Page Range | 42707-43005 | |
FR Document |
Page and Subject | |
---|---|
80 FR 43003 - Establishing an Emergency Board To Investigate Disputes Between New Jersey Transit Rail and Certain of Its Employees Represented by Certain Labor Organizations | |
80 FR 43001 - Delegation of Authority To Transfer Certain Funds in Accordance With Section 610 of the Foreign Assistance Act of 1961 | |
80 FR 42997 - Delegation of Authority Pursuant to Section 8 of the United States-Israel Strategic Partnership Act of 2014 | |
80 FR 42806 - Sunshine Act; Notice of Meeting | |
80 FR 42843 - Sunshine Act Meetings; National Science Board | |
80 FR 42845 - Sunshine Act Meeting Notice | |
80 FR 42810 - Dollar Tree, Inc. and Family Dollar Stores, Inc.; Analysis of Proposed Consent Orders To Aid Public Comment | |
80 FR 42796 - List of Correspondence From April 1, 2014 Through June 30, 2014 and July 1, 2014 Through September 30, 2014 | |
80 FR 42806 - Agency Information Collection Activities; Proposed Collection; Comment Request | |
80 FR 42846 - GE Hitachi Nuclear Energy; Vallecitos Nuclear Center | |
80 FR 42819 - Submission to OMB for Review; Federal Acquisition Regulation; U.S.-Flag Air Carriers Statement | |
80 FR 42789 - Foreign-Trade Zone (FTZ) 277-Western Maricopa County, Arizona; Notification of Proposed Production Activity; The Cookson Company, Inc. (Rolling Steel Doors); Goodyear, Arizona | |
80 FR 42774 - Approval and Promulgation of Implementation Plans; Mississippi: Miscellaneous Changes | |
80 FR 42730 - Approval and Promulgation of Implementation Plans; Texas; Low Reid Vapor Pressure Fuel Regulations | |
80 FR 42763 - Approval and Promulgation of Air Quality Implementation Plans; Texas; Low Reid Vapor Pressure Fuel Regulations | |
80 FR 42777 - Approval and Promulgation of Implementation Plans; Georgia Infrastructure Requirements for the 2008 8-Hour Ozone National Ambient Air Quality Standards | |
80 FR 42791 - Record of Decision for the Final NOAA Restoration Center Programmatic Environmental Impact Statement | |
80 FR 42802 - Pesticide Product Registration; Receipt of Applications for New Active Ingredients | |
80 FR 42739 - TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting | |
80 FR 42763 - Approval and Promulgation of Implementation Plans; Florida; Combs Oil Company Variance | |
80 FR 42822 - Informational Meeting: The Importation and Exportation of Infectious Biological Agents, Infectious Substances and Vectors; Public Webcast | |
80 FR 42819 - Multi-Agency Informational Meeting Concerning Compliance With the Federal Select Agent Program; Public Webcast | |
80 FR 42765 - Approval and Promulgation of Implementation Plans; Alabama; Infrastructure Requirements for the 2008 Lead National Ambient Air Quality Standards | |
80 FR 42789 - Polyethylene Retail Carrier Bags From Thailand: Notice of Initiation and Preliminary Results of Antidumping Duty Changed Circumstances Review | |
80 FR 42842 - Agency Information Collection Activities; Information Collection Request; Labor Organization and Auxiliary Reports Comment Period Extension | |
80 FR 42828 - Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness | |
80 FR 42827 - List of Bulk Drug Substances That May Be Used by an Outsourcing Facility To Compound Drugs for Use in Animals; Extension of Nomination Period | |
80 FR 42863 - Culturally Significant Objects Imported for Exhibition Determinations: “New Objectivity: Modern German Art in the Weimar Republic 1919-1933” Exhibition | |
80 FR 42864 - Culturally Significant Objects Imported for Exhibition Determinations: “Strength and Splendor: Wrought Iron From the Musée Le Secq des Tournelles” Exhibition | |
80 FR 42829 - Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry; Availability | |
80 FR 42823 - Agency Information Collection Activities; Proposed Collection; Comment Request; Market Claims in Direct-to-Consumer Prescription Drug Print Ads | |
80 FR 42864 - Culturally Significant Objects Imported for Exhibition Determinations: “Ancient Egypt Transformed: The Middle Kingdom” Exhibition | |
80 FR 42791 - North Pacific Fishery Management Council; Public Meeting | |
80 FR 42790 - Fisheries of the South Atlantic; Southeast Data, Assessment and Review (SEDAR); Public Meetings | |
80 FR 42841 - Trade Adjustment Assistance Program; Designation of Certifying Officers | |
80 FR 42795 - Judicial Proceedings Since Fiscal Year 2012 Amendments Panel (Judicial Proceedings Panel); Notice of Federal Advisory Committee Meeting | |
80 FR 42961 - Syed Jawed Akhtar-Zaidi, M.D.; Decision and Order | |
80 FR 42839 - Certain Resealable Packages With Slider Devices; Institution of Investigation | |
80 FR 42857 - Crescent Capital Group, LP; Notice of Application | |
80 FR 42723 - Regulatory Hearing Before the Food and Drug Administration; Technical Amendment | |
80 FR 42803 - Agency Information Collection Activities: Announcement of Board Approval Under Delegated Authority and Submission to OMB | |
80 FR 42826 - David J. Brancato: Grant of Special Termination; Final Order Terminating Debarment | |
80 FR 42840 - Notice of Lodging of Proposed Consent Decree Under the Clean Air Act | |
80 FR 42708 - Amendment of Class B Airspace; New Orleans, LA | |
80 FR 42787 - Meeting Notice of the National Agricultural Research, Extension, Education, and Economics Advisory Board | |
80 FR 42835 - Technical Mapping Advisory Council | |
80 FR 42837 - Endangered and Threatened Wildlife and Plants; Nevada Department of Wildlife; Application for Enhancement of Survival Permit; Proposed Programmatic Candidate Conservation Agreement With Assurances for the Relict Leopard Frog; Clark County, Nevada | |
80 FR 42822 - Advisory Board on Radiation and Worker Health (ABRWH or Advisory Board), National Institute for Occupational Safety and Health (NIOSH) | |
80 FR 42707 - Airworthiness Directives; General Electric Company Turbofan Engines | |
80 FR 42761 - Proposed Establishment of Restricted Area R-2507W; Chocolate Mountains, CA | |
80 FR 42864 - Notice of Final Federal Agency Actions on Proposed Highway in Hawaii | |
80 FR 42820 - Proposed Data Collection Submitted for Public Comment and Recommendations | |
80 FR 42843 - Notice of Intent To Seek Approval To Establish an Information Collection | |
80 FR 42840 - Agency Information Collection Activities; Proposed eCollection; eComments Requested; Unfair Immigration-Related Employment Practices Complaint Form | |
80 FR 42794 - Charter Renewal of Department of Defense Federal Advisory Committees | |
80 FR 42797 - Linden VFT, LLC v. PJM Interconnection, L.L.C.; Notice of Amended Complaint | |
80 FR 42797 - Combined Notice of Filings #2 | |
80 FR 42798 - Combined Notice of Filings #1 | |
80 FR 42798 - Combined Notice of Filings #2 | |
80 FR 42800 - Combined Notice of Filings #1 | |
80 FR 42802 - Caithness Long Island II, LLC v. New York Independent System Operator, Inc.; Notice of Complaint | |
80 FR 42865 - Agency Request for Emergency Processing of Collection of Information by the Office of Management and Budget | |
80 FR 42756 - Airworthiness Directives; The Boeing Company Airplanes | |
80 FR 42823 - Proposed Information Collection Activity; Comment Request | |
80 FR 42847 - New Postal Product | |
80 FR 42723 - Update to Product Lists | |
80 FR 42825 - Prescription Drug User Fee Act; Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization; Request for Notification of Stakeholder Intention To Participate | |
80 FR 42733 - Approval and Promulgation of Implementation Plans; North Carolina; Nitrogen Dioxide and Sulfur Dioxide National Ambient Air Quality Standards Changes | |
80 FR 42777 - Approval and Promulgation of Implementation Plans; North Carolina; Nitrogen Dioxide and Sulfur Dioxide National Ambient Air Quality Standards Revisions | |
80 FR 42842 - Arts Advisory Panel Meetings | |
80 FR 42747 - Fisheries of the Northeastern United States; Atlantic Surfclam and Ocean Quahog Fisheries | |
80 FR 42845 - Virgil C. Summer Nuclear Station, Units 2 and 3 | |
80 FR 42788 - Information Collection Activity; Comment Request | |
80 FR 42735 - Hazardous Waste Management System; Identification and Listing of Hazardous Waste Amendment | |
80 FR 42787 - Submission for OMB Review; Comment Request | |
80 FR 42832 - Texas; Amendment No. 3 to Notice of a Major Disaster Declaration | |
80 FR 42835 - Texas; Amendment No. 4 to Notice of a Major Disaster Declaration | |
80 FR 42830 - Final Flood Hazard Determinations | |
80 FR 42832 - Final Flood Hazard Determinations | |
80 FR 42726 - Approval and Promulgation of Air Quality Implementation Plans; Illinois; Midwest Generation Variances | |
80 FR 42820 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Health Disparities Subcommittee (HDS) | |
80 FR 42860 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Amending the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services | |
80 FR 42856 - Self-Regulatory Organizations; Miami International Securities Exchange LLC; Notice of Filing and Immediate Effectiveness of a Proposed Rule Change To Amend Exchange Rules 307 and 309 To Extend the SPY Pilot Program | |
80 FR 42847 - Self-Regulatory Organizations; The NASDAQ Stock Market LLC; Notice of Filing of Proposed Rule Change Relating to the Listing and Trading of Shares of the First Trust SSI Strategic Convertible Securities ETF of First Trust Exchange-Traded Fund IV | |
80 FR 42862 - Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Relating to the Exchange's Pricing Schedule under Section VIII With Respect to Execution and Routing of Orders in Securities Priced at $1 or More per Share | |
80 FR 42793 - Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Hearings | |
80 FR 42830 - Eunice Kennedy Shriver National Institute of Child Health and Human Development; Notice of Closed Meeting | |
80 FR 42830 - Center for Scientific Review; Notice of Closed Meeting | |
80 FR 42830 - Eunice Kennedy Shriver National Institute of Child Health and Human Development Notice of Closed Meeting | |
80 FR 42866 - Public Input on Expanding Access to Credit Through Online Marketplace Lending | |
80 FR 42838 - National Earthquake Prediction Evaluation Council | |
80 FR 42839 - Scientific Earthquake Studies Advisory Committee Meeting | |
80 FR 42792 - Fisheries of the Exclusive Economic Zone Off Alaska; Bering Sea and Aleutian Islands Crab Rationalization Cost Recovery Program | |
80 FR 42760 - Proposed Amendment of Class E Airspace; Portland, OR | |
80 FR 42727 - Approval and Promulgation of Implementation Plans; Texas; Revisions to the New Source Review State Implementation Plan; Flexible Permit Program | |
80 FR 42753 - Bird Strike Requirements for Transport Category Airplanes | |
80 FR 42836 - Receipt of Applications for Endangered Species Permits | |
80 FR 42869 - Protection of Stratospheric Ozone: Change of Listing Status for Certain Substitutes Under the Significant New Alternatives Policy Program | |
80 FR 42710 - Final Action Concerning Review of Interpretations of Magnuson-Moss Warranty Act; Rule Governing Disclosure of Written Consumer Product Warranty Terms and Conditions; Rule Governing Pre-Sale Availability of Written Warranty Terms; Rule Governing Informal Dispute Settlement Procedures; and Guides for the Advertising of Warranties and Guarantees |
Rural Utilities Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
National Institutes of Health
Federal Emergency Management Agency
Fish and Wildlife Service
Geological Survey
Drug Enforcement Administration
Employment and Training Administration
Labor-Management Standards Office
National Endowment for the Arts
Federal Aviation Administration
Federal Highway Administration
Federal Railroad Administration
Consult the Reader Aids section at the end of this issue for phone numbers, online resources, finding aids, and notice of recently enacted public laws.
To subscribe to the Federal Register Table of Contents LISTSERV electronic mailing list, go to http://listserv.access.thefederalregister.org and select Online mailing list archives, FEDREGTOC-L, Join or leave the list (or change settings); then follow the instructions.
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all General Electric Company (GE) GEnx turbofan engine models. This AD was prompted by reports of GEnx-1B and GEnx-2B engines experiencing power loss in ice crystal icing (ICI) conditions. This AD precludes the use of full authority digital engine control (FADEC) software, version B175 or earlier, in GEnx-1B engines, and the use of FADEC software, version C065 or earlier, in GEnx-2B engines. We are issuing this AD to prevent engine failure, loss of thrust control, and damage to the airplane.
This AD is effective August 24, 2015.
For service information identified in this AD, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email:
You may examine the AD docket on the Internet at
Christopher McGuire, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email:
We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 by adding an AD that would apply to all General Electric Company (GE) GEnx turbofan engine models. The NPRM published in the
We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the NPRM and the FAA's response to each comment.
United Airlines (United) commented that this AD should not be issued until after GEnx-1B FADEC software version B185 is released. United noted that software version B185 will provide a greater level of protection from damage to the engine due to ice crystal icing. United indicated that the proposed AD would allow engines to operate with FADEC software versions B178 and B180, which do not provide the protection of software version B185.
We do not agree. We find that precluding use of FADEC software version B175 or earlier provides an adequate level of safety for inadvertent encounters in ICI environments. We did not change this AD.
United requested that we withdraw the proposed rule and, instead supersede AD 2013-24-01 (78 FR 70851, November 27, 2013), which requires revising the airplane flight manual for Model 747-8 and 747-8F series airplanes and Model 787-8 airplanes powered by GEnx engines.
We do not agree. Our AD addresses the susceptibility of GEnx engines when operating inadvertently in ICI conditions. AD 2013-24-01 (78 FR 70851, November 27, 2013) is setting operational limitations on Boeing Model 747-8, 747-8F, and 787-8 airplanes equipped with GEnx engines. The ADs have different purposes, and superseding AD 2013-24-01 is outside the scope of this AD. We did not withdraw this AD.
The Boeing Company and the General Electric Company expressed support for the proposed rule.
We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting this AD as proposed.
We estimate that this AD affects 80 engines installed on airplanes of U.S. registry. We also estimate that it will take about 1 hour per engine to comply with this AD. The average labor rate is $85 per hour. No parts are required. Based on these figures, we estimate the total cost of the AD to U.S. operators to be $6,800.
Title 49 of the United States Code specifies the FAA's authority to issue
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
This AD will not have federalism implications under Executive Order 13132. This AD 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.
For the reasons discussed above, I certify that this AD:
(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),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD is effective August 24, 2015.
None.
This AD applies to all General Electric Company (GE) GEnx-1B model turbofan engines with full authority digital engine control (FADEC) software version B175 or earlier, installed, and GEnx-2B model turbofan engines with FADEC software version C065 or earlier, installed.
This AD was prompted by reports of GEnx-1B and GEnx-2B engines experiencing power loss in ice crystal icing (ICI) conditions. We are issuing this AD to prevent engine failure, loss of thrust control, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done.
(1) Thirty days after the effective date of this AD, do not operate any GE GEnx-1B engine with FADEC software version B175 or earlier, installed in the electronic engine control (EEC).
(2) Thirty days after the effective date of this AD, do not operate any GE GEnx-2B engine with FADEC software version C065 or earlier, installed in the EEC.
The Manager, Engine Certification Office, FAA, may approve AMOCs to this AD. Use the procedures found in 14 CFR 39.19 to make your request. You may email your request to:
(1) For more information about this AD, contact Christopher McGuire, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA 01803; phone: 781-238-7120; fax: 781-238-7199; email:
(2) GE GEnx-1B Service Bulletin (SB) No. 73-0036 R00, dated January 6, 2015, and GE GEnx-2B SB No. 73-0035 R00, dated September 16, 2014, which are not incorporated by reference in this AD, can be obtained from GE using the contact information in paragraph (g)(3) of this AD.
(3) For service information identified in this proposed AD, contact General Electric Company, GE Aviation, Room 285, 1 Neumann Way, Cincinnati, OH 45215; phone: 513-552-3272; email:
(4) You may view this service information at the FAA, Engine & Propeller Directorate, 12 New England Executive Park, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
None.
Federal Aviation Administration (FAA), DOT.
Final rule, technical amendment.
This action amends Class B airspace at the Louis Armstrong New Orleans International Airport, New Orleans, LA, by removing reference to the Instrument Landing System (ILS) Runway 10 Outer Compass Locator (LOM) from the text header information and surface area (Area A) description and replacing it in the Area A description with the geographic latitude/longitude coordinates of the LOM. This change is necessary due to the planned decommissioning of the LOM navigation aid. The Louis Armstrong New Orleans International Airport and New Orleans Naval Air Station Joint Reserve Base (Alvin Callender Field) airport names and airport reference point (ARP) geographic coordinates are also updated. The St. Charles and Lakefront airports, used in the Class B description, are added in the legal description text header information, as well as, the Harvey VHF Omnidirectional Range/Tactical Air Navigation (VORTAC) navigation aid. Lastly, general editing of the legal description is accomplished to improve clarity. These changes are editorial only to match existing FAA aeronautical database information and do not alter the current charted boundaries or altitudes or the ATC procedures for the New Orleans Class B airspace area.
Effective Date: 0901 UTC, November 12, 2015. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual
FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and Regulations Group, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
Colby Abbott, Airspace Policy and Regulations Group, Office of Airspace Services, Federal Aviation Administration, 800 Independence Avenue SW., Washington, DC 20591; telephone: (202) 267-8783.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends the Class B airspace at the Louis Armstrong New Orleans International Airport, New Orleans, LA.
The New Orleans Class B airspace area was established as a Terminal Control Area (TCA) on July 17, 1975 (40 FR 20269, May 9, 1975). In 1993, as part of the Airspace Reclassification Final Rule (56 FR 65638, December 17, 1991), the term “terminal control area” was replace by “Class B airspace area.” Because there was no VHF Omnidirectional Range (VOR) navigation aid located on the Louis Armstrong New Orleans International Airport (formerly New Orleans International Airport-Moisant Field), the Class B airspace area was designed using the ARP latitude/longitude coordinates as the center point. When established, the surface area (Area A) included an extension, described using an arc around the ILS Runway 10 LOM. In October 2015, the ILS Runway 10 LOM is being decommissioned because it cannot be cost-effectively maintained any longer. To retain the existing charted boundaries of the New Orleans Class B airspace surface area, the FAA is using the geographic latitude/longitude coordinates of the ILS Runway 10 LOM being decommissioned to describe the Class B airspace Area A extension. All references to the LOM in the New Orleans Class B airspace description are being removed and reference to the LOM in the Area A description is being replaced by a point using the geographic latitude/longitude coordinates of the ILS Runway 10 LOM.
In preparation of updating the New Orleans Class B airspace description, the FAA reviewed the aeronautical database and determined that the New Orleans International Airport-Moisant Field name had changed to the Louis Armstrong New Orleans International Airport, the NAS New Orleans-Alvin Callender Field name had changed to the New Orleans Naval Air Station Joint Reserve Base (Alvin Callender Field), and the respective ARP geographic coordinates for both had also changed. Further, the Class B airspace area legal description used the St. Charles and Lakefront airports in the Area C and Area D descriptions, respectively, and the Harvey VORTAC in the Area C description, but the airports and VORTAC information was omitted from the Class B description text header. This action makes the required edits above. Lastly, the descriptions have been edited to eliminate confusing wording and improve clarity.
The FAA is taking this action so that the current boundaries of the New Orleans Class B airspace area are not affected by the decommissioning of the ILS Runway 10 LOM.
This document amends FAA Order 7400.9Y, airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the
The FAA is amending Title 14 of the Code of Federal Regulations (14 CFR) part 71 by amending the New Orleans Class B airspace legal description for the Louis Armstrong New Orleans International Airport, New Orleans, LA. This action removes all references to the “ILS Runway 10 Outer Compass Locator” and replaces it in the Area A description with a point located at the same latitude/longitude geographic coordinates of the LOM. This rule updates the New Orleans International Airport-Moisant Field name to the Louis Armstrong New Orleans International Airport, and the ARP Geographic coordinates from “lat. 29°59′36″ N., long. 90°15′28″ W.” to “lat. 29°59′36″ N., long. 90°15′33″ W.” Additionally, it updates the NAS New Orleans-Alvin Callender Field name to New Orleans Naval Air Station Joint Reserve Base (Alvin Callender Field), and the ARP geographic coordinates from “lat. 29°49′31″ N., long. 90°02′06″ W.” to “lat. 29°49′38″ N., long. 90°01′36″ W.” This action also adds the St. Charles and Lakefront Airports and their associated ARP geographic coordinates, as well as the Harvey VORTAC and its geographic coordinates to the legal description text header information. Lastly, the Class B airspace description is edited to remove confusing wording and improve clarity.
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. Since this is a routine matter that only affects air traffic procedures and air navigation, it is certified that this rule, when promulgated, does not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Since this action merely involves editorial changes in the legal description of the New Orleans Class B airspace area, and does not involve a change in the boundaries or altitudes or operating requirements of that airspace, notice and public procedure under 5 U.S.C. 553(b) are unnecessary.
The FAA has determined that this action qualifies for categorical exclusion under the National Environmental Policy Act in accordance with 311a, FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures.” This airspace action is an editorial change only and is not expected to cause any potentially significant environmental impacts, and no extraordinary circumstances exist that warrant preparation of an environmental assessment.
Airspace, Incorporation by reference, Navigation (Air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120, E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Boundaries.
Area A. That airspace extending upward from the surface to and including 7,000 feet MSL within a 7-mile radius of the Louis Armstrong New Orleans International Airport and within a 1.5-mile radius of a point located at lat. 30°01′31″ N., long. 90°24′00″ W., excluding that airspace north of the south shore of Lake Pontchartrain, that airspace within and underlying Area C described hereinafter, and that airspace 0.5 mile either side of a line extending from lat. 30°01′10″ N., long. 90°07′47″ W. to lat. 29°59′31″ N., long. 90°15′37″ W. to lat. 30°03′37″ N., long. 90°22′10″ W.
Area B. That airspace extending upward from 600 feet MSL to and including 7,000 feet MSL north of the south shore of Lake Pontchartrain within a 7-mile radius of the Louis Armstrong New Orleans International Airport, excluding that airspace 0.5 mile either side of a line extending from lat. 30°01′10″ N., long. 90°07′47″ W. to lat. 29°59′31″ N., long. 90°15′37″ W. to lat. 30°03′37″ N., long. 90°22′10″ W.
Area C. That airspace extending upward from 1,000 feet MSL to and including 7,000 feet MSL within an area bounded by a line beginning 7 miles southwest of the Louis Armstrong New Orleans International Airport on the north shore of the Mississippi River; thence east along the Mississippi River north shore to a point 0.5 mile east of and parallel to the St. Charles Airport runway 17/35 extended centerline; thence southeast along a line 0.5 miles east of and parallel to the St. Charles Airport runway 17/35 extended centerline to the Southern Pacific Railroad track; thence southwest along the Southern Pacific Railroad track to a point 4 miles southwest of the Louis Armstrong New Orleans International Airport; thence counterclockwise along a 4-mile radius of the Louis Armstrong New Orleans International Airport to the north shore of the Mississippi River; thence east along the north shore of the Mississippi River to the Harvey VORTAC 300° radial; thence southeast along the Harvey VORTAC 300° radial to a point 7 miles southeast of the Louis Armstrong New Orleans International Airport; thence clockwise along the 7-mile radius of the Louis Armstrong New Orleans International Airport to the point of beginning.
Area D. That airspace extending upward from 2,000 feet MSL to and including 7,000 feet MSL within a 15-mile radius of the Louis Armstrong New Orleans International Airport, excluding that airspace within Areas A, B, and C previously described, that airspace within Area F described hereinafter, that airspace within the Lakefront Airport Class D airspace area, and that airspace within a 4.4-mile radius of New Orleans Naval Air Station Joint Reserve Base (Alvin Callender Field).
Area E. That airspace extending upward from 4,000 feet MSL to and including 7,000 feet MSL within a 20-mile radius of the Louis Armstrong New Orleans International Airport, excluding that airspace within Areas A, B, C, and D previously described, and that airspace within Area F described hereinafter.
Area F. That airspace extending upward from the surface to 1,000 feet MSL and from 2,000 feet MSL to 7,000 feet MSL 0.5 mile either side of a line extending from lat. 30°01′10″ N., long. 90°07′47″ W. to lat. 29°59′31″ N., long. 90°15′37″ W. to lat. 30°03′37″ N., long. 90°22′10″ W., excluding that airspace below 600 feet MSL north of the south shore of Lake Pontchartrain.
Federal Trade Commission.
Final revised Interpretations; Final clerical changes to Rules; and Conclusion of review proceedings.
The Federal Trade Commission (“the Commission”) is announcing its final action in connection with the review of a set of warranty-related Rules and Guides: The Interpretations of the Magnuson-Moss Warranty Act (“Interpretations” or “part 700”); the Rule Governing Disclosure of Written Consumer Product Warranty Terms and Conditions (“Rule 701”); the Rule Governing Pre-Sale Availability of Written Warranty Terms (“Rule 702”); the Rule Governing Informal Dispute Settlement Procedures (“Rule 703”); and the Guides for the Advertising of Warranties and Guarantees (“the Guides” or “part 239”). The Interpretations represent the Commission's views on various aspects of the Magnuson-Moss Warranty Act (“the Act” or “MMWA”), and are intended to clarify the Act's requirements. Rule 701 specifies the information that must appear in a written warranty on a consumer product. Rule 702 details the obligations of sellers and warrantors to make warranty information available to consumers prior to purchase. Rule 703 specifies the minimum standards required for any informal dispute settlement mechanism that is incorporated into a written consumer product warranty, and that the consumer must use prior to pursuing any legal remedies in court. The Guides are intended to help advertisers avoid unfair or deceptive practices in the advertising of warranties or guarantees.
The changes to the Interpretations and Rules will take effect on July 20, 2015.
Svetlana S. Gans, Staff Attorney, Division of Marketing Practices, Federal Trade Commission, Washington, DC 20580, (202) 326-3708.
The MMWA, 15 U.S.C. 2301-2312, is the federal law that governs consumer product warranties. Passed by Congress in 1975, the Act requires manufacturers and sellers of consumer products to provide consumers with detailed information about warranty coverage before and after the sale of a warranted product. When consumers believe they are the victim of an MMWA violation, the statute provides them the ability to proceed through a warrantor's informal dispute resolution process or sue in court. On August 23, 2011, the Commission published a
In addition, under the APA, a substantive final rule is required to take effect at least 30 days after publication in the
In addition, Commission staff has recently issued a number of guidance documents to better educate consumers and businesses concerning their rights and obligations under the MMWA. For example, in order to cure perceived misconceptions in the marketplace, staff issued and recently updated a consumer alert stating that the MMWA prohibits warrantors from voiding an automotive warranty merely because a consumer uses an aftermarket or recycled part or third-party services to repair one's vehicle (subject to certain exceptions).
The MMWA, 15 U.S.C. 2301-2312, which governs written warranties on consumer products, was signed into law on January 4, 1975. After the Act was passed, the Commission received many questions concerning the Act's requirements. In responding to these inquiries, the Commission initially published, on June 18, 1975, a policy statement in the
These Interpretations are intended to clarify the Act's requirements for manufacturers, importers, distributors, and retailers. The Interpretations cover a wide range of subjects, including: The types of products considered “consumer products” under the Act; the differences between a “written warranty,” “service contract” and “insurance”; written warranty term requirements; the use of warranty registration cards under full and limited warranties; and illegal tying arrangements under Section 2302(c) of the Act. These Interpretations, like industry guides, are administrative interpretations of the law. Therefore, they do not have the force of law and are not independently enforceable. The Commission can take action under the Federal Trade Commission Act (“FTC Act”) and the MMWA, however, against claims that are inconsistent with the Interpretations if the Commission has reason to believe that such claims are unfair or deceptive practices under Section 5 or violate the MMWA.
Section 2302(a) of the MMWA authorizes the Commission to promulgate rules regarding the disclosure of written warranty terms. Accordingly, on December 31, 1975, the Commission published in the
Under Rule 701, warranty information must be disclosed in simple, easily understandable, and concise language in a single document. In promulgating Rule 701, the Commission determined that material facts about product warranties, the nondisclosure of which would be deceptive or misleading, must
Section 2302(b)(1)(A) of the MMWA directs the Commission to prescribe rules requiring that the terms of any written warranty on a consumer product be made available to the prospective purchaser prior to the sale of the product. Accordingly, on December 31, 1975, the Commission published Rule 702. Rule 702 establishes requirements for sellers and warrantors to make the text of any warranty on a consumer product available to the consumer prior to sale. Among other things, Rule 702 requires sellers to make warranties readily available either by: (1) Displaying the warranty document in close proximity to the product or (2) furnishing the warranty document on request and posting signs in prominent locations advising consumers that warranties are available. The Rule requires warrantors to provide materials to enable sellers to comply with the Rule's requirements, and also sets out the methods by which warranty information can be made available prior to the sale if the product is sold through catalogs, mail order, or door-to-door sales. As discussed further below, Rule 702 also applies to online sales.
Section 2310(a)(2) of the MMWA directs the Commission to prescribe the minimum standards for any informal dispute settlement mechanism (“IDSM” or “Mechanism”) that a warrantor, by including a “prior resort” clause in its written warranty, requires consumers to use before they may file suit under the Act to obtain a remedy for warranty non-performance. Accordingly, on December 31, 1975, the Commission published Rule 703. Rule 703 contains extensive procedural safeguards for consumers that a warrantor must incorporate in any IDSM. These standards include, but are not limited to, requirements concerning the IDSM's structure (
The Guides for the Disclosure of Warranties and Guarantees, codified in part 239, provide guidance concerning warranty and guarantee disclosures. Part 239 intends to help advertisers avoid unfair and deceptive practices when advertising warranties and guarantees. The 1985 Guides advise that advertisements mentioning warranties or guarantees should contain a disclosure that the actual warranty document is available for consumers to read before they buy the advertised product. In addition, the Guides set forth advice for using the terms “satisfaction guarantee,” “lifetime,” and similar representations. Finally, the Guides advise that sellers or manufacturers should not advertise that a product is warranted or guaranteed unless they promptly and fully perform their warranty obligations. The Guides are advisory in nature.
Twenty-nine entities and individuals submitted public comments in response to the August 23, 2011
Generally, the MMWA prohibits warrantors from conditioning warranties on the consumer's use of a replacement product or repair service identified by brand or name, unless the article or service is provided without charge to the consumer or the warrantor has received a waiver.
Several commenters
The MMWA incorporates principles under Section 5 of the FTC Act that prohibit warrantors from disseminating deceptive statements concerning warranty coverage. The MMWA gives the Commission the authority to restrain a warrantor from making a deceptive warranty, which is defined as a warranty that “fails to contain information which is necessary in light of all of the circumstances, to make the warranty not misleading to a reasonable individual exercising due care.”
Moreover, misstatements leading a consumer to believe that the consumer's warranty is void because a consumer used “unauthorized” parts or service may also be deceptive under Section 5 of the FTC Act.
Therefore, to clarify the tying prohibition of the MMWA, § 700.10(c) will be changed as described in amendatory instruction 11.
Several commenters
The Commission declines to make this change. As an initial matter, the MMWA, unlike the Clean Air Act, does not require a mandatory disclaimer on all warranties. Further, the current record lacks sufficient evidence to justify the imposition of a mandatory warranty disclosure requirement for a subset of warrantors.
One commenter
Several commenters ask the Commission to better educate consumers on how to identify and report warranty tying in the marketplace. In July 2011, the staff
Several commenters
The Commission's Interpretations state that a warrantor is not precluded from denying warranty coverage for defects or damage caused by the use of “unauthorized” parts or service if the warrantor “demonstrates” that the “unauthorized” parts or service caused a defect or damage to the vehicle.
The Commission does not believe a change is warranted because the current record lacks sufficient evidence showing that warrantors routinely deny warranty coverage orally without demonstrating to the consumer that the “unauthorized” part or service caused damage to the vehicle. At this time, the Commission believes the existing Interpretations adequately address this issue.
Simply providing a consumer with a copy of a service bulletin or denying coverage with a bald, unsupported statement that the “unauthorized” parts or service caused the vehicle damage would be insufficient under the Commission's existing Interpretations. Warrantors must have a basis for warranty denials by demonstrating to consumers that the use of “unauthorized” parts or service caused the defect or damage to the vehicle. Further, denying warranty coverage by simply pointing to a service bulletin that informs consumers that only “authorized” parts or service should be used to maintain warranty coverage may also violate the MMWA's proscriptions against tying.
Two commenters
Existing staff guidance provides that “sellers of consumer products that merely sell service contracts as agents of service contract companies and do not themselves extend written warranties” do not “enter into” service contracts.
In keeping with the MMWA, the Commission's Interpretations concerning parties “actually making” a written warranty provide that a supplier who simply distributes or sells a consumer product warranted by another person or business is not liable for failure of the written warranty to comply with the Act.
The second commenter, the Center for Auto Safety, seeks clarity to address the discrepancy it perceives between the MMWA and the staff's guidance concerning the circumstances under which an auto dealer (
The Commission does not believe any discrepancy exists. The confusion may stem from the usage of the word “supplier,” defined in the MMWA as: “any person engaged in the business of making a consumer product directly or indirectly available to consumers.”
Suppliers, however, are not immune from liability. If a supplier sells a service contract that obligates it to perform under the contract, it will be deemed to have entered into the service contract within the meaning of the statute. In addition, suppliers who extend service contracts utilizing misrepresentations or material omissions may be subject to liability under the MMWA and Section 5 of the FTC Act.
Commenters
NCLC urges the Commission to amend § 700.10 to clarify that the MMWA covers consumer leases.
The Commission does not agree with the view held by a minority number of courts that lessees cannot be a “consumer” under the MMWA because each prong of the “consumer” definition
NCLC urges the Commission to reconsider its 2002 opinion letter
Although the Commission found that 50/50 warranties may violate the Act in certain circumstances in its 1999 rule review, in 2002, the Commission clarified its position on 50/50 warranties. The Commission stated that the Act prohibits warrantors from conditioning their warranties on the use of branded parts or service where the warranted articles or services are “severable from the dealer's responsibilities under the warranty.”
NCLC asserts that the Commission has incorrectly interpreted the meaning of the McCarran-Ferguson Act in § 700.11(a).
NCLC states that the Interpretation is inconsistent with both the McCarran-Ferguson Act and Supreme Court precedent.
The Commission agrees that the McCarran-Ferguson Act's “invalidate, impair, or supersede” standard is applicable to the MMWA. The Commission will revise the Interpretation as described in amendatory instruction 12.
SEMA asks the Commission to amend the definition of “consumer product” to include specialty equipment.
The request for public comment specifically asked whether the Commission should amend the Rules to cover service-contract disclosures.
On the other hand, two commenters, Mr. Evan Johnson and NCLC, argue that the Commission should amend the Rules to prescribe the manner and form in which service-contract terms are disclosed. Mr. Johnson argues that service contracts have been a “huge source” of consumer complaints. “Many of these complaints concern marketing but many also arise from the unclear wording and structure of the contracts.”
The Commission does not believe such a rule amendment is needed because the MMWA and Section 5 already require that warrantors, suppliers, and service contract providers clearly and conspicuously disclose service contract terms and conditions. Section 2306(b) of the Act provides: “[n]othing in this chapter shall be construed to prevent a supplier or warrantor from entering into a service contract with the consumer in addition to or in lieu of a written warranty if such contract fully, clearly, and conspicuously discloses its terms and conditions in simple and readily understood language.”
Generally, under Rule 702, sellers who offer written warranties on consumer products must include certain information in their warranties and make them available for review at the point of purchase. The Commission's request for public comment asked whether the Commission should amend Rule 702 to specifically address making warranty documents accessible online.
The Commission received seven comments on this specific question.
Three commenters ask the Commission to specifically reference Internet sales in Rule 702 and provide additional guidance on how retailers can comply with the Rule by referring consumers to warrantors' Web sites.
As with other online disclosures, warranty information should be displayed clearly and conspicuously. Therefore, for example, warranty terms buried within voluminous “terms and conditions” do not satisfy the Rule's requirement that warranty terms be in close proximity to the warranted product. Further, general references to warranty coverage, such as “one year warranty applies,” are also not sufficient.
The Commission however, does not agree with the view endorsed by commenters
The Commission agrees with the commenter who notes: “Internet availability, however, is not a substitute for availability as specified in Rule 702 because many consumers make little or no use of the internet, while those who do still need the information at the point of sale as a fallback for when they haven't obtained the information online or when they want to verify that their online information is accurate.”
In sum, because Rule 702 already covers the sale of consumer products online, and because staff has updated its .Com Guidance concerning compliance with pre-sale obligations online, the Commission has chosen not to engage in additional rulemaking as to Rule 702 at this time.
The Commission's request for public comment specifically asked whether it should change Rule 703, and if so, how. Six commenters submitted responses to this question.
AHAM claims that the procedures prescribed in Rule 703 are difficult to follow and implement.
Two commenters
No changes are warranted because Rule 703 already imposes specific requirements concerning the impartiality of both the Mechanism and the auditor that the Mechanism selects. For example, Rule 703.3(b) requires the warrantors and sponsors of IDSMs to take all necessary steps to ensure that the Mechanism, and its members and staff, are sufficiently insulated from the warrantor and the sponsor, so that the members' and staff's decisions and performance are not influenced by either the warrantor or the sponsor.
As to auditors' impartiality, although the Mechanism may select its own auditor, Rule 703.7(d) provides that “[n]o auditor may be involved with the Mechanism as a warrantor, sponsor or member, or employee or agent thereof, other than for purposes of the audit.”
Rule 703.5(d) requires the Mechanism to render a decision “at least within 40 days of notification of the dispute.”
Section 703.5 requires the Mechanism to “investigate, gather and organize all information necessary for a fair and expeditious decision in each dispute.”
The Commission received three comments concerning Rule 703.5(j)'s provision prohibiting binding arbitration provisions in warranty contracts.
When the Commission first promulgated Rule 703.5(j) in 1975, it did so based on the MMWA's language, legislative history, and purpose: to ensure that consumer protections were in place in warranty disputes.
During the 1996-97 rule review, some commenters asked the Commission to deviate from its position that Rule 703
Since the issuance of the 1999 FRN, courts have reached different conclusions as to whether the MMWA gives the Commission authority to ban mandatory binding arbitration in warranties.
First, as the Commission observed during the 1999 rule review, the text of section 2310(a)(3)(C)(i) contemplates that consumers will “initially resort” to IDSMs before commencing a civil action. That language clearly presupposes that “a mechanism's decision cannot be binding, because if it were, it would bar later court action.”
As the Commission has previously noted, the legislative history provides additional evidence that Congress intended all IDSMs, including arbitration proceedings, to be nonbinding.
The statutory scheme forecloses any argument that warranty-related arbitration proceedings fall outside the statutory category of “informal dispute resolution mechanisms” and thus outside the FTC's rulemaking authority. As many legislators, policymakers, and courts understood at the time of the MMWA's enactment, any arbitration proceeding is, by comparison to judicial proceedings, an “informal” “mechanism” for “dispute settlement,” and it thus falls squarely within the plain meaning of the term “informal dispute settlement mechanism.”
Just as important, any argument that an “arbitration” can somehow elude classification as an IDSM would subvert the purposes of the MMWA's IDSM provisions. To effectuate its declared policy of encouraging IDSMs that “fairly and expeditiously” settle consumer disputes, Congress: (1) Created incentives for warrantors to develop IDSMs and (2) directed the Commission to issue and enforce baseline rules for IDSMs.
AHAM also argues that eliminating the prohibition on binding arbitration would remove disincentives for warrantors to create a Mechanism and reduce judicial costs spent dealing with duplicative warranty cases. However,
Rule 703.6 requires the Mechanism to prepare indices and statistical compilations on a variety of issues, including warrantor performance, brands at issue, all disputes delayed beyond 40 days, and the number and percentage of disputes that were resolved, decided, or pending.
Two commenters, the Center for Auto Safety and Mr. Nowicki, ask the Commission to repeal the Mechanism's record-keeping requirements contained in Rule 703.6.
Similar comments were received during the previous rule review. Then, commenters urged the Commission to abolish Rule 703.6 because the categories of statistical compilation were “either moot, nebulous, or even worse, misleading or deceptive.”
Rule 703.7 contains the audit requirements for the Mechanism. The Rule requires that an audit be performed annually evaluating: (1) Warrantors' efforts to make consumers aware of the Mechanism and (2) a random sample of disputes to determine the adequacy of the Mechanism's complaint intake-process and investigation and accuracy of the Mechanism's statistical compilations.
One commenter asks the Commission to change Rule 703.8 to “mak[e] all IDSM documents available online, and requir[e] the Commission to review samples of disputes to determine whether the mechanism fairly and expeditiously resolves disputes.”
Several commenters ask the Commission to revise its Warranty Guides. First, three commenters
Trade practices, Warranties.
Trade practices, Warranties.
Trade practices, Warranties.
For the reasons set forth above, the Federal Trade Commission amends 16 CFR parts 700, 701, and 703 as follows:
Magnuson-Moss Warranty Act, Pub. L. 93-637, 15 U.S.C. 2301.
(g) * * * Section 103, 15 U.S.C. 2303, applies to consumer products actually costing the consumer more than $10, excluding tax.* * * This interpretation applies in the same manner to the minimum dollar limits in section 102, 15 U.S.C. 2302, and rules promulgated under that section.
(i) The Act covers written warranties on consumer products “distributed in commerce” as that term is defined in section 101(13), 15 U.S.C. 2301(13). * * *
Section 112 of the Act, 15 U.S.C. 2312, provides that the Act shall apply only to those consumer products manufactured after July 4, 1975.* * *
(a) * * * Section 101(6), 15 U.S.C. 2301(6), provides that a written affirmation of fact or a written promise of a specified level of performance must relate to a specified period of time in order to be considered a “written warranty.”
(b) Certain terms, or conditions, of sale of a consumer product may not be “written warranties” as that term is defined in section 101(6), 15 U.S.C. 2301(6), and should not be offered or described in a manner that may deceive consumers as to their enforceability under the Act.* * *
(c) * * * Such warranties are not subject to the Act, since a written warranty under section 101(6) of the Act, 15 U.S.C. 2301(6), must become “part of the basis of the bargain between a supplier and a buyer for purposes other than resale.” * * *
Section 110(f) of the Act, 15 U.S.C. 2310(f), provides that only the supplier “actually making” a written warranty is liable for purposes of FTC and private enforcement of the Act.* * *
(a) Under section 103(b), 15 U.S.C. 2303(b), statements or representations of general policy concerning customer satisfaction which are not subject to any specific limitation need not be designated as full or limited warranties, and are exempt from the requirements of sections 102, 103, and 104 of the Act, 15 U.S.C. 2302-2304, and rules thereunder. However, such statements remain subject to the enforcement provisions of section 110 of the Act, 15 U.S.C. 2310, and to section 5 of the Federal Trade Commission Act, 15 U.S.C. 45.
(b) The section 103(b), 15 U.S.C. 2303(b), exemption applies only to general policies, not to those which are limited to specific consumer products manufactured or sold by the supplier offering such a policy. In addition, to qualify for an exemption under section 103(b), 15 U.S.C. 2303(b), such policies may not be subject to any specific limitations.* * *
(a) Section 103 of the Act, 15 U.S.C. 2303, provides that written warranties on consumer products manufactured after July 4, 1975, and actually costing the consumer more than $10, excluding tax, must be designated either “Full (statement of duration) Warranty” or “Limited Warranty”.* * *
(b) Based on section 104(b)(4), 15 U.S.C. 2304(b)(4), the duties under subsection (a) of section 104, 15 U.S.C. 2304, extend from the warrantor to each person who is a consumer with respect to the consumer product. Section 101(3), 15 U.S.C. 2301(3), defines a consumer as a buyer (other than for purposes of resale) of any consumer product, any person to whom such product is transferred during the duration of an implied or written warranty (or service contract) applicable to the product.* * * However, where the duration of a full warranty is defined solely in terms of first purchaser ownership there can be no violation of section 104(b)(4), 15 U.S.C. 2304(b)(4), since the duration of the warranty expires, by definition, at the time of transfer.* * *
(a) Under section 104(b)(1) of the Act, 15 U.S.C. 2304(b)(1), a warrantor offering a full warranty may not impose on consumers any duty other than notification of a defect as a condition of securing remedy of the defect or malfunction, unless such additional duty can be demonstrated by the warrantor to be reasonable.* * *
* * * Such statements are deceptive since section 110(d) of the Act, 15 U.S.C. 2310(d), gives state and federal courts jurisdiction over suits for breach of warranty and service contract.
Under section 104(a)(1) of the Act, 15 U.S.C. 2304(a)(1), the remedy under a full warranty must be provided to the consumer without charge.* * * However, this does not preclude the warrantor from imposing on the consumer a duty to remove, return, or reinstall where such duty can be demonstrated by the warrantor to meet the standard of reasonableness under section 104(b)(1), 15 U.S.C. 2304(b)(1).
(a) Section 102(c), 15 U.S.C. 2302(c), prohibits tying arrangements that condition coverage under a written warranty on the consumer's use of an article or service identified by brand, trade, or corporate name unless that article or service is provided without charge to the consumer.
(b) Under a limited warranty that provides only for replacement of
(c) No warrantor may condition the continued validity of a warranty on the use of only authorized repair service and/or authorized replacement parts for non-warranty service and maintenance (other than an article of service provided without charge under the warranty or unless the warrantor has obtained a waiver pursuant to section 102(c) of the Act, 15 U.S.C. 2302(c)). For example, provisions such as, “This warranty is void if service is performed by anyone other than an authorized `ABC' dealer and all replacement parts must be genuine `ABC' parts,” and the like, are prohibited where the service or parts are not covered by the warranty. These provisions violate the Act in two ways. First, they violate the section 102(c), 15 U.S.C. 2302(c), ban against tying arrangements. Second, such provisions are deceptive under section 110 of the Act, 15 U.S.C. 2310, because a warrantor cannot, as a matter of law, avoid liability under a written warranty where a defect is unrelated to the use by a consumer of “unauthorized” articles or service. In addition, warranty language that implies to a consumer acting reasonably in the circumstances that warranty coverage requires the consumer's purchase of an article or service identified by brand, trade or corporate name is similarly deceptive. For example, a provision in the warranty such as, “use only an authorized `ABC' dealer” or “use only `ABC' replacement parts,” is prohibited where the service or parts are not provided free of charge pursuant to the warranty. This does not preclude a warrantor from expressly excluding liability for defects or damage caused by “unauthorized” articles or service; nor does it preclude the warrantor from denying liability where the warrantor can demonstrate that the defect or damage was so caused.
The revisions and addition read as follows:
(a) * * * The McCarran-Ferguson Act, 15 U.S.C. 1011
(b) “Written warranty” and “service contract” are defined in sections 101(6) and 101(8) of the Act, 15 U.S.C. 2301(6) and 15 U.S.C. 2301(8), respectively.* * *
(c) A service contract under the Act must meet the definitions of section 101(8), 15 U.S.C. 2301(8). An agreement which would meet the definition of written warranty in section 101(6)(A) or (B), 15 U.S.C. 2301(6)(A) or (B), but for its failure to satisfy the basis of the bargain test is a service contract.* * *
15 U.S.C. 2302 and 2309.
(d)
(a) * * *
(7) Any limitations on the duration of implied warranties, disclosed on the face of the warranty as provided in section 108 of the Act, 15 U.S.C. 2308, accompanied by the following statement:
Some States do not allow limitations on how long an implied warranty lasts, so the above limitation may not apply to you.
15 U.S.C. 2309 and 2310.
(e)
(a) * * * This paragraph (a) shall not prohibit a warrantor from incorporating into the terms of a written warranty the step-by-step procedure which the consumer should take in order to obtain performance of any obligation under the warranty as described in section 102(a)(7) of the Act, 15 U.S.C. 2302(a)(7), and required by part 701 of this subchapter.
(g) * * *
(2) The Mechanism's decision is admissible in evidence as provided in section 110(a)(3) of the Act, 15 U.S.C. 2310(a)(3); and
(i) A requirement that a consumer resort to the Mechanism prior to commencement of an action under section 110(d) of the Act, 15 U.S.C. 2310(d), shall be satisfied 40 days after notification to the Mechanism of the dispute or when the Mechanism completes all of its duties under paragraph (d) of this section, whichever occurs sooner. * * *
(j) * * * In any civil action arising out of a warranty obligation and relating to a matter considered by the Mechanism, any decision of the Mechanism shall be admissible in evidence, as provided in section 110(a)(3) of the Act, 15 U.S.C. 2310(a)(3).
The following dissent will not appear in the Code of Federal Regulations.
I voted against the Commission's Final Revised Interpretations of the Magnuson-Moss Warranty Act (MMWA) Rule because it retains Rule 703.5(j)'s prohibition on pre-dispute mandatory binding arbitration.
Since the last Rule review in 1997, two federal appellate courts have held that the MMWA does not prohibit binding arbitration.
The courts have sent a clear signal that the Commission's position that MMWA prohibits binding arbitration is no longer supportable.
Food and Drug Administration, HHS.
Final rule; technical amendment.
The Food and Drug Administration (FDA) is updating an authority citation for the Code of Federal Regulations. This action is technical in nature and is intended to provide accuracy of the Agency's regulations.
This rule is effective July 20, 2015.
Mary E. Kennelly, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993-0002, 240-402-9577,
In a previous rulemaking, the authority citation for 21 CFR part 16 was inadvertently altered to omit 28 U.S.C. 2112 and changed 21 U.S.C. 467f to 21 U.S.C. 467F. FDA is reversing those changes such that 28 U.S.C. 2112 and 21 U.S.C. 467f are included in the list of authority citations for 21 CFR part 16.
Administrative practice and procedure.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 16 is 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.
Postal Regulatory Commission.
Final rule.
The Commission is updating the product lists. This action reflects a publication policy adopted by Commission order. The referenced policy assumes periodic updates. The updates are identified in the body of this document. The product lists, which is re-published in its entirety, includes these updates.
David A. Trissell, General Counsel, at 202-789-6800.
This document identifies updates to the product lists, which appear as 39 CFR Appendix A to Subpart A of Part 3020—Mail Classification Schedule. Publication of the updated product lists in the
1. Parcel Return Service Contract 6 (MC2015-41 and CP2015-53) (Order No. 2421), added March 31, 2015.
2. Priority Mail Contract 121 (MC2015-43 and CP2015-54) (Order No. 2428), added April 8, 2015.
3. Parcel Select Contract 9 (MC2015-44 and CP2015-55) (Order No. 2429), added April 8, 2015.
4. Priority Mail & First-Class Package Service Contract 3 (MC2015-45 and CP2015-56) (Order No. 2430), added April 8, 2015.
5. Priority Mail Express & Priority Mail Contract 17 (MC2015-47 and CP2015-58) (Order No. 2447), added April 21, 2015.
6. Priority Mail Contract 122 (MC2015-46 and CP2015-57) (Order No. 2451), added April 21, 2015.
7. Priority Mail & First-Class Package Service Contract 4 (MC2015-48 and CP2015-60) (Order No. 2464), added May 1, 2015.
8. Priority Mail Express & Priority Mail Contract 18 (MC2015-49 and CP2015-61) (Order No. 2480), added May 12, 2015.
9. Global Expedited Package Services Contracts Non-Published Rates 6 (MC2015-23 and CP2015-65) (Order No. 2513), added May 27, 2015.
10. Parcel Return Service Contract 7 (MC2015-50 and CP2015-72) (Order No. 2515), added May 28, 2015.
11. Parcel Return Service Contract 8 (MC2015-51 and CP2015-73) (Order No. 2518), added May 28, 2015.
12. Priority Mail Contract 124 (MC2015-53 and CP2015-81) (Order No. 2534), added June 9, 2015.
13. Priority Mail Contract 123 (MC2015-52 and CP2015-80) (Order No. 2535), added June 9, 2015.
14. Priority Mail Contract 125 (MC2015-54 and CP2015-82) (Order No. 2542), added June 16, 2015.
The following negotiated service agreements have expired and are being deleted from the Mail Classification Schedule:
1. Discover Financial Services 1 (MC2011-19 and R2011-3) (Order No. 694).
2. Priority Mail Express Contract 10 (MC2011-12 and CP2011-48) (Order No. 640).
3. Parcel Return Service Contract 3 (MC2013-39 and CP2013-51) (Order No. 1672).
4. Parcel Return Service Contract 4 (MC2013-46 and CP2013-60) (Order No. 1711).
5. Priority Mail Contract 31 (MC2011-10 and CP2011-46) (Order No. 637).
6. Priority Mail Contract 32 (MC2011-11 and CP2011-47) (Order No. 639).
7. Priority Mail Contract 34 (MC2011-17 and CP2011-56) (Order No. 655).
8. Priority Mail Contract 35 (MC2011-18 and CP2011-57) (Order No. 656).
9. Priority Mail Contract 36 (MC2012-2 and CP2012-6) (Order No. 1170).
10. Priority Mail Contract 38 (MC2012-7 and CP2012-15) (Order No. 1197).
11. Priority Mail Contract 49 (MC2013-25 and CP2013-33) (Order No. 1607).
12. Priority Mail Contract 50 (MC2013-26 and CP2013-34) (Order No. 1608).
13. Priority Mail Contract 68 (MC2014-6 and CP2014-7) (Order No. 1893).
14. Priority Mail Contract 69 (MC2014-7 and CP2014-8) (Order No. 1895).
15. Priority Mail Express & Priority Mail Contract 15 (MC2014-3 and CP2014-3) (Order No. 1872).
16. Parcel Select Contract 1 (MC2011-16 and CP2011-53) (Order No. 686).
17. First-Class Package Service Contract 1 (MC2012-11 and CP2012-19) (Order No. 1339).
18. First-Class Package Service Contract 3 (MC2012-19 and CP2012-25) (Order No. 1355).
19. First-Class Package Service Contract 4 (MC2012-20 and CP2012-26) (Order No. 1356).
20. First-Class Package Service Contract 5 (MC2012-21 and CP2012-27) (Order No. 1357).
21. First-Class Package Service Contract 6 (MC2012-22 and CP2012-28) (Order No. 1358).
22. First-Class Package Service Contract 7 (MC2012-23 and CP2012-29) (Order No. 1359).
Administrative practice and procedure, Postal Service.
For the reasons discussed in the preamble, the Postal Regulatory Commission amends part 3020 of title 39 of the Code of Federal Regulations as follows:
39 U.S.C. 503; 3622; 3631; 3642; 3682.
(An asterisk (*) indicates an organizational class or group, not a Postal Service product.)
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving into the Illinois regional haze State Implementation Plan (SIP) variances affecting the following Midwest Generation, LLC facilities: Crawford Generating Station (Cook County), Joliet Generating Station (Will County), Powerton Generating Station (Tazewell County), Waukegan Generating Station (Lake County), and Will County Generating Station (Will County). The Illinois Environmental Protection Agency (IEPA) submitted these variances to EPA for approval on May 16, 2013, and August 18, 2014.
This final rule is effective on August 19, 2015.
EPA has established dockets for this action under Docket ID Nos. EPA-R05-OAR-2013-0436 and EPA-R05-OAR-2014-0663. All documents in the docket are listed on the
Kathleen D'Agostino, Environmental Engineer, Attainment Planning and Maintenance Section, Air Programs Branch (AR-18J), Environmental Protection Agency, Region 5, 77 West Jackson Boulevard, Chicago, Illinois 60604, (312) 886-1767,
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA. This supplementary information section is arranged as follows:
On June 24, 2011, Illinois submitted a plan to address the requirements of the Regional Haze Rule, as codified at 40 CFR 51.308. EPA approved Illinois' regional haze SIP on July 6, 2012 (77 FR 39943). Among the rules approved in this action to meet the best available retrofit technology (BART) requirements of the Regional Haze Rule are Illinois Administrative Code rules: 35 Ill. Adm. Code 225.292: “Applicability of the Combined Pollutant Standard;” 35 Ill. Adm. Code 225.295 “Combined Pollutant Standard: Emissions Standards for NO
The Illinois Pollution Control Board (IPCB) granted Midwest Generation variances to Section 225.296(a)(1) and 225.296(c)(1) on August 23, 2012, and to Section 225.295(b) and Section 225.296(a)(2) on April 4, 2013. IEPA submitted these variances as revisions to the Illinois regional haze SIP on May 16, 2013, and August 18, 2014. EPA proposed to approve these variances on April 23, 2015 (80 FR 22662). EPA received no comments on the proposed action.
EPA is finalizing approval of the Midwest Generation variances submitted by IEPA on May 16, 2013, and August 18, 2014, as revisions to the Illinois regional haze SIP.
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporation by reference of the Illinois Regulations described in the amendments to 40 CFR part 52 set forth below. EPA has made, and will continue to make, these
Under the Clean Air Act (CAA), the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 18, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
(205) On May 16, 2013, and August 18, 2014, Illinois submitted variances to its regional haze state implementation plan affecting the following Midwest Generation, LLC facilities: Crawford Generating Station (Cook County), Joliet Generating Station (Will County), Powerton Generating Station (Tazewell County), Waukegan Generating Station (Lake County), and Will County Generating Station (Will County).
(i) Incorporation by Reference. (A) Illinois Pollution Control Board Order PCB 12-121, adopted on August 23, 2012; Certificate of Acceptance, dated August 24, 2012, filed with the Illinois Pollution Control Board Clerk's Office August 27, 2012.
(B) Illinois Pollution Control Board Order PCB 13-24, adopted on April 4, 2013; Certificate of Acceptance, dated May 16, 2013, filed with the Illinois Pollution Control Board Clerk's Office May 17, 2013.
Environmental Protection Agency (EPA).
Final rule.
The EPA is fully approving revisions to the Texas New Source Review (NSR) State Implementation Plan (SIP) to establish the Texas Minor NSR Flexible Permits Program (FPP), submitted by the Texas Commission on Environmental Quality (TCEQ). The approval was predicated on the TCEQ meeting its commitment outlined in its letter dated December 9, 2013, to adopt certain minor clarifications to the Flexible Permit Program (FPP) by November 30, 2014. The TCEQ submitted the revised program rules to meet its commitment on July 31, 2014. The EPA is finalizing this action under section 110 of the Clean Air Act (CAA).
This final rule will be effective August 19, 2015.
The EPA has established a docket for this action under Docket ID
Ms. Stephanie Kordzi, telephone 214-665-7520; email address
Throughout this document whenever “we,” “us,” or “our” is used, we mean the EPA.
On July 14, 2014, the EPA took final rulemaking action conditionally approving revisions to the Texas NSR SIP to establish the Texas Minor NSR Flexible Permits Program, submitted by the TCEQ. The EPA's proposed conditional approval was published in 79 FR 8368, February 12, 2014. The conditional approval was predicated on a commitment from TCEQ in a letter dated December 9, 2013, to adopt certain minor clarifications to the FPP by November 30, 2014. (79 FR 40666, July 14, 2014).
On September 12, 2014, Environmental Integrity Project, et al., filed a Petition for Review challenging the EPA conditional approval of the FPP with the Fifth Circuit Court of Appeals. The U.S. Department of Justice submitted the response to the Petition, Case No. 14-60649, for the EPA on March 2, 2015. The Appeal is on-going as of the date of publication of this notice.
On July 31, 2014, the TCEQ submitted revisions to the Texas NSR SIP. The rulemaking properly structured the rules within and according to the rulemaking requirements of the Texas Administrative Procedure Act and the Texas Administrative Code. The EPA proposed full approval of the FPP (79 FR 7875, December 31, 2014) based on its determination that the SIP revisions complied with section 110(k) of the Federal Clean Air Act (the Act or CAA) and was consistent with the EPA's regulations and policies. These revisions supported this action to convert the approved conditional FPP to a fully approved FPP. The EPA reopened the public notice period for an additional 30 days (80 FR 21199, April 17, 2015), due to items being inadvertently omitted from the docket during the public notice period beginning December 31, 2014.
The EPA proposed an initial comment period of 30 days. We received comments from 3 organizations during the initial comment period as follows: The TCEQ, Baker Botts, and the Environmental Integrity Project (EIP) on behalf of the Environmental Justice Advocacy Services, Community in Power & Development Association, Citizens for Environmental Justice, Air Alliance Houston, Texas Campaign for the Environment, and the Texas Impact. All comments previously submitted under the first public notice for this action are being responded to as appropriate and the commenters were informed that they did not need to resubmit them during the reopened public notice period. The EPA did not receive any additional comments during the reopened public notice period. All comment letters can be found in their entirety in the docket for this rulemaking.
The EPA has determined that today's final approval of the Texas FPP is subject to the requirement to delay a rule's effective date until 30 days after publication in 5 U.S.C. 553(d) of the APA; therefore, the rule, will become effective 30 days after publication.
After careful consideration of submitted revisions to meet the requirements of the conditional approval and of the comments received and the responses to each comment provided above, and under section 110 of the Act, the EPA is finalizing our proposal to convert the conditional approval of the FPP to a full, final action. Further, we have found it complies with section 110(l) of the Act.
• Revisions to 30 TAC Section 116.13—Flexible Permit Definitions.
• Revisions to 30 TAC Section 116.710—Applicability.
• Revisions to 30 TAC Section 116.711(1), (2)(A), (B) and (C)(i) and (ii), (D)-(J), and (L)-(N)—Flexible Permit Application.
• Revisions to 30 TAC Section 116.715(a)-(e) and (f)(1) and (2)(B)—General and Special Conditions.
• Revisions to 30 TAC Section 116.716—Emission Caps and Individual Emission Limitations.
• Revisions to 30 TAC Section 116.717—Implementation Schedule for Additional Controls.
• Revisions to 30 TAC Section 116.718—Significant Emission Increase.
• Revisions to 30 TAC Section 116.720—Limitation of Physical and Operational Changes.
• Revisions to 30 TAC Section 116.721—Amendments and Alterations.
• Revisions to 30 TAC Section 116.740(a)—Public Notice.
• Revisions to 30 TAC Section 116.750—Flexible Permit Fee. Revisions to 30 TAC Section 116.765—Compliance Schedule.
The EPA has determined that the revised rule satisfies the December 9, 2013, Commitment Letter which was submitted in a timely manner.
In this rule, we are finalizing regulatory text that includes incorporation by reference. In accordance with the requirements of 1 CFR 51.5, we are finalizing the incorporation by reference of the revisions to the Texas regulations as described in the Final Action section above. We have made, and will continue to make, these documents generally available electronically through
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. See, 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 18, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The EPA is taking a direct final action to approve revisions to the Texas State Implementation Plan (SIP) related to Low Reid Vapor Pressure (RVP) Fuel Regulations that were submitted by the State of Texas on January 5, 2015. The EPA evaluated the SIP submittal from Texas and determined these revisions are consistent with the requirements of the Clean Air Act (Act or CAA). The EPA is approving this action under the federal CAA.
This direct final rule is effective on September 18, 2015 without further notice, unless the EPA receives relevant adverse comment August 19, 2015. If the EPA receives such comment, the EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R06-OAR-2015-0027, by one of the following methods:
(1)
(2)
(3)
Ms. Tracie Donaldson, (214) 665-6633,
Throughout this document wherever “we,” “us,” or “our” is used, we mean the EPA.
Section 110 of the CAA requires states to develop and submit to the EPA a SIP to ensure that state air quality meets National Ambient Air Quality Standards (NAAQS). The NAAQS currently address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide. Each federally-approved SIP protects air quality primarily by addressing air pollution at its point of origin through air pollution regulations and control strategies. The EPA-approved SIP provisions and control strategies are federally enforceable. States revise the SIP as needed and submit revisions to the EPA for review and approval.
On September 10, 2014, Texas Commission on Environmental Quality (TCEQ) adopted revisions to 30 Texas Administrative Code (TAC) Chapter 114, Control of Air Pollution from Motor Vehicles, Subchapter H.
As detailed in the Technical Support Document (TSD) accompanying this action, the TCEQ submitted a SIP revision to the Low RVP Fuels regulations. In this adoption, TCEQ amended sections 114.306, 114.307, 114.309 and deleted section 114.304. The amendments to the Regional Low RVP Gasoline Regulations remove obsolete requirements that provide no benefit to the state and are not necessary for the implementation and enforcement of the primary gasoline volatility control requirements of the rule. In addition, the proposal would provide regulatory consistency between the Chapter 114 gasoline volatility requirements and the El Paso Low RVP Gasoline requirements, specified in the 30 TAC Chapter 115 regulations in §§ 115.252, 115.253, 115.255-115.257, and 115.259, which do not prohibit the use of MTBE and do not require registration and annual reporting.
In addition, pursuant to section 110(k)(6) of the CAA, 30 TAC section 114.306(c) is being removed from the SIP. This section was inadvertently approved into the SIP by a previous action. In its April 25, 2000 SIP submittal, Texas specifically asked us to
The amendments remove the prohibition on the increased use of methyl-tertiary-butyl-ether (MTBE) in gasoline to conform to the low RVP gasoline requirements; remove the requirements for gasoline producers and importers that supply low RVP gasoline to the affected counties; remove annual reporting and certification requirements on the use of MTBE in low RVP gasoline; and make other non-substantive clarifying changes as needed for accuracy and consistency.
For the reasons stated above and in the TSD, the EPA is taking direct final action to approve revisions to the Texas SIP pertaining to Low RVP Fuel regulations. We are approving the revisions to the Texas SIP under section 110 of the Act. Each revision to an implementation plan submitted by a State under this chapter shall be adopted by such State after reasonable notice and public hearing. The Administrator shall not approve a revision of a plan if the revision would interfere with any applicable requirement concerning attainment and reasonable further progress. We are publishing this rule without prior proposal because we view this as a noncontroversial amendment and anticipate no relevant adverse comments. However, in the proposed rules section of this
In this direct final rule, the EPA is finalizing regulatory text that includes
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 18, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposed of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Reporting and recordkeeping requirements, Sulfur oxides.
40 CFR part 52 is amended as follows:
42 U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve the State Implementation Plan (SIP) revision submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources on August 13, 2012, pertaining to definition changes for the Nitrogen Dioxide (NO
This direct final rule is effective on September 18, 2015 without further notice, unless EPA receives relevant adverse comment by August 19, 2015. If EPA receives such comment, EPA will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2015-0368, by one of the following methods:
1.
2.
3.
4.
5.
Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9152. Mr. Farngalo can be reached via electronic mail at
Sections 108 and 109 of the CAA govern the establishment, review, and revision, as appropriate, of the NAAQS to protect public health and welfare. The CAA requires periodic review of the air quality criteria—the science upon which the standards are based—and the standards themselves. EPA's regulatory provisions that govern the NAAQS are found at 40 CFR 50—
On February 9, 2010, EPA promulgated a new 1-hour primary NAAQS for NO
On June 22, 2010, EPA promulgated a revised primary SO
In this rule, EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is finalizing the incorporate by reference of NCDENR regulations 15A NCAC 02D .0407
EPA is approving the aforementioned changes to the North Carolina SIP, because they are consistent with EPA's standards for NO
If EPA receives such comments, then EPA will publish a document withdrawing the final rule and informing the public that the rule will not take effect. All adverse comments received will then be addressed in a subsequent final rule based on the proposed rule. EPA will not institute a second comment period. Parties interested in commenting should do so at this time. If no such comments are received, the public is advised that this rule will be effective on September 18, 2015 and no further action will be taken on the proposed rule.
Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, the Agency may adopt as final those provisions of the rule that are not the subject of an adverse comment.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by September 18, 2015. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Sulfur dioxide, Reporting and recordkeeping requirements.
40 CFR part 52 is amended as follows:
42. U.S.C. 7401
(c) * * *
Environmental Protection Agency (EPA).
Final rule; amendment.
The Environmental Protection Agency (EPA) is amending the exclusion for International Business Machines Corporation (IBM) in Essex Junction, Vermont to reflect changes in ownership and name.
This amendment is effective on July 20, 2015.
Sharon Leitch, RCRA Waste Management and UST Section, Office of
In this document EPA is amending appendix IX to part 261 to reflect a change in the ownership and name of a particular facility. Today's notice documents the transfer of ownership and name change by updating appendix IX to incorporate the change in owner's name for the IBM Corporation, Essex Junction, Vermont facility. The exclusion or “delisting” was granted to IBM on September 13, 2012 (see 77 FR 56558). The EPA has been notified that the transfer of ownership of the Essex Junction facility to GLOBALFOUNDRIES U.S. 2 LLC will occur on July 1, 2015. GLOBALFOUNDRIES has certified that it plans to comply with all the terms and conditions set forth in the delisting and will not change the characteristics of the wastes subject to the exclusion at the Essex Junction facility. This notice documents the change by updating appendix IX to incorporate a change in name.
In accordance with the delisting approval, IBM has completed the quarterly verification testing requirements set forth in paragraph 3.(A) and has submitted the first set of annual testing results in accordance with paragraph 3.(B). As part of this notice, EPA is clarifying the requirements for annual reporting found in paragraph 3.(B)(iii) of the delisting approval. The paragraph currently requires that the annual test report include the annual testing data and the annual amount of waste in cubic yards disposed of during the calendar year. However, as a result of the timing of the delisting approval, annual testing occurs during August and September of each year and the reports are submitted to EPA soon thereafter. With this notice EPA is clarifying that the reporting of the annual sludge volumes shall occur separately from the annual testing reports. As a result, the delisting is being modified to include paragraph 3.(B)(iv) to reflect this change. We are also clarifying in paragraph 3.(B)(iii) that the annual testing results shall be submitted to EPA within thirty days after both annual samples have been taken.
The changes to appendix IX of part 261 are effective July 20, 2015. The Hazardous and Solid Waste Amendments of 1984 amended section 3010 of the Resource Conservation and Recovery Act (RCRA) to allow rules to become effective in less than six months when the regulated community does not need the six-month period to come into compliance. As described above, the facility has certified that it is prepared to comply with the requirements of the exclusion. Therefore, a six-month delay in the effective date is not necessary in this case. This provides the basis for making this amendment effective immediately upon publication under the Administrative Procedures Act pursuant to 5 United States Code (U.S.C.) 5531(d). The EPA has determined that having a proposed rule and public comment on this change is unnecessary, as it involves only a change in company ownership, and a clarification, with all of the same delisting requirements remaining in effect.
Environmental protection, Hazardous waste, Recycling, Reporting and recordkeeping requirements.
Section 3001(f) RCRA, 42 U.S.C. 6921(f)
For the reasons set out in the preamble, 40 CFR part 261 is amended as follows:
42 U.S.C. 6905, 6912(a), 6921, 6922, and 6938.
Environmental Protection Agency (EPA).
Direct Final Rule.
EPA is taking direct final action to amend the Toxic Substances Control Act (TSCA) section 5 electronic reporting regulations. These electronic reporting regulations establish standards and requirements for use of EPA's Central Data Exchange (CDX) to electronically submit premanufacture notices (PMNs), other TSCA section 5 notices, and support documents to the Agency. This rule provides the user community with new methods for accessing the e-PMN software, new procedures for completing the electronic-PMN (e-PMN) form, changes to the CDX registration process, adds the requirement to submit “
This direct final rule is effective January 19, 2016 without further notice, unless EPA receives adverse comment on or before August 19, 2015. If EPA receives adverse comments on this action, EPA will withdraw the rule before its effective date. EPA will then issue a proposed rule, providing a 30-day period for public comment.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPPT-2013-0385, by one of the following methods:
•
•
•
You may be affected by this action if you manufacture (which includes import) or process chemicals for commercial purposes that are subject to TSCA. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide for readers regarding industries within which entities are likely to be affected by this action. Potentially affected entities may include, but are not limited to:
• Manufacturers and processors of chemical substances or mixtures (NAICS codes 325 and 32411).
Full descriptions of these NAICS codes and related establishments are maintained by the U.S. Census Bureau online at
TSCA gives EPA broad authority to regulate the manufacture (including import) and processing of chemical substances. It is the expressed intent of Congress that EPA carry out TSCA in a reasonable and prudent manner, and in consideration of the impacts that any action taken under TSCA may have on the environment, the economy, and society (TSCA section 2). The underlying requirements promulgated under this broad authority and amended by this final rule require manufacturers (including importers) and processors of chemical substances and mixtures to:
• Notify EPA at least 90 days before manufacturing a new chemical substance for commercial purposes (TSCA section 5(a)(1)(A)).
• Notify EPA at least 90 days before manufacturing or processing the chemical substance for any use of a chemical substance that EPA has determined to be a “significant new use” (TSCA section 5(a)(1)(B)).
Section 5(h)(4) of TSCA authorizes EPA, upon application and by rule, to exempt the manufacturer of any new chemical substance from part or all of the provisions of TSCA section 5.
In addition, the Paperwork Reduction Act (PRA) requires Federal agencies to manage information resources to reduce information collection burdens on the public; increase program efficiency and effectiveness; and improve the integrity, quality, and utility of information to all users within and outside an agency, including capabilities for ensuring dissemination of public information, public access to Federal Government information, and protections for privacy and security (44 U.S.C. 3501
Finally, the Government Paperwork Elimination Act (GPEA) (Pub. L. 105-277 (44 U.S.C. 3504)) instructs Federal agencies to use and accept from the public, when practicable, electronic forms, electronic filings, and electronic signatures in the conduct of official business with the public.
This direct final rule amends the TSCA Section 5 Premanufacture and Significant New Use Notification regulations at 40 CFR parts 720, 721, 723 and 725, by mandating the use of an updated version of the e-PMN reporting software. In the
The Agency is taking this action to further facilitate electronic reporting under TSCA and to streamline and reduce the administrative costs and burdens of TSCA section 5 notifications for both industry and EPA. This change will eliminate certain firewall and file submission size limitations that exist with the current version of the software. This change will also enable submitters to work directly online within the Thin Client Version which provides a more efficient way of accessing the e-PMN software and transmitting data to EPA. In addition, the extension of the electronic reporting requirements ensures that submitters are able to use a single method of submission for related TSCA section 5 notifications.
EPA believes that both the transition from the Thick Client Version to the Thin Client Version of the e-PMN software, as well as the changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, will streamline and reduce slightly the administrative costs and burdens associated with TSCA section 5 notifications for both industry and EPA; the only burden expected is the time it takes a submitter to familiarize themselves with the rule. EPA believes that submitters of
EPA is publishing this rule without a prior proposed rule because the Agency views this as a noncontroversial action and anticipates no adverse comment. As addressed in Unit I.A., this action requires the use of a new version of the e-PMN software that is easier to access, features enhanced submission security, and eliminates size limitations on the submitted files. The action also corrects certain outdated regulatory cross-references, and standardizes terminology across certain regulatory provisions. If EPA receives adverse comment, the agency will publish a timely withdrawal in the
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CDX is EPA's electronic system for environmental data exchange to the Agency. CDX also provides the capability for submitters to access their data through the use of web services. CDX enables EPA to work with stakeholders, including governments, regulated industries, and the public, to enable streamlined, electronic submission of data via the Internet. For more information about CDX, go to
CISS is a web-based reporting tool developed by EPA for use in submitting data, reports, and other information under certain sections of TSCA electronically to the Agency. CISS provides user-friendly navigation, works with CDX to secure online communication, creates a completed Portable Document Format (PDF) for review prior to submission, and enables data, reports, and other information to be submitted easily as PDF attachments, or by other electronic standards, such as XML.
The thin client version of the e-PMN software is a submission module within CISS. Following promulgation of the e-PMN final rule in 2010, EPA launched submission modules in CISS for TSCA Chemical Data Reporting, TSCA section 4 test data submissions, TSCA section 8(a) preliminary assessment information rules, TSCA section 8(d) health and safety data reporting rules, and mandatory notifications of substantial risk under TSCA section 8(e) along with related, voluntary “For Your Information” submissions. EPA has enhanced the e-PMN software in the thin client version to incorporate several functions already available to submitters in the other CISS submission modules, including:
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EPA developed the Thin Client Version of the e-PMN software to provide a more efficient way of accessing the e-PMN software and completing the e-PMN form. The Thin Client Version of the software was also designed to enable more efficient data transmittal, including increasing the size of files that can be submitted to EPA. By moving from the Thick Client Version of the e-PMN software to the Thin Client Version, the Agency has eliminated the roadblocks associated with firewalls that were encountered by some users of the Thick Client Version by allowing submitters to work directly online within the Thin Client Version or, if they choose, to work offline using an XML schema which allows them to later upload their information to the Thin Client Version. When preparing and completing submissions in the thin client version, submitters will find that sharing files within the software makes the information readily accessible to registrants of the submitting company and their designated support persons. Also, once a user completes the relevant data fields and attaches appropriate PDF files or other allowable file types, the web-based tool validates the submission by performing a basic error check and makes sure all the required fields and attachments are provided and complete. Finally, the Thin Client Version assures that submitters will always use the most up-to-date version of the e-PMN software when initiating, updating, and/or completing their submissions in CISS.
In addition, the thin client version improves EPA data management by altering the process for submitting amendments to a valid notice. Currently, submitters would electronically submit only the amended sections of the form. Under the new procedure, companies will revise the necessary information in the initial notice or a previously modified version of the notice and an entire updated notice will then be resubmitted to EPA. This provides EPA with a complete, updated version of the entire submission in one document.
Yes. The application has been designed to support TSCA CBI needs by providing a secure environment that meets Federal standards. The application uses Transportation Layer Security with 256-bit digital encryption, and the data is encrypted at rest using a key that only a user knows. All data remains encrypted until it is behind several EPA firewalls and within the EPA CBI LAN, and all encryption algorithms are compliant with Federal Information Processing Standards. In addition, users must have valid CDX credentials (user name and password combination) to access the application, and they choose and provide answers to 5 of the 20 offered questions in CDX. In order to access the CDX account and submit data to the EPA or to download the Copy of Record, a user must correctly answer one of the 5 chosen questions associated with the CDX account.
EPA has prepared a comprehensive user guide for CISS users that addresses CDX registration and electronic signatures, general submission preparation and completion, and submission status tracking notifications (Ref. 1). This user guide is available through EPA's Web page at
This direct final rule extends the electronic reporting requirement to submit PMNs, other TSCA section 5 notices, and support documents to the Agency electronically to include the submissions of bona fides. A person who intends to manufacture a chemical substance not listed by specific chemical name in the public portion of the Inventory of Chemical Substances may ask EPA, through submission of a bona fide intent to manufacture, whether the substance is included in the confidential portion of the Inventory and, thus, be able to determine whether submission of a Premanufacture Notice or Significant New use Notice in accordance with TSCA section 5(a)(1) is required. Bona fides were not included within the scope of the January 2010 final rule due to the variability and frequency of these types of submissions. However, in that rule, EPA stated that this and other types of submissions could be considered for electronic reporting in the future. Bona fides are currently submitted in paper form only according to the requirements of 40 CFR 720.25, 721.11 and 725.15 which do not prescribe a format, only required content. This direct final rule requires that submitter to submit this information electronically using the Thin Client Version of the e-PMN software.
As required under 40 CFR 723.50(j)(6)(ii), a manufacturer (including importer) must notify EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. Under the existing regulation, companies may use, but are not required to use, the Notice of Commencement (NOC) to report manufacturing site changes to EPA. Under the existing regulation, however, if the NOC form is used for this purpose, the manufacturer must add a statement to the NOC form that the notification is an amendment to the original
EPA's electronic reporting program has evolved significantly following the promulgation of the e-PMN final rule in 2010. Following promulgation of that rule, EPA announced web-based electronic reporting workflows for TSCA Chemical Data Reporting, TSCA section 4 test data submissions, TSCA section 8(a) preliminary assessment information rules, TSCA section 8(d) health and safety data reporting rules, and mandatory notifications of substantial risk under TSCA section 8(e) along with related, voluntary “For Your Information” submissions.
Under the current e-PMN rule requirements, TSCA section 5 submitters already must register in CDX and complete an electronic signature agreement before submitting any information to EPA electronically via CDX using the e-PMN software. This direct final rule requires all persons who will be working online on a submission to register with EPA's CDX and to use the e-PMN module within CISS to prepare data for submission. EPA expects that most TSCA section 5 submitters are already registered in CDX. Those users do not need to re-register with CDX, nor will they need to re-verify their identities. In order to use the Thin Client Version of the e-PMN software required under this direct final rule, users who have previously registered with CDX under the TSCA workflow to submit TSCA section 5 submissions, or other CDX workflows such as the Toxics Release Inventory TRI-ME web reporting, will only need to add the “Submission for Chemical Safety and Pesticide Program (CSPP)” CDX workflow to their user profiles.
No. The Agency has concluded that the overall benefits from everyone using the more efficient Thin Client Version of the e-PMN software and submission through CDX exceed those associated with maintaining a multi-optioned reporting approach (Ref. 3). The Agency recognizes that there is the potential for costs and burden associated with unpredictable or unanticipated technical difficulties in electronic filing or with the conversion to the “Thin Client Version.” However, EPA expects that the transition costs and any transition difficulties will be mitigated by:
1. EPA's planned outreach and training sessions prior to the effective date of this direct final rule. EPA believes that the six-month phase-out period for the Thick Client Version between the date of publication and the effective date of this direct final rule provides submitters with ample time to register to use and become proficient with the Thin Client Version of the e-PMN software. EPA will accept submissions using the Thin Client Version of the e-PMN software beginning on September 3, 2015. After January 19, 2016, use of the Thin Client Version of the e-PMN software becomes mandatory.
2. EPA's offering of an XML schema to those submitters who choose to work on their submissions offline rather than online, which allows them to later upload their information to the Thin Client Version of the e-PMN software for submission using CDX. The six-month phase-out period for the period between the date of publication and the effective date of the final rule should provide these users adequate time to implement the XML schema on their systems.
3. EPA's technical support following the effective date of this final rule.
At this time, the Agency lacks electronic reporting capability for some TSCA section 5-related notices (
The direct final rule also corrects certain regulatory cross-references in 40 CFR parts 720 and 721 and standardizes the use of “manufacture” and similar language in 40 CFR parts 720, 721, and 725.
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The Agency's estimated economic impact of this direct final rule is presented in a document entitled “Economic Analysis of the TSCA Section 5 Premanufacture and Significant New Use Notification Electronic Reporting; Revisions to Notification Regulations” (Economic Analysis) (Ref. 3), a copy of which is available in the docket and is briefly summarized in this unit. In the economic analysis supporting the January 6, 2010 (75 FR 773) e-PMN final rule, EPA estimated that the electronic submission of TSCA section 5 notices and support documents would reduce the burden and cost associated with the paper-based reporting process of TSCA section 5 notices and support documents (Ref. 4). This direct final rule amends the existing premanufacture notification regulation to mandate the use of the Thin Client Version of the e-PMN reporting software, require use of electronic reporting of TSCA section 5 bona fides, and amends the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50. These amendments are expected to further streamline and reduce the administrative costs and burdens associated with TSCA section 5 notifications for both industry and EPA.
The Thin Client Version of the e-PMN software will reside as a module within CISS in CDX. The Thin Client Version will eliminate certain firewall and file submission size limitations, as well as reduce the potential for invalid submissions through built-in validation procedures. Use of the Thin Client Version also assures that should revisions be made by EPA, submitters will always use the most up-to-date version of the e-PMN software when initiating, updating, and/or completing their submission in CISS.
Making the software available to industry is expected to result in cost savings for both industry and EPA. However, this direct final rule, which includes a new requirement for electronic submission of bona fide notices and changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, may result in some temporary increase in cost to some industry users as they make the transition to the new method of submission. As a result of making the software available, EPA believes that submitters of bona fide notices will experience burden and cost savings because the time required to enter, review, and edit their notices using the e-PMN software and transmit their submissions to EPA electronically will be less than that for the existing paper-based process. In EPA's economic analysis (Ref. 3), estimated burden and cost savings are presented in comparison to the burden and costs that will be incurred if industry were to continue submitting notices via paper, as was outlined in the previous Information Collection Request (ICR) (Ref. 5). OMB has already approved the underlying information collection requirements described in this direct final rule under OMB control numbers 2070-0012 and 2070-0038 (EPA Information Collection Request (ICR) No. 0574.15,
Once the rule is fully implemented, EPA estimates a net burden savings to industry of 180 hours and a net cost of approximately $4,000 in the first year. In subsequent years, EPA estimates an annual net burden savings to industry of 489 hours and annual net cost savings of approximately $17,000. The Agency is projected to experience an annual net burden savings of 40 hours and annual net cost savings of $3,000 for these same submissions once the rule is fully implemented.
Requiring use of the e-PMN software for submission of bona fides (40 CFR 720.25, 40 CFR 721.11 and 40 CFR 725.15), suspension requests (40 CFR 720.75), and changes in manufacturing sites (40 CFR 723.50(j)(6)) eliminates the option of submitting paper. To the extent that any firms would otherwise submit these notices on paper, these firms may incur some costs in order to meet these mandatory submission requirements. For example, some industry users may incur costs related to adjustments to internal processes or recordkeeping systems, and investments in compatible information technology. At this time, EPA is unable to estimate what these costs might be. However, firms have generally been required to file section 5 notifications electronically using the e-PMN software since April 2012, and a final rule published in the
The total annual burden to society (industry plus EPA) from the e-PMN software is expected to decrease by 57 hours in the first year and 529 hours in subsequent years. The total cost to society is expected to increase by $1,000 in year one and decrease by $20,000 in future years. These cost savings may be diminished by any transactions costs that firms compelled to switch to the new software system might face for submission of bona fides. EPA believes that both the transition from the Thick Client Version to the Thin Client Version, as well as the changes to the procedures for notifying EPA of any new manufacturing site of a chemical substance for which an exemption was granted by EPA under 40 CFR 723.50, will have a negligible impact on industry or Agency burden or costs, and, therefore, the cost savings associated with these changes are only described qualitatively in the Economic Analysis (Ref. 3).
The public docket for this final rule has been established. The following is a listing of the documents referenced in this preamble that have been placed in the public docket for this final rule under docket ID number EPA-HQ-OPPT-2013-0385, which is available for inspection as specified under
This action is not a significant regulatory action as defined by Executive Order 12866 (58 FR 51735, October 4, 1993). Accordingly, this action was not submitted to the Office of Management and Budget (OMB) for review under Executive Orders 12866 and 13563 (76 FR 3821, January 21, 2011). EPA has prepared an Economic Analysis for this action (Ref. 3), which is available in the docket for this final rule and is summarized in Unit VI.
The information collection activities in this direct final rule been submitted for approval to OMB under the PRA (44 U.S.C. 3501
The Information Collection Request (ICR) document that EPA prepared to address the direct final rule requirements related to EPA's New Chemicals Program has been assigned EPA ICR number 0574.16 (Ref. 8). This ICR addresses the required use of the Thin Client version of the e-PMN software system in CDX to complete their TSCA section 5 submissions to EPA's New Chemicals Program instead of a downloadable Thick Client version of the e-PMN software system. In addition, this ICR addresses the mandatory electronic submission of bona fide notices and notifications of new manufacturing sites of chemical substances for which an exemption was granted by EPA under 723.50.
As addressed in EPA ICR No. 0574.16, the total burden to industry is expected to decrease 182 hours and the total cost is expected to increase by $3,988 in the first year of the rule, for a total burden of 2,312 hours and $155,699. This includes an average per firm burden of 0.82 hours for rule familiarization for 336 TSCA section 5 submitters, a per-submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions, a per-registrant burden 0.43 hours for 93 new technical labor CDX registrations, and a-per registrant burden of 1.07 hours for 23 new managerial CDX registrants. In all subsequent years of the rule the total industry burden is expected to decrease by 485 hours and $17,199. This includes a per submission burden of 17.0 hours for electronic reporting of 116 bona fide submissions, a per-registrant burden 0.43 hours for 46 new technical labor CDX registrations, and a per-registrant 1.07 hours for 12 new managerial CDX registrants.
In addition, EPA has been assigned EPA ICR number 1188.12 (Ref. 9) to the ICR document that addresses the direct final rule requirements related EPA's Existing Chemicals Program (
You can find a copy of these ICR documents in the docket for this direct final rule. Any comments on the Agency's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden must be to the EPA using the docket identified at the beginning of this direct final rule by August 19, 2015. You may also send your ICR-related comments to OMB's Office of Information and Regulatory Affairs via email to
Responses to the collection of information are mandatory, pursuant to EPA's authority under TSCA and PRA (as described in Unit I.C.). However, the changes to the information collection requirements in this direct final rule are not enforceable until OMB approves them. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA, 5 U.S.C § 601
As indicated previously, this final rule is expected to reduce the existing regulatory burden. The factual basis for the Agency's certification under the RFA is presented in the small entity impact analysis prepared as part of the Economic Analysis for this final rule (Ref. 3), and is briefly summarized in Unit IV.
This action will not have substantial direct effects on State, local, or tribal governments, on the relationship between the Federal Government and States or Indian Tribes, or on the distribution of power and responsibilities between the Federal Government and States or Indian Tribes. As a result, no action is required under Executive Order 13132, entitled “Federalism” (64 FR 43255, August 10, 1999), or under Executive Order 13175,
As indicated previously, this action is not a “significant regulatory action” as defined by Executive Order 12866. As a result, this action is not subject to Executive Order 13045, entitled “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997) and Executive Order 13211 entitled “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001). In addition, this action also does not require any special considerations under Executive Order 12898 entitled “Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations” (59 FR 7629, February 16, 1994).
Since this action does not involve any technical standards, NTTAA section 12(d), 15 U.S.C. 272 note, does not apply to this action.
Pursuant to the CRA, 5 U.S.C. 801
Environmental protection, Chemicals, Electronic reporting, Hazardous substances, Reporting and recordkeeping requirements.
Therefore, 40 CFR chapter I is amended as follows:
15 U.S.C 2604, 2607, and 2613.
The revisions read as follows:
(c)
(1) Which is formed to a specific shape or design during manufacture;
(2) Which has end use function(s) dependent in whole or in part upon its shape or design during end use; and
(3) Which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article and that may occur as described in § 720.30(h)(5), except that fluids and particles are not considered articles regardless of shape or design.
(kk)
(b) * * *
(1) A chemical substance is listed in the public portion of the Inventory by a specific chemical name (either a Chemical Abstracts (CA) Index Name or a CA Preferred Name) and a Chemical Abstracts Service (CAS) Registry Number if its identity is not confidential. If its identity is confidential, it is listed in the public portion of the Inventory by a TSCA Accession Number and a generic chemical name that masks the specific substance identity. The confidential substance is listed by its specific chemical name only in the confidential portion of the Inventory, which is not available to the public. A person who intends to manufacture (including import) a chemical substance not listed by specific chemical name in the public portion of the Inventory may ask EPA whether the substance is included in the confidential Inventory. EPA will answer such an inquiry only if EPA determines that the person has a
(2) To establish a
(i) Except as provided in paragraphs (b)(3)(i) and (ii) of this section, the specific chemical identity of the substance that the person intends to manufacture (including import), using the currently correct CA Index name for the substance and the other correct chemical identity information in accordance with § 720.45(a) (1), (2), and (3).
(ii) A signed statement that the person intends to manufacture (including import) that chemical substance for commercial purposes.
(4) EPA will review the information submitted by the proposed manufacturer (including importer) under this paragraph to determine whether it has a
(5) If the proposed manufacturer (including importer) has shown a
(6) If the chemical substance is found on the confidential Inventory, EPA will notify the person(s) who originally reported the chemical substance that another person has demonstrated a
(7) A disclosure of a confidential chemical identity to a person with a
(a) * * *
(2) * * *
(i)
(ii) You can access the e-PMN software as follows:
(e)
(2) * * *
(3) Only the Authorized Official (AO) of a submitting company can certify initial notices and submit all TSCA section 5 documents.
(i) An AO can authorize other persons to be non-certifying AOs who may conduct all section 5 business on behalf of the submitting company except for certifying and submitting initial notices to EPA via CDX.
(ii) An AO may grant access to a support registrant to edit section 5 documents.
The revisions read as follows:
(b) * * *
(2)(i)
(ii)
(e) * * *
(2) If a manufacturer (including importer) which withdrew a notice later resubmits a notice for the same chemical substance, a new notice review period begins.
15 U.S.C. 2604, 2607, and 2625(c).
(a) A person who intends to manufacture (including import) or process a chemical substance which is described by a generic chemical name in subpart E of this part may ask EPA whether the substance is subject to the requirements of this part. EPA will answer such an inquiry only if EPA determines that the person has a
(b) To establish a
(1) The specific chemical identity of the chemical substance that the person intends to manufacture (including import) or process.
(2) A signed statement that the person intends to manufacture (including import) or process the chemical substance for commercial purposes.
(3) A description of the research and development activities conducted to date, and the purpose for which the person will manufacture (including import) or process the chemical substance.
(d) EPA will review the information submitted by the manufacturer (including importer) or processor under paragraph (b) of this section to determine whether that person has shown a bona fide intent to manufacture (including import) or process the chemical substance. If necessary, EPA will compare this information to the information requested for the confidential chemical substance under § 720.85(b)(3)(iii) of this chapter.
(e) If the manufacturer (including importer) or processor has shown a
(f) A disclosure to a person with a
15 U.S.C. 2604.
The revision reads as follows:
(j) * * *
(6) * * *
(ii) * * *
(B) The notification must be submitted electronically to EPA via CDX as a support document to the original notification. Prior to submission to EPA via CDX, such notices must be generated and completed using the e-PMN software. See 40 CFR 720.40(a)(2)(ii) for
15 U.S.C. 2604, 2607, 2613 and 2625.
(a) * * *
(2) Uncertain microorganism identity. The current state of scientific knowledge leads to some imprecision in describing a microorganism. As the state of knowledge increases, EPA will be developing policies to determine whether one microorganism is equivalent to another. Persons intending to conduct activities involving microorganisms may inquire of EPA whether the microorganisms they intend to manufacture (including import) or process are equivalent to specific microorganisms described on the Inventory, in § 725.239, or in subpart M of this part.
(b) * * *
(2) To establish a
(ii) A signed statement certifying that the submitter intends to manufacture (including import) or process the microorganism for commercial purposes.
(iii) A description of research and development activities conducted with the microorganism to date, demonstration of the submitter's ability to produce or obtain the microorganism from a foreign manufacturer, and the purpose for which the person will manufacture (including import) or process the microorganism.
(d) EPA will review the information submitted by the manufacturer (including importer) or processor under this paragraph to determine whether that person has shown a
(e) In order for EPA to make a conclusive determination of the microorganism's status, the proposed manufacturer (including importer) or processor must show a
(f) If the microorganism is found on the confidential version of the Inventory, in § 725.239 or in subpart M of this part, EPA will notify the person(s) who originally reported the microorganism that another person (whose identity will remain confidential, if so requested) has demonstrated a
(g) A disclosure to a person with a
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final rule implements an information collection program for the Atlantic surfclam and ocean quahog fisheries. The information collection program is intended to obtain more detailed information about individuals and businesses that hold fishery quota allocation in these individual transferable quota fisheries. This action is necessary to ensure that the Mid-Atlantic Fishery Management Council has the information needed to develop a future management action intended to establish an excessive share cap in these fisheries.
Effective January 1, 2016.
Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in this final rule may be submitted to the Greater Atlantic Regional Fisheries Office and by email to
Douglas Potts, Fishery Policy Analyst, (978) 281-9341.
Section 402(a)(1) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) authorizes the Secretary of Commerce to implement an information collection program if a fishery management council determines that additional information would be beneficial for developing, implementing, or revising a fishery management plan (FMP). The Mid-Atlantic Fishery Management Council formally requested that NMFS implement an information collection program in the Atlantic surfclam and ocean quahog individual transferable quota (ITQ) fisheries. The purpose of this information collection is to better
Currently, NMFS collects only basic information about the individuals or businesses that hold surfclam and ocean quahog ITQ allocations. This information is collected at the time that an entity first acquires ITQ allocation and is not routinely verified or updated. The information collection program implemented in this action is intended to identify the specific individuals who have an ownership interest in surfclam or ocean quahog ITQ allocation through a corporation, partnership, or other business entity, or control the use of ITQ allocation through the use of long-term contracts or other agreements. This action also ensures that the ownership information on file remains up to date by modifying the procedures for receiving and maintaining an ITQ permit.
This action also makes minor corrections and clarifications to the surfclam and ocean quahog regulations.
Full details and background on the measures in this rule are explained in the proposed rule published on August 7, 2014 (79 FR 46233), and are not repeated here.
This final rule revises the regulations at § 648.74 to change the validity period for ITQ Permits. ITQ permits will now expire at the end of the year and need to be renewed annually. This annual renewal requirement better ensures that ITQ-related information is kept current. Expired permits are eligible for renewal until the last day of the year for which they are needed. Permits not renewed by the deadline are considered voluntarily relinquished and will have their quota share and eligibility permanently revoked. This is commonly referred to as a “renew or lose” provision. To renew a permit, an annual ITQ permit application must be completed. The ITQ permit application form requires information such as the applicant's name, address, telephone number, and date of birth (or taxpayer identification number for businesses). ITQ permit holders are also required to verify that they are eligible to own a U.S. Coast Guard documented vessel, as defined under 46 U.S.C. 12103(b), which serves as a check of U.S. citizenship or corporate control by U.S. citizens.
This final rule implements a new ITQ ownership form that must be submitted along with the ITQ permit application form for a permit to be issued. This form is being implemented to capture detailed ownership information, such as information on bank-held shares and identification of corporate officers, major shareholders, and partners as well as any immediate family members who also hold ITQ permits. Corporations or other business entities that hold an ITQ permit will be required to identify their corporate officers and all shareholders who have a 10-percent or larger stake in the company.
This action modifies the existing ITQ transfer form to collect more detailed financial information about transactions in which ITQ is transferred. Information about the allocation holder is removed, as that is now collected through the ITQ permit application and the ITQ ownership form. The ITQ transfer form now clarifies whether or not a permanent transfer of ITQ quota share includes all of the cage tags for the current fishing year. This action also adds additional questions to better understand the nature of the transfer. This includes a requirement to submit total price paid for the transfer, including any fees; broker fees paid, if applicable; whether the transfer is part of a long-term (more than 1 year) contract; if so, the duration of the contract and whether the price is fixed or flexible; and any other conditions on the transfer.
This final rule revises the regulations at § 648.74(a)(1)(i) to correct a cross reference to 46 U.S.C. 12103(b), which defines the persons or entities that are eligible to own a documented vessel. This rule also corrects several cross references in § 648.14(j) to other sections of the regulations in part 648 pertaining to surfclam and ocean quahogs. Finally, the regulations at § 648.74(b)(3) specifying when the Regional Administrator may deny a transfer of ITQ quota share or cage tags have been made more detailed and clear.
The new permit requirements in this rule are effective with the start of the next fishing year on January 1, 2016. However, the new forms will be distributed in early fall to give ITQ permit holders ample time to complete and submit the forms in order to receive their 2016 ITQ permits and 2016 cage tags before the start of the fishing year. Many ITQ shareholders choose to submit cage tags transfer requests in December, ahead of the new fishing year, so they can be processed and ready before January 1. We will continue to work to accommodate these requests for the industry.
We published a proposed rule in the
This information collection program is an important part of the Council's efforts to establish a cap that meets this requirement. See the response to Comment 2 for additional rationale for why this information collection is necessary.
We agree that some business transactions are confidential. Pursuant to section 402(b) of the Magnuson-Stevens Act, information submitted in compliance with the Act is confidential, and would not be distributed or made publicly available. These confidentiality requirements of the Magnuson-Stevens Act apply to information collected as a result of this action. Therefore, the collected information may be used to conduct analysis by NMFS, or Council staff who are subject to confidentiality agreements. Results of this analysis could only be presented in an aggregate form, which protects any confidential information.
All limited access vessel permits in the Greater Atlantic Region have been subject to these renew-or-lose provisions since they were implemented in the mid-1990s. The Golden Tilefish Individual Fishing Quota program has operated under renew-or-lose provisions for tilefish quota share since the program's inception in 2010. If a permit is not renewed, NMFS makes multiple attempts to notify the permit holder of the need to renew the permit well before the deadline. Permanent loss of fishing rights has occurred for these other fisheries. However, loss of the right to a permit is rarely due to a clerical error such as simply forgetting to renew a permit. We believe such instances are infrequent given the system that provides a year to renew after permit expiration and multiple reminders prior to loss of fishing rights.
Further, the ITQ permit must be current and valid in order for ITQ to be traded or for fishing activity to occur using ITQ. In 2014, there were 41 ocean quahog ITQ permits with quota share and 70 surfclam ITQ permits with quota share. Of these 111 ITQ permits, all but 15 transferred allocation, used cage tags to land clams, or otherwise participated in the fishery in a manner that will now require a current valid permit. The majority of those permits not used in 2014, were used in the preceding two years. Therefore, it is likely that most if not all permits will be renewed each year in order for ITQ shareholders to continue participating in the fishery as they have in previous years. As a result,
Certainly, lenders will continue to evaluate investment risk as it relates to these fisheries. We believe it unlikely that investors will find the “renew or lose” provision to be an additional risk that would preclude investment.
As mentioned above in the response to Comment 2, we anticipate that the specific data elements will be reevaluated and revised when an excessive share cap is implemented. For these reasons, we continue to support the inclusion of all of the proposed elements of this information collection program, at least for the short term. Therefore, this action implements the ITQ transfer form as described in the proposed rule.
There are no substantive changes from the measures described in the proposed rule. The preamble to the proposed rule explained that banks holding quota share as collateral on a loan would not need to provide as much detail about ownership if the borrower maintains a valid ITQ permit and the bank could only transfer quota share or cage tags to the borrower. However, the regulatory text in the proposed rule did not fully reflect these requirements. These requirements have been added at § 648.74(a)(1)(ii)(C) and (b)(3) in this final rule to reflect these provisions as they were described in the preamble of the proposed rule.
The Administrator, Greater Atlantic Region, NMFS, determined that this action is necessary for the conservation and management of the Atlantic surfclam and ocean quahog fishery and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.
This final rule has been determined to be not significant for purposes of Executive Order 12866.
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration 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 this 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.
This final rule contains a change to a collection-of-information requirement subject to the Paperwork Reduction Act (PRA) and which has been approved by the Office of Management and Budget (OMB) under OMB Control Number 0648-0240: Northeast Region Surfclam and Ocean Quahog Individual Transferable Quota (ITQ) Administration. The public reporting burden is estimated to average 5 minutes per response for the application for surfclam/ocean quahog ITQ permit; 60 minutes per response for new entrants completing the surfclam/ocean quahog ITQ ownership form and to average 5 minutes per response when the form is pre-filled for renewing entities; and the application to transfer surfclam/ocean quahog ITQ are estimated to average 5 minutes 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. The costs burden associated for all of the requirements is $.49 per submission for postage. Send comments regarding these burden estimates or any other aspect of this data collection, including suggestions for reducing the burden, to NMFS (see
Notwithstanding any other provision of the law, no person is required to respond to, and no person shall be subject to penalty for failure to comply with, a collection of information subject to the requirements of the PRA, unless that collection of information displays a currently valid OMB control number.
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons set out in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(j) * * *
(1) * * *
(ii) Shuck surfclams or ocean quahogs harvested in or from the EEZ at sea, unless permitted by the Regional Administrator under the terms of § 648.75.
(2)
(3) * * *
(v) Possess an empty cage to which a cage tag required by § 648.77 is affixed, or possess any cage that does not contain surfclams or ocean quahogs and to which a cage tag required by § 648.77 is affixed.
(vi) Land or possess, after offloading, any cage holding surfclams or ocean quahogs without a cage tag or tags required by § 648.77, unless the person can demonstrate the inapplicability of the presumptions set forth in § 648.77(h).
(5) * * *
(ii) Land unshucked surfclams and ocean quahogs harvested in or from the EEZ within the Maine mahogany quahog zone in containers other than cages from vessels capable of carrying cages unless, with respect to ocean quahogs, the vessel has been issued a Maine mahogany quahog permit under this part and is not fishing for an individual allocation of quahogs under § 648.74.
(iv) Offload unshucked ocean quahogs harvested in or from the EEZ within the Maine mahogany quahog zone from vessels not capable of carrying cages, other than directly into cages, unless the vessel has been issued a Maine mahogany quahog permit under this part and is not fishing for an individual allocation of quahogs under § 648.74.
(v) Land or possess ocean quahogs harvested in or from the EEZ within the Maine mahogany quahog zone after the effective date published in the
(6) * * *
(ii) Surfclams or ocean quahogs landed from a trip for which notification was provided under § 648.15(b) or § 648.74(b) are deemed to have been harvested in the EEZ and count against the individual's annual allocation, unless the vessel has a valid Maine mahogany quahog permit issued pursuant to § 648.4(a)(4)(i) and is not fishing for an individual allocation under § 648.74.
(iii) Surfclams or ocean quahogs found in cages without a valid state tag are deemed to have been harvested in the EEZ and are deemed to be part of an individual's allocation, unless the vessel has a valid Maine mahogany quahog permit issued pursuant to § 648.4(a)(4)(i) and is not fishing for an individual allocation under § 648.74; or, unless the preponderance of available evidence demonstrates that he/she has surrendered his/her surfclam and ocean quahog permit issued under § 648.4 and he/she conducted fishing operations exclusively within waters under the jurisdiction of any state. Surfclams and ocean quahogs in cages with a Federal tag or tags, issued and still valid pursuant to this part, affixed thereto are deemed to have been harvested by the individual allocation holder to whom the tags were issued or transferred under § 648.74 or § 648.77(b).
(a)
(1)
(i)
(ii)
(B)
(C)
(
(
(
(iii)
(iv)
(v)
(vi)
(vii)
(viii)
(ix)
(x)
(2) [Reserved]
(b)
(2)
(3)
Federal Aviation Administration (FAA), DOT.
Request for comments on bird strike requirements for transport category airplanes.
This document solicits public comments on the need for, and the possible scope of, changes to the bird strike certification requirements for transport category airplanes. The FAA is not currently proposing a specific regulatory action. The purpose of this request is to gather comments from airplane manufacturers and other interested parties on this subject.
Send comments by November 17, 2015.
Comments to:
Send comments, identified by Docket No. FAA-2015-2490, using any of the following methods:
•
•
•
•
Todd Martin, Airframe and Cabin Safety Branch, ANM-115, FAA, Transport Airplane Directorate, Aircraft Certification Service, 1601 Lind Avenue SW., Renton, WA 98057-3356; telephone (425) 227-1178; facsimile (425) 227-1232; email
The FAA invites interested persons to comment on the need for, and the possible scope of, changes to the bird strike requirements for transport category airplanes by submitting written data, views, or arguments as they may desire. We have conducted a review of bird strike data, and we are considering whether to revise the requirements, as described in this document. We invite comments relating to the technical or economic impact that might result from any of the rule changes discussed herein, as well as any alternative suggestions. Substantive comments should be accompanied by estimates of their economic impact if possible. All comments received by the closing date for comments will be considered by the FAA.
Bird strike requirements for transport category airplanes are specified in Title 14, Code of Federal Regulations (14 CFR), part 25, and vary depending on the structural component being evaluated. Section 25.775 requires windshields and their supporting structure withstand, without penetration, impact with a four-pound bird at V
Section 25.631 requires the empennage structure be designed to assure continued safe flight after impact with an eight-pound bird at V
Section 25.571 considers the rest of the airframe and requires the airplane be capable of continued safe flight after impact with a four-pound bird at V
In 1993, the FAA was developing a notice of proposed rulemaking to establish a consistent eight-pound bird requirement for all structures. The FAA decided instead to task the Aviation Rulemaking Advisory Committee (ARAC) to evaluate the bird strike requirements and make recommendations. The working group completed its deliberations in 2003 without reaching agreement. All members in the working group, except the FAA, favored reducing the eight-pound bird requirement in § 25.631 to four pounds, thus establishing a consistent four-pound bird requirement for all structures. Other changes to the requirements were considered by the group, but none were adopted. The working group report is available at:
More recently, the National Transportation Safety Board (NTSB) issued the following Safety Recommendation to the FAA as a result of a fatal Cessna 500 accident that occurred in 2008: A-09-072, “Revise the bird-strike certification requirements for Part 25 airplanes so that protection from in-flight impact with birds is consistent across all airframe structures. Consider the most current military and
To determine the adequacy of current bird strike certification requirements, the FAA reviewed a number of reports, including the 2003 ARAC report, and other reports that address bird populations. We also reviewed recent bird strike event data and compared the energy levels of bird strike events to the energy levels prescribed in the current requirements. We found numerous bird strike events in which the energy level exceeded that specified in current part 25 requirements.
The severity of a bird strike depends primarily on kinetic energy, which is proportional to mass times velocity squared. Bird strikes involving birds greater than four pounds occur often, but usually at speeds below the design cruising speed, V
In each of the bird strike events shown below, the FAA estimates that the energy level of the strike exceeded that specified in current requirements. This is not an exhaustive list; these are just some examples of events that occurred in the US since the 2008 Cessna accident. For these events, we estimated the energy level of the event and compared it to the current four-pound bird requirement specified in §§ 25.571 and 25.775.
These event data, including estimated airplane altitude and airspeed, are derived from the following reports:
1. The FAA Wildlife Strike Database, available at:
2. The FAA Aviation Safety Information Analysis and Sharing (ASIAS) System, available at:
3. National Transportation Safety Board. 2009.
In addition to the events listed above, there are hundreds of examples of bird strike events in which the energy level did not exceed current requirements, but substantial damage to the airframe occurred. In addition to structural damage, major damage to electrical, flight control and fuel systems has occurred, and there have been dozens of incidents in which the flight deck was penetrated.
The bird strike threat has increased, especially the threat due to larger birds. In a report commissioned by the FAA, Assessment of Wildlife Strike Risk to Airframes; Herricks, Mankin, and Shaeffer; December 2002; the authors wrote, “The findings of this report, supported by other literature, indicate that future operational environments for aircraft can be expected to contain larger numbers of birds, and larger numbers of birds with weights greater than four pounds.”
According to Wildlife Strikes to Civil Aircraft in the United States, 1990-2013, US Depts. of Transportation and Agriculture, July 2014: “Many populations of large bird and mammal species commonly involved in strikes have increased markedly in the last few decades and adapted to living in urban environments, including airports. For example, the resident (non-migratory) Canada goose population in the USA and Canada increased from about 0.5 million to 3.8 million from 1980 to 2013 (Dolbeer et al. 2014, U.S. Fish and Wildlife Service. 2013). During the same time period, the North American snow goose population increased from about 2.1 million to 6.6 million birds (U.S. Fish and Wildlife Service. 2013). Other large-bird species that have shown significant population increases from 1980 to 2012 include bald eagles (6.4 percent annual rate of increase), wild turkeys (9.5 percent), turkey vultures (2.7 percent), American white pelicans (7.9 percent), double-crested cormorants (6.1 percent), sandhill cranes (5.9 percent), great blue herons (1.2 percent), and ospreys (3.0 percent, Sauer et al. 2014). Dolbeer and Begier (2013) examined the estimated population
In the U.S., § 91.117 prescribes a speed restriction of 250 knots indicated airspeed below 10,000 feet mean sea level. The 250 knot speed restriction is also in place in Mexico and Canada, and in many areas around the world, but not everywhere. Where this speed restriction is in place, it provides a significant safety benefit with respect to bird strikes.
While deviations to this speed restriction are allowed, and the requirement is not global, it does indicate that limiting airspeed below 10,000 feet is operationally feasible for transport category airplanes. Indeed, to meet current bird strike criteria, some manufacturers specify relatively low V
To encourage these speed cutbacks, we believe establishing the bird strike speed criteria based on V
Our review of bird strike event data and bird population data indicates the following:
1. Bird strikes have occurred and will continue to occur at energy levels that exceed the level provided by current requirements.
2. Numerous bird strikes have resulted in penetration into the flight deck, mostly below the windshield, even at energy levels below current requirements. Penetration of the cockpit obviously introduces a number of significant risks to the airplane. Currently, there is no requirement that specifically prohibits penetration of the flight deck through structure other than the windshield.
3. The bird strike threat has increased, especially the threat due to larger birds. Therefore, current fleet history may not be indicative of what to expect in the future.
4. Bird strike events often involve more than one bird. Such multiple bird strikes may result in structural damage in several areas, pilot disorientation, engine failure and systems failures. Any one of these effects can significantly reduce the controllability of the airplane. Sections 25.571 and 25.631 assume a single bird strike, rather than multiple bird strikes. The FAA believes that this single bird strike approach is an adequate approach for airframe structure as long as the single bird strike criteria are robust. By showing the structure capable of withstanding a significant bird strike in any one area, a bird strike to that area should not compound the hazard from strikes in other areas.
5. Limiting airspeed below 10,000 feet is operationally feasible for transport category airplanes. Bird strike data indicate numerous damaging bird strikes have occurred above 8000 feet, but above 10,000 feet, bird strikes are rare. Therefore, expanding the envelope above 8000 feet, but limiting it at 10,000 feet, may be warranted.
6. Establishing reduced V
The FAA invites interested persons to comment on the need for, and the possible scope of, changes to the bird strike requirements for transport category airplanes by submitting written data, views, or arguments as they may desire. We invite comments relating to the technical or economic impact that might result from any considerations discussed herein, as well as any alternative suggestions. In particular, we invite information, comments, and opinion on the following questions:
1. Should the bird weight requirement be applied consistently across the airplane?
2. Should the bird weight requirement be increased, to eight pounds or some other value?
3. Should a “no-penetration” requirement be applied to the entire fuselage, not just the windshields?
4. Should the bird strike criteria be expanded to 10,000 feet?
5. Should the 0.85 speed reduction factor at 8000 feet, currently specified in § 25.571, be removed?
6. Should the speed criterion for bird strikes be based on V
This document solicits public comments on the need for, and the possible scope of, changes to the bird strike certification requirements for transport category airplanes.
Aircraft, Aircraft safety.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-100, -200, -200C, -300, -400, -500 series airplanes. This proposed AD was prompted by reports of cracked antenna support channels, skin cracking underneath the number 2 very high frequency (VHF) antenna, and cracking in the frames attached to the internal support structure. This proposed AD would require repetitive inspections to determine the condition of the skin and the internal support structure, and follow-on actions including corrective action as necessary. We are proposing this AD to detect and correct skin cracking of the fuselage which could result in separation of the number 2 VHF antenna from the airplane and rapid depressurization of the cabin.
We must receive comments on this proposed AD by September 3, 2015.
You may send comments, using the procedures found in 14 CFR 11.43 and 11.45, by any of the following methods:
• Federal eRulemaking Portal: Go to
• Fax: 202-493-2251.
• Mail: U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590.
• Hand Delivery: Deliver to Mail address above between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
For service information identified in this proposed AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
You may examine the AD docket on the Internet at
Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email:
We invite you to send any written relevant data, views, or arguments about this proposal. Send your comments to an address listed under the
We will post all comments we receive, without change, to
We have received reports of cracked antenna support channels, skin cracking underneath the number 2 VHF antenna, and cracking in the frames attached to the internal support structure. The cracking is caused when the nose gear is let down, resulting in turbulent airflow around the antenna. The turbulent airflow causes vibration in the antenna, which results in the skin, as well as the internal support structure and frames, to crack due to fatigue. This condition, if not corrected, could result in separation of the antenna from the airplane and rapid depressurization of the cabin.
We reviewed Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014. The service information describes procedures for repetitive inspections to determine the condition of the skin and the internal support structure, and follow-on actions including corrective action as necessary. This service information is reasonably available because the interested parties have access to it through their normal course of business or by the means identified in the
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would require accomplishing the actions specified in the service information identified previously, except as discussed under “Differences Between this Proposed AD and the Service Information.”
Tables 7, 8, and 9 in paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, specify post-modification and post-repair inspections, which may be used in support of compliance with section 121.1109(c)(2) or 129.109(b)(2) of the Federal Aviation Regulations 14 CFR 121.1109(c)(2) or 129.109(b)(2)). However, this NPRM does not propose to require those post-modification and post-repair inspections. This difference has been coordinated with Boeing.
Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, specifies to contact the manufacturer for instructions on how to repair certain conditions, but this proposed AD would require repairing those conditions in one of the following ways:
• In accordance with a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) whom we have authorized to make those findings.
The FAA worked in conjunction with industry, under the Airworthiness Directive Implementation Aviation Rulemaking Committee (ARC), to enhance the AD system. One enhancement was a new process for annotating which steps in the service information are required for compliance with an AD. Differentiating these steps from other tasks in the service information is expected to improve an owner's/operator's understanding of crucial AD requirements and help provide consistent judgment in AD compliance. The steps identified as RC (required for compliance) in any service information identified previously have a direct effect on detecting, preventing, resolving, or eliminating an identified unsafe condition.
For service information that contains steps that are labeled as Required for Compliance (RC), the following provisions apply: (1) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD, and an alternative method of compliance (AMOC) is required for any deviations to RC steps, including substeps and identified figures; and (2)
We estimate that this proposed AD affects 609 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary [repairs/modifications] that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these repairs/modifications.
According to the manufacturer, some of the costs of this proposed AD may be covered under warranty, thereby reducing the cost impact on affected individuals. We do not control warranty coverage for affected individuals. As a result, we have included all costs in our cost estimate.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. Subtitle VII: Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701: “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
We must receive comments by September 3, 2015.
None.
This AD applies to The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes, certificated in any category, as identified in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014.
Air Transport Association (ATA) of America Code 53, Fuselage.
This AD was prompted by reports of cracked antenna support channels, skin cracking underneath the number 2 VHF antenna, and cracking in the frames attached to the internal support structure. We are issuing this AD to detect and correct skin cracking of the fuselage that could result in separation of the antenna from the airplane and rapid depressurization of the cabin.
Comply with this AD within the compliance times specified, unless already done.
For airplanes identified as Group 1 in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014: Within 120 days after the effective date of this AD, inspect for cracking at the number 2 VHF antenna location, and do all applicable follow-on actions, using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
For airplanes identified as Groups 2 through 6, configurations 1 through 3 in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014: Within 1,250 flight cycles after the effective date of this AD, do an external detailed inspection for cracking of the fuselage skin, as applicable, and do all corrective actions, in accordance with Part 1 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014. Thereafter, at the applicable time specified in paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, except as required by paragraph (l)(1) of this AD: Do all applicable actions specified in paragraphs (h)(1) through (h)(4) of this AD.
(1) Repeat the Part 1 inspection specified in paragraph (h) of this AD until the accomplishment of paragraphs (k)(1) and (k)(2) of this AD, as applicable.
(2) Inspect for cracking at the number 2 VHF antenna location using internal and external detailed inspections, internal and external high frequency eddy current (HFEC) inspections, and an HFEC open-hole inspection, in accordance with Part 2 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014. Repeat the inspections until the accomplishment of paragraphs (k)(1) and (k)(2) of this AD, as applicable.
(3) Repair any crack found, in accordance with Part 3 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, except as required by paragraph (l)(2) of this AD.
(4) Do a preventive modification, in accordance with Part 4 of the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737 53 1159, Revision 1, dated October 20, 2014, except as specified in paragraph (l)(2) of this AD. The accomplishment of this preventive modification terminates the inspections required by paragraphs (g), (g)(1), and (h)(2) of this AD.
For airplanes identified as Groups 3 through 6, Configuration 4, in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014: At the applicable time specified in table 10 of paragraph 1.E., “Compliance,” of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014; Do an external detailed inspection for cracking at the outer row of fasteners common to the internal repair doubler, and do an internal general visual inspection for cracking on the modified internal support structure of the number 2 VHF antenna, skin, and surrounding stringers, channel, and frames, in accordance with the Accomplishment Instructions of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014.
(1) If any cracking is found, before further flight, repair using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(2) If no cracking is found, repeat the inspections at the time specified in table 10 of paragraph 1.E., “Compliance,” of Boeing SB 737-53-1159, Revision 1, dated October 20, 2014.
For airplanes identified as Group 2, Configuration 1, and Groups 3 through 6, Configurations 1 through 3, in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014: The post-repair/post-modification inspections specified in tables 7 through 9 of paragraph 1.E., “Compliance” of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, are not required by this AD.
The post-repair/post-modification inspections specified in tables 7 through 9 of paragraph 1.E., “Compliance” of Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, may be used in support of compliance with section 121.1109(c)(2) or 129.109(b)(2) for the Federal Aviation Regulations (14 CFR 121.1109(c)(2) or 14 CFR 129.109(b)(2)).
The following describes terminating action for the airplane groups and configurations, as identified in Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014.
(1) For airplanes in Group 2, Configuration 2; and Groups 3 through 6, Configuration 2: Accomplishment of the inspections specified in paragraph (h)(2) of this AD terminates the repetitive inspection requirements of paragraph (h)(1) of this AD.
(2) For airplanes in Group 2, Configuration 1, and Groups 3 through 6, Configuration 1, 2, and 3: Accomplishment of the repair specified in paragraph (h)(3) of this AD terminates the repetitive inspections specified in paragraph (h)(1) and (h)(2) of this AD.
(3) For airplanes in Group 2, Configuration 1; and Groups 3 through 6, Configurations 1 and 3: Accomplishment of the preventive modification specified in paragraph (h)(4) of this AD terminates the initial and repetitive inspections specified in paragraphs (h), (h)(1), and (h)(2) of this AD.
(1) Where Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014 compliance is “after the Revision 1 date of this service bulletin,” this AD requires compliance within the specified compliance time after the effective date of this AD. Do the inspection, in accordance with the Accomplishment Instructions of the Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014.
(2) Where Boeing Special Attention Service Bulletin 737-53-1159, Revision 1, dated October 20, 2014, specifies to contact Boeing for appropriate action, and specifies that action as “RC” (Required for Compliance): Before further flight, repair the cracking using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(1) The Manager, Los Angeles Aircraft Certification Office (ACO), FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in paragraph (n)(2) of this AD.
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Los Angeles ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) For service information that contains steps that are labeled as Required for Compliance (RC), the provisions of paragraphs (m)(4)(i) and (m)(4)(ii) apply.
(i) The steps labeled as RC, including substeps under an RC step and any figures identified in an RC step, must be done to comply with the AD. An AMOC is required for any deviations to RC steps, including substeps and identified figures.
(ii) Steps not labeled as RC may be deviated from using accepted methods in accordance with the operator's maintenance or inspection program without obtaining approval of an AMOC, provided the RC steps, including substeps and identified figures, can still be done as specified, and the airplane can be put back in an airworthy condition.
(1) For more information about this AD, contact Wayne Lockett, Aerospace Engineer, Airframe Branch, ANM-120S, FAA, Seattle Aircraft Certification Office (ACO), 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: 425-917-6447; fax: 425-917-6590; email:
(2) For information on AMOCs, contact Nenita Odesa, Aerospace Engineer, Airframe Branch, ANM-120L, FAA, Los Angeles Aircraft Certification Office (ACO), 3960 Paramount Boulevard, Lakewood, CA 90712-4137; phone: 562-627-5210; fax: 562-627-5234; email:
(3) For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P. O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone 206-544-5000, extension 1; fax 206-766-5680; Internet
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class E surface area airspace designated as an extension to the Class C airspace, and Class E airspace extending upward from 700 feet above the surface at Portland International Airport, Portland, OR. After reviewing the airspace, the FAA found the Portland VHF omnidirectional radio range/distance measuring equipment (VOR/DME) and Laker non-directional beacon (NDB) have been decommissioned, thereby necessitating airspace redesign for the safety and management of Instrument Flight Rules (IFR) operations at the airport. This proposal also would correct the geographic coordinates of the airport.
Comments must be received on or before September 3, 2015.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2015-1137; Airspace Docket No. 15-ANM-4, at the beginning of your comments. You may also submit comments through the Internet at
FAA Order 7400.9Y, Airspace Designations and Reporting Points, and subsequent amendments can be viewed online at
FAA Order 7400.9, Airspace Designations and Reporting Points, is published yearly and effective on September 15. For further information, you can contact the Airspace Policy and Regulations Group, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC, 20591; telephone: 202-267-8783.
Steve Haga, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue SW., Renton, WA 98057; telephone (425) 203-4563.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part, A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would amend Class E airspace at Portland International Airport, Portland, OR.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal. Communications should identify both docket numbers and be submitted in triplicate to the address listed above. Commenters wishing the FAA to acknowledge receipt of their comments on this notice must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to Docket No. FAA-2015-1137; Airspace Docket No. 15-ANM-4.” The postcard will be date/time stamped and returned to the commenter.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This document proposes to amend FAA Order 7400.9Y, Airspace Designations and Reporting Points, dated August 6, 2014, and effective September 15, 2014. FAA Order 7400.9Y is publicly available as listed in the
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace designated as an extension to Class C airspace, and Class E airspace extending upward from 700 feet above the surface at Portland International Airport, Portland, OR. A review of the
Class E airspace designated as an extension to Class C airspace would be modified to an area 4.7 miles west and 4 miles east of the 044° bearing from Portland International Airport extending to 18 miles northeast of the airport. The lateral boundary for Class E airspace extending upward from 700 feet above the surface would be defined utilizing latitudinal and longitudinal reference points instead of navigation aids. This would not change the lateral boundaries or operating requirements of the airspace.
Class E airspace designations are published in paragraph 6003 and 6005, respectively, of FAA Order 7400.9Y, dated August 6, 2014, and effective September 15, 2014, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in the Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subject to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures” prior to any FAA final regulatory action.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface bounded by a line beginning at lat. 45°40′10″ N., long. 122°37′24″ W.; to lat. 45°41′14″ N., long. 122°37′21″ W.; to lat. 45°51′45″ N., long. 122°22′16″ W.; to lat. 45°45′40″ N., long. 122°13′32″ W.; to lat. 45°35′11″ N., long. 122°28′45″ W.; thence counter-clockwise along the 5-mile radius of Portland International Airport to the point of beginning.
That airspace extending upward from 700 feet above the surface bounded by a line beginning at lat. 45°59′59″ N., long. 123°30′04″ W.; to lat. 46°00′00″ N., long. 122°13′00″ W.; thence via an 8.5-mile radius centered at lat. 45°55′07″ N., long. 122°03′02″ W. clockwise to lat. 45°46′39″ N., long. 122°04′00″ W.; thence via a line south to lat. 45°09′59″ N., long. 122°04′00″ W.; thence to lat. 45°09′59″ N., long. 123°02′23″ W.; and within a 4.3-mile radius of McMinnville Municipal Airport; and within 2 miles each side of the 215° bearing from McMinnville Municipal Airport to lat. 45°09′59″ N., long. 123°13′21″ W.; to lat. 45°09′59″ N., long. 123°30′04″ W.; thence to the point of beginning; that airspace extending upward from 1,200 feet above the surface bounded by a line beginning at lat. 46°30′29″ N., long. 124°06′51″ W.; to lat. 46°30′29″ N., long. 120°29′40″ W.; to lat. 45°42′49″ N., long. 121°06′03″ W.; to lat. 44°15′10″ N., long. 121°18′13″ W.; to lat. 44°29′59″ N., long. 123°17′38″ W.; to lat. 44°29′59″ N., long. 124°08′036″ W. to a point 2.7 miles offshore; thence along a line 2.7 miles offshore to the point of beginning.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish restricted area R-2507W, Chocolate Mountains, CA, to support training activities that involve the use of advanced weapons systems. Proposed R-2507W is needed by the United States Marine Corps (USMC) to enhance training and safety requirements in order to maintain, train, and equip combat-ready military forces.
Comments must be received on or before September 3, 2015.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M-30, 1200 New Jersey Avenue SE., West Building Ground Floor, Room W12-140, Washington, DC 20590-0001; telephone: (202) 366-9826. You must identify FAA Docket No. FAA-2015-2193 and Airspace Docket No. 15-AWP-8, at the beginning of your comments. You may also submit comments through the Internet at
Jason Stahl, Airspace Policy and Regulations Group, Office of Airspace
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the United States Code. Subtitle I, Section 106 describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would modify the restricted area airspace at Chocolate Mountains, CA, to enhance aviation safety and accommodate essential USMC training requirements.
The Chocolate Mountain Aerial Gunnery Range (CMAGR), located in Imperial and Riverside Counties, CA is primarily used for live-fire aviation and ground warfare training conducted by USMC and Navy forces. Marine aviation plays a crucial role in the ability of Marine Air-Ground Task Forces (MAGTF) to conduct maneuver warfare. The ultimate goal of Marine aviation is to attain the highest possible combat readiness to support expeditionary maneuver warfare while preserving and conserving Marine forces and equipment. Embedded within combat readiness is the requirement that Marine aviation units maintain the ability to rapidly, effectively, and efficiently deploy a combat-capable aircrew and aircraft on short notice, and maintain the ability to quickly and effectively plan for crises and/or contingency operations. R-2507W would allow Marine aviation to attain and maintain this capability.
Current procedures require the periodic renewal of the CFAs over this area. Because nonparticipating aircraft may transit the CFAs without limitation and without warning, safety of flight concerns often result in lengthy training interruptions and failure to meet training requirements. A higher-level demand for greater throughput of both ground and aviation training in order to support real world operations will likely increase the frequency of these incidents. The USMC considered the existing R-2507N and the adjacent R-2507S restricted areas in order to meet the expanded training requirements. The existing restricted areas, which are primarily used for aerial ordnance delivery and air strikes, are incompatible with required co-use ground training activities. Alternate location suitability studies were conducted to examine alternatives for the ground training activities. The studies determined that the training capabilities offered in the proposed R-2507W are unique and cannot be replicated elsewhere without significant cost, time, and undue degradation or failure to meet USMC requirements.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA-2015-2193 and Airspace Docket No. 15-AWP-8) and be submitted in triplicate to the Docket Management System (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed, stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2015-2193 and Airspace Docket No. 15-AWP-8.” The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received and any final disposition in person at the Dockets Office (see
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
This proposal would establish new restricted area. R-2507W to accommodate live direct and indirect surface to surface fires associated with established live fire ranges and maneuver areas supporting Naval Special Warfare and Marine Corps ground unit training. This proposed restricted area is required to effectively de-conflict Department of Defense and civilian air traffic from hazards associated with live fire training.
Specific aviation activities and maximum altitudes within the R-2507W would include both live fire and non-live fire aviation training activities such as Basic Ordnance Delivery, Close Air Support, Air-to-Air Gunnery, Laser Ranging and Designating, and Air Strikes. As part of the Marine Corps' training in R-2507, the Marine Corps Air Command and Control organization will develop a battle space management plan. This plan will establish ground fire support and airspace coordination measures in a way that integrates ground and air operations in planning and execution within the MAGTF. Supersonic flight will not be conducted as part of the above aviation training activities.
Surface-to-surface and surface-to-air activities conducted within the R-2507W would include live fire from various small arms, machine guns, anti-tank weapons, mortars, and hand grenades. Direct fire weapons will be used in this area 6-24 hours per day, no less than 300 days per year. A minimum of 40 percent use of the planned live fire ranges will occur during hours of darkness (from 2200-0700).
Expansion of the current restricted area complex supports an increase in both Marine Corps and Naval aviation and ground training requirements. In addition, the expansion would allow critically required co-use of R-2507W in order to meet those increased training requirements.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under Department of Transportation (DOT) Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
This proposal will be subjected to an environmental analysis in accordance with FAA Order 1050.1E, “Environmental Impacts: Policies and Procedures,″ prior to any FAA final regulatory action.
Airspace, Prohibited areas, Restricted areas.
In consideration of the foregoing, the Federal Aviation Administration proposes to amend 14 CFR part 73 as follows:
49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Boundaries. Beginning at latitude 33°14′00″ N., longitude 115°22′33″ W.; to latitude 33°13′14″ N., longitude 115°23′17″ W.; to latitude 33°13′58″ N., longitude 115°24′26″ W.; to latitude 33°14′22″ N., longitude 115°25′29″ W.; to latitude 33°15′40″ N., longitude 115°27′36″ W.; to latitude 33°17′28″ N., longitude 115°29′42″ W.; to latitude 33°19′17″ N., longitude 115°32′13″ W.; to latitude 33°21′11″ N., longitude 115°34′39″ W.; to latitude 33°22′58″ N., longitude 115°38′19″ W.; to latitude 33°27′26″ N., longitude 115°43′30″ W.; to latitude 33°29′25″ N., longitude 115°46′08″ W.; to latitude 33°31′09″ N., longitude 115°41′12″ W.; to latitude 33°32′50″ N., longitude 115°37′37″ W.; to latitude 33°32′40″ N., longitude 115°33′53″ W.; to latitude 33°28′30″ N., longitude 115°42′13″ W.; to latitude 33°23′40″ N., longitude 115°33′23″ W.; to latitude 33°21′30″ N., longitude 115°32′58″ W.; to the point of beginning.
Designated altitudes. Surface to FL 230.
Time of designation. Continuous.
Controlling agency. FAA, Los Angeles Air Route Traffic Control Center (ARTCC).
Using agency. USMC, Commanding Officer, Marine Corps Air Station (MCAS) Yuma, AZ.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Texas State Implementation Plan (SIP) related to Low Reid Vapor Pressure (RVP) Fuel Regulations that were submitted by the State of Texas on January 5, 2015. The EPA evaluated the Texas SIP submittal and determined these revisions are consistent with the requirements of the Clean Air Act (Act or CAA). The EPA is approving this action under the federal CAA.
Written comments should be received on or before August 19, 2015.
Comments may be mailed to Ms. Mary Stanton, Chief, Air Grants Section (6PD-S), Environmental Protection Agency, 1445 Ross Avenue, Suite 1200, Dallas, Texas 75202-2733. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the
Tracie Donaldson, (214) 665-6633,
In the final rules section of this
For additional information, see the direct final rule which is located in the rules section of this
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a revision to the State Implementation Plan (SIP) submitted by the State of Florida through the Department of Environmental Protection (DEP) on July
Written comments must be received on or before August 19, 2015.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2015-0133, by one of the following methods:
1.
2.
3.
4.
5.
Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9043. Mr. Lakeman can be reached via electronic mail at
The Florida Rule 62-296.418 requires bulk gasoline plants which began operation on or after August 1, 2007, to install and operate vapor collection and control systems on their loading racks. The rule became effective on May 9, 2007, and was submitted to EPA as a proposed SIP revision on May 31, 2007. EPA approved the SIP revision on June 1, 2009 (74 FR 26103).
On May 30, 2007, Combs Oil Company submitted a petition for variance from the requirements of Rule 62-296.418(2)(b)2, Florida Administrative Code (F.A.C.), for its new bulk gasoline plant. The company operates an existing bulk gasoline plant in Naples, Florida. The new plant would replace the existing plant and be constructed at a different site in the area. However, between July 2005 and January 2007, the company experienced substantial construction delays beyond its control due to the effects of hurricanes, both in Florida and along the upper Gulf Coast. The company experienced delays in obtaining steel for the office and loading/tank areas as well as the rationing of steel rebar and concrete supplies. Combs Oil Company had invested $67,053 in equipment and $40,235 in construction costs for the support structure of the loading rack prior to the DEP's initiation of rule 62-296.418(2)(b)2, requiring a vapor collection and control system on the loading racks of new bulk gasoline plants. However, the company was unable to complete construction and relocation of its plant by August 1, 2007, due to the aforementioned construction delays.
Under Section 120.542 of the Florida Statutes, the DEP may grant a variance when the person subject to a rule demonstrates that the purpose of the underlying statute will be or has been achieved by other means, or when application of a rule would create a substantial hardship or violate principles of fairness. The DEP determined that Combs Oil Company had demonstrated that principles of fairness would be violated because the delays in building and relocating to the new facility, related to hurricanes, were beyond the control of the company. Therefore, the DEP issued an Order Granting Variance to Combs Oil Company on August 20, 2008, relieving the company from the requirements of Rule 62-296.418(2)(b)2., F.A.C., for its proposed new facility.
Section 110(l) of the CAA requires that SIP revisions must not interfere with any applicable requirement concerning attainment and reasonable further progress. Like the facility it is replacing, the new Combs Oil facility is located in Collier County in Southwest Florida. Collier County has never been designated nonattainment for any air
The proposed SIP revision involves emissions of volatile organic compounds (VOC), a precursor to ozone. For fine particulate matter (PM
The proposed source is currently operating in the county and is simply moving a relatively short distance (1.6 miles) within the same general area. Emissions of VOC from gasoline operations at the relocated source are estimated to be the same as VOC emissions at the existing facility, even when the increased storage capacity at the new location is considered. Specifically, VOC emissions are estimated to be less than 3 tons per year—minor in comparison to the county total of 31,816 tons per year. Since ozone concentration levels are currently well below the ambient air quality standard of 0.075 ppm, and emissions of VOC will not increase as a result of the relocation of this source, EPA has preliminary determined that the variance will not interfere with the area's ability to continue to maintain the ozone standards. Thus, EPA has preliminarily determined that the changes are consistent with the Clean Air Act (CAA or Act).
In this rule, the EPA is proposing to include in a final EPA rule, regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference the “Combs Oil Company Source Specific Variance” order granting variance on August 20, 2008. EPA has made, and will continue to make, these documents generally available electronically through
EPA is proposing to approve a source specific SIP revision submitted by the Florida DEP on July 31, 2009. The revision grants a variance to the Combs Oil Company, located in Naples, Florida. This source specific revision relieves the Combs Oil Company of the requirement to comply with the Florida rule governing installation and operation of vapor collection and control systems on loading racks at bulk gasoline plants. It should be noted that approval of the variance for Combs Oil Company only relieves them from the requirements of Rule 62-296.418(2)(b)2 F.A.C., for its new bulk gasoline plant, it does not relieve them from any requirements established in 40 CFR parts 60 and 63.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Nitrogen dioxide, Particulate Matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve in part, and disapprove, the November 4, 2011, State Implementation Plan (SIP) submission, provided by the Alabama
Written comments must be received on or before August 19, 2015.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2013-0185, by one of the following methods:
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4.
5.
Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9152. Mr. Farngalo can be reached via electronic mail at
On October 5, 1978, EPA promulgated a primary and secondary NAAQS under section 109 of the Act.
Today's action is proposing to in part approve and in part disapprove portions of Alabama's infrastructure SIP submissions for the applicable requirements of the 2008 Lead NAAQS. On March 18, 2015, EPA approved Alabama's November 4, 2011, infrastructure SIP submission regarding the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of D(i) and (J) for the 2008 Lead NAAQS.
Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 2008 Lead NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with the 1978 Lead NAAQS.
Section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include SIP infrastructure elements such as modeling, monitoring, and emissions inventories that are designed to assure attainment and maintenance of the NAAQS. The requirements that are the subject of this proposed rulemaking are listed below
• 110(a)(2)(J): Consultation with government officials, public notification, PSD and visibility protection
• 110(a)(2)(K): Air quality modeling/data
• 110(a)(2)(L): Permitting fees
• 110(a)(2)(M): Consultation/participation by affected local entities
EPA is acting upon the SIP submission from Alabama that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the Lead NAAQS. The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.
EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review permit program submissions to address the permit requirements of CAA, title I, part D.
Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.
The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP requirements.
Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.
Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.
EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.
Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.
Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to
EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.
Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1) and 110(a)(2) because the CAA provides other avenues and mechanisms to address specific substantive deficiencies in existing SIPs. These other statutory tools allow EPA to take appropriately tailored action, depending upon the nature and severity of the alleged SIP deficiency. Section 110(k)(5) authorizes EPA to issue a “SIP call” whenever the Agency determines that a state's SIP is substantially inadequate to attain or maintain the NAAQS, to mitigate interstate transport, or to otherwise comply with the CAA.
The Alabama infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.
1. 110(a)(2)(A):
In this action, EPA is not proposing to approve or disapprove any existing State provisions with regard to excess emissions during startup, shutdown and malfunction (SSM) of operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and
Additionally, in this action, EPA is not proposing to approve or disapprove any existing State rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.
2. 110(a)(2)(B)
3.
EPA has made the preliminary determination that Alabama's SIP and practices are adequate for program enforcement of control measures and regulation of minor sources and modifications related to the 2008 Lead NAAQS.
4. 110(a)(2)(D)(i)
5. 110(a)(2)(D)(ii)
6. 110(a)(2)(E)
To satisfy the requirements of section 110(a)(2)(E)(i) and (iii), ADEM's infrastructure SIP submission describes Alabama Code section 22-28-11, which authorizes ADEM to adopt emission requirements though regulations that are necessary to prevent, abate, or control air pollution. Also, Alabama Code section 22-28-9 authorizes the Department to employ necessary staff to carry out responsibilities. The funding requirements are met through the 105 grants and the title V fee process. As further evidence of the adequacy of ADEM's resources, EPA submitted a letter to Alabama on April 24, 2014, outlining 105 grant commitments and the current status of these commitments for fiscal year 2014. The letter EPA submitted to Alabama can be accessed at
To satisfy the requirements of section 110(a)(2)(E)(ii), states must comply with the requirements respecting State Boards pursuant to section 128 of the Act. Section 110(a)(2)(E)(ii) requires that the state comply with section 128 of the CAA. Section 128 requires that the SIP contain provisions that provide: (1) The majority of members of the state board or body which approves permits or enforcement orders represent the public interest and do not derive any significant portion of their income from persons subject to permitting or enforcement orders under the CAA; and (2) any potential conflicts of interest by such board or body, or the head of an executive agency with similar powers be adequately disclosed. After reviewing Alabama's SIP, EPA has made the preliminary determination that the State's implementation plan does not contain provisions to comply with section 128 of the Act, and thus Alabama's November 4, 2011, infrastructure SIP submission does not meet the requirements of the Act. While Alabama has state statutes that may address, in whole or in part, requirements related to state boards at the state level, these provisions are not included in the SIP as required by the CAA. Based on an evaluation of the federally-approved Alabama SIP, EPA is proposing to disapprove Alabama's infrastructure SIP submission as meeting the requirements of 110(a)(2)(E)(ii) of the CAA for the 2008 Lead NAAQS. The submitted provisions which purport to address 110(a)(2)(E)(ii) are severable from the other portions of ADEM's infrastructure SIP submission, therefore, EPA is proposing to disapprove those provisions which relate only to sub-element 110(a)(2)(E)(ii).
7. 110(a)(2)(F)
Additionally, Alabama is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the Air Emissions Reporting Rule (AERR) on December 5, 2008, which modified the requirements for collecting and reporting air emissions data (73 FR 76539). The AERR shortened the time states had to report emissions data from 17 to 12 months, giving states one calendar year to submit emissions data. All states are required to submit a comprehensive emissions inventory every three years and report emissions for certain larger sources annually through EPA's online Emissions Inventory System. States report emissions data for the six criteria pollutants and their associated precursors—nitrogen oxides, sulfur dioxide, ammonia, Lead, carbon monoxide, particulate matter, and volatile organic compounds. Many states also voluntarily report emissions of hazardous air pollutants. Alabama made its latest update to the 2013 NEI on January 13, 2015. EPA compiles the emissions data, supplementing it where necessary, and releases it to the general public through the Web site
8. 110(a)(2)(G)
9. 110(a)(2)(H)
EPA has made the preliminary determination that Alabama's SIP and practices adequately demonstrate the State's ability to meet the general requirement in section 110(a)(2)(J) to include a program in the SIP that provides for meeting the applicable consultation requirements of section 121, the public notification requirements of section 127 and visibility protection associated with regional haze. EPA has also preliminarily determined that it is appropriate approve the State's Lead infrastructure SIP submission with respect to the visibility aspects of section 110(a)(2)(J). EPA is making no determinations with respect the PSD requirements of section 110(a)(2)(J), which will be addressed in a different notice.
11. 110(a)(2)(K)
12. 110(a)(2)(L)
12. 110(a)(2)(M)
With the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), prong 3 of (D)(i) and (J), and the state board requirements of section 110(a)(2)(E)(ii), EPA is proposing to approve that ADEM's infrastructure SIP submission, submitted November 4, 2011, for the 2008 Lead NAAQS meets the above described infrastructure SIP requirements. EPA is proposing to disapprove section 110(a)(2)(E)(ii) of Alabama's infrastructure submission because the State's implementation plan does not contain provisions to comply with section 128 of the Act, and thus Alabama's November 4, 2011, infrastructure SIP submission does not meet the requirements of the Act. This proposed approval in part and disapproval in part, however, does not include the PSD permitting requirements for major sources of section 110(a)(2)(C), prong 3 of (D)(i) and (J) because the Agency has taken final action on these requirements for 2008 Lead NAAQS for Alabama in a separate rulemaking.
Under section 179(a) of the CAA, final disapproval of a submittal that addresses a requirement of a CAA Part D Plan or is required in response to a finding of substantial inadequacy as described in CAA section 110(k)(5) (SIP call) starts a sanctions clock. The portion of section 110(a)(2)(E)(ii) provisions (the provisions being proposed for disapproval in today's notice) were not submitted to meet requirements for Part D or a SIP call, and therefore, if EPA takes final action to disapprove this submittal, no sanctions will be triggered. However, if this disapproval action is finalized, that final action will trigger the requirement under section 110(c) that EPA promulgate a federal implementation plan (FIP) no later than 2 years from the date of the disapproval unless the State corrects the deficiency, and EPA approves the plan or plan revision before EPA promulgates such FIP.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this proposed action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this proposed action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Lead, and Recordkeeping requirements.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of a State Implementation Plan (SIP) revision submitted by the Mississippi Department of Environmental Quality (MDEQ), to EPA on July 25, 2010. The SIP revision includes multiple changes to Mississippi's SIP to add definitions in accordance with federal regulations and to implement clarifying language. EPA is not proposing to take action on the aspects of the SIP revision related to the Clean Air Interstate Rule (CAIR) or hazardous air pollutants at this time.
Written comments must be received on or before August 19, 2015.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2013-0163, by one of the following methods:
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Sean Lakeman, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. Mr. Lakeman can be reached by phone at (404) 562-9043 or via electronic mail at
On June 25, 2010, MDEQ submitted a SIP revision to EPA for approval into the Mississippi SIP. MDEQ's July 25, 2010, SIP revision includes multiple changes to Mississippi's air pollution control regulation APC-S-1, entitled “Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants,” to add and amend definitions in accordance with federal regulations and to implement clarifying language. Specifically, these changes include amendments to Section 2—“Definitions” and Section 3—“Specific Criteria for Sources of Particulate Matter.” With the exception of the changes in Section 8 related to hazardous air pollutants and the changes in Section 14 related to Mississippi's CAIR provisions, EPA is proposing to approve Mississippi's July 25, 2010, SIP revision, which became state effective on February 6, 2009.
Mississippi is amending the definition of “Air Cleaning Device” by adding language to clarify that the term “air pollution control device” is synonymous with the term “air cleaning device.” The definition of “air cleaning device” includes “[a]ny method, process or equipment which removes, reduces or renders less noxious air contaminants discharged into the atmosphere.” Mississippi's July 25, 2010, SIP revision, simply clarifies that the term “air pollution control device” has the same definition as “air cleaning device” by adding a phrase noting that these two terms are “synonymous.” Mississippi chose to link the two terms rather than provide a separate definition entry for “air pollution control device.” Mississippi is making this change to provide clarity to the regulated community regarding the definition for the term “air pollution control device.”
Mississippi's July 25, 2010, SIP submission amends the definition for “Ozone Action Day” by changing the dates from April 1 and September 30 to March 1 and October 30, respectively, to align with the time period for ozone monitoring in Mississippi as specified in 40 CFR part 58. See table in 40 CFR part 58 entitled, “Table D-3 of Appendix D to Part 58—Ozone Monitoring Season by State.”
Mississippi added a definition of “PM
Mississippi added a definition of “PM
As it currently exists in the SIP, APC-S-1, Section 3.4(b)—“Combination Boilers”—states that particulate matter emissions from combination boilers involved in fuel burning operations that utilize a mixture of combustibles are allowed emission rates up to 0.30 grains per standard dry cubic foot. Mississippi's July 25, 2010, SIP submission added language to clarify that section 3.4(b) is only applicable to fuel burning operations that utilize a mixture of combustibles “to produce steam or heat water or any other heat transfer medium through indirect means.”
Mississippi is amending subparagraph (a) relating to particulate matter emission limits based on process weight rate to clarify that the emission limit listed in that subparagraph applies to the manufacturing process including any associated stacks, vents, outlets, or combination thereof.
Mississippi is amending subparagraph (a)(1) to clarify that fires set for burning of agricultural wastes in the field and/or silvicultural wastes for forest management purposes must obtain a permit from the Mississippi Forestry Commission regardless of whether there is an available Forestry Commission tower servicing the area in which the burning occurs.
Mississippi is adding subparagraph (c) to clarify that the particulate matter emission limit for incinerators, 0.2 grains per standard dry cubic foot of flue gas, does not apply to “afterburners, flares, thermal oxidizers, and other similar devices used to reduce the emissions of air pollutants from processes.” EPA notes that all particulate matter emissions discharged from such control devices are part of the total emissions from the process unit and are not excluded from determinations of compliance with applicable emission limitations. Mississippi also amended the text of subparagraph (a) to reference subparagraph (c) to further clarify that devices listed at paragraph (c) are not required to apply the particulate matter emission limit for incinerators identified in subparagraph (a).
In this rule, EPA is proposing to include in a final EPA rule regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, EPA is proposing to incorporate by reference certain changes to Mississippi's air pollution control regulation APC-S-1, entitled “Air Emission Regulations for the Prevention, Abatement, and Control of Air Contaminants.” Specifically, these changes include the amendments to Section 2—“Definitions” and Section 3—“Specific Criteria for Sources of Particulate Matter” described in section II, above. EPA has made, and will continue to make, these documents generally available electronically through
EPA is proposing to approve portions of Mississippi's July 25, 2010, SIP submission revising Rule APC-S-1 to add and amend definitions in accordance with federal regulations and to implement clarifying language. EPA has preliminarily determined that these changes to the Mississippi SIP are in accordance with the Clean Air Act (CAA or Act) and EPA policy and regulations. With the exception of changes in Section 8 related to hazardous air pollutants and the changes in Section 14 related to Mississippi's CAIR provisions, EPA is proposing to approve Mississippi's SIP revisions provided to EPA on July 25, 2010. EPA will consider action on Mississippi's changes to its CAIR provisions and its hazardous air pollutants provisions in a separate action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
The SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan revision submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources on August 13, 2012, pertaining to definition changes for the Nitrogen Dioxide and Sulfur Dioxide National Ambient Air Quality Standards. EPA is approving this SIP revision because the State has demonstrated that it is consistent with the Clean Air Act. In the Final Rules section of this issue of the
Written comments must be received on or before August 19, 2015.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2015-0368, by one of the following methods:
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Please see the direct final rule which is located in the Rules section of this
Zuri Farngalo, Air Regulatory Management Section, Air Planning and Implementation Branch, Air, Pesticides and Toxics Management Division, U.S. Environmental Protection Agency, Region 4, 61 Forsyth Street SW., Atlanta, Georgia 30303-8960. The telephone number is (404) 562-9152. Mr. Farngalo can also be reached via electronic mail at
For additional information see the direct final rule which is published in the Rules Section of this
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve portions of the May 14, 2012, State Implementation Plan (SIP) submission, provided by the Georgia Department of Natural Resources, Environmental Protection Division (hereafter referred to as GA EPD) for inclusion into the Georgia SIP. This proposal pertains to the Clean Air Act (CAA or the Act) infrastructure requirements for the 2008 8-hour ozone national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an “infrastructure” SIP. GA EPD certified that the Georgia SIP contains provisions that ensure the 2008 8-hour ozone NAAQS is implemented, enforced, and maintained in Georgia. With the exception of provisions pertaining to prevention of significant deterioration (PSD) permitting and interstate transport requirements, EPA is proposing to approve Georgia's infrastructure SIP submission provided to EPA on May 14, 2012, as satisfying the required infrastructure elements for the 2008 8-hour ozone NAAQS.
Written comments must be received on or before August 19, 2015.
Submit your comments, identified by Docket ID No. EPA-R04-OAR-2012-0696, by one of the following methods:
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Nacosta C. Ward,
On March 27, 2008, EPA promulgated a revised NAAQS for ozone based on 8-hour average concentrations. EPA revised the level of the 8-hour ozone NAAQS to 0.075 parts per million.
Today's action is proposing to approve Georgia's infrastructure submission for the applicable requirements of the 2008 8-hour ozone NAAQS, with the exception of the PSD permitting requirements for major sources of sections 110(a)(2)(C), (D)(i)(II) prong 3 and (J) and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2, and 4). With respect to Georgia's infrastructure SIP submission related to provisions pertaining to interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs, 1, 2, and 4), EPA is not proposing any action today regarding these requirements and will act on these requirements in a separate action. On March 18, 2015, EPA approved Georgia's May 14, 2012, infrastructure SIP submission regarding the PSD permitting requirements for major sources of sections 110(a)(2)(C), (D)(i)(II) prong 3 and (J) for the 2008 8-hour NAAQS.
Section 110(a) of the CAA requires states to submit SIPs to provide for the implementation, maintenance, and enforcement of a new or revised NAAQS within three years following the promulgation of such NAAQS, or within such shorter period as EPA may prescribe. Section 110(a) imposes the obligation upon states to make a SIP submission to EPA for a new or revised NAAQS, but the contents of that submission may vary depending upon the facts and circumstances. In particular, the data and analytical tools available at the time the state develops and submits the SIP for a new or revised NAAQS affects the content of the submission. The contents of such SIP submissions may also vary depending upon what provisions the state's existing SIP already contains. In the case of the 2008 8-hour ozone NAAQS, states typically have met the basic program elements required in section 110(a)(2) through earlier SIP submissions in connection with the 1997 8-hour ozone NAAQS.
More specifically, section 110(a)(1) provides the procedural and timing requirements for SIPs. Section 110(a)(2) lists specific elements that states must meet for “infrastructure” SIP requirements related to a newly established or revised NAAQS. As mentioned above, these requirements include basic SIP elements such as requirements for monitoring, basic program requirements and legal authority that are designed to assure attainment and maintenance of the NAAQS. The requirements of section 110(a)(2) are summarized below and in EPA's September 13, 2013, memorandum entitled “Guidance on Infrastructure State Implementation Plan (SIP) Elements under Clean Air Act Sections 110(a)(1) and 110(a)(2).”
• 110(a)(2)(A): Emission Limits and Other Control Measures
• 110(a)(2)(B): Ambient Air Quality Monitoring/Data System
• 110(a)(2)(C): Programs for Enforcement of Control Measures and for Construction or Modification of Stationary Sources
• 110(a)(2)(D)(i)(I) and (II): Interstate Pollution Transport
• 110(a)(2)(D)(ii): Interstate Pollution Abatement and International Air Pollution
• 110(a)(2)(E): Adequate Resources and Authority, Conflict of Interest, and Oversight of Local Governments and Regional Agencies
• 110(a)(2)(F): Stationary Source Monitoring and Reporting
• 110(a)(2)(G): Emergency Powers
• 110(a)(2)(H): SIP revisions
• 110(a)(2)(I): Plan Revisions for Nonattainment Areas
• 110(a)(2)(J): Consultation with Government Officials, Public Notification, and PSD and Visibility Protection
• 110(a)(2)(K): Air Quality Modeling and Submission of Modeling Data
• 110(a)(2)(L): Permitting fees
• 110(a)(2)(M): Consultation and Participation by Affected Local Entities
EPA is acting upon the SIP submission from Georgia that addresses the infrastructure requirements of CAA sections 110(a)(1) and 110(a)(2) for the 2008 8-hour ozone NAAQS. The requirement for states to make a SIP submission of this type arises out of CAA section 110(a)(1). Pursuant to section 110(a)(1), states must make SIP submissions “within 3 years (or such shorter period as the Administrator may prescribe) after the promulgation of a national primary ambient air quality standard (or any revision thereof),” and these SIP submissions are to provide for the “implementation, maintenance, and enforcement” of such NAAQS. The statute directly imposes on states the duty to make these SIP submissions, and the requirement to make the submissions is not conditioned upon EPA's taking any action other than promulgating a new or revised NAAQS. Section 110(a)(2) includes a list of specific elements that “[e]ach such plan” submission must address.
EPA has historically referred to these SIP submissions made for the purpose of satisfying the requirements of CAA sections 110(a)(1) and 110(a)(2) as “infrastructure SIP” submissions. Although the term “infrastructure SIP” does not appear in the CAA, EPA uses the term to distinguish this particular type of SIP submission from submissions that are intended to satisfy other SIP requirements under the CAA, such as “nonattainment SIP” or “attainment plan SIP” submissions to address the nonattainment planning requirements of part D of title I of the CAA, “regional haze SIP” submissions required by EPA rule to address the visibility protection requirements of CAA section 169A, and nonattainment new source review permit program submissions to address the permit requirements of CAA, title I, part D.
Section 110(a)(1) addresses the timing and general requirements for infrastructure SIP submissions, and section 110(a)(2) provides more details concerning the required contents of these submissions. The list of required elements provided in section 110(a)(2) contains a wide variety of disparate provisions, some of which pertain to required legal authority, some of which pertain to required substantive program provisions, and some of which pertain to requirements for both authority and substantive program provisions.
The following examples of ambiguities illustrate the need for EPA to interpret some section 110(a)(1) and section 110(a)(2) requirements with respect to infrastructure SIP submissions for a given new or revised NAAQS. One example of ambiguity is that section 110(a)(2) requires that “each” SIP submission must meet the list of requirements therein, while EPA has long noted that this literal reading of the statute is internally inconsistent and would create a conflict with the nonattainment provisions in part D of title I of the Act, which specifically address nonattainment SIP
Another example of ambiguity within sections 110(a)(1) and 110(a)(2) with respect to infrastructure SIPs pertains to whether states must meet all of the infrastructure SIP requirements in a single SIP submission, and whether EPA must act upon such SIP submission in a single action. Although section 110(a)(1) directs states to submit “a plan” to meet these requirements, EPA interprets the CAA to allow states to make multiple SIP submissions separately addressing infrastructure SIP elements for the same NAAQS. If states elect to make such multiple SIP submissions to meet the infrastructure SIP requirements, EPA can elect to act on such submissions either individually or in a larger combined action.
Ambiguities within sections 110(a)(1) and 110(a)(2) may also arise with respect to infrastructure SIP submission requirements for different NAAQS. Thus, EPA notes that not every element of section 110(a)(2) would be relevant, or as relevant, or relevant in the same way, for each new or revised NAAQS. The states' attendant infrastructure SIP submissions for each NAAQS therefore could be different. For example, the monitoring requirements that a state might need to meet in its infrastructure SIP submission for purposes of section 110(a)(2)(B) could be very different for different pollutants because the content and scope of a state's infrastructure SIP submission to meet this element might be very different for an entirely new NAAQS than for a minor revision to an existing NAAQS.
EPA notes that interpretation of section 110(a)(2) is also necessary when EPA reviews other types of SIP submissions required under the CAA. Therefore, as with infrastructure SIP submissions, EPA also has to identify and interpret the relevant elements of section 110(a)(2) that logically apply to these other types of SIP submissions. For example, section 172(c)(7) requires that attainment plan SIP submissions required by part D have to meet the “applicable requirements” of section 110(a)(2). Thus, for example, attainment plan SIP submissions must meet the requirements of section 110(a)(2)(A) regarding enforceable emission limits and control measures and section 110(a)(2)(E)(i) regarding air agency resources and authority. By contrast, it is clear that attainment plan SIP submissions required by part D would not need to meet the portion of section 110(a)(2)(C) that pertains to the PSD program required in part C of title I of the CAA, because PSD does not apply to a pollutant for which an area is designated nonattainment and thus subject to part D planning requirements. As this example illustrates, each type of SIP submission may implicate some elements of section 110(a)(2) but not others.
Given the potential for ambiguity in some of the statutory language of section 110(a)(1) and section 110(a)(2), EPA believes that it is appropriate to interpret the ambiguous portions of section 110(a)(1) and section 110(a)(2) in the context of acting on a particular SIP submission. In other words, EPA assumes that Congress could not have intended that each and every SIP submission, regardless of the NAAQS in question or the history of SIP development for the relevant pollutant, would meet each of the requirements, or meet each of them in the same way. Therefore, EPA has adopted an approach under which it reviews infrastructure SIP submissions against the list of elements in section 110(a)(2), but only to the extent each element applies for that particular NAAQS.
Historically, EPA has elected to use guidance documents to make recommendations to states for infrastructure SIPs, in some cases conveying needed interpretations on newly arising issues and in some cases conveying interpretations that have already been developed and applied to individual SIP submissions for particular elements.
As an example, section 110(a)(2)(E)(ii) is a required element of section 110(a)(2) for infrastructure SIP submissions. Under this element, a state must meet the substantive requirements of section 128, which pertain to state boards that approve permits or enforcement orders and heads of executive agencies with similar powers. Thus, EPA reviews infrastructure SIP submissions to ensure that the state's implementation plan appropriately addresses the requirements of section 110(a)(2)(E)(ii) and section 128. The 2013 Guidance explains EPA's interpretation that there may be a variety of ways by which states can appropriately address these substantive statutory requirements, depending on the structure of an individual state's permitting or enforcement program (
As another example, EPA's review of infrastructure SIP submissions with respect to the PSD program requirements in sections 110(a)(2)(C), (D)(i)(II), and (J) focuses upon the structural PSD program requirements contained in part C and EPA's PSD regulations. Structural PSD program requirements include provisions necessary for the PSD program to address all regulated sources and NSR pollutants, including greenhouse gases. By contrast, structural PSD program requirements do not include provisions that are not required under EPA's regulations at 40 CFR 51.166 but are merely available as an option for the state, such as the option to provide grandfathering of complete permit applications with respect to the 2012 PM
For other section 110(a)(2) elements, however, EPA's review of a state's infrastructure SIP submission focuses on assuring that the state's SIP meets basic structural requirements. For example, section 110(a)(2)(C) includes, among other things, the requirement that states have a program to regulate minor new sources. Thus, EPA evaluates whether the state has an EPA-approved minor new source review program and whether the program addresses the pollutants relevant to that NAAQS. In the context of acting on an infrastructure SIP submission, however, EPA does not think it is necessary to conduct a review of each and every provision of a state's existing minor source program (
With respect to certain other issues, EPA does not believe that an action on a state's infrastructure SIP submission is necessarily the appropriate type of action in which to address possible deficiencies in a state's existing SIP. These issues include: (i) Existing provisions related to excess emissions from sources during periods of startup, shutdown, or malfunction that may be contrary to the CAA and EPA's policies addressing such excess emissions (“SSM”); (ii) existing provisions related to “director's variance” or “director's discretion” that may be contrary to the CAA because they purport to allow revisions to SIP-approved emissions limits while limiting public process or not requiring further approval by EPA; and (iii) existing provisions for PSD programs that may be inconsistent with current requirements of EPA's “Final NSR Improvement Rule,” 67 FR 80186 (December 31, 2002), as amended by 72 FR 32526 (June 13, 2007) (“NSR Reform”). Thus, EPA believes it may approve an infrastructure SIP submission without scrutinizing the totality of the existing SIP for such potentially deficient provisions and may approve the submission even if it is aware of such existing provisions.
EPA's approach to review of infrastructure SIP submissions is to identify the CAA requirements that are logically applicable to that submission. EPA believes that this approach to the review of a particular infrastructure SIP submission is appropriate, because it would not be reasonable to read the general requirements of section 110(a)(1) and the list of elements in 110(a)(2) as requiring review of each and every provision of a state's existing SIP against all requirements in the CAA and EPA regulations merely for purposes of assuring that the state in question has the basic structural elements for a functioning SIP for a new or revised NAAQS. Because SIPs have grown by accretion over the decades as statutory and regulatory requirements under the CAA have evolved, they may include some outmoded provisions and historical artifacts. These provisions, while not fully up to date, nevertheless may not pose a significant problem for the purposes of “implementation, maintenance, and enforcement” of a new or revised NAAQS when EPA evaluates adequacy of the infrastructure SIP submission. EPA believes that a better approach is for states and EPA to focus attention on those elements of section 110(a)(2) of the CAA most likely to warrant a specific SIP revision due to the promulgation of a new or revised NAAQS or other factors.
For example, EPA's 2013 Guidance gives simpler recommendations with respect to carbon monoxide than other NAAQS pollutants to meet the visibility requirements of section 110(a)(2)(D)(i)(II), because carbon monoxide does not affect visibility. As a result, an infrastructure SIP submission for any future new or revised NAAQS for carbon monoxide need only state this fact in order to address the visibility prong of section 110(a)(2)(D)(i)(II).
Finally, EPA believes that its approach with respect to infrastructure SIP requirements is based on a reasonable reading of sections 110(a)(1)
The Georgia infrastructure submission addresses the provisions of sections 110(a)(1) and (2) as described below.
1. 110(a)(2)(A)
In this action, EPA is not proposing to approve or disapprove any existing State provisions with regard to excess emissions during startup, shutdown or malfunction (SSM) of operations at a facility. EPA believes that a number of states have SSM provisions which are contrary to the CAA and existing EPA guidance, “State Implementation Plans: Policy Regarding Excess Emissions During Malfunctions, Startup, and Shutdown” (September 20, 1999), and the Agency is addressing such state regulations in a separate action.
Additionally, in this action, EPA is not proposing to approve or disapprove any existing State rules with regard to director's discretion or variance provisions. EPA believes that a number of states have such provisions which are contrary to the CAA and existing EPA guidance (52 FR 45109 (November 24, 1987)), and the Agency plans to take action in the future to address such state regulations. In the meantime, EPA encourages any state having a director's discretion or variance provision which is contrary to the CAA and EPA guidance to take steps to correct the deficiency as soon as possible.
2. 110(a)(2)(B)
3. 110(a)(2)(C)
PSD program). To meet these obligations, Georgia cited Rules 391-3-
EPA has made the preliminary determination that Georgia's SIP and practices are adequate for enforcement of control measures and regulation of minor sources and modifications related to the 2008 8-hour ozone NAAQS.
4. 110(a)(2)(D)(i)(I) and (II)
5. 110(a)(2)(D)(ii)
6. 110(a)(2)(E)
In support of EPA's proposal to approve sub-elements 110(a)(2)(E)(i) and (iii), EPA notes that GA EPD is responsible for promulgating rules and regulations for the NAAQS, emissions standards general policies, a system of permits, and fee schedules for the review of plans, and other planning needs. Georgia's infrastructure SIP submission cites Georgia Air Quality Act Article 1: Air Quality (O.C.G.A. Section 12-9-10
With respect to the requirements of section 110(a)(2)(E)(ii) pertaining the state board requirements of CAA section 128, Georgia's infrastructure SIP submission cites Georgia Air Quality Act Article 1: Air Quality (O.C.G.A. Section 12-9-5
7. 110(a)(2)(F)
In addition, Rule 391-3-1-.02(3) “Sampling”
Georgia is required to submit emissions data to EPA for purposes of the National Emissions Inventory (NEI). The NEI is EPA's central repository for air emissions data. EPA published the Air Emissions Reporting Rule (AERR) on December 5, 2008, which modified the requirements for collecting and reporting air emissions data.
8. 110(a)(2)(G)
Rule 391-3-1-.04 “Air Pollution Episodes” provides that the Director of EPD “will proclaim that an Air Pollution Alert, Air Pollution Warning, or Air Pollution Emergency exists when the meteorological conditions are such that an air stagnation condition is in existence and/or the accumulation of air contaminants in any place is attaining or has attained levels which could, if such levels are sustained or exceeded, lead to a substantial threat to the health of persons in the specific area affected.” Collectively the cited provisions provide that Georgia EPD demonstrate authority comparable with section 303 of the CAA and adequate contingency plans to implement such authority in the state. EPA has made the preliminary determination that Georgia's SIP and practices are adequate to satisfy the emergency powers obligations of the 2008 8-hour ozone NAAQS.
9. 110(a)(2)(H)
10. 110(a)(2)(J)
EPA has made the preliminary determination that Georgia's SIP and practices adequately demonstrate the State's ability to provide consultation with government officials, public notification related to the 2008 8-hour ozone NAAQS when necessary, and, as explained above, is sufficient for visibility protection for this element.
11. 110(a)(2)(K)
12. 110(a)(2)(L)
To satisfy these requirements, Georgia's infrastructure SIP submission cites Rule 391-3-1-.03(9) “Permit Fees,”
13. 110(a)(2)(M)
With the exception of the PSD permitting requirements for major sources contained in section 110(a)(2)(C), (D)(i)(II) prong 3, and (J) and the interstate transport requirements of section 110(a)(2)(D)(i)(I) and (II) (prongs 1, 2 and 4), EPA is proposing to approve GA EPD's infrastructure SIP submission, submitted May 14, 2012, for the 2008 8-hour ozone NAAQS because it meets the above described infrastructure SIP requirements. EPA is proposing to approve these portions of Georgia's infrastructure SIP submission for the 2008 8-hour ozone NAAQS because these aspects of the submission are consistent with section 110 of the CAA. EPA previously acted upon Georgia's infrastructure submission for the PSD permitting requirements for major sources of sections 110(a)(2)(C), (D)(i)(II) prong 3 and (J) on March 18, 2015, and will address prongs 1, 2, and 4 of section 110(a)(2)(D)(i)(I) and (II) in a separate action.
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations.
• is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the Georgia SIP is not approved to apply on any Indian reservation land or in any other area where EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), nor will it impose substantial direct costs on tribal governments or preempt tribal law.
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
42 U.S.C. 7401
Research, Education, and Economics, USDA.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, 5 U.S.C. App 2, Section 1408 of the
The National Agricultural Research, Extension, Education, and Economics Advisory Board will meet via teleconference on August 11, 2015, at 2 p.m. Eastern Daylight Time.
The meeting will take place virtually at the AT&T Meeting Room below. Please follow the pre-registration instructions to ensure your participation in the meeting.
Michele Esch, Designated Federal Officer and Executive Director, National Agricultural Research, Extension, Education, and Economics Advisory Board, U.S. Department of Agriculture, 1400 Independence Avenue SW., STOP 0321, Washington, DC 20250-0321; telephone: (202) 720-3684; fax: (202) 720-6199; or email:
On Tuesday, August 11, 2015, at 2 p.m. Eastern Daylight Time, a virtual meeting of the National Agricultural Research, Extension, Education, and Economics Advisory Board will be conducted to hear the summary of findings and recommendations from the Animal Handling and Welfare Review Panel's Phase II report on the research animal care and well-being policies, procedures, and standards at the Agricultural Research Service. The National Agricultural Research, Extension, Education, and Economics Advisory Board will provide additional advice and recommendations to USDA on the report and hear stakeholder input received at this meeting, as well as, other written comments. The report, entitled
This meeting is open to the public and any interested individuals wishing to attend. Opportunity for verbal public comment will be offered on the day of the meeting. Written comments by attendees or other interested stakeholders will be welcomed for the public record before and up to the day of the meeting (by close of business Tuesday, August 11, 2015). All written statements must be sent to Michele Esch, Designated Federal Officer and Executive Director, National Agricultural Research, Extension, Education, and Economics Advisory Board, U.S. Department of Agriculture, 1400 Independence Avenue SW., STOP 0321, Washington, DC 20250-0321; or email:
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to
Rural Utilities Service, USDA.
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35, as amended), the United States Department of Agriculture (USDA) Rural Utilities Service (RUS) invites comments on the following information collections for which the RUS intends to request approval from the Office of Management and Budget (OMB).
Comments on this notice must be received by September 18, 2015.
Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. Fax: (202) 720-8435 or email
The Office of Management and Budget's (OMB) regulation (5 CFR 1320) implementing provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) requires that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [see 5 CFR 1320.8(d)]. This notice identifies information collections that USDA Rural Development is submitting to OMB for extension.
Comments are invited on: (a) Whether this collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of the burden of the collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of appropriate automated, electronic, mechanical or other technological collection techniques or other forms of information technology. Comments may be sent to Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP 1522, Room 5164, South Building, Washington, DC 20250-1522. Telephone: (202) 690-4492. Fax: (202) 720-8435 or email
All responses to this notice will be summarized and included in the request for OMB approval. All comments will also become a matter of public record.
The Cookson Company, Inc. (Cookson) submitted a notification of proposed production activity to the FTZ Board for its facility in Goodyear, Arizona within FTZ 277. The notification conforming to the requirements of the regulations of the FTZ Board (15 CFR 400.22) was received on July 13, 2015.
The Cookson facility is located within Site 11 of FTZ 277. The facility is used for the assembly and production of rolling steel doors. Pursuant to 15 CFR 400.14(b), FTZ activity would be limited to the specific foreign-status materials and components and specific finished products described in the submitted notification (as described below) and subsequently authorized by the FTZ Board.
Production under FTZ procedures could exempt Cookson from customs duty payments on the foreign status components used in export production. On its domestic sales, Cookson would be able to choose the duty rates during customs entry procedures that apply to rolling steel doors (duty-free) for the foreign status inputs noted below. Customs duties also could possibly be deferred or reduced on foreign status production equipment.
The components and materials sourced from abroad include: hand and roller steel chains; limit switches; single-phase AC electric motors/gear motors; multi-phase AC electric motors/gear motors; steel cranks; motor overload protectors; mounted and unmounted timers for door closure assemblies; power boards; transformers (40VA or greater); electro-mechanical alarm interfaces; fire door testing releases and converter mechanisms; steel door limits; contactors; battery backups; and, steel bolts (duty rate ranges from duty-free to 6.6%).
Public comment is invited from interested parties. Submissions shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is August 31, 2015.
A copy of the notification will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 21013, U.S. Department of Commerce, 1401 Constitution Avenue NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
For further information, contact Elizabeth Whiteman at
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) preliminarily determines that TPBI Public Company Limited (TPBI) is the successor-in-interest to Thai Plastic Bags Industries Company Limited (Thai Plastic Bags) for purposes of the antidumping duty order on polyethylene retail carrier bags (PRCBs) from Thailand and, as such, will be entitled to Thai Plastic Bags's exclusion from the antidumping duty order. We invite interested parties to comment on these preliminary results.
Thomas Schauer, AD/CVD Operations, Office I, Enforcement and Compliance, International Trade Administration, Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-0410.
On June 18, 2004, the Department published the
On June 4, 2015, TPBI requested that the Department initiate an expedited changed circumstances review to confirm that TPBI is the successor-in-interest to Thai Plastic Bags for purposes of determining antidumping duty liabilities.
The merchandise subject to the order includes PRCBs from the Thailand. PRCBs are currently classifiable under Harmonized Tariff Schedule of the United States (HTSUS) subheading 3923.21.0085. Although the HTSUS subheadings are provided for convenience and customs purposes, the written product description is dispositive.
In making a successor-in-interest determination, the Department typically examines several factors including, but not limited to, changes in: (1) Management; (2) production facilities; (3) supplier relationships; and (4) customer base.
Pursuant to section 751(b)(1) of the Act and 19 CFR 351.216(d), the Department will conduct a changed circumstances review (CCR) upon receipt of a request from an interested party or receipt of information concerning an antidumping duty order which shows changed circumstances sufficient to warrant a review of the order. Section 351.221(c)(3)(ii) of the Department's regulations permits the Department to combine the initiation and preliminary results of a CCR if the Department concludes that expedited action is warranted. In this instance, we have information on the record necessary to reach the preliminary results of CCR. As such, we find that expedited action is warranted. Accordingly, we have combined the preliminary results with the initiation.
We preliminarily determine that TPBI is the successor-in-interest to Thai Plastic Bags for the purposes of administering the
Interested parties may submit case briefs no later than 30 days after the date of publication of this notice.
In accordance with 19 CFR 351.216(e), the Department intends to issue the final results of this changed circumstance review not later than 270 days after the date on which the review is initiated, or within 45 days if all parties agree to our preliminary finding.
This notice is issued and published in accordance with sections 751(b) and 777(i)(1) of the Act, and 19 CFR 351.216 and 351.221(c)(3)(ii).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of SEDAR 41 Data Workshop II for South Atlantic red snapper and gray triggerfish.
The SEDAR 41 assessments of the South Atlantic stocks of red snapper (
The SEDAR 41 Data Workshop II will be held on August 4, 2015, from 8:30 a.m. until 6 p.m.; August 5, 2015, from 8 a.m. until 6 p.m.; and August 6, 2015, from 8 a.m. until 1 p.m. The established times may be adjusted as necessary to accommodate the timely completion of discussion relevant to the assessment process. Such adjustments may result in the meeting being extended from, or completed prior to the time established by this notice. The Assessment Workshop and Review Workshop dates and times will publish in a subsequent issue in the
The SEDAR 41 Data Workshop will be held at the Charleston Marriott, 170 Lockwood Boulevard, Charleston, SC 29403; phone: (843) 732-3000.
Julia Byrd, SEDAR Coordinator; phone: (843) 571-4366; email:
The Gulf of Mexico, South Atlantic, and Caribbean Fishery Management Councils, in conjunction with NOAA Fisheries and the Atlantic and Gulf States Marine Fisheries Commissions have implemented the Southeast Data, Assessment and Review (SEDAR) process, a multi-step method for determining the status of fish stocks in the Southeast Region. SEDAR is a three step process including: (1) Data Workshop(s); (2) Assessment Process utilizing workshops and webinars; and
An assessment data set and associated documentation will be developed during the Data Workshops. Participants will evaluate available data and select appropriate sources for providing information on life history characteristics, catch statistics, discard estimates, length and age composition, and fishery independent and fishery dependent measures of stock abundance, as specified in the Terms of Reference for the workshop. This workshop will build on the work and decisions made at the 2014 SEDAR 41 Data Workshop.
Although non-emergency issues not contained in this agenda may come before this group for discussion, those issues may not be the subject of formal action during this meeting. Action will be restricted to those issues specifically identified in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the intent to take final action to address the emergency.
This meeting is accessible to people with disabilities. Requests for auxiliary aids should be directed to the SEDAR office (see
The times and sequence specified in this agenda are subject to change.
16 U.S.C. 1801
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of availability of a Record of Decision.
The NOAA National Marine Fisheries Service (NMFS) announces the availability of the Record of Decision (ROD) for the Final NOAA Restoration Center Programmatic Environmental Impact Statement. The NMFS Office of Habitat Conservation Director signed the ROD on July 20, 2015, which constitutes the agency's final decision.
Frederick C. Sutter, Director, Office of Habitat Conservation, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Silver Spring, MD 20910.
Melanie Gange, by mail at NOAA Restoration Center/FHC3, 1315 East-West Highway, Silver Spring, MD 20910; or by telephone at 301-427-8664.
The PEIS evaluated broad issues and programmatic-level alternatives (compared to a document for a specific project or action) for future restoration activities to be carried out by NOAA. In addition to providing a programmatic analysis, NOAA intends to use this document to approve future site-specific actions, including grant actions, as long as the activity being proposed is within the range of alternatives and scope of potential environmental consequences described in the PEIS, and does not have significant adverse impacts. Any future site-specific restoration activities proposed by NOAA that are not within the scope of alternatives or environmental consequences considered in the PEIS will require additional analysis under the National Environmental Policy Act (NEPA).
The ROD documents the decision by NOAA to select and implement the “Current Management” alternative as its preferred alternative. The alternative represents a comprehensive programmatic restoration approach that includes funding or conducting activities such as providing technical assistance; on-the-ground riverine and coastal habitat restoration activities (including but not limited to: Fish passage projects; channel, bank, and floodplain restoration; buffer area and watershed revegetation; salt marsh restoration; oyster restoration; marine debris removal; submerged aquatic vegetation planting; invasive species removal; and coral restoration); and habitat conservation transactions. Because this is a continuation of NOAA Restoration Center's (RC) on-going restoration programs with no change in management direction, it was also considered to be the “No Action” alternative.
The NOAA RC is not soliciting comments on the PEIS but will consider any comments submitted that would assist us in preparing future NEPA documents. An electronic copy of the PEIS is available at:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The North Pacific Fishery Management Council's (Council)
The meeting will be held August 6-7, 2015, from 8 a.m. to 5 p.m.
The meeting will be held at the Ted Stevens Marine Research Institute, Auke Bay Laboratories, 17109 Pt. Lena Loop Road, Juneau, AK 99801.
Steve MacLean, Council staff; phone: (907) 271-2809.
The purpose of the Ecosystem Committee is to review progress on development of a strawman Fishery Ecosystem Plan (FEP) Module, and development of a discussion paper planned for presentation to the Council in December, 2015. The Committee will also discuss scheduling for future meetings. The Agenda is subject to change, and the latest version will be posted at
The meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Shannon Gleason at (907) 271-2809 at least 7 working days prior to the meeting date.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notification of fee percentage.
NMFS publishes notification of a 1.48 percent fee for cost recovery under the Bering Sea and Aleutian Islands Crab Rationalization Program. This action is intended to provide holders of crab allocations with the fee percentage for the 2015/2016 crab fishing year so they can calculate the required payment for cost recovery fees that must be submitted by July 31, 2016.
The Crab Rationalization Program Registered Crab Receiver permit holder is responsible for submitting the fee liability payment to NMFS on or before July 31, 2016.
Keeley Kent, 907-586-7228.
NMFS Alaska Region administers the Bering Sea and Aleutian Islands Crab Rationalization Program (Program) in the North Pacific. Fishing under the Program began on August 15, 2005. Regulations implementing the Program can be found at 50 CFR part 680.
The Program is a limited access system authorized by section 313(j) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act). The Program includes a cost recovery provision to collect fees to recover the actual costs directly related to the management, data collection, and enforcement of the Program. NMFS developed the cost recovery provision to conform to statutory requirements and to partially reimburse the agency for the actual costs directly related to the management, data collection, and enforcement of the Program. Section 313(j) of the Magnuson-Stevens Act provided supplementary authority to section 304(d)(2)(A) and additional detail for cost recovery provisions specific to the Program. The cost recovery provision allows collection of 133 percent of the actual management, data collection, and enforcement costs up to 3 percent of the ex-vessel value of crab harvested under the Program. Additionally, section 313(j) requires the harvesting and processing sectors to each pay half the cost recovery fees. Catcher/processor quota shareholders are required to pay the full fee percentage for crab processed at sea.
A crab allocation holder generally incurs a cost recovery fee liability for every pound of crab landed. The crab allocations include Individual Fishing Quota, Crew Individual Fishing Quota, Individual Processing Quota, Community Development Quota, and the Adak community allocation. The Registered Crab Receiver (RCR) permit holder must collect the fee liability from the crab allocation holder who is landing crab. Additionally, the RCR permit holder must collect his or her own fee liability for all crab delivered to the RCR. The RCR permit holder is responsible for submitting this payment to NMFS on or before July 31, in the year following the crab fishing year in which landings of crab were made.
The dollar amount of the fee due is determined by multiplying the fee percentage (not to exceed 3 percent) by the ex-vessel value of crab debited from the allocation. Specific details on the Program's cost recovery provision may be found in the implementing regulations at 50 CFR 680.44.
Each year, NMFS calculates and publishes in the
Based upon the fee percentage formula described above, the estimated percentage of costs to value for the 2014/2015 fishery was 1.48 percent. Therefore, the fee percentage will be 1.48 percent for the 2015/2016 crab fishing year. This is an increase of 0.83 percent from the 2013/2014 fee percentage of 0.65 percent (79 FR 44403, July 31, 2014). The change in the fee percentage from 2013/2014 to 2014/2015 is due to an increase in NMFS management costs. These additional costs were necessary to maintain and upgrade NMFS' permitting systems and the Internet-based crab landings system used for the program. The value of crab harvested under the Program also increased from 2013/2014 to 2014/2015 by $29 million. This increase in value of the fishery offset some of the management cost increases and so limited the change in the fee percentage between 2013/2014 and 2014/2015.
16 U.S.C. 1862; Pub. L. 109-241; Pub. L. 109-479.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of public hearings.
The South Atlantic Fishery Management Council (Council) will hold public hearings in North Carolina, South Carolina and Florida and a Question and Answer Webinar for Regulatory Amendment 16 to the Snapper Grouper Fishery Management Plan for the South Atlantic. The Council will also hold public hearings in North Carolina, South Carolina, Georgia, and Florida and a Question and Answer Webinar for Amendment 36 to the Snapper Grouper Fishery Management Plan for the South Atlantic. See
The public hearings will be held between August 10 and August 25, 2015. There will be a question and answer webinar on August 3 and August 5, 2015. Please see
The hearings for Snapper Grouper Regulatory Amendment 16 will be held in Little River, SC, Jacksonville, NC, Ormond Beach, FL. The hearings for Snapper Grouper Amendment 36 will be held in North Charleston, SC, Murrells Inlet, SC, Morehead City, NC, Brunswick, GA and Daytona Beach, FL, with an additional hearing being held via webinar. Please see
Kim Iverson, Public Information Officer, South Atlantic Fishery Management Council, 4055 Faber Place Drive, Suite 201, N. Charleston, SC 29405; phone: (843) 571-4366 or toll free (866) SAFMC-10; fax: (843) 769-4520; email:
The hearings on Snapper Grouper Regulatory Amendment 16 will take place August 11 (Little River, SC), August 12 (Jacksonville, NC), and August 17 (Ormond Beach, FL). The Question and Answer Webinar for Snapper Grouper Regulatory Amendment 16 will be on Monday, August 3, 2015.
The public hearings for Snapper Grouper Amendment 36 will take place August 10 (N. Charleston, SC), August 12 (Murrells Inlet, SC), August 13 (Morehead City, NC), August 18 (Webinar hearing), August 24 (Brunswick, GA), and August 25 (Daytona Beach, FL). The Question and Answer Webinar for Snapper Grouper Amendment 36 will be on Monday, August 5, 2015.
The Q&A Session for Regulatory Amendment 16 will begin at 6 p.m. on Monday, August 3, 2015. Registration is required and registration information will be posted on the Council's Web site at
Public Hearings for Snapper Grouper Regulatory Amendment 16 begin at 4 p.m. in the following locations:
1. August 11, 2015: Holiday Inn Express, 722 Highway 17, Little River, SC 29566; phone: (843) 281-9400.
2. August 12, 2015: Comfort Suites, 130 Workshop Lane, Jacksonville, NC 28546; phone: (910) 346-8900.
3. August 17, 2015: Hull's Seafood Market/Restaurant, 111 West Granada Blvd., Ormond Beach, FL 32174; phone: (386) 677-1511.
The Q&A Session for Snapper Grouper Amendment 36 will begin at 6 p.m. on Monday, August 5, 2015. Registration is required and registration information will be posted on the Council's Web site at
Public Hearings for Snapper Grouper Amendment 36 begin at 4 p.m. in the following locations:
1. August 10, 2015: Hilton Garden Inn, 5265 International Blvd., N. Charleston, SC 29418; phone: (843) 308-9330.
2. August 12, 2015: Murrells Inlet Community Center, 4462 Murrells Inlet Road, Murrells Inlet, SC 29576; phone: (843) 651-7373.
3. August 13, 2015: NC Division of Marine Fisheries, Central District Office, 5285 Highway 70 West, Morehead City, NC 28557; phone: (252) 726-7021.
4. August 18, 2015: Public Hearing via webinar—registration for the webinar is required. Information regarding registration will be posted on the Council's Web site at
5. August 24, 2015: Georgia Dept. of Natural Resources, Coastal Resources Division, One Conservation Way, Brunswick, GA 31520-8687; phone: (912) 264-7218.
6. August 25, 2015: Hilton Garden Inn—Daytona Beach Airport, 189 Midway Ave., Daytona Beach, FL 32114; phone: (386) 944-4000.
Snapper Grouper Regulatory Amendment 16 has two actions. The first action is to consider options for opening the commercial South Atlantic black sea bass pot fishery from November 1 through April 30 while still providing protection for ESA listed whales during that period. The second action has alternatives that would require modifications to black sea bass pot gear such as reducing buoy line and weak link strength, as well as require markings that would identify gear as being specific to the South Atlantic black sea bass pot fishery. Background information regarding Snapper Grouper Regulatory Amendment 16, including a public hearing draft of the document, a document summary, and a PowerPoint presentation will be posted to the South Atlantic Fishery Management Council's Web site
Snapper Grouper Amendment 36 has nine actions. Action 1 modifies the Special Management Zone (SMZ) procedures to include protection of natural bottom; Action 2 modifies the framework procedure to allow modification of and/or additional Spawning SMZs; Actions 3-7 includes alternatives to establish Spawning SMZs off NC, SC, GA, and FL where fishing for snapper grouper species would be prohibited, however, fishing for other species (
These hearings are physically accessible to people with disabilities. Requests for auxiliary aids should be directed to the council office (see
The times and sequence specified in this agenda are subject to change.
Department of Defense.
Amendment of Federal Advisory Committee.
The Department of Defense is publishing this notice to announce that it is amending the charter for the Defense Business Board (“the Board”).
Jim Freeman, Advisory Committee Management Officer for the Department of Defense, 703-692-5952.
This committee's charter is being amended in accordance with the Federal Advisory Committee Act (FACA) of 1972 (5 U.S.C., Appendix, as amended) and 41 CFR 102-3.50(d).
The Board is a discretionary Federal advisory committee that provides the Secretary of Defense and the Deputy Secretary of Defense with independent advice and recommendations on critical matters concerning the Department of Defense (DoD). The Board shall examine and advise on overall DoD management and governance from a private sector perspective.
The DoD, through the Office of the Deputy Chief Management Officer (DCMO), shall provide support for the performance of the Board's functions and shall ensure compliance with the requirements of the FACA, the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended) (“the Sunshine Act”), governing Federal statutes and regulations, and established DoD policies and procedures.
The Board shall be composed of no more than 35 members. The members must possess the following: (a) A proven track record of sound judgment in leading or governing large, complex private sector corporations or organizations and (b) a wealth of top-level, global business experience in the areas of executive management, corporate governance, audit and finance, human resources, economics, technology, or healthcare. The Board members will be appointed by the Secretary of Defense or the Deputy Secretary of Defense for a term of service of one-to-four years and will be renewed on an annual basis in accordance with DoD policies and procedures. Members of the Board who are not full-time or permanent part-time Federal officers or employees will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as special government employee (SGE) members. Members of the Board who are full-time or permanent part-time Federal officers or employees will be appointed pursuant to 41 CFR 102-3.130(a) to serve as regular government employee (RGE) members. All members of the Board are appointed to provide advice on the basis of their best judgment without representing any particular point of view and in a manner that is free from conflict of interest.
Consistent with Deputy Secretary of Defense policy, the DCMO may appoint the Board chair or vice chairs from among the Secretary of Defense approved Board membership and, in doing so, the DCMO shall determine the term of service for the Board chair and/or chairs, which shall not exceed the member's approved term of service.
All Board members will be reimbursed for travel and per diem as it pertains to official business of the Board. Board members will serve without compensation. No member, unless authorized by the Secretary of Defense or the Deputy Secretary of Defense, may serve more than two consecutive terms of service on the Board, to include its subcommittees, or serve on more than two DoD federal advisory committees at one time.
The Secretary of Defense or the Deputy Secretary of Defense, according to DoD policies and procedures pertaining to inviting or appointing individuals to serve on advisory committees, may invite the chairs of the Defense Policy Board and the Defense Science Board to serve as non-voting ex-officio SGE members of the Board and the Director of the Office of Management and Budget and the Comptroller General of the United States to serve as non-voting ex-officio RGE members of the Board. The non-voting ex-officio SGE members may speak to the Board membership only on those topics governed by their respective advisory boards provided the information has been voted on by their membership and is available to the general public. They do not represent their respective advisory boards. These non-voting ex-officio SGE and RGE members, when invited by the Secretary of Defense, will not count toward the Board's total membership and may not participate in the Board's deliberations.
The Director of Administration, Office of the DCMO, on behalf of the Secretary of Defense, the Deputy Secretary of Defense, and the DCMO and pursuant to DoD policies and procedures, may appoint, as deemed necessary, non-voting subject matter experts (SMEs) to assist the Board or its subcommittees on an ad hoc basis. These non-voting SMEs are not members of the Board or its subcommittees and will not engage or participate in any deliberations by the Board or its subcommittees. These non-voting SMEs, if not full-time or permanent part-time Federal government officers or employees, will be appointed pursuant to 5 U.S.C. 3109 on an intermittent basis to address specific issues under consideration by the Board.
DoD, when necessary and consistent with the Board's mission and DoD policies and procedures, may establish subcommittees, task forces, or working groups to support the Board. Establishment of subcommittees will be based upon a written determination, to include terms of reference, by the Secretary of Defense or the Deputy Secretary of Defense. Such subcommittees shall not work independently of the Board and shall report all their recommendations and advice solely to the Board for full deliberation and discussion. Subcommittees, task forces, or working groups have no authority to make decisions and recommendations, verbally or in writing, on behalf of the Board. No subcommittee or any of its members can update or report, verbally or in writing, directly to the DoD or to any Federal officer or employee.
The Secretary of Defense or the Deputy Secretary of Defense shall appoint subcommittee members even if the member in question is already a member of the Board. Subcommittee
Subcommittee members, if not full-time or permanent part-time Federal officers or employees, will be appointed as experts or consultants pursuant to 5 U.S.C. 3109 to serve as SGE members. Those subcommittee members who are full-time or permanent part-time Federal officers or employees will be appointed pursuant to 41 CFR 102-3.130(a) to serve as RGE employees. With the exception reimbursement of official travel and per diem related to the Board or its subcommittees, subcommittee members shall serve without compensation.
Each subcommittee member is appointed to provide advice on behalf of the Government on the basis of his or her best judgment without representing any particular point of view and in a manner that is free from conflict of interest.
Consistent with Deputy Secretary of Defense policy, the DCMO may appoint the subcommittee chair or chairs from among the Secretary of Defense approved subcommittee membership and, in doing so, the DCMO shall determine the term of service for the subcommittee chair or chairs, which shall not exceed the member's approved term of service.
All subcommittees operate under the provisions of FACA, the Sunshine Act, governing Federal statutes and regulations, and established DoD policies and procedures.
The Board's Designated Federal Officer (DFO) must be a full-time or permanent part-time DoD employee, designated in accordance with established DoD policies and procedures.
The Board's DFO is required to attend all meetings of the Board and its subcommittees for the entire duration of each and every meeting. However, in the absence of the Board's DFO, a properly approved Alternate DFO, duly appointed to the Board according to DoD policies and procedures, must attend the entire duration of all meetings of the Board or its subcommittees.
The DFO, or the Alternate DFO, shall call all of the Board and its subcommittees meetings; prepare and approve all meeting agendas; and adjourn any meeting when the DFO, or the Alternate DFO, determines adjournment to be in the public interest or required by governing regulations or DoD policies and procedures.
Pursuant to 41 CFR 102-3.105(j) and 102-3.140, the public or interested organizations may submit written statements to Board membership about the Board's mission and functions. Written statements may be submitted at any time or in response to the stated agenda of planned meeting of the Board.
All written statements shall be submitted to the DFO for the Board, and this individual will ensure that the written statements are provided to the membership for their consideration. Contact information for the Board's DFO can be obtained from the GSA's FACA Database—
The DFO, pursuant to 41 CFR 102-3.150, will announce planned meetings of the Board. The DFO, at that time, may provide additional guidance on the submission of written statements that are in response to the stated agenda for the planned meeting in question.
Department of Defense.
Notice of meeting.
The Department of Defense is publishing this notice to announce the following Federal Advisory Committee meeting of the Judicial Proceedings since Fiscal Year 2012 Amendments Panel (“the Judicial Proceedings Panel” or “the Panel”). The meeting is open to the public.
A meeting of the Judicial Proceedings Panel will be held on Thursday, August 6, 2015. The Public Session will begin at 10:00 a.m. and end at 5:00 p.m.
The George Washington University, School of Law, Faculty Conference Center, 2000 H St. NW., Washington, DC 20052.
Ms. Julie Carson, Judicial Proceedings Panel, One Liberty Center, 875 N. Randolph Street, Suite 150, Arlington, VA 22203. Email:
This public meeting is being held under the provisions of the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Government in the Sunshine Act of 1976 (5 U.S.C. 552b, as amended), and 41 CFR 102-3.150.
Office of Special Education and Rehabilitative Services, Department of Education.
Notice.
The Secretary is publishing the following list of correspondence from the U.S. Department of Education (Department) to individuals during the second and third quarters of 2014. The correspondence describes the Department's interpretations of the Individuals with Disabilities Education Act (IDEA) or the regulations that implement the IDEA. This list and the letters or other documents described in this list, with personally identifiable information redacted, as appropriate, can be found at:
Jessica Spataro or Mary Louise Dirrigl. Telephone: (202) 245-7605.
If you use a telecommunications device for the deaf (TDD) or a text telephone (TTY), you can call the Federal Relay Service (FRS), toll free, at 1-800-877-8339.
Individuals with disabilities can obtain a copy of this list and the letters or other documents described in this list in an accessible format (
The following list identifies correspondence from the Department issued from April 1, 2014 through June 30, 2014 and July 1, 2014 through September 30, 2014. Under section 607(f) of the IDEA, the Secretary is required to publish this list quarterly in the
○ Letter dated June 11, 2014, to Chief State School Officers, providing guidance on how recent changes to the National School Lunch Program could affect the manner in which State educational agencies allocate Part B of IDEA funds to local educational agencies (LEAs) based on their relative numbers of children living in poverty.
○ Letter dated September 29, 2014, to Teach NYS President Sam Sutton and consultant David Rubel, regarding whether certain inclusive models could be used in the delivery of special education and related services to children with disabilities enrolled by their parents in private schools.
○ Letter dated June 2, 2014, to Pennsylvania Attorney Mark W. Voigt, regarding a State's timeline for an LEA to implement a final due process hearing decision.
○ Letter dated July 10, 2014, to Texas Department of Assistive and Rehabilitative Services Part C Coordinator Kim Wedel, clarifying how the system of payment requirements can be implemented while using a parent's or child's public and private insurance or benefits as a funding source for services under Part C of IDEA.
○ Dear Colleague Letter from the Office for Civil Rights dated May 14, 2014, regarding the applicability to public charter schools of Federal civil rights laws, regulations, and guidance.
You may also access documents of the Department published in the
Take notice that on July 10, 2015, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824(e) and 825(e) and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Linden VFT, LLC (Complainant), filed an amended complaint against PJM Interconnection, L.L.C. (PJM or Respondent), alleging that the Respondent's proposed cost allocations for projects resulting from PJM's 2013 Regional Transmission Expansion Plan, including Public Service Electric and Gas Company upgrades, are unjust, unreasonable, unduly discriminatory, and preferential, as more fully explained in the complaint.
The Complainant certifies that copies of the complaint were served on the contacts for the Respondent as listed on the Commission's list of Corporate Officials.
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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission received the following electric rate filings:
Description: Section 205(d) Rate Filing: 2015-07-14_SA 2819 Certificate of Concurrence ComEd-Ameren TIA to be effective 7/13/2015.
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 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. 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 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. 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 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
Take notice that on July 10, 2015, pursuant to sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e and 825e and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206, Caithness Long Island II, LLC (Complainant) filed a formal complaint against New York Independent System Operator, Inc. (NYISO or Respondent) alleging that NYISO's application of certain interconnection requirements to the Class Year 2015 Interconnection Facilities Study violates Commission policy and the NYISO Open Access Transmission Tariff.
The Complainant certify that copies of the complaint were served on the contacts for NYISO as listed on the Commission's list of Corporate Officials.
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. The Respondent's answer and all interventions, or protests must be filed on or before the comment date. The Respondent's answer, motions to intervene, and protests must be served on the Complainants.
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.
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and opportunity to comment on these applications.
Comments must be received on or before August 19, 2015.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0021 and the File Symbol of interest as shown in the body of this document, by one of the following methods:
•
•
•
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available at
Jennifer Mclain, Acting Director, Antimicrobials Division (AD) (7510P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
Robert McNally, Director, Biopesticides and Pollution Prevention Division (BPPD) (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
Susan Lewis, Director, Registration Division (RD) (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
The Division to contact is listed at the end of each application in Unit II.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
1.
2.
EPA has received applications to register pesticide products containing active ingredients not included in any currently registered pesticide products. Pursuant to the provisions of FIFRA section 3(c)(4) (7 U.S.C. 136a(c)(4)), EPA is hereby providing notice of receipt and opportunity to comment on these applications. Notice of receipt of these applications does not imply a decision by the Agency on these applications.
7 U.S.C. 136
Board of Governors of the Federal Reserve System.
Notice is hereby given of the final approval of a proposed information collection by the Board of Governors of the Federal Reserve System (Board) under the Office of Management and Budget (OMB) delegated authority. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the Paperwork Reduction Act Submission, supporting statement and approved collection of information instruments are placed into OMB's public docket files. The Federal Reserve may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
Federal Reserve Board Clearance
OMB Desk Officer—Shagufta Ahmed—Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street NW., Washington, DC 20503.
A trade organization asked if the marginal increase in information from adding new U.S. bank reporters outweighs the increase in costs and burden on these additional institutions affected by the proposal. While the Federal Reserve is sensitive to the reporting burden of the affected depository institutions, revisions to the data are being made to fulfill high-priority policy objectives. First, the expanded and enhanced data collection is expected to improve unsecured money market monitoring and augment the ability of the Federal Reserve Bank of New York, on behalf of the Federal Reserve, to analyze these markets and implement monetary policy.
Second, the data set is expected to provide robust transaction data for calculating the effective federal funds rate (EFFR), an improvement over the current rate constructed from brokered data. The collection also is expected to allow for the calculation of a new overnight bank funding rate (OBFR) that uses both federal funds and Eurodollar data. Third, data collected under the FR 2420 report also represent an important source of information on individual depository institutions' borrowing rates, which is expected to allow for more effective monitoring of firm-specific liquidity risks for purposes of supervisory surveillance.
Given these critical uses for the data, the Federal Reserve is seeking to ensure that the reporting panel captures entities that are meaningfully involved in unsecured money markets and that it remains robust to changes in borrower composition in these markets. Additional U.S. bank reporters are necessary to provide insight into a distinct and important segment of the federal funds market. The federal funds borrowing in this segment can represent a significant proportion of overall activity in certain market environments, and can occur at rates that are distinct from funding activity conducted by other institutions. However, the Federal Reserve understands the need to strike a balance between reporting burden and the collection of information required to fulfill its policy objectives. As such, adjustments are being made to the asset-size thresholds to reduce reporting burden, as discussed below. In addition, exceptions may be made for those institutions that meet the asset-size threshold but can demonstrate that they have an ongoing business model that results in a negligible amount of activity in these markets. The “Reporting Exception” section below provides more information on how an exception may be obtained.
A trade organization wrote that the asset-size threshold imposes costs on institutions that may not have substantial activity and noted that, according to Call Report data, institutions with between $15 billion and $26 billion in assets hold only about five percent of total federal funds purchased. This trade organization noted that the activity threshold approach is more targeted and should be used for any institution to which the Federal Reserve intends to extend reporting requirements.
Asset-size thresholds create a stable panel of reporters, by ensuring that banks of meaningful size will be consistently required to report activity in a timely manner. This stable panel of banks is necessary to effectively analyze trends in unsecured funding markets and publish the EFFR and OBFR. The Federal Reserve proposed a lower asset-size threshold in order to create a more comprehensive dataset that captures an important segment of the federal funds
Activity thresholds, on the other hand, are beneficial for providing insight into activity that is outside the scope of the regular panel of reporters, and represents an important supplement to the asset-size thresholds. However, activity thresholds used alone can create gaps in reporting and a more inconsistent panel of banks. These thresholds necessarily require a look-back period to measure activity and some forward period to prepare for reporting; thus, there is a significant lag between the threshold for activity being met and the commencement of reporting. The Federal Reserve considered relying more heavily on an activity threshold and found that the panel of banks was more inconsistent and the data capture was less complete.
Nonetheless, the Federal Reserve understands the need to find a balance between the burden being placed on reporting institutions and the achievement of reporting objectives. In light of the burden on smaller institutions of FR 2420 reporting, the Federal Reserve will retain the asset-size thresholds, but raise the minimum reporting threshold for domestically chartered commercial banks and thrifts from $15 billion to $18 billion. With this revised criteria, U.S. institutions with between $15 billion and $18 billion in assets will now only report if they meet the activity threshold. This change in threshold will result in a reduction in the number of additional, smaller institutions being required to report under the asset-size threshold.
A trade organization asked for clarification on how and with what frequency institutions with ongoing business models that result in negligible activity can apply for exceptions to filing the FR 2420 report. Institutions can request a review of their reporting requirement at any point that they believe the reporting is an unreasonable burden. Requests should be made in writing and provide a look back of the data for at least two quarters and provide justification on why continuing to provide these data causes an undue burden.
Two trade organizations requested additional time to implement the revisions. One organization noted that the proposed timeline would be difficult to implement, as the recommended revisions add and redefine several elements of the FR 2420 report. This organization stated that the current panel of banks would need two quarters after final requirements and newly covered institutions would need one year. A second organization stated that although the proposal was well-developed and vetted, it would be difficult to commit systems and personnel until the final
The revisions to the FR 2420 data are being implemented to meet high priority policy objectives. Most of the reporters under the new criteria are active reporters under the existing criteria. However, in order to provide the lead time for new reporters to prepare for reporting and still fulfill these objectives, the initially proposed reporting date of September 9, 2015 will be extended to October 20, 2015 for Part A-Federal Funds, Part AA-Selected Borrowings from Non-Exempt Entities, and Part B-Eurodollars. The reporting date for Part C-Time Deposits and Certificates of Deposit will be extended until January 15, 2016. This delay will allow reporters to focus on the changes applicable to the most time-sensitive parts of the report.
A trade organization noted the 7 a.m. deadline imposes administrative costs for covered institutions and these costs are magnified, on a relative basis, for smaller institutions, which have fewer resources. A second organization stated that banks continue to experience challenges in meeting the 7 a.m. deadline for federal funds reporting as it conflicts with normal batch processing. This organization noted the time will also be a challenge for the expanded Eurodollar reporting requirements.
After considering these comments, the Federal Reserve determined that federal funds and Eurodollar data are needed by 7 a.m. each business day for the preceding day's reportable transactions to support the implementation of monetary policy and daily market monitoring. Therefore, the Federal Reserve is retaining the 7 a.m. deadline in the final report. The FR 2420 data provide a key insight on the previous day's unsecured market activity in the morning when the Federal Reserve is monitoring markets for the purposes of implementing monetary policy. In addition, in 2016, the data will be used as the source for daily calculation of the EFFR and OBFR. The EFFR is published in the morning in order to provide the market with a timely view on the previous day's activity.
A trade organization objected to the broadening of the purpose of the reporting form to include a supervisory component. According to this organization, the timing and frequency of FR 2420 reporting makes it difficult for covered institutions to subject data to proper regulatory reporting controls. The trade organization would prefer the Federal Reserve to use the supervisory and reporting framework already in place to monitor individual firm liquidity conditions. The organization requested clarification on the interaction of the FR 2420 with the FR 2052b, which eliminated the requirement for daily reporting from institutions with between $15 to $26 billion in total assets after acknowledging through the FR 2052b implementation process that daily reporting is burdensome and unnecessary for these institutions. The organization also wrote that given significant changes being implemented to the FR 2052a, banks do not have enough information to comment on whether the FR 2420 report is duplicative or complementary. The organization noted that not all institutions that would be required to file the FR 2420 are required to file the FR 2052b. Furthermore, according to this organization, the FR 2420 collection encompasses institutions for whom the Federal Reserve is not the primary regulator, and it is unclear by which process the Federal Reserve will coordinate with the other banking agencies.
FR 2420 data are used by the Federal Reserve to carry out both monetary policy and supervisory functions. Although daily reporting for smaller institutions may not be required for supervisory surveillance on the FR 2052b, reporting at a daily frequency is required on the FR 2420 for analysis of current money market conditions and publication of the EFFR and OBFR. Institutions with asset sizes under the
Utilization of the FR 2420 report for supervisory purposes will complement existing liquidity monitoring reports and allow the Federal Reserve to reduce reporting requirements in those reports. Specifically, with regard to the interaction between the FR 2420 and FR 2052, the Federal Reserve has reviewed the current and proposed reports and confirms there is no duplicated information or material overlaps between these reports. A subset of the FR 2420 pricing data was already being collected on the FR 2052a as part of supervisory liquidity monitoring. Going forward, information contained on the FR 2420 will replace certain information currently gathered on the FR 2052a, as these data elements will be dropped from the FR 2052a collection. Pricing information on the FR 2052b will not change, as that data is not similar to FR 2420 data. However, the amended FR 2420 will offer greater insight on the borrowing costs for these firms' liabilities. Pricing information, when used in tandem with liquidity data, is an area that supervisors review when gauging a firm's overall liquidity profile. Rapid changes in pricing can indicate a firm is entering a period of constrained market access and subsequent liquidity stress.
For institutions whose primary regulator is not the Federal Reserve and who do not file FR 2052 reports, the FR 2420 data is intended primarily for monetary policy purposes. The Federal Reserve does not plan to share these data with other agencies.
One trade organization asked for clarification on several definitions, including counterparty types, embedded options on CDS, borrowings from GSEs and FHLBs, deposits from non-financial corporations, and the office identifier on Part B. Each of these definitions will be updated with further clarification in the reporting instructions. The organization also asked for a formal process for Frequently Asked Questions. The Federal Reserve will have a process to document reporting questions and communicate these to reporters. Lastly, the organization asked for the Reporting Central application to be open for testing as soon as possible. The application will be available for testing at least one month before the implementation dates.
One commenter provided additional comments outside the scope of the data collection proposal that focused on the calculation of the published rates.
9:00 a.m. (Eastern Time) July 27, 2015.
10th Floor Board Meeting Room, 77 K Street NE., Washington, DC 20002.
Parts will be open to the public and parts closed to the public.
Kimberly Weaver, Director, Office of External Affairs, (202) 942-1640.
Federal Trade Commission (“FTC” or “Commission”).
Notice.
The FTC intends to ask the Office of Management and Budget (“OMB”) to extend through November 30, 2018, the current Paperwork Reduction Act (“PRA”) clearance for the information collection requirements in the FTC Red Flags, Card Issuers, and Address Discrepancies Rules
Comments must be submitted by September 18, 2015.
Interested parties may file a comment online or on paper by following the instructions in the Request for Comment part of the
Requests for additional information should be addressed to Steven Toporoff, Attorney, Bureau of Consumer Protection, (202) 326-2252, Federal Trade Commission, 600 Pennsylvania Avenue, Washington, DC 20580.
The Red Flags Rule requires financial institutions and certain creditors to develop and implement written Identity
The Rules implement sections 114 and 315 of the Fair Credit Reporting Act (“FCRA”), 15 U.S.C. 1681
Since promulgation of the original Rule, President Obama signed the Red Flag Program Clarification Act of 2010 (“Clarification Act”), which narrowed the definition of “creditor” for purposes of the Red Flags Rule. Specifically, the Clarification Act limits application of the Red Flags Rule to creditors that regularly and in the ordinary course of business: (1) Obtain or use consumer reports, directly or indirectly, in connection with a credit transaction; (2) furnish information to consumer reporting agencies in connection with a credit transaction; or (3) advance funds to or on behalf of a person, based on a person's obligation to repay the funds to or on behalf of a person, based on a person's obligation to repay the funds or on repayment from specific property pledged by or on the person's behalf. This third prong does not include a creditor that advances funds on behalf of a person for expenses incidental to a service provided by the creditor to that person.
The Red Flags Rule requires financial institutions and covered creditors to develop and implement a written Program to detect, prevent, and mitigate identity theft in connection with existing accounts or the opening of new accounts. Under the Rule, financial institutions and certain creditors must conduct a periodic risk assessment to determine if they maintain “covered accounts.” The Rule defines the term “covered account” as either: (1) A consumer account that is designed to permit multiple payments or transactions, or (2) any other account for which there is a reasonably foreseeable risk of identity theft. Each financial institution and covered creditor that has covered accounts must create a written Program that contains reasonable policies and procedures to identify relevant indicators of the possible existence of identity theft (“red flags”); detect red flags that have been incorporated into the Program; respond appropriately to any red flags that are detected to prevent and mitigate identity theft; and update the Program periodically to ensure it reflects change in risks to customers.
The Red Flags Rule also requires financial institutions and covered creditors to: (1) Obtain approval of the initial written Program by the board of directors; a committee thereof or, if there is no board, an appropriate senior employee; (2) ensure oversight of the development, implementation, and administration of the Program; and (4) exercise appropriate and effective oversight of service provider arrangements.
In addition, the Rules implement the section 114 requirement that card issuers generally must assess the validity of change of address notifications. Specifically, if the card issuer receives a notice of change of address for an existing account and, within a short period of time (during at least the first 30 days), receives a request for an additional or replacement card for the same account, the issuer must follow reasonable policies and procedures to assess the validity of the change of address.
In implementing section 315 of the FCRA, the Rules require each user of consumer reports to have reasonable policies and procedures in place to employ when the user receives a notice of address discrepancy from a CRA. Specifically, each user of consumer reports must develop reasonable policies and procedures to: (1) Enable the user to form a reasonable belief that a consumer report relates to the consumer about whom it has requested the report, when the user receives a notice of address discrepancy; and (2) furnish an address for the consumer that the user has reasonably confirmed is accurate to the CRA from which it receives a notice of address discrepancy, if certain conditions are met.
Under the PRA, 44 U.S.C. 3501-3521, Federal agencies must get OMB approval for each collection of information they conduct or sponsor. “Collection of information” includes 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). The figures below reflect FTC staff's estimates of the hours burden and labor costs to complete the tasks described above that fall within reporting, disclosure, or recordkeeping requirements. FTC staff believes that the Rules impose negligible capital or other non-labor costs, as the affected entities are likely to have the necessary supplies and/or equipment already (
Overall estimated burden hours regarding sections 114 and 315, combined, total 2,296,863 hours and the associated estimated labor costs are $92,465,982. Staff assumes that affected entities will already have in place, independent of the Rule, equipment and supplies necessary to carry out the tasks necessary to comply with it.
As noted above, the Rule requires financial institutions and certain creditors with covered accounts to develop and implement a written Program. Under the FCRA, financial institutions over which the FTC has jurisdiction include state chartered credit unions and certain insurance companies.
Although narrowed by the Clarification Act, the definition of “creditor” still covers a broad array of entities. Moreover, the Clarification Act does not set forth any exemptions from Rule coverage. Rather, application of the Rule depends upon an entity's course of conduct, not its status as a particular type of business. For these reasons, it is difficult to determine precisely the number of creditors subject to the FTC's jurisdiction. There are numerous small businesses under the FTC's jurisdiction that may qualify as “creditors,” and there is no formal way to track them. Nonetheless, FTC staff estimates that the Rule's requirement to have a written Program affects 6,298 financial institutions
To estimate burden hours for the Red Flags Rule under section 114, FTC staff divided affected entities into two categories, based on the nature of their business: (1) Entities that are subject to high risk of identity theft and (2) entities that are subject to a low risk of identity theft, but have covered accounts that will require them to have a written Program.
FTC staff estimates that high-risk entities
Thus, estimated hours for high-risk entities are as follows:
• 101,328 high-risk entities subject to the FTC's jurisdiction at an average annual burden of 13 hours per entity [average annual burden over 3-year clearance period for creation and implementation of a Program ((25+1+1)/3), plus average annual burden over 3-year clearance period for staff training ((4+1+1)/3), plus average annual burden over 3-year clearance period for preparing an annual report ((4+1+1)/3)], for a total of 1,317,264 hours.
Entities that have a minimal risk of identity theft,
Thus, the estimated hours burden for low-risk entities is as follows:
• 60,974 low risk entities that have covered account subject to the FTC's jurisdiction at an average annual burden of approximately 37 minutes per entity [average annual burden over 3-year clearance period for creation and implementation of streamlined Program ((60+5+5)/3), plus average annual burden over 3-year clearance period for staff training ((10+5+5)/3), plus average annual burden over 3-year clearance period for preparing annual report ((10+5+5)/3], for a total of 37,600 hours.
As noted above, section 114 also requires financial institutions and covered creditors that issue credit or debit cards to establish policies and procedures to assess the validity of a change of address request, including notifying the cardholder or using another means of assessing the validity of the change of address.
• FTC staff estimates that the Rule affects as many as 16,301
Thus, the total average annual estimated burden for Section 114 is 1,420,068 hours.
The FTC staff estimates labor costs by applying appropriate estimated hourly cost figures to the burden hours described above. It is difficult to calculate with precision the labor costs associated with compliance with the Rule, as they entail varying compensation levels of management (
Based on the above estimates and assumptions, the total annual labor costs for all categories of covered entities under the Red Flags and Card Issuers Rules for Section 114 is $76,683,672 (1,420,068 hours x $54).
As discussed above, the Rule's implementation of Section 315 provides guidance on reasonable policies and procedures that a user of consumer reports must employ when a user receives a notice of address discrepancy from a CRA. Given the broad scope of users of consumer reports, it is difficult to determine with precision the number of users of consumer reports that are subject to the FTC's jurisdiction. As noted above, there are numerous small businesses under the FTC's jurisdiction, and there is no formal way to track them; moreover, as a whole, the entities under the FTC's jurisdiction are so varied that there are no general sources that provide a record of their existence. Nonetheless, FTC staff estimates that the Rule's implementation of section 315 affects approximately 1,875,275 users of
For section 315, as detailed below, FTC staff estimates that the average annual burden during the three-year period for which OMB clearance is sought will be 876,795 hours with an associated labor cost of $15,782,310.
Prior to enactment of the Address Discrepancy Rule, users of consumer reports could compare the address on a consumer report to the address provided by the consumer and discern for themselves any discrepancy. As a result, FTC staff believes that many users of consumer reports have developed methods of reconciling address discrepancies, and the following estimates represent the incremental amount of time users of consumer reports may require to develop and comply with the policies and procedures for when they receive a notice of address discrepancy.
Given the varied nature of the entities under the FTC's jurisdiction, it is difficult to determine precisely the appropriate burden estimates. Nonetheless, FTC staff estimates that it would require an infrequent user of consumer reports no more than 16 minutes to develop and comply with the policies and procedures that it will employ when it receives a notice of address discrepancy, while a frequent user might require one hour. Similarly, FTC staff estimates that, during the remaining two years of clearance, it may take an infrequent user no more than one minute to comply with the policies and procedures it will employ when it receives a notice of address discrepancy, while a frequent user might require 45 minutes. Taking into account these extremes, FTC staff estimates that, during the first year, it will take users of consumer reports under the FTC's jurisdiction an average of 38 minutes [the midrange between 16 minutes and 60 minutes] to develop and comply with the policies and procedures that they will employ when they receive a notice of address discrepancy. FTC staff also estimates that the average recurring burden for users of consumer reports to comply with the Rule will be 23 minutes [the midrange between one minute and 45 minutes].
Thus, for these 1,875,275 entities, the average annual burden for each of them to perform these collective tasks will be 28 minutes [(38 + 23 + 23) ÷ 3]; cumulatively, 875,128 hours.
For the estimated 10,000 users of consumer reports that will additionally have to furnish to CRAs an address confirmation upon notice of a discrepancy, staff estimates that these entities will require, initially, 30 minutes to develop related policies and procedures. But, these 10,000 affected entities likely will have automated the process of furnishing the correct address in the first year of a three-year PRA clearance cycle. Thus, allowing for 30 minutes in the first year, with no annual recurring burden in the second and third years of clearance, yields an average annual burden of 10 minutes per entity to furnish a correct address to a CRA, for a total of 1,667 hours.
FTC staff assumes that the policies and procedures for compliance with the address discrepancy part of the Rule will be set up by administrative support personnel at an hourly rate of $18.
Cumulatively, then, estimated burden is 2,296,863 hours (1,420,068 hours for section 114 and 876,795 hours for section 315) and $92,465,982 ($76,683,672 and $15,782,310) in associated labor costs.
You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before [60 days after publication]. Write: “Red Flags Rule, PRA Comment, Project No. P095406” 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 of 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 provided 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, don't include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Red Flags Rule PRA, Project No. P095406” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite CC-5610 (Annex J), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before September 18, 2015. For information on the Commission's privacy policy, including routine uses by the Privacy Act, see
Federal Trade Commission.
Proposed consent agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent orders—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before August 3, 2015.
Interested parties may file a comment at
Sean Pugh, Bureau of Competition, (202-326-3201), 600 Pennsylvania Avenue NW., Washington, DC 20580.
Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent orders to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for July 2, 2015), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before August 3, 2015. Write “Dollar Tree, Inc. and Family Dollar Stores, Inc.—Consent Agreement; File No. 141-0207” 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).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Dollar Tree, Inc. and Family Dollar Stores, Inc.—Consent Agreement; File No. 141-0207” on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“Commission”) has accepted for public comment, subject to final approval, an Agreement Containing Consent Orders (“Consent Order”) from Dollar Tree, Inc. (“Dollar Tree”) and Family Dollar Stores, Inc. (“Family Dollar”), (collectively, the “Respondents”). On July 27, 2014, Dollar Tree and Family Dollar entered into an agreement whereby Dollar Tree would acquire Family Dollar for approximately $9.2 billion (the “Acquisition”). The purpose of the proposed Consent Order is to remedy the anticompetitive effects that otherwise would result from Dollar Tree's acquisition of Family Dollar. Under the terms of the proposed Consent Order, Respondents are required to divest 330 stores in local geographic markets (collectively, the “relevant markets”) in 35 states to the Commission-approved buyer. The divestitures must be completed within 150 days from the date of the Acquisition. The Commission and Respondents have agreed to an Order to Maintain Assets to maintain the viability of Respondents' assets until they are transferred to the Commission-approved buyer.
The proposed Consent Order has been placed on the public record for 30 days to solicit comments from interested persons. Comments received during this period will become part of the public record. After 30 days, the Commission again will review the proposed Consent Order and any comments received, and decide whether the Consent Order should be withdrawn, modified, or made final.
The Commission's Complaint alleges that the Acquisition, if consummated, would violate Section 7 of the Clayton Act, as amended, 15 U.S.C. § 18, and Section 5 of the Federal Trade Commission Act, as amended, 15 U.S.C. § 45, by removing an actual, direct, and substantial competitor in localized geographic markets in 222 cities nationwide.
As of January 31, 2015, Dollar Tree operated 5,157 discount general merchandise retail stores across the United States under the Dollar Tree and Deals banners. Presently, Dollar Tree banner stores are located in 48 states and the District of Columbia, while Deals banner stores are currently located in 18 states and the District of Columbia. In the Dollar Tree banner stores, Dollar Tree sells a wide selection of everyday basic, seasonal, closeout, and promotional merchandise for $1 or less. At its Deals banner stores, Dollar Tree offers an expanded assortment of this merchandise at prices generally less than $10. Dollar Tree and Deals banner stores range in size from 8,000 to 12,000 square feet of selling space and typically carry between 6,600 to 7,000 stock keeping units (“SKUs”).
As of February 28, 2015, Family Dollar operated approximately 8,184 discount general merchandise retail stores nationwide. Family Dollar sells an assortment of consumables, home products, apparel and accessories, seasonal items, and electronic merchandise at prices generally less than $10. Currently, Family Dollar stores are located in 46 states and the District of Columbia. Stores typically have 7,150 square feet of selling space and carry approximately 6,500 to 7,000 SKUs.
Dollar stores are small-format, deep-discount retailers that sell an assortment of consumables and non-consumables, including food, home products, apparel and accessories, and seasonal items, at prices typically under $10. Dollar stores differentiate themselves from other retailers on the basis of both convenience and value by offering a broad assortment but limited variety of general merchandise items at discounted prices in stores with small footprints (
Walmart competes closely with dollar stores and offers a wide assortment of products at deeply-discounted prices. Although Walmart does not provide the same kind of convenience as that of dollar stores given its less-accessible locations, larger store footprints, and greater assortment of products, Walmart nevertheless competes closely with dollar stores by offering a comparable or better value to consumers in terms of pricing. For purposes of this matter, “discount general merchandise retail stores” refers to dollar stores and the retailer Walmart.
Although other retail stores (
Thus, the relevant line of commerce in which to analyze the Acquisition is no narrower than discount general merchandise retail stores. In certain geographic markets, the relevant line of commerce may be as broad as the sale of discounted general merchandise in retail stores (
The relevant geographic market varies depending on the unique characteristics of each market, including the local road network, physical boundaries, and population density. A strong motivation of consumers shopping at discount general merchandise retail stores is convenience. As with grocery shopping, the vast majority of consumers who shop for discounted general merchandise do so at stores located very close to where they live or work. The draw area of a dollar store, which varies depending on whether it is located in an urban, suburban, or rural area, may range from a couple of city blocks to several miles. Other market participants, such as supermarkets and retail pharmacies, may have similar, although somewhat broader draw areas. Walmart's stores, particularly Walmart Supercenters, tend to have a considerably broader draw area. In highly urban areas, the geographic markets are generally no broader than a half-mile radius around a given store. In highly rural areas, the geographic market is generally no narrower than a three-mile radius around a given store. In areas neither highly urban nor highly rural, the geographic market is generally within a half-mile to three-mile radius around a given store.
Respondents are close competitors in terms of format, customer service, product offerings, and location in the relevant geographic markets. With regard to pricing, product assortment, and a host of other competitive issues, Respondents typically focus most directly on the actions and responses of each other and other dollar stores, while also paying close attention to Walmart. In many of the relevant geographic markets, Dollar Tree and Family Dollar operate the only dollar stores in the area or the vast majority of conveniently-located discount general merchandise retail stores. Absent relief, the Acquisition would increase the incentive and ability of Dollar Tree to raise prices unilaterally post-Acquisition in the relevant geographic markets. The Acquisition would also decrease incentives to compete on non-price factors, including product selection, quality, and service.
Entry into the relevant geographic markets that is timely and sufficient to prevent or counteract the expected anticompetitive effects of the Acquisition is unlikely. Entry barriers include the time, costs, and feasibility associated with identifying and potentially constructing an appropriate and available location for a discount general merchandise retail store, the resources required to support one or more new stores over a prolonged ramp-up period, and the sufficient scale to compete effectively. An entrant's ability to secure a viable competitive location may be hindered by restrictive-use commercial lease covenants, which can limit the products sold, or even the type of retailer that can be located, at a particular location.
The proposed remedy, which requires the divestiture of 330 Family Dollar stores in the relevant markets to Sycamore Partners (“Sycamore”), will restore fully the competition that otherwise would be eliminated in these markets as a result of the Acquisition. Sycamore is a private equity firm specializing in consumer and retail investments. The proposed buyer appears to be a highly suitable purchaser and is well positioned to enter the relevant geographic markets and prevent the likely competitive harm that otherwise would result from the Acquisition. Sycamore's proposed executive team has extensive experience operating discount general merchandise retail stores.
The proposed Consent Order requires Respondents to divest 330 stores to Sycamore within 150 days from the date of the Acquisition. If, at any time before the proposed Consent Order is made final, the Commission determines that Sycamore is not an acceptable buyer, Respondents must immediately rescind the divestitures and divest the assets to a different buyer that receives the Commission's prior approval.
The proposed Consent Order contains additional provisions to ensure the adequacy of the proposed relief. For example, Respondents have agreed to an Order to Maintain Assets that will be issued at the time the proposed Consent Order is accepted for public comment. The Order to Maintain Assets requires Family Dollar to operate and maintain each divestiture store in the normal course of business through the date the store is ultimately divested to Sycamore. Because the divestiture schedule runs for an extended period of time, the proposed Consent Order appoints Gary Smith as a Monitor to oversee Respondents' compliance with the requirements of the proposed Consent Order and Order to Maintain Assets. Mr. Smith has the experience and skills to be an effective Monitor, no identifiable conflicts, and sufficient time to dedicate to this matter through its conclusion.
The sole purpose of this Analysis is to facilitate public comment on the proposed Consent Order. This Analysis does not constitute an official interpretation of the proposed Consent Order, nor does it modify its terms in any way.
By direction of the Commission, Commissioner Wright dissenting.
The Federal Trade Commission has accepted a proposed settlement to resolve the likely anticompetitive effects of Dollar Tree, Inc.'s proposed $9.2 billion acquisition of Family Dollar Stores, Inc.
Dollar Tree operates over 5,000 discount general merchandise retail stores across the United States under two banners which follow somewhat different business models. In its Dollar Tree banner stores, Dollar Tree sells a wide selection of everyday basic, seasonal, closeout, and promotional merchandise—all for $1 or less. At its Deals banner stores, Dollar Tree sells an expanded assortment of this merchandise at prices that may go above the $1 price point but are generally less than $10. Family Dollar operates over 8,000 discount general merchandise retail stores. Family Dollar sells an assortment of consumables, home products, apparel and accessories, seasonal items, and electronic merchandise at prices generally less than $10, including items priced at or under $1.
Dollar Tree and Family Dollar compete head-to-head in numerous local markets across the United States. They are close competitors in terms of format, pricing, customer service, product offerings, and location. When making competitive decisions regarding pricing, product assortment, and other salient aspects of their businesses, Dollar Tree and Family Dollar focus most directly on the actions and responses of each other and other “dollar store” chains, while also paying close attention to Walmart. In many local markets, Dollar Tree and Family Dollar operate stores in close proximity to each other, often representing the only or the majority of conveniently located discount general merchandise retail stores in a neighborhood.
To evaluate the likely competitive effects of this transaction and identify the local markets where it may likely harm competition, the Commission considered multiple sources of quantitative and qualitative evidence. One component of the investigation involved a Gross Upward Pricing Pressure Index (“GUPPI”) analysis. As described in the 2010 Horizontal Merger Guidelines, this mode of analysis can serve as a useful indicator of whether a merger involving differentiated products is likely to result in unilateral anticompetitive effects.
The Commission's investigation involved thousands of Dollar Tree and Family Dollar stores with overlapping geographic markets. A GUPPI analysis served as a useful initial screen to flag those markets where the transaction might likely harm competition and those where it might pose little or no risk to competition. As a general matter, Dollar Tree and Family Dollar stores with relatively low GUPPIs suggested that the transaction was unlikely to harm competition, unless the investigation uncovered specific reasons why the GUPPIs may have understated the potential for anticompetitive effects. Conversely, Dollar Tree and Family Dollar stores with relatively high GUPPIs suggested that the transaction was likely to harm competition, subject to evidence or analysis indicating that the GUPPIs may have overstated the potential for anticompetitive effects.
While the GUPPI analysis was an important screen for the Commission's inquiry, it was only a starting point. The Commission considered several other sources of evidence in assessing the transaction's likely competitive effects, including additional detail regarding the geographic proximity of the merging parties' stores relative to each other and to other retail stores, ordinary course of business documents and data supplied by Dollar Tree and Family Dollar, information from other market participants, and analyses conducted by various state attorneys general who were also investigating the transaction. After considering all of this evidence, the Commission identified specific local markets where the acquisition would be likely to harm competition and arrived at the list of 330 stores slated for divestiture.
In his statement, Commissioner Wright criticizes the way that the Commission used the GUPPI analysis in this case and argues that GUPPIs below a certain threshold should be treated as a “safe harbor.”
As an initial matter, Commissioner Wright mischaracterizes the way that the GUPPI analysis was used in this case. Contrary to his suggestion, GUPPIs were not used as a rigid presumption of harm. As explained above, they were used only as an initial screen to identify those markets where further investigation was warranted. The Commission then proceeded to consider the results of the GUPPI analysis in conjunction with numerous other sources of information.
Our market-by-market review showed that the model of competition underlying the GUPPI analysis was largely consistent with other available evidence regarding the closeness of competition between the parties' stores in each local market. For example, stores with high GUPPIs were generally found in markets in which there were few or no other conveniently located discount general merchandise retail stores. The GUPPI analysis did have some limitations, however. For example, there were Family Dollar stores with relatively low GUPPIs in markets that were nevertheless price-zoned to Dollar Tree stores, which meant that if Dollar Tree stores were
More broadly, Commissioner Wright's view that the Commission should identify and treat GUPPIs below a certain threshold as a “safe harbor” ignores the reality that merger analysis is inherently fact-specific. The manner in which GUPPI analysis is used will vary depending on the factual circumstances, the available data, and the other evidence gathered during an investigation. Moreover, whether the value of diverted sales is considered “proportionately small” compared to lost revenues will vary from industry to industry and firm to firm.
Indeed, we agree with Commissioner Wright that “a GUPPI-based presumption of competitive harm is inappropriate at this stage of economic learning.”
Accordingly, in any case where a GUPPI analysis is used, the Commission will consider the particular factual circumstances and evaluate other sources of quantitative and qualitative evidence.
By direction of the Commission, Commissioner Wright not participating.
The Commission has voted to issue a Complaint and a Decision & Order against Dollar Tree, Inc. (“Dollar Tree”) and Family Dollar Stores, Inc. (“Family Dollar”) to remedy the allegedly anticompetitive effects of the proposed acquisition by Dollar Tree of Family Dollar. I dissent in part from and concur in part with the Commission's decision. I dissent in part because in 27 markets I disagree with the Commission's conclusion that there is reason to believe the proposed transaction violates the Clayton Act.
The record evidence includes a quantitative measure of the value of diverted sales as well as various forms of qualitative evidence. The value of diverted sales is typically measured as the product of the diversion ratio between the merging parties' products—the diversion ratio between two products is the percentage of unit sales lost by one product when its price rises, that are captured by the second product—and the profit margin of the second product. When the value of diverted sales is measured in proportion to “the lost revenues attributable to the reduction in unit sales resulting from the price increase,”
I also write to address an important merger policy issue implicated by today's decision—that is, whether the FTC should adopt a safe harbor in unilateral effects merger investigations by defining a GUPPI threshold below which it is presumed competitive harm is unlikely. The
Without more, one might reasonably conclude it is unclear whether the
Regarding
This is unfortunate. The legal, economic, and policy case for the GUPPI-based safe harbor contemplated by the
A second reason a safe harbor for proportionately small diversion might be desirable antitrust policy is to compensate for the sources of downward pricing pressure not measured by the GUPPI but expected with most transactions, including efficiencies, entry, or repositioning. Some have argued that—as a GUPPI attempts a rough measure of upward pricing pressure without a full blown analysis—a symmetrical approach would include a standard efficiencies deduction which would be applied to account for the downward pricing pressure from the marginal-cost efficiencies that can typically be expected to result from transactions.
Yet a third reason a safe harbor might be desirable is to compensate the well-known feature of GUPPI-based scoring methods to predict harm for any positive diversion ratio—that is, even for distant substitutes—by distinguishing
Against these benefits of adopting a GUPPI-based safe harbor, the Commission must weigh the cost of reducing its own flexibility and prosecutorial discretion. This begs the question: How likely are mergers within the proposed safe harbor to be anticompetitive? The benefits of this flexibility are proportional to the probability that the Commission's economic analysis leads them to conclude that mergers with a GUPPI of less than 5 percent are anticompetitive. I am not aware of any transactions since
The Commission rejects a GUPPI safe harbor on the grounds that such an approach “ignores the reality that merger analysis is inherently fact-specific.”
Existing antitrust law regularly embraces bright-line rules and presumptions—rejecting the flexibility of a case-by-case standard taking full account of facts that vary across industries and firms. A simple example is the application of
Whether the Commission should adopt a GUPPI-based safe harbor is particularly relevant in the instant matter, as the FTC had data sufficient to calculate GUPPIs for Dollar Tree, Deals,
What about the other stores? The Commission asserts I “mischaracterize[]” its use of GUPPIs and that “GUPPIs were not used as a rigid presumption of harm.”
The number of stores with GUPPIs exceeding the identified threshold that, after evaluation in conjunction with the qualitative and other evidence described by the Commission, were not slated for divestiture is nearly zero. This outcome is indistinguishable from the application of a presumption of competitive harm. The additional stores with GUPPIs below the threshold that were then identified for divestiture based upon additional qualitative factors included a significant number of stores with GUPPIs below 5 percent. The ratio of stores falling below the GUPPI threshold but deemed problematic after further qualitative evidence is taken into account to stores with GUPPIs above the threshold but deemed not to raise competitive problems after qualitative evidence is accounted for is unusual and remarkably high. It is difficult to conceive of a distribution of qualitative and other evidence occurring in real-world markets that would result in this ratio. Qualitative evidence should not be a one-way ratchet confirming the Commission's conclusion of likely anticompetitive effects when GUPPIs are high and providing an independent basis for the same conclusion when GUPPIs are low.
I applaud the FTC for taking important initial steps in applying more sophisticated economic tools in conducting merger analysis where the data are available to do so. Scoring metrics for evaluating incentives for unilateral price increases are no doubt a significant improvement over simply counting the number of firms in markets pre- and post-transaction. To be clear, it bears repeating that I agree that a GUPPI-based presumption of
The FTC has not publicly endorsed a GUPPI-based safe harbor of 5 percent and disappointingly, has rejected the concept in its statement today. The Commission's interpretation is that what is a “proportionately small” value of diverted sales should vary according to the industry—and even the individual firms—in a given investigation.
Once it is understood that a safe harbor should apply, it becomes obvious that, for the safe harbor to be effective, the threshold should not move. As the plane crash survivors in
In my view, the Commission should adopt a GUPPI-based safe harbor in unilateral effects investigations where data are available. While reasonable minds can and should debate the optimal definition of a “small” GUPPI, my own view is that 5 percent is a reasonable starting point for discussion. Furthermore, failure to adopt a safe harbor could raise concerns about the potential for divergence between Commission and Division policy in unilateral effects merger investigations.
For these reasons, I dissent in part from and concur in part with the Commission's decision.
Department of Defense (DOD), General Services Administration (GSA), and National Aeronautics and Space Administration (NASA).
Notice of request for public comments regarding an extension to an existing OMB clearance.
Under the provisions of the Paperwork Reduction Act, the Regulatory Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve a previously approved information collection requirement concerning U.S. Flag Air Carriers Statement. A notice was published in the
Submit comments on or before August 19, 2015.
Submit comments identified by Information Collection 9000-0054, U.S. Flag Air Carriers Statement by any of the following methods:
•
•
Mr. Curtis E. Glover, Sr. Procurement Analyst, Contract Policy Division, GSA 202-501-1448 or via email at
Section 5 of the International Air Transportation Fair Competitive Practices Act of 1974 (49 U.S.C. 1517) (Fly America Act) requires that all Federal agencies and Government contractors and subcontractors at FAR 47.402, use U.S.-flag air carriers for U.S. Government-financed international air transportation of personnel (and their personal effects) or property, to the extent that service by those carriers is available. It requires the Comptroller General of the United States, in the absence of satisfactory proof of the necessity for foreign-flag air transportation, to disallow expenditures from funds, appropriated or otherwise established for the account of the United States, for international air transportation secured aboard a foreign-flag air carrier if a U.S.-flag air carrier is available to provide such services. In the event that the contractor selects a carrier other than a U.S.-flag air carrier for international air transportation during performance of the contract, the contractor shall include per FAR clause 52.247-64 a statement on vouchers involving such transportation. The contracting officer uses the information furnished in the statement to determine whether adequate justification exists for the contractor's use of other than a U.S.-flag air carrier.
Public comments are particularly invited on: Whether this collection of information is necessary for the proper performance of functions of the FAR, and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected; and ways in which we can minimize the burden of the collection of information on those who are to respond, through the use of appropriate technological collection techniques or other forms of information technology.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of public webcast.
The HHS Centers for Disease Control and Prevention's Division of Select Agents and Toxins (DSAT) and the USDA Animal and Plant Health Inspection Service (APHIS), Agriculture Select Agent Services (AgSAS) are jointly charged with the oversight of the possession, use and transfer of biological agents and toxins that have the potential to pose a severe threat to public, animal or plant health or to animal or plant products (select agents and toxins). This joint effort constitutes the Federal Select Agent Program. The purpose of the webcast is to provide guidance related to the Federal Select Agent Program for interested individuals.
The webcast will be held on Thursday, November 19, 2015 from 12 p.m. to 4 p.m. EST. All who wish to join the webcast must register by October 23,
The webcast will be broadcast from the Centers for Disease Control and Prevention's facility, 1600 Clifton Road, Atlanta, GA 30333. This will only be produced as a webcast, therefore no accommodations will be provided for in-person participation.
CDC: Ms. Diane Martin, Division of Select Agents and Toxins, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, 1600 Clifton Road, NE., MS A-46, Atlanta, GA 30329; phone: 404-718-2000; email:
APHIS: Dr. Keith Wiggins, APHIS Agriculture Select Agent Services, 4700 River Road, Unit 2, Riverdale, MD 20737; phone: 301-851-3300 (option 3); email:
The public webcast is an opportunity for the affected community (
Representatives from the Federal Select Agent Program will be present during the webcast to address questions and concerns from the Web participants.
Individuals who want to participate in the webcast must complete their registration online by October 23, 2015. The registration instructions are located on this Web site:
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned subcommittee:
The agenda is subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice with comment period.
The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, 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. This notice invites comment on the Paul Coverdell National Acute Stroke Program (PCNASP) reporting system, which was established to improve quality of care for acute stroke patients from onset of signs and symptoms through hospital care and rehabilitation and recovery.
Written comments must be received on or before September 18, 2015.
You may submit comments, identified by Docket No. CDC-2015-0056 by any of the following methods:
All public comment should be submitted through the Federal eRulemaking portal (Regulations.gov) or by U.S. mail to the address listed above.
To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email:
Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. In addition, the PRA also requires Federal agencies to provide a 60-day notice in the
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology; and (e) estimates of capital or start-up costs and costs of operation, maintenance, and purchase of services to provide information. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information; to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information; and to transmit or otherwise disclose the information.
Paul Coverdell National Acute Stroke Program (PCNASP)—New—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
Stroke is the fifth leading cause of death in the United States and results in approximately 130,000 deaths per year. Additionally, approximately 800,000 stroke events are reported each year, including approximately 250,000 recurrent strokes. However, many strokes are preventable, or their severity can be reduced through coordinated care that is delivered in a timely manner.
Stroke outcomes depend upon the rapid recognition of signs and symptoms of stroke, prompt transport to a treatment facility, and early rehabilitation. Improving outcomes requires a coordinated systems approach involving pre-hospital care, emergency department and hospital care, rehabilitation, prevention of complications, and ongoing secondary prevention. Each care setting has unique opportunities for improving the quality of care provided and access to available professional and clinical care at the local level within a coordinated state-based system of care.
Through the Paul Coverdell National Acute Stroke Program (PCNASP), CDC has been continuously working to measure and improve acute stroke care using well-known quality improvement strategies coupled with frequent evaluation of results. PCNASP awardees are state health departments who work with participating hospitals and EMS agencies in their jurisdictions to improve quality of care for stroke patients. State-based efforts include identifying effective stroke treatment centers and building capacity and infrastructure to ensure that stroke patients are routed to effective treatment centers in a timely manner.
During initial cooperative agreement cycles, PCNASP awardees focused on in-hospital quality of care (QoC) issues with technical assistance provided by CDC. Through lessons learned during this process and other supporting evidence in the field, it has become evident that it is also important to examine pre- and post-hospital transitions of care to link the entire continuum of stroke care when improving QoC for stroke patients.
The PCNASP will continue under a new five-year cooperative agreement, subject to available funding, to begin on or around July 1, 2015. The new funding period reflects additional emphasis on pre-hospital quality of care as well as the post-hospital transition of care setting from hospital to home and the next care provider. Therefore, awardees will systematically collect and report data on hospital capacity and all three phases of the stroke care continuum.
The new cooperative agreement funding cycle will include pre-hospital (EMS), in-hospital, and post-hospital patient care data. Data to be collected for pre- and in-hospital care closely align with standards of The Joint Commission (TJC), the American Heart Association's Get With The Guidelines (GWTG) program, and the National Emergency Medical Services Information System (NEMSIS). CDC and awardees will work on defining performance measures for the post-hospital transition of care setting. Data from these three settings will be transmitted from the awardees to CDC quarterly. The average burden per response for this data will vary between 30-90 minutes. The burden will be 30 minutes each for independent submission of information relating to the pre-hospital, in-hospital, and post-hospital phases of patient care. Alternatively, the burden will be 90 minutes for awardees who transmitpre-, in-, and post-hospital data as one combined file. CDC accepts file transmissions as individual phases or combined.
In addition, the new cooperative agreement funding cycle will also include primary data collection of hospital inventory data to understand the capacity and infrastructure of the hospitals that admit and treat stroke patients. Each hospital will report inventory information to its PCNASP awardee annually. The average burden per response is 15 minutes. In addition, each PCNASP awardee will prepare an annual aggregate hospital inventory file for transmission to CDC. The average burden of reporting hospital inventory information for each PCNASP awardee is 8 hours per response. All patient, hospital, and EMS provider data that is submitted to CDC by PCNASP awardees will be de-identified and occur through secure data systems.
Proposed data elements and quality indicators may be updated over time to include new or revised items based on evolving recommendations and standards in the field to improve the quality of stroke care.
OMB approval is requested for three years. All information is submitted to CDC electronically. Participation is voluntary and there are no costs to respondents other than their time.
Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of public webcast.
The Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS) is hosting a public webcast which will include representatives from the U.S. Department of Transportation, USDA Animal and Plant Health Inspection Services, CDC Division of Global Migration and Quarantine, U.S. Customs and Border Protection, U.S. Department of Commerce, U.S. Food and Drug Administration, HHS/Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority. This public webcast will address import and export regulations for infectious biological agents, infectious substances, and vectors, and import and export exemptions. The purpose of this notice is to inform all interested parties, including those individuals and entities already possessing an import or export permit (or license) of the webcast.
The webcast will be held on September 16, 2015 from 11 a.m. to 4 p.m. EDT. Registration instructions are found on the HHS/CDC's Import Permit Program Web site,
The webcast will be broadcast from the Centers for Disease Control and Prevention, 1600 Clifton Road NE., Atlanta, Georgia 30329.
Von McClee, Division of Select Agents and Toxins, Office of Public Health Preparedness and Response, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS A-46, Atlanta, GA 30333; phone: 404-718-2000; email:
This webcast is an opportunity for the regulated community (
Instructions for registration are found on the HHS/CDC's Import Permit Program Web site,
The Director, Management Analysis and Services Office, has been delegated the authority to sign
In order to describe the activities and accomplishments of the NDVH and NDAH/LIR and develop potential new or revised performance measures, the Office of Planning, Research and Evaluation (OPRE), within ACF/HHS is proposing data collection activity as part of the Accomplishments of the Domestic Violence Hotline, Online Connections and Text (ADVHOCaT) Study.
This study will primarily analyze data previously collected by the NDVH and NDAH/LIR as part of their ongoing program activities and monitoring. ACF proposes to collect additional information, including information about the preferred mode (phone, chat, text), ease of use, and perceived safety of each mode of contact.
This data is to be collected through voluntary web-based surveys that are to be completed by those who access the NDVH and NDAH/LIR Web sites. This information will be critical to informing future efforts to monitor and improve the performance of domestic violence hotlines and provide hotline services.
In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L'Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. Email address:
The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the
Submit either electronic or written comments on the collection of information by September 18, 2015.
Submit electronic comments on the collection of information to
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002,
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined 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
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) authorizes the FDA to conduct research relating to health information. Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying out the provisions of the FD&C Act.
The marketing literature divides product attributes (“cues”) into intrinsic and extrinsic. Intrinsic cues are physical characteristics of the product (
The Office of Prescription Drug Promotion plans to investigate, through empirical research, the impact of market claims on prescription drug product perceptions with and without quantitative information about product efficacy. This will be investigated in DTC print advertising for prescription drugs.
The project consists of two parts; a main study and a followup study. Pretesting will be conducted to assess and identify problems with the questionnaire, stimuli, and procedures. Participants will be consumers who self-identify as having been diagnosed with diabetes. All participants will be 18 years of age or older. We will exclude individuals from the consumer sample who work in healthcare or marketing settings because their knowledge and experiences may not reflect those of the average consumer. Recruitment and administration of the study will take place over the Internet. Participation is estimated to take no more than 30 minutes.
In the main study, participants will be randomly assigned to view one of nine possible versions of an ad, as depicted in table 1. The two variables of interest are type of market claim (#1 Prescribed, New) and level of efficacy information (high, low, or none). Efficacy information will be operationalized in the form of simple quantitative information (for example, product X can provide 50 percent relief for up to 60 percent of patients). We will investigate memory, perception, and understanding of product risks and benefits; perception and understanding of the market claim; perception of product quality; perceptions of product acceptance by doctor, intention to seek more information about the product; and perceptions of trust/skepticism regarding product claims and the sponsor. To examine differences between experimental conditions, we will conduct inferential statistical tests such as analysis of variance. With the sample size described below, we will have sufficient power to detect small- to medium-sized effects in the main study.
The followup study will examine the tradeoff between efficacy level and market share claim using decision analysis techniques. Participants will be asked to choose between two different DTC print ads over 48 trials. One set of DTC ads will feature the two claims from the main study. The other set of DTC ads will depict 48 different levels of product efficacy. Participants will be asked to choose one product on one or more dependent measures.
FDA estimates the burden of this collection of information as follows:
The following references have been placed on display in the Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice; request for notification of participation.
The Food and Drug Administration (FDA or Agency) is issuing this notice to request that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of the Prescription Drug User Fee Act (PDUFA). The statutory authority for PDUFA expires in September 2017. At that time, new legislation will be required for FDA to continue collecting user fees for the prescription drug program. The Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires that FDA consult with a range of stakeholders in developing recommendations for the next PDUFA program. The FD&C Act also requires that FDA hold discussions (at least every month) with patient and consumer advocacy groups during FDA's negotiations with the regulated industry. The purpose of this request for notification is to ensure continuity and progress in these monthly discussions by establishing consistent stakeholder representation.
Submit notification of intention to participate in these series of meetings by August 28, 2015. Stakeholder meetings will be held monthly. It is anticipated that they will commence in September or October 2015.
Submit notification of intention to participate in monthly stakeholder meetings by email to
Graham Thompson, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993, 301-796-5003, FAX: 301-847-8443.
FDA is requesting that public stakeholders—including patient and consumer advocacy groups, health care professionals, and scientific and academic experts—notify the Agency of their intent to participate in periodic stakeholder consultation meetings on the reauthorization of PDUFA. PDUFA authorizes FDA to collect user fees from the regulated industry for the process for the review of human drugs. The authorization for the current program (PDUFA V) expires in September 2017. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the human drug review process.
Section 736B(d) of the FD&C Act (21 U.S.C. 379h-2(d)) requires that FDA consult with a range of stakeholders, including representatives from patient and consumer groups, health care professionals, and scientific and academic experts, in developing recommendations for the next PDUFA program. FDA will initiate the reauthorization process by holding a public meeting on July 15, 2015, where stakeholders and other members of the public will be given an opportunity to
FDA is issuing this
If you intend to participate in continued periodic stakeholder consultation meetings regarding PDUFA reauthorization, please provide notification by email to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) granting special termination of the debarment of David J. Brancato. FDA bases this order on a finding that Dr. Brancato provided substantial assistance in the investigations or prosecutions of offenses relating to a matter under FDA's jurisdiction, and that special termination of Dr. Brancato's debarment serves the interest of justice and does not threaten the integrity of the drug approval process.
This order is effective July 20, 2015.
Comments should reference Docket No. FDA-1992-N-0199 and be sent to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Kenny Shade, Office of Regulatory Affairs, Food and Drug Administration, 12420 Parklawn Dr. (ELEM-4144), Rockville, MD 20857, 301-796-4640.
In a
Under section 306(d)(4)(C) and (d)(4)(D) of the FD&C Act, FDA may limit the period of debarment of a permanently debarred individual if the Agency finds that: (1) The debarred individual has provided substantial assistance in the investigation or prosecution of offenses described in section 306(a) or (b) of the FD&C Act or relating to a matter under FDA's jurisdiction; (2) termination of the debarment serves the interest of justice; and (3) termination of the debarment does not threaten the integrity of the drug approval process.
Special termination of debarment is discretionary with FDA. FDA generally considers a determination by the Department of Justice concerning the substantial assistance of a debarred individual conclusive in most cases. Dr. Brancato cooperated with the United States Attorney's Office in the investigation of several individuals, as substantiated by letters submitted to the Agency by Thomas Holland, a Special Agent in the Office of the Inspector General, U.S. Department of Health and Human Services, and the U.S. Attorney's Office for the District of Columbia. His cooperation contributed to the successful prosecution of these individuals, and in one instance continued over a period of 7 years. Accordingly, FDA finds that Dr. Brancato provided substantial assistance as required by section 306(d)(4)(C) of the FD&C Act.
The additional requisite showings,
The evidence presented to FDA in support of termination shows that Dr. Brancato was convicted for a first offense; that he has no prior or subsequent convictions for conduct described under the FD&C Act and has committed no other wrongful acts affecting the drug approval process; and that his character and scientific accomplishments are highly regarded by his professional peers. The evidence
Under section 306(d)(4)(D) of the FD&C Act, the period of debarment of an individual who qualifies for special termination may be limited to less than permanent but to no less than 1 year. Dr. Brancato's period of debarment, which commenced on January 6, 1994, has lasted more than 1 year. Accordingly, the Director of the Office of Enforcement and Import Operations, under section 306(d)(4) of the FD&C Act and under authority delegated to the Director (Staff Manual Guide 1410.35), finds that David J. Brancato's application for special termination of debarment should be granted, and that the period of debarment should terminate immediately, thereby allowing him to provide services in any capacity to a person with an approved or pending drug product application. The Director of Enforcement and Import Operations further finds that because the Agency is granting Dr. Brancato's application, an informal hearing under section 306(d)(4)(C) of the FD&C Act is unnecessary.
As a result of the foregoing findings, Dr. David J. Brancato's debarment is terminated effective (see
Food and Drug Administration, HHS.
Notice; extension of nomination period.
The Food and Drug Administration (FDA) is extending the nomination period for the notice that appeared in the
Submit either electronic or written nominations for the bulk drug substances list by November 16, 2015.
You may submit nominations by any of the following methods:
Submit electronic nominations in the following way:
•
Submit written nominations in the following ways:
•
Neal Bataller, Center for Veterinary Medicine, Food and Drug Administration (HFV-210), 7519 Standish Pl., Rockville, MD 20855, 240-402-5745,
In the
FDA has received a request for a 90-day extension of the nomination period as the requestor wanted more time to nominate drugs to the list and to provide supporting data. FDA has considered the request and is extending the nomination period for 90 days, until November 16, 2015. The FDA believes that a 90-day extension allows adequate time for interested persons to submit nominations without significantly delaying consideration of these nominations.
The process for nominations for bulk drug substances that may be used by facilities registered as outsourcing facilities under section 503B of the FD&C Act to compound animal drugs from bulk drug substances is described in the previous notice published May 19, 2015. FDA cannot guarantee that all drugs nominated during the nomination period will be considered for initial inclusion in Appendix A at the time of its initial publication. Nominations submitted during the nomination period (ending on November 16, 2015) that are not evaluated and included in Appendix A at the time of its initial publication will receive consideration for later addition to Appendix A. In addition, individuals and organizations may petition FDA, in accordance with 21 CFR 10.30, to make additional amendments to Appendix A after the nomination period.
Interested persons may submit either electronic nominations to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the products as long as they meet relevant legal and regulatory requirements.
Stacy Kane, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6207, Silver Spring, MD 20993-0002, 301-796-8363.
In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products approved under an ANDA procedure. ANDA sponsors must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDAs applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA).
The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products with Therapeutic Equivalence Evaluations,” which is generally known as the “Orange Book.” Under FDA regulations, a drug is removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness, or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).
Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved, (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved, and (3) when a person petitions for such a determination under 21 CFR 10.25(a) and 10.30. Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for safety or effectiveness reasons, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.
FDA has become aware that the drug products listed in the table are no longer being marketed. (As requested by the applicant, FDA withdrew approval of NDA 050448 for GRIFULVIN (griseofulvin) Oral Suspension in the
FDA has reviewed its records and, under § 314.161, has determined that the drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness. Accordingly, the Agency will continue to list the drug products listed in this document in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” identifies, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness.
Approved ANDAs that refer to the NDAs and ANDAs listed in this document are unaffected by the discontinued marketing of the products subject to those NDAs and ANDAs. Additional ANDAs that refer to these products may also be approved by the Agency if they comply with relevant legal and regulatory requirements. If FDA determines that labeling for these drug products should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a revised draft guidance for industry on lubiprostone capsules entitled “Bioequivalence Recommendations for Lubiprostone.” The recommendations provide specific guidance on the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs) for lubiprostone capsules.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comments 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 September 18, 2015.
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
Submit electronic comments on the draft guidance to
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
FDA initially approved new drug application (NDA) 021908 for AMITIZA capsules in January 2006. There are no approved ANDAs for this product. In August 2010, we issued a draft guidance for industry on BE recommendations for generic lubiprostone capsules. We are now issuing a revised draft guidance for industry on BE recommendations for generic lubiprostone capsules (“Bioequivalence Recommendations for Lubiprostone”).
In January 2014, Sucampo Pharma Americas, LLC, manufacturer of the reference listed drug, AMITIZA, submitted a citizen petition requesting that FDA revise the BE requirements for any new drug product that references AMITIZA and seeks approval by means of demonstrating BE to AMITIZA. FDA has reviewed the issues raised in the petition and is responding to the petition (Docket No. FDA-2014-P-0144).
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 Agency's current thinking on the design of BE studies to support ANDAs for lubiprostone capsules. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either electronic comments regarding this document to
Persons with access to the Internet may obtain the document at either
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 meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 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 meeting.
The meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Federal Emergency Management Agency, DHS.
Final Notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of August 3, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Effective date: June 16, 2015.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
The notice of a major disaster declaration for the State of Texas is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of May 29, 2015.
Dallas and Nueces Counties for Individual Assistance.
Cooke, Fannin, Grayson, Liberty, and Walker Counties for Individual Assistance (already designated for Public Assistance).
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Final notice.
Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below.
The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.
The effective date of August 17, 2015 which has been established for the FIRM and, where applicable, the supporting FIS report showing the new or modified flood hazard information for each community.
The FIRM, and if applicable, the FIS report containing the final flood hazard information for each community is available for inspection at the respective Community Map Repository address listed in the tables below and will be available online through the FEMA Map Service Center at
Luis Rodriguez, Chief, Engineering Management Branch, Federal Insurance and Mitigation Administration, FEMA, 500 C Street SW., Washington, DC 20472, (202) 646-4064, or (email)
The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the new or modified flood hazard information for each community listed. Notification of these changes has been published in newspapers of local circulation and 90 days have elapsed since that publication. The Deputy Associate Administrator for Mitigation has resolved any appeals resulting from this notification.
This final notice is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.
Interested lessees and owners of real property are encouraged to review the new or revised FIRM and FIS report available at the address cited below for each community or online through the FEMA Map Service Center at
The flood hazard determinations are made final in the watersheds and/or communities listed in the table below.
I. Non-watershed-based studies:
II. Watershed-based studies:
Federal Emergency Management Agency, DHS.
Notice.
This notice amends the notice of a major disaster declaration for the State of Texas (FEMA-4223-DR), dated May 29, 2015, and related determinations.
Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW., Washington, DC 20472, (202) 646-2833.
Notice is hereby given that the incident period for this disaster is closed effective June 19, 2015.
The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance—Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.
Federal Emergency Management Agency, DHS.
Committee Management; Notice of Federal Advisory Committee Meeting.
The Federal Emergency Management Agency (FEMA) Technical Mapping Advisory Council (TMAC) will meet in person on August 4-5, 2015, in Reston, VA. The meeting will be open to the public.
The TMAC will meet on Tuesday, August 4, 2015, from 8:00 a.m.-5:30 p.m., and Wednesday, August 5, 2015, from 8:00 a.m.-5:00 p.m., Eastern Daylight Savings Time (EDT). Please note that the meeting will close early if the TMAC has completed its business.
The meeting will be held in the auditorium of the United States Geological Survey (USGS) headquarters building located at 12201 Sunrise Valley Drive Reston, VA 20192. Members of the public who wish to attend the meeting must register in advance by sending an email to
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact the person listed in
To facilitate public participation, members of the public are invited to provide written comments on the issues to be considered by the TMAC, as listed in the
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A public comment period will be held on August 4, 2015, from 4:30 p.m. to 5:00 p.m. and again on August 5, 2015, from 3:30 to 4:00 p.m. Speakers are requested to limit their comments to no more than three minutes. The public comment period will not exceed 30 minutes. Please note that the public comment period may end before the time indicated, following the last call for comments. Contact the individual listed below to register as a speaker by close of business on Wednesday, July 29, 2015.
Mark Crowell, Designated Federal Officer for the TMAC, FEMA, 1800 South Bell Street Arlington, VA 22202, telephone (202) 646-3432, and email
Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. Appendix.
As required by the
The TMAC must also develop recommendations on how to ensure that flood insurance rate maps incorporate the best available climate science to assess flood risks and ensure that FEMA uses the best available methodology to consider the impact of the rise in sea level and future development on flood risk. The TMAC must collect these recommendations and present them to the FEMA Administrator in a future conditions risk assessment and modeling report.
Further, in accordance with the
On August 5, 2015, the TMAC members will continue to deliberate on draft narratives and recommendations concerning (1) the flood hazard mapping process and product, and (2) future conditions methods and considerations that will be incorporated in the two reports. In addition, the TMAC members will identify and coordinate next steps of the TMAC report development. A brief public comment period will take place during the meeting. The full agenda and related briefing materials will be posted for review by July 27, 2015 at
Fish and Wildlife Service, Interior.
Notice.
We, the U.S. Fish and Wildlife Service, invite the public to comment on the following applications to conduct certain activities with endangered species. With some exceptions, the Endangered Species Act (ESA) prohibits activities with listed species unless a Federal permit is issued that allows such activities. The ESA requires that we invite public comment before issuing these permits.
We must receive written data or comments on the applications at the address given below by August 19, 2015.
Documents and other information submitted with the applications are available for review, subject to the requirements of the Privacy Act and Freedom of Information Act, by any party who submits a written request for a copy of such documents to the following office within 30 days of the date of publication of this notice: U.S. Fish and Wildlife Service, 1875 Century Boulevard, Suite 200, Atlanta, GA 30345 (Attn: James Gruhala, Permit Coordinator).
James Gruhala, 10(a)(1)(A) Permit Coordinator, telephone 404-679-7097; facsimile 404-679-7081.
The public is invited to comment on the following applications for permits to conduct certain activities with endangered and threatened species under section 10(a)(1)(A) of the Endangered Species Act of 1973, as amended (16 U.S.C. 1531
If you wish to comment, you may submit comments by any one of the following methods. You may mail comments to the Fish and Wildlife Service's Regional Office (see
Before including your address, telephone number, email address, or other personal identifying information in your comments, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comments to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The applicant requests an amendment of his current permit to add the state of Georgia for permitted activities with the gray bat (
The applicant requests renewal of his current permit to take (rehabilitate, mark, transport, release, and euthanize) Kemp's ridley
The applicant requests a permit to take (capture, identify, release) Nashville crayfish (
The applicant requests a permit to take (live-trap and release) American burying beetles (
The applicant requests renewal of his current permit to take (euthanize) Kemp's ridley
The applicant requests a permit to take (capture, identify, release) 33 species of mussels for the purpose of conducting presence absence surveys in Alabama, Georgia, and Tennessee.
The applicant requests an amendment of her current permit to add the states of Indiana, Illinois, Virginia, and West Virginia for already permitted activities with Indiana (
The applicant requests a permit to take (capture, identify, tag, and release) Virginia big-eared (
Fish and Wildlife Service, Interior.
Receipt of application; request for comment.
We, the U.S. Fish and Wildlife Service (Service) announce receipt from the Nevada Department of Wildlife (NDOW) of an application for an enhancement of survival permit (permit) under the Endangered Species Act of 1973, as amended (ESA). The requested permit would authorize take of the relict leopard frog (RLF) resulting from certain land use and conservation activities, should the species be listed as endangered or threatened in the future. The permit application includes a proposed programmatic candidate conservation agreement with assurances (CCAA) between NDOW and the Service. The requested term of the proposed CCAA and permit is 30 years. In accordance with the requirements of the National Environmental Policy Act (NEPA), we have prepared a draft low-effect screening form supporting our determination that the proposed action qualifies as a categorical exclusion under NEPA. We are accepting comments on the permit application, proposed CCAA, and draft NEPA compliance documentation.
Written comments on the permit application, proposed programmatic CCAA, and draft NEPA compliance documentation must be received on or before August 19, 2015.
Jeri Krueger, Reno Fish and Wildlife Office, at the address or telephone number listed above under
You may obtain copies of the permit application, proposed CCAA, draft NEPA compliance documentation, and other related documents from the individual listed under
Enhancement of survival permits issued for CCAAs encourage non-Federal landowners to implement conservation measures for species that are, or are likely to become, candidates for Federal listing as endangered or threatened by assuring landowners they will not be subjected to increased property use restrictions if the covered species becomes listed in the future. Application requirements and issuance criteria for enhancement of survival permits issued for CCAAs are in the Code of Federal Regulations (CFR) at 50 CFR 17.22(d) and 17.32(d). The policy
The proposed RLF CCAA is a programmatic agreement between the Service and NDOW to further the conservation of the RLF on non-Federal lands or on lands under the management authority of a non-Federal entity. A RLF Conservation Agreement and Strategy (CAS) that directs the implementation of conservation actions on Federal land was completed and approved in 2005, and is being implemented by the RLF Conservation Team, which is comprised of representatives from the signatory agencies of the CAS. One of the primary goals of the CAS is to establish additional populations of RLF within its historic range to secure species persistence into the future. However, the CAS does not provide a mechanism to establish populations on non-Federal lands while providing regulatory assurances to the landowner in the event the species becomes listed in the future. The proposed programmatic CCAA would provide these assurances to non-Federal landowners, thus promoting opportunities to implement conservation actions and increase RLF distribution on non-Federal land.
Under the proposed RLF CCAA, NDOW would establish a program in which individual landowners would enroll their property. To enroll in the program, a landowner would enter into a cooperative agreement (CA) with NDOW that contains a site-specific management plan for the enrolled lands. NDOW would then issue the landowner a Certificate of Inclusion that would authorize a certain level of take of RLF under NDOW's permit as described in the CCAA and CA if the species becomes listed under the ESA in the future. The CA would specify conservation measures to address known threats to the RLF which may include, but are not limited to, translocation of RLF, fencing, deepening a tank or pool, removal of non-native aquatic predators, maintenance of suitable habitat conditions, enhancement of dispersal corridors, vegetation enhancement, and public education. The CA would also specify measures to minimize the incidental take of RLF that might occur as a result of implementing the conservation measures or conducting other land use activities.
NDOW seeks to enroll lands in Clark County, Nevada, that are associated with the Virgin, Muddy, and Colorado River drainages within or in close proximity to the historic range of the RLF, identified as the Potential Management Zone in the CAS and CCAA. The proposed CCAA would include properties that have existing, historic, or potentially suitable habitat for RLF. Such habitats may include reliable and protected water supplies and water quality, limited or controllable public access, accessibility for management actions and RLF translocations or removal, permanent ponds and/or wetland areas, natural springs, spring outflows or reaches of springbrooks and streams that represent suitable habitat for any or all life stages of RLF. An enrolled property may include all or some combination of suitable habitat types, or the potential to create those habitats.
As required by NEPA, we evaluated impacts to the human environment that would result from issuance of the requested permit, and we do not foresee any significant effects. Therefore, we are proposing to categorically exclude this action from further analysis under NEPA. Entering into a cooperative agreement is strictly a voluntary action for landowners, and the activities to be covered under the permit are generally activities already occurring on these properties.
We will evaluate the permit application, associated documents, and comments we receive to determine whether the permit application meets the requirements of the ESA, NEPA, and implementing regulations. If we determine that all requirements are met, we will sign the proposed CCAA and issue a permit under section 10(a)(1)(A) of the ESA to NDOW for take of RLF. We will not make our final decision until after the end of the 30-day public comment period, and we will fully consider all comments we receive during the public comment period.
All comments we receive become part of the public record. Requests for copies of comments will be handled in accordance with the Freedom of Information Act, NEPA, and Service and Department of Interior policies and procedures. Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us to withhold your personal identifying information from public review, we cannot guarantee we will be able to do so.
We provide this notice under section 10(c) of the Act (16 U.S.C. 1531
U.S. Geological Survey, Interior.
Notice of meeting.
Pursuant to Public Law 106-503, the National Earthquake Prediction Evaluation Council (NEPEC) will hold its next meeting at the Southern Methodist University in Dallas, Texas. The Committee is comprised of members from academia, industry, and State government. The Committee shall advise the Director of the U.S. Geological Survey (USGS) on matters relating to the USGS's participation in the National Earthquake Hazards Reduction Program.
At the meeting, the Council will receive briefings and updates on: The USGS's strategic plan for operational earthquake forecasting and outcomes of a user-needs workshop on that subject held in March 2015; on USGS work to calculate the probability of future earthquakes in areas of the U.S. subject to induced seismicity; on the estimation of aftershock probabilities and on new modeled estimates of earthquake likelihood along the Wasatch fault zone by a technical working group; and on development of a plan for rapid communication of earthquake information in the Cascadia region. The NEPEC will review USGS procedures for calculating and communicating aftershock probabilities following large earthquakes in areas outside of California and the application of these procedures following the M7.8 Gorkha, Nepal earthquake of April 2015. The council will also finalize a statement for public release summarizing the proper procedures for posing and testing earthquake predictions and forecasts.
Meetings of the National Earthquake Prediction Evaluation Council are open
September 2, 2015, commencing at 2:00 p.m. in Room 190 in the Crow Building on the SMU campus and adjourning at 6:00 p.m. September 3, 2015, commencing at 9:00 a.m. in Room 220 (Earnst & Young Gallery) in the Fincher Building on campus and adjourning at 5:00 p.m.
U.S. Geological Survey.
Notice of meeting.
Pursuant to Public Law 106-503, the Scientific Earthquake Studies Advisory Committee (SESAC) will hold its next meeting in the Southern California Earthquake Center (SCEC) Boardroom at the University of Southern California in Los Angeles, California. The Committee is comprised of members from academia, industry, and State government. The Committee shall advise the Director of the U.S. Geological Survey (USGS) on matters relating to the USGS's participation in the National Earthquake Hazards Reduction Program.
The Committee will receive reports on the status of activities of the Program and progress toward Program goals and objectives. The Committee will assess this information and provide guidance on the future undertakings and direction of the Earthquake Hazards Program. Focus topics for this meeting include a program review and strategic planning for 2016-2018.
Meetings of the Scientific Earthquake Studies Advisory Committee are open to the public.
January 28-29, 2015, commencing at 9 a.m. on the first day and adjourning at 5 p.m. on January 29, 2015.
Dr. William Leith, U.S. Geological Survey, MS 905, 12201 Sunrise Valley Drive, Reston, Virginia 20192, (703) 648-6786,
U.S. International Trade Commission.
Notice.
Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on June 17, 2015, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of Reynolds Presto Products Inc. of Appleton, Wisconsin. A supplement to the complaint was filed on July 8, 2015. The complaint alleges violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain resealable packages with slider devices by reason of infringement of certain claims of U.S. Patent Reexamination Certificate No. 6,427,421 C1 (“the '421 patent”); U.S. Patent No. 6,524,002 (“the '002 patent”); and U.S. Patent No. 7,311,443 (“the '443 patent”). The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337.
The complainant requests that the Commission institute an investigation and, after the investigation, issue a general exclusion order, or in the alternative, a limited exclusion order, and cease and desist orders.
The complaint, except for any confidential information contained therein, is 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., Room 112, Washington, DC 20436, telephone (202) 205-2000. Hearing impaired individuals are advised that information on this matter can be obtained by contacting the Commission's TDD terminal on (202) 205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at (202) 205-2000. General information concerning the Commission may also be obtained by accessing its internet server at
The Office of Unfair Import Investigations, U.S. International Trade Commission, telephone (202) 205-2560.
The authority for institution of this investigation is contained in section 337 of the Tariff Act of 1930, as amended, and in section 210.10 of the Commission's Rules of Practice and Procedure, 19 CFR 210.10 (2015).
(1) Pursuant to subsection (b) of section 337 of the Tariff Act of 1930, as amended, an investigation be instituted to determine whether there is a violation of subsection (a)(1)(B) of section 337 in the importation into the United States, the sale for importation, or the sale within the United States after importation of certain resealable packages with slider devices by reason of infringement of one or more of claim 39 of the '421 patent; claim 1 of the '002 patent; and claim 1 of the '443 patent, and whether an industry in the United States exists as required by subsection (a)(2) of section 337;
(2) For the purpose of the investigation so instituted, the following are hereby named as parties upon which this notice of investigation shall be served:
(a) The complainant is: Reynolds Presto Products Inc., 670 N. Perkins Street, Appleton, WI 54912.
(b) The respondents are the following entities alleged to be in violation of section 337, and are the parties upon which the complaint is to be served:
(c) The Office of Unfair Import Investigations, U.S. International Trade Commission, 500 E Street SW., Suite 401, Washington, DC 20436; and
(3) For the investigation so instituted, the Chief Administrative Law Judge, U.S. International Trade Commission, shall designate the presiding Administrative Law Judge.
Responses to the complaint and the notice of investigation must be submitted by the named respondents in accordance with section 210.13 of the Commission's Rules of Practice and Procedure, 19 CFR 210.13. Pursuant to 19 CFR 201.16(e) and 210.13(a), such responses will be considered by the Commission if received not later than 20 days after the date of service by the Commission of the complaint and the notice of investigation. Extensions of time for submitting responses to the complaint and the notice of investigation will not be granted unless good cause therefor is shown.
Failure of a respondent to file a timely response to each allegation in the complaint and in this notice may be deemed to constitute a waiver of the right to appear and contest the allegations of the complaint and this notice, and to authorize the administrative law judge and the Commission, without further notice to the respondent, to find the facts to be as alleged in the complaint and this notice and to enter an initial determination and a final determination containing such findings, and may result in the issuance of an exclusion order or a cease and desist order or both directed against the respondent.
By order of the Commission.
On July 15, 2015, the Department of Justice lodged a proposed Consent Decree with the United States District Court for the Northern District of Iowa in the lawsuit entitled
In this civil enforcement action under the federal Clean Air Act (“Act”), the United States alleges that Interstate Power and Light Company (“Defendant”), failed to comply with certain requirements of the Act intended to protect air quality at power plants in Iowa. The complaint seeks injunctive relief and civil penalties for violations of the Clean Air Act's Prevention of Significant Deterioration (“PSD”) provisions, 42 U.S.C. 7470-92, and various Clean Air Act implementing regulations. Specifically, the complaint alleges that Defendant failed to obtain appropriate permits and failed to install and operate required pollution control devices to reduce emissions of sulfur dioxide (“SO
The proposed Consent Decree would resolve violations for certain provisions of the Act at the Ottumwa and Lansing plants as well as Defendant's five other coal-fired power plants in Iowa: The Burlington, Dubuque, M.L. Kapp, Prairie Creek, and Sutherland plants. The proposed Consent Decree would require the Defendant to reduce harmful SO
The publication of this notice opens a period for public comment on the proposed 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 proposed Consent Decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $ 29.50 (25 cents per page reproduction cost) payable to the United States Treasury.
Executive Office for Immigration Review, Department of Justice.
30-Day notice.
The Department of Justice (DOJ), Executive Office for Immigration Review, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was previously published in the
Comments are encouraged and will be accepted for an additional 30 days until August 19, 2015.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Charles Adkins-Blanch, Acting General Counsel, Executive Office for Immigration Review, U.S. Department of Justice, Suite 2600, 5107 Leesburg Pike, Falls Church, Virginia 20530; telephone: (703) 305-0470. Written comments and/or suggestions can also be directed to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention Department of Justice Desk Officer, Washington, DC 20530 or sent to
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information
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If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Employment and Training Administration, Labor.
Notice.
This notice is to designate Certifying Officers to carry out functions under the Trade Adjustment Assistance (TAA) program under chapter 2 of title II of the Trade Act of 1974, as amended (19 U.S.C. 2271
Norris T. Tyler III, 202-693-3651.
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a. Jessica R. Webster, Program Analyst, Office of Trade Adjustment Assistance
b. Jacquelyn R. Mendelsohn, Program Analyst, Office of Trade Adjustment Assistance
c. Hope D. Kinglock, Program Analyst, Office of Trade Adjustment Assistance
d. DelMin A. Chen, Program Analyst, Office of Trade Adjustment Assistance
e. Norris T. Tyler III, Director, Office of Trade Adjustment Assistance
The foregoing officials are delegated authority and assigned responsibility, subject to the general direction and control of the Assistant Secretary and Deputy Assistant Secretaries of the Employment and Training Administration, and the Administrator of the Office of Trade Adjustment Assistance or the successor office, to carry out the duties and functions of Certifying Officers under 29 CFR part 90 and any succeeding regulations.
5.
This order rescinds ETO 1-11.
This Employment and Training Order No. 1-15 was signed by Portia Wu on 7/7/15.
Office of Labor-Management Standards, Department of Labor.
Notice.
This document extends the period for comments on the proposal, published on May 20, 2015 (80 FR 29096), to amend the information collection request 1245-0003, particularly the Form LM-2, LM-3, and LM-4 Labor Organization Annual Report instructions, to require filers of such reports to submit the reports electronically, and to modify the hardship exemption process for Form LM-2 filers. The comment period, which was to expire on July 20, 2015, is extended to August 19, 2015. A copy of the proposed information collection request can be obtained by contacting the office listed below in the addresses section of this Notice.
Written comments on the proposal to amend the information collection request 1245-0003, published on May 20, 2015 (80 FR 29096), must be submitted to the office listed in the addresses section below on or before August 19, 2015.
Andrew R. Davis, Chief of the Division of Interpretations and Standards, Office of Labor-Management Standards, U.S. Department of Labor, 200 Constitution Avenue NW., Room N-5609, Washington, DC 20210,
Please use only one method of transmission (mail or submission via
In the
Interested persons were invited to submit comments on or before July 20, 2015, 60 days after the publication of the original notice. A public commenter has requested a 30-day extension of time to submit comments. In response to these requests, the Department has decided to extend the comment period for an additional 30 days. Comments on the proposed information collection must be received on or before August 19, 2015. An extension of this duration is appropriate, because it will afford parties a meaningful opportunity to submit comments on the proposal without unduly delaying final action on the proposed regulation.
National Endowment for the Arts, National Foundation on the Arts and Humanities.
Notice of meetings.
Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that three meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference.
All meetings are Eastern time and ending times are approximate:
National Endowment for the Arts, Constitution Center, 400 7th St. SW., Washington, DC 20506.
Further information with reference to these meetings can be obtained from Ms. Kathy Plowitz-Worden, Office of Guidelines & Panel Operations, National Endowment for the Arts, Washington, DC 20506;
The closed portions of meetings are for the purpose of Panel review, discussion, evaluation, and recommendations on financial assistance under the National Foundation on the Arts and the Humanities Act of 1965, as amended, including information given in
The National Science Board's Committee on Strategy and Budget (CSB), pursuant to NSF regulations (45 CFR part 614), the National Science Foundation Act, as amended (42 U.S.C. 1862n-5), and the Government in the Sunshine Act (5 U.S.C. 552b), hereby gives notice of the scheduling of a teleconference for the transaction of National Science Board business, as follows:
Tuesday July 28, 2015 at 3:00-4:00 p.m. EDT.
Discussion of the NSF's FT 2017 budget development.
Closed.
This meeting will be held by teleconference. Please refer to the National Science Board Web site for additional information and schedule updates (time, place, subject matter or status of meeting), which may be found at
National Science Foundation.
Notice and request for comments.
Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501
Comments are invited on whether the proposed collection of information is necessary for the proper performance of the functions of the Foundation, including whether the information will have practical utility; the accuracy of the Foundation's estimate of the burden of the proposed collection of information; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information on those who are to respond, including through the use of automated collection techniques or other forms of information technology.
Written comments on this notice must be received by September 18, 2015, to be assured consideration. Comments received after that date will be considered to the extent practicable. Send comments to address below.
Ms. Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 1265, Arlington, Virginia 22230; telephone (703) 292-7556; or send email to
NSF provides nearly 20 percent of federal funding for basic research to academic institutions.
Community colleges prepare technicians who will become an integral part of research efforts and students who will continue their education at four-year institutions. Further, they play a significant role in the preparation of underrepresented groups in science. Community colleges have long recognized the importance of mentoring students and have a history of success in educating underrepresented students for successful careers in STEM. Thus, community colleges play an important role in workforce development in their states and local communities. Industry frequently looks to community colleges to provide an educated and technologically up-to-date workforce. The National Science Foundation's (NSF) thrust of incorporating research into the traditional teaching mission of the community college is a relatively new expansion of its mission. This challenge furthers NSF's mission by enabling students to discover and demonstrate their capacity to use science to make a difference in the world, and to transfer knowledge into action.
The Office of Legislative and Public Affairs (OLPA) requests of the Office of Management and Budget (OMB) an approval for an information collection intended to monitor outputs, short-term, intermediate and long term outcomes of OLPA's new Community College Innovation Challenge.
The survey questionnaire, individually tailored to measure outputs and outcomes for this initiative, will provide essential information for program monitoring purposes. Data collected by this collection will be used for program planning, management, and evaluation. A summary of monitoring data can be used to respond to queries from Congress, the public, NSF's external merit reviewers who serve as advisors, including Committees of Visitors (COVs), and NSF's Office of the Inspector General. These data are needed for effective administration, program and project monitoring, evaluation, and for measuring
This data collection effort will enable OLPA to longitudinally monitor outputs and outcomes given the unique goals and purpose of the CCIC. This is very important to enable appropriate and accurate evidence-based management of the program and to determine whether or not the specific goals of the program are being met.
Participants will be invited to submit this information via data collection methods that include but are not limited to online surveys, interviews, phone interviews, etc. The indicators are both quantitative and descriptive and may include number of students majoring in STEM disciplines or joining the STEM workforce, faculty expressions of mentoring ability for STEM careers, number of participants continuing to participate in innovation or entrepreneurship activities among other indicators.
Below is an example that shows how the hour burden was estimated for the monitoring system.
The estimated average number of annual respondents is 410, with an estimated annual response burden of 10.25 hours. For post-award monitoring systems, OLPA expects to collect data at 6 months 1, 3, and 8 years post-challenge, in order to have the best chance of capturing the more immediate outcomes expected by ~1 year post-challenge, intermediate outcomes at 3 years post-challenge, and long-term outcomes/impacts at 8 years post challenge. These four (4) data collections spread over the span of 10 years; this averages to 0.25 data collections/year. The community college population may transition relatively quickly to another school or to the workforce and we might expect a shorter and more condensed timeline of outcomes and impacts. Thus, we wish to collect data at 6 months and one year after the challenge, and then once annually at 3 and 8 years post-award.
The respondents are faculty mentors and community college students.
The overall annualized cost to the respondents is estimated to be $8,800. The following table shows the annualized estimate of costs to faculty mentor respondents, who are community college professors. This estimated hourly rate is based on a report from the American Association of University Professors, “Annual Report on the Economic Status of the Profession, 2014-15,”
Data collection involves all finalists and semifinalists in the challenge. The table below shows the total universe and sample size for the collections.
July 20, 27, August 3, 10, 17, 24, 2015.
Commissioners' Conference Room, 11555 Rockville Pike, Rockville, Maryland.
Public and Closed.
There are no meetings scheduled for the week of July 20, 2015.
There are no meetings scheduled for the week of July 27, 2015.
This meeting will be webcast live at the Web address—
This meeting will be webcast live at the Web address—
There are no meetings scheduled for the week of August 17, 2015.
There are no meetings scheduled for the week of August 24, 2015.
The schedule for Commission meetings is subject to change on short notice. For more information or to verify the status of meetings, contact Glenn Ellmers at 301-415-0442 or via email at
The NRC Commission Meeting Schedule can be found on the Internet at:
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Members of the public may request to receive this information electronically. If you would like to be added to the distribution, please contact the Nuclear Regulatory Commission, Office of the Secretary, Washington, DC 20555 (301-415-1969), or email
Nuclear Regulatory Commission.
License amendment application; opportunity to comment, request a hearing, and petition for leave to intervene; correction.
The U.S. Nuclear Regulatory Commission (NRC) is correcting a notice that was published in the
This correction is effective on July 20, 2015.
Please refer to Docket ID NRC-2008-0441 when contacting the NRC about the availability of information regarding this action. You may obtain publicly-available information related to this action using any of the following methods:
•
•
• 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.
Denise McGovern, Office of New Reactors, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-0681; email:
In the
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Partial site release; public meeting and request for comment.
The U.S. Nuclear Regulatory Commission (NRC) is considering a request from GE Hitachi Nuclear Energy to approve the release from their NRC power reactor licenses of a portion of their Vallecitos Nuclear Center property for unrestricted use. The NRC will approve or deny the request based on its review of the request and the result of an NRC confirmatory survey of the property proposed for release. Approval of the request would allow GE to sell the released portion of the property to a non-GE controlled entity. The NRC is requesting public comment on the contemplated action and invites stakeholders and interested persons to participate. The NRC plans to hold a public meeting to promote full understanding of the contemplated action and facilitate public comment.
Submit comments by October 5, 2015. Comments received after this date will be considered if it is practical to do so, but the Commission is able to ensure consideration only for comments received before this date. A public meeting will be held on July 22, 2015.
You may submit comments by any of the following methods (unless this document describes a different method for submitting comments on a specific subject):
•
•
For additional direction on obtaining information and submitting comments, see “Obtaining Information and Submitting Comments” in the
Jack D. Parrott, Senior Project Manager, Office of Nuclear Material Safety and Safeguards; telephone: 301-415-6634; email:
Please refer to Docket ID NRC-2015-0169 when contacting the NRC about the availability of information for this action. You may obtain publicly-available information related to this action by any of the following methods:
•
•
•
The U.S. Nuclear Regulatory Commission (NRC) has received, by letter dated April 24, 2015 (ADAMS Accession No. ML15114A437), a request from GE Hitachi Nuclear Energy (GE or licensee), to approve a partial site release of its Vallecitos Nuclear Center (VNC) site located at 6705 Vallecitos Rd, Sunol, California. The VNC site contains two facilities licensed as power reactors under part 50, “Domestic Licensing of Production and Utilization Facilities,” of Title 10 of the
The NRC will determine whether the licensee has adequately evaluated the effect of releasing the property per the requirements of 10 CFR 50.83(a)(1), and determine whether the licensee's classification of any released areas as “non-impacted” is adequately justified. If the NRC determines that the licensee's submittal is adequate, the NRC will inform the licensee in writing that the release is approved.
The NRC will conduct a public meeting to discuss GE's request for approval of the partial site release.
The meeting will be held on Wednesday, July 22, 2015, from 6:30 p.m. until 8:30 p.m., Pacific Daylight Time, at the Holiday Inn Dublin, 6680 Regional St., Dublin, CA 94568.
This is a Category 3 public meeting where stakeholders are invited to fully engage NRC staff to provide a range of views, information, concerns and suggestions with regard to regulatory issues concerning the proposed action. After the licensee and NRC staff presentation portions of the meeting, the public is allowed to speak and ask questions. Comments can be provided orally or in writing to the NRC staff present at the meeting.
The NRC provides reasonable accommodation to individuals with disabilities where appropriate. If you need a reasonable accommodation to participate in these public meetings, or need this meeting notice or the transcript or other information from the public meetings in another format (
Stakeholders should monitor the NRC's public meeting Web site for information about the public meeting at:
For the Nuclear Regulatory Commission.
Postal Regulatory Commission.
Notice.
The Commission is noticing a recent Postal Service filing concerning the addition of International Merchandise Return Service Agreements with Foreign Postal Operators Non-Published Rates to the competitive product list. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Submit comments electronically via the Commission's Filing Online system at
David A. Trissell, General Counsel, at 202-789-6820.
In accordance with 39 U.S.C. 3642 and 39 CFR 3020.30
To support its Request, the Postal Service filed an application for non-public treatment of materials filed under seal; a redacted copy of Governors' Decision No. 11-6, which authorizes the product; a set of maximum and minimum prices; a statement of supporting justification, as required by 39 CFR 3020.32; a copy of proposed mail classification schedule language; a copy of the IMRS-FPO model agreement; a certification of compliance with 39 U.S.C. 3633(a); a redacted copy of a related management analysis; and supporting financial workpapers.
In the attached statement of supporting justification, the Postal Service asserts the IMRS-FPO would close a gap in currently available postal product offerings and that the proposed product would generate new revenue and encourage growth in cross-border e-commerce via the postal channel.
The Commission establishes Docket Nos. MC2015-68 and CP2015-99 to consider the Request pertaining to the addition of IMRS-FPO to the competitive products list.
The Commission invites comments on whether the Postal Service's filings in the captioned dockets are consistent with the policies of 39 U.S.C. 3632, 3633, or 3642, 39 CFR part 3015, and 39 CFR part 3020, subpart B. Comments are due no later than July 21, 2015. The public portions of these filings can be accessed via the Commission's Web site (
The Commission appoints James F. Callow to serve as an officer of the Commission to represent the interests of the general public in these proceedings (Public Representative).
1. The Commission establishes Docket Nos. MC2015-68 and CP2015-99 to consider the matters raised in each docket.
2. Pursuant to 39 U.S.C. 505, James F. Callow is appointed to serve as Public Representative in these dockets.
3. Comments are due no later than July 21, 2015.
4. The Secretary shall arrange for publication of this order in the
By the Commission.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
Nasdaq proposes to list and trade the shares of the First Trust SSI Strategic Convertible Securities ETF (the “Fund”) of First Trust Exchange-Traded Fund IV (the “Trust”) under Nasdaq Rule 5735 (“Managed Fund Shares”).
In its filing with the Commission, Nasdaq included statements concerning the purpose of, and basis for, the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. Nasdaq has prepared summaries, set forth in Sections A, B, and C below, of the most significant aspects of such statements.
The Exchange proposes to list and trade the Shares of the Fund under Nasdaq Rule 5735, which governs the listing and trading of Managed Fund Shares
First Trust Advisors L.P. will be the investment adviser (“Adviser”) to the Fund. SSI Investment Management Inc. will serve as investment sub-adviser (“Sub-Adviser”) to the Fund and provide day-to-day portfolio management. First Trust Portfolios L.P. (the “Distributor”) will be the principal underwriter and distributor of the Fund's Shares. The Bank of New York Mellon Corporation (“BNY”) will act as the administrator, accounting agent, custodian and transfer agent to the Fund.
Paragraph (g) of Rule 5735 provides that if the investment adviser to the investment company issuing Managed Fund Shares is affiliated with a broker-dealer, such investment adviser shall erect a “fire wall” between the investment adviser and the broker-dealer with respect to access to information concerning the composition and/or changes to such investment company portfolio.
The investment objective of the Fund will be to seek total return. To achieve its objective, the Fund will invest, under normal market conditions,
Through its investment process, the Sub-Adviser will attempt to identify attractive Convertible Securities based on its positive view of the Underlying Security or its view of the company's potential for credit improvement. The Sub-Adviser will begin its investment process by evaluating a large universe of available Convertible Securities and screening for liquidity and convexity. Convexity is the ratio of upside move in the Convertible Security in conjunction with appreciation of the Underlying Security relative to the downside move in the Convertible Security in conjunction with depreciation of the Underlying Security. The screening process will rely on the Sub-Adviser's fundamental credit evaluation of the issuers. This credit analysis will allow the Sub-Adviser to attempt to identify the downside risk of the Convertible Security, assess the value of the embedded equity and understand the amount of participation expected with a change in the price of the Underlying Security. Once attractive Convertible Securities (
The Fund will invest in Convertible Securities of any credit quality, including unrated securities, and with effective or final maturities of any length. Convertible Securities may be issued by domestic or foreign entities.
The Fund will hold debt securities (including, in the aggregate, Convertible Securities and the debt securities described below) of at least 13 non-affiliated issuers.
The Fund may invest up to 20% of its net assets in short-term debt securities and other short-term debt instruments (described below), as well as cash equivalents, or it may hold cash. The percentage of the Fund invested in such holdings will vary and will depend on several factors, including market conditions.
Short-term debt instruments are issued by issuers having a long-term debt rating of at least A by Standard & Poor's Ratings Services (“S&P Ratings”), Moody's Investors Service, Inc. (“Moody's”) or Fitch Ratings (“Fitch”) and have a maturity of one year or less. The Fund may invest in the following short-term debt instruments: (1) Fixed rate and floating rate 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,
The Fund may invest up to 20% of its net assets in exchange-traded notes (“ETNs”).
The Fund may invest up to 20% of its net assets in exchange-listed equity securities (referred to collectively as “Equity Securities”).
The Fund may invest up to 20% of its net assets in exchange-listed equity index futures contracts, in exchange-listed and over-the-counter (“OTC”) index credit default swaps, and in forward foreign currency exchange contracts. The use of futures contracts may allow the Fund to obtain net long or short exposures to selected equity indexes. Index credit default swaps may be used to gain exposure to a basket of credit risk by “selling protection” against default or other credit events, or to hedge a broad market credit risk by “buying protection.” Forward foreign currency exchange contracts may be used to protect the value of the Fund's portfolio against uncertainty in the level of future currency exchange rates.
The Fund may not invest 25% or more of the value of its total assets in securities of issuers in any one industry. This restriction does not apply to (a) obligations issued or guaranteed by the U.S. government, its agencies or instrumentalities or (b) securities of other investment companies.
The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including Rule 144A securities deemed illiquid by the Adviser and/or the Sub-Adviser.
The Fund will issue and redeem Shares on a continuous basis at net asset value (“NAV”)
Creations and redemptions must be made by or through an Authorized Participant that has executed an agreement that has been agreed to by the Distributor and BNY with respect to creations and redemptions of Creation Units. All standard orders to create Creation Units must be received by the transfer agent no later than the closing time of the regular trading session on the NYSE (ordinarily 4:00 p.m., Eastern Time) (the “Closing Time”) in each case on the date such order is placed in order for the creation of Creation Units to be effected based on the NAV of Shares as next determined on such date after receipt of the order in proper form. Shares may be redeemed only in Creation Units at their NAV next determined after receipt not later than the Closing Time of a redemption request in proper form by the Fund through the transfer agent and only on a business day.
The Fund's custodian, through the National Securities Clearing Corporation, will make available on each business day, prior to the opening of business of the Exchange, the list of the names and quantities of the instruments comprising the Creation Basket, as well as the estimated Cash Component (if any), for that day. The published Creation Basket will apply until a new Creation Basket is announced on the following business day prior to commencement of trading in the Shares.
The Fund's NAV will be determined as of the close of regular trading on the NYSE on each day the NYSE is open for trading. If the NYSE closes early on a valuation day, the NAV will be determined as of that time. NAV per Share will be calculated for the Fund by taking the market price of the Fund's total assets, including interest or dividends accrued but not yet collected, less all liabilities, and dividing such amount by the total number of Shares outstanding. The result, rounded to the nearest cent, will be the NAV per Share. All valuations will be subject to review by the Trust Board or its delegate.
The Fund's investments will be valued daily at market value or, in the absence of market value with respect to any investments, at fair value. Market value prices represent last sale or official closing prices from a national or foreign exchange (
Certain securities, including in particular Convertible Securities, in which the Fund may invest will not be listed on any securities exchange or board of trade. Such securities will typically be bought and sold by institutional investors in individually negotiated private transactions that function in many respects like an OTC secondary market, although typically no formal market makers will exist. Certain securities, particularly debt securities, will have few or no trades, or trade infrequently, and information regarding a specific security may not be widely available or may be incomplete. Accordingly, determinations of the fair value of debt securities may be based on infrequent and dated information. Because there is less reliable, objective data available, elements of judgment may play a greater role in valuation of debt securities than for other types of securities.
The following investments will typically be fair valued using information provided by a Pricing Service or obtained from broker-dealer quotations: (a) Convertible Securities (including convertible notes, bonds and debentures; convertible preferred securities; mandatory convertible securities; contingent convertible securities; synthetic convertible securities; corporate bonds and preferred securities with attached warrants;
Short-Term Debt Instruments having a remaining maturity of 60 days or less when purchased will typically be valued at cost adjusted for amortization of premiums and accretion of discounts, provided the Pricing Committee has determined that the use of amortized cost is an appropriate reflection of fair value given market and issuer-specific conditions existing at the time of the determination.
Repurchase agreements will typically be fair valued as follows: Overnight repurchase agreements will be fair valued at cost. Term repurchase agreements (
Common stocks and other equity securities (including Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities), as well as ETNs, listed on any exchange other than the Exchange and the London Stock Exchange Alternative Investment Market (“AIM”) will typically be valued at the last sale price on the exchange on which they are principally traded on the business day as of which such value is being determined. Such equity securities and ETNs listed on the Exchange or the AIM will typically be valued at the official closing price on the business day as of which such value is being determined. If there has been no sale on such day, or no official closing price in the case of securities traded on the Exchange or the AIM, such equity securities and ETNs will typically be valued using fair value pricing. Such equity securities and ETNs traded on more than one securities exchange will be valued at the last sale price or official closing price, as applicable, on the business day as of which such value is being determined at the close of the exchange representing the principal market for such securities.
Exchange-Listed Convertible Securities, exchange-listed equity index futures contracts and exchange-listed index credit default swaps will typically be valued at the closing price in the market where such instruments are principally traded. If no official closing price is available, such instruments will be fair valued at the mean of their most recent bid and asked price on the exchange on which they are principally traded, if available, and otherwise at their closing bid price.
Forward foreign currency exchange contracts will typically be fair valued at the current day's interpolated foreign exchange rate, as calculated using the current day's spot rate, and the thirty, sixty, ninety and one-hundred-eighty day forward rates provided by a Pricing Service or by certain independent dealers in such contracts.
Because foreign exchanges may be open on different days than the days during which an investor may purchase or sell Shares, the value of the Fund's assets may change on days when investors are not able to purchase or sell Shares. Assets denominated in foreign currencies will be translated into U.S. dollars at the exchange rate of such currencies against the U.S. dollar as provided by a Pricing Service. The value of assets denominated in foreign currencies will be converted into U.S. dollars at the exchange rates in effect at the time of valuation.
Valuing the Fund's assets using fair value pricing can result in using prices for those assets (particularly assets that trade in foreign markets) that may differ from current market valuations.
The Fund's Web site (
In addition, for the Fund, an estimated value, defined in Rule 5735(c)(3) as the “Intraday Indicative Value,” that reflects an estimated intraday value of the Fund's Disclosed Portfolio, will be disseminated. Moreover, the Intraday Indicative Value, available on the NASDAQ OMX Information LLC proprietary index data service,
The dissemination of the Intraday Indicative Value, together with the Disclosed Portfolio, will allow investors to determine the value of the underlying portfolio of the Fund on a daily basis and will provide a close estimate of that value throughout the trading day.
Investors will also be able to obtain the Fund's Statement of Additional Information (“SAI”), the Fund's annual and semi-annual reports (together, “Shareholder Reports”), and its Form N-CSR and Form N-SAR, filed twice a year. The Fund's SAI and Shareholder Reports will be available free upon request from the Fund, and those documents and the Form N-CSR and Form N-SAR may be viewed on-screen or downloaded from the Commission's Web site at
Additional information regarding the Fund and the Shares, including investment strategies, risks, creation and redemption procedures, fees, Fund holdings disclosure policies, distributions and taxes will be included in the Registration Statement.
The Shares will be subject to Rule 5735, which sets forth the initial and continued listing criteria applicable to Managed Fund Shares. The Exchange represents that, for initial and/or continued listing, the Fund must be in compliance with Rule 10A-3
With respect to trading halts, the Exchange may consider all relevant factors in exercising its discretion to halt or suspend trading in the Shares of the Fund. Nasdaq will halt trading in the Shares under the conditions specified in Nasdaq Rules 4120 and 4121, including the trading pauses under Nasdaq Rules 4120(a)(11) and (12). Trading may be halted because of market conditions or for reasons that, in the view of the Exchange, make trading in the Shares inadvisable. These may include: (1) The extent to which trading is not occurring in the securities and/or the other assets constituting the Disclosed Portfolio of the Fund; or (2) whether other unusual conditions or circumstances detrimental to the maintenance of a fair and orderly market are present. Trading in the Shares also will be subject to Rule 5735(d)(2)(D), which sets forth circumstances under which Shares of the Fund may be halted.
Nasdaq deems the Shares to be equity securities, thus rendering trading in the Shares subject to Nasdaq's existing rules governing the trading of equity securities. Nasdaq will allow trading in the Shares from 4:00 a.m. until 8:00 p.m., Eastern Time. The Exchange has appropriate rules to facilitate transactions in the Shares during all trading sessions. As provided in Nasdaq Rule 5735(b)(3), the minimum price variation for quoting and entry of orders in Managed Fund Shares traded on the Exchange is $0.01.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also the Financial Industry Regulatory Authority (“FINRA”) on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
The surveillances referred to above generally focus on detecting securities trading outside their normal patterns, which could be indicative of manipulative or other violative activity. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations.
FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund (including Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps) with other markets and other entities that are members of the Intermarket Surveillance Group (“ISG”),
At least 90% of the Fund's net assets that are invested in Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps (in the aggregate) will be invested in investments that trade in markets that are members of ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange. Further, at least 90% of the Underlying Securities corresponding to the pre-conversion Convertible Securities held by the Fund (measured by par value) will trade in markets that are members of ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange.
In addition, the Exchange also has a general policy prohibiting the distribution of material, non-public information by its employees.
Prior to the commencement of trading, the Exchange will inform its members in an Information Circular of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (1) The procedures for purchases and redemptions of Shares in Creation Units (and that Shares are not individually redeemable); (2) Nasdaq Rule 2111A, which imposes suitability obligations on Nasdaq members with respect to recommending transactions in the Shares to customers; (3) how information regarding the Intraday Indicative Value and the Disclosed Portfolio is disseminated; (4) the risks involved in trading the Shares during the Pre-Market and Post-Market Sessions when an updated Intraday Indicative Value will not be calculated or publicly disseminated; (5) the requirement that members deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (6) trading information. The Information Circular will also discuss any exemptive, no-action and interpretive relief granted by the Commission from any rules under the Act.
Additionally, the Information Circular will reference that the Fund is subject to various fees and expenses described in the Registration Statement. The Information Circular will also disclose the trading hours of the Shares of the Fund and the applicable NAV Calculation Time for the Shares. The Information Circular will disclose that information about the Shares of the Fund will be publicly available on the Fund's Web site.
Nasdaq believes that the proposal is consistent with Section 6(b) of the Act in general and Section 6(b)(5) of the Act in particular in that it is designed to prevent fraudulent and manipulative acts and practices, to promote just and equitable principles of trade, to foster cooperation and coordination with persons engaged in facilitating transactions in securities, and to remove impediments to and perfect the mechanism of a free and open market and, in general, to protect investors and the public interest.
The Exchange believes that the proposed rule change is designed to prevent fraudulent and manipulative acts and practices in that the Shares will be listed and traded on the Exchange pursuant to the initial and continued listing criteria in Nasdaq Rule 5735. The Exchange represents that trading in the Shares will be subject to the existing trading surveillances, administered by both Nasdaq and also FINRA on behalf of the Exchange, which are designed to detect violations of Exchange rules and applicable federal securities laws.
Neither the Adviser nor the Sub-Adviser is a broker-dealer, although the Adviser is affiliated with the Distributor, a broker-dealer. The Sub-Adviser is not affiliated with a broker-dealer. The Adviser has implemented a fire wall with respect to its broker-dealer affiliate regarding access to information concerning the composition and/or changes to the portfolio. In addition, paragraph (g) of Nasdaq Rule 5735 further requires that personnel of the Adviser who make decisions on the open-end fund's portfolio composition must be subject to procedures designed to prevent the use and dissemination of material non-public information regarding the open-end fund's portfolio.
FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund (including Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps) with other markets and other entities that are members of ISG, and FINRA may obtain trading information regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement. Moreover, FINRA, on behalf of the Exchange, will be able to access, as needed, trade information for certain fixed income securities held by the Fund reported to FINRA's TRACE.
At least 90% of the Fund's net assets that are invested in Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps (in the aggregate) will be invested in investments that trade in markets that are members of ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange. Further, at least 90% of the Underlying Securities corresponding to the pre-conversion Convertible Securities held by the Fund (measured by par value) will trade in markets that are members of ISG or are parties to a comprehensive surveillance sharing agreement with the Exchange.
The investment objective of the Fund will be to seek total return. To achieve its objective, the Fund will invest, under normal market conditions, at least 80% of its net assets (including investment borrowings) in a portfolio of Convertible Securities. The Fund may invest up to 20% of its net assets in exchange-listed equity index futures contracts, in exchange-listed and OTC index credit default swaps, and in forward foreign currency exchange contracts. The Fund's investments in derivative instruments will be consistent with the Fund's investment objective and the 1940 Act and will not be used to seek to achieve a multiple or inverse multiple of an index. The Fund may hold up to an aggregate amount of 15% of its net assets in illiquid assets (calculated at the time of investment), including Rule 144A securities deemed illiquid by the Adviser and/or the Sub-Adviser. The Fund will monitor its portfolio liquidity on an ongoing basis to determine whether, in light of current circumstances, an adequate level of liquidity is being maintained, and will consider taking appropriate steps in order to maintain adequate liquidity if, through a change in values, net assets, or other circumstances, more than 15% of the Fund's net assets are held in illiquid assets. Illiquid assets include securities subject to contractual or other restrictions on resale and other instruments that lack readily available markets as determined in accordance with Commission staff guidance.
The proposed rule change is designed to promote just and equitable principles of trade and to protect investors and the public interest in that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. In addition, a large amount of information will be publicly available regarding the Fund and the Shares, thereby promoting market transparency. Moreover, the Intraday Indicative Value, available on the NASDAQ OMX Information LLC proprietary index data service, will be widely disseminated by one or more major market data vendors and broadly displayed at least every 15 seconds during the Regular Market Session. On each business day, before commencement of trading in Shares in the Regular Market Session on the Exchange, the Fund will disclose on its Web site the Disclosed Portfolio that will form the basis for the Fund's calculation of NAV at the end of the business day. Information regarding market price and trading volume of the Shares will be continually available on a real-time basis throughout the day on brokers' computer screens and other electronic services, and quotation and last sale information for the Shares will be available via Nasdaq proprietary quote and trade services, as well as in accordance with the Unlisted Trading Privileges and the CTA plans for the Shares. Quotation and last sale information for U.S. exchange-listed equity securities will be available from the exchanges on which they are traded as well as in accordance with any applicable CTA plans. Pricing information for Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps will be available from the applicable listing exchange and from major market data vendors. Pricing information for OTC Convertible Securities (including convertible notes, bonds and debentures; convertible preferred securities; mandatory convertible securities; contingent convertible securities; synthetic convertible securities; corporate bonds and preferred securities with attached warrants; and convertible Rule 144A securities); Short-Term Debt Instruments (including short-term U.S. government securities, commercial paper, bankers' acceptances and short-term corporate debt obligations, all as set forth under “Other Investments of the Fund”); repurchase agreements; OTC index credit default swaps; and forward foreign currency exchange contracts will be available from major broker-dealer firms and/or major market data vendors and/or Pricing Services.
The Fund's Web site will include a form of the prospectus for the Fund and additional data relating to NAV and other applicable quantitative information. Trading in Shares of the Fund will be halted under the
The Fund's investments will be valued daily at market value or, in the absence of market value with respect to any investments, at fair value. Market value prices represent last sale or official closing prices from a national or foreign exchange (
The proposed rule change is designed to perfect the mechanism of a free and open market and, in general, to protect investors and the public interest in that it will facilitate the listing and trading of an additional type of actively-managed exchange-traded product that will enhance competition among market participants, to the benefit of investors and the marketplace. As noted above, FINRA, on behalf of the Exchange, will communicate as needed regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund (including Exchange-Listed Convertible Securities; ETNs; Depositary Receipts, BDCs, Post-Conversion Underlying Securities, and other Equity Securities; exchange-listed equity index futures contracts; and exchange-listed index credit default swaps) with other markets and other entities that are members of ISG, and FINRA may obtain trading information regarding trading in the Shares and the exchange-traded securities and instruments held by the Fund from such markets and other entities. In addition, the Exchange may obtain information regarding trading in the Shares and in the exchange-traded securities and instruments held by the Fund from markets and other entities that are members of ISG, which includes securities and futures exchanges, or with which the Exchange has in place a comprehensive surveillance sharing agreement. Furthermore, as noted above, investors will have ready access to information regarding the Fund's holdings, the Intraday Indicative Value, the Disclosed Portfolio, and quotation and last sale information for the Shares.
For the above reasons, Nasdaq believes the proposed rule change is consistent with the requirements of Section 6(b)(5) of the Act.
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act. The Exchange believes that the proposed rule change will facilitate the listing and trading of an additional type of actively-managed exchange-traded fund that will enhance competition among market participants, to the benefit of investors and the marketplace.
Written comments were neither solicited nor 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
SR-NASDAQ-2015-075 on the subject line.
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, Station Place, 100 F Street NE., Washington, DC 20549.
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 a proposal to amend Exchange Rules 307 and 309 to extend the pilot program that eliminates the position and exercise limits for physically-settled options on the SPDR S&P 500 ETF Trust (“SPY Pilot Program”).
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 307, Commentary .01, Position Limits, and Exchange Rule 309, Commentary .01, Exercise limits, to extend the duration of the SPY Pilot Program through July 12, 2016. There are no substantive changes being proposed to the SPY Pilot Program. In proposing to extend the SPY Pilot Program, the Exchange affirms its consideration of several factors that support the proposal to establish the SPY Pilot Program, which include: (1) The liquidity of the option and the underlying security; (2) the market capitalization of the underlying security and the securities that make up the S&P 500 Index; (3) options reporting requirements; and (4) financial requirements imposed by MIAX and the Commission.
The Exchange notes that it is not aware of any problems created by the current SPY Pilot Program and does not foresee any problems with the proposed extension. The Exchange formally submitted a Pilot Report for the SPY Pilot Program as part of this filing. In addition, the Exchange represents that if it chooses to extend or seek permanent approval of the SPY Pilot Program, the Exchange will submit another Pilot Report at least thirty (30) days prior to the expiration of the extended SPY Pilot Program time period which would cover the period between reports. The Pilot Report will compare the impact of the pilot program, if any, on the volumes of SPY options and the volatility in the price of the underlying SPY contract, particularly at expiration. The Pilot Report also will detail the size and different types of strategies employed with respect to positions established in SPY options; note whether any problems, in the underlying SPY ETF or otherwise, arose as a result of the no-limit approach; and include any other information that may be useful in evaluating the effectiveness of the pilot program. In preparing the Pilot Report, the Exchange will utilize various data elements such as volume and open interest. In addition the Exchange would make available to Commission staff data elements relating to the effectiveness of the SPY Pilot Program.
The Exchange purposes [sic] to extend the SPY Pilot Program in order for the Exchange and the Commission to have additional time to evaluate the Pilot and its effect on the market and to determine whether to seek permanent approval. Prior to the expiration of the SPY Pilot Program and based upon the findings of the Pilot Report, the Exchange will be able to either extend the SPY Pilot Program, adopt the SPY Pilot Program on a permanent basis, or terminate the SPY Pilot Program. If the SPY Pilot Program is not extended or adopted on a permanent basis by the expiration of the Extended Pilot, the position limits for SPY would revert to limits in effect prior to the commencement of the SPY Pilot Program.
MIAX believes that its proposed rule change is consistent with Section 6(b) of the Act
Specifically, the Exchange believes that extending the SPY Pilot Program promotes just and equitable principles of trade by permitting market participants, including market makers, institutional investors and retail investors, to establish greater positions when pursuing their investment goals and needs. The Exchange also believes that economically equivalent products should be treated in an equivalent manner so as to avoid regulatory arbitrage, especially with respect to position limits. Treating SPY and SPX options differently by virtue of imposing different position limits is inconsistent with the notion of promoting just and equitable principles of trade and removing impediments to perfect the mechanisms of a free and open market. At the same time, the Exchange believes that the elimination of position limits for SPY options would not increase market volatility or facilitate the ability to manipulate the market.
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 is not designed to address any aspect of competition,
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 and Rule 19b-4(f)(6) thereunder.
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 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.
Securities and Exchange Commission (“Commission”).
Notice of application for an exemptive order under Section 206A of the Investment Advisers Act of 1940 (the “Advisers Act”) and Rule 206(4)-5(e) thereunder.
Crescent Capital Group, LP (“Applicant”).
Exemption requested under Section 206A of the Advisers Act and Rule 206(4)-5(e) thereunder from Rule 206(4)-5(a)(1) under the Advisers Act.
Applicant requests that the Commission issue an order under Section 206A of the Advisers Act and Rule 206(4)-5(e) thereunder exempting Applicant from Rule 206(4)-5(a)(1) under the Advisers Act to permit Applicant to receive compensation from a government entity client for investment advisory services provided to the government entity within the two-year period following a contribution by a covered associate of Applicant to an official of the government entity.
The application was filed on October 31, 2013, and an amended and restated application was filed on March 12, 2015.
An order granting the application will be issued unless the Commission orders a hearing. Interested persons may request a hearing by writing to the Commission's Secretary and serving Applicant with a copy of the request, personally or by mail. Hearing requests should be received by the Commission by 5:30 p.m. on August 10, 2015, and should be accompanied by proof of
Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicant, Crescent Capital Group, LP, c/o George Hawley, Esq., 1100 Santa Monica Boulevard, Suite 2000, Los Angeles, CA 90025.
Kyle R. Ahlgren, Senior Counsel, or Holly L. Hunter-Ceci, Branch Chief, at (202) 551-6825 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site either at
1. Applicant is registered with the Commission as an investment adviser under the Advisers Act. Applicant provides investment advisory services to two private equity funds formed in 2006 and 2008, TCW/Crescent Mezzanine Partners IV, L.P. (“Fund IV”) and TCW/Crescent Mezzanine Partners V, L.P. (“Fund V”, and together with Fund IV, the “Funds”), as well as additional funds. The Funds are “covered investment pools” as defined in Rule 206(4)-5(f)(3)(ii) under the Advisers Act that make long-term investments in private companies and other illiquid assets.
2. Mr. Jean Marc Chapus (the “Contributor”) is a managing partner of Applicant. The Contributor is, and was at all relevant times, a “covered associate” of Applicant as that term is defined in Rule 206(4)-5(f)(2). The Contributor frequently has been solicited for, and has made, political contributions in the past.
3. The Los Angeles City Employees' Retirement System (the “Plan”) falls within the definition of a “government entity” as that term is defined in Rule 206(4)-5(f)(5)(iii). The Plan invested in the Funds in 2006 and 2008, (for Fund IV and Fund V, respectively) and each Fund has been closed to new investors since that time. Under the terms of the governing documents of the Funds, investors, including the Plan, are not permitted to withdraw their investments, except under extraordinary circumstances that are beyond the control of either Applicant or the Plan, for a period of ten years following the date of the investment (2016 or 2018 for Fund IV and Fund V, respectively). Applicant's fees were established at the inception of the Funds and are not subject to renegotiation during the term of the investment.
4. In June 2011, an individual known to the Contributor, but unrelated to Applicant, contacted him directly and requested a contribution to the campaign of Mr. Austin Beutner (the “Recipient”), a candidate for the office of Mayor of Los Angeles (the “Office”). The Office is entitled to appoint members of the Plan's Board of Administration who can influence the selection of investment advisers for the Plan and other related public pension plans. On June 10, 2011, the Contributor made a contribution of $1,000 (the “Contribution”) to the Austin Beutner for Los Angeles Mayor 2013 Exploratory Committee (the “Committee”). At the time of the Contribution, each of the Committee and the Recipient was an “official” for purposes of Rule 206(4)-5(f)(6). The Recipient withdrew from the campaign prior to the election.
5. At the time of the Contribution, there was no discussion of the Office's appointment powers, influence or responsibilities involving any investment of public pension funds. Neither Applicant nor the Contributor sought to interfere with the Plan's merit-based selection process for advisory services, nor did they seek to negotiate higher fees or greater ancillary benefits than would be achieved in an arm's length transactions, nor could they have, as the selections pre-dated the Contribution. Applicant had an existing relationship with the Plan at the time of the Contribution, but did not engage in any new sales efforts involving limited partnership interests in the Funds, including any efforts designed to retain the investments in the Funds or to renegotiate its fees.
6. Applicant first became aware of the Contribution one month following the date it was made when, in July 2011, as a result of a quarterly survey of political contributions conducted by Applicant's compliance department pursuant to Applicant's contribution policies and procedures, the Contribution was self-reported by the Contributor. Upon learning of the Contribution, Applicant's chief compliance officer, with the cooperation of the Contributor, promptly contacted the Committee, which returned the Contribution shortly thereafter. At the same time, Applicant created an escrow account to custody advisory fees for the Funds that were attributable to the Plan. The fees that Applicant otherwise would have earned during the two-year period following the Contribution (the “Time Out Period”) remain in the escrow account.
7. At the time of the Contribution, Applicant had developed written policies and procedures to assure compliance with Rule 206(4)-5. The policies and procedures included a requirement for pre-clearance of all political contributions and provided for quarterly surveys of all covered associates. Such policies and procedures were designed, among other things, to assure that any unreported political contributions were detected by Applicant's compliance department in a timely fashion.
8. At the time of the Contribution, communication from the Committee, as well as the Committee's Web site and other published information, referred consistently to its “exploratory” nature.
9. Subsequent to the Contribution, Applicant has enhanced its training program by stressing the importance of its pre-clearance requirement and has highlighted the fact that contributions to exploratory and other political committees are subject to its pre-clearance requirement, among other things.
1. Rule 206(4)-5(a)(1) under the Advisers Act prohibits a registered investment adviser from providing investment advisory services for compensation to a government entity within two years after a contribution to an official of the government entity is made by the investment adviser or any covered associate of the investment adviser. The Plan is a “government entity,” as defined in Rule 206(4)-5(f)(5), the Contributor is a “covered associate” as defined in Rule 206(4)-5(f)(2), and each of the Committee and the Recipient is an “official” as defined
2. Section 206A of the Advisers Act grants the Commission the authority to “conditionally or unconditionally exempt any person or transaction . . . from any provision or provisions of [the Advisers Act] or of any rule or regulation thereunder, if and to the extent that such exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of [the Advisers Act].”
3. Rule 206(4)-5(e) provides that the Commission may exempt an investment adviser from the prohibition under Rule 206(4)-5(a)(1) upon consideration of the factors listed below, among others:
(1) Whether the exemption is necessary or appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Advisers Act;
(2) Whether the investment adviser: (i) Before the contribution resulting in the prohibition was made, adopted and implemented policies and procedures reasonably designed to prevent violations of the rule; and (ii) prior to or at the time the contribution which resulted in such prohibition was made, had no actual knowledge of the contribution; and (iii) after learning of the contribution: (A) Has taken all available steps to cause the contributor involved in making the contribution which resulted in such prohibition to obtain a return of the contribution; and (B) has taken such other remedial or preventive measures as may be appropriate under the circumstances;
(3) Whether, at the time of the contribution, the contributor was a covered associate or otherwise an employee of the investment adviser, or was seeking such employment;
(4) The timing and amount of the contribution which resulted in the prohibition;
(5) The nature of the election (
(6) The contributor's apparent intent or motive in making the contribution which resulted in the prohibition, as evidenced by the facts and circumstances surrounding such contribution.
4. Applicant requests an order pursuant to Section 206A and Rule 206(4)-5(e), exempting it from the two-year prohibition on compensation imposed by Rule 206(4)-5(a)(1) with respect to investment advisory services provided to the Funds within the two-year period following the Contribution.
5. Applicant submits that the exemption is necessary and appropriate in the public interest and consistent with the protection of investors and the purposes fairly intended by the policy and provisions of the Act. Applicant further submits that the other factors set forth in Rule 206(4)-5 similarly weigh in favor of granting an exemption to Applicant to avoid consequences disproportionate to the violation.
6. Applicant states that the Plan first determined to invest in the Funds before the Contribution was made, and established and maintained its relationships with Applicant on an arm's length basis free from any improper influence as a result of the Contribution. Applicant notes that: (i) The Plan's most recent investment decision was made in 2008, prior to the Contribution, at the time of its last investment commitment in Fund V; and (ii) due to the committed nature of the Plan's investment in the Funds, the Plan had no investment decision to consider at the time of the Contribution.
7. Applicant states that it had developed policies and procedures to assure compliance with Rule 206(4)-5, which included a requirement for pre-clearance of all political contributions and provided for quarterly surveys of all covered associates, and that such quarterly survey prompted the Contributor to report the Contribution. Applicant further states that training was provided to Applicant's employees, including the Contributor, that addressed Rule 206(4)-5 and Applicant's policies and procedures.
8. Applicant states that at no time did any employees of Applicant, other than the Contributor, have any knowledge that the Contribution had been made prior to its disclosure by the Contributor in July 2011.
9. Applicant states that once the Contribution was discovered, Applicant began to gather additional facts about the Contribution and the Committee, and fees attributable to the Plan's investment in the Funds were placed in escrow. Applicant further states that after learning of the Contribution, Applicant took steps to limit the Contributor's contact with any representative of the Plan or related plans for the duration of the Time Out Period, and that the Contributor had no contact with any representative of the Plan or related plans during the Time Out Period.
10. Applicant states that the Contribution was made solely for the purpose of participating in the local election process, and was not intended to improperly influence any decision by the Plan. Applicant notes that the Contributor resides in the community in which the Recipient was running for office and that the Contributor was entitled to vote in the election. Applicant further states that the Contributor has a history of making political contributions to candidates for elected office.
11. Applicant states that Applicant had an existing relationship with the Plan at the time of the Contribution, but did not engage in any new sales efforts involving limited partnership interests in the Funds, including any efforts designed to retain the investments in the Funds or to renegotiate its fees.
12. Applicant contends that imposing a limitation on the receipt of advisory compensation associated with the Plan's investment in the Funds would result in a disproportionate consequence to Applicant that is not necessary to achieve the intended purposes of Rule 206(4)-5. Applicant states that neither Applicant nor the Contributor sought to interfere with the Plan's merit-based selection process for advisory services, nor did they seek to negotiate higher fees or greater ancillary benefits than would be achieved in an arm's length transactions, nor could they have, as the selections pre-dated the Contribution. Applicant further states that there was no violation of Applicant's fiduciary duty to deal fairly or disclose material conflicts of interest given the absence of any intent or action by Applicant or the Contributor to influence the selection process.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to amend the NYSE Arca Equities Schedule of Fees and Charges for Exchange Services (“Fee Schedule”) to (i) raise the fee for Market and Auction-Only Orders executed in an Opening, Market Order or Trading Halt Auction; (ii) modify the credits the Exchange provides for routing certain orders to the New York Stock Exchange LLC (“NYSE”); and (iii) revise the Tape B Step Up Tier. The Exchange proposes to implement the changes on July 1, 2015.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
The Exchange proposes to amend the Fee Schedule to (i) raise the Tier 1 and Tier 2 fee for Market and Auction-Only Orders executed in an Opening, Market Order or Trading Halt Auction and make corresponding changes in the Basic Rate pricing; (ii) modify the Tier 1 and Tier 2 credits the Exchange provides for routing certain orders to the NYSE and make corresponding changes in the Basic Rate pricing; and (iii) revise the Tape B Step Up Tier. The Exchange proposes to implement the fee changes on July 1, 2015.
For Tier 1 and Tier 2, the Exchange currently charges $0.0010 per share for Market and Auction-Only Orders executed in an Opening, Market Order or Trading Halt Auction with a cap of $20,000 per month per Equity Trading Permit ID. The Exchange proposes to raise this fee from $0.0010 to $0.0015 per share. The Exchange is not proposing any change to the cap.
The Exchange proposes to make corresponding changes to the Basic Rate pricing section of the Fee Schedule. Specifically, in the Basic Rate pricing section, the current fee for Market and Auction-Only Orders executed in an Opening, Market Order or Trading Halt Auction is $0.0010 per share, with a cap of $20,000 per month per Equity Trading Permit ID. The Exchange proposes to raise this fee to $0.0015 per share. The Exchange is not proposing any change to the cap.
In a recent rule filing, the NYSE has proposed to modify its fee structure for equities transaction, including changes to the rates for providing liquidity, to become effective July 1, 2015.
The Exchange proposes to make corresponding changes to the Basic Rate pricing section of the Fee Schedule. Currently, the credit for PO+ Orders that provide liquidity to the NYSE is set at $0.0015 per share. The Exchange proposes to lower this credit to $0.0014 per share. Again, this proposed fee change would maintain the current relationship with NYSE rates.
Finally, the Exchange proposes to revise the Tape B Step Up Tier. Currently, ETP Holders and Market Makers, that, on a daily basis, measured monthly, directly execute providing volume in Tape B Securities during a billing month (“Tape B Adding ADV”) that is equal to at least 0.275% of the U.S. Tape B Consolidated Average Daily Volume (“Tape B CADV”) for the billing month over the ETP Holder's or Market Maker's May 2013 Tape B Adding ADV taken as a percentage of Tape B CADV (“Tape B Baseline % CADV”) receive a credit of $0.0004 per share for orders that provide liquidity to the Exchange in Tape B Securities, which is in addition to the ETP Holder's Tiered or Basic Rate credit(s). The Exchange proposes to specify in the Fee Schedule that ETP Holders that qualify for the Cross-Asset Tier would not be eligible to qualify for the Tape B Step Up Tier. The Exchange believes that the credit of $0.0030 per share is sufficient that an ETP Holder that qualifies for the Cross-Asset Tier should not also receive the increased credits applicable to the Tape B Step Up Tier. Similar to Retail Order Tier ETP Holders and Market Makers, who are currently ineligible to qualify for the Tape B Step Up Tier, the Exchange proposes to exclude Cross-Asset Tier ETP Holders from also qualifying for the Tape B Step Up Tier.
The proposed changes are not otherwise intended to address any other issues, and the Exchange is not aware of any problems that ETP Holders would have in complying with the proposed changes.
The Exchange believes that the proposed rule change is consistent with
The Exchange believes that the proposed fee increase for Market and Auction-Only Orders executed in an Opening, Market Order or Trading Halt Auction are reasonable because they are the same as the fees imposed by at least one other exchange.
The Exchange believes that the proposed changes to routing credits for PO+ Orders that provide liquidity to the NYSE are reasonable because the Exchange's credits for routing such orders are closely related to the NYSE's rebates for its members for providing liquidity, and the proposed change is consistent with the change proposed by the NYSE to lower its rebate for providing liquidity. The proposed change would result in maintaining the existing relationship between the two sets of fees. In addition, the Exchange believes that the proposed rule change, which would result in a decrease in the per share credit for PO+ Orders routed to the NYSE that provide liquidity to the NYSE, would thereby align the rate that the Exchange provides to ETP Holders with the rate that NYSE provides to its members for providing liquidity. Further, the proposed change is equitable and not unfairly discriminatory because the rebate reduction would apply uniformly across pricing tiers and all similarly situated ETP Holders would be subject to the same credit.
The Exchange believes that prohibiting Cross-Asset Tier ETP Holders from qualifying for the Tape B Step Up Tier is reasonable, equitable and not unfairly discriminatory because ETP Holders that qualify for the Cross-Asset Tier would already receive a higher credit of $0.0030 before the Tape B Step Up Credit, which is higher than other tiers with the Tape B Step Up credit. For example, Tier 1 ETP Holders that qualify for Tape B Step Up Tier would receive a Tier 1 credit of $0.0023 plus a Tape B Step Up credit of $0.0004 for a total credit of $0.0027, compared with the standalone Cross-Asset credit of $0.0030. The Exchange notes that Cross-Asset Tier ETP Holders and Market Makers currently do not qualify for Tape C Step Up Tier 2 credit.
Finally, the Exchange believes that it is subject to significant competitive forces, as described below in the Exchange's statement regarding the burden on competition. For these reasons, the Exchange believes that the proposal is consistent with the Act.
In accordance with Section 6(b)(8) of the Act,
The Exchange does not believe prohibiting Cross-Asset Tier ETP Holders from qualifying for increased credit(s) will impair ETP Holders' ability to compete. The Exchange already provides a credit for Cross-Asset Tier ETP Holders and ETP Holders impacted by the proposed change may readily adjust their trading behavior to maintain or increase their credits or decrease their fees in a favorable manner.
The Exchange notes that it operates in a highly competitive market in which market participants can readily favor competing venues. In such an environment, the Exchange must continually review, and consider adjusting, its fees and credits to remain competitive with other exchanges. For the reasons described above, the Exchange believes that the proposed rule change promotes a competitive environment.
No written comments were solicited or received with respect to the proposed rule change.
The foregoing rule change is effective upon filing pursuant to Section 19(b)(3)(A)
At any time within 60 days of the filing of such proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings under Section 19(b)(2)(B)
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The Exchange proposes to amend the Exchange's Pricing Schedule under Section VIII, entitled “NASDAQ OMX PSX FEES,” with respect to execution and routing of orders in securities priced at $1 or more per share.
While the changes proposed herein are effective upon filing, the Exchange has designated that the amendments be operative on July 1, 2015.
The text of the proposed rule change is available on the Exchange's Web site at
In its filing with the Commission, the Exchange included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
The purpose of the proposed rule change is to amend certain credits for order execution and routing applicable to the use of the order execution and routing services of the NASDAQ OMX PSX System (“PSX”) by member organizations for all securities traded at $1 or more per share.
The Exchange will increase non-displayed order credits for all orders with midpoint pegging that provide liquidity through PSX. Specifically, the credit tiers for non-displayed orders of a $0.0015 per share executed credit for orders with midpoint pegging that provide liquidity entered by a member organization that provides 1,000,000 shares or more average daily volume of non-displayed liquidity during the month and the credit tier for non-displayed orders of $0.0010 per share executed will be replaced with a single credit tier of $0.0020 per share executed for all orders with midpoint pegging
The Exchange believes that the proposed rule change is consistent with the provisions of Section 6 of the Act,
The proposed increases to the credits in the fee schedule under the Exchange's Pricing Schedule under Section VIII are reflective of the Exchange's ongoing efforts to use pricing incentive programs to attract order flow to the Exchange and improve market quality. The goal of these pricing incentives is to provide meaningful incentives for members to increase their participation on the Exchange.
The Exchange is proposing to increase non-displayed order credits for all orders with midpoint pegging that provide liquidity through PSX by replacing the existing two such tiers with a single tier. Specifically, the credit tiers for non-displayed orders of a $0.0015 per share executed credit for orders with midpoint pegging that provide liquidity entered by a member organization that provides 1,000,000 shares or more average daily volume of non-displayed liquidity during the month and the credit tier for non-displayed orders of $0.0010 per share executed will be replaced with a single credit tier of $0.0020 per share executed for all orders with midpoint pegging that provide liquidity.
The Exchange believes the proposed change is reasonable because the increase to the credit for all orders with midpoint pegging that provide liquidity provides member organizations with a uniform credit designed to incentivize increased midpoint liquidity on PSX. Additionally, the Exchange believes providing a greater credit will act as an incentive for members to increase their participation on the Exchange.
The Exchange believes that the proposed rule change is consistent with an equitable allocation of fees and is not unfairly discriminatory because the single credit for all orders with midpoint pegging that provide liquidity is uniformly available to all members and affects all members equally and in the same way.
The Exchange 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 amended.
In this instance, the changes to the credits for all orders with midpoint pegging that provide liquidity do not impose a burden on competition because Exchange membership is optional and is the subject of competition from other exchanges. The increased credit is reflective of the intent to increase the order flow on the Exchange. For these reasons, the Exchange does not believe that the proposed changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets. Moreover, because there are numerous competitive alternatives to the use of the Exchange, it is likely that the Exchange will lose market share as a result of the changes if they are unattractive to market participants.
Accordingly, Phlx does not believe that the proposed rule changes will impair the ability of members or competing order execution venues to maintain their competitive standing in the financial markets.
No written comments were either solicited or received.
The foregoing rule change has become effective pursuant to Section 19(b)(3)(A)(ii) of the Act.
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 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 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:
Federal Highway Administration (FHWA), DOT.
Notice of limitation on claims for judicial review of actions by FHWA and other Federal agencies.
This notice announces actions taken by FHWA and other Federal agencies that are final within the meaning of 23 U.S.C. 139(1)(1). The actions relate to the Queen Ka‘ahumanu Highway Widening project located in North Kona, in the State of Hawai'i. These actions grant licenses, permits, and approvals for the project.
By this notice, FHWA is advising the public of final agency actions subject to 23 U.S.C. 139(1). A claim seeking judicial review of the Federal agency actions on the listed highway project will be barred unless the claim is filed on or before December 17, 2015. If the Federal law that authorizes judicial review of a claim provides a time period of less than 150 days for filing such claim, then that shorter time period still applies.
Mayela Sosa, Division Administrator, Federal Highway Administration, 300 Ala Moana Boulevard, Box 50206, Honolulu, Hawaii 96850, Telephone: (808) 541-2700; or Raymond J. McCormick, Highways Administrator, State of Hawaii Department of Transportation, 869 Punchbowl Street, Honolulu, Hawaii 96813, Telephone: (808) 587-2220;
Notice is hereby given that FHWA and other Federal agencies have taken final agency actions by issuing licenses, permits, and approvals for the following: In 1996, FHWA and HDOT published the EA to widen Queen Ka‘ahumanu Highway from a two lane to four lane facility. The FHWA issued a Finding of No Significant Impact on June 10, 1996. The original project limits extended from Palani Road to Keahole Airport Access Road, a total project length of 8.0 miles. However, due to funding constraints, the project was split into
These actions by the Federal agencies, and the laws under which such actions were taken, are described in the 1996 Environmental Assessment (EA), FONSI, and May 15, 2015, Reevaluation, and in other documents in the FHWA administrative record. The EA, FONSI, Reevaluation and other documents in the FHWA administrative record are available by contacting HDOT or FHWA at the addresses provided above.
This notice applies to all Federal agency decisions on the project as of the issuance date of this notice and all laws under which such actions were taken, including but not limited to:
1.
2.
3.
4.
5.
6.
7.
9.
23 U.S.C. 139(1)(1).
Federal Railroad Administration (FRA), United States Department of Transportation (USDOT).
Notice.
FRA hereby gives notice that it is submitting the following Information Collection request (ICR) to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995. FRA requests that OMB authorize the collection of information identified by July 24, 2015, for a period of 180 days.
A copy of this individual ICR, with applicable supporting documentation, may be obtained by telephoning FRA's Office of Safety Clearance Officer: Robert Brogan (tel. (202) 493-6292) or FRA's Office of Administration Clearance Officer: Kimberly Toone (tel. (202) 493-6132) (these numbers are not toll-free); or by contacting Mr. Brogan via facsimile at (202) 493-6216 or Ms. Toone via facsimile at (202) 493-6497, or via email by contacting Mr. Brogan at
The statutory deadline for Positive Train Control (PTC) system implementation is December 31, 2015, less than 6 months away. Congress and FRA are concerned that the railroads will not make the statutory deadline. To date, the vast majority of railroads have not submitted, in accordance with 49 CFR 236.1009 and 236.1015, a PTC Safety Plan (PTCSP) and have not submitted, in accordance with 49 CFR 236.1035, a request for testing approval to support a PTCSP, which is necessary to achieve PTC System Certification and operate in revenue service. So that Congress and FRA may better understand the status of each railroad's implementation efforts, FRA is seeking accurate and current information, with periodic updates, under its investigative authority pursuant to 49 U.S.C. 20103, 20107, and 20902, and 49 CFR 236.1009(h). The railroads' responses will help inform FRA of the current PTC implementation status.
FRA is requesting Emergency processing approval by July 24, 2015, because FRA cannot reasonably comply with normal clearance procedures on account of use of normal clearance procedures is reasonably likely to disrupt the collection of information. The proposed collection of information is summarized below.
Pursuant to 44 U.S.C. 3507(a) and 5 CFR 320.5(b), 1320.8(b)(3)(vi), FRA informs all interested parties that it may not conduct or sponsor, and a respondent is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
44 U.S.C. 3501-3520.
Office of the Undersecretary for Domestic Finance, Department of the Treasury.
Notice and request for information.
Online marketplace lending refers to the segment of the financial services industry that uses investment capital and data-driven online platforms to lend to small businesses and consumers. The Treasury Department is seeking public comment through this Request For Information (RFI) on (i) the various business models of and products offered by online marketplace lenders to small businesses and consumers; (ii) the potential for online marketplace lending to expand access to credit to historically underserved market segments; and (iii) how the financial regulatory framework should evolve to support the safe growth of this industry.
Submit comments on or before: August 31, 2015.
Submit your comments through the Federal eRulemaking Portal or via U.S. mail or commercial delivery. We will not accept comments by fax or by email. To ensure that we do not receive duplicate copies, please submit your comments only one time. In addition, please include the Docket ID and the term “Marketplace Lending RFI” at the top of your comments.
For general inquiries, submission process questions or any additional information, please email
The Treasury Department is seeking public comment through this RFI to study (i) the various business models of and products offered by online marketplace lenders to small businesses and consumers; (ii) the potential for online marketplace lending to expand access to credit to historically underserved market segments; and (iii) how the financial regulatory framework should evolve to support the safe growth of this industry.
In particular, the Treasury Department is interested in responses to the following questions. We also seek any additional information beyond these questions that market participants believe would assist in our efforts to become better informed of the impact of online marketplace lending on small businesses, consumers, and the broader economy.
Online marketplace lenders may be subject to regulations promulgated by various agencies including, but not limited to, the CFPB and the Federal Trade Commission.
Respondents should provide as much detail as possible about the particular type of institution, product (
Historically, many American households, small businesses, and promising new enterprises have faced barriers in accessing affordable credit from traditional lenders. To date, the large majority of online marketplace consumer loans have been originated to prime or near-prime consumers to refinance existing debt. Online marketplace lending has filled a need for these borrowers by often delivering lower costs and faster decision times than traditional lenders. Non-prime consumers face other challenges in obtaining traditional bank-originated credit, particularly due to having thin or no credit files or damaged credit. Moreover, high underwriting costs can make it uneconomical to make small-value consumer loans. For example, it can cost the same amount to underwrite a $300 consumer loan as a $3,000 loan. Small-value loans to non-prime consumers thus have often come with triple digit annual percentage rates (APR). Some online marketplace lenders, however, are developing product structures and underwriting models that might allow making loans to non-prime borrowers at lower rates.
With respect to small businesses, a number of studies have shown that these borrowers are more dependent on community banks for financing than larger firms, which have access to other forms of finance including public debt and equity markets. While larger businesses typically rely on banks for 30 percent of their financing, small businesses receive 90 percent of their financing from banks.
The challenge is particularly acute for small business loans of lower value and shorter terms. More than half of small businesses that applied for credit in 2014 sought loans of $100,000 or less. At the same time, more than two thirds of businesses with under $1 million in annual revenue that applied for credit received less than the full amount that they sought and half received none.
While online marketplace lending is still a very small component of the small business and consumer lending market, it is a rapidly developing and fast-growing sector that is changing the credit marketplace. In less than a decade, online marketplace lending has grown to an estimated $12 billion in new loan originations in 2014, the majority of which is consumer lending.
Online marketplace lending broadly refers to the segment of the financial services industry that uses investment capital and data-driven online platforms to lend either directly or indirectly to small businesses and consumers. This segment initially emerged with companies giving investors the ability to provide financing that would be used to fund individual borrowers through what became known as a “peer-to-peer” model. However, it has since evolved to include a diverse set of individual and institutional credit investors who seek to provide financing that ultimately is used to fund small business and consumer loans of various types to gain access to additional credit channels and favorable rates of return.
Companies operating in this industry tend to fall into three general categories: (1) Balance sheet lenders that retain credit risk in their own portfolios and are typically funded by venture capital, hedge fund, or family office investments; (2) online platforms (formerly known as “peer-to-peer”) that, through the sale of securities such as member-dependent notes, obtain the financing to enable third parties to fund borrowers and, due to the contingent nature of the payment obligation on such securities, do not retain credit risk that the borrowers will not pay; and (3) bank-affiliated online lenders that are funded by a commercial bank, often a regional or community bank, originate loans and directly assume the credit risk.
Additionally, some of these companies have adopted a business model in which they partner and have agreements with banks. In these arrangements, the bank acts as the lender to borrowers that apply on the platform. The loans are then purchased by a second party — either by an investor, in which the transaction is facilitated by the marketplace lender, or by the marketplace lender itself, which funds the loan purchase by note sales. While the loans are not pooled, small investors can obtain a return by making small investments in a number of notes offered by a marketplace lender through its platforms.
Online marketplace lenders share key similarities. They provide funding through convenient online loan applications and most have no retail branches. They use electronic data sources and technology-enabled underwriting models to automate processes such as determining a borrower's identity and credit risk. These data sources might include traditional underwriting statistics (
1. There are many different models for online marketplace lending including platform lenders (also referred to as “peer-to-peer”), balance sheet lenders, and bank-affiliated lenders. In what ways should policymakers be thinking about market segmentation; and in what ways do different models raise different policy or regulatory concerns?
2. According to a survey by the National Small Business Association, 85
3. How are online marketplace lenders designing their business models and products for different borrower segments, such as:
• Small business and consumer borrowers;
• Subprime borrowers;
• Borrowers who are “unscoreable” or have no or thin files;
Depending on borrower needs (
4. Is marketplace lending expanding access to credit to historically underserved market segments?
5. Describe the customer acquisition process for online marketplace lenders. What kinds of marketing channels are used to reach new customers? What kinds of partnerships do online marketplace lenders have with traditional financial institutions, community development financial institutions (CDFIs), or other types of businesses to reach new customers?
6. How are borrowers assessed for their creditworthiness and repayment ability? How accurate are these models in predicting credit risk? How does the assessment of small business borrowers differ from consumer borrowers? Does the borrower's stated use of proceeds affect underwriting for the loan?
7. Describe whether and how marketplace lending relies on services or relationships provided by traditional lending institutions or insured depository institutions. What steps have been taken toward regulatory compliance with the new lending model by the various industry participants throughout the lending process? What issues are raised with online marketplace lending across state lines?
8. Describe how marketplace lenders manage operational practices such as loan servicing, fraud detection, credit reporting, and collections. How are these practices handled differently than by traditional lending institutions? What, if anything, do marketplace lenders outsource to third party service providers? Are there provisions for back-up services?
9. What roles, if any, can the federal government play to facilitate positive innovation in lending, such as making it easier for borrowers to share their own government-held data with lenders? What are the competitive advantages and, if any, disadvantages for non-banks and banks to participate in and grow in this market segment? How can policymakers address any disadvantages for each? How might changes in the credit environment affect online marketplace lenders?
10. Under the different models of marketplace lending, to what extent, if any, should platform or “peer-to-peer” lenders be required to have “skin in the game” for the loans they originate or underwrite in order to align interests with investors who have acquired debt of the marketplace lenders through the platforms? Under the different models, is there pooling of loans that raise issues of alignment with investors in the lenders' debt obligations? How would the concept of risk retention apply in a non-securitization context for the different entities in the distribution chain, including those in which there is no pooling of loans? Should this concept of “risk retention” be the same for other types of syndicated or participated loans?
11. Marketplace lending potentially offers significant benefits and value to borrowers, but what harms might online marketplace lending also present to consumers and small businesses? What privacy considerations, cybersecurity threats, consumer protection concerns, and other related risks might arise out of online marketplace lending? Do existing statutory and regulatory regimes adequately address these issues in the context of online marketplace lending?
12. What factors do investors consider when: (i) Investing in notes funding loans being made through online marketplace lenders, (ii) doing business with particular entities, or (iii) determining the characteristics of the notes investors are willing to purchase? What are the operational arrangements? What are the various methods through which investors may finance online platform assets, including purchase of securities, and what are the advantages and disadvantages of using them? Who are the end investors? How prevalent is the use of financial leverage for investors? How is leverage typically obtained and deployed?
13. What is the current availability of secondary liquidity for loan assets originated in this manner? What are the advantages and disadvantages of an active secondary market? Describe the efforts to develop such a market, including any hurdles (regulatory or otherwise). Is this market likely to grow and what advantages and disadvantages might a larger securitization market, including derivatives and benchmarks, present?
14. What are other key trends and issues that policymakers should be monitoring as this market continues to develop?
Environmental Protection Agency (EPA).
Final rule.
This action changes the status from acceptable to unacceptable; acceptable, subject to use conditions; or acceptable, subject to narrowed use limits for a number of substitutes, pursuant to the U.S. Environmental Protection Agency's Significant New Alternatives Policy program. We make these changes based on information showing that other substitutes are available for the same uses that pose lower risk overall to human health and the environment. Specifically, this action changes the listing status for certain hydrofluorocarbons in various end-uses in the aerosols, refrigeration and air conditioning, and foam blowing sectors. This action also changes the status from acceptable to unacceptable for certain hydrochlorofluorocarbons being phased out of production under the Montreal Protocol on Substances that Deplete the Ozone Layer and section 605(a) of the Clean Air Act.
This rule is effective on August 19, 2015.
EPA has established a docket for this action under Docket ID No. EPA-HQ-OAR-2014-0198. All documents in the docket are listed in the index. Although listed in the index, some information is not publicly available,
Margaret Sheppard, Stratospheric Protection Division, Office of Atmospheric Programs, Mail Code 6205J, Environmental Protection Agency, 1200 Pennsylvania Avenue NW., Washington, DC 20460; telephone number (202) 343-9163; fax number (202) 343-2338, email address:
Under section 612 of the Clean Air Act (CAA), EPA reviews substitutes within a comparative risk framework. More specifically, section 612 provides that EPA must prohibit the use of a substitute where EPA has determined that there are other available substitutes that pose less overall risk to human health and the environment. Thus, EPA's Significant New Alternatives Policy (SNAP) program, which implements section 612, does not provide a static list of alternatives but instead evolves the list as the EPA makes decisions informed by our overall understanding of the environmental and human health impacts as well as our current knowledge about available substitutes. In the more than twenty years since the initial SNAP rule was promulgated, EPA has modified the SNAP lists many times, most often by expanding the list of acceptable substitutes, but in some cases by prohibiting the use of substitutes previously listed as acceptable. Where EPA is determining whether to add a new substitute to the list, EPA compares the risk posed by that new substitute to the risks posed by other alternatives on the list and determines whether that specific new substitute poses more risk than already-listed alternatives for the same use. As the lists have expanded, EPA has not reviewed the lists in a broader manner to determine whether substitutes added to the lists early in the program pose more risk than substitutes that have more recently been added. EPA is now beginning this process.
Global warming potential (GWP) is one of several criteria EPA considers in the overall evaluation of the alternatives under the SNAP program. The President's June 2013 Climate Action Plan (CAP) states that, “to reduce emissions of HFCs, the United States can and will lead both through international diplomacy as well as domestic actions.” Furthermore, the CAP states that EPA will “use its authority through the Significant New Alternatives Policy Program to encourage private sector investment in low-emissions technology by identifying and approving climate-friendly chemicals while prohibiting certain uses of the most harmful chemical alternatives.” In our first effort to take a broader look at the SNAP lists, we have focused on those listed substitutes that have a high GWP relative to other alternatives in specific end-uses. In determining whether to change the status of these substitutes for particular end-uses, we performed a full comparative risk analysis, based on our criteria for review, with other available alternatives also listed as acceptable for these end-uses.
In an August 6, 2014,
On that basis, EPA is modifying the following listings by sector and end-use as of the dates indicated. EPA will continue to monitor the development and deployment of other alternatives as well as their uptake by industries affected by today's action. If EPA receives new information indicating that other alternatives will not be available by the change of status dates specified, EPA may propose further action to adjust the relevant dates.
(1) Aerosols
• EPA is listing HFC-125 as unacceptable for use as an aerosol propellant as of January 1, 2016.
• EPA is listing HFC-134a, HFC-227ea, and blends of HFC-134a and HFC-227ea as unacceptable for use as aerosol propellants as of July 20, 2016, except for those uses specifically listed as acceptable, subject to use conditions.
• EPA is listing HFC-227ea and blends of HFC-134a and HFC-227ea as acceptable, subject to use conditions, as of July 20, 2016, for use in metered dose inhalers (MDIs) approved by the U.S. Food and Drug Administration (FDA).
• EPA is listing HFC-134a as acceptable, subject to use conditions, as of July 20, 2016, until January 1, 2018, for the following specific uses:
○ products for which new formulations require federal governmental review, including: EPA pesticide registration, military or space agency specifications, or FDA approval (aside from MDIs); and
○ products for smoke detector functionality testing.
• EPA is listing HFC-134a as acceptable, subject to use conditions, as of July 20, 2016, for the following specific uses:
○ cleaning products for removal of grease, flux and other soils from electrical equipment or electronics;
○ refrigerant flushes;
○ products for sensitivity testing of smoke detectors;
○ sprays containing corrosion preventive compounds used in the maintenance of aircraft, electrical equipment or electronics, or military equipment;
○ duster sprays specifically for removal of dust from photographic negatives, semiconductor chips, and specimens under electron microscopes or for use on energized electrical equipment;
○ adhesives and sealants in large canisters;
○ lubricants and freeze sprays for electrical equipment or electronics;
○ sprays for aircraft maintenance;
○ pesticides for use near electrical wires or in aircraft, in total release insecticide foggers, or in certified organic use pesticides for which EPA has specifically disallowed all other lower-GWP propellants;
○ mold release agents and mold cleaners;
○ lubricants and cleaners for spinnerettes for synthetic fabrics;
○ document preservation sprays;
○ MDIs approved by the FDA for medical purposes;
○ wound care sprays;
○ topical coolant sprays for pain relief; and
○ products for removing bandage adhesives from skin.
(2) Refrigeration and air conditioning sector; Motor vehicle air conditioning (MVAC) systems for newly manufactured light-duty vehicles
EPA is listing HFC-134a as unacceptable for newly manufactured light-duty motor vehicles beginning in Model Year (MY) 2021 except as allowed under a narrowed use limit for use in newly manufactured light-duty vehicles destined for use in countries that do not have infrastructure in place for servicing with other acceptable refrigerants. This narrowed use limit will be in place through MY 2025. Beginning in MY 2026, HFC-134a will be unacceptable for use in all newly manufactured light-duty vehicles. EPA is also listing the use of certain refrigerant blends as unacceptable in newly manufactured light-duty motor vehicles starting with MY 2017.
(3) Refrigeration and air conditioning sector; Retail food refrigeration and vending machines
EPA is listing a number of refrigerants as unacceptable in a number of retail food refrigeration categories and in the vending machines end-use, as follows:
• Retrofitted supermarket systems: R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A as of July 20, 2016
• New supermarket systems: HFC-227ea, R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A as of January 1, 2017
• Retrofitted remote condensing units: R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A as of July 20, 2016
• New remote condensing units: HFC-227ea, R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A as of January 1, 2018
• Retrofitted vending machines: R-404A and R-507A as of July 20, 2016
• New vending machines: FOR12A, FOR12B, HFC-134a, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-426A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), and SP34E as of January 1, 2019
• Retrofitted stand-alone retail food refrigeration equipment: R-404A and R-507A as of July 20, 2016
• New stand-alone medium-temperature units with a compressor capacity below 2,200 Btu/hr and not containing a flooded evaporator: FOR12A, FOR12B, HFC-134a, HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, and THR-03 as of January 1, 2019
• New stand-alone medium-temperature units with a compressor capacity equal to or greater than 2,200 Btu/hr and stand-alone medium-temperature units containing a flooded evaporator: FOR12A, FOR12B, HFC-134a, HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-428A, R-434A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, and THR-03 as of January 1, 2020
• New stand-alone low-temperature units: HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-428A, R-434A, R-437A, R-438A, R-507A, and RS-44 (2003 formulation) as of January 1, 2020
We are also providing clarification on several questions identified during the comment period. Specifically, we are providing clarification of the terms we are using for the various end-use categories covered by this rule, including “supermarket systems,” “remote condensing units,” and “stand-alone equipment.” We are also providing clarification on certain types of equipment that do not fall within the categories and end-uses covered by this
(4) Foams
EPA is listing a number of foam blowing agents unacceptable in each foams end-use excluding rigid PU spray foam, except as allowed under a narrowed use limit for military or space- and aeronautics-related applications. For military or space- and aeronautics-related applications, we are changing the listing status to acceptable, subject to a narrowed use limit, as of the status change date for the remainder of each end-use (January 1 of 2017, 2019, 2020 or 2021) and then to unacceptable as of January 1, 2022. We are not taking final action on rigid PU spray foam at this time. The unacceptable listing for all other end-uses is as follows:
• Rigid polyurethane (PU) appliance foam: HFC-134a, HFC-245fa, HFC-365mfc and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2020
• Rigid PU commercial refrigeration and sandwich panels: HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2020
• Rigid PU slabstock and other: HFC-134a, HFC-245fa, HFC-365mfc and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2019
• Rigid PU and polyisocyanurate laminated boardstock: HFC-134a, HFC-245fa, HFC-365mfc and blends thereof; as of January 1, 2017
• Flexible PU: HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; as of January 1, 2017
• Integral skin PU: HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2017
• Polystyrene extruded sheet: HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2017
• Polystyrene extruded boardstock and billet (XPS): HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; Formacel TI, Formacel B, and Formacel Z-6, as of January 1, 2021
• Polyolefin: HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2020
• Phenolic insulation board and bunstock: HFC-143a, HFC-134a, HFC-245fa, HFC-365mfc, and blends thereof; as of January 1, 2017
• Rigid PU marine flotation foam: HFC-134a, HFC-245fa, HFC-365mfc and blends thereof; Formacel TI, and Formacel Z-6, as of January 1, 2020
While EPA proposed and requested comments on interpreting the SNAP unacceptability determinations to apply to the import of foam products that retain the blowing agents (
(5) Hydrochlorofluorocarbons (HCFCs)
As proposed, EPA is also modifying the listings for HCFC-141b, HCFC-142b, and HCFC-22, as well as blends that contain these substances in aerosols, foam blowing agents, fire suppression and explosion protection agents, sterilants, and adhesives, coatings and inks. These modifications align the SNAP listings with other parts of the stratospheric protection program, specifically section 605 and the implementing regulations at 40 CFR part 82 subpart A and section 610 and the implementing regulations at 40 CFR part 82 subpart C. The modified listings will apply 60 days following publication of this final rule.
(6) Overview of public comments
EPA received over 7,500 comments on the proposed rule. EPA requested and received comments on the proposed listing decisions as well as the proposed change of status dates. As noted in response to comments throughout this document, the decision on modifying each listing is based on the SNAP program's comparative risk framework. This includes information concerning whether there are alternatives available with lower overall risk to human health and the environment for the end-uses considered. As part of our consideration of the availability of those alternatives, we considered all available information, including information provided during the public comment period, and information claimed as confidential and provided during meetings, regarding technical challenges that may affect the time at which the alternatives can be used safely and used consistent with other requirements such as testing and code compliance obligations. We grouped comments together and responded to the issues raised by the comments in the sections that follow, or in a separate response to comments document which is included in the docket for this rule (EPA, 2015a). This final rule reflects some changes to our proposal, based on information and data received during the public comment period.
The sections that follow describe EPA's final action for each of the three sectors covered in this rulemaking—aerosols; foam blowing; and refrigeration and air-conditioning, including commercial refrigeration and motor vehicle air conditioning. For the end-uses addressed within each sector we explain the change of status determination and the dates when the change of status will apply. EPA has updated documentation for this rule including market characterizations, analyses of costs associated with sector transitions, estimated benefits associated with the transition to other alternatives, and potential small business impacts.
Potential entities that may be affected by this final rule include:
This table is not intended to be exhaustive, but rather a guide regarding entities likely to use the substitute whose use is regulated by this action. If you have any questions about whether this action applies to a particular entity, consult the person listed in the above section,
Below is a list of acronyms and abbreviations used in the preamble of this document:
CAA section 612 requires EPA to develop a program for evaluating alternatives to ozone-depleting substances (ODS). This program is known as the SNAP program. The major provisions of section 612 are:
Section 612(c) requires EPA to promulgate rules making it unlawful to replace any class I (chlorofluorocarbon, halon, carbon tetrachloride, methyl chloroform, methyl bromide, hydrobromofluorocarbon, and chlorobromomethane) or class II (HCFC) substance with any substitute that the Administrator determines may present adverse effects to human health or the environment where the Administrator has identified an alternative that (1) reduces the overall risk to human health and the environment and (2) is currently or potentially available.
Section 612(c) requires EPA to publish a list of the substitutes that it finds to be unacceptable for specific uses and to publish a corresponding list of acceptable substitutes for specific uses. The list of “acceptable” substitutes is found at
Section 612(d) grants the right to any person to petition EPA to add a substance to, or delete a substance from, the lists published in accordance with section 612(c). The Agency has 90 days to grant or deny a petition. Where the Agency grants the petition, EPA must publish the revised lists within an additional six months.
Section 612(e) directs EPA to require any person who produces a chemical substitute for a class I substance to notify the Agency not less than 90 days before new or existing chemicals are introduced into interstate commerce for significant new uses as substitutes for a class I substance. The producer must also provide the Agency with the producer's unpublished health and safety studies on such substitutes.
Section 612(b)(1) states that the Administrator shall seek to maximize the use of federal research facilities and resources to assist users of class I and II substances in identifying and developing alternatives to the use of such substances in key commercial applications.
Section 612(b)(4) requires the Agency to set up a public clearinghouse of alternative chemicals, product substitutes, and alternative manufacturing processes that are available for products and manufacturing processes which use class I and II substances.
On March 18, 1994, EPA published the initial SNAP rule (59 FR 13044) which established the process for administering the SNAP program and issued EPA's first lists identifying acceptable and unacceptable substitutes in major industrial use sectors (40 CFR part 82, subpart G). These sectors are the following: Refrigeration and air conditioning; foam blowing; solvents cleaning; fire suppression and explosion protection; sterilants; aerosols; adhesives, coatings and inks; and tobacco expansion. These sectors comprise the principal industrial sectors that historically consumed the largest volumes of ODS.
Under the SNAP regulations, anyone who produces a substitute to replace a class I or II ODS in one of the eight major industrial use sectors must provide the Agency with notice and the required health and safety information on the substitute at least 90 days before introducing it into interstate commerce for significant new use as an alternative. 40 CFR 82.176(a). While this requirement typically applies to chemical manufacturers as the person likely to be planning to introduce the substitute into interstate commerce,
The Agency has identified four possible decision categories for substitute submissions: Acceptable; acceptable, subject to use conditions; acceptable, subject to narrowed use limits; and unacceptable.
After reviewing a substitute, the Agency may determine that a substitute is acceptable only if certain conditions in the way that the substitute is used are met to ensure risks to human health and the environment are not significantly greater than other available substitutes. EPA describes such substitutes as “acceptable subject to use conditions.” Entities that use these substitutes without meeting the associated use conditions are in violation of section 612 of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).
For some substitutes, the Agency may permit a narrow range of use within an end-use or sector. For example, the Agency may limit the use of a substitute to certain end-uses or specific applications within an industry sector. The Agency requires a user of a narrowed use substitute to demonstrate that no other acceptable substitutes are available for their specific application. EPA describes these substitutes as “acceptable subject to narrowed use limits.” A person using a substitute that is acceptable subject to narrowed use limits in applications and end-uses that are not consistent with the narrowed use limit is using these substitutes in violation of section 612 of the CAA and EPA's SNAP regulations. 40 CFR 82.174(c).
The section 612 mandate for EPA to prohibit the use of a substitute that may present risk to human health or the environment where a lower risk alternative is available or potentially available
In contrast, EPA publishes “notices of acceptability” to notify the public of substitutes that are deemed acceptable with no restrictions. As described in the preamble to the rule initially implementing the SNAP program (59 FR 13044; March 18, 1994), EPA does not believe that rulemaking procedures are necessary to list substitutes that are acceptable without restrictions because such listings neither impose any sanction nor prevent anyone from using a substitute.
Many SNAP listings include “comments” or “further information” to provide additional information on substitutes. Since this additional information is not part of the regulatory decision, these statements are not binding for use of the substitute under the SNAP program. However, regulatory requirements so listed are binding under other regulatory programs (
The seven guiding principles of the SNAP program, elaborated in the preamble to the initial SNAP rule and consistent with section 612, are discussed below.
•
The SNAP program evaluates the risk of alternative compounds compared to available or potentially available substitutes to the ozone depleting compounds which they are intended to replace. The risk factors that are considered include ozone depletion potential as well as flammability, toxicity, occupational health and safety, and contributions to climate change and other environmental factors.
•
Substitutes found to be acceptable must not pose significantly greater risk than other substitutes, but they do not have to be risk free. A key goal of the SNAP program is to promote the use of substitutes that minimize risks to human health and the environment relative to other alternatives. In some cases, this approach may involve designating a substitute acceptable even though the compound may pose a risk of some type, provided its use does not pose significantly greater risk than other alternatives.
•
EPA does not intend to restrict a substitute if it has only marginally greater risk. Drawing fine distinctions would be extremely difficult. The Agency also does not want to intercede in the market's choice of substitutes by listing as unacceptable all but a few substitutes for each end-use, and does not intend to do so unless a substitute has been proposed or is being used that is clearly more harmful to human health or the environment than other available or potentially available alternatives.
•
Central to SNAP's evaluations is the intersection between the characteristics of the substitute itself and its specific end-use application. Section 612 requires that substitutes be evaluated by use. Environmental and human health exposures can vary significantly depending on the particular application of a substitute. Thus, the risk characterizations must be designed to represent differences in the environmental and human health effects associated with diverse uses. This approach cannot, however, imply fundamental tradeoffs with respect to different types of risk to either the environment or to human health.
•
The Agency recognizes the need to provide the regulated community with information on the acceptability of various substitutes as soon as possible. To do so, EPA issues notices or determinations of acceptability and rules identifying substitutes as unacceptable, acceptable to use conditions or acceptable subject to narrowed use limits in the
•
The Agency does not issue company-specific product endorsements. In many cases, the Agency may base its analysis on data received on individual products, but the addition of a substitute to the acceptable list based on that analysis does not represent an endorsement of that company's products.
•
In some cases, EPA and other federal agencies have developed extensive regulations under other sections of the CAA or other statutes that address potential environmental or human health effects that may result from the use of alternatives to class I and class II substances. For example, use of some substitutes may in some cases entail increased use of chemicals that contribute to tropospheric air pollution. The SNAP program takes existing regulations under other programs into account when reviewing substitutes.
EPA applies the same criteria for determining whether a substitute is acceptable or unacceptable. These criteria, which can be found at § 82.180(a)(7), include atmospheric effects and related health and environmental effects, ecosystem risks, consumer risks, flammability, and cost and availability of the substitute. To enable EPA to assess these criteria, we require submitters to include various information including ozone depletion potential (ODP), GWP, toxicity, flammability, and the potential for human exposure.
When evaluating potential substitutes, EPA evaluates these criteria in the following groupings:
•
•
(1) Releases in the workplace and in homes;
(2) Releases to ambient air and surface water;
(3) Releases from the management of solid wastes.
•
(1) Permissible Exposure Limits (PELs) for occupational exposure;
(2) Inhalation reference concentrations (RfCs) for non-carcinogenic effects on the general population;
(3) Cancer slope factors for carcinogenic risk to members of the general population.
When considering risks in the workplace, if OSHA has not issued a PEL for a compound, EPA then considers Recommended Exposure Limits from the National Institute for Occupational Safety and Health (NIOSH), Workplace Environmental Exposure Limits (WEELs) set by the American Industrial Hygiene Association (AIHA), or threshold limit values (TLVs) set by the American Conference of Governmental Industrial Hygienists (ACGIH). If limits for occupational exposure or exposure to the general population are not already established, then EPA derives these values following the Agency's peer reviewed guidelines. Exposure information is combined with toxicity information to explore any basis for concern. Toxicity data are used with existing EPA guidelines to develop health-based limits for interim use in these risk characterizations.
•
(1) Flash point and flammability limits (
(2) Data on testing of blends with flammable components;
(3) Test data on flammability in consumer applications conducted by independent laboratories; and
(4) Information on flammability risk mitigation techniques.
•
Over the past twenty years, the menu of substitutes has become much broader and a great deal of new information has been developed on many substitutes. Because the overall goal of the SNAP program is to ensure that substitutes listed as acceptable do not pose significantly greater risk to human health and the environment than other available substitutes, the SNAP criteria should be informed by our current overall understanding of environmental and human health impacts and our experience with and current knowledge about available and potentially available
Three mechanisms exist for modifying the list of SNAP determinations. First, under section 612(d), the Agency must review and either grant or deny petitions to add or delete substances from the SNAP list of acceptable or unacceptable substitutes. That provision allows any person to petition the Administrator to add a substance to the list of acceptable or unacceptable substitutes or to remove a substance from either list. The second means is through the notifications which must be submitted to EPA 90 days before introduction of a substitute into interstate commerce for significant new use as an alternative to a class I or class II substance. These 90-day notifications are required by section 612(e) of the CAA for producers of substitutes to class I substances for new uses and, in all other cases, by EPA regulations issued under sections 114 and 301 of the Act to implement section 612(c).
Finally, since the inception of the SNAP program, we have interpreted the section 612 mandate to find substitutes acceptable or unacceptable to include the authority to act on our own to add or remove a substance from the SNAP lists. In determining whether to add or remove a substance from the SNAP lists, we consider whether there are other available substitutes that pose lower overall risk to human health and the environment. In determining whether to modify a listing of a substitute we undertake the same consideration, but do so in the light of new data not considered at the time of our original listing decision, including information on new substitutes and new information on substitutes previously reviewed.
As described in this document and elsewhere, including in the initial SNAP rule published in the
The initial SNAP rule included submission requirements and presented the environmental and health risk factors that the SNAP program considers in its comparative risk framework. Environmental and human health exposures can vary significantly depending on the particular application of a substitute; therefore, EPA makes decisions based on the particular end-use where a substitute is to be used. EPA has, in many cases, found certain substitutes acceptable only for limited end-uses or subject to use restrictions.
It has now been over twenty years since the initial SNAP rule was promulgated. In that period, the menu of available alternatives has expanded greatly and now includes many substitutes with diverse characteristics and varying effects on human health and the environment. When the SNAP program began, the number of substitutes available for consideration was, for many end-uses, somewhat limited. While the SNAP program's initial comparative assessments of overall risk to human health and the environment were rigorous, often there were few substitutes upon which to apply the comparative assessment. The immediacy of the class I phaseout often meant that SNAP listed class II ODS (
Since EPA issued the initial SNAP rule in 1994, the Agency has issued 19 rules and 30 notices that generally expand the menu of options for all SNAP sectors and end-uses. Comparisons today apply to a broader range of options—both chemical and non-chemical—than was available at the inception of the SNAP program. Industry experience with these substitutes has also grown during the history of the program. This varies by sector and by end-use.
In addition to an expanding menu of substitutes, developments over the past 20 years have improved our understanding of global environmental issues. With regard to that information, our review of substitutes in this rule includes comparative assessments that consider our evolving understanding of a variety of factors, including climate change. GWPs and climate effects are not new elements in our evaluation framework, but as is the case with all of our review criteria, the amount and quality of information has expanded.
To the extent possible, EPA's ongoing management of the SNAP program considers new information and improved understanding of the risk to the environment and human health. EPA previously has taken several actions revising listing determinations from acceptable or acceptable with use conditions to unacceptable based on information made available to EPA after a listing was issued. For example, on January 26, 1999, EPA listed the refrigerant blend known by the trade name MT-31 as unacceptable for all refrigeration and air conditioning end-uses. EPA previously listed this blend as an acceptable substitute in various end-uses within the refrigeration and air conditioning sector (June 3, 1997; 62 FR 30275). Based on new information about the toxicity of one of the chemicals in the blend, EPA subsequently removed MT-31 from the list of acceptable substitutes and listed it as unacceptable in all refrigeration and air conditioning end-uses (January 26, 1999; 64 FR 3861).
Another example of EPA revising a listing determination occurred in 2007 when EPA listed HCFC-22 and HCFC-142b as unacceptable for use in the foam sector (March 28, 2007; 72 FR 14432). These HCFCs, which are ozone depleting and subject to a global production phaseout, were initially listed as acceptable substitutes since they had a lower ODP than the substances they were replacing and there were no other available substitutes that posed lower overall risk at the time of EPA's listing decision. HCFCs offered a path forward for some sectors and end-uses at a time when substitutes were far more limited. In light of the expanded availability of other substitutes with lower overall risk to human health and the environment in specific foam end-uses, and taking into account the 2010 class II ODS phase-down step, EPA changed the listing for these HCFCs in relevant end-uses from acceptable to unacceptable. In that rule, EPA noted that continued use of these HCFCs would contribute to unnecessary depletion of the ozone layer and delay the transition to substitutes that pose lower overall risk to human health and the environment. EPA established a change of status date that recognized that existing users needed time to adjust their manufacturing processes to safely accommodate the use of other substitutes.
For copies of the comprehensive SNAP lists of substitutes or additional information on SNAP, refer to EPA's Web site at
GWP is one of several criteria EPA considers in the overall evaluation of alternatives under the SNAP program. During the past two decades, the general science on climate change and the potential contributions of greenhouse gases (GHGs) such as HFCs to climate change have become better understood.
On December 7, 2009, at 74 FR 66496, the Administrator issued two distinct findings regarding GHGs
• Endangerment Finding: The current and projected concentrations of the six key well-mixed greenhouse gases in the atmosphere—CO
• Cause or Contribute Finding: The combined emissions of these well-mixed greenhouse gases from new motor vehicles and new motor vehicle engines contribute to the greenhouse gas pollution which threatens public health and welfare.
Like the ODS they replace, HFCs are potent GHGs.
Annual global emissions of HFCs are projected to rise to about 6.4 to 9.9 Gt CO
EPA received three petitions requesting EPA to modify certain acceptability listings of HFC-134a and HFC-134a blends. These petitions are more fully described in the notice of proposed rulemaking (NPRM). The first petition was submitted on May 7, 2010, by Natural Resources Defense Council (NRDC) on behalf of NRDC, the Institute for Governance and Sustainable Development (IGSD), and the Environmental Investigation Agency-US (EIA). The petition requested that EPA remove HFC-134a from the list of acceptable substitutes in multiple end-uses and move it to the list of unacceptable substitutes in those end-uses. In support of their petition, the petitioners identified other substitutes that they claimed were available for use in those end-uses and they claimed these other substitutes present much lower risks to human health and environment than HFC-134a.
On February 14, 2011, EPA found the petition complete for MVAC in new passenger cars and light-duty vehicles and determined it was incomplete for other uses of HFC-134a. EPA noted in its response that, at a future date, the Agency would initiate a notice-and-comment rulemaking in response to the one complete aspect of the petition, noting in particular that EPA would evaluate and take comment on many factors, including, but not limited to, the timeframe for introduction of newer substitutes for MVAC systems into the automotive market and potential lead time for manufacturers of motor vehicles to accommodate such substitutes.
On April 26, 2012, EPA received a second petition submitted by EIA. EIA stated that, in light of the comparative nature of the SNAP program's evaluation of substitutes and given that other acceptable substitutes are on the market or soon to be available, EPA should remove HFC-134a and HFC-134a blends from the list of acceptable substitutes for uses where EPA found chlorofluorocarbons (CFCs) and HCFCs to be nonessential under section 610 of the Act. EIA also requested that the schedule for moving HFC-134a and HFC-134a blends from the list of acceptable to unacceptable substitutes be based on the “most rapidly feasible transitions to one or more of the” acceptable substitutes for each use. The petitioner noted that initial approvals of HFC-134a for a number of end-uses occurred in the 1990s and were based
On August 7, 2012, EPA notified the petitioner that this petition was incomplete. EPA and the petitioner have exchanged further correspondence that can be found in the docket.
A third petition was filed on April 27, 2012, by NRDC, EIA and IGSD. They requested that EPA:
• Remove HFC-134a from the list of acceptable substitutes for CFC-12 in household refrigerators and freezers and stand-alone retail food refrigerators and freezers;
• Restrict the sales of SNAP-listed refrigerants to all except certified technicians with access to service tools required under existing EPA regulations;
• Adopt a standardized procedure to determine the speed of transition from obsolete high-GWP HFCs to next-generation alternatives and substitutes;
• Remove, in addition to HFC-134a, all other refrigerants with 100-year GWPs greater than 150 from the acceptable list for household refrigerators and freezers and stand-alone retail food refrigerators and freezers.
On August 7, 2013, EPA found this petition to be incomplete. EPA and the petitioner have exchanged further correspondence that can be found in the docket.
This action is consistent with a provision in the President's CAP announced June 2013: Moving forward, the Environmental Protection Agency will use its authority through the Significant New Alternatives Policy Program to encourage private sector investment in low-emissions technology by identifying and approving climate-friendly chemicals while prohibiting certain uses of the most harmful chemical alternatives.
The CAP further states: “to reduce emissions of HFCs, the United States can and will lead both through international diplomacy as well as domestic actions.” This rule is also consistent with that call for leadership through domestic actions. As regards international leadership, for the past five years, the United States, Canada, and Mexico have proposed an amendment to the Montreal Protocol to phase down the production and consumption of HFCs. Global benefits of the amendment proposal would yield significant reductions of over 90 gigatons of carbon dioxide equivalent (CO
This action also addresses certain aspects of the three petitions referred to above. First, this action responds to the one aspect of the three petitions that EPA found complete, namely petitioners' request that EPA change the listing of HFC-134a from acceptable to unacceptable in new MVAC systems. (See section V.B.) Second, regarding the remaining aspects of the three petitions, which EPA found to be incomplete, EPA has independently acquired sufficient information to address certain other requests made by the petitioners. EPA's action in this final rule may be considered responsive to certain aspects of those petitions such as: Changing the listing of certain HFCs used in specific aerosol uses from acceptable to unacceptable or acceptable, subject to use conditions; changing the listing of certain HFCs used in specific foams end-uses from acceptable to unacceptable for most uses; changing the listing of HFC-134a from acceptable to unacceptable for new stand-alone retail food refrigerators and freezers; and changing the listing of a number of refrigerant blends with higher GWPs from acceptable to unacceptable for new and retrofit stand-alone retail food refrigerators and freezers. Specifically, as explained in more detail in the sector-specific sections of this document, we are revising the listings for substitutes in the aerosols, foams, and refrigeration and air conditioning sectors that pose significantly greater overall risk to human health and the environment as compared with other available or potentially available substitutes in the specified end-uses.
Throughout the process of our discussions with the regulated community, we have sought to convey our continued understanding of the role that certainty plays in enabling the robust development and uptake of alternatives. Unfortunately, some of the key strengths of the SNAP program, such as its chemical and end-use specific consideration, its multi-criteria basis for action, and its petition process, tend to militate against some measures that could provide more certainty, such as setting specific numerical criteria for environmental evaluations (
The SNAP program provides listings for two aerosol end-uses: Propellants and solvents. Aerosols typically use a liquefied or compressed gas to propel active ingredients in liquid, paste, or powder form. In the case of duster sprays used to blow dust and contaminants off of surfaces, the propellant is also itself the active ingredient. Some aerosols also contain a solvent, which may be used in manufacturing, maintenance and repair to clean off oil, grease, and other soils.
Historically, a variety of propellants and solvents have been available to formulators. HCs (
Many consumer products that previously used CFC propellants were reformulated or replaced with a variety of alternatives, including not-in-kind substitutes, such as pump sprays or solid and roll-on deodorants. Aerosol propellant substitutes included HCFCs, HCs, HFCs, compressed gases, and oxygenated organic compounds. However, since the 1990s HCFCs have been controlled substances under the Montreal Protocol and subject to regulation under the CAA, as amended in 1990, including a phaseout of production and import under section 605(b)-(c) and use restrictions under section 605(a).
For aerosol propellants, EPA proposed to list, as of January 1, 2016:
• HFC-125 as unacceptable;
• HFC-134a as acceptable, subject to use conditions, allowing its use only in specific types of technical and medical aerosols (
• HFC-227ea as acceptable, subject to use conditions, allowing its use only in MDIs.
Today's action changes the status of HFC-125; HFC-227ea; blends of HFC-134a and HFC-227ea; and HFC-134a, as follows:
• We are changing the status of the aerosol propellant HFC-125 from acceptable to unacceptable as of January 1, 2016.
• We are changing the status of HFC-134a, HFC-227ea, and blends of HFC-134a and HFC-227ea from acceptable to unacceptable for use as aerosol propellants as of July 20, 2016 except for those uses specifically listed as acceptable, subject to use conditions.
• We are changing the status of the aerosol propellant HFC-227ea and for blends of HFC-227ea and HFC-134a from acceptable to acceptable, subject to use conditions, as of July 20, 2016, for use in MDIs approved by FDA.
• We are changing the status of the aerosol propellant HFC-134a from acceptable to acceptable, subject to use conditions, as of July 20, 2016, until January 1, 2018, for the following specific uses: Products for which new formulations require federal governmental review, including: EPA pesticide registration, military (U.S. Department of Defense (DoD)) or space agency (National Aeronautics and Space Administration (NASA)) specifications, or FDA approval (aside from MDIs); and products for smoke detector functionality testing.
• We are changing the status of the aerosol propellant HFC-134a from acceptable to acceptable, subject to use conditions as of July 20, 2016, for the following specific uses: Cleaning products for removal of grease, flux and other soils from electrical equipment or electronics; refrigerant flushes; products for sensitivity testing of smoke detectors; lubricants and freeze sprays for electrical equipment or electronics; sprays for aircraft maintenance; sprays containing corrosion preventive compounds used in the maintenance of aircraft, electrical equipment or electronics, or military equipment; pesticides for use near electrical wires, in aircraft, in total release insecticide foggers, or in certified organic use pesticides for which EPA has specifically disallowed all other lower-GWP propellants; mold release agents and mold cleaners; lubricants and cleaners for spinnerettes for synthetic fabrics; duster sprays specifically for use on removal of dust from photographic negatives, semiconductor chips, specimens under electron microscopes, and energized electrical equipment; adhesives and sealants in large canisters; document preservation sprays; MDIs approved by FDA for medical purposes,
The change of status determinations for aerosols are summarized in the following table:
EPA is changing the listing decisions for HFC-125, HFC-134a, HFC-227ea, and blends of HFC-134a and HFC-227ea, with some exceptions, because, as discussed in more detail in this section, for the uses for which we are listing these substitutes as unacceptable, alternatives (
The aerosols industry is generally familiar with how to address flammability risks. The aerosols industry has been using flammable compounds, including flammable propellants, for decades, consistent with OSHA requirements addressing flammability. There may be greater flammability risks for some specific uses of aerosol products because of their use in situations where there is a source of heat or electrical energy that could cause a fire (
There are a number of alternatives with GWPs lower than the GWPs for the substitutes that we are listing as unacceptable and that are not defined as VOC for purposes of SIPs, including: HFC-152a with a GWP of 124, HFO-1234ze(E) with a GWP of 6, and CO
Aerosols for industrial and commercial uses often require nonflammability and in some cases, specific vapor pressure criteria. For example, nonflammable aerosols are needed for use on energized electrical circuits, where sparking can create a fire or explosion hazard. Of the different alternatives that have previously been listed as acceptable, the nonflammable options at room temperature include HFC-125, HFC-134a, HFC-227ea, HFO-1234ze(E), compressed gases including CO
Based on the information available today, EPA believes it cannot list HFC-134a as unacceptable for all aerosol uses. Thus, we are creating a use condition that would restrict use of HFC-134a to specific uses for which alternatives are not currently or potentially available.
Both HFC-227ea and HFC-125 have significantly higher GWPs than HFC-134a (HFC-227ea's GWP is 3220 and HFC-125's GWP is 3500) or other substitutes that could be potentially used where flammability is a concern, and there is not a significantly different level of risk based on the other factors that we consider. Thus, EPA has determined that HFC-227ea and HFC-125 pose significantly more risk than other available substitutes and EPA is changing their listing from acceptable to unacceptable in most uses where HFC-134a may be used to mitigate flammability risks. We note that we are not aware of any use of HFC-227ea or of HFC-125 in industrial aerosols to mitigate flammability risks.
For medical aerosols, there are special needs to address safety and toxicity. Furthermore, in order for a substitute to be available for use in medical devices, the device using the substitute must first be reviewed and approved by the FDA.
FDA has approved medications for use in MDIs using HFC-134a, HFC-227ea, and blends of these two HFCs as propellants. No medications have been approved for use in MDIs using other propellants. Although some dry powder inhalers that are not-in-kind substitutes are approved by FDA, these alternatives do not work for some situations. Thus, we cannot conclude that there are other alternatives available for use in MDIs that pose lower risk than HFC-134a, HFC-227ea, or blends of these two. In addition, it is our understanding that because of differences in the solubility of water in HFC-134a and HFC-227ea, there are some medications that are sensitive to the presence of water for which only HFC-227ea may be used in an MDI.
For other medical uses, EPA is aware of medical aerosols that currently are using hydrocarbons or DME as the propellant, as well as not-in-kind
The available substitutes for medical devices are limited to those approved by FDA, and the available substitutes differ by the type of product and medical conditions treated. For these reasons, we are listing HFC-134a, HFC-227ea and blends of HFC-134a and HFC-227ea as acceptable, subject to use conditions, for specific uses for which other alternatives that pose lower overall risk to human health and the environment are not currently or potentially available. The use conditions limit use of HFC-227ea and blends of HFC-227ea and HFC-134a to MDIs approved by FDA and limit use of HFC-134a to MDIs approved by FDA and the other medical uses listed above.
HFC-125 has a GWP of 3,500, which is higher than the GWP of all other alternatives that are available for use as aerosol propellants (HFC-227ea has a GWP of 3,220; HFC-134a has a GWP of 1,430; HFO-1234ze(E) has a GWP of 6). Like HFC-134a, HFC-227ea, CO
For more information on the environmental and health properties of the different aerosol substitutes, please see the proposed rule at 79 FR 46137-46138 and a technical support document that provides the additional
On or after January 1, 2016, aerosol products may not be manufactured with HFC-125 and on or after July 20, 2016, aerosol products may not be manufactured with HFC-134a or HFC-227ea, or blends thereof except for the specific uses allowed under the use conditions. In addition, as of January 1, 2018, HFC-134a will be unacceptable for certain uses, and aerosol products for those uses may not be manufactured with HFC-134a as of that date:
• Products for which new formulations require U.S. federal government review, including: EPA pesticide registration, military or space agency specifications, and FDA approval (aside from MDIs); and
• products for functional testing of smoke detectors.
In the case of HFC-125, EPA is unaware of any products using HFC-125, and no public commenters mentioned the existence of such products or requested a date other than the proposed date of January 1, 2016.
We are setting July 20, 2016, as the date on which the status of HFC-134a, HFC-227ea, and blends thereof will change to unacceptable, or to acceptable, subject to use conditions, for certain specific uses. For those uses that would no longer be allowed as of July 20, 2016, this timeframe will allow formulators and packagers of aerosols to make the necessary changes. (ICF, 2014a; Honeywell, 2014a). A number of formulators have already been testing, and in many cases introducing, new formulations with alternatives that remain listed acceptable. This timing will provide affected aerosol manufacturers and packagers sufficient time to change and test formulations and, to the extent necessary, to change the equipment in their factories.
For two aerosol uses, continued use of HFC-134a will be allowed under the use conditions until January 1, 2018. EPA is providing this longer transition time for these two uses because of additional safety precautions and approvals outside of the control of the aerosol formulator that must be addressed before transitioning. The first category is those that must undergo specific federal governmental reviews: EPA pesticide registration under the Federal Insecticide, Fungicide, and Rodenticide Act, military or space agency specifications, and FDA approval. The second category is aerosol products for functional testing of smoke detectors, which have National Fire Protection Association (NFPA) 72 requirements adopted in building codes. These types of aerosols must be tested not only for performance but also reviewed by third parties for compliance with regulatory or code requirements or military specifications. Given both the safety implications of insufficient testing and the additional time required for third-party testing and/or governmental approval that is not required for other aerosol formulations, we have determined that alternatives that reduce overall risk will not be available for these uses until January 1, 2018.
As of the change of status dates, products cannot be manufactured with HFC-134a or HFC-227ea or blends thereof except for the aerosol product types that are listed under the use conditions. Products manufactured prior to the change of status date may still be sold, imported, exported, and used by the end-user after that date. As discussed below in the responses to comment, restricting use of aerosols by the end-user, as well as restricting the sale of previously manufactured aerosols, may disrupt the market and may not result in environmental benefits.
For certain aerosol products using HFC-134a that must go through a federal government or other third-party approval process for new formulations, we are establishing a change of status date of January 1, 2018. These products include those needing EPA pesticide registration, testing to U.S. military or space agency specifications, and FDA approval (aside from MDIs). In addition, we are establishing a change of status date of January 1, 2018, for a product that requires extensive testing to NFPA standards, specifically for smoke detector functional testing. Based on information received during the public comment period, we have determined that for these specific uses, alternatives that pose less risk are not available until these testing and registration processes are complete.
EPA disagrees that we should align the timelines in this rule with the EU timelines. The EU regulations rely upon different authority than the SNAP program, and reflect the European context. We believe it is appropriate for EPA decisions to base timelines upon when alternatives that reduce overall risk are available in the United States.
For portable safety horns, personal defense sprays, and freeze sprays for wastes (as opposed to electronic freeze sprays), there are other alternatives that are available or potentially available that reduce overall risk to human health and the environment. Products using HFO-1234ze(E) already exist or are in development for these uses. EPA received no information indicating that alternatives other than HFC-125, HFC-134a or HFC-227ea, or blends thereof, cannot be safely used in tissue freeze sprays.
CSPA stated that it should be clarified that “Cleaning products for removal of grease, flux, and other soils from electrical equipment or electronics” includes cleaners for refrigeration coils because of similar requirements for nonflammability. NAA stated that its members did not reach consensus on whether refrigerant flushes should be added to the acceptable list. This commenter states that it is common practice in the industry to remove flushing agents from lines and blowing them dry with nitrogen or compressed air after flushing, which eliminates risks posed by welding lines after flushing.
MVAC systems cool passenger cars, light-duty trucks, buses, and rail vehicles. CFC-12 was the refrigerant historically used in the manufacture of MVAC systems. HFC-134a, along with a number of other substitutes, was found acceptable for use in light-duty vehicles in 1994 and at the same time, CFC-12 was being phased out of production. By the mid-1990s, use of CFC-12 in manufacturing new light-duty vehicles ceased in the United States and manufacturers of light-duty vehicles uniformly decided to adopt HFC-134a for use in MVAC. Today, while MVAC systems in some older vehicles may still be using CFC-12, HFC-134a remains the dominant refrigerant used in light-duty vehicles worldwide. More recently, additional alternatives for MVAC have been listed as acceptable, subject to use conditions,
Neither HFC-134a nor any of the refrigerants listed more recently is ozone-depleting. HFO-1234yf, HFC-152a, and CO
HFO-1234yf is being used in cars on the road today in the United States. At the time of the proposal for this rule, EPA was aware that HFO-1234yf was in use in MVAC systems in approximately nine
While EPA was aware in the 1990s that CO
In 2008, EPA found HFC-152a acceptable subject to use conditions. MVAC systems using HFC-152a have not been commercialized to date; however, EPA is aware of a demonstration project in India with a major Indian motor vehicle manufacturer considering HFC-152a in secondary loop MVAC systems.
In addition to the use and development of HFO-1234yf, HFC-152a, and CO
There are also several blend refrigerants that have been listed as acceptable or acceptable, subject to use conditions, since 1994, but that have never been developed for use in MVAC or used in manufacture of new vehicles. Today's action will change the status of these refrigerant blends to unacceptable as of MY 2017 for use in newly manufactured light-duty vehicles. These substitutes include HFC blends SP34E and R-426A (also known as RS-24) with GWPs of 1,380 and 1,508, respectively, and the HCFC blends, R-416A (also known as HCFC Blend Beta or FRIGC FR12), R-406A, R-414A (also known as HCFC Blend Xi or GHG-X4), R-414B (also known as HCFC Blend Omicron), HCFC Blend Delta (also known as Free Zone), Freeze 12, GHG-X5, and HCFC Blend Lambda (also known as GHG-HP), with GWPs ranging from 1,480 to 2,340 and ODPs ranging from 0.012 to 0.056. For simplicity, we refer to these substitutes as “the refrigerant blends” in the following discussion.
As noted above, none of these are currently used by the original equipment manufacturers (OEMs) nor are we aware that any models are being developed for use with these substitutes. All of these refrigerant blends have GWPs that are significantly higher than the GWPs for HFO-1234yf, HFC-152a, and CO
The change of status determinations for MVAC are summarized in the following table:
In the August 6, 2014, proposal, EPA proposed to change the listing status of HFC-134a from acceptable to unacceptable for use in air conditioning systems in newly manufactured passenger cars and light-duty trucks beginning in MY 2021.
This change of status applies to MVAC systems for passenger cars and light-duty trucks as defined at 40 CFR 86.1803-01, referred to jointly in this FRM as light-duty vehicles. As discussed in the NPRM and above, three alternatives currently on the SNAP list of substitutes that are acceptable, subject to use conditions—HFC-152a, CO
Without the use conditions these other substitutes do not pose overall lower risk than HFC-134a. Thus, in deciding when the unacceptability determination should apply, we considered when it would be feasible for manufacturers to develop systems meeting the use conditions. We proposed MY 2021 while also requesting comment on MY 2017, MY 2019 and MYs later than 2021. As explained in the NPRM, EPA considers MY 2021 the date by which automobile manufacturers will be able to redesign all vehicle models (including design of the MVAC systems) for use with a lower-GWP alternative, consistent with the use conditions.
EPA previously considered the model year by which manufacturers of light-duty vehicles would be able to transition away from use of HFC-134a in support of the greenhouse gas and fuel economy standards for MY 2017-2025 light-duty vehicles issued jointly by EPA and NHTSA on August 28, 2012.
In developing the LD GHG standards, EPA assumed that the transition to alternative refrigerants would generally need to occur during manufacturer model redesigns because of changes to the system design that are needed to allow the safe use of these alternatives consistent with the regulatory use conditions.
EPA proposed to modify the listing of HFC-134a to unacceptable as of MY 2021 for light-duty vehicles, and sought comment on MYs 2017, 2019, and MYs later than 2021. Some commenters argued that full transition cannot occur until after MY 2021 because a limited number of models do not currently have plans in place to transition by MY 2021. For these models, commenters claimed that two full design cycles, which could take 10 years, will be necessary in order to transition. Commenters also provided information that the vehicle redesign is not “locked-in” until two years before the model year. EPA understands that because MY 2016 vehicles are being produced in the 2015 calendar year, this means most manufacturers have “locked-in” their planned product designs for MY 2016 and MY 2017, or potentially even out to MY 2018.
EPA expressly requested specific information supporting claims that a transition by MY 2021 would not be technically feasible because specific model vehicles cannot be redesigned to safely use alternative refrigerants by MY 2021. No such information was forthcoming. Although one manufacturer did provide information on the increase in cost to transition for a particular type of vehicle that was originally not planned for a refrigerant change by MY 2021,
EPA also received comments on this rule requesting an earlier change of
We also considered the supply of the alternative refrigerants in determining when alternatives would be available. At the time the light-duty GHG rule was promulgated, there was a concern about the potential supply of HFO-1234yf. Some commenters indicated that supply is still a concern, while others, including two producers of HFO-1234yf, commented that there will be sufficient supply. Moreover, some automotive manufacturers are developing systems that can safely use other substitutes, including CO
Based on information the Agency possessed at the time of the proposal and additional information submitted during the comment period regarding the technical feasibility of transitioning the fleet of light-duty vehicles and refrigerant supply, we conclude that MY 2021 represents the time by which other alternative refrigerants that pose less overall risk than HFC-134a can be used in all light-duty vehicle models consistent with the use conditions. Thus, MY 2021 is the time at which those alternative refrigerants will be “available” within the meaning of CAA section 612(c)(2).
In today's action, EPA is also finalizing changes to the listing status of SP34E, R-426A, R-416A, R-406A, R-414A (also known as HCFC Blend Xi or GHG-X4), R-414B (also known as HCFC Blend Omicron), HCFC Blend Delta (also known as Free Zone), Freeze 12, GHG-X5, and HCFC Blend Lambda (also known as GHG-HP) from acceptable to unacceptable for use in newly manufactured light-duty motor vehicles beginning in MY 2017, as proposed. The GWPs of HFC-152a, HFO-1234yf, and CO
EPA did not propose and is not making any changes that would alter the ability to service existing motor vehicles designed to use HFC-134a or a refrigerant blend.
MVAC systems designed to use lower-GWP substitutes and installed in vehicles will need to be serviced. Some stakeholders and commenters have expressed a concern that the price differential between HFO-1234yf and HFC-134a provides an economic incentive to replace HFO-1234yf with HFC-134a during servicing.
For vehicles for which the manufacturer counts air conditioning credits toward its LD GHG compliance, the MVAC systems (or elements of those systems) are considered emission-related components as defined in 40 CFR 86.1803. This designation includes provisions for emission-related warranty, requirements that they operate properly for the specified useful life, as well as tampering restrictions. For example, if a manufacturer claims air conditioning credits for an MVAC system that uses a lower-GWP refrigerant on a particular vehicle as part of the LD GHG program, removing and replacing that refrigerant with any other refrigerant that has a higher GWP, including HFC-134a, would be considered tampering with an emission-related component under Title II of the CAA.
In their comments, AAM stated that “EPA should state clearly and unequivocally in the final rule that EPA is committed to continuing the A/C credits through MY 2025 and beyond.” Global Automakers made a similar request. EPA in fact stated in the NPRM, and reiterates here, that nothing in this final rule changes the regulations establishing the availability of air conditioning refrigerant credits under the GHG standards for MY 2017-2025, found at 40 CFR 86.1865-12 and 1867-12. Those standards and credits are established by rule and EPA did not reopen that rule in this proceeding.
Under 40 CFR 82.174, no person may introduce a refrigerant substitute into interstate commerce without notifying EPA 90 days in advance. Our longstanding interpretation of this regulatory provision is that the notification requirement applies to products manufactured in the United States and exported. EPA has defined interstate commerce in our labeling regulations at 40 CFR 82.104(n) as: “The distribution or transportation of any product between one state, territory, possession or the District of Columbia, and another state, territory, possession or the District of Columbia, or the sale, use or manufacture of any product in more than one state, territory, possession or the District of Columbia. The entry points for which the product is introduced into interstate commerce are the release of a product from the facility in which the product was manufactured, the entry into a warehouse from which the domestic manufacturer releases the product for sale or distribution, and at the site of United States Customs clearance.” While this definition appears in EPA's labeling regulations, EPA's practice is to use it for purposes of the SNAP program as well. See
In addition, under the SNAP regulations EPA regulates “use” in the United States and “use” is defined at 40 CFR 82.172 to include “use in a manufacturing process or product, in consumption by the end user, or in intermediate uses, such as formulation or packaging for other subsequent uses.” Charging a MVAC system with refrigerant during the manufacturing of a vehicle in the United States is considered a “use” under the SNAP program. This is consistent with our statement in the initial SNAP rule that “Substitutes manufactured within the U.S. exclusively for export are subject to SNAP since the definition of use in the rule includes use in the manufacturing process, which occurs within the United States.” (59 FR 13052; March 18, 1994)
Based on comments received, we understand that certain countries to which vehicles are exported do not, and may not for some period of time, have in place the infrastructure for servicing MVAC systems with flammable refrigerants. Because this raises concerns with the safe usage of HFC-152a and HFO-1234yf, we have determined that there may be circumstances in which alternatives that pose lower overall risk to human health and the environment will not be available for MVAC systems in those vehicles by MY 2021. Therefore, EPA is providing a narrowed use limit for MVAC systems that applies to vehicles being exported to countries that do not have infrastructure to service vehicles containing the alternatives found to pose less overall risk.
Under a narrowed use limit, the manufacturer needs to ascertain that these other alternatives are not technically feasible because of the lack of infrastructure for servicing with the alternative refrigerants and document the results of their analysis. See 40 CFR 82.180(b)(3). Users are not required to report the results of their investigations to EPA, but must retain the documentation in their files for the purpose of demonstrating compliance.
Documentation should include descriptions of:
• Products in which the substitute is needed;
• Substitutes examined and rejected for the destined country;
• Reason for rejection of other alternatives; and
• Anticipated date other substitutes will be available and projected time for switching.
Based on the comments received, EPA does not anticipate that a significant number of countries will lack the necessary infrastructure needed to service MVAC systems with the alternatives for which the equipment is designed by MY 2021. Also, based on the comments received, we do not believe that an extensive additional amount of time will be needed before the necessary infrastructure is in place. Therefore, under this final rule, the narrowed use limit will no longer be available beginning with MY 2026 vehicles.
AAM and Global Automakers “conducted an industry survey to create a `non-confidential' blinded summary of individual manufacturer refrigerant changeover plans.”
The Agency recognizes and appreciates the factual information supplied by the commenters, including the information shared as a result of the 2014 industry-led survey conducted by AAM and Global Automakers. EPA's responses to the comments submitted by AAM and Global Automakers within the context of the survey are provided below. EPA relied on all of the information in our possession as we made our decision on the change of status for HFC-134a.
EPA understands that many model types will require hardware changes that normally occur during a redesign, unlike the transition from CFC-12 to HFC-134a. HFO-1234yf has a slightly lower cooling efficiency than that of HFC-134a; offsetting this efficiency difference usually requires hardware changes, specifically the incorporation of an internal heat exchanger and potentially other system adjustments, which in some cases could result in changes to overall air conditioning system design and layout. CO
Some commenters stated that aligning with the EU transition by January 1, 2017, will signal to the international community that the United States is taking steps to “promote the rapid deployment of climate-friendly and safe alternatives in motor vehicle air conditioning” as agreed to in the Leaders' statement at the G-7 Summit in June 2014. Some commenters suggested an accelerated transition date is needed to achieve the President's environmental goals, and would have a significant trickle-down effect in other markets around the world, specifically commenting that selecting MY 2017 would encourage Japan to “set the same global motor vehicle air-conditioning phaseout schedule for HFC-134a.” Also, NRDC and IGSD commented that “matching the MY 2017 European schedule is protecting against American automakers finding themselves unprepared when other markets close their doors to automobiles made with HFC-134a.” Some commenters stated that the transition can be achieved by an earlier date and that greater environmental benefits would be achieved with an earlier transition. These commenters stated that MY 2021 would not provide benefits beyond those achieved under “business as usual.”
We note that even though we are establishing MY 2021 as the date by which HFC-134a will be unacceptable,
While not relevant to EPA's decision regarding the appropriate date for changing the status of HFC-134a for use in MVAC, EPA also agrees its action to change the status of HFC-134a will send a valuable signal to the international community regarding the continued use of high-GWP alternatives.
Concerning EIA's suggestion for a limited exemption until MY 2021 for companies who publicly pledge to convert to CO
While the AAM and Global Automakers survey does not indicate the impetus for the transition plans for the various manufacturers and models, EPA assumes the plans were adopted in response to the credits offered under EPA's LD GHG Rule. EPA further assumes these transition plans were based on strategic utilization of credits available under the rule as a flexibility measure, rather than technical feasibility of transition, and EPA did not receive any information to the contrary.
Given the transition plans in place, EPA disagrees that other alternatives, including CO
The comments submitted by Honeywell and DuPont, current suppliers of HFO-1234yf, indicate that both companies are confident in their ability to supply enough HFO-1234yf to support a full transition by MY 2018 and MY 2019, respectively. According to comments submitted by Honeywell “there is one commercial scale HFO-1234yf production plant operating today in China, a second one is expected to be commissioned in the first half of 2015 in Japan via a strategic supply relationship between Honeywell and Asahi Glass Company Ltd, and a third world-scale plant will be commissioned by Honeywell by the end of 2016 in Geismar, Louisiana.” DuPont submitted similar comments on announced or planned production capacity in Asia, the United States and Europe by multiple producers, including DuPont, Honeywell, and Asahi Glass Co. (AGC), indicating that production will begin in 2015-2017 at most of these facilities.
CARB commented that they understand that chemical manufacturers expect to be capable of providing a sufficient supply of HFO-1234yf for complete U.S. transition away from HFC-134a starting with MY 2018. In support of a MY 2017 transition date, NRDC and IGSD commented that the supply of alternatives (HFO-1234yf and others) is not a constraint; they believe EPA correctly recognizes that “production plans for the refrigerant appear to be in place to make it available in volumes that meet current and projected domestic auto industry demand.”
We are not adding a statement to the regulatory text in the final SNAP rule. As noted in the preamble to the proposed rule, and reiterated here: “The light duty standards do provide that manufacturers can generate credits from use of alternative refrigerants with lower GWPs than that of HFC-134a through MY 2025, and the ability to generate and use those credits towards compliance with the light duty standards will not change if this action is finalized as proposed.” (79 FR 46142)
Also, as discussed in more detail in section V.B.3, for vehicles for which the manufacturer counts air conditioning credits toward its LD GHG compliance, the MVAC systems (or elements of those systems) are considered emission-related components as defined in 40 CFR 86.1803. This designation includes provisions for emission-related warranty, requirements that they operate properly for the specified useful life, and tampering restrictions.
In past cases where the SNAP program has regulated other substitutes that posed high environmental risk due to collective global emissions, we have taken three different approaches. One approach has been to restrict the substitute to a niche use through a narrowed use limit, where it was particularly difficult to find any feasible substitute and the niche use was unlikely to result in significant total emissions (
Concerning Arkema's reference to a discussion on use conditions for charge size limits, we note that in the proposed rule we also stated, “However, given the high GWP of these refrigerants compared to other refrigerants that are available in these end-uses, we do not believe that use with a small charge size adequately addresses the greater risk they pose.” This is even more so in MVAC than in commercial refrigeration products, due to the more widespread use of MVAC in hundreds of millions of vehicles and the greater difference in GWP between the unacceptable substitute and other, lower-GWP alternative, compared to supermarket systems and remote condensing units.
In contrast, DuPont and Honeywell, manufacturers of HFO-1234yf, asserted that service supply follows demand and the equipment for low GWP refrigerant service is readily available. These commenters stated that dealers and service shops can be expected to acquire the necessary equipment and materials to serve the market demand and that it is the responsibility of the vehicle manufacturer to ensure that their authorized dealers in those countries are able to provide all the necessary service to these exported cars under warranty. Honeywell and DuPont both stated that
EPA does not agree that every country in the world would need as much time as was needed in North America and Europe to resolve barriers to transition. Many countries look to the SNAP program and the EU's REACH program as a source of information to inform their domestic programs and, thus transition for those countries should proceed more quickly. EPA notes the widespread use of flammable refrigerants for various end-uses in other countries (more so than in the United States) as well as the inclusion of such refrigerants for projects considered by the Executive Committee of the Montreal Protocol's Multilateral Fund. We anticipate that many countries that do not have adequate infrastructure in place in 2015 will have it in place in time to service MY 2021 vehicles.
In many cases international agencies, such as the United Nations Environment Programme (UNEP), have been working with developing countries to facilitate changes in domestic regulations to allow for the use of lower-GWP solutions. This has been particularly true since 2007 when the Parties to the Montreal Protocol adopted a more aggressive phaseout schedule for HCFCs, for end-uses using HCFCs such as stand-alone commercial refrigeration appliances. Thus there are systems in place for communicating information on new refrigerants and for sharing experience. Further, the experiences of the United States and Europe are being shared widely. We have provided information to the Montreal Protocol's Secretariat and to UNEP. We already are also seeing information shared through a range of mechanisms by the Secretariat and UNEP as well as included in reports of the Montreal Protocol's Technical and Economic Assessment Panel (TEAP), SAE, and other bodies.
In addition, EPA notes that the G-7 leaders committed in June 2014 to promote the rapid deployment of climate-friendly and safe alternatives to HFCs in motor vehicle air-conditioning and to promote public procurement of climate-friendly HFC alternatives. EPA notes that many countries already are committed to take action to promote public procurement of climate-friendly lower-GWP alternatives whenever feasible and would likely consider MVAC as a potentially feasible end-use. For the reasons above, we believe that sufficient progress is being made and will continue to be made such that the narrowed use limit need not apply beyond MY 2025.
EPA understands that the commenters are suggesting that there still may be markets that do not have infrastructure in place by MY 2025. Based on the speed of transition that we are seeing, EPA does not agree. However, the Agency could consider proposing a change in the future if needed.
EPA refers readers to section V.C.1 of the preamble to the proposed rule for a detailed discussion of the end-uses within the refrigeration sector covered by this rule as well as information on some of the refrigerants used within those end-uses.
In the proposed rule, EPA proposed to change the listing for certain refrigerants for two end-uses within the “commercial refrigeration” sector—retail food refrigeration and vending machines. Retail food refrigeration, as affected by today's rule, is composed of three main categories of equipment: Stand-alone equipment; remote condensing units; and supermarket systems. Stand-alone equipment consists of refrigerators, freezers, and reach-in coolers (either open or with doors) where all refrigeration components are integrated and, for the smallest types, the refrigeration circuit is entirely brazed or welded. These systems are termed “stand-alone” within the SNAP program because they are fully charged with refrigerant at the factory and typically require only an electricity supply to begin operation.
Condensing units, called remote condensing units in this final action as discussed below, exhibit refrigerating capacities that typically range from 1 kW to 20 kW (0.3 to 5.7 refrigeration tons) and are composed of one (and sometimes two) compressor(s), one condenser, and one receiver assembled into a single unit, which is normally
Typical supermarket systems are known as multiplex or centralized systems. They operate with racks of compressors installed in a machinery room. Two main design classifications are used: Direct and indirect systems. At least 70% of supermarkets in the United States use centralized direct expansion (DX) systems to cool their display cases.
Refrigerant choices depend on the refrigerant charge (
During a meeting with EPA just prior to publication of the proposed rule, an industry trade organization representing manufacturers of refrigeration equipment, Air-Conditioning, Heating, and Refrigeration Institute (AHRI), raised concerns that in some situations the definitions and categories used in the SNAP program differ from those used by the U.S. Department of Energy (DOE) and/or the industry and they submitted a document identifying those definitions and categories (see
EPA notes that the term “self-contained” is synonymous with the SNAP end-use category “stand-alone” and we are retaining use of the term stand-alone for this rulemaking action. The term “remote condensing” applies to the SNAP end-use categories of “supermarket systems” and “condensing units.” For the latter end-use category, in this final rule we are revising the term “condensing units” to be “remote condensing units.” EPA draws a distinction between “supermarket systems” and “remote condensing units” based on the number of compressors in the remote condensing system. Supermarket systems generally have more than two compressors arranged in a “rack” whereas remote condensing units typically have only one or two compressors linked to a single condenser. For purposes of this rule, we are keeping these two categories separate.
The AHRI document (Docket ID# EPA-HQ-OAR-2014-0198-0005) also attempts to draw an additional distinction regarding commercial walk-in coolers and freezers. We note that we do not treat such units separate from the categories described above. Rather such units would fall within the end-use category “supermarket system” if the refrigerant is supplied on the same multi-compressor circuit used to cool food elsewhere in the store or within the end-use category “remote condensing unit” if only a one- or two-compressor system is used (generally dedicated to just the individual walk-in cooler or freezer).
AHRI further notes that both supermarket systems and remote condensing units can be connected to various types of display cases designed to maintain products at various temperatures, often subdivided as “medium-temperature”—roughly between 32 °F (0 °C) and 41 °F (5 °C)—and “low-temperature”—roughly between −40 °F (−40 °C) and 32 °F (0 °C). EPA notes that within the SNAP end-uses and categories described above, no distinction is currently made based on application temperature (medium or low) and so the decisions finalized in today's rule apply to all equipment fitting within the supermarket and remote condensing units end-use categories as described; however, based on comments received, within the stand-alone equipment end-use category a distinction is made between equipment designed for “low” temperatures and other equipment.
During the comment period on the proposed rule, we received additional questions and comments about whether certain types of equipment were included in the end-uses addressed in this action. We are clarifying here that specific types of equipment used in the food industry do not fall within the end-uses and end-use categories affected by this rule: Blast chillers, ice making machines not connected to a supermarket system, very low temperature refrigeration, and certain food and beverage dispensing systems.
A “blast chiller” or “blast freezer” is a type of equipment in which cold air is supplied and circulated rapidly to a food product, generally to quickly cool or freeze a product before damage or spoilage can occur. Such units are typically used in industrial settings (
“Ice makers” are machines designed for the sole purpose of producing ice, in various sizes and shapes, and with different retrieval mechanisms (
Several commenters, including Master Bilt Products and Thermo Fisher, identified products they manufacture to reach temperatures of −50°F (−46°C) or even lower. These products fit under the end-use “very low temperature refrigeration” and hence are not covered by this rule. EPA also notes that it recently found R-170 (ethane) as acceptable, subject to use conditions, in the very low temperature refrigeration end-use. (April 10, 2015; 80 FR 19453)
Other commenters, such as Emerson, HC Duke/Electro-Freeze, and United Technologies, mentioned equipment designed to make or process cold food and beverages that are dispensed via a nozzle, including soft-serve ice cream machines, “slushy” iced beverage dispensers, and soft-drink dispensers. Such equipment can be self-contained or can be connected via piping to a dedicated condensing unit located elsewhere. EPA does not consider this equipment to fall under either the “stand-alone” or “remote condensing unit” categories of retail food refrigeration. While our definition of retail food refrigeration includes “cold storage cases designed to chill food for commercial sale,” these units generally do more than just store food or beverages. For instance, United Technologies states such equipment “transform[s] a liquid product into a frozen beverage or confection with the incorporation of air to provide uniformity and specific customer requirements. These products are transformed and manufactured within the equipment, held in a frozen state and ultimately dispensed into a serving vessel that is provided to an end customer.” Hence, these types of products are in a category separate from the three “retail food refrigeration” end-use categories addressed in today's rule.
We also received several comments and questions regarding energy conservation standards established by DOE and how the equipment subject to this rule is also subject to the DOE standards. While EPA is not making any decisions on the applicability of the DOE standards to specific equipment, we see that at least three such standards and perhaps more apply to types of equipment that are also subject to this rule. These three standards are titled Energy Conservation Standards for Commercial Refrigeration Equipment (79 FR 17725; March 28, 2014), Energy Conservation Standards for Walk-In Coolers and Freezers (79 FR 32049; June 3, 2014) and Energy Conservation Standards for Refrigerated Bottled or Canned Beverage Vending Machines (74 FR 44914; August 31, 2009). These are referred to in this rule using shortened names or a generic name such as “DOE Standards.”
The Commercial Refrigeration Equipment Standards have an effective date of May 27, 2014 and a compliance date of March 27, 2017. The Walk-In Coolers and Freezers Standards have an effective date of August 4, 2014 and a compliance date of June 5, 2017. The Beverage Vending Machines Standards have effective dates of October 30, 2009 and August 31, 2011 and a compliance date of August 31, 2012. DOE posted a notice of a public meeting and availability of the Framework document for an expected proposed rule to amend the standards for refrigerated bottled or canned beverage vending machines (78 FR 33262; June 4, 2013). Material in the docket for that action indicate DOE's plans for a final rule with a compliance date three years later (see EERE-2013-BT-STD-0022).
EPA's review indicates that equipment designated in the Commercial Refrigeration Equipment Standards may fall under the supermarket systems, remote condensing units, and stand-alone equipment end-use categories. Specifically, equipment classes designated in the DOE Standard as
EPA's review indicates that equipment designated in the Walk-In Cooler and Freezers Standards may fall under the supermarket systems, remote condensing units, and stand-alone equipment end-use categories. Specifically, equipment within the class descriptor Multiplex Condensing (either Medium or Low Temperature) may fall under the supermarket systems end-use category,
EPA's review indicates that equipment covered by the Beverage Vending Machine Standards (including Class A, Class B and Combination vending machines) falls under the vending machines end-use.
In all cases, the DOE Standards apply to new equipment, not retrofitted equipment. Also, any foam used in such systems or components that are also covered (
Several commenters, including the Food Marketing Institute (FMI),
For the refrigeration and air-conditioning sector, the SNAP program has, since the inception of the program, made a distinction between new equipment and retrofitted equipment. In some cases, a particular refrigerant is acceptable or acceptable subject to use conditions only in new equipment, not in retrofits. In other cases, a particular refrigerant is only acceptable in retrofits, not new equipment. In the NPRM, EPA evaluated whether to change the status of refrigerant substitutes for retrofits separate from its evaluation of whether to change the status of refrigerant substitutes for new equipment in each of the four end-uses and categories—supermarket systems, remote condensing units, stand-alone equipment, and vending machines—addressed. Since the inception of the SNAP program, EPA has made separate determinations for refrigerants used in “new” equipment and as a “retrofit” to existing equipment. We are likewise today making separate decisions for new and retrofit equipment within the retail food refrigeration and vending machines end-uses.
EPA uses the term “retrofit” to indicate the use of a refrigerant in an appliance (such as a supermarket system) that was designed for and originally operated using a different refrigerant
In addition to drawing a distinction between new and retrofit for the SNAP program, EPA also included a distinction between new and existing equipment in its regulations implementing the HCFC phaseout and use restrictions in section 605 of the CAA. As of January 1, 2010, use of HFC-22 and HFC-142b was largely restricted to use as a refrigerant in equipment manufactured before that date (40 CFR 82.15(g)(2); 74 FR 66412). Similarly, as of January 1, 2015, use of other HCFCs not previously controlled was largely restricted to use as a refrigerant in equipment manufactured before January 1, 2020 (40 CFR 82.15(g)(4); 74 FR 66412). In that context, EPA defined “manufactured,” for an appliance, as “the date upon which the appliance's refrigerant circuit is complete, the appliance can function, the appliance holds a full refrigerant charge, and the appliance is ready for use for its intended purposes” (40 CFR 82.3, 82.302). We provided further explanations and example scenarios of how the HCFC phaseout and use restrictions apply to supermarkets in the fact sheet
Under today's rule, existing systems may continue to be serviced and maintained for the useful life of that equipment using the original refrigerant, whereas new systems (including new supermarket systems) manufactured after the change of status date will not be allowed to use refrigerants for which the status has changed to unacceptable. Consistent with the definition in subparts A and I of part 82, quoted above, EPA will consider a system to be new for purposes of these SNAP determinations as of the date upon which the refrigerant circuit is complete, the system can function, the system holds a full refrigerant charge, and the system is ready for use for its intended purposes. As explained in the fact sheet referenced above, a supermarket may undergo an expansion and continue to use the existing refrigerant “if there is sufficient cooling capacity within the system to support the expansion” as EPA would consider that in such a situation “the store is not changing the intended purpose of the system.” As pointed out by FMI, the replacement of existing display cases with ones that operate at a higher evaporator temperature, but still provide the same purpose of maintaining products at required temperatures, is one way in which a system may be remodeled without changing the intended purpose of the system. On the other hand, if a supermarket remodel or expansion changes the intended purpose of the original equipment, for instance by adding additional cases, compressors, and refrigerant that were not supported by the original compressor system, EPA would consider the expanded system a “new” system. In that situation, a supermarket would not be allowed to use a refrigerant that was listed as unacceptable as of the date that new system was expanded or remodeled, even if the system had been using that refrigerant before the expansion or remodel.
The change of status determinations for retail food refrigeration (supermarket systems) are summarized in the following table:
For new supermarket systems, EPA had proposed to change the status, as of January 1, 2016, for nine HFC blends and HFC-227ea to unacceptable: The HFC blends are R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A. In today's final rule, we are changing the status of these ten refrigerants to unacceptable in new supermarkets as of January 1, 2017 (
A number of other refrigerants are listed as acceptable for new supermarket systems: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407A, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-422B, R-424A, R-426A, R-437A, R-438A, R-448A, R-449A, R-450A, R-513A, R-744, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02, and THR-03.
Several of these alternatives, such as R-407A, R-407F, and R-744, are in widespread use today in supermarket systems in the United States. EPA considers this widespread use as indicative of the availability of these acceptable alternatives. HFC/HFO blends are also entering the market. For instance, R-448A and R-449A are being used in supermarkets in the United States and R-450A is in use in a supermarket in Spain.
In the preamble to the NPRM, 79 FR at 46144, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable as compared with other available alternatives. In addition, EPA listed as acceptable R-450A on October 21, 2014 (79 FR 62863) and included information on its risk to human health and the environment. Concurrently with this rule, EPA is also listing R-448A, R-449A and R-513A as acceptable in this end-use category and is including information on their risk to human health and the environment. A technical support document that provides the additional
As explained here and in our responses to comments, EPA is finalizing a change of status date for new supermarket systems of January 1, 2017.
EPA noted in the NPRM, and multiple commenters echoed, that supermarket equipment using some of the acceptable alternatives, notably HFC-134a, R-407A, R-407C, R-407F and R-744, is available today and has been used in supermarkets for several years. While some, but not all, manufacturers argued more time was warranted to develop additional equipment and address performance issues, they did not provide adequate justification or specificity on when such equipment would be available or when such issues would be addressed.
A supermarket system manufacturer believed time was needed to develop contractor training materials. While EPA agrees that training is valuable, we note below that such training is already available and, given that acceptable alternatives have already been implemented in new supermarkets, we do not see the need to delay our proposed status change date for new equipment in this end-use category more than one year.
However, one system manufacturer noted that supermarket plans are developed in time frames that could hinder the proposed status change date of January 1, 2016. EPA understands that such planning is necessary and we are establishing a status change date of January 1, 2017, to accommodate those end users who have already planned changes to their systems or may have plans to manufacture a new system (
For retrofit supermarket systems, EPA proposed to list, as of January 1, 2016, nine HFC blends as unacceptable: R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A. In today's final rule we are finding these refrigerants unacceptable in retrofit supermarkets as of July 20, 2016.
Consistent with the proposal, this action does not apply to servicing equipment designed to use these nine refrigerants or servicing equipment that was retrofitted to use those refrigerants before the July 20, 2016, status change date. For example, supermarket systems designed for use with or retrofitted to R-404A or R-507A prior to July 20, 2016, may continue to operate and to be serviced using those refrigerants.
A number of other refrigerants are listed as acceptable for retrofit supermarket systems: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407A, R-407C, R-407F, R-417A, R-417C, R-421A, R-422B, R-424A, R-426A, R-427A, R-437A, R-438A, R-448A, R-449A, R-450A, R-513A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02, and THR-03.
Several of the alternatives that remain acceptable are in use today in the United States for supermarket system retrofits. While blends such as R-407A and R-407F have become the norm, GreenChill partners also report use of other refrigerants as retrofits in supermarket systems.
In the preamble to the NPRM, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable and those that remain acceptable. In addition, EPA listed R-450A as acceptable on October 21, 2014 (79 FR 62863) and included information on its risk to human health and the environment. Concurrently with this rule, EPA is also listing as acceptable R-448A, R-449A and R-513A and including information on their risk to human health and the environment. As discussed above, the producers of the substitutes that will remain acceptable do not expect supply problems. In summary, the refrigerants listed above that remain acceptable have zero ODP as do those that we are finding unacceptable. The refrigerants remaining acceptable have GWPs ranging from below 100 to 2,630, lower than the GWPs of the nine blends we are finding unacceptable, which have GWPs ranging from 2,730 to 3,985. All of the refrigerants remaining acceptable have toxicity lower than or comparable to the refrigerants whose listing status is changing from acceptable to unacceptable. None of the refrigerants that remain acceptable or those that are being listed as unacceptable are flammable. Some of the refrigerant blends that remain acceptable and some of those that we are finding unacceptable include small amounts (up to 3.4% by mass) of VOCs such as R-600 (butane) and R-600a (isobutane). Because these amounts are small, and EPA's analysis of hydrocarbon refrigerants shows that even when used neat (100% by mass), they are not expected to contribute significantly to ground level ozone formation (ICF, 2014e), these blends would also not contribute significantly to ground level ozone formation. Because the risks other than GWP are not significantly different for the other available alternatives than for those we proposed to list as unacceptable, and because the GWP for the refrigerants we proposed to list as unacceptable is significantly higher and thus poses significantly greater risk, we are listing the following refrigerants as unacceptable: R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A.
EPA regulations have eliminated or will eliminate by 2020 the production and import of HCFC-22. These and other regulations also affect end users who are using CFC-12, R-502, and several HCFC-containing blends such as R-401A, R-402A and R-408A. Therefore, we believe that the impact of this action addressing retrofits will primarily affect those owners who are faced with the choice of continuing to operate systems with a refrigerant that has been phased out of production and import or to switch to a refrigerant listed as acceptable for retrofit at the time the retrofit occurs.
Many retail chains maintain their own stockpile of HCFC-22, for instance by recovering from stores that are decommissioned or retrofitted and using such supplies to service stores that continue to operate with HCFC-22. In addition, over four millions pounds of HCFC-22 has been reclaimed every year since at least 2000 and over seven
We see that many retrofits are already directed towards lower-GWP blends such as R-407A and R-407F, which are widely available and remain acceptable for such use under today's rule, and not those of the refrigerants whose status will change to unacceptable under today's rule. These two refrigerants (R-407A and R-407F), other available HFC blends, the additional HFC/HFO options that EPA recently listed as acceptable, and other HFC/HFO blends that are being evaluated by chemical producers and equipment manufacturers, as well as the option of continuing to operate with HCFC-22, are sufficient to meet the various features—such as capacity, efficiency, materials compatibility, cost and supply—that affect the choice of a retrofit refrigerant.
As explained here and in our responses to comments, EPA is establishing a change of status date for retrofit supermarkets of July 20, 2016.
In the NPRM and above, EPA pointed out that retrofits of supermarkets using acceptable alternatives are already occurring. Supermarket Company ABC indicated that their experience with the use of R-407A in retrofits indicates the availability and viability of it and other alternatives. FMI similarly indicated that many of its members have already stopped performing retrofits with refrigerants we are finding unacceptable. EPA considers these comments directly from the supermarket retailer to indicate that adequate performance can be achieved using refrigerants that will remain listed as acceptable.
As indicated in section V.C.1.c above, retrofits may require various changes to the existing equipment, such as different lubricants, new materials such as gaskets and filter driers, and adjustments to expansion valves. These changes include readily available materials and common refrigeration practices. Such retrofits to acceptable alternatives are already occurring, and the option to continue to operate and service existing systems remains; however, EPA received comment that users may plan a “new store layout” in advance. While not specifically referencing retrofits, a new layout of an existing store may include the retrofitting of the existing supermarket system. Therefore, EPA is modifying the change of status date to provide a full year from publication of the final rule to ensure that any supermarkets that may have retrofits underway using a refrigerant that will no longer be acceptable will be able to complete those retrofits ahead of the change of status date. While EPA did not receive specific comments on the time to complete retrofits that are underway, it is our understanding that any ongoing retrofits can be completed within this timeframe .
Several other manufacturers of supermarket equipment, including Hussmann, Master-Bilt, Lennox, and Zero Zone, and an association representing such manufacturers—AHRI—suggested later dates for the change of status. Hussmann suggested a change of status date of 2018 for new equipment as store layouts of their customers are planned “up to three years in advance.” Another manufacturer, Lennox, requested three years from the date of any final rule, a position supported by AHRI, which also noted “alternatives are available and manufacturers have started re-designing products to minimize or eliminate the use of high GWP refrigerants.” Master-Bilt indicated that under the proposed January 1, 2016, change of status date for new supermarket systems, they would convert to HFC-134a and R-407A, but would have to address issues of energy efficiency and reliability. They believed “these HFCs will also be banned as soon as lower GWP alternatives are available” and therefore did not offer a long-term solution. Instead, they stated blends with even lower GWPs than the ones remaining acceptable would be available in 1-3 years and requested a minimum of 3 years from then to develop products. Zero Zone indicated that it has products available for R-407A and R-407C, but needs time to address performance issues.
We recognize the concern raised by Hussmann regarding store layout plans for new systems. Store design plans are generally developed well in advance of the physical change-over or construction, because of several different factors related to construction and installation as well as the need to address any commissioning, performance optimization or start-up procedures. Hussmann suggested a change of status date of 2018 to allow up to three years for design. Hussmann did not indicate if the “up to three years in advance” for planning a new design was a typical planning cycle or a rare maximum, nor did they indicate that any particular customer currently is in the planning stage but will not have equipment designed to use a refrigerant
With respect to contractor training, EPA agrees proper education and training is important, and we note that there are already many manufacturers and suppliers who have been conducting such training. For example, Hillphoenix, a manufacturer of supermarket systems and other equipment affected by this rule, operates a learning center with courses available including several on R-744 equipment.
The change of status determinations for retail food refrigeration (remote condensing units) is summarized in the following table:
For new remote condensing units, EPA proposed to list, as of January 1, 2016, nine HFC blends and HFC-227ea as unacceptable. The HFC blends are R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A. In today's final rule, we are finding that same list of nine HFC blends and HFC-227ea as unacceptable as of January 1, 2018. The change from the proposal is in response to information provided by commenters concerning technical challenges with meeting the January 1, 2016, proposed date.
A number of other refrigerants are listed as acceptable for new remote condensing units: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407A, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-422B, R-424A, R-426A, R-437A, R-438A, R-448A, R-449A, R-450A, R-513A, R-744, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02, and THR-03.
Some of these acceptable alternatives are currently in use in remote condensing unit systems in the United States, such as R-407C and R-407F. Others, such as R-744 and hydrocarbons, while not indicated as in use in the United States, are being used in limited demonstration trials in Europe and elsewhere. In addition, commenters have pointed out that testing of low-GWP HFC/HFO blends is underway; several of these HFC/HFO blends have been submitted to EPA for SNAP review in this end-use category and four are listed as acceptable.
See section V.C.2.a.1 above for a summary of our comparative assessment of the SNAP criteria (ODP, GWP, VOC, toxicity, flammability) for the refrigerants we are listing as unacceptable with the other available refrigerants. The refrigerants we are listing as unacceptable for new remote condensing units are the same as those we are listing unacceptable for new supermarket systems. Likewise, the other available refrigerants are the same for new remote condensing units as for new supermarket systems. For the same reasons as presented in section 2, EPA concludes that there are other refrigerants for use in new remote condensing units that pose lower overall risk to human health and the environment than the alternatives we are listing as unacceptable.
As explained here and in our responses to comments, EPA is establishing a change of status date for new remote condensing units of January 1, 2018.
Blends such as R-407A, R-407C and R-407F are technically viable options. We did not receive any comments suggesting that these or other alternatives that will remain acceptable could not be used in these systems. In fact, information in the docket to this rule supports the feasibility of these alternatives. For example, information in the Agency's possession from a manufacturer of remote condensing units provides an energy efficiency analysis for R-407A as compared with R-404A in remote condensing units, with results ranging from 10% lower to 1% higher in low-temperature equipment and 0% to 6% higher in medium-temperature equipment (EPA-HQ-OAR-2014-0198-0184). For unit coolers, this information showed improved results of 4.3% to 13.3% in medium-temperature applications. While the low-temperature applications showed 3.6% to 6.7% decreases, it was noted this came “as the capacity increased;” hence, we expect adjustments to the equipment could improve the efficiency while still meeting the original capacity requirements. In addition, Honeywell indicated that R-448A and R-449A, which have been submitted to SNAP for review in this end-use, are undergoing extensive field trials and that R-448A is “close to being qualified with numerous manufacturers,” indicating that manufacturers are developing equipment to use this alternative. DuPont indicates that R-449A (also referred to as DR-33 and XP40), which has been submitted to SNAP for review in this end-use, works well in their tests of a display case connected to a remote condensing unit. DuPont found that the energy consumption for this refrigerant in a remote condensing unit originally designed for R-404A was 3% to 4% less than R-404A in low-temperature tests and 8% to 12% less in medium-temperature tests.
Although there are technically viable alternatives, we recognize the testing and certification needs for this equipment. Compliance with DOE energy conservation standards will be required on March 27, 2017 for commercial refrigeration equipment and on June 5, 2017 for walk-in coolers and freezers (see also section V.C.1.b above and V.C.7 below). Commenters noted the challenges with timing for designing products with acceptable alternatives and testing these products to meet the 2017 DOE energy conservation standards for commercial refrigeration equipment and for walk-in coolers and freezers. EPA agrees with the commenters that the challenge of meeting both this status change rule and the DOE standards creates a significant technical hurdle that would be difficult to overcome by a January 2016 change of status date. A January 1, 2018, change of status date for remote condensing units recognizes the time needed for redesign and testing to meet both regulatory obligations.
For retrofit remote condensing units, EPA proposed to list, as of January 1, 2016, nine HFC blends as unacceptable: R-404A, R-407B, R-421B, R-422A, R-422C, R-422D, R-428A, R-434A, and R-507A. In today's final rule, we are establishing a change of status date for these refrigerants of July 20, 2016.
Consistent with the proposal, this action does not apply to servicing equipment designed to use these nine refrigerants or servicing equipment that was retrofitted to use those refrigerants before the January 1, 2018 status change date. For example, remote condensing units designed for use with or retrofitted to R-404A or R-507A prior to July 20, 2016, are allowed to continue to operate and to be serviced using those refrigerants.
A number of other refrigerants are listed as acceptable for retrofitting remote condensing units: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407A, R-407C, R-407F, R-417A, R-417C, R-421A, R-422B, R-424A, R-426A, R-427A, R-437A, R-438A, R-448A, R-449A, R-450A, R-513A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02, and THR-03.
Unlike retrofits of supermarket systems, which are common, retrofits of remote condensing units are unusual. However, given that the operating conditions and requirements between supermarket systems and remote condensing units are generally similar, EPA believes blends such as R-407A, R-407C and R-407F are available options.
See section V.C.2.b.1 above for a summary of our comparative assessment of the SNAP criteria (ODP, GWP, VOC, toxicity, flammability) for the refrigerants we are listing as unacceptable with the other available refrigerants. The refrigerants we are listing as unacceptable for retrofit remote condensing units are the same as those we are listing as unacceptable for retrofit supermarket systems. Likewise, the available alternatives for retrofit
EPA regulations have eliminated or will eliminate by 2020 the production and import of HCFC-22. These and other regulations also affect end users who are using CFC-12, R-502, and several HCFC-containing blends such as R-401A, R-402A and R-408A. Therefore, we believe that the impact of this action addressing retrofits will primarily affect those owners who are faced with the choice of continuing to operate systems with a refrigerant that has been phased out of production and import or to switch to a refrigerant listed as acceptable for retrofit at the time the retrofit occurs.
As noted in section V.2.b.1, millions of pounds of HCFC-22 are reclaimed every year, and this supply is available to remote condensing unit owners, operators and technicians, just as it is available for supermarket owners, operators and technicians. We also noted that many retail chains have maintained their own stockpile of HCFC-22, for instance by recovering from stores that are decommissioned or retrofitted and using such supplies to service stores that continue to operate with HCFC-22. This same strategy is possible for those who own or operate multiple facilities using remote condensing units. By establishing a change of status date of July 20, 2016, we are providing owners and operators of remote condensing units the opportunity to begin to address any HCFC-22 supply concerns they may have. Thus, owners have the option to continue to operate this equipment through its useful life with the refrigerant they are using, such as HCFC-22.
Supermarket Company ABC indicated that they have used R-407A to retrofit HCFC-22 systems and that their experience indicates the availability and viability of this and other alternatives. The success of R-407A as a retrofit refrigerant, the other available HFC blends, the additional HFC/HFO options that EPA recently listed as acceptable, and the other HFC/HFO blends that are being evaluated by chemical producers and equipment manufacturers, as well as the option of continuing to operate with HCFC-22, are sufficient to meet the various features—such as capacity, efficiency, materials compatibility, cost and supply—that affect the choice of a retrofit refrigerant.
As explained here and in our response to comments, EPA is establishing a change of status date for retrofit remote condensing units of July 20, 2016.
We did not receive any comments suggesting that alternatives that remain acceptable could not be used in these systems. As noted above, Supermarket Company ABC indicated that they have had success using R-407A to retrofit HCFC-22 systems. Results from testing of remote condensing units with R-407A and R-449A are presented above in section V.C.3.a.2. Those results showed increased energy efficiency and/or increased capacity with those refrigerants, indicating that they are viable for both new and retrofit equipment. As indicated in section V.C.1.c above, retrofits may require various changes to the existing equipment, such as different lubricants, new materials such as gaskets and filter driers, and adjustments to expansion valves. These changes include readily available materials and common refrigeration practices. Such retrofits to acceptable alternatives are already occurring, and the option to continue to operate and service existing systems remains. However, as discussed in Section V.C.2.b.2 above, comments indicate that a “new store layout” could be planned or otherwise underway, and that such layout may include the retrofitting of existing remote condensing units to a refrigerant that will no longer be acceptable. Therefore, by providing one full year from the final rule's publication, EPA is providing sufficient time for any such retrofits in this end-use category to occur as planned.
Many equipment manufacturers including: Hussmann; Continental Refrigerator; Nor-Lake; Master-Bilt Products; International Cold Storage, Crown Tonka, and ThermalRite Walk-Ins; Lennox; and Manitowoc requested later dates for the status change ranging from 2018 to 2025. In some cases the date requested applied to new equipment in other end-use categories as well as new remote condensing units. AHRI suggested a minimum of six years to transition. The North American Association of Food Equipment Manufacturers (NAFEM) and Howe Corporation submitted comments that were general rather than specific to any particular refrigeration end-use. Based on NAFEM's membership and the products Howe discussed, EPA believes these comments apply to remote condensing units and stand-alone equipment. Howe proposed that the status of R-404A and R-507A change “no sooner than year 2024” while NAFEM suggested a ten-year delay for all of the refrigeration end-uses addressed in the proposed rule and enumerated 14 tasks that they indicate are “necessary to safely introduce different/flammable refrigerants into the manufacturing process.” A separate comment from NAFEM listed five phases, totaling 10 to 12 years, to adopt hydrocarbon refrigerants but also stated that “in no case should any manufacturer be expected to transition prior to 2022.” These manufacturers and industry associations cited concerns over the availability of alternatives, the need to design and test products using those alternatives, as well as other concerns that we summarize and address in the Response to Comments Document that has been placed in the docket. Several manufacturers indicated that a January 1, 2016, change of status date would create significant difficulties in designing products with refrigerants that remain acceptable while also meeting the DOE energy conservation standards for commercial refrigeration equipment and for walk-in coolers and freezers that are scheduled to become effective in 2017 (see also section V.C.1.b above and V.C.7 below). In particular, the commenters claimed that additional development of low-temperature products may be necessary to match current efficiency levels.
Hussmann was concerned with the lead time of its customers in planning store layouts with “remote systems,” which could include remote condensing units as well as supermarket systems, and indicated that a date of 2018 would allow its customers to better determine what types of systems and refrigerants
Regarding HFC/HFO blend alternatives, Honeywell, indicates that supply of R-450A, an alternative listed as acceptable, will be available soon and that R-448A and R-449A, which are currently under SNAP review, are undergoing extensive field trials. Honeywell further stated that R-448A is “close to being qualified with numerous manufacturers,” indicating that manufacturers are developing equipment to use this refrigerant. DuPont indicated that R-449A works well in their tests of a display case connected to a remote condensing unit.
Although some use of alternatives is already occurring, we agree with the commenters that certain technical challenges still exist that support a change of status date later than we proposed for new and retrofit equipment. However, we do not agree that significant additional time is needed before alternatives listed as acceptable will be available for new equipment.
There are alternatives that are not subject to a status change that are used already in new and retrofit remote condensing units and others are being developed and deployed. As supported by the comments from FMI, many supermarkets have already transitioned away from the refrigerants we are listing as unacceptable and are using refrigerants that will remain acceptable after this final action. Supermarket Company ABC stated that alternatives were available, pointing towards their experience with R-407A in retrofits and HFC-134a, R-744 and the R-407 series in new equipment. Information in the Agency's possession from a manufacturer of such equipment, explained above, is indicative that R-407A, among other available alternatives, can be readily implemented now in new remote condensing units at medium-temperature applications both during and after meeting DOE energy conservation standards for commercial refrigeration equipment and for walk-in coolers and freezers. However, the information showed efficiency losses for this refrigerant in low-temperature applications. Although DuPont points to positive results using R-449A in a display case connected to a remote condensing unit, this refrigerant too showed lower energy efficiency in low-temperature than medium-temperature conditions. Both comments indicate that there is a more significant challenge for low-temperature applications.
Thus, while there has been significant progress in transitioning to alternatives that will remain acceptable in medium-temperature applications, there has been less progress in doing so for low-temperature applications. However, the information provided by Honeywell and DuPont indicates that significant additional time will not be needed before equipment is available. In recognition that new remote-condensing unit equipment will need to meet DOE and National Sanitation Foundation (NSF) standards, and some efficiency challenges exist particularly with low-temperature equipment, we are establishing a status change date of January 1, 2018, for new remote condensing units and July 20, 2016 for retrofits.
Given that the low-temperature results with R-407A showed only 3.6% to 6.7% efficiency declines along with capacity increases, and those from DuPont with R-449A showed a slight improvement in efficiency, we consider a status change date of January 1, 2018, to be adequate to adopt these or other acceptable alternatives into new equipment and perform any testing and certification necessary. A January 1, 2018, change of status date for new remote condensing units will allow time for manufacturers to redesign any products that require additional engineering to meet both this rule and the DOE standards. In situations where these refrigerants do not show energy efficiency improvements, other design changes as described in the DOE rulemakings and in the literature can be utilized to achieve required efficiencies. In addition, as indicated above, current research and testing on some HFC/HFO blends show similar or better energy efficiency for these products.
While we agree than a short additional amount of time is needed to address these technical challenges and the testing and certification requirements for new equipment, we disagree with commenters who suggest that a lengthy period is needed prior to the change of status. NAFEM estimated 10 to 12 years to adopt hydrocarbon refrigerants; however, as hydrocarbons are not listed as acceptable for remote condensing units, and no schedule was provided for nonflammable refrigerants, EPA views this comment as pertaining to stand-alone equipment. (See section V.C.4 below). All of the refrigerant blends that remain acceptable are nonflammable and some were designed to mimic HFC-134a and R-404A. EPA believes that these can be adopted into manufacturers' products with minor changes while still meeting the DOE requirements. The commenters failed to identify specific technical challenges that would support a more lengthy delay in the change of status date.
The change of status determination for retail food refrigeration (stand-alone equipment) is summarized in the following table:
For new stand-alone equipment, EPA proposed to list HFC-134a and 31 other refrigerants for new stand-alone retail food refrigeration equipment unacceptable, as of January 1, 2016. In today's final rule, EPA is subdividing the new retail food refrigeration (stand-alone equipment) end-use category. For new stand-alone medium-temperature units with a compressor capacity below 2,200 Btu/hr and not containing a flooded evaporator, EPA is changing the listing for HFC-134a and 30 other refrigerants from acceptable to unacceptable as of January 1, 2019. These 30 other refrigerants are FOR12A, FOR12B, R-426A, RS-24 (2002 formulation), SP34E, THR-03 and 24 additional refrigerants, listed below, for which EPA is changing the status in all types of stand-alone equipment. For new stand-alone medium-temperature units with a compressor capacity equal to or greater than 2,200 Btu/hr and all stand-alone medium-temperature units containing a flooded evaporator, EPA is changing the listing of HFC-134a and the same 30 other refrigerants from acceptable to unacceptable as of January 1, 2020. For new stand-alone low-temperature units, EPA is changing the status from acceptable to unacceptable of 24 refrigerants as of January 1, 2020. The 24 refrigerants are: HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-428A, R-434A, R-437A, R-438A, R-507A, and RS-44 (2003 formulation). While EPA proposed to change the status from acceptable to unacceptable for FOR12A, FOR12B, HFC-134a, R-426A, RS-24 (2002 formulation), SP34E, and THR-03 in all new stand-alone equipment, EPA is not changing the status for these refrigerants in this final rule in stand-alone low-temperature equipment, or for IKON B for any stand-alone equipment, for the reasons provided below. EPA clarifies below how the compressor capacity is to be determined as well as how to distinguish medium-temperature and low-temperature stand-alone equipment.
EPA has listed R-290, R-600a and R-441A acceptable subject to use conditions in new stand-alone equipment. R-290 is already in use globally, including in the United States, and R-600a is in use outside of the United States as well as in test market trials in the United States. For instance, at a recent exposition, stand-alone equipment using R-290 was displayed by multiple companies and component suppliers exhibited compressors, filter driers, controls and expansion valves that are designed to use R-290 or R-600a.
R-450A, R-513A, R-744, IKON A, IKON B and THR-02 are listed as acceptable substitutes in new stand-alone equipment without use conditions.
In the preamble to the NPRM, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable compared with other alternatives, including several refrigerants listed as acceptable (October 21, 2014, 79 FR 62863) or acceptable, subject to use conditions (April 10, 2015; 80 FR 19453) after the NPRM was issued. A technical support document that provides the additional
In summary, for stand-alone medium-temperature refrigeration equipment, the substitutes listed above that remain acceptable have zero ODP and GWPs ranging from 1 to about 630. In contrast, the alternatives that we are listing as unacceptable for stand-alone medium-temperature equipment also have zero ODP and they have GWPs ranging from approximately 900 to 3,985. Three of the substitutes that remain acceptable, R-290, R-600a, and R-441A, are or are composed primarily of VOC. EPA's analysis indicates that their use as refrigerants in this end-use are not expected to contribute significantly to ground level ozone formation (ICF, 2014e). These three substitutes are also flammable; however, the use conditions specified ensure that they do not pose greater overall risk than any of the substitutes currently listed as acceptable in new stand-alone medium-temperature equipment.
For stand-alone low-temperature refrigeration equipment, the substitutes that remain acceptable have zero-ODP and GWPs ranging from 1 to about 1,500. The alternatives we are listing as unacceptable have GWPs ranging from approximately 1,800 to 3,985. For the other risk criteria we review, the analysis provided above for stand-alone medium-temperature refrigeration equipment applies also to for the alternatives that remain acceptable and those we are listing as unacceptable. Because the risks other than GWP are not significantly different for the other available alternatives than for those we proposed to list as unacceptable and because the GWP for the refrigerants we proposed to list as unacceptable is significantly higher and thus poses significantly greater risk, we are listing the following refrigerants as unacceptable for new stand-alone low-temperature refrigeration equipment: HFC-227ea, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407A, R-407B, R-407C, R-407F, R-410A, R-410B, R-417A, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-428A, R-434A, R-437A, R-438A, R-507A, and RS-44 (2003 formulation).
We are establishing a status change date of January 1, 2019, for new stand-alone medium-temperature equipment with a compressor capacity below 2,200 Btu/hr and not containing a flooded evaporator, and a status change date of January 1, 2020, for all other types of new stand-alone equipment. For this equipment, there are several alternatives that can meet the technological needs of the market. EIA states that “R-744, R-290, R-441A, and isobutene (`R-600a') can satisfy the vast majority of the current market for refrigerants in stand-alone equipment.” We are aware of products using R-290, R-600a and R-744 that are already on the market. According to Shecco, based on its October 2014 survey, the manufacturers of stand-alone equipment they surveyed “are already today able to produce sufficient amount of such [R-290, R-600a and R-744] equipment to cover the needs of the entire market. All of the interviewed manufacturers confirmed that they plan to covert [sic] their whole manufacturing facilities to hydrocarbons and/or CO2 by 2018/2019 latest.” While the alternatives that remain acceptable will be able to meet the technical constraints for this equipment, time will be needed for the transition to occur. On the aspect of timing, Shecco, Supermarket Company ABC, Hatco, and H&K International suggested a 2018 change of status date, while DuPont and Honeywell suggested 2017. NRDC and IGSD believed EPA should maintain the proposed January 1, 2016, change of status date. In contrast, numerous other manufacturers of stand-alone equipment indicated concerns with hydrocarbons and R-744, and some referenced HFC/HFO blends as a potential solution. They recommended change of status dates ranging from 2020 to 20 years after the rule becomes final. While we agree that manufacturers will be able to produce equipment using lower-GWP refrigerants addressing a large portion of the market in the period of 2016-2018, we also agree that there are some technical challenges that support a change of status date of 2019 or 2020 for this end-use category.
Manufacturers indicated several necessary steps that will need to occur, including development and testing of components, such as compressors and condensing units, for the full range of stand-alone products. In addition, engineering, development, and testing to meet standards, such as those from UL, DOE and NSF, of the products would start as components became available. Modifications to the factory could be required, ranging from a simpler change of the refrigerant storage area to reconfiguration of the factory to address concerns such as ventilation or other safety measures. Information submitted by the commenters supported that these actions could take a few months or up to a couple of years. However, it is likely that these actions could occur simultaneously with other steps such as equipment design and testing.
Manufacturers identified three distinct refrigerant types. For hydrocarbons, including R-290, we do
EPA believes that much of the component and equipment development can occur at the same time; in other words, as certain components become available, appropriate units could be redesigned using those components, prototypes could be built and tested, and final designs could be produced, while additional components are released. Indeed, it appears that many manufacturers have already identified a portion of their products that they could redesign using R-290, as discussed below. Once product models are designed, testing and certification could take place.
In summary, to use hydrocarbon refrigerants, such as R-290, the comments support that approximately three and a half years is needed for equipment to become fully available. This includes one to two years to develop additional components beyond those that are currently available and to test the current and newly developed components in models. Equipment development and testing would occur in series, with the final units being developed and ready for testing approximately one year after the components for that unit were available. Testing and certification would likewise occur as products were developed and would span two to three years, much of which while other actions are occurring. We estimate the final units might take an additional six months to a year to test and certify once developed. As discussed above, any required modifications to the factory line and facilities would occur concurrently if a manufacturer chose to use R-290 or another acceptable hydrocarbon refrigerant. Hence, EPA believes that new stand-alone equipment for medium-temperature applications with a compressor capacity below 2,200 Btu/hr and not containing a flooded evaporator could be available and in compliance with a status change date of January 1, 2019.
The steps in developing products for R-744 would be similar and on a similar time frame as those for hydrocarbons. However, although R-744 is in wide supply, as supported by commenters such as Hillphoenix, Coca-Cola, Parker-Hannifin, and HC Duke & Son/Electro-Freeze, there has been limited development of components and development of necessary components in a variety of sizes could take two to three years.
Designing stand-alone equipment with R-744 presents challenges such as the need for a complete system redesign due to higher pressures and the different thermodynamic and transport properties. Additionally, as supported by commenters such as HC Duke & Son/Electro-Freeze, while CO
Although it may not be feasible to develop R-744 equipment for the full spectrum of stand-alone equipment by a status change date of January 1, 2019, other alternatives, such as the hydrocarbons and HFC/HFO blends would be available for those uses by the January 1, 2019, status change date.
The third group of alternatives is the HFC/HFO blends. Refrigerant producers DuPont and Honeywell provided detailed comments on the development of specific HFC/HFO blends and EPA listed one of these, R-450A, as acceptable in October 2014. Concurrently with this rule, EPA is also listing R-513A as acceptable in all stand-alone equipment and two additional HFC/HFO blends, R-448A and R-449A, acceptable in stand-alone low-temperature equipment.
Some samples of these refrigerants are available today and are being tested, as supported by comments from AHRI. However, supplies of some of these blends are limited at this time because of limits on some of the HFO components, HFO-1234yf and HFO-1234ze(E). However, as discussed above in section V.C.2.a.1, production facilities for these refrigerants have commenced operation and thus, as supported by Honeywell and DuPont, we expect adequate supplies to be available by January 2017 if not before. Unified Brands and Structural Concepts indicated that components for HFC/HFO equipment are being tested and developed today and Unified Brands further projected that it would be three years for a full line of production-ready components.
HFC/HFO blends found acceptable to date or submitted to the SNAP program are nonflammable, acceptable without use conditions, and designed to mimic the performance of either HFC-134a or R-404A, refrigerants in predominant use currently. Thus, as compared with hydrocarbons and R-744, there should be fewer technical challenges in developing equipment using these alternatives. Several commenters, including Master-Bilt, Structural Concepts, and Hoshizaki America, supported that transition to these alternatives would be simpler and quicker once components have been developed and there are adequate supplies.
In summary, should manufacturers choose to pursue HFC/HFO blends, EPA expects such equipment would be widely available in about four years and that R-450A could be available earlier as it was the first such blend found acceptable under SNAP. This includes one to two years for supplies to become widely available, approximately one year for development and testing of components, and approximately one year for equipment development. The short time for development of components and equipment is due to the fact that the properties of the blends are similar to the refrigerants most manufacturers are currently using. Similarly, we expect that there would be limited factory modifications, if any, and that these could occur concurrently with the design work. As with other refrigerants, EPA would expect equipment testing and certification to be rolled out as equipment models are redesigned, with the last units being available approximately six to twelve months after designs are developed.
We are finalizing a status change date of January 1, 2020, for stand-alone low-temperature retail food refrigeration units; stand-alone medium-temperature retail food refrigeration units with a compressor capacity equal to or exceeding 2,200 Btu/hr; and stand-alone retail food refrigeration units employing a flooded evaporator.
For these three types of stand-alone equipment, we find that an additional year beyond January 1, 2019, is needed for the change of status. For equipment using a flooded evaporator, Emerson indicated the lower-GWP refrigerants are all “high glide” often in the range of 7 °F to 10 °F (3.9 °C to 5.6 °C), and that such a characteristic presents unique redesign and performance challenges. Because of this unique design challenge that will require additional time to address, we are establishing a January 1, 2020, change of status date for new stand-alone equipment that utilizes a flooded evaporator.
The second segment of the stand-alone equipment end-use category that we found faced particular technical
We believe that these technical challenges for stand-alone low-temperature equipment will mean the date upon which technically feasible solutions are available will be later than small, medium-temperature equipment. For this reason, we are finalizing a change of status date of January 1, 2020, for stand-alone low-temperature equipment.
EPA points to the 2014 ASHRAE Handbook on Refrigeration, Chapter 15, which reads “medium-temperature refrigeration equipment maintains an evaporator temperature between 0 and 40 °F [−18 and 4.4 °C] and product temperatures above freezing; low-temperature refrigeration equipment maintains an evaporator temperature between −40 and 0 °F [−40 and −18 °C] and product temperatures below freezing.” We believe the product temperature is a more widely understood criteria, especially amongst equipment owners and users and for purposes of compliance, and therefore clarify here that for purposes of this rule “stand-alone medium-temperature equipment” is defined as that which is designed to maintain product temperatures above 32 °F (0 °C) and “stand-alone low-temperature equipment” is defined as that which is designed to maintain product temperatures at or below 32 °F (0 °C).
For large stand-alone equipment with additional cooling capacity requirements, there are challenges with using a number of the lower-GWP refrigerants because the refrigerants are subject to use conditions, including a restriction limiting the charge size to 150 grams per circuit. The charge size use condition applies to the alternative refrigerants that are the farthest along in design and testing for this end-use category, specifically, R-290 and R-600a. Because larger equipment often needs refrigerant charges that are larger than those provided in the use conditions, we sought comment on possible technical challenges in transitioning to another alternative and asked how charge size limits for these flammable refrigerants might affect our determination of whether and when alternatives that pose lower risk are available for larger equipment. In the NPRM, we sought comment on the possibility of establishing a use restriction that would allow continued use of some refrigerants for which we would otherwise change the status in “large” stand-alone equipment. We sought comment on how we could define “large” and “small” stand-alone units in particular considering charge size.
Several commenters addressed these issues during the comment period. Lennox said that over 98% of its “basic, self-contained refrigeration models exceed 500 grams of refrigerant charge,” precluding the use of flammable refrigerants in just one circuit. Manitowoc and Nor-Lake indicated that if they were to use R-290, multiple refrigeration circuits would be required considering the 150 gram use condition that applies to that refrigerant. Some manufacturers discussed the technical difficulties with using multiple circuits. Hillphoenix noted that the use of multiple compressors, each tied to an individual condensing unit, would require “more complex control synchronization that customers must be willing to master” and raised a concern about whether customers would do so. For some equipment, space constraints would limit the practicality of using multiple, separate refrigeration circuits. Minus Forty indicated that “A significant number of our models cannot be or would be very impractical to transition to R-290 due to their size, shape, and custom uniqueness.” Nor-Lake stated that multiple circuit equipment would use more energy and believed that the “energy efficiency of a dual system may also create issues with meeting DOE energy requirements.”
EPA agrees that there are additional technical challenges faced in converting this equipment that use large charge sizes. In some instances, the challenge may be in developing multi-circuit systems that use refrigerants subject to the charge-size use limits. In other cases, where multiple circuits are not an option, these manufacturers will need additional time to evaluate refrigerants R-744 or the newly listed HFC/HFO blends R-448A, R-449A, R-450A and R-513A. Therefore, we have established a later status change date of January 1, 2020, for “large” stand-alone equipment.
A few commenters addressed how EPA could distinguish “small” from “large” stand-alone equipment. Nor-Lake suggested a dividing line and recommended that it could be set based on compressor capacity, pointing to 2,400 Btu/hr and 2,200 Btu/hr for medium and low-temperature freezer systems, respectively. Hillphoenix also recommended looking at refrigerant capacity and performed an analysis that, under specific design prescriptions, indicated the maximum capacity achievable using 150 grams of R-290 would be 4,800 Btu/hr and 1,600 Btu/hr for medium-and low-temperature applications, respectively. Supermarket Company ABC suggested making a distinction based on interior volume and refrigeration requirements, but did not offer specifics. Southern Case Art indicated difficulty with using R-290 in its products that are open-display units reaching capacities up to 25,000 Btu/hr. Unified Brands indicated R-290 compressors are available to provide cooling capacity up to 5,000 Btu/hr for medium-temperature and 2,000 Btu/hr in low-temperature applications. Traulsen requested a narrowed use exemption for “large stand-alone units requiring 2 or more systems to operate within the 150 gram limit.”
We believe that the compressor capacity limits are a reasonable, easily-understood and easily-enforceable method to distinguish between products that may be unable to rely on flammable refrigerants or that will face greater challenges in doing so, and those that are more easily able to use flammable refrigerants consistent with the 150-gram charge size limits established in the use conditions. We considered separate capacity limits for medium and low-temperature systems as suggested by Nor-Lake and analyzed by Hillphoenix, but determined that establishing just one value would provide more clarity and ease of implementation. We chose the lower of Nor-Lake's capacity of 2,200 Btu/hr as a dividing line and explain how this applies further below. In setting one value, however, we considered the similarity of the capacities suggested by Nor-Lake, and the fact that these came within the range of sizes analyzed by Hillphoenix.
Although the 2,200 Btu/hr compressor capacity delineation was based on the particular comment from Nor-Lake, neither that commenter nor others
For retrofit stand-alone equipment, EPA proposed to change the listing for R-404A and R-507A from acceptable to unacceptable as of January 1, 2016. In today's final rule, we are establishing the change of status date of July 20, 2016.
This action does not apply to servicing existing equipment designed for those two refrigerants or servicing equipment that was retrofitted to use those refrigerants before the January 1, 2016, status change date. For instance, equipment designed for use with or retrofitted to R-404A prior to July 20, 2016, would be allowed to continue to operate using and could be serviced with R-404A.
While we do not believe retrofits are common in stand-alone retail food refrigeration equipment, a number of refrigerants are listed as acceptable for this purpose: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407A, R-407B, R-407C, R-407F, R-417A, R-417C, R-421A, R-421B, R-422A, R-422B, R-422C, R-422D, R-424A, R-426A, R-427A, R-428A, R-434A, R-437A, R-438A, R-450A, R-513A, RS-24 (2002 formulation), RS-44 (2003 formulation), SP34E, THR-02, and THR-03.
In the preamble to the NPRM, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable compared with other available alternatives. A technical support document that provides the additional
Commenters did not indicate any technical challenges in retrofitting stand-alone equipment with the refrigerants that remain acceptable. In fact, EIA felt “The poor energy efficiency performance of R-404A is another compelling reason to delist this refrigerant and replace it with R-134a for retrofits, which by comparison, has shown a 10 percent efficiency gain.” EPA does not believe retrofits are nearly as common for stand-alone equipment as for other retail food refrigeration uses considered in this final rule, particularly supermarket systems. However, similar to the other types of retail food refrigeration addressed today, EPA is providing one year to ensure that any retrofits that are already underway will have sufficient time to be completed. Therefore, we are establishing a change of status date of July 20, 2016.
Commenters suggested a wide-range of dates for the status change for new equipment. NRDC and IGSD urged EPA to maintain the proposed status change date of January 1, 2016 for new stand-alone units. These commenters pointed out that coolers using transcritical R-744 have already been developed. Unified Brands stated “it will be impossible to convert all our equipment from R134a and R404A to R290 by 2016.”
A number of commenters supported a change of status a year or two later than that proposed. Two refrigerant
Other commenters supported a much later change of status date for new equipment. Approximately 30 manufacturers, two industry associations representing equipment manufacturers (AHRI and NAFEM), an association representing supermarkets (FMI), and a beverage supplier (Coca-Cola) suggested dates ranging from 2020 to 2025. True Manufacturing, indicated they have been shipping products using hydrocarbons and R-744 for several years. Hillphoenix provided a refrigerant change schedule that discussed the development of R-744, hydrocarbons and HFO blends; this schedule suggested various dates for different tasks for these three refrigerant types. Based on the timeframes associated with these tasks, they suggested a change of status date of January 1, 2022, for stand-alone equipment. Lennox believed the NPRM “generally contemplates a wholesale switch to hydrocarbon refrigerants” in stand-alone equipment. NAFEM indicated it would “take ten to twelve years for manufacturers to convert their product lines to use isobutene or propane.”
As pointed out by Honeywell and DuPont, some of the HFC/HFO blend alternatives, such as R-448A, R-449A, R-450A and R-513A, can be used with little adjustment to existing designs, show energy efficiencies equal to or better than current refrigerants. While there is not currently sufficient supply of these refrigerants, Honeywell and DuPont have indicated that production facilities for the components are on-line (see V.C.2.a.1 above) and that the blends will be made available after listed acceptable with SNAP. As noted previously, Honeywell has stated that R-450A supplies will be “available soon” and multiple component manufacturers are developing equipment that uses these alternatives. Hillphoenix's refrigerant change schedule indicates that “Lab/User Testing” and “Test & Verification” is already underway with such blends. These blends offer equipment manufacturers additional energy efficient options to rapidly transition out of refrigerants listed as unacceptable while also avoiding some of the concerns (
Several commenters pointed out that at least some part of their product line can be converted to R-290 and some manufacturers are already offering products to the market using these options. For instance, Hillphoenix's refrigerant change schedule indicates that the step of “Convert Products” for “Hydrocarbons (on applicable systems)” can begin in 2015 and continue after that until 2020. They did not provide a full explanation of why the process would continue until 2020; however, EPA sees from commenters that there will be time necessary to develop products and have them undergo the testing and certification necessary to sell such products. EPA believes that by our status change dates of 2019 and 2020, and not before, manufacturers will be able to complete the development of products using R-290 or other hydrocarbons. EPA also believes that testing and certification resources are available to meet this deadline, and that more can be created if there is a demand for them.
As many commenters pointed out, compliance with new DOE energy conservation standards for certain commercial refrigeration equipment is required on March 27, 2017 and for stand-alone walk-in coolers and freezers is required on June 5, 2017 (see also sections V.C.1.b and V.C.7). EPA is establishing change of status dates of
The change of status determination for vending machines is summarized in the following table:
EPA proposed to change the listing for HFC-134a and 20 other refrigerants for new vending machines from acceptable to unacceptable as of January 1, 2016. In today's final rule, EPA is changing the listing for HFC-134a and 19 other refrigerants for new vending machines from acceptable to unacceptable as of January 1, 2019. While EPA proposed to change the status from acceptable to unacceptable for IKON B, EPA is not changing the status for this refrigerant in this final rule for the reasons provided below.
The 19 other refrigerants in addition to HFC-134a are: FOR12A, FOR12B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-404A, R-407C, R-410A, R-410B, R-417A, R-421A, R-422B, R-422C, R-422D, R-426A, R-437A, R-438A, R-507A, RS-24 (2002 formulation), and SP34E.
A number of other refrigerants are acceptable or acceptable subject to use conditions for new vending machines: IKON A, IKON B, R-290, R-441A, R-450A, R-513A, R-600a, R-744, and THR-02.
In the NPRM, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable and those that remain acceptable. Subsequent to the issuance of the proposal, EPA listed R-290, R-441A and R-600a, as acceptable, subject to use conditions (April 10, 2015, 80 FR 19453). In addition, concurrently with this rule, EPA is listing R-450A and R-513A acceptable in new vending machines. A technical support document that provides the additional
EPA is establishing a change of status date for the specified HFC refrigerants in new vending machines of January 1, 2019.
For new vending machines, there are several alternatives that can meet the technological needs of the market. EIA states that “R-744, R-290, R-441A, and isobutene (`R-600a') can satisfy the vast majority of the current market for refrigerants in . . . vending machines.” We are aware of products using R-290 and R-744 that are already in use. According to Shecco, based on its October 2014 survey, the manufacturers
Commenters indicated several necessary steps that will need to occur, including development and testing of components, such as compressors, for the full range of vending machines. In addition, engineering, development, and testing to meet standards, such as those from DOE, of the products would start as components became available. Modifications to the factory could be required, ranging from a simpler change of the refrigerant storage area to reconfiguration of the factory to address concerns such as ventilation or other safety measures. Information submitted by the commenters supported that for the portion of the vending machines that have not already transitioned to a lower-GWP refrigerant, these actions could take a few months or up to a couple of years. However, it is likely that these actions could occur simultaneous with other steps such as equipment design and testing.
One manufacturer identified two refrigerant types: R-744 and hydrocarbons. Refrigerant producers also pointed towards HFC/HFO blends as a third group. For R-744, we do not see any question regarding refrigerant supply. Information submitted by the commenters support that some components are already available. Coca-Cola indicated time was needed for testing and certifying new models of vending machines; however, additional information indicated that various types of R-744 vending machines are already available or are expected to be available by January 1, 2016. Pepsi has test-marketed R-744 vending machines in the United States as early as 2009.
Comments also supported that some components and equipment using hydrocarbons are available. AMS stated that one hurdle for using R-290 is finding 120-volt, 60-hertz components for the U.S. and Canadian markets. AMS also echoed the concern of Coca-Cola that more time is needed for testing and certifying new models of vending machines. EPA agrees time beyond the originally proposed January 1, 2016, status change date is necessary for further development of R-290 components and for necessary testing and certification of R-290 vending machines. Information in the comments indicate that some R-290 components are available from multiple suppliers and we believe that these components could be employed in vending machines.
In summary, to use hydrocarbons refrigerants, comments support that approximately three and a half years are needed for equipment to become fully available. This includes six months to test and design products using the available R-290 components and an additional year to two years for development of other components and equipment designs. Equipment development and testing would occur in series, with the final units being developed and ready for testing approximately six months after the components for that unit were available. Testing and certification would likewise occur as products were developed and would span up to three years, much of which while other actions are occurring. We estimate the final units might take an additional six months to test and certify once developed. As discussed above, any required modifications to the factory line and facilities would occur concurrently if a manufacturer chose to use R-290 or another acceptable hydrocarbon refrigerant. Hence, EPA believes that new vending machines could be available and in compliance with a status change date of January 1, 2019.
Comments also support that other options besides R-744 and hydrocarbons may be explored for those products that have not yet transitioned. Concurrently with this rule, EPA is listing two HFC/HFO blends, R-450A and R-513A, as acceptable for new vending machines. Although commenters did not indicate a current supply of components for these refrigerants, information indicates that component suppliers are committing additional resources to develop them. EPA believes their adoption can happen quickly as they are both nonflammable blends and are designed to mimic the performance of HFC-134a, the only refrigerant indicated by a manufacturer as used in its vending machines. As noted earlier, Honeywell, the producer of R-450A, indicated that it will be supplying that refrigerant soon. We expect that the refrigerant producers will be able to fully supply these blends in a year or two. EPA expects that components designed for the vending machine market using one or both of these blends could be developed within the next year to eighteen months as more refrigerant supplies become available. As components become available, additional design and testing in vending machines could begin. Because the comments indicated only one refrigerant to be replaced, and because the HFC/HFO blends are designed to mimic that refrigerant, equipment development time for vending machines is expected to be shorter than other end-uses, perhaps adding only six months. Limited factory modifications, if any, could happen concurrently with the design work. As with other refrigerants, EPA would expect equipment testing and certification to be rolled out as equipment models are redesigned, with the last units being available approximately six months after designs are developed.
In summary, we find that HFC/HFO blends could be implemented to meet the January 1, 2019, status change date for new vending machines.
For retrofit vending machines, EPA proposed to change the listing for R-
This action does not apply to servicing existing equipment designed for those two refrigerants or servicing equipment that was retrofitted to use those refrigerants before the January 1, 2016, status change date. For instance, vending machines designed for use with or retrofitted to use R-404A or R507A prior to July 20, 2016, would be allowed to continue to operate using and could be serviced with that refrigerant.
A number of refrigerants are acceptable for retrofitting vending machines: FOR12A, FOR12B, HFC-134a, IKON A, IKON B, KDD6, R-125/290/134a/600a (55.0/1.0/42.5/1.5), R-407C, R-417A, R-417C, R-421A, R-422B, R-422C, R-422D, R-426A, R-437A, R-438A, R-448A, R-449A, R-450A, R-513A, RS-24 (2002 formulation), SP34E, and THR-02.
We do not believe retrofits are common in vending machines. Many of the refrigerants remaining acceptable are blends with small amounts of hydrocarbons. The hydrocarbon content allows the possibility of retrofitting equipment from an ODS (which would have used alkylbenzene or a mineral oil) without changing the lubricant, whereas usually a polyolester is required when retrofitting to an HFC or HFC blend. Thus we believe these refrigerants would prove successful in retrofits of vending machines, should such a retrofit be desired by the owner.
In the preamble to the NPRM, EPA provided information on the risk to human health and the environment presented by the alternatives that are being found unacceptable and those that remain acceptable. A technical support document that provides the additional
Commenters did not indicate any technical challenges in retrofitting vending machines with the refrigerants that remain acceptable. In fact, EIA felt “The poor energy efficiency performance of R-404A is another compelling reason to delist this refrigerant and replace it with R-134a for retrofits, which by comparison, has shown a 10 percent efficiency gain.” As discussed above, however, commenters indicated that plans may be underway and that adequate time should be given to allow for those plans to be implemented or changed. Therefore, we are establishing a change of status date of July 20, 2016.
We do not agree with NAMA that the switch away from CFC-12 in the mid-1990s supports a four, five or even eight year period. The phaseout of CFC-12 consumption was January 1, 1996, less than two years after the initial SNAP listings were issued. Regardless, each transition is unique and the timing for transitions can vary end-use by end-use and even for the same end-uses depending on a number of factors, such as whether alternatives that perform similarly to the current refrigerant can be used or whether significant design changes may need to occur.
Regarding this current action for vending machines, the transition away from the substitutes we are listing as unacceptable is already underway based on public commitments made by some of the largest purchasers of vending machines. Shecco conducted a survey of vending machine manufacturers in October 2014 and found that all were planning to convert to hydrocarbons and/or R-744 in the 2018/2019 timeframe at the latest. Many companies have already made significant progress. For example, the Coca-Cola Company has placed over 1.4 million HFC-free
Thus, although significant progress has been made, in particular with the use of R-744 in vending machines that dispense canned beverages, it is necessary to provide some additional time beyond the proposed date of January 1, 2016 to allow further development of components for different types of vending machines and also to allow further development of components using other alternative refrigerants.
Regarding the suggestion that we establish a specific numerical limit for GWP, as noted in Section IV.B, the structure of the SNAP program, which is based on a comparative framework of available substitutes at the time a decision is being made, does not support the use of such limits. We note that in making our decision for new and retrofit supermarket systems and remote condensing units, EPA pointed to the multi-year history of the successful use of some blends that remain acceptable to support the “availability” of alternatives that pose less risk than those we are listing as unacceptable. Many of these blends have GWPs higher than the limits recommended by the commenters. Thus, at this time, we do not believe an analysis of refrigerants below those limits recommended by the commenters with those above the limit and which remain acceptable would support a conclusion that the lower-GWP refrigerants are available for use, as many have not been demonstrated to be technically feasible for products and systems in these specific end-use categories. As noted previously, there are a number of technical challenges that must be addressed in selecting a refrigerant for use in a specific system and we do not have information supporting use of these lower-GWP refrigerants. However, as we see from the current action, the refrigeration industry has made great progress in the last five to ten years in moving toward lower-GWP alternatives and we see that momentum continuing. Therefore, it is possible that at some future date, we could determine to list additional alternatives as unacceptable based on a determination that there are lower-GWP alternatives available that, based on consideration of the SNAP review criteria, pose lower overall risk.
The HFC/HFO blend alternatives, identified above, are nonflammable and operate at similar characteristics to those subject to the status change and therefore technicians should require only minimal extra training to use them. Because different change of status dates apply for the different refrigeration end-uses technicians will have an opportunity to stagger training relevant for the different end-uses and they can build their skills across those end-uses over time.
DOE has promulgated, in separate rulemakings and under separate authority, energy conservation standards for several types of equipment, including products that are affected by this rule. See section V.C.1.b for information regarding DOE energy conservation standards that are applicable to the equipment addressed in this rule. New equipment subject to this rule would need to meet the DOE requirements and the requirements of the status change by the dates established in these rules.
We note that we do not have a practice in the SNAP program of including energy efficiency in the overall risk analysis. We do, however, consider issues such as technical needs for energy efficiency (
The efficiency can change based on the refrigerant chosen and there are various metrics, such as Total Equivalent Warming Impact (TEWI) and Life Cycle Climate Performance (LCCP), that account for climate effects of both emissions of the refrigerant and the possible emissions of greenhouse gases, primarily carbon dioxide, from the source of power to operate equipment. Quantification of the portions of TEWI/LCCP from the refrigerant and energy use can only be done using broad assumptions that would not be applicable to all users of the myriad equipment models that are affected by today's rule. As noted in section V.C.1.b, energy conservation standards set by the DOE apply to some of the equipment covered by today's rule (
Throughout the history of the SNAP program, EPA has seen the energy efficiency of refrigeration and air-conditioning equipment increase, despite changing refrigerant options. In some cases, this was because new chemicals were developed that possessed unique properties that allowed high energy efficiency levels to be obtained. In many cases, technological improvement and optimization of equipment designs and controls has increased energy efficiency. Although today's rule lists some refrigerants as unacceptable, we do not believe it will have a detrimental effect on this trend in increased energy efficiency. In fact, there are multiple case studies available that highlight the energy efficiency gains achieved by some of the low-GWP refrigerants, such as R-744, which remains acceptable for the refrigeration end-uses addressed in this rule, and R-290 and R-600a, which remain acceptable subject to use conditions for new stand-alone equipment and new vending machines. (EPA-HQ-OAR-2014-0198-0134, Refrigeration and Air Conditioning Magazine, 2015).
Theoretical and prototype testing show similarly good energy efficiency results. For instance, in supermarket refrigeration, a theoretical analysis (Emerson Climate Technologies, 2014) examined the energy use of R-407A and R-410A, both of which are on the list of acceptable substitutes, against that of R-404A, which is listed as unacceptable in new supermarket systems as of January 1, 2017. Although this analysis found that both blends would see a 3.6% to 6.7% drop in efficiency in the low-temperature part of the store (
The analysis also showed a slightly higher energy consumption by stand-alone equipment designed to use other alternatives as compared with one designed to use R-404A. One user of stand-alone equipment did not provide any specific results, but stated that “HC freezers are significantly more energy-efficient.” (Ben and Jerry's, 2014). True recently displayed several stand-alone units using R-290 refrigerant that were reported to be 15% more efficient than similar equipment using HFC-134a and R-404A.
Similar results are being seen with vending machines. As noted in the NPRM, one purchaser of vending machines indicated that while introducing over one million units using R-744, they have increased the energy efficiency of their cooling equipment over 40% since 2000, at which time such equipment was exclusively using HFC-134a (Coca-Cola, 2014). More recently, it was reported that 78% of Coca Cola's models (vending machines and stand-alone cases) perform more efficiently than HFC units. (Refrigeration and Air Conditioning Magazine, 2015). Furthermore, it has been reported that PepsiCo has placed nearly one million hydrocarbon vending machines on the market and that these use 20% less energy than ENERGY STAR requirements.
As new products are designed to use particular refrigerants, manufacturers have the opportunity to change designs to take advantage of a given refrigerant's characteristics. The redesign and development phase is also an opportunity to improve other components that will affect the overall efficiency of the equipment, such as the use of more efficient motors and compressors, improved heat exchangers, better controls, improved insulation (
Foams are plastics (such as PU or polystyrene) that are manufactured using blowing agents to create bubbles or cells in the material's structure. The foam plastics manufacturing industries, the markets they serve and the blowing agents used are extremely varied. The range of uses includes building materials, appliance insulation, cushioning, furniture, packaging materials, containers, flotation devices, filler, sound proofing and shoe soles. Some foams are rigid with cells that still contain the foam blowing agent, which can contribute to the foam's ability to insulate. Other foams are open-celled, with the foam blowing agent escaping at the time the foam is blown, as for flexible foams.
A variety of foam blowing agents have been used for these applications. Historically, CFCs and HCFCs were typically used to blow foam given their favorable chemical properties. CFCs and HCFCs are controlled substances under
HCFCs, which have a longer phase-out period than CFCs since they are less potent ozone-depleting substances, have continued to be used to some extent as foam blowing agents. In addition, the SNAP program has found acceptable a variety of non-ODS blowing agents, including HFCs (
Blowing agents are approved on an end-use basis. The SNAP program considers the following end-uses:
• Rigid PU (appliance foam) includes insulation foam in domestic refrigerators and freezers.
• Rigid PU (spray, commercial refrigeration, and sandwich panels) includes buoyancy foams, insulation for roofing, wall, pipes, metal doors, vending machines, coolers, and refrigerated transport vehicles.
• Rigid PU (slabstock and other) includes insulation for panels and pipes.
• Rigid PU and polyisocyanurate laminated boardstock includes insulation for roofing and walls.
• Flexible PU includes foam in furniture, bedding, chair cushions, and shoe soles.
• Integral skin PU includes car steering wheels, dashboards, and shoe soles.
• Polystyrene (extruded sheet) includes foam for packaging and buoyancy or flotation.
• Polystyrene (extruded boardstock and billet) includes insulation for roofing, walls, floors, and pipes.
• Polyolefin includes foam sheets and tubes.
• Phenolic insulation board and bunstock includes insulation for roofing and walls.
For foam blowing end-uses, EPA proposed to change the status for several substitutes, as of January 1, 2017, as follows:
• HFC-134a and blends thereof as unacceptable for all end-uses;
• HFC-143a, HFC-245fa and HFC-365mfc and blends thereof; and the HFC blends Formacel B, and Formacel Z-6 as unacceptable in all foam blowing end-uses where they were on the list of acceptable substitutes at the time of proposal, except for rigid PU spray foam; and
• The HFC blend Formacel TI as unacceptable in all foam blowing end-uses where it was on the list of acceptable substitutes at the time of proposal.
After considering the comments received on the proposed rule, EPA is making several changes to what it proposed in this final action. First, EPA is creating narrowed use limits for HFC-134a and blends thereof, for HFC-365mfc and blends thereof, and HFC-245fa and blends thereof for all foam blowing end-uses except rigid PU spray foam. EPA is also creating narrowed use limits for certain HFC blends, including Formacel TI, Formacel Z-6, and Formacel B, for those end-uses that were on the list of acceptable substitutes at the time of proposal. For all these substitutes, the narrowed use limits would be for military or space- and aeronautics-related applications where reasonable efforts have been made to ascertain that other alternatives are not technically feasible due to performance or safety requirements. For all other uses in these identified end-uses, the status would change to unacceptable, with the exception of rigid PU spray foam, for which we are not taking final action in this rule. Second, we are establishing change of status dates that range from January 1, 2017, to January 1, 2021. And, further, for the uses subject to the narrowed use limits, the status would change to unacceptable as of January 1, 2022. The change of status determination for each end-use is summarized in the following table:
In the NPRM, EPA included a comparative analysis, end-use by end-use, of the substitutes for which EPA proposed to change the status and the other available alternatives. 79 FR at 46151 to 46154. Most of the other alternatives that EPA identified as having lower risk than those for which we proposed to change the status have zero ODP or have negligible impact on stratospheric ozone. One alternative that contains chlorine,
Most of the substitutes that remain acceptable are not VOC (
Some of the substitutes that remain acceptable are flammable, but the hazards of these flammable compounds can be adequately addressed in the process of meeting OSHA regulations and fire codes in all end-uses except certain rigid PU spray foam applications. Examples of acceptable flammable blowing agents are HFC-152a, ecomate, Exxsol blowing agents, methylal, methyl formate, and saturated light hydrocarbons.
Although EPA has listed a number of flammable alternatives as acceptable for most foam end-uses, that is not the case for rigid PU spray foams. Some of the lower-GWP, flammable alternatives that are listed as acceptable in other foam blowing end-uses, such as C3-C6 hydrocarbons and methylal, are not acceptable for use in rigid PU spray foam. For rigid PU spray foam applications, flammability risks are of particular concern, because they are applied onsite, sometimes in proximity to hot, flammable substances such as tar. Flammability risks are more difficult to mitigate in rigid PU spray foam than in most other foam end-uses because, unlike in a factory setting, in many cases ventilation cannot be provided that removes flammable vapors and maintains them below the lower flammability limit, and it is not practical to make all electrical fixtures explosion proof when applying rigid PU spray foam in a residential building. There are three main types of rigid PU spray foam: High-pressure two-part spray foam systems, low-pressure two-part spray foam systems, and one-component foam sealants.
For rigid PU spray foam, we are not taking final action in this rule. We intend to conduct a more extensive comparative risk analysis of the substitutes available before taking final action. Thus, the substitutes currently listed as acceptable for spray foam are not affected by this rule but may be the subject of future rulemaking.
For more information on the environmental and health properties of the different foam blowing agents, please see the proposed rule at 79 FR 46151 to 46154 and a technical support document that provides additional
For foam blowing agents, the time at which the status will change varies by end-use.
For the
For
For the
For all other foam blowing end-uses for which we are taking final action, we received comments identifying technical challenges that mean other alternatives would not be available until a later date than January 1, 2017. Systems houses and appliance manufacturers also mentioned the need for third-party testing for end-uses such as extruded polystyrene boardstock and billet, rigid PU appliance, and rigid PU commercial refrigeration and sandwich panels. Systems houses and DuPont, a manufacturer of foam blowing agents, also were concerned with the supply of lower-GWP foam blowing agents, especially supply of HFOs (HFO-1234ze(E) and HFO-1336mzz(Z)) and
For
For
For
For
For
For
We proposed to create a narrowed use limit exception to the unacceptable listing for military and space, and aeronautics uses that would allow continued use of HFC and HFC blend foam blowing agents through December 31, 2021. These blowing agents were proposed to be unacceptable for military or space- and aeronautics-related applications as of January 1, 2022. For the reasons discussed in the proposed rule, we are finalizing these provisions as proposed.
EPA received comments from DoD and NASA supporting EPA's proposed narrowed use limit, and suggesting that this additional time is needed to identify, test and qualify substitutes for certain specialty applications. Boeing commented that the DoD and NASA need adequate time to develop, test and qualify an acceptable substitute for HFC-245fa, which is used in many foams they rely on for density foam insulation for a number of space and defense applications (
Users that wish to use one of the substitutes listed as acceptable, subject
Documentation should include descriptions of:
• Process or product in which the substitute is needed;
• Substitutes examined and rejected;
• Reason for rejection of other alternatives,
• Anticipated date other substitutes will be available and projected time for switching.
Since regulations establishing the SNAP program were promulgated in 1994, we have interpreted the unacceptability determinations in this sector to apply to blowing foam with the foam blowing agent and not to products made with foam (
In the proposal, EPA took comment on a different interpretation of our regulations under which the unacceptability determination would apply to imported products containing closed cell foam that contain any of the blowing agents listed as unacceptable, as well as applying to the blowing agent itself. Public commenters stated that this was a significant departure from the Agency's previous interpretation and suggested that EPA needed to explain the basis for such a change. In addition, some commenters pointed out that the proposal only allowed 60 days before this change in interpretation would apply to HCFC-141b, which they viewed as insufficient time to adjust. EPA is not finalizing this change in its interpretation in this action; however, we plan to continue assessing the merits of this change and may provide further explanation and opportunity for comment in a subsequent rulemaking.
EPA agrees that additional time is needed for other specific foam types and addresses the basis for establishing later change of status dates in the discussion of each end-use above. We appreciate and agree with commenters that note the importance of maintaining energy efficiency for appliances and buildings by ensuring there is adequate time to develop and deploy new formulations that meet or exceed existing thermal insulating values. Further, we recognize that third-party testing or witness testing will require additional time that may be outside the control of the companies manufacturing the foam. Some of this testing, such as fire safety testing for construction foams, could help reduce any potential flammability risks associated with the use of flammable foam blowing agents. Businesses of all sizes will be able to benefit from the later change of status dates in this final rule. We discuss comments specific to each end-use below in this section.
As an initial matter, Huntsman and DuPont mentioned the lack of sufficient supply of alternatives to allow all foam users to convert in 2017. In support of a later change of status date, equipment manufacturers and systems houses such as Huntsman, Dow and BASF mentioned similar technical issues to those for appliance foam, such as the compatibility and stability of the blowing agents with the polyol blends and dimensional stability of the blown foam. BASF specifically mentioned reactions between the new blowing agents and the catalysts in the foam that could cause the finished foam to shrink, as well as the need to develop a new set of flame retardants. Commenters also stated that extended testing of more than six months was required to test strength, thermal insulation capability and dimensional stability of the foam, including aging testing. Huntsman specifically mentioned steps such as developing new foam formulations (one to one and a half years), trials at the customers' plants (half to one year), third-party certification by UL, Intertek or Factory Mutual (one to one and a half years), and implantation of engineering changes at the customers' facilities (half to one year), with iterative testing often required. Unified Brands and NAFEM suggested that there are limitations to using methyl formate in commercial refrigeration foam that would not allow a transition by January 1, 2017, stating: “Methyl Formate is also environmentally friendly, but has had significant shrinkage issues once units have been placed in the field. This agent requires very specific foaming processes to be developed to ensure proper stability of the foam over time.”
The later dates of ten years after finalization of the rule or 2025 suggested by NAFEM and other OEMs, appear to be based on the assumption that stand-alone retail food refrigeration equipment would need to use propane or other flammable refrigerants and that changes would need to be made to building codes to support the adoption of these flammable refrigerants. However, as discussed above in section V.C on commercial refrigeration, there are other available refrigerants that are nonflammable. Moreover, the commenters did not make clear why, even assuming that alternative refrigerants would not be available until 2025, the insulation foam for such equipment cannot be made using safer alternatives well before 2025. Thus we do not believe that safe alternative foam blowing agents will not be available before 2025.
IP Moulding commented that it had tried to use CO
EPA agrees that additional work with CO
• capital costs;
• research, reformulation, and testing;
• technology and equipment;
• conversion, system re-design, and retrofit;
• certification;
• costs for the recreational boating industry;
• increasing cost of HFC-134a;
• increases in costs to consumers;
• market competitiveness impacts;
• reduction in new product development;
• retesting required due to lack of coordination with timing of requirements for DOE energy conservation standards;
• economic impacts on branding;
• cost savings; and
• other general economic concerns.
Some commenters, such as Mexichem, Solvay, and AHAM, suggested that it was not necessary to change the status of HFC-134a and other HFC foam blowing agents or to require industry to incur the costs that these changes require. Other commenters, such as NMMA, NAFEM, XPSA, and their members, requested additional time for the change of status of HFC-134a and other HFC foam blowing agents in order to allow them to spread costs out over time and thus make costs of the transition more manageable. Imperial Brown suggested a later status change date to allow foam manufacturers to create sufficient supply, thereby alleviating a potential cost premium associated with scarcity of newer alternatives.
Although cost is not a consideration in our decision to change the status of certain substitutes, we note that based on technical concerns, the final rule establishes a later change of status date in a number of end-uses, which will allow manufacturers to spread costs over time. Regarding whether there will be a sufficient supply of alternatives, we considered this issue in establishing the change of status dates and believe that there will be more than adequate supplies of alternatives. This will also contribute to lower costs. We have addressed elsewhere why it is necessary to change the status of substitutes for the various end-uses based on whether alternatives that pose lower risk are available. Where we concluded that safer alternatives were available, we determined it was necessary to change the status. Thus, we disagree with the commenters who suggest that it is not necessary to change the status of various HFC foam blowing agents.
In the August 6, 2014 NPRM, EPA proposed to change the listings from acceptable to unacceptable for three HCFCs: HCFC-141b, HCFC-142b, and HCFC-22 (79 FR 46155). As discussed in the proposed rule, EPA proposed to modify the listings for these three HCFCs and blends containing these HCFCs to align the SNAP listings with other parts of the stratospheric protection program, specifically section 605 and its implementing regulations at 40 CFR part 82 subpart A and section 610 and its implementing regulations at 40 CFR part 82 subpart C. HCFCs are subject to the use restrictions in CAA section 605(a) and these specific HCFCs have been restricted under EPA's implementing regulations at 40 CFR part 82 subpart A since January 1, 2010. Additionally, the nonessential products ban under CAA section 610 restricts sale and distribution of certain products containing or manufactured with these three HCFCs. We believe it is important that the SNAP listings not indicate that these HCFCs may be used when another program under title VI of the CAA would prevent such use. Thus, we are aligning the requirements. The HCFCs addressed in this rule were previously listed as acceptable or acceptable subject to use conditions in the aerosols, foam blowing, fire suppression and explosion protection, sterilants, and adhesives, coatings and inks sectors. For more information, please refer to the relevant section of the proposed rule as noted above. The change of status determinations for the HCFCs addressed in this rule are summarized in the following table:
Consistent with the proposal, in today's final rule, EPA is modifying the listings for HCFC-141b, HCFC-142b, and HCFC-22, as well as blends that contain these substances, from acceptable to unacceptable
As provided in the proposal, EPA is not addressing HCFC use for refrigeration and air conditioning in this rulemaking because CAA section 605(a) and our implementing regulations allow for continuing use of HCFCs to service equipment. Recognizing that other HCFCs became subject to the use and interstate commerce prohibitions in 40 CFR 82.15(g) after issuance of the proposed rule, and that limited exemptions are available in section 82.15(g) for certain of those HCFCs, EPA is not modifying the SNAP listings for HCFCs other than HCFC-141b, -142b, and -22 and blends containing those substances at this time. EPA may revisit the acceptability of other HCFCs in a later rulemaking as appropriate. We are finalizing the proposal that the listings be modified 60 days following issuance of a final rule.
If the commenter is referring to applying the unacceptability determination for HCFC-141b to products containing HCFC-141b, as discussed above in this section, EPA is not finalizing the proposed change to the import of closed cell foam products blown with an agent listed as unacceptable.
In contrast, Mexichem, Solvay, AHAM/Electrolux and Arkema asserted that the proposed actions were outside the scope of Title VI, section 612 of the CAA, and EPA's SNAP regulations. Specifically, these commenters asserted that Congress and EPA designed the SNAP program to safeguard stratospheric ozone, and not to address climate change and greenhouse gases. AHAM stated that Title VI of the CAA does not provide EPA broad authority to regulate refrigerants, foams and chemicals in circumstances unrelated to ozone depletion. Mexichem stated that the repeated references in section 612 to class I and class II substances demonstrate that Congress was concerned with ODS.
Several commenters emphasized evaluation of a substitute in relation to ODS. Mexichem asserted that EPA recognized “the limited nature of the statute” in 1994 when it promulgated the statement of purpose and scope for the SNAP program (59 FR 13044, Mar. 18, 1994; 40 CFR 82.170). In its comment, Mexichem provided a quotation from the statement of purpose and scope, suggesting that substitutes are to be compared only to ODS. Arkema quoted an EPA “Guide to Completing a Risk Screen”
Several commenters also asserted that nothing has happened with respect to any attribute or impact of the HFCs addressed in this rulemaking that would warrant a change in the initial decisions to list HFCs as acceptable.
EPA cannot fulfill its section 612(c) mandate to compare alternatives with a view to reducing overall risk without considering impacts related to issues other than ozone depletion. Toward that end, the SNAP regulations require submitters to include information on a wide range of factors in addition to ODP, including GWP, toxicity, flammability, and the potential for human exposure (59 FR 13044, Mar. 18, 1994 and codified at 40 CFR 82.178). Further, the SNAP regulations state that EPA will consider atmospheric effects (including GWP), exposure assessments, toxicity data, flammability, and other environmental impacts such as ecotoxicity and local air quality impacts (59 FR 13044, Mar. 18, 1994; 40 CFR 82.180).
In addition, while section 612(a) states the Congressional policy of reducing overall risk in broad terms, section 612(c) specifically requires EPA to compare the risk of the substitute under review
To the extent possible, the Agency has always sought to ensure that our SNAP decisions are informed by the most current overall understanding of environmental and human health impacts associated with available and potentially available alternatives. In that regard, the Agency has, since the inception of the SNAP program, asserted its authority, consistent with the language of section 612(c) and the section's statement of congressional policy, to review substitutes listed as acceptable and to take action with respect to those substitutes on the basis either of new information generally, including that related to overall risk, or of the availability of new alternatives that pose less overall risk. Specifically, in the preamble to the initial SNAP rule, EPA made clear that “the Agency may revise these [listing] decisions in the future as it reviews additional substitutes and receives more data on substitutes already covered by the program” (59 FR 13044, 13047). We interpret section 612 as allowing both addition of new, safer alternatives to the listings and removal from the listings of substitutes found to pose more risk overall than other available alternatives.
With regard to additional data on substitutes already covered by the program, the Agency has previously responded to the evolution of scientific and technical information by revisiting the listing status of a substitute. For
With regard to additional alternatives, the suite of available or potentially available alternatives changes over time. For example, over the past several years, and as standards and familiarity with the safe use of various alternatives has developed, EPA has listed several specific flammable refrigerants as acceptable for some end-uses subject to use conditions (
Further, we disagree with the notion that our understanding of the impact of HFCs has remained static. Our understanding of the impact that HFCs have on climate has evolved and become much deeper over the years. As mentioned elsewhere in this rulemaking, a significant indication of that change can be seen in EPA's December 7, 2009, Endangerment Finding (74 FR 66496, 66517, 66539) which makes clear that like the ODS they replace, HFCs are potent GHGs. In addition, HFCs are now in widespread usage. The most commonly used HFC is HFC-134a. HFC-134a is 1,430 times more damaging to the climate system than carbon dioxide (see Table A-1 to subpart A of 40 CFR part 98). Further, HFC emissions are projected to accelerate over the next several decades; if left unregulated, emissions are projected to double by 2020 and triple by 2030.
AHAM commented that the appliance industry no longer intends HFCs as a substitute or replacement for ODS. The commenter stated that there are very few remaining models that ever used ODS, and that the substances used in today's models are not substitutes or replacements in the common-sense meaning of those words.
Arkema further stated that EPA should be precluded from comparing non-ODS first-generation alternatives (such as HFC-134a) to second-generation non-ODS alternatives (such as HFO-1234yf, HFC-152a, and R-744). Arkema contended that none of these second-generation compounds is a “substitute” for SNAP purposes.
EPA does not agree with the commenters who suggest that while HFC-134a may have replaced ODS at one point in time, it no longer does so. The term “replace” is not defined in section 612, EPA therefore interprets this term as it is commonly used. Dictionary definitions can provide insight into how a reasonable or ordinary person would interpret the term. Dictionary definitions of “replace” include the following: “to be used instead of”
Similarly, the mere passage of time does not mean that the substances addressed in this rulemaking have somehow ceased to be “substitutes or alternatives” under the regulatory definition at 40 CFR 82.172. No commenter suggests that at the time of their initial SNAP listing these substances were anything other than “chemicals . . . intended for use as a replacement for a class I or II compound.” Rather, commenters assert that these substances are no longer intended for use as an ODS replacement. However, introducing a temporal aspect into this definition would mean that a product manufacturer could make an initial substitution for a class I or II substance 90 days after providing the required notification to EPA and thereafter continue to use the substitute while disclaiming any intent to replace the ODS. This is not a supportable interpretation because it would allow the manufacturer to circumvent SNAP requirements simply by beginning to use a substitute prior to its SNAP listing.
In addition, EPA implements the section 612(c) mandate to list substances as acceptable or unacceptable “for specific uses” by listing substitutes on an end-use or sector basis.
Contrary to Solvay's comment, EPA has authority to regulate the continuing replacement of ODS with HFC-134a and the other substitutes whose listing status is addressed in this action. In this rulemaking, EPA considered whether such replacement should continue to occur given the expanded suite of other alternatives to ODS in the relevant end-uses and our evolving understanding of risks to the environment and public health. The commenter's line of reasoning would undermine EPA's ability to comply with the statutory scheme reflected in section 612(c), under which EPA's authority to prohibit use of a substitute is tied to information on overall risk and the availability of substitutes.
Regarding Arkema's suggestion that HFO-1234yf, HFC-152a, and R-744 are not “substitutes” for SNAP purposes and thus they cannot be used as part of a review of whether EPA should change the status of HFC-134a, we disagree. HFO-1234yf, HFC-152a and R-744 (as well as the other substances we used for comparison purposes in this rulemaking)
BASF commented that EPA proposed to find HFCs unacceptable because they have “high GWPs as compared with other available or potentially available substitutes in those end-uses and pose significantly greater overall risk to human health and the environment.” BASF noted that while CAA section 612 does require an assessment of risk, it does not explain how that assessment should be done. BASF added that whatever that assessment should involve, it is possible that Congress did not intend GWP to be part of that assessment.
Considerations of atmospheric effects and related health and environmental impacts have always been a part of SNAP's comparative review process, and the provision of GWP-related information is required by the SNAP regulations (see 40 CFR 82.178 and 82.180). The issue of EPA's authority to consider GWP in its SNAP listing decisions was raised in the initial rule establishing the SNAP program. In the preamble to the final 1994 SNAP rule, EPA stated: “The Agency believes that the Congressional mandate to evaluate substitutes based on reducing overall risk to human health and the environment authorizes use of global warming as one of the SNAP evaluation criteria. Public comment failed to identify any definition of overall risk that warranted excluding global warming” (59 FR 13044, March 18, 1994).
Consistent with that understanding, the 1994 SNAP rule specifically included “atmospheric effects and related health and environmental impacts” as evaluation criteria the Agency uses in undertaking comparative risk assessments (59 FR 13044, March 18, 1994; 40 CFR 82.180(a)(7)(i)). That rule also established the requirement that anyone submitting a notice of intent to introduce a substitute into interstate commerce provide the substitute's GWP (see 40 CFR 82.178(a)(6)). Accordingly, we have considered the relative GWP of alternatives in many SNAP listing decisions. For example, in the decision to list C7-Fluoroketone as acceptable we noted that “C7 Fluoroketone's GWP of about 1 is lower than or comparable to that of other non-ozone-depleting substitutes in heat transfer uses, such as HFE-7100 with GWP of 297, HFC-245fa with a GWP of 1030, and CO
In response to comments that EPA inappropriately used the physical characteristic of GWP as a surrogate for risk and that EPA failed to assess the significance to climate change of the emissions reductions estimated to be brought about by the action, as they relate to risk for each substance in each sector covered, we note that GWP is a relative measure and that if comparable amounts of two substitutes are used, then the relative climate effects of resultant emissions will be higher for the substitute with higher GWP. EPA considers factors such as charge size of refrigeration equipment and total estimates of production in its assessment of environmental and health risks of new alternatives, so we can consider if there would be substantial differences that might affect total atmospheric emissions. We believe that we have appropriately considered GWP as a metric for comparing climate effects of substitutes.
In response to comments that EPA failed to assess and account for indirect climate impacts, we note that we do not have a practice in the SNAP program of including indirect climate impacts in the overall risk analysis. We do consider issues such as technical needs for energy efficiency (
In this action, EPA used the same comparative risk approach it has used in the past, including the consideration of GWP.
Here, the change in the listing status of certain HFCs for specified end-uses is designed to “promote the common good” (
The commenter could not have had a reasonable investment-backed expectation that these HFCs would continue to be listed as acceptable indefinitely in all end-uses, or in any specific end-use, because EPA expressly stated in the preamble to the initial SNAP rule that “the Agency may revise these [listing] decisions in the future as it reviews additional substitutes and receives more data on substitutes already covered by the program” (59 FR 13044, 13047). In addition, EPA also noted the “significant global warming potentials” of some HFCs and stated “EPA is concerned that rapid expansion of the use of some HFCs could contribute to global warming” (
The CAP considers both domestic and multilateral action to address HFCs. The United States co-proposed and is strongly advocating for an amendment to the Montreal Protocol to phase down production and consumption of HFCs. EPA sees no conflict between the United States' strong support for a global phase-down and this domestic action. The amendment proposal calls for a phase-down of production and consumption of a group of HFCs, including HFC-134a as well as HFC-125 and HFC-143a (components of R-404A, R-507A and other blends), on a total CO
For petitions under section 612(d), the petition must “include a showing . . . that there are data on the substance adequate to support the petition.” The Agency disagrees that EPA stands in the shoes of a petitioner under 612(d) when it proposes to change the listing status of an alternative. Rather, EPA's action is governed by section 612(c), and EPA considers the criteria used in reviewing substitutes as provided in 40 CFR 82.180(a)(7). Regardless, we note that we also review section 612(d) petitions based on the same SNAP criteria and thus the “data on the substance adequate to support the petition” necessarily are the data required for review under 40 CFR 82.180(a)(7).
EPA has changed the listing status of substitutes in the past without having received a petition under section 612(d), as, for example, when we changed the listing status of MT-31 (64 FR 3861, Jan. 26, 1999; 40 CFR part 82 subpart G appendix E) and HBFC-22B1 (67 FR 4185, Jan. 29, 2002; 40 CFR part 82 subpart G appendix J).
While EPA has the right to act in the absence of a petition, as described above, EPA did receive three petitions filed under section 612(d) that are
Solvay further commented that in making a determination whether to list a substance as an approved substitute to replace an ODS, the Agency must conduct a comprehensive analysis of each alternative in each end-use, including considerations of the cost of the alternative, availability, and the overall practicability of effectuating a replacement. Solvay focused on the phrase “to the maximum extent practicable” in section 612(a) of the CAA, stating that Congress deliberately chose the term “practicable” to mandate an orderly transition from ODS. Solvay stated that the term “practicable” ordinarily includes consideration of cost and availability. Solvay further argued that EPA had acknowledged and agreed with this understanding of the term by including cost and availability in its list of criteria. Solvay referred to dictum in
Mexichem commented that the text of the proposed rule and the underlying docket, including the SNAP program's comparative risk framework, are vague on how EPA reached the required section 612(c) conclusion that the alternatives reduce overall risks to human health and the environment, leaving the impression that it considered only GWP. Specifically, they state that out of the seven documents that may be relevant to the comparative risk framework analysis, only the “Climate Benefits of the SNAP Program Status Change Rule” report refers to human health and the environment, with a focus on climate benefits, but that the report itself is silent on estimated reduction of “overall risks to human health.” Mexichem also noted that EPA promised to prepare a consolidated analysis document in the proposed rule, but no such document was available at the time the comments were drafted. Mexichem further stated that an assessment of HFC-134a and related alternatives is missing, and that such an assessment should have included several specific questions related to the following factors: Performance, availability, hazard, exposure, and cost of the alternatives. These questions include whether the other alternatives perform as well as HFC-134a in the specific end-use; whether the other alternatives will be available in the necessary quantities; whether the other alternatives present a better overall hazard profile; whether the other alternatives present a better overall exposure profile; whether use of the other alternatives involves an equivalent cost; and whether use of the other alternatives represents a cost-effective mitigation of CO
Bally Refrigerated Boxes, Inc. questioned whether the CAA authorizes EPA to delist non-ODS solely on the basis of GWP. Arkema commented that EPA is focusing on the potential hazard of GWP alone and stated that EPA is not evaluating HFC-134a within a comparative risk framework. Arkema stated that if the CAA were to authorize the SNAP program to “delist” previously approved non-ozone depleting substances based on climate, then EPA would need to develop an objective measure for deciding which substitute poses a greater risk and communicate that standard to the regulated community. Arkema claimed that any such measure would need to include methods for weighing different types of risks against one another (such as flammability versus climate) and for including mitigation, as the existing SNAP program, which did not originally provide for quantitative indexing of risks, does not convey sufficient information to the Agency or the regulated community regarding risk management decisions.
While EPA prepared a variety of documents in association with the proposed rule, the bulk of the comparison of human health and environmental impacts of alternatives appeared in the preamble to the
As stated in the NPRM, the documentation associated with the proposed rule includes “market characterizations, analyses of costs associated with sector transitions, estimated benefits associated with the transition to alternatives, and potential small business impacts” (79 FR 46126). These documents provide information to the public about estimated environmental benefits, the affected markets, and potential cost impacts, as well as provide EPA's screening analyses to determine whether this rule may have significant economic impacts or significant impacts on a substantial number of small businesses; they are not part of EPA's comparison of human health and environmental effects of alternatives.
Mexichem noted in its comments that EPA had included these documents in the docket for the proposed rule, but raised a concern about the availability of the consolidated analysis document anticipated in the NPRM. The consolidated analysis is included in the docket for the final rule, but was not available during the public comment period (ICF, 2015a). This document is a consolidated sector-by-sector market characterization for those sectors addressed in this action. While it incorporates some suggestions and information provided by commenters, it otherwise does not add new substantive information other than that provided in the individual market characterizations at the time of the proposed rulemaking. It merely consolidates the information for ease of reference.
We disagree with the comments suggesting that EPA did not consider factors other than GWP. In the NPRM, for each end-use or sector, EPA provided information comparing the alternatives and applying the full set of regulatory criteria, not solely GWPs, in deciding whether to change the status of a listed substitute, consistent with SNAP's past practices. As one example, in discussing the change in status for HFC-227ea in the aerosol propellant end-use, the Agency explained in the preamble that other available substitutes have zero ODP, are relatively low in toxicity, are capable of remaining below their respective exposure limits, and are expected to have negligible impact on ground-level ozone levels (79 FR 46126, 46173). In each case, consistent with the decision criteria listed at 40 CFR 82.180(a)(7), EPA has considered environmental impacts, flammability, toxicity, and exposure. In the context of this review, we considered a large amount of information including, among other things: Scientific findings, information provided by the Technology and Economic Assessment Panel (TEAP) that supports the Montreal Protocol, journal articles, submissions to the SNAP program, dockets for other EPA rulemakings, presentations and reports presented at domestic and international conferences, and materials from trade associations and professional organizations. References cited in the NPRM were listed in section IX of that document and the references cited in this final action are listed in section IX of this document.
Solvay suggested a number of considerations they believe should have been included as part of EPA's decision-making criteria, such as various standards and codes, product shelf-life, and equipment limits. Solvay does not discuss how the various considerations mentioned relate to the existing SNAP review process. In general, we took such considerations into account to the extent relevant to the criteria for review of a substitute or to the availability of other alternatives. For example, we considered such issues as the supply and characteristics of alternatives as well as the status of various regulations and codes and standards as they relate to the availability of the alternatives and thus the appropriate time for the change of status. EPA specifically mentioned building codes (
We also addressed certain of these issues in the context of the potential mitigation of risks both for those substitutes subject to the status change and those that remain available. For example, we noted in the preamble to the NPRM, in the context of alternatives in several of the foams end-uses, that flammability issues would be addressed in the process of meeting OSHA regulations and fire codes (
Similarly, Mexichem suggested that EPA was required to evaluate specific questions regarding performance, availability, hazard, exposure, and cost. Again, this ignores the established criteria that EPA uses in determining whether a substitute is acceptable or unacceptable in a specified end-use. In the NPRM, in determining whether other substitutes were available that posed lower risk than those for which we proposed to change the status, EPA evaluated the ozone-depletion, climate, local air quality, toxicity and flammability risks of the substitutes undergoing a change of status as well as of other alternatives, thereby addressing hazard and exposure concerns. We note that the statute refers to
We have considered whether other alternatives will be available in sufficient quantities as part of our analysis of the availability of alternatives. As discussed in the NPRM, we set dates for the proposed status changes that reflect when there will be a sufficient supply of the alternatives. (
One of the regulatory criteria for review of a substitute is the “cost and availability of the substitute” (59 FR 13044, Mar. 18, 1994; 40 CFR 82.180(7)(vii)). The consideration of cost under this criterion is limited to the cost of the substitute under review; it is distinct from consideration of costs associated with the use of other alternatives to which the substitute is being compared.
Several commenters suggested or implied that EPA's action was based “excessively” or solely on GWP. As discussed above, we performed a full comparative risk analysis for each of the substitutes and for each end-use for which we are changing the status. However, as noted in the preamble to the NPRM, EPA issued this proposal in response to the CAP. As such, in determining which substitutes and end-uses to address in the proposed rule, we evaluated the existing listing decisions in the eight sectors covered by the SNAP program. In three of the sectors, we identified a subset of substitutes that have a high GWP relative to other listed alternatives and for which we also had reason to believe other alternatives were “available” for the end-use. For those substitutes included in the proposed rule on the basis of having a relatively higher GWP, in most cases, EPA did not find significant potential differences in risk with respect to the other criteria, with the exceptions of flammability and local air quality impacts. However, where flammability risk was a potential concern, we concluded that such risk is mitigated by the existing use conditions or through other existing regulations (
EPA received a number of comments on the cost and economic impacts of the proposed rule. Some of these comments are summarized in the response to comments sections for the end-uses addressed in this final rule. We summarize and respond to the more general cost comments below.
We do not typically analyze cumulative regulatory burden in our cost analyses. Nonetheless, EPA notes that to the extent that affected entities recently incurred costs to comply with DOE rulemakings, the change of status dates in the final rule for the foam blowing sector and for some of the refrigeration end-uses (
Second, EPA has analyzed the costs of users that are directly regulated and has not analyzed the impacts on chemical producers, which are indirectly affected by the regulation. The commenters did not provide specific cost or supply information regarding redesigning equipment or specific information on operating costs for chemical plants that would have allowed us to analyze the impacts as requested by Arkema. We disagree with Arkema that it is necessary or appropriate to analyze the indirect impacts upon chemical plants and producers. Such analysis would be highly speculative about the degree of cost pass-through from producers to consumers of these chemicals. The total cost estimates would be unchanged; rather such an analysis would relate to transfers between producers of the substitutes undergoing a change of status, producers of the acceptable alternatives for the same uses, and consumers of these products rather than losses to the economy or to a market sector as a whole. We note that the transition affecting the majority of HFC-134a production, the transition away from HFC-134a in MVAC, is already occurring because of other regulations, and therefore changes to production and cost of HFC-134a cannot easily be attributed to this action.
EPA recognizes that transitioning to other alternatives is likely to require capital costs and investments in research, updated equipment, and their related financial impacts. Many chemical producers have either submitted SNAP notifications or expressed interest in submitting SNAP notifications concerning new molecules and blends of existing molecules. EPA agrees with Arkema that this rule is likely to stimulate demand in next-generation alternatives further.
EPA also notes that, for example, HFC-134a likely will be a component of many low-GWP blends that are being developed specifically to replace HFC-134a. EPA listed as acceptable one of those blends, R-450A, on October 21, 2014 at 79 FR 62863. The Agency is aware of additional blends that multiple chemical producers are developing. As noted throughout this document, the range of alternatives includes new molecules and existing compounds, encompassing fluorinated, non-fluorinated and in some cases not-in-kind alternatives.
Third, we question Arkema's assumption that competition will decrease and thus cost for low-GWP alternatives will rise. For each of the status changes in this final action, more than one other alternative is currently listed as acceptable or acceptable, subject to use conditions, for the relevant end-use. Moreover, we expect new SNAP submissions that would result in the introduction of further alternatives to increase, rather than reduce, competition. Further, because this rule does not regulate production of individual chemicals directly and allows servicing of existing refrigeration and AC equipment with the refrigerants for which they are designed, we expect there will continue to be a market for HFC-134a and other HFC refrigerants for years to come.
In those cases where commenters provided specific, detailed cost information, we used that information to revise the cost assumptions in our updated cost analysis for this final rule. For additional information on economic analysis conducted for this rule, see the supporting document “Revised Cost Analysis for Regulatory Changes to the Listing Status of High-GWP Alternatives” (ICF, 2015c).
EPA disagrees with the commenter that the “docket lacks a robust industry analysis on the effects on small business manufacturers and customers, or reasonable support for EPA's Regulatory Flexibility Act conclusions.” The Agency's screening analysis at proposal stage is included in the docket (ICF, 2014f). The commenters do not point to any specific aspect of that analysis that they believe are deficient. A Small Business Advocacy Panel is convened when a proposed rulemaking is expected to have a significant impact on a substantial number of small entities, or “SISNOSE.” We have updated our small business impacts screening analysis using the change of status decisions and dates in the final rule, adding boat manufacturers as affected entities, and using detailed cost information provided by commenters (ICF, 2015b). EPA's preliminary and final screening analyses concluded that this rulemaking would not pose a SISNOSE. In the analyses, EPA recognized that some small businesses may experience significant costs, but concluded that the number of small businesses that would experience significant costs was not substantial.
Both the screening analysis for purposes of determining whether there was a SISNOSE and the analysis to determine whether the rule was significant based upon economic grounds were conducted based on the best market and cost information available to the Agency. Where commenters provided specific market or cost information, the Agency used that information to update these analyses. The updated analyses came to the same conclusions: That the final rule would not pose a SISNOSE and that it is not an economically significant rule (ICF, 2015b,c).
EPA received submissions from 42 commenters related to the environmental impacts of the proposed status changes. Additionally, EPA received 7,022 mass mailing letters commenting on the importance of transitioning away from HFCs to more climate-friendly alternatives. Ten commenters referred to the CAP.
CARB comments the current regulations and the SNAP proposal meet only half of the 80% reduction necessary for the HFC sector if California is to meet its overall GHG reduction goal contained in California Executive Order (EO) S-3-05 (2005). Therefore, CARB believes additional HFC reductions are required to reduce this fastest-growing source of GHGs.
NRDC and IGSD comment that even though HFCs may currently make up a small piece of global climate emissions, their projected rapid growth underscores the urgent need to replace these chemicals with lower-GWP alternatives. Further, NRDC and IGSD comment that without stringent rules in place, HFC emissions increases could counteract the progress EPA is striving to make in other sectors to reduce carbon pollution.
As part of the process for listing alternatives, EPA evaluates information concerning a substitute according to the criteria in EPA's regulations at 82.180(a)(7) (
See the next response for further information about where one can find information on the modeling assumptions and methodology.
Given the variety of currently or potentially available alternatives, EPA believes it is unlikely that manufacturers will have to use refrigerants that will result in reduced energy efficiency compared to the refrigerants being listed unacceptable in this final rule.
Reasons given for this coordination of timeline with EU regulations include: Many companies are trans-national and had already been planning on a transition in line with the EU regulatory deadlines; the SNAP program has deferred to other regulations in the past; and the later deadlines will allow for redesign of refrigeration equipment for both alternative, flammable refrigerants and for new foam blowing agents and for needed third-party testing. Commenters stated that the proposed deadlines would create an extreme burden, particularly on small businesses; that part supplies needed for compliance are not offered in the United States; and that the transition is a complicated undertaking that cannot be performed in 18 months.
Additional public comments not already discussed above along with EPA's responses are available in the Response to Comments document which accompanies this action (EPA, 2015a).
EPA does not consider the cost of transition to other alternatives in making listing decisions because under the SNAP criteria for review in 40 CFR 82.180(a)(7), consideration of cost is limited to cost of the substitute under review. However, EPA has prepared technical support documents including analyses of costs associated with sector transitions, estimated avoided GHG emissions associated with the transition to alternatives, and potential small business impacts.
The transition scenarios analyzed possible ways to comply with the final rule. The transition scenario in the cost analysis reflects a direct compliance cost method and does not assume the regulated community chooses higher-cost solutions where known less costly solutions exist. The scenarios analyzed in the avoided GHG emissions analysis reflect possible transitions for compliance based on considerations of the market and activity towards lower-GWP solutions. While the emission reductions have been quantified, they have not been monetized. Thus, higher or lower GHG emission reductions do
To extend the assessment to all-sized businesses potentially affected by the rulemaking, EPA conducted an analysis on costs to all-sized businesses building on the approach taken to estimate potential economic impacts on small businesses. Using a 7% discount rate, total annualized compliance costs across affected businesses are estimated to range from $28.0 million to $50.6 million; total annual savings are estimated to be about $19.3 million. Using a 3% discount rate, total annualized compliance costs across affected businesses are estimated to range from $19.5 million to $37.8 million, total annual savings are estimated be about $19.3 million.
EPA conducted an analysis on the potential avoided GHG emissions associated with implementation of this final rule. The emissions avoided from this final rule are estimated to be 26 to 31 MMTCO
Additional information about these statutes and Executive Orders can be found at
This action is a significant regulatory action that was submitted to the Office of Management and Budget (OMB) for review. Any changes made in response to OMB recommendations have been documented in the docket.
This action does not impose any new information collection burden. OMB has previously approved the information collection requirements contained in the existing regulations and has assigned OMB control number 2060-0226. This final rule contains no new requirements for reporting or recordkeeping.
I certify that this action will not have a significant economic impact on a substantial number of small entities. The requirements of this final rule with respect to HFCs, will impact manufacturers of some consumer and technical aerosol products, retail food refrigeration equipment, vending machines, motor vehicles, and products containing phenolic, polyisocyanurate, polyolefin, PU, and polystyrene foams. The requirements of this final rule with respect to HCFCs could theoretically affect manufacturers of aerosols, foams, industrial cleaning solvents, fire suppressants, and adhesives, coatings, and inks; however, due to existing regulations that restrict the use of HCFCs in these products, no actual impact is expected. In some uses, there is no significant impact of the final rule because the substitutes proposed to be prohibited are not widely used (
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.
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 action does not have tribal implications, as specified in EO 13175. It will not have substantial direct effects on tribal governments, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 (62 FR 19885, April 23, 1997) because it is not economically significant as defined in EO 12866, and because the environmental health or safety risks addressed by this action do not present a disproportionate risk to children. This action restricts the use of certain substitutes that have greater overall risks for human health and the environment, primarily due to their high global warming potential. The reduction in GHG emissions would provide climate benefits for all people, including benefits for children and future generations.
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. Aerosol uses are not related to the supply, distribution, or use of energy. For the end-uses that are related to energy effects, including refrigeration and air conditioning and some rigid cell PU and polystyrene insulation foams, a number of alternatives are available to replace those refrigerants and foam blowing agents that are listed as unacceptable in this action; many of the alternatives are as energy-efficient or more energy-efficient than the substitutes being listed as unacceptable. As described in more detail in this document, energy efficiency is influenced, but not determined, by the refrigerant. Similarly, although foam blowing agents influence the insulation properties of rigid cell foams, this also can vary due
This action does not involve technical standards.
EPA has determined that this action will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations because it increases the level of environmental protection for all affected populations without having any disproportionately high and adverse human health or environmental effects on any population, including any minority or low-income population. This action would prohibit a number of substances with ODPs or high GWPs. The reduction in ODS and GWP emissions would assist in restoring the stratospheric ozone layer and provide climate benefits.
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).
This preamble references the following documents, which are also in the Air Docket at the address listed in section I.B.1. Unless specified otherwise, all documents are available electronically through the Federal Docket Management System, Docket #EPA-HQ-OAR-2014-0198.
Environmental protection, Administrative practice and procedure, Air pollution control, Incorporation by reference, Recycling, Reporting and recordkeeping requirements, Stratospheric ozone layer.
For the reasons stated in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
The revisions and additions read as follows:
In addition, the use of a) R-406A/“GHG”/“McCool”, “HCFC Blend Lambda”/“GHG-HP”, R-414A/“HCFC Blend Xi”/“GHG-X4/“Autofrost”/“Chill-It”, R-414B/“Hot Shot”/“Kar Kool”, and R-416A/“HCFC Blend Beta”/“FREEZE 12” as CFC-12 substitutes in retrofitted MVACs, and b) all refrigerants submitted for, and listed in, subsequent Notices of Acceptability as substitutes for CFC-12 in MVACs, must meet the following conditions.
On February 10, 2014, Administrative Law Judge (ALJ) Christopher B. McNeil issued the attached Recommended Decision.
Having reviewed the entire record, including the parties' Exceptions, I have decided to adopt the ALJ's findings of fact except as discussed below. I further adopt the ALJ's conclusions of law that:
(1) Respondent issued prescriptions for controlled substances to three undercover officers outside the usual course of professional practice and which lacked a legitimate medical purpose;
(2) Respondent violated Federal law when he issued controlled substance prescriptions which did not include the patient's address;
(3) Respondent violated Ohio law requiring that he “complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of [his] patients,” when, with respect to the three undercover officers, he “falsely reported the extent and nature of his examination of [them] and falsely reported the patients' reports of pain”;
(4) Respondent “failed to comply with the requirements of Ohio law applicable to the treatment of chronic pain.”
According to the ALJ's Recommended Decision, Respondent's registration was due to expire on June 30, 2014, and according to the registration records of the Agency, of which I take official notice,
Accordingly, on May 8, 2015, the former Administrator issued an Order directing the parties to address whether the case was moot. Thereafter, both parties filed responses asserting that the case remains a live controversy, with the Government specifically noting that various controlled substances including Demerol, morphine sulfate, hydrocodone, and midazolam were seized from Respondent's office during service of the Immediate Suspension Order. Gov't Response to Order, at 2. The Government further represents that there are no other proceedings pending to determine title to the drugs and therefore requests that I issue a final order to resolve this issue.
Accordingly, I conclude that this proceeding presents the collateral consequence of who has title to the controlled substances seized by the Government. While I do not adopt the ALJ's recommended order that I revoke Respondent's registration and deny any pending application to renew or modify his registration, I will affirm the issuance of the Immediate Suspension Order and declare that all right, title, and interest in the seized drugs is forfeited to the United States. A discussion of Respondent's Exceptions follows.
Pursuant to Congress's direction in 21 U.S.C. 824(a)(4) that the Agency may revoke a registration “upon a finding that the registrant . . . has committed such acts as would render his registration under section 823 of this title inconsistent with the public interest
Thus, the issue has been conclusively decided. Because the ALJ's decision is only a recommendation, the Agency has no obligation to publish any portion of it, let alone that which persists in re-arguing that which has been long decided.
Respondent argues that the ALJ's refusal to allow him to present testimony from his expert, Dr. Richard Stieg, three of his employees, and his patients, “was arbitrary, capricious, an abuse of discretion, and otherwise not in accordance with law.” Resp. Exceptions, at 1-2. While I find the ALJ's ruling denying Respondent the right to call Dr. Stieg to be problematic, for reasons explained below, I hold that Respondent has not demonstrated that the ALJ committed prejudicial error. I further find that Respondent has failed to demonstrate that the ALJ erred when he barred the employees and the patients from testifying, let alone that the error was prejudicial.
Respondent argues that even before the proceeding was initiated, “the Government had several months in which to . . . obtain an expert witness” and have the expert review the evidence against him. Resp. Exceptions, at 2. By contrast, Respondent argues he “had a very limited period of time in which to . . . retain an expert and have the expert review the documents and files” and form his opinion.
Respondent further contends that he “was placed in a perilous position by the” ALJ, apparently because after Respondent identified Dr. Stieg and disclosed “his expected testimony,” he “also discovered that Dr. Stieg” had a serious medical condition and was to undergo treatment on the dates set for the hearing (December 16-17, 2013) and “would be unable to testify.”
Respondent further argues that the ALJ's basis for denying his motion was inconsistent with agency precedent. In his Recommended Decision, the ALJ explained that he found Dr. Stieg's testimony “would likely have little probative value, as the witness did not appear to be familiar with Ohio medical practice standards.” R.D. at 4. Respondent argues that the ALJ's reason is “arbitrary, capricious, an abuse of discretion, and not in accord with DEA precedent,” noting that in
Finally, Respondent notes that while the ALJ had initially considered allowing Dr. Stieg to testify through video teleconference (and be taken out of order), he reversed his position after Respondent invoked his Fifth Amendment privilege and refused to testify when called as a witness by the Government.
While some of Respondent's arguments are well taken, I hold that Respondent has failed to demonstrate prejudicial error.
Moreover, “[a]n error is prejudicial only `if it can be reasonably concluded that with . . . such evidence, there would have been a contrary result.’ ”
According to Respondent's proffer, “Dr. Stieg would have testified that there is no `gold standard' or one defined standard which defines with certainty the accepted and prevailing standards of care for pain medicine medical services” and that “whether a physician has met the accepted and prevailing standards of care for pain medicine service is a case by case analysis, taking into account the individual circumstances of each patient and the relevant medical decisions in connection with the treatment of that patient.” Resp. Offer of Proof, at 3.
Moreover, Dr. Stieg “would have testified that a physician in [Respondent's] position has an ethical duty to believe what his patient tells him regarding his or her medical condition, and has a duty to attempt to provide appropriate treatment which he believes helps his patient with the condition the patient represents to him,” and that it is “reasonable and ethically imperative to believe” the patient until a “physician is presented with objective evidence that the patient is lying . . . or is otherwise non-compliant.”
Respondent further proffered that Dr. Stieg would testify “that the physician/patient relationship for pain medicine must evolve over time,”
On the issue of the adequacy of the physical exams, Respondent proffered that “Dr. Stieg would testify that there is no single standard to determine exactly what an adequate physical examination requires in every circumstance” and that “there is a consensus standard that a physical examination should focus on the cause of the pain.”
Respondent also proffered that “Dr. Stieg would have testified that the diagnosis made by Dr. Zaidi for each undercover agent were [sic] within the accepted and prevailing standards of care,” that the initial “diagnosis often becomes clearer as the physician/patient relationship yields more information over time,” and while an “MRI and further testing may have revealed [a] more specific pathological diagnosis . . . the diagnosis of lumbago and lumbar radiculosis can be justified, pending further analysis.”
I agree with Respondent that it was not reasonable to require him to identify his expert witness, have the expert review the Government's evidence against him, and prepare an adequate summary of the expert's testimony within the time period provided for in the ALJ's pre-hearing ruling. Indeed, it is not clear on this record how Respondent could have provided an adequate summary of his expert's
This aside, much of the proffered testimony is consistent with that given by the Government's expert. But most significantly, this is not a case in which the evidence is limited to the testimony of dueling experts. Rather, the Government presented substantial evidence beyond the testimony of its expert to support the conclusion that Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose in issuing the prescriptions to the undercover officers. Thus, even if Dr. Stieg had testified that Respondent acted within the accepted standard of care in making the diagnoses and prescribing controlled substances to the undercover patients, as ultimate factfinder, I would not find this sufficient to reject the ALJ's findings.
Here, with respect to each of the undercover officers, the record is replete with evidence that Respondent falsified each officer's medical record at every visit to document both: (1) The performance of physical exam tests which he never conducted, and (2) pain levels which were higher than the officers actually reported. Nothing in the proffered testimony of Dr. Stieg refutes the fair inference which arises from the falsifications—that Respondent falsified the records in order to justify the prescribing of controlled substances, and that in prescribing the controlled substances, Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose.
This conclusion is buttressed by Respondent's invocation of his Fifth Amendment privilege when called to testify by the Government. As the Supreme Court has explained, “the Fifth Amendment does not forbid adverse inference against parties to civil actions when they refuse to testify in response
In its prehearing statement, the Government provided notice that it intended to call Respondent to testify “that his treatment of the undercover officers fell below accepted medical standards and that the controlled drugs [were not] prescribed in the usual course of professional practice or for a legitimate medical purposes,” as well as “that his documentation of his examinations of [each undercover officer] was inaccurate and not based on objective data that he gathered during the exams.” ALJ Ex. 8. Respondent's invocation of his Fifth Amendment privilege, considered in light of the probative evidence weighed by the ALJ, thus supports the inference that he acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the undercover officers.
However, even in criminal cases, the Supreme Court has held that a violation of a defendant's Fifth Amendment privilege is subject to harmless-error analysis.
In justifying his refusal to grant a continuance to Respondent, the ALJ also explained that he was “guided by the expectation that where doing so is not inconsistent with a litigant's rights under the Due Process Clause or the Administrative Procedure Act, I should endeavor to submit the certified record of these proceedings to the Administrator . . . not later than the 150th day after the issuance of an immediate suspension (excepting any days caused by Respondent's own actions).” R.D. at 4-5. However, even where an immediate suspension order has been issued, the Administrator has clearly instructed the Agency's ALJs that they may grant a continuance upon a registrant's request. Here, but for the fact that Respondent cannot show prejudicial error, I would have remanded this matter.
Respondent further argues that the ALJ acted arbitrarily and capriciously when he barred the testimony of three employees (C.B., J.B., and R.Z.). Exceptions, at 5-6. Respondent maintains that the employees “were directly involved in the patient care of the undercover [officers] and were also interviewed by the . . . Agents when they raided [his] office.”
In his proffer, Respondent stated that C.B. is a certified medical assistant who took each undercover officer's history and that she “did extensive histories on
According to his proffer, R.O. would have largely duplicated C.B.'s testimony regarding Respondent's treatment of the patients, whom he helped to regain functionality and control of their pain, as well as those patients who were discharged for using either illegal drugs or for misusing drugs he had prescribed.
Finally, J.B. “would have testified regarding her observations concerning [Respondent's] interaction with and treatment of patients including the undercover agents and those patients” identified in Respondent's Exhibits A through R, as well as regarding the patients that Respondent discharged.
The ALJ barred Respondent from presenting the testimony of these three witnesses because the substance of their testimony was not timely disclosed and did not sufficiently establish relevance. Here, in contrast to the ALJ's rulings on Respondent's proposed expert, I conclude that the ALJ did not err in barring the testimony on the ground that it was not timely disclosed. Respondent had more than one month from the date of the ALJ's prehearing order to determine whether his employees could offer relevant evidence in the matter and a week from the time the Government provided a detailed summary of the testimony of each of its witnesses to disclose their anticipated testimony. Moreover, Respondent's proffer (which was filed even after the testimonial phase of the hearing was concluded) does not identify any material fact which any of the employees would have refuted. Accordingly, I conclude that Respondent has also failed to establish prejudice.
Respondent also sought to elicit testimony from ten patients regarding the care they received from Respondent and how his treatment of them “dramatically improved their lives, functionality, and ability to tolerate their ongoing pain.” Resp. Proffer, at 13;
Respondent argues that “the Government's expert failed to establish with any degree of medical certainty the standard of care which Respondent . . . failed to meet” and that the ALJ erred in applying Ohio Revised Code § 4731.052 and Ohio Admin. Code § 4731-21-02 “as the sole standard” when he held that Respondent violated 21 CFR 1306.04(a) when he prescribed to the undercover officers. Resp. Exceptions, at 6. Respondent argues that the ALJ's reliance on these provisions was misplaced because they apply only to the treatment of chronic or intractable pain and not acute pain, which was the condition presented by the undercover officers.
I reject Respondent's exception. Contrary to his contention, the ALJ specifically acknowledged (as did the Government's expert) that the Ohio provisions did “not apply during that phase of treatment where the diagnosis is of acute pain, but appl[ied] only after the treatment extend[ed] past twelve weeks.” R.D. at 69. However, as the ALJ explained, Ohio law defines “chronic pain” as “pain that has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months.”
However, based on the length of the prescribings, I agree with the ALJ's conclusion that Respondent failed to comply with Ohio's chronic pain statute.
Moreover, notwithstanding that neither of the Ohio provisions applied in the initial three-month period of the undercover officers' treatment, the record contains substantial evidence to support the conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose when he prescribed to each of the undercover officers during this period. For example, with respect to Patient Tyler Williams, Respondent diagnosed him as having “thoracic and lumbar radiculitis, lumbago.” GX 12, at 8. However, the Government's expert testified that he had reviewed the video recording of the UC's first visit and found that while Respondent documented that he had performed numerous tests during the physical examination, many of the tests were actually not performed. Tr. 71-76. The expert thus explained that his “impression of the physical examination is that it is falsified, it is embellished, and it is inaccurate, to the point that much of it, though documented here, was not performed.”
The Government's expert then explained that Respondent's diagnosis was not justified by the patient's history and the physical examination and that the diagnosis of radiculitis was “blatantly inaccurate.”
The progress note for the UC's second visit states that he had “moderate tenderness and spasm in paralumbar muscles with guarding in forward flexion” and that the “lower extremity examination is normal to sensory and motor testing.” GX 12, at 12. Here again, the Government's expert reviewed the recording and transcript of the visit and found that Respondent did not perform a physical examination (while documenting that he did) and that the findings were falsified. Tr. 80-81. He further noted that while the progress note stated that the treatment plan included a home exercise program (in addition to controlled substances), there was no evidence of “any educational endeavor that would allow someone to conduct a home exercise program.”
With respect to the third visit, the Government's expert similarly observed that there was no evidence that Respondent had examined the UC's lumbar spine or performed sensory or motor testing of his lower extremities,
With respect to the UC's fourth and fifth visits, the expert again found that there was no justification for the lumbar radiculitis diagnosis and that Respondent did not physically examine the UC's lumbar region and lower extremities while documenting that he did. Tr. 97-99. Moreover, at the fourth visit, Respondent again documented that the UC had a pain level of 5, although the transcript contains no indication that the UC was asked about his pain level by Respondent.
Respondent further contends that the ALJ erred in concluding that he “failed to fully document his periodic assessment and documentation of the patient's functional status, including the ability to engage in work or other purposeful activities, the interference with activities of daily living, quality of family life and social activities.” Exceptions, at 7 (quoting R.D. 79, Conclusion of Law #8). Respondent asserts that Ohio law does not require “a prescribing physician to perform these measures for acute pain patients.”
Notably, the Government's expert (who has been an expert reviewer for the state medical board) explained that at twelve weeks, Ohio law considers this to be “protracted prescribing,” which requires “a much higher level of intensity of service.” Tr. 100;
That 90 days is a pause, and it is a method of communicating very forcefully to the physician, that if this is going on for that time, there better be quite a bit of substantiation behind it, and intensity of service needs to justify the continued uses of that medication. . . . It's not reasonable, especially when a patient is being seen acutely, that even we see from the emergency department with several weeks of pain, it's really not reasonable to know how long that prediction is. But what the law is saying is that if somebody needs controlled substances that long, this is the level of intensity of service that somewhere along the line, needs to have been accomplished.
As the Government's expert explained, the prescriptions “were not for a legitimate medical purpose,” Tr. 103, because the diagnosis of lumbar radiculitis “is not justified or substantiated by either the history or the physical examination.”
During the UC's subsequent four visits, Respondent never performed a physical exam, while documenting having done so.
Also, the expert explained that the treatment plan “focuse[d] only on controlled substances and not on other alternative approaches to care,”
Respondent also asserts that the Government's expert applied “his own subjective interpretation of how he believed a physical examination should be conducted and diagnosis determined” and that “[t]here is no evidence in the record to establish what a physical exam or diagnosis requires.” Resp. Post-Hrng. Br., at 11. It is noted, however, that the Government's expert is board certified in anesthesiology, internal medicine, and pain medicine; that he is the Director of Pain Medicine Services and the Pain Medicine Fellowship at the Ohio State University Medical Center; that he has taught courses in Acute Pain, Chronic Pain, and Chronic Back Pain; and that he has served as an expert reviewer in pain medicine for the State Medical Board of Ohio. GX 2.
Moreover, in his testimony, the Government's expert acknowledged the “concept described as [the] minimal standard of care,” which he explained as “those actions and decisions that would be made by a reasonable physician under similar circumstances.” Tr. 204. The expert then testified that in the “environment under which we discuss this case, that standard of care and the minimal standard of care can be considered one [and] the same,” and that if a physician meets the minimal standard of care, he meets the standard of care.
So too, while the expert was not asked what tests are necessary to conduct a physical examination which meets the standard of care with respect to the specific diagnoses made by Respondent, on cross-examination, the expert explained that “[r]adiculopathy and radiculitis are very similar diagnoses and [have] very similar causes, but the diagnosis of radiculopathy is a nerve injury that is a permanent loss of nerve function and that the distribution of the change in permanent function is that which corresponds to those muscles or portions of . . . the body that that particular nerve serves.”
I therefore reject Respondent's exception to the ALJ's legal conclusion that the prescriptions were not issued for a legitimate medical purpose in the usual course of professional practice.
Respondent further argues that the ALJ “incorrectly determined that Factors 2, 4, and 5 support revocation” of his registration. Resp. Exceptions, at 10. While I find that some of Respondent's contentions are well taken, I conclude that the record as a whole supports the ALJ's ultimate conclusions that Respondent has committed such acts as to render his registration inconsistent with the public interest (had he submitted an application), and that Respondent failed to rebut this conclusion. R.D. at 87.
As this Agency has long held, I am not required to make findings under each of the factors and findings under a single factor are sufficient to support the revocation or suspension of a registration.
With respect to factor two—Respondent's experience in dispensing controlled substances—Respondent argues that the Government seized more than 400 patient files from his office “and failed to present any evidence . . . that the treatment of those patients failed to meet the standard of care.” Resp. Exceptions, at 10. He also argues that “there were over 400 additional patients' charts which were not seized and [that] no evidence was presented to question their treatment.”
The Agency has repeatedly rejected Respondent's contention.
However, as the Agency explained, the physician's “prescribings to thousands of other patients do not . . . render her prescribings to the undercover officers any less unlawful, or any less acts which are `inconsistent with the public interest.' ”
Accordingly, in
Subsequent to
The Agency also addressed and rejected the physician's contention that “[a] better assessment of [his] medical practice and habits can be ascertained from [his] numerous positive experiences in prescribing controlled substances, some of which were recounted by the patients themselves . . . at the hearing.”
The Tenth Circuit denied the physician's petition for review.
Despite Dr. MacKay's claim to the contrary, the Deputy Administrator considered the entire record, including the evidence in Dr. MacKay's favor. She determined, however, that none of Dr. MacKay's evidence negated the DEA's prima facie showing that Dr. MacKay had intentionally diverted drugs to K.D. and M.R. Indeed, she found that even if Dr. MacKay had provided proper medical care to all of his other patients, that fact would not overcome the government's evidence with regard to M.R. and K.D.
None of the evidence presented by Dr. MacKay undermines the evidence relating to M.R. and K.D. Although numerous patients and colleagues of Dr. MacKay related their positive experiences with him, none had any personal knowledge regarding his treatment of M.R. and K.R. Notably, Dr. MacKay's medical expert, Dr. Fine, failed to specifically discuss and justify Dr. MacKay's treatment of M.R. and K.D. As a result, none of Dr. MacKay's evidence contradicts the testimony and evidence presented by the DEA relating to the knowing diversion of drugs to these two patients.
The Court of Appeals thus concluded that “[a]lthough Dr. MacKay may have engaged in the legitimate practice of pain medicine for many of his patients, the conduct found by the Deputy Administrator with respect to K.D. and M.R. is sufficient to support her determination that his continued registration is inconsistent with the public interest.”
In this matter, I have assumed that Respondent lawfully complied with the CSA whenever he prescribed controlled substances to all of his patients (including the 800 patients with respect to whom no evidence was offered) other than the undercover officers.
Given that Respondent was the only doctor at the clinic, there is no need to decide whether the evidence establishes the existence of such a protocol (whether written or not) or whether such “operations” were established. As the evidence shows, Respondent repeatedly failed to perform physical examinations (or performed inadequate exams) and then falsified the undercover officers' medical records to reflect his having performed such exams; he also falsified the medical records by documenting higher pain levels than those reported by the undercover officers. As explained above, this evidence establishes that Respondent
Respondent notes that when the undercover officer posing as Patrick Tock requested that he be prescribed Opana (because a friend had said it worked for him), Respondent warned him about the dangers of the drug and did not prescribe the drug. Resp. Exceptions, at 11. Respondent further notes the testimony of the Government's expert that Respondent's decision not to prescribe the medication was appropriate.
While I agree with the ALJ's reasoning that “[a] practitioner's failure to resolve red flags strongly suggests that the practitioner's subsequent dispensation of controlled substances to that patient is not for a legitimate medical purpose,” R.D. at 60, this is so because such evidence is probative of the physician's knowledge or intent. However, in this matter, there is no need to resolve the issue of whether Respondent adequately addressed various red flags. This is so because the evidence that: 1) Respondent failed to performed physical exams (as well as various tests as part of the physical exams) yet falsified the medical records by documenting that he did, 2) falsified the medical records to reflect higher pain levels than those actually reported by the undercover officers, as well as 3) the adverse inference to be drawn from his refusal to testify, conclusively prove that Respondent acted outside the usual course of professional practice and lacked a legitimate medical purpose when he prescribed controlled substances to the undercover officers and thus knowingly diverted controlled substances.
Thus, to the extent Respondent failed to address any red flags, this is simply additional evidence probative of the illegality of the prescriptions.
With respect to factor four, Respondent contends that the ALJ took a “quantum leap” when he found “that Respondent intentionally kept inconsistent medical records on [the UC's] pain levels in order to protect himself from an audit.” Resp. Exceptions, at 13 (citing R.D. 66). According to Respondent, “[i]t defies logic to believe that [he] would attempt to intentionally create a false medical record by increasing a pain level from 3 to 4 or 5 on a 1-10 scale, especially knowing the chart accurately contains references to [the] pain levels communicated by the DEA agent,” which are still “in the same moderate range.”
It is true that the undercover officers' charts contain a nursing progress record which accurately reflects what they reported to Respondent's medical assistant. That being said, Respondent does not challenge the ALJ's findings that he falsified the medical records by documenting having performed various tests as part of a physical examination which he failed to do. Based on this evidence, as well as Respondent's refusal to testify and explain the disparity in the pain levels, I draw the same inference that the ALJ did—that the pain levels were falsified (along with the results of physical examinations he did not perform) to provide documentation to support the prescriptions.
Respondent's diversion of controlled substances is properly considered as evidence of his lack of compliance with applicable laws related to controlled substances. So too, his failure to comply with Ohio's regulation which requires that “[a] physician shall complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients,” Ohio Admin. Code § 4731-11-02(D), is also relevant in assessing his compliance with applicable laws related to controlled substances.
a strong argument can be made for the proposition that [Respondent's] failure to correctly understand the law enforcement exceptions to HIPAA and to discuss with his staff the role law enforcement plays in preventing abuse and diversion is important. If pain management staff members observe evidence of doctor shopping or diversion of prescribed narcotics, those staff members should be familiar with steps they can and must take to alert the relevant authorities of possible illicit action. [Respondent] is responsible for ensuring that his staff understands the practitioner's role in preventing abuse and diversion of controlled substances.
Respondent takes exception to the ALJ's findings and legal conclusions, noting that while the “HIPAA provides certain law enforcement exceptions to the confidentiality of protected health information, there is no provision in HIPAA that requires an office practice to report `doctor shopping' to law enforcement.” Resp. Exceptions, at 15. Respondent further notes that “[i]n this case, there is not even any evidence of `doctor shopping.' ”
I agree with Respondent that the HIPAA does not require such reporting (as well as that there is no evidence of doctor shopping in this case). Moreover, in this case, there is no evidence that either Ohio law or the standards of professional practice require a doctor to report a doctor shopper to law enforcement, and there may be valid reasons why a physician, who acts entirely within the bounds of both the law and the standards of professional practice, would take issue with the notion that his/her employees should report instances of doctor shopping to the authorities rather than to him or herself.
Accordingly, I reject the ALJ's reasoning. I also reject his finding of fact number twelve, to the extent it states that Respondent “did not provide training to his staff regarding exceptions to patient privacy laws that apply when the staff members observe behavior relating to controlled substance abuse, misuse, or diversion,” R.D. at 80, as well as his conclusion of law number thirteen.
While I reject the ALJ's finding and conclusion of law on this issue, I agree with the ALJ's finding that the pre-signing of prescriptions, even if there is no proof that the prescriptions were issued on a subsequent day, constitutes conduct which may threaten public health and safety.
While merged with his exception to the ALJ's factor five analysis, Respondent also takes exception to the ALJ's recommended order of revocation, arguing that this sanction “is unwarranted in law and without justification in fact.” Resp. Exceptions, at 16. He further asserts—notwithstanding his refusal to testify—that he “has accepted responsibility for
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a)(4), as well as 28 CFR 0.100(b), I affirm the Order of Immediate Suspension of DEA Certificate of Registration BA3842259, issued to Syed Jawed Akhtar-Zaidi, M.D. Also, pursuant to the authority vested in me by 21 U.S.C. 824(f), I further order that all right, title, and interest in the controlled substances seized by the Government during the execution of the Order of Immediate Suspension be, and hereby is, vested in the United States.
Administrative Law Judge Christopher B. McNeil. These are proceedings before the Drug Enforcement Administration and the United States Department of Justice, under docket number 14-2, captioned In the Matter of Syed Akhtar-Zaidi, M.D. The proceedings are being held pursuant to sections 303 and 304 of the Controlled Substances Act, Title 21 United States Code sections 823 and 824.
On October 8, 2013, the Drug Enforcement Administrator through her Deputy Administrator issued an order to show cause why the Administrator should not revoke DEA Certificate of Registration number BA3842259, issued to Syed Jawed Akhtar-Zaidi, M.D., and should not deny any application for renewal or modification of the same.
In the order, the Deputy Administrator alleged that Dr. Zaidi's continued registration is inconsistent with the public interest, in that between September 2012 and May 2013, Dr. Zaidi distributed controlled substances by issuing prescriptions under conditions that fell outside the usual course of professional practice or were for other than legitimate medical purposes.
On October 23, 2013, the Office of Administrative Law Judges for the DEA received Respondent's Request for a Hearing to determine whether Dr. Zaidi's continued registration would be consistent with the public interest.
I granted Respondent's request for a hearing, and in advance of the hearing I asked the parties to offer prehearing statements that included summaries of proposed testimony along with proposed stipulations of fact, with the Government being directed to file their proposal by November 19, 2013, and Respondent by November 26, 2013. I also set the matter for hearing to commence on December 10, 2013, with non-testimonial presentations to be held at the DEA's hearing facility in Arlington, Virginia, and with testimony to be taken during the week beginning January 6, 2014, in Cleveland, Ohio.
On November 6, 2013 I received the parties' consent motion to accelerate the hearing.
On December 10, 2013, the initial day of the hearing, federal offices were closed due to winter weather, and I ordered the cancelation of the initial day of hearing.
At that time I had before me the Government's motion for an order
Respondent, on the other hand, sought to delay the hearing in order to accommodate his expert witness, whom he described as having medical problems that prevented his appearance on December 16 or 17, 2013.
During the prehearing teleconference on December 12, 2013, I denied Respondent's renewed motion to delay the hearing, finding cause had not been shown to require a delay in the testimonial segment of this proceeding. Respondent first sought to delay the hearing on November 25, 2013, the day before prehearing statements were due, in order to have “adequate time to prepare,” citing the difficulties in doing so occasioned by the Government's “prehearing seizure of effectively all of Respondent's liquid assets.”
I received Respondent's second request to delay the hearing on December 6, 2013.
In reviewing Respondent's prehearing statement and each supplement thereto, I found that the proposed expert witness's testimony as summarized by Respondent did not need to be presented at the same time as the rest of the testimony being offered, and could be taken out of order without prejudice to Respondent. I further found that the evidence would likely have little probative value, as the witness did not appear to be familiar with Ohio medical practice standards. I also considered the uncertain nature of the length of the delay that would be needed to accommodate Dr. Stieg.
Additionally, I considered the potential adverse effects of such an uncertain delay in resolving this matter. In this regard I am guided by the expectation that where doing so is not inconsistent with a litigant's rights under the Due Process Clause or the Administrative Procedure Act, I should endeavor to submit the certified record of these proceedings to the Administrator in accordance with 21 CFR 1316.65 not later than the 150th day after the issuance of an immediate suspension (excepting any days caused by Respondent's own actions).
Further, I granted the Government's motion for an order
With respect to testimony from Respondent's expert, I found sufficient prejudice had been shown by the Government to sustain its motion and bar the testimony of Dr. Stieg, due to the untimely disclosure of the identity of the expert and the nature of his testimony, and due to the lack of detail in the description of the proposed testimony, including the description presented in Respondent's December 12, 2013 supplemental prehearing statement.
Regarding the lack of specificity and detail provided regarding Respondent's own testimony, I found Respondent's prehearing statement did not comply with my prehearing order in that it did not indicate clearly each and every matter as to which he intended to testify. While cause had been shown to bar Respondent's testimony, the Government did not seek to bar Respondent from testifying but instead sought to have Respondent supply the required summary prior to the conclusion of the first day of hearing, which had been scheduled for December 10, 2013.
When the parties convened in Cleveland for the testimonial portion of the hearing, acting on the advice of his attorney, Dr. Zaidi exercised his constitutional right against compulsory self-incrimination and, after being sworn and identifying himself, declined to answer questions presented to him on direct examination by the Government.
The Government's case was presented through testimony of three undercover agents who posed as patients; Dr. Zaidi's billing clerk, Kim Maniglia; Diversion Investigator Scott A. Brinks; and Steven Severyn, M.D., who testified as the Government's medical expert.
Dr. Severyn practices medicine at the Comprehensive Spine Center located at The Ohio State University Wexner Medical Center, in Columbus, Ohio.
Dr. Severyn holds a baccalaureate degree from Johns Hopkins University, a medical degree from The Ohio State University, a master's degree in business administration from Ohio University, and a master's degree in strategic studies at the United States Army War College.
In his current medical practice, Dr. Severyn works full time in the sub-specialty of pain medicine.
Dr. Severyn stated that he has been qualified in the past as an expert witness in matters concerning the evaluation and treatment of patients using controlled substances, for both the DEA and the United States Department of Justice.
In preparing to testify in this matter, Dr. Severyn reviewed video recordings of interactions between undercover agents Parkison, Leonard, and Moses, and Dr. Zaidi.
In reaching these conclusions, Dr. Severyn noted the requirements found in the Ohio Administrative Code regarding the use of controlled substances for the treatment of pain.
When selecting a treatment for a patient, the first principle is evaluation, establishing of a diagnosis, the considering of alternative treatments in making a recommendation to a patient [in] regard to treatment, a provision of the risk of each of those alternatives, and then the treating of the patients in a way that conforms with current professional standards of care.
Further, he stated that one part of the professional standard of care for such providers is that when prescribing controlled substances for the treatment of pain, a provider must take into account the medication's potential for diversion and abuse.
Dr. Severyn noted that when referring to the minimal standard of care throughout his testimony, he regards this as describing the standard of care for pain medicine physicians.
Beyond this, however, Dr. Severyn stated that in a pain medicine practice, there are “additional requirements for the specificity and the degree of detail in keeping medical records when prescribing controlled substances on a protracted basis, greater than twelve weeks,” calculated from the initial prescribing encounter.
Dr. Severyn explained that before a physician may prescribe controlled substances for pain, he or she must reach a medical diagnosis and determine the appropriate treatment plan.
Such a treatment plan would need to include “regular follow up and monitoring, not only of the patient
In those cases where a physician in Ohio prescribes controlled substances for pain on a protracted basis, which in this case means for greater than twelve weeks, Dr. Severyn said that the physician must obtain the patient's consent and inform the patient of the risks and benefits associated with such a treatment plan.
Dr. Severyn agreed with the proposition, presented during cross examination, that it will sometimes take a period of time and a number of visits for a physician to observe and evaluate a patient with respect to red flags associated with controlled substance diversion, misuse, or addiction.
When asked whether he believes community-based pain management clinics (
Another resource available to physicians in Ohio, according to Dr. Severyn, is the Ohio Automated Rx Reporting System, or OARRS.
Dr. Severyn also was asked whether transitioning from an immediate-release form of Oxycodone to a time-released form is another means of responding to red flags.
Two of the undercover agents represented to Dr. Zaidi they suffered from pain or stiffness in the lower back.
I want to find out some basic information about the patient. Where is your pain? Does it radiate into the legs? For how long have you had it? What makes it better? What makes it worse? Have any procedures or surgeries been done to make a difference in this, in the past, and zero to ten, what is your severity of pain? Have you had physical therapy? Has that been helpful for you in the past? Might it be something to consider again? Then I look at the OARRS report, because I want to know how accurate is my patient's reported history in comparison to what has already been documented as being dispensed. Next, I look through the medical record to see if at Ohio State, during any of the time that the patient has been seen, there is a urine drug screen present. If so, I copy it into the medical record and make a decision, then and there, if I'm going to be obtaining another one.
Dr. Severyn explained that because his practice at The Ohio State University is a referral practice, the patients he sees usually are being cared for by other members of OSU's medical staff.
Tyler Parkison is a DEA Special Agent, a position he has held since 2008.
Agent Parkison stated that the investigation into Dr. Zaidi's prescription practice began after an agent in his office received a complaint indicating “suspicious prescribing involving controlled substances” along with a complaint alleging a family member of the complainant “was addicted to Dilaudid” and an allegation that “there were drug transactions taking place in the parking lot” of Dr. Zaidi's practice.
In his investigation of Dr. Zaidi, Agent Parkison acted in an undercover capacity under the name Tyler Williams,
Agent Parkison's first of five visits to Dr. Zaidi's office was recorded in audio and audio/video recordings, the transcripts of which are in our record.
Ms. Maniglia explained that she has been employed at Pain Management of Northern Ohio for twelve and a half years.
According to Ms. Maniglia, Dr. Zaidi requires urine drug screening for all new patients, and uses such screens periodically throughout the patient's treatment.
Ms. Maniglia explained that there may be days when prescriptions that Dr. Zaidi has signed are not actually needed that day, so “[t]here might have been a few left over,” but when that happens the signed prescriptions are stored “triple-locked up in the drug cart” and are used the next day.
Affixed to the window separating the waiting area from the receptionists office are stickers indicating payment could be made using Visa, Diners Club, MasterCard and Discover, along with a sign that states the staff is not permitted
The receptionist area appeared to be equipped with telephones, computers, fax, copy, or multifunction machines, and file cabinets that typically are found in offices of this size.
Ms. Maniglia was asked to recall what she was asked when DEA agents came to Dr. Zaidi's office to search the premises.
Ms. Maniglia also testified about what she told DEA investigators with respect to doctor shopping. She said she understood doctor shopping involved patients going to different doctors in order to get multiple prescriptions for controlled substances.
At the time search warrants were being executed, DEA Diversion Investigator Scott Brinks questioned Dr. Zaidi regarding his office practice.
In addition to providing insight into the operations of Dr. Zaidi's medical office at the time of the execution of the DEA's search warrant, the Government also included in the record transcripts and recording showing how Dr. Zaidi's office staff handled patient visits. Generally, a staff assistant would conduct an initial intake interview with the patient, and then Dr. Zaidi would review the intake forms and meet with the patient.
Christy Barrett, a member of Dr. Zaidi's office staff, conducted an intake interview with Agent Parkison, lasting approximately nine minutes.
The doctor's examination took place in a room that appeared to be well-equipped with modern, functional furnishings, including a full-size examination table.
Dr. Zaidi discussed Agent Parkison's hypertension, and then had Agent Parkison stand, bend from the waist forward then back, walk on his toes and heels, and thereafter told Agent Parkison he had slight scoliosis, ending the examination after approximately 60
Without discussing the possibility of physical therapy or home exercises,
After confirming that he reviewed the undercover recordings and the entire medical record maintained by Dr. Zaidi regarding treatment of Agent Parkison (under the name Tyler Williams), Dr. Severyn expressed opinions regarding both Dr. Zaidi's physical examination of Agent Parkison and the medical history that supported Dr. Zaidi's decision to prescribe controlled substances to this patient.
Dr. Severyn noted that the patient “is acknowledging no past medical history, no past surgical history, and having been completely healthy all of his life” until two weeks prior to the visit, when he experienced lower back pain.
When Dr. Severyn compared what was in the written medical chart
Next, Dr. Severyn noted that a cranial nerve examination was indicated in the written notes.
Similarly, although the medical record indicates normal sensory and motor testing, “[t]here was no testing that went on with sensation of the arms, the hands, or the range of motion or strength of the fingers, the wrists, the biceps, and triceps.”
Dr. Severyn noted that Dr. Zaidi reported mild scoliosis without deformity, but also that the lower extremities were normal with respect to sensation and strength, and that the “[a]bdomen is soft and nontender.”
Next, Dr. Severyn said that while the medical records indicate a chest examination was performed, “to do that requires the use of a stethoscope, and a stethoscope was nothing that I could observe during any of the recording of this encounter.”
Dr. Severyn opined that the report of this patient's examination was falsified in that “it is embellished, and it is inaccurate, to the point that much of it, though documented here, was not performed.”
Also of concern, according to Dr. Severyn, was Dr. Zaidi's diagnosis indicating thoracic and lumbar radiculitis. Dr. Severyn stated:
Radiculitis is a diagnosis of nerve root dysfunction at the level of the spine, at the level where the nerve roots exit the spine. If it is lumbar radiculitis, then it is a nerve root that's exiting in the lumbar area, and so for the thoracic area, radiculitis is a condition
But, putting a diagnosis of radiculitis as opposed to other causes, that, based on this history and the lumbar portion of the examination are much more reasonable, brings to my mind the question as to the accuracy of that diagnosis, because I think that an experienced physician, especially one in the field of pain medicine, would recognize that this is not the presentation and the examination that's compatible with a diagnosis of radiculitis. This diagnosis is blatantly inaccurate.
Dr. Severyn expressed the same opinion regarding Dr. Zaidi's diagnosis of lumbar radiculitis during the follow-up visit on October 4, 2012, based on what he observed from the recordings of the follow-up visit and what appears in Dr. Zaidi's written notes of that encounter.
The October 4, 2012 visit began with Ms. Barrett
As Ms. Barrett finished her notes in the file, Dr. Zaidi entered and Ms. Barrett stood up from behind the examination table, at which point Dr. Zaidi took the seat and briefly turned his back to Agent Parkison and consulted his computer monitor.
Agent Parkison then asked Dr. Zaidi “if I could get a little bit more” and hoped “to try two in the morning and two in the evening.”
In his transcribed notes for the subjective examination, Dr. Zaidi wrote:
[Agent Parkison] is stable with his lower back pain at 5 on a scale of 0-10. No change in his personal, family, or social history. No focal weakness or numbness. No abdominal or chest pain. His blood pressure is again very elevated. We again discuss the potential complications from such high blood pressure and he is to go and see his PCP today or ER to have that addressed. Otherwise, no abdominal or chest pain at present. No headaches. No visual disturbances.
In his report of objective findings, Dr. Zaidi wrote that Agent Parkison's “vital signs are stable though blood pressure is elevated. Moderate tenderness and spasm in paralumbar muscles with guarding in forward flexion. Lower extremity examination is normal to sensory and motor testing. His gait is normal.”
By this point in the visit, Dr. Zaidi had spent approximately two minutes in the room with Agent Parkison, all of it seated, with the examination table between himself and Agent Parkison.
Dr. Severyn remarked that there was a notation regarding home exercise as part of the plan of treatment.
Despite the paucity of information gathered during this second visit, Dr. Zaidi increased by one hundred percent the number of Percocet tablets he prescribed to Agent Parkison.
According to Dr. Severyn, Agent Parkison's next visit, on November 14, 2012, did not include an examination of the lumbar spine, nor any testing for guarding in forward flexion, nor was there any sensory or motor testing of the lower extremities.
Having reviewed the audio-video recording of the November 14, 2012 office visit, I concur with Dr. Severyn's assessment and find there was no examination of Agent Parkison's lumbar spine during this visit, nor was there any testing for guarding in forward flexion, nor was there any sensory or motor testing of the lower extremities.
Agent Parkison stated that for this visit, he reported a current pain level of two and the worst level had been a three.
Based on this encounter, Dr. Zaidi made written subjective findings, stating that Agent Parkison's “lumbar pain is at 5 on a scale of 0-10” despite the notations to the contrary in the chart prepared by Ms. Barrett and despite the absence of any evidence indicating Agent Parkison was reporting pain at that level.
Consistent with what Agent Parkison told Dr. Zaidi, in the Objective findings section Dr. Zaidi noted Agent Parkison's continued high blood pressure, adding, “He has seen his PCP and has been asked to monitor it at home, and I asked him to make a follow-up again very soon.”
Dr. Severyn opined that Dr. Zaidi's diagnosis of lumbar radiculitis “is a more severe condition than what this patient is voicing complaints [] of,” and “is not justified on the basis of the entirety of the history and the physical examination.”
Dr. Severyn also noted that while the written record of treatment for November 14, 2012, reports Agent Parkison reported pain at level five (on a scale of ten), the recording and transcript show that Agent Parkison reported pain at level two to three—and there is no explanation to account for this difference.
The Government also presented testimony from DEA Diversion Investigator Brinks, who was present when Agent Parkison interviewed Dr. Zaidi at the time the DEA's search warrant was executed.
Dr. Severyn was asked to interpret the exchange between Dr. Zaidi and Agent Parkison, where the latter, during his visit of December 12, 2012, told Dr. Zaidi that his current medication has “been helping some at the end of the day,” but that he had “a little bit of nagging stiffness,” adding that one of his “buddies said something that [OxyContin] kind of helps him.”
The audio-video recording of the December 12, 2012 visit confirms Dr. Severyn's description of the sequence leading to this change in medication. For this visit, Ms. Barrett does not appear to have taken a history or recorded Agent Parkison's blood pressure, and Dr. Zaidi met with Agent Parkison for slightly less than three minutes.
Dr. Zaidi then engaged Agent Parkison with questions and advice about his blood pressure (although it appears no one recorded Agent Parkison's blood pressure for this visit).
Dr. Severyn said that requesting OxyContin under these circumstances “raises in my mind, as it does in that of my associates and colleagues, a question of why is this patient asking for a specific medication by name, instead of relying on my expertise to introduce a specific medication. . . .”
Dr. Severyn next explained there are more rigorous standards that apply in Ohio when using controlled substances to treat pain that no longer can be described as acute but is instead chronic or intractable.
At that point, there is a much higher level of service reflected by documentation that needs to take place. Some of those [include an] evaluation of what is the current employment history, what is the activity of daily living. . . . Is the treatment plan justified? [W]hat is the effectiveness of the treatment plan? That is not recorded here.
Dr. Severyn explained that by the time the protracted prescribing of controlled substances has begun, “the diagnosis needs to be substantiated by the physical findings and my opinion is that they are not, and it needs to be substantiated by the history, and my opinion is that it is not.”
Because Dr. Zaidi had been treating Agent Parkison for more than twelve weeks by January 2013, “[a]n entirely elevated level of service is called for,” which was not evidenced in either the medical chart or the recordings of the office visits from January 2013 forward.
In reviewing the audio-video recording of the January 9, 2013 visit, I found no examination took place other than the taking of Agent Parkison's blood pressure and oxygen levels by Ms. Barrett.
Pupils are equal and reacting to light. Skin is warm and dry. Moderate diffuse tenderness and spasm in paralumbar muscles with minimal guarding in forward flexion and extension. Lower extremity examination is normal to sensory and motor testing. His gait is normal.
During cross examination, Agent Parkison stated that after this visit, he determined no additional visits were warranted.
According to Dr. Severyn, Dr. Zaidi to this point had failed to make an adequate assessment of Agent Parkison' functional status, or of his activities of daily living.
Dr. Severyn also noted that when a patient reports “stiffness” in the mid-back, as Agent Parkison did during the visit on January 9, 2013,
Such a complaint would not justify prescribing controlled substances in the manner shown in the records for Agent Parkison, according to Dr. Severyn, “because there are so many less risky alternatives that can be offered, including muscle relaxants that can be very helpful here, and other approaches to care.”
In Dr. Severyn's opinion, Dr. Zaidi's controlled substance prescriptions for Agent Parkison were based on a diagnosis that is “completely inaccurate” and “focuses only on controlled substances and not on the several other alternative approaches to care [including] physical therapy, non-controlled substance medication, [and] the medications in several different classes.”
Dr. Severyn noted that by his fourth visit, Agent Parkison asked for OxyContin by name, something Dr. Severyn regarded as a red flag.
When asked how a physician should respond to a patient who sees an advertisement for a particular drug, Dr. Severyn stated that if the drug was a controlled substance, he would “incorporate that into the remainder of the medical decision-making process” although this did not mean the incident would necessarily be noted in the patient's medical record.
When asked on cross examination about things a physician must do to resolve red flags associated with potential diversion, misuse, or addiction, Dr. Severyn stated that first the physician must observe the patient over time, note the “maturation” of what is observed, and when encountering more than one “element of discontinuity” more than just observation is called for.
Dr. Severyn agreed, on cross examination, that there may have been instances where patients have deceived him without his knowledge.
Regarding a patient's decision not to seek treatment (such as a recommended epidural injection) or diagnostic measures (such as an MRI), Dr. Severyn was asked if he recalled whether the patient attributed the decision to cost or an inability to pay.
Dr. Severyn stated that an MRI is helpful in the context of pain medicine, “when it answers, in the mind of the physician . . . what is the cause of this patient's complaints, the etiology of the physical findings and the implication and impact of learning that information upon the recommendation to be made to the patient and the treatment plan to be put into effect.”
On cross examination, Dr. Severyn agreed that one appropriate means of responding to red flags in the context of prescribing pain medication is to use urine drug screens, and he acknowledged that Dr. Zaidi used these screens as part of his prescription practice.
Dr. Severyn next explained why the inaccuracies found in Dr. Zaidi's medical records of Agent Parkison's treatment are important in the review of Dr. Zaidi's prescription practice:
There is inaccuracy and a listing of a more severe level of pain than what the patient is actually voicing during the encounter with staff or with the physician. The diagnosis, the impression that is listed here, the most impressive and important of them, with regards to guiding the patient through treatment, would be the lumbar radiculitis, and that is not justified or substantiated by either the history or the physical examination. Finally, the approach to treatment that relies on only a controlled substance and does not include many of the other approaches, such as non-steroidal anti-inflammatory, neuromodulator, tricyclic medications [and] physical therapy. Those are absent. The home exercise program, I found no evidence that that is being provided.
I found, to a large degree, that if I were to have reviewed only the medical record, as it was presented here, I would have arrived at a different opinion than I am able to, having now had the ability to see a transcript and watch an audio/visual recording of what actually occurred during that encounter.
For these reasons, Dr. Severyn opined that Dr. Zaidi's prescriptions of controlled substances for Agent Parkison “were well outside the usual course of professional practice . . . .”
Patrick James Leonard has been employed at the Akron (Ohio) Police Department for about 20 years, the last sixteen of which he has been a detective in the narcotics diversion department.
Detective Leonard participated in the surveillance of Dr. Zaidi's medical office and was a patient in an undercover capacity, under the name Patrick J. Tock.
In his role as Patrick Tock, Detective Leonard reported that he had stiffness in his lower back.
As was the case with his review of Agent Parkison's treatment, Dr. Severyn reviewed the medical charts, transcripts, and recordings
In the “History and Physical Examination” for the visit on October 23, 2012, Dr. Zaidi reported the patient's “pupils are equal and reacting to light.”
I note that of the recordings included in Government Exhibit Four, audiovisual recordings were available only for the examinations of Officer
For the examinations conducted on December 13, 2012 and February 21, 2013, it is possible to confirm (and I do confirm) that no examination took place that would provide Dr. Zaidi with objective evidence to support these exam findings,
I find, however, that Dr. Zaidi's determination to remain silent in the face of testimony tending to show no examinations took place gives rise to a negative inference, one that supports a finding that his examinations on November 15, 2012; January 10, 2013; and March 21, 2013, were substantially similar to those shown in the videos of examinations on December 13, 2012 and February 21, 2013, and do not support the findings he reported in these medical records. It is unclear, however, what examinations, if any, took place on the first visit, on October 23, 2012.
Dr. Severyn noted that Officer Leonard reported a dull ache affecting the low back during his initial visit, at level three to four on a ten-point scale, without weakness and without numbness going into the legs.
In addition to concerns regarding Dr. Zaidi's written impressions, Dr. Severyn remarked that the patient presented red flags that went unresolved by Dr. Zaidi. One such red flag arose when the patient was unable to produce identification after the initial visit.
According to Dr. Severyn, after Officer Leonard admitted to using his wife's pain medication, Dr. Zaidi should have obtained more information.
Dr. Severyn explained that while Dr. Zaidi did use urine drug screens as part of his prescription practice, the screen would be useful here if Dr. Zaidi could determine when Officer Leonard actually took his wife's medication. “I think that what is so missing [about] this red flag, about receiving medication from the wife, is we all have no idea when that event would have been said to have occurred. But if it would have been said to have occurred the past day or so, its absence on the urine screen would have been an important red flag. Its presence would be just as important.”
Also of concern with this patient, according to Dr. Severyn, was the patient's request after the initial visit for an increase in oxycodone; and on the fourth visit the patient's request for Opana.
Dr. Severyn noted that at the initial visit, when Officer Leonard produced only a photocopy of his license (under the pretense that the original had been seized recently by the police), there was some mention that he would need to produce a license at the next visit,
Beyond these red flags, Dr. Severyn opined that even under a diagnosis of lumbar radiculitis, “[t]his patient has not had benefits of a more conservative plan of treatment. Modification of activities, non-controlled substances, physical therapy are the big three, the main important components of treatment that have to, over a period of several weeks, not result in an improvement” before resorting to controlled substances as treatment for pain.
[T]he treatment of that abnormality probably would not have taken place because it would not be medically necessary. What is medically necessary is [based on] what does the patient have? How is this affecting quality of life, employment, social history? How is the patient responding to the least risky forms of treatment?
Dr. Severyn stated that he reviewed each of the recordings of Officer Leonard's follow-up visits with Dr. Zaidi, and saw no evidence of any subsequent physical examinations, raising doubts about the validity of the diagnoses appearing in the reports of those visits.
During cross examination, when it was noted that Dr. Zaidi issued an order prescribing an MRI, Dr. Severyn stated that the MRI “became part of the medical treatment plan, and the patient's lack of follow up of the medical treatment plan is yet another red flag.”
At the same time, however, Dr. Severyn thought that these patients had paid $300 for their initial office visits and were paying $95 for each subsequent visit.
Dr. Severyn noted that as was the case with his treatment of Agent Parkison, when Officer Leonard's treatment extended beyond twelve consecutive weeks, treatment is considered to be on a protracted basis.
Dr. Severyn explained the significance of a course of pain medication that extends beyond twelve weeks. Under Ohio Administrative Code section 4731-21-02, when it appears that a patient will be treated with pain medication for twelve weeks or longer, “there better be quite a bit of substantiation behind it, and [the] intensity of service needs to justify the continued use of that medication.”
Dr. Severyn also noted the absence of information regarding the patient's functional capacities.
Dr. Severyn expressed the opinion that in prescribing controlled substances for Officer Leonard, Dr. Zaidi did so without having a legitimate medical purpose, because the patient's medical complaints did not justify the use of a controlled substance.
Shaun Moses is a Special Agent with the DEA, working out of the DEA's Cleveland, Ohio office.
Agent Moses visited Dr. Zaidi for treatment on five occasions, under the name Shaun Chandler.
Agent Moses described the physical examination performed by Dr. Zaidi in the first visit. Dr. Zaidi directed Agent Moses to roll up his left pant leg, at which point Dr. Zaidi “squeezed my knee a little bit,” then directed Agent Moses to walk on his heels and toes, bend over to touch his toes, straighten his leg while seated, and respond to questions about the presence of back pain.
As was the case with his review of Dr. Zaidi's treatment of Agent Parkison and Detective Leonard, Dr. Severyn reviewed the recordings, transcripts, and medical records regarding Dr. Zaidi's treatment of Agent Moses as Shaun Chandler.
During the visit on January 29, 2013, Agent Moses presented as having left knee stiffness, which he indicated to Dr. Zaidi was dull and aching, and which he said was at worst four on a ten point scale, and was presently two on that same scale.
When asked on cross examination whether a physician acting within the standard of care must decline to provide medical services to a patient who lacks records of prior medical treatment, Dr. Severyn said if there are no prior records then it would not be a breach of the standard of care, nor would it be unusual, as “[t]here will always be a case in which a physician is seeing a patient for the patient's first event of a condition associated with pain.”
Central to Dr. Severyn's analysis were reports of examination contained in the typed notes appearing in the “History and Physical Examination” report found in the patient's medical records.
Included in these inaccuracies were notations that the patient was “oriented times three,” which Dr. Severyn explained meant that the patient was oriented as to person, place and time.
As Dr. Severyn noted, Dr. Zaidi's written report of the physical examination states the patient's thyroid gland is not enlarged and there is no cervical or axillary lymphadenopathy, but at no time did Dr. Zaidi palpate the lymph or thyroid glands.
Having reviewed the video recording, including the time Agent Moses spent with the medical assistant Christy Barrett and the time spent with Dr. Zaidi, I find Dr. Severyn's observations to be supported by substantial evidence. It is clear that Dr. Zaidi instructed Agent Moses to raise his left pant leg, and that he palpated the patellar area of the left leg; and we see Agent Moses extending his leg and, when standing, rise on his toes and then on his heels.
While there is evidence that Dr. Zaidi tested Agent Moses' gait, finding good balance and coordination, and that Agent Moses performed normal heel and toe walking, Dr. Zaidi also indicated finding a “soft and nontender” abdomen, but never palpated the abdomen.
When stating the impressions formed from this examination, Dr. Zaidi indicated “knee pain, limb pain, and possible early osteoarthritis of knee.”
Early arthritis does cause knee pain, but so do many other things in young, healthy patients. Most common are ligament strains, followed by inflammation of the cartilage behind the knee cap, which is different than cartilage between the bones, between the tibia and the femur, which is the real communicated message, when we use the term osteoarthritis of the knee.
Also of concern to Dr. Severyn was the plan of treatment that Dr. Zaidi based on this examination and history. Dr. Zaidi prescribed Vicoprofen, which is a combination of ibuprofen, a non-steroidal anti-inflammatory, and hydrocodone (or Vicodin), a controlled substance pain medication.
Agent Moses returned for an office visit on February 12, 2013, which was preserved in an audio-video recording, the contents of which have been transcribed.
Dr. Severyn also noted with some concern the subjective report for this visit, where Dr. Zaidi states that Agent Moses was complaining of both knee and leg pain, and that the pain level he was experiencing was between four and five.
Agent Moses' third visit to Dr. Zaidi's office, on March 11, 2013, lasted two minutes and 25 seconds
[T]he reactivity of the pupils to light, the diffuse tenderness of the left knee, when the left knee is touched. The absence of redness or swelling being reported in here requires a physical examination to be performed, which was not. Range of motion testing requires a classic evaluation, or at least flexion and extension, and it was not [done]. The lower extremity examination being normal with both motor and sensory testing is reported here, and that did not occur.
Here again, Dr. Severyn noted that although it appears as a term of the treatment plan, there is no evidence suggesting Dr. Zaidi provided Agent Moses with information about a home exercise program.
In his review of Agent Moses' fourth office visit, on April 9, 2013, Dr. Severyn noted many of the same concerns—that Dr. Zaidi's written history and report of physical examination reported conditions that could be legitimately entered only if a physical examination had been performed. Having reviewed the recording of the visit on April 9, 2013 (which lasted three minutes and 33 seconds),
In his review of the fifth and final visit by Agent Moses on May 6, 2013, Dr. Severyn noted the same concerns as were presented in his discussion of the fourth visit.
I also concur with Dr. Severyn's observation that although his treatment plan indicates he prescribed a home exercise program, Dr. Zaidi failed to propose a home exercise plan for this patient.
Dr. Severyn also expressed the opinion that Dr. Zaidi failed to resolve red flags that arose when Agent Moses sought to increase his medication during the fourth visit.
According to Dr. Severyn, however, prescribing Percocet four times daily at this point was not a reasonable solution, and that decision in the face of these red flags “is one that I don't find to be medically in keeping with . . . prevailing standards of care.”
From this review of Dr. Zaidi's prescription practice concerning Agent Moses, Dr. Severyn stated that in his opinion, “the prescribing of controlled substances in this patient's treatment was not prescribing medication for a legitimate purpose or in the usual course of professional practice.”
Four core facts compel my determination that it would be inconsistent with the public interest for the Administrator to permit Dr. Zaidi to continue prescribing controlled substances. First, the evidence establishes that Dr. Zaidi repeatedly prescribed controlled substances under conditions that warranted further investigation and, in the absence of such investigation, were not for a legitimate medical purpose. His decision to prescribe narcotic pain medication to three undercover agents despite the presence of numerous red flags constituted a material breach of the duties owed by physicians practicing under the Controlled Substances Act, and his prescription practice in these three cases did not meet Ohio's requirements for the distribution of controlled substances.
Second, the evidence establishes that Dr. Zaidi lacks the experience and insight needed to participate in the controlled substance distribution system. His decision to manage a pain clinic using a protocol that permitted the issuance of prescriptions for controlled substances without conducting physical examinations threatens the public safety. Either through ignorance or deliberate indifference, Dr. Zaidi's decision to establish such operations indicates he lacks sufficient insight and experience to be trusted to participate in the controlled substance distribution process.
Third, the evidence establishes that Dr. Zaidi misrepresented the scope and character of both the physical examinations he performed and medical histories obtained during office visits with three DEA undercover agents. While such a practice may well constitute fraud, the Government made no claim of fraud here. Instead, it asserts that this feature of Dr. Zaidi's prescription practice constitutes conduct that is not otherwise addressed by the enumerated factors found in 21 U.S.C. 823(f)(1-4) but which nonetheless is conduct that “may threaten the public health and safety.”
Fourth, after the Government presented evidence sufficient to establish that his continued DEA registration would be inconsistent with the public interest, Dr. Zaidi failed to present evidence of an acknowledgement of wrongdoing and a proposal for meaningful remediation. Accordingly, I will recommend that the Administrator revoke Dr. Zaidi's DEA registration and deny any pending application for renewal of the same.
This administrative action began when the DEA's Administrator through her Deputy Administrator issued an order proposing to revoke Dr. Zaidi's DEA Certificate of Registration and ordering him to show cause why that
While the burden of establishing that Dr. Zaidi's certification contravenes the public interest never shifts from the Government, once the Government meets this burden, Dr. Zaidi has the opportunity to present evidence that he accepts responsibility for his misconduct, and has taken appropriate steps to prevent misconduct in the future.
Under the registration requirements found in 21 U.S.C. 823(f), the Administrator is expected to consider five factors in determining the public interest when presented with the actions of a physician engaged in prescribing controlled substances. These factors are:
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
Any one of these factors may constitute a sufficient basis for taking action with respect to a Certificate of Registration.
In making a medical judgment concerning the right treatment for an individual patient, physicians require a certain degree of latitude. Hence, “[w]hat constitutes bona fide medical practice must be determined upon consideration of evidence and attending circumstances.”
In its post-hearing brief, the Government does not propose to use Factor One as a basis for arguing that the continued registration of Dr. Zaidi is contrary to the public interest.
We do not have an express recommendation by the applicable regulators in Ohio. This may be a factor to consider when evaluating the weight to be given to Dr. Severyn's analysis. There is, however, no substantial evidence of a “recommendation” in support of Dr. Zaidi's continued practice in Ohio; nor is there evidence that the state's medical board elected to evaluate any of Dr. Zaidi's treatment records (or even that it is currently aware of this administrative action).
From the record before me I cannot discern a reason for the Board's inaction, and as such I cannot conclude that its inaction establishes that Dr. Zaidi's prescription practice conformed to Ohio law. Such evidence, standing alone, cannot support a finding under Factor One.
Under Factor Three the Administrator is to consider an applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
Under Factor Four the Administrator is required to consider Respondent's “compliance with applicable State, Federal, or local laws relating to controlled substances.”
As the Government aptly notes in its post-hearing brief, when she determines whether a practitioner's conduct “exceeds the bounds of professional practice when prescribing controlled substances,”
There is evidence, aptly noted in Respondent's post-hearing brief, that Dr. Zaidi did to some extent take into account the risks of abuse and diversion associated with the drugs he was prescribing. Dr. Zaidi, for example, screened all cases using the OARRS protocol, required urine drug screening at the initial visit, prescribed low doses of the narcotics (at least initially), required check-ins every two weeks, warned against taking medication that had been prescribed to others, and described the risks of moving quickly to ever stronger narcotic medication.
No one distinct set of circumstances permits me to determine the extent to which Dr. Zaidi recognized the potential for abuse or diversion when treating the undercover agents. All of the foregoing office protocols may have been instituted to reflect Dr. Zaidi's concern for the potential misuse or diversion of controlled substances. Given Respondent's decision to not testify, however, our record is silent with respect to Dr. Zaidi's mental assessment of these cases. I am thus left to discern what factors Dr. Zaidi took into account when prescribing these drugs based on the contents of the written medical records and on what I heard and saw in reviewing the recordings of the undercover agents' office visits. In doing so, I cannot help but be influenced by the evidence of falsification present in these records. Knowing now what actually occurred during the office visits and comparing that to what Dr. Zaidi wrote in the patient records, I find little reason to believe these protocols were instituted to reduce the risk of abuse or diversion, but were instead instituted to provide some degree of cover for Dr. Zaidi against regulatory action by the DEA, should his records ever by subject to audit.
As the Government correctly points out, in its prehearing statement the Government put Dr. Zaidi on notice well before the hearing that it intended to question him about his response to these red flags.
Independent of such an inference, however, the same result is warranted. I have considered the steps taken to resolve red flags identified by Dr. Severyn. As the Government has suggested, Dr. Severyn's conclusion is supported by evidence that Dr. Zaidi failed to resolve numerous red flags the agents presented during their office visits.
Testimony from Dr. Severyn helps to identify what red flags were presented to Dr. Zaidi during these visits. These include, for example, being presented by a patient's request for OxyContin by brand name.
I give great weight to Dr. Severyn's assessment of circumstances that constitute red flags, given his substantial relevant experience in prescribing controlled substances for treating pain, his understanding of the pressures facing pain medicine physicians, and his familiarity with Ohio's pain management regulations. Thus, when he relates that a pain management patient's request for OxyContin by name has been a red flag for pain management physicians for “a decade or more” I attribute great weight to that opinion. The same was true when Officer Leonard requested Opana, which both Officer Leonard and Dr. Severyn stated was now becoming increasingly diverted and abused.
Similarly, Dr. Severyn considered Agent Moses' request for an increase in medication at the fourth office visit to be a red flag, where the request was based solely on the recommendation of “a guy [Agent Moses] work[s] with”
To much the same effect was Dr. Zaidi's apparent complacence when a patient sought an increase in the amount of OxyContin being prescribed. Again, there was no evidence that Dr. Zaidi engaged Officer Parkison in any inquiry that would probe why existing levels of pain medication were inadequate.
Respondent in his post-hearing brief correctly points out that resolving red flags can take time—a point with which Dr. Severyn concurred.
Dr. Severyn added, however, that depending on the indicators presenting as red flags, the physician may have to do more than just wait.
Another red flag was the refusal of a patient to obtain an MRI despite the treating physician's order for such imaging.
While a patient's request for brand name opiates does not in and of itself compel a conclusion that the patient is seeking to divert or abuse pain medication, the request must be addressed by the treating physician. There is, however, nothing in the record suggesting that Dr. Zaidi regarded these requests for brand-name pain-killers as anomalous or requiring further inquiry. Similarly, a patient's decision not to pursue more conservative treatment (such as cortisone injections) or obtain diagnostic information (such as is available with an MRI) by itself is not conclusive of an intent to abuse or divert narcotics, but such decisions have to be taken into account by the prescribing source. To the extent Dr. Zaidi elected to not dispute Dr. Severyn's thoroughly documented observations, I am entitled to infer that Dr. Zaidi failed to consider the possibility that the undercover agents sought drugs for non-therapeutic reasons or that the drugs he prescribed could have led to dependence. To the extent such a failure indicates a lack of experience, Dr. Zaidi's failure to resolve red flags—standing alone—has been addressed in the Factor Two discussion above. To the extent it led to the issuance of actual prescriptions for controlled substances, Dr. Zaidi's practice violated Ohio law relating to the prescription of controlled substances.
Independent of Dr. Zaidi's failure to resolve red flags is evidence that the diagnoses upon which controlled substances were prescribed cannot withstand scrutiny. I find substantial evidence supports Dr. Severyn's opinion that Dr. Zaidi had no basis for diagnosing either Agent Parkison or Detective Leonard with lumbar radiculitis, given the examinations that supported those diagnoses and given that neither officer complained of pain radiating into the leg.
I find the evidence establishes that by prescribing controlled substances based on a diagnosis of radiculitis, Dr. Zaidi did so without a legitimate medical purpose. As such, Dr. Zaidi's continued DEA registration would be inconsistent with the public interest under Factor Four.
There is a third basis under Factor Four that warrants evaluation. Apart from failing to resolve red flags and basing controlled substance prescriptions upon an unsustainable diagnosis of radiculitis, Dr. Zaidi failed to comply with Ohio law in the maintenance of his medical records. Under Ohio law a physician prescribing controlled substances must “complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients.”
In addition, under this regulation, a medical record of treatment involving controlled substances must “accurately reflect the utilization of any controlled substances in the treatment of a patient and shall indicate the diagnosis and purpose for which the controlled substance is utilized, and any additional information upon which the diagnosis is based.”
I found this part of the record particularly troubling. Had I before me only Dr. Zaidi's written medical records of the officers' treatment, I would have reasonably concluded that Dr. Zaidi was responding to complaints of pain that were significantly more severe than what was actually presented during these office visits. Dr. Zaidi's assistant accurately recorded pain levels as they were presented to her by the undercover officers, generally noting pain in the range of two, three, or four on a ten-point scale. In his typewritten chart, however, Dr. Zaidi indicates pain levels of five, which could not be substantiated by either what the patients said to the assistant or what they said to Dr. Zaidi. The evidence shows Dr. Zaidi misrepresented and exaggerated the patients' complaints of pain.
As Dr. Severyn noted with some concern, once it became clear that Dr. Zaidi exaggerated the patients' reports of pain, and once it became clear that Dr. Zaidi's diagnoses for radiculitis could not be substantiated by the actual physical examinations he performed, “the entire validity of the record becomes subject to extreme doubt and questioning.”
Beyond exaggerating the patients' complaints of pain, Dr. Zaidi falsely reported results from tests that were never performed. From my review of the recordings of the undercover officers' visits, I find Dr. Zaidi falsely reported their pupils' reactivity to light, their heart and chest sounds, the condition of their abdomens, their lower extremity sensory and motor condition, and their limbs' range of motion. Further, I find Dr. Zaidi falsely described prescribing conservative measures (including home exercise programs) in their medical
Respondent in his post-hearing brief notes that Dr. Severyn offered no statutory or other authority “which sets forth mandatory requirements for a physical examination and diagnosis.”
Respondent also describes at length the attention Dr. Severyn gave to practice requirements that arise after a patient has been receiving pain medication for more than twelve weeks.
Having said that, I note that I do not interpret Dr. Severyn's testimony as having required Dr. Zaidi to conform to the standards for treating intractable pain from the start of the physician/patient relationship. As Respondent noted in his post-hearing brief, Dr. Severyn acknowledged that the statute and regulation treating chronic pain (Ohio Rev. Code § 4731.052) and intractable pain (Ohio Admin. Code 4731-21-02) do not apply during that phase of treatment where the diagnosis is of acute pain, but apply only after treatment extends past twelve weeks.
Our record reflects, however, that upon making his initial diagnoses in these cases, Dr. Zaidi elected not to characterize the patients' conditions (all of which involved potentially chronic conditions) as either chronic or acute. Instead, he prescribed opioid treatment exclusively, and during the first twelve weeks treated the patients as though their symptoms were not likely to change or improve. At no time during the first twelve weeks of treatment, for example, did Dr. Zaidi indicate he expected to reduce the officers' reliance on narcotics. Thus, from all outward appearances, Dr. Zaidi was treating these patients as though their conditions were not acute, but were instead chronic, from the outset of treatment.
I am mindful that Dr. Zaidi in his post-hearing brief notes that he did not diagnose any of the undercover agents with “chronic” pain; nor, for that matter, did he describe any of the pain as “acute.”
The distinction regarding chronic or acute designations made by Dr. Severyn, however, did not depend on the patients' condition during the first twelve weeks. My understanding of his testimony is that whether or not a patient is identified as having intractable or chronic pain during the first twelve weeks, the physician must re-assess the patient once the course of treatment enters into its twelfth week. That appears to be what the regulation cited by Respondent calls for. The regulation defines “intractable pain” as “a state of pain that is determined, after reasonable medical efforts have been made to relieve the pain or cure its cause, to have a cause for which no treatment or cure is possible or for which none has been found.”
From our record, I found no evidence that Dr. Zaidi regarded as clinically significant the twelve-week benchmark in his treatment of the three undercover agents. His actions during the office visits immediately before and after the twelfth week were remarkable only in that they remained essentially the same—they were cursory, involved no physical examinations, and focused almost entirely on the patients' requests for additional or different narcotics.
What is notable in the treatment of chronic pain in Ohio, however, is that once pain “has persisted after reasonable medical efforts have been made . . . either continuously or episodically, for longer than three continuous months,”
As noted in the Government's post-hearing brief, Dr. Severyn found that when treatment of the undercover agents extended into the twelfth week, Dr. Zaidi failed to assess the impact of pain on their physical and psychological functions, failed to discuss alternative treatment plans, and failed to document how their pain affected their employment, daily and social activities, and family life.
I note the Government also argues that Respondent violated Ohio law by prescribing a controlled substance to his daughter.
Accepted and prevailing standards of care require that a physician maintain detached professional judgment when utilizing controlled substances in the treatment of family members.
Ohio courts have stated that “utiliz[ing] controlled substances” includes “prescribing” them.
Respondent's counsel pointed out that the evidence does not show whether the prescription was filled.
Respondent's counsel also pointed out, however, that Investigator Brinks did not ask whether the prescription was issued during an emergency.
The Government also asserts that Dr. Zaidi violated Ohio law by instituting a practice by which he would pre-sign prescriptions at the beginning of a work day, leaving those prescriptions not needed on that day in storage, so that they could be used the following day; and that he failed to require patient addresses be included in each prescription.
The record does not, however, include substantial evidence of an actual instance where Ms. Maniglia had pre-signed prescriptions at the end of a work day, and used the carried-over script the following day for purposes of dispensing controlled substances. Accordingly, this is discussed under Factor Five, but does not serve as a basis for making an adverse finding under Factor Four.
While I do not endorse the Government's assertion that it proved Dr. Zaidi violated Ohio law regarding prescribing to family members, I do find substantial and persuasive evidence establishing that Dr. Zaidi otherwise failed to comply with applicable state and federal laws relating to controlled substances, and that this failure warrants a finding that his continued DEA registration would be inconsistent with the public interest under Factor Four.
Under Factor Five, after considering the public interest in the context of the first four factors, the Administrator will consider “other conduct which may threaten the public health and safety.”
In its post-hearing brief, the Government contends that Respondent “instituted and maintained policies that were contrary to Federal law” in two respects under Factor Five.
As a matter of procedure, I regard the scope of Factor Five to be limited to those portions of our record that do not establish violations of federal law. “Because section 823(f)(5) only implicates `such other conduct,' it necessarily follows that conduct considered in Factors One through Four may not ordinarily be considered at Factor Five.”
I am not, however persuaded that sufficient evidence has been presented to conclude Dr. Zaidi “maintained a policy by which employees were forbidden from contacting law enforcement”
I have carefully reviewed Ms. Maniglia's testimony regarding the reasons she felt constrained in reporting suspicious behavior to law enforcement personnel. Clearly the record indicates that Ms. Maniglia understood patient privacy laws to be very broad in scope. In her understanding of those laws, Ms. Maniglia said, “I ha[ve] been in the field for 20 years and we're not allowed to talk about any patient confidentiality stuff.”
Ms. Maniglia's understanding about federal privacy laws as they pertain to pain management clinics is understandable. Federal law in this area is complex and generally tends to restrict disclosure of medical records, as Ms. Maniglia correctly stated. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of Health and Human Services to create standards for privacy of “individually identifiable health information.”
The term “individually identifiable health information” means any information, including demographic information collected from an individual, that—
(A) is created or received by a health care provider, health plan, employer, or health care clearinghouse; and
(B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and—
(i) identifies the individual; or
(ii) with respect to which there is a reasonable basis to believe that the information can be used to identify the individual. 42 U.S.C. 1320d.
However, there are situations in which the covered entity may use or disclose protected health information without the individual's authorization or agreement. These are situations where the entity is obligated by law to disclose information, where the information is requested as part of a judicial or administrative proceeding, or where the information is needed for public health or safety purposes.
There are also several circumstances under which covered entities may disclose protected health information to law enforcement agencies or officials.
Assuming, as I do, that Ms. Maniglia's testimony is accurate, I think a strong argument can be made for the proposition that Dr. Zaidi's failure to correctly understand the law-enforcement exceptions to HIPAA and to discuss with his staff the role law enforcement plays in preventing abuse and diversion is important. If pain management staff members observe evidence of doctor shopping or diversion of prescribed narcotics, those staff members should be familiar with steps they can and must take to alert the relevant authorities of possible illicit action. Dr. Zaidi is responsible for ensuring that his staff understands the practitioner's role in preventing abuse and diversion of controlled substances. The evidence tends to demonstrate Dr. Zaidi failed to meet this responsibility in the management of his medical practice.
To some extent, therefore, there is evidence that Dr. Zaidi's management of his staff was materially deficient and was inconsistent with the public interest.
I cannot, however, agree with the Government's assertion that the evidence establishes Dr. Zaidi “maintained a policy by which employees were forbidden from contacting law enforcement in the event they suspected patients were obtaining multiple prescriptions for controlled substances from multiple doctors.”
Accordingly, while I find insufficient evidence establishing that Dr. Zaidi established a policy prohibiting his staff from reporting evidence of diversion or abuse, I find his office practice generally created a risk to the public safety in failing to properly train his staff regarding the role of law enforcement officers in detecting abuse and diversion of controlled substances. In this respect, the Government has met its burden of demonstrating that Dr. Zaidi's continued DEA registration would be inconsistent with the public interest under Factor Five.
Once the Government has proved that a registrant has committed acts inconsistent with the public interest, a registrant must “present[] sufficient mitigating evidence to assure the Administrator that [the registrant] can be entrusted with the responsibility carried by such a registration.”
Here the Administrator must proceed without testimony from Dr. Zaidi, and without evidence of remediation or of an admission of fault. I cannot concur with Respondent's claim that “there is no evidence to suggest that Dr. Zaidi is a threat to the public interest.”
1. On October 8, 2013, the Deputy Administrator for the Drug Enforcement Administration issued an order to show cause why the DEA should not revoke its Certificate of Registration BA3842259 issued to Syed Jawed Akhtar-Zaidi, M.D., and should not deny any application for renewal or modification of the same. That certificate authorizes the distribution of controlled substances out of an office located at 34055 Solon Road, Suite 201, Solon, Ohio 44139. The order also immediately suspended this DEA registration, under the authority found in 21 CFR 1301.36(e) and 1301.37(c). By its own terms, Respondent's DEA registration will expire on June 30, 2014.
2. Between September 11, 2012, and May 17, 2013, Respondent prescribed controlled substances to three undercover agents posing as patients. The dates these prescriptions were written; the name, dosage, and quantity of the controlled substances prescribed; and the identity of the agents who received these prescriptions are accurately set forth in paragraphs 2a through 2c in the order to show cause,
3. In each of the prescriptions for controlled substances Respondent issued to these agents identified in Finding of Fact Two, Respondent failed to include the patient's address.
4. In the cases of Agent Parkison and Detective Leonard, Respondent based his prescription for controlled substances on a diagnosis of lumbar radiculitis, under conditions where the patients' examination and history did not support such a diagnosis.
5. In the case of Agent Moses, Respondent based his prescription for controlled substances in part on diagnoses of limb pain, leg pain, and osteoarthritis, under conditions where the patient's examination and history did not support such diagnoses.
6. After his initial examination of each undercover officer, Respondent never performed physical examinations in subsequent office visits with these patients, but nonetheless either maintained or increased narcotic prescriptions throughout the course of treatment, generally based on no objective medical findings but instead based on requests by the undercover officers.
7. In the case of each undercover officer, Respondent failed to complete and maintain accurate medical records reflecting his examination of these patients in that he reported exaggerated levels of pain; reported completing examinations that were never performed; falsely stated he had examined the patients to detect pupil response to light, range of motion in the upper or lower extremities, chest and heart sounds, abdominal tenderness, and sensory and motor functions; and based his prescriptions for controlled substances on these false examination reports.
8. In the case of each undercover officer, Respondent treated for pain for a period exceeding twelve weeks, but failed either before or after the twelfth week to indicate in the patient's medical chart a diagnosis of chronic pain (including signs, symptoms, and causes); failed to develop a comprehensive assessment of the patient a description of the patient's response to treatment; failed to fully document his periodic assessment and documentation of the patient's functional status, including the ability to engage in work or other purposeful activities, the interference with activities of daily living, quality of family life and social activities; failed to fully document his periodic assessment and documentation of the patient's progress toward treatment objectives, including the intended role of controlled substances within the overall plan of treatment; and failed to fully document that he had addressed with the patient the risks associated with protracted treatment with controlled substances, including informing the
9. In the course of treating each of the undercover officers, Respondent failed to identify in his medical chart and resolve red flags indicating possible controlled substance abuse or diversion, including solicitation by the patient of specific narcotics by name as an initial course of treatment, particularly where the named drugs were OxyContin, Percocet, or Opana, all of which are recognized as frequently diverted narcotics; solicitation by the patient of increasing amounts of narcotic medication or changes in name-brand narcotics without objective medical reasons justifying the change; a patient presenting to the medical office without a government-issued identity card that included the patient's current address; a patient's use of medication provided by non-authorized sources such as a family member; and persistent patient noncompliance with orders for MRI-based studies and refusal to consider non-narcotic treatments including cortisone injections.
10. Contemporaneous to the execution of a search warrant of Respondent's premises, Respondent told DEA agents he had prescribed Vicodin to his daughter. There is, however, no copy of the prescription nor any evidence that would permit a determination of the circumstances under which this controlled substance was prescribed, including whether such treatment was provided in an emergency situation.
11. Included in Respondent's prescription practice was a protocol by which he would pre-sign prescriptions, many of which were used to prescribe controlled substances. The supply of pre-signed prescriptions would not always be exhausted at the end of the day, and remaining prescriptions would be used the following day. There is, however, insufficient evidence permitting a finding that any left-over prescriptions were used for prescribing controlled substances on a day other than the day the prescription was issued.
12. Respondent was the physician in charge of and the only authorized prescribing source at his pain management clinic. In training his clinical staff, Respondent did not require those who assisted in filling out controlled substance prescriptions to include patient addresses on the prescription. Further, he did not provide training to his staff regarding exceptions to patient privacy laws that apply when the staff members observe behavior relating to controlled substance abuse, misuse, or diversion.
13. Respondent has not provided substantial evidence that he has acknowledged any noncompliance with controlled substance laws, nor that he has undertaken efforts to avoid such noncompliance in the future.
1. When it proposes to revoke a DEA Certificate of Registration or deny any pending applications for such registration, the Government is required to establish by at least a preponderance of the evidence that the holder's continued registration is inconsistent with the public interest.
2. Five factors must be considered when determining the public interest in this case:
(1) The recommendation of the appropriate state licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable state, federal, or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
3. Under 21 U.S.C. 823(f)(1) (Factor One), as is the case here, where the record is silent with respect to the recommendation of the appropriate state licensing board or professional disciplinary authority, Factor One neither supports nor contradicts a finding that Respondent's continued DEA registration is inconsistent with the public interest.
4. In order to establish a basis for revoking a Certificate of Registration based on the provisions of 21 U.S.C. 823(f)(2) (Factor Two), and assuming Factor Two applies to Respondent, the Government must present preponderant evidence establishing that the experience of Respondent in dispensing controlled substances is of such character and quality that his continued registration is inconsistent with the public interest. Upon the determinations appearing in Finding of Fact Number Nine (above), where a preponderance of the evidence establishes that Respondent demonstrated a material lack of insight and experience regarding a prescribing source's responsibilities to resolve red flags when prescribing controlled substances for persons presenting with symptoms of chronic pain, the Government has met its burden of proving Respondent's continued DEA registration would be inconsistent with the public interest under Factor Two, warranting the revocation of that registration and the denial of any pending application for registration.
5. In order to establish a basis for revoking a Certificate of Registration based on the provisions of 21 U.S.C. 823(f)(3) (Factor Three), and assuming Factor Three applies to Respondent, the Government must present evidence of Respondent's conviction record under federal or state laws relating to the manufacture, distribution, or dispensing of controlled substances. As this Factor is neither alleged by the Government nor suggested by the evidence, this Factor may not be considered to support the revocation of Respondent's current DEA registration or deny any pending application for registration.
6. Under 21 U.S.C. 823(f)(4) (Factor Four), the Administrator is to consider the Respondent's compliance with applicable state, federal, or local laws relating to controlled substances.
7. Federal law relating to controlled substances includes the requirement that prescriptions for controlled substances include the patient's address.
8. Federal law relating to controlled substances include the requirement that all prescriptions for controlled substances must be for a legitimate medical purpose and must be issued in the ordinary course of a professional medical practice.
9. Ohio law includes the requirement that when prescribing controlled substances for pain, the prescribing source “shall complete and maintain accurate medical records reflecting the physician's examination, evaluation, and treatment of all the physician's patients.”
10. Ohio law defines “chronic pain” as pain that “has persisted after reasonable medical efforts have been made to relieve the pain or cure its cause and that has continued, either continuously or episodically, for longer than three continuous months.”
11. Ohio law provides that “intractable pain” is “pain that is determined, after reasonable medical efforts have been made to relieve the pain or cure its cause, to have a cause for which no treatment or cure is possible or for which none has been found.”
12. Ohio law permits a physician to utilize controlled substances when treating a family member only in an emergency situation, and requires the emergency situation to be documented in the patient's medical record.
13. Under 21 U.S.C. 823(f)(5) (Factor Five), the Administrator is to consider, “Such other conduct which may threaten the public health and safety.” Respondent's actions or omissions that threaten the public interest may constitute a basis for revoking a DEA registration under Factor Five, where
14. Federal law requires prescriptions for controlled substances be signed on the date the prescription is issued.
15. When responding to the Government's
As the Government has established its
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 |