer (EFT) information (for national and international charities);
3. the addition of a “thank you statement” field to facilitate immediate acknowledgement of electronic pledges;
4. the addition of three questions surrounding volunteers opportunities and solicitation of federal employees for these opportunities;
5. design of the schedule of services to align with an online form; and
6. revision of certification statements to make them parallel with eligibility requirements at 5 CFR 950 as revised April 16, 2014, effective January 1, 2017.
U.S. Office of Personnel Management.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Section 19(b) of the Act (15 U.S.C. 78s(b)) requires each self-regulatory organization (“SRO”) to file with the Commission copies of any proposed
The collection of information is designed to provide the Commission with the information necessary to determine, as required by the Act, whether the proposed rule change is consistent with the Act and the rules thereunder. The information is used to determine if the proposed rule change should be approved, disapproved, suspended, or if proceedings should be instituted to determine whether to approve or disapprove the proposed rule change.
The respondents to the collection of information are SROs (as defined by Section 3(a)(26) of the Act),
In calendar year 2015, each respondent filed an average of approximately 57 proposed rule changes. Each filing takes approximately 39 hours to complete on average. Thus, the total annual reporting burden for filing proposed rule changes with the Commission is 86,697 hours (57 proposals per year × 39 SROs × 39 hours per filing) for the estimated future number of 39 SROs.
Designated clearing agencies have additional information collection burdens. As noted above, pursuant to Rule 19b-4(n), a designated clearing agency must file with the Commission an Advance Notice of any proposed change to its rules, procedures, or operations that could materially affect the nature or level of risks presented by such designated clearing agency. The Commission estimates that four designated clearing agencies will each submit five Advance Notices per year, with each submission taking 90 hours to complete. The total annual reporting burden for filing Advance Notices is therefore 1,800 hours (4 designated clearing agencies × 5 Advance Notices per year × 90 hours per response).
Designated clearing agencies are required to post all Advance Notices to their Web sites, each of which takes approximately four hours to complete. For five Advance Notices, the total annual reporting burden for posting them to respondents' Web sites is 80 hours (4 designated clearing agencies × 5 Advance Notices per year × 4 hours per Web site posting). Respondents are required to update the postings of those Advance Notices that become effective, each of which takes approximately four hours to complete. The total annual reporting burden for updating Advance Notices on the respondents' Web sites is 80 hours (4 designated clearing agencies × 5 Advance Notices per year × 4 hours per Web site posting).
Pursuant to Rule 19b-4(n)(5), the respondents are also required to provide copies of all materials submitted to the Commission relating to an Advance Notice to the Board of Governors of the Federal Reserve System (“Board”) contemporaneously with such submission to the Commission, which is estimated to take two hours. The total annual reporting burden for designated clearing agencies to meet this requirement is 40 hours (4 designated clearing agencies × 5 Advance Notices per year × 2 hours per response).
The Commission estimates that three security-based swap clearing agencies will each submit 20 Security-Based Swap Submissions per year, with each submission taking 140 hours to complete resulting in a total annual reporting burden of 8,400 hours (3 respondent clearing agencies × 20 Security-Based Swap Submissions per year × 140 hours per response). Respondent clearing agencies are required to post all Security-Based Swap Submissions to their Web sites, each of which takes approximately four hours to complete. For 20 Security-Based Swap Submissions, the total annual reporting burden for posting them to the three respondents' Web sites is 240 hours (3 respondent clearing agencies × 20 Security-Based Swap Submissions per year × 4 hours per Web site posting). In addition, three clearing agencies that have not previously posted Security-Based Swap Submissions, Advance Notices, and proposed rule changes on their Web sites may need to update their existing Web sites to post such filings online. The Commission estimates that each of these three clearing agencies would spend approximately 15 hours updating its existing Web site, resulting in a total one-time burden of 45 hours (3
Respondent clearing agencies will also have to provide training to staff members using the Electronic Form 19b-4 Filing System (“EFFS”) to submit Security-Based Swap Submissions, Advance Notices, and/or proposed rule changes electronically. The Commission estimates that one anticipated security-based swap clearing agency will spend approximately 20 hours training all staff members who will use EFFS to submit Security-Based Swap Submissions, Advance Notices, and/or proposed rule changes electronically, or 6.7 hours annualized over three years. The Commission also estimates that one anticipated clearing agency will have a one-time burden of 130 hours to draft and implement internal policies and procedures for using EFFS to make these submissions, or 43.3 hours annualized over three years. The Commission estimates that each of the 39 respondents will spend 10 hours each year training new compliance staff members and updating the training of existing compliance staff members to use EFFS, for a total annual burden of 390 hours (39 respondent SROs × 10 hours).
In connection with Security-Based Swap Submissions, counterparties may apply for a stay from a mandatory clearing requirement under Rule 3Ca-1. The Commission estimates that each clearing agency will submit five applications for stays from a clearing requirement per year and it will take approximately 18 hours to retrieve, review, and submit each application. Thus, the total annual reporting burden for the Rule 3Ca-1 stay of clearing requirement would be 270 hours (3 respondent clearing agencies × 5 stay of clearing applications per year × 18 hours to retrieve, review, and submit the stay of clearing information).
Based on the above, the total estimated annual response burden pursuant to Rule 19b-4 and Form 19b-4 is the sum of the total annual reporting burdens for filing proposed rule changes, Advance Notices, and Security-Based Swap Submissions; training staff to file such proposals; drafting, modifying, and implementing internal policies and procedures for filing such proposals; posting each proposal on the respondents' Web sites; updating Web sites to enable posting of proposals; updating the respondents' online rulebooks to reflect the proposals that became effective; submitting copies of Advance Notices to the Board; and applying for stays from clearing requirements, which is 114,740 hours.
Compliance with Rule 19b-4 is mandatory. Information received in response to Rule 19b-4 shall not be kept confidential; the information collected is public information.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
The public may view background documentation for this information collection at the following Web site,
On December 4, 2015, the Financial Industry Regulatory Authority, Inc. (“FINRA”) filed with the Securities and Exchange Commission (the “Commission” or “SEC”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Exchange Act”)
The Commission published the proposed rule change for public comment in the
In response to comments, on March 29, 2016 FINRA filed a partial amendment (“Amendment No. 1”) to its proposed rule change to amend CAB Rule 016(c)(2) to clarify that the definition of “capital acquisition broker” does not include any broker or
FINRA filed a second amendment on June 28, 2016 (“Amendment No. 2”) to amend proposed CAB Rule 016(c)(1)(F) regarding a CAB's authority to engage in qualifying, identifying, soliciting, or acting as a placement agent or finder in connection with unregistered securities transactions. The Commission published Amendment No. 2 for public comment in the
This order grants approval of the proposed rule change, as modified by Amendment Nos. 1 and 2.
FINRA states that there are firms that are solely corporate financing firms that advise companies on mergers and acquisitions, advise issuers on raising debt and equity capital in private placements with institutional investors, or provide advisory services on a consulting basis to companies that need assistance analyzing their strategic and financial alternatives. FINRA explains that these firms often are registered as broker-dealers because of their activities and because they may receive transaction-based compensation as part of their services. Nevertheless, FINRA believes that these firms do not engage in many of the types of activities typically associated with traditional broker-dealers. For example, these firms typically do not carry or act as an introducing broker with respect to customer accounts, handle customer funds or securities, accept orders to purchase or sell securities either as principal or agent for the customer, exercise investment discretion on behalf of any customer, or engage in proprietary trading of securities or market-making activities. Therefore, FINRA proposed to create a separate rule set to apply to firms that meet the definition of CAB and elect to be governed under this rule set.
The proposed rules subject CABs to the FINRA By-Laws, as well as core FINRA rules that FINRA believes should apply to all of its members. The rule set applicable to CABs also includes other FINRA rules that are tailored to address CABs' business activities. A brief description of the rule set for CABs is included below.
CAB Rule 014 provides that all persons that have been approved for membership in FINRA as a CAB and persons associated with CABs shall be subject to the CAB rules and the FINRA By-Laws (including the schedules thereto), unless the context requires otherwise. CAB Rule 015 provides that FINRA Rule 0150(b) shall apply to CABs. FINRA Rule 0150(b) provides that the FINRA rules do not apply to transactions in, and business activities relating to, municipal securities as that term is defined in the Exchange Act.
CAB Rule 016 sets forth basic definitions that apply to CABs. The proposed definitions of “capital acquisition broker” and “institutional investor” are particularly important to the application of the rule set. The term “capital acquisition broker” means any broker that solely engages in one or more of the following activities:
• Advising an issuer, including a private fund, concerning its securities offerings or other capital raising activities;
• advising a company regarding its purchase or sale of a business or assets or regarding its corporate restructuring, including a going-private transaction, divestiture or merger;
• advising a company regarding its selection of an investment banker;
• assisting in the preparation of offering materials on behalf of an issuer;
• providing fairness opinions, valuation services, expert testimony, litigation support, and negotiation and structuring services;
• qualifying, identifying, soliciting, or acting as a placement agent or finder (i) on behalf of an issuer in connection with a sale of newly-issued, unregistered securities to institutional investors or (ii) on behalf of an issuer or control person in connection with a change of control of a privately-held company. For purposes of this part, a “control person” is a person who has the power to direct the management or policies of a company through ownership of securities, by contract, or otherwise. Control will be presumed to exist if, before the transaction, the person has the right to vote or the power to sell or direct the sale of 25% or more of a class of voting securities or in the case of a partnership or limited liability company has the right to receive upon dissolution or has contributed 25% or more of the capital. Also, for purposes of this part, a “privately-held company” is a company that does not have any class of securities registered, or required to be registered, with the SEC under Section 12 of the Exchange Act or with respect to which the company files, or is required to file, periodic information, documents, or reports under Section 15(d) of the Exchange Act;
• effecting securities transactions solely in connection with the transfer of ownership and control of a privately-held company through the purchase, sale, exchange, issuance, repurchase, or redemption of, or a business combination involving, securities or assets of the company, to a buyer that will actively operate the company or the business conducted with the assets of the company, in accordance with the terms and conditions of an SEC rule, release, interpretation or “no-action” letter that permits a person to engage in such activities without having to register as a broker or dealer pursuant to Section 15(b) of the Exchange Act.
A firm will be permitted to register as, or change its status to, a CAB
The term “capital acquisition broker” does not include any broker or dealer that:
• Carries or acts as an introducing broker with respect to customer accounts;
• holds or handles customers' funds or securities;
• accepts orders from customers to purchase or sell securities either as principal or as agent for the customer (except as permitted by paragraphs (c)(1)(F) and (G) of CAB Rule 016);
• has investment discretion on behalf of any customer;
• engages in proprietary trading of securities or market-making activities;
• participates in or maintains an online platform in connection with offerings of unregistered securities pursuant to Regulation Crowdfunding or Regulation A under the Securities Act of 1933; or
• effects securities transactions that will require the broker or dealer to report the transaction under the FINRA Rules 6300 Series, 6400 Series, 6500 Series, 6600 Series, 6700 Series, 7300 Series or 7400 Series.
The term “institutional investor” has substantially the same meaning as that term has under FINRA Rule 2210 (Communications with the Public). The term includes any:
• Bank, savings and loan association, insurance company or registered investment company;
• governmental entity or subdivision thereof;
• employee benefit plan, or multiple employee benefit plans offered to employees of the same employer, that meet the requirements of Section 403(b) or Section 457 of the Internal Revenue Code and in the aggregate have at least 100 participants, but does not include any participant of such plans;
• qualified plan, as defined in Section 3(a)(12)(C) of the Exchange Act, or multiple qualified plans offered to employees of the same employer, that in the aggregate have at least 100 participants, but does not include any participant of such plans;
• other person (whether a natural person, corporation, partnership, trust, family office or otherwise) with total assets of at least $50 million;
• person meeting the definition of “qualified purchaser” as that term is defined in Section 2(a)(51) of the Investment Company Act of 1940 (“1940 Act”); and
• person acting solely on behalf of any such institutional investor.
The CAB Rule 100 Series sets forth the requirements for a firm that wishes to register as a CAB. The CAB Rule 100 Series generally incorporates by reference FINRA Rules 1010 (Electronic Filing Requirements for Uniform Forms), and 1122 (Filing of Misleading Information as to Membership or Registration), and NASD Rules 1011 (Definitions), 1012 (General Provisions), 1013 (New Member Application and Interview), 1014 (Department Decision), 1015 (Review by National Adjudicatory Council), 1016 (Discretionary Review by FINRA Board), 1017 (Application for Approval of Change in Ownership, Control, or Business Operations), 1019 (Application to Commission for Review), 1090 (Foreign Members), 1100 (Foreign Associates) and IM-1011-1 (Safe Harbor for Business Expansions). Accordingly, a CAB applicant will follow the same procedures for membership as any other FINRA applicant, with four modifications.
• First, an applicant for membership that seeks to qualify as a CAB will have to state in its application that it intends to operate solely as such.
• Second, in reviewing an application for membership as a CAB, the FINRA Member Regulation Department will consider, in addition to the standards for admission set forth in NASD Rule 1014, whether the applicant's proposed activities are consistent with the limitations imposed on CABs under CAB Rule 016(c).
• Third, CAB Rule 116(b) sets forth the procedures for an existing FINRA firm to change its status to a CAB. If an existing firm is already approved to engage in the activities of a CAB, and the firm does not intend to change its existing ownership, control or business operations, it will not be required to file either a New Member Application (“NMA”) or a Change in Membership Application (“CMA”). Instead, the firm will be required to file a request to amend its membership agreement or obtain a membership agreement (if none exists currently) to provide that: (i) The firm's activities will be limited to those permitted for CABs under CAB Rule 016(c), and (ii) the firm agrees to comply with the CAB rules.
• Fourth, CAB Rules 116(c) and (d) set forth the procedures for an existing CAB to terminate its status as such and continue as a FINRA firm. Under Rule 116(c), such a firm will be required to file a CMA with the FINRA Member Regulation Department, and to amend its membership agreement to provide that the firm agrees to comply with all FINRA rules.
Under CAB Rule 116(d), however, if during the first year following an existing FINRA member firm's amendment to its membership agreement to convert a full-service broker-dealer to a CAB pursuant to Rule 116(b) a CAB seeks to terminate its status as such and continue as a FINRA member firm, the CAB may notify the FINRA Membership Application Program group of this change without having to file an application for approval of a material change in business operations pursuant to NASD Rule 1017. The CAB will instead file a request to amend its membership agreement to provide that the member firm agrees to comply with all FINRA rules, and execute an amended membership agreement that imposes the same limitations on the member firm's activities that existed prior to the member firm's change of status to a CAB.
The CAB Rule 100 Series also governs the registration and qualification examinations of principals and representatives that are associated with CABs. These rules incorporate by reference NASD Rules 1021 (Registration Requirements—Principals), 1022 (Categories of Principal Registration), 1031 (Registration Requirements—Representatives), 1032 (Categories of Representative Registration), 1060 (Persons Exempt from Registration), 1070 (Qualification Examinations and Waiver of Requirements), 1080 (Confidentiality of Examinations), IM-1000-2 (Status of Persons Serving in the Armed Forces of the United States), IM-1000-3 (Failure to Register Personnel) and FINRA Rule 1250 (Continuing Education Requirements). Accordingly, CAB firm principals and representatives are subject to the same registration, qualification examination, and continuing education requirements as principals and representatives of other FINRA firms. CABs are also subject to FINRA Rule 1230(b)(6) regarding Operations Professional registration.
The CAB Rule 200 Series establishes a streamlined set of conduct rules. CABs are subject to FINRA Rules 2010 (Standards of Commercial Honor and Principles of Trade), 2020 (Use of Manipulative, Deceptive or Other Fraudulent Devices), 2040 (Payments to Unregistered Persons), 2070 (Transactions Involving FINRA Employees), 2080 (Obtaining an Order of Expungement of Customer Dispute Information from the CRD System), 2081
CAB Rules 209 and 211 impose know-your-customer and suitability obligations similar to those imposed under FINRA Rules 2090 and 2111. CAB Rule 211(b) includes an exception to the customer-specific suitability obligations for institutional investors similar to the exception found in FINRA Rule 2111(b). CAB Rule 221 is an abbreviated version of FINRA Rule 2210 (Communications with the Public), essentially prohibiting false and misleading statements.
Under CAB Rule 240, if a CAB or associated person of a CAB has engaged in activities that require the CAB to register as a broker or dealer under the Exchange Act, and that are inconsistent with the limitations imposed on CABs under CAB Rule 016(c), FINRA could examine for and enforce all FINRA rules against such a broker-dealer or associated person, including any rule that applies to a FINRA member that is not a CAB or to an associated person who is not a person associated with a CAB.
FINRA is not subjecting CABs to FINRA Rules 2121 (Fair Prices and Commissions), 2122 (Charges for Services Performed), and 2124 (Net Transactions with Customers). FINRA Rule 2121 provides that, for both listed and unlisted securities, a member that buys for its own account from its customer, or sells for its own account to its customer, shall buy or sell at a price that is fair, taking into consideration all relevant circumstances, including market conditions with respect to the security at the time of the transaction, the expense involved, and the fact that the member is entitled to a profit. Further, if the member acts as agent for its customer in any such transaction, the member shall not charge its customer more than a fair commission or service charge, taking into consideration all relevant circumstances, including market conditions with respect to the security at the time of the transaction, the expense of executing the order and the value of any service the member may have rendered by reason of its experience in and knowledge of such security and the market therefor.
A CAB is not permitted to act as principal in a securities transaction. Accordingly, the provisions of FINRA Rule 2121 that govern principal transactions do not apply to a CAB's permitted activities. However, CABs are permitted to qualify, identify, solicit or act as placement agent or finder in a securities transaction, although only in very narrow circumstances on behalf of an issuer in connection with a sale of newly-issued, unregistered securities to institutional investors or on behalf of an issuer or control person in connection with a change of control of a privately-held company. CABs also are permitted to effect securities transactions solely in connection with the transfer of ownership and control of a privately-held company to a buyer that will actively operate the company or the business conducted with the assets of the company in accordance with the terms and conditions of an SEC rule, release, interpretation or “no-action” letter. FINRA believes that these narrow circumstances either involve institutional parties that are generally capable of negotiating fair prices, or involve the sale of a business as a going concern, which differ in nature from the types of transactions that typically raise issues under FINRA Rule 2121.
FINRA Rule 2122 provides that charges, if any, for services performed, including, but not limited to, miscellaneous services such as collections due for principal, dividends, or interest; exchange or transfer of securities; appraisals, safekeeping or custody of securities, and other services shall be reasonable and not unfairly discriminatory among customers. FINRA believes that CABs typically provide services to institutional customers that are capable of negotiating reasonable service charges.
FINRA Rule 2124 sets forth specific requirements for executing transactions with customers on a “net” basis. “Net” transactions are defined as a type of principal transaction, and CABs may not trade securities on a principal basis. Thus, FINRA does not believe it is necessary to include FINRA Rule 2124 as part of the CAB rule set.
Notwithstanding the foregoing, CAB Rule 201 will subject CABs to FINRA Rule 2010 (Standards of Commercial Honor and Principles of Trade), which requires a member, in the conduct of its business, to observe high standards of commercial honor and just and equitable principles of trade. FINRA notes that, depending on the facts, CAB Rule 201 may apply in situations in which a CAB charged a commission or fee that clearly is unreasonable under the circumstances.
The CAB Rule 300 Series establishes a limited set of supervisory rules for CABs. CABs are subject to FINRA Rules 3220 (Influencing or Rewarding Employees of Others), 3240 (Borrowing from or Lending to Customers), and 3270 (Outside Business Activities of Registered Persons).
CAB Rule 311 subjects CABs to some, but not all, of the requirements of FINRA Rule 3110 (Supervision) and, consistent with Rule 3110, is designed to provide CABs with the flexibility to tailor their supervisory systems to their business models. CABs are subject to the provisions of Rule 3110 concerning the supervision of offices, personnel, customer complaints, correspondence and internal communications. However, CABs are not subject to the provisions of Rule 3110 that require annual compliance meetings (paragraph (a)(7)), review and investigation of transactions (paragraphs (b)(2) and (d)), specific documentation and supervisory procedures for supervisory personnel (paragraph (b)(6)), and internal inspections (paragraph (c)).
FINRA does not believe that the annual compliance meeting requirement in FINRA Rule 3110(a)(7) should apply to CABs given the nature of their business model and structure. FINRA has observed that most current FINRA member firms that would qualify as CABs tend to be small and often operate out of a single office. In addition, the range of rules that CABs are subject to is narrower than the rules that apply to other broker-dealers. Moreover, as noted above, CABs are subject to both the Regulatory and Firm Element continuing education requirements. Accordingly, FINRA does not believe that CABs need to conduct an annual compliance meeting as required under FINRA Rule 3110(a)(7). The fact that the annual compliance meeting requirement does not apply to CABs or their associated persons is in no way intended to reduce their responsibility to have knowledge of and comply with applicable securities laws and regulations and the CAB rule set.
FINRA also does not believe that FINRA Rule 3110(b)(2), which requires members to adopt and implement procedures for the review by a registered principal of all transactions relating to the member's investment banking or securities business, or FINRA Rule 3110(d), which imposes requirements related to the investigation of securities transactions and heightened reporting requirements for members engaged in investment banking services, should apply to CABs. CABs are not permitted to carry or act as an introducing broker with respect to customer accounts, hold or handle customers' funds or securities, accept orders from customers to purchase or sell securities (except as permitted by CAB Rule 016(c)(1)(F) and (G)), have investment discretion on behalf of any customer, engage in proprietary trading or market-making activities, or participate in Crowdfunding or Regulation A securities offerings. Accordingly, due to these restrictions, FINRA does not believe a CAB's business model necessitates the application of these provisions, which primarily address trading and investment banking functions that are beyond the permissible scope of a CAB's activities.
FINRA also does not believe that the requirements of FINRA Rule 3110(b)(6) should apply to CABs. Paragraph (b)(6) generally requires a member to have procedures to prohibit its supervisory personnel from: (1) Supervising their own activities; and (2) reporting to, or having their compensation or continued employment determined by, a person the supervisor is supervising.
FINRA believes that it is providing CABs with flexibility to tailor their supervisory structures to their business model, which is geared toward acting as a consultant in capital acquisition transactions, qualifying, identifying, soliciting or acting as placement agent or finder in a securities transaction solely on behalf of an issuer in connection with a sale of newly-issued, unregistered securities to institutional investors or on behalf of an issuer or a control person in connection with a change of control of a privately-held company, or with the transfer of ownership and control of a privately-held company. As discussed above, many CABs operate out of a single office with a small staff, which reduces the need for internal inspections of numerous or remote offices. In addition, part of the purpose of creating a separate CAB rule set is to streamline and reduce existing FINRA rule requirements where doing so does not hinder investor protection. FINRA believes that the remaining provisions of FINRA Rule 3110, coupled with the CAB Rule 200 Series addressing duties and conflicts will sufficiently protect CABs' customers from potential harm due to insufficient supervision.
CAB Rule 313 requires CABs to designate and identify one or more principals to serve as a firm's chief compliance officer (“CCO”), similar to the requirements of FINRA Rule 3130(a). FINRA Rule 3130 requires a CAB to have its chief executive officer (“CEO”) certify that the member has in place processes to establish, maintain, review, test and modify written compliance policies and written supervisory procedures reasonably designed to achieve compliance with applicable federal securities laws and regulations, and FINRA and MSRB rules, which are required under FINRA Rules 3130(b) and (c). FINRA does not believe the CEO certification is necessary given a CAB's narrow business model and smaller rule set.
CAB Rule 328 prohibits any person associated with a CAB from participating in any manner in a private securities transaction as defined in FINRA Rule 3280(e).
CAB Rule 331 requires each CAB to implement a written anti-money laundering (“AML”) program. FINRA believes that this is consistent with the SEC's requirements and Chapter X of Title 31 of the Code of Federal Regulations. Accordingly, CAB Rule 331 is similar to FINRA Rule 3310 (Anti-Money Laundering Compliance Program); however, the CAB rule contemplates that all CABs will be eligible to conduct the required independent testing for compliance every two years (rather than annually as FINRA Rule 3310 requires of non-CAB members).
The CAB Rule 400 Series establishes a streamlined set of rules concerning firms' financial and operational obligations. CABs are subject to FINRA Rules 4140 (Audit), 4150 (Guarantees by, or Flow through Benefits for, Members), 4160 (Verification of Assets), 4511 (Books and Records—General Requirements), 4513 (Records of Written Customer Complaints), 4517 (Member Filing and Contact Information Requirements), 4524 (Supplemental FOCUS Information), 4530 (Reporting Requirements), and 4570 (Custodian of Books and Records). Under CAB Rule 411, which is modeled after FINRA Rule 4110, CABs are required to suspend business operations during any period a firm is not in compliance with the applicable net capital requirements set forth in Exchange Act Rule 15c3-1, and CAB Rule 411 also authorizes FINRA to direct a CAB to suspend its operation under those circumstances.
Because CABs may not carry or act as an introducing broker with respect to customer accounts, they will have more limited customer information requirements than those imposed under FINRA Rule 4512.
CABs are not subject to FINRA Rules 4370 (Business Continuity Plans and Emergency Contact Information) or 4380 (Mandatory Participation in FINRA BC/DR Testing under Regulation SCI). FINRA does not believe it is necessary to have a rule requiring a CAB to maintain a business continuity plan (“BCP”), given a CAB's limited activities, particularly since a CAB will not engage in retail customer transactions or clearance, settlement, trading, underwriting or similar investment banking activities. FINRA Rule 4380 relates to Rule SCI under the Exchange Act, which is not applicable to a member that limits its activities to those permitted under the CAB rule set.
The CAB Rule 500 Series subjects CABs to FINRA Rules 5122 (Private Placements of Securities Issued by Members) and 5150 (Fairness Opinions).
CAB Rule 800 provides that CABs are subject to the FINRA Rule 8000 Series governing investigations and sanctions of firms, other than FINRA Rules 8110 (Availability of Manual to Customers), 8211 (Automated Submission of Trading Data Requested by FINRA), and 8213 (Automated Submission of Trading Data for Non-Exchange-Listed Securities Requested by FINRA).
CABs are not subject to FINRA Rule 8110 (Availability of Manual to Customers), which requires members to make available a current copy of the FINRA manual for examination by customers upon request. FINRA represents that it will make the CAB rule set available through the FINRA Web site. Accordingly, FINRA does not believe this rule is necessary for CABs.
CABs also are not subject to FINRA Rules 8211 (Automated Submission of Trading Data Requested by FINRA) or 8213 (Automated Submission of Trading Data for Non-Exchange-Listed Securities Requested by FINRA). Given that these rules are intended to assist FINRA in requesting trade data from firms engaged in securities trading, and that CABs will not engage in securities trading, FINRA does not believe that these rules should apply to CABs.
CAB Rule 900 provides that CABs are subject to the FINRA Rule 9000 Series governing disciplinary and other proceedings involving firms, other than the FINRA Rule 9700 Series (Procedures on Grievances Concerning the Automated Systems). CAB Rule 900(c) provides that any CAB may be subject to a fine under FINRA Rule 9216(b) with respect to an enumerated list of FINRA By-Laws, CAB rules and SEC rules under the Exchange Act. CAB Rule 900(d) authorizes FINRA staff to require a CAB to file communications with the FINRA Advertising Regulation Department at least ten days prior to use if the staff determined that the CAB had departed from CAB Rule 221's standards.
CAB Rule 1000 provides that CABs are subject to the FINRA Rule 12000 Series (Code of Arbitration Procedure for Customer Disputes), 13000 Series (Code of Arbitration Procedure for Industry Disputes) and 14000 Series (Code of Mediation Procedure).
FINRA states that if the Commission approves the rule change it will announce the implementation date of the rule change in a
After careful review of the proposed rule change, the comment letters, and FINRA's response to the comments, the Commission finds that the rule change, as modified by Amendment Nos. 1 and 2, is consistent with the requirements of the Exchange Act and the rules and regulations thereunder that are applicable to a national securities association.
The Commission received a total of twenty comment letters and FINRA's response to those comment letters. Commenters were generally supportive of the proposal but had suggestions regarding areas where certain aspects of the proposal could be expanded or further explained.
In response, FINRA states that it disagrees that the SEC should delay acting on the CAB proposal. FINRA notes that the definition of CAB will permit CABs to engage, among other activities, in mergers and acquisition transactions. While FINRA acknowledges that NASAA has adopted a model rule for mergers and acquisition brokers, it does not believe that any differences between the NASAA model rule and the CAB rules should preclude the SEC from approving its proposal.
The Commission notes that approval of FINRA's proposed rule change will not preclude further coordination and discussion with FINRA and NASAA.
CAB Rule 014 requires that all persons that have been approved for membership in FINRA as a CAB and their associated persons shall be subject to the CAB rules and FINRA By-Laws (including the schedules thereto) “unless the context requires otherwise.” CAB Rule 014 also states that the terms used in the CAB rules, if defined in the FINRA By-Laws, shall have the same meaning as defined in the FINRA By-Laws, unless a term is defined differently in a CAB rule, “or unless the context of a term within a Capital Acquisition Broker Rule requires a different meaning.”
One commenter expresses concern that there is no guidance as to what “context” may “require otherwise” and when and under what circumstances. This commenter suggests that this language sets up an interpretive issue and will make it impossible to advise a client as to what the actual definition is and, more significantly, whether it applies in a particular context.
CAB Rules 101 through 115 generally apply the same standards for new member applications by CAB applicants as those that apply to non-CAB FINRA member firm applicants. CAB Rule 116 generally applies the same standards regarding changes in ownership, control or business operations to CABs as those that apply to non-CAB firms.
In response, FINRA states that it does not agree that it should revise its proposed rules to require it to act on a CAB's NMA within 60 days of filing an application that meets certain conditions.
CAB Rule 116 provides that if during the first year following an existing FINRA member's amendment electing to become a CAB the firm seeks to terminate its status as such and continue as a full FINRA member, the CAB may notify FINRA of this change without having to file an application for approval of a material change in business operations. One commenter states its view that this one-year grace period is not a sufficient amount of time for a firm to determine if CAB status is appropriate for its business model.
In response, FINRA states that it does not believe that the grace period during which a CAB may revert back to its prior non-CAB status should be lengthened.
After reviewing the CAB rules relating to the application of the FINRA By-laws and membership application process, the Commission believes that these rules are consistent with Section 15A(b)(6), in particular the requirements that FINRA's rules be reasonably designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest. In particular, given the limited activity of CABs, the Commission believes that it is reasonable for FINRA to provide a certain amount of flexibility through the use of the concept “unless the context otherwise requires” in the application of the By-laws and the definitions within the By-laws to CABs and the CAB Rules, so as to provide for a certain amount of flexibility if needed. The Commission notes that FINRA has committed to work with its members if interpretive issues arise. The Commission also believes it is reasonable for FINRA to provide for the same amount of time for approval of new CAB member applications as for non-CAB applications, to help ensure that FINRA
The CAB Rule 100 Series incorporates various NASD rules relating to the registration and qualification examinations of principals and representatives associated with CABS. Thus CAB firm principals and representatives are subject to the same registration, qualification examinations, and continued requirements as that of non-CAB FINRA member firms. One commenter suggests that FINRA should establish new examinations specifically for the registered representatives and supervisory principals of CABs that would test only that subject matter relevant to the business of CABs.
Two commenters request that FINRA clarify whether CABs may hold all registration and licenses previously attained by their associated persons, including Series 53, 4 and other licenses.
In response, FINRA states that associated persons of CABs will only be permitted to retain registrations and licenses that are appropriate to their functions.
The Commission believes that it is reasonable for FINRA to first assess the potential need for new examinations specific to CAB activities before determining whether such action is necessary or appropriate, particularly given that associated persons of CABs will be subject to existing FINRA examination requirements that apply to all members, including CABs, to the extent they apply to their CAB activities and functions. In this regard, the Commission agrees that it is reasonable to subject CABs to the FINRA operations professional registration rules, given that many of the functions for which an operations professional is responsible would apply to all types of FINRA member firms, including CABs. Likewise, the Commission believes that it is reasonable for FINRA to apply the same standard regarding the retention of licenses by associated persons to CAB member firms and non-CAB member firms. Thus, the Commission believes that the CAB registration and licensing rules are consistent with requirements in Section 15A(b)(6) of the Exchange Act that an association's rules be reasonably designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest.
As initially filed with the Commission, FINRA's definition of a CAB in Rule 016(c) would have included, among the permissible activities of a CAB, “qualifying, identifying, soliciting, or acting as a placement agent or finder with respect to institutional investors in connection with purchases or sales of unregistered securities.” One commenter interpreted that description as including both primary issuances and secondary transactions in unregistered securities and requested that FINRA confirm the intent to include secondary transactions among the permitted activities of a CAB.
Due to concerns that permitting CABs to act as agent in a wide array of secondary market transactions would be inconsistent with the purpose of its proposed rule set, FINRA subsequently amended proposed CAB Rule 016(c)(1)(F) to narrow the range of permitted secondary market activities.
In response to Amendment No. 2, one commenter states its view that CAB Rule 016(c)(1)(F) should expressly permit CABs to engage in secondary market transactions.
In response, FINRA states that it does not believe that proposed CAB Rule 016(c)(1)(F) should be amended. FINRA states that other provisions of the proposal that preceded the filing of Amendment No. 2 would prohibit some of the activities that the commenter recommends. FINRA further explains that allowing a CAB to dispose of securities that it receives as compensation for placement agent services would likely be inconsistent with the prohibition on a CAB engaging in proprietary trading, and could be interpreted as allowing trading activities that do not fall within a CAB's business model. FINRA states that the definition of a CAB also prohibits a CAB from holding or handling customer funds or securities. To the extent that a CAB handles a customer's stock certificate as part of its services, a CAB could not act as agent on behalf of an owner who is disposing of privately placed securities. FINRA states that amending these various provisions to accommodate these activities at this time would not be prudent, particularly given the risk that these amendments would inadvertently allow some firms that do not fall within the intended business model to elect CAB status. FINRA states that it will consider proposed changes to the CAB rules after FINRA and the industry have gained experience with their application to CABs.
One commenter objects to CAB Rule 328 (Prohibition on Private Securities Transactions)
In response, FINRA states that it does not agree that CAB Rule 328 should be revised to allow activities to be engaged in by associated persons in their capacities as RIA or bank employees, nor does it believe CABs should be allowed to supervise private securities transactions as a business decision.
One commenter suggests that FINRA should allow CABs to chaperone foreign associated persons under Exchange Act Rule 15a-6, since other broker-dealers that are subject to a $5,000 net capital requirement are permitted to engage in this activity.
One commenter suggests that the definition of a CAB is problematic because it allows CABs to provide services only to institutional investors as defined by the proposal, which it believes is too restrictive.
In addition to institutional investors, one commenter suggests that FINRA permit CAB transactions with certain other categories of persons, specifically: (1) A “knowledgeable employee” as defined in Investment Company Act Rule 3c-5, except that for purposes of the institutional investor definition, “covered company” would mean either the CAB or the issuer of the securities sold in the transaction; and (2) a person designated by the issuer of the securities sold in the transaction, provided that the CAB did not solicit the person or make a recommendation to the person with respect to purchase of the securities.
In response, FINRA states that the term “institutional investor” is relevant only with respect to CAB Rule 016(c)(1)(F), which permits CABs to qualify, identify, solicit or act as placement agent or finder on behalf of an issuer in connection with a sale of newly-issued, unregistered securities to institutional investors or on behalf of an issuer or control person in connection with a change of control of a privately-held company.
By adding qualified purchasers to the definition of “institutional investor,” FINRA states that its proposal permits CABs to solicit investors that have at least $5 million in investments pursuant to CAB Rule 016(c)(1)(F).
For these reasons, FINRA also does not believe it is appropriate at this time to revise the definition of institutional investor to include knowledgeable employees as that term is defined in Investment Company Act Rule 3c-5, as suggested by one commenter.
FINRA believes that any firm that wishes to engage in private placement activities beyond that contemplated for CABs should be registered as a non-CAB broker-dealer and be subject to all FINRA rules, not just the more limited rule set applicable to CABs.
The Commission believes that it is reasonable and consistent with the protection of investors and the public interest for FINRA to limit the permitted activities of CABs in the manner discussed above, given the stated purpose of its proposal and the limited rule set that is applicable to CABs. Specifically, FINRA states in the Notice of Filing that it is proposing a separate rule set that would apply to firms that it describes as those that are “solely corporate financing firms that advise companies on mergers and acquisitions, advise issuers on raising debt and equity capital in private placements with institutional investors, or provide advisory services on a consulting basis to companies that need assistance analyzing their strategic and financial alternatives.”
As detailed above in Section II.C., the CAB rule set imposes a streamlined set of conduct rules on CABS. One such rule, CAB Rule 209, states in part that a CAB must use reasonable diligence to know and retain the essential facts concerning a customer.
In response, FINRA states that it recognizes that firms that elect CAB status often will be dealing with customers that are represented by agents, and that CAB Rule 209 contemplates situations in which a customer is represented by an agent.
CAB Rule 211 states that a CAB or an associated person of a CAB must have a reasonable basis to believe that a recommended transaction or investment strategy (as defined in FINRA Rule 2111) involving a security or securities is suitable for the customer, based on the information obtained through the reasonable diligence of the broker or associated person to ascertain the customer's investment profile. CAB Rule 211 specifies that a CAB or associated person fulfills this customer-specific suitability obligation for an institutional investor, if: (1) The broker or associated person has a reasonable basis to believe that the institutional investor is capable of evaluating investment risks independently, both in general and with regard to particular transactions and investment strategies involving a security or securities; and (2) the institutional investor affirmatively indicates that it is exercising independent judgment in evaluating the broker's or associated person's recommendations. CAB Rule 211 also states in part that, where an institutional investor has delegated decision-making authority to an agent, such as an investment adviser or a bank trust department, the factors in determining whether a CAB has a reasonable basis to believe that the institutional investor is capable of evaluating investment risks independently and indicates that it is exercising independent judgment apply to the agent rather than to the investor.
One commenter generally agrees with CAB Rule 211, but believes that the rule fails by requiring the suitability analyses to be performed before any recommendation is made.
Two commenters request that FINRA clarify what it meant when it said that a CAB may look to an institutional investor's agent for suitability.
As noted, FINRA recognizes that CABs often will be dealing with customers represented by agents, and CAB Rule 211 contemplates such situations. FINRA emphasizes that CAB Rule 211 states in part that, where an institutional investor has delegated decision-making authority to an agent, such as an investment adviser or a bank trust department, the factors in determining whether a CAB has a reasonable basis to believe that the institutional investor is capable of evaluating investment risks independently and indicates that it is exercising independent judgment apply to the agent rather than to the investor.
FINRA's CAB rules do not apply FINRA Rules 2121 (Fair Prices and Commissions), 2122 (Charges for Services Performed), and 2124 (Net Transactions with Customers) to CABs. FINRA does state, however, that depending on the facts, CAB Rule 201 (Standards of Commercial Honor and Principles of Trade) may apply in situations in which a CAB charged a commission or fee that clearly is unreasonable under the circumstances. One commenter states its view that applying CAB Rule 201, which is modeled on FINRA Rule 2010, may lead to interpretive issues when a CAB charges a commission or fee that clearly is unreasonable under the circumstances.
The Commission believes that the CAB conduct rules are consistent with Section 15A(b)(6) of the Exchange Act in that they are reasonably designed to take into account the limited permissible activities of CABs, while still addressing the protection of investors and the public interest. The Commission also believes that FINRA has appropriately responded to comments regarding the proposed CAB conduct rules to clarify their scope and purpose. In this regard, we note that FINRA indicates that, depending on the facts, CAB Rule 201 (Standards of Commercial Honor and Principles of Trade) may apply in situations in which a CAB charges a commission or fee that clearly is unreasonable under the circumstances. We also note that FINRA clarifies that a CAB could comply with CAB Rule 209 (Know Your Customer) by reasonably relying on the assistance of a customer's agent in obtaining the essential facts about the customer, and that CAB Rule 211 (Suitability) contemplates situations where a CAB will be dealing with customers represented by agents for which such suitability determinations will vary depending on the facts and circumstances.
As detailed above in Section II.D., the CAB Rule 300 Series establishes a limited set of supervisory rules for CABs. FINRA states that the CAB supervisory rules are designed to streamline the requirements applicable to CABs where doing so does not hinder investor protection, and that doing so will provide flexibility to CABs to tailor their supervisory structure to their business model, which is limited in scope of permissible activities.
One commenter states its view that requirements related to supervisory procedures for supervisors should not be required for CABs.
In response, FINRA states that because the Bank Secrecy Act imposes AML obligations on all broker-dealers, FINRA does not believe it has the authority to exempt CABs from the requirements to adopt and implement an AML program. To the extent commenters are making suggestions directly to the SEC staff, FINRA states that it is willing to work with the Commission staff if asked. The Commission also notes that CABs, as registered broker-dealers, may rely on previous SEC staff guidance, if applicable to their anti-money laundering requirements and activities.
Also as discussed above in Section II.E, FINRA has not applied FINRA Rule 4370, which requires FINRA members to maintain a business continuity plan, to CABs. One commenter recommends that FINRA clarify the expectations of CABs with respect to cybersecurity.
The Commission believes that CAB rules are reasonably designed to provide flexibility to CABs to structure their business, including their supervisory and cybersecurity policies and procedures, while providing for
For the reasons discussed above, the Commission finds that the rule change, as modified by Amendment Nos. 1 and 2, is consistent with the Exchange Act and the rules and regulations thereunder, in particular with Section 15A(b)(6) of the Exchange Act, which requires in part that FINRA's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, and, in general, to protect investors and the public interest.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On June 20, 2016, NYSE Arca, Inc. filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds that it is appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 11, 2016, the Municipal Securities Rulemaking Board (the “MSRB” or “Board”) filed with the Securities and Exchange Commission (the “SEC” or “Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission received three comment letters on the proposal.
In the Proposing Release, the MSRB stated that a more timely resolution of inter-dealer fails would ultimately benefit customers by providing greater certainty that their fully paid for securities are in fact owned in their account, not allocated to a firm short, and would benefit dealers by reducing the risk and costs associated with inter-dealer fails.
As further described in the Proposing Release and the MSRB Response and Amendment Letter, the MSRB states that the purpose of the proposed rule change is to significantly compress the timing to initiate and complete a close-out by allowing a close-out notice to be issued the day after the purchaser's original settlement date, with the last day by which the purchasing dealer must complete a close-out on an open transaction being reduced to 10 calendar days, with an option for the buyer to grant the seller a one-time 10 calendar day extension.
With the vast majority of municipal securities in book entry form and the Depository Trust & Clearing Corporation's (“DTCC”) continued efforts to promote dematerialization, the MSRB proposed that firms should no longer have to provide a 10-day delivery window before implementing an execution period. The MSRB believes a three-day delivery window would be sufficient as the majority of inter-dealer fails are resolved within days of the original settlement and/or a fail situation is known prior to the original settlement date.
Additionally, the current rule requires that the earliest day that can be specified as the execution date is 11 days after telephonic notice. The proposed amendments would amend the current allowable execution time frame from 11 days to four days after electronic notification. Accelerating the execution date could improve a firm's likelihood of finding a security for a buy-in, lower overall counter-party risk and may further reduce accrual, capital and other expenses.
Under the proposed rule change, a purchasing dealer notifying the selling dealer of an intent to close out an inter-dealer fail would continue to prompt DTCC to “exit” the position from DTCC's continuous net settlement (“CNS”) and the two parties are responsible for effecting the close-out. Because a municipal security may not be available for purchase, incorporating the buy-in procedures of a registered clearing agency will often not solve the inter-dealer fail. The MSRB expects firms to not solely rely upon the CNS system or the services of a registered clearing agency to resolve inter-dealer fails and take prompt action to close out inter-dealer fails in a timely manner. Under the proposed rule change, regardless of the date the positions are exited from CNS, the inter-dealer fail must be resolved within 20 calendar days of the purchasing dealer's original settlement date. The MSRB is also proposing to retire the Manual on Close-Out Procedures.
Rule G-12, on uniform practice, establishes uniform industry practices for processing, clearance and settlement of transactions in municipal securities between a broker, dealer or municipal securities dealer and any other broker, dealer or municipal securities dealer. The proposed amendments would amend Rule G-12(h) by requiring close-outs to be settled no later than 20 calendar days after the settlement date. The proposed amendments to G-12(h)(i)(B) would allow for the close-out process to continue to provide three options to the purchasing dealer. The three options include: (1) Purchase (“buy-in”) at the current market all or any part of the securities necessary to complete the transaction for the account and liability of the seller; (2) accept from the seller in satisfaction of the seller's obligation under the original contract (which shall be concurrently cancelled) the delivery of municipal securities that are comparable to those originally bought in quantity, quality, yield or price, and maturity, with any additional expenses or any additional cost of acquiring such substituted securities being borne by the seller; or (3) require the seller to repurchase the securities on terms which provide that the seller pay an amount which includes accrued interest and bear the burden of any change in market price or yield.
Firms must coordinate internally to determine which of the three close-out options are appropriate for any given fail-to-deliver situation. While a buy-in may be the most preferred method, Rule G-12(h) provides two other options to a purchaser in the event a buy-in is not feasible. Firms are reminded that, regardless of the option agreed upon by the counterparties, including a cancelation of the original transaction, the close-out transaction is reportable to the Real-time Transaction Reporting System (“RTRS”) as currently required pursuant to Rule G-14.
Additionally, the proposed amendments to Rule G-12(h)(i)(A) would allow a purchaser to notify the seller of the purchaser's intent to close-out the transaction the first business day following the purchaser's original transaction settlement date, instead of waiting five business days as currently required in Rule G-12(h)(i)(A).
Currently Rule G-12(h) references use of the telephone and mail as part of the notification process. The proposed amendments would update Rule G-12(h) throughout, to reflect modern communication methods and widely-used industry practices that would facilitate more timely and efficient close-outs. For example, DTCC's SMART/Track is available for use by any existing NSCC clearing firm or DTCC settling member, allowing users to create, retransmit, respond, update, cancel and view a notice.
The proposed amendments to Rule G-12(h)(i)(D) would require sellers to use their best efforts to locate the securities that are subject to a close-out notice from a purchaser. The proposed amendments to Rule G-12(h)(i)(E)(1) would also require the seller to bear any burden in the market price, with any benefit from any change in the market price remaining with the purchaser.
The proposed amendments would also require a purchasing dealer that has multiple counterparties, to utilize the FIFO (first-in-first-out) method for determining the contract date for the failing quantity. Amendments to Rule G-12(h)(iv) would require dealers to maintain all records regarding the close-out transaction as part of the firm's books and records.
As noted previously, the Commission received three comment letters on the proposed rule change and a response
As noted above, the original proposed rule change provided for a close-out deadline of 20 calendar days. Both BDA and SIFMA commented that they would support an even shorter close-out period, with both suggesting a period of 10 calendar days, with an option for the buyer to consent to a 10-day extension, for a maximum aggregate total of 20 days.
In response to comments, the MSRB proposed, in Amendment No. 1, to amend the original proposed rule change to require firms to resolve an inter-dealer fail from 20 calendar days to 10 calendar days and permit the buyer to grant the seller a one-time 10 calendar day extension, which would allow the buyer flexibility, while still ensuring that inter-dealer fails would be closed-out in a maximum of 20 calendar days. The MSRB stated in the Proposing Release that “a more timely resolution of inter-dealer fails would ultimately benefit customers by providing greater certainty that their fully paid for securities are in fact owned in their account and not allocated to a firm short, and would also benefit dealers by reducing the risk and costs associated with inter-dealer fails.”
BDA commented that its member firms still have outstanding questions about how the proposed rule change would impact close-out processes related to accounts transferred to a broker-dealer via the Automated Customer Account Transfer Service (“ACATS”), and requested additional guidance from the MSRB regarding close-outs through ACATS.
The MSRB responded that both of these requests for guidance are beyond the scope of the proposed rule change, both as originally proposed and as amended by Amendment No. 1.
The Commission has carefully considered the proposed rule change, as modified by Amendment No. 1, as well as the three comment letters received and the MSRB's response. The Commission finds that the proposed rule change, as amended by Amendment No. 1, is consistent with the requirements of the Act and the rules and regulations thereunder applicable to the MSRB.
In particular, the proposed rule change is consistent with Section 15B(b)(2)(C) of the Act. Section 15B(b)(2)(C) of the Act requires that the MSRB's rules be designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in regulating, clearing, settling, processing information with respect to, and facilitating transactions in municipal securities and municipal financial products, to remove impediments to and perfect the mechanism of a free and open market in municipal securities and municipal financial products, in general, to protect investors, municipal entities, obligated persons, and the public interest.
The MSRB states that the proposed rule change would benefit investors, dealers and issuers. Specifically, the MSRB states that dealers may benefit from clarifications and revisions that more closely reflect actual market practices. In addition, dealers may be able to more quickly and efficiently resolve inter-dealer fails, which may reduce dealer risk, reduce the likelihood and duration that dealers are required to pay “substitute interest” to customers and reduce systemic risk. The MSRB further states that the proposed rule change may also reduce the likelihood and duration of firm short positions that allocate to customer long positions, reduce investor tax exposure and increase investor confidence in the market. According to the MSRB, issuers and the market as a whole may benefit from increased investor confidence.
In approving the proposed rule change, the Commission has considered the proposed rule's impact on efficiency, competition, and capital formation.
As noted above, the Commission received three comment letters on the filing. The Commission believes that the MSRB, through its responses and through proposed changes in Amendment No. 1, has addressed commenters' concerns.
For the reasons noted above, including those discussed in the MSRB Response and Amendment Letter, the Commission believes that the proposed rule change, as amended by Amendment No. 1, is consistent with the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether Amendment No. 1 to the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549.
The Commission finds good cause for approving the proposed rule change, as amended by Amendment No. 1, prior to the 30th day after the date of publication of notice in the
The MSRB has proposed the revisions included in Amendment No. 1 to further reduce the risk and cost associated with inter-dealer fails. As noted by the MSRB, the only substantive change to the proposed amendment, the shortening of the close-out period, was made to address concerns raised during the comment period. The MSRB has further noted that, in light of the stated goal of the original proposal to compress the timing for initiating and completing a close-out, the revisions are consistent with the original proposal and are unlikely to be controversial.
For the foregoing reasons, the Commission finds good cause for approving the proposed rule change, as modified by Amendment No. 1, on an accelerated basis, pursuant to Section 19(b)(2) of the Act.
For the Commission, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17a-3 under the Securities Exchange Act of 1934 establishes minimum standards with respect to business records that broker-dealers registered with the Commission must make and keep current. These records are maintained by the broker-dealer (in accordance with a separate rule), so they can be used by the broker-dealer and reviewed by Commission examiners, as well as other regulatory authority examiners, during inspections of the broker-dealer.
The collections of information included in Rule 17a-3 are necessary to provide Commission, self-regulatory organization (“SRO”) and state examiners to conduct effective and efficient examinations to determine whether broker-dealers are complying with relevant laws, rules, and regulations. If broker-dealers were not required to create these baseline, standardized records, Commission, SRO and state examiners could be unable to determine whether broker-dealers are in compliance with the Commission's antifraud and anti-manipulation rules, financial responsibility program, and other Commission, SRO, and State laws, rules, and regulations.
As of April 1, 2016 there were 4,104 broker-dealers registered with the Commission. The Commission estimates that these broker-dealer respondents incur a total burden of 2,763,566 hours per year to comply with Rule 17a-3.
In addition, Rule 17a-3 contains ongoing operation and maintenance costs for broker-dealers, including the cost of postage to provide customers with account information, and costs for equipment and systems development. The Commission estimates that under Rule 17a-3(a)(17), approximately 41,143,233 customers will need to be provided with information regarding their account on a yearly basis. The Commission estimates that the postage costs associated with providing those customers with copies of their account record information would be approximately $13,577,267 per year (41,143,233 × $0.33).
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
FINRA is proposing a proposed rule change relating to use of the Alternative Display Facility (“ADF”) by FINRA members for trade reporting purposes only.
The text of the proposed rule change is available on FINRA's Web site at
In its filing with the Commission, FINRA included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
On January 20, 2016, FINRA published a
Since publication of the
Because the substantive trade reporting and trade reporting participation requirements under current ADF rules are consistent with the trade reporting and participation requirements applicable to the TRFs,
FINRA is proposing to adopt new paragraph (b)(2)(E) of Rule 7120 (Trade Reporting Participation Requirements) to require members that intend to use the ADF for trade reporting purposes only and connect to the ADF via a Financial Information eXchange (“FIX”) line to participate in annual connectivity and capacity/stress testing. Members that use only the web browser for trade reporting to the ADF and do not have any FIX connections would not be required to participate in connectivity and capacity/stress testing.
FINRA is proposing to waive the testing requirements under Rule 7120(b)(2)(E) for members that meet certain thresholds. Specifically, members that report at least 100 trades per month to the ADF would not be required to participate in annual connectivity testing. Thus, a member that elects to use the ADF as its primary trade reporting facility likely would be excluded from this requirement. In addition, FINRA is proposing that members would not be required to participate in annual capacity/stress testing unless their actual ADF activity levels or their capacity projections based on their TRF usage
Pursuant to proposed Rule 7120(b)(2)(E), members that are required to participate in annual connectivity and capacity/stress testing will not be charged fees under current Rule 7530(c) for the annual testing. However, members that request additional testing beyond the required annual connectivity and capacity/stress testing would be required to pay fees for testing services under Rule 7530(c).
FINRA believes that the proposed testing requirements will help ensure that the ADF has sufficient capability and capacity to support trade reporting, particularly in the event that members relying on the ADF as their secondary facility for trade reporting must report to the ADF in response to a widespread systems issue in their primary facility.
FINRA is proposing to charge members that use the ADF for trade reporting purposes only and connect to the ADF via a FIX line a monthly fee of $500. The proposed fee would apply to all members that use the ADF for trade reporting purposes only (as either their primary or secondary facility for trade reporting).
The proposed fee would replace the fees for ADF terminal software and servers under current Rule 7520 (Equipment Related Charges).
The proposed FIX connectivity fee would help cover the costs associated with maintaining the ADF platform and ensuring that there is sufficient capacity on the platform and at the securities information processors to accommodate trade reporting, particularly in the event that firms relying on the ADF as their secondary facility for trade reporting must report to the ADF in response to a widespread systems issue in their primary facility.
FINRA is proposing the following technical conforming changes to the ADF rules.
First, FINRA is proposing to amend and rename Rule 6170 (Primary and Additional MPIDs for Alternative Display Facility Participants). With the exception of paragraphs (d) and (e), Rule 6170 relating to the use of multiple market participant identifiers (“MPIDs”) currently is limited to ADF quoting participants. FINRA is proposing to amend the Rule, as applicable, to also apply to members that use the ADF for trade reporting purposes only. In addition, FINRA is proposing to streamline and conform the Rule to Rule 6160 (Multiple MPIDs for Trade Reporting Facility Participants). The standards and processes applicable to the assignment and use of multiple MPIDs are the same for ADF and TRF participants, and as such, FINRA believes that the rules should be identical, to the extent possible.
As amended, paragraph (b) of Rule 6170 would provide that any ADF participant (which would include a member that uses the ADF for trade reporting only) that is required to obtain, or otherwise wishes to use, more than one MPID for purposes of displaying quotes/orders or reporting trades to the ADF must submit a written request, in the form required by FINRA, to, and obtain approval from, FINRA Market Operations for such additional MPID(s). As amended, this paragraph would conform to the language of current Rule 6160(a). Paragraph (c) of Rule 6170, which currently applies only to Registered Reporting ADF ECNs, would be amended to apply to “ADF Market Participants” (which term encompasses both categories of ADF quoting participant,
FINRA also is proposing to amend and reorganize the Supplementary Material under Rule 6170 to conform to Rule 6160 and to delete unnecessary, and in places repetitive, language regarding the specifics of assigning “Primary” and “Additional” MPIDs. As amended, Rule 6170.01 would apply to any ADF participant (which would include a member that uses the ADF for trade reporting purposes only) and provide that an ADF participant must identify the purpose(s) and system(s) for which the multiple MPIDs will be used. If FINRA determines that the use of multiple MPIDs is detrimental to the marketplace, or that an ADF participant
Amended Rule 6170.02 would continue to provide that each MPID belonging to a Registered Reporting ADF ECN is subject to the requirements of Rule 6279 (Alternative Trading Systems). Rule 6170.03 would be amended to apply to “ADF Market Participants,” which would encompass both categories of ADF quoting participant, and provide that if an ADF Market Participant no longer fulfills the conditions appurtenant to one of its MPIDs (
Second, FINRA is proposing to amend paragraph (c)(1) of Rule 7510 (System Related Fees) to clarify that the web browser fee of $20 per month per user ID will apply to all ADF participants, including members that use the ADF for trade reporting purposes only. The provision currently applies only to “ADF Market Participants,” which term is defined as a Registered Reporting ADF Market Maker or a Registered Reporting ADF ECN.
Finally, FINRA is proposing to delete paragraph (a)(9) of Rule 6220. The term “Non-Registered Reporting Member” is not used in the ADF rule set and as such should no longer be included in the definitions under Rule 6220.
FINRA has filed the proposed rule change for immediate effectiveness and the operative date will be 30 days from the date of filing.
FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(6) of the Act,
In addition, FINRA believes that the proposed rule change is consistent with the provisions of Section 15A(b)(5) of the Act,
FINRA does not believe that the proposed rule change will result in any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
As an initial matter, the
Moreover, members are not required to use the ADF for purposes of meeting their trade reporting obligations under FINRA rules. As noted above, the ADF would simply be another option available to members for trade reporting, particularly those members that elect to connect to a secondary facility in accordance with the
FINRA further notes that the proposed rule change does not create any new trade reporting obligations to members; rather it is designed to provide an alternative for members to meet their existing equity trade reporting obligations. Members that choose to rely upon the ADF as their primary or secondary facility for trade reporting will incur some costs. Members connecting to the ADF will incur a cost of $500 per month per FIX connection or $20 per month per user for web browser access. FINRA believes that members that report via FIX will also likely maintain at least one web user ID. Members reporting via FIX will also incur a NASDAQ charge of $575 per port per month. Members that report trades through the ADF will be assessed charges based upon the existing fee schedule, as detailed in Rule 7510(a).
In addition, members maintaining FIX connectivity to the ADF for trade reporting purposes only will be required to conduct annual testing. The connectivity testing requirement will be waived for members reporting at least 100 trades per month through the ADF and the capacity/stress testing requirement will be waived for members with reported trading activity that does not increase by more than 20% from the previous year.
By providing an alternative for trade reporting, FINRA is increasing the choices available to members. FINRA anticipates that few members will use the ADF for trade reporting purposes,
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-FINRA-2016-031. This file number should be included on the subject line if email is used. To help the Commission process and review your comments more efficiently, please use only one method. The Commission will post all comments on the Commission's Internet Web site (
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On July 1, 2016, Bats BZX Exchange, Inc. (the “Exchange” or “BZX”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
Section 19(b)(2) of the Act
The Commission finds it appropriate to designate a longer period within which to take action on the proposed rule change so that it has sufficient time to consider the proposed rule change. Accordingly, the Commission, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend Nasdaq Rule 5735 to adopt generic listing standards for Managed Fund Shares.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Nasdaq Rule 5735 to adopt generic listing standards for Managed Fund Shares, as well as to make additional changes as described below. Under the Exchange's current rules, a proposed rule change must be filed with the Commission for the listing and trading of each new series of Managed Fund Shares. The Exchange believes that it is appropriate to codify certain rules within Rule 5735 that would generally eliminate the need for such proposed rule changes, which would create greater efficiency and promote uniform standards in the listing process.
Rule 5735 sets forth certain rules related to the listing and trading of Managed Fund Shares.
(a) Represents an interest in a registered investment company (“Investment Company”) organized as an open-end management investment company or similar entity, that invests in a portfolio of securities selected by the Investment Company's investment adviser (hereafter “Adviser”) consistent with the Investment Company's investment objectives and policies;
(b) is issued in a specified aggregate minimum number in return for a deposit of a specified portfolio of securities and/or a cash amount with a value equal to the next determined net asset value; and
(c) when aggregated in the same specified minimum number, may be redeemed at a holder's request, which holder will be paid a specified portfolio of securities and/or cash with a value equal to the next determined net asset value.
Effectively, Managed Fund Shares are securities issued by an actively-managed open-end Investment Company (
All Managed Fund Shares listed and/or traded pursuant to Rule 5735 (including pursuant to unlisted trading privileges) are subject to the full panoply of Exchange rules and procedures that currently govern the trading of equity securities on the Exchange.
In addition, Rule 5735(d) currently provides for the criteria that Managed Fund Shares must satisfy for initial and continued listing on the Exchange, including, for example, that a minimum number of Managed Fund Shares are required to be outstanding at the time of commencement of trading on the Exchange. However, the current process for listing and trading new series of Managed Fund Shares on the Exchange requires that the Exchange submit a proposed rule change with the Commission. In this regard, Rule 5735(b)(1) specifies that the Exchange will file separate proposals under Section 19(b) of the Act (hereafter, a “proposed rule change”) before listing and trading shares of an issue of Managed Fund Shares.
The Exchange proposes to amend Rule 5735(b)(1) to specify that the Exchange may approve Managed Fund Shares for listing and/or trading (including pursuant to unlisted trading privileges) pursuant to SEC Rule 19b-4(e) under the Act, which pertains to derivative securities products (“SEC Rule 19b-4(e)”).
The Exchange would also specify within Rule 5735(b)(1) that components of Managed Fund Shares listed pursuant to SEC Rule 19b-4(e) must satisfy, upon initial listing and on a continual basis, certain specific criteria, which the Exchange would include within Rule 5735(b)(1), as described in greater detail below. As proposed, the Exchange would continue to file separate proposed rule changes before the listing and trading of Managed Fund Shares with components that do not satisfy the additional criteria described below or components other than those specified below. For example, if the components of a Managed Fund Share exceeded one of the applicable thresholds, the Exchange would file a separate proposed rule change before listing and trading such Managed Fund Share. Similarly, if the components of a Managed Fund Share included a security or asset that is not specified below, the Exchange would file a separate proposed rule change.
The Exchange would also add to Rule 5735(c) to provide that the Web site for each series of Managed Fund Shares shall disclose certain information regarding the Disclosed Portfolio, to the extent applicable. The required information includes the following, to the extent applicable: Ticker symbol, CUSIP or other identifier, a description of the holding, identity of the asset upon which the derivative is based, the strike price for any options, the quantity of each security or other asset held as measured by select metrics, maturity date, coupon rate, effective date, market value, and percentage weight of the holding in the portfolio.
In addition, the Exchange would amend Rule 5735(d) to specify that all Managed Fund Shares must have a stated investment objective, which must be adhered to under normal market conditions.
Finally, the Exchange would also amend the continued listing requirement in Rule 5735(d)(2)(A) by changing the requirement that an Intraday Indicative Value for Managed Fund Shares be widely disseminated by one or more major market data vendors at least every 15 seconds during the time when the Managed Fund Shares trade on the Exchange to a requirement that an Intraday Indicative Value be widely disseminated by one or more major market data vendors at least every 15 seconds during the Regular Market Session (as defined in Nasdaq Rule 4120(b)).
The Exchange is proposing standards that would pertain to Managed Fund Shares to qualify for listing and trading pursuant to SEC Rule 19b-4(e). These standards would be grouped according to security or asset type. The Exchange notes that the standards proposed for a Managed Fund Share portfolio that holds U.S. Component Stocks, Non-U.S. Component Stocks, Exchange Traded Derivative Securities, and Linked Securities are based in large part on the existing equity security standards applicable to Index Fund Shares in Rule 5705(b)(3).
The standards proposed for a Managed Fund Share portfolio that holds fixed income securities are based in large part on the existing fixed income security standards applicable to Index Fund Shares in Rule 5705(b)(4). Many of the standards proposed for other types of holdings in a Managed Fund Share portfolio are based on previous proposed rule changes for specific series of Managed Fund Shares.
Proposed Rule 5735(b)(1)(A) would describe the standards for a Managed Fund Share portfolio that holds equity securities, which are defined to be U.S. Component Stocks,
As proposed in Rule 5735(b)(1)(A)(i), the component stocks of the equity portion of a portfolio that are U.S. Component Stocks shall meet the following criteria initially and on a continuing basis:
(1) Component stocks (excluding Exchange Traded Derivative Securities and Linked Securities) that in the aggregate account for at least 90% of the equity weight of the portfolio (excluding such Exchange Traded Derivative Securities and Linked Securities) each must have a minimum market value of at least $75 million;
(2) Component stocks (excluding Exchange Traded Derivative Securities and Linked Securities) that in the aggregate account for at least 70% of the equity weight of the portfolio (excluding such Exchange Traded Derivative Securities and Linked Securities) each must have a minimum monthly trading volume of 250,000 shares or minimum notional volume traded per month of $25,000,000, averaged, over the last six months;
(3) The most heavily weighted component stock (excluding Exchange Traded Derivative Securities and Linked Securities) must not exceed 30% of the equity weight of the portfolio, and, to the extent applicable, the five most heavily weighted component stocks (excluding Exchange Traded Derivative Securities and Linked Securities) must not exceed 65% of the equity weight of the portfolio;
(4) Where the equity portion of the portfolio does not include Non-U.S. Component Stocks, the equity portion of the portfolio shall include a minimum of 13 component stocks; provided, however, that there shall be no minimum number of component stocks if (a) one or more series of Exchange Traded Derivative Securities or Linked Securities constitute, at least in part, components underlying a series of Managed Fund Shares, or (b) one or more series of Exchange Traded Derivative Securities or Linked Securities account for 100% of the equity weight of the portfolio of a series of Managed Fund Shares;
(5) Except as provided in proposed Rule 5735(b)(1)(A), equity securities in the portfolio must be U.S. Component Stocks listed on a national securities exchange and must be NMS Stocks as defined in Rule 600 of Regulation NMS;
(6) American Depositary Receipts (“ADRs”) may be exchange-traded or non-exchange-traded. However no more than 10% of the equity weight of the portfolio shall consist of non-exchange-traded ADRs.
As proposed in Rule 5735(b)(1)(A)(ii), the component stocks of the equity portion of a portfolio that are Non-U.S. Component Stocks shall meet the following criteria initially and on a continuing basis:
(1) Non-U.S. Component Stocks each shall have a minimum market value of at least $100 million;
(2) Non-U.S. Component Stocks each shall have a minimum global monthly trading volume of 250,000 shares, or minimum global notional volume traded per month of $25,000,000, averaged over the last six months;
(3) The most heavily weighted Non-U.S. Component Stock shall not exceed 25% of the equity weight of the portfolio, and, to the extent applicable, the five most heavily weighted Non-U.S. Component Stocks shall not exceed 60% of the equity weight of the portfolio;
(4) Where the equity portion of the portfolio includes Non-U.S. Component Stocks, the equity portion of the portfolio shall include a minimum of 20 component stocks; provided, however, that there shall be no minimum number of component stocks if (i) one or more series of Exchange Traded Derivative
(5) Each Non-U.S. Component Stock shall be listed and traded on an exchange that has last-sale reporting.
The Exchange notes that it is not proposing to require that any of the equity portion of the equity portfolio composed of Non-U.S. Component Stocks be listed on markets that are either a member of the Intermarket Surveillance Group (“ISG”) or a market with which the Exchange has a comprehensive surveillance sharing agreement (“CSSA”).
The Exchange notes that the generic listing standards for Index Fund Shares based on foreign indexes in Rule 5705 do not include specific ISG or CSSA requirements.
Proposed Rule 5735(b)(1)(B) would describe the standards for a Managed Fund Share portfolio that holds fixed income securities, which are debt securities
In addition, to the extent that a portfolio includes convertible securities, the fixed income security into which such security is converted would be required to meet the criteria of Rule 5735(b)(1)(B) after converting.
The components of the fixed income portion of the portfolio must meet the following criteria initially and on a continuing basis:
(1) Components that in the aggregate account for at least 75% of the fixed income weight of the portfolio each shall have a minimum original principal amount outstanding of $100 million or more;
(2) No component fixed-income security (excluding Treasury Securities and GSE Securities) could represent more than 30% of the fixed income weight of the portfolio, and the five most heavily weighted component fixed income securities in the portfolio (excluding Treasury Securities and GSE Securities) must not in the aggregate account for more than 65% of the fixed income weight of the portfolio;
(3) An underlying portfolio (excluding exempted securities) that includes fixed income securities must include a minimum of 13 non-affiliated issuers; provided, however, that there shall be no minimum number of non-affiliated issuers required for fixed income securities if at least 70% of the weight of the portfolio consists of equity securities as described in proposed Rule 5735(b)(1)(A).
(4) Component securities that in aggregate account for at least 90% of the fixed income weight of the portfolio must be either (a) from issuers that are required to file reports pursuant to Sections 13 and 15(d) of the Act; (b) from issuers that have a worldwide market value of its outstanding common equity held by non-affiliates of $700 million or more; (c) from issuers that have outstanding securities that are notes, bonds debentures, or evidence of indebtedness having a total remaining principal amount of at least $1 billion
(5) Non-agency, non-GSE, and privately-issued mortgage-related and other asset-backed securities components of a portfolio shall not account, in the aggregate, for more than 20% of the weight of the fixed income portion of the portfolio.
Proposed Rule 5735(b)(1)(C) would describe the standards for a Managed Fund Share portfolio that holds cash and cash equivalents.
(1) U.S. Government securities, including bills, notes, and bonds differing as to maturity and rates of interest, which are either issued or guaranteed by the U.S. Treasury or by U.S. Government agencies or instrumentalities;
(2) certificates of deposit issued against funds deposited in a bank or savings and loan association;
(3) bankers' acceptances, which are short-term credit instruments used to finance commercial transactions;
(4) repurchase agreements and reverse repurchase agreements;
(5) bank time deposits, which are monies kept on deposit with banks or savings and loan associations for a stated period of time at a fixed rate of interest;
(6) commercial paper, which are short-term unsecured promissory notes; and
(7) money market funds.
Proposed Rule 5735(b)(1)(D) would describe the standards for a Managed Fund Share portfolio that holds listed derivatives, including futures, options, and swaps on commodities, currencies, and financial instruments (
(1) In the aggregate, at least 90% of the weight of such holdings invested in futures, exchange-traded options, and listed swaps shall, on both an initial and continuing basis, consist of futures, options, and swaps for which the Exchange may obtain information via the ISG from other members or affiliates of the ISG or for which the principal market is a market with which the Exchange has a comprehensive surveillance sharing agreement (For purposes of calculating this limitation, a portfolio's investment in listed derivatives will be calculated as the aggregate gross notional value of the listed derivatives.); and
(2) the aggregate gross notional value of listed derivatives based on any five or fewer underlying reference assets shall not exceed 65% of the weight of the portfolio (including gross notional exposures), and the aggregate gross notional value of listed derivatives based on any single underlying reference asset shall not exceed 30% of the weight of the portfolio (including gross notional exposures).
Proposed Rule 5735(b)(1)(E) would describe the standards for a Managed Fund Share portfolio that holds over the counter (“OTC”) derivatives, including forwards, options and swaps on commodities, currencies and financial instruments (
Proposed Rule 5735(b)(1)(F) would provide that, to the extent that listed or OTC derivatives are used to gain exposure to individual equities and/or fixed income securities, or to indexes of equities and/or fixed income securities, the aggregate gross notional value of such exposure shall meet the criteria set forth in Rules 5735(b)(1)(A) and (B) (including gross notional exposures), respectively.
The following examples illustrate how certain of the proposed generic criteria of Rule 5735 would be applied:
1. An actively managed ETF holds non-agency MBS that represent 15% of the weight of the fixed income portion of the portfolio. The fixed income portion of the portfolio meets all the requirements of Rule 5735(b)(1)(B). The ETF also holds an OTC swap on a non-agency MBS Index that represents 10% of the fixed income weight of the portfolio calculated on a notional value basis. Separately, the OTC swap and fixed income portion of the portfolio would meet the requirements of Rule 5735(b)(1). However, when the 15% weight in non-agency MBS and the 10% weight in the non-agency MBS Index OTC swap are combined, as required by proposed 5735(b)(1)(F), the 25% total weight would exceed the 20% limit for non-agency GSE and privately-issued mortgage-related securities in 5735(b)(1)(B)(v). The portfolio, therefore, would not meet the proposed generic criteria of Rule 5735.
2. An actively managed ETF holds a portfolio of non-U.S. equity securities, S&P 500 Index and gold futures. S&P 500 Index futures and the gold futures held by the fund are listed on an ISG member exchange. The equity portion of the portfolio consists of developed and emerging markets equity securities with a current aggregate market value of $15 million and all components meet the requirements under Rule 5735(b)(1)(A)(ii). The gold futures contract trading unit size is 100 troy ounces and an ounce of gold is currently worth $1200. The fund holds 500 gold futures contracts with a notional value of $60 million (500*100*$1200). One S&P 500 contract represents 250 units of the S&P 500 Index and the S&P 500 Index is trading at $2,000. The portfolio holds 50 contracts, so the notional value of the S&P 500 Index futures position is $25 million (50*250*$2000). The S&P 500 Index futures meet the requirement under Rule 5735(b)(1)(F), that is, the S&P 500 Index meets the criteria in Rule 5735(b)(1)(A). The weights of the components are as follows; equity securities represent 15% of the portfolio, gold futures represent 60% of the portfolio and S&P 500 Index futures represent 25% of the portfolio. The gold futures represent 60% of the portfolio and exceeds the 30% concentration limitation on any single underlying reference asset as outlined in proposed Rule 5735(b)(1)(D)(ii). The portfolio, therefore, would not meet the proposed generic criteria of Rule 5735.
3. An actively managed ETF holds a portfolio of equity securities and call option contracts on company XYZ. The equity portion of the portfolio meets the requirements under Rule 5735(b)(1)(A). Company XYZ represents 20% of the weight of the equity portion of the portfolio. The equity portion of the fund has a market value of $100 million and the market value of the fund's holdings in company XYZ has a market value of $20 million. The fund also holds 10,000 call option contracts on company XYZ which has a current market price of $50 a share and, therefore, a notional value of $50 million (50*100*10,000) (that is, the $50 market price per share times the multiplier of 100 times 10,000 contracts). The option contracts are traded on an ISG member exchange. The total exposure to company XYZ is therefore $70 million and represents 46.7% ($70 million/$150 million=46.7%) of the portfolio. This fund would not meet the requirements of Rule 5735 because the exposure to XYZ at 46.7% exceeds the 30% concentration limitation of proposed Rule 5735(b)(1)(D)(ii).
The Exchange believes that the proposed standards would continue to ensure transparency surrounding the listing process for Managed Fund Shares. Additionally, the Exchange believes that the proposed portfolio standards for listing and trading Managed Fund Shares, many of which track existing Exchange rules relating to Index Fund Shares, are reasonably designed to promote a fair and orderly market for such Managed Fund Shares.
In support of this proposal, the Exchange represents that:
(1) The Managed Fund Shares will continue to conform to the initial and continued listing criteria under Rule 5735;
(2) the Exchange's surveillance procedures are adequate to continue to properly monitor the trading of the Managed Fund Shares in all trading sessions and to deter and detect violations of Exchange rules. Specifically, the Exchange intends to utilize its existing surveillance procedures applicable to derivative products, which will include Managed Fund Shares, to monitor trading in the Managed Fund Shares;
(3) prior to the commencement of trading of a particular series of Managed Fund Shares, the Exchange will inform its members in an information circular (“Circular”) of the special characteristics and risks associated with trading the Managed Fund Shares, including procedures for purchases and redemptions of Managed Fund Shares, suitability requirements under Rules 2090A and 2111A, the risks involved in trading the Managed Fund Shares during the Pre-Market and Post-Market Sessions when an updated Portfolio Indicative Value will not be calculated or publicly disseminated, information regarding the Portfolio Indicative Value and the Disclosed Portfolio, prospectus delivery requirements, and other trading information. In addition, the Circular will disclose that the Managed Fund Shares are subject to various fees and expenses, as described in the applicable registration statement, and will discuss any exemptive, no-action, and interpretive relief granted by the Commission from any rules under the Act. Finally, the Circular will disclose that the net asset value for the Managed Fund Shares will be calculated after 4 p.m., ET, each trading day; and
(4) the issuer of a series of Managed Fund Shares will be required to comply with Rule 10A-3 under the Act for the initial and continued listing of Managed Fund Shares, as provided under the Nasdaq Rule 5600 Series.
The Exchange, on a periodic basis and no less than annually, will review issues of Managed Fund Shares generically listed pursuant to Rule 5735, and will provide a report to the Regulatory Oversight Committee of the Exchange's Board of Directors regarding the Exchange's findings. In addition, the Exchange will provide the Commission staff with a report each calendar quarter that includes the following information for issues of Managed Fund Shares listed during such calendar quarter under Rule 5735(b)(1): (1) Trading symbol and date of listing on the Exchange; (2) the number of active authorized participants and a description of any failure of an issue of Managed Fund Shares or of an authorized participant to deliver shares, cash, or cash and financial instruments in connection with creation or redemption orders; and (3) a description of any failure of an issue of Managed Fund Shares to comply with Nasdaq Rule 5735.
Prior to listing pursuant to proposed amended Rule 5735(b)(1), an issuer would be required to represent to the Exchange that it will advise the Exchange of any failure by a series of Managed Fund Shares to comply with the continued listing requirements, and, pursuant to its obligations under Section 19(g)(1) of the Act, the Exchange will monitor for compliance with the continued listing requirements. If the Fund is not in compliance with the applicable listing requirements, the Exchange will commence delisting procedures under the Nasdaq Rule 5800 Series.
The Exchange notes that the proposed change is not otherwise intended to address any other issues and that the Exchange is not aware of any problems that members or issuers would have in complying with the proposed change.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act,
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest because it would facilitate the listing and trading of additional Managed Fund Shares, which would enhance competition among market participants, to the benefit of investors and the marketplace.
Specifically, after more than six years under the current process, whereby the Exchange is required to file a proposed rule change with the Commission for the listing and trading of each new series of Managed Fund Shares, the Exchange believes that it is appropriate to codify certain rules within Rule 5735 that would generally eliminate the need for separate proposed rule changes.
The Exchange believes that this would facilitate the listing and trading of additional types of Managed Fund Shares that have investment portfolios that are similar to investment portfolios for Index Fund Shares, which have been approved for listing and trading, thereby creating greater efficiencies in the listing process for the Exchange and the Commission.
In this regard, the Exchange notes that the standards proposed for Managed Fund Share portfolios that include U.S. Component Stocks, Non-U.S. Component Stocks, Exchange Traded
With respect to the proposed addition to the criteria of Rule 5735(c) to provide that the Web site for each series of Managed Fund Shares shall disclose certain information regarding the Disclosed Portfolio, to the extent applicable, the Exchange notes that proposed rule changes approved by the Commission for previously-listed series of Managed Fund Shares have similarly included disclosure requirements with respect to each portfolio holding, as applicable to the type of holding.
With respect to the proposed definition of the term “normal market conditions” in proposed Rule 5735(c)(5), such definition is similar to the definition of normal market conditions approved by the Commission for other issues of Managed Fund Shares.
With respect to the proposed amendment to the continued listing requirement in Rule 5735(d)(2)(A) to require dissemination of a Portfolio Indicative Value at least every 15 seconds during the Regular Market Session (as defined in Rule 4120(b)), such requirement conforms to the requirement applicable to the dissemination of the Intraday Indicative Value for Index Fund Shares in Rule 5705(b)(3)(C). In addition, such dissemination is consistent with representations made in proposed rule changes for issues of Managed Fund Shares previously approved by the Commission.
With respect to the proposed requirement in Rule 5735(b)(1)(A) that no more than 25% of the equity weight of the portfolio shall consist of leveraged and/or inverse leveraged Exchange Traded Derivative Securities or Linked Securities, such requirement would assure that only a relatively small proportion of a fund's investments could consist of such leveraged and/or inverse securities. In addition, such limitation would apply to both U.S. Component Stocks and Non-U.S. Component Stocks comprising the equity portion of a portfolio.
With respect to the proposed provision in Rule 5735(b)(1)(A) that, to the extent a portfolio includes a convertible security, the equity security into which such security is converted must meet the criteria in Rule 5735(b)(1)(A) after converting, such requirement would assure that the equity securities into which a convertible security could be converted meet the liquidity and other criteria in Rule 5735(b)(1)(A) applicable to such equity securities.
With respect to the proposed exclusion of Exchange Traded Derivatives Securities and Linked Securities from the requirements of proposed Rule 5735(b)(1)(A), the Exchange believes it is appropriate to exclude Linked Securities as well as Exchange Traded Derivative Securities from certain component stock eligibility criteria for Managed Fund Shares in so far as Exchange Traded Derivative Securities and Linked Securities are themselves subject to specific quantitative listing and continued listing requirements of a national securities exchange on which such securities are listed. Exchange Traded Derivative Securities and Linked Securities that are components of a fund's portfolio would have been listed and traded on a national securities exchange pursuant to a proposed rule change approved by the Commission pursuant to Section 19(b)(2) of the Act
The Exchange also notes that Exchange Traded Derivative Securities and Linked Securities are derivatively priced, and, therefore, the Exchange believes that it would not be necessary to apply the proposed generic quantitative criteria (
With respect to the proposed criteria applicable to U.S. Component Stocks, the Exchange notes that such criteria are similar to those in Rule 5705(b)(3) relating to criteria applicable to an index or portfolio of U.S. Component Stocks. In addition, Non-U.S. Component Stocks also will be required to meet criteria similar to certain generic listing standards in Rule 5705(b)(3) relating to criteria applicable to an index or portfolio of U.S. Component Stocks and Non-U.S. Component Stocks underlying a series of Index Fund Shares to be listed and traded on the Exchange pursuant to Rule 19b-4(e) under the Act.
With respect to the proposed requirement in Rule 5735(b)(1)(A)(i)f. that no more than 10% of the equity weight of the portfolio shall consist of non-exchange-traded ADRs, the Exchange notes that such requirement will ensure that non-exchange-traded ADRs, which are traded OTC and which generally have less market transparency than exchange-traded ADRs, could account for only a small percentage of the equity weight of a portfolio. Further, the requirement is consistent with representations made in proposed rule changes for issues of Managed Fund Shares previously approved by the Commission.
With respect to the proposed provision in Rule 5735(b)(1)(B) that, to the extent a portfolio includes convertible securities, the fixed income security into which such security is converted must meet the criteria in paragraph (B) of Rule 5735(b)(1) after converting, such requirement would assure that the fixed income securities into which a convertible security could be converted meet the liquidity and other criteria in Rule 5735(b)(1)(B) applicable to fixed income securities.
As proposed, pursuant to Rule 5735(b)(1)(B)(iii), an underlying portfolio (excluding exempted securities) that includes fixed income securities must include a minimum of 13 non-affiliated issuers, but there would be no minimum number of non-affiliated issuers required for fixed income securities if at least 70% of the weight of the portfolio consists of equity securities, as described in Rule 5735(b)(1)(A). The Exchange notes that, when evaluated in conjunction with proposed Rule 5735(b)(1)(B)(ii), the proposed rule is consistent with Rules 5705(b)(4)(A)(iv) and 5705(b)(4)(A)(v) in that it provides for a maximum weighting of a fixed income security in the fixed income portion of the portfolio of a fund that is comparable to the existing rules applicable to Index Fund Shares based on fixed income indexes.
With respect to the proposed requirement in Rule 5735(b)(1)(B)(v) that non-agency, non-GSE and privately-issued mortgage-related and other asset-backed securities components of a portfolio shall not account, in the aggregate, for more than 20% of the weight of the fixed income portion of the portfolio, the Exchange notes that such requirement is consistent with representations made in proposed rule changes for issues of Managed Fund Shares previously approved by the Commission.
With respect to the proposed amendment to Rule 5735(b)(1)(C) relating to cash and cash equivalents, while there is no limitation on the amount of cash and cash equivalents that can make up the portfolio, such instruments are short-term, highly liquid, and of high credit quality, making them less susceptible than other asset classes both to price manipulation and volatility. Further, the requirement is consistent with representations made in proposed rule changes for issues of Managed Fund Shares previously approved by the Commission.
With respect to proposed Rule 5735(b)(1)(D)(i) relating to listed derivatives, the Exchange believes that it is appropriate that there be no limit to the percentage of a portfolio invested in such holdings, provided that, in the aggregate, at least 90% of the weight of such holdings invested in futures, exchange-traded options, and listed swaps would consist of futures, options, and swaps for which the Exchange may obtain information via ISG from other members or affiliates or for which the principal market is a market with which the Exchange has a CSSA. Such a requirement would facilitate information sharing among market participants trading shares of a series of Managed Fund Shares as well as futures and options that such series may hold. In addition, listed swaps would be centrally cleared, reducing counterparty risk and thereby furthering investor protection.
With respect to proposed Rule 5735(b)(1)(D)(ii), requiring percentage caps on the aggregate gross notional value of listed derivatives based on any five or fewer underlying reference assets or based on any single underlying reference asset, the Exchange believes such requirements will help ensure that listed derivatives utilized by a fund are adequately diversified and not unduly concentrated.
With respect to proposed Rule 5735(b)(1)(E) relating to OTC derivatives, the Exchange believes that the limitation to 20% of a fund's assets would assure that the preponderance of fund investments would not be in derivatives that are not listed and centrally cleared. The Exchange believes that such a limitation is sufficient to mitigate the risks associated with price manipulation because a 20% cap on OTC derivatives will ensure that any series of Managed Fund Shares will be sufficiently broad-based in scope to minimize potential manipulation associated with OTC derivatives and because the remaining 80% of the portfolio will consist of instruments subject to numerous restrictions designed to prevent manipulation, including equity securities (which, as proposed, would be subject to market cap, trading volume, and diversity requirements, among others), fixed income securities (which, as proposed, would be subject to principal amount outstanding, diversity, and issuer requirements, among others), cash and cash equivalents (which, as proposed, would be limited to short-term, highly liquid, and high credit quality instruments), and/or listed derivatives (which would be subject to the limitations in proposed Rule 5735(b)(1)(D)).
The Exchange notes that a fund's investments in derivative instruments would be subject to limits on leverage imposed by the 1940 Act. Section 18(f) of the 1940 Act and related Commission guidance limit the amount of leverage an investment company can obtain. A fund's investments would be consistent with its investment objective and would not be used to enhance leverage. To limit the potential risk associated with a fund's use of derivatives, a fund will segregate or “earmark” assets determined to be liquid by a fund in accordance with the 1940 Act (or, as permitted by applicable regulation, enter into certain offsetting positions) to cover its obligations under derivative instruments.
With respect to proposed Rule 5735(b)(1)(F) relating to a fund's use of listed or OTC derivatives to gain exposure to individual equities and/or fixed income securities, or to indexes of equities and/or indexes of fixed income securities, the Exchange notes that the aggregate gross notional value of such exposure would be required to meet the numerical and other criteria set forth in proposed Rules 5735(b)(1)(A) and 5735(b)(1)(B) (including gross notional exposures), respectively.
Quotation and other market information relating to listed futures and options is available from the exchanges listing such instruments as well as from market data vendors. With respect to centrally-cleared swaps
With respect to security-based swaps regulated by the Commission, the Commission has adopted Regulation SBSR under the Act implementing requirements for regulatory reporting and public dissemination of security-based swap transactions set forth in Title VII of the Dodd-Frank Act. Regulation SBSR provides for the reporting of security-based swap information to registered security-based swap data repositories (“Registered SDRs”) or the Commission, and the public dissemination of security-based swap transaction, volume, and pricing information by Registered SDRs.
Price information relating to forwards and OTC options will be available from major market data vendors.
A fund's investments will not be used to seek performance that is the multiple or inverse multiple (
The proposed rule change is also designed to protect investors and the public interest because Managed Fund Shares listed and traded pursuant to Rule 5735, including pursuant to the proposed new portfolio standards, would continue to be subject to the full panoply of Exchange rules and procedures that currently govern the trading of equity securities on the Exchange.
The proposed rule change is also designed to protect investors and the public interest as well as to promote just and equitable principles of trade in that any Non-U.S. Component Stocks will each meet the following criteria initially and on a continuing basis: (1) Have a minimum market value of at least $100 million; (2) have a minimum global monthly trading volume of 250,000 shares, or minimum global notional volume traded per month of $25,000,000, averaged over the last six months; (3) most heavily weighted Non-U.S. Component Stock shall not exceed 25% of the equity weight of the portfolio, and, to the extent applicable, the five most heavily weighted Non-U.S. Component Stocks shall not exceed 60% of the equity weight of the portfolio; and (4) each Non-U.S. Component Stock shall be listed and traded on an exchange that has last-sale reporting.
The Exchange believes that such quantitative criteria are sufficient to mitigate any concerns that may arise on the basis of a series of Managed Fund Shares potentially holding 100% of its assets in Non-U.S. Component Stocks that are neither listed on members of ISG nor exchanges with which the Exchange has in place a CSSA because, as stated above, such criteria are either the same or more stringent than the portfolio requirements for Index Fund Shares that hold Non-U.S. Component Stocks and there are no such requirements related to such securities being listed on an exchange that is a member of ISG or with which the Exchange has in place a CSSA.
Further, the Exchange has not encountered and is not aware of any instances of manipulation or other negative impact in any series of Index Fund Shares that has occurred by virtue of the Index Fund Shares holding such Non-U.S. Component Stocks. Therefore, the Exchange believes that there should be no difference in the portfolio requirements for Managed Fund Shares and Index Fund Shares as it relates to holding Non-U.S. Component Stocks that are not listed on an exchange that is a member of ISG or with which the Exchange has in place a CSSA.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices because the Managed Fund Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in Rule 5735. The Exchange has in place surveillance procedures that are adequate to properly monitor trading in the Managed Fund Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. FINRA, on behalf of the Exchange, or the regulatory staff of the Exchange, will communicate as needed regarding trading in Managed Fund Shares with other markets that are members of the ISG, including all U.S. securities exchanges and futures exchanges on which the components are traded.
In addition, the Exchange may obtain information regarding trading in Managed Fund Shares from other markets that are members of the ISG, including all U.S. securities exchanges and futures exchanges on which the components are traded, or with which the Exchange has in place a CSSA.
The Exchange also believes that the proposed rule change would fulfill the intended objective of Rule 19b-4(e) under the Act by allowing Managed Fund Shares that satisfy the proposed listing standards to be listed and traded without separate Commission approval. However, as proposed, the Exchange would continue to file separate proposed rule changes before the listing and trading of Managed Fund Shares that do not satisfy the additional criteria described above.
The Exchange, on a periodic basis and no less than annually, will review issues of Managed Fund Shares listed pursuant to Rule 5735(b)(1), and will provide a report to the Regulatory Oversight Committee of the Exchange's Board of Directors regarding the Exchange's findings. In addition, the Exchange will provide the Commission staff with a report each calendar quarter that includes the following information for issues of Managed Fund Shares listed during such calendar quarter under Rule 5735(b)(1): (1) Trading symbol and date of listing on the Exchange; (2) the number of active authorized participants and a description of any failure of an issue of Managed Fund Shares listed pursuant to Rule 5735(b)(1) or of an authorized participant to deliver shares, cash, or cash and financial instruments in connection with creation or redemption orders; and (3) a description of any failure of an issue of Managed Fund Shares to comply with Rule 5735.
Prior to listing pursuant to proposed amended Rule 5735(b)(1), an issuer would be required to represent to the Exchange that it will advise the Exchange of any failure by a series of
For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
No written comments were either solicited or received.
Within 45 days of the date of publication of this notice in the
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange is filing with the Securities and Exchange Commission (“Commission”) a proposed rule change to amend the Fee Schedule to make a number of changes to the fees and credits for PIP and COPIP Transactions on the BOX Market LLC (“BOX”) options facility. The text of the proposed rule change is available from the principal office of the Exchange, at the Commission's Public Reference Room and also on the Exchange's Internet Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend the Fee Schedule for trading on BOX to make a number of changes to the fees and credits for PIP and COPIP Transactions.
The Exchange proposes to adjust certain fees for PIP and COPIP Transactions. Currently, Professional Customers, Broker Dealers and Market Makers are assessed a fee of $0.15 for PIP and COPIP Orders
Under the Primary Improvement Order
The Exchange proposes to first add language that will specify that the tiered fee schedule for initiating participants will only apply to Primary Improvement Order executions where the corresponding PIP or COPIP Order is from the account of a Public Customer. The Exchange then proposes to introduce a flat per contract fee of $0.05 for all Primary Improvement Orders where the corresponding PIP or COPIP Order is from the account of a Non-Public Customer.
The Exchange then proposes to amend Section I.B.2 of the Fee Schedule (BVR). Under the current BVR, the Exchange offers a tiered per contract rebate for all PIP Orders and COPIP orders of 100 contracts and under. Percentage thresholds are calculated on a monthly basis by totaling the Participant's PIP and COPIP volume submitted to BOX, relative to the total national Customer volume in multiply-listed options classes. The Exchange proposes to add language that will specify that only Public Customer PIP and COPIP Orders are eligible for the BVR.
The Exchange then proposes to amend Section II.A. of the BOX Fee Schedule, Liquidity Fees and Credits for PIP and COPIP transactions. Specifically, the Exchange proposes to amend Section II.A. to differentiate between PIP and COPIP transactions where the PIP and COPIP Orders are from the accounts of Public Customers and PIP and COPIP transactions where the PIP and COPIP Orders are from the accounts of Non-Public Customers.
First, the Exchange proposes to specify that the current liquidity fees and credits will only apply to PIP and COPIP transactions where the PIP and COPIP Order is from the account of a Public Customer. The liquidity fees and credits for these PIP and COPIP Orders, the Primary Improvement Order and any corresponding Improvement Orders remain unchanged and will be as follows:
The Exchange then proposes to establish a new section for the Liquidity Fees and Credits of PIP and COPIP transactions where the PIP and COPIP Order is from the account of a Non-Public Customer. First, the Exchange proposes to specify that PIP or COPIP Orders from the account of a Non-Public Customer are assessed the “removal” credit only if the PIP or COPIP Order does not trade with its contra order (the Primary Improvement Order). The
For example, if a Broker Dealer submits a PIP Order for the account of a Non-Public Customer to buy 100 contracts in the PIP and there are no responders, the PIP Order would execute against the matching Primary Improvement Order to sell 100 contracts and neither Order would be assessed a liquidity fee or credit. If, instead, the same PIP Order receives an Improvement Order response to sell 75 contracts, at the end of the auction the PIP Order would now execute against the Improvement Order for 75 contracts and the Primary Improvement Order for 25 contracts, and liquidity fees and credits would only be assessed on the 75 contracts which executed against the Improvement Order. Specifically, the 75 contracts from the PIP Order will receive the removal credit and the 75 contracts from the Improvement Order will be charged the add fee.
Lastly, the Exchange also proposes to update the footnote numbering and make other non-substantive technical changes within the BOX Fee Schedule.
The Exchange believes that the proposal is consistent with the requirements of Section 6(b) of the Act, in general, and Section 6(b)(4) and 6(b)(5)of the Act,
The Exchange believes that reducing the fees assessed to Professional Customers, Broker Dealers and Market Makers for PIP and COPIP Orders in Penny and Non-Penny Pilot Classes is reasonable, equitable, and not unfairly discriminatory. In particular, the Exchange believes that reducing these fees will encourage auction order flow to the Exchange, which will benefit all market participants on the Exchange. BOX believes that the proposed fee reductions from $0.15 to $0.05 are reasonable and in line with similar fees on other exchanges.
The Exchange believes that adding language to specify that the tiered fee schedule for initiating participants will only apply to Primary Improvement Order executions where the corresponding PIP or COPIP Order is from the account of a Public Customer, as well as introducing a flat per contract fee of $0.05 for all Primary Improvement Orders where the corresponding PIP or COPIP Order is from the account of a Non-Public Customer is reasonable, equitable and not unfairly discriminatory. The Exchange also believes the proposed $0.05 fee for Primary Improvement Order executions where the corresponding PIP or COPIP Order is from the account of a Non-Public Customer is reasonable, as it is within the range of fees currently assessed on all Primary Improvement Orders on BOX.
The Exchange believes the proposed changes to the BVR are reasonable, equitable and not unfairly discriminatory. The BVR was adopted to attract Public Customer order flow to the Exchange by offering these
The Exchange believes amending the Liquidity Fees and Credits for PIP and COPIP transactions to differentiate between PIP and COPIP transactions where the PIP or COPIP Order is from the account of a Public Customer, and the PIP or COPIP Order is from the account of a Non-Public Customer is reasonable, equitable and not unfairly discriminatory. As stated above, the current liquidity fees and credits for PIP and COPIP transactions are focused on incentivizing Public Customer order flow to the PIP and COPIP auctions. Therefore, the Exchange believes it is equitable and not unfairly discriminatory to establish different fees and credits for Non-Public Customer order flow to these auction mechanisms. The Exchange notes that the liquidity fees and credits for PIP and COPIP transactions where the PIP and COPIP Order is from the account of a Public Customer remain unchanged.
Accordingly, the Exchange believes the proposed liquidity fees and credits for PIP and COPIP transactions where the PIP or COPIP Order are from the account of a Non-Public Customer are reasonable, equitable and not unfairly discriminatory as they are identical to the current liquidity fees and credits assessed for PIP and COPIP transactions where the PIP or COPIP Order is from the account of a Public Customer.
The Exchange also believes it is reasonable, equitable and not unfairly discriminatory to only apply the liquidity fees and credits to the portion of the PIP or COPIP Order from the account of a Non-Public Customer that does not trade with its contra order, and the Improvement Order responses. Liquidity fees and credits on BOX do not directly result in revenue to BOX, but are meant to incentivize Participants to attract order flow. Because of the value of Public Customer order flow, the Exchange believes these incentives are appropriate even if the Public Customer PIP or COPIP Order is fully internalized and trades only against its matching Primary Improvement Order. However, as stated above, the Exchange believes that the same level of incentives is not necessary for Non-Public Customer PIP or COPIP order flow. Therefore, the Exchange believes it reasonable to only provide these incentives to the portion of the Non-Public Customer PIP or COPIP Orders where liquidity is being added in the form of Improvement Order responses. Further, the Exchanges notes that the liquidity fees and credits for transactions within the Facilitation and Solicitation auction mechanism (Section II.B. of the BOX Fee Schedule) are assessed in a similar manner, and that the distinction is also made within the price improvement mechanism fees and rebates on another exchange in the options industry.
The Exchange does not believe that the proposed rule change will impose any burden on competition not necessary or appropriate in furtherance of the purposes of the Act.
The Exchange believes that the proposed adjustments to the Non-Public Customer PIP and COPIP Transactions fees will not impose a burden on competition among various Exchange Participants. Rather, BOX believes that the changes will result in the Participants being charged appropriately for their Non-Public Customer PIP and COPIP Transactions and is designed to enhance competition in Auction transactions on BOX. Submitting an order is entirely voluntary and Participants can determine which type of order they wish to submit, if any, to the Exchange.
The Exchange also believes that amending the proposed liquidity fees and credits for Non-Public Customer PIP and COPIP Transactions will not impose a burden on competition among various Exchange Participants. The Exchange believes that the proposed changes will result these Participants being charged or credited appropriately for these transactions.
Finally, the Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing exchanges. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change reflects this competitive environment.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Exchange Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend the rule change if it appears to the Commission that the action is necessary or appropriate in the public interest, for the protection of investors, or would otherwise further the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On May 2, 2016, NYSE Arca, Inc. (“Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares under NYSE Arca Equities Rule 8.600, which governs the listing and trading of Managed Fund Shares on the Exchange. The Shares will be offered by AdvisorShares Trust (“Trust”), an open-end management investment company.
The Exchange states that the investment objective of the Fund will be to seek to provide long-term capital appreciation above the capital appreciation of its primary benchmark, the MSCI Korea Index, and other Korea-focused indexes. The Fund will seek to achieve its investment objective by investing primarily in growth-oriented stocks of any capitalization range listed on the Korea Exchange. Under normal circumstances,
The Exchange states that the Sub-Adviser will manage the Fund's portfolio by buying and holding stocks of companies at attractive valuation that it believes have growth potential. The Sub-Adviser will focus on corporate fundamental research in its stock selection, often called “bottom up” analysis. The Sub-Adviser will invest the Fund's assets with a mid- to- long-term view, typically seeking to avoid short-term trading. In selecting investments for the Fund's portfolio, the Sub-Adviser will place emphasis on fundamentals rather than on short-term momentum and continuously monitor market risks. In deciding whether to sell
In addition to individual stock selection, the Exchange states that the Sub-Adviser will engage in sector allocation based on analysis of the macro economy and its effect on corporate competitiveness and industry cycles. This is often called “top down” analysis. The Sub-Adviser will strive to invest with large economic cycles as compared to short-term market trends and short-term supply and demand.
The Exchange represents that while the Fund, under normal circumstances, will invest at least 80% of its assets in the securities described above in the “Principal Investments of the Fund,” the Fund may invest its remaining assets in the securities and financial instruments as described below.
The Fund may invest in the following equity securities traded on a U.S. or foreign exchange or over-the-counter, including equity securities of foreign issuers in emerging countries: Common stocks, preferred stocks, warrants, rights, securities convertible into common stock, and investments in master limited partnerships.
The Fund may invest in issuers located outside the United States directly and may invest in exchange-traded funds (“ETFs”),
The Fund may invest in non-exchange-traded investment company securities to the extent that such investments would be consistent with the requirements of Section 12(d)(1) of the 1940 Act or any rule, regulation, or order of the Commission or interpretation thereof. Consistent with the restrictions discussed above, the Fund may invest in U.S. and non-U.S. exchange-listed closed-end funds and business development companies. Except with respect to inverse ETFs as described above,
The Fund may invest in U.S. government securities and may invest in certain U.S. government securities that are issued or guaranteed by agencies or instrumentalities of the U.S. government.
The Exchange represents that the Fund may hold up to an aggregate amount of 15% of its net assets in assets deemed illiquid by the Adviser.
The Exchange also represents that the Fund will not invest in options, futures, swaps, or forward contracts. Further, the Fund's investments will be consistent with its investment objective and will not be used to provide multiple returns of a benchmark or to produce leveraged returns. Finally, the Exchange represents that not more than 10% of the net assets of the Fund in the aggregate invested in equity securities (other than non-exchange-traded investment company securities) shall consist of equity securities whose principal market is not a member of the ISG or is a market with which the Exchange does not have a comprehensive surveillance sharing agreement.
The Commission is instituting proceedings pursuant to Section 19(b)(2)(B) of the Act
Pursuant to Section 19(b)(2)(B) of the Act,
The Exchange provides that the Fund will invest at least 80% of its net assets in equity securities listed on the Korea Exchange. The Exchange, however, proposes no other quantitative standards with respect to the types of equity securities listed on the Korea Exchange in which the Fund, at the Sub-Adviser's discretion, may invest. The Commission has recently noted that appropriate quantitative standards, such as minimum market value and trading volume requirements, “should reduce the extent to which Managed Fund Shares holding Non-U.S. Component Stocks may be susceptible to manipulation.”
The Commission requests that interested persons provide written submissions of their views, data, and arguments with respect to the issues identified above, as well as any other concerns they may have with the proposal. In particular, the Commission invites the written views of interested persons concerning whether the proposal is consistent with Section 6(b)(5) or any other provision of the Act, or the rules and regulations thereunder. Although there do not appear to be any issues relevant to approval or disapproval that would be facilitated by an oral presentation of views, data, and arguments, the Commission will consider, pursuant to Rule 19b-4, any request for an opportunity to make an oral presentation.
Interested persons are invited to submit written data, views, and arguments regarding whether the proposal should be approved or disapproved by September 14, 2016. Any person who wishes to file a rebuttal to any other person's submission must file that rebuttal by September 28, 2016. The Commission asks that commenters address the sufficiency of the Exchange's statements in support of the proposal, which are set forth in the Notice
Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to the provisions of Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange is filing a proposal to amend Exchange Rule 803, Audits; and Exchange Rule 1308, Supervision of Accounts, to adopt new Interpretations and Policies .01 to each existing rule regarding the submission of annual reports.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to amend Exchange Rule 803, Audits, to adopt new Interpretations and Policies .01 to state that Members must now file annual reports electronically with the Exchange by utilizing the system or software prescribed by the Exchange which will be announced via Regulatory Circular. Additionally, the Exchange proposes to amend Exchange Rule 1308, Supervision of Accounts, to adopt new Interpretations and Policies .01 to state that Members required to file an annual report under paragraph (g) of Rule 1308 must now file such report electronically with the Exchange by utilizing the system or software prescribed by the Exchange which will be announced via Regulatory Circular.
The Exchange has a Regulatory Services Agreement (“RSA”) with the Financial Industry Regulatory Authority, Inc. (“FINRA”). FINRA provides its members, and the members of exchanges for which it provides regulatory services, access to its Firm Gateway system, which is a portal that provides consolidated access to various FINRA regulatory systems. As part of the RSA, FINRA will collect reports on behalf of the Exchange and provide a report to the Exchange indicating which Firms have submitted an annual audit report. Additionally, FINRA has a process in place to provide specific annual audit reports to the Exchange upon request.
The FINRA Firm Gateway is available to Members
Therefore the Exchange proposes to adopt Interpretations and Policies .01 to Rule 803 to state that reports must be filed electronically with the Exchange utilizing the system or software prescribed by the Exchange. Additionally, the Exchange proposes to adopt Interpretations and Policies .01 to Rule 1308 to state that if a Member is required to file a report, that such report must be filed electronically with the Exchange utilizing the system or software prescribed by the Exchange.
The Exchange believes that requiring Members to submit annual reports directly into the system of the Exchange's regulatory services provider will provide for a more efficient and effective process for the collection, tracking, consolidation, and review of Members' annual reports.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
In particular, the Exchange believes that the proposed rule change will create a more efficient and effective process for the Exchange's Members to submit annual reports to the Exchange, which fosters cooperation and coordination with FINRA in its performance of regulatory services with respect to the Exchange and Exchange Members. By enhancing the process through which the Exchange (through its regulatory services provider) receives annual reports, the Exchange believes the proposed rule changes will promote just and equitable principles of trade and ultimately protect investors. Additionally, upon implementation, all Members that are required to submit annual reports will be required to submit them in the same (and thus nondiscriminatory) electronic manner.
Regulation of Members continues to be performed by electronic processes, and thus the Exchange believes it is appropriate to require electronic submission of these reports so that they may be incorporated into these processes. By maintaining the flexibility
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The proposed rule change requires all Members that are required to submit annual reports to submit those reports electronically in the same manner.
The Exchange believes the proposed rule change will not impose any burden on intra-market competition because it applies equally to all Exchange Members with reporting obligations.
The Exchange does not believe that the proposed rule changes will impose any burden on intermarket competition as the proposed rule change is for regulatory purposes to enhance the process for Member's submission and the Exchange's collection, tracking, consolidation, and review of annual reports.
The Exchange believes that the proposed change is not controversial and does not impose any significant burden on the Exchange's Members. All Exchange Members have access to the FINRA Firm Gateway system and there is no additional financial cost to file the required reports electronically through this system. Additionally, the majority of Members of the Exchange are also Members of FINRA and use the FINRA Firm Gateway system on a regular basis. Therefore, the Exchange believes that any burden that the proposed rule change may impose on Members will be minimal. The Exchange believes any burden is outweighed by the benefits of electronic filing, which include a more efficient and effective process for the Exchange (through its regulatory services provider) to collect, track, and consolidate annual reports. The Exchange believes that an electronic filing process is in its, and its Members', best interest.
Written comments were neither solicited nor received.
Because the foregoing proposed rule change does not: (i) Significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days after the date of the filing, or such shorter time as the Commission may designate, it has become effective pursuant to 19(b)(3)(A) of the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Notice is hereby given that pursuant to the Paperwork Reduction Act of 1995 (“PRA”) (44 U.S.C. 3501
Rule 17a-4 requires exchange members, brokers and dealers (“broker-
There are approximately 4,104 active, registered broker-dealers. The staff estimates that the average amount of time necessary to preserve the books and records as required by Rule 17a-4 is 254 hours per broker-dealer per year. In addition, the Commission is moving into this information collection the annual burden hours for paragraph (b)(11) of Rule 17a-4, which requires any broker-dealer that sponsors an internal broker-dealer system to maintain certain records relating to such system for at least three years. The Commission estimates that paragraph (b)(11) of Rule 17a-4 imposes an annual burden of 3 hours per year to maintain the requisite records. The Commission estimates that there are approximately 150 internal broker-dealer systems, resulting in an annual recordkeeping burden of 450 hours. Therefore, the Commission estimates that compliance with Rule 17a-4 requires 1,042,866 hours each year ((4,104 broker-dealers × 254 hours) + (150 broker-dealers × 3 hours). These burdens are recordkeeping burdens.
The staff believes that compliance personnel would be charged with ensuring compliance with Commission regulation, including Rule 17a-4. The staff estimates that the hourly salary of a Compliance Clerk is $65 per hour.
Based on conversations with members of the securities industry and the Commission's experience in the area, the staff estimates that the average broker-dealer spends approximately $5,000 each year to store documents required to be retained under Rule 17a-4. Costs include the cost of physical space, computer hardware and software, etc., which vary widely depending on the size of the broker-dealer and the type of storage media employed. The Commission estimates that the annual reporting and recordkeeping cost burden is $20,520,000. This cost is calculated by the number of active, registered broker-dealers multiplied by the reporting and recordkeeping cost for each respondent (4,104 active, registered broker-dealers × $5,000).
Written comments are invited on: (a) 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; (b) the accuracy of the Commission's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted in writing within 60 days of this publication.
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information under the PRA unless it displays a currently valid OMB control number.
Please direct your written comments to: Pamela Dyson, Director/Chief Information Officer, Securities and Exchange Commission, c/o Remi Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or send an email to:
Pursuant to Section 19(b)(1)
The Exchange proposes to amend NYSE Arca Equities Rule 7.35P (Auctions), Rule 7.34P (Trading Sessions), Rule 7.18P (Halts), and 7.31P (Orders and Modifiers) regarding order processing following an auction or when transitioning from one trading sessions to another. The proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend NYSE Arca Equities Rule 7.35P (Auctions) (“Rule 7.35P”), Rule 7.34P (Trading Sessions) (“Rule 7.34P”), Rule 7.18P (Halts) (“Rule 7.18P”), and 7.31P (Orders and Modifiers) (“Rule 7.31P”) regarding order processing following an auction or when transitioning from one trading session to another. These proposed changes would revise how the Exchange processes orders on the Pillar trading platform only.
Currently, under Rule 7.35P(g), during the Auction Processing Period,
When the Exchange transitions to continuous trading, either after auction processing concludes or when transitioning from one trading session to another, the Exchange transitions to continuous trading pursuant to the steps specified in Rule 7.35P(h). Specifically, the Exchange will first expire orders that are no longer eligible to trade. Next, orders that are designated for a trading session and that were received during a prior trading session or during the Auction Processing Period, and that did not participate in the auction, will become eligible to trade. Then, before continuous trading will begin, the Exchange will process any order instructions received either during the Auction Imbalance Freeze or Auction Processing Period, which includes new orders and requests to cancel, will next adjust the display price and working price of orders based on the PBBO or NBBO, and if orders are marketable, will trade and/or route such orders based on price-time priority. After marketable orders have routed or traded, the Exchange will publish a quote for the next trading session.
With respect to order entry for the Core Trading Session, Rule 7.34P(c)(1)(C) currently provides that Limit Orders designated IOC and Cross Orders entered before or during the Early Trading Session and designated for the Core Trading Session will be rejected if entered before the Core Open Auction concludes. As such, a Limit Order designated IOC that is entered after 9:30:00, but before the Core Open Auction concludes, would be rejected.
Finally, Rule 7.18P(c)(2) provides that during a halt or pause in an Exchange-listed security, the Exchange retains resting orders in the NYSE Arca Book and assigns Limit Orders a working price and display price that is equal to the limit price of the order. The Exchange proposes to amend order and order instruction processing following an auction or when transitioning from one trading session to another to:
• Evaluate the status of orders that were live before the auction or in the earlier trading session and are eligible to trade after the auction/next trading session to assess whether to publish a new quote;
• After the Auction Processing Period ends, process orders that become eligible to trade in time sequence with specified cancel request; and
• Distinguish when requests to cancel, cancel and replace, and modify an order would be processed on arrival based on whether the impacted order was previously eligible to trade.
The Exchange believes that these proposed changes would simplify the transition to continuous trading following an auction or the transition from one trading session to another. Specifically, rather than waiting for all marketable orders to be traded or routed in price/time priority before publishing a quote, the Exchange would be evaluating orders at an earlier stage to determine whether to publish a quote. After publishing a quote, orders that become eligible to trade and related order instructions would be traded, routed, or quoted in time sequence. These proposed order processing changes would facilitate the Exchange in applying Price Bands, as defined in the Regulation NMS Plan to Address Extraordinary Market Volatility (“LULD Plan”),
To effect the rule change, the Exchange proposes to amend Rules 7.35P(g) and (h) to specify order and order instruction processing both during the Auction Processing Period and when transitioning to continuous trading. The Exchange also proposes to amend Rules 7.31P and 7.34P to specify that Limit Orders designated IOC and Cross Orders would be accepted during the Auction Processing Period. Finally, the Exchange proposes to amend Rule 7.18P to specify that orders that were on the NYSE Arca Book before a halt or pause would retain their last working and display price.
To effect the changes to how order instructions would be processed during the Auction Processing Period, the Exchange proposes to amend Rule 7.35P(g). As proposed, Rule 7.35P(g) would provide that new orders received during the Auction Processing Period would be accepted but would not be processed until after the Auction Processing Period. This proposed rule text is based on current Rule 7.35P(g), with a non-substantive change to specify that the processing would be “after the Auction Processing Period” rather than “until after the applicable auction concludes.” The proposed change is designed to use consistent terminology throughout proposed Rule 7.35P(g) and (h) without any change to its meaning.
Proposed Rule 7.35P(g) would further provide that for purposes of paragraphs (g) and (h) of that rule, an “order instruction” refers to a request to cancel, cancel and replace, or modify an order. The current rule text does not currently specify how the Exchange would process requests to modify an order during the Auction Processing Period. However, because requests to modify an order would be handled in the same manner as requests to cancel or requests to cancel and replace and [sic] order, the Exchange proposes to include modifying an order in the definition of “order instruction.” As further proposed, during the Auction Processing Period, order instructions would be processed as described in proposed Rules 7.35P(g)(1)-(2), which would replace the remainder of the current text of Rule 7.35P(g).
• Proposed Rule 7.35P(g)(1) would provide that an order instruction received during the Auction Processing Period would not be processed until after the Auction Processing Period if it relates to an order that was received before the Auction Processing Period. This proposed text is based on current Rule 7.35P(g) with no substantive changes, but with revised text to use consistent terminology. The proposed
• Proposed Rule 7.35P(g)(2) would provide that an order instruction received during the Auction Processing Period would be processed on arrival if it relates to an order that was received during the Auction Processing Period. This proposed rule text represents a substantive change from current Rule 7.35P(g), which provides that the Exchange rejects a request to cancel and replace an order that was entered during the Auction Processing Period. The Exchange believes that if the Exchange receives an order during the Auction Processing Period, because such order would not be eligible to participate in an auction and because such order is not yet eligible to trade following the auction or in the next trading session, there should be no restrictions on cancelling, replacing, or modifying such non-live order.
The Exchange also proposes to amend which orders may be entered during the Auction Processing Period. Currently, Rule 7.34P(c)(1)(C) provides that Limit Orders designated IOC and Cross Orders entered before or during the Early Trading Session and designated for the Core Trading Session will be rejected if entered before the Core Open Auction concludes. Because of the changes to order processing following the Auction Processing Period to process orders that are received during the Auction Processing Period in time sequence (as described in greater detail below), the Exchange proposes to accept Limit Orders designated IOC and Cross Orders during the Auction Processing Period. Because the Auction Processing Period occurs after 9:30 a.m. Eastern Time, an ETP Holder may be timing to send Limit Orders designated IOC as soon after 9:30 a.m. Eastern Time as feasible and would not know the precise time when the Exchange has transitioned to continuous trading. To avoid rejecting orders designated for the Core Trading Session that were entered during Core Trading Hours,
The Exchange further proposes to amend Rule 7.34P(c)(2) to add new subparagraph (C) that would provide that Limit Orders designated IOC and Cross Orders entered before and during the Core Trading Session and designated for the Late Trading Session would be rejected if entered before the Auction Processing Period for the Closing Auction. Currently, the rule is silent on the treatment of Limit Orders designated IOC and Cross Orders that are designated for the Late Trading Session only and entered during the Core Trading Session or earlier, but the treatment is the same as provided for in current Rule 7.34P(c)(1)(C). The Exchange proposes to codify the treatment of such orders entered during the Core Trading Session, and in so doing, make the same substantive change as proposed for Rule 7.34P(c)(1)(C).
To effect the changes to how the Exchange would transition to continuous trading, the Exchange proposes to amend Rule 7.35P(h). The Exchange proposes a non-substantive clarifying change to the text of Rule 7.35P(h) to replace the phrase “the Exchange will transition to continuous trading session for the applicable trading session” with the phrase “the Exchange will transition to continuous trading following an auction or when transitioning from one trading session to another” to specify that Rule 7.35P(h) governs both trading session transition (which may involve an auction) and transition to continuous trading following a Trading Halt Auction. Rule 7.35P(h)(1), which is not changing, and proposed Rules 7.35P(h)(2)-(3), which will be new rule text, would specify how orders and order instructions would be processed as the Exchange transitions to continuous trading. The Exchange proposes to delete current Rule 7.35P(h)(2), (h)(3), and (h)(3)(A)-(D) (with the exception of the second sentence of current Rule 7.35P(h)(3)(B), which, as described below, will be included in proposed Rule 7.35P(h)(3)(C)).
Proposed Rule 7.35P(h)(2) would specify how the Exchange would process order instructions during the transition to continuous trading:
• Proposed Rule 7.35P(h)(2)(A) would provide that an order instruction received during the Auction Imbalance Freeze,
• Proposed Rule 7.35P(h)(2)(B) would provide that an order instruction received during the transition to continuous trading would be processed on arrival if it relates to an order that was entered during the Auction Processing Period or the transition to continuous trading. This proposed processing would therefore apply to orders that were not previously live and were entered after the Auction Processing Period began. Similar to proposed Rule 7.35P(g)(2), because these orders have not yet been processed, the Exchange believes it is appropriate to apply order instructions against such orders immediately.
Proposed Rule 7.35P(h)(3) would specify how orders would be processed when transitioning to continuous
• Proposed Rule 7.35P(h)(3)(A) would provide that a quote would be published based on unexecuted orders that were eligible to trade in the trading sessions both before and after the transition or auction,
Proposed Rule 7.35P(h)(3)(A)(i) would provide that before publishing a quote when transitioning from a prior trading session or following the Early Open Auction, Core Open Auction, or Closing Auction: (1) Previously-live orders that are marketable would be traded, routed, or cancelled in time sequence; (2) a new quote would be published only if different from the last-published quote;
Because the Exchange does not currently update its quote solely because it transitions from one trading session to another, the Exchange would not be changing that behavior when evaluating whether to publish a quote. When assessing whether previously-live orders are marketable, the Exchange would re-price them first, as provided for in proposed Rule 7.35P(h)(3)(C). If such orders would become marketable against each other or a protected quote, they would be traded or routed, as applicable. In addition, because such orders would be subject to LULD Plan Price Bands, such orders may be cancelled if priced through a Price Band.
With respect to proposed cross reference to Rule 7.31P(a)(2)(C), that rule describes how the Exchange would not publish a new BBO that would lock or cross a PBBO that initially had locked or crossed our previously-displayed quote. Because of updates to the PBBO during the Auction Processing Period, a similar set of facts and circumstances could arise, and rather than publishing a new quote that would lock or cross the PBBO, the Exchange would adjust the display price of Limit Orders as provided for in Rule 7.31P(a)(2)(C) until such time that the limit price of such orders no longer locks or crosses the PBBO.
Proposed Rule 7.35P(h)(3)(A)(ii) would provide that before publishing a quote following a Trading Halt Auction: (1) Previously-live Limit Orders that are designated with a Proactive if Locked/Crossed Modifier or that would be the result of reserve interest replenishing the fully-executed display quantity of a routable Reserve Order would route, if marketable against protected quotations on Away Markets; (2) previously-live orders marketable against other orders in the NYSE Arca Book that would not trade-through a protected quotation would trade; and (3) the display price of all other orders that are marketable against a protected quotation on an Away Market would be adjusted consistent with Rule 7.31P(a)(2)(C). The Exchange proposes this difference in processing following a Trading Halt Auction to avoid locking or crossing a protected quotation, the Exchange proposes to re-price the display price of such orders as provided for in Rule 7.31P(a)(2)(C). In addition, unlike a trading session transition change, because the Exchange would not have a published quote during a halt or pause, if there is sufficient interest, the Exchange would publish a quote at this stage following a Trading Halt Auction.
• Proposed Rule 7.35P(h)(3)(B) would provide that next, unexecuted orders that were not eligible to trade in the prior trading session (or were received during a halt or pause) or that were received during the Auction Processing Period, would be assigned a new working time at the end of the Auction Processing Period in time sequence relative to one another based on original entry time. This would be new processing of such orders. Currently, as provided for in Rule 7.36P(f)(1), an order is assigned a working time based on its original order entry time. That would remain true for such orders for purposes of participation in the applicable auction.
• Proposed Rule 7.35P(h)(3)(C) would provide that when processing orders, the display price and working price of an order would be adjusted based on the PBBO or NBBO, as provided for in Rule 7.31P. This rule text is based on the first sentence of current Rule 7.31P(h)(3)(B). The second sentence of proposed Rule 7.35P(h)(3)(C) would retain the second sentence of current Rule 7.35P(h)(3)(B), which states that “when transitioning to continuous trading, the display price and working price of Day ISOs will be adjusted in the same manner as Arca Only Orders until the Day ISO is either traded in full or displayed at its limit price.”
The Exchange also proposes to amend Rule 7.18P regarding order handling during a halt or pause. During a UTP Regulatory Halt, the Exchange cancels any unexecuted portions of Market Orders. The Exchange proposes to add that the Exchange would also cancel
The Exchange also proposes to amend how orders are maintained on the NYSE Arca Book during a halt or pause. As proposed, rather than assign Limit Orders a working price and display price that is equal to the limit price of the Order, the Exchange proposes to amend Rule 7.18P(c)(2) to provide that during a halt or pause in Exchange-listed securities, it would maintain resting orders on the NYSE Arca Book at their last working price and display price. This proposed change would not alter how such orders would participate in a Trading Halt Auction, which would continue to be based on their limit price, and not their last working price.
Because of the technology changes associated with this proposed rule change, the Exchange will announce by Trader Update the implementation date.
The proposed rule change is consistent with Section 6(b) of the Securities Exchange Act of 1934 (the “Act”),
The Exchange believes the proposed changes would remove impediments to and perfect the mechanism of a free and open market and a national market system, and in general, to protect investors and the public interest, because they are designed to simplify order and order instruction processing both during the Auction Processing Period and when transitioning to continuous trading. Specifically, the Exchange believes that publishing a quote based on orders that were previously live before the new trading session or auction would result in the Exchange publishing an updated quote sooner than under current rules. In addition, the proposed change to process orders that become live after an auction or in a new trading session in time sequence rather than in price/time priority would similarly simplify order processing by processing such orders in the order they were received. The Exchange also believes that assigning a new working time to orders that were not live prior to the transition to continuous trading would preserve the time priority of those orders that were eligible to trade in an earlier trading session or before the auction. This proposed rule change is also based on how Bats and Nasdaq assign time priority to orders that were not live prior to an auction and that are added to the book after an auction.
The Exchange also believes that the proposed changes to when the Exchange would process order instructions, both during the Auction Processing Period and when transitioning to continuous trading, are designed to provide consistent treatment of when order instructions would be processed, which would be based on when an order was entered. The Exchange believes that waiting to process order instructions that relate to an order that was entered before the Auction Processing Period (including order instructions entered during the Auction Imbalance Freeze that were not yet processed) would remove impediments to and perfect a free and open market and a national market system because it would ensure that a customer's order instructions would be processed in time sequence with the underlying order. Likewise, the Exchange believes that the proposed change to reject subsequent order instructions when order instructions are not processed on arrival, as provided for in proposed Rules 7.35P(g)(1) and 7.35P(2)(A) [sic], would remove impediments to and perfect the mechanism of a free and open market and a national market system because it would reduce the potential for conflicting order instructions being entered for the same order. By contrast, the Exchange believes that if a new order is entered during a transition phase, such as the Auction Processing Period or the transition to continuous trading, ETP Holders do not have an expectation that such orders would be processed yet, and therefore processing order instructions relating to such new orders on arrival would remove impediments to and perfect the mechanism of a free and open market and a national market system by ensuring that the most recent instruction for such not-yet-live order is available when the order will be processed in time sequence with other orders.
The Exchange also believes that the proposed change to accept Limit Orders designated IOC and Cross Orders during the Auction Processing Period would remove impediments to and perfect the mechanism of a free and open market and a national market system. Specifically, the Exchange believes that ETP Holders that enter such orders after 9:30 a.m. Eastern Time or after 4:00 p.m. Eastern Time have an expectation that
The Exchange believes that the proposed changes to Rule 7.18P would remove impediments to and perfect the mechanism of a free and open market and a national market system because they are designed to streamline order processing during a halt or pause. The Exchange further believes that the proposed change during a UTP Regulatory Halt to cancel orders that are not eligible to trade in the current trading session would remove impediments and perfect the mechanism of a free and open market and a national market system because the changes are designed to reduce the potential for such orders to lock or cross a protected quotation if trading resumes in that security in the next trading session.
The Exchange further believes that the proposed changes would remove impediments to and perfect the mechanism of a free and open market and in general, to protect investors and the public interest because the proposed changes would facilitate the Exchange in applying Price Bands under the LULD Plan to Exchange-listed securities immediately following the transition to the Core Trading Session or following a Trading Halt Auction during Core Trading Hours without waiting for such Price Bands to be published by the SIP based on the reference price provided by the Exchange.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change is not designed to address any competitive issues, but rather, to streamline and simplify order and order instruction processing both during and immediately after the Auction Processing Period.
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section 19(b)(3)(A) of the Act
A proposed rule change filed pursuant to Rule 19b-4(f)(6) under the Act
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 08/14/2016, applications for disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14811B and for economic injury is 148120.
U.S. Small Business Administration.
Amendment 5.
This is an amendment of the Presidential declaration of a major disaster for the State of West Virginia (FEMA-4273-DR), dated 06/25/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
Alan 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 the State of West Virginia, dated 06/25/2016 is hereby amended to extend the deadline for filing applications for physical damages as a result of this disaster to 09/07/2016.
All other information in the original declaration remains unchanged.
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 Louisiana (FEMA-4277-DR), dated 08/16/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
Alan 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 Louisiana, dated 08/16/2016, is hereby amended to
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for the State of Louisiana (FEMA-4277-DR), dated 08/14/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the Presidential disaster declaration for the State of Louisiana, dated 08/14/2016 is hereby amended to include the following areas as adversely affected by the disaster:
All other information in the original declaration remains unchanged.
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), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
Notice is hereby given of the following determinations: Pursuant to the authority vested in me by the Act of October 19, 1965 (79 Stat. 985; 22 U.S.C. 2459), E.O. 12047 of March 27, 1978, the
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), E.O. 12047 of March 27, 1978, the Foreign Affairs Reform and Restructuring Act of 1998 (112 Stat. 2681,
For further information, including a list of the imported objects, contact the Office of Public Diplomacy and Public Affairs in the Office of the Legal Adviser, U.S. Department of State (telephone: 202-632-6471; email:
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:
State Justice Institute.
Notice of meeting.
The SJI Board of Directors will be meeting on Monday, September 12, 2016 at 1:00 p.m. The meeting will be held at the Multnomah County Circuit Court in Portland, Oregon. The purpose of this meeting is to consider grant applications for the 4th quarter of FY 2016, and other business. All portions of this meeting are open to the public.
Multnomah County Circuit Court, 1021 SW Fourth Avenue, Portland, Oregon, 97204.
Jonathan Mattiello, Executive Director, State Justice Institute, 11951 Freedom Drive, Suite 1020, Reston, VA 20190, 571-313-8843,
On August 4, 2016, BNSF Railway Company (BNSF) filed with the Surface Transportation Board (Board) a petition under 49 U.S.C. 10502 for exemption from the provisions of 49 U.S.C. 10903 to discontinue trackage rights over a 106.7-mile line of railroad (the Line) owned by Twin Cities & Western Railroad Company (TC&W), between milepost 600.7 at Ortonville and milepost 494.0 at Buffalo Lake in Big Stone, Swift, Chippewa, Yellow Medicine, and Renville Counties, Minn.
To BNSF's knowledge, the Line does not contain any federally granted rights-of-way. Any documentation in BNSF's possession will be made available promptly to those requesting it.
The interest of railroad employees will be protected by the conditions set forth in
By issuance of this notice, the Board is instituting an exemption proceeding pursuant to 49 U.S.C. 10502(b). A final decision will be issued by November 22, 2016.
Because this is a discontinuance proceeding and not an abandonment, trail use/rail banking and public use conditions are not appropriate. This action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Any offer of financial assistance (OFA) under 49 CFR 1152.27(b)(2) to subsidize continued rail service will be due no later than 10 days after service of a decision granting the petition for exemption. Each OFA must be accompanied by the filing fee, which is currently set at $1,600.
All filings in response to this notice must refer to Docket No. AB 6 (Sub-No. 467X) and must be sent to: (1) Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001; and (2) Karl Morell, 655 Fifteenth Street NW., Suite 225, Washington, DC 20005. Replies to the petition are due on or before September 13, 2016.
Persons seeking further information concerning discontinuance procedures may contact the Board's Office of Public Assistance, Governmental Affairs, and Compliance at (202) 245-0238 or refer to the full abandonment and discontinuance regulations at 49 CFR pt. 1152. Questions concerning environmental issues may be directed to the Board's Office of Environmental Analysis at (202) 245-0305. [Assistance for the hearing impaired is available through the Federal Information Relay Service (FIRS) at 1-800-877-8339.]
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Southeastern Land, LLC (Southeastern), a noncarrier, has filed a verified notice of exemption under 49 CFR 1150.31 to acquire from Vaughan Railroad Company (Vaughan), and to operate, approximately 14 miles of rail line between milepost 7.5 near Belva and milepost 22.0 on Twentymile Creek, northeast of Vaughan, in Nicholas and Fayette Counties, W. Va. (the Line).
In the verified notice, Southeastern states that Southeastern, Vaughan, and Vaughan's affiliates have entered into a Purchase and Sale Agreement (Agreement) under which Southeastern will purchase the 14-mile rail line in addition to certain other assets. The Line is currently not in use and has no active customers. After consummation of the transaction, Southeastern intends to provide service to future customers on the Line or contract with a third party to provide the service. According to Southeastern, the Line is subject to a trackage rights agreement with CSX Transportation, Inc.,
According to Southeastern, the Agreement between Southeastern and Vaughan does not contain any provision that prohibits Southeastern from interchanging traffic or limits Southeastern's ability to interchange traffic with a third party.
Southeastern certifies that its projected revenues upon consummation of the proposed transaction will not result in Southeastern's becoming a Class I or Class II rail carrier and states that its projected annual revenues will not exceed $5 million.
This transaction may be consummated on or after September 7, 2016, the effective date of the exemption (30 days after the verified notice was filed).
If the verified notice contains false or misleading information, the exemption is void ab initio. Petitions to revoke the exemption under 49 U.S.C. 10502(d) may be filed at any time. The filing of a petition to revoke will not automatically stay the effectiveness of the exemption. Petitions to stay must be filed no later than August 31, 2016 (at least seven days before the exemption becomes effective).
An original and 10 copies of all pleadings, referring to Docket No. FD 36055 must be filed with the Surface Transportation Board, 395 E Street SW., Washington, DC 20423-0001. In addition, a copy of each pleading must be served on Rebecca S. Gohmann, General Counsel of Southeastern Land, LLC, 2408 Sir Barton Way, Suite 325, Lexington, KY 40509.
According to Southeastern, this action is categorically excluded from environmental review under 49 CFR 1105.6(c).
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Federal Highway Administration (FHWA), DOT.
Notice.
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic iron and steel components of casings, housings, electrical, and mechanical equipment needed for rehabilitation of Isthmus Bridge in the State of Oregon.
The effective date of the waiver is August 25, 2016.
For questions about this notice, please contact Mr. Gerald Yakowenko, FHWA Office of Program Administration, (202) 366-1562, or via email at
An electronic copy of this document may be downloaded from the
The FHWA's Buy America policy in 23 CFR 635.410 requires a domestic manufacturing process for any steel or iron products (including protective coatings) that are permanently incorporated in a Federal-aid construction project. The regulation also provides for a waiver of the Buy America requirements when the application would be inconsistent with the public interest or when satisfactory quality domestic steel and iron products are not sufficiently available. This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for use of non-domestic iron and steel components of casings, housings, electrical, and mechanical equipment for rehabilitation of Isthmus Bridge in the State of Oregon.
In accordance with Division K, section 122 of the “Consolidated and Further Continuing Appropriations Act, 2015” (Pub. L. 113-235), FHWA published a notice of intent to issue a waiver on its Web site;
In accordance with the provisions of section 117 of the SAFETEA-LU Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572), FHWA is providing this notice as its finding that a waiver of Buy America requirements is appropriate. The FHWA invites public comment on this finding for an additional 15 days following the effective date of the finding. Comments may be submitted to FHWA's Web site via the link provided to the waiver page noted above.
23 U.S.C. 313; Pub. L. 110-161, 23 CFR 635.410)
Federal Highway Administration (FHWA), DOT.
Notice of Establishment of the Emergency Route Working Group; Request for Nominations.
FHWA announces the establishment of the Emergency Route Working Group (ERWG) for a 2-year period. The ERWG will provide the U.S. Secretary of Transportation, through the Administrator of the FHWA, with advice and recommendations for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG will provide the U.S. Secretary of Transportation a written report by December 4, 2016, on its findings and recommendation for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG's advice and recommendations will work within existing legal authorities and not require changes in State or Federal law for DOT to implement.
The deadline for nominations for ERWG members must be received on or before September 23, 2016.
All nomination materials should be emailed to
Crystal Jones, U.S. Department of Transportation, Federal Highway Administration, Room E84-314, 1200 New Jersey Avenue SE., Washington, DC 20590. Any person needing accessibility accommodations should contact Crystal Jones at (202) 366-2976; email:
Section 5502 of the Fixing America's Surface Transportation (FAST) Act (P.L. 114-94, 129 Stat. 1312) requires the Secretary of Transportation to establish a working group to determine best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. Pursuant to Section 9(a)(2) of the Federal Advisory Committee Act (FACA), and in accordance with 41 CFR 102-3.65, and following consultation with the Committee Management Secretariat, General Services Administration, notice is hereby given that the ERWG will be established for up to a 2-year period. The ERWG will provide the U.S. Secretary of Transportation, through the Administrator of the FHWA, with advice and recommendations for the implementation of best practices for expeditious State approval of special permits for vehicles involved in emergency response and recovery. The ERWG will provide the U.S. Secretary of Transportation a written report by December 4, 2016, on its findings and recommendations. The ERWG's advice and recommendations will work within existing legal authorities and not require changes in State or Federal law for DOT to implement.
The Department of Transportation is hereby soliciting nominations for members of the ERWG. The Federal Highway Administrator, on behalf of the Secretary of Transportation, will appoint up to 25 ERWG members. The
a. impediments currently exist that prevent expeditious State approval of special permits for vehicles involved in emergency response and recovery;
b. it is possible to pre-identify and establish emergency routes between States through which infrastructure repair materials could be delivered following a natural disaster or emergency;
c. a State could pre-designate an emergency route identified under paragraph (b) as a certified emergency route if a motor vehicle that exceeds the otherwise applicable Federal and State truck length or width limits may safely operate along such route during periods of declared emergency and recovery from such periods; and
d. an online map could be created to identify each pre-designated emergency route under paragraph (c), including information on specific limitations, obligations, and notification requirements along that route.
The ERWG membership will seek to balance the following interests to the extent practicable; but as required by law the membership shall include representatives from State highway transportation departments or agencies; relevant modal agencies within the DOT; emergency response or recovery experts; relevant safety groups; and entities affected by special permit restrictions during emergency response and recovery efforts. The ERGW members serve at the pleasure of the Secretary, but may serve for a term of 2 years or less. The Chair and Vice Chair of the ERWG will be appointed by the FHWA Administrator from among the selected members, and the ERWG is expected to meet 12 times before the termination, which is defined in law as 1 year after the group delivers the report to the Secretary of Transportation required under Section 5502(c) of the FAST Act. Subcommittees may be formed to address specific emergency route issues. Some ERWG members may be appointed as special Government employees and will be subject to certain ethical restrictions, and such members will be required to submit certain information in connection with the appointment process. With the exception of travel and per diem for official travel, members will serve without compensation.
(1) Name, title, and relevant contact information (including phone, fax, and email address) of the individual requesting consideration;
(2) A letter of support from a company, union, trade association, or non-profit organization on letterhead containing a brief description why the nominee should be considered for membership;
(3) Short biography of nominee including professional and academic credentials;
(4) An affirmative statement that the nominee is not a federally registered lobbyist, and that the nominee understands that if appointed, the nominee will not be allowed to continue to serve as a ERWG member if the nominee becomes a federally registered lobbyist;
(5) An affirmative statement that the nominee meets all ERWG eligibility requirements.
Please do not send company, trade association, or organization brochures or any other information. Materials submitted should total two pages or less. Should more information be needed, DOT staff will contact the nominee, obtain information from the nominee's past affiliations, or obtain information from publicly available sources, such as the Internet.
Nominations may be emailed to
A selection team comprising representatives from several DOT offices will review the nomination packages. The selection team will make recommendations regarding membership to the Secretary of Transportation through the Federal Highway Administrator based on criteria including (1) professional or academic expertise, experience, and knowledge; (2) stakeholder representation; (3) availability and willingness to serve; and (4) skills working in committees and advisory panels. The Federal Highway Administrator will submit a list of recommended candidates to the Secretary of Transportation for review and selection of ERWG members.
Nominations are open to all individuals without regard to race, color, religion, sex, national origin, age, mental or physical handicap, marital status, or sexual orientation. To ensure that recommendations to the Secretary take into account the needs of the diverse groups served by DOT, membership shall include, to the extent practicable, individuals with demonstrated ability to represent minorities, women, and persons with disabilities.
Federal Highway Administration (FHWA), DOT.
Notice.
This notice provides information regarding FHWA's finding that a Buy America waiver is appropriate for the use of non-domestic submersible pumps; 1,200 GPM, 6” diameter discharge with 42.4 ft. head compatible, with current well lift station 1 at I-94 in Fargo, North Dakota.
The effective date of the waiver is August 25, 2016.
For questions about this notice, please contact Mr. Gerald Yakowenko, FHWA Office of Program Administration, (202) 366-1562, or via email at
An electronic copy of this document may be downloaded from the
The FHWA's Buy America policy in 23 CFR 635.410 requires a domestic manufacturing process for any steel or iron products (including protective coatings) that are permanently incorporated in a Federal-aid
In accordance with Division K, section 122 of the “Consolidated and Further Continuing Appropriations Act, 2015” (Pub. L. 113-235), FHWA published a notice of intent to issue a waiver on its Web site;
In accordance with the provisions of section 117 of the SAFETEA-LU Technical Corrections Act of 2008 (Pub. L. 110-244, 122 Stat. 1572), FHWA is providing this notice as its finding that a waiver of Buy America requirements is appropriate. The FHWA invites public comment on this finding for an additional 15 days following the effective date of the finding. Comments may be submitted to FHWA's Web site via the link provided to the waiver page noted above.
23 U.S.C. 313; Pub. L. 110-161, 23 CFR 635.410.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 23, 2016.
Comments should refer to docket number MARAD-2016-0086. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel NISSI is:
The complete application is given in DOT docket MARAD-2016-0086 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 23, 2016.
Comments should refer to docket number MARAD-2016-0084. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel JULIA is:
The complete application is given in DOT docket MARAD-2016-0084 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 23, 2016.
Comments should refer to docket number MARAD-2016-0085. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel KIA ORA is:
The complete application is given in DOT docket MARAD-2016-0085 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 23, 2016.
Comments should refer to docket number MARAD-2016-0082. Written comments may be submitted by hand or by mail to the Docket Clerk,
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel ANGARI is:
The complete application is given in DOT docket MARAD-2016-0082 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
Maritime Administration, Department of Transportation.
Notice.
As authorized by 46 U.S.C. 12121, the Secretary of Transportation, as represented by the Maritime Administration (MARAD), is authorized to grant waivers of the U.S.-build requirement of the coastwise laws under certain circumstances. A request for such a waiver has been received by MARAD. The vessel, and a brief description of the proposed service, is listed below.
Submit comments on or before September 23, 2016.
Comments should refer to docket number MARAD-2016-0083. Written comments may be submitted by hand or by mail to the Docket Clerk, U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. You may also send comments electronically via the Internet at
Bianca Carr, U.S. Department of Transportation, Maritime Administration, 1200 New Jersey Avenue SE., Room W23-453, Washington, DC 20590. Telephone 202-366-9309, Email
As described by the applicant the intended service of the vessel OCEANFLYER is:
The complete application is given in DOT docket MARAD-2016-0083 at
Anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review DOT's complete Privacy Act Statement in the
By Order of the Maritime Administrator.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT)
Denial of petition.
BMW of North America, LLC (BMW), a subsidiary of BMW AG in Munich, Germany, has determined that certain model year (MY) 2014-2015 BMW R nineT motorcycles do not fully comply with paragraph S6.4.3(a) (Table V-b) of Federal Motor Vehicle Safety Standard (FMVSS) No. 108,
For further information on this decision contact Mike Cole, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5319, facsimile (202) 366-5930.
Notice of receipt of BMW's petition was published, with a 30-day public comment period, on June 4, 2015 in the
BMW has since revised its petition to indicate that the obstructed lens area was 666 sq-mm and that the photometric test point (20°IB/5° down) was also obstructed and measured only 1.1 cd (FMVSS No. 108, S6.1.3.1 and S7.1.2.13.2).
Paragraph S6.1.3.1: Each lamp, reflective device, and item of associated equipment must be securely mounted on a rigid part of the vehicle, other than glazing, that is not designed to be removed except for repair, within the mounting location and height limits as specified in Table I, and in a location where it complies with all applicable photometric requirements, effective projected luminous lens area requirements, and visibility requirements with all obstructions considered;
Paragraph S6.4.3(a): When a vehicle is equipped with any lamp listed in Table V-b each such lamp must provide not less than 1250 sq mm of unobstructed effective projected luminous lens area in any direction throughout the pattern defined by the corner points specified in Table V-b for each such lamp;
Paragraph S7.1.2.13.2: As an alternative to S7.1.2.13.1, a rear turn signal lamp installed on a motorcycle may be designed to conform to the photometry requirements of Table XIII-a.
(A) BMW states that when the subject motorcycles are upright on a level surface and equipped with standard tires at their recommended cold tire inflation pressure; the lower edge of the rear turn signal lenses are approximately 747 mm above ground, the lower edge of the tail lamp lens is approximately 710 mm above ground and the tail lamp lens extend upward. BMW believes that due to these geometric conditions there is some overlap in the vertical direction between the rear turn signal lenses and the tail lamp lens however, they are not aligned along the same longitudinal centerline [of the turn signals]. Specifically, the tail lamp is on the motorcycle's longitudinal centerline while the rear turn signals are on stalks offset from the centerline. As a result, BMW believes that this has a very minor affect upon the effective projected luminous lens area.
(B) BMW stated its belief that the obstruction from the tail lamp only occurs if another road user in a following vehicle has an eye-point of approximately 747 mm above ground (extremely low for an average vehicle) and is a worst-case-scenario. For other road users with a higher eye-point, there is no apparent obstruction and the turn signal would appear to meet the requirements of FMVSS No. 108.
(C) BMW also stated its belief that the effect of the noncompliance,
(D) BMW Customer Relations has not received any contacts from motorcycle riders, or other road users regarding this issue. Also, BMW is not aware of any accidents or injuries that have occurred as a result of this issue.
BMW has additionally informed NHTSA that it has corrected the noncompliance so that all future production of the subject vehicles will fully comply with FMVSS No. 108.
In summation, BMW believes that the described noncompliance of the subject motorcycles is inconsequential to motor vehicle safety, and that its petition, to exempt BMW from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the noncompliance as required by 49 U.S.C. 30120 should be granted.
The first condition BMW reviewed was the rear turn signal mounting height. BMW indicates that for another road user with a higher eye-point, there is no apparent obstruction
The second condition that BMW reviewed was a traffic condition of “
The third condition that BMW reviewed was a traffic condition of “
49 U.S.C. 30118, 30120: delegations of authority at 49 CFR 1.95 and 501.8.
Financial Crimes Enforcement Network, Department of the Treasury.
Notice and request for comments.
As part of our continuing effort to reduce paperwork and respondent burden, FinCEN invites comment on a renewal, without change, to information collection requirements finalized on March 15, 2006 (71 FR 13260, RIN 1506-AA64), imposing a special measure against the Commercial Bank of Syria, including its subsidiary Syrian Lebanese Commercial Bank, as a financial institution of primary money laundering concern. This request for comments is being made pursuant to the Paperwork Reduction Act of 1995 (“PRA”), Public Law 104-13, 44 U.S.C. 3506(c)(2)(A).
Written comments are welcome and must be received on or before October 24, 2016.
You may submit comments identified by OMB Control Number 1506-0036, by any of the following methods:
•
•
• Please submit by one method only.
• All comments submitted by either method in response to this notice will become a matter of public record. Therefore, you should submit only information that you wish to make publicly available.
The FinCEN Resource Center at 1-800-767-2825 or 1-703-905-3591 (not a toll free number) and select option 3 for regulatory questions. Email inquiries can be sent to
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 (“OMB”). Records required to be retained under the BSA must be retained for five years. Generally, information collected pursuant to the BSA is confidential but may be shared as provided by law with regulatory and law enforcement authorities.
Notice and request for comments.
The Department of the Treasury, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A). Currently the Bureau of the Fiscal Service within the Department of the Treasury is soliciting comments concerning the CMIA Annual Report and Direct Cost Claims.
Written comments should be received on or before October 24, 2016 to be assured of consideration.
Direct all written comments and requests for additional information to Bureau of the Fiscal Service, Bruce A. Sharp, 200 Third Street A4-A, Parkersburg, WV 26106-1328, or
United States Sentencing Commission.
Notice.
The Commission has decided to establish a Tribal Issues Advisory Group as a standing advisory group pursuant to 28 U.S.C. 995 and Rule 5.4 of the Commission's Rules of Practice and Procedure. Having adopted a formal charter for the Tribal Issues Advisory Group, the Commission is constituting
Application materials for the Federal judge, tribal court judge, and at-large memberships of the Tribal Issues Advisory Group should be received not later than October 24, 2016.
An applicant for the memberships of the Tribal Issues Advisory Group covered by this notice should apply by sending a letter of interest and resume to the Commission by electronic mail or regular mail. The email address is
Christine Leonard, Director, Office of Legislative and Public Affairs, (202) 502-4500,
The United States Sentencing Commission is an independent agency in the judicial branch of the United States Government. The Commission promulgates sentencing guidelines and policy statements for federal sentencing courts pursuant to 28 U.S.C. 994(a). The Commission also periodically reviews and revises previously promulgated guidelines pursuant to 28 U.S.C. 994(o) and submits guideline amendments to the Congress not later than the first day of May each year pursuant to 28 U.S.C. 994(p). Under 28 U.S.C. 995 and Rule 5.4 of the Commission's Rules of Practice and Procedure, the Commission may create standing or ad hoc advisory groups to facilitate formal and informal input to the Commission. Upon creating an advisory group, the Commission may prescribe the policies regarding the purpose, membership, and operation of the group as the Commission deems necessary or appropriate.
The Commission recently adopted a formal charter for the Tribal Issues Advisory Group. Under the charter, the purpose of the advisory group is:
(1) To assist the Commission in carrying out its statutory responsibilities under 28 U.S.C. 994(o);
(2) to provide to the Commission its views on federal sentencing issues relating to American Indian and Alaska Native defendants and victims, and to offenses committed in Indian country;
(3) to engage in meaningful consultation and outreach with tribes, tribal governments, and tribal organizations regarding federal sentencing issues that have tribal implications;
(4) to disseminate information regarding federal sentencing issues to tribes, tribal governments, and tribal organizations; and
(5) to perform any other related functions as the Commission requests.
The Tribal Issues Advisory Group shall consist of no more than 9 members. Of those 9 members, not more than 1 shall be a Federal judge; 2 shall be from the Executive Branch (one from the United States Department of Justice and one from the United States Department of the Interior); 1 shall be from a federal public defender organization or community defender organization; 1 shall be a tribal court judge; and not more than 4 shall be at-large members. All members are appointed by the Commission and shall have expertise, knowledge, and/or experience in the issues considered by the Tribal Issues Advisory Group. The Commission intends that the at-large membership shall include individuals with membership in or experience with tribes, tribal governments, and tribal organizations, appointed in a manner that ensures representation among tribal communities diverse in size, geographic location, and other unique characteristics.
All members of the Tribal Issues Advisory Group shall serve not more than two consecutive three-year terms. However, the terms of the initial membership shall be staggered so that 3 members serve a term of three years, 3 members serve a term of two years, and 3 members serve a term of one year.
The Commission invites any individual who is eligible to be appointed to the Federal judge membership, the tribal court judge membership, or the at-large membership of the Tribal Issues Advisory Group to apply by sending a letter of interest and a resume to the Commission as indicated in the
28 U.S.C. 994(a), (o), (p), § 995; USSC Rules of Practice and Procedure 5.2, 5.4.
United States Sentencing Commission.
Notice of final priorities.
In June 2016, the Commission published a notice of possible policy priorities for the amendment cycle ending May 1, 2017.
Christine Leonard, Director, Office of Legislative and Public Affairs, (202) 502-4500,
The United States Sentencing Commission is an independent agency in the judicial branch of the United States Government. The Commission promulgates sentencing guidelines and policy statements for federal sentencing courts pursuant to 28 U.S.C. 994(a). The Commission also periodically reviews and revises previously promulgated guidelines pursuant to 28 U.S.C. 994(o) and submits guideline amendments to the Congress not later than the first day of May each year pursuant to 28 U.S.C. 994(p).
Pursuant to 28 U.S.C. 994(g), the Commission intends to consider the issue of reducing costs of incarceration and overcapacity of prisons, to the
As part of its statutory authority and responsibility to analyze sentencing issues, including operation of the federal sentencing guidelines, the Commission has identified its policy priorities for the amendment cycle ending May 1, 2017. The Commission recognizes, however, that other factors, such as the enactment of any legislation requiring Commission action, may affect the Commission's ability to complete work on any or all of its identified priorities by the statutory deadline of May 1, 2017. Accordingly, it may be necessary to continue work on any or all of these issues beyond the amendment cycle ending on May 1, 2017.
As so prefaced, the Commission has identified the following priorities:
(1) Continuation of its work with Congress and other interested parties on statutory mandatory minimum penalties to implement the recommendations set forth in the Commission's 2011 report to Congress, titled Mandatory Minimum Penalties in the Federal Criminal Justice System, including its recommendations regarding the severity and scope of mandatory minimum penalties, consideration of expanding the “safety valve” at 18 U.S.C. 3553(f), and elimination of the mandatory “stacking” of penalties under 18 U.S.C. 924(c), and to develop appropriate guideline amendments in response to any related legislation.
(2) Continuation of its multi-year examination of the overall structure of the guidelines post-Booker, possibly including recommendations to Congress on any statutory changes and development of any guideline amendments that may be appropriate. As part of this examination, the Commission intends to study possible approaches to (A) simplify the operation of the guidelines, promote proportionality, and reduce sentencing disparities; and (B) appropriately account for the defendant's role, culpability, and relevant conduct.
(3) Continuation of its study of approaches to encourage the use of alternatives to incarceration.
(4) Continuation of its multi-year study of statutory and guideline definitions relating to the nature of a defendant's prior conviction (
(5) Continuation of its comprehensive, multi-year study of recidivism, including (A) examination of circumstances that correlate with increased or reduced recidivism; (B) possible development of recommendations for using information obtained from such study to reduce costs of incarceration and overcapacity of prisons, and promote effectiveness of reentry programs; and (C) consideration of any amendments to the
(6) Study of the findings and recommendations contained in the May 2016 Report issued by the Commission's Tribal Issues Advisory Group, and consideration of any amendments to the
(7) Study of the treatment of youthful offenders under the
(8) Examination of Chapter Four, Part A (Criminal History) to (A) study the treatment of revocation sentences under § 4A1.2(k), and (B) consider a possible amendment of § 4A1.3 (Departures Based on Inadequacy of Criminal History Category (Policy Statement)) to account for instances in which the time actually served was substantially less than the length of the sentence imposed for a conviction counted under the
(9) Study of offenses involving MDMA/Ecstasy, synthetic cannabinoids (such as JWH-018 and AM-2201), and synthetic cathinones (such as Methylone, MDPV, and Mephedrone), and consideration of any amendments to the
(10) Possible consideration of whether the weapon enhancement in § 2D1.1(b)(1) should be amended to conform to the “safety valve” provision at 18 U.S.C. 3553(f) and § 5C1.2 (Limitation on Applicability of Statutory Minimum Sentences in Certain Cases).
(11) Study of environmental offenses involving knowing endangerment resulting from mishandling hazardous or toxic substances, pesticides, or other pollutants, and consideration of any amendments to the
(12) Implementation of the Bipartisan Budget Act of 2015, Public Law 114-74, and any other crime legislation enacted during the 114th or 115th Congress warranting a Commission response.
(13) Resolution of circuit conflicts, pursuant to the Commission's continuing authority and responsibility, under 28 U.S.C. 991(b)(1)(B) and
(14) Consideration of any miscellaneous guideline application issues coming to the Commission's attention from case law and other sources, including possible consideration of whether a defendant's denial of relevant conduct should be considered in determining whether a defendant has accepted responsibility for purposes of § 3E1.1.
28 U.S.C. 994(a), (o); USSC Rules of Practice and Procedure 5.2.
Department of Veterans Affairs (VA).
Notice of amendment to system of records.
As required by the Privacy Act of 1974, 5 U.S.C. 552a(e), notice is hereby given that the Department of Veterans Affairs (VA) is amending the system of records currently entitled “My Health
Comments on the amendment of this system of records must be received no later than September 23, 2016. If no public comment is received, the amended system will become effective September 23, 2016.
Written comments concerning the amended system of records may be submitted through
Veterans Health Administration (VHA) Privacy Officer, Department of Veterans Affairs, 810 Vermont Avenue NW., Washington, DC 20420; telephone (704) 245-2492.
The System Number is changed from 130VA19 to 130VA10P2 to reflect the current organizational alignment.
The System Location in this system of records is being amended to include contracted data storage location.
The Categories of Individuals Covered by the System is being amended to remove “grantee, family members and friends” and add “power of attorney and legal guardian” to section (2). Section (4) is being amended to replace “VHA Information Technology (IT)” with “VA Office of Information and Technology (OI&T)”. The Categories of Records in the System is being amended to delete “grantee”. The Record Source Categories is being amended to add “power of attorney” to section (2). Routine Uses of Records Maintained in the System is being deleted:
“8. Disclosure of information may be made to VA approved researchers to enhance, advance and promote both the function and the content of the My HealtheVet application.”
This section is also being amended to add:
8. VA may disclose health information for research purposes determined to be necessary and proper to epidemiological and other research entities approved by the Under Secretary for Health or designee, such as the Medical Center Director of the facility where the information is maintained.
9. VA may disclose health information, including the name(s) and address(es) of present or former personnel of the Armed Services and/or their dependents, (a) to a Federal department or agency or (b) directly to a contractor of a Federal department or agency, at the written request of the head of the agency or the designee of the head of that agency, to conduct Federal research necessary to accomplish a statutory purpose of an agency. When this information is to be disclosed directly to the contractor, VA may impose applicable conditions on the department, agency, and/or contractor to ensure the appropriateness of the disclosure to the contractor.
The Retention and Disposal section is being amended to remove General Records Schedules (GRS) 20, item 1c and GRS 24, item 6a. This section will now include research and GRS 3.2 Item 031.
The System Manager(s) and Address, Notification Procedure, and Record Access Procedure sections are being amended to remove the Chief, Technical Infrastructure Division (31), Austin Automation Center, 1615 Woodward Street, Austin, Texas 78772. These sections will now include My Health
The Report of Intent to Amend a System of Records Notice and an advance copy of the system notice have been sent to the appropriate Congressional committees and to the Director of the Office of Management and Budget (OMB) as required by 5 U.S.C. 552a(r) (Privacy Act) and guidelines issued by OMB (65 FR 77677), December 12, 2000.
The Secretary of Veterans Affairs, or designee, approved this document and authorized the undersigned to sign and submit the document to the Office of the Federal Register for publication electronically as an official document of the Department of Veterans Affairs. Gina S. Farrisee, Deputy Chief of Staff, approved this document on August 2, 2016, for publication.
My Health
Records are maintained at Veterans Health Administration (VHA) facilities, VA National Data Centers, VA Health Data Repository (HDR), and at the contracted data storage system located in Culpepper, Virginia. Address locations for VHA facilities are listed in VA Appendix 1 of the biennial publications of the VA systems of records.
Title 38, United States Code, section 501.
The information in the My Health
Individuals covered by this system encompass: (1) All individuals who successfully register for a My Health
The records include personally identifiable information, such as an individual's full name; My Health
The sources of information for this system of records include the individuals covered by this notice and an additional contributor, as listed below:
(1) All individuals who successfully register for a My Health
(2) Representatives of the above individuals who have been provided access to the private health space by the Veteran user, including but not limited to, POA, or VA and non-VA health care providers;
(3) VA health care providers;
(4) VA OI&T staff and/or their contractors and subcontractors who may need to enter information into the system to initiate, support and maintain My Health
(5) VistA and other VA IT systems;
(6) VA researchers fulfilling VA required authorization procedures (see VHA Handbook 1200.01
To the extent that records contained in the system include information protected by 45 CFR. Parts 160 and 164 (
1. Disclosure of information in this system of records may be made to private or public sector organizations, individuals, agencies, etc., with whom VA has a contract or agreement, including subcontractors, in order to administer the My Health
2. On its own initiative, VA may disclose information, except for the names of My Health
3. VA may disclose information from this system to the National Archives and Records Administration (NARA) and General Services Administration in records management inspections conducted under title 44, United States Code (U.S.C.).
4. VA may disclose information from this system of records to the Department of Justice (DoJ), either on VA's initiative or in response to DoJ's request for the information, after either VA or DoJ determines that such information is relevant to DoJ's representation of the United States or any of its components in legal proceedings before a court or adjudicative body, provided that, in each case, the agency also determines prior to disclosure that release of the records to the DoJ is a use of the information contained in the records that is compatible with the purpose for which VA collected the records. VA, on its own initiative, may disclose records in this system of records in legal proceedings before a court or administrative body after determining that the disclosure of the records to the court or administrative body is a use of the information contained in the records that is compatible with the purpose for which VA collected the records.
5. Disclosure may be made to a congressional office from the record of an individual in response to an inquiry from the congressional office made at the request of that individual.
6. Disclosure to other Federal agencies may be made to assist such agencies in preventing and detecting possible fraud or abuse by individuals in their operations and programs.
7. Disclosure of information may be made when (1) VA suspects or has confirmed that the integrity or confidentiality of information in the system of records has been compromised; (2) the Department has determined that as a result of the suspected or confirmed compromise, there is a risk of embarrassment or harm to the reputations of the record subjects, harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (3) the disclosure is to agencies, entities, and persons whom VA determines are reasonably necessary to assist or carry out the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm. This routine use permits disclosure by the Department to respond to a suspected or confirmed data breach, including the conduct of any risk analysis or provision of credit protection services as provided in 38 U.S.C. 5724.
8. VA may disclose health information for research purposes determined to be necessary and proper to epidemiological and other research entities approved by the Under Secretary for Health or designee, such as the Medical Center Director of the facility where the information is maintained.
9. VA may disclose health information, including the name(s) and address(es) of present or former personnel of the Armed Services and/or their dependents, (a) to a Federal department or agency or (b) directly to a contractor of a Federal department or agency, at the written request of the head of the agency or the designee of the head of that agency, to conduct Federal research necessary to accomplish a statutory purpose of an agency. When this information is to be disclosed directly to the contractor, VA may impose applicable conditions on the department, agency, and/or contractor to ensure the appropriateness of the disclosure to the contractor.
My Health
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None.
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is finalizing requirements that state, local and tribal air agencies would have to meet as they implement the current and future national ambient air quality standards (NAAQS) for fine particulate matter (PM
This final rule is effective on October 24, 2016.
The EPA has established a docket for this action, identified by Docket ID No. EPA-HQ-OAR-2013-0691. All documents in the docket are listed in the
For general information on this rule, contact Mr. Rich Damberg, Office of Air Quality Planning and Standards, U.S. EPA, by phone at (919) 541-5592 or by email at
The following are abbreviations of terms used in the preamble.
Entities potentially affected directly by this final rule include state, local and tribal governments and air pollution control agencies responsible for attainment and maintenance of the NAAQS. Entities potentially affected indirectly by this final rule as regulated sources include owners and operators of sources that emit PM
In addition to being available in the docket, an electronic copy of this
The information presented in this document is organized as follows:
Ambient, or outdoor, air can contain a variety of pollutants, including particulate matter (PM). Airborne PM can be comprised of either solid or liquid particles, and can be a complex mixture of particles in both solid and liquid form. The most common constituents of airborne PM include the following: Sulfate (SO
The human health effects associated with long or short-term exposure to PM
On December 14, 2012, the EPA made revisions to the suite of the NAAQS for PM to provide requisite protection of public health and welfare with an adequate margin of safety. The EPA also made corresponding revisions to the data handling conventions for PM and the ambient air monitoring, reporting and network design requirements for PM. Specifically, the agency revised the primary annual PM
Estimates show that attainment of the primary PM
Sections 108 and 109 of the Clean Air Act (CAA or Act) govern the establishment, review and revision, as appropriate, of the NAAQS for widespread pollutants emitted from numerous and diverse sources considered harmful to public health and the environment. The CAA requires two types of NAAQS: (i)
The CAA also establishes important roles both for state and tribal governments and for the EPA in implementing the NAAQS. In accordance with the principle of cooperative federalism, both state and tribal governments and the EPA have respective authorities and responsibilities under the CAA. At the outset, the EPA has the authority and responsibility to promulgate the NAAQS. In turn, state, local and tribal air pollution control agencies (“air agencies”) have the authority and primary responsibility for developing and implementing attainment plans that contain emission control measures needed to achieve the air quality standards in a timely manner in each nonattainment area, consistent with the requirements of the CAA. The EPA often assists states by promulgating regulations or providing guidance for meeting implementation requirements and by providing technical tools, including information on control measures.
The EPA also promulgates nationally applicable control requirements and emission limits for many sources such as new motor vehicles, certain categories of new and modified major stationary sources and existing stationary sources of toxic air pollutants. These federal actions assist states by achieving emissions reductions from certain categories of sources nationwide, which can help with local attainment needs in a given nonattainment area. The EPA also has authority to provide funding, technical assistance, and guidance to states to support implementation of the NAAQS. In addition, the EPA has authority to address interstate transport of pollutants, in the event that states fail to do so. Through this authority, the EPA has addressed regional transport of pollutants from upwind states to downwind states, and has previously done so for purposes of the PM
The EPA first promulgated annual and 24-hour NAAQS for PM
Section 109(d)(1) of the CAA requires the EPA periodically to review the science upon which the standards are based and the standards themselves, and to revise the standards as may be appropriate. In October 2006, the EPA promulgated revisions to the suite of the NAAQS for PM, and in particular the EPA revised the 24-hour PM
The EPA initiated a review of the PM
On January 4, 2013, shortly after the EPA promulgated the 2012 revisions to the suite of PM NAAQS, the D.C. Circuit issued its decision in a challenge to the 2007 PM
The EPA issued a notice of proposed rulemaking (NPRM) on March 23, 2015 (80 FR 15340) titled, “Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements” (PM
The public comment period for the proposed PM
In order to determine how to regulate sources of direct PM
As noted earlier, the term PM
PM
OM is the fraction of ambient PM
EC refers to particulate carbon that has a graphitic molecular structure, and is sometimes referred to as “black carbon” (BC). It is emitted directly from emission sources and does not undergo any significant reactions with other gases in the atmosphere. EC particles result from primary emissions involving combustion, especially from diesel-fueled vehicles, but also from other processes involving the burning of fossil fuels. The latter include anthropogenic sources such as boilers and waste disposal. In addition, some EC particles originate from biomass combustion such as from prescribed fires, wildfires and residential wood combustion.
Crustal PM is comprised of particles of soil and oxides of metals from some industrial processes. Compounds comprised of elements such as silicon, aluminum, iron, calcium, titanium, magnesium and potassium, as well as oxygen, are major components.
The remaining portion of ambient PM
VOC (both anthropogenic and biogenic) are key precursors to the SOA component of PM
Anthropogenic sources of VOC include mobile sources, petrochemical manufacturing, oil and gas emissions, fire emissions, and solvents.
As indicated earlier, ammonia plays an important role in neutralizing acids, such as sulfuric acid and nitric acid, in clouds, precipitation and particles. On the other hand, deposited ammonia can contribute to problems of eutrophication in water bodies due to its nutritive properties.
Table 2 shows regional 3-year mean concentrations (2009-2011) of PM
The composition of PM
The EPA recognizes that the treatment of PM
Section III.A of this preamble provides background on the January 2013
The final rule describes how in some cases a state may demonstrate that the adoption of additional emission reduction measures for a particular precursor is not needed for purposes of achieving expeditious attainment nor for advancing the attainment date by at least a year in a nonattainment area. (This is referred in the preamble as an “expeditious attainment demonstration.”) The rule also describes three optional approaches for demonstrating that a particular precursor is not a significant contributor to ambient PM
Section III.C of this preamble also outlines certain technical issues, such as the appropriate geographic scope of a precursor demonstration, recommended significance thresholds, and recommended analytical approaches for evaluating precursor contributions to ambient PM
Ammonia is a precursor to fine particulate matter, making it a precursor to both PM
The court continued to hold that “[i]n light of our disposition, we need not address the petitioners' challenge to the presumptions in 40 CFR 51.1002(c)(3)-(4) that volatile organic compounds and ammonia are not PM
Section 189(e) of the CAA establishes requirements for precursors to PM
When Congress adopted the 1990 CAA Amendments, the NAAQS for PM
Consistent with past practice for implementation of the PM
While CAA section 189(e) expressly requires control of precursors from major stationary sources, it is clear that subpart 4 and other CAA provisions collectively require the control of direct PM
In light of the court's decision in
For the purposes of this rule, the EPA considers that for all PM
The EPA interprets the CAA to require states to inventory emissions and adopt control measures as appropriate for direct PM
The EPA also notes that CAA section 189(e) contains certain ambiguities that require interpretation. For example, CAA section 189(e) does not specify the precise method by which a state or the EPA should determine whether precursor emissions from major stationary sources do not “contribute significantly” to levels which exceed the standard in a given nonattainment area. Subpart 4 also does not explicitly address whether it would be appropriate to include a potential exemption from precursor controls for all source categories under certain circumstances, because a specific exemption from precursor controls is expressly made available in the statute only for major stationary sources. These issues are addressed in this final rule.
In the proposal, the EPA sought comment on how states could focus regulatory efforts on the appropriate PM
The EPA also described three technical issues associated with any such precursor demonstration and sought comment on the following: (1) The appropriate geographic scope of the analysis; (2) whether specific types of technical analyses (such as evaluating the contribution of the precursor to total PM
Lastly, the EPA indicated in the proposal that if a state had an approved precursor demonstration for a particular precursor in a Moderate area and the EPA later reclassifies the area to Serious, then the state would be required to develop an updated precursor demonstration if the state were again interested in having the precursor treated as insignificant for purposes of the Serious area plan. An updated precursor demonstration is necessary because many factors (
The EPA received many comments on the three proposed precursor demonstration approaches. Most commenters supported the inclusion of some kind of optional precursor demonstration in the final rule. Some commenters suggested that states should have the flexibility to develop any of the types of demonstrations that the EPA described in the three proposed options. One group of commenters opposed any option that would exempt a particular precursor from control measures even if the state could demonstrate it could expeditiously attain the standard by the attainment date without controls on sources of the precursor. Another group of commenters suggested that if only one option is finalized, it should allow a state to rely on a sensitivity analysis to show that changes in emissions of a particular precursor would not have a substantial contribution to PM
The EPA agrees with commenters who suggested that states should have the flexibility to conduct different types of precursor demonstrations appropriate to the area in question. Regardless of the type of precursor demonstration, the state will still need to provide adequate technical support and that demonstration will be subject to EPA approval. Thus, the EPA concludes that the specific form of the demonstration is not as crucial as its content and adequacy, in light of the facts and circumstances in the area. The EPA disagrees with commenters who argued that a state should not be able to determine insignificance for a precursor based on an attainment planning analysis showing expeditious attainment in the area without adopting new emissions reduction measures for the precursor in question. This approach has been upheld under subpart 4 with respect to implementation of the PM
After consideration of the numerous comments received on this issue, the EPA has decided to adopt a final approach that allows exclusion of certain precursor sources from certain SIP requirements, provided that states make the appropriate demonstrations. However, the EPA has revised the details of the specific types of demonstrations based on further evaluation of the comments received. Section III.C.1 of this preamble describes the expeditious attainment demonstration, in which a state shows that control requirements for a particular precursor are not needed for expeditious attainment by the Moderate area attainment date. Section III.C.2 of this preamble describes the three types of optional precursor demonstrations a state may submit to the EPA to establish that emissions of a precursor do not contribute significantly to PM
Section III.C.3 of this preamble highlights various technical issues associated with precursor demonstrations, including the appropriate geographic scope of the analyses, thresholds for characterizing an insignificant air quality change, and different analytical methods for assessing precursor contributions. Section III.C.4 of this preamble discusses certain procedural issues associated with precursor demonstrations. Section III.C.5 of this preamble addresses other relevant comments and responses.
As noted earlier, the EPA's interpretation of subpart 1 and 4 requirements with respect to precursors in attainment plans for PM
Under the expeditious attainment demonstration, a state may be able to determine through its identification of RACM/RACT for existing sources in an area whether expeditious attainment could be achieved without new control measures for a particular PM
For the expeditious attainment demonstration, the required analysis is what is already needed for a Moderate area attainment demonstration: The identification of reasonably available control measures that provide for expeditious attainment by the attainment date, and a determination that attainment cannot be advanced through the imposition of other reasonable measures (
After identifying the set of control measures that are economically and technologically feasible for all precursors, the state may be able to show (using best available information on emissions, control options, technologies, and costs, along with appropriate air quality modeling) that those measures that could be identified as RACM/RACT and additional reasonable measures would not need to include new control measures for sources of a given precursor.
If the attainment planning demonstration shows that the area can attain the NAAQS expeditiously without new emission reduction measures for a particular precursor, the state would be required to adopt control measures for only a subset of the four PM
It also should be noted that development of an approvable attainment plan that does not include new control measures for a particular precursor would not exempt the state from the requirements to address the same precursor with respect to the NNSR program, nor would it excuse the state from reconsidering the significance of the precursor to the PM nonattainment problem in any subsequent Serious area SIPs that could be required for the nonattainment area.
a.
If a comprehensive precursor demonstration for a precursor is approved, the state would not establish a motor vehicle emissions budget for the relevant precursor, and regional emissions analyses for the precursor would not be required to be included in transportation conformity determinations. This is consistent with the transportation conformity rule's provisions concerning PM
If a comprehensive precursor demonstration is approved by the EPA, then in developing the attainment plan for the area, the state would not be required to adopt control measures (
It also should be noted that development of an approvable attainment plan that does not include new control measures for a particular precursor would not exempt the state from the requirements to address that precursor with respect to the NNSR program, nor would it excuse the state from reevaluating the significance of the precursor to the PM nonattainment problem in any subsequent Serious area SIPs that could be required for the nonattainment area.
b.
If such a demonstration is approved by the EPA, then in developing the attainment plan for the area, the state would not be required to adopt control measures for the precursor for existing major stationary sources in the nonattainment area. The attainment plan also would not be required to address the emissions of the relevant precursor from major stationary sources in meeting the RFP or quantitative milestone requirements, or in adopting contingency measures. (Note that for purposes of meeting the contingency measure requirement, however, the state would still have the discretion to adopt emission reduction requirements on the precursor in question, in conjunction with emission reduction requirements on other pollutants.) The state would still need to include stationary source emissions of the precursor in all nonattainment area emission inventory submissions.
Note that a state might consider developing a major stationary source demonstration to avoid the requirement to adopt nonattainment planning control measures for a particular precursor emitted from existing major stationary sources in the area if the state does not believe that it could comprehensively demonstrate that the precursor does not have a significant contribution, and if major stationary source emissions of the precursor do not make up a very large percentage of the emissions inventory in the area. For example, it might be possible that in a particular area the overwhelming amount of emissions of a certain precursor could originate from mobile or area sources, or both, but not from existing major stationary sources. If the EPA approves a major stationary source precursor demonstration, the attainment plan would still need to evaluate and potentially impose control requirements for the relevant precursor for existing non-major stationary sources, area sources and mobile sources in order to demonstrate expeditious attainment.
It also should be noted that development of an approvable attainment plan that does not include new control measures for a particular precursor would not exempt the state from the requirements to address that precursor with respect to the NNSR program, nor would it excuse the state from the requirement to evaluate and adopt control measures for the precursor in any subsequent Serious area SIPs that could be required for the nonattainment area.
c.
Under the NNSR precursor demonstration, the state would need to conduct an analysis to evaluate the sensitivity of PM
The EPA believes that this approach to interpreting CAA section 189(e) of the statute as it applies to control requirements for the NNSR program is appropriate because (1) an analysis that evaluates the sensitivity of the atmosphere in an area to increases in emissions would most closely replicate the scenario of concern, where precursor emissions from new major stationary sources or major modifications are
For purposes of the NNSR precursor demonstration, the state is not required to first evaluate the contribution of existing major sources to PM
a.
b.
Some commenters supported the bright-line threshold concept, but they suggested thresholds across a broad range, from less than 1 percent of the relevant NAAQS, to up to 5 percent. Some commenters stated that inclusion of a bright-line threshold of 3 percent of the relevant NAAQS was preferred because without such a threshold, states would be unsure about whether their proposed precursor assessment would be acceptable. Other commenters supported having no bright line threshold because the circumstances of each area are unique, and for that reason
The EPA found merit in comments supporting both proposed options. The EPA agrees that an insignificance threshold can help avoid situations where lack of clarity may lead to delays in the EPA assessment of precursor demonstrations. At the same time, the EPA understands that PM
After considering the range of comments on this issue and the complexity of the types of analyses that may be conducted for precursor demonstrations, the EPA has decided that the best approach is for the final rule to codify the availability and basic requirements for precursor demonstrations, but to provide technical details (such as a recommended approach for assessing whether a particular air quality concentration threshold can be considered to be insignificant in a given area) in guidance supporting this final rule.
Other techniques such as the analysis of chemical speciation data and emissions inventories also may be appropriate for determining the contribution of a particular precursor to PM
The EPA also requires a sensitivity-based analysis as the means for conducting the NNSR precursor demonstration. In this case, in contrast to the assessment of decreases described for the comprehensive (or major source) precursor demonstration for existing sources, the appropriate sensitivity analysis is one that evaluates the impact of precursor emissions
The EPA states in the final rule that a sensitivity-based analysis is an appropriate approach for understanding whether emissions of a precursor make an insignificant contribution to PM
In another type of area, the PM
Thus, the most effective precursor strategies for reducing PM
For states that choose to develop an optional precursor demonstration, the final rule provides that in addition to the basic requirement to do a concentration-based contribution analysis, the state may choose to develop a sensitivity-based contribution analysis evaluating potential emissions reductions for either a comprehensive precursor demonstration or a major stationary source demonstration intended to show that emissions reductions of the particular precursor are not effective in reducing PM
In evaluating whether it would be appropriate to exclude sources of any precursors from NNSR regulation in a nonattainment area, it is important to understand the sensitivity of the atmosphere to potential increases in precursor emissions that could result from major source growth (from both new sources and major modifications at existing major sources) in the nonattainment area. For example, in some circumstances, adding a few hundred tons of a “less abundant” precursor to an area could result in a significant increase in PM
The critical first step in any precursor analysis is the development of a comprehensive inventory of all precursor emissions in the nonattainment area. A state will not be able to reasonably determine whether reductions of a given PM
In the preamble to proposed rule, we indicated that if a state developed a precursor demonstration as part of its draft attainment plan or NNSR program submission, then in accordance with the state rulemaking process, the demonstration would be subject to public review at the state level. We also stated that, as required under any rulemaking process, the state had to consider and provide a response in the rulemaking record to any information or evidence brought forward by commenters during the state's SIP planning, development and review process. By ensuring that this important issue was explicitly addressed and supported in any attainment plan or NNSR program revision submitted to the EPA, the EPA could better evaluate the precursor demonstration in accordance with its obligations under the CAA. The EPA believes these are sound procedural steps for a state rulemaking process, and the final rule includes similar language requiring public review of any proposed precursor demonstration.
If a state chooses to develop a comprehensive precursor demonstration or major stationary source precursor demonstration for a nonattainment area, it must submit a concentration-based contribution analysis and, if applicable, a sensitivity-based contribution analysis conducted for the area. In cases where a sensitivity-based analysis was developed the concentration-based analysis must also still be submitted. Although the rule clearly provides that the precursor demonstration requirement may still be satisfied in such cases, the information in the concentration-based analysis will help inform review of the overall demonstration by the EPA. Similarly, the data from the concentration-based analysis should be available in the public record because it will help inform the review of the overall precursor demonstration by the public.
When an area is reclassified to Serious, existing sources of all PM
Another group of commenters supported requiring only the concentration-based existing source contribution analysis because only that analysis would address the question alluded to in the statute, which is whether sources of the precursor contribute significantly to levels which exceed the standard in the area. These commenters stated that sensitivity-based analyses reflect localized conditions and do not represent a consistent effect across an air basin. The commenters suggested that sensitivity analyses might be considered to inform what pollutants are most cost-effective to control, but believed that this is dubious because the fact that certain pollutants are very abundant is likely the result of a history of under-regulation. They suggested that it actually may be cheaper to control the more abundant pollutant than the less abundant pollutant in order to achieve an equal amount of air quality improvement.
The EPA also believes that a sensitivity-based contribution analysis is consistent with the language and intent of CAA section 189(e). As applied to attainment plans, CAA section 189(e) allows states to evaluate whether PM
Sections 189(a), (c), and (e) of the CAA require that Moderate area attainment plans contain the following: (i) An approved permit program for construction of new and modified major stationary sources (CAA section 189(a)(1)(A)); (ii) a demonstration that the plan provides for attainment by no later than the applicable Moderate area attainment date or a demonstration that attainment by that date is impracticable CAA (section 189(a)(1)(B)); (iii) provisions for the implementation of RACM and RACT no later than 4 years after designation (CAA section 189(a)(1)(C)); (iv) quantitative milestones that will be used to evaluate compliance with the requirement to demonstrate reasonable further progress (RFP) (CAA section 189(c)); and, (v) evaluation and regulation of PM
The EPA proposed to require that all Moderate area plan elements for a nonattainment area be submitted by the state no later than 18 months from the effective date of designation. The attainment plan submission would thus include all necessary plan elements required under CAA subparts 1 and 4.
The final regulations at 51.1003(a) require all Moderate nonattainment area elements to be submitted by no later than 18 months from the date of designation, as proposed. Section 189 of the CAA specifies the schedule by which states must submit attainment plans for the PM
Although nothing in the CAA prohibits states from making separate attainment plan submissions to meet the
In the proposal, the EPA proposed for both Moderate and Serious areas to require both a “base year inventory for the nonattainment area” and an “attainment projected inventory for the nonattainment area.” The proposal spelled out a list of requirements for each of these inventories. The proposal also specified, based on the timing requirements of CAA section 172(b), that the emissions inventories required for a Moderate area must be submitted within 18 months after the effective date of the designation of the nonattainment area.
The EPA proposed that the base year inventory for the nonattainment area: (a) Be required to represent one of the 3 years used for designations or another technically appropriate year; (b) include actual emissions of all sources within the nonattainment area; (c) be annual total or average-season-day emissions in accordance with the NAAQS violation(s) (annual and/or 24-hour); (d) include direct PM
The EPA further proposed that the attainment projected inventory for the nonattainment area (a) be required to represent projected emissions in the first year for which attainment is demonstrated by the modeled attainment demonstration; (b) include projected emissions of the same sources included in the base year inventory for the nonattainment area; (c) use the same temporal period as the base year inventory (annual or average-season-day); (d) include the same pollutants as the base year inventory; (e) report as point sources the same sources treated as point sources in the base year inventory; (f) be consistent in inventory detail with the base year inventory; and (g) still meet the public review requirements even if submitted as a separate plan.
The final regulations at 51.1008 provide the inventory requirements for Moderate areas. The EPA received a number of comments on the emissions inventory requirements for Moderate areas. Commenters both supported the provisions of the proposed rule and objected to some aspects of the inventory requirements. The EPA is finalizing all of the proposed Moderate area requirements with some modifications based on comments. Specifically, the definition of what can constitute a seasonal inventory has been made more flexible to accommodate certain cases, as explained in Section IV.B.2.c of this preamble.
Pursuant to its authority under section 110 of title I of the CAA, the EPA has long required states to submit inventories of the emissions of criteria pollutants and their precursors. The EPA codified these requirements in 40 CFR part 51, subpart Q in 1979 and amended them in 1987. Additionally, the 1990 CAA Amendments revised many of the provisions of the CAA related to attainment of the NAAQS and the protection of visibility in mandatory Class I federal areas (certain national parks and wilderness areas). These revisions established new emissions inventory requirements applicable to areas that were designated nonattainment for certain pollutants. In the case of PM, Congress did not create a specific emissions inventory requirement in subpart 4 that would supersede the emissions inventory requirement under subpart 1. Thus, the CAA section 172 (c)(3) emissions inventory requirements continue to apply, and that provision explicitly requires “a comprehensive, accurate, and current inventory of actual emissions of the relevant pollutants” in the nonattainment area. In addition, the specific attainment plan requirements for the PM
Emissions inventory data serve as the foundation for various types of analyses performed by states and by the EPA. For example, these data enable states to evaluate the degree to which different emissions sources contribute to the nonattainment problem in a given nonattainment area and enable states to estimate the air quality improvement that can be achieved through different control measures. States should use the best available, current emissions inventory information for attainment plan development, because high quality emissions inventory data are essential for the development of an effective control strategy. To assist states in preparing complete, high quality inventories, the EPA provides guidance for developing emissions inventories called “Emissions Inventory Guidance for Implementation of Ozone and Particulate Matter National Ambient Air Quality Standards (NAAQS) and Regional Haze,” which is available from
There are three key facets of the emissions inventory requirements, as described later: (i) The type of inventories required; (ii) the timing of submission of these inventories; and (iii) the content of these inventories. These content requirements are described in this section; however, the EPA's rationale for these content requirements is in some cases further described in subsequent sections of this document.
First, states must submit at least two separate and distinct nonattainment area emissions inventories as elements of an attainment plan. The first emissions inventory is relevant for assessing the current or base year emissions from sources located in the nonattainment area; the second emissions inventory is a projected inventory relevant for assessing emissions in the target attainment year in the nonattainment area. The first type of inventory is called the “base year inventory for the nonattainment area,” and the second type of inventory is called the “attainment projected inventory for the nonattainment area.”
Second, as noted in Section IV.A of this preamble, to meet the statutory requirements for submission of certain attainment plan elements required under subpart 4, the EPA believes that states must meet the same submission schedule for emissions inventories as for the other elements of an attainment plan,
Third, the EPA is establishing specific requirements for both the base year inventory for the nonattainment area and for the attainment projected inventory for the nonattainment area in order to implement the PM
(1) The inventory year must be one of the 3 years used for designations for the relevant PM
(2) The inventory must include actual emissions of all sources within the nonattainment area. This requirement stems directly from the language in CAA section 172(c)(3). Sources outside of the nonattainment area are explicitly not included in the section 172(c)(3) requirement with the words “in such area.” Furthermore, the EPA interprets the Act requirement for “actual emissions from all sources” in CAA section 172(c)(3) as intending to include all emissions that may contribute to the formation of PM
(3) The emissions must be reported as annual total emissions, average-season-day emissions, or both, as appropriate for the relevant PM
(4) As discussed earlier and consistent with past implementation rule requirements, the inventory must include emissions of direct PM
(5) States must follow the Air Emissions Reporting Requirements (AERR), 40 CFR part 51, subpart A criteria for emissions thresholds for states to use to determine which emissions sources must be reported as point sources. This requirement is consistent with past implementation rules and is needed to specify whether emissions must be submitted as specific major source stationary facilities with detailed emissions processes or whether emissions can be provided as county totals (
(6) The level of detail of the emissions included in the inventory must be consistent with the detail required by 40 CFR part 51, subpart A. For example, all emissions must be subdivided to individual emissions processes within a facility or county. While these details should underlie the emissions
(7) If the base year inventory for the nonattainment area is submitted to the EPA as a separate plan submission (
For the attainment projected inventory for Moderate nonattainment areas, this final rule also establishes specific requirements necessary to implement the PM
(1) The year of the projected inventory must be the most expeditious year for which projected emissions show modeled PM
(2) The emissions must be projected emissions from the same sources included in the base year inventory for the nonattainment area and any new sources projected to locate within the boundaries of the nonattainment area. The projected emissions should be the best available representation of expected emissions, and thus should take into account emissions growth and contraction, facility closures, new facilities, new controls and other changes in emissions forecast to occur between the base year and the attainment year. In deciding what factors are relevant, states should consider factors affecting projected emissions that could significantly alter the conclusions of the modeled attainment demonstration.
(3) The temporal period of emissions must be the same temporal period (annual, average-season-day, or both) as the base year inventory for the nonattainment area.
(4) Consistent with the base year inventory for the nonattainment area, the inventory must include all emissions of direct PM
(5) The same sources reported as point sources in the base year inventory for the nonattainment area must also be provided as point sources in the attainment projected inventory for the nonattainment area. Likewise, nonpoint and mobile source projected emissions must also be provided using the same delineations as the base year inventory.
(6) The detail of the emissions included must be consistent with the level of detail in the base year inventory (
(7) If the attainment projected inventory for the nonattainment area is submitted to the EPA as a separate plan submission (
b.
The 2007 PM
c.
In contrast with the annual PM
Commenters recommended that the EPA should allow episode-specific inventories, in lieu of seasonal inventories. As a result, the EPA acknowledges in this final rule that, for some source categories, it may be advisable to limit the “season” considered in calculating emissions to an episodic period to reflect periods of higher emissions during periods of high ambient PM
d.
Section II.B of this preamble describes the background needed to understand the importance of including these precursors in emissions inventories for attainment plan purposes for the PM
The EPA requires states to use the best available methodologies for estimating emissions of PM
e.
Distinct from the emissions
In addition to defining the point source thresholds and data elements, 40 CFR part 51, subpart A also requires states to submit emissions information to the EPA. The EPA is not referring to those emissions submission requirements here, but rather to the emissions elements—the definitions, data codes and required data fields. Later, the EPA addresses the issue of whether the emissions values submitted through the AERR are relevant to the inventory requirements of this final rule (
As noted earlier, the EPA recommends that states consult the SIP Emissions Inventory Guidance in preparing the inventories required by this rule. In addition to the AERR, this guidance includes definitions for data fields that are not required by the AERR, such as seasonal emissions values and
In the case of prescribed fires and wildfires, the AERR no longer requires those categories to be submitted, but rather the emissions data can be optionally provided as an “Event” source, which is a day-specific source at a point location. For this rule as described earlier, states are required to include prescribed fires and wildfires for the base year inventory for the nonattainment area and the attainment projected inventory for the nonattainment area. For this rule, states are not expected to use the “Event” detail to meet their inventory reporting requirements. Instead, states can report these fire emissions by county as nonpoint sources are reported.
f.
As part of the modeled attainment demonstration, the EPA presumes that states will need to prepare attainment demonstration modeling inventories for both a modeled base year and projected attainment year. Respectively, these are called the “base year (baseline) inventory for modeling” and the “attainment projected inventory for modeling.” These inventories contain emissions for all regions (
The base year inventory and projected attainment year inventory include emissions from only within the nonattainment area. The EPA expects that modeling inventories will be consistent with those nonattainment area inventories; however, some exceptions may exist. Where possible, the nonattainment area base year and projected attainment year inventories can be a sum (for annual data) or average (for PM
g.
In the past, some states have incorrectly asserted that their AERR submission meets the requirements for base year inventories required by other implementation rules. To avoid confusion, the EPA explains here the limited circumstances under which the AERR emissions inventories will be considered to meet the base year inventory requirement for Moderate nonattainment areas. The following conditions must be met to use AERR inventories for attainment planning:
(1) The AERR emissions inventory must have gone through the notice and public hearing requirements of CAA sections 110(a)(1) and 110(a)(2).
(2) The AERR emissions inventory includes all sources of emissions and all pollutants required for the base year inventory for the nonattainment area. This is only possible if the year for the base year inventory for the nonattainment area aligns with a triennial AERR year, because the data system implementing the AERR only accepts emissions from point sources and not other source categories in non-triennial years.
(3) The EPA's inventory data system must be accepting data for the inventory year being submitted. Inventories are allowed to be submitted to the AERR for a given year for only a limited time during the development cycle of the National Emissions Inventory.
(4) The AERR submission must include emissions from all sources required for the base year inventory for the nonattainment area consistent with 40 CFR 51.1008(a)(1), and must include mobile source emissions in nonattainment areas (instead of simply providing inputs or other data that is allowed under the AERR). In some cases, the AERR requirement can be met without actually “submitting” emissions; for example, states may elect to accept the EPA estimates for some nonpoint emissions sectors. Accepting EPA emissions does not meet the requirements of CAA section 172(c)(3) or this rule. In addition, the AERR revision finalized in February 2015 (80 FR 8787) replaces the prior requirement of reporting onroad mobile and nonroad
When using MOVES, states should follow the most current version of the MOVES Technical Guidance, available at
Likewise, if states choose to fulfill various inventory requirements by using the latest EPA emissions model, the most current version of the NONROAD model or its successor must be used for estimates of nonroad mobile source emissions, preferably with state-supplied model input data. States can alternatively develop technologically equivalent or superior state-specific nonroad emissions estimates, but should explain why their approach gives a better estimate than the EPA model. For nonroad sources not estimated by the NONROAD model, the best available methods should be used, and the EPA recommends that states refer to the SIP Emissions Inventory Guidance for more information on emissions from these sources. Links to
Emissions uncertainty is a fact of air quality planning and cannot be avoided. Despite uncertainties in inventories of all kinds throughout the NAAQS program, great progress in improving air quality has been made through the attainment planning process and the implementation of control measures selected in part based on modeled attainment demonstrations. While emissions uncertainties remain, enough information is available for PM
Updated emissions estimating methodologies for animal feeding operations are under development using data collected during the period 2007-2009 from representative operations pursuant to the National Air Emissions
The EPA also notes that new electric generating units that are subject to (40 CFR part 60, subpart Da) without PM continuous emissions monitors (CEMs) have to conduct annual testing for condensable PM using Method 202 of appendix M of part 51.
Under subpart 4 of the CAA, states are presumptively required to analyze and evaluate emissions reduction measures for all sources of direct PM
With regard to PM
The attainment planning requirements of subparts 1 and 4 were established to ensure that two important CAA goals are met: (i) That states implement measures that provide for attainment of the PM
CAA section 172(c) of subpart 1 of the CAA describes the general attainment plan requirement for RACM and RACT, requiring that attainment plan submissions “provide for the implementation of all reasonably available control measures as expeditiously as practicable (including such reductions in emissions from existing sources in the area as may be obtained through the adoption, at a minimum, of reasonably available control technology) and shall provide for attainment” of the NAAQS.
The EPA's guidance on RACM for sources of PM
With respect to RACT requirements, the EPA's guidance in the General Preamble includes the following: (i) RACT has historically been defined as “the lowest emission limit that a source is capable of meeting by the application of control technology that is reasonably available considering technological and economic feasibility”; (ii) RACT generally applies to stationary sources, both stack and fugitive emissions; (iii) major stationary sources (
The appendices to the General Preamble noted that reducing air emissions may not justify adversely affecting other resources, for example, by increasing pollution in bodies of water, creating additional solid waste disposal problems or creating excessive energy demands. An otherwise available control technology may not be reasonable if these other environmental impacts are sufficiently adverse and cannot reasonably be mitigated. A state may consider a control measure for direct PM
This final rule specifies the basic requirements that states must meet in identifying and selecting the complete suite of measures needed for an attainment plan submission for a Moderate PM
The final rule requires that all moderate area plans contain RACM, which is defined as any technologically and economically feasible measure that can be implemented in whole or in part within 4 years after the effective date of designation of a PM
Measures that can only be implemented after the 4-year deadline for RACM and RACT, but before the end of the sixth calendar year following designation, are defined in the final rule as “additional reasonable measures.”
Lastly, the final rule requires the state to perform an analysis (typically an air quality modeling analysis) to determine the earliest practicable attainment date for the area. This analysis should take into account projected emissions reductions associated with existing federal and state regulations, plus any additional reductions that would be achieved due to new control measures that would be needed for expeditious attainment.
In the case of a Moderate area that can demonstrate it can attain by the statutory attainment date without implementing all reasonably available control measures (
The following sections of the preamble describe the steps of the control measure evaluation process in more detail, and include discussion of the consideration of public comments as appropriate.
The proposal stated that the identification of all sources of emissions of direct PM
The proposal also included discussion of a possible
The proposal also presented the concept of a possible bright line ambient impact threshold for determining whether a source category should be considered
Section 172(c)(3) of the CAA requires that attainment plans for PM
The rule requires that a state must identify all of the sources reflected in the nonattainment area's base year inventory as the initial step in developing reasonable control measures for the area, as each of these sources may play a role in the area's PM
Some commenters suggested that subpart 4 only provides authority to regulate precursors from major stationary sources and not from other types of sources, such as area or mobile sources. However, EPA disagrees with these commenters, given that the CAA provides an overarching requirement to attain the standard as expeditiously as practicable, PM
As discussed in the previous section, the final rule provides that states may develop a precursor demonstration showing that a particular PM
The EPA received a diverse set of comments on whether to include a
A number of commenters supported the
After taking the range of comments on the
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposal preamble described general guidance for identifying existing and potential control measures.
The guidance remains largely unchanged from the proposal. The state's compilation of existing and potential control measures
It is important to note that the emission inventory provisions of this rule require states with sources of direct PM
The control measure evaluation process described in this section generally allows states to apply reasoned judgment as they identify potential control measures for sources of direct PM
The EPA recognizes that for some sources located in a Moderate PM
Information about potential control measures and control technologies is available from a number of sources. One important source of information is the combined regulatory experience of other states. A compilation of existing control regulations that are on the books in other states can be a useful starting point for identifying potential control measures. Another source of information is the EPA's Office of Air Quality Planning and Standards (OAQPS) “Menu of Control Measures” document, available online at
The RACT/BACT/LAER Clearinghouse (RBLC) provides a central database of air pollution technology information (including past RACT, BACT and LAER decisions contained in NSR permits) to promote the sharing of information among permitting agencies and to aid in future case-by-case control measure determinations. The RBLC permit database contains over 5,000 determinations that can help a state identify appropriate technologies to mitigate most air pollutant emission streams. The RBLC includes data submitted by several U.S. territories and all 50 states on over 200 different air pollutants and 1,000 industrial processes, and can be searched for control approaches that address specific pollutants. The RBLC can be found at:
Additionally, the EPA maintains a Web site with links to other online sources of information on control measures for states to consider.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The EPA proposed to recommend as guidance but not as a requirement of the final rule that, if wildfire impacts are significant, contributing to exceedances of the standard, then states should consider RACM for wildfires (which RACM could include a required program of prescribed fires). The EPA also proposed to recommend that states should consider RACM for managing emissions from prescribed fires (including those prescribed fires conducted to reduce future wildfire emissions). The proposal noted that information is available from the DOI and the USDA Forest Service on smoke management programs and basic smoke management practices (BSMP). The EPA requested comment on the concept of, and practical considerations associated with RACM for wildfire and RACM for prescribed fire, including such issues as how such measures can be characterized in the emissions inventory and attainment demonstration and made federally enforceable for adoption in a SIP.
Wildfire can make a large contribution to air pollution (including PM
Upon consideration of public comments and further consultation with other federal agencies, the EPA recommends, as guidance for states as they implement the final rule, that states follow a different approach to addressing RACM for wildland fire than the approach that the EPA proposed to recommend. Before explaining this recommendation further, the EPA wishes to clarify that the recommendation is focused on wildland fire management. There are other uses of prescribed fire and other types of burning that occur in nonattainment areas, or that affect downwind nonattainment areas, such as burning of land clearing debris, agricultural burning, and burning of logging slash on land where the primary purpose of the logging is for commercial timber sale.
The EPA also wants to clarify that it is not the intention to in any way discourage federal, state, local or tribal agencies or private land owners from taking situation-appropriate steps to minimize impacts from prescribed fire emissions on wildland. The EPA encourages all land owners and managers to apply appropriate basic smoke management practices to reduce emissions from prescribed fires, especially where a state has determined that prescribed fires are a significant source affecting air quality. The EPA understands that the federal land managers (FLMs) apply these measures routinely and will be available to consult with other agencies and private parties interested in doing the same.
However, for several reasons, the EPA does not believe it would be effective policy or technically appropriate to recommend that control measures for wildland fire be adopted into the SIP as enforceable measures and credited for emissions reductions (of PM
The EPA acknowledges that some temporal and spatial patterns of fire emissions must still be assumed in the attainment demonstration in order to ensure that the required air quality modeling results in a realistic physical and chemical environment and a correspondingly realistic model response against which to analyze the changes from categories where express accounting of changes is still being done. This rule is not intended to constrain the options for states regarding the appropriate assumptions to make for fire emissions. Rather, it simply recommends that once this base level is established, PM
States still have flexibility in determining how best to represent baseline wildland fire emissions. As noted earlier, base year emission inventories for the nonattainment areas should represent the conditions leading to nonattainment and be consistent with inventories used for modeling. For fires, the EPA additionally encourages states to use a representative mix of prescribed fire and wildfire in their inventories. In the past, some plans under previous PM
A consequence of the recommendation of not expressly accounting for changes in wildland fires in attainment demonstrations is that measures to reduce emissions from wildland fires, such as prescribed fire for wildland wildfire prevention and mitigation purposes or smoke management programs and BSMP for prescribed fires in wildland, need not be included as RACM for the respective fire types. This is because the changes in emissions due to such measures would not be accounted for in determining what is necessary for attainment and/or what would advance the attainment date, which is how the EPA is recommending that RACM be determined. So, for example, in an area that can attain in 6 years with measures that do not address wildland fire, the EPA does not recommend that states attempt to quantify whether increased prescribed fire could advance the attainment date by 1 year, due to aforementioned difficulties associated with such quantification.
To be clear, nothing about this policy regarding RACM is intended to suggest that fires should be ignited in wildland (or elsewhere) without regard to the air quality or public health consequences. As noted earlier, the EPA believes these consequences are important to address, and intends to engage in dialogue with the FLMs, air agencies, tribes, state and private land owners and other stakeholders at appropriate times, such as during the process for the development of land management plans, about how land managers determine when and where prescribed fire is appropriate for particular wildlands and how to identify and implement appropriate mitigation measures. The policy simply makes clear the EPA's view regarding its recommendation for RACM for wildland fires.
The EPA notes that this recommendation regarding RACM differs somewhat from the recommendation that was offered in the preamble as guidance to states as they implement the EPA's recent SIP Requirements Rule for the 1997 and 2008 ozone NAAQS. The reasons for the strategy outlined earlier apply equally well to attainment demonstrations for the ozone NAAQS, and so EPA hereby makes the same recommendation for implementation of these ozone NAAQS as well. This recommendation, offered here in the same manner as the prior recommendation, supersedes the prior recommendation on RACM for wildfire in the preamble to the final SIP Requirements Rule for the 1997 and 2008 ozone NAAQS. The EPA will convey this revised recommendation to the air agencies that are working to prepare these ozone SIPs. The EPA also anticipates making this recommendation as part of our planned rulemaking on implementation of the 2015 ozone NAAQS. Note that this discussion pertains only to the RACM policy, and that other aspects of the fire discussions in the ozone SIP Requirements Rule remain applicable.
Finally, the EPA notes that, because a significant element of the rationale for this policy is the uncertainty in the timing of wildfires, we may reconsider this recommendation in the future, if adequate tools emerge that allow for predicting fire emissions with sufficient specificity. However, even if such tools emerge, due to inherent uncertainties it may be impossible to satisfactorily incorporate the use of such information into an attainment demonstration framework.
The EPA received many comments expressing agreement with EPA's recognition of the importance of wildland prescribed fire, and welcoming continued dialogue among states, the EPA, and other federal agencies on how best to ensure that land managers have adequate management tools available, including prescribed fire and some wildfire, but also to ensure that use of these tools does not result in unhealthy air. The EPA intends to engage in such dialogue.
Some commenters also took positions on how specifically to define RACM for wildfires, ranging from required smoke management plans to simply stating that fires themselves are RACM with no further measures required. In light of the fact that EPA did not propose specific guidance on defining RACM for wildfires and typically does not define RACM for specific categories, and the fact that EPA is not recommending that states include RACM as proposed, we are not providing further guidance in response to those comments. Similarly, regarding baseline fire emissions, some commenters provided detailed suggestions regarding approaches to calculating baselines based not on actual fires (which may include periods when fires were suppressed) but on science-based fire regimes, fire return intervals and ecosystem types, including characteristics of wildland vegetation. The EPA notes that this guidance is not establishing or recommending any particular approach to calculating baseline fire emissions.
Through guidance in the preamble to the 2007 PM
In June 2007, the EPA received a petition for reconsideration questioning the legality of this presumption, which the D.C. Circuit later found to be unlawful in the context of a similar presumption in the Phase 2 Ozone (NAAQS) Implementation Rule.
Accordingly, in the proposal the EPA stated that it did not intend to include any rebuttable presumption that the CAIR or any other regional control strategy constitutes RACM or RACT for EGUs or any other source category. Instead, the EPA stated that it is clarifying that in order to meet the RACM and RACT requirements for the PM
The final rule maintains the proposed policy approach as described earlier. As required by the CAA, states are required to analyze what constitutes RACM and RACT for EGUs in each nonattainment area, just as they are required to do for all other types of sources.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposal cited longstanding guidance from the General Preamble regarding factors to consider when determining the technological feasibility of a potential control measure or control technology, and it requested comment on the factors. These factors included a source's processes and operating procedures, raw materials, physical plant layout, and potential environmental impacts such as increased water pollution, waste disposal, and energy requirements. One sentence in the proposal stated: “With respect to determining whether a given control measure might not be technologically feasible for an area or mobile source, the EPA also proposes to retain its longstanding practice that a state may consider relevant factors in conducting its analysis, such as the social acceptability of the measure . . .”
Several comments addressed the EPA's inclusion of the social acceptability factor in the proposal. In reviewing this issue, the EPA determined that this factor actually has not been identified as a factor in the EPA's longstanding guidance, and thus was mischaracterized in the proposal. Nevertheless, some commenters supported inclusion of the factor because no other factor is presented to help limit or eliminate a potential measure with strong public opposition. Other commenters that opposed use of such a factor suggested that including it in the final rule could allow a state to reject almost any control measures that is otherwise found to be technically and economically feasible.
When the EPA issued a proposed PM
The following guidance is similar to what was presented in the proposal but has been updated to exclude the social acceptability factor:
Once a state has identified existing and potential control measures and technologies for sources of direct PM
With respect to the technological feasibility of control technologies for stationary sources, the EPA has a longstanding approach to evaluating facts relevant to this criterion under subpart 4.
In addition, with respect to determining whether a given control measure might not be technologically feasible for an area or mobile source, the EPA also retains its longstanding practice that a state may consider relevant factors in conducting its analysis, such as the condition and extent of needed infrastructure, population size, or workforce type and habits, which may prohibit certain potential control measures from being implementable.
The EPA believes the determination of best control practices for any operation, particularly for animal production or crop production operations, should be a case-specific process. The process should start with the identification of PM
Although the EPA is not making any national determinations of best control practices for animal production and crop production operations, we do note that there are many relevant references on potential emissions reduction options, including the Agricultural Air Quality Conservation Measures Reference Guide for Cropping Systems and Land Management.
The proposal described that in the 1992 General Preamble, EPA's longstanding interpretation of the term “economic feasibility” in the context of evaluating potential RACM and RACT has included a presumption that it is reasonable for similar sources to bear similar costs of emissions reductions, even if they are in different nonattainment areas or different states. The proposal indicated that this presumption was not included in the 2007 implementation rule for the PM
The proposal also characterized past guidance from the 1992 General Preamble as stating that if a state contends that a source-specific control level should not be established because the source(s) cannot afford the control measure that is demonstrated to be economically feasible for other sources in its source category, then the state must support the claim with information regarding the impact of imposing the identified control measure or technology on the several financial indicators. The proposal also recommended that cost effectiveness should generally be evaluated by assessing the cost per ton of emissions reduced associated with a control measure, but the proposal also requested comment on an alternative metric to assess cost effectiveness in terms of the cost per unit of air quality improvement (
Based on a consideration of the comments received, the EPA has determined that economic feasibility considerations should generally align with the interpretation in the 1992 General Preamble. Note that the proposal indicated that if it is claimed that a control approach is not economically feasible for a specific source, the state needs to provide information related to several financial indicators to support the claim. We note that the original policy in the 1992 General Preamble suggests that if a source desires to make such a claim, it should provide such information to the state for its consideration. This final rule characterizes the policy in a similar manner, where the source would have the option of providing this financial information to the state for its review. This approach should address the concerns of some commenters that such financial information may not be readily available to the state. Thus, the final policy for considering economic feasibility of control measures is described in the following paragraphs.
The EPA has a longstanding interpretation of the term “economic feasibility” in the context of evaluating potential RACM and RACT which involves considering the cost of reducing emissions and the difference between the cost of an emissions reduction measure at a particular source and the cost of emissions reduction measures that have been implemented at other similar sources in the same or other areas.
For each technologically feasible control measure, a state should evaluate the economic feasibility of the measure or control, through consideration of factors such as the capital costs, operating and maintenance costs, and cost effectiveness (
The EPA believes that it is appropriate for states to give substantial weight to cost effectiveness in evaluating the economic feasibility of an emission reduction measure or technology. The cost effectiveness of a measure is its annualized cost ($/year) divided by the emissions reduced (tons/year) which yields a cost per amount of emission reduction ($/ton). Cost effectiveness provides a relative value for each emissions reduction option that is comparable with other options and, in the case of control technologies, other facilities. In considering what level of control is reasonable, the EPA does not recommend a specific fixed dollar per ton cost threshold for economic feasibility of controls identified as potential RACM and RACT.
If a source contends that a source-specific control-level should not be established because the source cannot afford the control measure or technology that is demonstrated to be economically feasible for other sources in its source category, the source should make its claim known to the state and support the claim with information regarding the impact of imposing the identified control measure or technology on the following financial indicators, to the extent applicable:
(1) Fixed and variable production costs ($/unit)
(2) Product supply and demand elasticity
(3) Product prices (cost absorption vs. cost pass-through)
(4) Expected costs incurred by competitors
(5) Company profits
(6) Employment costs
(7) Other costs (
Some commenters supported using an alternative cost effectiveness metric such as cost per microgram of air quality improvement where appropriate air quality modeling has been developed for the area and can reasonably characterize the relative importance of various precursors. Some commenters opposed the proposal's alternative cost-effectiveness metric because the approach is overly complex and the impacts are rarely uniform across an area.
In this section, the proposal discussed two main issues related to the date by which control measures can be implemented. First, it proposed that when a state is determining RACM/RACT, it must consider whether a control measure can be implemented in part when full implementation of the measure within 4 years of designation is not feasible. The proposal also introduced the concept of “additional reasonable measures,” meaning those measures that can only be implemented after the fourth year but prior to the Moderate area 6-year attainment date. It was proposed that a state must identify additional reasonable measures and adopt those measures as needed for expeditious attainment.
This section remains relatively unchanged from the proposal. CAA section 189(a)(1)(C) requires that the attainment plan for a Moderate PM
The EPA recognizes that a state may be able to implement a given control measure only partially within 4 years after designation. The EPA addressed this situation in the General Preamble, stating: “It is important to note that a State should consider the feasibility of implementing measures in part when full implementation would be infeasible.”
Therefore, for the purposes of meeting the RACM/RACT requirement, a state must identify those technologically and economically feasible control measures and technologies that it can implement fully or partially within 4 years of designation of its Moderate PM
In addition, a state must separately identify those technologically and economically feasible control measures that can only be implemented after the statutory window for implementing RACM and RACT, but before the attainment date. The statutory 4-year timing requirement for implementing RACM and RACT under CAA section 189(a)(1)(C) limits the control measures and technologies that can qualify as RACM and RACT for a Moderate PM
The proposal described the control measure requirements for two situations: The case where the state can demonstrate attainment by the attainment date; and the case where the state demonstrates the area cannot practicably attain by the attainment date. If a state determines that a Moderate nonattainment area can attain the PM
For the situation where a state determines that it is impracticable to attain by the Moderate area attainment date, the proposal included two policy options for describing what control measures must be adopted and implemented. One option would have required the state to adopt all technologically and economically feasible control measures, as stated in past guidance in the General Preamble. The other option would have required adoption of technologically and economically feasible control measures with an explicit exception for those measures that collectively are determined to be “ineffective in reducing ambient PM
For an area that can demonstrate that it will attain by the attainment date, the final rule maintains the same approach as described in the proposal regarding the collective evaluation of potential control measures to determine whether the area can advance the attainment date by 1 year. For an area that demonstrates that it would be impracticable to attain by the attainment date, the final rule does not include an explicit exception for those measures that collectively are determined to be “ineffective in reducing ambient PM
Section 189(a)(1) of the CAA establishes a requirement that the attainment plan for a Moderate PM
Section 188 establishes the attainment dates for Moderate and Serious PM
If a state determines that a Moderate nonattainment area can attain the PM
For this type of situation, the state may reject any otherwise technologically or economically feasible measures that are not needed to demonstrate attainment or that will not advance the attainment date by at least 1 year. That is, for a Moderate area that can demonstrate attainment by the statutory Moderate area attainment date, the EPA defines as “reasonable” only those technologically and economically feasible measures that are necessary for expeditious attainment of the NAAQS, as the CAA does not require a state to adopt measures that are not needed for expeditious attainment in a Moderate PM
Section 189(a)(1)(B) of the CAA anticipates that not all Moderate nonattainment areas will be able to demonstrate attainment by the attainment date, and it incorporates the concept of an “impracticability demonstration” for such areas.
After considering comments on the two options described in the proposal, the EPA has decided to keep the policy in this final rule consistent with past guidance in the General Preamble. This guidance stated that “the EPA believes it is reasonable for all available control measures that are technologically and economically feasible to be adopted for areas that do not demonstrate attainment [by the applicable attainment date].”
Under this approach, if the state had an approved precursor demonstration (as described in Section III of this preamble) showing that a particular precursor does not have a significant contribution on PM
Subpart 4 requires that Moderate areas that cannot or do not meet the Moderate area attainment date be reclassified as Serious nonattainment areas, in which case sources in the areas are then subject to BACM and BACT requirements. In the General Preamble, the EPA indicated that “it may be reasonable, in some limited circumstances, for states to consider the compatibility of RACM and RACT with the BACM and BACT that will ultimately be implemented under the Serious area plans for those areas.”
The General Preamble also provided guidance for stationary source controls in this situation: “In many instances, the installation of pollution controls representing RACT may involve substantial capital expenditures. In the event that BACT is later required for those sources, this may require controls significantly incompatible with those recently installed as RACT, largely wasting those recent expenditures. Under such circumstances, the installation of controls in the first round of SIP planning would be unreasonable.” Accordingly, SIPs for the Moderate areas that cannot practicably attain need not require major changes to the control systems for specific stack and process sources where a State reasonably demonstrates that such changes will be significantly
The EPA believes that in such cases, a state should consider selecting and implementing controls that may qualify as BACM or BACT in a Moderate nonattainment area as part of their RACM and RACT analysis. Early adoption of controls that would constitute BACM or BACT could be more efficient and could further the objectives of attaining the NAAQS expeditiously to protect public health and the environment.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposal described a set of submission requirements for RACM/RACT and additional reasonable measures.
The requirements in the final rule remain very similar to those that were included in the proposal. To ensure that attainment plan submissions contain the necessary supporting information to enable the EPA to review and approve a state's evaluation and selection of measures that constitute RACM and RACT in a given nonattainment area, the EPA requires under the authority of section 301(a) of the CAA that a state must submit the following information as part of its submission:
(1) A list of all sources and activities in the nonattainment area that emit direct PM
(2) For each source or activity in the nonattainment area, an inventory of direct PM
(3) For each potential control measure considered by the state but eliminated from further consideration due to a determination by the state that the control measure or technology was not technologically feasible, a narrative explanation and quantitative or qualitative supporting documentation to justify the state's conclusion.
(4) For each technologically feasible emission control measure or technology, a determination of whether the measure is economically feasible must be included, with narrative explanation and quantitative supporting documentation to justify the state's conclusion.
(5) For each technologically and economically feasible emission control measure or technology, the date by which the technology or measure could reasonably be implemented, in whole or in part.
Each of these elements will provide information needed by the EPA to evaluate whether the state is meeting the statutory requirements for an attainment plan, and in particular meeting the statutory requirement for states to implement RACM and RACT on sources within the nonattainment area. The EPA recognizes that the base year emissions inventory for the area that the state submits in conjunction with its attainment plan will likely contain some of the information proposed to be required under the first two items in this list. However, the EPA is finalizing a requirement for emissions inventory information specifically relevant to the RACM and RACT element of the state's attainment plan in order to ensure that the EPA or any other party can appropriately evaluate the state's RACM and RACT analysis.
The preamble to the proposed rule described the four main criteria for effective control measure regulations: Such regulations must be quantifiable, enforceable, replicable and accountable.
The guidance in this preamble to the final rule remains very similar to what was proposed. After a state has identified a particular control measure as RACM or RACT or additional reasonable measure for a particular nonattainment area, it must then implement that measure through a legally enforceable mechanism that will be included in the SIP (
First, the base year emissions from the source or group of sources to which the control measure applies and the future year projected emissions from those sources once controlled must be quantifiable so that the projected emissions reductions from the sources can be attributed to the specific measures being implemented. It is important that the emissions from the source category in question are accurately represented in the base year inventory so that emissions reductions are properly calculated. In particular, it is especially important to ensure that both the filterable and condensable components of direct PM
Second, the control measures must be enforceable. This means that they must specify clear, unambiguous and measurable requirements. The measurable requirements for larger emitting facilities must include periodic source testing, monitoring or other viable means to establish whether the
In response to a comment on this criterion, the EPA clarifies that an enforceable regulation for a CAA program must be enforceable by the EPA, the state, and citizens. By taking action to approve emissions limitations and related provisions into the SIP, the EPA thereby makes those emission limitations a federally enforceable component of the SIP that the state, the EPA, and citizens can enforce thereafter in the event of a violation. SIP provisions that effectively preclude enforcement of violations by the EPA or citizens, whether through impermissible exemptions or other SIP provisions that function to bar effective enforcement, are not acceptable.
Third, the results of application of the control measures must be replicable. This means that where a rule contains procedures for interpreting, changing or determining compliance with the rule, the procedures are sufficiently specific and objective so that two independent entities applying the procedures would obtain the same result.
Fourth, the control measures must be accountable. This means, for example, that source-specific emission limits must be permanent and must reflect the assumptions used in the attainment plan for the area, including the modeling conducted in conjunction with the attainment demonstration. It also means that the attainment plan must establish requirements to track emissions changes at sources and provide for corrective action if emissions reductions are not achieved according to the plan.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposal included several proposed recommendations about the development of control measures by states with multi-state nonattainment areas.
The guidance in the final preamble remains very similar to what was proposed. States in multi-state nonattainment areas will need to consult with each other on appropriate control measures for the shared nonattainment area. The agency anticipates that states could decide upon RACM and RACT and additional reasonable measures that differ from state to state in a shared nonattainment area, based upon each state's determination of the most effective strategies given the relevant mixture of sources and potential controls in the respective states' portions of a shared nonattainment area. As long as each state can adequately demonstrate that its chosen attainment strategy, including its selection and adoption of RACM and RACT and additional reasonable measures, will provide for meeting RFP requirements and for attainment of the NAAQS as expeditiously as practicable for the nonattainment area at issue, the EPA anticipates being able to approve individual state plans that may elect to control a different mix of sources or to implement different controls, under the proper circumstances. Nevertheless, in evaluating RACM and RACT and additional reasonable measures for a particular nonattainment area, states must consider potential reasonable control measures developed for other areas or other states, and particularly for other portions of an interstate nonattainment area. In addition, states in multi-state nonattainment areas must evaluate whether the reasonable measures each state may have identified as not being necessary for attainment could collectively advance the attainment date for the area by at least 1 year. The EPA may consider such measures in assessing the approvability of each state's individual attainment plan for a multistate nonattainment area.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposal provided guidance about environmental justice considerations in developing the attainment plan control strategy for a Moderate area.
The guidance remains very similar to what was proposed. Current air quality data indicate that the more severe PM
Any comments received on this section are addressed in the Response to Comments document found in the docket for this action.
Section 189(a) of the CAA generally requires a state with a designated Moderate nonattainment area to submit an attainment plan for such area. Section 189(a)(1)(B) of the CAA requires the state to submit an attainment demonstration including air quality modeling to establish either: (i) That the area will attain the relevant NAAQS by the applicable attainment date; or (ii) that it is impracticable for the area to attain the relevant NAAQS by the applicable attainment date. For Moderate nonattainment areas, the attainment date is as expeditiously as practicable, but no later than the end of the sixth calendar year after designation as nonattainment. The EPA therefore proposed to require all Moderate nonattainment areas to submit either an attainment demonstration which includes air quality modeling which establishes that the area will attain the PM
An attainment demonstration is a plan that provides an explanation of how a state will attain the PM
The EPA further proposed that each state with a Moderate nonattainment area must submit an attainment plan with an attainment demonstration that includes analyses supporting the state's determination of its proposed attainment date. In all cases, the state must show that the area will attain the NAAQS as expeditiously as practicable, but not later than the sixth calendar year after designation. In order to establish that the attainment date is as expeditious as practicable, the state must explain why the control measures adopted in the attainment plan provide for the most expeditious attainment and, in particular, must explain why any cumulative group of reasonable and available control measures that the state elected not to adopt will not collectively advance the attainment date by at least 1 year.
As proposed, attainment demonstrations must include analyses (including air quality modeling) supporting the state's determination of its proposed attainment date. In all cases, the state must show that the area will attain the NAAQS as expeditiously as practicable, but not later than the sixth calendar year after designation. The demonstration must include implementation of all measures identified as RACT/RACM plus additional reasonable measures, as necessary, for expeditious attainment. In order to establish that the attainment date is as expeditious as practicable, the state must explain why the control measures adopted in the attainment plan provide for the most expeditious attainment and, in particular, must explain why the cumulative group of reasonable and available control measures that the state elected not to adopt will not collectively advance the attainment date by at least 1 year.
The EPA is not finalizing a regulatory requirement for air quality modeling to be included as part of an impracticability demonstration.
The EPA continues to assume that in most cases photochemical grid modeling will be required to demonstrate attainment with the PM
a.
The PM
The EPA has updated the 2007 PM
The modeling guidance continues to recommend a relative attainment test for both the annual and 24-hour PM
The EPA has developed software to perform both the annual and 24-hour PM
The modeling guidance continues to describe the opportunity for states to supplement their modeling with a “weight of evidence” demonstration. States may use other information and analyses, in addition to the modeled attainment test to estimate whether future attainment of the NAAQS in an area is likely. Other analyses may include, but are not limited to, emissions trends, ambient data trends and analyses, other modeling analyses, and documentation of other non-modeled emissions control strategies, including voluntary programs.
The application of air quality models requires a substantial effort by state and local agencies. Therefore, states should work closely with their EPA regional office in executing each step of the modeling process. By doing so, it will increase the likelihood of the EPA's approval of the state demonstration submitted at the end of the modeling and overall attainment plan development process.
The technical tools to perform photochemical modeling are well established and have been improved almost continuously over many years. New versions of the CMAQ and CAMx models with numerous science updates are released every 1 to 2 years. National emissions inventories that include primary PM
In addition, the commenters refer to VOC and ammonia as “new precursors,” which is not accurate. VOC and ammonia have always been “scientific” PM
The commenters were concerned that model errors in the formation of PM
a.
The revised PM
a.
Option 1 would require the attainment demonstration modeling to demonstrate attainment at ambient monitoring locations. There would be no requirement to specifically examine attainment in unmonitored areas. Option 2 would require modeling to demonstrate attainment at ambient monitoring locations and in unmonitored areas within the nonattainment area. Enforceable emissions reductions would be required to eliminate any potential future year NAAQS violations in all locations within the nonattainment area (including unmonitored areas). Option 3 would require modeling to demonstrate attainment at ambient monitoring locations and in unmonitored areas within the nonattainment area. However, rather than requiring states to impose additional enforceable emissions reductions in the SIP to address potential violations in unmonitored areas, states would be required to use the unmonitored area analysis results to develop an assessment of the likelihood of violations in unmonitored areas. The assessment would be used to evaluate the need for additional controls and/or could be used to inform the ambient monitoring plan (the need to add additional monitors or move existing monitors). Option 4 would require modeling to demonstrate attainment at ambient monitoring locations and recommend the analysis of unmonitored areas within the nonattainment area. This differs from Option 3 in that there would be no rule requirement to perform an unmonitored area analysis. But the submission of an unmonitored area analysis would still be recommended, especially in areas with a relatively sparse PM
The EPA is requiring an attainment demonstration approach that relies primarily on existing monitoring sites and modeling to project attainment in future years. This approach to evaluating monitored and unmonitored areas is consistent with how EPA determines whether an area meets the PM
In addition, the “relative” attainment test for PM
While the unmonitored area analysis is not a regulatory requirement, and states are not required to identify enforceable emissions reductions to eliminate potential violations in unmonitored areas, an unmonitored area analysis has the potential to provide additional important information about PM
Where information is available, states and the EPA have obligations to address potential violations in unmonitored areas, and, although we expect this to be relatively rare, attainment plans need to address air quality in unmonitored areas where information exists suggesting the potential for such violations. Where an unmonitored area analysis is performed, states should use model results and available ambient data to develop an assessment of the likelihood of violations in unmonitored areas. The nature of the assessment depends on the available information and the nature of the local PM
The PM
In addition, the EPA believes that a monitor based attainment demonstration satisfies the CAA requirement to show that “the entire geographic area” will attain the NAAQS. The EPA's monitoring requirements for PM
States with Moderate areas that submit an impracticability demonstration must show that the area cannot attain the NAAQS by the end of the sixth calendar year following designation of the area. Therefore, the appropriate future modeling year for such a demonstration is also the sixth calendar year after designation.
For the reasons stated earlier, it is both acceptable, and will in fact be most efficient, for a state to begin the attainment demonstration process by modeling the last year permitted under the statute to determine future year modeled PM
Because an area must attain “as expeditiously as practicable,” additional considerations are necessary before an attainment date can be established. For purposes of determining the attainment date that is as expeditious as practicable, the state must conduct future year modeling which takes into account expected growth and known controls that are already in effect or that are adopted and will be in effect by January 1 of the future year. For example, for a Moderate nonattainment area for the 2012 PM
If, on the other hand, the future base case scenario does not demonstrate attainment, then a control case scenario is needed to examine whether the reasonable, technically and economically feasible measures identified by the state would result in attainment in the analysis year (
In conducting this assessment, the EPA believes that it is not reasonable to require states to model each and every calendar year to determine the
The transportation conformity rule requires that attainment plans establish motor vehicle emissions budgets for the area's attainment year. Therefore, once an area's attainment date has been established, the state would establish motor vehicle emissions budgets for direct PM
Reasonable further progress (RFP) is a concept included in the CAA under part D, title I to assure that states make steady, incremental progress toward attaining air quality standards in the years prior to the attainment date for a nonattainment area, rather than merely deferring implementation of control measures and therefore emissions reductions until the date by which the standards are to be attained. As discussed elsewhere in this preamble, section 172 of the CAA addresses attainment plan provisions in general. Section 172(c)(2) of the CAA requires attainment plans to provide for RFP, which is defined in CAA section 171(l) as “such annual incremental reductions in emissions of the relevant air pollutant as are required by [part D of title I] or may reasonably be required by the Administrator for the purpose of ensuring attainment of the applicable national ambient air quality standard by the applicable date.” Section 189(c) of the CAA requires that “[P]lan revisions demonstrating attainment submitted to the Administrator for approval under this subpart shall contain quantitative milestones which are to be achieved every 3 years until the area is redesignated attainment and which demonstrate reasonable further progress, as defined in CAA section 171(1), toward attainment by the applicable date.” Quantitative milestones are discussed later in Section IV.G of the preamble.
Section 172(c)(3) of the CAA requires the state plan to include “a comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants
Under the first option, the EPA proposed that the RFP analysis for any Moderate PM
Under the second proposed option, the state would provide the control strategy implementation schedule and estimate the emissions reductions anticipated from the control measures (
The first component of the RFP plan is the implementation schedule for all required control measures contained in the control strategy. The schedule should describe which measures will be implemented within the first 4 years following designation (and therefore would meet the statutory requirement for RACM and RACT). It should also describe the implementation schedule of additional reasonable measures (to be implemented more than 4 years following designation but before the attainment date) that have been adopted to help provide for expeditious attainment of the standard. Any Moderate area that cannot demonstrate attainment by the statutory Moderate area attainment date is required to provide an implementation schedule for all of the control measures identified as RACM/RACT and additional reasonable measures, in the same manner as an area that can demonstrate attainment.
The second component of the RFP plan is an analysis by the state identifying the RFP projected emissions by pollutant that are expected to be achieved by the control measures implemented within the nonattainment area according to the implementation schedule. The EPA requires the state to estimate these RFP projected emissions for each quantitative milestone year (
The final component of the RFP plan is an analysis demonstrating that the schedule of emissions changes achieves reasonable progress toward attainment between the applicable baseline year and the attainment year. This demonstration can be expressed in the form of emissions reductions only, or emissions reductions converted to air quality concentrations. This optional air quality RFP analysis is discussed later in this section.
Because the statute does not clearly establish the applicable baseline year from which to begin calculating annual emissions reductions for purposes of demonstrating RFP, the EPA is finalizing a requirement that states use the same year as the base year inventory used for developing the control strategy and associated air quality modeling demonstrating that the area will attain expeditiously.
A demonstration based on only emissions reductions must show that the implementation schedule achieves either: (i) Generally linear progress toward the projected attainment date; or (ii) stepwise progress toward the projected attainment date. For example, in one area new emission standards for mobile sources may achieve reductions in a generally linear manner over time, as a portion of the existing vehicle fleet is replaced each year with new vehicles meeting the more stringent standards. In another area, regulations to reduce emissions from certain stationary source sectors could have a single compliance date by which controls must be in place, which could result in a significant drop in emissions in a “stepwise” manner over a relatively short period.
In the first case, the EPA expects that, so long as the attainment date is as expeditious as practicable, then generally linear progress toward attainment by that date would satisfy the RFP requirement. In the second case, where progress is slower than generally linear, the state is required to submit a clear rationale and supporting information to explain why generally linear progress is not appropriate (
Similarly, for areas that cannot demonstrate attainment within the
In some circumstances, the EPA expects that a state could develop an approvable RFP plan even if emissions of one or more PM
The EPA is also providing an additional optional RFP analysis that evaluates the collective changes in emissions of multiple pollutants during the attainment period in terms of changes in air quality concentration. Under this optional approach, a state would have to show that the air quality improvement that is anticipated by milestone dates due to the identified control measures in the implementation schedule supports expeditious attainment of the PM
The EPA recognizes that because atmospheric processes are complex, a specific percent change in emissions of PM
As previously noted, submission of the air quality-based RFP plan is optional. However, in certain circumstances, the applicable Regional Administrator may strongly recommend that a state or local agency submit an RFP plan with air quality targets for milestone years in order to satisfy the statutory RFP requirement. This approach could be appropriate when one or more pollutants is not decreasing over the attainment planning period or for areas that have experienced longstanding and persistent PM
The transportation conformity rule requires that RFP plans establish motor vehicle emissions budgets. RFP plans would therefore be required to establish motor vehicle emissions budgets for direct PM
In the preamble to the remanded 2007 PM
Both the Phase 2 ozone implementation rule and the 2007 PM
In light of this court decision, the EPA has determined that the best reading of the statute is that the term “sources in the area” should be interpreted in the same manner as ozone. The term appears in CAA section 182 (requirements for ozone nonattainment areas) with regard to RFP as well as RACT. The decision on the Phase 2 ozone rule found that CAA section 182(b)(2) requires that a SIP must provide for implementation of RACT (under CAA section 172(c)) for emissions sources “in the area,” meaning in the nonattainment area. Similarly, the EPA position is that when CAA section 182(b)(1)(A)-(B) defines baseline emissions for RFP as “the total amount of actual VOC or NO
Turning to PM
Beyond the Court's interpretation, the EPA believes that the most appropriate approach with regard to the geographic area required to be covered for demonstrating RFP in a PM
Other commenters disagreed with the EPA's interpretation of the CAA on this issue and advocated that the EPA should provide an option for states to meet the RFP requirement with emissions reductions from sources outside the designated nonattainment area in addition to reductions from sources inside the area. One commenter suggested the EPA should provide this option to states and also consider alternatives to simplify the “overly complicated analysis” needed to support this option in the now superseded 2007 PM
Another commenter asserted that the EPA should interpret the statute to permit states to meet the RFP requirement through emissions reductions from sources outside the designated area based upon several practical arguments. The commenter stated that, as the PM
In response to the EPA's request for comment on any potential legal basis for authorizing states to meet the RFP requirement with emissions reductions from outside the nonattainment area, the commenter suggested potential theories. The primary legal theory was that EPA should by regulation redefine the term “area” for purposes of the RFP requirement so that it would encompass geographic areas that are not part of the designated nonattainment area. Through this theory, the commenters suggested that the EPA could authorize states to meet the RFP requirement based on reductions from the “total area” affecting that nonattainment area, rather than from the actual designated nonattainment area. As an alternative theory, the commenter argued that the EPA could regulatorily redefine the emissions inventory requirement of section 172(c)(3). To support this theory, the commenter disagreed with the EPA's position that because the base year inventory required by section 172(c)(3) includes the emissions from sources within the designated nonattainment area, it supports the EPA's reading of the statute with respect to the RFP requirement. The commenter instead argued that because the emissions information used for modeling purpose includes emissions from a much broader region (not just within the nonattainment area or even just within the state), the EPA was wrong to say in the proposal that the base year inventory for sources in the area is the “foundation for the attainment plan.” Finally, the commenter argued more broadly for the EPA to alter its interpretation of the statutory language to allow for the commenter's preferred approach to RFP. In support of their preferred approach to the RFP requirement, the commenters noted that the EPA acknowledged in the proposal that “a literal interpretation is illogical” for other statutory requirements. To support this contention, the commenters point to the criteria in section 188(d) that provide the criteria for an extension of the Moderate area attainment date that require significant interpretation in order to make them appropriate for the statistical form of the current PM
The EPA does not agree with the statutory interpretation of the RFP requirement preferred by the commenters who suggested that the EPA allow credit for emissions reductions from outside the area. Pursuant to section 171(1), the statute defines the term “reasonable further progress” to mean “such annual incremental reductions in emissions . . . as are required by this part or may reasonably be required by the Administrator for the purposes of ensuring attainment of the applicable [NAAQS] by the applicable date.” This provision plainly provides EPA with discretion to interpret this term within certain statutory parameters,
To the contrary, the EPA believes that interpretation of the RFP requirement to reflect reductions in emissions “as are required by this part,” properly includes consideration of the context and structure of the statute with respect to the other attainment plan requirements. As explained in the proposal for this action, the EPA has concluded that several other related requirements for attainment plans support an interpretation of the RFP requirement for purposes of PM
With respect to the inventory requirement of section 172(c)(3), the EPA explained in the proposal its view that because the emissions inventory requirement explicitly refers to a comprehensive, accurate, and current emissions inventory of emissions “from all sources of the relevant pollutant or pollutants in such area,” this statutory language supports the view that the primary focus of the attainment plan is reductions of emissions from the nonattainment area, not emissions reductions from sources elsewhere. Similarly, EPA explained in the proposal its views that the court's decision in
The EPA also considers this interpretation of the RFP requirement to be consistent with the comparable requirements of CAA section 189(d). Specifically, section 189(d) requires that states with nonattainment areas that fail to attain by the applicable attainment date must make a new attainment plan submission in order to achieve emissions reductions of not less than 5 percent of the most recent emissions inventory “for such area.” As discussed in Section VII.F of this rule, the EPA interprets the statute to require an area subject to section 189(d) to achieve not less than a 5 percent reduction of the most recent emissions inventory of direct PM
As explained in the proposal, the EPA also sees no appropriate legal or policy basis for addressing the geographic area from which emissions reductions for RFP must be achieved for PM
One commenter recommended a potential statutory interpretation in support of an outside-the-area approach. The EPA appreciates the suggestion, but has determined that it would be too inconsistent with the structure and purpose of the attainment plan requirements of the statute. The commenter specifically suggested that EPA should redefine the term “area” to encompass not just the designated nonattainment area, but also some larger geographic area with sources of emissions that cause or contribute to the ambient air quality; and that reductions from such sources should be allowed to count towards meeting the RFP requirement in addition to reductions
Finally, the EPA acknowledges that in the prior 2007 PM
For a multi-state or multi-jurisdictional nonattainment area, the RFP plans for each state represented in the nonattainment area shall demonstrate RFP on the basis of common multi-state inventories. The states or jurisdictions within which the area is located must provide a coordinated RFP plan. Each state must ensure that the sources within its boundaries comply with enforceable emission levels and other requirements that in combination with the reductions planned in other states within the nonattainment area will provide for attainment as expeditiously as practicable and demonstrate RFP consistent with these regulations. In general, the EPA seeks to ensure that PM
The EPA's approach for states to meet the RFP requirement is designed to ensure emissions reductions will yield incremental improvements in air quality on the path to attainment, while being sufficiently flexible to accommodate the range of control strategies necessary to address the complex mixtures of pollutants comprising PM
For all areas designated nonattainment for the 1997 and/or 2006 PM
Regardless of whether or not an attainment plan demonstrates attainment by the statutory attainment date, the EPA requires that all Moderate area PM
A similar issue would result in the event that a Moderate area that did demonstrate attainment in the original attainment plan fails to attain by the statutory attainment date. In this case, the area would have failed to meet the attainment date which is as expeditiously as practicable but no later than the end of the sixth calendar year after designation as required by CAA section 188(c)(1). Section 188(b)(2) of the Act allows the Administrator up to
The quantitative milestones contained in the attainment plan for a Moderate nonattainment area should be constructed such that they can be tracked, quantified and/or measured adequately in order for the state to meet its milestone reporting obligations, which come due 90 days after a given milestone date. In the Addendum, the EPA suggested some possible metrics that “support and demonstrate how the overall quantitative milestones identified for an area may be met,” such as percent implementation of control strategies, percent compliance with implemented control measures, and adherence to a compliance schedule. This list was not exclusive or exhaustive but reflected the EPA's view that the purpose of the quantitative milestone requirement is to provide an objective way to determine whether the area is making the necessary progress towards attainment by the applicable attainment date.
This rule requires that each attainment plan for a Moderate PM
The Addendum stated that the Moderate area quantitative milestones “will be met by showing that emissions reductions scheduled to be made between the SIP due date and the attainment date for these moderate areas were actually achieved. Most of these emissions reductions will result from implementation of RACM (including RACT) as part of the moderate area SIP.” However, this rule does not specify that quantitative milestones must be expressed in terms of emissions reductions. The EPA recognizes that it is impractical to expect that a state will always be able to quantify and compare real and projected emissions reductions, and submit a report to the EPA within 90 days of a given milestone as required under CAA section 189(c)(2). Therefore, the final rule requires that, at a minimum, states must include in all attainment plans for Moderate PM
For an area that submitted air quality targets with the RFP plan under the optional provision that was described in Section IV.F of this preamble, an air quality based milestone (
The EPA also sought comment on how electronic reporting could facilitate a state's submission of the required milestone report, how it could accommodate the various narrative and data-dependent components that the EPA proposed be part of such a submission, and what particular system features might be desirable to accommodate milestone report submissions through the eSIP system.
The EPA will work with a state to assist them in meeting the reporting deadline, and expects that, because the report is to be fairly low burden and may be submitted electronically through eSIP, in most cases the state will submit it on time, especially if they have implemented the programs required to meet their milestones. If, however, a state fails to submit a milestone demonstration report by the due date or the EPA determines that a milestone was not met, the final rule requires the state to submit a SIP revision within 9 months of either the missed reporting deadline or the EPA's determination of the state's failure to meet a milestone. According to the statutory requirements of CAA section 189(c)(3), the new SIP revision must assure “that the State will achieve the next milestone (or attain the national ambient air quality standard . . . , if there is no next milestone) by the applicable date.” If a state fails to make a SIP submission to correct a failure to meet RFP expeditiously, sanctions under CAA sections 110(m) and 179(b) may apply. If a state is unable to correct a failure to meet RFP, this may be evidence that the state cannot practicably attain the NAAQS by the applicable attainment date and may serve as a basis for reclassification of the area to Serious under CAA section 188(b)(1).
As previously noted, the EPA has offered guidance about what the milestone report should contain. The Addendum says, “This report must contain technical support sufficient to document completion statistics for appropriate milestones. For example, the demonstration should graphically display RFP over the course of the relevant 3 years and indicate how the emissions reductions achieved to date compare to those required or scheduled to meet RFP and the required [quantitative] milestones. The calculations (and any assumptions made) necessary to determine the emissions reductions to date should also be submitted. The demonstration should also contain an evaluation of whether the PM
First, the report must include a certification by the Governor or Governor's designee that the SIP control strategy is being implemented consistent with the RFP plan, as described in the applicable attainment plan. Second, the report must contain technical support, including calculations, sufficient to document completion statistics for each quantitative milestone and to demonstrate that the quantitative milestones have been satisfied and how the emissions reductions achieved to date compare to those required or scheduled to meet RFP. Additionally, the report must include a discussion of whether the PM
As stated in the Addendum, the milestone report must be submitted from the Governor or Governor's designee to the Regional Administrator of the respective EPA Regional Office serving the submitting state. The EPA will notify the state of its determination (regarding whether or not the state's report is adequate) by sending a letter to the appropriate Governor or Governor's designee. The EPA encourages states to submit milestone reports, including supporting documents, through the agency's electronic SIP (eSIP) submission system in order to simplify the process and reduce resource burden on all sides.
The Act requires Moderate PM
Consistent with the proposal, the final rule codifies existing policies on contingency measures, but does not make significant changes to these policies. Although CAA section 172(c)(9) requires contingency measures, the provision does not specify exactly what parameters such measures must meet. The EPA is finalizing an approach to contingency measures for the PM
(1) Contingency measures must be fully adopted rules or control measures that are ready to be implemented quickly upon a determination by the Administrator of the nonattainment area's failure to meet RFP, failure to meet any quantitative milestone, failure to submit a quantitative milestone report or failure to attain the standard by the applicable attainment date.
(2) The state's attainment plan submission must contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measures will be implemented with minimal further action by the state or by the EPA.
(3) The contingency measures shall consist of control measures that are not otherwise included in the control strategy or that achieve emissions reductions not otherwise relied upon in the control strategy for the area.
(4) Contingency measures should provide for emissions reductions approximately equivalent to 1 year's worth of reductions needed for RFP, based on the overall level of reductions needed to demonstrate attainment divided by the number of years from the base year to the attainment year, or approximately equivalent to 1 year's worth of air quality improvement or emissions reductions proportional to the overall amount of air quality improvement or emissions reductions to be achieved by the area's attainment plan.
Regarding the first two points, consistent with prior guidance, states must show that their contingency measures can be implemented with minimal further action on their part and with no additional rulemaking actions such as public hearings or legislative review. After the EPA determines that a moderate PM
Regarding the third point, the EPA interprets the contingency measure requirement of CAA section 172(c)(9) to require control measures that are not otherwise included in the control strategy or that achieve emissions reductions not otherwise relied upon in the control strategy for the area. However, suitable contingency measures may be measures that were technologically and economically feasible for the area, but did not qualify as RACM or RACT or additional reasonable measures for one or more reasons. For example, a candidate contingency measure may have been deemed technologically and
As discussed in Section IV.D of this preamble, the RACM/RACT provisions in this rule require that, for Moderate areas that cannot practicably attain the NAAQS by the statutory attainment date, states must implement all control measures that they determine to be reasonable (
The final rule continues to allow states to rely on federal measures (
For these reasons, the EPA concluded that this approach is reasonable for Moderate PM
Finally, consistent with the EPA's past approach for contingency measures for PM
This rule requires that states must implement contingency measures after the EPA determines that the area has either failed to meet RFP requirements, failed to meet any quantitative milestone, failed to submit a quantitative milestone report, or failed to attain the standards by the applicable attainment date. The purpose of the contingency measure provision is to ensure that corrective measures are put in place automatically at the time that the EPA makes its determination that an area has either failed to meet RFP or failed to meet the standard by its attainment date. The EPA is required to
Finally, the EPA notes that its longstanding guidance is that contingency measures should provide approximately 1 year's worth of RFP, but this amount may vary based upon appropriate facts and circumstances of each unique nonattainment area. As discussed, states should explain the amount of anticipated emissions reductions to be accomplished by the contingency measures outlined in the plan. In the rare event that an area is unable to identify contingency measures to account for approximately 1 year's worth of emissions reductions, the state should provide a reasoned justification why the smaller amount of emissions reductions is appropriate.
The proposal described the CAA section 188(c)(1) requirement for Moderate areas to attain the standard as expeditiously as practicable, but no later than the end of the sixth calendar year after the “area's designation as nonattainment.” For purposes of clarity, the EPA proposed to interpret the term “area's designation” as meaning “the area's effective date of designation,” consistent with the agency's past approach for implementing the 1997 and 2006 PM
The final rule maintains the requirement interpreting of CAA section 188(c)(1) to mean that the attainment date must be as expeditiously as practicable, but no later than the end of the sixth calendar after the
The EPA's approach to approving an attainment date for a PM
Once an area has an approved attainment date and has implemented its plan, the EPA has the responsibility for determining whether the nonattainment area has attained the standard by its applicable attainment date. Section 179(c)(1) of the CAA requires the EPA to make determinations of attainment no later than 6 months following the attainment date for the area. Under CAA section 179(c)(2), the EPA must publish a notice in the
Section 179(c)(1) of the CAA provides that the EPA is to base the attainment determination for an area upon an area's “air quality data as of the attainment date.” The EPA will make the determination of whether an area's air quality is meeting the PM
A Moderate PM
The EPA will begin processing and analyzing data related to the attainment of Moderate PM
While the EPA may determine that an area's air quality data indicate that an area may be meeting the PM
In order for an area to be redesignated as attainment, the state must comply with the five requirements listed under section 107(d)(3)(E) of the CAA. Briefly, this section requires that:
(1) The EPA has determined that the area has attained the PM
(2) The EPA has fully approved the applicable state implementation plan;
(3) The improvement in air quality is due to permanent and enforceable reductions in emissions;
(4) The EPA has fully approved a maintenance plan for the area; and
(5) The state(s) containing the area or portions of the area have met all applicable requirements under CAA section 110 and part D.
First, the proposal addressed the statutory language explicitly setting ambient air quality conditions for an attainment date extension in terms that relate factually to the 24-hour PM
The EPA included a proposed option and requested comment on two other alternatives. The preferred proposed approach would only require a state to demonstrate that in the year prior to the applicable attainment date for the area, a Moderate area did not exceed the level of (
Second, the proposal addressed how the language of CAA section 188(d)(2) should apply to the PM
Regarding the “requirements and commitments” criterion, the EPA proposed to interpret this provision to mean that the state has adopted and is implementing the control measures in the SIP submission it made to address the attainment plan requirements for the applicable PM
After considering the comments received on this issue, the EPA is finalizing an approach similar to the preferred option in the proposal. This interpretation is based on the plain language of CAA section 188(d) that does not explicitly require that the state comply with all requirements pertaining to the area in the CAA, but merely requires that the state comply with all requirements in the applicable SIP.
With respect to the air quality criterion, several commenters supported the EPA's preferred option because it would require an area to show clean data only for the specific standard for which it is seeking an extension year. Some commenters acknowledged that a literal reading of the statute may seem to require a showing of clean data for both the annual and 24-hour PM
After considering the comments on the air quality criterion, the EPA has decided to finalize the approach that would require an area to show clean data during the attainment year only for
The EPA believes this interpretation of CAA section 188(d)(2) is appropriate for two main reasons. First, while most PM
Some commenters suggested that in some cases a state will not know if it should seek an extension request until after the attainment date has passed, particularly for areas that commonly have higher air quality levels in the cooler months at the end of the calendar year. The commenter recommended that states should have until February 28 of the following year to submit an extension request along with certified air quality data. Other commenters stated that there is no legal basis for requiring the certification of monitoring data by February 28th of the following year, and therefore it should not be a requirement that could potentially disqualify a state from having an extension request be approved.
The EPA considered these comments in light of the EPA's obligation under the CAA to issue a determination of attainment or failure to attain within 6 months of the original attainment date. After considering these comments, the EPA strongly recommends that a state should submit a Moderate area 1-year extension request to the appropriate EPA Regional Office by February 28 of the following year. In addition, the EPA strongly recommends that the state provide certified air quality data for the previous calendar year by this date or as close to this date as possible. The EPA understands that there may be certain situations that prevent the full certification of filter-based PM
As indicated in the proposal, the EPA believes that an attainment date
Regarding the extension period, the EPA interprets CAA section 188(d) to authorize the EPA to stipulate that any extension would begin on January 1 and end on December 31 of the extension year, and these dates would not depend on when the state submitted its request for an extension or was granted the extension by the EPA. The EPA is finalizing this interpretation at 40 CFR 51.1005(a)(4). The EPA believes this is a reasonable approach, as the original attainment date for the area will either be the end of the sixth calendar year following designation of the area, or the end of an earlier calendar year if the state demonstrated that it could advance attainment by at least 1 year. In addition, compliance with the relevant NAAQS will be evaluated based on monitored data collected over a full calendar year (
As noted earlier in this discussion of Moderate area attainment date extensions, CAA section 188(d) provides that a state may seek up to two 1-year extensions of the Moderate area attainment date if it meets the applicable criteria of CAA sections 188(d)(1) and 188(d)(2). The statute makes no distinction between the criteria that must be met for the first 1-year extension and the criteria for the second 1-year extension. Therefore, for a second 1-year attainment date extension request, the EPA intends to apply the same interpretations of the statutory criteria as described earlier in this section, including the recommended deadlines for the state to submit the extension request and the certified air quality data.
As discussed elsewhere in this preamble, subpart 4, part D of title I of the CAA establishes a two-tier classification system for areas designated nonattainment for the PM
The proposal provided background on the EPA's discretionary authority to reclassify a Moderate area to Serious. It proposed to interpret the statute to give EPA broad authority to reclassify based on available information, noting that the EPA could base this determination upon whatever factors are pertinent. The proposal sought comment on whether EPA should discretionarily reclassify an area without a request or submission from the affected state. The proposal also addressed the mandatory statutory timing for discretionary reclassification (
The final rule remains largely unchanged with regard to this issue. The EPA's discretionary authority to reclassify a Moderate area to Serious derives from language in section 188(b)(1) of the CAA, which provides that: “The Administrator may reclassify as a Serious PM
The CAA does not specify the basis on which the EPA may make a determination that the area cannot practicably attain by the applicable attainment date. In the General Preamble, the EPA explained that the agency could base this determination upon whatever facts are pertinent, and could do so whether or not the state in question has submitted a Moderate area attainment plan, and whether or not the state has made the demonstration contemplated in CAA section 189(a)(1)(B).
However, the CAA does not specify the basis for the EPA's exercise of its discretionary authority and does not require the EPA to make its determination based on a submission from the state. Indeed, such a prerequisite would be illogical in the case of a state that fails to make any attainment plan submission or fails to address the issue of the need for reclassification in such submission. The EPA believes that while a Moderate area impracticability demonstration as contemplated in CAA section 189(a)(1)(B) is desirable in order to help the agency make a determination that the area cannot practicably attain by its attainment date, such a demonstration is not necessary to trigger action by the EPA to reclassify a Moderate area to Serious. The statute does not prohibit the EPA from using the weight of available evidence, including information available in the public record of a state, to make such a determination, even in the absence of a complete attainment plan submission.
Regarding the timing of discretionary reclassifications, CAA section 188(b)(1)(B) establishes timeframes by which EPA is to act if it intends to exercise its discretionary authority to reclassify areas as appropriate following the Moderate area attainment plan due date, stating that “the Administrator shall reclassify appropriate areas within 18 months after the required date for the state's submission of a SIP for the Moderate Area.” In the case of areas designated nonattainment for the 2012 PM
However, as noted earlier, there may be situations in which it may be appropriate to reclassify an area at a point in time more than 18 months after the SIP due date. On this issue, the General Preamble stated that:
“. . . under the plain meaning of the terms of section 188(b)(1), EPA has general discretion to reclassify at any time before the applicable attainment date any area EPA determines cannot practically attain the standards by such date. Accordingly, CAA section 188(b)(1) is a general expression of delegated rulemaking authority. In addition, subparagraphs (A) and (B) of CAA section 188(b)(1) mandate that the EPA reclassify at specified timeframes any areas it determines appropriate for reclassification at those dates. These subparagraphs do not restrict the general authority but simply specify that, at a minimum, it must be exercised at certain times.”
The EPA continues to consider this the correct interpretation of the statutory requirements concerning its authority to reclassify a Moderate nonattainment area to Serious at any time prior to the area's Moderate area attainment date, if the agency determines that the area cannot practicably attain the relevant PM
The EPA emphasizes that a state with an area designated as nonattainment for the PM
. . . creates an incentive for the timely submittal and effective implementation of moderate area SIP requirements and facilitates the PM
The EPA considers this longstanding interpretation of CAA section 188(b)(1) to be the correct interpretation of the statutory requirements governing the discretionary reclassification of Moderate areas. The EPA will reclassify any area it determines cannot practicably attain by the Moderate area attainment date through notice-and-comment rulemaking.
The proposal provided background on the EPA's mandatory duty pursuant to CAA section 188(b)(2) to reclassify a Moderate area to Serious when the area fails to attain the standard by the attainment date. The CAA directs the EPA to reclassify an area from Moderate to Serious if the area fails to attain the relevant NAAQS by the applicable Moderate area attainment date
The EPA proposed that the date of reclassification would be the effective date of the
The proposal also discussed a possible alternative option, which would be to consider the date of reclassification to Serious to be the same as the Moderate area attainment date. Applying this approach in the example earlier would yield an earlier date of reclassification of December 31, 2021, and an earlier Serious area attainment plan due date of June 30, 2023.
Several commenters supported the EPA's proposed approach to interpret the date of reclassification as the effective date of the
After taking the comments received under consideration, the EPA has decided to retain the proposed approach. The date of reclassification is the effective date of the
Although CAA section 188(b)(2) does not explicitly address this issue, the EPA believes that this approach is a reasonable interpretation of statutory ambiguity in CAA section 188(b)(2) and preferable over the alternative approach for two additional reasons. First, the statute at CAA section 189(b)(2) gives a state 18 months from the date of reclassification of an area to submit for the EPA's approval an attainment demonstration with air quality modeling and provisions to assure timely implementation of BACM and BACT on sources in the nonattainment area. The workload associated with developing a Serious area plan can be substantial, and the EPA believes that it is reasonable to resolve the statutory ambiguity in favor of providing the state with the full 18 months from the effective date of reclassification to develop and submit a thorough, complete and accurate Serious area attainment plan that will provide for expeditious attainment of the NAAQS.
Second, the statutory attainment date for a Serious area reclassified under any circumstances is as expeditious as practicable but no later than the end of the tenth year following designation of the area, and is thus independent of the date of reclassification of the area. Allowing a state some additional amount of time beyond 18 months from the missed attainment date to develop and submit a complete Serious area attainment plan, including adopting BACM and BACT, will not change the statutory obligation on the state for the area to attain the relevant NAAQS by the applicable attainment date. On the contrary, the EPA believes that the extra time may in fact help the area timely attain the relevant NAAQS by allowing the state to develop a more effective attainment plan for the area.
Thus, the EPA interprets the CAA such that the date of reclassification for an area reclassified under the EPA's mandatory duty is to be considered the effective date of the
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
Sections 189(b) and (c) of the CAA include the following requirements for Serious area attainment plan submissions: (i) An attainment demonstration (CAA section 189(b)(1)(A)); (ii) provisions for the implementation of best available control measures (BACM) no later than 4 years after reclassification of the area to Serious (CAA section 189(b)(1)(B)); (iii) quantitative milestones that will be used to evaluate compliance with the requirement to demonstrate RFP (CAA section 189(c)); and (iv) regulation of PM
Additionally, CAA section 189(b)(1) requires that “in addition” to the attainment plan requirements specific to Serious areas, states must also meet all Moderate area attainment plan requirements. The EPA interprets the statutory language of CAA section 189(b)(1) to require states with areas that are reclassified to Serious to meet Moderate area attainment plan requirements, including all areas that the EPA reclassifies through rulemaking under its discretionary authority, even if that occurs before the area has met all of its Moderate area attainment plan requirements.
The proposal discussed the statutory provisions that informed the options for the submission due dates for the various components of Serious area attainment plans. The timing of Serious area attainment plan elements is dictated by two provisions of the CAA: CAA section 189(b)(2) for certain subpart 4 elements and CAA section 172(b) for subpart 1 elements not superseded by subpart 4 requirements. Section 189(b)(2) of the CAA addresses the due dates for Serious area attainment demonstrations due under CAA section 189(b)(1)(A) and provisions for BACM and BACT implementation under CAA section 189(b)(1)(B). Specifically, section 189(b)(2) stipulates two alternative schedules for states to submit Serious area attainment demonstrations, depending upon the statutory authority governing the reclassification action. For an area reclassified to Serious by operation of law under CAA section 188(b)(2) upon a determination by the EPA that the area failed to attain the relevant NAAQS by the applicable Moderate area attainment date, a state must submit a new attainment demonstration for the area no later than 18 months after reclassification. For an area reclassified to Serious pursuant to the agency's discretionary authority provided under CAA section 188(b)(1), a state must submit a new attainment demonstration no later than 4 years after reclassification of the area.
When considering attainment plan due dates for areas that have been discretionarily reclassified, it is also important to keep in mind the requirements of CAA section 188(b)(1). Section 188(b)(1) of the CAA generally states that: “The Administrator may reclassify as a Serious PM
Lastly, because some of the Serious area plan requirements noted earlier are established in subpart 1 of the Act (CAA section 172), the proposal also noted that CAA section 172(b) provides the EPA discretion to set a due date for submission of these subpart 1 attainment plan elements that is no later than 3 years after
After taking these comments into consideration, the EPA has decided to require all Serious area plan elements to be due within 18 months of the effective date of reclassification for any area reclassified due to a failure to attain by the Moderate area attainment date. The EPA believes that the proposed alternative 3 year deadline, which would have allowed some elements to be submitted as late as 6 months prior to the attainment date, would mean that the state would be required to submit two different SIPs and would require greater state government resources to conduct the administrative and public procedures required to submit the separate plans to the EPA. This approach also would not provide the EPA with sufficient time to appropriately review and take action on the state's submission prior to the attainment date. It also is appropriate to have the RFP, quantitative milestones, and contingency measures elements be developed and submitted at the same time as the attainment demonstration because they build from the information in the attainment demonstration. The EPA also maintains that requiring states to submit all elements of an attainment plan by the same date is reasonable because it allows for a complete review of the state submission by the EPA, regulated entities, and the general public, and it also should prove to be most efficient for states and the EPA. The EPA further agrees with commenters that a program requiring two submissions rather than one can generally be expected to be less administratively efficient because it will involve separate public hearings and comment periods at the state level, and separate proposed and final approval actions in the
The notice also discussed a potential control measure option (described in Section VI.D. of the proposal, Attainment Plan Control Strategy, at page 15410) that would closely link the BACM/BACT determinations to the attainment demonstrations (rather than consider BACM/BACT as an independent requirement). Therefore, to facilitate this linked approach to BACM/BACT, an alternative option was proposed for submission of the attainment demonstration within 18 months of reclassification, instead of within 4 years.
The proposal also addressed the remaining plan elements: additional feasible measures (
Some commenters stated that for an area that is reclassified to Serious because it cannot practicably attain the NAAQS by the Moderate area attainment date, CAA section 188(b)(1)(B) requires the EPA to reclassify the area within 3 years of designation (
For discretionary reclassification areas, just as for mandatory reclassification areas, the EPA is finalizing the statutory due date of 18 months for the BACT/BACM submission. However, after considering comments received on the timing options for submission of the attainment demonstration, the EPA has determined that the attainment demonstration should generally be due later than 18 months for areas subject to discretionary reclassifications. Because the statutory provision in CAA section 189(b)(2) provides up to 4 years, the EPA believes that an appropriate default due date for
The circumstance that one of the commenters identifies, where the EPA reclassifies an area to Serious at a point in time more than 3 years after designation, raises an important timing issue that was not explicitly addressed in the proposal. The EPA was aware that it might need to reclassify an area to Serious beyond 3 years after designation (
The EPA maintains that the statutory authority to “reclassify as a Serious PM-10 nonattainment area . . . any area that the Administrator determines cannot practicably attain [the NAAQS] by the attainment date . . . for Moderate Areas” includes the authority to make that determination and issue a discretionary reclassification any time before the Moderate area attainment date, as long as doing so does not otherwise unreasonably frustrate the primary goals of the statute. For example, the EPA must consider the timing for submission of Serious area SIP requirements to ensure the state has sufficient time to implement an effective plan and the agency has sufficient time to review and act on the plan in advance of the outermost Serious area attainment date (
The EPA interprets the statute to provide authority to require submission of attainment plan requirements, including the attainment demonstration, by a date less than 4 years from reclassification to Serious when exercising its discretionary authority to reclassify an area to serious nonattainment pursuant to CAA section 188(b)(1). While the EPA generally prefers to give states as much time as possible to develop and submit plans, the agency concluded that allowing 4 years for submission of the attainment demonstration in all discretionary reclassification actions would potentially frustrate the goals of the statute.
To resolve this issue, EPA is finalizing a specific schedule for submission of the attainment demonstration following discretionary reclassification. As discussed earlier, the terms of the statute provide some guidance as to the appropriate schedule because, as explained earlier, a state would have until the end of the 7th calendar year to submit the attainment demonstration after a discretionary reclassification that follows the timing in CAA section 188(b)(1)(B), and a state would have until the end of the 8th calendar year after a mandatory reclassification to submit the attainment demonstration.
While not dispositive, these provisions indicate that Congress believes that Serious area attainment plans should be submitted at least 2 years in advance of the outermost statutory attainment date for Serious areas to ensure expeditious attainment of the NAAQS. The EPA finds that a minimum of 2 years is appropriate because (1) it provides time for emission reduction measures adopted by the state to take effect and improve air quality; (2) it will allow the agency sufficient time to evaluate and act on the Serious area attainment demonstration; and (3) for every other NAAQS, the CAA SIP submission dates are generally 2 years or more prior to the attainment date. If for example the plan is not submitted until just before year 10, and the agency determines the plan will not lead to attainment, there will be no time to take corrective action before the attainment date to ensure attainment of the NAAQS. Such a result would not be reasonable.
Therefore, the EPA believes that a reasonable attainment demonstration due date for any discretionary reclassification to Serious would be the earlier of (1) 4 years from the date of reclassification, or (2) the end of the eighth calendar year after designation. As an example, an area that is reclassified at the end of year 5 would have 3 years rather than four years to submit the attainment demonstration and other plan elements by the end of year 8. An area that is reclassified no later than the end of year 4 would have the full four years, and any area reclassified after this point would have less than 4 years. At the outer extreme, in the unlikely event that the EPA chooses to exercise its discretion to reclassify an area in the sixth calendar year after designation (
Lastly, this section addresses appropriate SIP submission dates for the other required plan elements. Regarding the base year emission inventory, the EPA believes it is appropriate to require the updated base year emissions inventory at the same time that the BACM/BACT submission is due (18 months) because the updated inventory will be a critical element relied on for making control measure determinations. Regarding the remaining planning elements (
With regard to the due date for submission of NNSR program revisions that may be required when an area is reclassified to Serious, such as revisions to meet nonattainment NSR program requirements to lower the “major stationary source” threshold from 100 tons per year (tpy) to 70 tpy (CAA section 189(b)(3)) and to address the control requirements for major stationary sources of PM
The EPA proposed that the inventory requirements for Serious areas were the same as those for Moderate areas with some additions. In addition to the Moderate area requirements, the EPA proposed that Serious area inventory requirements would include using a major source threshold of 70 tons/year for reporting sources as point sources for both the base year inventory for the nonattainment area and the attainment projected inventory for the nonattainment area.
With regard to the due date for the attainment projected inventory for the nonattainment area, the EPA proposed two cases. In the case where the area is reclassified after failing to attain the NAAQS by the Moderate area attainment date, the attainment projected inventory for the nonattainment area was proposed to be submitted no later than 18 months after reclassification. In the case where the area is reclassified by the EPA because the area cannot practicably attain the NAAQS by the statutory attainment date, the EPA proposed that the attainment projected inventory for the nonattainment area would be due no later than 4 years after reclassification.
As noted earlier in this preamble, states must use the best available, current emissions inventory information for attainment plan development, because complete, high quality emissions inventory data are essential for the development of an effective control strategy. To assist states in preparing complete, high quality inventories, the EPA provides guidance for developing emissions inventories in its SIP Emissions Inventory Guidance, available at
Like Moderate areas, there are three key facets of the emissions inventory requirements: (i) The types of inventories required; (ii) the content of these inventories; and, (iii) the timing of submission of these inventories. The three facets are addressed in the following paragraphs.
First, the same two types of inventories required for Moderate areas are also required for Serious areas. While these inventories are the same types and names of inventories as for Moderate areas, they must be created specifically for Serious area attainment plans in accordance with the applicable Serious area requirements. The first type of inventory is called the “base year inventory for the nonattainment area,” and the second type of inventory is called the “attainment projected inventory for the nonattainment area.”
Second, the content of the inventories will follow the content requirements for Moderate area inventories, with two exceptions needed to meet the requirements of section 189(b)(3). The first exception for Serious areas stems from the Section 189(b)(3) definition of a separate emissions threshold for major sources in Serious nonattainment areas (70 tpy potential to emit of PM
As described previously for Moderate areas, Appendix A of Table 1 of 40 CFR part 51, subpart A (the AERR) is required by this rule to define which sources must be reported as point sources for inventories associated with this rule (base year and projected attainment year inventories). To be consistent with the 70 tpy threshold finalized in this rule, this rule is also amending Table 1 of Appendix A of the AERR to include the 70 tpy threshold for PM
The second difference between the Serious area and Moderate area inventory requirements is a minor wording difference for the year that should be chosen for the base year inventory. The year should be one of the 3 years used for reclassification (rather than designation for Moderate areas) or another technically appropriate inventory year. Another inventory year may be chosen under specific circumstances (
The third facet of the Serious area inventory requirements is the timing, which is somewhat different than for Moderate areas. Section VI.A of this preamble describes the requirement that states submit the base year inventory for a Serious nonattainment area at the same time that it submits provisions to implement BACM and BACT on sources in the area (due no later than 18 months from reclassification of the area pursuant to section 189(b)(2)). This is because the base year inventory serves as the starting point for conducting a BACM and BACT determination. In contrast to the base year inventory, the attainment projected inventory is more closely related to the Serious area attainment demonstration. Thus, the attainment projected inventory is most appropriately submitted with the attainment demonstration for a given Serious area to allow effective evaluation of the attainment plan as a whole.
Consequently, this rule requires that attainment projected emissions inventories be submitted at the same time as the Serious area attainment demonstration. This requirement gives rise to two possible deadlines for Serious areas to submit the attainment projected emissions inventory for the nonattainment area. For areas that are reclassified after failing to attain the NAAQS by the applicable Moderate area attainment date, the deadline is no later than 18 months after reclassification (same time period as for Moderate areas). For areas reclassified by the EPA because the area cannot practicably attain the NAAQS by the statutory Moderate area attainment date, the deadline is the earlier of 4 years from the date of reclassification, or the end of the eighth calendar year after designation.
All PM
As noted in Section III of this preamble, if the EPA approves a state's precursor demonstration for the Moderate area plan, the state would need to re-evaluate whether the precursor contributes significantly to PM
If the EPA approves a comprehensive precursor demonstration for the Serious area plan, then the state would not be
The statutory attainment planning requirements of subparts 1 and 4 were established to ensure that states meet the following goals of the CAA: (i) Implement measures that provide for attainment of the PM
The following sections describe the recommended approach for a state to follow in order to identify and select the complete suite of measures needed for an approvable attainment plan submission for a Serious PM
Under the second proposed option, there would be a greater emphasis on linking the control strategy evaluation process with the attainment needs for the area. Accordingly, this option would not include a “
A Serious area attainment plan must include provisions to implement BACM on sources in a Serious nonattainment area, as provided by section 189(b)(1)(B), no later than 4 years after reclassification. Under section 189(b)(2), a state has 18 months following reclassification to submit these BACM provisions.
Section 189(b)(1)(B) refers only to BACM, but the EPA has long interpreted this term to include BACT, just as the analogous term for RACM includes RACT for Moderate areas. For implementation of the PM
Longstanding guidance in the General Preamble and Addendum, together with past practice associated with implementing the PM
Congress first defined BACT in CAA section 169(3) for the PSD permitting program as: “an emission limitation based on the maximum degree of reduction of each pollutant . . . which the permitting authority, on a case-by-case basis, taking into account energy, environmental, and economic impacts and other costs, determines is achievable for such facility through application of production processes and available methods, systems, and techniques . . .”
In the Addendum, the EPA provided guidance concerning the requirements for BACM and BACT for Serious area attainment plan requirements for the PM
As noted earlier, the issue of whether BACM/BACT should be considered generally independent of attainment or more closely tied to attainment for purposes of implementing the PM
In the Serious Area Addendum, the EPA described BACM as a generally independent requirement, to be determined without regard to the specific attainment analysis (
The view that BACM and BACT measures are generally independent of the attainment needs of the area is also consistent with the statutorily specified submission date for BACM and BACT control measures, contrasted against the statutorily specified submission date for the attainment demonstration for Serious areas. Specifically, states with Serious nonattainment areas must submit BACM and BACT measures within 18 months of reclassification of areas to Serious, whereas they are given up to 4 years from reclassification (for areas where it is impracticable to attain by the attainment date) to submit the attainment demonstration for such areas.
Additionally, the EPA believes that interpreting the Serious PM
Another central issue distinguishing the two proposed options for how to determine BACM/BACT was the issue of whether, before analyzing any potential BACM/BACT, the state should conduct technical analyses to identify whether there are any source categories having a
As noted previously, the proposal requested comment on inclusion of an ambient impact threshold of 3 percent for determining whether a source category impact would be
The EPA also proposed a similar
A number of commenters supported the
After taking the range of comments on the
Moreover, as noted in Section IV.D of this preamble on Moderate areas, the EPA also finds that from a technical perspective, it would be very challenging to implement a
While the proposed approaches and criteria for identifying appropriate control measures for a Serious area are necessarily different than for a Moderate area, it is important to note two similarities: First, that the EPA interprets the requirement under CAA section 172(c)(6) for a state to adopt “other measures” needed for attainment to apply to sources located inside and outside of any PM
Taking these two statutory provisions together, the EPA proposed that the other measures required under CAA section 172(c)(6) must include “additional feasible measures,” which would be those measures and technologies that otherwise meet the criteria for BACM/BACT but that can only be implemented in whole or in part beginning 4 years after reclassification of an area, but no later than the statutory attainment date for the area.
Some commenters agreed that an area must also consider adopting control measures that cannot be implemented within the 4-year deadline for implementation of BACM and BACT. Some commenters suggested that additional feasible measures should only be tied to expeditious attainment.
In the final rule, additional feasible measures would necessarily be implemented by sources in the nonattainment area, and a state is required to implement them if they are needed in addition to BACM and BACT to bring the area into expeditious attainment. The state must also adopt other emission reduction measures for sources within the state but outside the nonattainment area if such measures in conjunction with other control measures would enable the area to attain the standard by the attainment date, or enable the area to advance the attainment date by at least 1 year.
These “additional feasible measures” would be analogous to the “additional reasonable measures” in the RACM and RACT analysis process, which are technologically and economically feasible measures that cannot qualify as RACM or RACT because they cannot be implemented within 4 years of designation of a Moderate nonattainment area. Under the approach for determining BACM and BACT for sources in a Serious nonattainment area described later in this section, a state would identify additional feasible measures as part of the BACM and BACT determination process, just as additional reasonable measures would be identified as part of the state's RACM and RACT determination process.
The EPA recognizes that with regard to Serious areas, only a nonattainment area that is reclassified under the agency's discretionary authority might have sufficient time between the date for implementing BACM and BACT and the statutory Serious area attainment date to implement additional measures beyond BACM and BACT. BACM and BACT must be implemented no later than 4 years after reclassification of the area; areas reclassified to Serious because they cannot practicably attain the relevant NAAQS by the applicable attainment date could potentially have significantly more than 4 years between the date of reclassification and the statutory Serious area attainment date, during which time the area could continue to implement additional feasible measures to bring the area into attainment.
By way of illustration, for areas designated in the first round of designations for the 2012 PM
In addition to the regulatory decisions earlier, the EPA summarized and sought comment on further guidance for states
The BACM/BACT selection process for implementation of the PM
The EPA's RBLC provides a central data base of air pollution technology information that may be highly relevant to states seeking information on stationary source control technology that may qualify as BACT for PM
The state must incorporate appropriate measures into the list of potential control measures for the source categories in the Serious nonattainment area. The EPA would expect the state to identify an array of existing and potential new measures at least as broad as the list identified for the same area as part of the RACM and RACT analysis, in order to ensure that the state has a sufficiently expansive and comprehensive set of potential measures to evaluate. The list of potential measures must include all measures identified as potential control measures for the nonattainment area when it was classified as Moderate or, for a given source category, one or more alternative control measures that would control emissions even more stringently than the measures included in the RACM/RACT analysis. In this way, the state will begin its BACM/BACT determination with a list of potential control options that is as complete and up-to-date as possible.
(1) Stationary sources. As described under the technological feasibility criteria for the control measures analysis for Moderate area attainment plans in Section IV.D of this preamble, the EPA's prior guidance on factors to consider for judging whether a particular control technology is technologically feasible should include a source's processes and operating procedures, raw materials, physical plant layout and potential environmental impacts such as increased water pollution, waste disposal and energy requirements. For example, the EPA recognizes that the process, operating procedures and raw materials used by a source can affect the feasibility of implementing process changes that reduce emissions and can also affect the selection of add-on emission control equipment. The feasibility of modifying processes or applying control equipment also can be influenced by the physical layout of the particular plant, if the physical space available in which to implement such changes limits the choices.
(2) Area and mobile sources. With respect to determining whether a given control measure might not be technologically feasible as BACM for an area or mobile source, a state may consider factors in conducting its analysis that are similar to factors the state may have considered during the RACM and RACT determination process, such as local circumstances, the condition and extent of needed infrastructure, or population size or workforce type and habits, which may
Indeed, consistent with prior guidance on evaluating costs of a potential BACM/BACT, the EPA maintains that while the economic feasibility of a control measure is as important as its technological feasibility under the RACM and RACT determination process, economic feasibility is a less significant factor in the BACM and BACT determination process. In other words, a state must apply a higher standard for eliminating a technologically feasible control measure from further consideration as BACM due to cost alone.
In the Addendum, the EPA stated that “for PM
In addition, a state may not automatically eliminate a particular control measure merely because other sources have not implemented the measure. In other words, a state must continue to consider technologically feasible measures that have not been implemented by similar sources but that can nonetheless effectively reduce emissions from the source category in question at a cost that is not cost prohibitive.
As with the EPA's approach for evaluating economic feasibility of potential reasonable measures for Moderate area attainment plans, for each technologically feasible control measure or technology, a state must evaluate the economic feasibility of the measure through consideration of the capital costs, operating and maintenance costs, and cost effectiveness (
1. Fixed and variable production costs ($/unit);
2. Product supply and demand elasticity;
3. Product prices (cost absorption vs. cost pass-through);
4. Expected costs incurred by competitors;
5. Company profits;
6. Employment costs;
7. Other costs (
A state must identify those technologically and economically feasible control measures and technologies that it can implement fully or partially within 4 years of reclassification of its Serious PM
Where the earliest date that a measure can be implemented is beyond the 4 year mark following reclassification to Serious, the measure may still be needed as an “additional feasible measure” if the 4 year mark occurs before the Serious area attainment date. “Additional feasible measures” would be “best”-level, feasible measures that a state could implement in whole or in part on sources in the area sometime after the fourth year following reclassification and prior to the statutory attainment date for the area.
(1) A list of all emissions source categories, sources and activities in the nonattainment area that emit direct PM
(2) For each source category, source or activity in the nonattainment area, an inventory of direct PM
(3) For each source category, source or activity in the nonattainment area, a comprehensive list of potential control measures considered by the state for the nonattainment area;
(4) For each potential control measure considered by the state but eliminated from further consideration due to a determination by the state that the control measure or technology was not technologically feasible, a narrative explanation and quantitative or qualitative supporting documentation to justify the state's conclusion;
(5) For each technologically feasible emission control measure or technology, the state must provide the following information relevant to economic feasibility: (i) The control efficiency by pollutant; (ii) the possible emissions reductions by pollutant; (iii) the estimated cost per ton of pollutant reduced; and, (iv) a determination of whether the measure is economically feasible, with narrative explanation and quantitative supporting documentation to justify the state's conclusion;
(6) For each technologically and economically feasible emission control measure or technology, the date by which the technology or measure can be implemented.
As with a Moderate area attainment plan submission, the EPA recognizes that the base year emissions inventory that the state submits for the area in conjunction with its Serious area attainment plan will likely contain the information required under the first two items in this list. However, the EPA believes that it is incumbent on the state to ensure that the information needed for the EPA to evaluate the state's BACM and BACT and additional feasible measures analysis is presented as part of that analysis and in a format that provides transparency, consistency and the ability for another party to evaluate the state's analysis effectively and to duplicate the state's results. For this reason, the EPA is requiring the state to include the base year emissions inventory information with the BACM and BACT submission and as one element of the state's attainment plan due 18 months after reclassification of the area to Serious.
Attainment demonstrations are due 18 months after reclassification if the EPA reclassifies the area to Serious after failure of the area to attain the applicable Moderate area deadline. Alternatively, CAA section 189(b)(2) requires states with designated Serious nonattainment areas to submit attainment demonstrations no later than 4 years after reclassification of the area to Serious if the reclassification occurs before the Moderate area attainment deadline. The EPA proposed an approach for determining an appropriate attainment plan control strategy for a Serious PM
The EPA is not finalizing the proposed approach of requiring all Serious area attainment demonstrations to be due 18 months after reclassification. If the EPA reclassifies the area to Serious after failure of the area to attain the applicable Moderate area deadline, the attainment demonstration will be due in 18 months. States with Serious nonattainment areas that were reclassified before the Moderate area attainment deadline must submit attainment demonstrations the earlier of 4 years after reclassification of the area to Serious or the end of the eighth calendar year after initial designation. However, these areas are still required to submit BACT/BACM measures within 18 months of being reclassified as Serious. Sections VI.A and VI.D of this preamble describe more fully the EPA's approach for plan due dates and control strategy analyses for all elements of a Serious area attainment plan. Section VI.J of this preamble provides a complete discussion of the EPA's criteria for granting a Serious area attainment date extension.
A state with a Serious nonattainment area can also submit an impracticability demonstration (under CAA section 189(b)(1)(A)(ii)) as part of seeking an extension of the attainment date under CAA section 188(e). The impracticability demonstration for a Serious area would be similar to an impracticability demonstration for Moderate areas because it must show that the area will not be able to attain the PM
In order to support a Serious area impracticability demonstration, the state must show (through modeling) that attainment cannot be reached by the latest statutory Serious area attainment date, even if all RACM and RACT and BACM and BACT controls, as well as other measures either inside the nonattainment area or outside the nonattainment area but within the state (as may be necessary to meet the requirements of 172(c)(6)), were implemented before the attainment date. Moreover, in addition to the Serious area impracticability demonstration, to support an extension of the attainment date, the Serious area plan must demonstrate (again, using air quality modeling) that it provides for attainment by the most expeditious alternative date practicable employing MSM, as specified in CAA section 188(e). (MSM are discussed in more detail in Section VI.J of this preamble). As a result, the required plan in the case of a Serious area that cannot attain by the statutory attainment date is both an impracticability demonstration (to justify an extension beyond the statutory attainment date) and an attainment demonstration that serves as the basis for proposing an appropriate alternative attainment date. Note that this is different from a Moderate area impracticability demonstration, which is not required to serve as the basis for proposing a new area attainment date.
Some commenters believed that both Moderate and Serious area impracticability demonstrations must include air quality modeling. The EPA does not agree and believes the statute only requires air quality modeling for Serious area impracticability demonstrations. This stems from the slightly different statutory construction in CAA section 189(b)(1)(A) compared to CAA section 189(a)(1)(B). Section 189(b)(1)(A) of the CAA specifies an air quality modeling requirement as a parenthetical, which the EPA interprets to apply to both the requirements in CAA section 189(b)(1)(A)(i) [attainment demonstrations] and CAA section 189(b)(1)(A)(ii) [impracticability demonstrations]. Additionally, the fact that a Serious area impracticability demonstration must also include an attainment demonstration with an alternative attainment date logically supports the final rule conclusion that a Serious area impracticability demonstration must include air quality modeling. Modeling is needed to demonstrate attainment and to propose an alternative attainment date for the Serious area. This differs from a Moderate area impracticability demonstration, which only serves to demonstrate that attainment cannot be reached by the Moderate area attainment date. A Moderate area impracticability demonstration does not require a demonstration of attainment or setting of an alternative future attainment date. It merely starts the process of reclassifying an area to Serious and the eventual required submission of a Serious area implementation plan.
Other than the timing of plan submissions and additional required elements of a Serious area plan (such as BACM and BACT), the relevant air quality modeling procedures and guidance for Moderate and Serious area plans are the same.
While states should choose the future modeling year based on a number of factors, the EPA recommends the last year of the statutory attainment date as a starting point for modeling for two reasons. First, a state with a Serious area for which it submits an attainment date extension request under CAA section 188(e) must show that the area cannot practicably attain the NAAQS by the end of the tenth calendar year following designation of the area. Therefore, the appropriate future modeling year for making such a demonstration is the tenth year after designations. Even if a state does not submit (or does not intend to submit) a Serious area attainment date extension request, modeling the tenth year is a logical starting point to determine if attainment by year ten is likely. If attainment-level concentrations of PM
Second, even though attainment of any PM
Because an area must attain “as expeditiously as practicable,” additional considerations are necessary before an attainment date can be established. Criteria for establishment of the Serious area attainment date are discussed in Section VI.I of this preamble. In evaluating such considerations, the question arises as to whether additional future modeling is required beyond the recommended final year modeling just discussed. For purposes of determining the attainment date that is as expeditious as practicable, the state must conduct future year modeling that takes into account growth and known controls (including any controls that were previously determined to be RACM and RACT for the area). For example, for an area designated nonattainment for the 2012 PM
As with Moderate area attainment demonstrations, the EPA believes that it is not necessary or reasonable to require states to model each and every year to determine the appropriate attainment date for a Serious PM
As with Moderate areas, the transportation conformity rule requires that Serious area attainment plans establish motor vehicle emissions budgets for the area's attainment year. Therefore, once a Serious area's attainment date has been established, the state is required to establish motor vehicle emissions budgets for direct PM
As with a Moderate area attainment plan, the EPA is finalizing that a state must submit an RFP plan as part of any Serious area attainment plan in order to satisfy the statutory requirements for RFP. The plan must contain appropriate information to demonstrate that adequate emissions reductions will be achieved through control measures in the attainment plan in order to meet the
The EPA requires that the applicable baseline year must be the same year as that represented by the latest base year inventory for the Serious area. The projected attainment year may be up to the end of the tenth year following designation for a Serious area that can demonstrate attainment pursuant to CAA section 189(b)(1)(A), or up to the end of the fifteenth year following designation for a Serious area that sought an extension of the statutory attainment date pursuant to CAA section 188(e).
Additionally, the EPA requires that motor vehicle emissions budgets must also be established for direct PM
Finally, similar to Moderate areas, Serious areas that are multi-state or multi-jurisdictional shall provide RFP plans for each state represented in the nonattainment area that demonstrate RFP on the basis of common multi-state inventories. The states or jurisdictions within which the area is located must provide a coordinated RFP plan. For further information,
The EPA proposed that a Serious area plan for an area that can demonstrate attainment by the statutory Serious area attainment date must also include quantitative milestones to be reached 7.5 and 10.5 years from designation, to help assess the state's progress toward attaining the PM
The EPA proposed that the general approach to selecting quantitative milestones outlined in the Moderate nonattainment area section of the proposal should apply to any attainment plan for a PM
The final rule provisions for Serious area quantitative milestones are similar to such provisions for Moderate areas discussed in Section IV.G of this preamble. As required for Moderate areas, Serious area attainment plans must include quantitative milestones that demonstrate RFP towards attainment to be achieved every 3 years until the area is redesignated to attainment. To account for variations in the timing of possible additional plans that may be required beyond the Serious area attainment plan (such as a plan revision under CAA section 189(d) for a Serious area that fails to attain) the EPA is also clarifying, consistent with the requirements discussed in Section IV.G of this preamble for Moderate areas, that all Serious area attainment plans must contain one additional quantitative milestone to be met in the 3-year period beyond the applicable Serious area attainment date. This will provide the EPA with appropriate tools necessary to continue to monitor the area's continued progress toward attainment in the event that the area fails to attain and develops a new attainment plan.
For an area that is discretionarily reclassified to Serious under the provisions of CAA section 188(b)(1), the Serious area plan must contain quantitative milestones to be achieved by 7.5 years from the area's date of designation as nonattainment. In this case, the 7.5 year quantitative milestone that was submitted with the Moderate area plan may still be sufficient to demonstrate RFP or may have to be adjusted to reflect the difference in actual progress from the projections of the Moderate area plan. For an area that is reclassified to Serious under CAA section 188(b)(2) due to failure to attain, the 7.5 year quantitative milestones that were submitted with the Moderate area plan are still required and would be sufficient for the EPA to evaluate the area's progress toward attaining the NAAQS while the Serious area plan is being developed. All Serious area plans must also include quantitative milestones to be achieved 10.5 years from designation, to help assess the state's progress toward attaining the
The Addendum included guidance that recommended milestones “should be addressed by quantifying and comparing the annual incremental emissions reductions which result from implementation of BACM and BACT (required within 4 years after the area is reclassified as serious) and from additional measures included in the final serious area SIP to those reductions which were identified in the SIP as quantitative milestones necessary to achieve the NAAQS by the applicable attainment date.”
In addition to this general approach for selecting quantitative milestones and similar to what the final rule requires for Moderate area attainment plans, the final rule requires that, at a minimum, states must ensure that the quantitative milestones for Serious PM
Additional provisions discussed in the Moderate area quantitative milestones requirements in Section IV.G of the preamble also apply to Serious areas. Specifically, if a Serious area submitted the optional air quality targets with the RFP plan then an air quality based milestone (
Finally, the quantitative milestone report requirements outlined in Section IV.G of this preamble apply to Serious areas as well. Specifically, the requirements associated with the timing and contents of the quantitative milestone report submission for a Moderate area also requirements in a Serious area. For additional details on these requirements, refer to Section IV.G of this preamble.
Any additional comments received on this section are addressed in Section IV.G of this preamble or in the Response to Comments document found in the docket for this action.
In the proposal, the EPA proposed that the criteria for identifying and selecting contingency measures for a Serious area attainment plan should be the same as those for Moderate area plans. The EPA also proposed that, as with Moderate areas, a state may elect to rely on contingency measures that achieve emissions reductions not only from sources within the nonattainment area, but also from sources located outside the nonattainment area but within the state, provided that the measures on sources outside the designated nonattainment area are demonstrated to produce the appropriate air quality impact within the nonattainment area. As with contingency measures for Moderate area attainment plans, the EPA proposed that the emissions reductions associated with contingency measures for Serious area plans must be equal to approximately 1 year's worth of emissions reductions necessary to achieve RFP for the area, unless the state adequately demonstrates that some smaller amount of reductions is appropriate while the state is revising its attainment plan for the area. The agency also proposed options for submission deadlines for Serious area contingency measures.
As noted in Section IV.G of this preamble, all PM
The statutory contingency measure requirement at CAA section 172(c)(9) is not superseded or subsumed by any requirement under subpart 4, nor does it apply only to Moderate area attainment plans. Thus, contingency measures are required for Serious PM
(1) Contingency measures must be fully adopted rules or control measures that are ready to be implemented quickly upon a determination by the Administrator of the nonattainment area's failure to meet RFP, failure to meet any quantitative milestone, failure to submit a quantitative milestone report or failure to meet the standard by the applicable attainment date.
(2) The SIP must contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measures will be implemented without significant further action by the state or by the EPA.
(3) Contingency measures should consist of control measures that are not otherwise included in the control strategy for the SIP, or that achieve emissions reductions not otherwise relied upon in the control strategy for the area.
(4) Contingency measures should provide for emissions reductions equivalent to 1 year's share of reductions needed to demonstrate attainment (
The EPA is also finalizing its proposal to allow a state to rely on contingency measures that achieve emissions reductions on sources located outside the nonattainment area, but within the state provided that the measures on sources outside the designated nonattainment area are demonstrated to produce the appropriate air quality impact within the nonattainment area.
As with contingency measures for Moderate nonattainment areas, the EPA allows a state under these circumstances to rely on additional reductions from federal or local measures already scheduled for implementation as part or all of their contingency measures. The EPA could consider such measures as meeting the contingency measure requirement as long as they produce emissions reductions in excess of those required to meet other statutory nonattainment provisions (such as to meet BACM/BACT requirements) and they can be relied on to achieve a sufficient portion of the actual emissions reductions necessary to reduce emissions in the area while the state develops a new plan to bring the area into attainment.
The Addendum provided guidance related specifically to the selection and implementation of contingency measures for Serious nonattainment areas. First, the guidance indicated that “for those moderate areas reclassified as serious, if all or part of the moderate area plan contingency measures become part of the required serious area control measures (
With regard to the timing for implementing contingency measures, the EPA reiterates that the purpose of contingency measures is to ensure that corrective measures are put in place automatically at the time that the EPA makes a determination that an area has failed to meet RFP, failed to meet any quantitative milestone, failed to submit a quantitative milestone report or failed to meet the NAAQS by the applicable attainment date. For any nonattainment area, the EPA is required to determine within 90 days after receiving a state's RFP demonstration, and within 6 months after the attainment date for an area, whether the state has met their statutory obligations for demonstrating RFP or attaining the standard, as appropriate. As with Moderate areas, the EPA expects that contingency measures should become effective for Serious areas within 60 days of the EPA making its determination that the area failed to meet RFP or attain the NAAQS.
Section 188(c) of the CAA states that the attainment date for a Serious area is to be the end of the tenth calendar year after designation. The EPA proposed to interpret the reference to “designation” in section 188(c) as meaning the “effective date of designation.”
As explained earlier, section 188 establishes the attainment dates for both Moderate and Serious areas. For a
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The statute also includes factors that the EPA may consider in determining whether to grant the extension and the length of the extension, including “the nature and extent of nonattainment, the types and numbers of sources or other emitting activities in the area (including the influence of uncontrollable natural sources and transboundary emissions from foreign countries), the population exposed to concentrations in excess of the standard, the presence and concentrations of potentially toxic substances in the mix of particulate emissions in the area, and the technological and economic feasibility of various control measures.”
The proposal described the four main elements the state must submit when requesting a Serious area attainment date extension: (1) A demonstration that attainment by the statutory Serious area attainment date is impracticable; (2) a demonstration that the area is complying with all requirements and commitments in the applicable attainment plan; (3) a demonstration that the plan includes the MSM that are included in the implementation plan of any state, or are achieved in practice in any state; and (4) a demonstration of attainment by the most expeditious alternative date practicable. The proposal also included a discussion about the timing of extension request submissions, and how to interpret the second element in cases where the extension request is submitted after the state has already submitted an initial Serious area attainment plan. These topics are addressed in the following sections.
a.
The EPA proposed to interpret the criterion under CAA section 188(e) that requires a state to have “complied with all requirements and commitments pertaining to that area in the implementation plan” simply to mean that the state has implemented the control measures in the SIP revisions it has submitted to address the applicable requirements in CAA sections 172 and 189. For a Serious area attainment date extension request being submitted contemporaneously with the “original” Serious area attainment plan for the area, the EPA proposed to read CAA section 188(e) not to require the area to have a fully approved attainment plan that meets the CAA's requirements for Moderate areas. The EPA also proposed to read this provision not to bar an extension if all or part of an area's Moderate area plan is disapproved or has been promulgated as a FIP, provided the area has complied with all of the requirements in the applicable FIP, or in the applicable SIP and FIP.
Some commenters stated that an area should only be able to receive an extension if the Moderate area plan had been fully approved by the EPA. Other commenters agreed with the EPA's proposed approach. They suggested that if a part of the Moderate plan had been disapproved, but it was clear that the
The final rule does not require the area to have a fully approved Moderate area plan when the attainment date extension request is submitted at the same time as the Serious area plan. An extension is allowed if the area is complying with all Moderate area requirements and commitments pertaining to that area in the state's submitted Moderate area implementation plan, but the plan does not need to be fully approved by EPA. The EPA considers this to be a reasonable interpretation of the statute because, as noted by commenters, there may be various reasons why an area may not have a fully approved Moderate area SIP by the time an extension request may be granted.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
For a Serious area extension request that was submitted after submission of an “original” Serious area attainment plan that contained an attainment demonstration meeting the requirements of CAA section 189(b)(1)(A)(i), the EPA proposed to read CAA section 188(e) not to require the area to have a fully approved attainment plan that meets the CAA's requirements for Serious areas, but to have a fully approved Moderate area attainment plan. The EPA stated that this proposed interpretation of this criterion would apply whether the area was reclassified to Serious under the EPA's discretionary authority (CAA section 188(b)(1)) or by operation of law upon failing to attain by the Moderate area attainment date (CAA section 188(b)(2)).
The proposal also requested comment on an “alternative interpretation” that, as pointed out by some commenters, appears to also have mistakenly required the same thing as the first option: That the state would need to have a fully approved Moderate area attainment plan in order to receive an extension.
The EPA notes that Section VI.C of this preamble, Timing of Extension Request Submission, also discusses this issue. It requested comment on whether, for areas that had already submitted Serious area attainment plans, it would be appropriate that the state must have complied with all requirements and commitments in the area's initial Serious area plan (the EPA's preferred option), or in the Moderate area plan.
After considering the comments received on this issue, the EPA is finalizing an approach that requires that, where a Serious area attainment date extension is being submitted
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
To qualify for any extension of a Serious area attainment date, CAA section 188(e) requires a state to “demonstrate to the satisfaction of the Administrator that the plan for the area includes the most stringent measures that are included in the implementation plan of any state, or are achieved in practice in any state, and can feasibly be implemented in the area.” In its prior guidance in the Addendum, the EPA interpreted the term “most stringent measures” (MSM) to mean the maximum degree of emission reduction that has been required or achieved from a source or source category in any other attainment plans or in practice in any other states and that can feasibly be implemented in the area seeking the extension, such as what LAER represents for new or modified sources under the NNSR permit program.
For each approach, the proposal described a five step process for determining MSM: (1) Update the emissions inventories for the nonattainment area; (2) identify
After considering the comments received on the
The EPA believes the rule provides sufficient flexibility in the MSM area control measure analysis and attainment demonstration process enabling states to identify sources that should not be subject to control measures, including the ability to develop precursor demonstrations to exclude precursors from control requirements, and to consider case-specific factors in determining technological and economic feasibility of potential control measures. If the final rule were to include an explicit step to conduct a
The first step would be for the state to update as needed the emissions inventory of direct PM
The second step in determining MSM involves identifying the potentially MSM in other state implementation plans for PM
For each measure, the state is required to determine its technological and economic feasibility for sources in the area. States should apply more stringent criteria for determining the feasibility of potential MSM than that described for BACM and BACT in Section VI.D of this preamble. In some situations, MSM could involve increasing the coverage of measures that were already adopted and implemented as BACM and BACT (for example, changing out an even greater percentage of woodstoves in an area, if such sources were major contributors to the air quality problem in the nonattainment area).
However, because BACM and BACT represent the “best” level of control feasible for an area, in some cases it may be possible for the MSM requirement to result in no more controls and no more emissions reductions in an area than result from the implementation of BACM and BACT. Stated another way, there may be sources or categories for which no other feasible controls exist beyond what a state has already adopted as BACM or BACT. Given the strategy in the nonattainment provisions of the CAA to offset longer attainment timeframes with more stringent control requirements, the EPA therefore
The third step requires the state to compare the potential MSM that have been identified for each source type or source category against the measures, if any, already adopted into the Serious area SIP for that source category to determine if such MSM would provide any additional reductions. This comparison will be used in determining what measures to adopt in the next step.
The fourth step requires the adoption of any MSM that are more stringent than existing measures as a regulation, and requires submission of the regulation as part of the SIP, as well as expeditious implementation of the regulation. For any measures that the state determines cannot be feasibly implemented in the area, it should provide a reasoned justification for rejecting the potential MSM.
The EPA notes that CAA section 188(e) does not identify a deadline for a state to implement MSM, whereas elsewhere the statute establishes a deadline for implementing RACM and RACT and BACM and BACT [
Section 189(b)(1)(A) of the CAA requires that a Serious area plan demonstrate attainment, using air quality modeling, by the most expeditious date practicable after the statutory Serious area attainment date. This demonstration is the final criterion that must be met before the EPA may consider granting an extension. The agency's determination of whether the plan provides for attainment by the most expeditious date practicable would depend on whether the plan provides for implementation of BACM and BACT by the statutory implementation deadline and MSM as expeditiously as practicable. In no case would a state be able to seek an extension of a Serious area attainment date to a date more than 5 years past the statutory attainment date for Serious areas. Section VI.E of this preamble describes the EPA's proposed requirements for attainment demonstration modeling for Serious area attainment plans.
The state would have to apply to the EPA for any extension of a Serious area attainment date. The request would have to accompany an attainment plan submission containing an attainment demonstration showing attainment by the most expeditious alternative date practicable, and the state would need to submit modeling as part of the attainment demonstration in accordance with Section VI.E of this preamble. Furthermore, the state would have to provide the public reasonable notice and a public hearing on the attainment date extension request before submitting it to the EPA, as the EPA would consider it an integral part of the attainment demonstration and part of the revised SIP submission which is subject to the requirements of the CAA and federal regulations for public notice and hearing on SIP revisions.
The EPA has identified two potential Serious area attainment date extension scenarios: (1) The more straightforward scenario where the attainment date extension is included with the initial Serious area plan, and (2) the scenario where a state may prepare and fully implement a timely Serious area plan that includes a modeling analysis that demonstrates the area would attain no later than the statutory Serious area attainment date (the end of the tenth calendar year following designation), and yet the state may see as the attainment date nears that the Serious area will in fact fail to attain by its projected attainment date. While the statute provides a remedy to be instituted immediately upon failure of a Serious area to attain the standard (through contingency measures and other measures stipulated in CAA section 189(d)), the EPA also believes that the criteria of CAA section 188(e) could be applied after a state submits a Serious area attainment plan but prior to the area failing to attain (as long as the area had not already been granted a prior Serious area attainment date extension under CAA section 188(e)).
In the first scenario, there is no need to specify any further timing requirements beyond those previously described for Serious area plan submission. However, for the second scenario the final rule needs to specify a due date for the request. The EPA believes that it would be acceptable for a state to submit a Serious area attainment date extension request (as described earlier) together with a new Serious area attainment plan meeting all of the statutory requirements that apply to such plans. The state should submit the extension request and new implementation plan to EPA as early as possible, but the final rule requires that it must be submitted no later than 60 days prior to the approved attainment date for the area or, in the absence of an approved attainment date, no later than 60 days prior to the applicable statutory attainment date for Serious areas (
In addition to the requirement for the submission of control measures providing for a 5 percent reduction in emissions of certain pollutants on an annual basis, the EPA interprets CAA section 189(d) as requiring the State to submit an attainment plan that includes the same basic statutory plan elements that are required for other attainment plans. Because section 189(d) does not include a specific provision specifying a new attainment date, the EPA relies on sections 179(d)(3) and 172(a)(2) of the CAA to establish the attainment date for such plans to be as expeditiously as practicable, and no later than five years from the effective date of the EPA's determination that the area failed to attain. Pursuant to those provisions, the Administrator may also extend the attainment date to the extent the Administrator deems appropriate, for a period no greater than 10 years from the effective date of the EPA's determination that the area failed to attain, considering the severity of nonattainment and the availability and feasibility of pollution control measures. The state must submit as part of the new attainment plan a justification explaining that it represents an attainment date that is as expeditious as practicable.
A state must submit to the EPA its plan to meet the requirements of CAA section 189(d) in the form of a complete attainment plan submission that includes the following elements: (i) Base year and attainment projection year emissions inventory requirements; (ii) additional attainment plan control strategy requirements, including control measures and a demonstration that each year the area will achieve at least a 5 percent reduction in emissions of direct PM
The proposed rule indicated that under CAA section 189(d), the state would be required to submit the attainment plan for a Serious area that failed to attain the NAAQS by the Serious area attainment date within 12 months after the applicable attainment date.
The final rule remains unchanged from the proposal. Section 189(d) of the CAA requires a state with a Serious PM
Any comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The EPA also proposed that the inventory requirements under section 189(d) for Serious areas that fail to attain by the attainment date should be the same as those for Moderate and Serious areas, but with a change to the appropriate year for the inventory. The EPA proposed that for these areas, the inventory year must be one of the 3 years from which monitored data was used to determine that the area failed to attain the PM
The statute requires states to use an emissions inventory that meets the requirements of section 172(c)(3). The final rule recommends using an inventory for one of the 3 years for which air quality data were used to determine that the area failed to attain in order to meet this requirement. However it also allows the state to use an earlier inventory year under certain circumstances.
As with all other attainment plan submissions required for Moderate and Serious PM
One important aspect of the emissions inventory required to be submitted with an attainment plan under CAA section 189(d) is its role as the basis for calculating the emissions reductions of direct PM
To ensure that the inventory is representative of the nonattainment problem in the area current at the time of the CAA section 189(d) submission, the EPA strongly recommends that the inventory year be one of the 3 years from which monitored air quality data were used to determine that the area failed to attain the PM
The EPA recognizes that the timing and resource requirements for inventory preparation may make it challenging in some cases for a state to use an inventory for a year that is one of the 3 years from which monitored data were used to determine that the area failed to attain the NAAQS by the applicable attainment date. To address such cases, the final rule allows states to use an earlier inventory year in the plan, provided that (1) the year is selected in consultation with the appropriate EPA Regional Office, and (2) the state provides a written justification for selecting the earlier year in its SIP submission.
Any additional comments received on this section are addressed in the Response to Comments document found in the docket for this action.
The proposed rule indicated that to determine what pollutants need to be addressed in the attainment plan and 5 percent requirement in CAA section 189(d), the state could provide a demonstration to the EPA showing that a particular precursor does not significantly contribute to PM
The final rule remains relatively unchanged with respect to this issue. Section 189(d) of the CAA requires states to develop a new attainment plan for an area that failed to attain by the applicable Serious area attainment date that provides for “an annual reduction in PM
Any comments received on this section are addressed in the Response to Comments document found in the docket for this action.
As for other PM
After considering comments on this issue, the EPA agrees that the second option is the more appropriate reading of the statute. When paired with the overarching requirement for the area to reach attainment of the NAAQS as expeditiously as practicable, and with provisions in the rule allowing a state to demonstrate that a precursor does not provide a significant contribution to PM
Thus, in applying the statutory language to implementation of the PM
Because this requirement is an annual one, the final rule also authorizes the state to meet the 5 percent requirement to vary between direct PM
For example, assume it is 2026, and based on monitoring data from years 2023-2025, a Serious area has failed to attain the 2012 PM
Although CAA section 189(d) requires that a state develop measures that will obtain annual emissions reductions of “not less than 5 percent” from the most recent inventory, the EPA interprets this language to authorize states to maximize emissions reductions in earlier years and still meet the 5 percent per year requirement for subsequent years. The EPA notes that interpreting the statute in this way will encourage states to implement measures earlier, where possible, rather than delay implementation of measures merely to assure that the 5 percent requirement can be met in later years. Thus, using the example described earlier, the annual reduction requirement for the area would be 500 tons/year from a base year emissions level of 10,000 tons/year. The required level after year 1 would be 9500 tons/year, after year 2 the level would be 9000 tons/year, and so on. If the area reached a level of 8100 tons/year by the end of year 3, then by the end of year 4 it would only need to reduce emissions by 100 tons/year to yield an emissions level of 8000 tons/year. Thus, this approach will allow states to carry forward any emissions reductions beyond the required minimum 5 percent in a given year to the next year as a means to encourage states to achieve emissions reductions as quickly as possible, as long as those emissions reductions are realized after the Serious area attainment date.
The previous example addresses a situation where the state chooses to reduce only direct PM
The EPA is also clarifying its interpretation of the statutory language under CAA section 189(d) that requires a state to submit a new attainment plan to achieve annual reductions “from the date of such submission until attainment,” to mean annual reductions beginning from the due date of such submission until the new projected attainment date for the area based on the new or additional control measures identified to achieve at least 5 percent emissions reductions annually. This clarification is intended to make clear that even if a state is late in submitting its CAA section 189(d) plan, the area must still achieve its annual 5 percent emissions reductions beginning from the date by which the state is required to make its CAA section 189(d) plan submission, not by some later date. Because attainment dates for PM
The EPA believes that an appropriate starting point for a state to identify measures to provide for attainment and to meet the requisite minimum 5 percent annual emissions reductions of direct PM
In addition, a state may include in the CAA section 189(d) plan control strategy for the area any control measures triggered as contingency measures after the area failed to attain the PM
To ensure that attainment plan submissions contain the necessary supporting information for the EPA to review and approve the state's new control strategy to achieve at least 5 percent annual reductions in emissions of direct PM
As with other PM
Section 189(d) of the CAA requires a state with a Serious nonattainment area that failed to attain the relevant NAAQS by the applicable Serious area attainment date to submit a new attainment plan for such area within 12 months after the missed attainment date. The same general requirements for attainment demonstrations and modeling that apply to Moderate area plans and Serious area plans due under CAA sections 189(a) and 189(b) should also apply to CAA section 189(d) attainment plans. However, the EPA is including additional requirements in the final rule specific to plans submitted pursuant to CAA section 189(d), as described in the following sections.
For purposes of determining the attainment date that is as expeditious as practicable, the state must conduct future year modeling that takes into account emissions growth, known controls (including any controls that were previously determined to be RACM and RACT, BACM and BACT, and MSM if appropriate, for the area), the 5 percent per year emissions reductions required by CAA section 189(d), plus any other emissions controls that are needed for expeditious attainment of the NAAQS. A state performing a modeling analysis for a plan submitted under CAA section 189(d) must select a future modeling year such that all emissions control measures relied on for attainment will have been implemented by the beginning of that year. To demonstrate attainment, the modeling results for the nonattainment area must predict that emissions reductions implemented by the beginning of the last calendar year preceding the attainment date will result in PM
For a PM
c.
As with all other PM
The RFP analysis must contain appropriate information to demonstrate that the state will achieve the emissions reductions from the control strategy necessary to result in generally linear reductions in emissions and provide for expeditious attainment as discussed in Section VII.D of this preamble. As with other Serious area RFP analyses, the state may consider PM
The state's RFP analysis must include three components: (1) An implementation schedule for control measures on sources in the nonattainment area, (2) RFP projected emissions for each applicable quantitative milestone year (discussed in Section VII.G of this preamble), based on the anticipated control measure implementation schedule; and (3) an analysis that demonstrates that this schedule of aggregate emissions reductions achieves sufficient progress toward attainment between the applicable baseline year to the attainment year. For additional discussion of each of the components of the RFP analysis, refer to Section IV.F of this preamble.
In the proposal, the EPA proposed an option to require at least 5 percent
The EPA requires that the applicable baseline year for the RFP analysis must be the same year as that represented by the latest base year inventory for the Serious area. The projected attainment date should be as expeditiously as practicable and is discussed further in Section VII.I of this preamble. The RFP analysis must clearly convey how the schedule for implementing the control strategy will provide for generally linear or stepwise progress towards attainment. If stepwise progress is more appropriate for the specific nonattainment area, the state is required to submit a clear rationale and supporting information to explain why generally linear progress towards attainment in the area is not appropriate (
Additionally, the EPA requires states to establish motor vehicle emissions budgets for direct PM
The EPA also proposed that the requirements for quantitative milestones, described in Section VI.G of this preamble, should also apply to quantitative milestones submitted with any revised Serious area attainment plan pursuant to CAA section 189(d).
The quantitative milestones need to be achieved every 3 years until the area attains the relevant NAAQS. Therefore, at a minimum, the final rule requires that quantitative milestones selected for an attainment plan submitted under CAA section 189(d) need to track progress in the implementation of control measures required to achieve RFP in emissions reductions of direct PM
The EPA is also finalizing that the requirements for quantitative milestones described in Section VI.G of this preamble shall also apply to quantitative milestones submitted with any revised attainment plan pursuant to CAA section 189(d), including but not limited to, the construction, content, reporting requirements and a quantitative milestone that specifically tracks implementation of control measures identified in the plan to attach the standard as expeditiously as practicable.
The EPA proposed that contingency measures for attainment plans under CAA section 189(d) for Serious areas that fail to attain the NAAQS by the applicable attainment date must meet the same criteria as contingency measures for a Serious area attainment plan outlined in Section VI.H of this preamble. The EPA also proposed that the contingency measures should achieve approximately 1 year's worth of emissions reductions.
All PM
The statutory contingency measure requirement at CAA section 172(c)(9) is not superseded or subsumed by any requirement under subpart 4. Thus, contingency measures are required as part of a state's attainment plan submission under section 189(d). Accordingly, the final rule requires the criteria for identifying and selecting contingency measures for a section 189(d) submission that are the same as for Moderate or Serious area attainment plans.
Specifically, the EPA is finalizing that the following requirements must be met in order for contingency measures to be approvable as part of a state's attainment plan submission for purposes of section 189(d):
(1) Contingency measures must be fully adopted rules or control measures that are ready to be implemented quickly upon a determination by the Administrator of the nonattainment area's failure to meet RFP, failure to meet any quantitative milestone, failure to submit a quantitative milestone report or failure to meet the standard by the applicable attainment date.
(2) The SIP must contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measures will be implemented without significant further action by the state or by the EPA.
(3) Contingency measures should consist of control measures that are not otherwise included in the control strategy for the SIP, or that achieve emissions reductions not otherwise relied upon in the control strategy for the area.
(4) Contingency measures should provide for emissions reductions equivalent to 1 year's share of reductions needed to demonstrate attainment (
The EPA is also finalizing its proposal to allow a state to rely on contingency measures that achieve emissions reductions on sources located outside the nonattainment area, but within the state provided that the measures on sources outside the designated nonattainment area are demonstrated to produce the appropriate air quality impact within the nonattainment area.
As with contingency measures for Moderate or Serious areas, the EPA allows a state under these circumstances to rely on additional reductions from federal or local measures already scheduled for implementation as part or all of their contingency measures. The EPA could consider such measures as meeting the contingency measure requirement as long as they produce emissions reductions in excess of those required to meet other statutory nonattainment provisions (
The EPA recognizes that identifying contingency measures for a Serious PM
The proposed rule indicated that the new attainment date for an area that failed to attain by the Serious area attainment date would be governed by sections 172(a)(2) and 179(d)(3) of the CAA. Under the proposal, the attainment date would be as expeditiously as practicable, but no later than 5 years from the date of publication in the
As described in the proposal, the final rule includes the overarching requirement for a Serious area that failed to attain by the previous attainment date to establish a new date for attaining the standard as expeditiously as practicable. However, neither CAA section 189(d) nor other sections in subpart 4 explicitly establish or provide the authority to establish a new attainment date for the area. Therefore, once an area is beyond the attainment dates that Congress specified in subpart 4 for the PM
Applying these provisions, the final rule therefore provides that the new attainment date in a CAA section 189(d) plan must be as expeditious as practicable, but no later than 5 years from the date of publication in the
Section 110(a)(2)(C) of the CAA requires states to include in their SIPs a preconstruction review permitting program that regulates the construction and modification of stationary sources
The EPA has adopted numerous NNSR regulations in 40 CFR parts 51 and 52, including § 51.165; part 51 Appendix S; and § 52.24. An approvable NNSR program in a state's implementation plan must, at a minimum, meet the applicable program requirements set forth in the federal NNSR provisions at 40 CFR 51.165, which for PM
The EPA interprets the requirement established under section 110(a)(2)(C) of the CAA that states regulate the construction and modification of sources to apply as of the effective date of an area's designation to nonattainment for a given pollutant.
Accordingly, states with newly designated nonattainment areas for the revised primary PM
For each proposed new major stationary source and major modification, the general NNSR requirements to be included in a state's SIP include the following: (i) The installation and continuous operation of pollution control technology that complies with the Lowest Achievable Emission Rate (LAER); (ii) the acquisition of creditable emissions reductions to adequately offset the proposed emissions increase of the nonattainment pollutant; and (iii) a certification that all other sources owned by the applicant are complying with all applicable requirements of the
CAA.
With regard to NSR applicability for PM
As described in Section II.B of this preamble, in January 2013 the court's decision in
The
It is worth noting that the 2008 PM
This section provides a description of the changes that the EPA is making to the NNSR requirements for PM
For both sets of regulations, we will describe the changes that were proposed, the final requirements, the comments received, and the EPA's responses to them.
In this final rule, as explained in more detail later, the EPA is making the following revisions that affect the NNSR regulations for PM
Also, the EPA explains in this section that it is codifying the schedule for states to submit NNSR SIP revisions for PM
CAA section 189(e) requires that the control requirements applicable to major stationary sources of PM
The EPA also proposed to add language to the definition of “regulated NSR pollutant” to address the provision of CAA section 189(e) that allows an exemption from the NNSR permit requirements for major stationary sources or major modifications of a particular precursor if the state demonstrates to the satisfaction of the EPA that major stationary sources of such precursor do not contribute significantly to PM
The EPA is amending the definition of “regulated NSR pollutant” at 40 CFR 51.165 to include a new provision stating that SO
In addition, the provision has also been revised to focus on the exemption of control requirements for sources of a particular precursor rather than the exemption of the precursor itself. The EPA believes that this shift in focus is more consistent with the statutory language at CAA section 189(e), which also focuses on the exemption of sources from the control requirements for that precursor. As explained in Section III of this preamble, the EPA has defined a precursor demonstration specifically for exempting major sources of a particular precursor from regulation under the NNSR program. This demonstration involves a sensitivity-based analysis that evaluates the sensitivity of ambient PM
The EPA recommends that the state consult with the appropriate EPA Regional Office as early as possible to discuss appropriate analyses for the NNSR precursor demonstration. If the appropriate precursor demonstration is submitted to and approved by the Administrator, the state would not be required to regulate new major stationary sources and major modifications of the insignificant precursor under the state's approved NNSR program in a particular nonattainment area. Such exemption from the NNSR control requirements would include an exemption from all of the prerequisite conditions set forth in 40 CFR 51.165 for PM
On the other hand, several commenters urged the EPA not to begin regulating VOC and ammonia as PM
In some PM
Moreover, as described in Section VIII.B.2 of this preamble, the EPA is not commencing with the regulation of VOC and ammonia (hence not requiring NNSR review of any new major stationary sources and major modifications of such precursors) for those states relying on Appendix S to issue NNSR permits during the interim SIP development period.
Subpart 4, as described earlier in this document, contains provisions for the classifications of PM
Second, the EPA proposed to amend the definition of “major stationary source” consistent with section 189(b)(3) of the CAA to establish a lower major source threshold for new major stationary sources and major modifications locating in PM
In its effort to ensure that major sources of PM
Regardless of whether the major source threshold for direct PM
In this final rule, the EPA has followed its preferred approach and has made the changes necessary to ensure that “major” is defined for direct PM
We also agree that it would be difficult to establish a lower uniform major source threshold for PM
On the other hand, some commenters wanted the EPA to include a provision
Moreover, section 302(j) of the CAA contains a definition of “major emitting facility” and “major stationary source” that applies to, among other things, programs implemented under subpart 1 such as the general NNSR program requirements in CAA section 173.
With regard to the setting of the major source thresholds for PM
Since the EPA may not have the legal authority to establish major source thresholds for PM
The commenter also did not explain, and it is not clear, how a relaxation versus a strengthening of the NAAQS would bear on whether the EPA has authority to set different control requirements (
The EPA therefore believes that at this time the most reasonable approach for defining the major source threshold for PM
As noted earlier, stationary sources locating in nonattainment areas are subject to the NNSR permitting requirements to the extent construction at the source qualifies as a major modification with respect to a pollutant for which the area is designated nonattainment. A major modification of a stationary source is defined in the NNSR regulations at 40 CFR 51.165(a)(1)(v)(A) as “any physical change in or change in the method of operation of a major stationary source” that would result in (1) a significant emissions increase of a regulated NSR pollutant, and (2) a significant net emissions increase of that pollutant. The term “significant” is separately defined at 40 CFR 51.165(a)(1)(x)(A) to mean a rate of emissions specified for each pollutant or precursor for that pollutant. This is known as a significant emissions rate (SER). In the 2008 PM
The EPA did not include any changes to the existing SERs for SO
The EPA is finalizing its proposed approach with some changes to the final regulatory language. The final rule amends the definition of “significant” in the NNSR regulations at 40 CFR 51.165(a)(1)(x)(A) to add a SER for VOC. Thus, the revised definition contains individual SERs for direct PM
Another of the commenters supporting higher significance thresholds for each precursor stated that the CAA's definitions of “major source” and “major emitting facility” trigger the statutory control requirements and its permit requirements for affected sources, but they do not define how much of a pollutant is regulated after the control or permit requirement is triggered by the CAA. The commenter stated that the EPA would appear to have ample authority to require that precursors be regulated based on different thresholds once a major source triggers a particular control or permit requirement, provided there is adequate technical basis for doing so.
Some commenters stated that, while the EPA indicates that a SER for ammonia may be developed in a subsequent rulemaking, if that rulemaking is not timely, the state would need to develop a SER for ammonia to reduce the burden on permit applicants and avoid permit issuance delays related to major source applicability determinations and permit development for ammonia and PM
Some commenters recommended that the EPA propose a SER for ammonia before finalizing the March 23, 2015, proposal and suggested the EPA should also provide definitive guidance for state and local agencies on how to conduct permitting of major sources of ammonia until a SER is established. Other commenters stated that, at the time the EPA proposes new significant emission rates for precursors, the EPA should also establish the significant emission rate for ammonia. Yet another commenter stated that any precursor analyses conducted by the EPA should be done in close coordination with designated nonattainment areas to reduce duplication of efforts and conflicting outcomes that could in turn lead to more costly impacts on sources and on agencies' limited resources. Finally, some commenters stated that the EPA should at least provide guidance for states to develop a SER for ammonia as a PM
Unlike the EPA's PSD regulations, the definition of “significant” in the NNSR regulations at 40 CFR 51.165 does not include a provision stipulating that, for any pollutant that does not have a listed emissions rate, “any increase” must be considered significant.
In setting SERs and major source thresholds for emissions of direct PM
The EPA is revising the NNSR regulations at 40 CFR 51.165(a)(2)(i) to codify the EPA's policy that direct emissions of a pollutant and emissions of any applicable precursor are to be considered independently for purposes of determining the applicability of the NNSR requirements for PM
In the proposal, the EPA explained that CAA section 189(a)(2)(B) requires states to submit to the EPA an attainment plan satisfying the applicable requirements within 18 months of an area being designated nonattainment pursuant to a new or revised PM
The EPA also noted that the CAA does not specify a deadline for the states' submittal of NNSR program revisions in the event that a Moderate PM
The EPA is finalizing an 18-month deadline for states to submit plan revisions for NNSR requirements for PM
The requirements for submitting plan revisions at 40 CFR 51.1003 also provide for situations where an area classified as Serious is subject to CAA section 189(d) for failing to attain the PM
In this final rule, as explained later, the EPA is making the following revisions for PM
The definition of “regulated NSR pollutant” contained in Appendix S at section II.A.31(ii)(
The EPA also proposed an alternative approach based on similar logic that would initially require only SO
The EPA is amending Appendix S in this final rule to provide for the immediate regulation of SO
The alternative proposal featuring the phase-in approach balances the opportunity for states to demonstrate in the short-term that certain precursors need not be regulated with the need to ensure that the appropriate precursors are controlled in a manner consistent with the CAA. NNSR is unique among the nonattainment area requirements in that sources seeking a construction permit must comply with NNSR requirements for a particular pollutant as soon as an area is designated nonattainment for that pollutant and not some months or years later, when the EPA formally approves a state plan and the sources comply with the remaining plan provisions. With respect to precursors in particular, this means that new and modified major sources of direct PM
The EPA is also cognizant, however, that some states have relied on Appendix S to conduct NNSR permitting well beyond the statutory SIP development period. In such cases, it would be inequitable if states could indefinitely rely on Appendix S that requires little to no regulation of some of the scientific PM
In order to balance these competing interests and concerns, the EPA has determined in this final rule to revise Appendix S in order to require that any state relying on Appendix S initially regulate both SO
Under the phase-in schedules being finalized in Appendix S, permits issued by states under the requirements in Appendix S will not be required to address VOC and ammonia as regulated NSR pollutants (PM
The EPA chose this 24-month period for phase-in of VOC and ammonia as PM
The EPA has specifically included the 6-month period for EPA's completeness review because we believe it is important to discourage states from submitting SIPs that do not meet the minimum completeness criteria found in 40 CFR part 51, Appendix V. Conditioning the phase-in on a completeness review will not only encourage states to make timely SIP submissions addressing the NNSR requirements, but also ensure that those submissions contain the minimum information necessary to enable the Administrator to determine whether the SIP complies with the statute. If a state with a designated PM
The timing of the phase-in for a particular area will depend upon the effective date of the designation to nonattainment for PM
For any existing nonattainment area that was first designated nonattainment for PM
Although areas were designated nonattainment for the 1997, 2006, and 2012 standards at different times, the EPA believes it is reasonable to apply the same phase-in date for all areas designated nonattainment as of the date of the designations for the 2012 standard. Area designations for the 2012 PM
For any area that is first designated nonattainment for any PM
As noted earlier, the second phase-in provision applies to PM
Commenters supporting the preferred approach did not believe that it was appropriate to require NSR permitting during an interim period for sources that may be exempted from control requirements if a state can demonstrate that these sources do not contribute significantly to nonattainment in a particular area. These commenters stated that, since most, if not all, areas will not be able to demonstrate that SO
One commenter who supported the EPA's alternative approach to phase in VOC and ammonia as PM
A commenter who opposed any approach that did not immediately require the control of all four scientific precursors of PM
Moreover, the EPA believes it is reasonable to construct the Appendix S provisions regulating PM
The phase-in schedule contained in this final rule requires that VOC and ammonia be phased in as PM
In initially requiring sources to control SO
With regard to the commenter's concern that states might delay submitting NNSR programs as part of their PM
The EPA proposed to amend Appendix S by revising the definition of “major stationary source” to include a separate PM
In this final rule, the EPA is amending the definition of “major stationary source” in Appendix S to include 70 tpy major source thresholds for direct PM
As explained in Section VIII.B.1.b of this preamble, commenters addressing the proposed major source threshold of 70 tpy for sources of PM
As explained earlier, the EPA proposed as its preferred approach to add NO
The EPA is revising the definition of “significant” in Appendix S at section II.A.31(ii)(
The EPA is not adding a SER for ammonia (as a PM
The comments regarding the proposed addition of SERs for NO
The EPA did not propose any transition provisions for NNSR permit applications in either 40 CFR 51.165 or Appendix S that would expressly grandfather pending PSD or NNSR permit applications for proposed new and modified major stationary sources from newly established NNSR permit requirements applicable to PM
Several comments received during the 2012 p.m. NAAQS rulemaking recommended that the EPA establish a grandfathering provision for NNSR as was proposed for the PSD program. A subset of these commenters recommended that PSD permit applications be grandfathered from the NNSR requirements for the revised 2012 PM
The EPA explained at the time that the obligation to adopt new provisions under a state's NNSR program will not apply with regard to the revised NAAQS until such time as an area is designated nonattainment, and beginning on the effective date of the new area designations for PM
In response to the EPA's request for comments in the proposal, commenters recommended that the EPA clarify the PM
The EPA does not find a compelling reason to grandfather pending NNSR permit applications for which a permit has not yet issued once the new NNSR requirements—primarily affecting the control of PM
While the final rule contains no general grandfathering provision, this final rule does provide a phase-in process for states relying on Appendix S for purposes of issuing NNSR permits for PM
With regard to grandfathering PSD permit applications, we do not interpret the CAA to allow for the issuance of a PSD permit in an area that is designated nonattainment. The CAA requires proposed major stationary sources and major modifications to meet major NSR permitting requirements that apply on the basis of the area's designation.
The Exceptional Events Rule addresses elevated emissions from specific events that influence monitored air quality concentrations. The EPA's regulations at 40 CFR 50.1(j) define an “exceptional event” as one that “affects air quality, is not reasonably controllable or preventable, is an event caused by human activity that is unlikely to recur at a particular location or a natural event, and is determined by the Administrator in accordance with 40 CFR 50.14 to be an exceptional event.” Further, 40 CFR 50.1(j) explicitly provides that exceptional events do “. . . not include stagnation of air masses or meteorological inversions, a meteorological event involving high temperatures or lack of precipitation, or air pollution relating to source noncompliance.” At 40 CFR 50.1(k), the EPA's regulations define a “natural event” as an event in which human activity plays little or no direct causal role to the event in question.
Air quality monitoring data that the EPA determines to have been influenced by an exceptional event under the procedural steps, substantive criteria, and schedule specified in the Exceptional Events Rule may be excluded from regulatory decisions such as initial area designations decisions and decisions associated with implementing the PM
If wildfire is a potential contributor to exceedances of the NAAQS and exceptional events, the EPA urges state and local agencies to coordinate with the land management agencies, as appropriate, in developing plans and appropriate public communications regarding public safety and reducing exposure. This action can directly help states meet their Exceptional Events Rule obligation whereby “states must provide public notice, public education, and must provide for implementation of reasonable measures to protect public health when an event occurs.” When wildfire impacts are significant in a particular area, states and communities may be able to lessen the impacts of wildfires by working collaboratively with land managers and land owners to employ various mitigation measures including taking steps to minimize fuel loading in areas vulnerable to fire.
The EPA notes that there could be some potential overlap between the application of the Exceptional Events Rule and CAA section 188(f) because the conditions necessary for the Administrator to make a determination under CAA section 188(f)—
The EPA recognizes the implementation challenges associated with the 2007 Exceptional Events Rule and recently proposed revisions to this rule to address certain substantive issues raised by state, local and tribal co-regulators and other stakeholders since promulgation of the rule and to increase the administrative efficiency of the Exceptional Events Rule criteria and process (80 FR 72840, November 20, 2015). The public comment period on this rule closed on February 3, 2016. The EPA will consider timely comments provided to the Exceptional Events Rule docket as we finalize the revisions to this rule.
The EPA's Transportation Conformity Rule (40 CFR 51.390 and part 93, subpart A) establishes the criteria and procedures for determining whether transportation activities conform to the SIP. These activities include adopting, funding or approving transportation plans, transportation improvement programs (TIPs) and federally supported highway and transit projects. The EPA first promulgated the Transportation Conformity Rule on November 24, 1993 (58 FR 62188), and subsequently published several amendments. For example, the EPA published a final rule on July 1, 2004 (69 FR 40004) that provided conformity procedures for state and local agencies under the 1997 PM
With regard to general conformity, the EPA first promulgated general conformity regulations in November 1993 (40 CFR part 51, subpart W and 40 CFR part 93, subpart B). Subsequently, the EPA finalized revisions to the general conformity regulations on April 5, 2010. (75 FR 17254-17279) The general conformity program ensures that federal actions not covered by the transportation conformity rule will not interfere with the SIP. General conformity also fosters communications between federal agencies and state/local air quality agencies, provides for public notification of and access to federal agency conformity determinations and allows for air quality review of individual federal actions. More information on the general conformity program is available at
With regard to transportation conformity, the conformity grace period applies to all areas designated nonattainment for a new or revised PM
Isolated rural nonattainment and maintenance areas are areas that do not contain or are not part of an MPO (40 CFR 93.101). Transportation conformity requirements for isolated rural nonattainment and maintenance areas can be found at 40 CFR 93.109(g). The CAA section 176(c)(6) 1-year grace period for newly designated nonattainment areas applies to isolated rural areas. Therefore, 1 year after the effective date of the initial nonattainment designation for a given pollutant and the NAAQS, conformity requirements with regard to that pollutant and standard would apply in any nonattainment areas that are isolated rural areas. Per the transportation conformity rule, an isolated rural area would be required to make a transportation conformity determination only at the point when an applicable transportation project needs funding or approval. This project level conformity determination may occur significantly after the 1-year grace period has ended.
CAA section 176(c)(5) requires compliance with transportation and general conformity only in: (1) Nonattainment areas and (2) areas that have been redesignated to attainment and are required to develop a maintenance plan under CAA section 175A.
CAA section 175A(a), in turn, establishes the requirements that must be fulfilled by nonattainment areas in order to be redesignated to attainment. That section only requires that nonattainment areas for the
Elsewhere in this final rule, the EPA is finalizing one of the proposed options for revoking the 1997 primary annual PM
For any area that has been redesignated to attainment for the 1997 annual PM
e.
In the event that a nonattainment designation causes transportation conformity to apply for the first time in a state,
In a few cases, tracts of land under federal management may also be included in nonattainment and maintenance area boundaries. The role of fire in these areas should be assessed and emissions budgets developed in concert with those federal land management agencies. In such areas the EPA encourages states to consider in any baseline, modeling and SIP attainment inventory used and/or submitted to include emissions expected from projects subject to general conformity, including emissions from wildland fire that may be reasonably expected in the area. Where appropriate, states may consider developing plans for addressing wildland fuels in collaboration with land managers and owners. Information is available from DOI and USDA Forest Service on the ecological role of fire and on smoke management programs and basic smoke management practices.
In the proposed rule, the EPA described its longstanding clean data policy and proposed to codify the policy in regulatory text. A clean data determination (CDD) is a notice-and-comment rulemaking wherein the EPA determines that a specific nonattainment area has attained the relevant NAAQS based on 3 years of quality-assured certified air quality monitoring data. The CDD suspends the state's obligation to submit to the EPA the planning elements related to attaining the standard required of nonattainment areas under the Clean Air Act for as long as the area continues to attain the standard.
The proposal provided additional discussion about attainment demonstrations, control requirements for Moderate areas, RFP and quantitative milestones, and contingency measures. With regard to control requirements for Serious areas, the proposal included two options: one option would suspend BACT/BACM requirements under a CDD if elsewhere in the rule such requirements were considered necessary for expeditious attainment, and the other option would not suspend BACT/BACM requirements if elsewhere in the rule such requirements were considered to be generally independent of attainment.
The final rule codifies the clean data policy in rules governing the implementation of current and future PM
The planning elements under subpart 1 and subpart 4 generally include reasonable further progress (RFP) requirements, attainment demonstrations, RACM and RACT, nonattainment area contingency measures, and other state planning requirements related to attaining the NAAQS.
This rule specifies that a determination that a nonattainment area is attaining the current and future PM
For a Serious area that failed to attain the relevant PM
Finally, some commenters noted that the Act requires that RACM/RACT be
In response to the requests for clarification of which RACM requirements are suspended by a CDD, we note that, for over 30 years, the EPA has consistently interpreted the RACM requirement in CAA section 172(c)(1) to apply only to those measures that, individually or collectively, contribute to expeditious attainment of the NAAQS. The suspension of the statutory requirement to submit RACM is premised on the idea that, “[t]o the extent an area is already achieving attainment as expeditiously as possible, imposition of additional control [measures] would not hasten achievement of the NAAQS. In such a situation, the EPA may reasonably conclude that no control [measures] are reasonably available and the area need not implement further [measures] to satisfy the [RACM] requirement.”
In this case, it is not clear to the EPA what the commenter means by the phrase “original SIP,” since the SIP is only those measures that have been submitted and approved by the EPA. To the extent that a measure was adopted into the SIP prior to an area's attainment of the NAAQS, and therefore contributed to an area's attainment, that measure is therefore required to remain as part of the SIP. We infer that the comment might be referring to commitments that were approved into a SIP to adopt future measures, or that commenters might be asking for clarification regarding measures that have been adopted locally or at a state level prior to the area's coming into attainment but have not yet been submitted to the EPA for approval into the federally-approved SIP. As explained above, a CDD has no effect on the state's obligation to demonstrate that an area's improvement in air quality is due to “permanent and enforceable” emissions reductions in order to meet the statutory requirements for redesignation to attainment in CAA section 107(d)(3)(E). Additionally, a CDD does not alter the effect of any measure (including any state commitment) that has
The EPA also proposed that any Moderate area attainment plan submitted under CAA section 179B must include an RFP plan with required air quality targets consistent with the RFP Option 2. In addition, the EPA proposed requirements for establishing and reporting on quantitative milestones for areas with approved “but for” demonstrations.
Section 179B(a) of the CAA provides that the EPA shall approve an attainment plan for a nonattainment area that is an international border area if: (i) the attainment plan meets all other applicable requirements of the CAA, and (ii) the submitting state can demonstrate satisfactorily that “but for emissions emanating from outside of the United States,” the area would attain and maintain the relevant NAAQS. In addition, CAA section 179B(d) provides that if a state demonstrates that an area would have attained the NAAQS but for emissions emanating from outside the U.S., then the area is not subject to the mandatory reclassification element of CAA section 188(b)(2) for Moderate areas that fail to attain by the applicable attainment date.
Under CAA section 179B, areas affected by emissions from outside the U.S. continue to have attainment plan obligations. First, even if the area is impacted by emissions from outside the U.S., that fact does not affect the designation of the area. Such an area that is violating the relevant NAAQS will be designated nonattainment even if emissions from outside the U.S. contribute to that violation. Second, as a result of that designation, the state is required to meet the applicable attainment plan requirements for the relevant NAAQS. Section 179B of the CAA does not negate the attainment plan requirements. Rather, it allows the EPA to approve an attainment plan that demonstrates attainment and maintenance of the NAAQS “but for” international emissions.
The EPA has determined that under the best reading of CAA section 179B, states remain obligated to meet the attainment plan requirements other than the requirement to demonstrate attainment and maintenance of the relevant NAAQS. This determination is based upon the fact that 179B(a)(1) explicitly states that such an attainment plan must meet all the requirements of the CAA with that exception. The applicable requirements for an attainment plan for PM
In the proposal, the EPA specifically took comment on the most appropriate way to address the RACM and RACT requirements. The past interpretation of RACM and RACT requirements in the context of CAA section 179B was considered when the agency proposed an option to allow a state not to adopt such measures if the state could demonstrate that collectively the measures will not be effective in reducing PM
Regarding RACM/RACT and additional reasonable measures, the EPA reviewed the comments received and its past interpretation of RACM and RACT requirements in the context of CAA section 179B attainment plans for PM
Therefore, the EPA requires that Moderate area attainment plans approved under CAA section 179B must implement all technologically and economically feasible measures that can be implemented on sources in the area by the end of the sixth calendar year following designation of the area (
The EPA has determined that it will not finalize the proposed option of achieving reductions in PM
Section 179B(d) of the CAA states that any area for which the state establishes to the EPA's satisfaction that the area “would have attained the NAAQS by the applicable attainment date, but for emissions emanating from outside the United States, shall not be subject to the provisions of section [188(b)(2)].” CAA section 188(b)(2) requires the EPA to determine, within 6 months following the applicable attainment date for a Moderate PM
In the event that the EPA has already reclassified an international border area as Serious, when the state submits a “but for” demonstration under section 179B, all of the Serious area requirements that apply to the area (
Where a Serious area fails to attain by the Serious area attainment date and is therefore subject to the requirements of section 189(d), the EPA's approval of a section 189(d) plan and 179B demonstration would mean that the EPA is no longer obligated to make further determinations of failure to attain or to trigger additional planning requirements. The EPA intends to review each SIP submission containing a “but for” attainment demonstration for an international border area for compliance with the requirements of section 179B.
The EPA notes that, with one exception for contingency measures, the final rule provisions governing for the RFP, quantitative milestone, and contingency measure requirements for PM
Regarding the “but for” demonstrations under CAA section 179B, the EPA has historically evaluated these demonstrations on a case-by-case basis, based on the individual circumstances and data provided by the submitting state. These demonstrations have included information such as ambient air quality monitoring data, modeling scenarios, emissions inventory data and meteorological or satellite data.
Where international transport of emissions contributes to an exceedance or violation, such data may be excluded from consideration only if they were significantly influenced by exceptional events under section 319(b) of the CAA. If the data meet the criteria contained in the EPA's Exceptional Events Rule, the exceedance can be addressed by that rule.
The EPA expects that the best approach for evaluating the potential impacts of international transport on nonattainment is for states to work with the EPA on a case-by-case basis to determine the most appropriate information and analytical methods for each area's unique situation. The EPA will work with states that are developing exceptional events demonstrations and attainment plans for which CAA section 179B is relevant, and ensure the states have the benefit of the EPA's understanding of international transport of PM
However, the EPA expects states with a section 179B area to follow the guidance and requirements outlined in Section IV.H of this preamble to identify contingency measures that can provide emissions reductions from sources within the state's jurisdiction. As discussed in Section IV.H of the preamble, this should include an explanation of the amount of anticipated emissions reductions to be accomplished by the contingency measures. If such an area is unable to identify approximately 1 year's worth of emissions reductions to constitute contingency measures, the explanation should describe the factors considered by the state when reaching this conclusion.
The EPA continues to believe that complete and effective regulations that ensure compliance with an applicable emissions limit must include requirements for both performance testing of emissions and ongoing monitoring of the compliance performance of control measures, and the agency requires that SIP regulations that establish emission limits include the following for performance testing:
(1) Indicator(s) of compliance—the pollutant or pollutants of interest (
(2) Test method—reference to a specific EPA or other published set of sample collection and analytical procedures, equipment design and performance criteria, and the calculations providing data in units of the indicator of compliance (Section IX.K of this preamble presents a discussion of specific test methods for condensable PM
(3) Sample collection characteristics—conditions related to the sample collection portion of the performance test. Such conditions would include duration of sampling period, either on a time or volume collected basis; the number of runs comprising a test (
(4) Frequency—the time between emissions or performance tests (
In order to be complete with regard to compliance monitoring provisions, the EPA requires that regulations adopted into the SIP must include the following critical elements:
(1) Indicator(s) of performance—the parameter or parameters measured or observed for demonstrating proper operation of the pollution control measure or compliance with the applicable emissions limitation or standard. Indicators of performance could include direct or predicted emissions measurements, process or control device (and capture system) operational parametric values that correspond to compliance with efficiency or emissions limits, and recorded findings of verification of work practice activities, raw material or fuel pollutant content, or design characteristics. Indicators could be expressed as a single maximum or minimum value, a function of process variables (
(2) Measurement technique—the means used to gather and record information of or about the indicators of performance. The components of the measurement technique include the detector type or analytical method, location and installation specifications, inspection procedures, and quality assurance and quality control measures. Examples of measurement approaches include continuous emissions monitoring systems (CEMS), continuous opacity monitoring systems (COMS), continuous parametric monitoring systems (CPMS), performance testing, vendor or laboratory analytical data, and manual inspections and data collection that include making records of process conditions, raw materials or fuel specifications, or work practices. Directly enforceable emission measurements, such as PM CEMS, are preferred wherever feasible. Where COMS are feasible, it should be clear that opacity is a directly enforceable standard, not merely an indicator of compliance;
(3) Averaging time—the period over which to average data to verify compliance with the emissions limitation or standard or proper operation of the pollution control measure. Examples of averaging time include a 3-hour average in units of the emissions limitation, a 30-day rolling average emissions value, a daily average of a control device operational parametric range, periodic (
(4) Monitoring frequency—the number of monitoring data values recorded over a specified time interval. Examples of monitoring frequencies include at least one data value every 15 minutes for CEMS or CPMS, at least every 10 seconds for COMS, upon receipt or application of raw materials or fuel to the process, or at least once per operating day (or week, month, etc.) for performance testing, work practice verification, or equipment design inspections; and,
(5) Reporting and record retention requirements—criteria for retaining monitoring and test data in an electronic form and periodic electronic reporting of information as needed to the compliance office. Electronic record retention and submission have been widely adopted, and the EPA believes that such readily accessible documentation could be used by state, federal and other analysts to spot trends and non-compliance more easily than if these entities conducted reviews of paper documents. The EPA also recommends that compliance reports be made available online so that the general public can readily access the information without the need to submit Freedom of Information Act (FOIA) requests to the EPA. The EPA is in the process of revising federal rules to make similar requirements apply.
The EPA acknowledges that one way for regulatory authorities to have owners or operators of regulated sources demonstrate compliance via ongoing monitoring is to use a Compliance Assurance Monitoring (CAM) rule-type approach.
The EPA continues to believe that approval of regulations adopted into SIPs should ensure that these critical elements are present and clearly defined to be approvable. In particular, the compliance obligations, including emissions limits and other applicable requirements, should be representative of and accountable to the assumptions used in a state's attainment demonstration. This accountability should include the ability to transfer the applicable regulatory requirements to a title V operating permit subject to the EPA and public review.
The EPA believes neither a change in term from “test method” to “measurement method” nor an additional acknowledgement regarding its current wording “specific EPA or other published set of [criteria]” is needed. The component to which the commenter refers is based on performance testing; ongoing measurement components are covered as `measurement technique' in one of the five critical elements for ongoing measurement.
The EPA agrees with the commenters that in some circumstances, test methods rely on sample volumes as opposed to specific durations. The `averaging time' component of performance tests will be changed to `sample collection characteristics', where such characteristics will include averaging time, duration, or sample volume and number of runs, as applicable. While the EPA does not believe it to be necessary to identify that the sample collection characteristics could be minima, maxima, or ranges, the preamble discussion associated with this change indicates that specific test methods, or regulatory agencies, may impose restrictions or specific conditions on sample collection characteristics.
The EPA described many benefits of coordinating air quality planning efforts across a range of air quality programs addressing the NAAQS, air toxics, and climate change and encouraged states to pursue multipollutant planning approaches where possible.
The final rule reiterates many of the points made in support of multipollutant planning efforts in the proposal. Efforts to reduce fine particle concentrations fit well as part of multi pollutant planning efforts because of the involvement of PM
Multipollutant planning issues have been an area of strong interest by scientists and policymakers for many years. In 1995-1997, the EPA sought recommendations from a federal advisory committee with broad stakeholder representation on ways to coordinate and make more efficient the implementation programs for upcoming ozone and PM
The EPA believes that in many cases it can be more efficient for states to develop integrated control strategies that address multiple pollutants rather than separate strategies for individual air quality programs. An integrated air quality control strategy that reduces multiple pollutants can help ensure that reductions are efficiently achieved and produce the greatest overall air quality benefits. The EPA has encouraged states to take a multi-pollutant approach to managing air quality to the extent possible.
While the agency encourages states to develop multi-pollutant plans, it recognizes that certain factors can make such efforts challenging. For example, the NAAQS are to be reviewed every 5 years, and any revisions to the standards will lead to a series of implementation steps required by specific statutory schedules. In some cases program requirements and deliverables may not be coordinated easily, but in other situations there are good opportunities for conducting technical analyses and developing policy approaches that can have important health and environmental benefits while addressing multiple key air pollution issues at the same time.
One such opportunity is the increased use of multi-pollutant assessments. A multi-pollutant assessment, or one-atmosphere modeling, is conducted with a single air quality model (such as CMAQ or CAMx) that is capable of simulating transport and formation of
Models and data analysis intended to address PM
States may also find it desirable to assess the impact of PM
The EPA requested comments on ways that states can provide public health protection specifically for overburdened populations when preparing attainment plans for the PM
Environmentally overburdened, underserved, and economically distressed communities may be subject to a higher risk of pollutant-related health effects than the general population because they may be exposed to higher pollutant concentrations than the general population; they may experience a larger health impact at a given pollutant concentration; or they may be adversely affected by lower pollutant concentrations than the general population.
Section 109(d) of the CAA requires the EPA to periodically review (every 5 years) the science upon which the standards are based and the standards themselves. The policy assessment for the 2012 PM NAAQS review (U.S. EPA, 2011a, p. 2-60) observed that the highest concentrations of PM
In conjunction with these revisions, the EPA retained the primary 24-hour PM
The process for developing attainment plans for the current and future PM
There are a number of actions that states could take to focus resources in this way. Some of these actions can help identify areas where additional ambient monitoring may be needed in low income and overburdened communities. Such information can be used to support updates to the state's annual monitoring plan.
Screening is a useful first step in understanding or highlighting locations that may be candidates for further review. The EPA has developed EJSCREEN, a public screening tool that allows users to access high-resolution environmental and demographic information for locations in the United States, and compare their selected locations to the rest of the state, the EPA region, or the nation. The tool may help users identify areas with minority and/or low-income populations, potential environmental quality issues, a combination of environmental and demographic indicators that is greater than usual, and other factors that may be of interest. Other examples of actions to support updates to the annual monitoring plan include:
• Develop databases and online mapping tools that enable users (including state staff, public, and the regulated community) to understand where sources of direct PM
• Incorporate existing mapping tools that identify target areas in the attainment plan development process and related actions; and,
• Analyze emissions data, ambient data, and available modeling to identify potential unmonitored PM
Once target areas for addressing these sensitive population needs within a nonattainment area have been identified, the state could consider taking any of the following actions, which help target emissions reductions that may be needed to attain the PM
• Prioritize the selection of control measures that target reductions of direct PM
• Improve the understanding of the potential impact of minor sources by improving or generating an emissions inventory for such minor sources, including sources that are not currently required to report emissions, to generate options on how emissions can be reduced in the target area;
• Design voluntary programs to reduce VMT and mobile source-related PM
• Incorporate environmental justice criteria into the alternatives analysis to ensure appropriate siting and require cumulative impact studies for proposed projects;
• Eliminate exemptions from and/or lower thresholds for minor source permitting;
• Prioritize targeted enforcement strategies; and
• Develop a list of potential supplemental environmental projects (SEPs)
In addition to the previous steps, states could increase opportunities for meaningful involvement of community groups in attainment plan development, annual monitoring network plan reviews, and permitting processes
• Develop advisory boards and/or develop enhanced notice-and-comment requirements for low income and minority communities to assure meaningful involvement relative to projects that impact their communities;
• Provide special notice of important actions affecting target areas in appropriate languages and with attention to cultural barriers;
• Provide advance notification for low income and minority communities of upcoming opportunities for public comment on SIPs, ambient air monitoring plans, and other relevant actions such as permit actions;
• Maintain multi-lingual Web sites and offer translators for public meetings and hearings; and,
• Coordinate with the state's EJ coordinator, if applicable, to assist with outreach efforts.
With regard to the comment about having easy access to facility compliance information, the EPA directs the commenter to the Enforcement and Compliance History Online Web site to search for facilities to assess compliance with environmental regulations. The site provides the ability to investigate pollution sources, examine and create enforcement-related maps, or explore an individual state's performance. As noted earlier in this section, the EJSCREEN tool can also provide important information about estimated pollution impacts in specific communities.
The 1998 Tribal Authority Rule (TAR) (40 CFR part 49), which implements section 301(d) of the CAA, gives tribes the option of developing Tribal Implementation Plans (TIPs). Specifically, the TAR provides for the tribes to be treated in the same manner as a state in implementing certain sections of the CAA. However, tribes are not required to develop implementation plans. The EPA determined in the TAR that it was inappropriate to treat tribes in a manner similar to a state with regard to specific plan submission and implementation deadlines for the NAAQS-related requirements, including, but not limited to, such deadlines in CAA sections 110(a)(1), 172(a)(2), 182 187, and 191.
If a tribe elects to do a TIP, the agency will work with the tribe to develop an appropriate schedule that meets the needs of the tribe and does not interfere with the attainment of the NAAQS in other jurisdictions. The tribe developing a TIP can work with the EPA Regional Office on the appropriateness of addressing RFP and other substantive SIP requirements that may or may not be appropriate for the tribe's situation.
The CAA and the TAR provide tribes opportunity and flexibility, but not the obligation to develop a TIP to address the NAAQS. If a tribe elects to develop a TIP, the TAR offers flexibility for the tribe to identify and implement on a case-by-case basis only those CAA programs or reasonably severable program elements needed to address their specific air quality problems. In the TAR, the EPA described this flexible implementation approach as a modular approach. Each tribe may evaluate the particular activities, including potential sources of air pollution within the exterior boundaries of its reservation (or within non-reservation areas for which it has demonstrated jurisdiction), that cause or contribute to its air pollution problem. A tribe may adopt measures for controlling those sources of PM
The EPA would review and approve, where appropriate, these TIPs as one step of an overall air quality plan to attain the NAAQS. A tribe may step in later to add other elements to the plan, or the EPA may step in to fill gaps in the air quality plan as necessary or appropriate. In approving a TIP, the agency would evaluate whether the plan appropriately coordinates with the overall air quality plan for an area when tribal lands are part of a multi-jurisdictional area.
Because many PM
To date, very few tribes have submitted for the EPA's approval TIPs covering areas over which they have jurisdiction. In the absence of a TIP, the EPA is authorized under the TAR to implement CAA programs in such areas as necessary or appropriate. For example, an unhealthy air quality situation on an Indian reservation may require the EPA to develop a FIP to reduce emissions from sources on the reservation. Likewise, if the agency determines that sources in an area under tribal jurisdiction could interfere with a larger nonattainment area meeting the NAAQS by its attainment date, it would develop a FIP for those sources in consultation with the tribe as necessary or appropriate.
States have an obligation to notify other states in advance of any public hearing(s) on their state plans if such plans will significantly impact such other states. 40 CFR 51.102(d)(5). Under section 301(d) of the CAA and the TAR, tribes may become eligible to be treated in a manner similar to states (TAS) for this purpose. Affected tribes with this status must also be informed of the contents of such state plans and given access to the documentation supporting these plans. In addition to this mandated process, the EPA encourages states to extend the same notice to all affected tribes, regardless of their TAS status.
Executive Orders and the EPA's Indian policies generally call for the EPA to coordinate and consult with tribes on matters that affect tribes. Executive Order 13175, titled, “Consultation and Coordination with Indian Tribal Governments” requires the EPA to develop a process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have Tribal implications.” In addition, the EPA's policies include the agency's 1984 Indian Policy relating to Indian tribes and implementation of federal environmental programs, the 2014 Office of Air and Radiation's “Handbook for Interacting with Tribal Governments,” and the “EPA Policy on Consultation and Coordination with Indian Tribes.” Consistent with these policies, the EPA intends to meet with tribes on activities potentially affecting the attainment and maintenance of the current and future PM
The EPA believes there are significant advantages for states, tribes and local agencies to take steps to reduce direct PM
In January 2013, the EPA began a new early emissions reduction program for attainment areas called “PM Advance,” which is much like the related “Ozone Advance” program that began in April 2012. For additional information and a list of areas that are currently participating in the program,
The EPA recognizes that residential wood smoke is a concern for many nonattainment areas. The EPA estimates that wood stoves, indoor wood furnaces, hydronic heaters and fireplaces emit more than 382,000 tons of PM
To reduce fine particle pollution, many PM
For purposes of demonstrating compliance with the EPA's air quality regulatory requirements, the EPA, states, and sources rely on two basic types of monitoring: ambient air quality monitoring and stationary source emissions monitoring. Ambient air quality monitoring entails collecting and measuring samples of criteria pollutants in ambient air to evaluate air quality as compared to clean air standards and historical information. Stationary source emissions monitoring, on the other hand, entails collecting and using measurement data (or other information) from individual stationary sources to demonstrate compliance with emissions standards, to assess process or control device performance, or to verify work practices. While ambient air quality monitoring is used to assess compliance with the NAAQS, stationary source emissions monitoring is used to assess compliance with source-specific regulations under programs like the New Source Performance Standards (NSPS), the National Emissions Standards for Hazardous Air Pollutants (NESHAP), the compliance assurance monitoring (CAM) program, the title V air operating permits program, and the acid deposition control program, as well as specific SIP control measures.
Accurate stationary source emissions monitoring is also critical for the purposes of developing accurate emissions inventories and in order to identify appropriate control measures to reduce emissions from stationary sources. In addition, after control measures are in place, stationary source emissions monitoring provides process and control device performance information to the facility operator so that appropriate corrective action can be taken if indicated that emission levels may exceed applicable thresholds. Thus, appropriate stationary source emissions monitoring requirements, like the control measures with which they are associated, are a fundamental element of an approvable SIP.
Because of the important role that effective stationary source emissions monitoring can play in informing the development of attainment strategies for PM
The EPA did not propose any specific changes to source monitoring requirements for PM
As discussed in the proposal, direct PM
The EPA did propose to require that, where a state needs to adopt new or revised control measures for direct PM
The 2007 PM
In the preamble to the 2007 PM
The EPA is finalizing the PM
The EPA continues to believe that using these improved test methods, including methods to quantify condensable PM
If the state has submitted an attainment demonstration that includes an adequate RACT, BACT, and/or MSM analysis, and has taken into account all known emissions of filterable and condensable PM
Additionally, the commenters stated that emissions inventories would not be “accurate” and states could not satisfy their RACM/BACM requirements if condensable emissions were not included in the SIP. Regardless of emissions limits and source testing requirements, quantification and reporting of filterable and condensable PM
The EPA proposed two options for revoking the 1997 primary annual PM
The two proposed options were:
•
•
Under the first proposed option, the EPA would revoke the 1997 primary annual PM
• Those that were originally designated as attainment areas for the 1997 annual PM
• those that were originally designated as nonattainment but have since or will in the future be redesignated to attainment for that NAAQS.
Under this option, the EPA would not revoke the 1997 primary annual PM
Areas designated nonattainment for the 2012 primary annual PM
Under the second proposed option, the EPA would revoke the 1997 primary annual PM
The EPA also requested comment on not revoking the 1997 primary annual PM
The EPA did not propose to revoke the 1997 secondary annual PM
For details on past revocations of the NAAQS including the 1-hour and 1997 ozone NAAQS and prior SO
The EPA is finalizing the revocation of the 1997 primary annual PM
On the effective date of this final rule, the 1997 primary annual PM
This final rule also revokes the 1997 primary annual PM
Similarly, all states will be required to continue to implement applicable control requirements in a FIP or approved SIP designed to address the interstate transport requirements of CAA section 110(a)(2)(D)(i) and (ii) with respect to the 1997 primary annual PM
For areas that remain nonattainment for the 1997 annual PM
After revocation of the 1997 primary annual PM
The EPA notes that areas designated nonattainment for the 1997 annual PM
As with other NAAQS revocations, this revocation is framed in the context of the CAA requirements that apply to the NAAQS transitions to ensure that states and nonattainment areas continue to make progress and do not reverse progress, or backslide, from improvements already made in air quality. The CAA contains several provisions indicating Congressional intent not to allow a state to alter or remove provisions from an approved attainment or maintenance plan if the revision would reduce air quality protection. CAA section 193 prohibits modification of a control requirement in effect or required to be adopted as of November 15, 1990 (the date of enactment of the 1990 CAA Amendments), unless such a modification would ensure equivalent or greater emissions reductions. CAA section 172(e), which addresses relaxations of the NAAQS, requires protections for areas that have not attained the NAAQS prior to a relaxation by requiring controls which are at least as stringent as the controls applicable in nonattainment areas prior to any such relaxation. CAA Section 110(l) provides that a SIP revision cannot be approved if it will interfere with attainment or other CAA requirements. Under CAA section 175A(d), an area that is redesignated to attainment may, with an appropriate showing of no interference, cease to implement a measure that is contained in the SIP at the time of redesignation, but only if that measure is retained as a contingency measure in the area's maintenance plan.
The EPA has concluded that revoking the 1997 primary annual PM
Continued attainment of the 1997 primary annual PM
Under the selected option for revocation, it is unnecessary to finalize anti-backsliding requirements that would apply to nonattainment areas for the 1997 primary annual PM
The NAAQS is not being revoked in nonattainment areas. Therefore, nonattainment areas will continue to comply with the requirements applicable to their classification for the 1997 annual PM
As the EPA proposed, the areas where the NAAQS is being revoked are not required to submit a second 10-year maintenance plan for the 1997 primary annual PM
The EPA notes that most of the 39 areas that were initially designated as nonattainment for the 1997 annual PM
In addition, transportation and general conformity will apply in all areas that are designated nonattainment for the more health protective 2012 primary annual PM
With regard to general conformity, the D.C. Circuit Court did not address the need for specific anti-backsliding measures in its initial decision or in the modified decision on the
The EPA believes that revoking the 1997 primary annual PM
An area that is attaining the more health-protective 2012 primary annual PM
• Any area that is attaining the more health protective 2012 primary annual PM
• revoking the 1997 primary annual NAAQS in areas that have either always been in attainment for that NAAQS or have been redesignated to attainment reduces confusion concerning implementation of the various PM
• burden on states is reduced because a second 10-year maintenance plan is not being required for the 1997 primary annual PM
If the 1997 primary annual PM
The EPA agrees with the commenter's assessment that attaining the 1997 annual PM
The EPA is finalizing the revocation of the 1997 primary annual PM
The EPA also disagrees with the commenter's assertion that the final rule changes CAA subpart 4's requirements. Revocation under Option 1 requires that nonattainment areas attain the 1997 annual PM
The EPA has concluded that the final rule fully complies with CAA requirements and is consistent with both past precedents for revoking the original SO
With regard to the comment that the EPA needs a better rationale for the revocation, the EPA is revoking the 1997 primary annual PM
The EPA believes that appropriately integrating prior requirements with new goals facilitates coherent, effective and timely planning and controls, and minimizes the separate potentially duplicative submission of requirements left over from previous standards. Expeditious attainment of the 1997 annual PM
The EPA also notes it retained the 1997 secondary annual NAAQS when the PM
The EPA believes the human health or environmental risk addressed by this action will not have disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations because it would not negatively affect the level of protection provided to human health or the environment under the PM
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review because it raises novel policy issues. Any changes made in response to OMB recommendations have been documented in the docket.
The information collection activities in this rule have been submitted to the Office of Management and Budget (OMB) under the PRA. The Information Collection Request (ICR) document prepared by the EPA has been assigned the EPA ICR number 2258.04, OMB Control No. 2060-0611. You can find a copy of the ICR in the docket for this rule, and it is briefly summarized here.
The EPA is finalizing this PM
For purposes of analysis of the estimated paperwork burden, the EPA assumed there were 14 existing nonattainment areas for the 1997and 2006 PM
The annual state burden for this information collection for the 14 designated 2012 PM
The annual state burden for this information collection for the 14 existing nonattainment areas for the 1997 and 2006 PM
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.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This rule will not impose any requirements directly on small entities. Entities potentially affected directly by this final rule include state, local and tribal governments and none of these governments are small governments. Other types of small entities are not directly subject to the requirements of this rule.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. This action imposes no enforceable duty on any state, local or tribal governments or the private sector. The CAA imposes the obligation for states to submit attainment plans to implement the PM
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This final rule does not have tribal implications. It would not have a substantial direct effect on one or more Indian tribes. Furthermore, these regulation revisions do not affect the relationship or distribution of power and responsibilities between the federal government and Indian tribes. The CAA and the TAR establish the relationship of the federal government and tribes in characterizing air quality and developing plans to attain the NAAQS, and these revisions to the regulations do nothing to modify that relationship. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it implements a previously promulgated health or safety-based federal standard established pursuant to the CAA.
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 rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. The results of this evaluation are contained in Section XI of this preamble. However, because of the benefits of improved air quality on low SES populations, the EPA conducted outreach to communities on the proposal to encourage comment including a March 2014 environmental justice conference in Research Triangle Park, NC, conference calls and a meeting with the National Environmental Justice Advisory Committee.
This action is subject to the CRA, and the EPA will submit a rule report to each House of the Congress and to the Comptroller General of the United States. This action is not a “major rule” as defined by 5 U.S.C. 804(2).
Pursuant to sections 307(d)(1)(E) and 307(d)(1)(V) of the CAA, the Administrator proposes to determine that this action is subject to the provisions of section 307(d). Under section 307(d)(1)(V), the provisions of section 307(d) apply to “such other
Section 307(b)(1) of the CAA indicates which Federal Courts of Appeal have venue for petitions of review of final agency actions by the EPA under the CAA. This section provides, in part, that petitions for review must be filed in the U.S. Court of Appeals for the District of Columbia Circuit (i) when the agency action consists of “nationally applicable regulations promulgated, or final actions taken, by the Administrator” or (ii) when such action is locally or regionally applicable, if “such action is based on a determination of nationwide scope or effect and if in taking such action the Administrator finds and publishes that such action is based on such a determination.”
This rule implementing the PM
Under section 307(b)(1) of the Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the District of Columbia Circuit by October 24, 2016. Any such judicial review is limited to only those objections that are raised with reasonable specificity in timely comments. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule 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. Under section 307(b)(2) of the Act, the requirements of this final action may not be challenged later in civil or criminal proceedings brought by us to enforce these requirements.
The statutory authority for this action is provided by 42 U.S.C. 7403, 7407, 7410, and 7601.
Environmental protection, Air pollution control, Intergovernmental relations, Particulate matter, Sulfur dioxide, Nitrogen oxides, Volatile organic compounds, Ammonia.
Environmental protection, Air pollution control, Intergovernmental relations, Particulate matter, Sulfur dioxide, Nitrogen oxides, Volatile organic compounds, Ammonia.
Environmental protection, Air pollution control, Intergovernmental relations, Particulate matter, Sulfur dioxide, Nitrogen oxides, Volatile organic compounds, Ammonia.
For the reasons stated in the preamble, Title 40, Chapter I of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401,
(d) Until the effective date of the final Fine Particulate Matter National Ambient Air Quality Standards: State Implementation Plan Requirements rule to be codified at 40 CFR 51.1000 through 51.1016, the 1997 annual PM
23 U.S.C. 101; 42 U.S.C. 7401-7671q.
The revisions and additions read as follows:
(a) * * *
(1) * * *
(iv)(A) * * *
(
(
(
(
(
(
(
(
(
(x)(A)
(F) For the purposes of applying the requirements of paragraph (a)(13) of this section to modifications at existing major stationary sources of Ammonia located in a PM
(xxxvii) * * *
(C) * * *
(
(2)
(ii) * * *
(A) Except as otherwise provided in paragraphs (a)(2)(iii) and (iv) of this section, and consistent with the definition of major modification contained in paragraph (a)(1)(v)(A) of this section, a project is a major modification for a regulated NSR pollutant (as defined in paragraph (a)(1)(xxxvii) of this section) if it causes two types of emissions increases—a significant emissions increase (as defined in paragraph (a)(1)(xxvii) of this section), and a significant net emissions increase (as defined in paragraphs (a)(1)(vi) and (x) of this section). The project is not a major modification if it does not cause a significant emissions increase. If the project causes a significant emissions increase, then the project is a major modification only if it also results in a significant net emissions increase.
(13) The plan shall require that the control requirements of this section applicable to major stationary sources and major modifications of PM
The following definitions apply for purposes of this subpart. Any term not defined herein shall have the meaning as defined in 40 CFR 51.100 or Clean Air Act section 302.
The provisions in subparts A through X of this part apply to areas for purposes of the PM
(a)
(b)
(1) The EPA shall reclassify as Serious through notice-and-comment rulemaking any Moderate PM
(2) A Moderate PM
(a)
(i) Base year emissions inventory requirements set forth at § 51.1008(a)(1);
(ii) Attainment projected emissions inventory requirements set forth at § 51.1008(a)(2);
(iii) Moderate area attainment plan control strategy requirements set forth at § 51.1009;
(iv) Attainment demonstration and modeling requirements set forth at § 51.1011;
(v) Reasonable Further Progress (RFP) requirements set forth at § 51.1012;
(vi) Quantitative milestone requirements set forth at § 51.1013;
(vii) Contingency measure requirements set forth at § 51.1014; and,
(viii) Nonattainment new source review plan requirements pursuant to § 51.165.
(2) The state(s) shall submit its Moderate area attainment plan to the EPA no later than 18 months from the effective date of designation of the area.
(b)
(i) Base year emissions inventory requirements set forth at § 51.1008(b)(1);
(ii) Attainment projected emissions inventory requirements set forth at § 51.1008(b)(2);
(iii) Serious area attainment plan control strategy requirements set forth at § 51.1010;
(iv) Attainment demonstration and modeling requirements set forth at § 51.1011;
(v) Reasonable Further Progress (RFP) requirements set forth at § 51.1012;
(vi) Quantitative milestone requirements set forth at § 51.1013;
(vii) Contingency measure requirements set forth at § 51.1014; and,
(viii) Nonattainment new source review plan requirements pursuant to § 51.165.
(2) The state(s) shall submit its Serious area attainment plan to the EPA according to the following schedule:
(i)
(
(
(
(B) The state(s) shall submit to the EPA the portion of the Serious area attainment plan that meets the requirements set forth at paragraphs (b)(1)(ii), and (b)(1)(iv) through (vii) of this section to the EPA by a date that is no later than 4 years after the effective date of reclassification, or 2 years prior to the attainment date, whichever is earlier.
(ii) Mandatory reclassification. For any nonattainment area reclassified to Serious for a particular PM
(iii) If the state(s) submits to the EPA a request for a Serious area attainment date extension simultaneous with the Serious area attainment plan due under paragraph (b)(1) of this section, such a plan shall meet the most stringent measure (MSM) requirements set forth at § 51.1010(b) in addition to the BACM and BACT and additional feasible measure requirements set forth at § 51.1010(a).
(c)
(i) Emissions inventory requirements set forth at § 51.1008(c)(1);
(ii) Emissions inventory requirements set forth at § 51.1008(c)(2);
(iii) Serious area attainment plan control strategy requirements set forth at § 51.1010;
(iv) Attainment demonstration and modeling requirements set forth at § 51.1011;
(v) Reasonable Further Progress (RFP) requirements set forth at § 51.1012;
(vi) Quantitative milestone requirements set forth at § 51.1013;
(vii) Contingency measure requirements set forth at § 51.1014; and
(viii) Nonattainment new source review plan requirements pursuant to § 51.165.
(2) The state(s) shall submit to the EPA the revised attainment plan meeting the requirements set forth at paragraphs (c)(1)(i) through (vii) of this section no later than 12 months from the applicable Serious area attainment date that was previously missed.
(d) Any attainment plan submitted to the EPA under this section shall establish motor vehicle emissions budgets for the projected attainment year for the area, if applicable. The state shall develop such budgets according to the requirements of the transportation conformity rule as they apply to PM
(a) The state shall submit a projected attainment date as part of its attainment plan submission under § 51.1003 for any PM
(1) Nonattainment areas initially classified as Moderate.
(i) Except for nonattainment areas that meet the criterion under paragraph (a)(1)(ii) of this section, the projected attainment date for a Moderate PM
(ii) The projected attainment date for a Moderate PM
(2)
(ii) A state that submits an attainment plan that demonstrates that a Serious PM
(3) Serious nonattainment areas subject to CAA section 189(d) for failing to attain by the applicable Serious area attainment date. The projected attainment date for a Serious PM
(b) Except for attainment plans that meet the conditions of paragraphs (a)(1)(ii) or (a)(3) of this section, the Administrator shall approve an attainment date at the same time and in the same manner in which the Administrator approves the attainment plan for the area.
(1) In accordance with paragraph (a)(1)(ii) of this section, if a state demonstrates that a Moderate PM
(2) [Reserved]
(a)
(i) The state has complied with all requirements and commitments pertaining to the area in the applicable implementation plan;
(ii) For an area designated nonattainment for a particular 24-hour PM
(iii) For an area designated nonattainment for a particular annual PM
(2) The applicable implementation plan for a Moderate PM
(3) A Moderate area 1-year attainment date extension runs from January 1 to December 31 of the year following the year that includes the applicable attainment date.
(4) A state with a Moderate area that received an initial 1-year attainment date extension may apply for a second 1-year attainment date extension for the area if the state meets the conditions described in paragraph (a)(1) of this section for the first 1-year extension year.
(b)
(i) The state demonstrates that attainment of the applicable PM
(ii) The state has complied with all requirements and commitments pertaining to the area in the applicable implementation plan; and,
(iii) The state demonstrates that the attainment plan for the area includes the most stringent measures (MSM) that are included in the attainment plan of any state or are achieved in practice in any state, and can feasibly be implemented in the area consistent with § 51.1010(b).
(2) At the time of application for an attainment date extension, the state shall submit to the EPA a Serious area attainment plan that meets the following requirements:
(i) Base year and attainment projected emissions inventory requirements set forth at § 51.1008(b);
(ii) Most stringent measures (MSM) requirement described under paragraph (b)(1)(iii) of this section and § 51.1010(b), and best available control measures not previously submitted;
(iii) Attainment demonstration and modeling requirements set forth at § 51.1011 that justify the state's conclusion under paragraph (b)(1)(i) of this section, and that demonstrate attainment as expeditiously as practicable;
(iv) Reasonable Further Progress (RFP) requirements set forth at § 51.1012;
(v) Quantitative milestone requirements set forth at § 51.1013;
(vi) Contingency measure requirements set forth at § 51.1014; and,
(vii) Nonattainment new source review plan requirements pursuant to § 51.165.
(3) The applicable implementation plan for a Serious PM
(4) The applicable implementation plan for a Serious PM
(5) A state applying for an attainment date extension for a Serious nonattainment area under § 51.1004(a)(2)(ii) shall submit to the EPA a request for an extension at the same time as it submits the Serious area attainment plan due under § 51.1003(b)(1).
(6) A state applying for an attainment date extension for a Serious nonattainment area subsequent to submitting an initial Serious area attainment plan that demonstrated attainment of the NAAQS by the applicable attainment date consistent with § 51.1004(a)(2)(i) at the time of submission may apply for such an extension no later than 60 calendar days prior to the approved attainment date for the area or, in the absence of an approved attainment date, no later than 60 calendar days prior to the applicable statutory attainment date for the area.
(c)
(d) For any attainment date extension request submitted pursuant to this section, the requesting state (or states) shall submit a written request and evidence of compliance with these regulations which includes both of the following:
(1) Evidence that all control measures submitted in the applicable attainment plan have been implemented, and
(2) Evidence that the area has made emission reduction progress that represents reasonable further progress toward timely attainment of the applicable PM
(e) For a PM
(a) A state may elect to submit to the EPA one or more precursor demonstrations for a specific nonattainment area. The analyses conducted in support of any precursor demonstration must be based on precursor emissions attributed to sources and activities in the nonattainment area.
(1) A comprehensive precursor demonstration must show that emissions of a particular precursor from all existing stationary, area, and mobile sources located in the nonattainment area do not contribute significantly to PM
(i)
(ii)
(iii) If a comprehensive precursor demonstration is approved by the EPA, the state will not be required to control emissions of the relevant precursor from existing sources in the current attainment plan.
(2) A major stationary source precursor demonstration must show that emissions of a particular precursor from all existing major stationary sources located in the nonattainment area do not contribute significantly to PM
(ii)
(iii) If a major stationary source precursor demonstration is approved by the EPA, the state will not be required to control emissions of the relevant precursor from existing major stationary sources in the current attainment plan.
(3)(i) A NNSR precursor demonstration must evaluate the sensitivity of PM
(ii) If a NNSR precursor demonstration for a particular PM
(b) If an area with one or more precursor demonstrations approved by the EPA is required to submit another PM
(a) For any nonattainment area initially classified as Moderate, the state shall submit to the EPA all of the following:
(1) A base year inventory for the nonattainment area for all emissions sources that meets the following minimum criteria:
(i) The inventory year shall be one of the 3 years for which monitored data were used for designations or another technically appropriate inventory year if justified by the state in the plan submission.
(ii) The inventory shall include actual emissions of all sources within the nonattainment area.
(iii) The emissions values shall be either annual total emissions, average-season-day emissions, or both, as appropriate for the relevant PM
(iv) The inventory shall include direct PM
(v) The state shall report emissions as point sources according to the point source emissions thresholds of the Air Emissions Reporting Requirements (AERR), 40 CFR part 51, subpart A.
(vi) The detail of the emissions inventory shall be consistent with the detail and data elements required by 40 CFR part 51, subpart A.
(2) An attainment projected inventory for the nonattainment area that meets the following minimum criteria:
(i) The year of the projected inventory shall be the most expeditious year for which projected emissions show modeled PM
(ii) The emissions values shall be projected emissions of the same sources included in the base year inventory for the nonattainment area (
(iii) The temporal period of emissions shall be the same temporal period (annual, average-season-day, or both) as the base year inventory for the nonattainment area.
(iv) Consistent with the base year inventory for the nonattainment area, the inventory shall include direct PM
(v) The same sources reported as point sources in the base year inventory for the nonattainment area shall be included as point sources in the attainment projected inventory for the nonattainment area. Stationary nonpoint and mobile source projected emissions shall be provided using the same detail (
(vi) The same detail of the emissions included shall be consistent with the level of detail and data elements as in the base year inventory for the nonattainment area (
(b) For any nonattainment area reclassified as Serious, the state shall submit to the EPA all of the following:
(1) For purposes of meeting the emissions inventory requirements of CAA section 172(c)(3), a base year inventory for the nonattainment area for all emissions sources that meets the requirements listed under paragraphs (a)(1) (ii) through (a)(1)(vi) of this section. In addition, the inventory shall use the Serious area definition of a major source listed under § 51.165(a)(1)(iv)(A), and(a)(1)(vii) and (viii), and consistent with Table 1 of Appendix A to subpart A of this part in determining sources to include as point sources. Finally, the inventory year shall be one of the 3 years for which monitored data were used for reclassification to Serious, or another technically appropriate inventory year if justified by the state in the plan submission.
(2) An attainment projected inventory for the nonattainment area that meets the criteria listed under paragraph (a)(2) of this section.
(c)
(1) For purposes of meeting the emissions inventory requirements of CAA section 172(c)(3), a base year inventory for the nonattainment area for all emissions sources that meets the requirements listed under paragraphs (a)(1) (ii) through (a)(1)(vi) of this section. In addition, the inventory shall use the Serious area definition of a major source listed under § 51.165(a)(1)(iv)(A)(vii) and (viii) and consistent with Table 1 of Appendix A to subpart A of this part in determining sources to include as point sources. The inventory year shall be one of the 3 years for which monitored data were used to determine that the area failed to attain the PM
(2) An attainment projected inventory for the nonattainment area as defined by § 51.1000(e) and that meets the criteria listed under paragraph (a)(2) of this section.
(a) The state shall identify, adopt, and implement control measures, including control technologies, on sources of direct PM
(1) The state shall identify all sources of direct PM
(2) The state shall identify all potential control measures to reduce emissions from all sources of direct PM
(i) The state is not required to identify and evaluate potential control measures to reduce emissions of a particular PM
(ii) The state is not required to identify and evaluate potential control measures to reduce emissions of a particular PM
(3) For any potential control measure identified under paragraph (a)(2) of this section, the state may make a demonstration that such measure is not technologically or economically feasible to implement in whole or in part by the end of the sixth calendar year following the effective date of designation of the area, and the state may eliminate such whole or partial measure from further consideration under this paragraph.
(i) For purposes of evaluating the technological feasibility of a potential control measure, the state may consider factors including but not limited to a source's processes and operating procedures, raw materials, physical plant layout, and potential environmental impacts such as increased water pollution, waste disposal, and energy requirements.
(ii) For purposes of evaluating the economic feasibility of a potential control measure, the state may consider factors including but not limited to capital costs, operating and maintenance costs, and cost effectiveness of the measure.
(iii) The state must submit to the EPA as part of its Moderate area attainment plan a detailed written justification for eliminating from further consideration any potential control measure identified under paragraph (a)(2) of this section on the basis of technological or economic infeasibility.
(4) The state shall use air quality modeling that meets the requirements of § 51.1011(a) and that accounts for emissions reductions estimated due to all technologically and economically feasible control measures identified for sources of direct PM
(i) If the state demonstrates through air quality modeling that the area can attain the applicable PM
(A) Any control measure identified for adoption and implementation under this paragraph that can be implemented in whole or in part by 4 years after the effective date of designation of the Moderate PM
(B) Any control measure identified for adoption and implementation under this paragraph that can only be implemented in whole or in part during the period beginning 4 years after the effective date of designation of the Moderate PM
(ii) If the state demonstrates that the area cannot practicably attain the applicable PM
(A) Any control measure identified for adoption and implementation under this paragraph that can be implemented in whole or in part by 4 years after the effective date of designation of the Moderate PM
(B) Any control measure identified for adoption and implementation under this paragraph that can only be implemented in whole or in part during the period beginning 4 years after the effective date of designation of the Moderate PM
(b) The state shall adopt control measures, including control technologies, on sources of direct PM
(c) For new or revised source emissions limitations on sources of direct PM
(a) The state shall identify, adopt, and implement best available control measures, including control technologies, on sources of direct PM
(1) The state shall identify all sources of direct PM
(2) The state shall identify all potential control measures to reduce emissions from all sources of direct PM
(i) The state shall survey other NAAQS nonattainment areas in the U.S. and identify any measures for direct PM
(ii) The state is not required to identify and evaluate potential control measures to reduce emissions of a particular PM
(iii) The state is not required to identify and evaluate potential control measures to reduce emissions of a particular PM
(3) The state may make a demonstration that any measure identified under paragraph (a)(2) of this section is not technologically or economically feasible to implement in whole or in part by the end of the tenth calendar year following the effective date of designation of the area, and may eliminate such whole or partial measure from further consideration under this paragraph.
(i) For purposes of evaluating the technological feasibility of a potential control measure, the state may consider factors including but not limited to a source's processes and operating procedures, raw materials, physical plant layout, and potential environmental impacts such as increased water pollution, waste disposal, and energy requirements.
(ii) For purposes of evaluating the economic feasibility of a potential control measure, the state may consider capital costs, operating and maintenance costs, and cost effectiveness of the measure.
(iii) The state shall submit to the EPA as part of its Serious area attainment plan submission a detailed written justification for eliminating from further consideration any potential control measure identified under paragraph (a)(2) of this section on the basis of technological or economic infeasibility. The state shall provide as part of its written justification an explanation of how its criteria for determining the technological and economic feasibility of potential control measures under paragraphs (a)(3)(i) and (ii) of this section are more stringent than its criteria for determining the
(4) Except as provided under paragraph (a)(3) of this section, the state shall adopt and implement all potential control measures identified under paragraph (a)(2) of this section.
(i) Any control measure that can be implemented in whole or in part by the end of the fourth year following the date of reclassification of the area to Serious shall be considered a best available control measure for the area. Any such control measure that is also a control technology for a stationary source in the area shall be considered a best available control technology for the area.
(ii) Any control measure that can be implemented in whole or in part between the end of the fourth year following the date of reclassification of the area to Serious and the applicable attainment date for the area shall be considered an additional feasible measure.
(5) The state shall use air quality modeling that meets the requirements of § 51.1011(b) and that accounts for emissions reductions estimated due to all best available control measures, including best available control technologies, and additional feasible measures identified for sources of direct PM
(b) For a Serious PM
(1) The state shall identify all sources of direct PM
(2) The state shall identify all potential control measures to reduce emissions from all sources of direct PM
(i) For the sources and source categories represented in the emission inventory for the nonattainment area, the state shall identify the most stringent measures for reducing direct PM
(ii) The state shall reconsider and reassess any measures previously rejected by the state during the development of any previous Moderate area or Serious area attainment plan control strategy for the area.
(3) The state may make a demonstration that a measure identified under paragraph (b)(2) of this section is not technologically or economically feasible to implement in whole or in part by 5 years after the applicable attainment date for the area, and may eliminate such whole or partial measure from further consideration under this paragraph.
(i) For purposes of evaluating the technological feasibility of a potential control measure, the state may consider factors including but not limited to a source's processes and operating procedures, raw materials, physical plant layout, and potential environmental impacts such as increased water pollution, waste disposal, and energy requirements.
(ii) For purposes of evaluating the economic feasibility of a potential control measure, the state may consider capital costs, operating and maintenance costs, and cost effectiveness of the measure.
(iii) The state shall submit to the EPA as part of its Serious area attainment plan submission a detailed written justification for eliminating from further consideration any potential control measure identified under paragraph (b)(2) of this section on the basis of technological or economic infeasibility.
(4) Except as provided under paragraph (b)(3) of this section, the state shall adopt and implement all control measures identified under paragraph (b)(2) of this section that collectively shall achieve attainment as expeditiously as practicable but no later than 5 years after the applicable attainment date for the area.
(5) The state shall use air quality modeling that meets the requirements of § 51.1011(b) and that accounts for emissions reductions estimated due to all most stringent measures; best available control measures, including best available control technologies; and additional feasible measures identified for sources of direct PM
(c) For a Serious PM
(1) The state shall identify all sources of direct PM
(2) The state shall identify all potential control measures to reduce emissions from all sources of direct PM
(i) For the sources and source categories represented in the emission inventory for the nonattainment area, the state shall identify the most stringent measures for reducing direct PM
(ii) The state shall reconsider and reassess any measures previously rejected by the state during the development of any Moderate area or Serious area attainment plan control strategy for the area.
(3) The state may make a demonstration that a measure identified under paragraph (c)(2) of this section is not technologically or economically feasible to implement in whole or in part within 5 years or such longer period as the EPA may determine is appropriate after the EPA's determination that the area failed to attain by the Serious area attainment date, and may eliminate such whole or partial measure from further consideration under this paragraph.
(i) For purposes of evaluating the technological feasibility of a potential
(ii) For purposes of evaluating the economic feasibility of a potential control measure, the state may consider capital costs, operating and maintenance costs, and cost effectiveness of the measure.
(iii) The state shall submit to the EPA as part of its Serious area attainment plan submission a detailed written justification for eliminating from further consideration any potential control measure identified under paragraph (c)(2) of this section on the basis of technological or economic infeasibility.
(4) Except as provided under paragraph (c)(3) of this section, the state shall adopt and implement all control measures identified under paragraph (c)(2) of this section that collectively achieve attainment of the standard as expeditiously as practicable pursuant to § 51.1004(a)(3).
(5) The state shall conduct air quality modeling that meets the requirements of § 51.1011(b) and that accounts for emissions reductions due to control measures needed to meet the annual reduction requirement of 5 percent of direct PM
(d) The state shall adopt control measures, including control technologies, on sources of direct PM
(e) For new or revised source emissions limitations on sources of direct PM
(a)
(1) The attainment demonstration shall show the projected attainment date for the Moderate nonattainment area that is as expeditious as practicable in accordance with the requirements of § 51.1004(a)(1).
(2) The attainment demonstration shall meet the requirements of Appendix W of this part and shall include inventory data, modeling results, and emission reduction analyses on which the state has based its projected attainment date.
(3) The base year for the emissions inventory required for an attainment demonstration under this paragraph shall be one of the 3 years used for designations or another technically appropriate inventory year if justified by the state in the plan submission.
(4) The control strategies modeled as part of the attainment demonstration shall be consistent with the following as applicable:
(i) For a Moderate area that can demonstrate attainment of the applicable PM
(ii) For a Moderate area that cannot practicably attain the applicable PM
(5) Required time frame for obtaining emissions reductions. For each Moderate nonattainment area, the attainment plan must provide for implementation of all control measures needed for attainment as expeditiously as practicable. All control measures in the attainment demonstration must be implemented no later than the beginning of the year containing the applicable attainment date, notwithstanding RACM implementation deadline requirements in § 51.1009.
(b)
(1) The attainment demonstration shall show the projected attainment date for the Serious nonattainment area that is as expeditious as practicable.
(2) The attainment demonstration shall meet the requirements of Appendix W of this part and shall include inventory data, modeling results, and emission reduction analyses on which the state has based its projected attainment date.
(3) The base year for the emissions inventories required for attainment demonstrations under this paragraph shall be one of the 3 years used for designations or another technically appropriate inventory year if justified by the state in the plan submission.
(4) The control strategies modeled as part of a Serious area attainment demonstration shall be consistent with the control strategies required pursuant to § 51.1003 and § 51.1010.
(5) Required timeframe for obtaining emissions reductions. For each Serious nonattainment area, the attainment plan must provide for implementation of all control measures needed for attainment as expeditiously as practicable. All control measures must be implemented no later than the beginning of the year containing the applicable attainment date, notwithstanding BACM implementation deadline requirements in § 51.1010.
(a) Each attainment plan for a PM
(1) A schedule describing the implementation of control measures during each year of the applicable attainment plan. Control measures for Moderate area attainment plans are required in § 51.1009, and control measures for Serious area attainment plans are required in § 51.1010.
(2) RFP projected emissions for direct PM
(3) An analysis that presents the schedule of control measures and estimated emissions changes to be achieved by each milestone year, and that demonstrates that the control strategy will achieve reasonable progress toward attainment between the applicable base year and the attainment year. The analysis shall rely on information from the base year inventory for the nonattainment area required in § 51.1008(a)(1) and the attainment projected inventory for the nonattainment area required in § 51.1008(a)(2), in addition to the RFP projected emissions required in paragraph (a)(2) of this section.
(4) An analysis that demonstrates that by the end of the calendar year for each milestone date for the area determined in accordance with § 51.1013(a), pollutant emissions will be at levels that reflect either generally linear progress or stepwise progress in reducing emissions on an annual basis between the base year and the attainment year. A demonstration of stepwise progress must be accompanied by appropriate justification for the selected implementation schedule.
(5) At the state's election, an analysis that identifies air quality targets associated with the RFP projected emissions identified for the milestone years at the design value monitor locations.
(b) For a multi-state or multi-jurisdictional nonattainment area, the RFP plans for each state represented in the nonattainment area shall demonstrate RFP on the basis of common multi-state inventories. The states or jurisdictions within which the area is located must provide a coordinated RFP plan. Each state in a multi-state nonattainment area must ensure that the sources within its boundaries comply with enforceable emission levels and other requirements that in combination with the reductions planned in other state(s) within the nonattainment area will provide for attainment as expeditiously as practicable and demonstrate RFP consistent with these regulations.
(a) Consistent with CAA section 189(c)(1), the state must submit in each attainment plan for a PM
(1)
(ii) The plan shall contain quantitative milestones to be achieved by the milestone dates specified in paragraph (a)(1)(i) of this section, as applicable, and that provide for objective evaluation of reasonable further progress toward timely attainment of the applicable PM
(2)
(ii) Except as provided in paragraph (a)(4) of this section, each attainment plan submission that demonstrates that a Serious PM
(iii) The plan shall contain quantitative milestones to be achieved by the milestone dates specified in paragraphs (a)(2)(i) and (ii) of this section, as applicable, and that provide for objective evaluation of reasonable further progress toward timely attainment of the applicable PM
(3)
(A) If the attainment plan is due prior to a date 13.5 years from designation of the area, then the plan shall contain milestones to be achieved by no later than a milestone date of 13.5 years from the date of designation of the area, and every 3 years thereafter, until the milestone date that falls within 3 years after the applicable attainment date.
(B) If the attainment plan is due later than a date 13.5 years from designation of the area, then the plan shall contain milestones to be achieved by no later than a milestone date of 16.5 years from the date of designation of the area, and every 3 years thereafter, until the milestone date that falls within 3 years after the applicable attainment date.
(ii) The plan shall contain quantitative milestones to be achieved by the milestone dates for the area, and that provide for objective evaluation of reasonable further progress toward timely attainment of the applicable PM
(4) Each attainment plan submission for an area designated nonattainment for the 1997 and/or 2006 PM
(b) Not later than 90 days after the date on which a milestone applicable to a PM
(1) A certification by the Governor or Governor's designee that the SIP control strategy is being implemented consistent with the RFP plan, as described in the applicable attainment plan;
(2) Technical support, including calculations, sufficient to document completion statistics for appropriate milestones and to demonstrate that the quantitative milestones have been satisfied and how the emissions reductions achieved to date compare to those required or scheduled to meet RFP; and,
(3) A discussion of whether the area will attain the applicable PM
(c) If a state fails to submit a milestone report by the date specified in paragraph (b) of this section, the Administrator shall require the state to submit, within 9 months after such failure, a plan revision that assures that the area will achieve the next milestone or attain the applicable NAAQS by the applicable date, whichever is earlier. If the Administrator determines that an area has not met any applicable milestone by the milestone date, the state shall submit, within 9 months after such determination, a plan revision that assures that the area will achieve the next milestone or attain the applicable NAAQS by the applicable date, whichever is earlier.
(a) The state must include as part of each attainment plan submitted under this subpart for a PM
(1) To meet any RFP requirement in an attainment plan approved in accordance with § 51.1012;
(2) To meet any quantitative milestone in an attainment plan approved in accordance with § 51.1013;
(3) To submit a quantitative milestone report required under § 51.1013(b); or,
(4) To attain the applicable PM
(b) The contingency measures adopted as part of a PM
(1) The contingency measures shall consist of control measures that are not otherwise included in the control strategy or that achieve emissions reductions not otherwise relied upon in the control strategy for the area; and,
(2) Each contingency measure shall specify the timeframe within which its requirements become effective following a determination by the Administrator under paragraph (a) of this section.
(c) The attainment plan submission shall contain a description of the specific trigger mechanisms for the contingency measures and specify a schedule for implementation.
(a)
(1) The area is redesignated to attainment, after which such requirements are permanently discharged; or,
(2) The EPA determines that the area has re-violated the PM
(b)
(1) The area is redesignated to attainment, after which such requirements are permanently discharged; or,
(2) The EPA determines that the area has re-violated the PM
All control requirements associated with a FIP or approved SIP in effect for an area pursuant to obligations arising from CAA section 110(a)(2)(D)(i) and (ii) as of October 24, 2016, such as the CAIR or the CSAPR, shall continue to apply after revocation of the 1997 primary annual PM
The revisions and additions read as follows:
II. * * *
A. * * *
4. (i) * * *
(
(
(
10.(i)
(vi) In any nonattainment area for PM
31. * * *
(ii) * * *
(
(
(
(
42 U.S.C. 7401-7671q.
(b) * * *
(1) For purposes of paragraph (b) of this section the following rates apply in nonattainment areas (NAA's):
(2) For purposes of paragraph (b) of this section the following rates apply in maintenance areas:
Office of Energy Efficiency and Renewable Energy, Department of Energy.
Supplemental notice of proposed rulemaking.
The U.S. Department of Energy (DOE) proposes to revise its test procedures for central air conditioners and heat pumps (CAC/HP) established under the Energy Policy and Conservation Act. DOE published several proposals in a November 2015 supplemental notice of proposed rulemaking (SNOPR). DOE finalized some of the proposed test procedure amendments in a June 2016 final rule. This SNOPR proposes additional revisions to some of the amendments proposed in the past notices and proposes some additional amendments. Specifically, this SNOPR proposes two sets of amendments to the test procedure: Amendments to appendix M that would be required as the basis for making efficiency representations starting 180 days after final rule publication; and amendments as part of a new appendix M1 that would be the basis for making efficiency representations as of the compliance date for any amended energy conservation standards. Broadly speaking, the proposed amendments address the off-mode test procedures, clarifications on test set-up and fan delays, limits to gross indoor fin surface area for valid combinations, external static pressure conditions for testing, clarifications on represented values for CAC/HP that are distributed in commerce with multiple refrigerants, and the methodology for testing and calculating heating performance. DOE does not expect the proposed changes to appendix M to change measured efficiency. However, DOE has determined that the proposed procedures in new appendix M1 would change measured efficiency. DOE welcomes comments from the public on any subject within the scope of this test procedure rulemaking.
DOE will accept comments, data, and information regarding this supplemental notice of proposed rulemaking (SNOPR) no later than September 23, 2016. See section V, “Public Participation,” for details.
DOE will hold a public meeting on Friday, August 26, 2016, from 10 a.m. to 2 p.m., in Washington, DC. The meeting will also be broadcast as a webinar. See section V, Public Participation, for webinar registration information, participant instructions, and information about the capabilities available to webinar participants.
The public meeting will be held at the U.S. Department of Energy, Forrestal Building, Room 1E-245, 1000 Independence Avenue SW., Washington, DC 20585.
Any comments submitted must identify the Test Procedure SNOPR for central air conditioners and heat pumps, and provide docket number EERE-2016-BT-TP-0029 and/or regulatory information number (RIN) number 1904-AD 71. Comments may be submitted using any of the following methods:
(1)
(2)
(3)
(4)
For detailed instructions on submitting comments and additional information on the rulemaking process, see section V of this document (Public Participation).
The docket Web page can be found at
For further information on how to submit a comment, review other public comments and the docket, or participate in the public meeting, contact the Appliance and Equipment Standards Program staff at (202) 586-6636 or by email:
DOE is not proposing to incorporate any new standards by reference in this supplemental notice of proposed rulemaking.
Title III, Part B
Under EPCA, DOE's energy conservation program generally consists of four parts: (1) Testing; (2) labeling; (3) Federal energy conservation standards; and (4) certification, compliance, and enforcement. The testing requirements consist of test procedures that manufacturers of covered products must use as the basis of: (1) Certifying to DOE that their products comply with applicable energy conservation standards adopted pursuant to EPCA, and (2) making other representations about the efficiency of those products. (42 U.S.C. 6293(c); 42 U.S.C. 6295(s)) Similarly, DOE must use these test procedures to determine whether covered products comply with any relevant standards promulgated under EPCA. (42 U.S.C. 6295(s))
EPCA sets forth criteria and procedures DOE must follow when prescribing or amending test procedures for covered products. (42 U.S.C. 6293(b)(3)) EPCA provides, in relevant part, that any test procedures prescribed or amended under this section shall be reasonably designed to produce test results which measure the energy efficiency, energy use, or estimated annual operating cost of a covered product during a representative average use cycle or period of use, and shall not be unduly burdensome to conduct.
In addition, if DOE determines that a test procedure amendment is warranted, it must publish proposed test procedures and offer the public an opportunity to present oral and written comments on them. (42 U.S.C. 6293(b)(2)) Finally, in any rulemaking to amend a test procedure, DOE must determine to what extent, if any, the amended test procedure would alter the measured energy efficiency of any covered product as determined under the existing test procedure. (42 U.S.C. 6293(e)(1))
The Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, amended EPCA to require that, at least once every 7 years, DOE must review test procedures for all covered products and either amend the test procedures (if the Secretary determines that amended test procedures would more accurately or fully comply with the requirements of 42 U.S.C. 6293(b)(3)) or publish a notice in the
DOE's existing test procedures for CAC/HP adopted pursuant to these provisions appear under Title 10 of the Code of Federal Regulations (CFR) part 430, subpart B, appendix M (“Uniform Test Method for Measuring the Energy Consumption of Central Air Conditioners and Heat Pumps”). These procedures establish the currently permitted means for determining energy efficiency and annual energy consumption for CAC/HP. Some of the amendments proposed in this SNOPR will alter the measured efficiency, as represented in the regulating metrics of seasonal energy efficiency ratio (SEER), energy efficiency ratio (EER), and heating seasonal performance factor (HSPF). These amendments are proposed as part of a new appendix M1. Use of the test procedure changes proposed in this notice as part of a new appendix M1, if adopted, would become mandatory to demonstrate compliance if the existing energy conservation standards are revised. (42 U.S.C. 6293(e)(2)) In revising the energy conservation standards in a separate rulemaking, DOE would create a cross-walk from the existing standards under the current test procedure to what the standards would be if tested using the revised test procedure.
On December 19, 2007, the President signed the Energy Independence and Security Act of 2007 (EISA 2007), Public Law 110-140, which contains numerous amendments to EPCA. Section 310 of EISA 2007 established that the Department's test procedures for all covered products must account for standby mode and off mode energy consumption. (42 U.S.C. 6295(gg)(2)(A)) For CAC/HP, standby mode is incorporated into the SEER and HSPF metrics, while off mode power consumption is separately regulated. This SNOPR includes proposals relevant to the determination of both SEER and HSPF (including standby mode) and off mode power consumption. DOE would then use the cross-walked equivalent of the existing standard as the baseline for its standards analysis to prevent backsliding as required under 42 U.S.C. 6295(o)(1).
DOE initiated a round of test procedure revisions for CAC/HP by
On November 5, 2014, DOE published a request for information for energy conservation standards (ECS) for CAC/HP (November 2014 ECS RFI). 79 FR 65603. In response, several stakeholders provided comments suggesting that DOE amend the current test procedure. The November 2015 SNOPR addressed those test procedure-related comments, but, as mentioned in this preamble, not all of the related issues were resolved in the June 2016 final rule.
On July 14, 2015, DOE published a notice of intent to form a Working Group to negotiate a NOPR for energy conservation standards for CAC/HP and requested nominations from parties interested in serving as members of the Working Group. 80 FR 40938. The Working Group, which ultimately consisted of 15 members in addition to one member from Appliance Standards and Rulemaking Federal Advisory Committee (ASRAC), and one DOE representative, identified a number of issues related to testing and certification and made several recommendations that are being addressed in the proposals of this SNOPR. DOE believes proposed changes are consistent with the intent of the Working Group.
This SNOPR addresses proposals and comments from two rulemakings: (1) Stakeholder comments and proposals regarding the CAC test procedure (CAC TP: Docket No. EERE-2009-BT-TP-0004); and (2) stakeholder comments and proposals regarding the CAC energy conservation standard from the Working Group (CAC ECS: Docket No. EERE-2014-BT-STD-0048). Comments received through documents located in the test procedure docket are identified by “CAC TP” preceding the comment citation. Comments received through documents located in the energy conservation standard docket (EERE-2014-BT-STD-0048) are identified by “CAC ECS” preceding the comment citation. Further, comments specifically received during the CAC/HP ECS Working Group meetings are identified by “CAC ECS: ASRAC Public Meeting” preceding the comment citation.
In this SNOPR, DOE proposes revising the certification requirements and test procedure for CAC/HP based on public comment on various published materials and the ASRAC negotiation process discussed in section I.B. In this SNOPR, DOE proposes two sets of changes: One set of proposed changes to Appendix M effective 30 days after publication of a final rule and required for testing and determining compliance with current energy conservation standards; and another set of proposed changes to create a new Appendix M1 that would be used for testing to demonstrate compliance with any amended energy conservation standards (agreed to be January 1, 2023 by the Working Group in the CAC rulemaking negotiations (CAC ECS: ASRAC Term Sheet, No. 76)). DOE requests comment on whether representations in accordance with Appendix M1 should be permitted prior to the compliance date of any amended energy conservation standards. DOE does not expect the proposed changes to Appendix M to change measured efficiency. However, DOE has determined that the proposed procedures in the new Appendix M1 would change measured efficiency.
In this SNOPR, DOE proposes the following changes to certification requirements:
(1) Certification of the indoor fan off delay used for coil-only tests.
(2) Codifying the CAC/HP ECS Working Group's recommendation regarding delayed implementation of testing to demonstrate compliance with amended energy conservation standards;
(3) Relaxing the requirement that a split system's tested combination be a high sales volume combination;
(4) Revising requirements for certification of multi-split systems in light of the proposed adoption of multiple categories of duct pressure drop that the indoor units can provide;
(5) Making explicit certain provisions of the service coil definition;
(6) Certification of separate individual combinations within the same basic model for each refrigerant that can be used in a model of split system outdoor unit without voiding the warranty; and
(7) Certification of details regarding the indoor units with which unmatched outdoor units are tested.
DOE proposes the following changes to Appendix M:
(1) Establishment of a 4-hour or 8-hour delay time before the power measurement for units that require the outdoor temperature setting to reach thermal equilibrium;
(2) A limit on the internal volume of lines and devices connected to measure pressure at refrigerant circuit locations where the refrigerant state can switch from liquid to vapor for different test operating conditions;
(3) Requiring bin-by-bin EER and coefficient of performance (COP) interpolations for all variable speed units, to calculate performance at intermediate compressor speeds;
(4) Requiring a 30-minute test without the outside-air apparatus connected (a “non-ducted” test) to be the official test as part of all cooling and heating mode tests which use the outdoor air enthalpy method as the secondary measurement; and
(5) Imposing indoor coil size limits for split system ratings.
DOE proposes the following provisions for new Appendix M1:
(1) New higher external static pressure requirements for all units, including unique minimum external static pressure requirements for mobile home systems, ceiling-mount and wall-mount systems, low and mid-static multi-split systems, space-constrained systems, and small-duct, high-velocity systems;
(2) A unique default fan power for rating mobile home coil-only units and new default fan power for all other coil-only units;
(3) Revisions to the heating load line equation in the calculation of HSPF; and
(4) Amendments to the test procedures for variable speed heat pumps that change speed at lower ambient temperatures and a 5 °F heating mode test option for calculating full-speed performance below 17 °F.
If adopted, the test procedures proposed in this SNOPR to appendix M for subpart B to 10 CFR part 430 pertaining to the efficiency of CAC/HP would be effective 30 days after publication in the
If adopted, the test procedures proposed in this SNOPR for appendix M1 to subpart B of 10 CFR part 430 pertaining to the efficiency of CAC/HP would be effective 30 days after publication in the
As noted in section I.A, 42 U.S.C. 6293(e) requires DOE to determine to what extent, if any, the proposed test procedure would alter the measured energy efficiency and measured energy use. DOE has determined that some of the proposed amendments in the new Appendix M1 would result in a change in measured energy efficiency and measured energy use for CAC/HP. DOE is conducting a separate rulemaking to amend the energy conservation standards for CAC/HP, which will take into account the test procedure revisions in Appendix M1. (CAC ECS: Docket No. EERE-2014-BT-STD-0048)
This section discusses the revisions to the certification requirements and test procedure that DOE proposes in this SNOPR.
The CAC/HP ECS Working Group made certain recommendations related to the Appendix M1 test procedure, with a recommended compliance date of January 1, 2023, for representations based on Appendix M1. (Docket No. EERE-2014-BT-STD-0048, No. 76, Recommendation #7) While the June 2016 Test Procedure Final Rule adopted mandatory testing requirements for representations of all basic models [81 FR at 37050-37051; 10 CFR 429.16(b)(2)(i)], the Working Group recommended several accommodations for representations for split systems:
○ DOE will implement the following accommodation for representative values of split system air conditioners and heat pumps based on the M1 methodology:
○ By January 1, 2023, manufacturers of single-split systems must validate an AEDM that is representative of the amended M1 test procedure by:
Testing a single-unit sample for 20-percent of the basic models certified.
The predicted performance as simulated by the AEDM must be within 5 percent of the performance resulting from the test of each of the models.
Although DOE will not require that a full complement of testing be completed by January 1, 2023, manufacturers are responsible for ensuring their representations are appropriate and that the models being distributed in commerce meet the applicable standards (without a 5% tolerance).
○ By January 1, 2023, manufacturers must either determine representative values for each combination of single-split-system CAC/HP based on the M1 test procedures using a validated AEDM or through testing and the applicable sampling plan.
○ By January 1, 2023, manufacturers of multi-split, multi-circuit, or multi-head mini-split systems must determine representative values for each basic model through testing and the applicable sampling plan.
○ By July 1, 2024, each model of condensing unit of split system CAC/HP must have at least 1 combination whose rating is based on testing using the M1 test procedure and the applicable sampling plan.
DOE proposes to implement these recommendations, in their entirety, in 10 CFR 429.16 and 429.70.
The CAC/HP ECS Working Group recommended that DOE implement the following requirements for single-split-system air conditioners and suggested implementing regulatory text:
• Every combination distributed in commerce must be rated.
○ Every single-stage and two-stage condensing unit distributed in commerce (other than a condensing unit for a 1-to-1 mini split) must have at least 1 coil-only rating that is representative of the least efficient coil distributed in commerce with a particular condensing unit.
• Every condensing unit distributed in commerce must have at least 1 tested combination.
○ For single-stage and two-stage condensing units (other than condensing units for a 1-to-1 mini split), this must be a coil-only combination.
• All other combinations distributed in commerce for a given condensing unit may be rated based on the application of an AEDM or testing in accordance with the applicable sampling plan.
DOE addressed the first and third bullets in a final rule published on June 8, 2016, (June 2016 final rule), but at that time declined to implement the second bullet, which recommends removing the requirement that the tested combination be the highest sales volume combination (HSVC). DOE also received comments from non-working group members regarding this requirement. JCI commented that the current language used in Appendix M denoting the HSVC match cannot be determined with exact statistics and that it actually inhibits the adoption of new and promising advancements in product design. (CAC TP: JCI, No. 66 at p. 4) In contrast, Unico commented that, as an indoor coil manufacturer, it believes it to be important that the outdoor unit manufacturer continue to test and rate the HSVC, as this is an integral requirement for their AEDM to maintain accuracy. (CAC TP: Unico, No. 63 at p. 2)
DOE believes the CAC/HP ECS Working Group recommendation adequately addresses JCI's concern about using the HSVC as a tested combination. In response to Unico, DOE notes that the requirements adopted in the June 2016 final rule require independent coil manufacturers (ICMs) to test their own equipment. It is the ICM's own responsibility to ensure the accuracy of its AEDMs. ICMs may conduct additional testing or work with outdoor unit manufacturers (OUMs) as needed to do so. For these reasons, DOE is proposing to remove the requirement that the tested combination be the HSVC. DOE proposes to apply the requirements as recommended by the CAC/HP ECS Working Group to all single-split-system air conditioners and heat pumps, including space-constrained and small-duct, high-velocity, distributed in commerce by an OUM.
In the June 2016 final rule, DOE modified the testing requirements for multi-head mini-split systems and multi-split systems, and added similar requirements for testing multi-circuit systems. DOE also clarified that these requirements apply to variable refrigerant flow (VRF) systems that are
DOE also added a requirement that for any models of outdoor units also sold with models of small-duct, high velocity (SDHV) indoor units, a “tested combination” composed entirely of SDHV indoor units must be used for testing and rating. However, such a system must be certified as a different basic model. Finally, DOE allowed mix-match ratings for SDHV and other non-ducted or ducted indoor units based on an average of the ratings of the two individual indoor unit types. 81 FR 37004 (June 8, 2016)
In the June 2010 NOPR, DOE had proposed lower minimum external static pressure (ESP) requirements for ducted multi-split systems (75 FR at 31232), and in the November 2015 SNOPR, DOE proposed to implement these requirements using the term “short duct systems,” which could refer to multi-split, multi-head mini-split, or multi-circuit systems with indoor units that produce a limited level of external static pressure. 80 FR at 69314 (Nov. 9, 2015). In response to the SNOPR, DOE received several comments regarding its terminology and testing requirements related to short-duct systems as well as requests for changing terminology and testing requirements to include low-static and mid-static systems, as recommended in the CAC/HP ECS Working Group Term Sheet. Therefore in the June 2016 final rule, DOE maintained the existing ducted system terminology and is addressing the earlier comments from stakeholders and recommendations from the Working Group in this SNOPR.
Unico supported DOE's definition of short-ducted systems which would create four indoor unit types for multi-split systems: Short-ducted (previously described as “ducted”), conventional ducted, SDHV-ducted, and non-ducted. (CAC TP: Unico, No. 63 at p. 11) In the Term Sheet, the CAC/HP ECS Working Group recommended that DOE define “low-static system” and “mid-static system” as discussed in section III.C.1. (CAC ECS: Docket No. EERE-2014-BT-STD-0048, No. 76 at p. 1-2) These systems are essentially sub-categories of DOE's earlier proposal for short-ducted systems.
In addition, several stakeholders commented that multi-split systems may also be paired with models of conventional ducted indoor units. UTC/Carrier commented that some manufacturers also offer ducted units with external static pressure capabilities greater than 0.65 in w.c., the maximum external static pressure proposed by the Working Group for mid-static ducted units and recommended that DOE also include a requirement for separate multi-split system ratings with these “standard” ducted indoor units. (CAC TP: UTC/Carrier, No. 62 at p. 3-4)
Rheem commented that the definition of multi-split system is not limited to a specific duct configuration and that testing of all possible duct configurations should be considered. Rheem further commented that the testing requirements should be the same as single-split systems using conventional ducted indoor units because multi-split systems duct losses are the same as the standard single-split system. (CAC TP: Rheem, No. 69 at p. 5)
NEEA and NPCC commented that multi-split systems paired with more conventional blower coil indoor units should be testable with the external static pressure conditions specified for conventional blower coil units. (CAC TP: NEEA and NPCC, No. 64 at p. 3-4)
The California IOUs commented that additional testing is needed to ensure that the AEDM gives accurate ratings for all of the possible combinations when an outdoor unit of a multi-split system is paired with a conventional central forced air indoor unit. They said that, at present, a variable speed, mini-split outdoor unit is connected to an indoor unit(s) from the same manufacturer with complex software controls that produce the variable modes of operation needed to respond to indoor and outdoor conditions. They also asserted that the indoor units can be short ducted or ductless cassettes. Finally, they commented that, if the same outdoor section is installed with a central forced air unit, it will have indoor fan operation modes and significantly different power draw and may not be representative of the nuanced behavior of the ductless and short duct components. (CAC TP: California IOUs, No. 67 at p. 3)
Given the multiple types of indoor units with which these systems can be paired, several stakeholders also made recommendations related to the testing and rating requirements.
Unico commented that multi-split ratings should be listed with homogeneous type of indoor units, which should be based on tests or a valid AEDM. Unico commented that short-ducted, conventional-ducted, SDHV-ducted and non-ducted are different types and should all be tested and rated using the appropriate test procedure for the type, and that ratings with mixed types should be an average. (CAC TP: Unico, No. 63 at p. 2)
Mitsubishi proposed that given the potential additional testing requirements presented for systems with multiple families of ducted indoor unit (low-static, mid-static and standard-static ducted), a manufacturer be allowed to produce tested combinations of all low-static, all mid-static or all standard-static indoor units, and that, if they do not wish to have separate ratings, they must use the highest rating of external static pressure to establish the tested combination. (CAC TP: Mitsubishi, No. 68 at p. 3)
Goodman suggested that any combinations of non‐ducted, low-static, mid-static and/or high-static indoor units be based on the highest static units in the combination if a single rating is to be used for all short‐ducted indoor units. In addition, Goodman stated that it believes these combinations should have the capability of being rated and certified using either test data or an AEDM. Goodman suggested that, if multiple combinations of non-ducted, low-static, mid-static and/or high-static indoor units are matched with a particular outdoor unit, the testing should be performed using the appropriate test static for each indoor unit. (CAC TP: Goodman, No. 73 at p. 13-14)
DOE supports the Working Group recommendations to replace its proposal to use the terminology short-duct with low-static and mid-static. The proposed definitions for these terms are discussed in section III.C.1. In addition, DOE agrees that multi-split, multi-head mini-split, or multi-circuit systems can include conventional ducted indoor units. DOE notes that the proposed test procedure allows selection of an appropriate external static pressure for this case.
After reviewing the comments, DOE proposes that multi-split, multi-head mini-split, and multi-circuit systems can be tested and rated with five kinds of indoor units: Non-ducted, low-static ducted, mid-static ducted, conventional ducted, or SDHV. However, DOE agrees that if a manufacturer offers an outdoor model with all five kinds of indoor units, a requirement to determine a rating through testing of each could be burdensome. Therefore, DOE proposes that, when determining represented values including certifying compliance with amended energy conservation standards, at a minimum, a manufacturer must test and rate a “tested combination” composed entirely of non-ducted units. If a manufacturer also offers the model of outdoor unit with models of low-static, mid-static, and/or conventional ducted indoor units, the manufacturer must at a minimum also test and rate a second “tested combination” with the highest static variety of indoor unit offered. The manufacturer may also choose to test and rate additional “tested combinations” composed of the lower static varieties. In each case, the manufacturer must test with the appropriate external static pressure. DOE believes that this option reduces test burden sufficiently and is not proposing use of AEDMs for these systems.
DOE proposes to maintain its requirement from the June 2016 final rule that, if a manufacturer also sells a model of outdoor unit with SDHV indoor units, the manufacturer must test and rate the SDHV system (
In the June 2016 final rule, to distinguish newly installed cased and uncased coils from replacement cased and uncased coils, DOE added a definition for service coils and explicitly excluded them from indoor units in the indoor unit definition:
In this SNOPR, DOE proposes to modify the adopted definition of service coil to more explicitly define what “labeled accordingly” means. Under 42 U.S.C. 6295(r), the Secretary may include any requirement which the Secretary determines is necessary to assure that each covered product to which such standard applies meets the required minimum level of energy efficiency or maximum quantity of energy use specified in such standard.
Split-system CAC/HP are required to be tested as a system. Prior to the June 2016 final rule, the condensing unit was required to be tested with “the evaporator coil that is likely to have the largest volume of retail sales with the particular model of condensing unit” (commonly referred to as the highest sales volume combination or HSVC). 10 CFR 429.16(a)(2)(ii) as of January 1, 2016. The June 2016 final rule amended the definition of “central air conditioner or central air conditioning heat pump” to recognize instances in which there is no HSVC,
As discussed in the June 2016 final rule, outdoor units with no match are typically a result of the phase-out of HCFC-22 refrigerant. Effective January 1, 2010, the U.S. Environmental Protection Agency (EPA) banned the sale and distribution of those central air conditioning systems and heat pump systems that are designed to use HCFC-22 refrigerant. 74 FR 66450 (Dec. 15, 2009). EPA's rulemaking included an exception for the manufacture and importation of replacement components, as long as those components are not pre-charged with HCFC-22. Id. at 66459-60. Because complete HCFC-22 systems can no longer be distributed, DOE established test procedure requirements for outdoor units that have “no match,” or are not sold with a matching indoor unit, which includes those units designed to use HCFC-22.
The “no match” test procedure's goal is that the test should produce measurements of energy efficiency during a representative average use cycle (see 42 U.S.C. 6293(b)(3)) while also ensuring that any field-matched combination (including the new “no-match” outdoor unit and an existing indoor unit) meets the standard. Due to the nature of these no-match systems, however, neither the manufacturer nor DOE knows exactly what the paired system will be for an outdoor unit with no match. To ensure compliance, DOE established indoor unit specifications that are representative of a less efficient unit (representative of units on the market at the time of the change in EPA regulations) that could be paired with the given outdoor unit with no match. Specifically, DOE established a requirement that outdoor units without a matching indoor unit must be tested with an indoor unit with a normalized gross indoor fin surface (NGIFS)
In response to the phase-out of HCFC-22, one course pursued by manufacturers has been to use the refrigerant R-407C, which can be used as a drop-in replacement for HCFC-22 if oil compatibility issues are addressed. (No. 1 at pp. 2-6) Because R-407C is a replacement for HCFC-22, it is possible for a central air conditioner to operate either with R-407C or with HCFC-22. Such a unit could be shipped charged with R-407C, or shipped without the refrigerant charge (
To address instances in which the manufacturer indicates that more than one refrigerant is acceptable for use in a unit (
Under this proposal, if an outdoor unit manufacturer (OUM) indicates as an acceptable refrigerant for a model of outdoor unit a refrigerant that is banned for inclusion in CAC/HP distributed as systems, such as HCFC-22, the OUM would have to determine represented values (
Inclusion of HCFC-22 as an acceptable refrigerant by the manufacturer indicates that the model of outdoor unit was designed and manufactured to be sold separately as a replacement component (
As indicated previously in this discussion, it is DOE's understanding that the listing of acceptable refrigerants also impacts the unit's warranty. In order for a unit to remain under warranty, the unit generally must be operated and maintained as recommended by the manufacturer. If a manufacturer indicates that HCFC-22 is an acceptable refrigerant, its use in an outdoor unit would not be expected to void the warranty. Again, DOE understands conformance with the warranty to be an indication of the intended use for which a model is designed and manufactured. Additionally, DOE understands that manufacturer literature for some models may not explicitly state which refrigerants may be used without voiding the warranty and may instead generally refer to specific refrigerant characteristics for the warranty to remain valid. If for such a case, HCFC-22 meets the specified characteristics, DOE's proposal would require that the manufacturer certify, within the same basic model, an individual split-system combination or outdoor unit with no match for each refrigerant that meet these warranty criteria or characteristics.
Under the certification requirements proposed in this SNOPR, an outdoor unit for which both R-407C and HCFC-22 are acceptable refrigerants would need to be certified as a split-system combination and as an outdoor unit with no match, with representations for each. Per DOE's regulations established in the June 2016 final rule, outdoor units with no match cannot be certified using an AEDM, and the model of outdoor unit must be tested with an indoor unit meeting specified criteria. 81 FR at 37051 (June 8, 2016). Therefore, for a model of outdoor unit for which both R-407C and HCFC-22 are acceptable refrigerants, the outdoor unit with no match (with HCFC-22) must be tested and certified. In addition, DOE proposes to require that any split-system combination (with R-407C) must also be tested. The proposed certification requirements would represent the energy efficiency of an outdoor unit during a representative average use cycle for each intended sales scenario (
In addition, DOE recognizes that concerns regarding warrantee coverage for a given refrigerant may not be a concern for all installers and consumers. Consequently, DOE is concerned that the lack of explicit indication that a unit is acceptable for use with HCFC-22 may not prevent installation of such units with the refrigerants, if the installers and consumers have reasonable confidence that the unit can operate with this refrigerant. Because of the similarity of HCFC-22 and R-407C and the history of CAC/HP being used interchangeably with both of these refrigerants, this issue could very well arise for any unit certified and warranted for use with R-407C. Hence, DOE proposes that any outdoor unit intended for use in a split system with R-407C,
Nearly all outdoor units of split systems are shipped with a quantity of refrigerant charge that is close to the required charge for installation. This has been confirmed by observation of units tested by DOE. Line sets for connecting indoor units to outdoor units also are sold with an appropriate pre-charge to compensate for the different amount of charge that remains in the lines of different-length line sets. During set-up, the refrigerant charge of the assembled system is adjusted, and the pre-charging of the components limits the amount of refrigerant that is needed to be added or removed in order to match the charging conditions specified in the manufacturer's installation instructions. Because of this general practice to ship outdoor units with close to full charge, DOE considers use of a charge quantity that is much less than the charge specified by the instructions to be equivalent to shipping a unit without refrigerant. Hence, DOE proposes to require a no-match rating for outdoor units that are shipped with a charge amount such that adjustment of charge as specified in manufacturer's instructions requires addition of more than one pound of refrigerant.
As an example illustrating the certification requirement proposals discussed in this section, assume a manufacturer advertises a model of outdoor unit for use with either HCFC-22 or R-407C.
In 10 CFR 430.2 (as amended in the June 2016 final rule), DOE defines “basic model” for OUMs as “all individual combinations having the same model of outdoor unit, which means comparably performing compressor(s) [a variation of no more than five percent in displacement rate (volume per time) as rated by the compressor manufacturer, and no more than five percent in capacity and power input for the same operating conditions as rated by the compressor manufacturer], outdoor coil(s) [no more than five percent variation in face area and total fin surface area; same fin material; same tube material], and outdoor fan(s) [no more than ten percent variation in air flow and no more than twenty percent variation in power input].” According to this definition, the model of outdoor unit intended to be sold with both HCFC-22 and R-407C would represent multiple individual combinations within the same basic model. Therefore, a manufacturer has to determine a represented value for each single-split-system combination (sold for use with R-407C) as well as determine a represented value for the outdoor unit with no match (sold for use with HCFC-22).
Paragraph 10 CFR 429.16(b)(2)(i) (as amended in the June 2016 final rule) details the minimum testing requirements for each basic model, specified by equipment category. In this SNOPR, DOE is proposing to further specify in that same paragraph that when a basic model spans listed categories, as in this example, multiple testing requirements apply. Therefore, the manufacturer would have to test at least one single-split-system combination as well as the model of outdoor unit with a model of coil-only indoor unit meeting the requirements of section 2.2e of Appendix M or M1 to subpart B of part 430 (
In the event that DOE determines a basic model is noncompliant with an applicable energy conservation standard, DOE may issue a notice of noncompliance determination that, among other things, informs the manufacturer of its obligation to cease distribution of the basic model immediately. (10 CFR 429.114(a)) Therefore, if any individual combination (including the outdoor unit with no match) fails to comply with the applicable standard, whether the combination has been tested or rated using an AEDM, the entire basic model must be removed from the market and the model of outdoor unit may not be sold at all.
DOE also notes that although the discussion in this section of the SNOPR is directly related to refrigerants, a basic model may span listed categories in
DOE also proposes to add information to the items required to be provided in certification reports to address outdoor units with no match. The general certification requirements for air conditioners and heat pumps as amended in the June 2016 final rule already apply to outdoor units with no match. These requirements include reporting of SEER, the average off mode power consumption, the cooling capacity, the region(s) in which the basic model can be sold, HSPF (for heat pumps), and EER (for air conditioners), and non-public information including indoor air volume rate for the relevant operating modes (
In the June 2016 final rule, DOE discussed compliance with Federal (base national or regional) standards for CAC/HP. Specifically DOE cited a proposal in the November 2015 SNOPR to amend 10 CFR 430.32 to clarify that the least-efficient combination within each basic model must comply with the regional SEER and EER standards. 80 FR 69277, 69290 (Nov. 9, 2015). However, DOE declined to modify section 430.32 in the June 2016 final rule, instead stating that it would do so in the regional standards enforcement rulemaking. 81 FR 36991, 37012 (June 8, 2016). Instead, DOE adopted language in 10 CFR 429.16 specifying that a basic model may only be certified as compliant with a regional standard if all individual combinations within that basic model meet the regional standard for which that basic model would be certified and that an ICM cannot certify a basic model containing a representative value that is more efficient than any combination certified by an OUM containing the same outdoor unit. 81 FR at 37050.
In response to the June 2016 final rule, Advanced Distributor Products (ADP) and Lennox International submitted separate but essentially identical letters and AHRI submitted a similar letter (Docket No. EERE-2016-BT-TP-0029-0006, -0005, and -0003) stating that this language, while intended to define that ICM ratings cannot provide a means for an outdoor unit to span regions, is inconsistent with the Regional Standards ASRAC Working Group agreement (Docket No. EERE-2011-BT-CE-0077-0070). ADP, Lennox, and AHRI suggested that language proposed in the regional standards enforcement NOPR (80 FR 72389-72390), but not finalized, captured the enforcement working group intent and avoids inadvertent limitations on independent coil manufacturers. Mortex also submitted a letter (Docket No. EERE-2016-BT-TP-0029-0004) commenting on the same language, also stating that it seems inconsistent with agreements made during the Regional Standards ASRAC Working Group. Mortex suggested that the requirement be removed from the test procedure.
DOE did not adopt the language proposed in the regional standards enforcement NOPR in response to comments submitted in that rulemaking. DOE agrees, however, that the language adopted at 429.16 inadvertently constrains ICMs beyond the bounds agreed to in the Regional Standards ASRAC Working Group. Accordingly, DOE proposes to remove the sentence: “An ICM cannot certify a basic model containing a representative value that is more efficient than any combination certified by an OUM containing the same outdoor unit.” and replace it with the following language in 429.16(a)(4)(i): An ICM cannot certify an individual combination with a rating that is compliant with a regional standard if the individual combination includes a model of outdoor unit that the OUM has certified with a rating that is not compliant with a regional standard. Conversely, an ICM cannot certify an individual combination with a rating that is not compliant with a regional standard if the individual combination includes a model of outdoor unit that an OUM has certified with a rating that is compliant with a regional standard.
The current SEER and HSPF equations (4.1-1 and 4.2-1) in the DOE test procedure for a CAC/HP having a two-capacity compressor require different calculations of quantities depending on whether the test unit would operate at low capacity, cycle between low and high capacity, or operate at high capacity in response to the building load (see sections 4.1.3 and 4.2.3). To determine which calculations to use for units that lock out low capacity operation at higher outdoor temperatures, the outdoor temperature at which the unit locks out low capacity operation must be known. Section 4.1.3 of Appendix M indicates that this information must be provided by the manufacturer. Similarly, a two-stage heat pump may lock out low capacity heating operation below a certain lock-out temperature, as indicated in section 4.2.3 of Appendix M. Therefore, DOE proposes to add language to require that the lock-out temperatures for such systems for both cooling and heating modes be provided in the certification report.
In the November 2015 SNOPR, DOE proposed adding a requirement that the represented values of cooling capacity and heating capacity must be the mean of the values measured for the sample. In response, AHRI, Lennox, JCI, Ingersoll Rand, Goodman, UTC/Carrier, Nortek, and Rheem disagreed with the requirement that the represented capacity values must be the mean of the tested values, and recommended that DOE allow manufacturers to rate capacity conservatively. (CAC TP: AHRI, No. 70 at p. 10; Lennox, No. 61 at p. 8, 15; JCI, No. 66 at p. 15-16; Ingersoll Rand, No. 65 at p. 5; Goodman, No. 73 at p. 15; UTC/Carrier, No. 62 at p. 8; Nortek, No. 58 at p. 6; Rheem, No. 69 at p. 8) The commenters provided additional detail as summarized in the
After reviewing the comments, in the June 2016 final rule DOE required the represented value of cooling (or heating) capacity to be a self-declared value that is no less than 95 percent of the mean of the cooling (or heating) capacities measured for the units in the sample selected for testing or of the output simulated by the AEDM. DOE stated that this would allow manufacturers the flexibility to derate capacity with conservative values as requested by multiple commenters, while still providing consumers with information that is reasonably close to the performance they may expect when purchasing a system.
Upon review, DOE has determined that the regulatory text adopted allows for unlimited overrating of capacity but only underrating of 5 percent. Consequently, in this SNOPR, DOE is proposing to revise the regulatory text in three locations (10 CFR 429.16(b)(3), 10 CFR 429.16(d), 10 CFR 429.70(e)(5)(iv)) to allow a one-sided tolerance on cooling and heating capacity that allows underrating of any amount but only overrating up to 5 percent (
In this SNOPR, DOE proposes revisions to appendix M to subpart B of 10 CFR part 430. This section provides a discussion of those proposed changes. DOE proposes to make these changes to Appendix M effective 30 days after publication of a final rule in the
DOE finalized an off-mode test procedure in the June 2016 final rule. 81 FR, 36991, 37022-5 (June 8, 2016). However, DOE recognizes that the current regulations may not account for excessive variation in the test results for units with self-regulating crankcase heaters or for units where the crankcase heater power measurement could be affected by the ambient temperature. These potential variations could be due to the large thermal mass of the compressor and the resulting time required for the compressor temperature to reach equilibrium. Because the power input of a self-regulating heater would depend on the compressor temperature, the test result would depend on the temperature of the unit just prior to the test. If conducted shortly after the B test, which is one of the steady-state wet coil cooling-mode tests conducted in an 82 °F ambient temperature, the compressor would still be quite warm, and the measured power input would be significantly lower than if the test were conducted after the compressor equilibrates with the surrounding space temperature. DOE proposes further revision to the test procedure to resolve this issue. The proposal in this section would not impact the measured off-mode power input beyond potentially reducing variation in the measured result.
In the off-mode test procedure established in the June 2016 final rule, DOE established a test method for units with self-regulating crankcase heaters that called for start of the test in a room conditioned to 82 °F temperature, with the compressor at a temperature no lower than 81 °F. The room temperature is then adjusted at a rate of change of no more than 20 °F per hour to approach 72 °F for conducting a first heater power measurement, and then to approach a manufacturer-specified lower temperature, again at a rate of change no more than 20 °F per hour, before conducting the second power measurement. 81 FR at 37022 (June 8, 2016). A half-hour duration in the initial reduction in room temperature from 82 °F to 72 °F would be compliant with the prescribed 20 °F maximum temperature reduction rate. However, DOE testing shows that the time constant for compressor cooldown, or for approach to equilibrium of the power input a self-regulating crankcase heater attached to a compressor, is much longer than a half-hour. This issue would be exacerbated if the compressor has a sound blanket. Self-regulating crankcase heaters draw less power when they are warmer. Hence, if the temperature cooldown from 82 °F is initiated when the compressor is hot (
To determine the reasonable delay time for units to reach thermal equilibrium, DOE conducted tests using a 5-ton residential condensing unit. DOE connected a self-regulating crankcase heater to the compressor and measured heater power input, compressor shell temperature, and ambient temperature. DOE observed cooldown behavior and the corresponding increase in heater input power in a 60 °F environment both with and without a sound blanket covering the compressor after initially preheating the compressor to 120 °F to simulate warmup associated with refrigeration system operation. DOE used an exponential equation for the power input to the heater as a function of time to fit to the test data. The time constant for approach to equilibrium (time for the difference between the power input and the value it would attain after an infinite amount of time to drop by 63 percent) DOE observed in the tests was approximately 2 hours for tests without the sound blanket (bare shell) and 4 hours for tests with the sound blanket. DOE also observed that the crankcase heater power input generally approached to within 10 percent of its final value after passage of about two time constants (4 hours for bare-shell testing and 8 hours for sound blanket testing).
Based on the testing and analysis described in this preamble, DOE proposes adopting a time delay for testing units with self-regulating crankcase heaters or crankcase heating systems in which the heater control temperature sensor is affected by the heater. DOE proposes a 4-hour time delay for units where the compressors have no sound blanket, and an 8-hour time delay for units where the compressors do have sound blankets. The delay would take place after the room temperature reaches the lower target value and before making each of the power measurements (P
In DOE's current test procedures at Appendix M, refrigerant pressure measurement is required when using the refrigerant enthalpy method as the secondary capacity measurement (see section 2.10.3 of 10 CFR part 430, subpart B, appendix M). Refrigerant pressure measurement is also required for some methods for setting or confirming refrigerant charge (see section 2.2.5 of 10 CFR part 430, subpart B, appendix M), unless otherwise instructed by the manufacturer's installation instructions.
DOE is aware that the pressure measurement devices may be installed at a location where the refrigerant state switches between liquid and vapor under different cooling and heating modes. In this case, the actual refrigerant charge in the unit could be different under different modes due to the transfer of refrigerant to and from the extra internal volumes in the refrigerant pressure lines, connections, and transducers or gauges.
DOE is also aware that the refrigerant charge in pressure measurement systems may affect cyclic testing. In a cooling test, the liquid refrigerant in the liquid refrigerant pressure measurement system is cooler than the refrigerant in the condenser. For a system with a fixed orifice expansion device, allowing the cooler refrigerant from the pressure measurement systems to flow into the evaporator before the fan delay ends could affect the cyclic performance.
These issues have the potential to impact test reproducibility and repeatability, in particular for small capacity mini-split heat pump systems with low system refrigerant charges, depending on the differences in internal volumes of the tubing, connections, and transducers, particularly from one laboratory to the next.
As part of the compressor calibration method, ASHRAE 37-2009 section 7.4.2 provides instructions for making refrigerant pressure measurements. For equipment not sensitive to refrigerant charge, the pressure measurement instruments may be connected via pressure measurement lines to the refrigerant lines without requiring that any preliminary tests be conducted to confirm that displacement of refrigerant into the pressure lines does not affect performance. The test standard sets a threshold for sensitivity to refrigerant charge, indicating that for equipment that is not sensitive to the charge, the refrigerant pressure lines must not affect the total charge by more than 0.5%.
To limit the amount of refrigerant charge that can transfer to and from the pressure measurement system, DOE proposes to require manufacturers to limit the total internal volume of pressure lines and pressure measurement devices connected at locations that can switch states from liquid to vapor for different operating modes or conditions. Based on the ASHRAE 37-2009 precedent, DOE selected a maximum internal volume connected at these locations that would represent at most 0.5 percent of the total system charge for the lowest-charge systems for which DOE collected information. The proposed maximum total internal volume of the pressure lines, connections and gauges would be 0.25 cubic inches per 12,000 Btu/hr certified cooling capacity. DOE selected this maximum volume based on a survey of refrigerant charge in mini-split heat pumps with capacities ranging from 9,000 to 33,000 Btu/hr.
DOE notes that the charge adjustment approach prescribed by ASHRAE 37-2009 for systems that are sensitive to refrigerant charge would not resolve the issue of displacement of refrigerant into the pressure lines because that approach is based on steady-state testing, for which the displaced refrigerant would remain in the lines. The required adjustment would add that same amount of refrigerant so that the charge actively circulating in the refrigerant circuit would be the same as if no pressure lines had been connected. In the present case, where refrigerant would be displaced between heating and cooling mode or between cycles of a cyclic test, simply adding the “missing” charge would not resolve the issue.
The internal volume of pressure measurement lines and connections can be determined using the tubing inner diameter or internal volume values found on pressure gauge or transducer manufacturer specification sheets. However, DOE is aware that the manufacturer specification sheets may not provide the internal volume of pressure gauges or pressure transducers, and they may not be easy to measure. Thus, DOE proposes to use 0.1 cubic inches as the default internal volume for each pressure transducer and 0.2 cubic inches for each pressure gauge, if internal volume is not provided in specification sheets. DOE proposes to include this requirement in section 2.2 of 10 CFR part 430, subpart B, appendix M.
In the current DOE test procedure specified in section 3.2.4 and 3.6.4 of 10 CFR part 430, subpart B, appendix M, the building load is determined as a function of temperature, for both cooling and heating. Units equipped with variable speed compressors are tested at full, intermediate and minimum speeds. In calculating SEER and HSPF for variable speed units, there are three possible scenarios: (a) When the building load requires less than the minimum-speed capacity, the unit cycles at the minimum compressor speed to meet the load; (b) when the load requires more than the maximum-speed capacity, the unit operates constantly at full load; and (c) when the unit operates at an intermediate speed to meet a building load that is between the minimum-speed and maximum-speed capacities. Three outdoor temperatures are calculated for cooling and/or heating units equipped with variable speed compressors to bound the conditions in which scenario c would apply. These three outdoor temperatures are the balance points (temperatures at which the building load and delivered capacity are equal) for operation at the tested minimum, intermediate, and full compressor speeds. For all variable speed units operating in cooling mode and non-multi-split variable speed units operating in heating mode, the unit's EER and COP are calculated using quadratic functions. These quadratic functions are determined based on the EER or COP evaluated for the three calculated outdoor temperatures representing the minimum, intermediate, and full speed balance points.
In a final rule published October 22, 2007, DOE adopted a different approach for multi-split heat pumps. 72 FR 59906 (October 2007 Final Rule). DOE determined in that final rule that the quadratic fit would not be well-suited for multi-split units because the intermediate speed initially defined for variable-speed units is not likely the peak efficiency point for multi-split units. (see 71 FR 41320, 41325 (July 20, 2006)). In addition to allowing multi-split manufacturers some flexibility in selecting intermediate speeds for testing, DOE also adopted in the October 2007 final rule a two-piece linear relationship to represent EER and COP vs. temperature, rather than the quadratic fit used for other variable-speed units. 72 FR 59906 (Oct. 22, 2007).
As discussed in section III.C.3.d, AHRI provided variable speed and two stage heat data (under a Non-Disclosure Agreement to DOE's contractor) to allow evaluation of the impact on the HSPF differential associated with the new heating load line equation. In reviewing AHRI's variable speed heat pump heating test data, DOE's contractor discovered that the quadratic interpolation in some cases provides very poor estimation of COPs in the intermediate-speed operating range—in some cases predicting higher or lower COP values than all of the measured COP results. DOE has found similar issues with prediction of the cooling EER using the quadratic function, although DOE has less cooling mode data to review, and the most egregious errors in EER prediction for cooling mode are not as bad as the observed COP errors. Nevertheless, DOE believes such issues could very well cause significant errors in calculation of SEER for variable-speed units.
In this SNOPR, DOE evaluated two alternative interpolation methods for calculating SEER and HSPF for variable-speed CAC/HP in addition to the current quadratic function approach: (1) The linear interpolation method which currently applies only to multi-split units in heating mode (section 4.2.4.2 of 10 CFR part 430, subpart B, appendix M); and (2) a bin-by-bin interpolation method. The bin-by-bin method uses interpolation of EER or COP for each temperature bin based on the estimates of capacity and power input for the specific bin temperature (EER is equal to cooling capacity divided by power input, while COP is proportional to heating capacity divided by power input). Under the bin-by-bin method, an interpolation factor is first calculated, which represents the compressor operating speed needed to achieve balance between house load and delivered capacity. For example, if, for the specific temperature bin, the heating load is between the minimum-speed capacity and the intermediate-speed capacity, the interpolation factor is equal to the difference between the heating load and the minimum-speed capacity divided by the difference between the intermediate-speed capacity and the minimum-speed capacity. This factor is then applied to the COP values to determine COP when operating at the speed needed to deliver the desired heating load. The desired load is divided by this COP to determine power input. The interpolation is between the minimum speed and the intermediate speed performance values if the load is between the minimum and intermediate-speed capacities, or between the intermediate speed and the full speed performance values, if the load is between the intermediate and full speed capacities.
DOE found that HSPFs calculated with the current quadratic method deviated from HSPFs calculated using the bin-by-bin method up to 7.4 percent and the linear interpolation method deviated up to 2.9 percent from the bin-by-bin method. Calculations conducted for cooling mode SEER showed that SEER for the quadratic method deviated from the SEER calculated for the bin-by-bin method up to 2.5 percent. DOE believes that the bin-by-bin interpolation method is the most accurate of the three approaches (
In DOE's current test procedure in Section 2.10 of appendix M to subpart B of part 430, the outdoor air enthalpy method is an allowable secondary test method for split systems and single-package units. DOE currently requires that the outdoor air-side test apparatus be connected to the outdoor unit and used for measurements for the outdoor air enthalpy method during the “official” test. Additionally, DOE requires a preliminary test be conducted prior to conduct of the official test, in which the unit operates without the outdoor air-side test apparatus connected. After operating without the apparatus, the apparatus is connected, and the apparatus exhaust fan speed is adjusted until performance is verified as consistent with performance prior to attaching the apparatus. Specifically, the unit must operate for 30 minutes without the apparatus connected, followed by at least five consecutive readings with the apparatus connected (with measurements taken at one-minute intervals). The apparatus exhaust fan speed must be adjusted so that the averages for the evaporator and condenser temperatures, or the saturated temperatures corresponding to the measured pressures, agree within ± 0.5 °F between the tests with and without the apparatus connected. Additionally, a preliminary test is only required prior to the first steady-state cooling mode test and the first steady-state heating mode test, as long as the outdoor fan operates during all cooling mode steady-state tests at the same speed and during all heating mode steady-state tests at the same speed. However, the test procedure requires that a preliminary test be conducted prior to each cooling mode test where a different fan speed is used, and a similar requirement applies for heating mode tests.
The outdoor air enthalpy method includes two steps in order to verify the capacity determined from the indoor air enthalpy method during the official test. However, DOE is concerned that the tolerances on achieving the same condensing and evaporating conditions in the tests with and without the airflow measurement apparatus attached inherently introduces variability to the test results that could be eliminated by shifting to an official test with the apparatus not attached. DOE proposes to make such a change for the official test.
In this SNOPR, DOE proposes to require two-step measurements in the
(1) The energy balance specified in section 3.1.1 of appendix M to subpart B of part 430 is achieved for the ducted test (
(2) The capacities determined using the indoor air enthalpy method from the ducted and non-ducted tests cannot deviate more than 2.0 percent.
If the test is valid, the non-ducted test would be used as the official measurement for the specific test condition.
DOE believes that use of the outdoor air enthalpy method for only certain tests sufficiently measures and verifies the capacity determined from the indoor air enthalpy method, and that losing the benefit of two-step verification of the capacity determined during all of the official tests is outweighed by the three following benefits to DOE's proposal:
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In the cyclic dry-coil cooling-mode tests, the current regulatory text requires coil-only units to be tested with a time-delay relay. Section 3.5.1 of the current Appendix M states that the automatic controls that are normally installed with the test unit must govern the OFF/ON cycling of the air moving equipment on the indoor side. (10 CFR 430 Subpart B, App. M, 3.5.1) Under that section, the manufacturer is to control the indoor coil airflow for ducted coil-only units according to the rated ON and/or OFF delays provided by the relay. However, DOE understands that in typical installations, a time-delay relay, if it exists, would be part of the furnace function. DOE reviewed furnace product literature collected during the furnace fan rulemaking (see Docket Number EERE-2010-BT-STD-0011) representing a broad range of furnaces sold by major furnace manufacturers to determine whether they have time-delay relays available for cooling mode when installed with coil-only air conditioners. DOE found that in many furnace series, both old and new, from multiple manufacturers, cooling time delays are common, but they are exclusively used for the compressor off-cycle, and they have varying time-delay durations. Thus, DOE concludes that coil-only units are likely to be installed with time-delay relay control for cooling, but that the duration of the delay varies by furnace. DOE is proposing no change in the use of time delays for testing of coil-only units, but proposes to amend its certification report requirements to require coil-only ratings specify whether a time delay is included, and if so, the duration of the delay used. DOE would use the certified time delay for any testing to verify performance. Section 3.5.1 would indicate that the time delay used for testing of a coil-only system shall be as listed in the certification report.
DOE must establish test procedures that are reasonably designed to measure energy efficiency during a representative average use cycle as determined by DOE. (42 U.S.C. 6293 (b)(3)) DOE is aware that many potential combinations of single-split-system condensing units and indoor coils could be tested even if they are not typically installed as a combination. Ratings of single-split-system coil-only combinations, for which the outdoor unit and indoor unit are not typically installed as a combination, would not be representative of an average use cycle. The CAC/HP ECS Working Group discussed this concept and the potentially undesirable impacts of rating combinations that are not distributed in commerce or installed for consumers. Specifically, the CAC/HP ECS Working Group addressed ratings based on a combination using a blower coil indoor unit consisting of a low-efficiency condensing unit paired with an indoor blower with unusually low input power, a concept the participants referred to as a “golden blower.” Such a combination would result in an inflated rating for a low-efficiency condensing unit that is not representative of its typical installed performance. (CAC ECS: ASRAC Public Meeting, No. 87 at p. 88) The concept of unrepresentative, high performance can apply to other design aspects of indoor units, such as units with an indoor coil size far larger than would be installed for the given system capacity. To help ensure that the test procedure results in ratings that are representative of average use, DOE proposes to include a provision that would prevent testing certain combinations that are not representative of single-split systems with coil-only indoor units that are commonly distributed in commerce.
Specifically, DOE proposes to limit the normalized gross indoor fin surface (NGIFS) for the indoor unit used for single-split-system coil-only tests be no greater than 2.0 square inches per British thermal unit per hour (sq.in./Btu/hr). NGIFS is equal to total fin surface multiplied by the number of fins and divided by system capacity. An NGIFS greater than 2.0 sq.in./Btu/hr indicates that the system combines a low-capacity condensing unit with a high capacity indoor coil,
DOE evaluated the NGIFS for a representative data set of single-split-system coil-only combinations currently offered in the market to set this value. DOE's dataset included close to 100 two, three, and five-ton single-split-system coil-only combinations from multiple manufacturers that represent a majority of market share and span the available range of efficiency. Testing with a NGIFS no greater than 2.0 sq.in/Btu/hr would still reflect approximately 95 percent of the split-system coil-only combinations reviewed by DOE. DOE understands a single-split-system coil-only combination with an NGIFS that exceeds 2.0 sq.in/Btu/hr to be unrepresentative because it is unlikely to be distributed in commerce, which is supported by the review of NGIFS values for numerous rated combinations, as noted previously.
In the November 2015 SNOPR, DOE proposed several changes to the test procedure for variable-speed heat pumps. First, DOE proposed that the maximum compressor speed used for the test be fixed at the absolute maximum speed at which the compressor operates for the given operating mode (heating or cooling). In other words, the maximum compressor speed used in different cooling mode test conditions would be the same, equal to the absolute maximum speed used for cooling at any operating condition. DOE proposed a similar approach for heating, allowing for a different maximum speed than for cooling. 80 FR at 69307 (Nov. 9, 2015).
The June 2016 final rule discussed comments on this proposal, several of which indicated that the compressors of variable speed heat pumps very often operate at higher speeds at colder temperatures, which can enhance measured HSPF. 81 FR at 37029 (June 8, 2016). The comments indicated that for some of these heat pumps, the compressor cannot operate in a 47 °F ambient temperature at the same full speed that it uses in a 17 °F ambient temperature. Although DOE did not in that final rule modify the test procedure to allow different compressor speeds for the full-speed tests conducted at 17 °F, 35 °F, and 47 °F ambient temperatures, DOE did acknowledge that addressing this issue would improve the test method's representation of the improved performance of variable speed heat pumps that use higher speeds at lower temperatures, indicating that consideration would be given to such a test procedure revision in the future.
The possible adoption of a 2 °F test for rating of variable speed heat pumps was proposed in the November 2015 SNOPR. 80 FR 69323 (Nov. 9, 2015) It was also discussed during the CAC/HP ECS Working Group meetings, ultimately leading to Recommendation #5 in the Term Sheet, that a 5 °F ambient temperature optional test be adopted for variable speed heat pumps under the new Appendix M1. (CAC ECS: ASRAC Term Sheet, No. 76 at p. 3) This proposed revision is discussed in greater detail in section III.C.4. Because the Appendix M1 test procedure changes would be required as the basis for efficiency representations on the effective date of any new energy conservation standards (January 1, 2023), the 5 °F test for variable speed heat pumps would not become an option for several years. Based on the stakeholder comments discussed in this preamble, some variable-speed heat pumps may be unable to operate as required by the appendix M procedure as finalized by the June 2016 final rule. In order to resolve this issue sooner than 2021, DOE proposes that the test procedure revisions to address it be adopted in appendix M rather than appendix M1. Hence, DOE proposes the following amendments for appendix M.
• A 47 °F full-speed test used to represent the heating capacity would be required and designated as H1
• The full-speed tests conducted at 17 °F and 35 °F ambient temperatures would still have to use the same speed, which would be the maximum speed at which the system controls would operate the compressor in normal operation in a 17 °F ambient temperature, although the 35 °F full-speed test is and would remain optional.
• It would be optional to conduct a second full-speed test at 47 °F ambient temperature at the same compressor speed as used for the 17 °F test, if this speed is higher than the speed used for the H1
• If no 47 °F full-speed test is conducted at the same speed as used for the 17 °F full-speed test, standardized slope factors for capacity and power input would be used to estimate the performance of the heat pump for the 47 °F full-speed test point for the purpose of calculating HSPF.
• The capacity measured for the H1
Development of these proposals and decisions regarding their details is explained further below.
As discussed in the June 2016 final rule, DOE believes that extrapolations of performance to lower temperatures should be based on tests conducted at the same speed and used to estimate performance where there is a good expectation that the speeds are also the same or at least not very different. Hence, DOE believes that calculation of performance below 17 °F must be based on a same-speed extrapolation (or on an interpolation using measurements for a lower-temperature test, such as for the proposed 5 °F test discussed in section III.C.4). For those heat pumps which cannot operate in the 47 °F ambient temperature at the same compressor speed used for the 17 °F full-speed test, DOE proposes use of average performance trends to represent the 47 °F test point so that a representative same-speed extrapolation can be done.
DOE evaluated the 17 °F-to-47 °F same-speed performance trends of heat pumps based on several sources including the AHRI database, data for two stage and variable speed heat pumps provided to DOE's contractor by AHRI during the CAC/HP ECS meetings, and product data sheets for 51 single-package heat pumps. The ratios for capacity and power input for the 17 °F test condition as compared to the 47 °F test condition are presented in Table III.4. The AHRI database provides capacity information for both 17 °F and 47 °F test conditions, but not power input for both. DOE did not consider variable speed models from the AHRI database in this analysis because of questions about whether the compressor speeds were the same for both test conditions for tests of these units. For the data provided by AHRI during the CAC/HP ECS meetings, DOE evaluated the two stage units and the variable speed units with a capacity ratio within a narrow range, to be sure that the results for these units were based on use of the same speed for both test conditions. Evaluation of the data for single-package units shows that they have a significantly lower capacity ratio, but roughly the same power input ratio, as compared with split systems. Consequently, DOE is proposing in this SNOPR a different standard capacity slope factor for single-package units.
Based on the reviewed data, DOE selected capacity ratios equal to 0.62 for split systems and 0.56 for single-package units in order to calculate capacity slope factors. Also, DOE selected 0.88 as the power input ratio to use for calculating the power input slope factor. DOE proposes adopting slope factors that would be multiplied by the capacity or power input measured for the 17 °F ambient temperature in order to obtain the slope of the evaluated parameter per degree temperature rise. For example:
The CSF is calculated from the selected capacity ratio as follows:
The resulting values for the capacity slope factors are 0.0204/°F for split
DOE proposes use of these slope factors for any variable speed heat pumps for which the 47 °F full-speed test cannot be conducted at the same speed (represented by RPM or power input frequency) used in the 17 °F full-speed test. The slope factors would be used for calculation of representative capacity and power for operation at 47 °F ambient temperature for the purposes of calculating HSPF.
As mentioned in this preamble, DOE proposes that the 17 °F test be conducted using the maximum speed at which the system controls would operate the compressor during normal operation in this ambient temperature. This would help to ensure that the test procedure be representative of field operation, since, for cold temperatures close to 17 °F, the heat pump would be expected to be operating at full speed to satisfy the high heating loads expected for these temperatures. Further, DOE proposes that the 35 °F full-speed test, if conducted, use the same compressor speed as the 17 °F test, so that the impact of frosting and defrost for this test is not masked by an adjustment in compressor speed.
In addition, DOE proposes that the H1
In the June 2016 final rule, DOE maintained its proposal from the November 2015 SNOPR to allow manufacturers the option of specifying a break-in period to be conducted prior to testing under the DOE test procedure. DOE limited the optional break-in period to 20 hours, which is consistent with the test procedure final rule for commercial HVAC equipment (10 CFR 431.96). The duration of the compressor break-in period, if used, must be included in the certification report for CAC/HP (10 CFR 429.16). DOE also adopted the same provisions as the commercial HVAC rule regarding the requirement for manufacturers to record the use of a break-in period and its duration as part of the test data underlying their product certifications, the use for testing conducted by DOE of the same break-in period specified in product certifications, and use of the 20 hour break-in period for DOE testing of products certified using an AEDM. 81 FR at 37033 (Jun. 8, 2016).
Section 3.1.7 of Appendix M, “Test Sequence” indicates that manufacturers have the option to operate the equipment for a break-in period on to exceed 20 hours, and that this break-in period must be recorded in the test data underlying the certified rating if the manufacturer uses a break-in period. DOE has made reporting of the break-in period a certification report requirement. 81 FR at 37053 (June 8, 2016). Hence, the instructions to record the break-in period in the test report is not necessary in section 3.1.7. Also, DOE intends that tests conducted by third-party testing facilities should use the break-in period that is certified and proposes to modify the language to clarify that the certified break-in period is used for the test (whether conducted by a manufacturer or other party). DOE also proposes to clarify that each compressor should undergo the break-in according to the certified number of hours, for units with multiple compressors. Finally, DOE proposes to clarify that the break-in period should be conducted prior to the first 30 minutes test data collection period as required by the test methods in section 3 of Appendix M.
In addition to the adopted portions of the AHRI Standard 1230-2010, DOE proposed additional provisions in the November 2015 SNOPR for testing of VRF Multi-Split Systems. This included a provision adopted as part of section 2.2.3.a of Appendix M in the June 2016 final rule requiring that for part load tests, the sum of the nominal heating or cooling capacities of the operational indoor units be within 5 percent of the intended system part load heating or cooling capacity. 81 FR at 37066 (June 8, 2016). DOE recognizes the intended system part load heating or cooling capacity is not clearly defined in the test procedure and that the sum of nominal capacities of the indoor units may very well be higher than the system part load capacity during the test (since the indoor units would be expected to be operating at part load, less than their nominal capacity, during a part load test). Therefore, DOE proposes to remove this 5 percent tolerance requirement.
The June 2016 final rule provided instructions in 2.2.c of Appendix M for uncased coils, including instructions
The November 2015 SNOPR proposed to establish a new Appendix M1 to Subpart B of 10 CFR part 430, which would be required to demonstrate compliance with any new energy conservation standards. 80 FR 69278, 69397 (Nov. 9, 2015) In this SNOPR, DOE also proposes to establish a new Appendix M1. The appendix would include all of the test procedure provisions in Appendix M as finalized in the June 2016 final rule, all of the proposed changes to Appendix M that are discussed in section III.B, and all of the additional proposals discussed in this section III.C, which would be included only in the new Appendix M1. DOE proposes to make Appendix M1 mandatory for representations of efficiency starting on the compliance date of any amended energy conservation standards for CAC/HP (however, note that phase-in of testing requirements for certain proposed new requirements for split systems would be as discussed in section III.A.1).
Most of the CAC/HP in the United States use ductwork to distribute air in a residence, using either a fan inside the indoor unit or housed in a separate component, such as a furnace, to move the air. External static pressure (ESP) for a CAC/HP is the static pressure rise between the inlet and outlet of the indoor unit that is needed to overcome frictional losses in the ductwork. The external static pressure imposed by the ductwork affects the power consumed by the indoor fan, and therefore also affects the SEER and/or HSPF of a CAC/HP.
The current DOE test procedure
DOE did not propose revisions to minimum external static pressure requirements for conventional blower coil systems in the June 2010 test procedure NOPR, stating that new values and a consensus standard were not readily available.
ACCA. 1995. Manual D: Duct Systems. Washington, DC, Air Conditioning Contractors of America.
Parker, D.S., J.R. Sherwin, et al. 1997. “Impact of evaporator coil airflow in air conditioning systems” ASHRAE Transactions 103(2): 395-405.
In response to the November 2015 SNOPR, Lennox supported DOE's proposal to increase the minimum test static pressure to more accurately reflect field installation conditions. Lennox recommended that this level be set to 0.50 in. wc. for all capacities, commenting that the single set point simplifies the test procedure, is consistent with levels found in field studies, and avoids compliance issues related to minimum static pressure settings based upon capacity. (CAC TP:
Many interested parties supported the proposal to increase the external static pressure requirement. NEEA and NPCC commented that the minor adjustments on either side of 0.50 in. wc. on the basis of system capacity would be a needless complication of the test procedure because NEEA and NPPC's field data does not suggest any correlation between the external static pressure a system faces and the system capacity. (CAC TP: NEEA and NPCC, No. 64 at p. 8) The California IOUs recommended that all capacities use 0.50 in. wc. to simplify testing. (CAC TP: California IOUs, No. 67 at p. 2) ACEEE, NRDC, and ASAP fully supported adopting 0.50 in. wc. for all units (in blower coil configuration), as 0.5 in. wc. would be closer to the levels found in thousands of residential duct systems tested. (CAC TP: ACEEE, NRDC, ASAP, No. 72 at p. 4)
Lennox and Rheem commented that DOE's assumption that a CAC system would be poorly maintained, such as containing fouled coils and filters, should not be built into the test procedure. (CAC TP: Lennox, No. 61 at p. 19; Rheem, No. 69 at p. 16) Lennox further commented that any accommodation for poor field conditions should be administered equitably across all product types. (CAC TP: Lennox, No. 61 at p. 19) Rheem also commented that although dirty filters and fouled coils can increase system static, Rheem considers undersized duct work as the leading cause of high pressure drop measured in field applications. (CAC TP: Rheem, No. 69 at p. 16) Rheem believed that requiring higher minimum external static pressure would reduce published ratings, which could confuse installers and consumers. Rheem commented that a new energy metric should be introduced that would distinguish ratings based on appendix M from ratings based on appendix M1. The California IOUs commented that, as shown in the ACCA Manual D,
After discussions that included the concerns from the comments summarized previously in this section, the CAC/HP ECS Working Group members weighed in on appropriate minimum external static pressure requirements. (CAC ECS: CAC/HP ECS Working Group meeting, No. 86 at pp. 31-128) Recommendation #2 of the CAC/HP ECS Working Group Term Sheet states that the minimum required external static pressure for CAC/HP blower coil systems other than mobile home systems, ceiling-mount and wall-mount systems, low and mid-static multi-split systems, space constrained systems, and small-duct, high-velocity systems should be 0.50 in. wc. for all capacities. (CAC ECS: ASRAC Term Sheet, No. 76 at p. 2) In comments in response to the November 2015 SNOPR, Unico supported the values discussed during the ASRAC meetings. (CAC TP: Unico, No. 63 at p. 12) JCI and Carrier commented that this topic has already been resolved through the ASRAC meetings.
Based on DOE's analysis and consistent with the CAC/HP ECS Working Group Term Sheet, DOE proposes to adopt, for inclusion into 10 CFR part 430, subpart B, appendix M1, for systems other than mobile home, ceiling-mount and wall-mount systems, low and mid-static multi-split systems, space-constrained systems, and small-duct, high-velocity systems, a minimum external static pressure requirement of 0.50 in. wc. DOE is aware that such changes will impact the certification ratings for SEER, HSPF, and EER and is addressing such impact in the current energy conservation standards rulemaking.
In response to the November 2015 SNOPR and during the CAC/HP ECS Working Group negotiations, DOE also received comment regarding the minimum external static pressure requirements for mobile home systems, ceiling-mount and wall-mount systems, low and mid-static multi-split systems, space-constrained systems, and small-duct, high-velocity systems. In its comments, First Co. proposed to reduce the minimum static pressure for space-constrained and multi-family blower coils to 0.25 in. wc. or lower. (CAC TP: First Co., No. 56 at p. 2) The CAC/HP ECS Working Group included in its Final Term Sheet Recommendation #2, which is summarized in Table III.4 below. (CAC ECS: ASRAC Term Sheet, No. 76 at p. 2)
Recommendation #1 of the CAC/HP ECS Working Group included suggested definitions for distinguishing the CAC/HP varieties included in Recommendation #2 (Table III.4) to enable the proper administration of the CAC/HP ECS Working Group's recommended minimum external static pressure requirements. Recommendation #1 stated:
• Suggested definitions capture the intent of the Working Group and DOE should adopt them as is or modify them in a manner that captures the same intent.
• For those definitions that contain a maximum external static pressure requirement, the unit's maximum external static pressure would be determined using a dry coil test without electric heat installed and without an air filter installed at the unit's certified airflow, or, if the airflow is not certified, at an airflow of 400 cfm per ton of certified capacity.
• For those condensing units distributed in commerce with different indoor unit combinations, each specific combination would need to meet the applicable definition in order to be rated with the associated static.
The CAC/HP ECS Working Group's recommended definitions are as follows:
• A ceiling-mount blower coil system is a split-system central air conditioner or heat pump that contains a condensing unit and an indoor unit intended to be exclusively installed by being secured to the ceiling of the conditioned space, with return air directly to the bottom of the unit (without ductwork), having an installed height no more than 12 inches (not including condensate drain lines) and depth (in the direction of airflow) of no more than 30 inches, with supply air discharged horizontally. The certified cooling capacity must be less than or equal to 36,000 Btu/h.
• A wall-mount blower coil system is a split-system central air conditioner or heat pump that contains a condensing unit and an indoor unit intended to be exclusively installed by having the back side of the unit secured to the wall within the conditioned space, with capability of front air return (without ductwork) and not capable of horizontal airflow, having a height no more than 45 inches, a depth of no more than 22 inches (including tubing connections), and a width no more than 24 inches. The certified cooling capacity must be less than or equal to 36,000 Btu/h.
• Manufactured housing air conditioner coil system is a split-system air conditioner or heat pump that contains a condensing unit with an indoor unit that: (1) Is distributed in commerce for installation only in a manufactured home with the home and equipment complying with HUD Manufactured Home Construction Safety Standard 24 CFR part 3280; (2) has an external static pressure that must not exceed 0.4 inches of water; and (3) has an indoor unit that must bear a label in at least
• Low-static system means a ducted multi-split or multi-head mini-split system where all indoor sections produce greater than 0.01 and a maximum of 0.35 inches of water of external static pressure when operated at the full-load air volume rate not exceeding 400 cfm per rated ton of cooling.
• Mid-static system means a ducted multi-split or multi-head mini-split system where all indoor sections produce greater than 0.20 and a maximum of 0.65 inches of water of external static pressure when operated at the full-load air volume rate not exceeding 400 cfm per rated ton of cooling.
UTC/Carrier supported the low and medium static definitions as presented during the CAC/HP ECS Working Group meetings, in place of the short-duct unit definition DOE proposed in the November 2015 SNOPR. (CAC TP: UTC/Carrier, No. 62 at p. 3-4,19) AHRI and Mitsubishi recommended in their comments nearly identical definitions to those recommended in the CAC/HP ECS Working Group term sheet. (CAC TP: AHRI, No. 70 at p. 17; Mitsubishi, No. 68 at p. 2-3) Goodman generally supported the comments made by industry during the initial meetings of the CAC/HP ECS Working Group, in which additional sub‐categories of “short-ducted” systems were proposed. Goodman recommended that DOE only include CAC/HP ECS Working Group's definitions and modifications to the test procedure in the “M1” test procedure and not part of “M” test procedure because the proposed modification to the test procedure would increase the measured energy consumption for those “short-ducted” systems being marketed under the current “M” test procedure. (CAC TP: Goodman, No. 73 at p. 6-7)
DOE agrees with the intent of Recommendation #1 and #2 of the CAC/HP ECS Working Group Term Sheet. DOE recognizes that the CAC/HP varieties included in these recommendations have unique installation characteristics that result in different field external static pressure conditions, and in turn, indoor fan power consumption in the field. While conventional split systems are typically installed in attics or basements and require long ductwork to deliver conditioned air to the conditioned space, ceiling-mount systems, wall-mount systems, space-constrained systems, low-static systems and mid-static systems are installed in or in closer proximity to the spaces they condition, typically requiring shorter ductwork than conventional split systems. The field external static pressure for these non-conventional systems is lower than the external static pressure for conventional split systems as a result. In this SNOPR, DOE proposes to adopt the CAC/HP ECS Working Group recommended minimum external static pressure requirements for space-constrained systems, low-static systems, and mid-static systems to be more reflective of field conditions for these reasons, with one modification. DOE understands that when some space-constrained outdoor units are paired with conventional indoor units, the minimum external static pressure requirement for space constrained systems recommended by the CAC/HP ECS Working Group, 0.30 in. wc., would not be appropriate for these installations. Therefore, DOE also proposes to limit the CAC/HP ECS Working Group recommended minimum external static pressure requirement for space-constrained systems only to space-constrained indoor units and single-package space-constrained units.
The CAC/HP ECS Working Group tasked DOE with the determination of the appropriate minimum external static pressure for ceiling-mount and wall-mount systems. During the CAC/HP ECS Working Group meetings, manufacturers of these systems suggested a minimum external static pressure requirement of 0.30 in. wc. (CAC ECS: CAC/HP ECS Working Group meeting, No. 88 at p. 31) However, the CAC/HP ECS Working Group did not adopt this as a recommendation primarily due to lack of time to thoroughly review the subject. DOE proposes to specify a minimum external static pressure requirement of 0.30 in. wc. for ceiling-mount and wall-mount systems, consistent with manufacturers' recommendations.
Mobile home
In this SNOPR, DOE proposes to adopt the CAC/HP ECS Working Group recommendations for minimum external static pressure requirements for low-static and mid-static systems. By the definitions recommended by the Working Group, these systems are not capable of producing external static pressure significantly higher than the recommended minimum external static
The CAC/HP ECS Working Group did not recommend a change to the current minimum external static pressure required (1.15 in. wc.) for SDHV systems with a cooling or heating capacity between 29,000 to 42,500Btu/h. However, the CAC/HP ECS Working Group recommended that 1.15 in. wc. also be used as the minimum external static pressure requirement for SDHV systems of all other capacities. Using a single minimum external static pressure value for all capacities of a given CAC/HP variety is consistent with the approach recommended by the Working Group for all CAC/HP varieties. DOE proposes to adopt the Working Group recommendation for the minimum external static pressure requirement for SDHV systems.
Table III.5 summarizes DOE's proposed minimum external static pressure requirements.
DOE also agrees with the intent of the definitions recommended by the CAC/HP ECS Working Group. DOE proposes to adopt those definitions with minor modifications to make them consistent with other proposed regulatory language. For example, DOE is proposing to replace the term “condensing unit” in the CAC/HP ECS Working Group recommended definition for mobile home systems with the term “outdoor unit” to ensure that the definition applies to both mobile home air conditioners and heat pumps. DOE proposes to adopt the following definitions for the CAC/HP varieties included in Recommendations #1 and #2 in the CAC/HP ECS Working Group Term Sheet:
•
•
•
•
•
DOE proposes to establish the certification requirements for Appendix M1 to require manufacturers to certify the kind(s) of CAC/HP associated with the minimum external static pressure used in testing or rating (
In the November 2015 SNOPR, DOE requested comment on its proposal to implement a 0.10 in. wc. reduction in the minimum external static pressure requirement for air conditioning units tested in blower coil (or single-package) configuration in which a condensing furnace is in the airflow path during the test. This issue was also discussed as part of the CAC/HP ECS Working Group negotiation process. ADP, Lennox, NEEA, NPCC, California IOUs, Rheem, ACEEE, NRDC, and ASAP did not support the proposal because it would make the ratings for units paired with condensing furnaces less reflective of field energy use. (CAC TP: ADP, No. 59 at p. 12; Lennox, No. 61 at p. 20; NEEA and NPCC, No. 64 at p. 8; California IOUs, No. 67 at p. 6; Rheem, No. 69 at p. 17; ACEEE, NRDC, ASAP, No. 72 at
In light of public comments and the consensus of the CAC/HP ECS Working Group, DOE is not proposing to adopt a reduced minimum external static pressure requirement for air conditioning units tested in blower coil (or single-package) configuration in which a condensing furnace is in the airflow path during the test.
The default fan power value (hereafter referred to as “the default value”) is used to represent fan power input when testing coil-only air conditioners, which do not include their own fans.
DOE calculated the adjusted default fan power to be 441 W/1000 scfm. In the November 2015 SNOPR, DOE proposed to use this value in Appendix M1 of 10 CFR part 430 subpart B where Appendix M included a default fan power of 365 W/1000 scfm. DOE proposed not to make such replacements in Appendix M of 10 CFR part 430 subpart B.
In response to the November 2015 SNOPR, NEEA, NPCC, ACEEE, NRDC, ASAP, and the California IOUs supported raising the coil-only test default fan power to 441 W/1000 scfm to allow for more representative ratings of units. (CAC TP: NEEA and NPCC, No. 64 at p. 8; ACEEE, NRDC, ASAP, No. 72 at p. 4; California IOUs, No. 67 at p. 2) ACEEE, NRDC, and ASAP also commented that they would be happy with 440 W/1000 scfm, as the implied precision of using 441W/1000 scfm is artificial. (CAC TP: ACEEE, NRDC, ASAP, No. 72 at p. 4)
The CAC/HP ECS Working Group also discussed the default value as part of the negotiation process. Ultimately, the Working Group came to a consensus on a recommendation for the default value. Recommendation #3 of the CAC/HP ECS Working Group Term Sheet states that the default fan power for rating the performance of all coil-only systems other than manufactured housing products shall be 441W/1000 scfm. (CAC ECS: ASRAC Working Group Term Sheet, No. 76 at p. 3)
Consistent with the CAC/HP ECS Working Group Term Sheet, DOE maintains its previous proposal to use a default value of 441 W/1000 scfm for split-system air conditioner, coil-only tests. DOE proposes to use this value in appendix M1 of 10 CFR part 430 subpart B in place of the default fan power of 365 W/1000 scfm that has been used previously in Appendix M.
Recommendation #3 of the CAC/HP ECS Working Group Term Sheet also stated that DOE should calculate an alternative default fan power for rating mobile home air conditioner coil-only units based on the minimum external static pressure requirement for blower coil mobile home units (0.30 in. wc.) that it suggested in recommendation #2 of the Term Sheet. (CAC TP: ASRAC Working Group Term Sheet, No. 76 at p. 3) As discussed in section III.C.1, the CAC/HP ECS Working Group included this recommendation because HUD requires less restrictive ductwork for mobile homes than for other types of housing, which reduces electrical energy consumption of the indoor fan. The default value used to rate coil-only mobile home systems should reflect this difference in field energy consumption to improve the field representativeness of the test procedure.
DOE agrees with the CAC/HP ECS Working Group's recommendation to use a different default value for coil-only mobile home systems to reflect the difference in ductwork and, in turn, external static pressure of field installations of these systems. In this SNOPR, DOE used the same aforementioned furnace fan power consumption data and methodology to calculate the appropriate default value for mobile home fan power consumption. However, in this case, DOE evaluated furnace fan power consumption at 0.54 in. wc., which is the 0.30 in. wc. recommended by the CAC/HP ECS Working Group plus 0.24 in. wc. to account for filter and indoor coil pressure drop. The resulting average indoor fan power consumption at the external static pressure representative of mobile home systems is 8% lower than the average indoor fan power consumption at the external static pressure representative of conventional systems. Applying the 8% reduction to the 441W/1000 scfm representing conventional indoor fan power consumption yields 406 W/1000 scfm. Thus, DOE proposes to use 406 W/1000 scfm as the default value for mobile home systems.
DOE notes that it used data from all of the furnaces in its database to calculate this value, instead of only mobile home furnaces, because its database includes a small number of mobile home furnaces that do not represent all capacities or motor technologies. DOE recognizes that including non-mobile home furnaces in this analysis may bias the result. Due to the space constraints typical of mobile home system installations, mobile home indoor units generally have more restrictive cabinets compared to conventional indoor units, which would be expected to increase the static pressure experienced by the indoor fan
The DOE test procedure needs a definition for a mobile home coil-only unit to appropriately apply the proposed default value for these kinds of CAC/HP. DOE proposes to define mobile home coil-only unit as:
•
In the current test procedure, the HSPF determined for heat pumps in heating mode is calculated by evaluating the energy usage of both the heat pump unit (reverse refrigeration cycle) and the resistive heat component when matching the house heating load for the range of outdoor temperatures representing the heating season. The temperature range is split into 5-degree “bins”, and an average temperature and total number of hours are assigned to each bin, based on weather data used to represent the heating season for each climate region. An HSPF value can be calculated for each climate region, but the HSPF rating is based on Region IV. In the HSPF calculation, the amount of heating delivered is set equal to the heating load, which increases as the bin temperature decreases. In the current test procedure, the heating load is proportional to the difference between 65 °F and the outdoor (bin) temperature. The heating load also is dependent on the size of the house that the unit heats. For the HSPF calculation the size of the house is set based on the capacity of the heat pump. For the current test procedure, the heating load is proportional to the heating capacity of the heat pump when operating at 47 °F outdoor temperature. The resulting relationship between heating load and outdoor temperature is called the heating load line equation—it slopes downward from low temperatures, dropping to zero at 65 °F. The slope of the heating load line equation affects HSPF both by dictating the heat pump capacity level used by two stage or variable speed heat pumps at a given outdoor temperature, and also by changing the amount of auxiliary electric resistance heat required when the unit's heat pumping capacity is lower than the heating load. The current test procedure defines two heating load levels, called the minimum heating load line and maximum heating load line. However, it is the minimum heating load line in Region IV that is used to determine HSPF for rating purposes.
Studies have indicated that the current HSPF test and calculation procedure overestimates ratings because the current minimum heating load line equation is too low compared to real world situations.
Francisco, Paul W., Larry Palmiter, and David Baylon, 2004. “Understanding Heating Seasonal Performance Factors for Heat Pumps”, 2004 Proceedings of the ACEEE Summer Study on Energy Efficiency in Buildings.
Fairey, Philip, Danny S. Parker, Bruce Wilcox, and Matthew Lombardi, 2004. “Climatic Impacts on Seasonal Heating Performance Factor (HSPF) and Seasonal Energy Efficiency Ratio (SEER) for Air-Source Heat Pumps”, ASHRAE Transactions, Volume 110, Part 2.
DOE agreed with the NEEA and NPCC regarding balance point in the November 2015 SNOPR and noted that the heating balance point determined for a typical heat pump using the current minimum heating load line equation in Region IV is near 17 °F, while the typical balance point is in the range 26 to 32 °F, resulting from installing a proper-sized unit based on the design cooling load according to ACCA Manual S, 2014.
As part of its review for the November 2015 SNOPR, DOE considered a 2015
In the November 2015 SNOPR, DOE proposed a new heating load line equation based on the findings of the ORNL study:
The proposed equation included the following changes from the current heating load line equation used for the HSPF calculation:
• A zero-load temperature that varies by climate region, as shown in Table III.6, and is 55 °F for Region IV;
• The building load is proportional to the nominal cooling capacity at 95 °F,
• The slope (adjustment) factor, C, is 1.3 rather than 0.77;
The November 2015 SNOPR also proposed revised heating load hours for each climate region, as shown in Table III.6. These hours are less than the current heating load hours by the number of hours in the temperature bins between the current and proposed zero-load temperatures.
The ORNL study developed heating load line equations consistent with the similar equations of the current test procedure, using the EnergyPlus heating and cooling loads calculated for the IECC 2006 building models developed for numerous cities of the climate regions of interest. The approach sized the house based on the heat pump cooling capacity rather than heating capacity, consistent with the sizing approach prescribed for heat pumps in ACCA Manual S, which is also based on cooling capacity. The study used the heat pump size recommendations based on the design cooling load calculated by EnergyPlus in its analysis. The design cooling load was determined for the 0.4% cooling design day dry-bulb temperature based on a 24-hour design day calculation using the heat balance method, which includes the effects of house thermal mass on the peak load. For Climate Region IV, used as the basis for the HSPF calculation, the study concluded that the appropriate slope factor (C in the equation defined above) is 1.3.
In the November 2015 SNOPR, DOE also proposed to eliminate maximum and minimum heating load line equations in an effort to focus on one load level that would best represent heating. As mentioned, the proposed heating load line equation is based on nominal cooling capacity rather than nominal heating capacity, which is intended to better reflect field installation practices than the basis on heating capacity of the current test procedure. This approach also justifiably benefits units with higher heating to cooling capacity ratios. Such units would have improved HSPF ratings, reflecting the shift of more heat from electric resistance to heat pumping. For the special case of heating-only heat pumps, DOE proposed to maintain a sizing approach based on heating capacity.
The ORNL study also evaluated the impact of the proposal on HSPF ratings. Based on the results, DOE estimated that HSPF would be reduced on average about 16 percent for single speed and two-stage heat pumps. Consistent with the requirements of 42 U.S.C. 6293(e), DOE will account for these changes in any proposed energy conservation standard, and this test procedure proposal would not be required as the basis for efficiency representations until the compliance date of any new energy conservation standard.
Comments expressed by stakeholders on the proposed heating load line equation, both in written form in response to the November 2015 SNOPR and verbally during the CAC/HP ECS Working Group meetings, are summarized in the following paragraphs, organized by common themes.
One common theme raised in the comments concerned the field representativeness of the data used to generate the proposed heating load line equation. Unico expressed concern regarding the data collected, requesting more time dedicated to research, particularly on the northward shift of heat pump use despite the majority still being sold in temperate climates. (CAC TP: Unico, No. 63 at p. 13) Lennox expressed concern that the building stock used to evaluate the change was outdated; the current load line should be aligned with the time period of the standard. (CAC TP: Lennox, No. 61 at p. 20) During the ASRAC meetings, Ingersoll-Rand expressed the same concern, adding that the housing stock would continue to improve over time, driving the slope down. (CAC ECS: ASRAC Public Meeting, No. 87 at p. 7) Ingersoll-Rand also expressed reservations that the ORNL report relied on data generated through simulations. (CAC ECS: ASRAC Public Meeting, No. 85 at p. 134).
Southern Company commented that basing the heating load line equation exclusively on the 2006 IECC standard unrealistically assumes flawless adoption and enforcement of building code standards and that even future housing stock would be much less tight (
DOE understands the importance of developing the heating load line equation with data that accurately represents field conditions and operation. Regarding the relevancy of the 2006 IECC code, DOE maintains that it is an appropriate representation of the housing stock in 2021 for the purposes of developing the heating load line equation. A follow-up investigation by Lawrence Berkeley National Laboratory (LBNL) examining RECS data corroborated this claim, showing that vintage housing characteristics in 2021 would at best resemble new housing characteristics in 2005. (CAC ECS: ASRAC Public Meeting, No. 85 at p. 81) DOE also maintains that EnergyPlus simulation results provide the most accurate available picture of heating load requirements and their dependence on independent parameters, (
Another common theme expressed in the comments concerned the impact of the proposed heating load line equation on model differentiation. Mitsubishi suggested that the proposed changes would decrease performance differentiation between single stage, two stage, and variable speed systems and recommended DOE refrain from making any HSPF changes. (CAC TP: Mitsubishi, No. 68 at p. 5) Rheem, JCI, and Carrier/UTC concurred. (CAC TP: Rheem, No. 69 at p. 17; JCI, No. 66 at p. 13; Carrier/UTC, No. 62 at p. 21) ACEEE added that, in the short-term, accurately capturing relative performance of products should take precedence over better reflecting field energy use if the two are mutually exclusive. (CAC TP: ACEEE, No. 72 at p. 5) During the 2015-2016 CAC/HP ECS Working Group meetings, AHRI expressed concern over the lack of differentiation for variable speed products resulting from the proposed heating load line equation. (CAC ECS: ASRAC Public Meeting, No. 88 at p. 83) AHRI suggested a load line having a lower slope factor (equal to 1.02) and presented an initial assessment of the impact of both the DOE and AHRI proposals on product differentiation. Additionally, Southern Company stressed the importance of encouraging variable speed operation. (CAC ECS: ASRAC Public Meeting, No. 88 at p. 87).
To allow more detailed examination of this question, AHRI provided test data to DOE's contractor under a non-disclosure agreement. The data included performance measurements required to calculate HSPF using the current and the proposed test procedures, for a number of two stage and variable speed heat pumps. The calculations showed that the proposed heating load line equation (1.3 slope factor and 55 °F zero-load temperature, with sizing based on the nominal cooling capacity) would reduce the average HSPF difference between two stage and variable speed models as compared to the current heating load line equation (0.77 slope factor and 65 °F zero-load temperature, with sizing based on the nominal heating capacity) from 1 HSPF point currently to roughly 0.35. DOE presented the methodology, findings, conclusions, and implications of the analysis during the CAC/HP ECS Working Group meetings. (CAC ECS: ASRAC Public Meeting, No. 63 at pp.1-7).
DOE acknowledges the impact on differentiation of variable speed heat pumps when calculating HSPF with a higher-slope factor heating load line equation. However, EPCA requires test procedures to be representative of the covered product's average use cycle—not that the test procedure should favor particular design options. (42 U.S.C. 6292(b)(3)) DOE evaluated the proposed amendment with a focus on accurately capturing field performance and believes that the performance of models that clearly perform better in the field will be captured and reflected in higher ratings when tested using a field-representative efficiency metric. Nevertheless, DOE agrees that all variable speed CAC/HP designs should be considered carefully in the analysis to assure that the resulting test procedure fairly represents their performance. As described below, ORNL has made some revisions in its analysis that DOE has incorporated into a revised proposal that improves the differentiation of variable speed heat pumps.
Comments on the overall impact of the proposed heating load line equation on current HSPF ratings were also received. Carrier/UTC reported a dramatic impact on all types of equipment, with reductions in HSPF ranging from 15 to 25 percent as a result of the proposed change in the November 2015 SNOPR. (CAC TP: Carrier/UTC, No. 62 at p. 21). Rheem commented that the proposal would reduce the HSPF of heat pumps designed for southern market installations but did not clarify why southern market heat pumps would be more affected. (CAC TP: Rheem, No. 69 at p. 17).
DOE notes that, as indicated in the ORNL report, field studies have shown that HSPF ratings based on the current test procedure may be higher than actual performance. Hence, a reduction in the rating with the revised test procedure would be consistent with observations of actual heat pump field performance.
Other comments addressed DOE's proposal in the November 2015 SNOPR to base the heating load line equation on cooling capacity rather than heating capacity. NEEA and NPCC recommended that each heat pump be assigned one of several heating load line equations based on heating capacity and
DOE understands that the balance point temperature for heat pumps operating in the field is closer to 30 °F than the 17 °F calculated for the current heating load line equation. For the heating load line equation proposed in the November 2015 SNOPR, the average balance point temperature is between 27 and 28 °F. However, DOE does not agree with NEEA and NPCC that heat pumps are typically sized in the field based on heating capacity or the balance point temperature. The sizing instructions outlined in ACCA Manual S specifically state that “heat pump equipment shall not be sized for the design day heating load, or for an arbitrary thermal balance point.” DOE further understands that most heat pump units in the field are sized based on cooling capacity as opposed to heat pump capacity, which is consistent with the Manual S provision that “heat pumps shall be sized for cooling.”
Other comments concerned the regulatory approach regarding the heating load line equation. Carrier/UTC encouraged DOE to go beyond adjusting the heating load line equation, suggesting that the current HSPF procedure does not adequately account for the benefits of variable speed designs and that DOE should fund research into a completely new procedure rather than applying corrections to the existing procedure by changing the slope (CAC TP: Carrier/UTC, No. 62 at p. 21). Unico suggested tabling the change until the next [CAC test procedure] rulemaking when and if there would be support for changing it (CAC TP: Unico, No. 63 at p. 13). JCI added that changing the temperature at which the heating cyclic test is performed would be acceptable for Appendix M1 but not for Appendix M. (CAC TP: JCI, No. 66 at p. 21).
ACEEE, NRDC, and ASAP proposed that AHRI, ASHRAE, DOE, and all other stakeholders begin work now on a new “clean-sheet” rating method for heat pumps, to be effective in the next rule after this current rulemaking, as was recently done for water heaters. ACEEE, NRDC, and ASAP stated that the current heat pump test method is obsolete. It was developed when essentially all air-source heat pumps were single-stage, and it appears that the present method is not technology-neutral. According to ACEEE, NRDC, and ASAP, the current test method should be revised to avoid penalizing advanced technologies with the potential for higher efficiency, lower heating bills, and reduced impact on winter grid peaks. ACEEE, NRDC, and ASAP recommended that the test procedure for variable speed heat pumps be revised in a future rulemaking to better reflect both the relative performance and field energy use of this equipment. (CAC TP: ACEEE, NRDC, and ASAP, No. 72 at p. 5-6).
CAC/HP ECS Working Group members ultimately did not agree on a resolution on the current heating load line equation regulatory approach and agreed (as reflected in the Final Term Sheet Recommendation #4) that DOE should make a final decision based on a review of available information. (CAC ECS: ASRAC Term Sheet, No. 76 at p. 3).
DOE acknowledges that another test method could be developed rather than the current heating load line equation approach, but DOE does not wish to propose a sweeping overhaul with this notice. DOE has taken the steps agreed to in the ASRAC Final Term Sheet: To evaluate past comments, improve the current analysis, and recommend an improved heating load line equation based on a modest departure from the existing approach. These steps taken leading up to the proposal in this notice do not preclude DOE from evaluating more fundamental changes in future rulemakings. DOE will continue to evaluate test methodologies and will work with AHRI and other interested parties to evaluate other approaches for testing heat pumps, determining the suitability of a more fundamental change in a future rulemaking.
In response to JCI's comment regarding changes to the cyclic test, DOE proposed in the November 2015 SNOPR to change the cyclic test temperature for variable speed heat pumps only in Appendix M1 of 10 CFR part 430 subpart B, and not to Appendix M of the same Part and Subpart—DOE has not changed this aspect of the proposal in this notice.
DOE also received specific recommendations on the heating load line equation slope factor and zero-load temperature. In its comments, Lennox opposed the heating load line equation slope factor change from 0.77 to 1.3 and recommended 1.02, citing better field representativeness and wider product differentiation. (CAC TP: Lennox, No. 61 at p. 12) During the ASRAC meetings, AHRI concurred, indicating that (a) differentiation of variable speed products from two stage or single stage products is better with the 1.02 slope factor, and (b) the 2012 IECC building requirements (for which the ORNL study showed a 1.02 slope) would better represent building stock in 2021 than the 2006 IECC requirements. (CAC ECS: ASRAC Public Meeting, No. 88 at p. 83).
Regarding the heating load line equation zero-load temperature, the California IOUs deferred to the CAC/HP ECS Working Group consensus, generally accepting the 55 °F zero-load temperature proposed in the November 2015 SNOPR. (CAC TP: CA IOUs, No. 67 at p.7) JCI suggested retaining the 65 °F intercept and 0.7 slope factor of the current test procedure. JCI argued for the 65 °F intercept, referring to evidence shared during the ASRAC meetings by Ingersoll-Rand, which JCI indicated shows that heat pump operation does occur at these mild conditions. JCI cited the negative impact on variable speed product differentiation in supporting the lower slope factor. (CAC TP: JCI, No. 66 at p. 13).
In response to JCI's concerns outlined in this preamble, model differentiation is not an EPCA requirement for test procedures.
In the November 2015 SNOPR, DOE requested comment regarding the appropriate approach for rating of variable-speed heat pumps if DOE were not to adopt the proposed general heating load line equation. More specifically, DOE was concerned about a potential inaccuracy associated with the use of extrapolation of the minimum-speed performance measured in 47 °F and 62 °F ambient temperatures for characterization of heat pump performance below 47 °F. In the November 2015 SNOPR, DOE described two options. In Option 1, DOE would base performance on minimum speed tests at 47 °F and intermediate speed tests at 35 °F, an approach which would involve no additional test burden. In Option 2, DOE would require an additional minimum speed test at 35 °F, which would likely be more accurate, at the cost of a higher test burden.
In its comments, UTC/Carrier supported Option 1, because it would
DOE has responded to the comments received and addressed this issue in the context of the revised heating load line equation proposed in section III.C.3.i of this notice.
Following the conclusion of the CAC/HP ECS Working Group meetings, ORNL reexamined key assumptions adopted in its 2015 report
First, ORNL removed continuous mechanical ventilation as a feature of the Prototype Residential Houses used in the analysis. While housing models used in the initial analysis included continuous mechanical ventilation, the 2006 IECC does not include that requirement, and DOE believes that a prototype design without continuous mechanical ventilation would be more representative of the average housing stock.
ORNL also modified the heat pump sizing approach used by the analysis. In the 2015 study, the auto-sizing feature of EnergyPlus was used. The auto-sizing feature uses a heat pump sized for the 0.4% cooling design dry-bulb temperature, based on a 24-hour design day calculation using the heat balance method, which includes the effects of house thermal mass on the peak load. However, this approach does not provide cooling capacity sufficient to meet the load for all hours of the year. For the revised analysis, ORNL increased the heat pump size so that cooling capacity would match or exceed the cooling load for all hours of the year. This increases heat pumps capacities from 6% to 12%, depending on the cities evaluated. This approach also better aligns the sizing approach of the analysis with the sizing assumptions used in the DOE test procedure, meaning that the heat pump's cooling capacity is very close to 1.1 times the cooling load for 95 °F ambient temperature, consistent with equation 4.1-2 of the current test procedure. ORNL also applied an additional 10% oversizing to heat pumps for Region V, based on the observation that this adjustment is required to achieve consistency with the 1.1 factor oversizing for cooling used in the DOE test procedure.
The changes in heating load and heat pumps sizing led to reduction in all of the regional heating load line equation slope factors. Removing continuous ventilation reduced both the zero-load temperatures and the heating load line equation slope factor across each region. This change reduced the heating load line equation slope factor an average (across all regions) of 5% while the zero-load temperatures dropped on average by about 1-2 °F. The adjustment in heat pump size led to an average additional reduction in the slope factor of roughly 9%, but did not change the zero-load temperatures. The calculated heating load line equation slope factors of the modified analysis vary sufficiently that DOE is proposing regional heating load line equation slope factors as opposed to a single slope factor, using Region IV as the basis for the HSPF rating. (CAC TP: ORNL Report Addendum, No. 2)
Based on ORNL's revised findings, DOE has revised its heating load line equation proposal from the November 2015 SNOPR. DOE introduced a final adjustment to the slope factors developed by ORNL to address variable speed systems. This aligns the analysis more closely with the range of capacity recommended in ACCA Manual S, which allows significantly more oversizing for variable-speed heat pumps than for single speed or two-stage heat pumps. The range of recommended capacity factor is 0.9 to 1.15 for single-stage heat pumps and 0.9 to 1.30 for variable-speed. DOE recognizes that such oversizing is much more tolerable with variable-speed heat pumps as compared to single-speed heat pumps, due to their ability to better match mild-weather loads in both heating and cooling seasons, and thus limit the inefficiencies associated with cycling losses. Based on the averages of these ranges, DOE calculated a size adjustment factor for variable-speed units equal to (0.9 + 1.30) divided by (0.9 + 1.15), which equals 1.07, essentially suggesting an additional 7 percent oversizing for variable-speed heat pumps. Applying this to the heating load line equation analysis leads to a corresponding reduction in the slope factors for variable-speed products. DOE notes that for consistency, this oversizing would be applied in seasonal performance calculations for cooling mode and for heating mode.
With the analysis changes and the adjustment for variable-speed models, DOE is proposing the following heating load line equation changes from the November 2015 SNOPR:
• The zero-load temperature would vary by climate region according to the values provided in Table III.10, but remain at 55 °F for Region IV;
• The heating load line equation slope factor for single- and two-stage heat pumps would vary by climate region, as shown in Table III.7, and be 1.15 for Region IV; and
• For variable speed heat pumps, the heating load line equation slope factor would be 7 percent less than for single- and two-stage heat pumps. It would vary by climate region, as shown in Table III.7, and be 1.07 for Region IV;
DOE also revised the heating load hours based on the new zero load temperatures of each climate region. The revised heating load hours are also given in Table III.10.
Following from this proposed heating load line equation change, DOE also proposes in this SNOPR to require cyclic testing for variable speed heat pumps be run at 47 °F, rather than using the 62 °F ambient temperature that is required by the current test procedure (see Appendix M, section 3.6.4 Table 11). The test would still be conducted using minimum compressor speed. The modified heating load line cyclic test at 47 °F would be more representative of the conditions for which cycling operation is considered in the HSPF calculation.
In addition, for variable-speed heat pumps, the SEER would be calculated using a building load that is adjusted downwards by 7 percent, consistent with the heating load adjustment.
DOE examined the impact of the present proposal on HSPF ratings based on test results for 2, 3, and 5-ton heat pumps provided by AHRI. Table III.8 presents the effect of different Region IV heating load line equation slope factors on the average HSPF of two-stage and variable speed units using these results. For two-stage units, the average HSPF reduction from measurements using the current test procedure to the current proposal would be 13.9%. For variable speed products, the average reduction resulting from the current proposal would be 15.3%. The purpose of the test procedure is to evaluate the performance during a representative average use cycle. Nevertheless, DOE believes that reasonable differentiation is still preserved with the current proposal in this SNOPR. Further, DOE believes that heat pumps with good heating mode performance will continue to stand out as compared to heat pumps without good heating mode performance. The test procedure changes proposed in this notice to allow higher speed operation at lower temperature and for a 5 °F optional test (see section III.C.4) should allow for even greater differentiation for variable-speed heat pumps with good heating performance.
Recommendation #9 of the CAC/HP ECS Working Group Term Sheet included two sets of recommended national HSPF standard levels. The Working Group based these levels on heating load line equation slope factors of 1.02 and 1.30 to reflect the two factors primarily discussed during the negotiations. The Working Group designated these levels as “HSPF2” to indicate that they are not equivalent to current HSPF ratings. Table III.9 includes the Working Group's recommended HSPF levels:
As mentioned, the Working Group ultimately left the decision of the appropriate heating load line equation factor up to DOE. The HSPF levels recommended by the Working Group are based on different heating load line equation factors than DOE is proposing in this SNOPR. Consequently, DOE determined HSPF levels that are consistent with those recommended by the Working Group but based on the 1.15 heating load line equation factor DOE proposes in this notice. DOE does not have access to all of the data or details of the methodology used by the Working Group to derive the HSPF levels it recommended. In the absence of this information, DOE used linear interpolation between the HSPF values recommended by the Working Group using 1.02 and 1.30 to derive the associated HSPF values using a heating load line equation factor of 1.15. DOE confirmed that linear interpolation provides good match to directly calculated results using available heat pump performance data. Specifically,
DOE discussed in the November 2015 SNOPR potential inaccuracy associated with the use of test data conducted at minimum speed in 47 °F and62 °F ambient temperature to estimate heat pump performance below 47 °F. 80 FR at 69322-3 (Nov. 9, 2015). Specifically, for heat pumps that increase compressor speed as ambient temperature drops below 47 °F, the extrapolation of performance based on the 47 °F and 62 °F minimum-speed tests over-estimates efficiency. Because the bins in this temperature range have many hours associated with them, the impact on HSPF of this inaccuracy can be significant, particularly with the current test procedure, which uses a 0.77 heating load line equation slope factor. However, for the 1.3 slope factor proposed in the November 2015 SNOPR, DOE found that the impact on HSPF for the available heat pump data was too small to justify modifying the test procedure. The higher slope factor reduces the impact of the issue because the higher heating load reduces the weighting of the HSPF on minimum-speed performance. DOE indicated that, because the higher slope factor alleviated the minimum-speed inaccuracy, it did not propose any test procedure amendment to address this issue, but that it might reconsider this possibility if a lower heating load line equation slope factor were adopted. Id.
DOE proposed two potential approaches to resolve this minimum-speed issue. The first would have involved approximation of minimum-speed performance between 35 °F and 47 °F based on the intermediate-speed frosting-operation test at 35 °F and the minimum-speed test at 47 °F, and assuming that below 35 °F the nominal minimum speed is the same as the intermediate speed. This first approach would not have required any additional testing. The second approach discussed for resolving the issue was to require two additional tests, one intermediate-speed test at 17 °F and one minimum-speed frosting-operation test at 35 °F. DOE requested comment on which of these approaches would be preferable. 80 FR at 69323 (Nov. 9, 2015). A summary of the comments received is located in section III.C.3.d.
As discussed in this preamble, DOE is proposing in this SNOPR to reduce the heating load line equation slope factor to 1.07 for variable-speed heat pumps. At this level, the data currently available to DOE suggests that the HSPF may be overestimated by as much as 16 percent as a result of the inaccuracy associated with the minimum-speed extrapolation. Hence, DOE is also proposing revision to the estimation of minimum-speed performance to reduce the impact of the error. Consistent with stakeholder comments, DOE is proposing to adopt the approach discussed in the November 2015 SNOPR that does not require additional testing. Further, DOE proposes that the approach be used only for heat pumps that vary the minimum speed when operating in outdoor temperatures that are in a range for which the minimum-speed performance factors into the HSPF calculation. For example, if the rotational compressor operating speed for a heat pump operating at its minimum speed remains constant down to 37 °F and the HSPF calculation considers minimum-speed operation only down to the 37 °F temperature bin (this would occur if the calculated heating load is equal to or greater than the intermediate-speed capacity for temperature bins below 37 °F), any rotational speed increase below 37 °F would not require use of the alternative calculation. DOE proposes adoption of a definition, “minimum-speed-limiting variable-speed heat pump,” to refer to such heat pumps.
For the variable-speed heat pumps for which DOE's contractor received data from AHRI during the 2015-2016 ASRAC Negotiations, use of this approach would reduce average HSPF from 9.26 to 9.13, reducing the VS/TS differential to 0.96, which is equivalent to the differential for a 1.02 slope factor without considering any different treatment of variable-speed heat pumps (see Table III-11). However, it is not clear that all the heat pumps of the AHRI dataset would have required use of the alternative calculation approach, so the actual reduction in the average HSPF could be less.
DOE notes that it described another option for reducing the minimum-speed inaccuracy in the November 2015 SNOPR, specifically requiring additional tests to more thoroughly explore the heat pump's performance for the range of different operating speeds and ambient conditions. DOE could consider additional tests to improve accuracy further. Potential additional tests would include an intermediate-speed test at 17 °F, and either minimum-speed frosting-condition tests near 35 °F or minimum-speed steady-state tests at 40 °F or above. The HSPF calculation could be adjusted to provide better estimates of variable-speed heat pump performance over the range of conditions considered in the calculation based on one or more of these tests.
DOE also proposes that certification reports indicate as part of non-public data whether the alternative calculation method was used to determine the heat pump's rating.
In the November 2015 SNOPR, DOE revisited the heating season ratings procedure for variable speed heat pumps found in section 4.2.4 of Appendix M of 10 CFR part 430 subpart B. 80 FR at 69322 (Nov. 9, 2015).
DOE proposed as part of Appendix M1 that for variable speed units that
Testing done by ORNL found that the unit efficiency at maximum speed below 17 °F is slightly higher than the extrapolated values in the current test procedure, and this proposed option would provide a more accurate prediction of heat pump low-ambient performance, not only for those units that limit maximum speed operation below 17 °F, but also for those that do not.
DOE developed the proposal based on review of the results of a limited number of tests. DOE requested test results and other data to show whether the impact on HSPF of the proposal is similar for other variable speed heat pumps, and also requested comment on the additional test burden of the proposed modification. 80 FR at 69323 (Nov. 9, 2015).
Several stakeholders provided comments in response to these requests for data and comments.
JCI supported the proposal on the condition that the tests be made optional, but at a higher temperature (
Lennox and ADP expressed concerns over the difficulty of testing at 2 °F for many labs, commenting that the test would greatly increase the burden on manufacturers as it would greatly increase the test time to achieve the 2 °F test point, possibly require expensive hardware upgrades for labs, or force manufacturers to use outside labs. (CAC TP: Lennox, No. 61 at p. 20; ADP, No. 59 at p. 13)
Rheem commented that the proposed 2 °F outdoor temperature introduces testing variability, and that the very low test temperature introduces a significant test burden because it is rare for manufacturers or independent labs to have such facilities. Rheem commented that there is no justification that the resulting HSPF results will more closely match the resulting energy costs to consumers. Major capital investment by manufacturers and independent-labs would be required to add this capability. (CAC TP: Rheem, No. 69 at p. 17)
Unico commented that most heat pumps are not able to be tested below 17 °F and that most test laboratories cannot test below 17 °F. Nevertheless, they also mentioned (a) public interest in heat pumps that operate at significantly lower temperatures and (b) manufacturers that are publishing data and promoting such cold climate heat pumps. Unico expressed support for a separate heat pump test standard for cold-weather heat pumps, indicating that such a test standard would require testing at 2 °F. (CAC TP: Unico, No. 63 at p. 13)
UTC/Carrier commented that the test point at 2 °F outdoor temperature is challenging for most test facilities (if it is possible at all). (CAC TP: UTC/Carrier, No. 62 at p. 22)
The California IOUs and ACEEE, NRDC, and ASAP commented that in response to industry's concerns over testing at 2 °F, they recommend that variable speed heat pumps be tested at 5 °F, in addition to the 17 °F cold temperature point. ACEEE, NRDC, and ASAP commented that requiring the 5 °F test seems to be a reasonable way to differentiate excellent cold-temperature performance, which is critical for customer acceptance nationally, and for mitigating winter peaks for utilities. The California IOUs noted that the European standard requires testing at 5 °F and that manufacturers participate in the global market and Europe, so that they must test at 5 °F. (CAC TP: California IOUs, No. 67 at p. 7; ACEEE, NRDC, and ASAP, No. 72 at p. 5)
NEEA and NPCC commented that they do not believe that the current test procedure for variable speed systems in any way delivers annual energy use or efficiency ratings that are reasonably reflective of an average use cycle. (CAC TP: NEEA and NPCC, No. 64 at p. 9)
The possible adoption of a very-low-temperature test for rating of variable speed heat pumps was also discussed during the CAC/HP ECS Working Group meetings, ultimately leading to Recommendation #5 in the Term Sheet, that a 5 °F ambient temperature optional test be adopted for variable speed heat pumps. (CAC ECS: ASRAC Term Sheet, No. 76 at p. 3) Given the consensus among Working Group members regarding this recommendation, DOE believes that the concerns expressed by the initial comments about this optional test would be resolved by adopting a 5 °F ambient temperature for the test rather than the 2 °F initially proposed.
In addition, DOE discussed in the November 2015 SNOPR the possibility of making an adjustment to the test procedure to address potential accuracy issues associated with estimation of minimum-speed heat pump performance for temperatures below 47 °F based on extrapolation of the results of tests conducted in 47 °F and 62 °F ambient temperatures. Specifically, testing by ORNL indicated that the HSPF may be over-predicted for heat pumps that do not allow use of the same minimum speed for ambient temperatures below 47 °F. 80 FR 69322-3 (Nov. 9, 2015). However, DOE did not propose to make this change in the November 2015 SNOPR, explaining that the modification of the heating load line equation would sufficiently alleviate the potential inaccuracy, making adjustment to the test procedure unnecessary. However, DOE did request comment on preferences for approaches to modification to the test procedure in case the modified heating load line equation was not adopted, describing approaches that would involve an additional test and an approach that would not require additional testing.
The revised variable speed heat pump test procedure proposed in this notice would include the following changes in Appendix M1.
• If the optional 5 °F full-speed test (to be designated H4
• A target wet bulb temperature of 3.5 °F for the optional 5 °F test.
• If the optional 5 °F full-speed test is conducted, performance for ambient temperatures below 5 °F would be calculated using extrapolation below 5 °F using the same slopes (capacity vs. temperature and power input vs. temperature) as determined for the heat pump between 17 °F and 47 °F. Specifically, the extrapolation would be based on the 17 °F-to-47 °F slope rather than the 5 °F-to-17 °F slope. If the 47 °F full-speed test is conducted at a different speed than the 17 °F full-speed test, the extrapolation would be based on the standardized slope discussed in section III.B.7.
• Manufacturers would have to indicate in certification reports whether the 5 °F full-speed test was conducted.
• As proposed for Appendix M and discussed in section III.B.7, a 47 °F full-speed test, designated the H1
• If the heat pump limits the use of the minimum speed (measured in terms of RPM or power input frequency) of the heat pump when operating at ambient temperatures below 47 °F (
Development of these proposals and decisions regarding their details is explained further below (except for the last proposal, which is discussed in section III.C.3.i).
For heat pumps using the 5 °F test, the CAC/HP ECS Working Group Term Sheet recommended use of interpolation to calculate heat pump performance in the temperature range from 5 °F to 17 °F based on the test results for the 5 °F and 17 °F tests (CAC ECS: ASRAC Term Sheet, No. 76 at p. 3, Recommendation #5) DOE considered what approach to use for calculation of heat pump performance below 5 °F, with the understanding that extrapolation of the 5 °F-to-17 °F trend below 5 °F is not likely to be accurate because full-speed operation could be very different at 5 °F than it is at 17 °F. Although the November 2015 SNOPR primarily addressed cases where the compressor speed could be lower at the lower temperature (see,
DOE chose a target wet bulb temperature for the 5 °F test equal to 3.5 °F, corresponding to roughly 60 percent relative humidity which is consistent with the range of relative humidity of the other low temperature heating mode tests.
As discussed in this preamble, DOE has proposed changing the ambient temperature requirement for the very-low-temperature heating mode test for variable-speed heat pumps from 2 °F to 5 °F. DOE notes that it proposed a 2 °F test for triple-capacity northern heat pumps in the June 2010 NOPR which was established as part of the test procedure in the June 2016 final rule. 81 FR at 37020 (June 8, 2016).
The Office of Management and Budget (OMB) has determined that test procedure rulemakings do not constitute “significant regulatory actions” under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 58 FR 51735 (Oct. 4, 1993). Accordingly, this action was not subject to review under the Executive Order by the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget.
The Regulatory Flexibility Act (5 U.S.C. 601
DOE reviewed this proposed rule, which would amend the test procedure for CAC/HP, under the provisions of the Regulatory Flexibility Act and the procedures and policies published on February 19, 2003. DOE has estimated
For the purpose of the regulatory flexibility analysis for this rule, the DOE adopts the Small Business Administration (SBA) definition of a small entity within this industry as a manufacturing enterprise with 1,250 employees or fewer. DOE used the small business size standards published by the SBA to determine whether any small entities would be required to comply with this rule. The size standards are codified at 13 CFR part 121. The standards are listed by North American Industry Classification System (NAICS) code and industry description and are available at
CAC/HP manufacturing is classified under NAICS 333415, “Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing.” 70 FR 12395 (March 11, 2005). DOE reviewed publicly available data and contacted various companies on its complete list of manufacturers to determine whether they met the SBA's definition of a small business manufacturer. As a result of this review, DOE identified 22 manufacturers of CAC/HP that would be considered domestic small businesses with a total of less than 3 percent of the market sales.
Potential impacts of the proposed test procedure on all manufacturers, including small businesses, come from impacts associated with the cost of proposed additional testing. DOE expects that many of the provisions proposed in this notice will result in no increase to test burden. DOE's proposals to use new heating load line equation provisions to calculate HSPF for heat pumps, new default values for indoor fan power consumption, and a new interpolation approach for COP of variable speed heat pumps are changes to calculations and do not require any additional time or investment from manufacturers. Similarly, DOE's proposal to require certification of the time delay used when testing coil-only units does not affect testing. DOE's proposal to test at new minimum external static pressure conditions would require manufacturers to test at different, but not additional test points using the same equipment and methodologies required by the current test procedure. DOE's proposal for single-package units to make the official test the test that does not include the secondary outdoor air enthalpy method measurement also does not require any additional testing. Similarly, DOE's proposal to include an optional test at 5 °F for variable speed heat pumps does not require manufacturers to do any additional testing. Other proposed provisions may increase test burden. DOE anticipates that its proposed changes to provisions for mini-split refrigerant pressure lines may cause labs and manufacturers to relocate pressure transducers or in a worst case scenario, build a separate satellite test instrumentation console for pressure measurements closer to the test samples. DOE estimates that building such a satellite console would constitute a one-time cost on the order of $1,000 per test room. DOE's proposal to modify the off mode test for units with self-regulated crankcase heaters could result in more significant increases to test burden, but for a small number of models. DOE estimates that the new provisions could add 8 hours per test for units with self-regulated crankcase heaters and an additional 8 hours for those units with self-regulated crankcase heaters that also have a compressor sound blanket. Sound blankets are premium features. DOE estimates that less than 25 percent of all units have self-regulated crankcase heaters and less than 5 percent have self-regulated crankcase heaters and sound blankets. DOE estimates the additional cost of testing to be $250 for units with self-regulating crankcase heaters and $500 for units with self-regulating crankcase heaters and sound blankets. DOE also estimates that testing of basic models may not have to be updated more than once every five years, and therefore the average incremental burden of testing one basic model may be one-fifth of these values when the cost is spread over several years.
DOE is proposing labeling requirements for the indoor and outdoor units of mobile home blower coil and coil-only systems and is also proposing that manufacturers include a specific designation in the installation instructions for these units. For further discussion of the proposed labeling requirements, see section III.C.1. As discussed in that section, DOE expects the additional cost to manufacturers associated with meeting the labeling requirement would be marginal as compared to the total production cost. The overall impact would be small.
As discussed in this preamble, DOE identified 22 domestic small business manufacturers of CAC/HP. Of these, only OUMs that operate their own manufacturing facilities (
DOE requires that only one combination associated with any given outdoor unit be laboratory tested. 10 CFR 429.16(b). The majority of CAC/HP offered by a manufacturer are split-system combinations that are not required to be laboratory tested but can be certified using an AEDM that does not require DOE testing of these units. DOE reviewed available data for the nine small businesses to estimate the incremental testing cost burden those firms might experience due to the revised test procedure. These manufacturers had an average of 35 models requiring testing. DOE determined the numbers of models using the AHRI Directory of Certified Product Performance,
DOE does not expect ICMs to incur any additional burden as a result of the proposed changes because the changes for which DOE estimates there will be increased burden do not apply to ICMs. Only outdoor units include self-regulating crankcase heaters with or without blankets, and DOE assumes that ICM manufacturers do not produce indoor units that have components with off mode power consumption. Consequently, ICMs would be able to use the off mode power measurements acquired and certified by OUMs to meet
Manufacturers of central air conditioners and heat pumps must certify to DOE that their products comply with any applicable energy conservation standards. In certifying compliance, manufacturers must test their products according to the DOE test procedures for central air conditioners and heat pumps, including any amendments adopted for those test procedures. DOE has established regulations for the certification and recordkeeping requirements for all covered consumer products and commercial equipment, including central air conditioners and heat pumps. 76 FR 12422 (March 7, 2011); 80 FR 5099 (Jan. 30, 2015). The collection-of-information requirement for the certification and recordkeeping is subject to review and approval by OMB under the Paperwork Reduction Act (PRA). This requirement has been approved by OMB under OMB control number 1910-1400. Public reporting burden for the certification is estimated to average 30 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB Control Number.
In this proposed rule, DOE proposes test procedure amendments that it expects will be used to develop and implement future energy conservation standards for central air conditioners and heat pumps. DOE has determined that this rule falls into a class of actions that are categorically excluded from review under the National Environmental Policy Act of 1969 (42 U.S.C. 4321
DOE's CX determination for this proposed rule is available at
Executive Order 13132, “Federalism,” 64 FR 43255 (August 4, 1999) imposes certain requirements on agencies formulating and implementing policies or regulations that preempt State law or that have Federalism implications. The Executive Order requires agencies to examine the constitutional and statutory authority supporting any action that would limit the policymaking discretion of the States and to carefully assess the necessity for such actions. The Executive Order also requires agencies to have an accountable process to ensure meaningful and timely input by State and local officials in the development of regulatory policies that have Federalism implications. On March 14, 2000, DOE published a statement of policy describing the intergovernmental consultation process it will follow in the development of such regulations. 65 FR 13735. DOE has examined this proposed rule and has determined that it 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. EPCA governs and prescribes Federal preemption of State regulations as to energy conservation for the products that are the subject of this proposed rule. States can petition DOE for exemption from such preemption to the extent, and based on criteria, set forth in EPCA. (42 U.S.C. 6297(d)) No further action is required by Executive Order 13132.
Regarding the review of existing regulations and the promulgation of new regulations, section 3(a) of Executive Order 12988, “Civil Justice Reform,” 61 FR 4729 (Feb. 7, 1996), imposes on Federal agencies the general duty to adhere to the following requirements: (1) Eliminate drafting errors and ambiguity; (2) write regulations to minimize litigation; (3) provide a clear legal standard for affected conduct rather than a general standard; and (4) promote simplification and burden reduction. Section 3(b) of Executive Order 12988 specifically requires that Executive agencies make every reasonable effort to ensure that the regulation: (1) Clearly specifies the preemptive effect, if any; (2) clearly specifies any effect on existing Federal law or regulation; (3) provides a clear legal standard for affected conduct while promoting simplification and burden reduction; (4) specifies the retroactive effect, if any; (5) adequately defines key terms; and (6) addresses other important issues affecting clarity and general draftsmanship under any guidelines issued by the Attorney General. Section 3(c) of Executive Order 12988 requires Executive agencies to review regulations in light of applicable standards in sections 3(a) and 3(b) to determine whether they are met or it is unreasonable to meet one or more of them. DOE has completed the required review and determined that, to the extent permitted by law, the proposed rule meets the relevant standards of Executive Order 12988.
Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) requires each Federal agency to assess the effects of Federal regulatory actions on State, local, and Tribal governments and the private sector. Public Law 104-4, sec. 201 (codified at 2 U.S.C. 1531). For a proposed regulatory action likely to result in a rule that may cause the expenditure by State, local, and Tribal governments, in the aggregate, or by the private sector of $100 million or more in any one year (adjusted annually for inflation), section 202 of UMRA requires a Federal agency to publish a written statement that estimates the resulting costs, benefits, and other effects on the national economy. (2 U.S.C. 1532(a), (b)) The UMRA also requires a Federal agency to develop an effective process to permit timely input by elected officers of State, local, and Tribal governments on a proposed “significant intergovernmental mandate,” and
Section 654 of the Treasury and General Government Appropriations Act, 1999 (Pub. L. 105-277) requires Federal agencies to issue a Family Policymaking Assessment for any rule that may affect family well-being. This rule would not have any impact on the autonomy or integrity of the family as an institution. Accordingly, DOE has concluded that it is not necessary to prepare a Family Policymaking Assessment.
DOE has determined, under Executive Order 12630, “Governmental Actions and Interference with Constitutionally Protected Property Rights” 53 FR 8859 (March 18, 1988), that this regulation would not result in any takings that might require compensation under the Fifth Amendment to the U.S. Constitution.
Section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note) provides for agencies to review most disseminations of information to the public under guidelines established by each agency pursuant to general guidelines issued by OMB. OMB's guidelines were published at 67 FR 8452 (Feb. 22, 2002), and DOE's guidelines were published at 67 FR 62446 (Oct. 7, 2002). DOE has reviewed this proposed rule under the OMB and DOE guidelines and has concluded that it is consistent with applicable policies in those guidelines.
Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 22, 2001), requires Federal agencies to prepare and submit to OMB, a Statement of Energy Effects for any proposed significant energy action. A “significant energy action” is defined as any action by an agency that promulgated or is expected to lead to promulgation of a final rule, and that: (1) Is a significant regulatory action under Executive Order 12866, or any successor order; and (2) is likely to have a significant adverse effect on the supply, distribution, or use of energy; or (3) is designated by the Administrator of OIRA as a significant energy action. For any proposed significant energy action, the agency must give a detailed statement of any adverse effects on energy supply, distribution, or use should the proposal be implemented, and of reasonable alternatives to the action and their expected benefits on energy supply, distribution, and use.
The proposed regulatory action to amend the test procedure for measuring the energy efficiency of central air conditioners and heat pumps is not a significant regulatory action under Executive Order 12866. Moreover, it would not have a significant adverse effect on the supply, distribution, or use of energy, nor has it been designated as a significant energy action by the Administrator of OIRA. Therefore, it is not a significant energy action, and, accordingly, DOE has not prepared a Statement of Energy Effects.
Under section 301 of the Department of Energy Organization Act (Pub. L. 95-91; 42 U.S.C. 7101), DOE must comply with section 32 of the Federal Energy Administration Act of 1974, as amended by the Federal Energy Administration Authorization Act of 1977. (15 U.S.C. 788; FEAA) Section 32 essentially provides in relevant part that, where a proposed rule authorizes or requires use of commercial standards, the notice of proposed rulemaking must inform the public of the use and background of such standards. In addition, section 32(c) requires DOE to consult with the Attorney General and the Chairman of the Federal Trade Commission (FTC) concerning the impact of the commercial or industry standards on competition.
The proposed rule incorporates testing methods contained in the following commercial standards: AHRI 210/240-2008 with Addendum 1 and 2, Performance Rating of Unitary Air Conditioning & Air-Source Heat Pump Equipment; and ANSI/AHRI 1230-2010 with Addendum 2, Performance Rating of Variable Refrigerant Flow Multi-Split Air Conditioning and Heat Pump Equipment. While the proposed test procedure is not exclusively based on AHRI 210/240-2008 or ANSI/AHRI 1230-2010, one component of the test procedure, namely test setup requirements, adopts language from AHRI 210/240-2008 without amendment; and another component of the test procedure, namely test setup and test performance requirements for multi-split systems, adopts language from ANSI/AHRI 1230-2010 without amendment. The Department has evaluated these standards and is unable to conclude whether they fully comply with the requirements of section 32(b) of the FEAA, (
In this SNOPR, DOE proposes to incorporate by reference (IBR) into the proposed Appendix M1 to subpart B of part 430 specific sections, figures, and tables of several test standards published by AHRI, ASHRAE, and AMCA that are already incorporated by reference into Appendix M to subpart B of part 430: ANSI/AHRI 210/240-2008 with Addenda 1 and 2, titled “Performance Rating of Unitary Air-Conditioning & Air-Source Heat Pump Equipment;” ANSI/AHRI 1230-2010 with Addendum 2, titled “Performance Rating of Variable Refrigerant Flow (VRF) Multi-Split Air-Conditioning and Heat Pump Equipment;” ASHRAE 23.1-2010, titled “Methods of Testing for Rating the Performance of Positive Displacement Refrigerant Compressors and Condensing Units that Operate at Subcritical Temperatures of the Refrigerant;” ASHRAE Standard 37-2009, titled “Methods of Testing for Rating Electrically Driven Unitary Air-Conditioning and Heat Pump Equipment;” ASHRAE 41.1-2013, titled “Standard Method for Temperature Measurement;” ASHRAE 41.2-1987 (RA 1992), titled “Standard Methods for Laboratory Airflow Measurement;” ASHRAE 41.6-2014, titled “Standard Method for Humidity Measurement;”
ANSI/AHRI 210/240-2008 is an industry accepted test procedure that measures the cooling and heating performance of central air conditioners and heat pumps and is applicable to products sold in North America. The test procedure proposed in this SNOPR references various sections of ANSI/AHRI 210/240-2008 that address test setup, test conditions, and rating requirements. ANSI/AHRI 210/240-2008 is readily available on AHRI's Web site at
ANSI/AHRI 1230-2010 is an industry accepted test procedure that measures the cooling and heating performance of variable refrigerant flow (VRF) multi-split air conditioners and heat pumps and is applicable to products sold in North America. The test procedure proposed in this SNOPR for VRF multi-split systems references various sections of ANSI/AHRI 1230-2010 that address test setup, test conditions, and rating requirements. ANSI/AHRI 1230-2010 is readily available on AHRI's Web site at
ASHRAE 23.1-2010 is an industry accepted test procedure for rating the thermodynamic performance of positive displacement refrigerant compressors and condensing units that operate at subcritical temperatures. The test procedure proposed in this SNOPR references sections of ASHRAE 23.1-2010 that address requirements, instruments, methods of testing, and testing procedure specific to compressor calibration. ASHRAE 23.1-2010 can be purchased from ASHRAE's Web site at
ASHRAE Standard 37-2009 is an industry accepted standard that provides test methods for determining the cooling capacity of unitary air conditioning equipment and the cooling or heating capacities, or both, of unitary heat pump equipment. The test procedure proposed in this SNOPR references various sections of ASHRAE Standard 37-2009 that address test conditions and test procedures. ASHRAE Standard 37-2009 can be purchased from ASHRAE's Web site at
ASHRAE 41.1-2013 is an industry accepted method for measuring temperature in testing heating, refrigerating, and air conditioning equipment. The test procedure proposed in this SNOPR references sections of ASHRAE 41.1-2013 that address requirements, instruments, and methods for measuring temperature. ASHRAE 41.1-2013 can be purchased from ASHRAE's Web site at
ASHRAE 41.2-1987 (RA 1992) is an industry accepted test method for measuring airflow. The test procedure proposed in this SNOPR references sections of ASHRAE 41.2-1987 (RA 1992) that address test setup and test methods. ASHRAE 41.2-1987 (RA 1992) can be purchased from ASHRAE's Web site at
ASHRAE 41.6-2014 is an industry accepted test method for measuring humidity of moist air. The test procedure proposed in this SNOPR references sections of ASHRAE 41.6-2014 that address requirements, instruments, and methods for measuring humidity. ASHRAE 41.6-2014 can be purchased from ASHRAE's Web site at
ASHRAE 41.9-2011 is an industry accepted standard that provides recommended practices for measuring the mass flow rate of volatile refrigerants using calorimeters. The test procedure proposed in this SNOPR references sections of ASHRAE 41.9-2011 that address requirements, instruments, and methods for measuring refrigerant flow during compressor calibration. ASHRAE 41.9-2011 can be purchased from ASHRAE's Web site at
ANSI/ASHRAE Standard 116-2010 is an industry accepted standard that provides test methods and calculation procedures for determining the capacities and cooling seasonal efficiency ratios for unitary air-conditioning, and heat pump equipment and heating seasonal performance factors for heat pump equipment. The test procedure proposed in this SNOPR references various sections of ANSI/ASHRAE 116-2010 that addresses test methods and calculations. ANSI/ASHRAE Standard 116-2010 can be purchased from ASHRAE's Web site at
AMCA 210-2007 is an industry accepted standard that establishes uniform test methods for a laboratory test of a fan or other air moving device to determine its aerodynamic performance in terms of airflow rate, pressure developed, power consumption, air density, speed of rotation, and efficiency for rating or guarantee purposes. The test procedure in this SNOPR references various sections of AMCA 210-2007 that address test conditions. AMCA 210-2007 can be purchased from AMCA's Web site at
The time, date, and location of the public meeting are listed in the
Please note that foreign nationals participating in the public meeting are subject to advance security screening procedures which require advance notice prior to attendance at the public meeting. If a foreign national wishes to participate in the public meeting, please inform DOE as soon as possible by contacting Ms. Regina Washington at (202) 586-1214 or by email:
DOE requires visitors to have laptops and other devices, such as tablets, checked upon entry into the building. Any person wishing to bring these devices into the Forrestal Building will be required to obtain a property pass. Visitors should avoid bringing these devices, or allow an extra 45 minutes to check in. Please report to the visitor's desk to have devices checked before proceeding through security.
Due to the REAL ID Act implemented by the Department of Homeland Security (DHS), there have been recent changes regarding ID requirements for individuals wishing to enter Federal buildings from specific states and U.S. territories. Driver's licenses from the following states or territory will not be accepted for building entry and one of the alternate forms of ID listed below will be required. DHS has determined that regular driver's licenses (and ID cards) from the following jurisdictions are not acceptable for entry into DOE facilities: Alaska, American Samoa, Arizona, Louisiana, Maine, Massachusetts, Minnesota, New York, Oklahoma, and Washington. Acceptable alternate forms of Photo-ID include: U.S. Passport or Passport Card; an Enhanced
In addition, you can attend the public meeting via webinar. Webinar registration information, participant instructions, and information about the capabilities available to webinar participants will be published on DOE's Web site at:
Any person who has plans to present a prepared general statement may request that copies of his or her statement be made available at the public meeting. Such persons may submit requests, along with an advance electronic copy of their statement in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format, to the appropriate address shown in the
DOE will designate a DOE official to preside at the public meeting and may also use a professional facilitator to aid discussion. The meeting will not be a judicial or evidentiary-type public hearing, but DOE will conduct it in accordance with section 336 of EPCA (42 U.S.C. 6306). A court reporter will be present to record the proceedings and prepare a transcript. DOE reserves the right to schedule the order of presentations and to establish the procedures governing the conduct of the public meeting. After the public meeting, interested parties may submit further comments on the proceedings as well as on any aspect of the rulemaking until the end of the comment period.
The public meeting will be conducted in an informal, conference style. DOE will present summaries of comments received before the public meeting, allow time for prepared general statements by participants, and encourage all interested parties to share their views on issues affecting this rulemaking. Each participant will be allowed to make a general statement (within time limits determined by DOE), before the discussion of specific topics. DOE will allow, as time permits, other participants to comment briefly on any general statements.
At the end of all prepared statements on a topic, DOE will permit participants to clarify their statements briefly and comment on statements made by others. Participants should be prepared to answer questions by DOE and by other participants concerning these issues. DOE representatives may also ask questions of participants concerning other matters relevant to this rulemaking. The official conducting the public meeting will accept additional comments or questions from those attending, as time permits. The presiding official will announce any further procedural rules or modification of the above procedures that may be needed for the proper conduct of the public meeting.
A transcript of the public meeting will be included in the docket, which can be viewed as described in the Docket section at the beginning of this document. In addition, any person may buy a copy of the transcript from the transcribing reporter.
DOE will accept comments, data, and information regarding this proposed rule no later than the date provided in the
Under EPCA, DOE may not amass more than 270 days of public comment during a test procedure rulemaking. (42 U.S.C. 6293(b)(2)) Since the beginning of this test procedure rulemaking on June 2, 2010 (75 FR 31223), DOE has provided 216 days of public comment, in all.
However, your contact information will be publicly viewable if you include it in the comment or in any documents attached to your comment. Any information that you do not want to be publicly viewable should not be included in your comment, nor in any document attached to your comment. Persons viewing comments will see only first and last names, organization names, correspondence containing comments, and any documents submitted with the comments.
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Include contact information each time you submit comments, data, documents, and other information to DOE. If you submit via mail or hand delivery, please provide all items on a CD, if feasible. It is not necessary to submit printed copies. No facsimiles (faxes) will be accepted.
Comments, data, and other information submitted to DOE electronically should be provided in PDF (preferred), Microsoft Word or Excel, WordPerfect, or text (ASCII) file format. Provide documents that are not secured, written in English and free of any defects or viruses. Documents should not contain special characters or any form of encryption and, if possible, they should carry the electronic signature of the author.
Factors of interest to DOE when evaluating requests to treat submitted information as confidential include: (1) A description of the items; (2) whether and why such items are customarily treated as confidential within the industry; (3) whether the information is generally known by or available from other sources; (4) whether the information has previously been made available to others without obligation concerning its confidentiality; (5) an explanation of the competitive injury to the submitting person which would result from public disclosure; (6) when such information might lose its confidential character due to the passage of time; and (7) why disclosure of the information would be contrary to the public interest.
It is DOE's policy that all comments may be included in the public docket, without change and as received, including any personal information provided in the comments (except information deemed to be exempt from public disclosure).
Although DOE welcomes comments on any aspect of this proposal, DOE is particularly interested in receiving comments and views of interested parties concerning the following issues:
Issue 1: DOE requests comment on its proposed certification requirements for outdoor units with no match. Also, DOE seeks comment on what fin style options should be considered as options for CCMS database data entry.
Issue 2: DOE requests comment on its proposed language in 429.16 related to allowable ICM ratings and compliance with regional standards.
Issue 3: DOE requests comment on its proposal to allow a one-sided tolerance on represented values of cooling and heating capacity that allows underrating of any amount but only overrating up to 5 percent.
Issue 4: DOE seeks comments from interested parties about its proposal to impose time delays to allow approach to equilibrium for measurements of off-mode power for units with self-regulating crankcase heaters. DOE requests comment regarding the 4-hour and 8-hour delay times proposed for units without and with compressor sound blankets, respectively.
Issue 5: DOE requests comment on its proposal to limit the internal volume of pressure measurement systems for cooling/heating heat pumps where the pressure measurement location may switch from liquid to vapor state when changing operating modes and for all systems undergoing cyclic tests. DOE also requests comment specifically on (a) the proposed 0.25 cubic inch per 12,000 Btu/h maximum internal volume for such systems, and (b) the proposals for default internal volumes to assign to pressure transducers and gauges of 0.1 and 0.2 cubic inches, respectively.
Issue 6: DOE requests comment on the proposal to require the use of a bin-by-bin method to calculate EER and COP for intermediate-speed operation for SEER and HSPF calculations for variable-speed units.
Issue 7: DOE requests comment on its proposed modifications to requirements when using the outdoor air enthalpy method as the secondary test method, including its proposal that the official test be conducted without the outdoor air-side test apparatus connected.
Issue 8: DOE requests comments on its proposal to require certification reports for coil-only units to indicate whether testing was conducted using a time-delay relay to provide an off-cycle time delay, and the duration of the time delay.
Issue 9: DOE requests comment on its proposal to limit the NGIFS of tested coil-only single-split systems to 2.0 sq.in/Btu/hr.
Issue 10: DOE requests comments on its proposal to require that full-speed tests conducted in 17 °F and 35 °F ambient temperatures use the maximum compressor speed at which the system controls would operate the compressor in normal operation in a 17 °F ambient temperatures. DOE requests comment on the proposed approach of using standardized slope factors for calculation of representative performance at 47 °F ambient temperature for heat pumps for which the 47 °F full-speed test cannot be conducted at the same speed as the 17 °F full-speed test. Further, DOE requests comment on the specific slope factors proposed, and/or data to show that different slope factors should be used.
Issue 11: DOE requests comments on its proposal to allow the full speed test in 47 °F ambient temperature that is used to represent heat pump heating capacity, to use any speed that is no lower than used for the 95 °F full-speed cooling test for Appendix M.
Issue 12: DOE requests comments on its clarifications regarding use of break-in, including use of the certified break-in period for each compressor of the unit, regardless of who conducts the test, prior to any test period used to measure performance.
Issue 13: DOE requests comments on removing from section 2.2.3.a of Appendix M the 5 percent tolerance for part load operation when comparing the sum of nominal capacities of the indoor units and the intended system part load capacity.
Issue 14: DOE requests comment on whether removing the statement about insulating or sealing cased coils in Appendix M, section 2.2.c would be sufficient to avoid confusion regarding whether sealing of duct connections is allowed.
Issue 15: DOE requests comments on the proposed minimum external static pressure requirements.
DOE proposes to establish the certification requirements for Appendix M1 to require manufacturers to certify the kind(s) of CAC/HP associated with the minimum external static pressure used in testing or rating (
The Secretary of Energy has approved publication of this proposed rule.
Administrative practice and procedure, Confidential business information, Energy conservation, Reporting and recordkeeping requirements.
Administrative practice and procedure, Confidential business information, Energy conservation, Energy conservation test procedures, Household appliances, Imports, Incorporation by reference, Intergovernmental relations, Small businesses.
For the reasons stated in the preamble, DOE is proposing to amend parts 429 and 430 of chapter II of title 10, subpart B, Code of Federal Regulations, as set forth below:
42 U.S.C. 6291-6317.
(a) When testing of covered products or covered equipment is required to comply with section 323(c) of the Act, or to comply with rules prescribed under sections 324, 325, or 342, 344, 345 or 346 of the Act, a sample comprised of production units (or units representative of production units) of the basic model being tested must be selected at random and tested, and must meet the criteria found in §§ 429.14 through 429.62. Components of similar design may be substituted without additional testing if the substitution does not affect energy or water consumption. Any represented values of measures of energy efficiency, water efficiency, energy consumption, or water consumption for all individual models represented by a given basic model must be the same, except for central air conditioners and central air conditioning heat pumps, as specified in § 429.16.
The revisions and addition read as follows:
(a)
(3)
(4) * * *
(i)
(b) * * *
(2)
(3)
(iii)
(A) To the nearest 100 Btu/h if cooling capacity is less than 20,000 Btu/h,
(B) To the nearest 200 Btu/h if cooling capacity is greater than or equal to 20,000 Btu/h but less than 38,000 Btu/h, and
(C) To the nearest 500 Btu/h if cooling capacity is greater than or equal to 38,000 Btu/h and less than 65,000 Btu/h.
(iv)
(A) To the nearest 100 Btu/h if heating capacity is less than 20,000 Btu/h,
(B) To the nearest 200 Btu/h if heating capacity is greater than or equal to 20,000 Btu/h but less than 38,000 Btu/h, and
(C) To the nearest 500 Btu/h if heating capacity is greater than or equal to 38,000 Btu/h and less than 65,000 Btu/h.
(c)
(1) * * *
(i) * * *
(B) The representative values of the measures of energy efficiency or energy consumption through the application of an AEDM in accordance with paragraph (d) of this section and § 429.70. An AEDM may only be used to determine represented values for individual models or combinations in a basic model other than the individual model or combination(s) required for mandatory testing under paragraph (b)(2) of this section, except that, for single-split, non-space-constrained systems, when testing is required in accordance with 10 CFR part 430, subpart B, appendix M1, an AEDM may be used to rate the individual model or combination(s) required for mandatory testing under paragraph (b)(2) of this section until July 1, 2024, in accordance with paragraph (e)(2)(i)(A) of § 429.70.
(3)
(i) For basic models that include additional varieties of ducted indoor units (
(ii) For basic models composed of both non-ducted and ducted combinations, the represented value based on testing in accordance with 10 CFR part 430, subpart B, appendix M for the mixed non-ducted/ducted combination is the mean of the represented values for the non-ducted and ducted combinations as determined in accordance with paragraph (b)(3)(i) of this section. For basic models that include mixed combinations of indoor units (any two kinds of non-ducted, low-static, mid-static, and conventional ducted indoor units), the represented value based on testing in accordance with 10 CFR part 430, subpart B, appendix M1 for the mixed combination is the mean of the represented values for the individual component combinations as determined in accordance with paragraph (b)(3)(i) of this section.
(iii) For basic models composed of both SDHV and non-ducted or ducted combinations, the represented value based on testing in accordance with 10 CFR part 430, subpart B, appendix M for the mixed SDHV/non-ducted or SDHV/ducted combination is the mean of the represented values for the SDHV, non-ducted, or ducted combinations, as applicable, as determined in accordance with paragraph (b)(3)(i) of this section. For basic models including mixed combinations of SDHV and another kind of indoor unit (any of non-ducted, low-static, mid-static, and conventional ducted), the represented value based on testing in accordance with 10 CFR part 430, subpart B, appendix M1 for the mixed SDHV/other combination is the mean of the represented values for the SDHV and other tested combination as determined in accordance with paragraph (b)(3)(i) of this section.
(iv) All other individual combinations of models of indoor units for the same model of outdoor unit for which the manufacturer chooses to make representations must be rated as separate basic models, and the provisions of paragraphs (b)(1) through (3) and (c)(3)(i) through(iii) of this section apply.
(v) With respect to P
(A) The testing result from an individual model or combination of similar off-mode construction, or
(B) Application of an AEDM in accordance with paragraph (d) of this section and § 429.70.
(d) * * *
(3) Cooling capacity. The represented value of cooling capacity of an individual model/combination must be no greater than 105% of the cooling capacity output simulated by the AEDM.
(4) Heating capacity. The represented value of heating capacity of an individual model/combination must be no greater than 105% of the heating capacity output simulated by the AEDM.
(e) * * *
(2)
(i) For heat pumps, the heating seasonal performance factor (HSPF in British thermal units per Watt-hour (Btu/W-h));
(ii) For central air conditioners (excluding space constrained products), the energy efficiency ratio (EER in British thermal units per Watt-hour (Btu/W-h));
(iii) For single-split-systems, whether the represented value is for a coil-only or blower coil system;
(iv) For multi-split, multiple-circuit, and multi-head mini-split systems (including VRF and SDHV), when certifying compliance with current energy conservation standards, whether the represented value is for a non-ducted, ducted, mixed non-ducted/ducted system, SDHV, mixed non-ducted/SDHV system, or mixed ducted/SDHV system;
(v) For all split systems including outdoor units with no match, the refrigerant.
(3)
(4)
(i) For heat pumps, whether the optional tests were conducted to determine the C
(ii) For multi-split, multiple-circuit, and multi-head mini-split systems, the number of indoor units tested with the outdoor unit; the nominal cooling capacity of each indoor unit and outdoor unit in the combination; and the indoor units that are not providing heating or cooling for part-load tests;
(iii) For ducted systems having multiple indoor fans within a single indoor unit, the number of indoor fans; the nominal cooling capacity of the indoor unit and outdoor unit; which fan(s) operate to attain the full-load air volume rate when controls limit the simultaneous operation of all fans within the single indoor unit; and the allocation of the full-load air volume rate to each operational fan when different capacity blowers are connected to the common duct;
(iv) For blower coil systems, the airflow-control settings associated with full load cooling operation; and the airflow-control settings or alternative instructions for setting fan speed to the speed upon which the rating is based;
(v) For models with time-adaptive defrost control, the frosting interval to be used during Frost Accumulation tests and the procedure for manually initiating the defrost at the specified time;
(vi) For models of indoor units designed for both horizontal and vertical installation or for both up-flow and down-flow vertical installations, the orientation used for testing;
(vii) For variable speed models, the compressor frequency set points, and the required dip switch/control settings for step or variable components; and
(viii) For variable speed heat pumps, whether the optional H4
(ix) For models of outdoor units with no match, the following characteristics of the indoor coil: the face area, the coil depth in the direction of airflow, the fin density (fins per inch), the fin material, the fin style, the tube diameter, the tube material, and the numbers of tubes high and deep;
(x) For single-split-system coil-only ratings, NGIFS and the OFF-cycle time delay for the indoor fan, if used for certification testing; and
(xi) For central air conditioners and heat pumps that have two-capacity compressors that lock out low capacity operation for cooling at higher outdoor temperatures and/or heating at lower outdoor temperatures, the outdoor temperature(s) at which the unit locks out low capacity operation.
(f)
(1)
(i) The value determined in paragraph (A) if using appendix M to subpart B of part 430 or the value determined in paragraph (B) if using appendix M1 to subpart B of part 430;
(A) the quotient of the represented value of cooling capacity, in Btu's per hour as determined in paragraph (b)(3)(i)(C) of this section, divided by the represented value of SEER, in Btu's per watt-hour, as determined in paragraph (b)(3)(i)(B) of this section;
(B) the quotient of the represented value of cooling capacity, in Btu's per hour as determined in paragraph (b)(3)(i)(C) of this section, and multiplied by 0.93 for variable-speed heat pumps only, divided by the represented value of SEER, in Btu's per watt-hour, as determined in paragraph (b)(3)(i)(B) of this section.
(ii) The representative average use cycle for cooling of 1,000 hours per year;
(iii) A conversion factor of 0.001 kilowatt per watt; and
(iv) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act.
(2)
(i) When using appendix M to subpart B of part 430, the product of:
(A) The quotient of the mean of the standardized design heating requirement for the sample, in Btu's per hour, nearest to the Region IV minimum design heating requirement, determined for each unit in the sample in section 4.2 of appendix M to subpart B of part 430, divided by the represented value of heating seasonal performance factor (HSPF), in Btu's per watt-hour, calculated for Region IV corresponding to the above-mentioned standardized design heating requirement, as determined in paragraph (b)(3)(i)(B) of this section;
(B) The representative average use cycle for heating of 2,080 hours per year;
(C) The adjustment factor of 0.77, which serves to adjust the calculated design heating requirement and heating load hours to the actual load experienced by a heating system;
(D) A conversion factor of 0.001 kilowatt per watt; and
(E) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act;
(ii) When using appendix M1 to subpart B of part 430, the product of:
(A) The quotient of the represented value of cooling capacity (for air-source heat pumps that provide both cooling and heating) in Btu's per hour, as determined in paragraph (b)(3)(i)(C) of this section, or the represented value of heating capacity (for air-source heat pumps that provide only heating), as determined in paragraph (b)(3)(i)(D) of this section, divided by the represented value of heating seasonal performance factor (HSPF), in Btu's per watt-hour, calculated for Region IV, as determined in paragraph (b)(3)(i)(B) of this section;
(B) The representative average use cycle for heating of 1,572 hours per year;
(C) The adjustment factor of 1.15 (for heat pumps that are not variable-speed) or 1.07 (for heat pumps that are variable-speed), which serves to adjust the calculated design heating requirement and heating load hours to the actual load experienced by a heating system;
(D) A conversion factor of 0.001 kilowatt per watt; and
(E) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act;
(4)
(i) The value determined in paragraph (A) if using appendix M to subpart B of part 430 or the value determined in paragraph (B) if using appendix M1 to subpart B of part 430;
(A) the quotient of the represented value of cooling capacity, in Btu's per hour as determined in paragraph (b)(3)(i)(C) of this section, divided by the represented value of SEER, in Btu's per watt-hour, as determined in paragraph (b)(3)(i)(B) of this section;
(B) the quotient of the represented value of cooling capacity, in Btu's per hour as determined in paragraph (b)(3)(i)(C) of this section, and multiplied by 0.93 for variable-speed heat pumps only, divided by the represented value of SEER, in Btu's per watt-hour, as determined in paragraph (b)(3)(i)(B) of this section;
(ii) The value determined in paragraph (A) if using appendix M to subpart B of part 430 or the value determined in paragraph (B) if using appendix M1 to subpart B of part 430;
(A) the estimated number of regional cooling load hours per year determined from Table 21 in section 4.4 of appendix M to subpart B of part 430;
(B) the estimated number of regional cooling load hours per year determined from Table 20 in section 4.4 of appendix M1 to subpart B of part 430;
(iii) A conversion factor of 0.001 kilowatts per watt; and
(iv) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act.
(5)
(i) When using appendix M to subpart B of part 430, the product of:
(A) The estimated number of regional heating load hours per year determined from Table 21 in section 4.4 of appendix M to subpart B of part 430;
(B) The quotient of the mean of the standardized design heating requirement for the sample, in Btu's per hour, for the appropriate generalized climatic region of interest (
(C) The adjustment factor of 0.77; which serves to adjust the calculated design heating requirement and heating load hours to the actual load experienced by a heating system;
(D) A conversion factor of 0.001 kilowatts per watt; and
(E) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act.
(ii) When using appendix M1 to subpart B of part 430, the product of:
(A) The estimated number of regional heating load hours per year determined from Table 20 in section 4.4 of appendix M1 to subpart B of part 430;
(B) The quotient of the represented value of cooling capacity (for air-source
(C) The adjustment factor of 1.15 (for heat pumps that are not variable-speed) or 1.07 (for heat pumps that are variable-speed), which serves to adjust the calculated design heating requirement and heating load hours to the actual load experienced by a heating system;
(D) A conversion factor of 0.001 kilowatts per watt; and
(E) The representative average unit cost of electricity in dollars per kilowatt-hour as provided pursuant to section 323(b)(2) of the Act.
(e) * * *
(2) * * *
(i) Conduct minimum testing and compare to AEDM output as described in paragraphs (A) and (B) respectively.
(A)
(
(B) Using the AEDM, calculate the energy use or efficiency for each of the tested individual models/combinations within each basic model. Compare the represented value based on testing and the AEDM energy use or efficiency output according to paragraph (e)(2)(ii) of this section. The manufacturer is responsible for ensuring the accuracy and reliability of the AEDM and that their representations are appropriate and the models being distributed in commerce meet the applicable standards, regardless of the amount of testing required in paragraphs (e)(2)(i)(A) and (e)(2)(i)(B) of this section.
(5) * * *
(iv)
42 U.S.C. 6291-6309; 28 U.S.C. 2461 note.
(m)
(1) Determine cooling capacity from the steady-state wet-coil test (A or A2 Test), as described in section 3.2 of appendix M or M1 to this subpart, and rounded off to the nearest
(i) To the nearest 50 Btu/h if cooling capacity is less than 20,000 Btu/h;
(ii) To the nearest 100 Btu/h if cooling capacity is greater than or equal to 20,000 Btu/h but less than 38,000 Btu/h; and
(iii) To the nearest 250 Btu/h if cooling capacity is greater than or equal to 38,000 Btu/h and less than 65,000 Btu/h.
(2) Determine seasonal energy efficiency ratio (SEER) as described in section 4.1 of appendix M or M1 to this subpart, and round off to the nearest 0.025 Btu/W-h.
(3) Determine EER as described in section 4.7 of appendix M or M1 to this subpart, and round off to the nearest 0.025 Btu/W-h.
(4) Determine heating seasonal performance factors (HSPF) as described in section 4.2 of appendix M or M1 to this subpart, and round off to the nearest 0.025 Btu/W-h.
(5) Determine average off mode power consumption as described in section 4.3 of appendix M or M1 to this subpart, and round off to the nearest 0.5 W.
(6) Determine all other measures of energy efficiency or consumption or other useful measures of performance using appendix M or M1 of this subpart.
The additions and revisions read as follows:
c. Testing a ducted unit without having an indoor air filter installed is permissible as long as the minimum external static pressure requirement is adjusted as stated in Table 3, note 3 (see section 3.1.4 of this appendix). Except as noted in section 3.1.10 of this appendix, prevent the indoor air supplementary heating coils from operating during all tests. For uncased coils, create an enclosure using 1 inch fiberglass foil-faced ductboard having a nominal density of 6 pounds per cubic foot. Or alternatively, construct an enclosure using sheet metal or a similar material and insulating material having a thermal resistance (“R” value) between 4 and 6 hr·ft
g. If pressure measurement devices are connected to refrigerant lines at locations where the refrigerant state changes from liquid to vapor for different parts of the test (
h. For single-split-system coil-only air conditioners, test using an indoor coil that has a normalized gross indoor fin surface (NGIFS) no greater than 2.0 square inches per British thermal unit per hour (sq. in./Btu/hr). NGIFS is calculated as follows:
a. Additional requirements for multi-split air conditioners and heat pumps. For any test where the system is operated at part load (
Before making test measurements used to calculate performance, operate the equipment for a “break-in” period, which may not exceed 20 hours. Each compressor of the unit must undergo this “break-in” period. Record the duration of the break-in period. When testing a ducted unit (except if a heating-only heat pump), conduct the A or A2 Test first to establish the cooling full-load air volume rate. * * *
The automatic controls that are normally installed with the test unit must govern the OFF/ON cycling of the air moving equipment on the indoor side (exhaust fan of the airflow measuring apparatus and the indoor blower of the test unit). For ducted coil-only systems rated based on using a fan time-delay relay, control the indoor coil airflow according to the OFF delay listed by the manufacturer in the certification report. For ducted units having a variable-speed indoor blower that has been disabled (and possibly removed), start and stop the indoor airflow at the same instances as if the fan were enabled. * * *
a. Conduct one maximum temperature test (H0
b. If the H1
Evaluate the quantities Q
Otherwise, if the H1
Evaluate the quantities
Otherwise (if no high temperature test is conducted using the same speed (RPM or power input frequency) as the H3
c. If the H2
d. Determine the quantities Q
a. For all cooling mode and heating mode tests, first conduct a test without the outdoor air-side test apparatus described in section 2.10.1 of this appendix connected to the outdoor unit (“non-ducted” test).
b. For the first section 3.2 steady-state cooling mode test and the first section 3.6 steady-state heating mode test, conduct a second test in which the outdoor-side apparatus is connected (“ducted” test). No other cooling mode or heating mode tests require the ducted test so long as the unit operates the outdoor fan during all cooling mode steady-state tests at the same speed and all heating mode steady-state tests at the same speed. If using more than one outdoor fan speed for the cooling mode steady-state tests, however, conduct the ducted test for each cooling mode test where a different fan speed is first used. This same requirement applies for the heating mode tests.
a. For the non-ducted test, connect the indoor air-side test apparatus to the indoor coil; do not connect the outdoor air-side test apparatus. Allow the test room reconditioning apparatus and the unit being tested to operate for at least one hour. After attaining equilibrium conditions, measure the following quantities at equal intervals that span 5 minutes or less:
(1) The section 2.10.1 evaporator and condenser temperatures or pressures;
(2) Parameters required according to the indoor air enthalpy method.
Continue these measurements until a 30-minute period (
b. For cases where a ducted test is not required per section 3.11.1.b of this appendix, the non-ducted test constitutes the “official” test for which validity is not based on comparison with a secondary test.
c. For cases where a ducted test is required per section 3.11.1.b of this appendix, the following conditions must be met for the non-ducted test to constitute a valid “official” test:
(1) The energy balance specified in section 3.1.1 of this appendix is achieved for the ducted test (
(2) The capacities determined using the indoor air enthalpy method from the ducted and non-ducted tests must agree within 2.0 percent.
a. The test conditions and tolerances for the ducted test are the same as specified for the official test.
b. After collecting 30 minutes of steady-state data during the non-ducted test, connect the outdoor air-side test apparatus to the unit for the ducted test. Adjust the exhaust fan of the outdoor airflow measuring apparatus until averages for the evaporator and condenser temperatures, or the saturated temperatures corresponding to the measured pressures, agree within ±0.5 °F of the averages achieved during the non-ducted test. Calculate the averages for the ducted test using five or more consecutive readings taken
c. During the ducted test, at one minute intervals, measure the parameters required according to the indoor air enthalpy method and the outdoor air enthalpy method.
d. For cooling mode ducted tests, calculate capacity based on outdoor air-enthalpy measurements as specified in sections 7.3.3.2 and 7.3.3.3 of ASHRAE 37-2009 (incorporated by reference, see § 430.3). For heating mode ducted tests, calculate heating capacity based on outdoor air-enthalpy measurements as specified in sections 7.3.4.2 and 7.3.3.4.3 of the same ASHRAE Standard. Adjust the outdoor-side capacity according to section 7.3.3.4 of ASHRAE 37-2009 to account for line losses when testing split systems.
3.13.2 This test determines the off mode average power rating for central air conditioners and heat pumps for which ambient temperature can affect the measurement of crankcase heater power.
b. Configure Controls: Position a temperature sensor to measure the outdoor dry-bulb temperature in the air between 2 and 6 inches from the crankcase heater control temperature sensor or, if no such temperature sensor exists, position it in the air between 2 and 6 inches from the crankcase heater. Utilize the temperature measurements from this sensor for this portion of the test procedure. Configure the controls of the central air conditioner or heat pump so that it operates as if connected to a building thermostat that is set to the OFF position. Use a compatible building thermostat if necessary to achieve this configuration.
Conduct the test after completion of the B, B
d. Reduce outdoor temperature: Approach the target outdoor dry-bulb temperature by adjusting the outdoor temperature. This target temperature is five degrees Fahrenheit less than the temperature certified by the manufacturer as the temperature at which the crankcase heater turns on. If the unit's compressor has no sound blanket, wait at least 4 hours after the outdoor temperature reaches the target temperature. Otherwise, wait at least 8 hours after the outdoor temperature reaches the target temperature. Maintain the target temperature within +/-2 °F while the compressor temperature equilibrates and while making the power measurement, as described in section 3.13.2.e of this appendix.
The calculation of Equation 4.1-1 quantities q
4.1.4.2 Unit operates at an intermediate compressor speed (k=i) in order to match the building cooling load at temperature T
Obtain the fractional bin hours for the cooling season, n
For each temperature bin where Q
For each temperature bin where Q
b. For a section 3.6.2 single-speed heat pump or a two-capacity heat pump not covered by item d, Q
c. For a variable-speed heat pump, Q
d. For two-capacity, northern heat pumps (see section 1.2 of this appendix, Definitions), Q
For all heat pumps, HSPF accounts for * * *
The calculation of the Equation 4.2-1 quantities differ depending upon whether the heat pump would operate at low capacity (section 4.2.3.1 of this appendix), cycle between low and high capacity (section 4.2.3.2 of this appendix), or operate at high capacity (sections 4.2.3.3 and 4.2.3.4 of this appendix) in responding to the building load. For heat pumps that lock out low capacity operation at low outdoor temperatures, the outdoor temperature at which the unit locks out must be that specified by the manufacturer in the certification report so that the appropriate equations can be selected.
Evaluate the space heating capacity, Q
4.2.4.2 Heat pump operates at an intermediate compressor speed (k=i) in order to match the building heating load at a temperature T
For each temperature bin where the heat pump operates at an intermediate compressor speed, determine COP
For each temperature bin where Q
Prior to January 1, 2023, any representations, including compliance certifications, made with respect to the energy use, power, or efficiency of central air conditioners and central air conditioning heat pumps must be based on the results of testing pursuant to Appendix M of this subpart.
On or after January 1, 2023, any representations, including compliance certifications, made with respect to the energy use, power, or efficiency of central air conditioners and central air conditioning heat pumps must be based on the results of testing pursuant to this appendix.
This test procedure provides a method of determining SEER, EER, HSPF and P
For the purposes of this appendix, the Department of Energy incorporates by reference specific sections of several industry standards, as listed in § 430.3. In cases where there is a conflict, the language of the test procedure in this appendix takes precedence over the incorporated standards.
All section references refer to sections within this appendix unless otherwise stated.
(1) Monitor one or more parameters that always vary with the amount of frost accumulated on the outdoor coil (
(2) Operate as a feedback system that measures the length of the defrost period and adjusts defrost frequency accordingly. In all cases, when the frost parameter(s) reaches a predetermined value, the system initiates a defrost. In a demand-defrost control system, defrosts are terminated based on monitoring a parameter(s) that indicates that frost has been eliminated from the coil. (Note: Systems that vary defrost intervals according to outdoor dry-bulb temperature are not demand-defrost systems.) A demand-defrost control system, which otherwise meets the requirements, may allow time-initiated defrosts if, and only if, such defrosts occur after 6 hours of compressor operating time.
(1) An arrangement of refrigerant-to-air heat transfer coil(s) for transfer of heat between the refrigerant and the indoor air,
(2) A condensate drain pan, and may or may not include
(3) Sheet metal or plastic parts not part of external cabinetry to direct/route airflow over the coil(s),
(4) A cooling mode expansion device,
(5) External cabinetry, and
(6) An integrated indoor blower (
(1) Both the indoor and outdoor unit are shipped with manufacturer-supplied installation instructions that specify installation only in a mobile home with the home and equipment complying with HUD Manufactured Home Construction Safety Standard 24 CFR part 3280;
(2) The indoor unit cannot exceed 0.40 in. wc. when operated at the cooling full-load air volume rate not exceeding 400 cfm per rated ton of cooling; and
(3)The indoor and outdoor unit each must bear a label in at least
(1) The outdoor unit is shipped with manufacturer-supplied installation instructions that specify installation only for mobile homes that comply with HUD Manufactured Home Construction Safety Standard 24 CFR part 3280,
(2) The coil-only indoor unit is shipped with manufacturer-supplied installation instructions that specify installation only in a mobile home furnace, modular blower, or designated air mover that complies with HUD Manufactured Home Construction Safety Standard 24 CFR part 3280, and
(3) The coil-only indoor unit and outdoor unit each has a label in at least
(1) The system consists of one outdoor unit with one or more compressors matched with between two and five indoor units;
(2) The indoor units must:
(i) Collectively, have a nominal cooling capacity greater than or equal to 95 percent and less than or equal to 105 percent of the nominal cooling capacity of the outdoor unit;
(ii) Each represent the highest sales volume model family, if this is possible while meeting all the requirements of this section. If this is not possible, one or more of the indoor units may represent another indoor model family in order that all the other requirements of this section are met.
(iii) Individually not have a nominal cooling capacity greater than 50 percent of the nominal cooling capacity of the outdoor unit, unless the nominal cooling capacity of the outdoor unit is 24,000 Btu/h or less;
(iv) Operate at fan speeds consistent with manufacturer's specifications; and
(v) All be subject to the same minimum external static pressure requirement while able to produce the same external static pressure at the exit of each outlet plenum when connected in a manifold configuration as required by the test procedure.
(3) Where referenced, “nominal cooling capacity” means, for indoor units, the highest cooling capacity listed in published product literature for 95 °F outdoor dry bulb temperature and 80 °F dry bulb, 67 °F wet bulb indoor conditions, and for outdoor units, the lowest cooling capacity listed in published product literature for these conditions. If incomplete or no operating conditions are published, use the highest (for indoor units) or lowest (for outdoor units) such cooling capacity available for sale.
In a second application of the control scheme, one or more parameters are measured (
(A) Test VRF systems using AHRI 1230-2010 (incorporated by reference, see § 430.3) and appendix M. Where AHRI 1230-2010 refers to the appendix C therein substitute the provisions of this appendix. In cases where there is a conflict, the language of the test procedure in this appendix takes precedence over AHRI 1230-2010.
For definitions use section 1 of appendix M and section 3 of AHRI 1230-2010 (incorporated by reference, see § 430.3). For rounding requirements, refer to § 430.23(m). For determination of certified ratings, refer to § 429.16 of this chapter.
For test room requirements, refer to section 2.1 of this appendix. For test unit installation requirements refer to sections 2.2.a, 2.2.b, 2.2.c, 2.2.1, 2.2.2, 2.2.3.a, 2.2.3.c, 2.2.4, 2.2.5, and 2.4 to 2.12 of this appendix, and sections 5.1.3 and 5.1.4 of AHRI 1230-2010. The “manufacturer's published instructions,” as stated in section 8.2 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3) and “manufacturer's installation instructions” discussed in this appendix mean the manufacturer's installation instructions that come packaged with or appear in the labels applied to the unit. This does not include online manuals. Installation instructions that appear in the labels applied to the unit take precedence over installation instructions that are shipped with the unit.
For general requirements for the test procedure, refer to section 3.1 of this appendix, except for sections 3.1.3 and 3.1.4, which are requirements for indoor air volume and outdoor air volume. For indoor air volume and outdoor air volume requirements, refer instead to section 6.1.5 (except where section 6.1.5 refers to Table 8, refer instead to Table 3 of this appendix) and 6.1.6 of AHRI 1230-2010.
For the test method, refer to sections 3.3 to 3.5 and 3.7 to 3.13 of this appendix. For cooling mode and heating mode test conditions, refer to section 6.2 of AHRI 1230-2010. For calculations of seasonal performance descriptors, refer to section 4 of this appendix.
(B) For systems other than VRF, only a subset of the sections listed in this test procedure apply when testing and determining represented values for a particular unit. Table 1 shows the sections of the test procedure that apply to each system. This table is meant to assist manufacturers in finding the appropriate sections of the test procedure; the appendix sections rather than the table provide the specific requirements for testing, and given the varied nature of available units, manufacturers are responsible for determining which sections apply to each unit tested based on the model characteristics. To use this table, first refer to the sections listed under “all units”. Then refer to additional requirements based on:
(1) System configuration(s),
(2) The compressor staging or modulation capability, and
(3) Any special features.
Testing requirements for space-constrained products do not differ from similar equipment that is not space-constrained and thus are not listed separately in this table. Air conditioners and heat pumps are not listed separately in this table, but heating procedures and calculations apply only to heat pumps.
a. Test using two side-by-side rooms: an indoor test room and an outdoor test room. For multiple-split, single-zone-multi-coil or multi-circuit air conditioners and heat pumps, however, use as many indoor test rooms as needed to accommodate the total number of indoor units. These rooms must comply with the requirements specified in sections 8.1.2 and 8.1.3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3).
b. Inside these test rooms, use artificial loads during cyclic tests and frost accumulation tests, if needed, to produce stabilized room air temperatures. For one room, select an electric resistance heater(s) having a heating capacity that is approximately equal to the heating capacity of the test unit's condenser. For the second room, select a heater(s) having a capacity that is close to the sensible cooling capacity of the test unit's evaporator. Cycle the heater located in the same room as the test unit evaporator coil ON and OFF when the test unit cycles ON and OFF. Cycle the heater located in the same room as the test unit condensing coil ON and OFF when the test unit cycles OFF and ON.
a. Install the unit according to section 8.2 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3), subject to the following additional requirements:
(1) When testing split systems, follow the requirements given in section 6.1.3.5 of AHRI 210/240-2008 (incorporated by reference, see § 430.3). For the vapor refrigerant line(s), use the insulation included with the unit; if no insulation is provided, use insulation meeting the specifications for the insulation in the installation instructions included with the unit by the manufacturer; if no insulation is included with the unit and the installation instructions do not contain provisions for insulating the line(s), fully insulate the vapor refrigerant line(s) with vapor proof insulation having an inside diameter that matches the refrigerant tubing and a nominal thickness of at least 0.5 inches. For the liquid refrigerant line(s), use the insulation included with the unit; if no insulation is provided, use insulation meeting the specifications for the insulation in the installation instructions included with the unit by the manufacturer; if no insulation is included with the unit and the installation instructions do not contain provisions for insulating the line(s), leave the liquid refrigerant line(s) exposed to the air for air conditioners and heat pumps that heat and cool; or, for heating-only heat pumps, insulate the liquid refrigerant line(s) with insulation having an inside diameter that matches the refrigerant tubing and a nominal thickness of at least 0.5 inches. Insulation must be the same for the cooling and heating tests.
(2) When testing split systems, if the indoor unit does not ship with a cooling mode expansion device, test the system using the device as specified in the installation instructions provided with the indoor unit. If none is specified, test the system using a fixed orifice or piston type expansion device that is sized appropriately for the system.
(3) When testing triple-split systems (see section 1.2 of this appendix, Definitions), use the tubing length specified in section 6.1.3.5 of AHRI 210/240-2008 (incorporated by reference, see § 430.3) to connect the outdoor coil, indoor compressor section, and indoor coil while still meeting the requirement of exposing 10 feet of the tubing to outside conditions;
(4) When testing split systems having multiple indoor coils, connect each indoor blower coil unit to the outdoor unit using:
(a) 25 feet of tubing, or
(b) Tubing furnished by the manufacturer, whichever is longer.
(5) When testing split systems having multiple indoor coils, expose at least 10 feet of the system interconnection tubing to the outside conditions. If they are needed to make a secondary measurement of capacity or for verification of refrigerant charge, install refrigerant pressure measuring instruments as described in section 8.2.5 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). Section 2.10 of this appendix specifies which secondary methods require refrigerant pressure measurements and section 2.2.5.5 of this appendix discusses use of pressure measurements to verify charge. At a minimum, insulate the low-pressure line(s) of a split system with insulation having an inside diameter that matches the refrigerant tubing and a nominal thickness of 0.5 inch.
b. For units designed for both horizontal and vertical installation or for both up-flow and down-flow vertical installations, use the orientation for testing specified by the manufacturer in the certification report. Conduct testing with the following installed:
(1) The most restrictive filter(s);
(2) Supplementary heating coils; and
(3) Other equipment specified as part of the unit, including all hardware used by a heat comfort controller if so equipped (see section 1 of this appendix, Definitions). For small-duct, high-velocity systems, configure all balance dampers or restrictor devices on or inside the unit to fully open or lowest restriction.
c. Testing a ducted unit without having an indoor air filter installed is permissible as long as the minimum external static pressure requirement is adjusted as stated in Table 3, note 3 (see section 3.1.4 of this appendix). Except as noted in section 3.1.10 of this appendix, prevent the indoor air supplementary heating coils from operating during all tests. For uncased coils, create an enclosure using 1 inch fiberglass foil-faced ductboard having a nominal density of 6 pounds per cubic foot. Or alternatively, construct an enclosure using sheet metal or a similar material and insulating material having a thermal resistance (“R” value) between 4 and 6 hr·ft
d. When testing a coil-only system, install a toroidal-type transformer to power the system's low-voltage components, complying with any additional requirements for the transformer mentioned in the installation manuals included with the unit by the system manufacturer. If the installation manuals do not provide specifications for the transformer, use a transformer having the following features:
(1) A nominal volt-amp rating such that the transformer is loaded between 25 and 90 percent of this rating for the highest level of power measured during the off mode test (section 3.13 of this appendix);
(2) Designed to operate with a primary input of 230 V, single phase, 60 Hz; and
(3) That provides an output voltage that is within the specified range for each low-voltage component. Include the power consumption of the components connected to the transformer as part of the total system power consumption during the off mode tests; do not include the power consumed by the transformer when no load is connected to it.
e. Test an outdoor unit with no match (
(1) Round tubes of outer diameter no less than 0.375 inches, and
(2) A normalized gross indoor fin surface (NGIFS) no greater than 1.0 square inches per British thermal unit per hour (sq. in./Btu/hr). NGIFS is calculated as follows:
g. If pressure measurement devices are connected to refrigerant lines at locations where the refrigerant state changes from liquid to vapor for different parts of the test (
h. For single-split-system coil-only air conditioners, test using an indoor coil that has a normalized gross indoor fin surface (NGIFS) no greater than 2.5 square inches per British thermal unit per hour (sq. in./Btu/hr). NGIFS is calculated as follows:
Set heat pump defrost controls at the normal settings which most typify those encountered in generalized climatic region IV. (Refer to Figure 1 and Table 19 of section 4.2 of this appendix for information on region IV.) For heat pumps that use a time-adaptive defrost control system (see section 1.2 of this appendix, Definitions), the manufacturer must specify in the certification report the frosting interval to be used during frost accumulation tests and provide the procedure for manually initiating the defrost at the specified time.
Configure the multiple-speed outdoor fan according to the installation manual included with the unit by the manufacturer, and thereafter, leave it unchanged for all tests. The controls of the unit must regulate the operation of the outdoor fan during all lab tests except dry coil cooling mode tests. For dry coil cooling mode tests, the outdoor fan must operate at the same speed used during the required wet coil test conducted at the same outdoor test conditions.
Because these systems will have more than one indoor blower and possibly multiple outdoor fans and compressor systems, references in this test procedure to a singular indoor blower, outdoor fan, and/or compressor means all indoor blowers, all outdoor fans, and all compressor systems that are energized during the test.
a. Additional requirements for multi-split air conditioners and heat pumps. For any test where the system is operated at part load (
b. Additional requirements for ducted split systems with a single indoor unit containing multiple indoor blowers (or for single-package units with an indoor section containing multiple indoor blowers) where the indoor blowers are designed to cycle on and off independently of one another and are not controlled such that all indoor blowers are modulated to always operate at the same air volume rate or speed. For any test where the system is operated at its lowest capacity—
c. For test setups where the laboratory's physical limitations require use of more than the required line length of 25 feet as listed in section 2.2.a.(4) of this appendix, then the actual refrigerant line length used by the laboratory may exceed the required length and the refrigerant line length correction factors in Table 4 of AHRI 1230-2010 are applied to the cooling capacity measured for each cooling mode test.
For wet-coil cooling mode tests, regulate the water vapor content of the air entering the indoor unit so that the wet-bulb temperature is as listed in Tables 4 to 7. As noted in these same tables, achieve a wet-bulb temperature during dry-coil cooling mode tests that results in no condensate forming on the indoor coil. Controlling the water vapor content of the air entering the outdoor side of the unit is not required for cooling mode tests except when testing:
(1) Units that reject condensate to the outdoor coil during wet coil tests. Tables 4-7 list the applicable wet-bulb temperatures.
(2) Single-package units where all or part of the indoor section is located in the outdoor test room. The average dew point temperature of the air entering the outdoor coil during wet coil tests must be within ±3.0 °F of the average dew point temperature of the air entering the indoor coil over the 30-minute data collection interval described in section 3.3 of this appendix. For dry coil tests on such units, it may be necessary to limit the moisture content of the air entering the outdoor coil of the unit to meet the requirements of section 3.4 of this appendix.
For heating mode tests, regulate the water vapor content of the air entering the outdoor unit to the applicable wet-bulb temperature listed in Tables 11 to 14. The wet-bulb temperature entering the indoor side of the heat pump must not exceed 60 °F. Additionally, if the Outdoor Air Enthalpy test method (section 2.10.1 of this appendix) is used while testing a single-package heat pump where all or part of the outdoor section is located in the indoor test room, adjust the wet-bulb temperature for the air entering the indoor side to yield an indoor-side dew point temperature that is as close as reasonably possible to the dew point temperature of the outdoor-side entering air.
a. Where the manufacturer's installation instructions contain two sets of refrigerant charging criteria, one for field installations and one for lab testing, use the field installation criteria.
b. For systems consisting of an outdoor unit manufacturer's outdoor section and indoor section with differing charging procedures, adjust the refrigerant charge per the outdoor installation instructions.
c. For systems consisting of an outdoor unit manufacturer's outdoor unit and an independent coil manufacturer's indoor unit with differing charging procedures, adjust the refrigerant charge per the indoor unit's installation instructions. If instructions are provided only with the outdoor unit or are provided only with an independent coil manufacturer's indoor unit, then use the provided instructions.
a. Use the tests or operating conditions specified in the manufacturer's installation instructions for charging. The manufacturer's installation instructions may specify use of tests other than the A or A
b. If the manufacturer's installation instructions do not specify a test or operating conditions for charging or there are no manufacturer's instructions, use the following test(s):
(1) For air conditioners or cooling and heating heat pumps, use the A or A
(2) For cooling and heating heat pumps that do not operate in the H1 or H1
a. Consult the manufacturer's installation instructions regarding which parameters (
b. In the event of conflicting information between charging instructions (
(1) For fixed orifice systems:
(2) For expansion valve systems:
c. If there are no installation instructions and/or they do not provide parameters and target values, set superheat to a target value of 12 °F for fixed orifice systems or set subcooling to a target value of 10 °F for expansion valve systems.
a. If the manufacturer's installation instructions specify tolerances on target values for the charging parameters, set the values within these tolerances.
b. Otherwise, set parameter values within the following test condition tolerances for the different charging parameters:
If, using the initial charge set in the A or A
i. Unless otherwise directed by the manufacturer's installation instructions, install one or more refrigerant line pressure gauges during the setup of the unit, located depending on the parameters used to verify or set charge, as described:
(1) Install a pressure gauge at the location of the service valve on the liquid line if charging is on the basis of subcooling, or high side pressure or corresponding saturation or dew point temperature;
(2) Install a pressure gauge at the location of the service valve on the suction line if charging is on the basis of superheat, or low side pressure or corresponding saturation or dew point temperature.
ii. Use methods for installing pressure gauge(s) at the required location(s) as indicated in manufacturer's instructions if specified.
Perform charging of near-azeotropic and zeotropic refrigerants only with refrigerant in the liquid state.
After charging the system as described in this test procedure, use the set refrigerant charge for all tests used to determine performance. Do not adjust the refrigerant charge at any point during testing. If measurements indicate that refrigerant charge has leaked during the test, repair the refrigerant leak, repeat any necessary set-up steps, and repeat all tests.
If a unit's controls allow for overspeeding the indoor blower (usually on a temporary basis), take the necessary steps to prevent overspeeding during all tests.
a. Set indoor blower airflow-control settings (
b. Express the Cooling full-load air volume rate, the Cooling Minimum Air Volume Rate, and the Cooling Intermediate Air Volume Rate in terms of standard air.
a. Set indoor blower airflow-control settings (
b. Express the heating full-load air volume rate, the heating minimum air volume rate, the heating intermediate air volume rate, and the heating nominal air volume rate in terms of standard air.
2.4 Indoor Coil Inlet and Outlet Duct Connections. Insulate and/or construct the outlet plenum as described in section 2.4.1 of this appendix and, if installed, the inlet plenum described in section 2.4.2 of this appendix with thermal insulation having a nominal overall resistance (R-value) of at least 19 hr·ft
a. Attach a plenum to the outlet of the indoor coil. (Note: For some packaged systems, the indoor coil may be located in the outdoor test room.)
b. For systems having multiple indoor coils, or multiple indoor blowers within a single indoor section, attach a plenum to each indoor coil or indoor blower outlet. In order to reduce the number of required airflow measurement apparati (section 2.6 of this appendix), each such apparatus may serve multiple outlet plenums connected to a single common duct leading to the apparatus. More than one indoor test room may be used, which may use one or more common ducts leading to one or more airflow measurement apparati within each test room that contains multiple indoor coils. At the plane where each plenum enters a common duct, install an adjustable airflow damper and use it to equalize the static pressure in each plenum. The outlet air temperature grid(s) (section 2.5.4 of this appendix) and airflow measuring apparatus shall be located downstream of the inlet(s) to the common duct(s). For multiple-circuit (or multi-circuit) systems for which each indoor coil outlet is measured separately and its outlet plenum is not connected to a common duct connecting multiple outlet plenums, install the outlet air temperature grid and airflow measuring apparatus at each outlet plenum.
c. For small-duct, high-velocity systems, install an outlet plenum that has a diameter that is equal to or less than the value listed in Table 2. The limit depends only on the Cooling full-load air volume rate (see section 3.1.4.1.1 of this appendix) and is effective regardless of the flange dimensions on the outlet of the unit (or an air supply plenum adapter accessory, if installed in accordance with the manufacturer's installation instructions).
d. Add a static pressure tap to each face of the (each) outlet plenum, if rectangular, or at four evenly distributed locations along the circumference of an oval or round plenum. Create a manifold that connects the four static pressure taps. Figure 9 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3) shows allowed options for the manifold configuration. The cross-sectional dimensions of plenum must be equal to the dimensions of the indoor unit outlet. See Figures 7a, 7b, and 7c of ANSI/ASHRAE 37-2009 for the minimum length of the (each) outlet plenum and the locations for adding the static pressure taps for ducted blower coil indoor units and single-package systems. See Figure 8 of ANSI/ASHRAE 37-2009 for coil-only indoor units.
Install an inlet plenum when testing a coil-only indoor unit, a ducted blower coil indoor unit, or a single-package system. See Figures 7b and 7c of ANSI/ASHRAE 37-2009 for cross-sectional dimensions, the minimum length of the inlet plenum, and the locations of the static-pressure taps for ducted blower coil indoor units and single-package systems. See Figure 8 of ANSI/ASHRAE 37-2009 for coil-only indoor units. The inlet plenum duct
Follow instructions for indoor coil air property measurements as described in section 2.14 of this appendix, unless otherwise instructed in this section.
a. Measure the dry-bulb temperature and water vapor content of the air entering and leaving the indoor coil. If needed, use an air sampling device to divert air to a sensor(s) that measures the water vapor content of the air. See section 5.3 of ANSI/ASHRAE 41.1-2013 (incorporated by reference, see § 430.3) for guidance on constructing an air sampling device. No part of the air sampling device or the tubing transferring the sampled air to the sensor must be within two inches of the test chamber floor, and the transfer tubing must be insulated. The sampling device may also be used for measurement of dry bulb temperature by transferring the sampled air to a remotely located sensor(s). The air sampling device and the remotely located temperature sensor(s) may be used to determine the entering air dry bulb temperature during any test. The air sampling device and the remotely located sensor(s) may be used to determine the leaving air dry bulb temperature for all tests except:
(1) Cyclic tests; and
(2) Frost accumulation tests.
b. Install grids of temperature sensors to measure dry bulb temperatures of both the entering and leaving airstreams of the indoor unit. These grids of dry bulb temperature sensors may be used to measure average dry bulb temperature entering and leaving the indoor unit in all cases (as an alternative to the dry bulb sensor measuring the sampled air). The leaving airstream grid is required for measurement of average dry bulb temperature leaving the indoor unit for the two special cases noted in preamble. The grids are also required to measure the air temperature distribution of the entering and leaving airstreams as described in sections 3.1.8 of this appendix. Two such grids may be applied as a thermopile, to directly obtain the average temperature difference rather than directly measuring both entering and leaving average temperatures.
c. Use of airflow prevention devices. Use an inlet and outlet air damper box, or use an inlet upturned duct and an outlet air damper box when conducting one or both of the cyclic tests listed in sections 3.2 and 3.6 of this appendix on ducted systems. If not conducting any cyclic tests, an outlet air damper box is required when testing ducted and non-ducted heat pumps that cycle off the indoor blower during defrost cycles and there is no other means for preventing natural or forced convection through the indoor unit when the indoor blower is off. Never use an inlet damper box or an inlet upturned duct when testing non-ducted indoor units. An inlet upturned duct is a length of ductwork installed upstream from the inlet such that the indoor duct inlet opening, facing upwards, is sufficiently high to prevent natural convection transfer out of the duct. If an inlet upturned duct is used, install a dry bulb temperature sensor near the inlet opening of the indoor duct at a centerline location not higher than the lowest elevation of the duct edges at the inlet, and ensure that any pair of 5-minute averages of the dry bulb temperature at this location, measured at least every minute during the compressor OFF period of the cyclic test, do not differ by more than 1.0 °F.
a. Install an airflow prevention device as specified in section 2.5.1.1 or 2.5.1.2 of this appendix, whichever applies.
b. For an inlet damper box, locate the grid of entering air dry-bulb temperature sensors, if used, and the air sampling device, or the sensor used to measure the water vapor content of the inlet air, at a location immediately upstream of the damper box inlet. For an inlet upturned duct, locate the grid of entering air dry-bulb temperature sensors, if used, and the air sampling device, or the sensor used to measure the water vapor content of the inlet air, at a location at least one foot downstream from the beginning of the insulated portion of the duct but before the static pressure measurement.
2.5.1.1 If the section 2.4.2 inlet plenum is installed, construct the airflow prevention device having a cross-sectional flow area equal to or greater than the flow area of the inlet plenum. Install the airflow prevention device upstream of the inlet plenum and construct ductwork connecting it to the inlet plenum. If needed, use an adaptor plate or a transition duct section to connect the airflow prevention device with the inlet plenum. Insulate the ductwork and inlet plenum with thermal insulation that has a nominal overall resistance (R-value) of at least 19 hr ·ft
2.5.1.2 If the section 2.4.2 inlet plenum is not installed, construct the airflow prevention device having a cross-sectional flow area equal to or greater than the flow area of the air inlet of the indoor unit. Install the airflow prevention device immediately upstream of the inlet of the indoor unit. If needed, use an adaptor plate or a short transition duct section to connect the airflow prevention device with the unit's air inlet. Add static pressure taps at the center of each face of a rectangular airflow prevention device, or at four evenly distributed locations along the circumference of an oval or round airflow prevention device. Locate the pressure taps at a distance from the indoor unit inlet equal to 0.5 times the square root of the cross sectional area of the indoor unit inlet. This location must be between the damper and the inlet of the indoor unit, if a damper is used. Make a manifold that connects the four static pressure taps using one of the configurations shown in Figure 9 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). Insulate the ductwork with thermal insulation that has a nominal overall resistance (R-value) of at least 19 hr·ft
If using the section 2.4.2 inlet plenum and a grid of dry bulb temperature sensors, mount the grid at a location upstream of the static pressure taps described in section 2.4.2 of this appendix, preferably at the entrance plane of the inlet plenum. If the section 2.4.2 inlet plenum is not used (
Fabricate pressure taps meeting all requirements described in section 6.5.2 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3) and illustrated in Figure 2A of AMCA 210-2007 (incorporated by reference, see § 430.3), however, if adhering strictly to the description in section 6.5.2 of ANSI/ASHRAE 37-2009, the minimum pressure tap length of 2.5 times the inner diameter of Figure 2A of AMCA 210-2007 is waived. Use a differential pressure measuring instrument that is accurate to within ±0.01 inches of water and has a resolution of at least 0.01 inches of water to measure the static pressure difference between the indoor coil air inlet and outlet. Connect one side of the differential pressure instrument to the manifolded pressure taps installed in the outlet plenum. Connect the other side of the instrument to the manifolded pressure taps located in either the inlet plenum or incorporated within the airflow prevention device. For non-ducted systems that are tested with multiple outlet plenums, measure the static pressure within each outlet plenum relative to the surrounding atmosphere.
a. Install an interconnecting duct between the outlet plenum described in section 2.4.1 of this appendix and the airflow measuring apparatus described below in section 2.6 of this appendix. The cross-sectional flow area of the interconnecting duct must be equal to or greater than the flow area of the outlet plenum or the common duct used when testing non-ducted units having multiple indoor coils. If needed, use adaptor plates or
b. Install a grid(s) of dry-bulb temperature sensors inside the interconnecting duct. Also, install an air sampling device, or the sensor(s) used to measure the water vapor content of the outlet air, inside the interconnecting duct. Locate the dry-bulb temperature grid(s) upstream of the air sampling device (or the in-duct sensor(s) used to measure the water vapor content of the outlet air). Turn off the sampler fan motor during the cyclic tests. Air leaving an indoor unit that is sampled by an air sampling device for remote water-vapor-content measurement must be returned to the interconnecting duct at a location:
(1) Downstream of the air sampling device;
(2) On the same side of the outlet air damper as the air sampling device; and
(3) Upstream of the section 2.6 airflow measuring apparatus.
If using an outlet air damper box (see section 2.5 of this appendix), the leakage rate from the combination of the outlet plenum, the closed damper, and the duct section that connects these two components must not exceed 20 cubic feet per minute when a negative pressure of 1 inch of water column is maintained at the plenum's inlet.
Use these procedures if necessary to correct temperature maldistributions. Install a mixing device(s) upstream of the outlet air, dry-bulb temperature grid (but downstream of the outlet plenum static pressure taps). Use a perforated screen located between the mixing device and the dry-bulb temperature grid, with a maximum open area of 40 percent. One or both items should help to meet the maximum outlet air temperature distribution specified in section 3.1.8 of this appendix. Mixing devices are described in sections 5.3.2 and 5.3.3 of ANSI/ASHRAE 41.1-2013 and section 5.2.2 of ASHRAE 41.2-1987 (RA 1992) (incorporated by reference, see § 430.3).
For small-duct, high-velocity systems, install an air damper near the end of the interconnecting duct, just prior to the transition to the airflow measuring apparatus of section 2.6 of this appendix. To minimize air leakage, adjust this damper such that the pressure in the receiving chamber of the airflow measuring apparatus is no more than 0.5 inch of water higher than the surrounding test room ambient. If applicable, in lieu of installing a separate damper, use the outlet air damper box of sections 2.5 and 2.5.4.1 of this appendix if it allows variable positioning. Also apply these steps to any conventional indoor blower unit that creates a static pressure within the receiving chamber of the airflow measuring apparatus that exceeds the test room ambient pressure by more than 0.5 inches of water column.
a. Measure dry bulb temperatures as specified in sections 4, 5.3, 6, and 7 of ANSI/ASHRAE 41.1-2013 (incorporated by reference, see § 430.3).
b. Distribute the sensors of a dry-bulb temperature grid over the entire flow area. The required minimum is 9 sensors per grid.
Determine water vapor content by measuring dry-bulb temperature combined with the air wet-bulb temperature, dew point temperature, or relative humidity. If used, construct and apply wet-bulb temperature sensors as specified in sections 4, 5, 6, 7.2, 7.3, and 7.4 of ASHRAE 41.6-2014 (incorporated by reference, see § 430.3). The temperature sensor (wick removed) must be accurate to within ±0.2 °F. If used, apply dew point hygrometers as specified in sections 4, 5, 6, 7.1, and 7.4 of ASHRAE 41.6-2014. The dew point hygrometers must be accurate to within ±0.4 °F when operated at conditions that result in the evaluation of dew points above 35 °F. If used, a relative humidity (RH) meter must be accurate to within ±0.7% RH. Other means to determine the psychrometric state of air may be used as long as the measurement accuracy is equivalent to or better than the accuracy achieved from using a wet-bulb temperature sensor that meets the above specifications.
If used (see section 2.5 of this appendix), the air damper box(es) must be capable of being completely opened or completely closed within 10 seconds for each action.
a. Fabricate and operate an airflow measuring apparatus as specified in section 6.2 and 6.3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). Place the static pressure taps and position the diffusion baffle (settling means) relative to the chamber inlet as indicated in Figure 12 of AMCA 210-07 and/or Figure 14 of ASHRAE 41.2-1987 (RA 1992) (incorporated by reference, see § 430.3). When measuring the static pressure difference across nozzles and/or velocity pressure at nozzle throats using electronic pressure transducers and a data acquisition system, if high frequency fluctuations cause measurement variations to exceed the test tolerance limits specified in section 9.2 of this appendix and Table 2 of ANSI/ASHRAE 37-2009, dampen the measurement system such that the time constant associated with response to a step change in measurement (time for the response to change 63% of the way from the initial output to the final output) is no longer than five seconds.
b. Connect the airflow measuring apparatus to the interconnecting duct section described in section 2.5.4 of this appendix. See sections 6.1.1, 6.1.2, and 6.1.4, and Figures 1, 2, and 4 of ANSI/ASHRAE 37-2009; and Figures D1, D2, and D4 of AHRI 210/240-2008 (incorporated by reference, see § 430.3) with Addendum 1 and 2 for illustrative examples of how the test apparatus may be applied within a complete laboratory set-up. Instead of following one of these examples, an alternative set-up may be used to handle the air leaving the airflow measuring apparatus and to supply properly conditioned air to the test unit's inlet. The alternative set-up, however, must not interfere with the prescribed means for measuring airflow rate, inlet and outlet air temperatures, inlet and outlet water vapor contents, and external static pressures, nor create abnormal conditions surrounding the test unit. (Note: Do not use an enclosure as described in section 6.1.3 of ANSI/ASHRAE 37-2009 when testing triple-split units.)
Perform all tests at the voltage specified in section 6.1.3.2 of AHRI 210/240-2008 (incorporated by reference, see § 430.3) for “Standard Rating Tests.” If either the indoor or the outdoor unit has a 208V or 200V nameplate voltage and the other unit has a 230V nameplate rating, select the voltage supply on the outdoor unit for testing. Otherwise, supply each unit with its own nameplate voltage. Measure the supply voltage at the terminals on the test unit using a volt meter that provides a reading that is accurate to within ±1.0 percent of the measured quantity.
a. Use an integrating power (watt-hour) measuring system to determine the electrical energy or average electrical power supplied to all components of the air conditioner or heat pump (including auxiliary components such as controls, transformers, crankcase heater, integral condensate pump on non-ducted indoor units, etc.). The watt-hour measuring system must give readings that are accurate to within ±0.5 percent. For cyclic tests, this accuracy is required during both the ON and OFF cycles. Use either two different scales on the same watt-hour meter or two separate watt-hour meters. Activate the scale or meter having the lower power rating within 15 seconds after beginning an OFF cycle. Activate the scale or meter having the higher power rating within 15 seconds prior to beginning an ON cycle. For ducted blower coil systems, the ON cycle lasts from compressor ON to indoor blower OFF. For ducted coil-only systems, the ON cycle lasts from compressor ON to compressor OFF. For non-ducted units, the ON cycle lasts from indoor blower ON to indoor blower OFF. When testing air conditioners and heat pumps having a variable-speed compressor, avoid using an induction watt/watt-hour meter.
b. When performing section 3.5 and/or 3.8 cyclic tests on non-ducted units, provide instrumentation to determine the average electrical power consumption of the indoor blower motor to within ±1.0 percent. If required according to sections 3.3, 3.4, 3.7, 3.9.1 of this appendix, and/or 3.10 of this appendix, this same instrumentation requirement (to determine the average electrical power consumption of the indoor blower motor to within ±1.0 percent) applies when testing air conditioners and heat pumps having a variable-speed constant-air-volume-rate indoor blower or a variable-speed, variable-air-volume-rate indoor blower.
Make elapsed time measurements using an instrument that yields readings accurate to within ±0.2 percent.
For all tests, use the indoor air enthalpy method to measure the unit's capacity. This method uses the test set-up specified in sections 2.4 to 2.6 of this appendix. In addition, for all steady-state tests, conduct a second, independent measurement of capacity as described in section 3.1.1 of this appendix. For split systems, use one of the following secondary measurement methods: outdoor air enthalpy method, compressor calibration method, or refrigerant enthalpy method. For single-package units, use either the outdoor air enthalpy method or the compressor calibration method as the secondary measurement.
a. To make a secondary measurement of indoor space conditioning capacity using the outdoor air enthalpy method, do the following:
(1) Measure the electrical power consumption of the test unit;
(2) Measure the air-side capacity at the outdoor coil; and
(3) Apply a heat balance on the refrigerant cycle.
b. The test apparatus required for the outdoor air enthalpy method is a subset of the apparatus used for the indoor air enthalpy method. Required apparatus includes the following:
(1) On the outlet side, an outlet plenum containing static pressure taps (sections 2.4, 2.4.1, and 2.5.3 of this appendix),
(2) An airflow measuring apparatus (section 2.6 of this appendix),
(3) A duct section that connects these two components and itself contains the instrumentation for measuring the dry-bulb temperature and water vapor content of the air leaving the outdoor coil (sections 2.5.4, 2.5.5, and 2.5.6 of this appendix), and
(4) On the inlet side, a sampling device and temperature grid (section 2.11.b of this appendix).
c. During the non-ducted tests described in sections 3.11.1 and 3.11.1.1 of this appendix, measure the evaporator and condenser temperatures or pressures. On both the outdoor coil and the indoor coil, solder a thermocouple onto a return bend located at or near the midpoint of each coil or at points not affected by vapor superheat or liquid subcooling. Alternatively, if the test unit is not sensitive to the refrigerant charge, install pressure gages to the access valves or to ports created from tapping into the suction and discharge lines according to sections 7.4.2 and 8.2.5 of ASHRAE 37-2009. Use this alternative approach when testing a unit charged with a zeotropic refrigerant having a temperature glide in excess of 1 °F at the specified test conditions.
Measure refrigerant pressures and temperatures to determine the evaporator superheat and the enthalpy of the refrigerant that enters and exits the indoor coil. Determine refrigerant flow rate or, when the superheat of the refrigerant leaving the evaporator is less than 5 °F, total capacity from separate calibration tests conducted under identical operating conditions. When using this method, install instrumentation and measure refrigerant properties according to section 7.4.2 and 8.2.5 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). If removing the refrigerant before applying refrigerant lines and subsequently recharging, use the steps in 7.4.2 of ANSI/ASHRAE 37-2009 in addition to the methods of section 2.2.5 of this appendix to confirm the refrigerant charge. Use refrigerant temperature and pressure measuring instruments that meet the specifications given in sections 5.1.1 and 5.2 of ANSI/ASHRAE 37-2009.
For this method, calculate space conditioning capacity by determining the refrigerant enthalpy change for the indoor coil and directly measuring the refrigerant flow rate. Use section 7.5.2 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3) for the requirements for this method, including the additional instrumentation requirements, and information on placing the flow meter and a sight glass. Use refrigerant temperature, pressure, and flow measuring instruments that meet the specifications given in sections 5.1.1, 5.2, and 5.5.1 of ANSI/ASHRAE 37-2009. Refrigerant flow measurement device(s), if used, must be either elevated at least two feet from the test chamber floor or placed upon insulating material having a total thermal resistance of at least R-12 and extending at least one foot laterally beyond each side of the device(s)' exposed surfaces.
Follow instructions for setting up air sampling device and aspirating psychrometer as described in section 2.14 of this appendix, unless otherwise instructed in this section.
a. If using a test set-up where air is ducted directly from the conditioning apparatus to the indoor coil inlet (see Figure 2, Loop Air-Enthalpy Test Method Arrangement, of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3)), add instrumentation to permit measurement of the indoor test room dry-bulb temperature.
b. On the outdoor side, use one of the following two approaches, except that approach (1) is required for all evaporatively-cooled units and units that transfer condensate to the outdoor unit for evaporation using condenser heat.
(1) Use sampling tree air collection on all air-inlet surfaces of the outdoor unit.
(2) Use sampling tree air collection on one or more faces of the outdoor unit and demonstrate air temperature uniformity as follows. Install a grid of evenly-distributed thermocouples on each air-permitting face on the inlet of the outdoor unit. Install the thermocouples on the air sampling device, locate them individually or attach them to a wire structure. If not installed on the air sampling device, install the thermocouple grid 6 to 24 inches from the unit. Evenly space the thermocouples across the coil inlet surface and install them to avoid sampling of discharge air or blockage of air recirculation. The grid of thermocouples must provide at least 16 measuring points per face or one measurement per square foot of inlet face area, whichever is less. Construct this grid and use as per section 5.3 of ANSI/ASHRAE 41.1-2013 (incorporated by reference, see § 430.3). The maximum difference between the average temperatures measured during the test period of any two pairs of these individual thermocouples located at any of the faces of the inlet of the outdoor unit, must not exceed 2.0 °F, otherwise use approach (1).
Locate the air sampling devices at the geometric center of each side; the branches may be oriented either parallel or perpendicular to the longer edges of the air inlet area. Size the air sampling devices in the outdoor air inlet location such that they cover at least 75% of the face area of the side of the coil that they are measuring.
Review air distribution at the test facility point of supply to the unit and remediate as necessary prior to the beginning of testing. Mixing fans can be used to ensure adequate air distribution in the test room. If used, orient mixing fans such that they are pointed away from the air intake so that the mixing fan exhaust does not affect the outdoor coil air volume rate. Particular attention should be given to prevent the mixing fans from affecting (enhancing or limiting) recirculation of condenser fan exhaust air back through the unit. Any fan used to enhance test room air mixing shall not cause air velocities in the vicinity of the test unit to exceed 500 feet per minute
The air sampling device may be larger than the face area of the side being measured. Take care, however, to prevent discharge air from being sampled. If an air sampling device dimension extends beyond the inlet area of the unit, block holes in the air sampling device to prevent sampling of discharge air. Holes can be blocked to reduce the region of coverage of the intake holes both in the direction of the trunk axis or perpendicular to the trunk axis. For intake hole region reduction in the direction of the trunk axis, block holes of one or more adjacent pairs of branches (the branches of a pair connect opposite each other at the same trunk location) at either the outlet end or the closed end of the trunk. For intake hole region reduction perpendicular to the trunk axis, block off the same number of holes on each branch on both sides of the trunk.
Connect a maximum of four (4) air sampling devices to each aspirating psychrometer. In order to proportionately divide the flow stream for multiple air sampling devices for a given aspirating psychrometer, the tubing or conduit conveying sampled air to the psychrometer must be of equivalent lengths for each air sampling device. Preferentially, the air sampling device should be hard connected to the aspirating psychrometer, but if space constraints do not allow this, the assembly shall have a means of allowing a flexible tube to connect the air sampling device to the aspirating psychrometer. Insulate and route the tubing or conduit to prevent heat transfer to the air stream. Insulate any surface of the
Take pairs of measurements (
When required, measure fan speed using a revolution counter, tachometer, or stroboscope that gives readings accurate to within ±1.0 percent.
Determine the average barometric pressure during each test. Use an instrument that meets the requirements specified in section 5.2 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3).
Make air temperature measurements in accordance with ANSI/ASHRAE 41.1-2013 (incorporated by reference, see § 430.3), unless otherwise instructed in this section.
The air sampling device is intended to draw in a sample of the air at the critical locations of a unit under test. Construct the device from stainless steel, plastic or other suitable, durable materials. It shall have a main flow trunk tube with a series of branch tubes connected to the trunk tube. Holes must be on the side of the sampler facing the upstream direction of the air source. Use other sizes and rectangular shapes, and scale them accordingly with the following guidelines:
The minimum average velocity through the air sampling device holes must be 2.5 ft/s as determined by evaluating the sum of the open area of the holes as compared to the flow area in the aspirating psychrometer.
The psychrometer consists of a flow section and a fan to draw air through the flow section and measures an average value of the sampled air stream. At a minimum, the flow section shall have a means for measuring the dry bulb temperature (typically, a resistance temperature device (RTD) and a means for measuring the humidity (RTD with wetted sock, chilled mirror hygrometer, or relative humidity sensor). The aspirating psychrometer shall include a fan that either can be adjusted manually or automatically to maintain required velocity across the sensors.
Construct the psychrometer using suitable material which may be plastic (such as polycarbonate), aluminum or other metallic materials. Construct all psychrometers for a given system being tested, using the same material. Design the psychrometers such that radiant heat from the motor (for driving the fan that draws sampled air through the psychrometer) does not affect sensor measurements. For aspirating psychrometers, velocity across the wet bulb sensor must be 1000 ± 200 ft/min. For all other psychrometers, velocity must be as specified by the sensor manufacturer.
If, during the testing process, an equipment set-up adjustment is made that would have altered the performance of the unit during any already completed test, then repeat all tests affected by the adjustment. For cyclic tests, instead of maintaining an air volume rate, for each airflow nozzle, maintain the static pressure difference or velocity pressure during an ON period at the same pressure difference or velocity pressure as measured during the steady-state test conducted at the same test conditions.
Use the testing procedures in this section to collect the data used for calculating:
(1) Performance metrics for central air conditioners and heat pumps during the cooling season;
(2) Performance metrics for heat pumps during the heating season; and
(3) Power consumption metric(s) for central air conditioners and heat pumps during the off mode season(s).
For all tests, use the indoor air enthalpy method test apparatus to determine the unit's space conditioning capacity. The procedure and data collected, however, differ slightly depending upon whether the test is a steady-state test, a cyclic test, or a frost accumulation test. The following sections described these differences. For all steady-state tests (
Where needed, the manufacturer must provide a means for overriding the controls of the test unit so that the compressor(s) operates at the specified speed or capacity and the indoor blower operates at the specified speed or delivers the specified air volume rate.
For all tests, meet the requirements given in section 6.1.3.4 of AHRI 210/240-2008 (incorporated by reference, see § 430.3) when obtaining the airflow through the outdoor coil.
For products intended to be installed with the outdoor airflow ducted, install the unit with outdoor coil ductwork installed per manufacturer installation instructions. The unit must operate between 0.10 and 0.15 in H
Determine airflow setting(s) before testing begins. Unless otherwise specified within this or its subsections, make no changes to the airflow setting(s) after initiation of testing.
Identify the certified Cooling full-load air volume rate and certified instructions for setting fan speed or controls. If there is no certified Cooling full-load air volume rate, use a value equal to the certified cooling capacity of the unit times 400 scfm per 12,000 Btu/h. If there are no instructions for setting fan speed or controls, use the as-shipped settings. Use the following procedure to confirm and, if necessary, adjust the Cooling full-load air volume rate and the fan speed or control settings to meet each test procedure requirement:
a. For all ducted blower coil systems, except those having a constant-air-volume-rate indoor blower:
Step (1) Operate the unit under conditions specified for the A (for single-stage units) or A
Step (2) Measure the external static pressure;
Step (3) If this external static pressure is equal to or greater than the applicable minimum external static pressure cited in Table 3, the pressure requirement is satisfied; proceed to step 7 of this section. If this external static pressure is not equal to or greater than the applicable minimum external static pressure cited in Table 3, proceed to step 4 of this section;
Step (4) Increase the external static pressure by adjusting the exhaust fan of the airflow measuring apparatus until either
(i) The applicable Table 3 minimum is equaled or
(ii) The measured air volume rate equals 90 percent or less of the Cooling full-load air volume rate, whichever occurs first;
Step (5) If the conditions of step 4 (i) of this section occur first, the pressure requirement is satisfied; proceed to step 7 of this section. If the conditions of step 4 (ii) of this section occur first, proceed to step 6 of this section;
Step (6) Make an incremental change to the setup of the indoor blower (
Step (7) The airflow constraints have been satisfied. Use the measured air volume rate as the Cooling full-load air volume rate. Use the final fan speed or control settings for all tests that use the Cooling full-load air volume rate.
b. For ducted blower coil systems with a constant-air-volume-rate indoor blower. For all tests that specify the Cooling full-load air volume rate, obtain an external static pressure as close to (but not less than) the applicable Table 3 value that does not cause automatic shutdown of the indoor blower or air volume rate variation Q
Additional test steps as described in section 3.3.e of this appendix are required if the measured external static pressure exceeds the target value by more than 0.03 inches of water.
c. For coil-only indoor units. For the A or A
d. For ducted systems having multiple indoor blowers within a single indoor section, obtain the full-load air volume rate with all indoor blowers operating unless prevented by the controls of the unit. In such cases, turn on the maximum number of indoor blowers permitted by the unit's controls. Where more than one option exists for meeting this “on” indoor blower requirement, which indoor blower(s) are turned on must match that specified in the certification report. Conduct section 3.1.4.1.1 setup steps for each indoor blower separately. If two or more indoor blowers are connected to a common duct as per section 2.4.1 of this appendix, temporarily divert their air volume to the test room when confirming or adjusting the setup configuration of individual indoor blowers. The allocation of the system's full-load air volume rate assigned to each “on” indoor blower must match that specified by the manufacturer in the certification report.
For non-ducted units, the Cooling full-load air volume rate is the air volume rate that results during each test when the unit is operated at an external static pressure of zero inches of water.
Identify the certified cooling minimum air volume rate and certified instructions for setting fan speed or controls. If there is no certified cooling minimum air volume rate, use the final indoor blower control settings as determined when setting the cooling full-load air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling full load air volume obtained in section 3.1.4.1 of this appendix. Otherwise, calculate the target external static pressure and follow instructions a, b, c, d, or e below. The target external static pressure, ΔP
a. For a ducted blower coil system without a constant-air-volume indoor blower, adjust for external static pressure as follows:
Step (1) Operate the unit under conditions specified for the B
Step (2) Measure the external static pressure;
Step (3) If this pressure is equal to or greater than the minimum external static pressure computed above, the pressure requirement is satisfied; proceed to step 7 of this section. If this pressure is not equal to or greater than the minimum external static pressure computed above, proceed to step 4 of this section;
Step (4) Increase the external static pressure by adjusting the exhaust fan of the airflow measuring apparatus until either
(i) The pressure is equal to the minimum external static pressure computed above or
(ii) The measured air volume rate equals 90 percent or less of the cooling minimum air volume rate, whichever occurs first;
Step (5) If the conditions of step 4 (i) of this section occur first, the pressure requirement is satisfied; proceed to step 7 of this section. If the conditions of step 4 (ii) of this section occur first, proceed to step 6 of this section;
Step (6) Make an incremental change to the setup of the indoor blower (
Step (7) The airflow constraints have been satisfied. Use the measured air volume rate as the cooling minimum air volume rate. Use the final fan speed or control settings for all tests that use the cooling minimum air volume rate.
b. For ducted units with constant-air-volume indoor blowers, conduct all tests that specify the cooling minimum air volume rate—(
c. For ducted two-capacity coil-only systems, the cooling minimum air volume rate is the higher of—
(1) The rate specified by the installation instructions included with the unit by the manufacturer; or
(2) 75 percent of the cooling full-load air volume rate. During the laboratory tests on a coil-only (fanless) system, obtain this cooling minimum air volume rate regardless of the pressure drop across the indoor coil assembly.
d. For non-ducted units, the cooling minimum air volume rate is the air volume rate that results during each test when the unit operates at an external static pressure of zero inches of water and at the indoor blower setting used at low compressor capacity (two-capacity system) or minimum compressor speed (variable-speed system). For units having a single-speed compressor and a variable-speed variable-air-volume-rate indoor blower, use the lowest fan setting allowed for cooling.
e. For ducted systems having multiple indoor blowers within a single indoor section, operate the indoor blowers such that the lowest air volume rate allowed by the unit's controls is obtained when operating the lone single-speed compressor or when operating at low compressor capacity while meeting the requirements of section 2.2.3.2 of this appendix for the minimum number of blowers that must be turned off. Using the target external static pressure and the certified air volume rates, follow the procedures described in section 3.1.4.2.a of this appendix if the indoor blowers are not constant-air-volume indoor blowers or as described in section 3.1.4.2.b of this appendix if the indoor blowers are not constant-air-volume indoor blowers. The sum of the individual “on” indoor blowers' air volume rates is the cooling minimum air volume rate for the system.
Identify the certified cooling intermediate air volume rate and certified instructions for setting fan speed or controls. If there is no certified cooling intermediate air volume rate, use the final indoor blower control settings as determined when setting the cooling full load air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling full load air volume obtained in section 3.1.4.1 of this appendix. Otherwise, calculate target minimum external static pressure as described in section 3.1.4.2 of this appendix, and set the air volume rate as follows.
a. For a ducted blower coil system without a constant-air-volume indoor blower, adjust for external static pressure as described in section 3.1.4.2.a of this appendix for cooling minimum air volume rate.
b. For a ducted blower coil system with a constant-air-volume indoor blower, conduct the E
c. For non-ducted units, the cooling intermediate air volume rate is the air volume rate that results when the unit operates at an external static pressure of zero inches of water and at the fan speed selected by the controls of the unit for the E
a. Use the Cooling full-load air volume rate as the heating full-load air volume rate for:
(1) Ducted blower coil system heat pumps that do not have a constant-air-volume indoor blower, and that operate at the same airflow-control setting during both the A (or A
(2) Ducted blower coil system heat pumps with constant-air-flow indoor blowers that provide the same airflow for the A (or A
(3) Ducted heat pumps that are tested with a coil-only indoor unit (except two-capacity northern heat pumps that are tested only at low capacity cooling—see section 3.1.4.4.2 of this appendix).
b. For heat pumps that meet the above criteria “1” and “3,” no minimum requirements apply to the measured external or internal, respectively, static pressure. Use the final indoor blower control settings as determined when setting the Cooling full-load air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling full-load air volume obtained in section 3.1.4.1 of this appendix. For heat pumps that meet the above criterion “2,” test at an external static pressure that does not cause an automatic shutdown of the indoor blower or air volume rate variation Q
Identify the certified heating full-load air volume rate and certified instructions for setting fan speed or controls. If there is no certified heating full-load air volume rate, use the final indoor blower control settings as determined when setting the cooling full-load air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling full-load air volume obtained in section 3.1.4.1 of this appendix. Otherwise, calculate the target minimum external static pressure as described in section 3.1.4.2 of this appendix and set the air volume rate as follows.
a. For ducted blower coil system heat pumps that do not have a constant-air-volume indoor blower, adjust for external static pressure as described in section 3.1.4.2.a of this appendix for cooling minimum air volume rate.
b. For ducted heat pumps tested with constant-air-volume indoor blowers installed, conduct all tests that specify the heating full-load air volume rate at an external static pressure that does not cause an automatic shutdown of the indoor blower or air volume rate variation Q
c. When testing ducted, two-capacity blower coil system northern heat pumps (see section 1.2 of this appendix, Definitions), use the appropriate approach of the above two cases. For coil-only system northern heat pumps, the heating full-load air volume rate is the lesser of the rate specified by the manufacturer in the installation instructions included with the unit or 133 percent of the cooling full-load air volume rate. For this latter case, obtain the heating full-load air volume rate regardless of the pressure drop across the indoor coil assembly.
d. For ducted systems having multiple indoor blowers within a single indoor section, obtain the heating full-load air volume rate using the same “on” indoor blowers as used for the Cooling full-load air volume rate. Using the target external static pressure and the certified air volume rates, follow the procedures as described in section 3.1.4.4.2.a of this appendix if the indoor blowers are not constant-air-volume indoor blowers or as described in section 3.1.4.4.2.b of this appendix if the indoor blowers are constant-air-volume indoor blowers. The sum of the individual “on” indoor blowers' air volume rates is the heating full-load air volume rate for the system.
Identify the certified heating full-load air volume rate and certified instructions for setting fan speed or controls. If there is no certified heating full-load air volume rate, use a value equal to the certified heating capacity of the unit times 400 scfm per 12,000 Btu/h. If there are no instructions for setting fan speed or controls, use the as-shipped settings.
a. For all ducted heating-only blower coil system heat pumps, except those having a constant-air-volume-rate indoor blower. Conduct the following steps only during the first test, the H1 or H1
Step (1) Adjust the exhaust fan of the airflow measuring apparatus to achieve the certified heating full-load air volume rate.
Step (2) Measure the external static pressure.
Step (3) If this pressure is equal to or greater than the Table 3 minimum external static pressure that applies given the heating-only heat pump's rated heating capacity, the pressure requirement is satisfied; proceed to step 7 of this section. If this pressure is not
Step (4) Increase the external static pressure by adjusting the exhaust fan of the airflow measuring apparatus until either—
(i) The pressure is equal to the applicable Table 3 minimum external static pressure; or (ii) The measured air volume rate equals 90 percent or less of the heating full-load air volume rate, whichever occurs first;
Step (5) If the conditions of step 4 (i) of this section occur first, the pressure requirement is satisfied; proceed to step 7 of this section. If the conditions of step 4 (ii) of this section occur first, proceed to step 6 of this section;
Step (6) Make an incremental change to the setup of the indoor blower (
Step (7) The airflow constraints have been satisfied. Use the measured air volume rate as the heating full-load air volume rate. Use the final fan speed or control settings for all tests that use the heating full-load air volume rate.
b. For ducted heating-only blower coil system heat pumps having a constant-air-volume-rate indoor blower. For all tests that specify the heating full-load air volume rate, obtain an external static pressure that does not cause an automatic shutdown of the indoor blower or air volume rate variation Q
c. For ducted heating-only coil-only system heat pumps in the H1 or H1
For non-ducted heat pumps, the heating full-load air volume rate is the air volume rate that results during each test when the unit operates at an external static pressure of zero inches of water.
a. Use the cooling minimum air volume rate as the heating minimum air volume rate for:
(1) Ducted blower coil system heat pumps that do not have a constant-air-volume indoor blower, and that operates at the same airflow-control setting during both the A
(2) Ducted blower coil system heat pumps with constant-air-flow indoor blowers installed that provide the same airflow for the A
(3) Ducted coil-only system heat pumps.
b. For heat pumps that meet the above criteria “1” and “3,” no minimum requirements apply to the measured external or internal, respectively, static pressure. Use the final indoor blower control settings as determined when setting the cooling minimum air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling minimum air volume rate obtained in section 3.1.4.2 of this appendix. For heat pumps that meet the above criterion “2,” test at an external static pressure that does not cause an automatic shutdown of the indoor blower or air volume rate variation Q
Identify the certified heating minimum air volume rate and certified instructions for setting fan speed or controls. If there is no certified heating minimum air volume rate, use the final indoor blower control settings as determined when setting the cooling minimum air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling minimum air volume obtained in section 3.1.4.2 of this appendix. Otherwise, calculate the target minimum external static pressure as described in section 3.1.4.2 of this appendix.
a. For ducted blower coil system heat pumps that do not have a constant-air-volume indoor blower, adjust for external static pressure as described in section 3.1.4.2.a of this appendix for cooling minimum air volume rate.
b. For ducted heat pumps tested with constant-air-volume indoor blowers installed, conduct all tests that specify the heating minimum air volume rate—(
c. For ducted two-capacity blower coil system northern heat pumps, use the appropriate approach of the above two cases.
d. For ducted two-capacity coil-only system heat pumps, use the cooling minimum air volume rate as the heating minimum air volume rate. For ducted two-capacity coil-only system northern heat pumps, use the cooling full-load air volume rate as the heating minimum air volume rate. For ducted two-capacity heating-only coil-only system heat pumps, the heating minimum air volume rate is the higher of the rate specified by the manufacturer in the test setup instructions included with the unit or 75 percent of the heating full-load air volume rate. During the laboratory tests on a coil-only system, obtain the heating minimum air volume rate without regard to the pressure drop across the indoor coil assembly.
e. For non-ducted heat pumps, the heating minimum air volume rate is the air volume rate that results during each test when the unit operates at an external static pressure of zero inches of water and at the indoor blower setting used at low compressor capacity (two-capacity system) or minimum compressor speed (variable-speed system). For units having a single-speed compressor and a variable-speed, variable-air-volume-rate indoor blower, use the lowest fan setting allowed for heating.
f. For ducted systems with multiple indoor blowers within a single indoor section, obtain the heating minimum air volume rate using the same “on” indoor blowers as used for the cooling minimum air volume rate. Using the target external static pressure and the certified air volume rates, follow the procedures as described in section 3.1.4.5.2.a of this appendix if the indoor blowers are not constant-air-volume indoor blowers or as described in section 3.1.4.5.2.b of this appendix if the indoor blowers are constant-air-volume indoor blowers. The sum of the individual “on” indoor blowers' air volume rates is the heating full-load air volume rate for the system.
Identify the certified heating intermediate air volume rate and certified instructions for setting fan speed or controls. If there is no certified heating intermediate air volume rate, use the final indoor blower control settings as determined when setting the heating full-load air volume rate, and readjust the exhaust fan of the airflow measuring apparatus if necessary to reset to the cooling full-load air volume obtained in section 3.1.4.2 of this appendix. Calculate the target minimum external static pressure as described in section 3.1.4.2 of this appendix.
a. For ducted blower coil system heat pumps that do not have a constant-air-volume indoor blower, adjust for external static pressure as described in section 3.1.4.2.a of this appendix for cooling minimum air volume rate.
b. For ducted heat pumps tested with constant-air-volume indoor blowers installed, conduct the H2
c. For non-ducted heat pumps, the heating intermediate air volume rate is the air volume rate that results when the heat pump operates at an external static pressure of zero inches of water and at the fan speed selected by the controls of the unit for the H2
The manufacturer must specify the heating nominal air volume rate and the instructions for setting fan speed or controls. Calculate target minimum external static pressure as described in section 3.1.4.2 of this appendix. Make adjustments as described in section 3.14.6 of this appendix for heating intermediate air volume rate so that the target minimum external static pressure is met or exceeded.
If using a test set-up where air is ducted directly from the air reconditioning apparatus to the indoor coil inlet (see Figure 2, Loop Air-Enthalpy Test Method Arrangement, of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3)), maintain the dry bulb temperature within the test room within ±5.0 °F of the applicable sections 3.2 and 3.6 dry bulb temperature test condition for the air entering the indoor unit. Dew point must be within 2 °F of the required inlet conditions.
For all steady-state tests and for frost accumulation (H2, H2
(Note: In the first printing of ANSI/ASHRAE 37-2009, the second IP equation for
Before making test measurements used to calculate performance, operate the equipment for the “break-in” period specified in the certification report, which may not exceed 20 hours. Each compressor of the unit must undergo this “break-in” period. When testing a ducted unit (except if a heating-only heat pump), conduct the A or A
For at least the first cooling mode test and the first heating mode test, monitor the temperature distribution of the air leaving the indoor coil using the grid of individual sensors described in sections 2.5 and 2.5.4 of this appendix. For the 30-minute data collection interval used to determine capacity, the maximum spread among the outlet dry bulb temperatures from any data sampling must not exceed 1.5 °F. Install the mixing devices described in section 2.5.4.2 of this appendix to minimize the temperature spread.
Monitor the temperatures of the air entering the outdoor coil using air sampling devices and/or temperature sensor grids, maintaining the required tolerances, if applicable, as described in section 2.11 of this appendix.
Except as noted, disable heat pump resistance elements used for heating indoor air at all times, including during defrost cycles and if they are normally regulated by a heat comfort controller. For heat pumps equipped with a heat comfort controller, enable the heat pump resistance elements only during the below-described, short test. For single-speed heat pumps covered under section 3.6.1 of this appendix, the short test follows the H1 or, if conducted, the H1C Test. For two-capacity heat pumps and heat pumps covered under section 3.6.2 of this appendix, the short test follows the H1
This set of tests is for single-speed-compressor units that do not have a cooling minimum air volume rate or a cooling intermediate air volume rate that is different than the cooling full load air volume rate. Conduct two steady-state wet coil tests, the A and B Tests. Use the two optional dry-coil tests, the steady-state C Test and the cyclic D Test, to determine the cooling mode cyclic degradation coefficient, C
Conduct four steady-state wet coil tests: The A
The testing requirements are the same as specified in section 3.2.1 of this appendix and Table 4. Use a cooling full-load air volume rate that represents a normal installation. If performed, conduct the steady-state C Test and the cyclic D Test with the unit operating in the same S/T capacity control mode as used for the B Test.
a. Conduct four steady-state wet coil tests: the A
b. For units having a variable speed indoor blower that is modulated to adjust the sensible to total (S/T) cooling capacity ratio, use cooling full-load and cooling minimum air volume rates that represent a normal installation. Additionally, if conducting the dry-coil tests, operate the unit in the same S/T capacity control mode as used for the B
c. Test two-capacity, northern heat pumps (see section 1.2 of this appendix, Definitions) in the same way as a single speed heat pump with the unit operating exclusively at low compressor capacity (see section 3.2.1 of this appendix and Table 4).
d. If a two-capacity air conditioner or heat pump locks out low-capacity operation at higher outdoor temperatures, then use the two dry-coil tests, the steady-state C
a. Conduct five steady-state wet coil tests: The A
b. For units that modulate the indoor blower speed to adjust the sensible to total (S/T) cooling capacity ratio, use cooling full-load, cooling intermediate, and cooling minimum air volume rates that represent a normal installation. Additionally, if conducting the dry-coil tests, operate the unit in the same S/T capacity control mode as used for the F
c. For multiple-split air conditioners and heat pumps (except where noted), the following procedures supersede the above requirements: For all Table 7 tests specified for a minimum compressor speed, turn off at least one indoor unit. The manufacturer shall designate the particular indoor unit(s) that is turned off. The manufacturer must also specify the compressor speed used for the Table 7 E
Test triple-capacity, northern heat pumps for the cooling mode in the same way as specified in section 3.2.3 of this appendix for units having a two-capacity compressor.
Conduct the cooling mode tests specified in section 3.2.3 of this appendix.
a. For the pretest interval, operate the test room reconditioning apparatus and the unit to be tested until maintaining equilibrium conditions for at least 30 minutes at the specified section 3.2 test conditions. Use the exhaust fan of the airflow measuring apparatus and, if installed, the indoor blower of the test unit to obtain and then maintain the indoor air volume rate and/or external static pressure specified for the particular test. Continuously record (see section 1.2 of this appendix, Definitions):
(1) The dry-bulb temperature of the air entering the indoor coil,
(2) The water vapor content of the air entering the indoor coil,
(3) The dry-bulb temperature of the air entering the outdoor coil, and
(4) For the section 2.2.4 of this appendix cases where its control is required, the water vapor content of the air entering the outdoor coil.
Refer to section 3.11 of this appendix for additional requirements that depend on the selected secondary test method.
b. After satisfying the pretest equilibrium requirements, make the measurements specified in Table 3 of ANSI/ASHRAE 37-2009 for the indoor air enthalpy method and the user-selected secondary method. Make said Table 3 measurements at equal intervals that span 5 minutes or less. Continue data sampling until reaching a 30-minute period (
c. Calculate indoor-side total cooling capacity and sensible cooling capacity as specified in sections 7.3.3.1 and 7.3.3.3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). To calculate capacity, use the averages of the measurements (
d. For mobile home ducted coil-only system tests, decrease Q
For non-mobile home ducted coil-only system tests, decrease Q
where
e. For air conditioners and heat pumps having a constant-air-volume-rate indoor blower, the five additional steps listed below are required if the average of the measured external static pressures exceeds the applicable sections 3.1.4 minimum (or target) external static pressure (ΔP
(1) Measure the average power consumption of the indoor blower motor (E
(2) After completing the 30-minute interval and while maintaining the same test conditions, adjust the exhaust fan of the airflow measuring apparatus until the external static pressure increases to approximately ΔP
(3) After re-establishing steady readings of the fan motor power and external static pressure, determine average values for the indoor blower power (E
(4) Approximate the average power consumption of the indoor blower motor at ΔP
(5) Increase the total space cooling capacity, Q
a. Except for the modifications noted in this section, conduct the steady-state dry coil cooling mode tests as specified in section 3.3 of this appendix for wet coil tests. Prior to recording data during the steady-state dry coil test, operate the unit at least one hour after achieving dry coil conditions. Drain the drain pan and plug the drain opening. Thereafter, the drain pan should remain completely dry.
b. Denote the resulting total space cooling capacity and electrical power derived from the test as Q
c. If the temperature sensors used to provide the primary measurement of the indoor-side dry bulb temperature difference during the steady-state dry-coil test and the subsequent cyclic dry-coil test are different, include measurements of the latter sensors among the regularly sampled data. Beginning at the start of the 30-minute data collection period, measure and compute the indoor-side air dry-bulb temperature difference using both sets of instrumentation, ΔT (Set SS) and ΔT (Set CYC), for each equally spaced data sample. If using a consistent data sampling rate that is less than 1 minute, calculate and record minutely averages for the two temperature differences. If using a consistent sampling rate of one minute or more, calculate and record the two temperature differences from each data sample. After having recorded the seventh (i=7) set of temperature differences, calculate the following ratio using the first seven sets of values:
After completing the steady-state dry-coil test, remove the outdoor air enthalpy method test apparatus, if connected, and begin manual OFF/ON cycling of the unit's compressor. The test set-up should otherwise
a. For all cyclic tests, the measured capacity must be adjusted for the thermal mass stored in devices and connections located between measured points. Follow the procedure outlined in section 7.4.3.4.5 of ASHRAE 116-2010 (incorporated by reference, see § 430.3) to ensure any required measurements are taken.
b. For units having a single-speed or two-capacity compressor, cycle the compressor OFF for 24 minutes and then ON for 6 minutes (Δτ
c. Sections 3.5.1 and 3.5.2 of this appendix specify airflow requirements through the indoor coil of ducted and non-ducted indoor units, respectively. In all cases, use the exhaust fan of the airflow measuring apparatus (covered under section 2.6 of this appendix) along with the indoor blower of the unit, if installed and operating, to approximate a step response in the indoor coil airflow. Regulate the exhaust fan to quickly obtain and then maintain the flow nozzle static pressure difference or velocity pressure at the same value as was measured during the steady-state dry coil test. The pressure difference or velocity pressure should be within 2 percent of the value from the steady-state dry coil test within 15 seconds after airflow initiation. For units having a variable-speed indoor blower that ramps when cycling on and/or off, use the exhaust fan of the airflow measuring apparatus to impose a step response that begins at the initiation of ramp up and ends at the termination of ramp down.
d. For units having a variable-speed indoor blower, conduct the cyclic dry coil test using the pull-thru approach described below if any of the following occur when testing with the fan operating:
(1) The test unit automatically cycles off;
(2) Its blower motor reverses; or
(3) The unit operates for more than 30 seconds at an external static pressure that is 0.1 inches of water or more higher than the value measured during the prior steady-state test.
For the pull-thru approach, disable the indoor blower and use the exhaust fan of the airflow measuring apparatus to generate the specified flow nozzles static pressure difference or velocity pressure. If the exhaust fan cannot deliver the required pressure difference because of resistance created by the unpowered indoor blower, temporarily remove the indoor blower.
e. Conduct three complete compressor OFF/ON cycles with the test tolerances given in Table 9 satisfied. Calculate the degradation coefficient C
f. With regard to the Table 9 parameters, continuously record the dry-bulb temperature of the air entering the indoor and outdoor coils during periods when air flows through the respective coils. Sample the water vapor content of the indoor coil inlet air at least every 2 minutes during periods when air flows through the coil. Record external static pressure and the air volume rate indicator (either nozzle pressure difference or velocity pressure) at least every minute during the interval that air flows through the indoor coil. (These regular measurements of the airflow rate indicator are in addition to the required measurement at 15 seconds after flow initiation.) Sample the electrical voltage at least every 2 minutes beginning 30 seconds after compressor start-up. Continue until the compressor, the outdoor fan, and the indoor blower (if it is installed and operating) cycle off.
g. For ducted units, continuously record the dry-bulb temperature of the air entering (as noted above) and leaving the indoor coil. Or if using a thermopile, continuously record the difference between these two temperatures during the interval that air flows through the indoor coil. For non-ducted units, make the same dry-bulb temperature measurements beginning when the compressor cycles on and ending when indoor coil airflow ceases.
h. Integrate the electrical power over complete cycles of length Δτ
If the Table 9 tolerances are satisfied over the complete cycle, record the measured electrical energy consumption as e
Adjust the total space cooling delivered, q
The automatic controls that are normally installed with the test unit must govern the OFF/ON cycling of the air moving equipment on the indoor side (exhaust fan of the airflow measuring apparatus and the indoor blower of the test unit). For ducted coil-only systems rated based on using a fan time-delay relay, control the indoor coil airflow according to the OFF delay listed by the manufacturer in the certification report. For ducted units having a variable-speed indoor blower that has been disabled (and possibly removed), start and stop the indoor airflow at the same instances as if the fan were enabled. For all other ducted coil-only systems, cycle the indoor coil airflow in unison with the cycling of the compressor. If air damper boxes are used, close them on the inlet and outlet side during the OFF period. Airflow through the indoor coil should stop within 3 seconds after the automatic controls of the test unit (act to) de-energize the indoor blower. For mobile home ducted coil-only systems increase e
a. The product of [τ
b. The following algorithm if the indoor blower ramps its speed when cycling.
(1) Measure the electrical power consumed by the variable-speed indoor blower at a minimum of three operating conditions: at the speed/air volume rate/external static pressure that was measured during the steady-state test, at operating conditions associated with the midpoint of the ramp-up interval, and at conditions associated with the midpoint of the ramp-down interval. For these measurements, the tolerances on the airflow volume or the external static pressure are the same as required for the section 3.4 steady-state test.
(2) For each case, determine the fan power from measurements made over a minimum of 5 minutes.
(3) Approximate the electrical energy consumption of the indoor blower if it had operated during the cyclic test using all three power measurements. Assume a linear profile during the ramp intervals. The manufacturer must provide the durations of the ramp-up and ramp-down intervals. If the test setup instructions included with the unit by the manufacturer specifies a ramp interval that exceeds 45 seconds, use a 45-second ramp interval nonetheless when estimating the fan energy.
Do not use airflow prevention devices when conducting cyclic tests on non-ducted indoor units. Until the last OFF/ON compressor cycle, airflow through the indoor coil must cycle off and on in unison with the compressor. For the last OFF/ON compressor cycle—the one used to determine e
Use the two dry-coil tests to determine the cooling-mode cyclic-degradation coefficient, C
This set of tests is for single-speed-compressor heat pumps that do not have a heating minimum air volume rate or a heating intermediate air volume rate that is different than the heating full load air volume rate. Conduct the optional high temperature cyclic (H1C) test to determine the heating mode cyclic-degradation coefficient, C
Conduct five tests: Two high temperature tests (H1
The quantities Q
a. Conduct one maximum temperature test (H0
(1) Knowledge of the heat pump's capacity and electrical power at low compressor capacity for outdoor temperatures of 37 °F and less is needed to complete the section 4.2.3 of this appendix seasonal performance calculations; and
(2) The heat pump's controls allow low-capacity operation at outdoor temperatures of 37 °F and less.
If the two conditions in a.(1) and a.(2) of this section are met, an alternative to conducting the H2
Determine the quantities Q
b. Conduct the optional high temperature cyclic test (H1C
a. Conduct one maximum temperature test (H0
b. If one of the high temperature tests (H1
Evaluate the quantities Q
Otherwise (if no high temperature test is conducted using the same speed (RPM or power input frequency) as the H3
c. If the H2
d. Determine the quantities Q
e. For multiple-split heat pumps (only), the following procedures supersede the above requirements. For all Table 13 tests specified for a minimum compressor speed, turn off at least one indoor unit. The manufacturer shall designate the particular indoor unit(s) that is turned off. The manufacturer must also specify the compressor speed used for the Table 13 H2
Test any heat pump that has a heat comfort controller (see section 1.2 of this appendix, Definitions) according to section 3.6.1, 3.6.2, or 3.6.3, whichever applies, with the heat comfort controller disabled. Additionally, conduct the abbreviated test described in section 3.1.9 of this appendix with the heat comfort controller active to determine the system's maximum supply air temperature. (Note: heat pumps having a variable speed compressor and a heat comfort controller are not covered in the test procedure at this time.)
Test triple-capacity, northern heat pumps for the heating mode as follows:
a. Conduct one maximum-temperature test (H0
In evaluating the above equations, determine the quantities Q
b. Conducting a frost accumulation test (H2
Determine the quantities Q
c. Conduct the optional high-temperature cyclic test (H1C
Conduct the heating mode tests specified in section 3.6.3 of this appendix.
a. For the pretest interval, operate the test room reconditioning apparatus and the heat pump until equilibrium conditions are maintained for at least 30 minutes at the specified section 3.6 test conditions. Use the exhaust fan of the airflow measuring apparatus and, if installed, the indoor blower of the heat pump to obtain and then maintain the indoor air volume rate and/or the external static pressure specified for the particular test. Continuously record the dry-bulb temperature of the air entering the indoor coil, and the dry-bulb temperature and water vapor content of the air entering the outdoor coil. Refer to section 3.11 of this appendix for additional requirements that depend on the selected secondary test method. After satisfying the pretest equilibrium requirements, make the measurements specified in Table 3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3) for the indoor air enthalpy method and the user-selected secondary method. Make said Table 3 measurements at equal intervals that span 5 minutes or less. Continue data sampling until a 30-minute period (
b. Calculate indoor-side total heating capacity as specified in sections 7.3.4.1 and 7.3.4.3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). To calculate capacity, use the averages of the measurements (
c. For mobile home coil-only system heat pumps, increase Q
d. If conducting the cyclic heating mode test, which is described in section 3.8 of this appendix, record the average indoor-side air volume rate, V
(1) The section 3.8 cyclic test will be conducted and the heat pump has a variable-speed indoor blower that is expected to be disabled during the cyclic test; or
(2) The heat pump has a (variable-speed) constant-air volume-rate indoor blower and during the steady-state test the average external static pressure (ΔP
Determine E
(i) While maintaining the same test conditions, adjust the exhaust fan of the airflow measuring apparatus until the external static pressure increases to approximately ΔP
(ii) After re-establishing steady readings for fan motor power and external static pressure, determine average values for the indoor blower power (E
(iii) Approximate the average power consumption of the indoor blower motor if the 30-minute test had been conducted at ΔP
(iv) Decrease the total space heating capacity, Q
e. If the temperature sensors used to provide the primary measurement of the indoor-side dry bulb temperature difference during the steady-state dry-coil test and the subsequent cyclic dry-coil test are different, include measurements of the latter sensors among the regularly sampled data. Beginning at the start of the 30-minute data collection period, measure and compute the indoor-side air dry-bulb temperature difference using both sets of instrumentation, ΔT (Set SS) and ΔT (Set CYC), for each equally spaced data sample. If using a consistent data sampling rate that is less than 1 minute, calculate and record minutely averages for the two temperature differences. If using a consistent sampling rate of one minute or more, calculate and record the two temperature
Each time a subsequent set of temperature differences is recorded (if sampling more frequently than every 5 minutes), calculate F
a. Except as noted below, conduct the cyclic heating mode test as specified in section 3.5 of this appendix. As adapted to the heating mode, replace section 3.5 references to “the steady-state dry coil test” with “the heating mode steady-state test conducted at the same test conditions as the cyclic heating mode test.” Use the test tolerances in Table 16 rather than Table 9. Record the outdoor coil entering wet-bulb temperature according to the requirements given in section 3.5 of this appendix for the outdoor coil entering dry-bulb temperature. Drop the subscript “dry” used in variables cited in section 3.5 of this appendix when referring to quantities from the cyclic heating mode test. If available, use electric resistance heaters (see section 2.1 of this appendix) to minimize the variation in the inlet air temperature. Determine the total space heating delivered during the cyclic heating test, q
(1) When evaluating Equation 3.5-1, use the values of V
(2) Calculate Γ using, Γ=
b. For ducted coil-only system heat pumps (excluding the special case where a variable-speed fan is temporarily removed), increase q
c. For non-ducted heat pumps, subtract the electrical energy used by the indoor blower during the 3 minutes after compressor cutoff from the non-ducted heat pump's integrated heating capacity, q
d. If a heat pump defrost cycle is manually or automatically initiated immediately prior to or during the OFF/ON cycling, operate the heat pump continuously until 10 minutes after defrost termination. After that, begin cycling the heat pump immediately or delay until the specified test conditions have been re-established. Pay attention to preventing defrosts after beginning the cycling process. For heat pumps that cycle off the indoor blower during a defrost cycle, make no effort here to restrict the air movement through the indoor coil while the fan is off. Resume the OFF/ON cycling while conducting a minimum of two complete compressor OFF/ON cycles before determining q
Use the results from the required cyclic test and the required steady-state test that were conducted at the same test conditions to determine the heating mode cyclic-degradation coefficient C
Round the calculated value for C
a. Confirm that the defrost controls of the heat pump are set as specified in section 2.2.1 of this appendix. Operate the test room reconditioning apparatus and the heat pump for at least 30 minutes at the specified section 3.6 test conditions before starting the “preliminary” test period. The preliminary test period must immediately precede the “official” test period, which is the heating and defrost interval over which data are collected for evaluating average space heating capacity and average electrical power consumption.
b. For heat pumps containing defrost controls which are likely to cause defrosts at intervals less than one hour, the preliminary test period starts at the termination of an automatic defrost cycle and ends at the termination of the next occurring automatic defrost cycle. For heat pumps containing defrost controls which are likely to cause defrosts at intervals exceeding one hour, the preliminary test period must consist of a heating interval lasting at least one hour followed by a defrost cycle that is either manually or automatically initiated. In all cases, the heat pump's own controls must govern when a defrost cycle terminates.
c. The official test period begins when the preliminary test period ends, at defrost termination. The official test period ends at the termination of the next occurring automatic defrost cycle. When testing a heat pump that uses a time-adaptive defrost control system (see section 1.2 of this appendix, Definitions), however, manually initiate the defrost cycle that ends the official test period at the instant indicated by instructions provided by the manufacturer. If the heat pump has not undergone a defrost after 6 hours, immediately conclude the test and use the results from the full 6-hour period to calculate the average space heating capacity and average electrical power consumption.
For heat pumps that turn the indoor blower off during the defrost cycle, take steps to cease forced airflow through the indoor coil and block the outlet duct whenever the heat pump's controls cycle off the indoor blower. If it is installed, use the outlet damper box described in section 2.5.4.1 of this appendix to affect the blocked outlet duct.
d. Defrost termination occurs when the controls of the heat pump actuate the first change in converting from defrost operation to normal heating operation. Defrost initiation occurs when the controls of the heat pump first alter its normal heating operation in order to eliminate possible accumulations of frost on the outdoor coil.
e. To constitute a valid frost accumulation test, satisfy the test tolerances specified in Table 17 during both the preliminary and official test periods. As noted in Table 17, test operating tolerances are specified for two sub-intervals: (1) When heating, except for the first 10 minutes after the termination of a defrost cycle (sub-interval H, as described in Table 17) and (2) when defrosting, plus these same first 10 minutes after defrost termination (sub-interval D, as described in Table 17). Evaluate compliance with Table 17 test condition tolerances and the majority of the test operating tolerances using the averages from measurements recorded only during sub-interval H. Continuously record the dry bulb temperature of the air entering the indoor coil, and the dry bulb temperature and water vapor content of the air entering the outdoor coil. Sample the remaining parameters listed in Table 17 at equal intervals that span 5 minutes or less.
f. For the official test period, collect and use the following data to calculate average space heating capacity and electrical power. During heating and defrosting intervals when the controls of the heat pump have the indoor blower on, continuously record the dry-bulb temperature of the air entering (as noted above) and leaving the indoor coil. If using a thermopile, continuously record the difference between the leaving and entering dry-bulb temperatures during the interval(s) that air flows through the indoor coil. For coil-only system heat pumps, determine the corresponding cumulative time (in hours) of indoor coil airflow, Δτ
a. Evaluate average space heating capacity, Q
To account for the effect of duct losses between the outlet of the indoor unit and the section 2.5.4 dry-bulb temperature grid, adjust Q
b. Evaluate average electrical power, E
c. For heat pumps having a constant-air-volume-rate indoor blower, the five additional steps listed below are required if the average of the external static pressures measured during sub-interval H exceeds the applicable section 3.1.4.4, 3.1.4.5, or 3.1.4.6 minimum (or targeted) external static pressure (ΔP
(1) Measure the average power consumption of the indoor blower motor (E
(2) After the frost accumulation heating mode test is completed and while maintaining the same test conditions, adjust the exhaust fan of the airflow measuring apparatus until the external static pressure increases to approximately ΔP
(3) After re-establishing steady readings for the fan motor power and external static pressure, determine average values for the indoor blower power (E
(4) Approximate the average power consumption of the indoor blower motor had the frost accumulation heating mode test been conducted at ΔP
(5) Decrease the total heating capacity, Q
a. Assign the demand defrost credit, F
b. For two-capacity heat pumps and for section 3.6.2 units, evaluate the above equation using the Δτ
Except for the modifications noted in this section, conduct the low temperature and very low temperature heating mode tests using the same approach as specified in section 3.7 of this appendix for the maximum and high temperature tests. After satisfying the section 3.7 requirements for the pretest interval but before beginning to collect data to determine the capacity and power input, conduct a defrost cycle. This defrost cycle may be manually or automatically initiated. Terminate the defrost sequence using the heat pump's defrost controls. Begin the 30-minute data collection interval described in section 3.7 of this appendix, from which the capacity and power input are determined, no sooner than 10 minutes after defrost termination. Defrosts should be prevented over the 30-minute data collection interval.
a. For all cooling mode and heating mode tests, first conduct a test without the outdoor air-side test apparatus described in section 2.10.1 connected to the outdoor unit (“non-ducted” test).
b. For the first section 3.2 steady-state cooling mode test and the first section 3.6 steady-state heating mode test, conduct a second test in which the outdoor-side apparatus is connected (“ducted” test). No other cooling mode or heating mode tests require the ducted test so long as the unit operates the outdoor fan during all cooling mode steady-state tests at the same speed and all heating mode steady-state tests at the same speed. If using more than one outdoor fan speed for the cooling mode steady-state tests, however, conduct the ducted test for each cooling mode test where a different fan speed is first used. This same requirement applies for the heating mode tests.
a. For the non-ducted test, connect the indoor air-side test apparatus to the indoor coil; do not connect the outdoor air-side test apparatus. Allow the test room reconditioning apparatus and the unit being tested to operate for at least one hour. After attaining equilibrium conditions, measure the following quantities at equal intervals that span 5 minutes or less:
(1) The section 2.10.1 evaporator and condenser temperatures or pressures;
(2) Parameters required according to the Indoor Air Enthalpy Method.
Continue these measurements until a 30-minute period (
b. For cases where a ducted test is not required per section 3.11.1.b of this appendix, the non-ducted test constitutes the “official” test for which validity is not based on comparison with a secondary test.
c. For cases where a ducted test is required per section 3.11.1.b of this appendix, the following conditions must be met for the non-ducted test to constitute a valid “official” test:
(1) The energy balance specified in section 3.1.1 is achieved for the ducted test (
(2) The capacities determined using the indoor air enthalpy method from the ducted and non-ducted tests must agree within 2.0 percent.
a. The test conditions and tolerances for the ducted test are the same as specified for the official test.
b. After collecting 30 minutes of steady-state data during the non-ducted test, connect the outdoor air-side test apparatus to the unit for the ducted test. Adjust the exhaust fan of the outdoor airflow measuring apparatus until averages for the evaporator and condenser temperatures, or the saturated temperatures corresponding to the measured pressures, agree within ±0.5 °F of the averages achieved during the non-ducted test. Calculate the averages for the ducted test using five or more consecutive readings taken at one minute intervals. Make these consecutive readings after re-establishing equilibrium conditions.
c. During the ducted test, at one minute intervals, measure the parameters required according to the indoor air enthalpy method and the outdoor air enthalpy method.
d. For cooling mode ducted tests, calculate capacity based on outdoor air-enthalpy measurements as specified in sections 7.3.3.2 and 7.3.3.3 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3). For heating mode ducted tests, calculate heating capacity based on outdoor air-enthalpy measurements as specified in sections 7.3.4.2 and 7.3.3.4.3 of the same ANSI/ASHRAE Standard. Adjust the outdoor-side capacity according to section 7.3.3.4 of ANSI/ASHRAE 37-2009 to account for line losses when testing split systems.
a. Conduct separate calibration tests using a calorimeter to determine the refrigerant flow rate. Or for cases where the superheat of the refrigerant leaving the evaporator is less than 5 °F, use the calorimeter to measure total capacity rather than refrigerant flow rate. Conduct these calibration tests at the same test conditions as specified for the tests in this appendix. Operate the unit for at least one hour or until obtaining equilibrium conditions before collecting data that will be used in determining the average refrigerant flow rate or total capacity. Sample the data at equal intervals that span 5 minutes or less. Determine average flow rate or average capacity from data sampled over a 30-minute period where the Table 8 (cooling) or the Table 15 (heating) tolerances are satisfied. Otherwise, conduct the calibration tests according to sections 5, 6, 7, and 8 of ASHRAE 23.1-2010 (incorporated by reference, see § 430.3); sections 5, 6, 7, 8, 9, and 11 of ASHRAE 41.9-2011 (incorporated by reference, see § 430.3); and section 7.4 of ANSI/ASHRAE 37-2009 (incorporated by reference, see § 430.3).
b. Calculate space cooling and space heating capacities using the compressor calibration method measurements as specified in section 7.4.5 and 7.4.6 respectively, of ANSI/ASHRAE 37-2009.
Conduct this secondary method according to section 7.5 of ANSI/ASHRAE 37-2009. Calculate space cooling and heating capacities using the refrigerant-enthalpy method measurements as specified in sections 7.5.4 and 7.5.5, respectively, of the same ASHRAE Standard.
a. When reporting rated capacities, round them off as specified in § 430.23 (for a single unit) and in 10 CFR 429.16 (for a sample).
b. For the capacities used to perform the calculations in section 4 of this appendix, however, round only to the nearest integer.
Voltage tolerances: As a percentage of reading, test operating tolerance must be 2.0 percent and test condition tolerance must be 1.5 percent (see section 1.2 of this appendix for definitions of these tolerances).
Conduct one of the following tests: If the central air conditioner or heat pump lacks a compressor crankcase heater, perform the test in section 3.13.1 of this appendix; if the central air conditioner or heat pump has a compressor crankcase heater that lacks controls and is not self-regulating, perform the test in section 3.13.1 of this appendix; if the central air conditioner or heat pump has a crankcase heater with a fixed power input controlled with a thermostat that measures ambient temperature and whose sensing element temperature is not affected by the heater, perform the test in section 3.13.1 of this appendix; if the central air conditioner or heat pump has a compressor crankcase heater equipped with self-regulating control or with controls for which the sensing element temperature is affected by the heater, perform the test in section 3.13.2 of this appendix.
3.13.1 This test determines the off mode average power rating for central air conditioners and heat pumps that lack a
a. Test Sample Set-up and Power Measurement: For coil-only systems, provide a furnace or modular blower that is compatible with the system to serve as an interface with the thermostat (if used for the test) and to provide low-voltage control circuit power. Make all control circuit connections between the furnace (or modular blower) and the outdoor unit as specified by the manufacturer's installation instructions. Measure power supplied to both the furnace or modular blower and power supplied to the outdoor unit. Alternatively, provide a compatible transformer to supply low-voltage control circuit power, as described in section 2.2.d of this appendix. Measure transformer power, either supplied to the primary winding or supplied by the secondary winding of the transformer, and power supplied to the outdoor unit. For blower coil and single-package systems, make all control circuit connections between components as specified by the manufacturer's installation instructions, and provide power and measure power supplied to all system components.
b. Configure Controls: Configure the controls of the central air conditioner or heat pump so that it operates as if connected to a building thermostat that is set to the OFF position. Use a compatible building thermostat if necessary to achieve this configuration. For a thermostat-controlled crankcase heater with a fixed power input, bypass the crankcase heater thermostat if necessary to energize the heater.
c. Measure
d. Measure
e. Calculate
For single-package systems and blower coil split systems for which the designated air mover is not a furnace or modular blower, divide the heating season total off mode power (
For coil-only split systems and blower coil split systems for which a furnace or a modular blower is the designated air mover, subtract the low-voltage power (
f. Shoulder-season per-compressor off mode power,
Otherwise, de-energize the crankcase heater (by removing the thermostat bypass or otherwise disconnecting only the power supply to the crankcase heater) and repeat the measurement as described in section 3.13.1.c of this appendix. Designate the measured average power as
Determine the number of compressors as described in section 3.13.1.e of this appendix.
For single-package systems and blower coil systems for which the designated air mover is not a furnace or modular blower, divide the shoulder season total off mode power (
For coil-only split systems and blower coil split systems for which a furnace or a modular blower is the designated air mover, subtract the low-voltage power (
3.13.2 This test determines the off mode average power rating for central air conditioners and heat pumps for which ambient temperature can affect the measurement of crankcase heater power.
a. Test Sample Set-up and Power Measurement: set up the test and measurement as described in section 3.13.1.a of this appendix.
b. Configure Controls: Position a temperature sensor to measure the outdoor dry-bulb temperature in the air between 2 and 6 inches from the crankcase heater control temperature sensor or, if no such temperature sensor exists, position it in the air between 2 and 6 inches from the crankcase heater. Utilize the temperature measurements from this sensor for this portion of the test procedure. Configure the controls of the central air conditioner or heat pump so that it operates as if connected to a building thermostat that is set to the OFF position. Use a compatible building thermostat if necessary to achieve this configuration.
Conduct the test after completion of the B, B
c. Measure
d. Reduce outdoor temperature: Approach the target outdoor dry-bulb temperature by adjusting the outdoor temperature. This target temperature is five degrees Fahrenheit less than the temperature certified by the manufacturer as the temperature at which the crankcase heater turns on. If the unit's compressor has no sound blanket, wait at least 4 hours after the outdoor temperature reaches the target temperature. Otherwise, wait at least 8 hours after the outdoor temperature reaches the target temperature. Maintain the target temperature within +/-2 °F while the compressor temperature equilibrates and while making the power measurement, as described in section 3.13.2.e of this appendix.
e. Measure
f. Measure
g. Calculate
Set the number of compressors equal to the unit's number of single-stage compressors plus 1.75 times the unit's number of compressors that are not single-stage.
For single-package systems and blower coil split systems for which the air mover is not a furnace or modular blower, divide the shoulder season total off mode power (
For coil-only split systems and blower coil split systems for which a furnace or a modular blower is the designated air mover, subtract the low-voltage power (
h. Calculate
Determine the number of compressors as described in section 3.13.2.g of this appendix.
For, single-package systems and blower coil split systems for which the air mover is not a furnace, divide the heating season total off mode power (
For coil-only split systems and blower coil split systems for which a furnace or a modular blower is the designated air mover, subtract the low-voltage power (
4.1 Seasonal Energy Efficiency Ratio (SEER) Calculations. Calculate SEER as follows: For equipment covered under sections 4.1.2, 4.1.3, and 4.1.4 of this appendix, evaluate the seasonal energy efficiency ratio,
The temperatures 95 °F and 65 °F in the building load equation represent the selected outdoor design temperature and the zero-load base temperature, respectively.
V is a factor equal to 0.93 for variable-speed heat pumps and otherwise equal to 1.0.
a. Evaluate the seasonal energy efficiency ratio, expressed in units of Btu/watt-hour, using:
b. Refer to section 3.3 of this appendix regarding the definition and calculation of Q
4.1.2.1 Units Covered by Section 3.2.2.1 of This Appendix Where Indoor Blower Capacity Modulation Correlates With the Outdoor Dry Bulb Temperature. The manufacturer must provide information on how the indoor air volume rate or the indoor blower speed varies over the outdoor temperature range of 67 °F to 102 °F. Calculate SEER using Equation 4.1-1. Evaluate the quantity q
a. For the space cooling season, assign n
b. For units where indoor blower speed is the primary control variable, FP
c. The quantities X(T
d. Evaluate E
e. The parameters FP
Calculate SEER using Equation 4.1-1. Evaluate the space cooling capacity, Q
The calculation of Equation 4.1-1 quantities q
4.1.3.1 Steady-state space cooling capacity at low compressor capacity is greater than or equal to the building cooling load at temperature T
Obtain the fractional bin hours for the cooling season, n
4.1.3.2 Unit alternates between high (k=2) and low (k=1) compressor capacity to satisfy the building cooling load at temperature T
Obtain the fractional bin hours for the cooling season, n
4.1.3.3 Unit only operates at high (k=2) compressor capacity at temperature T
Obtain the fractional bin hours for the cooling season, n
4.1.3.4 Unit must operate continuously at high (k=2) compressor capacity at temperature T
Obtain the fractional bin hours for the cooling season, n
Calculate SEER using Equation 4.1-1. Evaluate the space cooling capacity, Q
Use Equations 4.1.4-1 and 4.1.4-2, respectively, to calculate Q
4.1.4.1 Steady-state space cooling capacity when operating at minimum compressor speed is greater than or equal to the building cooling load at temperature T
Obtain the fractional bin hours for the cooling season, n
4.1.4.2 Unit operates at an intermediate compressor speed (k=i) in order to match the building cooling load at temperature T
Obtain the fractional bin hours for the cooling season, n
For each temperature bin where Q
4.1.4.3 Unit must operate continuously at full (k=2) compressor speed at temperature Tj, BL(T
4.1.5 SEER calculations for an air conditioner or heat pump having a single indoor unit with multiple indoor blowers.
Calculate SEER using Eq. 4.1-1, where q
4.1.5.1 For multiple indoor blower systems that are connected to a single, single-speed outdoor unit.
a. Calculate the space cooling capacity,
b. Determine the cooling mode cyclic degradation coefficient, C
c. Except for using the above values of
4.1.5.2 For multiple indoor blower systems that are connected to either a lone outdoor unit having a two-capacity compressor or two separate but identical model single-speed outdoor units. Calculate the quantities q
Unless an approved alternative efficiency determination method is used, as set forth in 10 CFR 429.70(e). Calculate HSPF as follows: Six generalized climatic regions are depicted in Figure 1 and otherwise defined in Table 19. For each of these regions and for each applicable standardized design heating requirement, evaluate the heating seasonal performance factor using,
Evaluate the building heating load using
For heating-only heat pump units, replace
a. For all heat pumps, HSPF accounts for the heating delivered and the energy consumed by auxiliary resistive elements when operating below the balance point. This condition occurs when the building load exceeds the space heating capacity of the heat pump condenser. For HSPF calculations for all heat pumps, see either section 4.2.1, 4.2.2, 4.2.3, or 4.2.4 of this appendix, whichever applies.
b. For heat pumps with heat comfort controllers (see section 1.2 of this appendix, Definitions), HSPF also accounts for resistive heating contributed when operating above the heat-pump-plus-comfort-controller balance point as a result of maintaining a minimum supply temperature. For heat pumps having a heat comfort controller, see section 4.2.5 of this appendix for the additional steps required for calculating the HSPF.
4.2.1 Additional Steps for Calculating the HSPF of a Blower Coil System Heat Pump Having a Single-Speed Compressor and Either a Fixed-Speed Indoor Blower or a Constant-Air-Volume-Rate Indoor Blower Installed, or a Coil-Only System Heat Pump.
Use Equation 4.2-2 to determine BL(T
Determine the low temperature cut-out factor using
Calculate Q
The manufacturer must provide information about how the indoor air volume rate or the indoor blower speed varies over the outdoor temperature range of 65 °F to −23 °F. Calculate the quantities
For units where indoor blower speed is the primary control variable, FP
The calculation of the Equation 4.2-1 quantities differ depending upon whether the heat pump would operate at low capacity (section 4.2.3.1 of this appendix), cycle between low and high capacity (section 4.2.3.2 of this appendix), or operate at high capacity (sections 4.2.3.3 and 4.2.3.4 of this appendix) in responding to the building load. For heat pumps that lock out low capacity operation at low outdoor temperatures, the outdoor temperature at which the unit locks out must be that specified by the manufacturer in the certification report so that the appropriate equations can be selected.
a. Evaluate the space heating capacity and electrical power consumption of the heat pump when operating at low compressor capacity and outdoor temperature T
b. Evaluate the space heating capacity and electrical power consumption (Q
4.2.3.1 Steady-state space heating capacity when operating at low compressor capacity is greater than or equal to the building heating load at temperature T
Evaluate the heating mode cyclic degradation factor C
Determine the low temperature cut-out factor using
a. The heat pump locks out low capacity operation at low outdoor temperatures and
b. T
4.2.3.2 Heat pump alternates between high (k=2) and low (k=1) compressor capacity to satisfy the building heating load at a temperature T
Determine the low temperature cut-out factor, δ′(T
4.2.3.3 Heat pump only operates at high (k=2) compressor capacity at temperature T
If the H1C
Determine the low temperature cut-out factor, δ(T
4.2.3.4 Heat pump must operate continuously at high (k=2) compressor capacity at temperature T
a. Minimum Compressor Speed. Evaluate the space heating capacity, Q
b. Minimum Compressor Speed for Minimum-speed-limiting Variable-speed Heat Pumps: Evaluate the space heating capacity, Q
c. Full Compressor Speed for Heat Pumps for which the H4
Evaluate the space heating capacity, Q
d. Full Compressor Speed for Heat Pumps for which the H4
For T
Determine Q
For T
Determine Q
Determine Q
e. Intermediate Compressor Speed. Calculate the space heating capacity, Q
Use Equations 4.2.4-1 and 4.2.4-2, respectively, to calculate Q
4.2.4.1 Steady-state space heating capacity when operating at minimum compressor speed is greater than or equal to the building heating load at temperature T
4.2.4.2 Heat pump operates at an intermediate compressor speed (k=i) in order to match the building heating load at a temperature T
For each temperature bin where the heat pump operates at an intermediate compressor speed, determine COP
For each temperature bin where Q
4.2.4.3 Heat pump must operate continuously at full (k=2) compressor speed at temperature T
Heat pumps having heat comfort controllers, when set to maintain a typical minimum air delivery temperature, will cause the heat pump condenser to operate less because of a greater contribution from the resistive elements. With a conventional heat pump, resistive heating is only initiated if the heat pump condenser cannot meet the building load (
Calculate the space heating capacity and electrical power of the heat pump without the heat comfort controller being active as specified in section 4.2.1 of this appendix (Equations 4.2.1-4 and 4.2.1-5) for each outdoor bin temperature, T
Evaluate e
Case 1. For outdoor bin temperatures where T
Case 2. For outdoor bin temperatures where T
Even though T
Calculate the space heating capacity and electrical power of the heat pump without the heat comfort controller being active as specified in section 4.2.2 of this appendix (Equations 4.2.2-1 and 4.2.2-2) for each outdoor bin temperature, T
Evaluate e
Case 1. For outdoor bin temperatures where T
Even though T
Case 2. For outdoor bin temperatures where T
Even though T
Calculate the space heating capacity and electrical power of the heat pump without the heat comfort controller being active as specified in section 4.2.3 of this appendix for both high and low capacity and at each outdoor bin temperature, T
Repeat the above calculations to determine the mass flow rate (m
Evaluate e
Case 1. For outdoor bin temperatures where T
Even though T
Case 2. For outdoor bin temperatures where T
Even though T
Case 3. For outdoor bin temperatures where T
Even though T
Case 4. For outdoor bin temperatures where T
Even though T
4.2.5.4 Heat pumps Having a Heat Comfort Controller: Additional Steps for Calculating the HSPF of a Heat Pump Having a Variable-Speed Compressor [Reserved]
4.2.6 Additional Steps for Calculating the HSPF of a Heat Pump Having a Triple-Capacity Compressor
The only triple-capacity heat pumps covered are triple-capacity, northern heat pumps. For such heat pumps, the calculation of the Eq. 4.2-1 quantities
a. Evaluate the space heating capacity and electrical power consumption of the heat pump when operating at low compressor capacity and outdoor temperature Tj using the equations given in section 4.2.3 of this appendix for Q
b. Evaluate the space heating capacity and electrical power consumption (Q
c. Evaluate the space heating capacity and electrical power consumption of the heat pump when operating at booster compressor capacity and outdoor temperature Tj using
4.2.6.1 Steady-state Space Heating Capacity when Operating at Low Compressor Capacity is Greater than or Equal to the Building Heating Load at Temperature T
4.2.6.2 Heat Pump Only Operates at High (k=2) Compressor Capacity at Temperature T
4.2.6.3 Heat Pump Only Operates at High (k=3) Compressor Capacity at Temperature T
4.2.6.4 Heat Pump Alternates Between High (k=2) and Low (k=1) Compressor Capacity to Satisfy the Building Heating Load at a Temperature T
4.2.6.5 Heat Pump Alternates Between High (k=2) and Booster (k=3) Compressor Capacity to Satisfy the Building Heating Load at a Temperature T
4.2.6.6 Heat Pump Only Operates at Low (k=1) Capacity at Temperature T
4.2.6.7 Heat Pump Only Operates at High (k = 2) Capacity at Temperature Tj and its Capacity is less than the Building Heating Load, BL(Tj) > Q
Evaluate the quantities
4.2.6.8 Heat Pump Only Operates at Booster (k = 3) Capacity at Temperature Tj and its Capacity is less than the Building Heating Load, BL(T
4.2.7 Additional Steps for Calculating the HSPF of a Heat Pump having a Single Indoor Unit with Multiple Indoor Blowers. The calculation of the Eq. 4.2-1 quantities e
4.2.7.1 For Multiple Indoor Blower Heat Pumps that are Connected to a Singular, Single-speed Outdoor Unit.
a. Calculate the space heating capacity,
b. Determine the heating mode cyclic degradation coefficient, C
c. Except for using the above values of
4.2.7.2 For Multiple Indoor Blower Heat Pumps Connected to either a Single Outdoor Unit with a Two-capacity Compressor or to Two Separate but Identical Model Single-speed Outdoor units. Calculate the quantities e
For central air conditioners and heat pumps with a cooling capacity of:
After calculating SEER according to section 4.1 of this appendix and HSPF according to section 4.2 of this appendix round the values off as specified per § 430.23(m) of title 10 of the Code of Federal Regulations.
The SHR is defined and calculated as follows:
Where both the total and sensible cooling capacities are determined from the same cooling mode test and calculated from data collected over the same 30-minute data collection interval.
Calculate the energy efficiency ratio using,
Federal Communications Commission.
Proposed rule.
In this document, the Federal Communications Commission (Commission or FCC) seeks comment on proposed service rules to allow flexible fixed and mobile uses in additional bands and on refinements to the rules the Commission adopted in FCC 16-89. These refinements include: Providing additional detail on the sharing arrangement the Commission adopted in FCC 16-89 for the 37 GHz band; performance requirements for innovative uses such as Internet of Things (IoT) and machine-to-machine communications; additional issues relating to our mobile spectrum holdings policies; whether antenna height limits are necessary in mmW bands; whether minimum bandwidth scaling factors are necessary for transmitter power limits; whether allowing higher Power Flux Density (PFD) levels for Fixed Satellite Service (FSS) in the 37 and 39 GHz bands would be consistent with terrestrial use of those bands; refining the coordination limits for point-to-point operations; and on sharing analysis and modeling.
Comments are due on or before September 30, 2016; reply comments are due on or before October 31, 2016.
You may submit comments, identified by GN Docket No. 14-177, by any of the following methods:
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•
•
For detailed instructions for submitting comments and additional information on the rulemaking process, see the
John Schauble of the Wireless Telecommunications Bureau, Broadband Division, at 202-418-0797 or
This is a summary of the
•
• Parties may also submit an electronic comment by Internet email. To get filing instructions, filers should send an email to
•
• 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. All hand deliveries must be held together with rubber bands or fasteners. The filing hours are 8:00 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 E. Hampton Drive, Capitol Heights, MD 20743.
• U.S. Postal Service first-class, Express, and Priority must be addressed to 445 12th Street SW., Washington, DC 20554.
Pursuant to Section 1.1200(a) of the Commission's rules, this
As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this present IRFA of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the attached
This document does not contain new or modified information collection requirements subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13.
1. This
2. In the
3. Several factors lead us to conclude that it is now appropriate to consider additional bands for mobile use. First, as the record to the
4. Specifically, the Commission proposes authorizing flexible use licenses that would permit fixed and mobile services in the following bands: 24.25-24.45 GHz and 24.75-25.25 GHz, 31.8-33.4 GHz, 42-42.5 GHz, 47.2-50.2 GHz, 50.4-52.6 GHz, 71-76 GHz, and 81-86 GHz. Each of these bands was identified as a candidate band for IMT-2020.
5. At the same time, the Commission recognizes that there are challenges that must be overcome before the Commission can authorize service in these bands, including existing allocations and/or operations in these bands. The Commission will continue to work with existing stakeholders, wireless providers, the satellite industry, National Telecommunications and Information Administration (NTIA), and other interested Federal stakeholders to determine where different services can coexist and develop ways to maximize flexible use. In several bands, the Commission believes sharing mechanisms that the Commission has adopted in the
6. The Commission discusses each of the bands in additional detail below. The Commission generally proposes to use the licensing and service rule framework the Commission adopted in the
7. In the
8. The Commission also proposes to generally apply the Part 30 technical rules the Commission has adopted in the
9. As the Commission explained in the
10. The Commission proposes to add a mobile allocation to the 24.25-24.45 and 24.75-25.25 GHz segments of the 24 GHz band, a fixed allocation to 24.75-25.05 GHz, and to authorize both mobile and fixed operations in those segments under the new Part 30 UMFUS rules. This band is already used internationally for fixed service and is included in the WRC study for future international mobile allocation. The existing manufacturing base and global harmonization of this band make it an attractive option for mobile use. The Commission further proposes to grant mobile rights to the existing fixed licensees, in order to facilitate coordination between fixed and mobile uses in the areas that are currently licensed. The Commission proposes to add these new fixed and mobile authorizations on a co-primary basis. The Commission seeks comment on that arrangement, as well as on the alternative of making mobile or fixed use secondary to FSS.
11. The Commission recognizes that there are existing satellite interests and operations in this band, and the Commission seeks comment on the best way to promote effective sharing between satellite and mobile uses. Given that the current use of the band for satellite appears to be rather limited, should the Commission maintain the existing limits and coordination procedures on satellite operations in the 25.05-25.25 GHz band, and apply those same limits to the 24.75-25.05 GHz band? Alternatively, are there other sharing mechanisms that would better achieve coexistence? Would the sharing regime the Commission has adopted for the 28 GHz band be appropriate in this band, or do the differences between FSS earth stations in that band and BSS feeder links here suggest a different solution?
12. The Commission also proposes to modify the existing band plan for new licenses in the 24 GHz band. Currently, the 24 GHz bands is channelized into five 40 MHz by 40 MHz channel pairs. As with the 39 GHz band, the Commission sees benefits to converting the 24 GHz band plan to unpaired blocks. Going forward, the Commission proposes to license the 24.25-24.45 GHz band segment as a single, unpaired block of 200 MHz, and the 24.75-25.25 GHz band segment as two unpaired blocks of 250 MHz each. The Commission seeks comment on this proposal, as well as the alternative of using 100 MHz unpaired channels, or two 200 MHz channels and one 100 MHz channel in 24.75-25.25 GHz. The Commission also seeks comment on how to treat existing 24 GHz band licensees. Should incumbent licenses be converted to UMFUS licenses, as the Commission has done in 28 GHz and 39 GHz? Also, is it necessary to repack existing licensees, or can they keep their existing frequency assignments because there are so few licensees?
13. The Commission proposes to add primary non-Federal fixed and mobile service allocations to the 32 GHz band
14. However, there are still two major challenges to authorizing mobile operations in the 32 GHz band: (1) Protecting radionavigation operations in the 32 GHz band; and (2) protecting radio astronomy observations in the adjacent 31.3-31.8 GHz band. The Commission discusses those challenges and invites further comment on those issues below.
15. In the
16. The Commission seeks comment on the compatibility of fixed and mobile services with existing allocated services in the 32 GHz band. In the
17. The Commission also seeks comment on protecting other allocated service within the 32 GHz band. For Space Research Service operations in the Goldstone, California area, would coordination requirements be sufficient to protect those operations? In the
18. The 32 GHz band is adjacent to the 31.3-31.8 GHz band. In the United States, the 31.3-31.8 GHz band is allocated for Earth Exploration Satellite (passive), radio astronomy, and Space Research (passive). No station is authorized to transmit in the 31.3-31.8 GHz band and the radio astronomy operations in the 31.3-31.8 GHz band are protected from unwanted emissions only to the extent that such radiation exceeds the level which would be present if the offending station were operating in compliance with the technical standards or criteria applicable to the service in which it operates.
19. In the
20. In the
21. CORF stresses the importance of the data collected from Earth Exploration Satellite Service (EESS) and that billions of dollars have been invested in EESS satellites. CORF notes that for certain applications, satellite-based microwave remote sensing is the only practical method of obtaining atmospheric and surface data for the entire planet. Data derived from EESS have contributed substantially to the study of meteorology, atmospheric chemistry, climatology, and oceanography and is used by multiple governmental agencies. CORF indicates that incumbent users designed and developed EESS missions without the expectation of transmissions in close proximity to the 31.3-31.8 GHz band. They also report that most incumbent users at 31.5 GHz operate in a direct detection (homodyne) mode. CORF recommends that the Commission adopt adequate guard bands to protect EESS operations in the 31.3-31.8 GHz “until the current satellites can be replaced with satellites with filtering suited to the new spectral environment.” CORF claims that proportionally larger guard bands are needed as the frequency increases. In direct detection, CORF explains, band definition is achieved with filters that are limited by the properties of the materials used in the filter itself. Thus, for example, “for a given material, the minimum bandwidth of a filter is proportional to the central frequency, so that the width of the necessary guard bands to suppress emissions to a desired level also increases in proportion to the frequency.” CORF continues, “it is impossible to reject a signal 10 MHz away from a band edge at these higher frequencies, so guard bandwidths must be scaled in frequency to accommodate this physical limitation.” The Commission seeks comment on whether the Commission should adopt a guard band to protect EESS operations in the 31.3-31.8 GHz band, and if so, how large should the guard band be? ESOA, disagrees with CORF and states that services operating in the 31.3-31.8 GHz band can be protected through “carefully crafted operating requirements.” The Commission seeks comment on ESOA's statement and ask what these “carefully crafted operating requirements” might be.
22. CORF also expresses concern that “mobile devices with limited size and cost will not be able to adequately filter their out-of-band emissions to meet the stringent requirements” of the 31.3-31.8 GHz band. Avanti responds that under agenda item 1.13 for WRC-19 (World Radiocommunication Conference), the International Telecommunication Union-Radiocommunication (ITU-R) will develop technical measures, if necessary, to protect passive services from interference from 5G mobile
23. The Commission also seeks comment on the appropriate band plan for the 32 GHz band. The Commission proposes to license the band using channels of either 200 MHz or 400 MHz bandwidth. Given the contemplated use cases and the nature of this band, what channel size would be best? The Commission encourages commenters to discuss the specific advantages and disadvantages of various band plans.
24. The Commission proposes to authorize fixed and mobile service operations to operate in the 42 GHz band (42-42.5 GHz) under the Part 30 Upper Microwave Flexible Use Service rules, as long as the Commission can ensure that adjacent channel RAS services will be protected. The band potentially offers 500 megahertz for new flexible use services, has existing fixed and mobile allocations, and is being studied internationally for possible mobile use. The Commission also proposes to adopt geographic area licensing using PEAs as the geographic area. The Commission seeks comment on this proposal, as well as alternatives.
25. The Commission denies FWCC's request that the Commission establish service rules to enable fixed service at 42.-42.5 GHz, but keeps its request pending for the 42.5-43.5 GHz band. The Commission believes that flexible use licensing, which would allow a variety of services to be offered, would be more likely to place the spectrum in its highest and best use, as opposed to rules that would only allow point-to-point operation. Nevertheless, the Commission does not deny FWCC's petition with respect to the 42.5-43.5 GHz band because point-to-point operation may be more likely to co-exist with co-channel RAS. The Commission will give further consideration to the 42.5-43.5 GHz band separately.
26. The Commission seeks comment on whether it is possible to authorize fixed and mobile use in the 42 GHz band while protecting RAS observations in the adjacent 42.5-43.5 GHz band. If protection is possible, the Commission seeks comment on what protections should be established. CORF notes that frequency lines at 42.519, 42.821, 43.122, and 43.424 GHz (for observations of silicon monoxide) are among those of greatest importance to radio astronomy. CORF represents, “The detrimental levels for continuum and spectral line radio astronomy observations for single dishes are −227 dBW/m2/Hz and −210 dBW/m2/Hz, respectively, for the average across the full 1 GHz band and the peak level in any single 500 kHz channel. For observations using the entire Very Long Baseline Array (VLBA), the corresponding limit is −175 dBW/m2/Hz.” Does the Commission need to establish special out-of-band emission limits into the 42.5-43.5 GHz band? Is it necessary or appropriate to establish a guard band below 42.5 GHz? The Commission asks proponents of terrestrial use in the 42 GHz band to provide detailed studies demonstrating how such use can be compatible with RAS use in the 42.4-43.5 GHz band. The Commission also asks CORF and other radio astronomy interests to provide additional information on the locations where observations are made in the 42.4-43.5 GHz band.
27. The Commission also seeks comment on the appropriate band plan for the 42 GHz band. Should the band be licensed as a single channel, split into two channels, or split into multiple 100 megahertz channels? The Commission recognizes that if the Commission adopts a guard band to protect adjacent channel radio astronomy, the guard band will affect the band plan by making less spectrum available. Given the contemplated use cases and the nature of this band, what channel size would be best? The Commission encourages commenters to discuss the specific advantages and disadvantages of various band plans.
28. Finally, the Commission proposes to add Federal fixed and mobile allocations into this band, and additionally seek comment on establishing a framework under which Federal and non-Federal users could share the band. Given the short propagation distances, lack of incumbent licensees, and other factors, as described in the 37 GHz sharing section and the rules the Commission adopted in the
29. The Commission proposes to authorize fixed and mobile operations in the 47 GHz band (47.2-50.2 GHz) under the Part 30 Upper Microwave Flexible Use Service rules. The band potentially offers 3 GHz of spectrum and is being studied internationally for possible mobile use.
30. At the same time, the Commission recognizes that this band is authorized for FSS use. While there are no current authorized operations, this band may be paired with the 40-42 GHz downlink band. Unlike in the 28 GHz or 39 GHz bands, where FSS can use other spectrum to operate user equipment, FSS would have to use some portion of the 47 GHz band to operate user equipment. Sharing between terrestrial mobile and FSS user equipment is more complicated, particularly when the FSS user equipment is transmitting.
31. With respect to individually licensed earth stations, it appears that the Commission could adopt the sharing framework the Commission has adopted for the 28 GHz band. Specifically, in each PEA, the Commission proposes that there can be one location where FSS earth stations can be located on a co-primary basis, subject to the conditions and limitations the Commission has adopted in other bands. The Commission seeks comment on this proposal, as well as alternatives.
32. The Commission seeks comment on the best approach for sharing between FSS user equipment and terrestrial operations. One option would be to have geographic area licensing on a PEA basis, but also authorize database-driven sharing between terrestrial licensees and stationary FSS user equipment. In the
33. Another option would be to divide the band into a segment where FSS has priority and a segment where UMFUS operations has priority.
34. A third option would be to develop specific criteria for assigning priority between FSS and terrestrial operations. For example, the Commission could require both FSS and UMFUS licensees to register their operations in a database, and the Commission could assign interference protection on a first-come, first-served basis. The Commission seeks comment on a first-come, first-served approach, and the Commission also invites commenters to propose alternative criteria for assigning priority. Commenters should provide detailed information on the costs and benefits of their proposed mechanisms for assigning priorities. The Commission also seeks comment on other alternatives for sharing between UMFUS and FSS in this band.
35. The Commission also seeks comment on sharing with co-primary Federal services in the 48.2-50.2 GHz band, as well as protection of passive services in the adjacent 50.2-50.4 GHz band. Our understanding is that there are currently no authorized Federal or non-Federal operations in the 48.2-50.2 GHz band but that there may be future Federal operations in that band. Are the rules and framework the Commission adopted in the
36. The Commission also seeks comment on the appropriate band plan for the 47 GHz band. One possibility would be to divide the band into six channels of 500 MHz each. One advantage of that band plan is that the channels would align with 48.2 GHz, which is where the Federal allocation and current FSS designation begin and where FSS user equipment can begin to be deployed. On the other hand, 500 megahertz channels would not align with the band plan in other bands, where the Commission is using multiples of 200 MHz. Given the contemplated use cases and the nature of this band, what channel size would be best? The Commission encourages commenters to discuss the specific advantages and disadvantages of various band plans.
37. The Commission proposes to authorize fixed and mobile operations in the 50 GHz band (50.4-52.6 GHz) under the Part 30 Upper Microwave Flexible Use Service rules. The band potentially offers 2 GHz of spectrum and is being studied internationally for possible mobile use. The Commission also proposes to use geographic area licensing in this band and license the band on a PEA basis. The Commission seeks comment on these proposals, as well as alternatives. The Commission also seeks comment on the non-Federal satellite allocations in the 50.4-51.4 GHz band.
38. The Commission also seeks comment on sharing with co-primary Federal services in the 50.4-52.6 GHz band, as well as protection of passive services in the adjacent 50.2-50.4 GHz and 52.6-54.25 GHz bands. The Commission's understanding is that there are currently no authorized Federal or non-Federal operations in this band but that there may be future Federal operations in that band. Are the rules and framework the Commission adopted in the
39. The Commission also seeks comment on the appropriate band plan for the 50 GHz band. One option is to establish ten channels of 200 MHz each, which would be consistent with the channel plan for the 39 GHz band. Other options include four channels of 500 megahertz each or five channels of 400 MHz each, with one extra 200 MHz channel. Is there any value in establishing a guard band immediately below 52.6 GHz to protect the passive band above 52.6 GHz? Given the contemplated use cases and the nature of this band, what channel size would be best? The Commission encourages commenters to discuss the specific advantages and disadvantages of the various band plans.
40. When evaluating services or uses that could be viable if the Commission authorize their introduction into the 71-76 and 81-86 GHz bands, the Commission must consider three basic issues. First, the Commission needs to consider whether the bands offer adequate spectrum for the proposed new services or uses in bands where tens of thousands of incumbent operations are already registered. Second, the Commission needs to consider whether the new services or uses are compatible with the fundamental electromagnetic characteristics of the relevant spectrum. And third, the Commission needs to consider whether more than one service or use can coexist in the bands. The Commission addresses each of these considerations and corollary concerns below.
41. The
42. The Commission must also consider whether the physical characteristics of the bands are suitable for the kinds of services that might be authorized in the bands—this is particularly true for mmW bands where atmospheric and other environmental phenomena affect the utility of the band. In general, for example, atmospheric attenuation increases the higher one goes in the electromagnetic spectrum, limiting the potential length of transmission paths. However, the 71-76 and 81-86 GHz bands experience less attenuation than frequencies in the 50-60 GHz range.
43. In addition to atmospheric attenuation, spreading loss also becomes an issue in the mmW bands. As the Friis transmission law states, path loss grows with the square of the frequency, even when radio waves are traveling through a vacuum. The caveat, however, is that Friis's law applies only to transmissions from omnidirectional antennas. As a recent technical study and analysis explains, “[T]he smaller wavelength of mmW signals also enables proportionally greater antenna gain for the same physical antenna size. Consequently, the higher frequencies of mmW signals do not in themselves result in any increased free space propagation loss, provided the antenna area remains fixed and suitable directional transmissions are used.” In short, the directionality of the antennas that are feasible at shorter wavelengths may result in less path loss than theorized. Based upon this preliminary analysis, the Commission believes the bands might be valuable for a variety of uses, including mobile as well as fixed uses. In determining whether new and different services can coexist in these bands, the Commission must also look at whether the new service use can be authorized in a manner that does not disrupt the incumbent use (or otherwise, the Commission could decide to disrupt the incumbent use), and whether the existing use can and should continue to expand. Specific to this analysis is whether the current and potential future fixed point-to-point uses of these bands might be compatible with other types of fixed or mobile uses.
44. When evaluating the compatibility between fixed and mobile services in the 70/80 GHz band, one important consideration is the beamwidths of their transmission paths because tighter beams are less likely to cause interference. Historically, the Commission has tried to balance the desire for smaller antennas against the spectrum efficiencies of narrow beamwidths in the 70/80 GHz band. Over the last decade, the Commission has continued to explore modifying the technical rules to allow larger beamwidths. Most recently, on October 13, 2015, WTB's Broadband Division opened a new docket (Public Notice 30 FCC Rcd 10961 (WTB 2015)) to address two waiver requests seeking a further relaxation of antenna standards in the 71-76 and 81-86 GHz bands. As the waiver requests and comments filed in that docket attest, evidence suggests that the Commission might further relax the allowed beamwidth to 2.2 degrees. That step, if taken, would bring the bands' technical standards into a realm that is at least potentially compatible with dynamic beamforming technology because a 2.2-degree beamwidth is also achievable by the kinds of MIMO base stations that will be supporting mmW mobile services. At least when operating with beamforming MIMO, these base stations would likely be able to coexist with conventional point-to-point Fixed Service links.
45. The introduction of fixed services under somewhat relaxed directionality requirements in addition to mmW mobile services pose a new coexistence consideration. It is likely that, when both fixed and mobile mmW services are operated by the same entity, they can sufficiently plan, coordinate, and time their use to facilitate coexistence. In looking at whether incumbent fixed services, new more dynamic fixed services, and potential mobile services (and equipment) in these bands may coexist, it is apparent that the use of a central coordinating database capable of calculating and enforcing protections among different types of users, like a Spectrum Access System, could facilitate this coexistence.
46. Initially, coordination of non-Federal links with Federal operations in the 71-76 GHz, 81-86 GHz, and 92-95 GHz (70/80/90) bands was accomplished under a traditional coordination process: that is, requested non-Federal links were recorded in the Commission's Universal Licensing
47. This system has been effectively used for over a decade to facilitate coexistence between commercial systems and Federal systems: the technical data needed to avoid interfering with incumbent non-Federal licensees is already available in existing registration databases, and an automated system to prevent interference with Federal systems is already in place and has been in operation for years.
48. Recently, the Commission has developed other means of facilitating spectrum sharing. In May 2016, seven parties filed applications to be certified SAS Administrators for the Citizens Broadband Radio Service. The SAS is a critical tool to enable spectrum sharing in the band. SAS will protect incumbent users based on technical criteria, authorize all devices in the band, protect a Priority Access Tier, and coordinate a General Authorized Access (GAA) Tier. By leveraging the SAS computational power, protections can be tailored to the characteristics of the systems that require protection, different uses with different characteristics can be coordinated in a similar area, and spectrum efficiency can be maximized. Based on the experience with the coordination system for the 70/80 GHz band, and the existing rules for the SAS, the Commission proposes to establish a SAS-based regulatory framework adapted to the constraints and the opportunities of the 71-76 and 81-86 GHz bands. In particular, the Commission invites comments on the following questions and proposals:
• The Commission proposes to establish three tiers of users for the 71-76 and 81-86 GHz band, consisting of: (1) Incumbent Access users, which would receive the highest level of protection; (2) Priority Access Licensees (PALs); and (3) GAA users. Each tier would be required to prevent interference to, and accept interference from, higher tier users.
• The Commission seeks comment on whether the rules for these bands should be included in Part 30 (Upper Microwave Flexible Use Service) or Part 96 (Citizens Broadband Radio Service).
• Incumbent Access: The Commission proposes to continue to protect existing Federal locations and seek comment on the ability to add future sites on the same protected basis. The Commission seeks comment on whether existing 70/80 GHz licensees and registered links should also qualify for incumbent protection. Alternatively, the Commission seeks comment on whether they should be grandfathered for some period of time, then required to transition to the new service the Commission proposes here (most notably, deploy equipment consistent with the technical rules and capable of communicating to an SAS). To the extent grandfathered links are protected, the Commission proposes to require the links to be operational and in service, and seek comment on requiring incumbent licensees to certify their construction and operational status with the Commission. The Commission also seeks comment on the appropriate means for protecting Federal incumbents, including whether the Commission should modify the existing system or utilize a more automated system (like a sensor-based system). Finally, the Commission seeks comment on the extent to which Federal users could expand their service area and gain protected status under the incumbent tier.
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•
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a. Require SAS to calculate expected aggregate interference at each incumbent or Priority Access receiver, based on their positions and the technical parameters of their equipment, together with the corresponding parameters of intruding transmitters.
b. Establish a maximum aggregate received signal level within Priority Access license areas, which would be measured in terms of power flux density (PFD) per megahertz of bandwidth at specified heights above the ground.
c. Implement an alternate protection scheme whereby the SAS would protect operator-defined contours around Priority Access base stations to a protection level at a specified dBm per megahertz of bandwidth anywhere within the contour.
•
a. Class A licenses would be authorized only for operations at a minimum specified height above ground level, would be authorized to use comparatively high power levels, and would be required to use tight-beamwidth antennas. Class B point-to-point licenses would be authorized transmit at streetlamp level, with somewhat relaxed beamwidth requirements in order to accommodate
b. The Commission proposes to authorize dynamic beamforming antennas to provide in-band backhaul so long as they conform to the same beamwidth requirements, height limitations, and other requirements that apply to conventional antennas used for point-to-point links.
c. The Commission proposes to authorize the same dynamic beamforming antennas to serve mobile user equipment, with further relaxation of beamwidth requirements, provided that they are situated no higher than streetlamp level and provided further that their antennas are inclined downward at a minimum specified angle when they are communicating with mobile user equipment. The Commission invites comment on appropriate beamwidths, inclination angles, power levels, and height constraints for these purposes.
d. The Commission proposes to require that Class A license equipment be professionally installed but that non-professionals be allowed to install Class B license equipment and mobile base station equipment, provided that the installer is equipped with the necessary geo-location equipment or that the equipment itself is capable of ascertaining its location and its orientation.
e. The Commission invites comment on technical requirements that would be appropriate for different kinds of user equipment in these bands, differentiating between point-to-point, handheld mobile equipment, and mobile equipment that will typically be situated more than 20 centimeters away from people. The Commission proposes to require that user equipment be allowed to transmit only when it is locked onto a serving base station, with the possible exception of brief pilot or sounding signals.
f. The Commission proposes to require SAS to maintain and verify information from registered base stations and Fixed Service transmitters and receiver equipment under their coordination, and the Commission invites comment on the minimum geographic positioning accuracy that the Commission should require, including accuracy with respect to altitude as well as latitude and longitude. The Commission also seeks comment on requiring licenses to update registration information if the location or operational status of registered base station equipment changes. The Commission does not propose to require SAS to maintain position awareness of mobile user equipment.
g. The Commission proposes to establish out of band emissions (OOBE) limits for all equipment authorized to operate in these bands, and the Commission invites comments on the appropriate technical parameters to apply for that purpose.
•
• The Commission proposes to extend the same requirements and privileges to all parts of the United States, but the Commission also invites comment on the alternative of establishing a separate regulatory framework for the 16 counties that are heavily registered with incumbent users.
• The Commission proposes to require SAS to be capable of performing the following operations:
a. Determine the available frequencies at a given geographic location and assign them to PAL and/or GAA licensees;
b. Determine the maximum permissible transmission power level for incumbent, PAL, and GAA licensees at a given location and communicate that information;
c. Register and authenticate the identification information and location of incumbent, PAL and GAA licensees;
d. Enforce Exclusion and Protection Zones, including any future changes to such Zones, to ensure compatibility between non-Federal users of spectrum in the 71-76 GHz and 81-86 GHz bands and incumbent Federal operations;
e. Ensure that PAL and GAA licensees protect non-Federal incumbent users consistent with the rules;
f. Protect Priority Access Licensees from impermissible interference from other users;
g. Facilitate coordination between GAA users to promote a stable spectral environment;
h. Ensure secure and reliable transmission of information between the SAS, ESC, and PAL and GAA licensees;
i. Provide any ESC that the Commission might approve with any sensing information reported by PAL and GAA licensees if available;
j. Facilitate coordination and information exchange with other SASs and exchange information, as needed, with NTIA.
49. The Commission also seeks comment on alternative methods of authorizing additional access to these bands, including exclusive use licensing and unlicensed. As discussed, authorizing new flexible use operations in these bands is difficult given the incumbent fixed commercial and Federal operations. How would an exclusive use licensing or unlicensed access models work? How would incumbents be protected and be permitted to expand? Could the Commission auction overlay licenses that allow the auction winner to negotiate with the incumbents in the area for their rights? How could unlicensed operations sufficiently protect incumbents? Have circumstances changed since the Commission declined to allow unlicensed operations in these bands in 2003? The Commission seeks comment on these and other issues implicated in any alternative licensing or authorization scheme.
50. In the
75. The spectrum from 95 to 275 GHz has been allocated for a variety of different types of Federal and non-Federal radio services. In addition, the international Table of Frequency Allocations has been extended from 275 to 1,000 GHz for specific services and, in a separate proceeding, the Commission is considering how to amend the United States table. The bands above 95 GHz have already been identified for services that typically involve the reception of extremely weak signals, such as radio astronomy, space research, and Earth Exploration Satellite. All of the bands, with some minor exceptions, are allocated on a co-primary basis for Federal and non-Federal use.
51. The Commission recognizes that signals in the frequency bands above 95 GHz will attenuate rapidly, intuitively tending to minimize the risk of harmful interference to other radio services. However, this does not by itself provide a basis for proposing to allow use of any spectrum above 95 GHz. The Commission believes the process of facilitating technology above 95 GHz can best be advanced by identifying specific frequency bands rather than attempting to address all parts of the spectrum above 95 GHz. Accordingly, the Commission takes this opportunity to solicit information on the specific parts of the spectrum that would be most attractive from the standpoint of technology development while successfully coexisting with the types of radio communications services that operate under the existing allocations.
52. In identifying specific frequency bands, the Commission asks commenters to provide specific analyses to justify any claims that there are no risks of harmful interference to other radio services. Which bands should be made available for licensed or unlicensed use? Is there sufficient information to identify where and on what frequencies both existing and planned radio astronomy, space research, Earth Exploration Satellite, and similar users will actually operate? What technical rules may be appropriate? For parties supporting unlicensed use, will it be necessary to control the locations of operation to prevent harmful interference to radio astronomy, space research, Earth Exploration Satellite, or other services? If so, how could the areas of permissible operations be controlled under the unlicensed rules? For bands that commenters believe should be made available on a licensed basis, should the new Part 30 rules or other service rules apply? How would the Commission create a licensing scheme for signals that generally propagate over very short distances? Should the Commission permit both mobile and fixed service? What technical rules should apply? The Commission encourages parties to file comments addressing these matters.
53. As the Commission indicated in the
54. As explained in the
55. The Commission believes that a robust coordination mechanism is essential to ensuring that both Federal and non-Federal fixed and mobile users have effective coordinated access to the lower band segment. The coordination mechanism will authorize a particular user to use a particular bandwidth of spectrum at a particular location. To do so efficiently and effectively, it must be able to obtain information about the type of equipment used, the signal contour from the coordinated location, and the bandwidth requested compared with the bandwidth available. As discussed below, it must also be capable of regularly updating the status of a coordinated location (on/off or authorized/unauthorized). Moreover, it will have to incorporate this type of information for both Federal and non-Federal fixed and mobile uses. Here, the sharing environment is relatively straight forward—there are limited incumbent uses that need to be protected, and Federal and non-Federal fixed and mobile users will have coequal rights to the band. The Commission also believes that the propagation characteristics of this band might help minimize the complexity of the coordination mechanism.
56. The Commission notes that historically the Commission has used manual frequency coordination managed by third party frequency coordinators. Recently however, the Commission finalized the rules for the 3.5 GHz Citizens Broadband Radio Service, which relies not on a static frequency coordination mechanism, but on a dynamic mechanism known as a SAS that coordinates uses among different tiers of users, rather than on an individual basis. The Commission seeks comment on the most appropriate mechanism for the lower band segment. Should the Commission rely on static, manual frequency coordination, a dynamic SAS-type mechanism, or something in between? For instance, would the advanced capabilities of automated coordination from SAS present advantages over other types of coordination? Is a full SAS implementation, consistent with the Part 96 requirements, appropriate here?
57. The Commission also seeks comment on the protection or operation contours necessary for the coordination mechanism to reserve a quantity of spectrum at a location for a user. In the
58. Although non-Federal fixed and mobile users must follow the coordination requirements that the Commission adopted in the
59. Finally, the Commission seeks comment on how best to coordinate Federal access. Is it feasible for Federal users to rely on the same coordination mechanism as non-Federal? How should the coordination mechanism address information security issues particular to Federal users? The Commission seeks comment on the means of achieving information security, including ways for the information to be masked,
60. As discussed in the
61. The Commission also finds that our proposal to adopt a minimum channel size of 100 MHz strikes the right balance between providing enough spectrum for a diversity of wireless uses with helping to minimize the complexity of the coordination mechanism. The Commission notes that while most commenters in this proceeding generally favor channel sizes of 200 MHz or greater, other commenters suggest that smaller channel sizes can still facilitate robust wireless broadband services. By permitting users to aggregate up to 600 MHz channels, the Commission found that it has enabled maximum flexibility for a variety of use cases involving a variety of channel sizes. The Commission seeks comment on these proposals. The Commission also seeks comment on alternative approaches, including whether the Commission should adopt 100 MHz or a larger minimum channel size. In addition, the Commission seeks comment on whether the Commission should refrain from setting a minimum channel size and instead require the coordination mechanism to attempt to maximize the number of users in a given area.
62. To achieve a robust and efficient sharing environment and prevent spectrum warehousing, the Commission proposes that registered non-Federal sites must be put into service within seven days of coordination and that registered and coordinated sites must reassert their registration every seven days. For example, if the Commission relies on a database for coordination, a user could query the database for available frequencies at a location, and reserve those frequencies for seven days. Within seven days, it would need to activate a device that is capable of notifying the database that it is active on the channel. That device would then check in with the database (or receive and respond to a message from the database) at least once every seven days. If the device fails to check in within the seven day period, its authorization would lapse. The Commission seeks comment on this proposal. Are these time frames appropriate? Are there other tools to ensure the spectrum is put to use consistent with the public interest?
63. The Commission recognizes that Federal users' needs are not necessarily commensurate with non-Federal users' needs. The use cases will likely differ, the level of certainty and protection or a use related to a critical defense or national security mission may vary. The Commission therefore seeks comment on whether the Commission should make a portion of the lower band segment available for priority access by Federal users. For instance, should the Commission allow Federal users to claim priority access to up to 200 MHz of the 600 MHz lower band segment? Could the coordination mechanism statically reserve this space or dynamically make it available when requested? For instance, if the entire band is in use, could the database reconfigure the channels or clear the necessary channel size?
64. The Commission seeks comment on any necessary enforcement mechanism in the lower band segment to help identify and rectify interference events. Because the Commission proposes to require users in the lower band segment to coordinate on a site-basis, it may be easier to identify and rectify any interference issues that may arise. The Commission recognizes, however, that there may be users and uses, both Federal and non-Federal, for which any interference may be significantly problematic. Therefore, the Commission seeks comment on any additional interference mitigation and enforcement mechanisms that might be necessary.
65. Finally, the Commission seeks comment on whether and how to apply secondary market rules to the lower band segment. As proposed, the band will be made available on a site-by-site basis. Partitioning and disaggregation generally do not apply in site-based licensing circumstances. Should they apply here, and if so, how? Should the Commission apply our leasing rules? What are the benefits to secondary market rules for the lower band segment relative to other ways to gain access to the spectrum?
66. As described in the
67. The Commission notes that it has found spectrum sharing to be an effective tool to maximize spectrum efficiency. In the 700 MHz band, the Commission adopted a performance requirement that results in the licensee losing its unconstructed license area. In the Citizens Broadband Radio Service, Priority Access License areas that are not in use must be made available for General Authorized Access use. Moreover, in the
68. The Commission understands that upper band segment licensees may make reasonable business decisions to not serve particular parts of a licensed area, and that these decisions may change over time. In an environment where these unserved areas are shared, it is important to be able to both accurately identify the areas in use and enable the geographic area licensees to expand or contract their coverage as necessary. Under our proposal, the upper band segment licensee would retain the primary right to construct and provide service anywhere within its license area at any time, and any operations undertaken on a shared basis would be subject to displacement by the primary licensee. The Commission therefore proposes to require licensees to provide information about the extent of their operations at some future point in order to enable shared access.
69. The Commission also seeks comment on when the Commission should phase in shared access. Would it be appropriate to phase in shared access at the end of the initial license term, or would it be appropriate to adopt a sharing requirement at an earlier time (
70. In the
71. In particular, the Commission seeks comment on an appropriate metric to evaluate the deployment and performance of an Internet of Things (IoT) type service, which is designed primarily to facilitate machine-to-machine communication. Such services may or may not be deployed in areas of substantial residential population, and may or may not be designed to serve unaffiliated customers. Examples of this type of service would include the Supervisory Control and Data Acquisition (SCADA) systems described by Southern Co. Because of the unique characteristics of these machine-to-machine services, the Commission proposes to develop a distinct metric by which to measure the deployment of such services, rather than attempting to modify a population coverage approach for this purpose. The Commission seeks comment on this proposal, including specific suggestions for what aspects of such services should be measured, how they should be measured, and what specific levels would constitute an acceptable level of service.
72. In the
73. As some commenters note in this proceeding, licensees in these bands may seek to provide service to areas with high daytime or transient populations but low or no residential populations, such as corporate campuses, interstate highways, or event venues. The Commission seeks comment on how to define such locations for the purposes of evaluating service coverage. The Commission also seeks comment on the appropriate framework for incorporating coverage of such locations into an overall performance metric. Would a venue per population metric be appropriate, similar to the current treatment for fixed links? Should the applicable milestone be based on the daytime or transient population served by such venues or traffic corridors? How should such population be measured?
74. The Commission also seeks comment on any other types of service being contemplated by potential providers, as well as metrics that would be appropriate to measure performance or build-out of those services.
75. Finally, in the
76. Given the relatively limited record on the substantive issues regarding mechanisms for sharing unused portions of UMFUS licenses, the Commission seeks further comment on the possibility of implementing a use-or-share regime in the UMFUS bands. The Commission continues to believe that a use-or-share regime may have the potential to enhance the efficiency and productivity of spectrum, if properly implemented. In particular, given the propagation characteristics, and high potential for re-use, of the mmW spectrum, the Commission seeks comment on whether such a regime could maximize the efficient use of these spectrum bands. The Commission further seeks comment on the costs and benefits of adopting mechanisms for sharing unused UMFUS spectrum, as well as on the incentives that particular sharing regimes will create. In addition, the Commission seeks comment on the appropriateness of requiring UMFUS licensees to share unused portions of their license in addition to, or in lieu of, meeting specific construction requirements, particularly in geographically licensed bands such as 28 GHz and 39 GHz.
77. In crafting an effective mechanism to share unused spectrum, there are two governing considerations: first, ensuring the licensee has exclusive use of the areas in which it is using the spectrum; and second, creating an efficient mechanism that both makes unused spectrum available and protects the licensee from interference. There are a variety of potential options for enhanced sharing mechanisms that address these considerations. The Commission seeks comment generally on the following opportunistic sharing mechanisms: a fully dynamic sharing solution, facilitated by a SAS or other third-party database; a modified shared access system that would be less dynamic but simpler; an unlicensed shared access approach, similar to white spaces, and other alternatives.
78. The Commission seeks comment on variations of a use it or share it mechanism. A potential drawback of a keep what you use mechanism is that the Commission must reclaim, and later re-auction, the unused portions of the band, which takes time and minimizes a licensee's ability to decide later to deploy in an area (which is also a feature of the approach because it incentivizes maximum initial deployment). Use or share mechanisms permit a licensee to retain control of its license area, but require the licensee to share with other entrants in portions of the license area in which it is not operating. A use or share mechanism may be less administratively burdensome than keep what you use, and may also allow a greater number of users to access the shared spectrum. There are a number of possible variations of use or share, all of which share characteristics of basic frequency coordination.
79. One option would be to automate shared access to enable dynamic opportunistic sharing. In a dynamic sharing solution, licensees would have some initial period of time to build out their networks. After this period, information about the extent of licensees' deployment would be made available, and other entities would be free to deploy outside of the area used by the licensee's operations on a coordinated basis, subject to further expansion by the licensee. The Commission seeks comment on whether an automated dynamic use or share mechanism would be appropriate in the mmW bands. Generally, these shared users would need to operate similar technologies subject to the same technical rules as the licensee to maximize spectrum efficiency and economies of scale with respect to equipment. The Commission seeks comment on whether the propagation characteristics of these bands might facilitate shared access with slightly different technical rules. With respect to the sharing mechanism, what types of information, and what level of detail, would be required to facilitate dynamic sharing? Should opportunistic users be authorized on a license-by-rule basis, or by some other method? Should opportunistic users be afforded some level of interference protection from each other, and if so what should that level be?
80. Another option is to rely on more traditional frequency coordination, typically used in point-to-point microwave, shared millimeter wave bands, and other services today. Under a simple frequency coordination process, the licensee's operations would
81. Yet another option is to established pre-defined geographic areas that will be available for shared access, depending on a licensee's construction. For instance, if a licensee meets its performance requirement, the Commission could find that any county (or other unit of geographic area) in which it has any operation is unavailable for sharing. For example, a licensee of a PEA might deploy heavily in some counties but not others; the heavily-deployed counties would then be deemed “in use,” while the counties with no deployment would be available for opportunistic use in undeployed areas. The Commission seeks comment on the appropriateness of this mechanism as a whole, and on the specific details. What level of subdivision would best accommodate both licensee certainty and sharing opportunity? Should the Commission stop at the county level, or should the Commission further subdivide into census tracts or census blocks? What level of deployment in each subdivision should qualify that area for “used” status? How should the Commission enable sharing—through a database, individual coordination, or some other method?
82. Finally, the Commission also seeks comment on implementing unlicensed shared access, similar to TV white spaces, in the unused portions of the UMFUS bands. In this case, opportunistic users would operate on an unlicensed basis at lower power in any area where the licensee was not actually deployed. The Commission seeks comment on whether and how to implement such a system in the millimeter wave bands. Would this system require a third-party database, similar to the dynamic sharing solution? How should the Commission draw the contours around licensee deployments? Should the Commission use a fixed radius, or an interference contour at a certain level, or some other metric? Would this method be preferable to a dynamic sharing solution where the opportunistic users and the licensee followed the same technical rules? Are there technical benefits to this approach? Will there be sufficient scale to drive more special-purpose equipment development?
83. To the extent that the Commission implements any variation of a use it or share it mechanism in the mmW bands, certain key aspects of that mechanism must be defined. Most importantly, the Commission seeks comment on how to define a licensee's “use” of its licensed spectrum. Should “use” be defined geographically, either by the service area of a network or by a defined radius or contour around deployed equipment? In the Citizens Broadband Radio Service, the Commission recently adopted an engineering metric to determine the extent to which Priority Access Licenses are in use. Licensees can define the area of use subject to an objective maximum. Should the Commission follow this model? Should “use” be defined differently for different types of deployments, for example mobile vs. fixed links? Additionally, the Commission seeks comment on how best to allow the licensee room to expand beyond its area of actual deployment (or its “used” spectrum, however ultimately defined). For example, should the Commission define a contour for an additional protected area? If so, on what basis and how often should the Commission do so? Should the Commission set some level at which a subdivision of a license area would be declared “used” in its entirety, and off-limits to opportunistic use? If so, what subdivisions and what level of deployment would be appropriate (
84. In addition to the inquiries above, the Commission seeks comment on any other mechanisms of opportunistic sharing that could enhance spectrum efficiency in the UMFUS bands, as well as any other aspects of such a system that would be required to ensure it could be reliably and effectively implemented. The Commission especially seeks comment from any entity interested in using spectrum on an opportunistic basis in these bands. What technologies or business cases would lend themselves to this type of spectrum access? Which sharing mechanism, described above or otherwise, would best accommodate that use?
85. In the
86. Of the 986 designated license areas in the 28 GHz band, 412 areas have active licenses, which cover about 75 percent of the U.S. population, while the 37 GHz band is not yet licensed, and in the 39 GHz band, current licensed areas cover about 49 percent of the U.S. population. Further, in terms of geographic licensed areas, the 28 GHz band will be licensed on a county basis across the U.S., while the 37 GHz and 39 GHz bands will be licensed by PEA.
87. For purposes of assessing eligibility to bid across the three spectrum bands any given entity cannot hold more than 1250 MHz of this spectrum in total. Taking into account existing incumbents' holdings in the 28 GHz band and the 39 GHz band, as well as different geographical license areas, the Commission put forward and seeks comment on two alternative methodologies for assessing bidding eligibility. The Commission asks for comment on which methodology is more appropriate, and why. The Commission also asks that interested parties comment on the likely costs and benefits associated with each methodology. Are there additional methodologies beyond the two alternatives set out below that would be more appropriate to adopt? If so, the
88. The first methodology that the Commission invites comment on is the “maximum county-to-PEA” option. Under this option, if any incumbent licensee in the 28 GHz band, for example, holds such spectrum, its spectrum holdings at the county level would be counted at the PEA level when determining eligibility to bid on 37 GHz and 39 GHz spectrum. For instance, if an incumbent licensee currently holds two licenses, or 850 MHz of spectrum, in the 28 GHz band in any county within a PEA, then that licensee's 28 GHz spectrum holdings would be counted as 850 MHz for the PEA as a whole. In addition, that same licensee's 39 GHz holdings, if any, would be added on to its 28 GHz holdings of 850 MHz. That licensee would then be able to acquire a maximum of an additional 400 MHz of spectrum across the 37 GHz and 39 GHz bands if it so chose (this maximum of 400 MHz assumes it has no current holdings in the 39 GHz band). Similar calculations would apply in the 39 GHz band. For instance, for those licensees that currently hold more than 400 MHz of spectrum in the 39 GHz band in any county in a given PEA, such entities would be unable to bid on both licenses in the 28 GHz band but potentially could still bid for one license in the 28 GHz band, as well as on 37 GHz spectrum and additional 39 GHz spectrum. To determine bidding eligibility across the three bands for those entities who do not currently hold licenses in the 28 GHz or 39 GHz band, the Commission would similarly count maximum spectrum holdings in counties at the PEA level. The “maximum county-to-PEA” option is a simple way to calculate spectrum holdings in which the licensing areas of each band have varied geographies, and the Commission seeks comment on this first methodology for determining eligibility to bid.
89. The second methodology that the Commission invites comment on is the “population-weighted-average” option. This option involves calculating an entity's current spectrum holdings on a county-by-county basis within a PEA in the 28 GHz and 39 GHz bands, and then constructing a population the weighted average for that PEA as a whole. For incumbent licensees in the 28 GHz and 39 GHz bands, the Commission would sum the product of county spectrum holdings and county population within the PEA (using U.S. Census 2010 population data), and then divide that sum by the total population of the PEA. This would provide us with the population-weighted amount of 28 GHz and 39 GHz spectrum held by that incumbent in that PEA. The entity would then be able to bid on 28 GHz spectrum (by county, and any winning bid would be weighted by the county population divided by the PEA population), and 37 GHz and 39 GHz spectrum (by PEA or partial PEA), up to the population-weighted limit of 1250 MHz. To determine eligibility to bid for those entities who do not currently hold licenses in the 28 GHz or 39 GHz bands, the Commission would also calculate prospective holdings based on a population-weighted average within the PEA. Overall, any entity would not be able to bid on certain spectrum if, across the three bands, it would hold 1250 megahertz or more on a population-weighted basis. The Commission seeks comment on this second methodology for determining eligibility to bid.
90. In addition to the decisions made in the
91. The Commission proposes to adopt a holding period for licensees acquiring spectrum in the 28 GHz, 37 GHz, and/or 39 GHz bands. In particular, the Commission seeks comment on our proposal to adopt a holding period that would restrict certain proposed secondary market transactions for mmW licensees necessary to support the spectrum aggregation policies the Commission adopted in the
92. The Commission proposes a period of three years, given the nascent nature of the frontier spectrum in the 28 GHz, 37 GHz, and 39 GHz bands and the likely rapid development of multiple use cases for this spectrum. While the Commission could establish a holding period tied to the length of the license term or build out period for licensees in these bands, a shorter three-year holding period that is half of the buildout period the Commission established for incumbent licensees in the 28 GHz and 39 GHz bands may best serve the public interest by allowing flexibility while still preventing entities from undermining our ex ante spectrum aggregation policies. The Commission seeks comment on our proposal. To the extent commenters support a longer holding period, the Commission seeks comment on how a longer holding period would better help the Commission achieve its objectives for the use of this spectrum. If a longer holding period is warranted, how long should it be? For example, should the length of the holding period be based on the 10 year license term and performance benchmarks for new licensees that the Commission adopted in the
93. The Commission determined in the
94. The Commission does not believe the current record is sufficient for us to conclude that authorizing satellites to operate at the higher PFD of −105 dBW/m2/MHz would be consistent with terrestrial use of the 37.5-40 GHz band. In theory, the same rain storm that impairs satellite reception might be able to shield earth stations if the satellite raises its power level; the problem is that rain will rarely be uniformly present throughout a spot beam's footprint, leaving at least some terrestrial stations unshielded or inadequately shielded by rain and, hence, vulnerable to any increase in the spot beam's PFD level. Unlike with respect to the 28 GHz band, the issue of satellite-terrestrial coexistence in the 39 GHz band has received relatively little attention.
95. At the same time, the Commission recognizes that Boeing has submitted a study which shows that coexistence is possible, even at the higher PFD level. Boeing's presentation suggests that terrestrial mobile units might be able to suppress interfering signals from satellites if the satellite signals arrive at sufficiently high angles of elevation. On the other hand, Boeing assumes a maximum distance of 200 meters between mobile units and base stations. The Commission believes the record would benefit from further development on this issue.
96. Accordingly, the Commission seeks further comment on whether there are any circumstances under which allowing FSS satellites in the 37.5-40 GHz band to operate at a higher PFD level than permitted under the existing rules would be consistent with terrestrial use of the 37.5-40 GHz band. If a higher PFD limit would be appropriate, what limit should the Commission adopt? Commenters should provide detailed technical studies that explicitly list the assumptions they made concerning both terrestrial and satellite operations. Studies should study both fixed and mobile terrestrial operations. If a commenter believes a study submitted by another commenter is not valid, it should list the specific assumptions or analysis that it believes are not valid and provide its own assumptions or analysis. Ultimately, the Commission believes the burden is on FSS interests to show that the higher PFD level is consistent with terrestrial use. Terrestrial interests do have an obligation to provide sufficient information concerning the nature of their systems to allow other parties to analyze the interference impact of a higher PFD level.
97. The Commission seeks comment on the possibility of repealing the prohibition on satellite user equipment in the 37.5-40 GHz band. Initially, the Commission asks satellite interests to provide further information concerning the need and demand for user equipment in that band. The Commission notes that FSS user equipment can receive in the 40-42 GHz band, which is not licensed for terrestrial operations. Are there uses for which access to the 40-42 GHz band is insufficient? The Commission asks FSS providers to provide specific examples and data demonstrating the need for user equipment in the 37.5-40 GHz band.
98. Assuming a need exists, the Commission seeks comment on the appropriate manner of authorizing satellite user equipment. The Commission agrees with ViaSat's observation that because user equipment in this band would be receiving, it would not cause interference to terrestrial operations. One option would be to adopt ViaSat's proposal to allow FSS user equipment purely on a secondary basis at their own risk. If the Commission adopted that proposal, the Commission emphasizes that the equipment would truly be on a secondary basis and that FSS user equipment would have no expectation of interference protection. A variation on that option, based on the analysis Boeing has done, would be to require terrestrial operators to provide information on their deployments to FSS providers through a database, which the FSS providers could then use to determine where user equipment could operate without interference. The Commission asks other parties to comment on Boeing's technical analysis. To the extent Boeing relies on erroneous data concerning the nature of technical operations, the Commission asks terrestrial operators and equipment manufacturers to provide a specific analysis in response, with an explanation for the specific parameters used in their analysis. The Commission also seeks comment on whether the benefit to FSS operators of enhancing the ability to operate user equipment in the band outweighs the burden to UMFUS licensees of providing information on their deployments. The Commission asks both FSS operators and terrestrial operators to provide specific data on the relative costs and benefits.
99. Currently, AM/FM/TV broadcasters are required to announce their call signs, as are land mobile station operators. Adopting a similar requirement for millimeter wave band operations could make it easier to identify and monitor signals, which in turn could make it easier to find sources of interference to these systems. Accordingly, the Commission seeks comment on requiring a digital identification (digital ID) for the millimeter wave band systems under consideration in this proceeding. Specifically, should operators be required to transmit an ID that is readily observable and decipherable by the Commission and/or other users that could be used to identify the operator/licensee of an unknown and/or interference source?
100. If so, the Commission seeks comment on the details of such a digital ID requirement. For example, should the ID requirement apply to all millimeter wave band services, or be limited to licensed services, non-licensed services, or fixed operations? Alternatively, should it apply to all transmissions above a certain power limit or antenna height, or be limited to transmissions with some other technical parameter? If so, what should those technical parameters be? If there is an ID requirement for unlicensed equipment, what should the content of the ID be? Should unlicensed equipment authorization holder or equipment user be required to register in a nationwide database that would allow either the FCC and/or anyone to search an ID for operator contact information? Should the ID be continuously broadcast, similar to consumer Wi-Fi routers, only when the transmitter is operational, or only at regular intervals? Finally, should there be a labeling (or software screen display) requirement for the equipment itself that identifies the owner/operator? If so, should the requirement apply to all millimeter wave band equipment, or
101. The Commission seeks further comment on whether antenna height limits are appropriate and, if so, what thresholds and corresponding reductions in power should apply at higher antenna heights. Considering what future wireless networks are envisioned to be, are the antenna height thresholds and corresponding power reductions in the existing Part 24 (PCS) or Part 27 rules appropriate for future mmW mobile base stations? Based on what has been presented on the record, mobile mmW base stations in this band may be more likely deployed at street lamp post height, and will not be deployed at the heights of traditional mobile base station deployments. In that context is the 305 meter threshold currently in Part 27 valid or would lower thresholds be appropriate? Is there an alternative maximum height that should be considered? Conversely, given the existing PFD limits that the Commission has adopted to control interference at market boundaries and at the edge of an earth station contour, are additional antenna height restrictions and corresponding power reductions even necessary? The Commission tentatively proposes to adopt antenna height and power limits similar to those in our Part 27 rules. However, the Commission seeks comment on whether power limits based on antenna height are necessary and/or whether any modifications should be made to either the height thresholds or the power limits at specific heights that the Commission have proposed. The Commission also seeks comment on whether there would there be any benefit in requiring antenna downtilt for antennas above a certain height?
102. For applications and technologies that operate under the umbrella of the next generation of wireless networks, is it worth considering a sub-set of networks that might operate with band widths less than 100 MHz and how the maximum power limits adopted should be evaluated? What minimum band width should be established for base stations, transportable station, and mobile station classes of equipment? Is there value in establishing these bandwidth scaling limits for mobile and transportable classes such as the Commission did for base stations? If so what should the minimum band width scaling factors be for these classes of equipment based on the power levels the Commission adopted in the
103. In the
104. The wireless industry, standards groups, government organizations, and academia are currently engaged in developing propagation models for millimeter wave bands. The National Institute of Standards and Technology (NIST) and the European Commission's 5G partnership with industry have active study groups looking at millimeter wave propagation modeling. Academia have published papers describing several models such as the Close In (CI) and alpha-beta-gamma (ABG) free space reference distance models. The Commission seeks comment on whether these or other models are appropriate propagation models to apply when analyzing inter-service interference between terrestrial-based transmitters and receivers of different services. There are several factors that are common to the interference effects in both directions to and from 5G stations, including antenna beam forming, the location and height of antennas, and the propagation distance and environment between other systems and the 5G stations. Lower gain 5G antennas that are mostly indoors in cluttered environments and at lower heights will reduce the degree of RF coupling in both directions, and therefore reduce the propagation path loss required to meet interference threshold limits. Which millimeter wave propagation models are most appropriate for sharing analyses where the interfering emitters may be assembled from a group of indoor and outdoor emitters? When applying transmitter or receiver isolation factors
105. If the terrestrial receiver or transmitter is fixed at a specific location then a terrain-based propagation loss model can be employed; what terrain based propagation models are most appropriate for millimeter wave analyses? When the terrestrial receiver is not at a known location, what are the most appropriate millimeter wave models to apply? How much isolation could one typically assume due to antenna beam forming techniques? What other interference mechanism, such as clutter, should be considered when modeling inter-service interference in millimeter wave bands? Generally, the Commission seeks further comment on millimeter wave propagation models appropriate for spectrum sharing studies between fixed, mobile and satellite systems, as well as active and passive services.
107. The Commission is seeking further technical analyses and sharing studies, specifically with respect to the various types of unlicensed applications envisioned on-board aircraft, the priority/order of their planned introduction, as well as their associated potential harmful interference profile with respect to passive sensor services. For example, is the intent to provide only for applications that are used by the aircraft itself to reduce weight by replacing cabling and wiring with radio for applications, such as for connecting inflight entertainment systems, seatback display consoles, or connecting with sensors used to monitor the health of the aircraft structure and its critical systems in wireless avionics intra-communication (WAIC)? Or is the intent to provide for the direct streaming of movies/news/internet service from ceiling-mounted access points to portable electronic devices carried aboard the aircraft by passengers in nearby seats? Are there additional inflight applications that commenters further envision?
108. What harmful interference profile could be expected from each of these various types of on-board aircraft provisions of 60 GHz transmitters? How much difference would the type of aircraft body make in providing additional protection to passive sensor services from operation of these transmitters? Should the Commission propose, as a first cautious step, to allow WiGig transmissions on-board aircraft only for certain applications, such as inflight entertainment provision beaming from seatback display to user-provided devices, because such transmissions would be at a very short distance (1-2 feet, or 30 to 60 cm), in a direct line-of-sight between each seatback display and user-provided device, with little risk of escaping through cabin windows? If the Commission were to prohibit the first WiGig channel (57.24-59.4 GHz) as CORF suggested to protect EESS, would this limitation ameliorate in any way the need to protect RAS, as WiGig devices will be using the rest of the spectrum from 59.4 GHz to 71 GHz? How would RAS and EESS be protected from potential WAIC applications using external structural sensors or cameras mounted on the outside of the aircraft structure to monitor the performance of the aircraft during various phases of aircraft operation (taxi, take-off, landing, cruise, etc.)? Commenters should provide detailed technical analyses, with possible real-world transmission scenarios on aircraft, including expected signal leakage in this particular frequency band through unshielded cabin windows for the various types of inflight applications (
109. As required by the Regulatory Flexibility Act of 1980, as amended (RFA), the Commission has prepared this present Initial Regulatory Flexibility Analysis (IRFA) of the possible significant economic impact on a substantial number of small entities by the policies and rules proposed in the
110. In this
111. Until recently, the mmW bands were generally considered unsuitable for mobile applications because of propagation losses at such high frequencies and the inability of mmW signals to propagate around obstacles. As increasing congestion has begun to fill the lower bands and carriers have resorted to smaller and smaller microcells in order to re-use the available spectrum, however, industry is taking another look at the mmW bands and beginning to realize that at least some of its presumed disadvantages can be turned to advantage. For example, short transmission paths and high propagation losses can facilitate spectrum re-use in microcellular deployments by limiting the amount of interference between adjacent cells. Furthermore, where longer paths are desired, the extremely short wavelengths of mmW signals make it feasible for very small antennas to concentrate signals into highly focused beams with enough gain to overcome propagation losses. The short wavelengths of mmW signals also make it possible to build multi-element, dynamic beam-forming antennas that will be small enough to fit into handsets—a feat that might never be possible at the lower, longer-wavelength frequencies below 6 GHz where cell phones operate today.
112. The Commission proposes to include the 24 GHz, 32 GHz, 42 GHz, 47 GHz, 50 GHz and 70/80 GHz bands in the Part 30 Upper Microwave Flexible Use Service. The Commission also proposes to add a mobile allocation in the 24 GHz and 32 GHz bands. This additional spectrum for mobile use will help ensure that the speed, capacity, and ubiquity of the nation's wireless networks keeps pace with the skyrocketing demand for mobile service. It could also make possible new types of services for consumers and businesses.
113. In proposing service rules for these bands, which include technical rules to protect against harmful interference, licensing rules to establish geographic license areas and spectrum block sizes, and performance requirements to promote robust buildout, the Commission advances toward enabling rapid and efficient deployment. The Commission does so by proposing flexible service, technical, assignment, and licensing rules for this spectrum, except where special provisions are necessary to facilitate shared use with other co-primary users.
114. For the 24 GHz, 32 GHz, 42 GHz, 47 GHz and 50 GHz bands the Commission proposes to assign PEA-based licenses through competitive bidding. In the 48.2-50.2 GHz portion of the 47 GHz band, the Commission proposes to require licensees to provide information on their facilities to enable sharing with FSS user equipment. Finally, in the 71-76/81-86 GHz bands, the Commission seeks comment on various systems managed by database operators which will coordinate use as between mmW base stations, fixed point-to-point links used for backhaul, and Federal operations.
115. A portion of the 24 GHz band is allocated for satellite service but is limited to only feeder links for the Broadcast Satellite Service (BSS), and the Commission has proposed to either retain existing coordination procedures or to adopt the sharing regime used for the 28 GHz band to manage interference between terrestrial and satellite operations. Meanwhile, the 47 GHz band is also allocated for satellite and is intended to be used for FSS user equipment. The Commission has proposed that FSS operation at 47 GHz be limited to individually licensed earth stations subject to the same sharing framework the Commission adopted in the 28 GHz band except with SAS-based sharing between terrestrial and satellite operations. Finally, although the 50 GHz band is also allocated for satellite, it contains no present satellite use and the Commission is exploring sharing mechanisms for the band in the future, including SAS.
116. Overall, these proposals are designed to provide for flexible use of this spectrum by allowing licensees to choose their type of service offerings, to encourage innovation and investment in mobile broadband use in this spectrum, and to provide a stable regulatory environment in which fixed, mobile, and satellite deployment would be able to develop through the application of flexible rules. The market-oriented licensing framework for these bands would ensure that this spectrum is efficiently utilized and will foster the development of new and innovative technologies and services, as well as encourage the growth and development of a wide variety of services, ultimately leading to greater benefits to consumers.
117. In the
118. The Commission seeks comment on whether the Commission can allow FSS satellites in the 37.5-40 GHz band to operate at higher power and transmit a higher power flux density at the Earth's surface. If the Commission can allow such higher power without causing interference to terrestrial operations, this change could allow FSS operators to make greater use of the band. The Commission also asks whether the Commission should repeal the prohibition on satellite (FSS) user equipment in the 37.5-40 GHz band and seek comment on whether terrestrial operators should have to divulge their deployments to FSS providers through a database in order to allow individual users to install their own receiving equipment without interfering with terrestrial operations. In addition, the Commission asks whether the Commission should adopt a requirement that millimeter wave band systems transmit an ID identifying themselves to enable better identification and control of sources of interfering signals much the same way that TV, radio or even WiFi systems presently identify themselves. Finally, the Commission seeks comment on revisions to the technical rules for the Upper Microwave Flexible Use Service, including revising coordination criteria between adjacent licensees for point-to-point operations; establishing a minimum bandwidth and bandwidth scaling factor corresponding to various power levels; proposing a reduction in transmit power limits responsive to increasing antenna height, and obtaining further information on millimeter wave propagation models, and whether Part 15 operations in the 57-71 GHz band can be allowed on board aircraft. These portions of the
119. The proposed action is authorized pursuant to Sections 1, 2, 3, 4, 5, 7, 10, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, and 336 of the Communications Act of 1934, 47 U.S.C. 151, 152, 153, 154, 155, 157, 160, 201, 225, 227, 301, 302, 302a, 303, 304, 307, 309, 310, 316, 319, 332, 336 and Section 706 of the Telecommunications Act of 1996, as amended, 47 U.S.C. 1302.
120. The RFA directs agencies to provide a description of, and, where feasible, an estimate of the number of small entities that may be affected by the proposed rules and policies, 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
121. Our action may, over time, affect small entities that are not easily categorized at present. The Commission therefore describe here, at the outset, three comprehensive, statutory small entity size standards. First, nationwide, there are a total of approximately 28.2 million businesses, 99.7 percent of which are small, according to the SBA. In addition, a “small organization” is generally “any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.” Nationwide, as of 2007, there were approximately 1,621,315 small organizations. Finally, the term “small governmental jurisdiction” is defined generally as “governments of cities, towns, townships, villages, school districts, or special districts, with a population of less than fifty thousand.” Census Bureau data for 2011 indicate that there were 89,476 local governmental jurisdictions in the United States. The Commission estimates that, of this total, as many as 88, 506 entities may qualify as “small governmental jurisdictions.” Thus, the Commission estimates that most governmental jurisdictions are small.
122. The appropriate size standard under SBA rules is for the category Wireless Telecommunications Carriers. Under that size standard, such a business is small if it has 1,500 or fewer employees. Census Bureau data for 2012, show that there were 967 firms in this category that operated for the entire year. Of this total, 955 had employment of 999 or fewer, and 12 firms had employment of 1,000 employees or more. Thus under this category and the associated small business size standard, the Commission estimates that the majority of wireless telecommunications carriers (except satellite) are small entities that may be affected by our action.
123. Microwave services include common carrier, private-operational fixed, and broadcast auxiliary radio services. They also include the Local Multipoint Distribution Service (LMDS), the Digital Electronic Message Service (DEMS), the 39 GHz Service (39 GHz), the 24 GHz Service, and the Millimeter Wave Service where licensees can choose between common carrier and non-common carrier status. At present, there are approximately 61,970 common carrier fixed licensees, 62,909 private and public safety operational-fixed licensees, 20,349 broadcast auxiliary radio licensees, 412 LMDS licenses, 35 DEMS licenses, 870 39 GHz licenses, and five 24 GHz licenses, and 408 Millimeter Wave licenses in the microwave services. The Commission has not yet defined a small business with respect to microwave services. For purposes of the FRFA, the Commission will use the SBA's definition applicable to Wireless Telecommunications Carriers (except satellite)—
124. Two economic census categories address the satellite industry. The first category has a small business size standard of $32.5 million or less in average annual receipts, under SBA rules. The second also has a size standard of $32.5 million or less in annual receipts.
125. The category of Satellite Telecommunications “comprises establishments primarily engaged in providing telecommunications services to other establishments in the telecommunications and broadcasting industries by forwarding and receiving communications signals via a system of satellites or reselling satellite telecommunications.” Census Bureau data for 2012 show that 333 Satellite Telecommunications firms operated for that entire year. Of this total, 275 firms had annual receipts of under $10 million, and 58 firms had receipts of $10 million to $24,999,999. Consequently, the Commission estimates that the majority of Satellite Telecommunications firms are small entities that might be affected by our action.
126. The second category,
127. The proposed rules relating to Part 15 operation pertain to manufacturers of unlicensed communications devices. The Census Bureau defines this category as follows: “This industry comprises establishments primarily engaged in manufacturing radio and television broadcast and wireless communications equipment. Examples of products made by these establishments are: Transmitting and receiving antennas, cable television equipment, GPS equipment, pagers, cellular phones, mobile communications equipment, and radio and television studio and broadcasting equipment.” The SBA has developed a small business size standard for firms in this category, which is: All such firms having 750 or fewer employees. According to Census Bureau data for 2007, there were a total of 939 establishments in this category that operated for part or all of the entire year. Of this total, 784 had less than 500 employees and 155 had more than 100 employees. Thus, under this size standard, the majority of firms can be considered small.
128. The projected reporting, recordkeeping, and other compliance requirements proposed in the
129. Any applicants for UMFUS licenses will be required to file license applications using the Commission's automated ULS. ULS is an online electronic filing system that also serves as a powerful information tool, one that enables potential licensees to research applications, licenses, and antenna structures. It also keeps the public informed with the weekly public notices, FCC rulemakings, processing utilities, and a telecommunications glossary. UMFUS applicants that must submit long-form license applications must do so through ULS using Form 601, FCC Ownership Disclosure Information for the Wireless Telecommunications Services using FCC Form 602, and other appropriate forms.
130. Applicants in the UMFUS will be required to meet buildout requirements at the end of their initial license terms. In doing do, they will be required to provide information to the Commission on the facilities they have constructed, the nature of the service they are providing, and the extent to which they are providing coverage in their license area.
131. The Commission also proposes to require UMFUS licensees to provide information on their proposed operations in order to facilitate sharing with other authorized services. This may include the possibility that UMFUS licensees will have to digitally identify their stations in order to help identify and eliminate causes of interference. In the 48.2-50.2 GHz band, terrestrial licensees may have to report their deployment information to FSS providers to facilitate the deployment of FSS user equipment. The Commission seeks comment on the scope of the information to be provided and the manner in which it should be provided.
132. The Commission expects that all of the filing, recordkeeping and reporting requirements associated with the demands described above, including professional, accounting, engineering or survey services used in meeting these requirements will be the same for large and small businesses that intend to utilize these new UMFUS licenses, but the Commission seeks comment on any steps that could be taken to minimize any significant economic impact on small businesses.
133. The RFA requires an agency to describe any significant alternatives that it has considered in reaching its 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. Accordingly, the Commission seeks comment on whether any of burdens associated the filing, recordkeeping and reporting requirements described above can be minimized for small businesses. In particular, the Commission seeks comment on whether any of the costs associated with our construction or performance requirements in these bands can be alleviated for small businesses.
134. The Commission intends to license the 24 GHz, 32 GHz, 42 GHz, and 50 GHz bands on a PEA basis, but the Commission will also permit partitioning and disaggregation by licensees in the mmW bands. As the Commission noted in the
135. For UMFUS bands for which the Commission accept mutually exclusive initial applications, the Commission will resolve such applications by competitive bidding conducted pursuant to Part 1 Subpart Q of the Commission's rules, including rules governing designated entity preferences. In the
136. In the
137. The technical rules the Commission now proposes will allow licensees of mmW band spectrum to operate while also protecting licensees of nearby spectrum, some of whom are small entities, from harmful interference, and the Commission also seeks comment on these proposals.
138. None.
Reporting and recordkeeping requirements, Communications equipment.
For the reasons discussed in the preamble, the Federal Communications Commission proposes to amend 47 CFR parts 2, 25, 30 and 101 as follows:
47 U.S.C. 154, 302a, 303, and 336, unless otherwise noted.
Interprets or applies Sections 4, 301, 302, 303, 307, 309, 319, 332, 705, and 721 of the Communications Act, as amended, 47 U.S.C. 154, 301, 302, 303, 307, 309, 319, 332, 605, and 721, unless otherwise noted.
(q) In the band 37.5-40.0 GHz, the power flux-density at the Earth's surface produced by emissions from a geostationary space station for all methods of modulation shall not exceed the following values:
−127 dB(W/m
−127 + 4/3 (δ−5) dB(W/m
−107 + 0.4 (δ−20) dB(W/m
−105 dB(W/m
(r) In the band 37.5-40.0 GHz, the power flux-density at the Earth's surface produced by emissions from a non-geostationary space station for all methods of modulation shall not exceed the following values:
−120 dB(W/m
−120 + 0.75 (δ−5) dB(W/m
−105 dB(W/m
47 U.S.C. 151, 152, 153, 154, 301, 303, 304, 307, 309, 310, 316, 332, 1302.
As of [effective date of final rule], Local Multipoint Distribution Service licenses for the 27.5-28.35 GHz band, and licenses issued in the 38.6-40 GHz band under the rules in part 101 of this chapter shall be reassigned to the Upper Microwave Flexible Use Service. Local Multipoint Distribution Service licenses in bands other than 27.5-28.35 GHz shall remain in that service and shall be governed by the part 101 of this chapter applicable to that service.
The following definitions apply to this part:
Any entity who meets the technical, financial, character, and citizenship qualifications that the Commission may require in accordance with such Act, other than those precluded by section 310 of the Communications Act of 1934, as amended, 47 U.S.C. 310, is eligible to hold a license under this part.
The following frequencies are available for assignment in the Upper Microwave Flexible Use Service:
(a) 27.5 GHz-28.35 GHz band—27.5-27.925 GHz and 27.925-28.35 GHz.
(b) 38.6-40 GHz band:
(1) New channel plan:
(2) Pending transition to the new channel plan, existing 39 GHz licensees licensed under part 101 of this chapter may continue operating on the following channel plan:
(c) 37-38.6 GHz band: 37,600-37,800 MHz; 37,800-38,000 MHz; 38,000-38,200 MHz; 38,200-38,400 MHz, and 38,400-38,600 MHz. The 37,000-37,600 MHz band segment shall be available on a site-specific, coordinated shared basis with eligible Federal entities;
(d) 24.25-24.45 GHz band:
(e) 24.75-25.25 GHz band: 24.75-25.00 GHz, 25.00-25.25 GHz;
(f) 31.8-33.4 GHz band:
(g) 42-42.5 GHz band:
(h) 47.2-50.2 GHz band:
(i) 50.4-52.6 GHz band:
(j) The 71-76 GHz and 81-86 GHz bands shall be available on a shared basis pursuant to the rules in subpart F of this part.
(a) Except as noted in paragraphs (b) and (c) of this section, and except for the shared 37-37.6 GHz, 71-76 GHz, and 81-86 GHz bands, the service areas for the Upper Microwave Flexible Use Service are Partial Economic Areas.
(b) For the 27.5-28.35 GHz band, the service areas shall be counties.
(c) Common Carrier Fixed Point-to-Point Microwave Stations licensed in the 38.6-40 GHz bands licensed with Rectangular Service Areas shall maintain their Rectangular Service Area as defined in their authorization. The frequencies associated with Rectangular Service Area authorizations that have expired, cancelled, or otherwise been recovered by the Commission will automatically revert to the applicable county licensee.
(d) In the 37.5-40 GHz band, Upper Microwave Flexible Use Service licensees shall not place facilities within the protection zone of Fixed-Satellite Service earth stations authorized pursuant to § 25.136 of this chapter, absent consent from the Fixed-Satellite Service earth station licensee.
(a) A licensee in the frequency bands specified in § 30.4 may provide any services for which its frequency bands are allocated, as set forth in the non-Federal Government column of the Table of Frequency Allocations in § 2.106 of this chapter (column 5).
(b) Fixed-Satellite Service shall be provided in a manner consistent with part 25 of this chapter.
(a) The 37-37.6 GHz band will be available for site-based registrations on a coordinated basis with co-equal eligible Federal entities.
(b) Any non-Federal entity meeting the eligibility requirements of § 30.3 of this part may operate equipment that complies with the technical rules of this
(c) Licensees in the 37-37.6 GHz band must register their individual base stations and access points prior to placing them in operation.
(d) The minimum authorized channel bandwidth in this band is 100 megahertz.
(e) Registered non-Federal sites must be put placed service within seven days of coordination.
(f) Equipment in this band must be capable of notifying the database that it is active on the channel. At least once every seven days, the equipment must be capable of notifying the coordination mechanism that the equipment is active and operating. If the equipment fails to make such a notification, the registration to operate that equipment is automatically terminated.
(g) Federal licensees may claim access to 200 megahertz of spectrum in this area on a priority basis.
(a)
(1)
(i) A device to the licensee's network;
(ii) One element of the licensee's network to another element on the licensee's network;
(iii) The licensee's network to another network; and
(iv) Device to device (with respect to telephone voice and messaging services).
(2)
(i) Communications between a wireless device and the licensee's network;
(ii) Communications within and between each licensee's network;
(iii) Communications between mobile devices that are under end-to-end control of the licensee; and
(iv) Communications between mobile devices that are not under the end-to-end control of the licensee;
(3)
(4)
(5)
(6)
(b)
(c)
(i)
(ii)
(iii)
Except with respect to in the 37-37.6 GHz band, an applicant must file a single application for an initial authorization for all markets won and frequency blocks desired. Initial authorizations shall be granted in accordance with § 30.4. Applications for individual sites are not required and will not be accepted, except where required for environmental assessments, in accordance with §§ 1.1301 through 1.1319 of this chapter.
Local Multipoint Distribution Service licenses in the 27.5-28.35 GHz band issued on a Basic Trading Area basis shall be disaggregated into county-based licenses and 39 GHz licenses issued on an Economic Area basis shall be disaggregated into Partial Economic Area-based licenses on [effective date of final rule]. For each county in the Basic Trading Area or Partial Economic Area in the Economic Area which is part of the original license, the licensee shall receive a separate license. If there is a co-channel Rectangular Service Area licensee within the service area of a 39 GHz Economic Area licensee, the disaggregated license shall not authorize operation with the service area of the Rectangular Service Area license.
Initial authorizations will have a term not to exceed ten years from the date of initial issuance or renewal.
(a) Upper Microwave Flexible Use Service licensees must make a buildout showing as part of their renewal applications. Licensees relying on mobile or point-to-multipoint service to demonstrate that they are providing reliable signal coverage and service to at least 40 percent of the population within the service area of the licensee, and that they are using facilities to provide service in that area either to customers or for internal use. Licensees relying on point-to-point service must demonstrate that they have four links operating and providing service, either to customers or for internal use. If the population within the license area is equal to or less than 268,000. If the population within the license area is greater than 268,000, a licensee relying on point-to-point service must demonstrate it has at least one link in operation and providing service for each 67,000 population within the license area.
(b) Showings that rely on a combination of multiple types of service will be evaluated on a case-by-case basis.
(c) If a licensee in this service is also a Fixed-Satellite Service licensee and uses the spectrum covered under its UMFUS license in connection with a satellite earth station, it can demonstrate compliance with the requirements of this section by demonstrating that the earth station in question is in service,
(d) Failure to meet this requirement will result in automatic cancellation of the license. In bands licensed on a Partial Economic Area basis, licensees will have the option of partitioning a license on a county basis in order to reduce the population within the license area to a level where the licensee's buildout would meet one of the applicable performance metrics.
(e) Existing 28 GHz and 39 GHz licensees shall be required to make a showing pursuant to this rule by June 1, 2024.
(a) Parties seeking approval for partitioning and disaggregation shall request from the Commission an authorization for partial assignment of a license pursuant to § 1.948 of this chapter. Upper Microwave Flexible Use Service licensees may apply to partition their licensed geographic service area or disaggregate their licensed spectrum at any time following the grant of their licenses.
(b)
(2) Spectrum may be disaggregated in any amount.
(3) The Commission will consider requests for partial assignment of licenses that propose combinations of partitioning and disaggregation.
(4) For purposes of partitioning and disaggregation, part 30 systems must be designed so as not to exceed the signal level specified for the particular spectrum block in § 30.204 at the licensee's service area boundary, unless the affected adjacent service area licensees have agreed to a different signal level.
(c)
(d)(1) Parties to partitioning agreements must satisfy the construction requirements set forth in § 30.105 by the partitioner and partitionee each certifying that it will independently meet the construction requirement for its respective partitioned license area. If the partitioner or partitionee fails to meet the construction requirement for its respective partitioned license area, then the relevant partitioned license will automatically cancel.
(2) Parties to disaggregation agreements must satisfy the construction requirements set forth in § 30.105 by the disaggregator and disaggregatee each certifying that it will independently meet the construction requirement for its respective disaggregated license area. If the disaggregator or disaggregatee fails to meet the construction requirement for its respective disaggregated license area, then the relevant disaggregated license will automatically cancel.
(a) An Upper Microwave Flexible Use License authorization will automatically terminate, without specific Commission action, if the licensee permanently discontinues service after the initial license term.
(b) For licensees with common carrier regulatory status, permanent discontinuance of service is defined as 180 consecutive days during which a licensee does not provide service to at least one subscriber that is not affiliated with, controlled by, or related to the licensee in the individual license area. For licensees with non-common carrier status, permanent discontinuance of service is defined as 180 consecutive days during which a licensee does not operate.
(c) A licensee that permanently discontinues service as defined in this section must notify the Commission of the discontinuance within 10 days by filing FCC Form 601 or 605 requesting license cancellation. An authorization will automatically terminate, without specific Commission action, if service is permanently discontinued as defined in this section, even if a licensee fails to file the required form requesting license cancellation.
(a) Except as provided under paragraph (c) of this section, each transmitter utilized for operation under this part must be of a type that has been authorized by the Commission under its certification procedure.
(b) Any manufacturer of radio transmitting equipment to be used in these services may request equipment authorization following the procedures set forth in subpart J of part 2 of this chapter. Equipment authorization for an individual transmitter may be requested by an applicant for a station authorization by following the procedures set forth in part 2 of this chapter.
(c) Unless specified otherwise, transmitters for use under the provisions of subpart E of this part for fixed point-to-point microwave and point-to-multipoint services must be a type that has been verified for compliance.
(a) For fixed and base stations operating in connection with mobile systems, the average power of the sum of all antenna elements is limited to a maximum equivalent isotopically radiated power (EIRP) density of +75dBm/100MHz, except as specified in paragraph (e) of this section.
(b) For mobile stations, the average power of the sum of all antenna elements is limited to a maximum EIRP density of +43 dBm/100MHz.
(c) For transportable stations, as defined in § 30.2, the average power of the sum of all antenna elements is limited to a maximum EIRP density of +55 dBm/100MHz.
(d) For fixed point-to-point and point-to-multipoint limits see § 30.405.
(e) Antenna Height Limits
(a) The conductive power or the total radiated power of any emission outside a licensee's frequency block shall be −13 dBm/MHz or lower. However, in the bands immediately outside and adjacent to the licensee's frequency block, having a bandwidth equal to 10 percent of the channel bandwidth, the conductive power or the total radiated power of any emission shall be −5 dBm/MHz or lower.
(b)(1) Compliance with this provision is based on the use of measurement instrumentation employing a resolution bandwidth of 1 megahertz or greater.
(2) When measuring the emission limits, the nominal carrier frequency shall be adjusted as close to the licensee's frequency block edges as the design permits.
(3) The measurements of emission power can be expressed in peak or average values.
(c) For fixed point-to-point and point-to-multipoint limits see § 30.404.
(a)
(b) Fixed Point-to-Point Operations:
(1) Prior to operating a fixed point-to-point transmitting facility in the 27,500-28,350 MHz band where the facilities are located within 20 kilometers of the boundary of the licensees authorized market area, the licensee must complete frequency coordination in accordance with the procedures specified in § 101.103(d)(2) of this chapter with respect to neighboring licensees that may be affected by its operations.
(2) Prior to operating a fixed point-to-point transmitting facility in the 37,000-40,000 MHz band where the facilities are located within 16 kilometers of the boundary of the licensees authorized market area, the licensee must complete frequency coordination in accordance with the procedures specified in § 101.103(d)(2) of this chapter with respect to neighboring licensees that may be affected by its operations.
(a) Licensees in the 37-38 GHz band located within the zones defined by the coordinates in the tables below must coordinate their operations with Federal Space Research Service (space to Earth) users of the band via the National Telecommunications and Information Administration (NTIA). All licensees operating within the zone defined by the 60 dBm/100 MHz EIRP coordinates in the tables below must coordinate all operations. Licensees operating within the area between the zones defined by the 60 dBm and 75 dBm/100 MHz EIRP coordinates in the tables below must coordinate all operations if their base station EIRP is greater than 60 dBm/100 MHz or if their antenna height exceeds 100 meters above ground level. Licensees operating outside the zones defined by the 75 dBm/100 MHz EIRP coordinates in the tables below are not required to coordinate their operations with NTIA.
(b) Licensees in the 37-38.6 GHz band located within the zones defined by the coordinates in the table below must coordinate their operations with the Department of Defense via the National Telecommunications and Information Administration (NTIA).
Operations in the 27.5-28.35 GHz, 37-38.6, and 38.6-40 GHz bands are subject to existing and future international agreements with Canada and Mexico.
Licensees and manufacturers are subject to the radio frequency radiation exposure requirements specified in §§ 1.1307(b), 1.1310, 2.1091, and 2.1093 of this chapter, as appropriate. Applications for equipment authorization of mobile or portable devices operating under this section must contain a statement confirming compliance with these requirements. Technical information showing the basis for this statement must be submitted to the Commission upon request.
Mobile and transportable stations that operate on any portion of frequencies within the 27.5-28.35 GHz or the 37-40 GHz bands must be capable of operating on all frequencies within those particular bands.
Stations authorized under this rule part may employ frequency division duplexing, time division duplexing, or any other duplexing scheme, provided that they comply with the other technical and operational requirements specified in this part.
(a) Each operator of a Fixed Service or Mobile Service system in the 48.2-50.2 GHz band will make the technical information about its system listed in paragraphs (b) and (c) of this section available to FSS operators by one or more of the following means:
(1) An online database operated by the Upper Microwave Flexible Use licensee;
(2) An online database operated by a third-party database manager, or
(3) A continuously transmitted pilot signal receivable throughout the terrain within which a FSS facility could cause interference to or receive interference from the terrestrial system.
(b) All licensees deploying fixed systems in the48.2-50.2 GHz bands will make the following information about each such system available to FSS operators in those bands by one or more of the means described in paragraph (a) of this section:
(1) Licensee's name and address.
(2) Transmitting station name.
(3) Transmitting station coordinates.
(4) Frequencies and polarizations.
(5) Transmitting equipment, its stability, effective isotropic radiated power, emission designator, and type of modulation (digital).
(6) Transmitting antenna(s), model, gain, and a radiation pattern provided or certified by the manufacturer.
(7) Transmitting antenna center line height(s) above ground level and ground elevation above mean sea level.
(8) Transmitting antenna boresight(s) angle of elevation with respect to the horizon.
(9) Receiving station name.
(10) Receiving station coordinates.
(11) Receiving antenna(s), model, gain, and, if required, a radiation pattern provided or certified by the manufacturer.
(12) Receiving antenna center line height(s) above ground level and ground elevation above mean sea level.
(13) Receiving antenna boresight(s) angle of elevation with respect to the horizon.
(14) Path azimuth and distance.
(c) All licensees deploying mobile service base stations in the 48.2-50.2 GHz bands will make the following information about each such base station available to FSS operators by one or both of the means described in paragraph (a) of this section:
(1) Licensee's name and address.
(2) Transmitting station name.
(3) Transmitting station coordinates.
(4) Frequencies and polarizations.
(5) Transmitting equipment, its stability, maximum effective isotropic radiated power, emission designator, and types of modulation.
(6) Transmitting antenna(s), model, maximum gain, and maximum extent of all possible radiation patterns provided or certified by the manufacturer.
(7) Transmitting antenna center line height(s) above ground level and ground elevation above mean sea level.
(8) Transmitting antenna boresight(s) maximum and minimum angles of elevation with respect to the horizon.
(9) Transmitting antenna boresight minimum and maximum azimuths, or designation of omnidirectionality.
(10) Boundary of the area served by the base station for purposes of communication with mobile user equipment.
(11) Receiving antenna(s), model, gain, and maximum extent of all possible radiation patterns provided or certified by the manufacturer.
(12) Receiving antenna center line height(s) above ground level and ground elevation above mean sea level.
(13) Receiving antenna boresight maximum and minimum angles of elevation with respect to the horizon.
(14) Receiving antenna boresight minimum and maximum azimuths, or designation of omnidirectionality.
Mutually exclusive initial applications for Upper Microwave Flexible User Service licenses are subject to competitive bidding. The general competitive bidding procedures set forth in part 1, subpart Q of this chapter will apply unless otherwise provided in this subpart.
(a)
(2) A very small business is an entity that, together with its affiliates, its controlling interests and the affiliates of its controlling interests, has average gross revenues that are not more than $20 million for the preceding three (3) years.
(b)
(c) A rural service provider, as defined in § 1.2110(f)(4) of this chapter, who has not claimed a small business bidding credit may use a bidding credit of 15 percent bidding credit, as specified in § 1.2110(f)(4)(i) of this chapter.
Stations authorized under this subpart may deploy stations used solely as fixed point-to-point stations, fixed point-to-multipoint hub stations, or fixed point-to-multipoint user stations, as defined in § 30.2 subject to the technical and operational requirements specified in this subpart.
The carrier frequency of each transmitter authorized under this subpart must be maintained within the following percentage of the reference frequency (unless otherwise specified in the instrument of station authorization the reference frequency will be deemed to be the assigned frequency):
(a) Stations under this sub-part will be authorized any type of emission, method of modulation, and transmission characteristic, consistent with efficient use of the spectrum and good engineering practice.
(b) The maximum bandwidth authorized per frequency to stations under this subpart is set out in the table that follows.
(a) The mean power of emissions must be attenuated below the mean output power of the transmitter in accordance with the following schedule:
(1) When using transmissions other than those employing digital modulation techniques:
(i) On any frequency removed from the assigned frequency by more than 50 percent up to and including 100 percent of the authorized bandwidth: At least 25 decibels;
(ii) On any frequency removed from the assigned frequency by more than 100 percent up to and including 250 percent of the authorized bandwidth: At least 35 decibels;
(iii) On any frequency removed from the assigned frequency by more than 250 percent of the authorized bandwidth: At least 43 + 10 Log
(2) When using transmissions employing digital modulation techniques in situations not covered in this section:
(i) In any 1 MHz band, the center frequency of which is removed from the assigned frequency by more than 50 percent up to and including 250 percent of the authorized bandwidth: As specified by the following equation but in no event less than 11 decibels:
A = 11 + 0.4(P − 50) + 10 Log
(ii) In any 1 MHz band, the center frequency of which is removed from the assigned frequency by more than 250 percent of the authorized bandwidth: At least 43 + 10 Log
(iii) The emission mask in paragraph (a)(2)(i) of this section applies only to the band edge of each block of spectrum, but not to subchannels established by licensees. The value of P in the equation is the percentage removed from the carrier frequency and assumes that the carrier frequency is the center of the actual bandwidth used. The emission mask can be satisfied by locating a carrier of the subchannel sufficiently far from the channel edges so that the emission levels of the mask are satisfied. The emission mask shall use a value B (bandwidth) of 40 MHz, for all cases even in the case where a narrower subchannel is used (for instance the actual bandwidth is 10 MHz) and the mean output power used in the calculation is the sum of the output power of a fully populated channel. For block assigned channels, the out-of-band emission limits apply only outside the assigned band of operation and not within the band.
(b) [Reserved]
On any authorized frequency, the average power delivered to an antenna in this service must be the minimum amount of power necessary to carry out the communications desired. Application of this principle includes, but is not to be limited to, requiring a licensee who replaces one or more of its antennas with larger antennas to reduce its antenna input power by an amount appropriate to compensate for the increased primary lobe gain of the replacement antenna(s). In no event shall the average equivalent isotropically radiated power (EIRP), as referenced to an isotropic radiator, exceed the following:
(a) Unless otherwise authorized upon specific request by the applicant, each station authorized under the rules of this subpart must employ a directional antenna adjusted with the center of the major lobe of radiation in the horizontal plane directed toward the receiving station with which it communicates;
(b) Fixed stations (other than temporary fixed stations) must employ transmitting and receiving antennas (excluding second receiving antennas for operations such as space diversity) meeting the appropriate performance Standard A indicated below, except that in areas not subject to frequency congestion, antennas meeting performance Standard B may be used. For frequencies with a Standard B1 and a Standard B2, in order to comply with Standard B an antenna must fully meet either Standard B1 or Standard B2. Licensees shall comply with the antenna standards table shown in this paragraph in the following manner:
(1) With either the maximum beamwidth to 3 dB points requirement or with the minimum antenna gain requirement; and
(2) With the minimum radiation suppression to angle requirement.
In the 27,500-28,350 MHz band, system operators are permitted to use any polarization within its service area, but only vertical and/or horizontal polarization for antennas located within 20 kilometers of the outermost edge of their service area.
(a) This section sets forth the regulations governing use of devices in the 71-76 GHz and 81-86 GHz bands. The operation of all equipment in this band shall be coordinated by one or more authorized Spectrum Access Systems (SASs).
(b) Operations in this band include Priority Access and General Authorized Access tiers of service. Priority Access Licensees and General Authorized Access Users must not cause harmful interference to Incumbent Users and must accept interference from Incumbent Users. General Authorized Access Users must not cause harmful interference to Priority Access Licensees and must accept interference from Priority Access Licensees.
(a) Devices must be used and operated consistent with the rules in this subpart.
(b) Authorizations for PALs may be granted upon proper application, provided that the applicant is qualified in regard to citizenship, character, financial, technical and other criteria established by the Commission, and that the public interest, convenience and necessity will be served. See 47 U.S.C. 301, 308, 309, and 310. The holding of an authorization does not create any rights beyond the terms, conditions, and period specified in the authorization and shall be subject to the provisions of the Communications Act of 1934, as amended, and the Commission's rules and policies thereunder.
(c) Grandfathered registered fixed links are authorized to operate consistent with § 101.1529 of this chapter.
(a) Any frequencies designated for Priority Access that are not in use by a Priority Access Licensee may be utilized by General Authorized Access Users.
(b) An SAS shall assign authorized devices to specific frequencies, which may be reassigned by that SAS, consistent with this part.
Devices in these bands shall be subject to the technical rules in subpart C of this part.
Prior to commencing operation, all operations in these bands must complete coordination with Federal Government links according to the coordination standards and procedures adopted in Report and Order, FCC 03-248, and as further detailed in subsequent implementation public notices issued consistent with that order.
(a) Applications for Priority Access Licenses must:
(1) Demonstrate the applicant's qualifications to hold an authorization;
(2) State how a grant would serve the public interest, convenience, and necessity;
(3) Contain all information required by FCC rules and application forms;
(4) Propose operation of a facility or facilities in compliance with all applicable rules; and
(5) Be amended as necessary to remain substantially accurate and complete in all significant respects, in accordance with the provisions of § 1.65 of this chapter.
(b) Devices used for Priority Access must register with a Spectrum Access System and comply with its instructions pursuant to § 30.508.
(c) Records pertaining to PALs, including applications and licenses, shall be maintained by the Commission in a publicly accessible system.
(a) Devices used for General Authorized Access must register with the Spectrum Access System and comply with its instructions.
(b) General Authorized Access Users shall be permitted to use frequencies assigned to Priority Access Licenses when such frequencies are not in use, as determined by the Spectrum Access System.
(c) Frequencies that are available for General Authorized Access Use shall be made available on a shared basis.
(d) General Authorized Access Users shall have no expectation of interference protection from other General Authorized Access Users operating in accordance with this part.
(e) General Authorized Access Users must not cause harmful interference to and must accept interference from
The Spectrum Access System shall:
(a) Enact and enforce all policies and procedures developed by the SAS Administrator.
(b) Determine and provide to devices the permissible channels or frequencies at their location.
(c) Determine and provide to devices the maximum permissible transmission power level at their location.
(d) Register and authenticate the identification information and location of devices.
(e) Ensure that devices protect Grandfathered Register Links from harmful interference.
(f) Protect Priority Access Licensees from interference caused by other Priority Access Licenses and from General Authorized Access Users.
(g) Resolve conflicting uses of the band while maintaining, as much as possible, a stable radio frequency environment.
(h) Ensure secure and reliable transmission of information between the SAS and devices.
(i) Protect Grandfathered Registered Links consistent with § 101.1529 of this chapter.
(j) Implement the terms of applicable current and future international agreements.
(a) A Spectrum Access System must register, authenticate, and authorize operations of devices consistent with this part.
(b) Devices composed of a network of base and fixed stations may employ a subsystem for aggregating and communicating all required information exchanges between the SAS and devices.
(c) A Spectrum Access System must also verify that the FCC identifier (FCC ID) of any device seeking access to its services is valid prior to authorizing it to begin providing service. A list of devices with valid FCC IDs and the FCC IDs of those devices is to be obtained from the Commission's Equipment Authorization System.
47 U.S.C. 154, 303.
Links registered with a third party database administrator on or before [insert effective date of rules] that are constructed, in service, and fully compliant with the rules in part 101, subpart Q as of [insert date one year after effective date of rules] will be afforded protection from harmful interference caused by Upper Microwave Flexible Use users until the end of their license term.
Bureau of Consumer Financial Protection.
Proposed rule with request for public comment.
The Bureau of Consumer Financial Protection (Bureau) proposes amendments to the procedures used by the public to obtain information from the Bureau under the Freedom of Information Act, the Privacy Act of 1974, and in legal proceedings. The Bureau also proposes amendments to its rule regarding the confidential treatment of information obtained from persons in connection with the exercise of its authorities under Federal consumer financial law.
Comments must be received on or before October 24, 2016.
You may submit comments, identified by Docket No. CFPB-2016-0039 or RIN 3170-AA63, by any of the following methods:
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David Snyder, Senior Counsel, Legal Division, 202-435-7758.
On July 21, 2010, the President signed into law the Dodd-Frank Wall Street Reform and Consumer Protection Act (Pub. L. 111-203, codified at 12 U.S.C. 5301
In order to establish safeguards for protecting the confidentiality of information, as well as procedures for disclosing information as appropriate, the Bureau published an interim final rule on July 28, 2011, 76 FR 45371 (Jul. 28, 2011), followed by a final rule on February 15, 2013, 78 FR 11483 (Feb. 15, 2013). The Bureau now proposes to amend the rule to clarify, correct, and amend certain provisions based on its experience over the last several years. The Bureau solicits comments on all aspects of its proposal.
The Bureau proposes revising all five subparts of part 1070. It seeks comment on all aspects of its proposed rule.
Subpart A of the rule consists largely of definitions of terms that are used throughout the remainder of the part. The Bureau proposes revising several of these definitions to clarify their intended meanings as well as Bureau practices.
Subpart B of the rule implements the Freedom of Information Act, 5 U.S.C. 552 (the FOIA). The Bureau proposes revising this subpart to clarify its practices, provide additional flexibility for requesters, and reflect recent changes made to the FOIA by the FOIA Improvement Act of 2016 (Pub. L. 114-185). Additionally, these changes streamline the Bureau's process for assessing FOIA fees and notifying requesters of such fees. These changes will allow the Bureau to process FOIA requests more efficiently and provide records to requesters more quickly.
Subpart C of the rule (sometimes referred to as
Subpart D of the rule pertains to the protection and disclosure of confidential information that the Bureau generates and receives during the course of its work. Various provisions of the Dodd-Frank Act require the Bureau to promulgate regulations providing for the confidentiality of certain types of information and protecting such information from public disclosure. The Bureau has sought to provide the maximum protection for confidential information, while ensuring its ability to share or disclose information to the extent necessary to achieve its mission. The Bureau has included detailed procedures in its rule in order to promote transparency regarding its practices and anticipated uses of confidential information.
The Bureau has sought to balance concerns regarding the need to protect confidential information, including sensitive personal information, business information, and confidential supervisory information, against the need to use and disclose certain information in the course of its work or, as appropriate, the work of other agencies with overlapping statutory or regulatory authority. The Bureau proposes amending subpart D to clarify, correct, and amend certain aspects of the rule based on its experience over the last several years.
In addition, in amending this subpart, the Bureau intends to codify its revised interpretation of 12 U.S.C. 5512(c)(6). The Bureau has previously interpreted 12 U.S.C. 5512(c)(6)(C)(ii), which discusses discretionary disclosure of confidential supervisory information to certain agencies with “jurisdiction,” to set forth a positive grant of authority that limits the Bureau's discretion to disclose confidential supervisory information under the rules authorized by 12 U.S.C. 5512(c)(6)(A). The Bureau now believes that the better interpretation of 12 U.S.C.
Subpart E contains the Bureau's rule implementing the Privacy Act of 1974, 5 U.S.C. 552a. The Bureau proposes revising the subpart to clarify the Chief Privacy Officer's authority, to provide additional flexibility for requestors, and to make technical corrections.
The Bureau is proposing this rule pursuant to its authority under the following statutory provisions: (1) Title X of the Dodd-Frank Act, 12 U.S.C. 5481
The Bureau proposes adding a new definition, “agency,” which it will define to include “a Federal, State, or foreign governmental authority or an entity exercising governmental authority.” As currently drafted, § 1070.43 provides the Bureau with discretion to share confidential information with Federal or State agencies in certain circumstances. The proposed definition, combined with proposed revisions to §§ 1070.43 and 1070.45, will clarify the Bureau's ability to share confidential information with foreign regulators and certain entities that exercise governmental authority, such as registration and disciplinary organizations like state bar associations, and the procedures that should be used to do so. The Bureau may at times collaborate with such entities in the course of carrying out its authorities under Federal consumer financial laws. Proposed revisions to § 1070.47 would expand protections for confidential information disclosed under subpart D to include information shared with these additional entities. The Bureau proposes additional technical corrections throughout the rule to account for use of this new term.
The Bureau proposes adding a new definition for “Associate Director for Supervision, Enforcement and Fair Lending” in order to clarify the meaning of a term used in the current rule, as well as several times in the proposed revisions to the rule.
Section 1070.2(e) defines the term “civil investigative demand material.” For purposes of clarity and efficiency, the Bureau proposes incorporating this definition into the definition of “confidential investigative information” in § 1070.2(j). Because the term “civil investigative demand material” only arises in the rule in § 1070.2(j), the separate definition is unnecessary.
Section 1070.2(g) defines the term “confidential information.” Confidential information refers to three defined categories of non-public information—confidential consumer complaint information, confidential investigative information, and confidential supervisory information—as well as other Bureau information that is exempt from disclosure pursuant to one or more of the statutory exemptions to the FOIA.
Confidential information does not include information contained in records that have been made publicly available or otherwise publicly disclosed by the Bureau. The Bureau proposes revising the definition to clarify that such appropriate disclosures may be made by either Bureau employees or other authorized agents of the Bureau. An unauthorized disclosure of information would not affect the information's confidentiality.
In addition, the Bureau proposes revising the definition to clarify that confidential information disclosed to a third party in accordance with subpart D shall remain the Bureau's confidential information.
Section 1070.2(h) defines the term “confidential consumer complaint information.” The Bureau proposes expanding the definition to include any
Section 1070.2(i) defines the term “confidential investigative information.” As discussed above with respect to § 1070.2(e), the Bureau proposes incorporating the definition of “civil investigative demand material” into § 1070.2(i). In addition, we propose revising the term to clarify that confidential investigative information includes any information obtained or generated in the course of Bureau enforcement activities, including general investigative activities that may not pertain to a specific institution. The Bureau also proposes replacing § 1070.2(i)(2)'s reference to “materials” with “documents, materials, or records” in order to parallel similar language in the definition of “confidential supervisory information” at § 1070.2(j)(2).
Section 1070.2(j) defines the term “confidential supervisory information.” The Bureau proposes revising § 1070.2(j)(1)(i) to clarify that the term includes supervisory letters and similar documents. Since adopting the current definition of “confidential supervisory information,” the Bureau has refined the formats it uses for summarizing and memorializing the results of an examination or other supervisory review of a supervised financial institution. The Bureau currently issues different types of documents, including examination reports and supervisory letters, to convey the results of its examinations and other supervisory reviews. These documents are the property of the Bureau and are provided to the supervised financial institution for its confidential use only.
In addition, the Bureau proposes revising § 1070.2(j)(1)(ii) to state that, in addition to “documents” prepared by, or on behalf of, or for the use of the Bureau or any other Federal, State, or foreign government agency in the exercise of its supervisory authority over a financial institution, confidential supervisory information also includes “materials[] or records” prepared by, or on behalf of, or for the use of the Bureau or any other Federal, State, or foreign government agency in the exercise of its supervisory authority over a financial institution. This revision is intended to clarify that any such physical materials can include confidential supervisory information, regardless of the format. Likewise, the Bureau proposes revising the definition to include information derived from such “materials[] or records.” We note that information “derived” from such documents, materials, or records could include either physical materials (such as other documents, materials, or records) or information known to individuals (such as oral testimony or interviews based on knowledge gleaned from the documents, materials, or records).
In addition, the Bureau proposes revising § 1070.2(j)(1)(iv) to delete the reference to information collected using the Bureau's authority to monitor for risks to consumers in the offering or provision of consumer financial products or services under 12 U.S.C. 5512(c)(4) (sometimes referred to as the Bureau's “market monitoring” authority). The Bureau believes that it is not necessary to classify such information as “confidential supervisory information” if it is not used for supervisory purposes. In accordance with the definition of “confidential information” in § 1070.2(g), market monitoring information will continue to be classified and protected as “confidential information” to the extent that it is exempt from disclosure pursuant to one or more of the statutory exemptions to the FOIA. For example, market monitoring information that contains confidential business information or personal information would generally be classified as confidential information because that information generally is exempt from disclosure under the FOIA exemptions (b)(4) or (b)(6), respectively.
In contrast, information collected for market monitoring purposes that is already publicly available generally would not be classified as confidential information because such information generally would not be exempt from disclosure under the FOIA. Under the proposed revision, the Bureau would have more flexibility to use and disclose less-sensitive, non-confidential information as appropriate.
The Bureau proposes replacing the “market monitoring” reference in § 1070.2(j)(1)(iv) with new language stating that confidential supervisory information includes information obtained by the Bureau “for purposes of detecting and assessing risks to consumers and to markets for consumer financial products or services pursuant to 12 U.S.C. 5514(b)(1)(C), 5515(b)(1)(C), and 5516(b).” The purpose of this revision is to clarify that confidential supervisory information continues to include information obtained by the Bureau under its supervisory authorities at 12 U.S.C. 5514(b)(1)(C), 5515(b)(1)(C), and 5516(b). The Bureau has previously interpreted § 1070.2(j)(1)(iv) to address information obtained using these authorities as well as information obtained using its market monitoring authority. The revision is intended to retain the former, but exclude the latter.
Finally, the Bureau proposes deleting § 1070.2(i)(2), which currently states that confidential information does not include documents prepared by a supervised financial institution for its own business purposes and that the Bureau does not possess. This provision was intended to prevent any implication that a supervised financial institution's copies of internal documents would be deemed to be confidential supervisory information on the grounds that those documents had been submitted to the Bureau in the course of a Bureau supervisory process. However, the Bureau believes that this interpretation already follows from the other provisions of the rule, including the definition of “confidential supervisory information,” and therefore this exception is unnecessary. Should a supervised financial institution submit copies of such documents to the Bureau in the course of a Bureau supervisory process, the copies of the documents in the Bureau's possession would be Bureau confidential supervisory information. However, submission of those documents to the Bureau does not convert the copies of those documents that are in the possession of the financial institution into Bureau confidential information. The Bureau proposes renumbering § 1070.2(j) in light of this revision.
Section 1070.2(l) defines the term “employee”. The Bureau proposes revising the definition to clarify that, for purposes of this rule, Bureau “employees” include certain contract personnel and employees of the Bureau's Inspector General.
Section 1070.3(b) authorizes the Bureau's Chief Operating Officer to certify the authenticity of any Bureau record or any copy of such record. The Bureau proposes revising the rule to clarify that the Chief Operating Officer can also certify the absence of a record. Such certification is contemplated in Rule 44 of the Federal Rules of Civil Procedure and Rule 902 of the Federal Rules of Evidence.
Currently, § 1070.31 provides the process for serving the Bureau with summonses or complaints. The Bureau proposes moving the provision to a new section in subpart A for clarity in order to separate the rule governing service when the Bureau is a party from the remaining provisions in subpart C, which deal with requests for information for other proceedings. In addition, the Bureau proposes revising paragraph (d)'s requirement that documents be “stamped” “Service Accepted for Official Capacity Only” by replacing the word “stamped” with the word “marked.” This proposal would clarify that the documents may be labeled using a variety of methods.
The Bureau proposes to remove the phrase “and copying” and replace it with “in an electronic format.” The Bureau proposes similar revisions to section 1070.13. These changes are required by the FOIA Improvement Act of 2016.
Section 1070.14(b) specifies the form of FOIA requests. The current text distinguishes between requests made in writing and by electronic means. The Bureau proposes a technical change to this provision. It proposes to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposes changes to sections 1070.14(b)(1) and (2) to clarify how requesters must submit FOIA requests to the Bureau. The Bureau proposes similar changes to the following sections: 1070.17(b)(1); 1070.21(c); and 1070.22(e)(1)(i).
Section 1070.14(c)(4) provides that a FOIA requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media, governmental entity, or “other” requester, as those terms are defined in § 1070.22(b). The section also informs requesters that they may contact the Bureau's FOIA Public Liaison to seek assistance in determining the appropriate fee category. The current language only permits the Bureau to use information provided to the FOIA Public Liaison by a requester for the purpose of determining the requester's fee category. The Bureau proposes to remove this limitation so that it can use this information for other purposes, such as aiding a requester in clarifying the scope of a request, assisting in identifying records sought by a requester, and helping to resolve disputes related to a request.
Section 1070.14(c)(5) provides that if a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect. The current language also includes a statement that any request that does not seek a waiver or reduction of fees constitutes an agreement of the requester to pay all fees up to $25. The Bureau proposes to remove this language in light of other proposed fee related revisions. Under the Bureau's proposed revisions to § 1070.22(d) and (f), FOIA requesters may still specify an upper limit on the fees that they are willing to pay to process a request and the Bureau will notify a requester of any potential fees beyond that limit before processing the request.
Section 1070.18(a)(4) specifies what fee related information the Bureau will include in acknowledgement letters it sends to requesters. The Bureau proposes to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for the proposed revisions to fee-related provisions in § 1070.22(d) and (f).
The Bureau proposes to add a new provision at section 1070.18(b)(4)(iv) requiring it to inform requesters of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or the Office of Government Information Services. The Bureau also proposes to renumber the existing provisions under section 1070.18(b)(4) to accommodate this change. This change is required by the FOIA Improvement Act of 2016.
The Bureau proposes a new paragraph to inform requesters about the resources available to resolve any disputes that may arise during the request process. These resources are the Bureau's FOIA Public Liaison and mediation services provided by the National Archives and Records Administration (NARA), Office of Government Information Services (OGIS).
The Bureau proposes a new paragraph to inform requesters that they may request records in a particular format. The Bureau will provide records in a requested format when the requested format can readily be reproduced from the original file.
Section 1070.20(f) provides a submitter of business information with ten business days to object to the Bureau's disclosure of the submitter's business information. The Bureau proposes to make two technical changes to this provision clarifying that the Bureau will delay any release of
Section 1070.21(b) provides the time limits for filing administrative appeals. The Bureau proposes to revise this provision to clarify that the time period for filing an appeal begins on the day after the date the initial determination is sent to the requester or the date of the letter transmitting the last records released, whichever is later. The Bureau also proposes to change the time limit for filing an administrative appeal from 45 days to 90 days. This change is required by the FOIA Improvement Act of 2016.
Section 1070.21(d) specifies how the Bureau will process administrative appeals. The Bureau proposes to remove the requirement that appeals be stamped with the date of their receipt by the FOIA Office. The FOIA Office does not stamp an appeal with the date the Bureau received it, but the date is recorded in Bureau's system for tracking FOIA requests. This requirement is outmoded and the Bureau proposes to remove it to account for its current practice.
Section 1070.21(d) also currently provides that appeals will be processed in the order in which they are received. Since adopting this provision in 2011, the Bureau has found that it is not always practicable to complete action on appeals in the order in which they are received, and sometimes has chosen to act on a simple later-received appeal rather than delay action pending completion of a more complex earlier-received appeal. In order to better align the regulation with current practice, the Bureau is proposing to delete the provision calling for first-in-first-out processing of appeals.
Section 1070.21(e) authorizes the General Counsel to decide administrative appeals, and § 1070.21(e)(3) currently allows for remand of a FOIA determination as one option for the General Counsel's disposition of an appeal. The Bureau proposes to amend the first sentence of § 1070.21(e) to add a reference to remands so that all options for disposition of appeals are listed in that sentence.
Section 1070.22(b)(1)(i) defines the “Commercial user” category of requester. The Bureau proposes to amend this provision to clarify that the Bureau's decision to place a requester in the commercial user category will be made on a case-by-case basis based on how the requester will use the information. The Bureau proposes this change to clarify how it will make decisions whether to place a requester in the commercial user category.
Section 1070.22(b)(2) provides that the Bureau will notify a requester of its determination as to the proper fee category to apply to the requester. The current language of the provision provides that the Bureau will make its determination based on a review of the requester's submission and the Bureau's own records. The Bureau proposes to delete this limitation to clarify that it may base its determination on other appropriate information, including phone conversations with the requester and publicly available information.
The Bureau proposes to insert a new paragraph at § 1070.22(d)(2); existing paragraphs in § 1070.22(d) will be renumbered to accommodate the new paragraph. Section 1070.22(d) provides certain circumstances where the Bureau may not charge a requester a fee for processing a FOIA request. The proposed new paragraph would provide that the Bureau will not charge a requester any fees when the fee, excluding duplication costs, is less than $250. The Bureau proposes this change as part of its larger goal of revising the process for how it assesses FOIA processing fees and how the Bureau notifies requesters of such fees. This new provision would streamline the Bureau's process for assessing FOIA fees. This change would allow the Bureau to process FOIA requests more quickly and efficiently because the Bureau will no longer need to contact a FOIA requester concerning processing fees when the cost to process the request is less than $250. As such, this provision would provide information to these requesters more quickly and at a reduced cost to the requesters.
The Bureau proposes to revise this provision to prohibit it from charging search fees, or in certain cases duplication fees, when the Bureau has failed to comply with time limits under § 1070.15 or § 1070.21, unless (1) unusual circumstances apply to the processing of the request; (2) the Bureau has provided timely written notice of the unusual circumstances to the requester; (3) more than 5,000 pages are necessary to respond to the request; and (4) the Bureau has discussed with the requester (or made three good-faith attempts to do so) how the requester could effectively limit the scope of the request. These changes are required by the FOIA Improvement Act of 2016.
Section 1070.22(e)(5) provides that the Bureau will decide whether to grant or deny a request to reduce or waive fees prior to processing the FOIA request and that the Bureau will notify the requester of such a determination in writing. The Bureau proposes to delete this requirement because it is unnecessary in light of other proposed fee related revisions. In many cases involving requests for fee waivers, the Bureau will be able to process the FOIA request without deciding the merits of the fee waiver request because the processing fees will be less than $250. Furthermore, removing this requirement will allow the Bureau to process FOIA requests more efficiently and provide information to requesters more quickly. Under the Bureau's proposed revisions, the Bureau will notify a requester when it has denied a fee waiver request and processing the request would incur fees.
Section 1070.22(e)(6) specifies what information the Bureau will include in the letter it sends notifying the requester that the Bureau has denied a request for a waiver or reduction of fees. The Bureau proposes to make a technical change to this provision, removing the phrase “(of not less than $25)” to account for other newly proposed fee related provisions.
Section 1070.22(f) describes the Bureau's process for notifying a requester of any processing fees associated with a FOIA request. The Bureau proposes several changes to this provision to clarify and streamline its process for assessing FOIA processing
Paragraph 1070.22(a) discusses the role of the Bureau's Chief FOIA Officer. The Bureau proposes insert two new subparagraphs to this paragraph. The first concerns the Chief FOIA Officer's responsibility to offer training to Bureau staff regarding their responsibilities under the FOIA and the second concerns the Chief FOIA Officer's role as the primary Bureau liaison with the Office of Government Information Services and the Department of Justice's Office of Information Policy. The Bureau also proposes to renumber the provisions in this section to accommodate these changes. These changes are required by the FOIA Improvement Act of 2016.
Subpart C addresses the disclosure of Bureau information in connection with legal proceedings. The Bureau proposes several technical corrections throughout the subpart.
Section 1070.30(a) defines the circumstances for which the procedures outlined in subpart C apply. The Bureau proposes to delete paragraph (a)(1) from this provision and to renumber the section accordingly. The Bureau proposes this revision as a technical change to account for moving § 1070.31 to subpart A.
Section 1070.30(e)(2) defines the term “legal proceeding” for subpart C. The Bureau proposes to add the phrase “their agents” to the last sentence of this provision to clarify that this definition applies to formal and informal requests made by both attorneys and their agents.
Section 1070.31 provides the process for serving the Bureau with summonses or complaints. As discussed above, the Bureau proposes to delete § 1070.31 from subpart C and move it to a new section in subpart A, § 1070.5. The Bureau also proposes to renumber sections and cross-references in subpart C to account for this change. For additional information, see the discussion of § 1070.5.
Section 1070.31(d) provides that the Bureau is not authorized to accept on behalf of its employees any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties. In addition, the current text of the provision implies that it is the Bureau's practice to accept such demands or requests “upon the express, written authorization of the individual CFPB employee to whom such demand or request is directed.” The Bureau proposes to delete this part of the provision because it is not the general practice of the Bureau to accept service on behalf of individual employees. The Bureau further proposes deleting the paragraph's introductory caveat, “[e]xcept as otherwise provided in this subpart,” because the subpart does not otherwise provide for the Bureau to act as an agent for service for subpoenas, orders, or other demands or requests that do not relate to employees' official conduct.
Section 1070.33(b) provides that the General Counsel may require a party seeking official information through testimony, CFPB records, or other material, to describe all reasonably foreseeable demands for such information. The Bureau proposes to make several technical changes to clarify this provision.
Section 1070.41(b) provides that contractors and consultants in possession of confidential information must treat it in accordance with these rules, Federal laws and regulations that apply to Federal agencies for the protection of the confidentiality of personally identifiable information and for data security and integrity, as well as any additional conditions or limitations that the Bureau may impose. The current language includes a requirement that contractors and consultants certify in writing that they will follow this provision. The Bureau proposes replacing the certification requirement with an affirmative statement that contractors and consultants must follow this provision. The revision is intended to clarify that contractors and consultants are subject to § 1070.41(b)'s requirements irrespective of any affirmative certification. We note that this revision will in no way alter the Bureau's current practices related to requiring contractors and consultants to sign non-disclosure agreements, agree to protections in contracts, or take other appropriate steps to protect confidential information.
Section 1070.41(c) addresses the disclosure of materials derived from confidential information. It requires that, when the Bureau discloses such materials, they may not directly or indirectly identify any particular person to whom the confidential information pertains. The Bureau proposes replacing the phrase “[n]othing in this subpart shall limit the discretion of the CFPB” with “[t]he CFPB may . . .” in order to clarify that § 1070.41(c) authorizes such disclosure by the Bureau.
The Bureau proposes a new paragraph that, where practicable, authorizes the Bureau to, upon receipt of prior consent, disclose confidential information that directly or indirectly identifies particular persons. The provision would require consent from all such persons to the extent that the identification constitutes confidential information, and any such disclosure would have to comply with applicable law. The Bureau believes that it may at times be useful to disclose such information in order to achieve its mission objectives. By conditioning disclosure on consent, affected persons' interests would be appropriately protected. This new provision is intended to serve as a distinct authority for disclosure, and it in no way impacts other methods of disclosure currently addressed in the Rule, such as in § 1070.43. The Bureau proposes renumbering the section to account for the new paragraph.
Section 1070.41(e) provides that nothing in subpart D requires or authorizes the Bureau to disclose confidential information that it has received from other agencies where such disclosure would contravene applicable law or conflict with any agreement between the CFPB and the provider agency. The Bureau proposes replacing the word “disclosability” in the paragraph's title with “nondisclosure” in order to clarify that this provision protects the confidentiality of other agencies' confidential information. This revision would not make any substantive change to the provision.
Section 1070.42 provides that the Bureau may, in its discretion, disclose confidential supervisory information concerning a supervised financial institution or its service providers to that supervised financial institution or its affiliates. In addition, § 1070.42 provides that, unless directed otherwise by the Bureau's Associate Director for Supervision, Enforcement, and Fair Lending or by his or her delegee, any supervised financial institution in possession of confidential supervisory information pursuant to this section may further disclose the information to certain recipients and subject to certain conditions.
The Bureau proposes expanding the scope of § 1070.42 to address its enforcement activities in addition to its supervisory activities. This revision will lend clarity to the Bureau's disclosures in the enforcement context, and to the extent of financial institutions' discretion to further disclose confidential investigative information (such as civil investigative demands (“CIDs”) or notice and opportunity to respond and advise (“NORA”) letters). The resulting rule will provide that recipients of confidential investigative information have the same discretion with respect to disclosing confidential investigative information that they currently have with respect to confidential supervisory information. In addition, the proposal will establish a single process for such recipients to follow if they wish to further disclose confidential information obtained in the course of the Bureau's supervisory or enforcement activities. The proposed revisions will result in no substantive change to the Bureau's supervisory activities or supervised financial institutions' discretion to disclose confidential supervisory information, as currently articulated in the rule.
To achieve these ends, the Bureau proposes revising the section's title to read “Disclosure of confidential supervisory information and confidential investigative information.” In addition, all references in the section to “confidential supervisory information” will be accompanied by the phrase “or confidential investigative information.” Furthermore, references to any “supervised financial institution” will be replaced by a broader reference to any “person.” “Supervised financial institutions” are a kind of “person,” which is defined at § 1070.2. The Bureau proposes using this broader term because the recipients of confidential investigative information may not be supervised financial institutions, and at times some recipients, such as third-party recipients of civil investigative demands, may not be financial institutions. Finally, the Bureau proposes several non-substantive technical revisions for purposes of clarity.
The Bureau also proposes revising § 1070.42(a) to provide that, in addition to disclosing information concerning a person, its affiliates, or its service providers to that person or its affiliates, the Bureau may also disclose such information to its service providers. The Bureau proposes this change because such information may at times be relevant to supervision or enforcement activities related to service providers.
In addition, the Bureau proposes revising § 1070.42(b)(2) to clarify that a person in possession of confidential supervisory information or confidential investigative information relating to that person may disclose such information to an insurance provider pursuant to a claim for coverage made by that person under an existing policy. Such disclosures may only be made if the Bureau has not precluded indemnification or reimbursement for the claim.
We note that this revised language only authorizes disclosure to the extent necessary for the insurance provider to process and administer the claim for coverage. Further distribution or use of the information is prohibited. These limitations do not foreclose an insurance provider from using information that has been publicly disclosed by the Bureau in making future underwriting determinations regarding the person or for other purposes—even if that information was originally submitted to the insurance provider as confidential information under this provision.
Finally, the Bureau proposes to remove references to the Associate Director for Supervision, Enforcement, and Fair Lending's delegee. Such reference is no longer necessary because the new definition of Associate Director for Supervision, Enforcement, and Fair Lending, located at § 1070.2(b), includes delegees.
Section 1070.43 sets forth the circumstances in which the Bureau may disclose confidential information to other government agencies. The Bureau proposes revising the section's title and subtitles to delete the references to “law enforcement agencies” and “government” agencies because the references are superfluous. Instead, the title and subtitles will reference “Agencies.” Likewise, as discussed above with respect to § 1070.2(a), the Bureau proposes revisions throughout the section to account for the newly proposed defined term “Agency.” The Bureau proposes various other non-substantive technical corrections.
Section 1070.43(b)(1) sets forth the standard under which the Bureau may disclose confidential information to
This change is intended to facilitate communication and information-sharing among the Bureau and other governmental authorities. The Bureau has determined that sharing confidential supervisory information in situations where the disclosure of the information is relevant to the exercise of the receiving agency's statutory or regulatory authority will facilitate the Bureau's purposes and objectives. Multiple agencies engage in operations that have the potential to affect the offering and provision of consumer financial products and services, as well as the markets, industries, companies, and other persons relevant to the Bureau's work. In addition, multiple agencies have interests and obligations relating to implementation, interpretation, and enforcement of the Dodd-Frank Act and the other Federal consumer financial law administered by the Bureau. The proposed change will assist the Bureau in implementing and administering Federal consumer financial law in a more consistent and effective fashion, and enable the Bureau to work together with other agencies having responsibilities related to consumer financial matters. The Bureau also believes that the proposed change would comport with the intent of the Dodd-Frank Act, since effective coordination and communication among agencies is essential in order for the regulatory framework established by that Act to work as Congress intended.
In the Bureau's judgment, the current rule's restrictions have proven overly cumbersome in application, pose unnecessary impediments to cooperating with other agencies, and otherwise risk impairing the Bureau's ability to fulfill its statutory duties. Unnecessary impediments to information-sharing in such circumstances impede supervisory and enforcement coordination and create opportunities for potential conflict, inefficiency, and duplication of efforts across agencies. The Bureau believes that retaining discretion to share confidential supervisory information in such situations would better promote the Bureau's mission and overall effectiveness.
This proposal would codify the Bureau's revised interpretation of 12 U.S.C. 5512(c)(6). 12 U.S.C. 5512(c)(6) has three subparagraphs. 12 U.S.C. 5512(c)(6)(A) directs the Bureau to “prescribe rules regarding the confidential treatment of information obtained from persons in connection with the exercise of its authorities under Federal consumer financial law.” 12 U.S.C. 5512(c)(6)(B) addresses disclosure of confidential supervisory information
The Bureau had previously interpreted 12 U.S.C. 5512(c)(6)(C)(ii) to set forth a positive grant of authority that limits the Bureau's discretion to disclose confidential supervisory information under the rules authorized by 12 U.S.C. 5512(c)(6)(A). By only providing for the discretion to disclose confidential supervisory information to “prudential regulator[s] or other agenc[ies] having jurisdiction,” it was assumed that the provision prohibited disclosure by the Bureau to agencies that lack “jurisdiction.” The Bureau articulated this interpretation in the interim final rule and the final rule that established this subpart.
12 U.S.C. 5512(c)(6)'s framework—providing the Bureau with broad discretion to draft confidentiality rules, followed by instructions related to the exchange of confidential supervisory information with certain agencies—is ambiguous.
12 U.S.C. 5512(c)(6)(A) provides the Bureau with broad discretion to draft rules regarding the confidential treatment of information. We think the better view is that Congress did not intend 12 U.S.C. 5512(c)(6)(C)(ii) to restrict that discretion. The language in subparagraph (C)(ii) is permissive—it says “the Bureau may, in its discretion” disclose confidential supervisory information to certain agencies. Notably, Congress did not include any restrictive language, such as “the Bureau may
Furthermore, 12 U.S.C. 5512(c)(6)(C)(ii) contrasts with 12 U.S.C. 5562(d)(2), where Congress clearly and unambiguously restricted the Bureau's discretion in drafting these same confidentiality rules by stating that “[n]o rule . . . shall be intended to prevent disclosure [to Congress].” The difference between the permissive language used in 12 U.S.C. 5512(c)(6)(C)(ii) and the restrictive language used in 12 U.S.C. 5562(d)(2) indicates that Congress intended the two provisions to act in different ways.
We also think that the presence of subparagraphs (B)(i), (B)(ii), and (C)(i) in 12 U.S.C. 5512(c)(6) demonstrate that subparagraph (C)(ii) could serve a purpose other than limiting
The Bureau believes that subparagraphs (B) and (C) can reasonably be read to establish an information-sharing regime with a limited set of agencies. The purpose of subparagraphs (B)(ii) and (C)(ii) is to contrast and limit the mandatory disclosures in subparagraphs (B)(i) and (C)(i), respectively. Whereas subparagraph (B)(i) requires a set of agencies (prudential regulators and Federal agencies having jurisdiction) to provide reports of examination or financial condition to the Bureau, subparagraph (B)(ii) clarifies that those same agencies have discretion with respect to disclosing other reports or other confidential supervisory information. Likewise, whereas subparagraph (C)(i) requires the Bureau to disclose reports of examination to prudential regulators, state regulators, and Federal regulators having jurisdiction, subparagraph (C)(ii) clarifies that disclosure of other reports and other confidential supervisory information to prudential regulators and other agencies is discretionary. The phrase “other report and other confidential supervisory information” clarifies, contrasts and narrows the reference to “report of examination” in subparagraph (C)(i).
The Bureau has already addressed subparagraph (C)(i)'s mandatory disclosures in the confidentiality rules at § 1070.43(a), and this paragraph remains unchanged. The Bureau's proposed revision to § 1070.43(b)(1) will include 12 U.S.C. 5512(c)(6)(C)(ii)'s discretionary disclosures of confidential supervisory information, and it will allow for additional disclosures to agencies that do not “hav[e] jurisdiction,” so long as such disclosure is “relevant to the exercise of the [agency's] statutory or regulatory authority.” 12 U.S.C. 5512(c)(6)(A)'s broad grant of authority to draft confidentiality rules provides the Bureau sufficient discretion to make this change.
Please note that the Bureau's policy regarding the disclosure of confidential supervisory information to law enforcement agencies, which we previously articulated in CFPB Bulletin 12-01 (Jan. 4, 2012), remains in place. The Bureau's revised interpretation of 12 U.S.C. 5512(c)(6) and its proposed revision to § 1070.43(b)(1) do not alter CFPB Bulletin 12-01.
Section 1070.43(b)(2) sets forth a process for agencies to submit written requests (sometimes referred to as “access requests”) to the Bureau in order to obtain access to its confidential information pursuant to § 1070.43(b). Whereas the section currently requires submission of access requests to the General Counsel, the Bureau proposes to instead require submission to the Associate Director for Supervision, Enforcement, and Fair Lending. The Bureau believes that this change would lead to increased efficiency because the vast majority of access requests submitted to the Bureau pertain to work conducted by its Division of Supervision, Enforcement, and Fair Lending. The Associate Director for Supervision, Enforcement, and Fair Lending will continue to consult with other Bureau stakeholders, including the Legal Division, as necessary. The Bureau also proposes that access requests be emailed to a single email address,
In addition, for purposes of clarity, the Bureau proposes revising § 1070.43(b)(2)(iii) to state that, among other things, access requests must include a statement certifying and identifying the agency's “statutory or regulatory authority that is relevant to the requested information, as required by paragraph (b)(1).” We have found in our experience that the current formulation (the agency must certify or identify its “authority for requesting the documents”) can lead to confusion.
Section 1070.43(c) states that state agency requests for information other than confidential information are not to be made and considered under § 1070.43. The Bureau proposes deleting this paragraph because it is unnecessary and can lead to confusion. Because, by its own terms, § 1070.43 only applies to confidential information, there is no need to state that it does not apply to information that is not confidential.
Section 1070.44 addresses the Bureau's disclosure of confidential consumer complaint information in the course of investigating, resolving, or otherwise responding to consumer complaints. The Bureau proposes replacing the phrase “[n]othing in this subpart shall limit the discretion of the CFPB” with “[t]he CFPB may . . . .” This revision is intended to clarify that § 1070.44 authorizes such disclosure by the Bureau. The Bureau also proposes replacing the phrase “concerning financial institutions or consumer financial products and services” with “concerning consumer financial products and services or a violation of Federal consumer financial law” in order to clarify that the section broadly addresses any information received or generated by the Bureau through processes or procedures established under 12 U.S.C. 5493(b)(3), including where complaints do not concern financial institutions, or where the Bureau lacks authority to act on them.
Section 1070.45 addresses various instances where the Bureau may make disclosures of confidential information on its own initiative. The Bureau proposes several revisions to clarify, supplement, or amend the disclosures currently addressed in the section. Any disclosures made pursuant to this section must be made in accordance with applicable law.
The Bureau proposes deleting the reference in § 1070.45(a) to “confidential investigative information” in the phrase “confidential investigative information or other confidential information.” Because confidential investigative information is a sub-category of confidential information, and § 1070.45(a) already addresses confidential information generally, the separate reference to confidential
Subparagraph (a)(2) addresses disclosure of confidential information to either House of the Congress, or to an appropriate committee or subcommittee of the Congress, as set forth in 12 U.S.C. 5562(d)(2). The current text states that, upon receipt of a request from the Congress for confidential information that a financial institution submitted to the Bureau along with a claim that such information consists of trade secret or privileged or confidential commercial or financial information, or confidential supervisory information, the Bureau “shall notify” the financial institution in writing of its receipt of the request and provide the institution with a copy of the request. The Bureau proposes revising the text to state that it “may notify” the financial institution in such circumstances. This revision will provide greater flexibility and more closely align with 12 U.S.C. 5562(d)(2), which states that the Bureau “is permitted to adopt rules allowing prior notice to any party that owns or otherwise provided the material to the Bureau and had designated such material as confidential.”
Subparagraph (a)(3) pertains to the disclosure of confidential information in “investigational hearings and witness interviews, as is reasonably necessary, at the discretion of the CFPB.” This paragraph was initially intended to address disclosure in the course of investigations and enforcement actions.
Subparagraph (a)(4) authorizes the disclosure of confidential information “[i]n an administrative or court proceeding to which the CFPB is a party.” The Bureau proposes revising this paragraph to state that it may disclose confidential information “[i]n or related to an administrative or court proceeding to which the Bureau is a party.” This revision clarifies that the Bureau may disclose confidential information not only during an administrative or court proceeding to which the Bureau is a party, such as in complaints and consent orders, but also when related to the Bureau's implementation of ongoing administrative or court orders. Such disclosures may be made in furtherance of the Bureau's reporting requirements and include, for example, updates on required consumer remuneration and the payment of civil money penalties.
Subparagraph (a)(4) also enables the submitter of such information to seek a protective or other order prior to such disclosure. For clarity, the Bureau proposes replacing the phrase “confidential investigatory materials” with “confidential investigative information,” a defined term used throughout the rule. Likewise, the Bureau proposes replacing the reference to “appropriate protective or in camera order” with “appropriate order,” which would encompass both examples in the current version. Finally, the Bureau proposes revising the rule to also allow the Bureau to seek an appropriate order in its discretion. Whereas the current text only discusses the submitter seeking such an order, there may be times where it would be more efficient or appropriate for the Bureau itself to make such a request.
Subparagraph (a)(5) addresses disclosure to other agencies of confidential information in summary form to notify them about potential violations of law subject to their jurisdiction. The purpose of this provision is to allow the Bureau to inform agencies about potential legal violations in which they may have an interest, including situations in which they may wish to submit a request for information under § 1070.43. The Bureau proposes revising this paragraph to authorize disclosure to “Agencies in summary form to the extent necessary to confer with such Agencies about matters relevant to the exercise of the Agencies' statutory or regulatory authority.” This revision would clarify the paragraph's intended purpose and more closely align with the standard used for disclosing confidential information to agencies under § 1070.43.
Finally, the Bureau proposes a new subparagraph that states that the Bureau may disclose confidential information in “CFPB personnel matters, as necessary and subject to appropriate protections.” This revision is intended to clarify that confidential information may at times be disclosed in the course of equal employment opportunity matters, grievance proceedings, and other personnel matters. Any such disclosures would only be made as necessary, in accordance with applicable law, and subject to appropriate protections. The Bureau proposes re-numbering § 1070.45 to account for this new paragraph.
The Bureau proposes reorganizing § 1070.47 for clarity. Specifically, it proposes moving subparagraph 1070.47(a)(5) to immediately after subparagraph 1070.47(a)(2). The Bureau proposes this change because the two subparagraphs both address further disclosure by the recipient of confidential information. The Bureau further proposes making subparagraph 1070.47(a)(3), which addresses third-party requests for information, a new paragraph titled “Third party requests for information.” This revision will highlight the provision and lead to better ease of use. Finally, the Bureau proposes re-numbering the section to account for these changes.
Section 1070.47(a) describes certain steps that recipients of confidential information under subpart D must take to protect the information. It notes that confidential information disclosed under this subpart remains Bureau property, it prohibits further disclosure of confidential information without the Bureau's prior written permission, and it sets forth procedures to follow in the event that a recipient of confidential information receives from a third party a legally enforceable demand for the information.
Consistent with proposed revisions to § 1070.43(b), the Bureau proposes shifting from its General Counsel to the Associate Director for Supervision, Enforcement, and Fair Lending the authority in subparagraph (a)(1) to provide in writing that confidential information is no longer Bureau property, and the authority in subparagraph (a)(2) to provide written permission to further disclose
The Bureau proposes adding a new paragraph (d) to clarify that the Bureau may require any person in possession of confidential information to return the records to the Bureau or destroy them.
The Bureau proposes adding a new paragraph (e) to clarify that the Bureau's disclosure of confidential information under subpart D does not waive the Bureau's right to control, or impose limitations on, the subsequent use and dissemination of its confidential information.
The Bureau proposes moving the former paragraph (c),
The Bureau proposes adding a new paragraph (g) to require any persons in possession of confidential information to immediately notify the Bureau upon discovery of any disclosures of confidential information made in violation of subpart D.
Section 1070.48 provides that the submission by any person of any information to the Bureau in the course of the Bureau's supervisory or regulatory processes will not waive or otherwise affect any privilege such person may claim with respect to such information under Federal or State law as to any other person or entity. This section was promulgated separately from the rest of this rule in a final rule, Confidential Treatment of Privileged Information, 77 FR 39617 (Jul. 5, 2012). Congress subsequently enacted Public Law 112-215, 126 Stat. 1589, Dec. 20, 2012, which amended 12 U.S.C. 1828(x) to provide these same protections to privileged information submitted to the Bureau. Because 12 U.S.C. 1828(x), as revised, provides the exact same protections as § 1070.48, it renders § 1070.48 superfluous and unnecessary going forward. To avoid confusion, the Bureau proposes deleting the current text of § 1070.48.
The Bureau proposes adding a new section to clarify that part 1070 does not limit the discretion of its Inspector General's office to disclose confidential information as needed in fulfilling its responsibilities under the Inspector General Act of 1978, 5 U.S.C. App. 3. Because the Bureau proposes deleting the current text of § 1070.48, this new section would replace that text.
Section 1070.51 specifies the authority and responsibilities of the Bureau's Chief Privacy Officer. The Bureau proposes to add a new paragraph at § 1070.51(a) authorizing the Chief Privacy Officer to “[d]evelop, implement, and maintain an organization-wide privacy program” and to renumber the other paragraphs in § 1070.51 to reflect this change. This change is in accordance with National Institute of Standards and Technology (NIST) Special Publication 800-53 Revision 4, which provides that agencies should “[appoint] a Senior Agency Official for Privacy (SAOP)/Chief Privacy Officer (CPO) accountable for developing, implementing, and maintaining an organization-wide governance and privacy program to ensure compliance with all applicable laws and regulations regarding the collection, use, maintenance, sharing, and disposal of personally identifiable information (PII) by programs and information systems . . . .” The Bureau proposes this change to clarify the authority of its Chief Privacy Officer.
Section 1070.53(a) specifies the procedures for making Privacy Act requests for records. The current text distinguishes between requests made in writing and by electronic means. The Bureau proposes a technical change to this provision. It proposes to remove the phrase “or by electronic means” and add “as follows:” in its place. The Bureau also proposes changes to section 1070.53(a)(1) to clarify how requesters must submit Privacy Act requests to the Bureau. The Bureau proposes similar changes to sections 1070.56(a) and 1070.58(b).
Section 1070.56(a)(2)(i) provides that an individual requesting an amendment of a record must identify the system of records containing the record. The Bureau proposes to revise this provision to allow an individual to provide a description of the record in sufficient detail to allow Bureau personnel to locate the system of records containing the record. This revision would provide a requester with more flexibility in the event that the requester does not know the precise name of the applicable system of records. Furthermore, this change is consistent with § 1070.53(b)(2), which specifies requirements for requests for access to records.
Section 1070.61 addresses, among other things, the CFPB's obligations to conduct privacy-related training and establish rules of conduct related to privacy. The Bureau proposes to replace references to “employees of Government contractors” with the term “contract personnel” to avoid confusion with respect to § 1070.2(l), which defines the term “employee.”
The Bureau proposes to revise subparagraph 1091.103(a)(2)(vii) to remove the cross-reference to § 1070.2(i)(1) and replace it with the appropriate cross-reference to § 1070.2(j).
The Bureau proposes to revise paragraph 1091.115(c) to remove the cross-reference to § 1070.2(i)(1) and replace it with the appropriate cross-reference to § 1070.2(j).
In developing this proposed rule, the Bureau has considered the potential benefits, costs, and impacts required by section 1022(b)(2)(A) of the Dodd-Frank Act. The Bureau has consulted, or offered to consult with, the prudential regulators and the Federal Trade Commission including consultation regarding consistency with any prudential, market, or systemic objectives administered by such agencies.
The Bureau has chosen to consider the benefits, costs, and impacts of the proposed provisions as compared to the status quo: The current statutory provisions and the regulations as set forth by the Bureau on February 15, 2013, 78 FR 11483 (Feb. 15, 2013) (which includes the protections for privileged information which Congress enacted in Public Law 112-215, 126 Stat. 1589, Dec. 20, 2012, which amended 12 U.S.C. 1828(x)).
In this analysis, the Bureau focuses on the benefits, costs, and impacts of the main aspects of the proposed rule. The proposed changes to the definitions in subpart A would alter the treatment of certain information submitted to the Bureau. The revised definition of confidential consumer complaint information would now include any information received or generated by the CFPB through processes or procedures established under 12 U.S.C. 5493(b)(3), clarifying that any complaints submitted to the CFPB through its Consumer Response system, and any information generated therein, are similarly classified under its confidentiality rules and subject to the same confidentiality protections. The revised definition of confidential supervisory information will no longer include reference to information collected using the Bureau's market monitoring authority.
The proposed changes in subpart D would alter the rules concerning the disclosure of confidential investigative information to and by financial institutions and their affiliates by lending clarity to the Bureau's disclosures of confidential investigative information in the enforcement context; providing that recipients of confidential investigative information have the same discretion with respect to disclosing confidential investigative information that they currently have with respect to confidential supervisory information; providing that, in addition to disclosing information concerning a person, its affiliates, or its service providers to that person or its affiliates, the Bureau may also disclose such information to its service providers; and providing that a person lawfully in possession of confidential supervisory information or confidential investigative information provided directly to it by the Bureau pursuant to § 1070.42 may disclose the information to an insurance provider to the extent necessary for the insurance provider to process and administer any claims for coverage.
The proposed changes also alter the rules concerning the sharing of confidential supervisory information between the Bureau and other agencies by providing the Bureau with discretion to disclose confidential supervisory information to another agency “to the extent that the disclosure of the information is relevant to the exercise of the [agency's] statutory or regulatory authority,” rather than to another agency “having jurisdiction over a supervised financial institution.”
Lastly, the proposed rule would authorize the Bureau, upon receipt of prior consent, to disclose confidential information that directly or indirectly identifies particular persons. The proposed rule also includes clarifications that the Bureau may disclose confidential information in its discretion as needed to conduct its investigations or perform administrative tasks to further its own enforcement actions; and, that the Bureau may disclose confidential information not only during an administrative or court proceeding to which the Bureau is a party, such as in complaints and consent orders, but also when related to the Bureau's implementation of ongoing administrative or court orders.
The Bureau views the remainder to the proposed rule to mainly include clarifications, corrections and technical changes.
The proposed revisions to the definition of confidential consumer complaint information would provide benefits for consumers and covered persons. Specifically, the expansion of the definition of confidential consumer complaint information should afford greater protections to consumers submitting, and covered persons referenced by, any misdirected complaints that the Bureau receives and that are now covered under the definition.
The change to the definition of confidential supervisory information and the proposed changes regarding information sharing would also benefit consumer and covered persons. Removing market monitoring information that contains confidential business information or personal information from the definition would have limited effect since such information would be subject to the same protections currently accorded to it, including the limitations on public disclosures and disclosures to other regulators. In contrast, the Bureau would have more flexibility to use and disclose less sensitive, non-confidential information collected for market monitoring purposes such as data that are already publicly available. The lesser burden should allow the Bureau to implement and administer Federal consumer financial law more efficiently.
Regarding the proposed provisions related to sharing information, consumers would benefit, to the extent that each of these changes allows more efficient sharing of confidential information between the CFPB and various parties and thus also results in more efficient administration of consumer financial laws. Covered persons would benefit, to the extent that the efficiencies embodied in these changes reduce costs either by altering and simplifying the covered person's obligations or by allowing for more efficient sharing among regulators that interact with the covered person. For
The changes in the sharing provisions of the rule may entail certain costs to covered persons. The broader sharing of information provided for in the proposed rule has an increased risk for a loss of confidentiality. However, as noted above, the Bureau has sought to provide the maximum protection for confidential information, while ensuring its ability to share or disclose information to the extent necessary to achieve its mission. The Bureau will continue to appropriately protect sensitive information. Further, as noted in the original 2013 rule, increased sharing of information under the proposed the rule may increase the volume and costs of litigation or regulatory action for covered persons whose information the Bureau will share with other agencies, and which such agencies may use as bases for administrative or judicial actions against covered persons. To the extent that such costs occur, the Bureau believes that in most cases these costs would be associated with concomitant benefits to consumers from the prevention or remedy of harms associated with violations of law by covered persons.
The CFPB does not expect that the proposed rule would have an appreciable impact on consumers' access to consumer financial products or services. The scope of the rulemaking is limited to matters related to access to and disclosure of certain types of information, and does not relate to credit access.
The Bureau does not believe that this proposed rule would have a unique impact on insured depository institutions or insured credit unions with less than $10 billion in assets as described in section 1026(a) of the Dodd-Frank Act. Since such institutions are not supervised by the Bureau, they are generally less likely to share information with the Bureau and therefore any impacts of the rule from the provisions on supervisory information may indeed be less compared to other institutions.
The Bureau also does not believe that this proposed rule would have a unique impact on consumers in rural areas. To the extent that these consumers may use smaller financial service providers not supervised by the Bureau, and therefore less likely to share information with the Bureau, the impacts of the rule from the provisions on supervisory information for these consumers may indeed be less than for other consumers.
The Regulatory Flexibility Act, 5 U.S.C. 601
Finally, the Bureau has determined that this proposed rule does not impose any new recordkeeping, reporting, or disclosure requirements on members of the public that would be collections of information requiring approval under the Paperwork Reduction Act, 44 U.S.C. 3501
Confidential business information, Consumer protection, Freedom of information, Privacy.
Administrative practice and procedure, Consumer protection, Credit, Trade practices.
For the reasons set forth in the preamble, the Bureau proposes to amend chapter X of title 12 of the CFR to read as follows:
12 U.S.C. 5481
(a)
(2) This part establishes mechanisms for carrying out the CFPB's statutory responsibilities under the statutes in paragraph (a)(1) of this section to the extent those responsibilities require the disclosure, production, or withholding of information. In this regard, the CFPB has determined that the CFPB, and its delegates, may disclose information of the CFPB, in accordance with the procedures set forth in this part, whenever it is necessary or appropriate to do so in the exercise of any of the CFPB's authority. The CFPB has determined that all such disclosures, made in accordance with the rules and procedures specified in this part, are authorized by law.
(b)
(1) Subpart A contains general provisions and definitions used in this part.
(2) Subpart B implements the Freedom of Information Act, 5 U.S.C. 552.
(3) Subpart C sets forth the procedures with respect to subpoenas, orders, or other requests for CFPB information in connection with legal proceedings.
(4) Subpart D provides for the protection of confidential information and procedures for sharing confidential information with supervised institutions, government agencies, and others in certain circumstances.
(5) Subpart E implements the Privacy Act of 1974, 5 U.S.C. 552a.
For purposes of this part:
(a)
(b)
(c)
(d)
(e)
(f)
(g)
(h)
(i)
(1) Any documentary material, written report, or written answers to questions, tangible thing, or transcript of oral testimony received by the CFPB in any form or format pursuant to a civil investigative demand, as those terms are set forth in 12 U.S.C. 5562, or received by the CFPB voluntarily in lieu of a civil investigative demand; and
(2) Any other documents, materials, or records prepared by, on behalf of, received by, or for the use by the CFPB or any other Agency in the conduct of enforcement activities, and any information derived from such materials.
(j)
(1) Reports of examination, inspection and visitation, non-public operating, condition, and compliance reports, supervisory letter, or similar document, and any information contained in, derived from, or related to such documents;
(2) Any documents, materials, or records, including reports of examination, prepared by, or on behalf of, or for the use of the CFPB or any other Agency in the exercise of supervisory authority over a financial institution, and any information derived from such documents, materials, or records;
(3) Any communications between the CFPB and a supervised financial institution or a Federal, State, or foreign government agency related to the CFPB's supervision of the institution;
(4) Any information provided to the CFPB by a financial institution for purposes of detecting and assessing risks to consumers and to markets for consumer financial products or services pursuant to 12 U.S.C. 5414(b)(1)(C), 5515(b)(1)(C), or 5516(b), or to assess whether an institution should be considered a covered person, as that term is defined by 12 U.S.C. 5481, or is subject to the CFPB's supervisory authority; and/or
(5) Information that is exempt from disclosure pursuant to 5 U.S.C. 552(b)(8).
(k)
(l)
(m)
(n)
(o)
(p)
(q)
(r)
(a)
(b)
(c)
Except as provided by this part, employees or former employees of the CFPB, or others in possession of a record of the CFPB that the CFPB has not already made public, are prohibited from disclosing such records, without authorization, to any person who is not an employee of the CFPB.
(a) Only the General Counsel is authorized to receive and accept summonses or complaints sought to be served upon the CFPB or CFPB employees sued in their official capacity. Such documents should be served upon the General Counsel, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552. This authorization for receipt shall in no way affect the requirements of service elsewhere provided in applicable rules and regulations.
(b) If, notwithstanding paragraph (a) of this section, any summons or complaint described in that paragraph is delivered to an employee of the CFPB, the employee shall decline to accept the proffered service and may notify the person attempting to make service of the regulations set forth herein. If, notwithstanding this instruction, an employee accepts service of a document described in paragraph (a) of this section, the employee shall immediately notify and deliver a copy of the summons and complaint to the General Counsel.
(c) When a CFPB employee is sued in an individual capacity for an act or omission occurring in connection with duties performed on behalf of the CFPB (whether or not the officer or employee is also sued in an official capacity), the employee by law is to be served personally with process.
(d) The CFPB will only accept service of process for an employee sued in his or her official capacity. Documents for which the General Counsel accepts service in official capacity shall be marked “Service Accepted in Official Capacity Only.” Acceptance of service shall not constitute an admission or waiver with respect to jurisdiction, propriety of service, improper venue, or any other defense in law or equity available under applicable laws or rules.
This subpart contains the regulations of the CFPB implementing the Freedom of Information Act (the FOIA), 5 U.S.C. 552, as amended. These regulations set forth procedures for requesting access to records maintained by the CFPB. These regulations should be read together with the FOIA, the 1987 Office of Management and Budget Guidelines for FOIA Fees, the CFPB's Privacy Act regulations set forth in subpart E, and the FOIA Web page on the CFPB's Web site,
(a)
(1) Information required to be published in the
(2) Information required to be made available for public inspection and in an electronic format or, in the alternative, to be published and offered for sale (see § 1070.13); and
(3) Information required to be made available to any member of the public upon specific request (see §§ 1070.14 through 1070.22).
(b)
(c)
(a)
(1) Descriptions of its central and field organization and the established place at which, the persons from whom, and the methods whereby, the public may obtain information, make submissions or requests, or obtain decisions;
(2) Statements of the general course and method by which its functions are channeled and determined, including the nature and requirements of all formal and informal procedures available;
(3) Rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;
(4) Substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the CFPB; and
(5) Each amendment, revision, or repeal of matters referred to in paragraphs (a)(1) through (4) of this section.
(b)
(a)
(1) Final opinions, including concurring and dissenting opinions, and orders made in the adjudication of cases;
(2) Those statements of policy and interpretations which have been adopted by the CFPB but are not published in the
(3) Its administrative staff manuals and instructions to staff that affect a member of the public;
(4) Copies of all records made publicly available pursuant to § 1070.11; and
(5) A general index of the records referred to in paragraph (a)(4) of this section.
(b
(c)
(d)
(a)
(b)
(1) If a request is submitted by mail or delivery service, it shall be addressed to the Chief FOIA Officer, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552. The request shall be labeled “Freedom of Information Act Request.”
(2) If a request is submitted by electronic means, it shall be submitted as set forth on the CFPB's Web site,
(c)
(2) In order to ensure the CFPB's ability to communicate effectively with the requester, a request should include contact information for the requester, including the name of the requester and, to the extent available, a mailing address, telephone number, and email address at which the CFPB may contact the requester regarding the request;
(3) The request should state whether the requester wishes to inspect the records or desires to receive an electronic copy or have a copy made and furnished without first inspecting the records;
(4) For the purpose of determining any fees that may apply to processing a request, a requester should indicate in the request whether the requester is a commercial user, an educational institution, non-commercial scientific institution, representative of the news media, governmental entity, or “other” requester, as those terms are defined in § 1070.22(b), and the basis for claiming that fee category. Requesters may seek assistance in determining the appropriate fee category by contacting the CFPB's FOIA Public Liaison at the telephone number listed on the CFPB's Web site,
(5) If a requester seeks a waiver or reduction of fees associated with processing a request, then the request shall include a statement to that effect as is required by § 1070.22(e); and
(6) If a requester seeks expedited processing of a request, then the request must include a statement to that effect as is required by § 1070.17.
(d)
(e)
(f)
(a)
(b)
(c)
(2) When a FOIA request is received for a record created by the CFPB that includes information originated by another agency, the CFPB shall consult the originating agency for review and recommendation on disclosure. The CFPB shall not release any such records without prior consultation with the originating agency.
(d)
(a)
(b)
(2) The CFPB may provide a requester in its complex track with an opportunity to limit the scope of the request to qualify for faster processing within the specified limits of the simple track(s).
(c)
(1) Make one reasonable demand to the requester for clarifying information about the request and toll the twenty (20) business day time period while it awaits the clarifying information; or
(2) Toll the twenty (20) business day time period while it awaits clarification from or addresses any dispute with the requester regarding the assessment of fees.
(d)
(2) As used in this paragraph, “unusual circumstances” means:
(i) The need to search for and collect the requested records from field facilities or other establishments that are separate from the office processing the request;
(ii) The need to search for, collect, and appropriately examine a voluminous amount of separate and distinct records which are demanded in a single request; or
(iii) The need for consultation, which shall be conducted with all practicable speed, with another Agency having a substantial interest in the determination of the request, or among two or more CFPB offices having substantial subject matter interest therein.
(a)
(b)
(1) A request for expedited processing shall be made in writing and submitted as part of a request for records in accordance with § 1070.14(b). When a request for records includes a request for expedited processing, the request shall be labeled “Expedited Processing Requested.”
(2) A request for expedited processing shall contain a statement that demonstrates a compelling need for the requester to obtain expedited processing of the requested records. A “compelling need” is defined as follows:
(i) Failure to obtain the requested records on an expedited basis could reasonably be expected to pose an imminent threat to the life or physical safety of an individual. The requester shall fully explain the circumstances warranting such an expected threat so that the CFPB may make a reasoned determination that a delay in obtaining the requested records could pose such a threat; or
(ii) With respect to a request made by a person primarily engaged in disseminating information, urgency to inform the public concerning actual or alleged Federal government activity. A person “primarily engaged in disseminating information” does not include individuals who are engaged only incidentally in the dissemination of information. The standard of “urgency to inform” requires that the records requested pertain to a matter of current exigency to the American public and that delaying a response to a request for records would compromise a significant recognized interest to and throughout the American general public. The requester must adequately explain the matter or activity and why the records sought are necessary to be provided on an expedited basis.
(3) The requester shall certify the written statement that purports to demonstrate a compelling need for expedited processing to be true and correct to the best of the requester's knowledge and belief. The certification must be in the form prescribed by 28 U.S.C. 1746: “I declare under penalty of perjury that the foregoing is true and correct to the best of my knowledge and belief. Executed on [date].” The requester shall mail or submit electronically a copy of such written certification to the Chief FOIA Officer as set forth in § 1070.14(b). The CFPB may waive this certification requirement in appropriate circumstances.
(c)
(d)
(e)
(a)
(1) The applicable request tracking number;
(2) The date of receipt of the request, as determined in accordance with section 1070.14(d), as well as the date when the requester may expect a response;
(3) A brief statement identifying the subject matter of the request; and
(4) A confirmation, with respect to any fees that may apply to the request pursuant to § 1070.22, that the requester has sought a waiver or reduction in such fees, has agreed to pay any and all applicable fees, or has specified an upper limit that the requester is willing to pay in fees to process the request.
(b)
(2) If the request is granted in full or in part, and if the requester requests a copy of the records requested, then a copy of the records shall be mailed or emailed to the requester in the requested format, to the extent the records are readily producible in the requested format. The CFPB shall also send the requester a statement of the applicable fees, either at the time of the determination or shortly thereafter.
(3) In the case of a request for inspection, the requester shall be notified in writing of the determination, when and where the requested records may be inspected, and of the fees incurred in complying with the request. The CFPB shall then promptly make the records available for inspection at the time and place stated, in a manner that will not interfere with CFPB's operations and will not exclude other persons from making inspections. The requester shall not be permitted to remove the records from the room where inspection is made. If, after making inspection, the requester desires copies of all or a portion of the requested records, copies shall be furnished upon payment of the established fees prescribed by § 1070.22. Fees may be charged for search and review time as stated in § 1070.22.
(4) If it is determined that the request for records should be denied in whole or in part, the requester shall be notified by mail or by email. The letter of notification shall:
(i) State the exemptions relied upon in denying the request;
(ii) If technically feasible, indicate the amount of information deleted and the exemptions under which the deletion is made at the place in the record where such deletion is made (unless providing such indication would harm an interest protected by the exemption relied upon to deny such material);
(iii) Set forth the name and title or position of the responsible official;
(iv) Advise the requester of the right to seek dispute resolution services from the Bureau's FOIA Public Liaison or the Office of Governmental Information Services;
(v) Advise the requester of the right to administrative appeal in accordance with § 1070.21; and
(vi) Specify the official or office to which such appeal shall be submitted.
(5) If it is determined, after a reasonable search for records, that no responsive records have been found to exist, the requester shall be notified in writing or by email. The notification shall also advise the requester of the right to administratively appeal the CFPB's determination that no responsive records exist (
(c)
(1)
(2)
(d)
(2) The CFPB may charge fees associated with converting records or files into the requested format in accordance with § 1070.22.
Whenever a request is made for a record containing information that another agency has classified, or which may be appropriate for classification by another agency under Executive Order 13526 or any other executive order concerning the classification of information, the CFPB shall refer the responsibility for responding to the request to the classifying or originating agency, as appropriate.
(a)
(b)
(1)
(2)
(c)
(d)
(e)
(i) The information has been designated in good faith by the submitter as information considered protected from disclosure under Exemption 4; or
(ii) The CFPB has reason to believe that the information may be protected from disclosure under Exemption 4.
(2) The notice requirements of this paragraph shall not apply if:
(i) The CFPB determines that the information is exempt under the FOIA;
(ii) The information lawfully has been published or otherwise made available to the public;
(iii) Disclosure of the information is required by statute (other than the FOIA) or by a regulation issued in accordance with the requirements of Executive Order 12600 (3 CFR, 1988 Comp., p. 235); or
(iv) The designation made by the submitter under paragraph (e)(1)(i) of this section appears obviously frivolous, except that, in such a case, the CFPB shall, within a reasonable time prior to a specified disclosure date, give the submitter written notice of any final decision to disclose the information.
(f)
(2) When notice is given to a submitter under this section, the requester shall be advised that such notice has been given to the submitter. The requester shall be further advised that a delay in responding to the request may be considered a denial of access to records and that the requester may proceed with an administrative appeal or seek judicial review, if appropriate. However, the requester will be invited to agree to a voluntary extension of time so that the CFPB may review the submitter's objection to disclose, if any.
(g)
(1) A statement of the reasons for which the submitter's disclosure objections were not sustained;
(2) A description of the business information to be disclosed; and
(3) A specified disclosure date which is not less than ten (10) business days after the notice of the final decision to release the requested information has been mailed to the submitter. Except as otherwise prohibited by law, a copy of the disclosure notice shall be forwarded to the requester at the same time.
(h)
(i)
(a)
(1) To deny access to records in whole or in part (as provided in § 1070.18(b));
(2) To assign a particular fee category to the requestor (as provided in § 1070.22(b));
(3) To deny a request for a reduction or waiver of fees (as provided in § 1070.22(e));
(4) That no records exist that are responsive to the request (as provided in § 1070.18(b)); or
(5) To deny a request for expedited processing (as provided in § 1070.17(e)).
(b)
(c)
(1) If appeal is submitted by mail or delivery service, it shall be addressed to and submitted to the officer specified in paragraph (e) of this section at the address set forth in 1070.14(b). The appeal shall be labeled “Freedom of Information Act Appeal.”
(2) If an appeal is submitted by electronic means, it shall be addressed to the officer specified in paragraph (e) of this section and submitted as set forth on the CFPB's Web site,
(3) The appeal shall set forth contact information for the requester, including, to the extent available, a mailing address, telephone number, or email address at which the CFPB may contact the requester regarding the appeal; and
(4) The appeal shall specify the applicable request tracking number, the date of the initial request, and the date of the letter of initial determination, and, where possible, enclose a copy of the initial request and the initial determination being appealed.
(d)
(e)
(1) If it is decided that the appeal is to be denied (in whole or in part) the requester shall be:
(i) Notified in writing of the denial;
(ii) Notified of the reasons for the denial, including which of the FOIA exemptions were relied upon;
(iii) Notified of the name and title or position of the official responsible for the determination on appeal;
(iv) Provided with a statement that judicial review of the denial is available in the United States District Court for the judicial district in which the requester resides or has a principal place of business, the judicial district in which the requested records are located, or the District of Columbia in accordance with 5 U.S.C. 552(a)(4)(B); and
(v) Provided with notification that mediation services are available to the requester as a non-exclusive alternative to litigation through the Office of Government Information Services in accordance with 5 U.S.C. 552(h)(3).
(2) If the initial determination is reversed on appeal, the requester shall be so notified and the request shall be processed promptly in accordance with the decision on appeal.
(3) If the initial determination is remanded on appeal to the Chief FOIA Officer for further action, the requester shall be so notified and the request shall be processed in accordance with the decision on appeal. The remanded request shall be treated as a new request received by the CFPB as of the date when the General Counsel transmits the remand notification to the requester. The procedures and deadlines set forth in this subpart for processing, deciding, responding to, and filing administrative appeals of new FOIA requests shall apply to the remanded request.
(f)
(a)
(1) The CFPB shall charge a requester fees for the cost of copying or printing records at the rate of $0.10 per page.
(2) The CFPB shall charge a requester for all time spent by its employees searching for records that are responsive to a request. The CFPB shall charge the requester fees for search time as follows:
(i) The CFPB shall charge for search time at the salary rate(s) (basic pay plus sixteen (16) percent) of the employee(s) who conduct the search. However, the CFPB shall charge search fees at the rate of $9.00 per fifteen (15) minutes of search time whenever only administrative/clerical employees conduct a search and at the rate of $23.00 per fifteen (15) minutes of search time whenever only professional/executive employees conduct a search. Search charges shall also include transportation of employees and records necessary to the search at actual cost. Fees may be charged for search time even if the search does not yield any responsive records, or if records are exempt from disclosure.
(ii) The CFPB shall charge the requester for the actual direct costs of conducting an electronic records search, including computer search time, runs, and output. The CFPB shall also charge for time spent by computer operators or programmers (at the rates set forth in paragraph (a)(2)(i) of this section) who conduct or assist in the conduct of an electronic records search.
(3) The CFPB shall charge a requester for time spent by its employees
(4) Fees for all services provided shall be charged whether or not copies are made available to the requester for inspection. However, no fee shall be charged for monitoring a requester's inspection of records.
(5) Other services and materials requested which are not covered by this part nor required by the FOIA are chargeable at the actual cost to the CFPB. This includes, but is not limited to:
(i) Certifying that records are true copies; or
(ii) Sending records by special methods such as express mail, etc.
(b)
(i)
(ii)
(iii)
(iv)
(v)
(2) Within twenty (20) calendar days of its receipt of a request, the CFPB shall make a determination as to the proper fee category to apply to a requester. The CFPB shall inform the requester of the determination in the request acknowledgment letter, or if no such letter is required, in another writing. Where the CFPB has reasonable cause to doubt the use to which a requester will put the records sought, or where that use is not clear from the request itself, the CFPB should seek additional clarification before assigning the request to a specific category.
(3) If the CFPB assigns to a requester a fee category, then the requester shall have the right to submit an appeal of the CFPB's determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester of an adverse fee category determination. The requester shall label its appeal request “Appeal of Fee Category Determination.”
(c)
(1) Commercial users shall be charged the full direct costs of searching for, reviewing, and duplicating the records they request. Moreover, when a request is received for disclosure that is primarily in the commercial interest of the requester, the CFPB is not required to consider a request for a waiver or reduction of fees based upon the assertion that disclosure would be in the public interest. The CFPB may recover the cost of searching for and reviewing records even if there is ultimately no disclosure of records or no records are located.
(2) Educational and non-commercial scientific institution requesters shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide the first one hundred (100) pages of duplication free of charge. To be eligible, requesters must show that the request is made under the auspices of a qualifying institution and that the records are not sought for a commercial use, but are sought in furtherance of scholarly (if the request is from an educational institution) or scientific (if the request is from a non-commercial scientific institution) research. These categories do not include requesters who want records for use in meeting individual academic research or study requirements.
(3) Representatives of the news media shall be charged only for the cost of duplicating the records they request, except that the CFPB shall provide them with the first one hundred (100) pages of duplication free of charge.
(4) Other requesters who do not fit any of the categories described above shall be charged the full direct cost of searching for and duplicating records that are responsive to the request, except that the CFPB shall provide the first one hundred (100) pages of duplication and the first two hours of search time free of charge. The CFPB may recover the cost of searching for records even if there is ultimately no disclosure of records, or no records are located. Requests from persons for
(d)
(1) The cost of collecting a fee would be equal to or greater than the fee itself;
(2) The fee is less than $250, excluding duplication costs;
(3) The fees were waived or reduced in accordance with paragraph (e) of this section;
(4) If the CFPB fails to comply with any time limit under § 1070.15 or § 1070.21, then the CFPB shall not assess search fees, or if the requester is a representative of the news media or an educational or noncommercial scientific institution, then the CFPB shall not assess duplication fees, unless the CFPB has:
(i) Determined that unusual circumstances apply to the processing of the request;
(ii) Provided timely written notice to the requester of the unusual circumstances in accordance with § 1070.16(d);
(iii) Determined that more than 5,000 pages are necessary to respond to the request; and
(iv) Discussed with the requester via mail, email, or telephone (or made not less than three good-faith attempts to do so) how the requester could effectively limit the scope of the request.
(5) If the CFPB determines, as a matter of administrative discretion, that waiving or reducing the fees would serve the interest of the United States Government.
(e)
(i) Requests such waiver or reduction of fees in writing as part of the FOIA request;
(ii) Labels the request for waiver or reduction of fees “Fee Waiver or Reduction Requested” on the FOIA request; and
(iii) Demonstrates that the fee reduction or waiver request that a waiver or reduction of the fees is in the public interest because:
(A) Furnishing the information is likely to contribute significantly to public understanding of the operations or activities of the government; and
(B) Furnishing the information is not primarily in the commercial interest of the requester.
(2) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(A), the CFPB shall consider the following factors:
(i) The subject of the requested records must concern identifiable operations or activities of the Federal government, with a connection that is direct and clear, and not remote or attenuated.
(ii) The disclosable portions of the requested records must be meaningfully informative about government operations or activities in order to be “likely to contribute” to an increased public understanding of those operations or activities. The disclosure of information that already is in the public domain, in either a duplicative or a substantially similar form, is not as likely to contribute to the public's understanding.
(iii) The disclosure must contribute to the understanding of a reasonably broad audience of persons interested in the subject, as opposed to the individual understanding of the requester. A requester's expertise in the subject area and ability and intention to effectively convey information to the public shall be considered. It shall be presumed that a representative of the news media will satisfy this consideration.
(iv) The public's understanding of the subject in question, as compared to the level of public understanding existing prior to the disclosure, must be enhanced by the disclosure to a significant extent.
(3) To determine whether the requester has satisfied the requirements of paragraph (e)(1)(iii)(B), the CFPB shall consider the following factors:
(i) The CFPB shall consider any commercial interest of the requester (with reference to the definition of “commercial user” in (b)(1)(i) of this section), or of any person on whose behalf the requester may be acting, that would be furthered by the requested disclosure. Requesters shall be given an opportunity in the administrative process to provide explanatory information regarding this consideration.
(ii) A fee waiver or reduction is justified where the public interest standard is satisfied and that public interest is greater in magnitude than that of any identified commercial interest in disclosure. The CFPB ordinarily shall presume that where a news media requester has satisfied the public interest standard, the public interest will be the interest primarily served by disclosure to that requester. Disclosure to data brokers or others who merely compile and market government information for direct economic return shall not be presumed to primarily serve the public interest.
(4) Where only some of the records to be released satisfy the requirements for a waiver of fees, a waiver shall be granted for those records.
(5) If the CFPB denies a request to reduce or waive fees, then the CFPB shall advise the requester, in the denial notification letter, that the requester may incur fees if the CFPB proceeds to process the request. The notification letter shall also advise the requester that the CFPB will not proceed to process the request further unless the requester, in writing, directs the CFPB to do so and either agrees to pay any fees that may apply to processing the request or specifies an upper limit that the requester is willing to pay to process the request. If the CFPB does not receive this written direction and agreement/specification within thirty (30) calendar days of the date of the denial notification letter, then the CFPB shall deem the request to be withdrawn.
(6) If the CFPB denies a request to reduce or waive fees, then the requester shall have the right to submit an appeal of the denial determination in accordance with § 1070.21. The CFPB shall communicate this appeal right as part of its written notification to the requester denying the fee reduction or waiver request. The requester should label its appeal request “Appeal for Fee Reduction/Waiver.”
(f)
(i) The fees exceed the limit set by the requester;
(ii) The requester did not specify a limit; or
(iii) The CFPB has denied a request for a reduction or waiver of fees.
The requester must provide an agreement to pay the estimated fees; however, the requester shall also be given an opportunity to reformulate the request in an attempt to reduce fees.
(2) If the fees are estimated to exceed $1000, the requester must pre-pay such amount prior to the processing of the request, or provide satisfactory assurance of full payment if the requester has a history of prompt payment of FOIA fees. The requester shall also be given an opportunity to reformulate the request in such a way as to lower the applicable fees.
(3) The CFPB reserves the right to request prepayment after a request is processed and before documents are released.
(4) If a requester has previously failed to pay a fee within thirty (30) calendar days of the date of the billing, the requester shall be required to pay the full amount owed plus any applicable interest and to make an advance payment of the full amount of the estimated fee before the CFPB begins to process a new request or the pending request.
(5) When the CFPB acts under paragraphs (f)(1) through (4) of this section, the statutory time limits of twenty (20) days (excluding Saturdays, Sundays, and legal public holidays) from receipt of initial requests or appeals, plus extensions of these time limits, shall begin only after fees have been paid, a written agreement to pay fees has been provided, or a request has been reformulated.
(g)
(h)
(i)
(a)
(1) Have CFPB-wide responsibility for efficient and appropriate compliance with the FOIA;
(2) Monitor implementation of the FOIA throughout the CFPB and keep the Director, the General Counsel, and the Attorney General appropriately informed of the CFPB's performance in implementing the FOIA;
(3) Recommend to the Director such adjustments to agency practices, policies, personnel and funding as may be necessary to improve the Chief FOIA Officer's implementation of the FOIA;
(4) Review and report to the Attorney General, through the Director, at such times and in such formats as the Attorney General may direct, on the CFPB's performance in implementing the FOIA;
(5) Facilitate public understanding of the purposes of the statutory exemptions of the FOIA by including concise descriptions of the exemptions in both the CFPB's handbook and the CFPB's annual report on the FOIA, and by providing an overview, where appropriate, of certain general categories of CFPB records to which those exemptions apply;
(6) Designate one or more FOIA Public Liaisons;
(7) Offer Training to Bureau staff regarding their responsibilities under the FOIA;
(8) Serve as the primary Bureau liaison with the Office of Government Information Services and the Office of Information Policy; and
(9) Maintain and update, as necessary and in accordance with the requirements of this subpart, the CFPB's FOIA Web site, including its e-FOIA Library.
(b)
(a) This subpart sets forth the procedures to be followed with respect to subpoenas, court orders, or other requests or demands for any CFPB information, whether contained in the files of the CFPB or acquired by a CFPB employee as part of the performance of that employee's duties or by virtue of employee's official status.
(b) This subpart does not apply to requests for official information made pursuant to subparts B, D, and E of this part.
(c) This subpart does not apply to requests for information made in the course of adjudicating claims against the CFPB by CFPB employees (present or former) or applicants for CFPB employment for which jurisdiction resides with the U.S. Equal Employment Opportunity Commission, the U.S. Merit Systems Protection Board, the Office of Special Counsel, the Federal Labor Relations Authority, or their successor agencies, or a labor arbitrator operating under a collective bargaining agreement between the CFPB and a labor organization representing CFPB employees.
(d) This subpart is intended only to inform the public about CFPB procedures concerning the service of process and responses to subpoenas, summons, or other demands or requests for official information or action and is not intended to and does not create, and may not be relied upon to create any right or benefit, substantive or procedural, enforceable at law by a party against the CFPB or the United States.
(e) For purposes of this subpart:
(1)
(2)
(3)
(4)
(5)
(a) Except in cases in which the CFPB is represented by legal counsel who have entered an appearance or otherwise given notice of their representation, only the General Counsel is authorized to receive and accept subpoenas or other demands or requests directed to the CFPB or its employees, whether civil or criminal in nature, for:
(1) Records of the CFPB;
(2) Official information including, but not limited to, testimony, affidavits, declarations, admissions, responses to interrogatories, or informal statements, relating to material contained in the files of the CFPB or which any CFPB employee acquired in the course and scope of the performance of his or her official duties;
(3) Garnishment or attachment of compensation of current or former employees; or
(4) The performance or non-performance of any official CFPB duty.
(b) Documents described in paragraph (a) of this section should be served upon the General Counsel, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552. Service must be effected as provided in applicable rules and regulations governing service in Federal judicial and administrative proceedings. Acceptance of such documents by the General Counsel does not constitute a waiver of any defense that might otherwise exist with respect to service under the Federal Rules of Civil or Criminal Procedure or other applicable laws or regulations.
(c) In the event that any demand or request described in paragraph (a) of this section is sought to be delivered to a CFPB employee other than in the manner prescribed in paragraph (b) of this section, such employee shall decline service and direct the server of process to these regulations. If the demand or request is nonetheless delivered to the employee, the employee shall immediately notify, and deliver a copy of that document to, the General Counsel.
(d) The CFPB is not an agent for service for, or otherwise authorized to accept on behalf of its employees, any subpoenas, orders, or other demands or requests, which are not related to the employees' official duties.
(e) Copies of any subpoenas, orders, or other demands or requests that are directed to former employees of the CFPB in connection with the performance of official CFPB duties shall also be served upon the General Counsel. The CFPB shall not, however, serve as an agent for service for the former employee, nor is the CFPB otherwise authorized to accept service on behalf of its former employees. If the demand involves their official duties as CFPB employees, former employees who receive subpoenas, orders, or similar compulsory process should also notify, and deliver a copy of the document to, the General Counsel.
(a) Unless authorized by the General Counsel, no employee or former employee of the CFPB shall, in response to a demand or a request provide oral or written testimony by deposition, declaration, affidavit, or otherwise concerning any official information.
(b) Unless authorized by the General Counsel, no employee or former employee shall, in response to a demand or request, produce any document or any material acquired as part of the performance of that employee's duties or by virtue of that employee's official status.
(a) If, as part of a proceeding in which the United States or the CFPB is not a party, official information is sought through a demand for testimony, CFPB records, or other material, the party seeking such information must (except as otherwise required by Federal law or authorized by the General Counsel) set forth in writing:
(1) The title and forum of the proceeding, if applicable;
(2) A detailed description of the nature and relevance of the official information sought;
(3) A showing that other evidence reasonably suited to the requester's needs is not available from any other source; and
(4) If testimony is requested, the intended use of the testimony, a general summary of the desired testimony, and a showing that no document could be provided and used in lieu of testimony.
(b) To the extent he or she deems necessary or appropriate, the General Counsel may also require from the party seeking such information a plan of all reasonably foreseeable demands, including but not limited to the names of all employees and former employees from whom testimony or discovery will be sought, areas of inquiry, expected duration of proceedings requiring oral testimony, identification of potentially relevant documents, or any other information deemed necessary to make a determination. The purpose of this requirement is to assist the General Counsel in making an informed decision regarding whether testimony, the production of documents, or the provision of other information should be authorized.
(c) The General Counsel may consult or negotiate with an attorney for a party, or the party if not represented by an attorney, to refine or limit a request or demand so that compliance is less burdensome.
(d) The General Counsel will notify the CFPB employee and such other persons as circumstances may warrant of his or her decision regarding compliance with the request or demand.
(a) If a response to a demand described in § 1070.34 is required before the General Counsel renders a decision, the CFPB will request that the appropriate CFPB attorney or an attorney of the Department of Justice, as appropriate, take steps to stay, postpone, or obtain relief from the demand pending decision. If necessary, the attorney will:
(1) Appear with the employee upon whom the demand has been made;
(2) Furnish the court or other authority with a copy of the regulations contained in this subpart;
(3) Inform the court or other authority that the demand has been, or is being, as the case may be, referred for the prompt consideration of the appropriate CFPB official; and
(4) Request the court or authority to stay the demand pending receipt of the requested instructions.
(b) In the event that an immediate demand for production or disclosure is made in circumstances which would preclude the proper designation or appearance of an attorney of the CFPB or the Department of Justice on the employee's behalf, the employee, if necessary, shall request from the demanding court or authority a reasonable stay of proceedings for the purpose of obtaining instructions from the General Counsel.
If a stay of, or other relief from, the effect of a demand made pursuant to §§ 1070.33 and 1070.34 is declined or not obtained, or if the court or other judicial or quasi-judicial authority declines to stay the effect of the demand made pursuant to §§ 1070.33 and 1070.34, or if the court or other authority rules that the demand must be complied with irrespective of the General Counsel's instructions not to produce the material or disclose the information sought, the employee upon whom the demand has been made shall decline to comply with the demand citing this subpart and
(a) In deciding whether to comply with a demand or request, CFPB officials and attorneys shall consider, among other pertinent considerations:
(1) Whether such compliance would be unduly burdensome or otherwise inappropriate under the applicable rules of discovery or the rules of procedure governing the case or matter in which the demand arose;
(2) Whether the number of similar requests would have a cumulative effect on the expenditure of CFPB resources;
(3) Whether compliance is appropriate under the relevant substantive law concerning privilege or disclosure of information;
(4) The public interest;
(5) The need to conserve the time of CFPB employees for the conduct of official business;
(6) The need to avoid spending time and money of the United States for private purposes;
(7) The need to maintain impartiality between private litigants in cases where a substantial government interest is not implicated;
(8) Whether compliance would have an adverse effect on performance by the CFPB of its mission and duties;
(9) The need to avoid involving the CFPB in controversial issues not related to its mission;
(10) Whether compliance would interfere with supervisory examinations, compromise the CFPB's supervisory functions or programs, or undermine public confidence in supervised financial institutions; and
(11) Whether compliance would interfere with the CFPB's ability to monitor for risks to consumers in the offering or provision of consumer financial products and services.
(b) Among those demands and requests in response to which compliance will not ordinarily be authorized are those with respect to which any of the following factors, inter alia, exist:
(1) Compliance would violate a statute or applicable rule of procedure;
(2) Compliance would violate a specific regulation or Executive order;
(3) Compliance would reveal information properly classified in the interest of national security;
(4) Compliance would reveal confidential or privileged commercial or financial information or trade secrets without the owner's consent;
(5) Compliance would compromise the integrity of the deliberative processes of the CFPB;
(6) Compliance would not be appropriate or necessary under the relevant substantive law governing privilege;
(7) Compliance would reveal confidential information; or
(8) Compliance would interfere with ongoing investigations or enforcement proceedings, compromise constitutional rights, or reveal the identity of a confidential informant.
(c) The CFPB may condition disclosure of official information pursuant to a request or demand on the entry of an appropriate protective order.
(a) Except as provided in this section, and subject to 5 CFR 2635.805, CFPB employees or former employees shall not provide opinion or expert testimony based upon information which they acquired in the scope and performance of their official CFPB duties, except on behalf of the CFPB or the United States or a party represented by the CFPB, or the Department of Justice, as appropriate.
(b) Any expert or opinion testimony by a former employee of the CFPB shall be excepted from paragraph (a) of this section where the testimony involves only general expertise gained while employed at the CFPB.
(c) Upon a showing by the requestor of exceptional need or unique circumstances and that the anticipated testimony will not be adverse to the interests of the United States, the General Counsel may, consistent with 5 CFR 2635.805, exercise his or her discretion to grant special, written authorization for CFPB employees, or former employees, to appear and testify as expert witnesses at no expense to the United States.
(d) If, despite the final determination of the General Counsel, a court of competent jurisdiction or other appropriate authority orders the appearance and expert or opinion testimony of a current or former CFPB employee, that person shall immediately inform the General Counsel of such order. If the General Counsel determines that no further legal review of or challenge to the court's order will be made, the CFPB employee, or former employee, shall comply with the order. If so directed by the General Counsel, however, the employee, or former employee, shall decline to testify.
This subpart does not apply to requests for official information made pursuant to subparts B, C, or E of this part.
(a)
(1) Any person who is not an employee, contractor, or consultant of the CFPB; or
(2) Any CFPB employee, contractor, or consultant when the disclosure of such confidential information to that employee, contractor, or consultant is not relevant to the performance of the employee's, contractor's, or consultant's assigned duties.
(b)
(c)
(d)
(e)
(a)
(b)
(1) Any person lawfully in possession of confidential supervisory information or confidential investigative information provided directly to it by the CFPB pursuant to this section may disclose such information, or portions thereof, to its affiliates and to the following individuals to the extent that the disclosure of such confidential supervisory information or confidential investigative information is relevant to the performance of such individuals' assigned duties:
(i) Its directors, officers, trustees, members, general partners, or employees; and
(ii) The directors, officers, trustees, members, general partners, or employees of its affiliates.
(2) Any person lawfully in possession of confidential supervisory information or confidential investigative information provided directly to it by the CFPB pursuant to this section may disclose such information, or portions thereof, to:
(i) Its certified public accountant, legal counsel, contractor, consultant, or service provider;
(ii) Its insurance provider pursuant to a claim made under an existing policy, provided that the Bureau has not precluded indemnification or reimbursement for the claim; information disclosed pursuant to this subparagraph may be used by the insurance provider solely for purposes of administering such a claim; or
(iii) Another person, with the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending.
(3) Where a person discloses confidential supervisory information or confidential investigative information pursuant to paragraph (b) of this section:
(i) The recipient of such confidential supervisory information or confidential investigative information shall not, without the prior written approval of the Associate Director for Supervision, Enforcement, and Fair Lending, utilize, make, or retain copies of, or disclose confidential supervisory information or confidential investigative information for any purpose, except as is necessary to provide advice or services to the person or its affiliate; and
(ii) The person disclosing the confidential supervisory information or confidential investigative information shall take reasonable steps to ensure that the recipient complies with paragraph (b)(3)(i) of this section.
(a)
(1) Disclose a draft of a report of examination of a supervised financial institution prior to its finalization, in accordance with 12 U.S.C. 5515(e)(1)(C), and disclose a final report of examination, including any and all revisions made to such a report, to a Federal or State agency with jurisdiction over that supervised financial institution, provided that the CFPB receives from the agency reasonable assurances as to the confidentiality of the information disclosed; and
(2) Disclose confidential consumer complaint information to a Federal or State agency to facilitate preparation of reports to Congress required by 12 U.S.C. 5493(b)(3)(C) and to facilitate the CFPB's supervision and enforcement activities and its monitoring of the market for consumer financial products and services, provided that the agency shall first give written assurance to the CFPB that it will maintain such information in confidence, including in a manner that conforms to the standards that apply to Federal agencies for the protection of the confidentiality of personally identifiable information and for data security and integrity.
(b)
(2) To obtain access to confidential information pursuant to paragraph (b)(1) of this section, an authorized officer or employee of the agency shall submit a written request to the CFPB's Associate Director for Supervision, Enforcement, and Fair Lending at
(i) A description of the particular information, kinds of information, and where possible, the particular documents to which access is sought;
(ii) A statement of the purpose for which the information will be used;
(iii) A statement certifying and identifying the Agency's statutory or regulatory authority that is relevant to the requested information, as required by paragraph (b)(1) of this section;
(iv) A statement certifying and identifying the agency's legal authority for protecting the requested information from public disclosure; and
(v) A certification that the agency will maintain the requested confidential information in confidence, including in a manner that conforms to the standards that apply to Federal agencies for the protection of the confidentiality of personally identifiable information and for data security and integrity, as well as any additional conditions or limitations that the CFPB may impose.
(c)
The CFPB may, to the extent permitted by law, disclose confidential consumer complaint information as it deems necessary to investigate, resolve, or otherwise respond to consumer complaints or inquiries concerning consumer financial products and services or a violation of Federal consumer financial law.
(a) The CFPB may disclose confidential information, in accordance with applicable law, as follows:
(1) To a CFPB employee, as that term is defined in § 1070.2 and in accordance with § 1070.41;
(2) To either House of the Congress or to an appropriate committee or subcommittee of the Congress, as set forth in 12 U.S.C. 5562(d)(2), provided that, upon the receipt by the CFPB of a request from the Congress for confidential information that a financial institution submitted to the CFPB along with a claim that such information consists of a trade secret or privileged or confidential commercial or financial information, or confidential supervisory information, the CFPB may notify the financial institution in writing of its receipt of the request and provide the institution with a copy of the request;
(3) In investigational hearings and witness interviews, or otherwise in the investigation and administration of enforcement actions, as is reasonably necessary, at the discretion of the CFPB;
(4) In or related to an administrative or court proceeding to which the CFPB is a party. In the case of confidential investigative information that contains any trade secret or privileged or confidential commercial or financial information, as claimed by designation by the submitter of such material, or confidential supervisory information, the submitter, or the CFPB, in its discretion, may seek an appropriate order prior to disclosure of such material in a proceeding;
(5) In CFPB personnel matters, as necessary and subject to appropriate protections;
(6) To Agencies in summary form to the extent necessary to confer with such Agencies about matters relevant to the exercise of the Agencies' statutory or regulatory authority; or
(7) As required under any other applicable law.
(a) To the extent permitted by law and as authorized by the Director in writing, the CFPB may disclose confidential information other than as set forth in this subpart.
(b) Prior to disclosing confidential information pursuant to paragraph (a) of this section, the CFPB may, as it deems appropriate under the circumstances, provide written notice to the person to whom the confidential information pertains that the CFPB intends to disclose its confidential information in accordance with this section.
(c) The authority of the Director to disclose confidential information pursuant to paragraph (a) of this section shall not be delegated. However, a person authorized to perform the functions of the Director in accordance with law may exercise the authority of the Director as set forth in this section.
(a)
(2) Except as set forth in this subpart, no supervised financial institution, Agency, any officer, director, employee or agent thereof, or any other person to whom the confidential information is made available under this subpart, may further disclose such confidential information without the prior written permission of the Associate Director for Supervision, Enforcement, and Fair Lending.
(3) No person obtaining access to confidential information pursuant to this subpart may make a personal copy of any such information, and no person may remove confidential information from the premises of the institution or agency in possession of such information except as permitted under this subpart or by the CFPB.
(b)
(i) Inform the General Counsel of such request or demand in writing and provide the General Counsel with a copy of such request or demand as soon as practicable after receiving it;
(ii) To the extent permitted by applicable law, advise the requester that:
(A) The confidential information sought may not be disclosed insofar as it is the property of the CFPB; and
(B) Any request for the disclosure of such confidential information is properly directed to the CFPB pursuant to its regulations set forth in this part.
(iii) Consult with the General Counsel before complying with the request or demand, and to the extent applicable:
(A) Give the CFPB a reasonable opportunity to respond to the demand or request;
(B) Assert all reasonable and appropriate legal exemptions or privileges that the CFPB may request be asserted on its behalf; and
(C) Consent to a motion by the CFPB to intervene in any action for the purpose of asserting and preserving any claims of confidentiality with respect to any confidential information.
(2) Nothing in this section shall prevent a supervised financial institution, agency, any officer, director, employee or agent thereof, or any other person to whom the information is made available under this subpart from complying with a legally valid and enforceable order of a court of competent jurisdiction compelling production of the CFPB's confidential information, or, if compliance is deemed compulsory, with a request or demand from either House of the Congress or a duly authorized committee of the Congress. To the extent that compulsory disclosure of confidential information occurs as set forth in this paragraph, the producing party shall use its best efforts to ensure that the requestor secures an appropriate protective order or, if the requestor is a legislative body, use its best efforts to obtain the commitment or agreement of the legislative body that it will maintain the confidentiality of the confidential information.
(c)
(d)
(e)
(f)
(2)
(g)
(a) Nothing in this subpart shall limit the discretion of the Office of the Inspector General of the Board of Governors of the Federal Reserve System and the Consumer Financial Protection Bureau to disclose confidential information as needed in accordance with the Inspector General Act of 1978, 5 U.S.C. App. 3.
(a) This subpart implements the provisions of the Privacy Act of 1974, 5 U.S.C. 552a (the Privacy Act). The regulations apply to all records maintained by the CFPB and which are retrieved by an individual's name or personal identifier. The regulations set forth the procedures for requests for access to, or amendment of, records concerning individuals that are contained in systems of records maintained by the CFPB. These regulations should be read in conjunction with the Privacy Act, which provides additional information about this topic.
(b) For purposes of this subpart, the following definitions apply:
(1) The term
(2) The term
(3)
(4)
(5)
(6)
(7)
(8)
The Chief Privacy Officer is authorized to:
(a) Develop, implement, and maintain an organization-wide privacy program;
(b) Respond to requests for access to, accounting of, or amendment of records contained in a system of records maintained by the CFPB;
(c) Approve the publication of new systems of records and amend existing systems of record; and
(d) File any necessary reports related to the Privacy Act.
(a)
(b)
(1) Total charges associated with a request are less than $5, or
(2) The requester is a CFPB employee or former employee, or an applicant for employment with the CFPB, and the request pertains to that employee, former employee, or applicant.
(a)
(1) If submitted by mail or delivery service, the request shall be labeled “Privacy Act Request” and shall be addressed to the Chief Privacy Officer, Consumer Financial Protection Bureau, 1700 G Street NW., Washington, DC 20552.
(2) If submitted by electronic means, the request shall be labeled “Privacy Act Request” and the request shall be submitted as set forth at the CFPB's Web site,
(b)
(1) A statement that the request is made pursuant to the Privacy Act;
(2) The name of the system of records that the requester believes contains the record requested, or a description of the nature of the record sought in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;
(3) Whenever possible, a description of the nature of the record sought, the date of the record or the period in which the requester believes that the record was created, and any other information that might assist the CFPB in identifying the record sought (
(4) Information necessary to verify the requester's identity pursuant to paragraph (c) of this section;
(5) The mailing or email address where the CFPB's response or further correspondence should be sent.
(c)
(1) In general, the following will be considered adequate proof of a requester's identity:
(i) A photocopy of two forms of identification, including one form of identification that bears the requester's photograph, and one form of identification that bears the requester's signature;
(ii) A photocopy of a single form of identification that bears both the requester's photograph and signature; or
(iii) A statement swearing or affirming the requester's identity and to the fact that the requester understands the
(2) Notwithstanding paragraph (c)(1) of this section, a designated official may require additional proof of the requester's identity before action will be taken on any request, if such official determines that it is necessary to protect against unauthorized disclosure of information in a particular case. In addition, if a requester seeks records pertaining to an individual in the requester's capacity as that individual's guardian, the requester shall be required to provide adequate proof of the requester's legal relationship before action will be taken on any request.
(d)
(a)
(b)
(2) The requester may bring with him or her anyone whom the requester chooses to see the requested material. All visitors to the CFPB's buildings must comply with the applicable security procedures.
(c)
If an individual requests medical or psychological records pursuant to § 1070.53, the CFPB will disclose them directly to the requester unless the CFPB determines that such disclosure could have an adverse effect on the requester. If the CFPB makes that determination, the CFPB shall provide the information to a licensed physician or other appropriate representative that the requester designates, who shall disclose those records to the requester in a manner he or she deems appropriate.
(a)
(2) A request for amendment of a record must:
(i) Identify the name of the system of records that the requester believes contains the record for which the amendment is requested, or a description of the nature of the record in detail sufficient to enable CFPB personnel to locate the system of records containing the record with a reasonable amount of effort;
(ii) Specify the portion of that record requested to be amended; and
(iii) Describe the nature and reasons for each requested amendment.
(3) When making a request for amendment of a record, the CFPB will require a requester to verify his or her identity under the procedures set forth in § 1070.53(c), unless the requester has already done so in a related request for access or amendment.
(b)
(a)
(b)
(1) Why the request (or portion of the request) was denied;
(2) That the requester has a right to appeal; and
(3) How to file an appeal.
(a)
(b)
(1) Specify the background of the request; and
(2) Provide reasons why the requester believes the denial is in error.
(c)
(1) If the General Counsel grants an appeal regarding a request for amendment, he or she will take the necessary steps to amend the record and, when appropriate and possible, notify prior recipients of the record of its action.
(2) If the General Counsel denies an appeal, he or she will inform the requester of such determination in writing, including the reasons for the denial, and the requester's right to file a statement of disagreement and to have a court review its decision.
(d)
(2) When practicable and appropriate, the CFPB will provide a copy of the statement of disagreement to any prior recipients of the record.
The CFPB will not disclose any record about an individual contained in a system of records to any person or agency without the prior written consent of that individual unless the
(a)
(1) CFPB.002 Depository Institution Supervision Database.
(2) CFPB.003 Non-Depository Institution Supervision Database.
(3) CFPB.004 Enforcement Database.
(4) CFPB.005 Consumer Response System.
(b)
(a)
(b)
(1) The head of each office of the CFPB shall be responsible for assuring that employees subject to such official's supervision are advised of the provisions of the Privacy Act, including the criminal penalties and civil liabilities provided therein, and the regulations in this subpart, and that such employees are made aware of their individual and collective responsibilities to protect the security of personal information, to assure its accuracy, relevance, timeliness and completeness, to avoid unauthorized disclosure either orally or in writing, and to ensure that no system of records is maintained without public notice.
(2) Employees of the CFPB involved in the design, development, operation, or maintenance of any system of records, or in maintaining any record shall:
(i) Collect no information of a personal nature from individuals unless authorized to collect it to achieve a function or carry out a responsibility of the CFPB;
(ii) Collect information, to the extent practicable, directly from the individual to whom it relates;
(iii) Inform each individual asked to supply information, on the form used to collect the information or on a separate form that can be retained by the individual of—
(A) The authority (whether granted by statute, or by executive order of the President) which authorizes the solicitation of the information and whether disclosure of such information is mandatory or voluntary;
(B) The principal purpose or purposes for which the information is intended to be used;
(C) The routine uses which may be made of the information, as published pursuant to 5 U.S.C. 552a(e)(4)(D); and
(D) The effects on the individual, if any, of not providing all or any part of the requested information.
(iv) Not collect, maintain, use or disseminate information concerning an individual's religious or political beliefs or activities or membership in associations or organizations, unless expressly authorized by statute or by the individual about whom the record is maintained or unless pertinent to and within the scope of an authorized law enforcement activity;
(v) Advise their supervisors of the existence or contemplated development of any record system which is capable of retrieving information about individuals by individual identifier;
(vi) Assure that no records maintained in a CFPB system of records are disseminated without the permission of the individual about whom the record pertains, except when authorized by 5 U.S.C. 552a(b);
(vii) Maintain and process information concerning individuals with care in order to ensure that no inadvertent disclosure of the information is made either within or without the CFPB;
(viii) Prior to disseminating any record about an individual to any person other than an agency, unless the dissemination is made pursuant to 5 U.S.C. 552a(b)(2) of this section, make reasonable efforts to assure that such records are accurate, complete, timely, and relevant for agency purposes; and
(ix) Assure that an accounting is kept in the prescribed form, of all dissemination of personal information outside the CFPB, whether made orally or in writing, unless disclosed under 5 U.S.C. 552 or subpart B of this part.
(3) The head of each office of the CFPB shall, at least annually, review the record systems subject to their supervision to ensure compliance with the provisions of the Privacy Act of 1974 and the regulations in this subpart.
The CFPB will preserve all correspondence pertaining to the requests that it receives under this part, as well as copies of all requested records, until disposition or destruction is authorized by title 44 of the United States Code or the National Archives and Records Administration's General Records Schedule 14. Records will not be disposed of or destroyed while they are the subject of a pending request, appeal, proceeding, or lawsuit.
The CFPB will ensure that employees authorized to collect information are aware:
(a) That individuals may not be denied any right, benefit, or privilege as a result of refusing to provide their Social Security numbers, unless the collection is authorized either by a statute or by a regulation issued prior to 1975; and
(b) That individuals requested to provide their Social Security numbers must be informed of:
(1) Whether providing Social Security numbers is mandatory or voluntary;
(2) Any statutory or regulatory authority that authorizes the collection of Social Security numbers; and
(3) The uses that will be made of the numbers.
12 U.S.C. 5512(b)(1), 5514(a)(1)(C), 5514(b)(7).
(a) * * *
(2) * * *
(vii) In connection with a proceeding under this part, including a petition for termination under § 1091.113, all documents, records or other items submitted by a respondent to the Bureau, all documents prepared by, or on behalf of, or for the use of the Bureau, and any communications between the Bureau and a person, shall be deemed confidential supervisory information under 12 CFR 1070.2(j).
(c) In connection with a proceeding under this part, including a petition for termination under § 1091.113, all documents, records or other items submitted by a respondent to the Bureau, all documents prepared by, or on behalf of, or for the use of the Bureau, and any communications between the Bureau and a person, shall be deemed confidential supervisory information under 12 CFR 1070.2(j).
Food and Drug Administration, HHS.
Proposed rule.
The Food and Drug Administration (FDA) is proposing to amend the regulations for good laboratory practice (GLP) for nonclinical laboratory studies to require a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications or submissions for products regulated by FDA. We are proposing additional management responsibilities and standard operating procedures (SOPs) consistent with the proposed requirement for a GLP Quality System. We also propose to revise the testing facility definition to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies. These proposals are intended to build quality into planning, conducting, and reporting a nonclinical laboratory study and to help ensure data quality and integrity.
Submit either electronic or written comments on the proposed rule by November 22, 2016. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by September 23, 2016 see section IX). See section VII for the proposed effective date of a final rule based on this proposed rule.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Submit comments on information collection issues to the Office of Management and Budget (OMB) in the following ways:
Fax to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or email to
Vernon Toelle, Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., MPN4-142, Rockville, MD 20855, 240-402-5637; or Kristin Webster Maloney, Office of Policy and Risk Management, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4373, Silver Spring, MD 20993, 240-402-4993.
Nonclinical laboratory studies, often referred to as preclinical studies when conducted before first-in-human clinical studies, provide safety or toxicity information, or both, that is essential for the development of FDA-regulated products and help determine the safety of new food ingredients. For drugs administered to animals whose products will be consumed by humans, nonclinical laboratory studies are critical for determining safe levels of residual drug product. For tobacco products, nonclinical laboratory studies may provide evidence regarding the relative toxicities of new or modified risk tobacco products. FDA's regulation of the conduct of nonclinical laboratory studies is important to help ensure the quality and integrity of data derived from those studies, the protection of human subjects, and that marketing decisions are based on accurate and reliable data.
Therefore, FDA proposes to amend the GLP regulations to require the use of a complete quality system approach (proposed GLP Quality System) when a nonclinical laboratory study supports or is intended to support an application or submission to FDA. Part 58 (21 CFR part 58) presently includes many aspects of a quality system approach. However, certain fundamentals of a fully implemented GLP Quality System considered essential to a quality system, such as certain SOPs and adequate management roles, responsibilities, and accountability, are not presently required. We therefore propose a fully implemented GLP Quality System as the proper framework for building quality into planning, conducting, and reporting a nonclinical laboratory study to help ensure the quality and integrity of the resulting data used to support FDA regulatory decisions.
We also propose to amend the GLP regulations to reflect current practices for the conduct of nonclinical laboratory studies, particularly multisite studies, while allowing industry flexibility to meet the proposed requirements.
Under the proposed GLP Quality System, FDA intends to enhance the current quality system approach for nonclinical laboratory studies. The GLP Quality System will provide additional responsibilities for testing facility management and new responsibilities for maintaining SOPs. We propose modifications to the definition of a testing facility to be applicable to all nonclinical laboratory studies, whether they are conducted at a single facility or at multiple sites. We propose amending roles and functions consistent with the revised testing facility definition. FDA expects that a GLP Quality System will provide the appropriate framework for building quality into a nonclinical laboratory study and will result in more reliable data for FDA to consider when making regulatory decisions.
FDA proposes to issue this rule under the authority of the provisions in sections 351 and 354-360F of the Public Health Service Act (PHS Act) and the provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act) applicable to the conduct of nonclincial laboratory studies, specifically under section 701(a) of the FD&C Act (21 U.S.C. 371(a), as essential to enforcement of the Agency's responsibilities under sections 402, 406, 408, 409, 501, 502, 503, 505, 510, 512-516, 518-520, 571, 721, 801, 905, 910, and 911 of the FD&C Act (21 U.S.C. 342, 346, 348, 349, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360ccc, 379, 381, 387e, 387j, and 387k).
Costs estimates of the rule include annual costs from the additional reporting and recordkeeping responsibilities required under the proposed GLP Quality System. One-time costs include reading and understanding the rule, updating existing SOPs, writing new SOPs, and training. We estimate annualized costs, over a 10-year period, at a 7-percent discount rate would average $51.9 million, or $51.5 million with a 3-percent discount rate. We lack sufficient information to quantify the benefits of the proposed rule, but we anticipate that it would result in better quality and more reliable data to support applications and submissions to us. The table summarizes these estimates along with their ranges.
FDA is proposing to amend the GLP regulations in part 58 to require the use of a complete quality system approach, referred to as a GLP Quality System, for the conduct of nonclinical laboratory studies when safety or toxicity studies, or both, support or are intended to support applications or submissions to FDA. FDA proposes to define a GLP Quality System as the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management in the conduct of nonclinical laboratory studies.
While many aspects of a quality system approach are presently included in part 58, we expect that implementation of a GLP Quality System will provide an improved framework that is more flexible and will help ensure quality in planning, conducting, and reporting nonclinical laboratory studies. Consistent with the proposed requirement for a GLP Quality System, we propose additional management responsibilities, with accompanying SOPs, to ensure management's responsibility for establishing and maintaining the quality system. We also propose to revise the definition of a testing facility to reflect current practices for the conduct of nonclinical laboratory studies, particularly the conduct of multisite studies. Conforming modifications are proposed for consistency with the proposed GLP Quality System and today's prevalence of multisite studies.
FDA is proposing these changes to help ensure the quality and integrity of data from nonclinical laboratory studies conducted in support of applications and submissions to FDA. We also are modernizing the regulations to further the Agency's efforts to encourage the implementation of the principles of the “3Rs,” to reduce, refine, and replace animal use in testing. This approach seeks to minimize the use of animals in such testing and promote more humane, appropriate, and specific test methods for evaluating product safety. These proposed changes will clarify and update the regulations. In particular, we are proposing changes recognizing the current prevalence of multisite studies while adding flexibility consistent with current practices and the use of ever-changing technology.
On December 21, 2010, FDA published an advanced notice of proposed rulemaking (ANPRM), “Good Laboratory Practice for Nonclinical Laboratory Studies” (December 2010 ANPRM) (75 FR 80011), to solicit stakeholder input regarding FDA's intention to modify the GLP regulations in part 58. As stated in the December 2010 ANPRM, FDA is proposing to require that all facilities conduct nonclinical laboratory studies under a GLP Quality System when those studies support or are intended to support an application or submission to FDA.
The December 2010 ANPRM addressed nine specific areas to consider for amending part 58. Those nine areas are: (1) The GLP Quality System, (2) Multisite Studies, (3) Electronic/Computerized Systems, (4) Sponsor Responsibilities, (5) Animal Welfare, (6) Information on Quality Assurance Inspection Findings, (7) Process-Based Systems Inspections, (8) Test and Control Article Information, and (9) Sample Storage Container Retention.
FDA received about 90 comments to the December 2010 ANPRM. Most of the comments address the nine specific areas; however, a number of the comments include additional areas for FDA's consideration. All comments were reviewed and considered by a working group with representatives from all FDA Centers, along with representatives from the U.S. Environmental Protection Agency (EPA), the Animal and Plant Health Inspection Service of the U.S.
In addition to the December 2010 ANPRM comments, we reviewed and considered the documents of the working group on GLP of the Organisation for Economic Co-operation and Development (OECD), including the general principles of GLP and consensus and advisory documents (Ref. 1). The United States is a signatory to OECD's GLP Mutual Acceptance of Data agreement (Ref. 2) and, as an OECD member country, FDA participated in the development of OECD's GLP documents. For this proposal, we strive for consistency with the relevant OECD documents whenever possible.
The proposed GLP Quality System would help to provide a flexible framework for building quality into planning, conducting, and reporting a nonclinical laboratory study, and would help ensure the integrity of data submitted to FDA to support FDA regulatory decisions. The present regulations do not require certain fundamentals considered essential to a complete quality system. For example, the present regulations do not specifically require SOPs for developing and maintaining SOPs, or SOPs for developing and periodically assessing a quality system, nor do they provide for adequate management roles, responsibilities, and accountability. We note that a major principle of a complete quality system is management's ultimate responsibility for establishing and maintaining the quality system.
This proposal also is intended to update the regulations to reflect today's conduct of nonclinical laboratory studies, particularly the conduct of multisite studies. For multisite studies that may have multiple contracts and subcontracts for various study phases, effective communication is essential, especially considering the proposed requirement for a single final study report. We agree with the numerous comments to the December 2010 ANPRM that support a clear delineation of study responsibilities and effective communication among all parties involved in multisite studies.
Some stakeholders suggest that certain provisions in part 58 are outdated and hamper efficient use of present technology (for example, requiring hard copies of records and documentation instead of allowing computerized options). Several industry organizations approached FDA after the announcement of the Bioresearch Monitoring (BIMO) Modernization Initiative in 2006 (Ref. 3), requesting that we modernize the GLP regulations. One request, among others, was to remove the requirement that the quality assurance unit (QAU) must maintain the master schedule and copies of protocols. These requests were echoed in several comments to the December 2010 ANPRM. FDA agrees with those comments and proposes to update part 58 to help address the use of present technology.
Because the number of FDA inspections is limited by competing priorities and limited resources, we look to sponsors and nonclinical laboratory management to help ensure that data submitted to FDA in support of applications and submissions are reliable. For those nonclinical laboratory studies that are the bases for allowing a new medical product into first-in-human clinical studies, the quality and integrity of the data are crucial to human subject protection.
This proposal complements the intent of the original GLP proposed rule to ensure the quality and integrity of the resulting data (41 FR 51206 at 51210, November 19, 1976) (Ref. 4). FDA expects that requiring a GLP Quality System will help ensure data quality and integrity. The proposed GLP Quality System also will allow the flexibility to develop site-specific procedures for related SOPs. Because of the great diversity in institutions, research activities, and organizational structures covered by these regulations, it is important to have sufficient flexibility in the regulations to allow the regulated parties to meet these requirements in a manner that best suits their organizational needs.
Several comments to the December 2010 ANPRM requested that FDA modify part 58 to accommodate studies conducted in animals to support the effectiveness of human drugs or biological products when human efficacy studies are not ethical or feasible. Those comments refer to the “Animal Rule” (21 CFR parts 314 and 601) (67 FR 37988, May 31, 2002).
The Animal Rule provides a pathway for FDA to grant marketing approval based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drugs or biological products are reasonably likely to produce clinical benefit in humans. Products evaluated for efficacy under the Animal Rule should be evaluated for safety under the existing requirements for establishing the safety of new drugs and biological products. The provisions in part 314, subpart I for drugs and part 601, subpart H for biological products apply only to situations when adequate and well-controlled human efficacy studies cannot ethically be conducted because they would involve deliberate exposure of healthy human volunteers to a potentially lethal or permanently disabling toxic chemical, biological, radiological, or nuclear substance, and field trials to study the product's effectiveness after an accidental or hostile exposure have not been feasible.
In the past, FDA has said that “All studies subject to this rule must be conducted in accordance with preexisting requirements under the good laboratory practices (21 CFR part 58) regulations” (67 FR 37988 at 37989, May 31, 2002). FDA made this statement because part 58 includes requirements for a quality system structure to ensure the quality and integrity of animal study data. These studies are intended to generate data that are essential for the approval or licensure of products intended for human use. Thus, ensuring the quality and integrity of data from these studies is critical as they serve as substantial evidence of effectiveness of the product.
Part 58 was issued to ensure the quality and integrity of nonclinical laboratory studies conducted to assess the safety of FDA-regulated products. In response to comments made to the ANPRM, FDA questions whether any requirement presently in part 58 or in this proposal poses a unique or disproportionate obstacle or burden on the conduct of certain animal studies specific to product development under the Animal Rule.
FDA, however, tentatively concludes there may be justifiable limitations to applying GLP regulations when conducting Animal Rule-specific studies, especially for studies using challenge agents that require high-containment facilities (for example, biosafety level 4 (BSL-4)
Accordingly, although not included in the regulatory text portion of this proposal, FDA is considering expanding part 58 to include the conduct of certain Animal Rule studies that support approval or licensure of products for human use under the established data quality and integrity standards. We seek comment on this proposal. In particular, we invite comment on the possibility of amending the scope of the regulation in § 58.1(a) to encompass not only nonclinical laboratory studies, but also to include certain Animal Rule-specific studies. Correspondingly, we are considering adding a definition in § 58.3 for “Animal Rule-specific studies subject to GLP” (for purposes of this document, “Animal Rule-specific studies subject to GLP” are referred to as “covered Animal Rule studies”).
Specifically, FDA is considering including within the definition of covered Animal Rule studies only the following types of studies to support product approval under the Animal Rule: (1) The adequate and well-controlled animal efficacy studies that serve as substantial evidence of the effectiveness necessary for approval or licensure of human drugs or biological products, respectively; (2) pharmacokinetic and/or pharmacodynamic studies in animals used to select a dose and regimen in humans; and (3) if seeking qualification through FDA's Animal Model Qualification Program,
FDA seeks comment on the impact of expanding part 58 to include these covered Animal Rule studies. We also request comment on what other changes to the regulations, beyond amending the scope and definitions, are needed to address issues unique to covered Animal Rule studies. FDA specifically requests comments in response to the following questions:
1. Would amending part 58 to expand the scope to include covered Animal Rule studies establish an appropriate quality system approach to the conduct of such studies to ensure data quality and integrity? If not, what gaps or shortcomings would remain, and how should they be addressed?
2. Would such an amendment provide sufficient clarity and flexibility to sponsors and investigators? If not, what alternatives or changes to this approach are needed?
3. FDA is considering adding a definition in part 58 for “Animal Rule-specific studies subject to GLP” (referred to as “covered Animal Rule studies”). As discussed in section III.A.1., the proposed definition contains three specific types of studies that would be subject to part 58. Is the term “Animal Rule-specific studies subject to GLP,” as defined in § 58.3, clear and appropriately inclusive?
4. What are the benefits, challenges, and burdens of amending part 58 to include covered Animal Rule studies?
a. Would this proposed expansion of the scope in § 58.1(a) impact entities conducting covered Animal Rule studies?
b. Would the proposed expansion of the scope in § 58.1(a) impact those entities engaged in conducting nonclinical laboratory studies to assess product safety?
c. What could be done to minimize burdens or costs, including costs or burdens on small entities, associated with part 58 compliance for covered Animal Rule studies?
5. Are there any challenges or differences involved in the conduct of covered Animal Rule studies (versus nonclinical laboratory studies) that merit different standards or establishment of a separate regulation? If so, what are those challenges or differences, and what alternative(s) would be preferable?
6. Based on possible differences identified in question 5, are there any particular aspects in the current or proposed part 58 that would be unduly difficult to meet? What changes to current part 58, or the proposed amendments, could be made to address or accommodate these issues? For example:
a. Would it be satisfactory to include a provision to allow on a case-by-case basis a covered Animal Rule study sponsor to seek FDA agreement on deviations from certain part 58 requirements that may not be practicable to meet as follows: “When the study is an Animal Rule-specific study subject to GLP, FDA may agree to deviations from any requirement of this part that it finds unnecessary to ensure the quality and integrity of the study by written agreement with the sponsor before the conduct of the study. In such cases, FDA's acceptance of deviations from the requirements will be contingent upon compliance with any alternative requirements included in that agreement.”
b. Would it be workable or appropriate to entirely exempt covered Animal Rule studies from certain requirements of part 58? If so, what exemption(s) would be necessary or appropriate?
As discussed in section III.A.1., FDA considers GLP regulations to be a well-established and relevant system for ensuring data quality and integrity for covered Animal Rule studies. Therefore, until a final rule is published, FDA recommends the use of the current GLP framework (for example, definitions, procedures, roles and responsibilities, and controls) for covered Animal Rule studies to the extent practicable, and intends to provide more information about FDA's expectations for adapting a GLP framework to these studies.
Before initiating covered Animal Rule studies, sponsors should identify aspects of the studies anticipated to be challenging with regard to GLP and propose methods for adapting the studies to ensure the quality and integrity of the resulting data. Sponsors should submit this information to FDA for concurrence on the data quality and integrity plan before the studies are initiated. A guidance document is available regarding the essential elements necessary to address efficacy under the Animal Rule.
Many comments to the December 2010 ANPRM note that the International Organization for Standardization (ISO) 9001 is very general and not all aspects outlined in ISO 9001 are applicable to GLPs. FDA acknowledges this.
Some comments to the December 2010 ANPRM state that consistency with the ISO 9001 standard would be acceptable if we retained what they perceived as the present flexibility of the regulations. A number of comments state that it would be beneficial to borrow elements of a quality system from the QSR requirements in part 820 rather than reference ISO 9001:1994. Many comments also request that we define the operational areas necessary for broader adoption of a quality system approach.
In this proposal, we incorporate aspects of ISO 9001:1994 that are consistent with part 820 and our desire to propose a complete quality system approach. For example, we propose to address establishing and maintaining a GLP quality system by adding to part 58 certain definitions, relevant SOPs, and management roles and responsibilities modeled after the part 820 requirements. Our proposed additions to more fully enable a GLP quality system will help expand the present flexibility in part 58. Our proposals also are consistent with OECD guidance documents for GLP wherever possible and, at the very least, do not conflict with them.
Many comments to the December 2010 ANPRM note that § 58.90 covers animal care and thus, FDA investigators review documentation of animal care during GLP inspections. This is true. If animal care is not compliant with appropriate standards, there is a high likelihood that such noncompliance could confound the results of affected studies. Since the good laboratory practice regulations were published, the Animal Welfare Act has been amended and the public's perception of animal welfare has changed. Therefore, we propose specific responsibilities regarding animal welfare because the humane treatment of animals in research settings is essential to the quality and integrity of GLP studies.
Many comments to the December 2010 ANPRM state that addressing animal welfare in part 58 would be a duplication of USDA/APHIS or the NIH regulations. That is not our intention. FDA has a Memorandum of Understanding (MOU) (Ref. 5) with USDA/APHIS and NIH/OLAW regarding animal welfare oversight. FDA forwards to the relevant regulatory agency any concerns regarding animal welfare observed during FDA inspections for their followup. Those animal welfare observations are not included on a Form FDA 483 (Inspectional Observations) that may be issued at the close of an FDA inspection, unless the observations also show noncompliance with § 58.90.
While this proposal addresses animal welfare concerns, FDA supports the use of non-animal testing methods when scientifically valid alternatives are available. We encourage sponsors with questions about non-animal testing methods to approach FDA early in the development process for consultation on the suitability and acceptability of non-animal tests for their particular product. This approach reflects FDA's position in its May 20, 2010, citizen petition response to the Mandatory Alternatives Petition Coalition and subsequent Agency statements. That petition requested that FDA require only non-animal test methods instead of corresponding animal test methods whenever such scientifically satisfactory methods are available. (See Docket No. FDA-2007-P-0109.)
As stated in the December 2010 ANPRM, FDA's intent was simply to add new definitions relevant to roles and responsibilities specific to multisite studies. Many comments to the December 2010 ANPRM state that the present regulations are basically adequate and suggested only minimal modifications.
Since publication of the December 2010 ANPRM, we have changed our thinking concerning regulatory changes needed to address multisite studies. For example, we have determined that amending the definition of a testing facility will help address the current conduct of multisite studies. We discuss in section III.B.2. our proposed changes to that definition.
Many comments to the December 2010 ANPRM suggest that we align our requirements regarding multisite studies with the OECD consensus document entitled,
We propose to maintain the current GLP roles for management, study director, and QAU. We propose that the overarching responsibilities of those who fulfill these roles remain as follows: Management is responsible for establishing and maintaining conditions and procedures necessary for the conduct of nonclinical laboratory studies compliant with GLPs; the study director, as the sole point of study control, is responsible for implementing those procedures in specific studies; and the QAU is responsible for inspecting and general oversight of studies, verifying that they are GLP compliant or recommending changes needed for bringing them into compliance.
These responsibilities complement each other and sometimes overlap in multiple areas, providing for a system of checks and balances. We intend for this proposal to maintain the authority necessary for fulfilling each of these roles while allowing maximum flexibility for the conduct of a GLP-compliant nonclinical laboratory study.
We are interested in feedback about whether this proposal will accomplish our goal of maintaining the necessary interrelationships among these roles, and whether our proposal undermines any one of these roles or fails to provide adequate flexibility.
We propose to expand the scope of FDA-regulated nonclinical laboratory studies to specifically include toxicity studies. For purposes of this proposal, toxicity means the acute or long-term adverse effects that could result from use of the FDA-regulated product. While some nonclinical laboratory studies of FDA-regulated products evaluate a product's safety, including toxicity, most are conducted solely to determine a product's toxicity. For example, when combined with the results of clinical trials, determination of toxicity at various doses can inform an appropriate risk-to-benefit analysis when relevant to FDA's consideration of a product's marketing application or submission.
For drugs administered to animals whose products will be consumed by humans, toxicity studies are critical for determining safe levels of residual drug product. Nonclinical laboratory studies of food ingredients and food contact substances provide the basis for
Additional proposed modifications to the scope in § 58.1 expand the language to include FDA jurisdictional oversight of tobacco products as specified in the FD&C Act, sections 905, 910, and 911. We also propose to modify and broaden “medical devices for human use” to “devices” to include FDA's Center for Veterinary Medicine (CVM), which has jurisdiction over devices used in veterinary medicine.
In addition, we propose changing the provision “for research and marketing permits” to “applications or submissions” for FDA-regulated products. This proposed change will include the applications and submissions to FDA listed in the definitions section of this proposal.
As stated in both the preamble to the original proposed regulations (original GLP proposed rule) (41 FR 51206 at 51210) and the preamble to the original GLP final rule (43 FR 59986 at 59988), the GLP “regulations are intended to ensure, as far as possible, the quality and integrity of test data that are submitted to FDA and become the basis for regulatory decisions made by the Agency.” Therefore, the phrase “intended to support” in present and proposed § 58.1(a) means that any nonclinical laboratory study included within the proposed expanded scope of Part 58 that is conducted with the intent that it may support an application or submission to FDA should be conducted in compliance with the GLP regulations.
Also, we propose adding § 58.1(c) to describe what we mean by “where appropriate” when used in the part 58 regulatory text. This proposal addresses studies conducted at a single testing facility as well as at multiple sites. We propose using “where appropriate” in many of the revised or added provisions because not all requirements are applicable to all studies. For example, a test site tasked only with interpreting a study's histopathology would not require all of the SOPs required for a test site responsible for multiple phases.
The current § 58.3
We propose modifying current § 58.3(e) to change the defined term from “Application for research or marketing permit” to “Applications and Submissions to FDA”. We propose this change because nonclinical laboratory studies can support applications and submissions to FDA other than those for research and marketing. Also, in the definition for “Applications and Submissions to FDA” proposed paragraphs (1) through (35), we add certain relevant statutory or regulatory citations for consistency.
We propose including applications and submissions for tobacco products described in the FD&C Act. We note that FDA plans to issue regulations under section 910(g), providing conditions under which tobacco products intended for investigational use may be exempted from the requirements of chapter IX of the FD&C Act. It is our intent that applications for such investigational tobacco products will be included within the scope of § 58.3.
We also propose adding those applications and submissions for FDA-regulated products that include nonclinical laboratory study results but are not currently specifically included. For example, Humanitarian Device Exemption applications are new since publishing in 1987 the last final rule modifying part 58. We also propose expressly adding the medical device Premarket Notification (also known as a “510(k)” submission).
The comments also request that FDA include specifics for multisite studies as to how responsibilities are to be met and by whom. In response to these comments, we intend that a contracted person includes any person (for example, testing facility or individual) that the sponsor contracts with to conduct a phase (defined activity or set of activities) of a nonclinical laboratory study. Also, the term contracted person includes any person that is under a subcontract to conduct a phase of a nonclinical laboratory study.
See, also, section III.B.3. where we discuss § 58.5 (Sponsor responsibilities).
We propose this change because, in a multisite study, the testing facility might not be the person treating the test system with the test article as specified in the current definition. Rather, the person treating the test system with the test article might be a contracted or subcontracted person. Therefore, this general definition of a testing facility is necessary to capture all possible contractual relationships in a multisite study.
The present regulations in § 58.10 cover only a sponsor's responsibilities to notify a consulting laboratory, contractor, or grantee that their service “is part of a nonclinical laboratory study that must be conducted in compliance with the provisions of this part [part 58]”. FDA received many comments to the December 2010 ANPRM noting that there are other sponsor responsibilities implicit throughout the present regulations, and stating that the study sponsor must share in the responsibility for complying with part 58. We agree with those comments.
Therefore, we propose adding § 58.5
For each nonclinical laboratory study, we propose that the sponsor must ensure the study protocol meets the requirements specified in § 58.120 (
For any phase of a nonclinical laboratory study that includes the use of animals, we propose that the sponsor contract with persons accredited as following appropriate animal welfare procedures. If, for any reason, the sponsor does not use an accredited person for a phase that includes the use of animals, we propose that the sponsor must document the reason for using the non-accredited person. (See proposed § 58.5(d).) If the study supports an application or submission to FDA, we propose requiring in the application or submission the reason for using a non-accredited person, along with supporting information to show the qualifications of that person, such as a copy of SOPs showing the application of current animal welfare laws, regulations, policies, and guidelines. This information must be included in the compliance statement. (See proposed § 58.5(d) and (k).) We are proposing these requirements to help ensure animal welfare concerns are adequately addressed, and to help safeguard the reliability of study results.
A sponsor may transfer to another party responsibility for any or all of the obligations set forth in this part. A party that assumes any obligation of a sponsor must comply with the specific regulations in this chapter applicable to this obligation and must be subject to the same regulatory action as a sponsor for failure to comply with any obligation assumed under these regulations. Although a sponsor might transfer certain responsibilities, the sponsor is still ultimately responsible for compliance with all sponsor responsibilities provided in this chapter. When referring to the sponsor throughout this proposal, we also mean any person that assumes, as an independent contractor with the sponsor, one or more of the obligations of a sponsor.
We propose that the sponsor must document that the contracted person conducting a phase of the nonclinical laboratory study is qualified according to the provisions in part 58 applicable for the phase or phases that person is contracted to perform. (See proposed § 58.5(e).) Using qualified contracted persons is essential for ensuring GLP compliance and the quality and integrity of the resulting data.
We propose adding communication requirements to sponsor responsibilities. The OECD consensus document,
We propose that the sponsor must document that test, control, and reference articles are prepared, characterized, and labeled according to part 58, subpart F, and are appropriately shipped. In addition, the sponsor must obtain, and provide to the study director as soon as available, information about test, control, and reference article characterization as specified in § 58.105. (See proposed § 58.5(g).) We propose this requirement in § 58.5(g), because the study director must have characterization information to help ensure appropriate dosing of the test article and to interpret study results in the final study report.
We propose that the sponsor inform the study director of any known potential risks of the test article to human health or to the environment, and any measures necessary to protect study personnel. (See proposed § 58.5(h).) Since the sponsor is most familiar with test article characteristics because of either direct testing or receiving results from a contracted person that characterized the test article, we propose this requirement as a sponsor responsibility. If there are known or suspected risks to human health or the environment, it is essential that the study director, as the single point of study control, is aware of the risks and the measures necessary to protect study personnel and the environment. This is consistent with OECD's advisory document,
We propose that the sponsor must review, approve, sign, and date each protocol amendment before implementation. (See proposed § 58.5(i).) Many comments to the December 2010 ANPRM recommend this requirement and we agree. After initiating the study, the sponsor must be aware of proposed study protocol changes and why the changes are proposed. This requirement is part of our proposed checks and balances in part 58 and will help ensure that the amended protocol complies with GLP.
We propose that the sponsor must document and update, as necessary, the archive location of all raw data and records described in proposed §§ 58.190 and 58.195. When we conduct BIMO GLP inspections as a result of an application or submission to FDA, we rely on the sponsor to provide the location of the study archives. (See proposed § 58.5(j).)
We propose that the sponsor must include, in any application or submission to FDA that contains the results of a nonclinical laboratory study, the final study report of the nonclinical laboratory study and all amendments to the final report described in proposed § 58.185. Also, we propose that the sponsor must include either a statement that the study was conducted in compliance with the requirements in part 58 or, if not conducted in compliance with part 58, a brief statement of the reason for noncompliance. (See proposed § 58.5(k)). We propose this requirement,
We propose significant changes to current § 58.10 to help address the possibility of multiple contractual relationships, including subcontracting, in multisite nonclinical laboratory studies, and to conform as much as possible to the regulations in 21 CFR 312.52, Transfer of obligations to a contract research organization, and 21 CFR 511.1(f), Contract research organizations. Many comments to the December 2010 ANPRM suggest that we specify in part 58 the parties responsible in a multisite study and how any transfer of responsibilities is accomplished. We agree with those suggestions. We also propose the changes because the current regulations address explicitly only testing facilities.
We propose changing the title of § 58.10 from “Applicability to studies performed under grants and contracts” to “Transfer of responsibilities” to reflect the proposed changes to this section. We also propose adding paragraph designations (a), (b), and (c).
In § 58.10(a), we propose to require written documentation of any transfer of responsibilities to a “contracted person”, as that term is proposed in § 58.3, referring to any person a sponsor utilizes to provide a service for the conduct of a nonclinical laboratory study. Contracted persons may, for example, serve as the study director, management with executive responsibility, the QAU, a testing facility, a test site, or an independent contributing scientist. These contracted persons may further contract with other individuals or entities. Specifically, we propose that any responsibility required by the regulations that is transferred must be described in writing, and that any responsibility not covered by the written description is considered not transferred.
We propose to add in § 58.10(b) that any person transferring to a contracted person any regulatory responsibility for a phase of a nonclinical laboratory study must inform that contracted person that the transferred responsibility is required to be performed in compliance with the provisions in part 58. Proposed paragraph (b) therefore includes what is currently in § 58.10.
In § 58.10(c), we propose adding that a contracted person assuming any regulatory responsibility for a phase of a nonclinical laboratory study must comply with the regulations in chapter I (21 CFR chapter I) applicable to the transferred responsibility. That contracted person will be subject to the same regulatory requirements as those regulated persons transferring the responsibility.
We propose these requirements for transfer of responsibilities in a nonclinical laboratory study to help ensure contracted persons perform any transferred responsibilities in compliance with part 58 and to help ensure the quality and integrity of data supporting applications and submissions to FDA. Also, our proposal is consistent with industry's desire for flexible relationships among persons conducting phases of a nonclinical laboratory study.
We propose revising § 58.15 to clarify FDA's inspection authority to include inspecting any person that conducts a phase of a nonclinical laboratory study of an FDA-regulated product. This includes all contracted and subcontracted persons that agree to assume one or more regulatory responsibilities. We propose revising the heading of § 58.15 to be consistent with these proposed changes.
Also, we propose modifying the provision about FDA inspection of QAU records. In the preamble to the original GLP final rule (43 FR 59986 at 59998, December 22, 1978) (Ref. 12) and repeated in FDA's compliance policy guide (CPG 7151.02) (Ref. 13), we state our policy that FDA investigators will not
In § 58.15(b), we propose changing certain terms for consistency within this proposal. For example, we propose changing “the testing facility” to “any person conducting a phase of the nonclinical laboratory study”.
We propose no changes to the intent of current § 58.29(a). However, we propose adding to the end of this provision clarifying sentences, “This must include training and experience with GLP requirements. Personnel who work with animals must have both general and species-specific training and experience.”
Several comments to the December 2010 ANPRM state that training on GLP requirements is essential for all personnel in a nonclinical laboratory study. This proposed training requirement also is consistent with the personnel requirements in the
As we state elsewhere in section III.A.3., we propose specific responsibilities regarding animal welfare because compliance with animal care requirements helps ensure the quality and integrity of study data. Therefore, we propose that all personnel involved with animal treatment and care must have relevant training and experience, including species-specific training when applicable.
In § 58.29(b), we propose adding a requirement that all study personnel must have access to and comply with the study protocol and applicable protocol amendments and SOPs, and any protocol deviation must be reported to the study director. In § 58.29(c), we propose adding a requirement that all study personnel must record raw data promptly and accurately as required by a new regulatory provision in § 58.180 Data quality and integrity. We propose these new provisions to help ensure compliance with GLPs and to update the regulations consistent with current practices and the prevalence of multisite studies. This proposal also is consistent with personnel responsibilities in the
In proposed § 58.29(d) (currently, § 58.29(b)), we replace “Each testing facility” with “Any person conducting a phase of a nonclinical laboratory study”. We propose this and other conforming changes in § 58.29 to address the occurrence of contracting and subcontracting in multisite studies, to update the regulations, and for consistency with our proposals in part 58.
We propose significant changes in § 58.31 consistent with our proposal requiring a GLP Quality System. To clarify who is responsible for the proposed requirements in § 58.31, we propose adding “with executive responsibility” to the current heading of “Testing facility management.” We propose this change to specify that upper management at a testing facility or test site is ultimately responsible for GLP compliance. We also propose summarizing in the introductory paragraph the expanded responsibilities of management consistent with the regulatory text in part 820 (see § 820.20).
The current provisions in § 58.31(c) through (g) require only assurances that certain activities are available, performed, understood, or communicated. For those responsibilities currently in § 58.31, we propose clarifying and expanding them, requiring actions and referencing specific SOPs (where applicable). We also propose adding new responsibilities consistent with a GLP Quality System and the conduct of multisite studies.
We propose a new § 58.31(a) requiring testing facility management with executive responsibility to establish and update written GLP Quality System SOPs. For continuing oversight of the GLP Quality System, in new § 58.31(b), we propose requiring testing facility management with executive responsibility to review at specified and sufficient intervals and document that the GLP Quality System meets the requirements in proposed part 58. We propose that testing facility management with executive responsibility is responsible for overseeing the implementation of the requirements in proposed § 58.31(b), according to established procedures to be included in proposed § 58.81(b)(2) (establishment and periodic review of a GLP Quality System).
In § 58.31(e), we propose that testing facility management with executive responsibility appoint and document the appointment of a management representative who is a member of the testing facility management with authority over and responsibility for documenting that GLP Quality System requirements are effectively established and maintained. We also propose that this appointed member reports to management with executive responsibility about the performance of the GLP Quality System, which includes reports from the QAU. Appointment of this individual is an organizational responsibility of the testing facility management with executive responsibility such as in part 820, Quality System Regulation, the model for the GLP Quality System.
In § 58.31(f), we propose that testing facility management with executive responsibility is responsible for documenting that all persons in a multisite study follow adequate equipment-related SOPs. In § 58.31(h), we propose this same management is responsible for documenting that all study personnel are trained to perform their assigned functions. In § 58.31(k), we propose this same management is responsible for appointing a person to maintain the master schedule along with other requirements concerning the master schedule, such as requiring in a master schedule the core information presently specified under QAU responsibilities in § 58.35(b)(1). This core information is essential on each master schedule to ensure consistent identification across all persons (individuals or entities) in a multisite study. We propose adding § 58.31(m), requiring testing facility management with executive responsibility to review all protocols to ensure that environmental, animal welfare, or work resource issues or issues with scientific methodology do not affect or bias any phase of the study's conduct.
We propose adding § 58.31(r) to require testing facility management with executive responsibility to review the suitability and effectiveness of the QAU or lead QAU, as applicable, at defined intervals and with sufficient frequency, according to established SOPs as required in proposed § 58.81(b)(17). Periodic review of the QAU's capability to fulfill their responsibilities helps to ensure the quality and integrity of study data and is also consistent with a quality system.
We propose adding § 58.31(u), requiring testing facility management with executive responsibility to establish SOPs for archiving records and materials generated during the course of a nonclinical laboratory study, including the designation and replacement of the archivist and any supporting staff. This archiving process is an essential aspect of compliance with GLPs because maintenance of raw data and specimens from a specific study enables reconstruction of that study for verification of the information in the final study report and confirmation of the study's compliance with part 58.
These and other proposals in § 58.31 are consistent with the preamble to the original GLP final rule that states, “A determination of the adequacy of each standard operating procedure is the responsibility of the management” (43 FR 59986 at 60002) (Ref. 12). Also, our proposals are responsive to many comments to the December 2010 ANPRM asking that we define operational areas necessary for broader adoption of a quality system approach to the conduct of nonclinical laboratory studies.
Rather than specifying how essential activities of a GLP Quality System must be conducted, we propose requiring management with executive responsibility at testing facilities and test sites to establish essential SOPs. This flexible approach would allow testing facilities and test sites to establish SOPs best suited to their specific organizational structure.
We propose updating the regulations by adding § 58.32. This new provision would address the current prevalence of multisite studies and require test site management with executive responsibility to comply with relevant requirements in proposed § 58.31 and develop and maintain SOPs described in § 58.81, “where appropriate”, as that term is proposed in § 58.1(c).
We expect that a test site, like a testing facility, has management with executive responsibility and appropriate SOPs. Therefore, while a test site might be conducting a phase of a particular multisite study, for a different study the same test site could function as a testing facility by coordinating, conducting, or completing the entire study.
In § 58.33, we propose modifying and adding study director requirements to update the regulations and to address the prevalence of multisite studies. We propose certain study director requirements for consistency with our other proposals in part 58 (for example, our proposals for a GLP Quality System and for checks and balances to help ensure data quality and integrity).
In § 58.33(a), we propose keeping the current requirement that the study director is the single point of study control. We propose adding that the study director cannot delegate overall responsibility for a nonclinical laboratory study. This proposed addition clarifies and emphasizes that a study director cannot delegate oversight of an entire nonclinical laboratory study, even though a study director may delegate to a principal investigator certain responsibilities.
This proposed change is consistent with FDA's longstanding interpretation
We propose in § 58.33(a)(2) the study director's responsibility for implementing procedures that ensure adequate communication among all study personnel and with the sponsor, as applicable, because communication is essential in a nonclinical laboratory study.
In § 58.33(b), we propose new requirements for the study director for documenting, consulting, signing, and archiving (see proposed §§ 58.33(b)(2) through (7) and (12) through (14)). In § 58.33(b)(13), we propose that the study director must sign and date the final study report. FDA agrees with OECD's discussion in this regard in both the
We propose adding in § 58.33(b)(5) and (6) new study director responsibilities affecting the welfare of test animals. When a protocol and its amendments impact test animal use, we propose the study director must document that a committee whose function is ensuring the appropriate and humane care of animals must first review and approve the protocol and applicable amendments before initiating the study or implementing the amendments. The study director also must document that such a committee has reviewed and approved general procedures for commonly conducted animal tests. Any protocol requiring only those tests, with their approved parameters, would not require additional review before study initiation. However, if a protocol increases the numbers of animals to be used or alters any of the approved testing parameters, specific review and approval of that protocol would be required before study initiation.
We propose in 58.35(b)(6), that the study director must consult with the attending veterinarian during review of proposed study protocols to determine potential animal welfare concerns and appropriate responses to likely contingencies. Early identification of potential animal welfare concerns benefits the test animals because they will receive prompt care, which improves the quality of the data collected.
In 58.33(b)(11), we propose adding that the study director must document that all applicable GLP regulations are followed and include a study compliance statement in the final study report. FDA agrees with the statement in the OECD consensus document,
In § 58.33(b)(14), we propose adding a timeframe for archiving of no later than 2 weeks after the study completion date. We think that timely archiving of raw data, documents, protocols, specimens, and final reports will help prevent their loss or destruction. Stakeholders requesting modernizing part 58 asked specifically for a reasonable time period after the study completion date to complete study archiving. Numerous comments to the December 2010 ANPRM agree, particularly with regard to archiving computerized systems. We propose the 2-week timeframe to allow flexibility for archiving material without jeopardizing study material integrity.
In § 58.35, we propose keeping the QAU functions currently in the regulations. We propose modifying § 58.35(a) by separating it into paragraph (1) QAU function and paragraph (2) QAU location. We propose this change for consistency with our other proposals in part 58 (for example, to address the location of the lead QAU for multisite studies), and in response to comments to the December 2010 ANPRM requesting a clear description of the relationship between the QAU and testing facility management.
We propose in § 58.35(a)(2)(ii) that, for multisite studies, testing facility management with executive responsibility must designate a lead QAU. The concept of a lead QAU is consistent with the discussion in the preamble of the original GLP final rule stating that when portions of a study must be contracted to a site that lacks a QAU “the person letting the contract, and not the contract facility, is responsible for the performance of the quality assurance functions” (43 FR 59986 at 59997) (Ref. 12). This change also is consistent with the OECD consensus document,
We propose several modifications to current § 58.35(b). We propose changing the present QAU requirement to maintain a copy of the master schedule and all protocols to require that the QAU maintain “access” to them. For example, if the QAU is a contracted person, then the QAU might not have overall knowledge about the person (
We recognize that many sites have a central computerized system for maintenance of essential documents. Our proposed change about QAU access to the master schedule responds to stakeholder requests to modernize part 58 and also to comments to the December 2010 ANPRM. This change also is consistent with our proposal in § 58.195(d) that management with executive responsibility must ensure “maintenance” of the master schedule and copies of study protocols.
Because the lead QAU is responsible for ensuring GLP compliance of all phases of a multisite study, we propose that the lead QAU must maintain access to the master schedule of any person that lacks a QAU. We consider the master schedule an important tool for determining whether a person is capable of conducting a GLP compliant study. For example, a person with numerous scheduled studies still in progress may lack sufficient resources to begin the conduct of a GLP compliant study.
Also, as many comments to the December 2010 ANPRM suggest, we propose removing the word “sheet” from the term “master schedule sheet”. We propose removing “sheet” because we do not want to imply that a paper copy is required for electronic systems.
In new § 58.35(b)(3), we propose requiring the QAU to review the study protocol before initiating the study and all protocol amendments before implementing them, along with documenting this review. In new
Our proposed initial review by the QAU of the study protocol and applicable facility SOPs will help ensure compliance with part 58 from the start of the study. Otherwise, when the study is underway, amendments to the study protocol and SOPs might be needed if QAU inspections reveal compliance deficiencies.
We propose in § 58.35(b)(5) expanding the types of QAU inspections recognized by FDA by adding process-based and facility-based inspections.
However, many comments to the December 2010 ANPRM express concern about how process-based inspection results will be appropriately considered for all relevant studies, particularly when an inspection reveals problems. This concern is especially relevant to any phase involving a short-term study, as we propose to define this term. Process-based inspections are conducted on a prearranged schedule, which is not connected to the timing of any particular nonclinical laboratory study. Therefore, a facility utilizing process-based inspections might conduct a short-term study that is not inspected during its in-life period (that is, during the time data are collected). This concern also is addressed in the OECD consensus document,
To ensure that any problem revealed during a process-based inspection is properly captured in the reports of all relevant studies, we propose adding § 58.35(e). This provision requires preparation of a written certification, by the person conducting a phase of the study, whenever a process-based inspection reveals problems. As proposed, this certification requires documenting actions taken to properly inform, and modify (when applicable), reports for all studies impacted by the results of that process or procedure. While a management responsibility, we propose adding this requirement in § 58.35 because of its similarity to the existing requirement in current § 58.35(d) for management to provide an FDA representative, upon request, a certification regarding the implementation of required QAU inspections.
In § 58.35(b)(7) (a redesignation and revision of current § 58.35(b)(4)), we propose expanding the requirement that the QAU must submit to management with executive responsibility and the study director a periodic written status report on each study. We propose that these periodic reports “discuss the overall progress and compliance status of the study and include any problems observed and the corrective actions taken.” In conjunction with this requirement, we propose that the content and frequency of these reports be specified in SOPs as required in proposed § 58.81(b)(21).
We propose this revision in § 58.35(b)(7) because feedback to management with executive responsibility and the study director about the overall progress and compliance status of the study is essential to ensure study compliance. We intend these periodic reports to give a general overview of the study. We expect these periodic reports to complement any inspection reports for the study, which only provide a snapshot in time.
We are interested in receiving feedback about the use and relevance of periodic status reports. Specifically, we are seeking comment about whether QAUs regularly provide such reports and whether they are useful to the study director and management when provided.
Consistent with our proposals addressing multisite studies, we propose adding in new § 58.35(b)(8) (revision of current § 58.35(b)(5)) that the lead QAU must identify all deviations occurring in the entire study, including deviations identified by any other existing QAUs participating in the study. We expect this requirement may be facilitated by principal investigator reports to the study director, documentation by other existing QAUs, and direct oversight by the lead QAU of independent contributing scientists and any persons conducting a phase of the study lacking either a principal investigator or a QAU or both. We propose this requirement to ensure the lead QAU is made aware of protocol deviations in a timely manner. This awareness will help alert the lead QAU to the need to correct or modify relevant SOPs and the study protocol when necessary to maintain data integrity.
The remaining additions we propose in § 58.35 relate to QAU oversight of the integrity of data in the final study report. Current responsibilities in § 58.35(b)(6) (revised and redesignated as § 58.35(b)(10)) are to ensure the quality and integrity of the final study report. Therefore, we propose in § 58.35(b)(9)that the QAU must audit the reports of all contributing scientists and all existing principal investigators.
Currently § 58.35(b)(6) requires the QAU to assure that the “reported results accurately reflect the raw data of the nonclinical laboratory study.” However, QAU members might not have the scientific judgment needed for evaluating the scientific merits of the final report and determining whether the results accurately reflect the data. In the preamble to the original GLP final rule (43 FR 59986 at 59998, comment 90) (Ref. 12), we agreed that “the QAU should not attempt to evaluate the scientific merits of the final report.” Therefore, in § 58.35(b)(9) and (10), we propose clarifying our intent.
Specifically, we propose that the QAU must audit all contributing scientists' reports and any report amendments to ensure they include a report of all data and reflect the protocol, and amendments, and applicable SOPs. This requires that all data generated during the study are included and discussed, which is essential for the full transparency necessary for reconstruction of the study.
For multisite studies, we propose that other QAUs participating in the study must audit the reports and report amendments of any principal investigators and all contributing scientists for whom they are responsible. We also propose in § 58.35(b)(9), for any person that lacks a QAU, that the lead QAU audits the reports and amendments of all contributing scientists and any principal investigators. This includes audits of any independent contributing scientist. This proposed requirement will ensure all data from a nonclinical laboratory study will receive QAU review, thus improving the quality and integrity of the final study report.
In § 58.35(b)(10), we propose that the QAU must verify that all original and amended signed and dated reports from contributing scientists are appended to the final study report. For multisite studies, we propose that the lead QAU is responsible for this requirement. Under existing regulations that require providing the final study report and any
As discussed in section III.B.2., we propose adding a definition for a contributing scientist. In that definition, we include an independent contributing scientist as an individual expert or specialist who is an independently employed contracted person. We propose adding responsibilities for contributing and independent contributing scientists to help facilitate the development of a GLP Quality System. To describe the responsibilities of these positions, we propose adding § 58.37(a) and (b), respectively.
When a contributing scientist is responsible for a phase, we propose in § 58.37(a) that the contributing scientist must comply with part 58; provide a signed and dated report for inclusion in the final study report; and permit oversight by the designated QAU. (See proposed § 58.37(a)(1) through (3)).
In § 58.37(b), we propose requirements for an independent contributing scientist in addition to those requirements in § 58.37(a). The proposed requirements in § 58.37(b) include, among others, that independent contributing scientists must document, maintain, and update information about their education, training, and experience related to their responsibilities for a particular phase. Also, we propose they must archive all materials as required by the protocol and by proposed § 58.195.
Our proposal for adding § 58.37 is consistent with the expectations in the present regulations for individual scientists and professionals. We propose these requirements in part to help clarify the regulations.
We propose adding § 58.39 to include principal investigator requirements related to a principal investigator's responsibilities for a phase of a nonclinical laboratory study. We propose that designating a principal investigator is optional.
The
We also recognize that a testing facility may conduct a multisite study where, at all sites, only the study director oversees the study. Several comments to the December 2010 ANPRM note these various practices. We therefore propose in § 58.39 principal investigator requirements for specific responsibilities in one or more phases as delegated to the principal investigator by the study director.
We propose principal investigator responsibilities consistent with a principal investigator's role of ensuring compliance with part 58 for a specific phase. For example, we propose the principal investigator must document and report to the study director all deviations the principal investigator observes during the conduct of the study. These requirements also are consistent with the responsibilities of a principal investigator in
In § 58.41, we propose changing “Each testing facility shall be” to “Any person conducting a phase of a nonclinical laboratory study must have facilities” of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. We propose this change to include multisite studies.
In § 58.43, we propose changes to include multisite studies and to cover any phase involving the use of animals. We propose these changes consistent with our proposal revising the testing facility definition and our goal of applying the GLP regulations to all nonclinical laboratory studies, including multisite studies.
In § 58.47 we propose adding “reference” to refer to “reference articles” for consistency with our other proposals.
In § 58.61, we propose adding that equipment includes computerized systems. We also propose adding in § 58.61, equipment used for maintenance, archiving, and retrieval of data. We propose these additions to update and clarify the regulations.
In § 58.63, we propose adding to paragraph (a) maintenance, archiving, and retrieval of data. In paragraph (b), we propose changing the citation reference from § 58.81(b)(11) to (14) and adding a reference to the written SOP requirement in § 58.81(b)(15). Also, in paragraph (b), we propose adding “as applicable” to address the possibility of a multisite study. We propose these changes for consistency with our other proposed changes in part 58 and to update the regulations to address multisite studies.
Consistent with our proposals in part 58 to address multisite studies, we propose revising the heading of subpart E from “Testing Facilities Operation” to “Nonclinical Laboratory Study Operations”. Also, accordingly, we propose modifying the sections in subpart E.
We propose modifying § 58.81 Standard operating procedures (SOPs), consistent with our proposals for a GLP Quality System and to address multisite studies. In § 58.81(a), we propose adding to the current requirement that a testing facility must have written SOPs, that all test sites, too, must have written SOPs. Also, in § 58.81(a), we propose changing “management” to “management with executive responsibility”.
In § 58.81(b), consistent with our proposal in § 58.81(a), we propose adding that the testing facility and all test sites must establish SOPs for an applicable phase of a nonclinical laboratory study. As discussed in section III.B.1., we use the terms “applicable phases” and “where appropriate” because in a multisite study no one person will conduct all phases of the study. Therefore, each person requires SOPs only for those phases which that person conducts.
We propose adding to the current list of SOPs in § 58.81(b) numerous topics that require SOPs. For example, we propose adding that SOPs must include an SOP for preparing, modifying, and administering all SOPs. We propose these additional SOP requirements because they are essential components of a complete quality system approach (
Our proposal in § 58.81 will require initial efforts by testing facilities and test sites to modify or add SOPs as needed for a GLP Quality System. However, once established, the GLP Quality System will facilitate greater flexibility and efficiency for the conduct of nonclinical laboratory studies and, over time, will help reduce costs.
In § 58.90, we propose modifying paragraph (b) to require, throughout the study, evaluation of the health status of test animals according to acceptable veterinary medical practices for the care of test animals. We propose this change because proper animal care is essential during the entire study to ensure the welfare of test animals and the integrity of test results. However, test animal evaluations can be performed by the attending veterinarian or appropriately-trained personnel who are delegated this responsibility by the attending veterinarian.
In § 58.90(c), we propose removing from the third sentence the phrase “provided that such treatment does not interfere with the study”, and replacing this phrase with “as deemed necessary by the study's attending veterinarian.” We propose few changes in § 58.90(d) and (e). In the first sentence of current § 58.90(d), we propose replacing “excluding suckling rodents” with “except nursing neonates” to update the regulation to be more inclusive and appropriate. In § 58.90(e), we propose adding the word “reference” to conform to changes proposed elsewhere in this document.
We propose these changes in § 58.90 to update and clarify the regulations, and because test animal welfare concerns are an essential part of a GLP Quality System.
We propose adding the term “Reference” to the heading in subpart F, and in certain applicable provisions in subpart F. We also propose adding in subpart F specifics concerning tobacco products, and a reference to method validation.
We propose modifying § 58.105 to require that all information about test, control, and reference article characterization be provided to the study director as soon as available. This information is necessary for determining appropriate dosing and drafting conclusions in the final study report. The lack of this information limits the important test result discussion in the final study report.
Reports submitted to FDA must provide study information based on the characteristics of the product (test article) studied. We expect a test article to be characterized to the extent required to interpret the study properly. For nonclinical laboratory studies conducted in support of initiating clinical “first-in-human” studies, this characterization information is particularly important for human subject protection.
We propose modification of § 58.105(a) to exclude the use of a marketed tobacco product's labeling to characterize such a product if it is used as a control or reference article in a nonclinical laboratory study. The labeling of currently marketed tobacco products does not provide the information required for full product characterization. That is, the chemical composition (including mainstream smoke composition), microbiological composition, and design parameters of the product are not fully described in tobacco product labels. Thus, the composition and toxicant deliveries of currently marketed tobacco products are less well defined in tobacco product labeling than the safety and efficacy information described in the labels of marketed drug products. Therefore, FDA notes that when using a marketed tobacco product as a control or reference article, the marketed tobacco product's characteristics must be determined and documented as required in this part.
We propose revising and redesignating the current provisions in § 58.105(b), (c), and (d). These proposed changes are necessary for consistency with our other proposals in part 58, such as the addition of reference articles.
The current regulations imply that empty containers from test articles must be retained. Comments to the December 2010 ANPRM did not see the need to retain the empty containers provided appropriate product information is maintained and test article accountability is fully documented. We agree with those comments and propose to remove this implied requirement. To provide for adequate test article accountability, in lieu of retaining empty test article containers, we propose requiring in § 58.105(d) that the study director verify and document by dated signature the distribution and final disposition of the test article.
We propose minimal conforming changes in § 58.107, such as adding “reference” to the section heading and first sentence.
We propose modifying § 58.113 by adding “reference” to the provisions proposed in § 58.113(a), (a)(1), (a)(2), (b)(2), and (d). Also, we propose requiring that the results from the determination of the uniformity, concentration, and stability of mixtures of test articles with carriers are provided to the study director as soon as available. We propose these changes in § 58.113 for the same reasons we propose changes in § 58.105.
We propose modifying § 58.120 to address multisite studies more specifically, and to provide consistency with our other proposed changes discussed elsewhere.
Many comments to the December 2010 ANPRM suggest that the study protocol identify all sites participating in a multisite study. We agree, and propose adding in § 58.120(a)(3) that the protocol contain contact information for all persons conducting a phase of the nonclinical laboratory study.
Current § 58.120(a)(6) includes in the protocol the methods for controlling bias. We propose adding to this provision the analysis and reporting of study test results and procedures to be followed if a study includes a peer review of any phase. Also, for multisite studies, we propose adding a requirement that the protocol identify the person(s) conducting the phases of the nonclinical laboratory study.
We propose expanding current § 58.120(a)(10) to clarify that the protocol must include a listing of the study-specific records that are required to be maintained. We think this clarification will help assure that study-specific records are maintained.
Current § 58.120(a)(11) requires the date of protocol approval by the sponsor, and the dated signature of the study director. We propose expanding this provision to indicate study protocol approval by the dated signature of the study sponsor, the study director, independent contributing scientists, principal investigators, and any other person conducting a phase of the nonclinical laboratory study, as applicable.
We propose redesignating and modifying § 58.120(b) as § 58.120(d). In § 58.120(d), we propose requiring, before implementing any change or revision to an approved protocol, that the study sponsor and the study director document their approval of the change or revision. For a multisite study, any person affected by the proposed changes (for example, the principal investigator or independent contributing scientist) also must document approval. We consider a person's dated signature on the protocol revision to be acceptable documentation indicating approval. We propose that these signed and dated protocol amendments must be maintained with the protocol.
Before initiating any study using animals, we propose requiring in new § 58.120(b) protocol review and approval by “a committee whose function is to ensure that the care and use of animals in studies is appropriate and humane”. In new § 58.120(e), we propose the same review and approval by this committee before implementing any protocol changes that affect animal welfare. These additions are consistent with the proposal in § 58.33(b)(5) that the study director must ensure that all studies that include the use of animals are approved by such a committee.
In new § 58.120(c), we propose requiring that the study sponsor and testing facility management with executive responsibility sign and date a statement that the study will be conducted in compliance with part 58. We propose appending this statement to the protocol. This proposal is consistent with the requirement in § 58.10(b) that a sponsor must inform a contracted person that the study must be conducted in compliance with chapter I. This proposal also is consistent with the requirements discussed elsewhere in this document that the study director documents applicable GLP regulations are followed (section III.C.4.), and that the QAU ensures studies conform to the regulations in part 58 (section III.C.5.).
We propose redesignating current § 58.130(a) through (c), as (d), (f), and (g) respectively. In new proposed § 58.130(a), we require demonstration that all analytical methods are accurate, sufficiently precise, and sensitive enough to result in accurate and reproducible data. We expect this requirement will help ensure data quality and integrity as its intent is to produce accurate and reproducible data. This requirement also is consistent with requirements in part 320 (21 CFR part 320), “Bioavailability and Bioequivalence Requirements” (see § 320.29(a)).
In new § 58.130(b), we propose conducting test, control, and reference article characterization as specified in part 58, subpart F. We propose this requirement to clarify our current and future expectations regarding test, control, and reference article characterization.
In new § 58.130(c), we propose that “humane care and ethical treatment of test animals must be considered in advance and upheld in conjunction with achieving study objectives.” We propose this provision is consistent with our other proposals addressing animal welfare discussed elsewhere in section III.A.3.
In new § 58.130(e), we propose that any change to the protocol must be approved as an amendment. We propose this requirement consistent with the proposed requirement in § 58.120(d) for approval of protocol amendments. However, we understand the importance of test animal welfare along with maintaining the integrity of the study. Therefore, FDA intends to evaluate on a case-by-case basis certain circumstances when a protocol deviation is necessary to prevent a potential hazard to animal welfare or study integrity.
In proposed § 58.130(h) (revised and redesignated current § 58.130(d)), postmortem observations must be available to the pathologist unless specified otherwise in the study protocol. We understand that some study protocols might blind the pathologist to postmortem observations. We expect, however, in most cases the pathologist will not need to be blinded to postmortem observations.
We propose adding a new § 58.180 for data quality and integrity. Ensuring data quality and integrity in a nonclinical laboratory study is one of our critical goals in this part 58 proposal. Therefore, we propose adding this separate § 58.180 to clearly identify requirements for data quality and integrity. We propose this new section in subpart J because data are part of study records and reports.
We propose moving to this new section, and revising, the requirements in current § 58.130(e). In § 58.180(a), we propose creating the acronym “ALCOA”. This is a mnemonic that signifies quality data to stakeholders that conduct clinical and nonclinical studies. We propose therefore that all nonclinical laboratory study data are “accurate, legible, contemporaneous, original, and attributable”.
In § 58.180(b), we propose modifying and updating the provisions currently in § 58.130(e) to address electronic data capture and maintenance. Numerous comments to the December 2010 ANPRM note that part 11 (21 CFR part 11, “Electronic Records; Electronic Signatures”) is applicable to part 58 and therefore parts 11 and 58 should be consistent. We agree, and do not intend to duplicate in part 58 the requirements in part 11. As a result, we propose that electronic records systems need to be compliant with applicable regulations.
In § 58.180(c), we propose adding that the final study report must contain all data accrued during the study. This proposed requirement is consistent with our proposal in § 58.120(b)(6) requiring that the protocol describe methods for controlling bias. We propose this requirement because selective data inclusion in the study analysis could introduce bias into the final study report.
Study data must be maintained in a manner that allows for “reconstruction of the study for the purpose of assessing the quality and integrity of the results or the reinterpretation of the data in the light of later findings” (41 FR 51206 at 51215) (Ref. 4). Study records and reports required in part 58, subpart J, are acceptable in electronic or paper medium, or a combination of both. In § 58.185, we propose eliminating any current requirements that might impede a fully computerized facility.
Many comments to the December 2010 ANPRM suggest we allow testing
We continue to affirm these statements. However, we support processes used for the efficient review of the draft study report to facilitate completion of the final study report.
In § 58.185, we propose adding general statements for consistency with our other part 58 proposals. We propose adding two provisions specific to animal welfare. In § 58.185(a)(2), we propose requiring that final study reports contain the names of all study attending veterinarians. We propose redesignating and modifying § 58.185(a)(9) as (a)(10) to add the example of “all health-related issues reported by an attending veterinarian or appropriately designated personnel during the course of the study”. This provision recognizes that circumstances affecting the quality and integrity of the data could include health-related issues noted and reported by the attending veterinarian or appropriately designated personnel. We propose this addition to help ensure that all untoward health-related observations of test animals are captured and reported so that FDA reviewers can consider their possible effect on study results.
We propose redesignating and modifying § 58.185(a)(12) as (a)(13) to be consistent with the EPA's GLP regulations (see 40 CFR 160.185(a)(12) and 792.185(a)(12)). That is, we propose requiring a signed and dated report from each person conducting an analysis or evaluation of study data or specimens after data generation was completed. We propose this addition to provide transparency regarding the review of study findings and the development of conclusions submitted in the final study report.
In new § 58.185(a)(16), we propose that the study director provide with the final study report a statement about the study's extent of compliance with part 58, including any study deviations. This requirement is consistent with OECD's consensus document
Many testing facilities provide services internationally and therefore, this statement is commonly seen in final study reports submitted to FDA. Such a statement also is included in EPA's study profile templates, which outline the necessary documents for submission of supporting data.
Several comments to the December 2010 ANPRM suggest modifying part 58 to include requirements for studies discontinued before completion. In response to this suggestion, we propose new § 58.185(d) requiring the study director to write, sign, and date a short written summary report closing the study and discussing why the study was discontinued. This report and study material must be archived as required in § 58.190 in case of future study review or study completion.
We propose modifying § 58.190(a) to add reserve samples to those items generated as a result of a nonclinical laboratory study that must be retained. We also propose adding a requirement for retention of “Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final study report.” We propose this addition to harmonize with the EPA GLP regulations (see 40 CFR 160.190(a) and 792.190(a)) and to clarify our requirement for retaining these documents.
Our other proposed modifications in § 58.190 provide timeframes for archiving required study material and requirements for the SOPs about archiving to include procedures specific to removing study material from the archives. Stakeholders who asked that we modernize part 58 requested a reasonable timeframe after the study completion date to complete study archiving. Comments to the December 2010 ANPRM also made this request. The SOP requirement for procedures specific to removing study material from the archives is to address concerns that material in the archives could be lost or destroyed if removed without having in place adequate and specific procedures.
We propose that archiving occur no later than 2 weeks after the study completion date (see study completion date defined in § 58.3). We propose this 2-week timeframe to prevent required material from being inadvertently misplaced, lost, or destroyed over the long term. We understand that certain situations may prevent archiving study material during, or at the completion of, a nonclinical laboratory study as currently required of the study director in § 58.33(f).
We also propose, when the study sponsor delays finalizing the final study report, that the study director must complete, sign, and date the final study report and archive all study material no later than 6 months after completion of the last draft of the final study report. Additionally, if the study sponsor stops a nonclinical laboratory study before all protocol requirements are complete, a decision about discontinuing the study must be made no later than 6 months after stopping the study. For discontinued studies, a summary report and study material must be archived within 2 weeks of the study director signing the summary report. We propose these timeframes to provide the requested flexibility without compromising the integrity of study material.
We propose modifying § 58.195(b) to conform with§ 58.190(a) for the listing arrangement. We also propose modifying § 58.195(b)(1) to address those applications and submissions to FDA that might not result in an approval, clearance, or a premarket authorization. We therefore propose adding an additional required retention period from the date an application or submission is administratively closed by FDA. “Administratively closed” includes those applications and submissions closed administratively with or without a decision.
In § 58.195(h), we propose adding a statement recognizing that a change of archive location may be due to reasons other than closure of a testing facility. For example, changes in ownership as well as changes in physical location would change the archive location. We also propose including a timeframe of “no later than 10 working days after the transfer occurs” for reporting to FDA
We propose this timeframe to ensure that FDA is informed of the location of study materials if a GLP BIMO inspection of the study is warranted. This requirement is necessary to prevent waste of inspectional resources and delay in receiving FDA inspectional findings, which provide FDA reviewers information about data quality and integrity.
Other proposed changes to § 58.195 are for consistency with our proposals throughout this document and to update the regulations consistent with current practices.
We propose modifying subpart K to extend the authority of the Commissioner of Food and Drugs to disqualify any person conducting a phase of a nonclinical laboratory study upon finding either or both of the conditions for disqualification in the proposed revisions in § 58.202. We propose adding any person conducting a phase of a nonclinical laboratory study for consistency with other modifications throughout this proposal.
We propose modifying § 58.202 to clarify the conditions for disqualification. To help provide uniformity in FDA regulations, we propose adding as a basis for initiating disqualification proceedings the repeated or deliberate submission of false information in any required report. FDA intends to reserve disqualification for the rare case when the rejection of a particular study is an inadequate regulatory response (see 43 FR 59986 at 60011) (Ref. 12).
In addition, we propose to amend the current provision in § 58.206(a) so that a person disqualified under part 58 would no longer be eligible to receive a test article under part 511, New Animal Drugs For Investigational Use. A clinical investigator who is ineligible to receive a test article under part 511 also would be ineligible to conduct any nonclinical laboratory study that is intended to support an application for a research or marketing permit.
For certain FDA-regulated products, such as new animal drugs, the study subjects are animals in both “nonclinical laboratory studies” and “clinical investigations.” In the new animal drug approval process, nonclinical laboratory studies, such as those that target animal safety and human food safety, may be essential in determining whether to approve an application for a research or marketing permit for a new animal drug. For new animal drugs, the same clinical investigator could conduct both nonclinical laboratory studies and clinical investigations. Therefore, we propose this action to help protect the safety and welfare of animal research subjects involved in FDA-regulated nonclinical laboratory studies and clinical investigations, and to help ensure the reliability and integrity of the data submitted to FDA to support FDA decisions concerning new animal drugs.
Concurrent with this proposal, FDA is publishing elsewhere in this issue of the
When a clinical investigator is disqualified pursuant to part 511, the basis for that disqualification typically is the repeated or deliberate submission of false information to FDA or a sponsor in any required report. For new animal drugs, the same investigator could conduct both nonclinical laboratory studies and clinical investigations. The proposed amendment to part 511 would make a clinical investigator disqualified under part 511 ineligible to conduct any nonclinical laboratory study intended to support an application for a research or marketing permit for a new animal drug. In addition, the proposed amendment to part 511 would help to provide consistency for disqualification proceedings in parts 58 and 511.8.
Other proposed provisions in §§ 58.200, 58.202, 58.204, 58.206, 58.210, 58.213, 58.215, and 58.217 are for clarity and consistency with our proposals throughout this document. In § 58.210, when a study is determined to be unacceptable, we propose to eliminate from consideration data in support of the application or submission to FDA, as defined in proposed § 58.3. We also propose to add that such elimination may serve as new information justifying appropriate regulatory action not limited to termination or withdrawal of approval.
We propose modifying § 58.219 to reference § 58.210(b) and to require an FDA inspection of a disqualified person before reinstatement can be considered. Presently, § 58.219 states that the Commissioner “may” require such an inspection. Before a request for reinstatement can be appropriately considered by FDA, we propose requiring an inspection. This inspection would help provide additional information about the disqualified person that may be relevant to the consideration for reinstatement.
We propose to add to 21 CFR 16.1(b)(2) a new provision for 21 CFR part 58, subpart K relating to disqualifying any person that conducts a phase of nonclinical laboratory studies of FDA-regulated products.
The Agency has determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
Legal authority to issue good laboratory practice regulations exists under section 701(a) of the FD&C Act, as essential to enforcement of the Agency's responsibilities under sections 402, 406, 408, 409, 501, 502, 503, 505, 510, 512-516, 518-520, 571, 721, 801, 905, 910, and 911 of the FD&C Act; and, sections 351 and 354-360F of the PHS Act.
FDA proposes that any final rule that may issue based on this proposal become effective 1 year after the date of publication of the final rule in the
We have examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive
The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. Because the proposed requirements are likely to impose a significant burden on small entities employing fewer than 10 workers in “Dental Equipment and Supplies” (between 1.87 and 8.94 percent of average annual sales), we find that the proposed rule would have a significant economic impact on a substantial number of small entities, but the impacts are uncertain.
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 $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This proposed rule would not result in an expenditure in any year that meets or exceeds this amount.
This proposed rule would amend the regulations regarding GLPs and would require that nonclinical laboratory studies (sometimes referred to as preclinical studies) follow a complete quality system approach, referred to as a GLP Quality System, when safety and toxicity studies support or are intended to support applications and submissions to FDA. The proposed rule would expand the scope to include all products for which nonclinical laboratory studies are currently conducted that are not explicitly discussed in the current regulations, specifically tobacco products. The proposed expanded scope also includes all applications and submissions under the FD&C Act that can be supported by the results of nonclinical laboratory studies. In addition, the proposed rule would introduce and modify definitions, terms, and organizational and personnel roles and responsibilities consistent with the implementation of the proposed GLP Quality System and the prevalence of multisite studies. Finally, the proposed rule would incorporate wording consistent with some of the existing domestic and international guidelines, rules or regulations covering good laboratory practices such as those established by the OECD.
Costs of the rule, when final, would include annual and one-time costs. Annual costs would include the additional reporting and recordkeeping responsibilities required under the proposed GLP Quality System. One-time costs include reading and understanding the rule, updating existing SOPs, writing new SOPs, and training. Combined, all costs annualized over a ten-year period at a 7-percent discount rate are estimated to range between $34.4 million and $69.3 million, with an average annualized cost of $51.9 million. By contrast, with a 3 percent discount rate, annualized cost would range from $34.2 million to $68.9 million, with an average annualized cost of $51.5 million.
Conducting nonclinical laboratory studies under the proposed GLP Quality System is expected to improve the reliability and quality of the data that support applications and submissions to us, including those applications and submissions that lead to the use of new medical products in first-in-human clinical studies. In addition, the proposed system is conducive to improving compliance and accountability by all involved in the conduct of nonclinical laboratory studies.
As described, we understand the potential effects on small entities. We therefore seek comment, particularly from small entities, about the proposed effective date of 1 year after the date of publication of any final rule that may issue (see section VII. Proposed Implementation Plan).
The full discussion of economic impacts is available in docket FDA-2010-N-0548 at
Table 1 summarizes the costs and benefits.
This proposed rule contains information collection provisions that are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). A description of these provisions is given in the Description section of this document with an estimate of the annual reporting and recordkeeping burden. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information.
FDA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
The proposed rule will revise these requirements to include: (1) A final study report incorporating additional information about all persons conducting one or more nonclinical laboratory study phases and a study director's compliance statement; (2) QAU reports on facility-based inspections and process-based inspections, where conducted; (3) written certification whenever a process-based QAU inspection reveals problems, with documentation that records the actions taken; (4) summaries of the closeout of discontinued studies; (5) notification of the change of archival site within a specified timeframe; (6) reports by the study sponsor to the study director of known risks of the test article and necessary measures to protect study personnel; and (7) reports by the study sponsor to the study director of the results of characterization of any reference articles that may be employed in a study as well of mixtures of such reference articles with carriers. Finally, for sponsors who submit the results of nonclinical laboratory studies in support of applications or submissions to FDA that are proposed additions to the scope of part 58 and that lack enacting regulations, (8) submission of the final study report and a GLP compliance statement.
QAU inspection reports provide the study director and management with executive responsibility information about the progress of a study and its
We estimate the reporting burden of this collection of information as follows:
Table 2 shows the estimated one-time burden associated with the new reporting provisions of the proposed rule. We expect that persons conducting a phase of a nonclinical laboratory study that is within the proposed expanded scope of part 58 will need to read and understand the proposed rule. We expect that some entities would face lower complexity from reading the proposed rule and some entities would face higher complexity. In the Preliminary Regulatory Impact Analysis (PRIA), we calculated lower and upper estimates of time to read and understand the proposed rule under a low-complexity scenario for sponsors of nonclinical laboratory studies who would face fewer provisions. Our estimates under a high-complexity scenario apply to testing facilities of nonclinical laboratory studies that would have to read and understand more provisions in the rule. As stated in the PRIA, we estimate that there are 2193 sponsors of nonclinical laboratory studies and 300 testing facilities of nonclinical laboratory studies. We estimate that the 2193 sponsors of nonclinical laboratory studies will take from 4.8 to 9.6 hours, for an average of 7.2 hours, to read and understand the proposed rule. We expect that the 300 testing facilities of nonclinical laboratory studies will take from 12 to 24 hours, for an average of 18 hours, to read and understand the proposed rule.
Table 3 shows the estimated recurring reporting burden associated with the proposed rule. Together, this results in a total of 90,576.25 hours and 69,958 responses.
This proposed rule will add to the existing requirements with regard to initial changes and additions to SOPs for both testing facilities and test sites to develop, implement, and maintain a GLP Quality System and to expand many SOPs to specifically include multisite studies.
This proposed rule would also expand personnel record maintenance to require records of training and experience on GLP requirements and species-specific animal care. In addition, this proposed rule includes revisions to the required content of study protocols as part of a GLP Quality System and for multisite study specifics.
The additional documentation by management with executive responsibility and study directors is for the implementation of a GLP Quality System and the resulting additional burden is nominal. Documentation by independent contributing scientists, as defined in this proposed rule, includes records these individuals would usually retain, so a nominal added burden is predicted.
To implement the proposed checks and balances discussed previously in the preamble, proposed revisions will require that added documentation be made by the study director and the QAU to ensure the viability of the proposed GLP Quality System (see Table 5).
This proposed rule also adds requirements for the study sponsor to maintain records of: (1) Protocol and protocol amendment approval; (2) the accreditation status of a contracted person (as defined in this proposed rule) that conducts a phase of the study that involves the use of animals; (3) test, control, and reference article characterization; and (4) the qualifications of all contracted persons.
In addition, the proposed rule includes recordkeeping requirements for nonclinical laboratory studies that choose to utilize the option of having a principal investigator, particularly for multisite studies. These individuals will have recordkeeping responsibilities comparable to those of the study director for the nonclinical laboratory study phases for which they are responsible.
The persons potentially retaining nonclinical laboratory study documents are persons conducting a phase of a nonclinical laboratory study that is within the proposed expanded scope of part 58, including independent contributing scientists, and study sponsors as defined in this proposed rule. Results of nonclinical laboratory studies may be used by firms in support of applications and submissions to FDA, including applications and submissions for research and marketing of new products. The additional documentation of the conduct and data collection of nonclinical laboratory studies of FDA-regulated products will help ensure the quality and integrity of final study reports. FDA conducts on-site reviews of records and study reports during inspections of persons conducting one or more nonclinical laboratory study phases to verify the reliability of results submitted in support of applications and submissions to FDA.
We estimate the recordkeeping burden of this collection of information as follows:
Table 4 shows the estimated one-time burden associated with the revised recordkeeping provisions of the proposed rule. We expect that the 300 testing facilities of nonclinical laboratory studies will need to update existing SOPs and to write new SOPs. In the PRIA, we estimated that each facility would need to update 12 existing SOPs and write 10 new SOPs. We calculated lower and upper estimates of time to update existing SOPs and to write new SOPs. We estimate that it will take from 4 to 11 hours, for an average of 7.5 hours, to update 12 existing SOPs. We estimate that it will take from 15 to 33 hours, for an average of 24 hours, to write 10 new SOPs. We also expect that the 300 testing facilities of nonclinical laboratory studies will need to conduct training. In the PRIA, we estimated that for the low estimate one person would be doing the training and one person would be trained. By contrast, for the high estimate, we estimated that also one person would be doing the training and potentially three people would receive such training, for an average of two employees for each facility. We calculated lower and upper estimates of time to train, estimating that it will take from 5 to 23 hours, for an average of 14 hours, to train.
Table 5 shows the estimated recurring recordkeeping burden associated with the proposed rule. Together, this results in a total of 1,013,689.5 hours and 1,195,231 records.
To ensure that comments on information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB (see
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3407(d)), the Agency has submitted the information collection provisions of this proposed rule to OMB for review. These requirements will not be effective until FDA obtains OMB approval. FDA will publish a notice concerning OMB approval of these requirements in the
FDA has analyzed this proposed rule according to 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.
The following references are on display in the Division of Dockets Management (see
1. “OECD Series on Principles of Good Laboratory Practice (GLP) and Compliance Monitoring,” (the link provided is to an index of all OECD documents related to GLPs, with links to each of the individual documents) (
2. “Mutual Acceptance of Data (MAD),” (
3. FDA, “FDA Announces New Initiative to Modernize the Regulation of Clinical Trials and Bioresearch Monitoring,” FDA News Release, June 26, 2006 (
4. FDA, “Nonclinical Laboratory Studies; Proposed Regulations for Good Laboratory Practice Regulations” 41 FR 51206 (November 19, 1976).
5. MOU 225-06-4000. “Memorandum of Understanding Among the Animal and Plant Health Inspection Service, U.S. Department of Agriculture, and the Food and Drug Administration, U.S. Department of Health and Human Services, and the National Institutes of Health, U.S. Department of
6. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 13,”
7. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 4 (Revised),” Consensus Document;
8. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 1,”
9. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 11,” Advisory Document of the Panel on Good Laboratory Practices,
10. Council for International Organization of Medical Sciences and The International Council for Laboratory Animal Science,
11. Institute for Laboratory Animal Research,
12. FDA, “Nonclinical Laboratory Studies, Good Laboratory Practice Regulations,” Final Rule, 43 FR 59986 (December 22, 1978).
13. Compliance Policy Guide (CPG 7151.02), Sec. 130.300—FDA Access to Results of Quality Assurance Program Audits and Inspections (
14. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 8 (Revised),” Consensus Document,
15. “OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring Number 7 (Revised),” Consensus Document,
16. Bioanalytical Method Validation Draft Guidance for Industry (
17. Pesticide Registration Notice 2011-3 “Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act and Certain Provisions of the Federal Food, Drug, and Cosmetic Act” (
18. Full Analysis of Economic Impacts (Docket Number FDA-2010-N-0548). Preliminary Regulatory Impact Analysis, Initial Regulatory Flexibility Analysis, and Unfunded Mandates Reform Act Analysis for Good Laboratory Practice for Nonclinical Laboratory Studies; Proposed Rule, available at
Administrative practice and procedure.
Laboratories, Reporting and recordkeeping requirements.
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 parts 16 and 58 be amended as follows:
15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
(b) * * *
(2) * * *
§§ 58.200 through 58.219 (see part 58, subpart K of this chapter), relating to disqualifying any person conducting a phase of a nonclinical laboratory study of FDA-regulated products.
21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 360ccc, 371, 379e, 381, 387e, 387j, 387k; 42 U.S.C. 216, 262, 263b-263n.
(a) This part prescribes good laboratory practices (GLPs) for conducting nonclinical laboratory studies of safety or toxicity or both that support or are intended to support an application or submission for products regulated by the Food and Drug Administration (FDA), including food and color additives, animal food additives, human and animal drugs, devices, biological products, electronic products, and tobacco products. Applications and submissions to FDA affected by these regulations include those listed in § 58.3. Compliance with this part is intended to assure the quality and integrity of data from nonclinical laboratory studies filed or submitted pursuant to sections 402, 406, 408, 409, 501, 502, 503, 505, 510, 512-516, 518-520, 571, 701, 721, 801, 905, 910, and 911 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.
(c) In this part the term “where appropriate” is used several times. When a requirement is qualified by “where appropriate,” it is deemed to be “appropriate” unless justification can be otherwise documented. A requirement is “appropriate” if non-implementation could reasonably be expected to result in a nonclinical laboratory study whose results lack the required reliability.
As used in this part, the following terms have the meanings specified:
(1) A color additive petition, described in section 721 of the Federal Food, Drug, and Cosmetic Act, and as described in part 71 of this chapter.
(2) A food additive petition, described in section 409 of the Federal Food, Drug and Cosmetic Act, and as described in parts 171 and 571 of this chapter.
(3) Data and information regarding a substance submitted as part of the procedures for establishing that a substance is generally recognized as safe for use, which use results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food, described in §§ 170.35 and 570.25 of this chapter.
(4) Data and information regarding a food additive submitted as part of the procedures regarding food additives permitted to be used on an interim basis pending additional study, described in § 180.1 of this chapter.
(5) A petition for a nutrient content claim, described in section 403 of the Federal Food, Drug, and Cosmetic Act, and as described in subpart D of part 101 of this chapter.
(6) A petition for a health claim, described in section 403 of the Federal Food, Drug, and Cosmetic Act, and as described in subpart E of part 101 of this chapter.
(7) An
(8)
(9) Data and information regarding an over-the-counter drug for human use, submitted as part of the procedures for classifying such drugs as generally recognized as safe and effective and not misbranded, described in part 330 of this chapter.
(10) Data and information about a substance submitted as part of the procedures for establishing a tolerance for unavoidable contaminants in food and food-packaging materials, described in sections 406, 408, and 409 of the Federal Food, Drug, and Cosmetic Act, and as described in parts 109 and 509 of this chapter.
(11) A
(12)
(13) An
(14) An
(15)
(16) A request to establish or amend an import tolerance described in section 512 of the Federal Food, Drug, and Cosmetic Act.
(17) [Reserved]
(18) An
(19) An
(20) An
(21) An
(22) A
(23) A
(24) Data and information regarding a medical device submitted as part of the procedures for classifying such devices described in part 860, subpart B of this chapter, reclassification petitions described in part 860, subpart C of this chapter, and requests associated with the evaluation of automatic class III designations, authorized under section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act.
(25) Data and information regarding a medical device submitted as part of the procedures for establishing, amending, or revoking a performance standard for such devices, described in section 514 of the Federal Food, Drug, and Cosmetic Act, and as described in part 861 of this chapter.
(26) Data and information regarding an electronic product submitted as part of the procedures for obtaining an exemption from notification of a radiation safety defect or failure of compliance with a radiation safety performance standard, described in subpart D of part 1003 of this chapter.
(27) Data and information regarding an electronic product submitted as part of the procedures for establishing, amending, or repealing a standard for such product, described in section 358 of the Public Health Service Act.
(28) Data and information regarding an electronic product submitted as part of the procedures for obtaining a variance from any electronic product performance standard as described in § 1010.4 of this chapter.
(29) Data and information regarding an electronic product submitted as part of the procedures for granting, amending, or extending an exemption from any electronic product performance standard, as described in § 1010.5 of this chapter.
(30) A
(31) [Reserved]
(32) A
(33) A
(34) A
(35) An
(2) A person that submits a nonclinical laboratory study in support of an application or submission to FDA; or
(3) A person that initiates a nonclinical laboratory study and functions as, and has the same responsibilities as, a testing facility, test site, or contributing scientist, as those terms are defined in this section.
For each nonclinical laboratory study, the sponsor must:
(a) Ensure the nonclinical laboratory study protocol (the study protocol) meets the requirements in § 58.120.
(b) Ensure that the study protocol provides for humane care and ethical treatment of animals.
(c) Sign and date the study protocol to indicate approval.
(d) Contract with persons accredited as following appropriate animal welfare procedures for phases of a nonclinical laboratory study that include the use of animals. If these contracted persons are not accredited, document this fact, the reason for using a non-accredited person, and the qualifications of the non-accredited person. This information must be included in the compliance statement required in paragraph (k) in this section.
(e) Document that any contracted person conducting a phase of a nonclinical laboratory study is qualified according to the provisions in this part.
(f) Ensure that appropriate lines of communication are established among all persons conducting a phase of the nonclinical laboratory study and document all study-related communications that involve the sponsor.
(g) Document that test, control, and reference articles are prepared, characterized, and labeled according to subpart F of this part, and are appropriately shipped. Obtain, and provide to the study director as soon as available, information regarding test, control, and reference article characterization as specified in § 58.105.
(h) Inform the study director of any known potential risks of the test article to human health or the environment and any measures necessary to protect study personnel and the environment.
(i) Review, approve, sign, and date each protocol amendment before implementation.
(j) Document and update as necessary the archive location of all raw data and records as described in §§ 58.190 and 58.195.
(k) Include, in any application or submission to FDA that includes the results of a nonclinical laboratory study, the final study report and all amendments. If a summary report of the nonclinical laboratory study is included in such applications or submissions, a copy of the final study report, as described in § 58.185, must be appended or provided elsewhere within the application or submission. Also, include either a statement that the study was conducted in compliance with the requirements set forth in this part, or, if the study was not conducted in compliance with these regulations, a brief statement of the reason for the noncompliance.
(a) Any person utilizing the services of a contracted person (as defined in § 58.3) to perform a phase (as defined in § 58.3) of a nonclinical laboratory study may transfer to the contracted person any regulatory responsibility in this chapter, unless delegation of such responsibility is expressly prohibited. Any such transfer must be described in writing. Any responsibility not covered by the written description is deemed not transferred.
(b) Any person transferring to a contracted person any responsibility for a phase of a nonclinical laboratory study must inform that contracted person that the transferred responsibility must be performed in compliance with the provisions in this part.
(c) A contracted person assuming any responsibility for a phase of a nonclinical laboratory study must comply with the regulations in this chapter applicable to the transferred responsibility and is subject to the same regulatory actions as those transferring the responsibility.
(a) Any person conducting a phase of a nonclinical laboratory study must permit, at reasonable times and in a reasonable manner, an authorized employee of FDA to inspect and copy all records and inspect all specimens required to be maintained for nonclinical laboratory studies within the scope of this part and, where applicable, to collect reserve samples for such studies. The records inspection and copying requirements do not routinely apply to QAU records of findings and problems or to actions recommended and taken. However, FDA retains the authority to inspect all QAU records when necessary to ensure compliance with this part.
(b) FDA will not consider a nonclinical laboratory study submitted in support of an application or submission to FDA if any person conducting a phase of the nonclinical laboratory study refuses to permit inspection. The determination that a nonclinical laboratory study will not be considered in support of an application or submission to FDA does not, however, relieve the applicant of any obligation under any other applicable statute or regulation to submit the results of the study to FDA.
(a) Each individual engaged in the conduct of, or responsible for the supervision of, a nonclinical laboratory study must have education, training, and experience, or a combination thereof, to enable that individual to perform the assigned functions. This must include training and experience with GLP requirements. Personnel who work with animals must have both general and species-specific training and experience.
(b) All study personnel must have access to and comply with the protocol and all applicable protocol amendments and SOPs. Any deviation must be reported to the study director.
(c) All study personnel must record raw data, as defined in § 58.3, promptly and accurately as required by § 58.180.
(d) Any person conducting a phase of a nonclinical laboratory study must maintain a current summary of training and experience and a job description for each individual in the person's employment engaged in or supervising the phase of the study for which the person is responsible.
(e) There must be a sufficient number of personnel for the timely and proper conduct of the study according to the protocol.
(f) Personnel must take necessary personal sanitation and health precautions designed to avoid contamination of test, control, and reference articles and test systems.
(g) Personnel engaged in a nonclinical laboratory study must wear clothing appropriate for the duties they perform. Such clothing must be changed as often as necessary to prevent microbiological, radiological, or chemical contamination of test systems and test, control, and reference articles.
(h) Any individual found at any time to have an illness that may adversely affect the quality and integrity of the nonclinical laboratory study must be excluded from direct contact with test systems; test, control, and reference articles; and any other operation or function that may adversely affect the study until the condition is corrected.
Management with executive responsibility is ultimately responsible for the GLP Quality System and must establish policy and objectives for a GLP Quality System and a commitment to quality, as defined in § 58.3. Management with executive responsibility must ensure that the quality policy, as defined in § 58.3, is implemented and maintained at all levels of the organization. Management with executive responsibility must:
(a) Establish and update written SOPs, as required in § 58.81(b)(2) for a GLP Quality System.
(b) Review the suitability and effectiveness of the GLP Quality System at defined intervals and with sufficient frequency according to established procedures, to be included in SOPs for the GLP Quality System (§ 58.81(b)(2)), to ensure that the GLP Quality System satisfies the established quality policy and objectives and the requirements of this part. The dates and results of these reviews must be documented.
(c) Establish and maintain an adequate organizational structure (personnel, resources, facilities, equipment, materials, and methodologies) to ensure that all testing complies with the established GLP Quality System, according to the requirements of this part.
(d) Establish procedures, to be included in SOPs for the GLP Quality System (§ 58.81(b)(2)), for the appropriate responsibility, authority, and interrelationship among all personnel who manage, perform, and assess work affecting quality, and provide the independence and authority necessary to perform these tasks.
(e) Appoint and document the appointment of, according to procedures to be included in SOPs for the GLP Quality System (§ 58.81(b)(2)), a management representative who is a member of the testing facility management with authority over and responsibility for:
(1) Documenting that GLP Quality System requirements are effectively established and effectively maintained; and
(2) Reporting on the performance of the GLP Quality System to management with executive responsibility for review, including all reports from the QAU.
(f) Establish SOPs for equipment, as required in § 58.81(b)(14), including standards for appropriate documentation of equipment validation, as defined in § 58.3. For multisite studies, document that any person conducting a phase of the nonclinical laboratory study follows adequate equipment-related SOPs.
(g) Establish SOPs to ensure that computerized systems are suitable for their intended purposes and are appropriately validated, operated, and maintained as required in § 58.81(b)(15).
(h) Document that all study personnel are trained to perform their assigned functions.
(i) Establish SOPs, as required in § 58.81(b)(18), for ensuring and documenting the qualifications of any person conducting a phase of a nonclinical laboratory study.
(j) Establish SOPs for the development and maintenance of the master schedule as required in § 58.81(b)(13).
(k) Appoint and document the appointment of a person to maintain the master schedule. The master schedule must be indexed by test article and contain the identification of the test system, the nature of the study, the date the study was initiated, the current status of each study, the identity of the sponsor, and the name of the study director. For multisite studies, the master schedule of each person conducting a phase of a nonclinical laboratory study must also include the specific phases that person conducts.
(
(m) Review all protocols to determine that there are no environmental, animal welfare, or work resource issues or issues with scientific methodology that might affect or bias any phase of the conduct of the proposed study. Document the review and acceptance of each protocol.
(n) Establish SOPs, as required in § 58.81(b)(3), for designation of a study director, as described in § 58.33, before the study is initiated and prompt replacement of the study director if it becomes necessary to do so during the conduct of a study.
(o) Establish procedures, to be included in SOPs for the GLP Quality System (§ 58.81(b)(2)), to ensure a clear line of communication among the study director, principal investigator(s), QAU(s), the sponsor, and all study personnel, as applicable.
(p) Provide for a QAU as described in § 58.35. Before initiating a multisite study, as defined in § 58.3, designate and document the designation of the lead QAU with overall responsibility for the entire study. Provide the information described in § 58.35(a) of the lead QAU to all persons involved in the conduct of the study and all QAUs serving those persons.
(q) Establish procedures, to be included in SOPs for the GLP Quality System (§ 58.81(b)(2)), to ensure QAU review of SOPs and study protocols to verify that they meet GLP requirements. This review must be documented.
(r) Review the suitability and effectiveness of the QAU or lead QAU, as applicable, at defined intervals and with sufficient frequency, according to established SOPs as required in § 58.81(b)(17), to ensure that the QAU satisfies established quality policy and objectives and the requirements of this part. For multisite studies, testing facility management with executive responsibility must periodically review the suitability and effectiveness of the lead QAU. The dates and results of reviews of the QAU must be documented.
(s) Establish SOPs, as required in § 58.81(b)(6), for the receipt of information regarding the characterization of all test, control, and reference articles or mixtures, including data on their identity, strength, purity, stability, and uniformity, as applicable.
(t) Establish SOPs, with appropriate timeframes, for the conduct of QAU inspections and for the receipt, review, and followup of all concerns, problems, and regulatory deviations reported by the QAU. These SOPs must include procedures for correcting reported problems and, as necessary, for modification of relevant SOPs to prevent a recurrence of any problems, as required in § 58.81(b)(20) and (21).
(u) Establish SOPs, as required in § 58.81(b)(13), for the development and maintenance of an archive system, including the designation and replacement of the archivist and any supporting staff.
(v) Establish procedures to ensure maintenance of a historical file of all SOPs as required in § 58.81(b)(1).
For multisite studies, each test site participating in the study must have
(a) Comply with responsibilities delineated for testing facility management with executive responsibility, as described in section § 58.31, where appropriate.
(b) Develop and maintain SOPs as specified in § 58.81, where appropriate.
(a) For each nonclinical laboratory study, a scientist or other professional of appropriate education, training, and experience, or combination thereof, must be identified as the study director. The study director represents the single point of study control and has overall responsibility, which cannot be delegated, for:
(1) The technical conduct of the entire study;
(2) The implementation of procedures to ensure adequate communication among all study personnel and with the study sponsor, as applicable; and
(3) The interpretation, analysis, documentation, and reporting of results and study compliance.
(b) The study director must:
(1) Approve the protocol, including any changes, as provided by § 58.120, and document that it is followed.
(2) Document that the QAU has reviewed the protocol and all applicable SOPs, and any amendments, before study initiation and implementation of applicable amendments to ensure that they are compliant with GLP requirements.
(3) Document that testing facility management with executive responsibility has committed adequate resources for the conduct of the specific study.
(4) Document that computerized systems are validated and fit for use in the specific study.
(5) For studies requiring the use of animals, document that the initial protocol and any amendments that impact the use of animals are reviewed and approved, as required in § 58.120(b) and (e), by a committee whose function is to ensure that the care and use of animals in studies is appropriate and humane, before study initiation and the implementation of applicable amendments.
(6) Consult with the attending veterinarian, as defined in § 58.3, during review of proposed study protocols to determine potential animal welfare concerns and appropriate responses to likely contingencies. Defer to the attending veterinarian when decisions regarding animal welfare arise, particularly when animals are in pain or distress.
(7) For multisite studies:
(i) Document the qualifications of any person conducting a phase of the nonclinical laboratory study.
(ii) Determine and document the need for principal investigators.
(8) Document that all experimental data, including observations of unanticipated responses of the test system, are accurately recorded and verified.
(9) Document unforeseen circumstances that may affect the quality and integrity of the nonclinical laboratory study when they occur and the corrective action taken.
(10) Document that test systems are as specified in the approved study protocol.
(11) Document that all applicable GLP regulations are followed and include a study compliance statement in the final study report.
(12) Document all communications with all persons conducting a phase of the nonclinical laboratory study and with the sponsor, as applicable.
(13) Sign and date the final study report.
(14) Archive all raw data, documentation, protocols, specimens, reserve samples, and final reports no later than 2 weeks after the study completion date.
(a)(1)
(2)
(ii) For multisite studies, a lead QAU must be designated by testing facility management with executive responsibility and must have responsibility for the QA of the entire study. The lead QAU can consist of personnel at the testing facility, be a QAU for another person conducting a phase of the study, or be a separately contracted unit. QAUs for persons conducting a phase of the study must coordinate with the lead QAU as specified in SOPs as described in § 58.81(b)(17) and (20). The lead QAU has direct QA responsibility for any person lacking a QAU.
(b) QAUs must: (1) Maintain access to the master schedule (defined in § 58.3) of all nonclinical laboratory studies conducted by the person employing the QAU or contracting for QA services. For multisite studies, the lead QAU must maintain access to the master schedule of any person lacking a QAU.
(2) Maintain access to copies of all protocols pertaining to all nonclinical laboratory studies for which the QAU is responsible.
(3) Review all protocols before study initiation, and all protocol amendments before implementation, to ensure that they can be conducted in compliance with this part. This review must be documented.
(4) Review all SOPs to be used for the conduct of all phases of a nonclinical laboratory study to assess their clarity and compliance with this part. This review must be documented.
(5) Inspect each nonclinical laboratory study for which the QAU is responsible at intervals adequate to ensure the integrity of the specific study. Inspections must determine compliance with the protocol, applicable SOPs, and the requirements of this part. These can include study-based, process-based, and facility-based inspections as defined in § 58.3 and as specified in SOPs as required in § 58.81(b)(20). For multisite studies, the lead QAU must coordinate the conduct of study inspections with any other existing QAUs, as specified in SOPs as required in § 58.81(b)(20). Upon discovery, any problems found during an inspection which are likely to affect study integrity must be reported to the study director and management with executive responsibility for the study or studies affected.
(6) Maintain written and properly signed records of all inspections that include the date of the inspection, the individual performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for reinspection. For study-specific inspections, reports must also include the identity of the study and the phase of the study inspected.
(7) Periodically submit to management with executive responsibility and the study director written status reports on each study that discuss the overall progress and compliance status of the study and that include any problems observed and the corrective actions taken. The content and frequency of these reports must be specified in SOPs, as described in § 58.81(b)(21).
(8) Determine that no deviations from approved protocols or SOPs were made without proper authorization and
(9) Audit the reports of all contributing scientists, and any amendments to such reports, to ensure such reports reflect the protocol and all amendments, accurately describe the methods and SOPs, and report all of the raw data of the specific phases covered by each report. For multisite studies, QAUs for persons conducting a phase of the study must audit the reports of any principal investigators and all contributing scientists for whom they are responsible, and any amendments to such reports, as specified in SOPs as described in § 58.81(b)(17). The lead QAU must audit the reports, and any amendments to such reports, of any principal investigators and all contributing scientists for any person lacking a QAU and of any independent contributing scientists.
(10) Audit the final study report, and any amendments to this report, to ensure that such report accurately describes the methods and SOPs, all raw data of the nonclinical laboratory study are reported, and that all original and amended signed and dated reports from all contributing scientists are appended. For multisite studies, this is the responsibility of the lead QAU.
(11) Prepare, sign, and date a statement to be included with the final study report that specifies:
(i) The dates of study-specific inspections, process-based inspections if applicable, and facility-based inspections;
(ii) Findings reported to management with executive responsibility and to the study director; and
(iii) The dates of QAU audits of the reports of all contributing scientists (including any independent contributing scientists), any principal investigators, and of the final study report and all amendments to such. For multisite studies, this is the responsibility of the lead QAU. When other persons conducting a phase of the study have QAUs, those QAUs must provide to the lead QAU such statements regarding the audits they conducted, for appending to the final study report.
(c) The responsibilities and procedures applicable to the QAU, the records maintained by the QAU, and the method of indexing such records must be in writing and must be maintained as specified in SOPs as required in § 58.81(b)(17). For multisite studies, the lead QAU and all other QAUs participating in the study must maintain those documents relevant to their oversight. These SOPs as well as documentation of the dates of all QAU inspections, the study or process or procedure, or facility inspected as applicable, the phase or segment of the study inspected for study-specific inspections, and the name of the individual performing the inspection must be made available for inspection to authorized employees of FDA.
(d) A designated representative of FDA must, upon request, be given access to the written SOPs established for QAU inspections. If requested by FDA, the person inspected must certify that inspections are being implemented, performed, documented, and followed up according to this part.
(e) If a person conducting a phase of a nonclinical laboratory study chooses to conduct process-based inspections, that person must prepare a written certification, as specified in SOPs as required in § 58.81(b)(21), whenever a process-based inspection reveals problems. This certification must document actions taken to properly inform and, when applicable, modify reports for all studies impacted by the results of the process or procedure in question.
(a) Each contributing scientist must:
(1) Conduct, oversee, analyze, and provide any other service for the conduct of all phases of the nonclinical laboratory study for which the contributing scientist is responsible according to the requirements of this part.
(2) Provide a signed and dated report of all phases for which the contributing scientist is responsible, to be included in the final study report. When there are amendments to the original report, provide a signed and dated copy of the amended report, to be included in the final study report along with the original report. Provide the report, and all amendments, to the study director or, when a multisite study employs principal investigators, through the principal investigator.
(3) Permit oversight by the designated QAU.
(b) In addition to the requirements in paragraphs (a)(1) through (3) of this section, an independent contributing scientist must:
(1) Date and sign the study protocol to indicate agreement to comply with protocol requirements for all phases of the nonclinical laboratory study the independent contributing scientist will conduct and the applicable requirements of this part. Date and sign any protocol amendments applicable to the phases of the nonclinical laboratory study conducted by the independent contributing scientist to indicate agreement.
(2) Maintain and update documentation of education, training, and experience pertinent to those phases of the nonclinical laboratory studies for which the independent contributing scientist is responsible.
(3) If conducting phases of a nonclinical laboratory study that include the use of animals:
(i) Document that housing, feeding, handling, and care of the animals as specified in § 58.90 are available.
(ii) Document that an attending veterinarian is available for consult and deferred to as necessary, particularly when animals are in pain or distress.
(iii) Document corrective actions required to assure the humane care and ethical treatment of animals.
(4) Archive all materials pertinent to all phases of the nonclinical laboratory the independent contributing scientist conducted, as required by the protocol and § 58.195; document when and where archiving was completed.
The study director can delegate to principal investigators responsibility for phases of a nonclinical laboratory study but not responsibility for an entire study. For all phases of the nonclinical laboratory study for which the principal investigator is responsible, a principal investigator must:
(a) Sign and date the study protocol, and any applicable amendments, to document agreement to comply with the protocol requirements and the applicable requirements of this part.
(b) Verify that the study is conducted according to the requirements of this part.
(c) Document all deviations noted during the conduct of the study, report those deviations to the study director as soon as possible after discovery, and document that the information was forwarded to the study director.
(d) Submit to the study director either:
(1) The signed and dated reports from all contributing scientists for whom the principal investigator is responsible and any amendments to such reports, any raw data not covered by such reports, and a signed compliance statement indicating any areas of noncompliance; or
(2) Signed and dated report of all phases for inclusion in the final study report. The signed report must include the original principal investigator's report and any amendments, reports of all contributing scientists for whom the principal investigator is responsible and any amendments to such reports, and a signed compliance statement indicating any areas of noncompliance.
(e) Document that all materials and records are appropriately archived, as required by the protocol and § 58.195.
Any person conducting a phase of a nonclinical laboratory study must have facilities of suitable size and construction to facilitate the proper conduct of nonclinical laboratory studies. Facilities must be designed so that there is a degree of separation that will prevent any function or activity from having an adverse effect on the study.
(a) Any person conducting a phase of a nonclinical laboratory study that utilizes animals must have a sufficient number of animal rooms or areas, as needed, to assure proper:
(1) Separation of species or test systems,
(2) Isolation of individual projects,
(3) Quarantine of animals, and
(4) Routine or specialized housing of animals.
(b) Any person conducting a phase of a nonclinical laboratory study that utilizes animals must have a number of animal rooms or areas separate from those described in paragraph (a) of this section to ensure isolation of studies being done with test systems or test, control, or reference articles known to be biohazardous, including volatile substances, aerosols, radioactive materials, and infectious agents.
(d) When animals are housed, facilities must exist for the collection and disposal of all animal waste and refuse or for safe sanitary storage of waste before removal from any facility at which a phase of a nonclinical laboratory study that utilizes animals is conducted. Disposal facilities must be so provided and operated as to minimize vermin infestation, odors, disease hazards, and environmental contamination.
(a) As necessary to prevent contamination or mixups, there must be separate areas for:
(1) Receipt and storage of the test, control, and reference articles.
(2) Mixing of the test, control, and reference articles with a carrier,
(3) Storage of the test, control, and reference article mixtures.
(b) Storage areas for the test, control, and reference articles and test, control, and reference article mixtures must be separate from areas housing the test systems and must be adequate to preserve the characteristics of the articles and mixtures, including their identity, strength, purity, and stability, as applicable.
Equipment, including computerized systems, used in the generation, measurement, maintenance, archiving, retrieval, or assessment of data (or any combination thereof) and equipment used for facility environmental control must be of appropriate design and adequate capacity to function according to the protocol and must be suitably located for operation, inspection, cleaning, and maintenance.
(a) Equipment must be adequately inspected, cleaned, and maintained. Equipment used for the generation, measurement, maintenance, archiving, retrieval, or assessment of data (or any combination thereof) must be adequately tested, calibrated, and standardized, as applicable.
(b) The written SOPs required under § 58.81(b)(14) and (15) must set forth in sufficient detail the methods, materials, and schedules to be used in the routine inspection, cleaning, maintenance, testing, calibration, and standardization of equipment, as applicable, and must specify, when appropriate, remedial action to be taken in the event of failure or malfunction of equipment. The written SOPs must designate the person responsible for the performance of each operation.
(a) The testing facility and all test sites must have SOPs in writing setting forth nonclinical laboratory study procedures that management with executive responsibility is satisfied are adequate to ensure the quality and integrity of the data generated in the course of a study. All deviations from SOPs in a study must be authorized by the study director and must be documented in the raw data. Significant changes in established SOPs must be properly authorized in writing by management with executive responsibility.
(b) The testing facility and all test sites must establish SOPs for all applicable phases of a nonclinical laboratory study. Where appropriate, SOPs must include the following:
(1) Preparation, modification, and administration of all SOPs. These must include procedures for developing and maintaining a historical file of SOPs and all revisions, including the dates of such revisions.
(2) Establishment and periodic review of a GLP Quality System.
(3) Designation and replacement of the study director.
(4) Animal room preparation.
(5) Animal care.
(6) Receipt, identification, storage, handling, mixing, and method of sampling of the test, control, and reference articles.
(7) Test system observations for in vivo and in vitro testing, as applicable.
(8) Laboratory tests.
(9) Handling of animals found moribund or dead during study.
(10) Necropsy of animals or post mortem examination of animals.
(11) Collection and identification of specimens.
(12) Histopathology.
(13) Data handling, storage, and retrieval, including maintenance of the master schedule and all study protocols, and the establishment and maintenance of an archive system.
(14) Validation, maintenance, and calibration of equipment.
(15) Ensuring computerized systems are suitable for their intended purpose and are appropriately validated, operated, and maintained and that electronic records from computerized systems are readily available for review and assessment.
(16) Transfer, proper placement, and identification of animals.
(17) QAU functions, including QA oversight for multisite studies.
(18) Multisite studies.
(19) Designation and replacement of a principal investigator.
(20) Planning, performing, documenting, and reporting inspections conducted by the QAU.
(21) Receipt, review, and followup of all concerns, problems, and regulatory deviations reported by the QAU, including the frequency and content of periodic study reports required by § 58.35(b)(7), and for modifying relevant SOPs when necessary to prevent recurrence.
(22) Certifying copies of study records as true copies of the original that maintain the original intent and meaning.
(c) Each laboratory area must have immediately available laboratory manuals and SOPs relative to the laboratory procedures being performed. Published literature may be used as a supplement to SOPs.
(b) All newly received animals from outside sources must be isolated and their health status must be evaluated according to acceptable veterinary medical practices. Also, throughout the study, all test animals must be evaluated for their health status according to acceptable veterinary medical practices.
(c) At the initiation of a nonclinical laboratory study, animals must be free of any disease or condition that might interfere with the purpose or conduct of the study. If, during the course of the study, the animals contract such a disease or condition, the diseased animals must be isolated, if necessary. These animals may be treated for disease or signs of disease as deemed necessary by the study's attending veterinarian. The diagnosis, treatment authorizations, treatment description, and each treatment date must be documented and must be retained as part of the study raw data.
(d) Warm-blooded animals, except nursing neonates, used in laboratory procedures that require manipulations and observations over an extended period of time or in studies that require the animals to be removed from and returned to their home cages for any reason (
(e) Animals of different species must be housed in separate rooms when necessary. Animals of the same species, but used in different studies, should not ordinarily be housed in the same room when inadvertent exposure to control, reference, or test articles or animal mixup could affect the outcome of either study. If such mixed housing is necessary, adequate differentiation by space and identification must be made.
(a) For all test, control, and reference articles other than tobacco products, the identity, strength, purity, and composition or other characteristics which will appropriately define the test, control, or reference article must be determined for each batch and must be documented. For test, control, and reference articles for tobacco products, the chemical composition (including mainstream or aerosol smoke composition, when applicable), microbiological characterization (fermented tobacco products), and design parameters which will appropriately define the test, control, or reference article must be determined for each batch and must be documented. These analyses must be performed by the sponsor or by a contracted person either:
(1) Before study initiation, or
(2) Concomitantly according to written SOPs as required in § 58.81(b)(6). The results of such analyses must be provided to the study director as soon as available. In those cases where marketed products are used as control or reference articles, with the exception of tobacco products, such products can be characterized by their labeling.
(b) Methods of synthesis, fabrication, or derivation of the test, control, and reference articles must be documented by the person who conducts the analyses.
(c) The stability of each test, control, and reference article must be determined as required by the conditions of the study either:
(1) Before study initiation, or
(2) Concomitantly according to written SOPs, as required in § 58.81(b)(6), which provide for periodic analysis of each batch. The results of such testing must be provided to the study director as soon as available.
(d) Each storage container for a test, control, or reference article must be labeled by name; Chemical Abstract Service (CAS) number or code number, where such identification exists; batch number; expiration date, if any; and, where applicable, storage conditions necessary to maintain the identity, strength, purity, and composition of the test, control, or reference article, other than tobacco products. For tobacco product test, control, and reference articles, labeling must include storage conditions necessary to maintain the chemical composition (including mainstream smoke composition), microbiological composition, and design parameters, where applicable. Storage containers must be assigned to a particular test article for the duration of the study. Empty test article containers may be disposed of once the study director verifies and documents the distribution and final disposition of the test article. Approval for the disposal of empty containers must be in writing and signed and dated by the study director.
(e) For studies of more than 4 weeks duration, reserve samples from each batch of test, control, and reference article must be retained for the period of time provided by § 58.195.
Procedures must be established, as required in § 58.81(b)(6), for a system for the handling of the test, control, and reference articles to ensure that:
(a) For each test, control, and reference article that is mixed with a carrier, tests by appropriate analytical methods must be conducted:
(1) To determine the uniformity of the mixture and to determine, periodically, the concentration of the test, control, or reference article in the mixture; and
(2) To determine the stability of the test, control, and reference articles in the mixture as required by the conditions of the study.
(b) Determination of uniformity, concentration, and stability must be conducted either:
(1) Before study initiation; or
(2) Concomitantly according to written SOPs, as required by § 58.81(b)(6), which provide for periodic analysis of the test, control, or reference articles in the mixture.
(c) The results of such testing, performed by the sponsor or by a contracted person, must be provided to the study director as soon as available.
(d) Where any of the components of the test, control, or reference article carrier mixture has an expiration date,
(a) Each study must have an approved written protocol that clearly indicates the specific objectives and all methods for the conduct of the study. The protocol must contain, where appropriate, the following information:
(1) A descriptive title and statement of the purpose of the study.
(2) Identification of test, control, and reference articles by:
(i) Name;
(ii) Chemical Abstract Service (CAS) number or code number, where such identification exists;
(iii) The name and address of the manufacturer(s); and
(iv) The person(s) determining their characteristics, as applicable.
(3) The name and contact information (including address, phone number, email address, and facsimile number) for the sponsor and the testing facility and the name and affiliation of the study director. Also, for multisite studies, the contact information for all persons conducting a phase of the nonclinical laboratory study, including all principal investigators and independent contributing scientists.
(4) The number, body weight range, sex, source of supply, species, strain, substrain, and age of the test system.
(5) The procedure for identification of the test system.
(6) A description of the experimental design, including the methods for the control of bias in the conduct of the study and the analysis and reporting of study test results and procedures to be followed when a study includes a peer review of any phase. For multisite studies, identification of which phases of the nonclinical laboratory study will be conducted by which person or persons.
(7) A description or identification, as applicable, of the diet used in the study as well as solvents, emulsifiers, and/or other materials used to solubilize or suspend the test, control, or reference articles, as applicable, before mixing with the carrier. The description must include specifications for acceptable levels of contaminants that are reasonably expected to be present in the dietary materials and are known to be capable of interfering with the purpose or conduct of the study if present at levels greater than established by the specifications.
(8) Each dosage level, expressed in milligrams per kilogram of body weight or other appropriate units, of the test, control, or reference article to be administered and the method and frequency of administration. For each test, control, or reference article that is mixed with a carrier for administration, limits for the results of concentration, uniformity, and stability testing and the name and address of the person conducting the testing.
(9) The type and frequency of tests, analyses, and measurements to be made.
(10) A list or description of the records to be maintained for the specific study. For multisite studies, the archive location(s) of study materials and records from all phases of the nonclinical laboratory study.
(11) The dated signature of the study sponsor, the study director, independent contributing scientists, principal investigators, and any other person conducting a phase of the nonclinical laboratory study, as applicable.
(12) A statement of the proposed statistical methods to be used.
(b) For studies that include the use of animals, a committee whose function is to ensure that the care and use of animals is appropriate and humane must review and approve the study before initiation of the study and approval must be documented.
(c) A statement that the study must be conducted in compliance with the provisions of this part, to be signed and dated by the study sponsor and testing facility management with executive responsibility, must be appended to the protocol.
(d) All changes in or revisions of an approved protocol and the reasons for the changes must be documented. These amendments to the protocol must be signed and dated by the study sponsor and the study director. For multisite studies, these amendments must also be signed and dated by all independent contributing scientists, principal investigators, and any other person conducting a phase of the nonclinical laboratory study affected by the amendment. Signed and dated amendments must be maintained with the protocol.
(e) A committee whose function is to ensure that the care and use of animals in studies is appropriate and humane must review and approve any protocol changes that would impact animal welfare before implementation and approval must be documented.
(a) The analytical methods used for all phases of a nonclinical laboratory study must be demonstrated to be accurate and of sufficient sensitivity to measure, with appropriate precision, the analytes in question.
(b) Test, control, and reference article characterization testing must be conducted as described in subpart F of this part.
(c) Humane care and ethical treatment of test animals must be considered in advance and upheld in conjunction with achieving study objectives. The attending veterinarian must be included in consultations regarding the impact of a given protocol on the welfare of test animals, in particular the recognition and alleviation of species-specific pain or distress and methods of euthanasia. The attending veterinarian must be deferred to when decisions regarding animal welfare arise, particularly when animals are in pain or distress.
(d) The nonclinical laboratory study must be conducted according to the protocol. The person responsible for a given phase of a nonclinical laboratory study must sign and date the protocol, as required in § 58.120(a)(11), before initiation of that phase of the study.
(e) Any change to the protocol must be approved as an amendment, as required in § 58.120(d), before implementation.
(f) The test systems must be monitored in conformity with the protocol.
(g) Specimens must be identified by test system, study, nature, and date of collection. This information must be located on the specimen container or must accompany the specimen in a manner that precludes error in the recording and storage of data.
(h) Records of gross findings for a specimen from post mortem observations must be available to a pathologist when examining that specimen histopathologically, unless specified otherwise in the study protocol.
(a) All data generated during the conduct of a nonclinical laboratory study must be accurate, legible, contemporaneous, original, and attributable (ALCOA). Also, data must be credible, internally consistent, and corroborated.
(b) All data must be recorded indelibly, directly, and promptly to a permanent medium at the time of observation and must identify unambiguously the person entering the data. Any change to any entry must be made so as not to obscure the original entry, must indicate the reason for such
(c) All data accrued as required in paragraphs (a) and (b) of this section must be included in the final study report.
(a) A final study report must be prepared for each nonclinical laboratory study and must include the following:
(1) Name and address of the testing facility and the dates on which the study was initiated and completed. For multisite studies, additionally the name and address of any person conducting a phase of the nonclinical laboratory study, including the location of all independent contributing scientists.
(2) Names of the attending veterinarians for all phases of the nonclinical laboratory study that included the use of animals.
(3) Objectives and procedures stated in the approved protocol, including any changes in the original protocol.
(4) Statistical methods employed for analyzing the data.
(5) Test, control, and reference articles identified by:
(i) Name;
(ii) Chemical Abstract Service (CAS) number or code number, where such identification exists;
(iii) Strength, purity, and composition or other appropriate characteristics, and for tobacco products as described in § 58.105(a);
(iv) The name and address of the manufacturer(s); and
(v) The name and address of the person(s) conducting the testing to define their characteristics, as applicable.
(6) Stability of test, control, and reference articles under the conditions of administration, including the name and address of the person(s) conducting the testing.
(7) A description of the methods used, including methods for the control of bias in the conduct of the study and the analysis and reporting of test results.
(8) A description of the test system used. Where applicable, the final study report must include the number of animals used, sex, body weight range, source of supply, species, strain and substrain, age, and procedure used for identification.
(9) A description of the dosage, dosage regimen, route of administration, and duration, including the results of testing conducted to determine the concentration, uniformity, and stability of mixtures of articles with carriers, as applicable, and the name and address of the person conducting the testing.
(10) A description of all circumstances that may have affected the quality or integrity of the data, including those documented by the study director as described in § 58.33(b)(9) and all health-related issues reported by an attending veterinarian or appropriately designated personnel during the course of the study as described in § 58.90(b) and (c).
(11) The name and affiliation of the study director, the names of all contributing scientists, principal investigators, and other professionals, the sponsor, and all supervisory personnel who were involved in the study or in the preparation or review of the final study report.
(12) A description of the transformations, calculations, or operations performed on the data, a summary and analysis of the data, and a statement of the conclusions drawn from the analysis.
(13) The original, and any amended, signed and dated reports of each of the contributing scientists, principal investigators, or any other person involved in the study, including each person who conducted an analysis or evaluation of data or specimens from the study after data generation was completed. These reports must contain all data generated.
(14) The locations where all specimens, reserve samples, raw data, and the final study report are to be stored.
(15) The statement prepared and signed by the responsible QAU as described in § 58.35(b)(11).
(16) A statement by the study director of the study's extent of compliance with this part, including a discussion of any study deviations found to impact the integrity of the study as described in § 58.185(a)(10).
(b) The final report must be signed and dated by the study director.
(c) Corrections or additions to a final report must be in the form of an amendment by the study director. The amendment must clearly identify that part of the final report that is being added to or corrected and the reasons for the correction or addition, and must be signed and dated by the person responsible.
(d) If for any reason a study is discontinued before completion, the study director must write, sign, and date a short summary report closing the study. This report must discuss the reasons for closure and must be archived, along with all study material, as described in § 58.190.
(a) All raw data, documentation, protocols, final reports, reserve samples, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study must be retained. Correspondence and other documents relating to interpretation and evaluation of data, other than those documents contained in the final study report, must also be retained.
(b) There must be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage must minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.
(c) Material retained or referred to in the archives must be indexed to permit expedient retrieval.
(d) All study material described in paragraph (a) of this section must be archived no later than 2 weeks after the study completion date (as defined in § 58.3).
(e) If a sponsor delays completion of the final study report, the study director must complete, sign, and date the final study report and archive all study material no later than 6 months after completion of the last draft of the final study report.
(f) If a study sponsor halts a nonclinical laboratory study before all protocol-required testing is completed, a decision that the study is discontinued must be made no later than 6 months after the study was stopped. Once the study has been determined to be discontinued, the study director must prepare a summary report, as required by § 58.185(d). The summary report and all study material must be archived no later than 2 weeks after the study director signs the summary report.
(g) An individual must be identified as responsible for the archives. Archiving specifications for multisite
(h) Only authorized personnel can have access to the archives.
(i) SOPs regarding archiving, required in § 58.81(b)(13), must include specific procedures for removal of study materials from the archives, including maximum timeframes material can remain outside of the archives.
(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter nor do they supersede any other legal requirements elsewhere in applicable statutes or regulations.
(b) Except as provided in paragraph (c) of this section, all raw data, documentation, protocols, final study reports, reserve samples, and specimens pertaining to a nonclinical laboratory study and required to be made by this part must be retained in the archive(s) for whichever of the following periods is shortest:
(1) A period of at least 2 years following the date on which an application or submission to FDA, in support of which the results of the nonclinical laboratory study were submitted, is approved or cleared by FDA, a premarket authorization is issued, or the application or submission is administratively closed. This requirement does not apply to studies supporting investigational new drug applications (INDs) or applications for investigational device exemptions (IDEs), records of which are governed by the provisions of paragraph (b)(2) of this section.
(2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to FDA in support of an application or submission.
(3) In other situations (
(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test, control, and reference articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, must be retained only as long as the quality of the preparation affords evaluation. In no case is retention required for longer periods than those set forth in paragraphs (a) and (b) of this section.
(d) Management with executive responsibility must ensure maintenance of the master schedule and copies of study protocols, as specified in SOPs as described in § 58.81(b)(13) and as specified in paragraphs (a) and (b) of this section. QAUs must maintain records of QAU inspections, as required by § 58.35(c) for the period of time specified in paragraphs (a) and (b) of this section.
(e) Summaries of training and experience and job descriptions required to be maintained by § 58.29(d) may be retained along with all other employment records for the length of time specified in paragraphs (a) and (b) of this section.
(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by § 58.63(b) and (c), must be retained for the length of time specified in paragraph (b) of this section.
(g) Records required by this part may be retained either as original records or as true copies that maintain the original intent and meaning and are made according to the person's SOPs as described in § 58.81(b)(22).
(h) If a facility conducting nonclinical laboratory testing goes out of business or for any reason can no longer serve as the archive site for a particular study, all raw data, documentation, and other material specified in this section must be transferred to the archives of the sponsor of the study or to another appropriate archive facility. The facility must notify FDA in writing (and the study sponsor if not the recipient of the study material) of the transfer no later than 10 working days after the transfer occurs.
(i) A copy of the notification of change of archive site, as required by paragraph (h) of this section, can serve as the amendment to the final study report required in § 58.185(c) when appended to that report.
(a) The purposes of disqualification are:
(1) To permit the exclusion from consideration of completed studies for which a phase was conducted by any person failing to comply with the requirements of the GLP regulations until it can be adequately demonstrated that such noncompliance did not occur during, or did not affect the validity or acceptability of data generated by, a particular study; and
(2) To exclude from consideration all studies completed after the date of disqualification until the disqualified person can satisfy the Commissioner that it will conduct studies in compliance with such regulations.
(b) The determination that a nonclinical laboratory study may not be considered in support of an application or submission to FDA does not, however, relieve the applicant of any obligation under any other applicable regulation to submit the results of the study to FDA.
FDA may disqualify any person conducting a phase of a nonclinical laboratory study upon finding that person repeatedly or deliberately failed to comply with one or more of the regulations set forth in this part (or any other regulations regarding such facilities in this chapter) or repeatedly or deliberately submitted false information in any required report.
(a) Whenever FDA has information indicating that grounds exist under § 58.202, which justifies disqualification of any person conducting a phase of a nonclinical laboratory study, FDA may issue to that person a written notice proposing that person be disqualified.
(a) If the Commissioner, after the regulatory hearing, or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, makes the findings required in § 58.202, the Commissioner issues a final order disqualifying that person. Such order must include a statement of the basis for that determination. Upon issuing a final order, the Commissioner notifies (with a copy of the order) the disqualified person of the action. The notification also will explain that a person who is disqualified under this part will be ineligible to receive a test article under part 511 of this chapter. A clinical investigator ineligible to receive a test article under part 511 of this chapter
(b) If the Commissioner, after a regulatory hearing or after the time for requesting a hearing expires without a request being made, upon an evaluation of the administrative record of the disqualification proceeding, does not make the findings required in § 58.202, the Commissioner issues a final order terminating the disqualification proceeding. Such order must include a statement of the basis for that determination. Upon issuing a final order the Commissioner notifies that person and provides a copy of the order.
(a) Once a person has been disqualified, each application and submission to FDA containing or relying upon any nonclinical laboratory study for which a phase was conducted by the disqualified person may be examined to determine whether such study was or would be essential to a decision. If it is determined that a study was or would be essential, FDA must also determine whether the study is acceptable, notwithstanding the disqualification of that person. Any study for which a phase was conducted by the disqualified person before disqualification may be presumed to be unacceptable, and the person relying on the study may be required to establish that the study was not affected by the circumstances that led to the disqualification,
(b) No nonclinical laboratory study for which any phase was begun by a disqualified person after the date of that person's disqualification can be considered in support of any application or submission to FDA, unless the disqualified person has been reinstated under § 58.219. The determination that a study may not be considered in support of an application or submission to FDA does not, however, relieve the applicant of any obligation under any other applicable regulation to submit the results of the study to FDA.
(a) Upon issuance of a final order disqualifying a person under § 58.206(a), the Commissioner may notify all or any interested persons. Such notice may be given at the discretion of the Commissioner whenever the Commissioner believes that such disclosure would further the public interest or would promote compliance with the GLP regulations set forth in this part. Such notice, if given, must include a copy of the final order issued under § 58.206(a) and must state that the disqualification constitutes a determination by FDA that nonclinical laboratory studies for which a phase was performed by the disqualified person will not be considered by FDA in support of any application or submission to FDA. If such notice is sent to another Federal Government agency, FDA will recommend that the agency also consider whether or not it should accept nonclinical laboratory studies for which a phase was performed by the disqualified person. If such notice is sent to any other person, it states that it is given because of the relationship between the disqualified person and the person being notified and that FDA is not advising or recommending that any action be taken by the person notified.
(b) A determination that a person has been disqualified and the administrative record regarding such determination are disclosable to the public under part 20 of this chapter.
(a) Disqualification of any person under this subpart is independent of, and neither in lieu of nor a precondition to, other proceedings or actions authorized by the Federal Food, Drug, and Cosmetic Act. FDA may, at any time, institute against a disqualified person or against the sponsor of a nonclinical laboratory study that has been submitted to FDA, or both, any appropriate judicial proceedings (civil or criminal) and any other appropriate regulatory action, including civil money penalties, in addition to or in lieu of, and before, simultaneously with, or subsequent to, disqualification. FDA may also refer the matter to another Federal, State, or local government law enforcement or regulatory agency for such action as that agency deems appropriate.
(b) FDA may refuse to consider any particular nonclinical laboratory study in support of an application or submission to FDA, if it finds that the study was not conducted according to the GLP regulations set forth in this part, without disqualifying any person that conducted one or more phases of the study or undertaking other regulatory action.
Termination of any person conducting a phase of a nonclinical laboratory study by a sponsor is independent of, and neither in lieu of nor a precondition to, proceedings or actions authorized by this subpart. If a sponsor terminates or suspends any person conducting a phase of a nonclinical laboratory study from further participation in a study that is being conducted as part of any application or submission to FDA that has been submitted to any Center of FDA (whether approved or cleared, premarket authorization issued, or administratively closed), the sponsor must notify that Center in writing within 15 working days of the action; the notice must include a statement of the reasons for such action. Suspension or termination of any person conducting a phase of a nonclinical laboratory study by a sponsor does not relieve the sponsor of any obligation under any other applicable regulation to submit the results of the study to FDA.
Any person that has been disqualified may be reinstated as an acceptable source of data for a phase of a nonclinical laboratory study to be submitted to FDA if the Commissioner determines, upon an evaluation of materials submitted by that person, as well as the results from an FDA inspection of that person, that procedures are in place that would allow that person to conduct a phase of future nonclinical laboratory studies in compliance with the GLP regulations set forth in this part. As noted in § 58.210(b), no nonclinical laboratory study for which a phase was begun by a disqualified person after the date of that person's disqualification is considered in support of any application or submission to FDA, unless that person has been reinstated. A disqualified person that wishes to be so reinstated must present in writing to the Commissioner reasons why it believes it should be reinstated and a detailed description of the corrective actions it has taken or intends to take to assure that the acts or omissions which led to its disqualification will not recur.
| 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 |