| Page Range | 6745-7024 | |
| FR Document |
| Page and Subject | |
|---|---|
| 81 FR 6922 - Sunshine Act Meeting Notice | |
| 81 FR 6903 - Submission for Review: Annuitant's Report of Earned Income, RI 30-2, 3206-0034 | |
| 81 FR 6904 - Submission for Review: 3206-0228, CSRS/FERS Documentation in Support of Disability Retirement Application, SF 3112 | |
| 81 FR 6903 - Submission for Review: 3206-0138, Reinstatement of Disability Annuity Previously Terminated Because of Restoration to Earning Capacity, RI 30-9 | |
| 81 FR 6902 - Submission for Review: 3206-0099, Initial Certification of Full-Time School Attendance, RI 25-41 | |
| 81 FR 6902 - Civilian Acquisition Workforce Personnel Demonstration Project in the Department of Defense: Correction | |
| 81 FR 6898 - Excepted Service | |
| 81 FR 6768 - National Oil and Hazardous Substance Pollution Contingency Plan: Partial Deletion of the California Gulch Superfund Site; National Priorities List | |
| 81 FR 6912 - Sunshine Act Meeting | |
| 81 FR 6827 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Partial Deletion of the California Gulch Superfund Site | |
| 81 FR 6859 - Sunshine Act Meetings | |
| 81 FR 6791 - Clarifications and Revisions to Military Aircraft, Gas Turbine Engines and Related Items License Requirements | |
| 81 FR 6813 - Nondiscrimination in Programs or Activities Receiving Federal Assistance From the Environmental Protection Agency; Comment Extension | |
| 81 FR 6895 - Revisions to Radioactive Waste Management Guidance for NRC Staff | |
| 81 FR 6797 - Amendment to the International Traffic in Arms Regulations: U.S. Munitions List Categories VIII and XIX | |
| 81 FR 6921 - Overseas Security Advisory Council (OSAC) Meeting Notice | |
| 81 FR 6864 - Tribal Consultation Meetings | |
| 81 FR 6921 - 30-Day Notice of Proposed Information Collection: Courier Drop-Off List for U.S. Passport Applications | |
| 81 FR 6832 - Initiation of Antidumping and Countervailing Duty Administrative Reviews | |
| 81 FR 6919 - California Disaster #CA-00243 Declaration of Economic Injury | |
| 81 FR 6757 - Passports: Official Passports for Officials or Employees of State, Local, Tribal or Territorial Governments Traveling Abroad and Carrying Out Official Duties in Support of the U.S. Government | |
| 81 FR 6862 - Board of Scientific Counselors, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (BSC, NCEH/ATSDR), Lead Poisoning Prevention (LPP) Subcommittee; Notice of Meeting | |
| 81 FR 6826 - Receipt of a Pesticide Petition Filed for Residues of Pesticide Chemicals in or on Various Commodities | |
| 81 FR 6857 - National Environmental Justice Advisory Council; Notification of Public Teleconference and Public Comment | |
| 81 FR 6923 - Petition for Exemption; Summary of Petition Received; Bowhead Mission Solutions | |
| 81 FR 6924 - Petition for Exemption; Summary of Petition Received; Sky-Futures USA, Inc. | |
| 81 FR 6897 - Revision Probabilistic Risk Assessment and Severe Accident Evaluation for New Reactors | |
| 81 FR 6923 - Notice of Intent To Rule on Request To Release Airport Property at the Monroe Regional Airport at Monroe, Louisiana. | |
| 81 FR 6920 - Texas Disaster Number TX-00462 | |
| 81 FR 6924 - Sixty-Seventh Meeting: RTCA Special Committee (135) Environmental Conditions and Test Procedures for Airborne Equipment | |
| 81 FR 6879 - Establishment of Dispersant Preauthorization Area in Alaska | |
| 81 FR 6831 - University of Minnesota, et al.; Notice of Decision on Application for Duty-Free Entry of Scientific Instruments | |
| 81 FR 6893 - NASA Advisory Council; Human Exploration and Operations Committee; Research Subcommittee; Meeting | |
| 81 FR 6893 - NASA Advisory Council; Human Exploration and Operations Committee; Meeting | |
| 81 FR 6880 - Receipt of Domestic Interested Party Petition Concerning the Tariff Classification of a Steel Tube Fitting | |
| 81 FR 6873 - The Use of Chimpanzees in NIH-Supported Research | |
| 81 FR 6841 - Certain Magnesia Carbon Bricks From Mexico: Rescission of Antidumping Duty Administrative Review; 2014-2015 | |
| 81 FR 6831 - University of Kentucky, et al.; Notice of Consolidated Decision on Applications for Duty-Free Entry of Electron Microscope | |
| 81 FR 6922 - Seventh Meeting; RTCA Special Committee (229) Aircraft Emergency Locator Transmitters (ELTs) (Joint With EUROCAE WG-98) | |
| 81 FR 6924 - Twelfth Meeting; RTCA Tactical Operations Committee (TOC) | |
| 81 FR 6920 - Idaho Disaster #ID-00061 | |
| 81 FR 6869 - Independent Assessment of the Process for the Review of Device Submissions; Implementation Evaluation Report | |
| 81 FR 6842 - U.S. Air Force Reminder Re: United Launch Alliance (ULA) Consent Order and Recent Change in Department of Defense (DOD) Compliance Officer | |
| 81 FR 6829 - Agenda and Notice of Public Meeting of the South Dakota Advisory Committee | |
| 81 FR 6858 - Agency Information Collection Activities OMB Responses | |
| 81 FR 6878 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 6873 - National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings | |
| 81 FR 6874 - National Human Genome Research Institute; Notice of Closed Meetings | |
| 81 FR 6875 - National Human Genome Research Institute; Notice of Closed Meeting | |
| 81 FR 6877 - National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings | |
| 81 FR 6878 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting | |
| 81 FR 6872 - National Cancer Institute; Notice of Closed Meetings | |
| 81 FR 6879 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 81 FR 6872 - National Institute of Allergy and Infectious Diseases; Notice of Closed Meetings | |
| 81 FR 6882 - Agency Information Collection Activities: Notice of Naturalization Oath Ceremony, Form Number N-445; Extension, Without Change, of a Currently Approved Collection | |
| 81 FR 6745 - Conditions for Payment of Highly Pathogenic Avian Influenza Indemnity Claims | |
| 81 FR 6890 - Agency Information Collection Activities; Proposed eCollection eComments Requested; Revision of a Currently Approved Collection Request To Add a Privacy Act Statement and a Paperwork Reduction Act Notice | |
| 81 FR 6889 - Agency Information Collection Activities; Proposed eCollection, eComments Requested; Extension Without Change of a Previously Approved Collection; Report of Mail Order Transactions | |
| 81 FR 6863 - Privacy Act of 1974 | |
| 81 FR 6828 - Highly Pathogenic Avian Influenza; Availability of Final Environmental Assessment and Finding of No Significant Impact | |
| 81 FR 6830 - National Sunshine Week Public Event | |
| 81 FR 6775 - Safety Glazing Standards | |
| 81 FR 6828 - Information Collection Activity; Comment Request | |
| 81 FR 6865 - Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications | |
| 81 FR 6869 - Display Devices for Diagnostic Radiology; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 6894 - Agency Information Collection Activities: Comment Request; Education and Human Resources Program Monitoring Clearance | |
| 81 FR 6862 - Agency Forms Undergoing Paperwork Reduction Act Review | |
| 81 FR 6861 - Office of Federal High-Performance Green Buildings; Green Building Advisory Committee; Notification of Upcoming Public Advisory Committee Meeting and Conference Calls | |
| 81 FR 6860 - Information Collection; Use of Data Universal Numbering System (DUNS) as Primary Contractor Identification | |
| 81 FR 6867 - Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays; Guidance for Industry and Food and Drug Administration Staff; Availability | |
| 81 FR 6867 - Training Program for Regulatory Project Managers; Information Available to Industry | |
| 81 FR 6843 - Notice of Intent To Grant Exclusive Patent License; NCP Coatings, Inc. | |
| 81 FR 6843 - Meeting of the U.S. Naval Academy Board of Visitors | |
| 81 FR 6843 - Notice of Availability of Record of Decision for the Final Environmental Impact Statement/Legislative Environmental Impact Statement for Renewal of the Naval Air Weapons Station China Lake Public Land Withdrawal, California | |
| 81 FR 6927 - Parts and Accessories Necessary for Safe Operation; TowMate, LLC Application for an Exemption | |
| 81 FR 6925 - Motor Carriers of Passengers That Serve Primarily Urban Areas With High Passenger Loads | |
| 81 FR 6848 - Seneca Generation, LLC; Notice of Application Accepted for Filing, Soliciting Comments, Motions To Intervene, and Protests | |
| 81 FR 6844 - Commission Information Collection Activities (FERC-500, FERC-542); Consolidated Comment Request; Extension; Errata Notice | |
| 81 FR 6856 - FFP Project 92, LLC; Notice of Revised Restricted Service List | |
| 81 FR 6853 - Coleman Hydro, LLC; Notice of Availability of Final Environmental Assessment | |
| 81 FR 6846 - Notice of Commission Staff Attendance | |
| 81 FR 6848 - Iron Springs Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6849 - Granite Mountain Solar West, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6856 - Granite Mountain Solar East, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6849 - Escalante Solar III, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6853 - Escalante Solar II, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6850 - Escalante Solar I, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6853 - Enterprise Solar, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6856 - Nassau Energy, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6852 - Innovative Solar 43, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6850 - ANR Pipeline Company; Notice of Application | |
| 81 FR 6854 - Combined Notice of Filings #2 | |
| 81 FR 6854 - Combined Notice of Filings #1 | |
| 81 FR 6847 - Reliability Technical Conference; Notice of Technical Conference | |
| 81 FR 6932 - 30-Day Notice of Application for New Information Collection Request | |
| 81 FR 6904 - MassMutual Premiere Funds, et al.; Notice of Application | |
| 81 FR 6758 - Drawbridge Operation Regulation; Youngs Bay, Astoria, OR | |
| 81 FR 6920 - Reporting and Recordkeeping Requirements Under OMB Review | |
| 81 FR 6919 - Mississippi Disaster Number MS-00083 | |
| 81 FR 6885 - Notice of March 14, 2016, Meeting for Cape Cod National Seashore Advisory Commission | |
| 81 FR 6883 - Notice of March 9, 2016, Meeting of the Boston Harbor Islands National Recreation Area Advisory Council | |
| 81 FR 6863 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC): Notice of Charter Renewal | |
| 81 FR 6885 - Notice of March 3, 2016, Meeting for the Paterson Great Falls National Historical Park Advisory Commission | |
| 81 FR 6884 - National Register of Historic Places; Notification of Pending Nominations and Related Actions | |
| 81 FR 6753 - Airworthiness Directives; Turbomeca S.A. Turboshaft Engines | |
| 81 FR 6755 - Airworthiness Directives; Rolls-Royce plc Turbofan Engines | |
| 81 FR 6889 - Notice of Lodging of Proposed Consent Decree Under the Clean Water Act | |
| 81 FR 6871 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request | |
| 81 FR 6855 - LQA, LLC; Supplemental Notice That Initial Market-Based Rate Filing Includes Request for Blanket Section 204 Authorization | |
| 81 FR 6850 - Southern Maryland Electric Cooperative, Inc. v. J.P. Morgan Ventures Energy Corporation; Notice of Complaint | |
| 81 FR 6844 - Combined Notice of Filings #1 | |
| 81 FR 6846 - James W. Park; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene | |
| 81 FR 6851 - Castle Valley Special Service District; Notice of Preliminary Determination of a Qualifying Conduit Hydropower Facility and Soliciting Comments and Motions To Intervene | |
| 81 FR 6886 - Certain Footwear Products: Commission Determination To Review-in-Part a Final Initial Determination Finding a Violation of Section 337; and To Request Written Submissions Regarding the Issues Under Review and Remedy, Bonding, and the Public Interest | |
| 81 FR 6872 - National Center for Complementary & Integrative Health; Notice of Closed Meeting | |
| 81 FR 6875 - National Heart, Lung, and Blood Institute; Notice of Closed Meetings | |
| 81 FR 6872 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 6875 - National Heart, Lung, and Blood Institute; Notice of Closed Meeting | |
| 81 FR 6876 - Center for Scientific Review; Amended Notice of Meeting | |
| 81 FR 6876 - Center for Scientific Review; Notice of Closed Meetings | |
| 81 FR 6860 - D.F. Young, Inc. v. NYK Line (North America) Inc.; Notice of Filing of Complaint and Assignment | |
| 81 FR 6876 - Submission for OMB Review; 30-Day Comment Request; Drug Accountability Report Form and Investigator Registration Procedure in the Conduct of Investigational Trials for the Treatment of Cancer (NCI) | |
| 81 FR 6874 - Submission for OMB Review; 30-Day Comment Request; Application Forms for the NIDA Summer Research Internship Program | |
| 81 FR 6842 - Publication of Housing Price Inflation Adjustment | |
| 81 FR 6917 - Self-Regulatory Organizations; The Options Clearing Corporation; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To Revise the Options Clearing Corporation's Schedule of Fees | |
| 81 FR 6905 - Medallion Financial Corp.; Notice of Application | |
| 81 FR 6912 - Self-Regulatory Organizations; New York Stock Exchange LLC; NYSE MKT LLC; Notice of Withdrawal of Proposed Rule Changes Amending the NYSE Trades Market Data and NYSE MKT Trades Market Data Product Offerings | |
| 81 FR 6916 - Self-Regulatory Organizations; NYSE Arca, Inc.; Order Approving a Proposed Rule Change Relating to the Index Underlying the WisdomTree Put Write Strategy Fund | |
| 81 FR 6908 - Self-Regulatory Organizations; NYSE Arca, Inc.; Notice of Filing and Immediate Effectiveness of Proposed Rule Change To List and Trade Binary Return Derivatives | |
| 81 FR 6913 - Self-Regulatory Organizations; The Depository Trust Company; Notice of Filing and Immediate Effectiveness of Proposed Rule Change Regarding the Discontinuance of the Facsimile and Hardcopy Delivery Methods of Security Position Reports | |
| 81 FR 6915 - Self-Regulatory Organizations; The Options Clearing Corporation; Order Approving the Adoption of a Charter of a New Committee of The Options Clearing Corporation's Board of Directors, the Technology Committee | |
| 81 FR 6933 - Sanctions Actions Pursuant to the Sergei Magnitsky Rule of Law Accountability Act of 2012 | |
| 81 FR 6859 - Information Collection Being Reviewed by the Federal Communications Commission | |
| 81 FR 6858 - Federal Advisory Committee Act; Technological Advisory Council | |
| 81 FR 6830 - Notice of National Advisory Council on Innovation and Entrepreneurship Meeting | |
| 81 FR 6813 - Approval of California Air Plan Revisions, Yolo-Solano Air Quality Management District | |
| 81 FR 6763 - Approval of California Air Plan Revisions, Yolo-Solano Air Quality Management District | |
| 81 FR 6891 - Comment Request for Information Collection for the Workforce Investment Act (WIA) Management Information and Reporting System (OMB Control No. 1205-0420), Extension With Minor Revisions | |
| 81 FR 6814 - Revisions to the California State Implementation Plan, Santa Barbara County Air Pollution Control District; Permit Program | |
| 81 FR 6758 - Revisions to the California State Implementation Plan, Santa Barbara County Air Pollution Control District; Permit Program | |
| 81 FR 6886 - Certain Rack Mountable Power Distribution Units; Commission Decision Not To Review an Initial Determination Terminating the Investigation in Its Entirety Based on a Settlement Agreement; Termination of the Investigation | |
| 81 FR 6928 - General Motors LLC, Grant of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 6930 - McLaren Automotive, Inc. (McLaren), Grant of Petition for Decision of Inconsequential Noncompliance | |
| 81 FR 6761 - Approval and Promulgation of Implementation Plans; California; San Joaquin Valley Unified Air Pollution Control District; Employer Based Trip Reduction Programs | |
| 81 FR 6841 - Proposed Information Collection; Comment Request; West Coast Fisheries Participation Survey | |
| 81 FR 6806 - Manufactured Home Procedural and Enforcement Regulations; Revision of Exemption for Recreational Vehicles | |
| 81 FR 6936 - Approval and Disapproval of California Air Plan; San Joaquin Valley Serious Area Plan and Attainment Date Extension for the 1997 PM2.5 | |
| 81 FR 6765 - Protection of Stratospheric Ozone: Revisions To Reporting and Recordkeeping for Imports and Exports | |
| 81 FR 6824 - Protection of Stratospheric Ozone: Revisions to Reporting and Recordkeeping for Imports and Exports | |
| 81 FR 6814 - National Emission Standards for Hazardous Air Pollutant Emissions: Petroleum Refinery Sector Amendments | |
| 81 FR 6751 - Airworthiness Directives; Airbus Helicopters Deutschland GmbH Helicopters | |
| 81 FR 6810 - Tariff of Tolls | |
| 81 FR 6988 - Confidentiality of Substance Use Disorder Patient Records |
The printed version of the
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Animal and Plant Health Inspection Service, USDA.
Interim rule and request for comments.
We are amending the regulations pertaining to certain diseases of livestock and poultry to specify conditions for payment of indemnity claims for highly pathogenic avian influenza (HPAI). Specifically, we are providing a formula that will allow us to split such payments between poultry and egg owners and parties with which the owners enter into contracts to raise or care for the eggs or poultry based on the proportion of the production cycle completed. This action is necessary to ensure that all contractors are compensated appropriately. We are also providing for the payment of indemnity for eggs required to be destroyed due to HPAI, thus clarifying an existing policy. Finally, we are requiring owners and contractors, unless specifically exempted, to provide a statement that at the time of detection of HPAI in their facilities, they had in place and were following a biosecurity plan aimed at keeping HPAI from spreading to commercial premises.
This interim rule is effective February 9, 2016. We will consider all comments that we receive on or before April 11, 2016.
You may submit comments by either of the following methods:
•
•
Supporting documents and any comments we receive on this docket may be viewed at
Dr. Troy Bigelow, Senior Staff Veterinarian, Surveillance, Preparedness and Response Services; VS, APHIS, Federal Building, Room 891, 210 Walnut Street, Des Moines, IA 50309; (515) 284-4121.
The Animal and Plant Health Inspection Service (APHIS) of the United States Department of Agriculture (USDA or the Department) administers regulations at 9 CFR part 53 (referred to below as the regulations) that provide for the payment of indemnity to owners of animals that are required to be destroyed because of foot-and-mouth disease, pleuropneumonia, rinderpest, Newcastle disease, highly pathogenic avian influenza (HPAI), infectious salmon anemia, or any other communicable disease of livestock or poultry that, in the opinion of the Secretary of Agriculture, constitutes an emergency and threatens the U.S. livestock or poultry population. Payment for animals destroyed is based on the fair market value of the animals at the time of their destruction.
Section 53.2 of the regulations authorizes the APHIS Administrator to cooperate with a State in the control and eradication of disease. Paragraph (b) of this section allows for the payment of indemnity to cover the costs for purchase, destruction, and disposition of animals and materials required to be destroyed because of being contaminated by or exposed to such disease.
Section 53.3 provides for the appraisal of such animals and materials. Paragraph (a) of § 53.3 states that the appraisals shall be carried out by an APHIS employee and a representative of the State jointly, or, if the State authorities approve, by an APHIS employee alone. Under § 53.3(b), the appraisal must be based on the fair market value and shall be determined by the meat, egg production, dairy, or breeding value of such animals.
Section 53.10 provides conditions under which payments will not be made on indemnity claims. Such conditions include, but are not limited to, noncompliance by the claimant with all quarantine requirements, as well the violation of laws, regulations, or cooperative agreements pertaining to movement or handling of animals by the animals' owner or employee or agent. Payments will also be disallowed for claims arising out of the destruction of animals or materials if those animals and materials have not been appraised in accordance with part 53 or if the owner has not executed a written agreement to the appraisals.
There are many strains of avian influenza (AI) virus that can cause varying degrees of clinical illness in poultry. AI viruses can infect chickens, turkeys, pheasants, quail, ducks, geese, and guinea fowl, as well as a wide variety of other birds. AI viruses can be classified as highly pathogenic or low pathogenic (LPAI) strains based on the severity of the illness they cause. HPAI is an extremely infectious and fatal form of the disease that, once established, can spread rapidly from flock to flock. Certain strains of AI have the potential to affect humans.
The U.S. poultry industry recently experienced a severe outbreak of HPAI. The outbreak was discovered in December 2014 in backyard flocks in the Pacific Northwest, and in two commercial turkey and chicken flocks in California. As of August 2015, 21 States had had HPAI detections in backyard flocks, commercial premises, captive wild birds, and/or wild birds. Established U.S. animal health policy is to eliminate notifiable AI virus (both HPAI and LPAI strains), when it is
During the 2014-2015 outbreak, APHIS has been paying the full indemnity amount to the birds' owners—usually the poultry company—with the understanding that parties that have entered into contracts with the owners to grow or care for the animals would then be paid by the owner in accordance with contractual agreements. During the course of addressing the current 2015 outbreak, we determined that the existing regulations in part 53 do not specify that the indemnity be split between owners and contractors. Since both owners and contractors incur losses when a flock is depopulated, both should be compensated appropriately.
A similar gap in the regulations concerning the payment of indemnity for LPAI became an issue for APHIS during an outbreak of LPAI in Virginia in 2002. In an interim rule published in the
Following approval by delegates during the 2004 National Poultry Improvement Plan (NPIP) Conference, APHIS amended the regulations via an interim rule
First established under that interim rule, § 56.8 contains conditions for payments to flock owners and parties with which the owners contracted to grow and care for poultry and eggs. The section provides a formula for the distribution by APHIS of LPAI indemnity payments between owners and contractors.
Due to the absence, noted above, of a provision in part 53 for split indemnity payments prior to this interim rule, there was the possibility of contractors not being compensated for losses incurred as a result of our HPAI control efforts during the 2014-2015 outbreak. APHIS believes it is important to ensure that all participants in the poultry industry with a stake in the continued health of the U.S. poultry stock are compensated for costs associated with eradication of HPAI, as well as LPAI. In this interim rule, therefore, we are incorporating into the HPAI regulations in part 53 conditions from the LPAI regulations in § 56.8 for the splitting of indemnity payments between owners and contractors. Only those conditions that are applicable to HPAI will be incorporated into part 53. These conditions are contained in a new § 53.11, titled “
Paragraph (a) of 53.11 provides a formula to enable the Administrator to determine the share of the indemnity payment that should be disbursed to the contractor. This is a two-step process. The dollar value of the contract the owner entered into with the contractor will be divided by the duration of the contract in days as it was signed prior to the HPAI outbreak. The resulting figure will then be multiplied by the time in days between the date the contractor began to provide services relating to the destroyed poultry or eggs under the contract and the date the poultry or eggs were destroyed.
Paragraph (b) states that if a contractor has received any payment under his or her contract from the owner of the poultry or eggs at the time the poultry or eggs are destroyed, the amount of indemnity from APHIS for which the contractor will be eligible will be reduced by the amount of the payment the contractor has already received from the owner. This provision will ensure that contractors will not receive indemnity payments that exceed the fair market value of the poultry or eggs.
Under § 53.11(c), if indemnity is paid to a contractor, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the contractor and the total amount of indemnity that may be paid for the poultry or eggs. This provision ensures that the owner will receive a fair share of the indemnity.
Finally, § 53.11(d) states that if the Administrator determines that the method described in § 53.11(a) for determining the amount of indemnity to be paid to a contractor, proves to be impractical or inappropriate in a particular case, APHIS may use any other method that the Administrator deems appropriate to determine the amount of indemnity due a contractor. This paragraph provides the Administrator with the flexibility to distribute indemnity payments equitably between owner and contractor in unusual or especially complex cases.
The above-listed conditions will allow contractors, as well as poultry and egg owners, to be compensated for economic losses suffered due to the destruction of poultry and eggs resulting from HPAI outbreaks.
Prior to this interim rule, the regulations in part 53 covered the destruction and indemnification of eggs under the general term “materials.” APHIS has covered eggs as being materials. To provide greater clarity, we are adding references to eggs to § 53.2(b), § 53.3(a), § 53.9, and § 53.10(c) and (d).
We are also adding a new paragraph (e) to § 53.3, pertaining to the appraisal of the value of eggs destroyed due to HPAI. As is the case for the animals themselves, under § 53.3(e), indemnity payments for eggs required to be destroyed due to HPAI will be based on the fair market value of the eggs, as determined by an appraisal. Appraisals will be reported on forms furnished by APHIS. The amount of indemnity paid, together with the amount for net salvage the owner or contractor received, if any, may not exceed the appraised fair market value of the eggs. Salvage refers to any payment the owner or contractor may receive from a third party, such as a breaker facility for the eggs. Such facilities may purchase the eggs and then pasteurize them to kill the HPAI virus, so that the eggs can be used in food products. APHIS will subtract the amount of any such payments made to the owners or contractors from the indemnity amount paid out by APHIS.
In addition, because § 53.4 has not specifically provided for the destruction of eggs pursuant to the eradication of HPAI, we are adding a new paragraph (b) (currently reserved) to that section. The paragraph states that eggs infected with, exposed to, or contaminated by HPAI shall be disposed of pursuant to the regulations in part 53 under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a report identifying all eggs disposed thereof.
In some instances during the 2014-2015 outbreak, poor biosecurity practices may have led to HPAI introduction or spread within and among some commercial poultry facilities. More specifically, as discussed in our July 2015 report on HPAI-infected flocks (
As a step toward achieving the goal of enhancing biosecurity, this interim rule requires both owners of poultry or eggs and contractors to provide to APHIS a statement that at the time of detection of HPAI in their facilities, they had in place and were following a biosecurity plan. Indemnity claims will be denied if the owner or contractor, unless exempted, does not provide such a statement. This requirement will be placed in a new paragraph (g) to be added to § 53.10, the section in part 53 that covers claims not allowed
Paragraph (g)(1) contains a list of several measures that a biosecurity plan should include in order to be effective at preventing the introduction of HPAI to a poultry facility. First, personnel working at such a facility should be given appropriate biosecurity training and should be subject to certain biosecurity requirements,
The inclusion of the measures discussed above in an HPAI biosecurity plan is supported by the findings of our September 2015 report on HPAI-infected flocks (
Under paragraph (g)(2), owners and contractors will be exempted from the requirement to submit a biosecurity statement if their facilities fall under one of the following categories: Premises covered under the NPIP regulations in 9 CFR 146.22(b) (commercial table-egg laying premises with fewer than 75,000 birds) or § 146.52(b) (raised for release upland game bird and waterfowl premises that raise fewer than 25,000 birds annually) and premises where fewer than 100,000 broilers or 30,000 turkeys are raised for meat annually. Exempting such facilities will allow APHIS to concentrate on helping large commercial facilities with their biosecurity activities. These larger operations were hardest hit by the 2015 outbreak, and are in the best position to address biosecurity issues. More than 99 percent of broilers are raised on farms with more than 100,000 birds, and 97 percent of turkeys are raised on farms with more than 30,000 birds. In addition, the smaller facilities that we are exempting from the requirement are less likely to have HPAI outbreaks than are the non-exempt ones. On smaller facilities, birds density tends to be less which minimizes overall viral load. Additionally, if a smaller facility was identified with HPAI the disease is less likely to spread outward to other premises because there are fewer birds, vehicles, pieces of equipment, and employees moving onto and off of the smaller, exempted facilities when compared to the larger, non-exempted ones.
To facilitate owners' and contractors' biosecurity planning, APHIS has created and distributed biosecurity training materials, which include specific examples of approaches to developing and implementing biosecurity protocols for the various types of commercial poultry operations. Further, we are increasing outreach to all producers—large, small and backyard—to educate them about biosecurity plans and how they can be implemented at the local level.
APHIS is phasing in implementation and documentation of enhanced biosecurity through a biosecurity self-assessment. Initially, commercial poultry owners and contractors will be asked to voluntarily self-assess, whether their operations have implemented the measures in a general biosecurity checklist developed by APHIS (
In addition to adding the references to eggs to § 53.2(b), we are making a couple of minor edits to the paragraph for the sake of clarity. We are incorporating footnote 1 into the text and editing one clause of the paragraph that, as written, could be interpreted as referring to the ineligibility of the animals covered by the paragraph, rather than their owners, to receive indemnity payments. The clause has been revised for accuracy, and we have also added a reference to contractors, in keeping with the other changes we are making to part 53.
This rulemaking is necessary on an emergency basis to provide timely and equitable compensation to owners and contractors for flocks destroyed due to the disease, which may reoccur in 2016. Under these circumstances, the Administrator has determined that prior notice and opportunity for public comment are contrary to the public interest and that there is good cause under 5 U.S.C. 553 for making this rule effective less than 30 days after publication in the
We will consider comments we receive during the comment period for this interim rule (see
This interim rule has been determined to be significant for the purposes of Executive Order 12866 and, therefore, has been reviewed by the Office of Management and Budget.
We have prepared an economic analysis for this interim rule. The
APHIS is amending the regulations to include conditions for the splitting of HPAI indemnity payments when multiple parties are involved in order to ensure that all parties who suffer losses resulting from the destruction of poultry or eggs due to HPAI are compensated and compensation is distributed to parties who suffer losses based on the terms of the contract. The vast majority of contracts are expected to reflect the relative level of inputs or investments of the parties who suffer losses. This interim rule also clarifies that APHIS will pay indemnity for eggs destroyed due to HPAI and requires owners and contractors, unless exempted because their facilities are small, to provide a statement that at the time of detection of HPAI in their facilities, they had in place and were following a written biosecurity plan to address the potential spread of HPAI.
The entities affected by this interim rule will be U.S. facilities primarily engaged in breeding, hatching, and raising poultry for meat or egg production, and facilities primarily engaged in slaughtering poultry. There were about 25,000 farms categorized as breeding, hatching, or raising poultry for meat production, about 28,000 farms categorized as egg producers, and 517 poultry processors in the 2012 Agricultural Census. In particular, this rule will affect poultry owners and contractors who produce poultry under production contracts. It is estimated that 97 percent of broilers were raised on production contract operations in 2011.
The United States is the world's largest poultry producer and the second-largest egg producer. The combined value of production from broilers, eggs, turkeys, and the value of sales from chickens in 2014 was $48.3 billion, up 9 percent from $44.4 billion in 2013. Of the combined total, 68 percent was from broilers, 21 percent from eggs, 11 percent from turkeys, and less than 1 percent from chickens.
In 2014, the United States exported nearly 4 million metric tons (MT) of poultry meat valued at about $5 billion. The vast majority of exports consisted of chicken meat. Export demand for U.S. broiler products has fluctuated over the last several years because of changing economic conditions and currency exchange rates. Since the first HPAI findings in December 2014, a number of trading partners have imposed complete or partial bans on shipments of U.S. poultry and products.
Broilers account for nearly all U.S. chicken consumption. Broiler production and processing occurs within highly integrated production systems. Owners of the processing facilities own, as well, the birds that are processed and contract with growers (contractors) to raise those birds before processing. The top 20 owners together accounted for 94 percent of all broilers produced in the United States in 2012, and the top 3 accounted for 49 percent.
Expanded broiler production has been made possible to a large extent by the vertically integrated production system and through the use of production contracts. Almost all commercial operations raising broilers are contract growers.
Under the system of production contracts, the contractor normally supplies the grow-out house with all the necessary heating, cooling, feeding, and watering systems. The contractor also supplies the labor needed in growing the birds. The owner normally supplies the chicks, feed, veterinary medicines and transportation. Contractors have exclusive contracts with an owner and receive payment for the services that they provide, with premiums and discounts tied to the efficiency with which feed is converted to live-weight broilers, the minimization of mortality, or the number of eggs produced. Specific contract terms and the period covered can vary.
Embedded in the value of a bird at any point in time is the value of inputs by both parties. Contractors' costs are more or less fixed and are heavily committed early in the production cycle. Investments in poultry housing cannot be shifted readily to other farming activities.
Currently, indemnity payments go directly to the owner of the birds who, depending on the terms of the contractual arrangement, might or might not compensate the contractor. It is important to formalize provisions to share indemnity payments between poultry owners and contractors, both of whom have productive assets imbedded in the value of the bird. When USDA pays to compensate owners and contractors for losses, that compensation should be distributed to parties who suffer losses based on the terms of the contract.
APHIS' determination of the total amount of indemnity will remain the same under the interim rule as at present, based on the appraised value of the bird or eggs, the number of birds depopulated or eggs destroyed, and the age of the birds when depopulated. However, to determine the appropriate payment split between owner and contractor, APHIS may have to examine contract specifics on a case-by-case basis. This interim rule will not change the total amount of compensation paid in a given situation, but will ensure timely distribution of that compensation between the owner and contractor. This interim rule will benefit contractors who otherwise may suffer uncompensated economic losses from participating in an eradication program.
To date, the generic term “materials” within the existing regulations in part 53 has been used to provide for indemnification for eggs required to be destroyed pursuant to HPAI eradication efforts. This rule will specify appropriate references to eggs, and a description of the appraisal of the value of eggs destroyed due to HPAI to the regulations. The rule will therefore simply clarify existing practice for the indemnification of destroyed eggs and will not change the total amount of any compensation paid in a given future situation.
The vast majority of contractors have some level of biosecurity in place on their operations. This rule will require large owners and contractors to provide a statement that a written biosecurity plan was in place and was followed if HPAI is detected at their facilities. There are approximately 18,900 poultry operations that will be subject to this requirement. Many operations will need to review their existing biosecurity plans, and some will need to newly develop plans. We estimate that the development of a biosecurity plan could cost between about $525 and $700, while the review of an existing plan could cost about $70. If 5 percent of producers need to newly develop biosecurity plans and 95 percent need to review existing biosecurity plans, the total one-time cost for all producers could be between $1.7 million and $1.9 million.
Most producers should be readily able to affirm that they were following a biosecurity plan in the case of an HPAI incident. We estimate that an owner or contractor will need at most about 0.25 to 0.50 hours to comply with this affirmation requirement, at a cost of $8.73 to $17.45 per occurrence. The total cost of this affirmation requirement will depend on the number of producers affected by a given HPAI outbreak who submit paperwork to receive indemnity. If a given outbreak were to affect 100 flocks, the total cost of this affirmation requirement would be from about $900 to $1,800 and if a given outbreak were to affect 500 flocks, the total cost would be from about $4,400 to $8,800 when rounded up to the nearest hundred.
It should be noted that these total cost estimates are limited to the cost of developing or reviewing biosecurity plans and providing a statement attesting that a biosecurity plan was in place and followed. Because this rule does not require the implementation of specific biosecurity measures, the costs associated with implementing new biosecurity measures are not included in these totals. We expect that most producers already have or will voluntarily adopt new biosecurity measures prior to the interim rule becoming effective.
APHIS is distributing biosecurity training materials that include specific examples of approaches to developing and implementing biosecurity protocols for various types of commercial poultry operations. APHIS is phasing in enhanced biosecurity initially through voluntary self-assessments. Results of self-assessments in the fall of 2015 show that a significant majority of poultry producers have in place or are in the process of implementing a variety of recommended biosecurity practices. Development, following public input, of Federal, State or industry-led oversight and verification will follow.
This program/activity is listed in the Catalog of Federal Domestic Assistance under No. 10.025 and is subject to Executive Order 12372, which requires intergovernmental consultation with State and local officials. (See 2 CFR chapter IV.)
This rule has been reviewed under Executive Order 12988, Civil Justice Reform. This rule: (1) Preempts all State and local laws and regulations that are in conflict with this rule; (2) has no retroactive effect; and (3) does not require administrative proceedings before parties may file suit in court challenging this rule.
In accordance with section 3507(j) of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
Please send written comments on the information collection and recordkeeping requirements included in this interim rule to the following addresses: (1) Office of Information and Regulatory Affairs, OMB, Attention: Desk Officer for APHIS, Washington, DC 20503; and (2) Docket No. APHIS-2015-0061, Regulatory Analysis and Development, PPD, APHIS, Station 3A-03.8, 4700 River Road, Unit 118, Riverdale, MD 20737-1238. Please state that your comments refer to Docket No. APHIS-2015-0061 and send your comments within 60 days of publication of this rule.
This interim rule establishes regulations to provide for the equitable distribution of indemnity payment to owners and contractors by the Department for the depopulation of poultry and destruction of eggs known to be infected with HPAI and to require that, in order to receive indemnity payments, owners and contractors, unless specifically exempted, must submit a statement indicating that they had in place and were following a biosecurity plan at the time of HPAI detection in their facilities. In addition to submitting the biosecurity statement, owners and contractors must sign a payment, appraisal and agreement form and must certify as to whether any other parties hold mortgages on the flock. This interim rule also clarifies that eggs are a commodity eligible for indemnity.
We are soliciting comments from the public (as well as affected agencies) concerning our information collection and recordkeeping requirements. These comments will help us:
(1) Evaluate whether the information collection is necessary for the proper performance of our agency's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of our estimate of the burden of the information collection, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the information collection on those who are to respond (such as through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology;
Copies of this information collection can be obtained from Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
The Animal and Plant Health Inspection Service is committed to compliance with the E-Government Act to promote the use of the Internet and other information technologies, to provide increased opportunities for citizen access to Government information and services, and for other purposes. For information pertinent to E-Government Act compliance related to this interim rule, please contact Ms. Kimberly Hardy, APHIS' Information Collection Coordinator, at (301) 851-2727.
Animal diseases, Indemnity payments, Livestock, Poultry and poultry products.
Accordingly, we are amending 9 CFR part 53 as follows:
7 U.S.C. 8301-8317; 7 CFR 2.22, 2.80, and 371.4.
(b) Upon agreement of the authorities of the State to enforce quarantine restrictions and orders and directives properly issued in the control and eradication of such a disease, the Administrator is hereby authorized to agree, on the part of the Department, to cooperate with the State in the control and eradication of the disease, and to pay 50 percent (and in the case of Newcastle disease or highly pathogenic avian influenza, up to 100 percent, and in the case of infectious salmon anemia, up to 60 percent) of the expenses of purchase, destruction and disposition of animals, eggs, and materials required to be destroyed because of being contaminated by or exposed to such disease:
The addition and revision read as follows:
(e) Indemnity for eggs required to be destroyed due to an outbreak of highly pathogenic avian influenza will be based on the fair market value of the eggs, as determined by an appraisal. Appraisals of eggs shall be reported on forms furnished by APHIS. The amount of indemnity paid, together with the amount for net salvage the owner or contractor received, if any, shall not exceed the appraised fair market value of the eggs.
The addition and revision read as follows:
(b) Eggs infected with, exposed to, or contaminated by highly pathogenic avian influenza shall be disposed of pursuant to the regulations in this part under the supervision of an APHIS employee who shall prepare and transmit to the Administrator a report identifying all eggs disposed thereof.
The revision reads as follows:
The addition reads as follows:
(g) The Department will not allow claims arising out of the destruction of animals or eggs destroyed due to an outbreak of highly pathogenic avian influenza unless the owner of the animals or eggs and any party that enters into a contract with the owners to grow or care for the poultry or eggs, unless exempted under paragraph (g)(2) of this section, provide to APHIS a statement that at the time of detection of highly pathogenic avian influenza in the facility, the owner and contractor (if applicable), had in place and was following a biosecurity plan.
(1) The biosecurity plan should include the following:
(i) A biosecurity training program for premises/farm personnel;
(ii) Biosecurity protocols for personnel;
(iii) Procedures to control wild birds, rodents, and insects to reduce the risk of introduction or spread of HPAI;
(iv) Measures taken to prevent HPAI introduction via vehicles and equipment;
(v) Maintenance of a line of separation; and
(vi) A clean water source for the facility.
(2) Owners and contractors are exempted from the requirements of paragraph (g)(1) of this section if the facilities where the animals or eggs are raised or cared for falls under one of the following categories:
(i) Premises meeting the criteria of the National Poultry Improvement Plan regulations in §§ 146.22(b) or 146.52(c) of this chapter;
(ii) Premises on which fewer than 100,000 broilers are raised annually; and
(iii) Premises on which fewer than 30,000 meat turkeys are raised annually.
(a) When poultry or eggs have been destroyed pursuant to this part, the Administrator may pay claims to any party with whom the owner of the
(1) Divide the value in dollars of the contract the owner entered into with the contractor by the duration in days of the contract as it was signed prior to the highly pathogenic avian influenza outbreak;
(2) Multiply this figure by the time in days between the date the contractor began to provide services relating to the destroyed poultry or eggs under the contract and the date the poultry or eggs were destroyed due to highly pathogenic avian influenza.
(b) If a contractor receiving indemnity under this section has received any payment under his or her contract from the owner of the poultry or eggs at the time the poultry or eggs are destroyed, the amount of indemnity for which the contractor is eligible will be reduced by the amount of the payment the contractor has already received.
(c) If indemnity is paid to a contractor under this section, the owner of the poultry or eggs will be eligible to receive the difference between the indemnity paid to the contractors and the total amount of indemnity that may be paid for the poultry or eggs.
(d) In the event that determination of indemnity due a contractor using the method described in paragraph (a) of this section is determined to be impractical or inappropriate, APHIS may use any other method that the Administrator deems appropriate to make that determination.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Final rule; request for comments.
We are superseding airworthiness directive (AD) 2014-13-01 for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 C-2 helicopters with a certain Goodrich rescue hoist damper unit (damper unit) installed. AD 2014-13-01 required repairing or replacing the damper unit or deactivating the rescue hoist. AD 2014-13-01 was prompted by a report of an uncommanded detachment of a damper unit from the cable. This new AD retains the optional requirement of deactivating the rescue hoist, expands the applicability, and requires either replacing or modifying the damper unit with a newly developed single-piece retainer. These actions are intended to prevent the hoist damper unit detaching from the cable resulting in loss of an external load or person from the helicopter hoist and injury to persons being lifted by the hoist.
This AD becomes effective February 24, 2016.
The Director of the Federal Register approved the incorporation by reference of certain documents listed in this AD as of February 24, 2016.
We must receive comments on this AD by April 11, 2016.
You may send comments by any of the following methods:
•
•
•
•
You may examine the AD docket on the Internet at
For service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
David N. Hatfield, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone (817) 222-5110; email
This AD is a final rule that involves requirements affecting flight safety, and we did not provide you with notice and an opportunity to provide your comments prior to it becoming effective. However, we invite you to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, or federalism impacts that resulted from adopting this AD. The most helpful comments reference a specific portion of the AD, explain the reason for any recommended change, and include supporting data. To ensure the docket does not contain duplicate comments, commenters should send only one copy of written comments, or if comments are filed electronically, commenters should submit them only one time. We will file in the docket all comments that we receive, as well as a report summarizing each substantive public contact with FAA personnel concerning this rulemaking during the comment period. We will consider all the comments we
On June 13, 2014, we issued AD 2014-13-01, Amendment 39-17875 (79 FR 36635, June 30, 2014), to correct an unsafe condition for Airbus Helicopters Model MBB-BK 117 C-2 helicopters with certain part-numbered damper units installed. AD 2014-13-01 required either repairing the damper unit, replacing the damper unit with a repaired damper unit, or deactivating the rescue hoist system.
AD 2014-13-01 was prompted by AD No. 2014-0057, dated March 6, 2014, and corrected March 7, 2014, issued by EASA, which is the Technical Agent for the Member States of the European Union. EASA advised that a damper unit detached from the cable when the hoist damper was lifted by hand with no load attached. According to EASA, the retaining ring inside the damper unit was not located in the proper position because of a maintenance error or as a result of interference with the bonding strap unit during normal use. To address this unsafe condition, EASA AD No. 2014-0057 required modifying the bonding strap unit installation with an improved retaining ring and post-modification repetitive inspection.
Since we issued AD 2014-13-01, a damper unit with the improved retaining ring detached from its strap. Additionally, this damper unit was approved for installation on Airbus Helicopters Model MBB-BK 117 D-2 helicopters. EASA issued Emergency AD No. 2015-0019-E, dated February 5, 2015, which superseded EASA AD No. 2014-0057, to add Model MBB-BK117 D-2 helicopters to the applicability. Airbus subsequently introduced a new single-piece retainer part number (P/N) B851M2060201 to strengthen the interconnection of the damper unit and attached cable.
EASA has revised Emergency AD No. 2015-0019-E by issuing EASA AD No. 2015-0019R1, dated February 13, 2015, for Model MBB-BK117 C-2 and MBB-BK117 D-2 helicopters with a Goodrich external mounted hoist. EASA AD No. 2015-0019R1 introduces installation of single-piece retainer P/N B851M2060201 as an option for compliance and allows installation of damper units provided if equipped with the new single-piece retainer.
These helicopters have been approved by the aviation authority of Germany and are approved for operation in the United States. Pursuant to our bilateral agreement with Germany, EASA, its technical representative, has notified us of the unsafe condition described in the EASA AD. We are issuing this AD because we evaluated all information provided by EASA and determined the unsafe condition exists and is likely to exist or develop on other helicopters of these same type designs.
We reviewed Airbus Helicopters Emergency Alert Service Bulletin (ASB) No. ASB MBB-BK117 C-2-85A-041, Revision 4, dated February 12, 2015, for Model MBB-BK 117 C-2 helicopters and Emergency ASB No. ASB MBB-BK117 D-2-85A-002, Revision 1, dated February 12, 2015, for Model MBB-BK 117 D-2 helicopters. These Emergency ASBs specify replacing the split retainers with a single-piece retainer and re-identifying the damper housing.
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
This AD requires, before the next hoist operation, either replacing the damper unit with a unit that has been repaired in accordance with the service information, deactivating the rescue hoist, or replacing each split retainer with a single-piece retainer and marking the damper housing in accordance with the service information.
We estimate that this AD affects 137 helicopters of U.S. Registry. We estimate that operators may incur the following costs in order to comply with this AD. Labor costs are estimated at $85 per work-hour. We estimate it takes 1 work-hour to replace a damper unit and $8,715 for the required parts for a total cost of $8,800 per helicopter. We estimate it takes 0.5 work-hour to deactivate a rescue hoist for a total cost of $43 per helicopter. We estimate it takes 2 work-hours to replace the split retainer with a single-piece retainer and $171 for the required parts for a total cost of $341 per helicopter.
Providing an opportunity for public comments prior to adopting these AD requirements would delay implementing the safety actions needed to correct this known unsafe condition. Therefore, we find that the risk to the flying public justifies waiving notice and comment prior to the adoption of this rule because the required corrective actions must be completed before the next hoist operation.
Since an unsafe condition exists that requires the immediate adoption of this AD, we determined that notice and opportunity for public comment before issuing this AD are impracticable and contrary to the public interest and that good cause exists for making this amendment effective in less than 30 days.
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 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, 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.
We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA amends 14 CFR part 39 as follows:
49 U.S.C. 106(g), 40113, 44701.
This AD applies to Model MBB-BK 117 C-2 and MBB-BK 117 D-2 helicopters with a Goodrich hoist damper unit, part number (P/N) 44307-480, 44307-480-1, or 44307-480-2 installed, certificated in any category.
This AD defines the unsafe condition as uncommanded detachment of the external hoist damper unit, which could result in loss of an external load or person from the helicopter hoist, resulting in injury to persons being lifted by the hoist.
This AD supersedes AD 2014-13-01, Amendment 39-17875 (79 FR 36635, June 30, 2014).
This AD becomes effective February 24, 2016.
You are responsible for performing each action required by this AD within the specified compliance time unless it has already been accomplished prior to that time.
Before the next hoist operation, comply with paragraph (f)(1), (f)(2), or (f)(3) of this AD:
(1) Replace the split retainers and re-identify each hoist damper unit in accordance with the Accomplishment Instructions, paragraph 3.B.1, of Airbus Helicopters Emergency Alert Service Bulletin (ASB) No. ASB MBB-BK117 C-2-85A-041, Revision 4, dated February 12, 2015, or Emergency ASB No. ASB MBB-BK117 D-2-85A-002, Revision 1, dated February 12, 2015, as applicable to your model helicopter; or
(2) Replace each hoist damper unit with a unit that has been repaired as required by paragraph (f)(1) of this AD; or
(3) Deactivate the rescue hoist system.
(1) The Manager, Safety Management Group, FAA, may approve AMOCs for this AD. Send your proposal to: David N. Hatfield, Aviation Safety Engineer, Safety Management Group, Rotorcraft Directorate, FAA, 10101 Hillwood Pkwy, Fort Worth, TX 76177; telephone (817) 222-5110; email
(2) For operations conducted under a 14 CFR part 119 operating certificate or under 14 CFR part 91, subpart K, we suggest that you notify your principal inspector, or lacking a principal inspector, the manager of the local flight standards district office or certificate holding district office, before operating any aircraft complying with this AD through an AMOC.
The subject of this AD is addressed in European Aviation Safety Agency (EASA) AD No. 2015-0019R1, dated February 13, 2015. You may view the EASA AD on the Internet at
Joint Aircraft Service Component (JASC) Code: 2500, Cabin Equipment/Furnishings.
(1) The Director of the Federal Register approved the incorporation by reference of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Airbus Helicopters Emergency Alert Service Bulletin (ASB) No. ASB MBB-BK117 C-2-85A-041, Revision 4, dated February 12, 2015.
(ii) Airbus Helicopters Emergency ASB No. ASB MBB-BK117 D-2-85A-002, Revision 1, dated February 12, 2015.
(3) For Airbus Helicopters service information identified in this final rule, contact Airbus Helicopters, 2701 N. Forum Drive, Grand Prairie, TX 75052; telephone (972) 641-0000 or (800) 232-0323; fax (972) 641-3775; or at
(4) You may view this service information at FAA, Office of the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX 76177. For information on the availability of this material at the FAA, call (817) 222-5110.
(5) You may view this service information that is incorporated by reference at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call (202) 741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all Turbomeca S.A. ARRIEL 2C, 2C1, 2C2, 2S1, and 2S2 turboshaft engines with modification TU34 or TU34A installed. This AD requires inspecting the torque conformation box (TCB) for correct resistance values and removing TCBs that fail inspection before further flight. This AD was prompted by TCB failures. We are issuing this AD to prevent failure of the TCB, loss of engine thrust control, and damage to the helicopter.
This AD becomes effective March 15, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 15, 2016.
For service information identified in this AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15. You may view this service information at the FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125. It is also available on the Internet at
You may examine the AD docket on the Internet at
Brian Kierstead, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7772; 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 the specified products. The NPRM was published in the
Several cases of torque conformation box (TCB) failures have been reported on engines incorporating mod TU34 or mod TU34A. Investigation concluded that these failures were caused by cracks on soldered joints of TCB resistors.
This condition, if not corrected, could lead to limited power availability in a One Engine Inoperative (OEI) case, possibly resulting in reduced control of the helicopter.
We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (80 FR 68475, November 5, 2015).
We reviewed the available data and determined that air safety and the public interest require adopting this AD as proposed.
Turbomeca S.A. has issued Mandatory Service Bulletin (MSB) No. 292 72 2860, Version A, dated July 15, 2015. The MSB describes procedures for checking TCB resistance values. 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 estimate that this AD affects 300 engines installed on helicopters of U.S. registry. We estimate that it would take about 1 hour to perform an inspection. We also estimate that 20% of these engines would fail the inspection and require TCB removal, which would take about 1 hour. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $30,600.
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 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 this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 becomes effective March 15, 2016.
None.
This AD applies to Turbomeca S.A. ARRIEL 2C, 2C1, 2C2, 2S1, and 2S2 turboshaft engines with modification TU34 or TU34A installed.
This AD was prompted by torque conformation box (TCB) failures. We are issuing this AD to prevent failure of the TCB, loss of engine thrust control, and damage to the helicopter.
Comply with this AD within the compliance times specified, unless already done.
(1) Within 600 engine flight hours (EFHs) or 6 months after the effective date of this AD, whichever occurs first, check the resistance values on the TCB. Use Accomplishment Instructions, paragraph 2.3.2 of Turbomeca S.A. Mandatory Service Bulletin 292 72 2860, Version A, dated July 15, 2015, to do the inspection. Repeat this inspection every 600 EFHs since last inspection.
(2) Remove before further flight any TCB that fails the inspection required by paragraph (e)(1) of this AD.
The Manager, Engine Certification Office, FAA, may approve AMOCs for 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 Brian Kierstead, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7772; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0177, dated August 25, 2015, for more information. You may examine the MCAI in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Turbomeca S.A. Mandatory Service Bulletin No. 292 72 2860, Version A, dated July 15, 2015.
(ii) Reserved.
(3) For Turbomeca S.A. service information identified in this AD, contact Turbomeca S.A., 40220 Tarnos, France; phone: 33 (0)5 59 74 40 00; fax: 33 (0)5 59 74 45 15.
(4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Federal Aviation Administration (FAA), DOT.
Final rule.
We are adopting a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-C-37 turbofan engines. This AD requires recalculating the cyclic life for certain engine life-limited rotating parts and removing those parts that have exceeded their cyclic life limit within specified compliance times. This AD was prompted by a review of operational data that determined certain RR RB211-535E4-37 engines have been operated to a more severe flight profile than is consistent with the flight profile used to establish the cyclic life limits for the rotating parts. We are issuing this AD to prevent failure of life-limited rotating parts, uncontained parts release, damage to the engine, and damage to the airplane.
This AD becomes effective March 15, 2016.
The Director of the Federal Register approved the incorporation by reference of a certain publication listed in this AD as of March 15, 2016.
For service information identified in this AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
You may examine the AD docket on the Internet at
Robert Green, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7754; 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 the specified products. The NPRM was published in the
A review of operational flight data has revealed that some RB211-535 engines may have been operated beyond the flight profile (FP) assumed by the operator when establishing the operational limits (life limits) within which the corresponding critical parts are allowed to remain installed.
This condition, if not corrected, may lead to critical part failure, possibly resulting in release of high energy debris, damage to the aeroplane and/or injury to the occupants.
To preclude failure of an engine life-limited part, the MCAI specifies, and this AD would require, recalculating the cyclic life for certain parts and removing from service those parts that have exceeded their cyclic life limit within specified compliance times. This AD would establish a new default Flight Profile G for RR RB211-535E4-37 engine life-limited parts. If, however, operators meet the requirements of Appendix 6 of RR Alert Non-Modification Service Bulletin (NMSB) No. RB.211-72-AH972, Revision 3, dated August 28, 2015, they may operate to Flight Profile A or B. You may obtain further information by examining the MCAI in the AD docket on the Internet at
We reviewed RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015. The Alert NMSB describes a new flight profile, provides procedures for the consumed cyclic life corrections for prior operation of affected parts, and provides the removal from service recommendations for parts that have exceeded their cyclic life limit. 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 gave the public the opportunity to participate in developing this AD. We considered the comments received.
The Boeing Company, FedEx, United Airlines, and American Airlines expressed support for the NPRM.
United Parcel Service (UPS) requested that the NPRM recognize digital flight data taken from either the digital flight data recorder (DFDR) or the digital flight data acquisition unit (DFDAU) as valid data for RR RB211 flight profile monitoring purposes. The data captured by the DFDAU is recorded on the DFDR, but DFDAUs are regularly downloaded for UPS' flight operations quality assurance program. The DFDAU data is easier to access than pulling a DFDR for data download purposes.
We agree. We added a new paragraph to paragraph (e)(1) of this AD as follows: “(e)(1)(iv) You may use data from either a digital flight data acquisition unit or a digital flight data recorder for flight profile monitoring.”.
We reviewed the available data, including the comments received, and determined that air safety and the public interest require adopting this AD with the changes described previously. We determined that these changes will not increase the economic burden on any operator or increase the scope of this AD.
We estimate that this AD affects 107 engines installed on airplanes of U.S. registry. Pro-rated cost of the lost cyclic life as a result of the corrections would be about $25,417,324. We estimate it will take 1 hour to recalculate the consumed cyclic life and revise the engine records which include 5 minutes (0.083 hours) for record entries. The average labor rate is $85 per hour. Based on these figures, we estimate the cost of this AD on U.S. operators to be $25,426,419.
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 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 this AD:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska to the extent that it justifies making a regulatory distinction, and
(4) Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
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 becomes effective March 15, 2016.
None.
This AD applies to all Rolls-Royce plc (RR) RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-C-37 turbofan engines.
This AD was prompted by a review of operational data that determined that certain RR RB211-535E4-37 engines have been operated to a more severe flight profile than is consistent with the flight profile used to establish the cyclic life limits for the rotating parts. We are issuing this AD to prevent failure of life-limited rotating parts, which could result in uncontained parts release, damage to the engine, and damage to the airplane.
Comply with this AD within the compliance times specified, unless already done. Within 21 days after the effective date of this AD:
(1) For RR RB211-535E4-37 engines, establish a new flight profile, Flight Profile G, as the new default profile for flight operations and new part lives for life-limited parts.
(i) Use Appendix 6 of RR Alert Non-Modification Service Bulletin (NMSB) No. RB.211-72-AH972, Revision 3, dated August 28, 2015, to define Flight Profile G.
(ii) Use the definition of Flight Profile G in Appendix 6 and the maximum approved cyclic lives in Appendix 2 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015, to identify the new lives for life-limited parts.
(iii) If operators meet the requirements of Appendix 6 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015, they may operate to Flight Profile A or B.
(iv) You may use data from either a digital flight data acquisition unit or a digital flight data recorder for flight profile monitoring.
(2) For all RR RB211-535E4-37, RB211-535E4-B-37, and RB211-535E4-C-37 engines, determine if any part identified by part number and serial number in Appendix 4 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015, is installed on the engine.
(i) Do not return to service any engine with a part identified in paragraph (e)(2) of this AD after the part reaches the “Compliance Time” date or cycles, whichever occurs first, as specified in Appendix 4 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015.
(ii) For each part identified in paragraph (e)(2) of this AD without a “Compliance Time” that has a lifing correction identified, apply the lifing correction for each part using the “Additional Life Consumed Flight Cycles” specified in Appendix 4 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015.
(3) For RR RB211-535E4-37 engines operated to Flight Profile G with parts listed in Appendix 4 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015, do the following:
(i) Re-calculate the consumed cyclic life of the low-pressure (LP) compressor shaft, LP turbine shaft, LP turbine disk Stage 2,
(ii) Determine the Flight Profile G cycles in service (CIS). Count all CIS accumulated since April 1, 2015, inclusive.
(iii) Use the Flight Profile G cycles in service from paragraph (e)(3)(ii) of this AD, the maximum approved lives in Appendix 2 of RR Alert NMSB No. RB.211-72-AH972, Revision 3, dated August 28, 2015, and Figure 1 to paragraph (e) of this AD to calculate the new consumed cyclic lives.
The Manager, Engine Certification Office, FAA, may approve AMOCs for 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 Robert Green, Aerospace Engineer, Engine Certification Office, FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA 01803; phone: 781-238-7754; fax: 781-238-7199; email:
(2) Refer to MCAI European Aviation Safety Agency AD 2015-0148, dated July 23, 2015 (Corrected July 24, 2015), for more information. You may examine the MCAI in the AD docket on the Internet at
(1) The Director of the Federal Register approved the incorporation by reference (IBR) of the service information listed in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
(2) You must use this service information as applicable to do the actions required by this AD, unless the AD specifies otherwise.
(i) Rolls-Royce (RR) Alert Non-Modification Service Bulletin No. RB.211-72-AH972, Revision 3, including Appendices 1 through 6, dated August 28, 2015.
(ii) Reserved.
(3) For RR service information identified in this AD, contact Rolls-Royce plc, Corporate Communications, P.O. Box 31, Derby, England, DE24 8BJ; phone: 011-44-1332-242424; fax: 011-44-1332-249936; email:
(4) You may view this service information at FAA, Engine & Propeller Directorate, 1200 District Avenue, Burlington, MA. For information on the availability of this material at the FAA, call 781-238-7125.
(5) You may view this service information at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Department of State.
Final rule.
The Department of State finalizes its amendment of the passport rules for issuance of an official passport to an official or employee of a state,
Effective February 9, 2016.
Alice Kottmyer, Attorney-Adviser,
This rule was published as an interim rule on May 15, 2015 (80 FR 27856), with a 60-day period for public comments. No public comments were received.
As explained in the interim final rule, 22 CFR 51.3(b) provides that an “official passport” may be issued to: An official or employee of the U.S. government traveling abroad to carry out official duties; spouses and family members of such persons; and, when authorized by the Department of State, U.S. government contractors traveling abroad to carry out official duties on behalf of the U.S. government.
Increasingly, the federal government utilizes officials or employees of state, local, tribal, and territorial governments in support of federal activities, both domestically and overseas, such as the Federal Bureau of Investigation's Joint Terrorism Task Force. When required to travel internationally in support of such federal activities, these individuals are not currently eligible for official passports. Issuance of an official passport to such individuals signifies to foreign governments that they are carrying out official duties in support of the U.S. government. The activities undertaken by these officials are often of pressing national security, law enforcement, or humanitarian importance and occur with little advance notice. It is in the U.S. government's interest to provide these individuals the travel documents necessary to allow them to travel in a timely manner.
Under 22 U.S.C. 211a
The Regulatory Findings included in the interim final rule are incorporated herein.
Passports.
Accordingly, the interim rule amending 22 CFR part 51 which was published at 80 FR 27857 on May 15, 2015, is adopted as a final rule without change.
Coast Guard, DHS.
Notice of deviation from drawbridge regulation.
The Coast Guard has issued a temporary deviation from the operating schedule that governs the Oregon State highway bridge across Youngs Bay foot of Fifth Street, mile 2.4, at Astoria, OR. The common name of this bridge is Old Youngs Bay Bridge. The deviation is necessary to accommodate extensive maintenance and restoration efforts on this bridge. This deviation allows the double bascule span to operate in a single leaf mode when at least a three-hour advance notification is given by marine vessels that require an opening, and the vertical clearance of the bridge to be reduced.
This deviation is effective from 7 a.m. on February 15, 2016 to 11 p.m. on June 15, 2016.
The docket for this deviation, [USCG-2016-0090] is available at
If you have questions on this temporary deviation, call or email Steven M. Fischer, Thirteenth Coast Guard District Bridge Program Administrator, telephone 206-220-7282, email
The Oregon Department of Transportation (ODOT) requested to reduce the vertical clearance of the Old Youngs Bay Bridge, mile 2.4, across Youngs Bay foot of Fifth Street at Astoria, OR, and to open half of the draw span when at least a three-hour notice is given to the bridge operator by vessels wishing to pass. The requested period of deviation is from 7 a.m. on February 15, 2016 to 11 p.m. on June 15, 2016. The deviation is necessary to accommodate extensive maintenance and restoration efforts on this bridge. The Old Youngs Bay Bridge provides a vertical clearance approximately 19 feet above mean high water when in the closed-to-navigation position. The double bascule span of the bridge will have a containment system installed which will reduce the vertical clearance by 5 feet from 19 feet above mean high water to 14 feet above mean high water. The normal operating schedule can be found in 33 CFR 117.899(b). The deviation allows the double bascule span of the Old Youngs Bay Bridge to operate single leaf when at least three-hours of notice are given by mariners requiring an opening during the deviation period. Waterway usage on Youngs Bay is primarily small recreational boaters and fishing vessels.
Vessels able to pass through the bridge in the closed positions may do so at any time. The bridge will be able to open for emergencies if a three-hour notice is given to the bridge operator, and there is no immediate alternate route for vessels to pass. The Coast Guard will also inform the users of the waterways through our Local and Broadcast Notices to Mariners of the change in operating schedule for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the effective period of this temporary deviation. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Santa Barbara County Air Pollution Control District (SBCAPCD or District) portion of the California State Implementation Plan (SIP). These revisions concern administrative and procedural requirements to obtain preconstruction permits which regulate emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).
This rule is effective on April 11, 2016 without further notice, unless the EPA receives adverse comments by March 10, 2016. If we receive such comments, we will publish a timely withdrawal in the
Submit comments, identified by docket number [EPA-R09-OAR-2015-0784, by one of the following methods:
1.
2.
3.
Ya-Ting (Sheila) Tsai, EPA Region IX, (415) 972-3328,
Throughout this document, “we,” “us” and “our” refer to the EPA.
Table 1 lists the rules addressed by this proposal with the dates that they were adopted or revised by the SBCAPCD and submitted by the California Air Resources Board (CARB).
On November 18, 2008, the EPA determined that the submittal for SBCAPCD Rule 201 met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review. On May 21, 1998, the submittals of Rules 203 and 204 were found to meet the completeness criteria. On April 28, 1992, the submittal for Rule 206 was found to meet the completeness criteria.
Table 2 lists the dates of the SIP approved versions of Rules 201, 203 and 206. There is no previous version of Rule 204 approved in the SIP, although the SBCAPCD adopted and revised an earlier version of this rule on April 17, 1997, and CARB submitted it to us on March 10, 1998. We approved an earlier version of Rule 201 into the SIP on May 5, 1982. The SBCAPCD adopted revisions to the SIP-approved version on April 17, 1997 and CARB submitted it to us on March 10, 1998. While we can act on only the most recently submitted version, we have reviewed materials provided with previous submittals.
Section 110(a) of the CAA requires States to submit regulations that will assure attainment and maintenance of the National Ambient Quality Air Quality Standards (NAAQS). These rules were developed as part of the local agency's general programmatic requirement to implement the requirement commonly referred to as the minor or general New Source Review (NSR) program. The revisions made by the submitted rules listed in Table 1 are mostly administrative in nature. New Rule 204 lists information required to apply for an Authority to Construct (ATC) or a Permit to Operate (PTO). Rule 201 has been reformatted for clarity. Several additions were also made to add provisions related to state law. Rules 203 and 206 have been reformatted with minor revisions for clarity. There are no substantive changes to these rules.
The TSD has more information about these rules.
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193). The submitted rules, except Rule 204, are revisions to existing SIP approved general NSR permit program requirements under 40 CFR 51.160-51.164. The revisions are primarily administrative in nature (reformatting, provide additional clarity), but we also discuss the rules or portions of each rule, that serve to satisfy any of these general permit program requirements. Rule 204 contains requirements for ATC and PTO applications improving the clarity of the general NSR permit program.
These rules are consistent with CAA requirements and relevant guidance regarding enforceability and SIP revisions. These changes are mostly administrative in nature and their approval will not interfere with any applicable requirement concerning attainment and reasonable further progress, or any other CAA applicable requirement.
The TSD has more information on our evaluation.
As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this
Please note that if the 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 EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SBCAPCD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the 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 April 11, 2016. 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 this
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements.
42 U.S.C. 7401
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(51) * * *
(xiii) * * *
(E) Previously approved on May 18, 1981 in paragraph (c)(51)(xiii)(A) of this section and now deleted with replacement in paragraph (c)(187)(i)(E)(
(F) Previously approved on May 18, 1981 in paragraph (c)(51)(xiii)(A) of this section and now deleted with replacement in paragraph (c)(254)(i)(C) of this section, Rules 203 and 204.
(G) Previously approved on May 18, 1981 in paragraph (c)(51)(xiii)(A) of this section and now deleted with replacement in paragraph (c)(361)(i)(A)(
(187) * * *
(i) * * *
(E) Santa Barbara County Air Pollution Control District.
(
(254) * * *
(i) * * *
(C) * * *
(
(
(361) * * *
(i) * * *
(A) * * *
(
Environmental Protection Agency (EPA).
Final rule.
The Environmental Protection Agency (EPA) is approving a regulation submitted for incorporation into the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD or District) portion of the California State Implementation Plan (SIP). The regulation, Rule 9410 (Employer Based Trip Reduction), establishes requirements for employers in the San Joaquin Valley to implement programs encouraging employees to use ridesharing and alternative transportation methods to reduce air pollution. The effect of this action is to make the requirements of Rule 9410 federally enforceable as part of the California SIP.
This rule will be effective on March 10, 2016.
The EPA has established docket number EPA-R09-OAR-2014-0715 for this action. Generally, documents in the docket for this action are available electronically at
Jeffrey Buss, EPA Region IX, (415) 947-4152,
Throughout this document, “we,” “us” and “our” refer to the EPA.
On August 24, 2015 at 80 FR 51153, the EPA proposed to approve the following rule into the California SIP.
We proposed to approve this rule because we determined that it complied with the relevant Clean Air Act (“CAA” or “Act”) requirements. Our proposed action contains more information on the rule and our evaluation.
The EPA's proposed action provided a 30-day public comment period. During this period, which ended on September 23, 2015, we received one comment from a member of the public. We are summarizing that comment and providing our response below.
No comments were submitted that change our assessment of the rule as described in our proposed action. Therefore, as authorized in section 110(k)(3) of the Act, the EPA is fully approving this rule into the California SIP.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the SJVUAPCD rule described in the amendments to 40 CFR part 52 set forth below. The EPA had made, and will continue to make, these documents available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this 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).
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 proposed rule does not have tribal implications and will not impose substantial direct costs on tribal governments or preempt tribal law as specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Oxides of nitrogen, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, Chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(379) * * *
(i) * * *
(C) * * *
(
Environmental Protection Agency (EPA).
Direct final rule.
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California State Implementation Plan (SIP). These revisions concern emissions of volatile organic compounds (VOCs) and oxides of nitrogen (NO
This rule is effective on April 11, 2016 without further notice, unless the EPA receives adverse comments by March 10, 2016. If we receive such comments, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0756 at
Kevin Gong, EPA Region IX, (415) 972 3073,
Throughout this document, “we,” “us,” and “our” refer to the EPA.
Table 1 lists the rules addressed by this action with the dates that they were adopted by the local air agency and submitted by the California Air Resources Board (CARB).
On August 13, 2015, the EPA determined that the submittal for YSAQMD Rules 2.22 and 2.34 met the completeness criteria in 40 CFR part 51, appendix V, which must be met before formal EPA review.
We approved an earlier version of Rule 2.22 into the SIP on January 23, 2003 (68 FR 3190), and an earlier version of Rule 2.34 into the SIP on September 3, 1998 (63 FR 46892).
VOCs help produce ground-level ozone, smog and PM, which harm human health and the environment. Section 110(a) of the CAA requires States to submit regulations that control VOC emissions. The revisions to Rule 2.22 exempt certain categories of facilities that have other vapor recovery control measures in place, require aboveground storage tanks to install additional approved vapor recovery systems, require Phase II enhanced vapor recovery systems at all dispensing facilities, and require operators to conduct appropriate inspection and maintenance procedures.
NO
The EPA's technical support documents (TSDs) have more information about these rules.
SIP rules must be enforceable (see CAA section 110(a)(2)), must not interfere with applicable requirements concerning attainment and reasonable further progress or other CAA requirements (see CAA section 110(l)), and must not modify certain SIP control requirements in nonattainment areas without ensuring equivalent or greater emissions reductions (see CAA section 193).
Generally, SIP rules must require Reasonably Available Control Technology (RACT) for each category of sources covered by a Control Techniques Guidelines (CTG) document
Guidance and policy documents that we use to evaluate enforceability, revision/relaxation and rule stringency requirements for the applicable criteria pollutants include the following:
1. “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” (57 FR 13498, April 16, 1992 and 57 FR 18070, April 28, 1992).
2. “Issues Relating to VOC Regulation Cutpoints, Deficiencies, and Deviations” (“the Bluebook,” U.S. EPA, May 25, 1988; revised January 11, 1990).
3. “Guidance Document for Correcting Common VOC & Other Rule Deficiencies” (“the Little Bluebook”, EPA Region 9, August 21, 2001).
4. “State Implementation Plans; Nitrogen Oxides Supplement to the General Preamble; Clean Air Act Amendments of 1990 Implementation of Title I; Proposed Rule” (“the NO
5. “Design Criteria for Stage 1 Vapor Control Systems,” (EPA-450/R-75-102).
6. “Technical Guidance—Stage II Vapor Recovery Systems for Control of Refueling Emissions at Gasoline Dispensing Facilities,” (EPA-450/3-91-022).
7. “Restatement to Update of EPA's SSM Policy Applicable to SIPs,” (80 FR 33839, June 12, 2015).
8. “Alternative Control Techniques Document—NO
We believe these rules are consistent with the relevant policy and guidance regarding enforceability, RACT, Reasonably Available Control Measures, and SIP relaxations. The TSDs have more information on our evaluation.
The TSDs describe additional rule revisions that we recommend for the next time the local agency modifies the rules but are not currently the basis for rule disapproval.
As authorized in section 110(k)(3) of the Act, the EPA is fully approving the submitted rules because we believe they fulfill all relevant requirements. We do not think anyone will object to this approval, so we are finalizing it without proposing it in advance. However, in the Proposed Rules section of this
Please note that if the 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 EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.
In this rule, the EPA is finalizing regulatory text that includes incorporation by reference. In accordance with requirements of 1 CFR 51.5, the EPA is finalizing the incorporation by reference of the YSAQMD rules described in the amendments to 40 CFR part 52 set forth below. The EPA has made, and will continue to make, these documents available electronically through
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, the EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a significant regulatory action subject to review by the Office of Management and Budget under Executive Orders 12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
• does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• does not provide the EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, the SIP is not approved to apply on any Indian reservation land or in any other area where the EPA or an Indian tribe has demonstrated that a tribe has jurisdiction. In those areas of Indian country, the 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 April 11, 2016. 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 this
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
Part 52, chapter I, title 40 of the Code of Federal Regulations is amended as follows:
42 U.S.C. 7401
(c) * * *
(199) * * *
(i) * * *
(E) * * *
(
(303) * * *
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(B) * * *
(
(463) * * *
(i) * * *
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(
(
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action on minor conforming edits to the stratospheric protection regulations to implement the International Trade Data System. This system allows businesses to transmit the transactional data required by multiple Federal agencies for the import and export of cargo through a single “window.” As businesses currently must submit trade data to multiple agencies, in multiple ways, and often on paper, the transition to electronic filing is expected to save businesses time and money. Specifically, this rule removes the requirement that the petition for used ozone-depleting substances accompany the shipment through U.S. Customs and removes references to Customs forms that are obsolete under the new system.
This rule is effective on May 9, 2016 without further notice, unless EPA receives adverse comment by March 10, 2016. If EPA receives adverse comment, we will publish a timely withdrawal in the
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0309, at
Jeremy Arling by regular mail: U.S. Environmental Protection Agency, Stratospheric Protection Division (6205T), 1200 Pennsylvania Avenue NW., Washington, DC, 20460; by telephone: (202) 343-9055; or by email:
EPA is publishing this rule without a prior proposed rule because we view this as a noncontroversial action and anticipate no adverse comment. This rule is intended to make minor changes like the removal of references to U.S. Customs forms that will no longer be available when the electronic International Trade Data System is implemented. However, in the “Proposed Rules” section of today's
If EPA receives adverse comment, we will publish a timely withdrawal in the
This rule may affect the following categories: Industrial Gas Manufacturing entities (NAICS code 325120), including fluorinated hydrocarbon gas manufacturers, importers, and exporters; Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690), including chemical gases and compressed gases merchant importers and exporters; and refrigerant reclaimers or other such entities that might import virgin, recovered, or reclaimed refrigerant gas.
This list is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility, company, business, or organization could be regulated by this action, you should carefully examine the regulations promulgated at 40 CFR part 82, subpart A. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding section.
In 2006, U.S. Customs and Border Protection (CBP) began automating processes for the import and export of goods to improve the control of what enters and leaves the U.S., as well as to improve efficiency. Launched under the Security and Accountability for Every Port Act of 2006 (SAFE Port Act, Pub. L. 109-347) and the 2007 Import Safety Executive Order 13439, the multi-agency program called the International Trade Data System (the ITDS) assists 48 Federal agencies with import/export responsibilities in their efforts to integrate import and export cargo processing with CBP's Automated Commercial Environment (ACE) for imports, and the Automated Export System (AES) for exports.
On February 19, 2014, the White House issued E.O. 13659 titled “Streamlining the Export/Import Process for America's Businesses.” Under E.O. 13659, participating agencies must have all requirements in place and in effect to utilize the ITDS, which includes the ACE and the AES systems for receiving documentation required for the release of imported cargo and the clearance of cargo for export, no later than December 31, 2016.
Under the ITDS, agencies with existing paper-based import and export clearance procedures at the port of exit or entry are working with CBP to enable electronic filing and processing of the import or export shipments based on one set of submitted data that can then be checked against all relevant U.S. agency requirements.
The
At the present time, allowances are required for the import of class II controlled substances, all of which are hydrofluorocarbons (HCFCs), and for the import of methyl bromide for critical uses. Allowances are not required, however, for the import of used controlled substances. Used controlled substances are defined as “substances that have been recovered from their intended use systems (may include controlled substances that have been, or may be subsequently, recycled or reclaimed)” (40 CFR 82.3). Imports of used controlled substances are regulated under § 82.13(g)(2) (for imports of used Class I controlled substances) and § 82.24(c)(3) (for imports of used Class II controlled substances). Persons seeking to import used controlled substances are required to submit a petition to the Agency. The petition to import a used controlled substance must contain detailed information such as the previous use of the substance, including the identity of all previous source facilities from which the material was recovered. After review, EPA issues either a “non-objection notice” allowing the import to proceed or an “objection notice” prohibiting the import.
For purposes of the ITDS, there are three pathways for the import of ozone depleting substances: Imports that require allowances; Imports that require a “non-objection” notice issued by EPA; and imports that do not require any documentation to be reviewed by CBP officers. The distinctions between these three categories relate to the type of documentation reviewed by CBP upon entry of the shipment. In all instances the recordkeeping and quarterly and/or annual reporting requirements under 40 CFR part 82, subpart A continue to apply.
Importers are not required to present documentation of allowances to CBP upon import. Some companies choose to include allowance balance statements provided by EPA with documentation accompanying the import. This is not a requirement of EPA's regulations but is done by the importer to facilitate the entry of the shipment. Under the ITDS, providing a paper copy of an allowance statement will be unnecessary as information being provided for the CBP entry and TSCA certification parts of the filing allow EPA to verify whether the importer has an allowance for the import.
EPA is not changing the reporting and recordkeeping requirements in 40 CFR part 82, subpart A to integrate these ODS imports into the ITDS. Importers are not required to provide a statement of allowances to CBP and this would not change under the ITDS.
For imports of used controlled substances, current regulations require that the petition and non-objection notice “accompany the shipment through U.S. Customs.” EPA is removing the requirement that the petition accompany the shipment through U.S. Customs. EPA does not
One component of the ITDS is the Document Image System (DIS) which allows the importer or their broker to file and an agency to view the image of a document, as it appears on paper, without paper needing to physically be provided. Under the ITDS, the non-objection notice would be filed to the DIS. Because this document would be available to CBP, EPA finds that filing a non-objection notice to the DIS meets the requirements in § 82.13(g)(3)(v) and § 82.24(c)(4)(v) that the non-objection notice “accompany the shipment.” Therefore, the only change EPA is making to the recordkeeping and reporting requirements in 40 CFR part 82, subpart A to implement the ITDS is to remove the requirement that the petition accompany the shipment.
A third category of ODS imports do not require verification by CBP. These include ODS that fall under the following exemptions: Imports for purposes of transformation or destruction; imports for laboratory and analytical uses; heels or transshipments; and methyl bromide imported under the quarantine and preshipment exemption. EPA is not making any changes to the reporting and recordkeeping requirements in 40 CFR part 82, subpart A to integrate these ODS imports into the ITDS.
EPA is making minor changes to the stratospheric protection regulations at 40 CFR part 82, subpart A, to remove references to U.S. Customs Service forms that will no longer exist when the ITDS is implemented.
The definition of importer at 40 CFR 82.3 and 82.104 includes the importer of record “listed on U.S. Customs Service forms” for the import. The definition of importer would still include the importer of record but because CBP will no longer be maintaining forms, EPA is removing the clause referencing the Customs Service forms. This change does not affect the scope of who would be considered an importer for the purposes of 40 CFR part 82.
The recordkeeping and reporting requirements at 40 CFR 82.13(g)(1) and 82.24(c)(2) state that an importer of Class I and Class II controlled substances, respectively, must maintain the U.S. Customs entry form. Under the ITDS, the entry form will no longer exist. EPA uses the Customs entry form to verify that a shipment of ODS has been properly imported into the United States. EPA believes that some type of verifying information is necessary and to the benefit of the importer if the origin of the controlled substance is ever in question. In order for the Agency to identify an individual shipment within the ITDS, EPA is replacing the requirement to keep a record of the Customs form with the requirement to keep a record of the entry number. This will still be generated by the ITDS and will help EPA to identify the specific shipment within the ITDS.
Similarly, the recordkeeping and reporting requirements at 40 CFR 82.13(g)(3)(viii) and 82.24(c)(4)(viii) state that an importer of used Class I and Class II controlled substances, respectively, must maintain the U.S. Customs entry documents for the import. For the reasons discussed above, EPA is removing the recordkeeping requirements for the U.S. Customs entry documents but is substituting the requirement to maintain the entry number for the shipment of used ODS.
In addition, reporting requirements for exporters of class II substances under § 82.24(d)(2) (related to export production allowances) or § 82.24(d)(3) (related to Article 5 allowances) reference the Shipper's Export Declaration Form and U.S. Customs Form 7525 as locations for the Employer Identification Number (EIN) of the shipper or their agent. EPA is removing references to these two forms but is maintaining the requirement that the EIN be provided.
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA because the requirements to maintain entry numbers and EINs are a subset of the previous requirements to maintain forms containing this information. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0170 and 2060-0438.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small entities subject to the rule. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. This action merely makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
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 Executive Order 13175. This rule does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose any enforceable duties on communities of Indian tribal governments. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
This rulemaking does not involve technical standards.
EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations because it does not affect the level of protection provided to human health or the environment. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
This action is subject to the CRA, and 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).
Environmental protection, Administrative practice and procedure, Air pollution control, Chemicals, Imports, Ozone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, 40 CFR part 82 is amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
Importer means any person who imports a controlled substance or a controlled product into the United States. “Importer” includes the person primarily liable for the payment of any duties on the merchandise or an authorized agent acting on his or her behalf. The term also includes, as appropriate:
(1) The consignee;
(2) The importer of record;
(3) The actual owner; or
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred.
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(xii) The U.S. Customs entry number;
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(v) To pass the approved used class I controlled substances through U.S. Customs, the non-objection notice issued by EPA must accompany the shipment through U.S. Customs.
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(D) The U.S. Customs entry number.
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(xiii) The U.S. Customs entry number;
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(v) To pass the approved used class II controlled substances through U.S. Customs, the non-objection notice issued by EPA must accompany the shipment through U.S. Customs.
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(D) The U.S. Customs entry number.
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(2) * * *
(i) The Employer Identification Number of the shipper or their agent;
(3) * * *
(i) The Employer Identification Number of the shipper or their agent; and
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(2) The importer of record;
Environmental Protection Agency (EPA).
Direct final rule.
The U.S. Environmental Protection Agency (EPA) Region 8 is publishing a direct final Notice of Partial Deletion of Operable Unit 1 (OU1) Yak Tunnel/Water Treatment Plant; and Operable Unit 3 (OU3), Denver & Rio Grande Western Railroad Company (D&RGW) Slag Piles/Railroad Easement/Railroad Yard, of the California Gulch Superfund Site (Site), located in Lake County, Colorado, from the National Priorities List (NPL). The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and
This direct final partial deletion is effective April 11, 2016 unless EPA receives adverse comments by March 10, 2016. If adverse comments are received, EPA will publish a timely withdrawal of the direct final partial deletion in the
Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-1983-0002, by one of the following methods:
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Linda Kiefer, Remedial Project Manager, U.S. Environmental Protection Agency, Region 8, Mailcode EPR-SR, 1595 Wynkoop Street, Denver, CO 80202-1129, (303) 312-6689, email:
EPA Region 8 is publishing this direct final Notice of Partial Deletion for all of Operable Unit 1 (OU1), Yak Tunnel/Water Treatment Plant; and Operable Unit 3 (OU3), Denver & Rio Grande Western Railroad Company (D&RGW) Slag Piles/Railroad Easement/Railroad Yard, from the NPL. The NPL constitutes Appendix B of the NCP, 40 CFR part 300, which EPA promulgated pursuant to Section 105 of CERCLA of 1980, as amended. EPA maintains the NPL as the list of sites that appear to present a significant risk to public health, welfare, or the environment. Sites on the NPL may be the subject of remedial actions financed by the Hazardous Substance Superfund (Fund). This partial deletion of the Site is proposed in accordance with 40 CFR 300.425(e) and is consistent with the Notice of Policy Change: Partial Deletion of Sites Listed on the NPL. 60 FR 55466 (November 1, 1995). As described in 300.425(e)(3) of the NCP, a portion of a site deleted from the NPL remains eligible for Fund-financed remedial action if future conditions warrant such actions.
Section II of this document explains the criteria for deleting sites from the NPL. Section III discusses procedures that EPA is using for this action. Section IV discusses OU1, Yak Tunnel/Water Treatment Plant; and OU3, D&RGW Slag Piles/Railroad Easement/Railroad Yard, and demonstrates how they meet the deletion criteria. Section V discusses EPA's action to partially delete the Site parcels from the NPL unless adverse comments are received during the public comment period.
This partial deletion pertains to all of OU1 and OU3. Operable Unit 2 (OU2), Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial Tailing; Operable Unit 4 (OU4) Upper California Gulch; Operable Unit 5 (OU5), ASARCO Smelters/Slag/Mill Sites; Operable Unit 7 (OU7), Apache Tailing Impoundment; Operable Unit 8 (OU8), Lower California Gulch; Operable Unit 9 (OU9), Residential Populated Areas; and Operable Unit 10 (OU10), Oregon Gulch, were deleted from the NPL in previous partial deletion actions. Operable Unit 6 (OU6), Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste Pile; Operable Unit 11 (OU11), Arkansas River Floodplain; and Operable Unit 12 (OU12), Site-wide Surface and Groundwater Quality, are not being considered for deletion as part of this action and will remain on the NPL.
The NCP establishes the criteria that EPA uses to delete sites from the NPL. In accordance with 40 CFR 300.425(e), sites may be deleted from the NPL where no further response is appropriate. In making such a determination pursuant to 40 CFR 300.425(e), EPA will consider, in consultation with the State, whether any of the following criteria have been met:
i. Responsible parties or other persons have implemented all appropriate response actions required;
ii. all appropriate Fund-financed response under CERCLA has been implemented, and no further response action by responsible parties is appropriate; or
iii. the remedial investigation has shown that the release poses no significant threat to public health or the environment and, therefore, the taking of remedial measures is not appropriate.
Pursuant to CERCLA section 121(c) and the NCP, EPA conducts five-year reviews to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at a site above levels that allow for unlimited use and unrestricted exposure. EPA conducts such five-year reviews even if a site is deleted from the NPL. EPA may initiate further action to ensure continued protectiveness at a deleted site if new information becomes available that indicates it is appropriate. Whenever there is a significant release from a site deleted from the NPL, the deleted site may be restored to the NPL without application of the hazard ranking system.
The following procedures apply to the deletion of OU1 and OU3:
(1) EPA has consulted with the State prior to developing this direct final Notice of Partial Deletion and the Notice of Intent for Partial Deletion co-published in the “Proposed Rules” section of the
(2) EPA has provided the State 30 working days for review of this notice and the parallel Notice of Intent for Partial Deletion prior to their publication today, and the State, through the CDPHE, has concurred on the partial deletion of OU1 and OU3 of the Site from the NPL.
(3) Concurrently with the publication of this direct final Notice of Partial Deletion, a notice of the availability of the parallel Notice of Intent for Partial Deletion is being published in a major local newspaper, the Leadville Herald Democrat. The newspaper notice announces the 30-day public comment period concerning the Notice of Intent for Partial Deletion of OU1 and OU3 of the Site from the NPL.
(4) The EPA placed copies of documents supporting the partial deletion in the deletion docket and made these items available for public inspection and copying at the Site information repositories identified above.
(5) If adverse comments are received within the 30-day public comment period on this partial deletion action, EPA will publish a timely notice of withdrawal of this direct final Notice of Partial Deletion before its effective date and will prepare a response to comments and continue with the deletion process on the basis of the Notice of Intent for Partial Deletion and the comments already received.
Deletion of a portion of a site from the NPL does not itself create, alter, or revoke any individual's rights or obligations. Deletion of a portion of a site from the NPL does not in any way alter EPA's right to take enforcement actions, as appropriate. The NPL is designed primarily for informational purposes and to assist EPA management. Section 300.425(e)(3) of the NCP states that the deletion of a site from the NPL does not preclude eligibility for further response actions, should future conditions warrant such actions.
The following information provides EPA's rationale for deleting OU1 and OU3 of the Site from the NPL.
The California Gulch Superfund Site, EPA ID No. COD980717938, CERCLIS Site ID 0801478, is located in Lake County, Colorado approximately 100 miles southwest of Denver. The Site was proposed for inclusion on the NPL on December 30, 1982, (47 FR 58476), and listed on September 8, 1983, (48 FR 40658). The Site is in a highly mineralized area of the Colorado Rocky Mountains covering approximately 18 square miles of a watershed that drains along California Gulch to the Arkansas River. The Site includes the City of Leadville, various parts of the Leadville Historic Mining District, Stringtown, and a section of the Arkansas River from the confluence of California Gulch to the confluence of Two-Bit Gulch. Mining, mineral processing, and smelting activities have occurred at the Site for more than 130 years. Mining in the district began in 1860, when placer gold was discovered in California Gulch. As the placer deposits were exhausted, underground mine workings became the principal method for removing gold, silver, lead and zinc ore. As these mines were developed, waste rock was excavated along with the ore and placed near the mine entrances. Ore was crushed and separated into metallic concentrates at mills, with mill tailing generally released into surrounding streams and after about 1930 slurried into tailing impoundments. Many of the mining operations ceased operations around 1900, although several smelters continued operations into the 1920s (Western Zinc) and the 1960s (AV Smelter) and the last active mine, the Black Cloud, shut down in 1999.
All of the mines within the Site boundaries are presently inactive, and all of the mills and smelters have been demolished. Mining remains that contributed to environmental contamination are (1) mill tailing (the fine-grained residue remaining after milling has removed the metal concentrates form the ore) in impoundments and fluvial deposits; (2) mine waste rock piles (mine development rock and low grade ore removed to gain access to an ore body, and often deposited near adits and shaft openings); (3) mine water drainage tunnels; (4) draining adits; and (5) various smelter wastes including slag piles, flue dust and fallout from stack emissions.
The Site was placed on the NPL due to concerns regarding the impact of acidic and metals laden mine drainage on surface waters leading to California Gulch and the impact of heavy metals loading into the Arkansas River. A Site-wide Phase I Remedial Investigation (Phase I RI), which primarily addressed surface water and groundwater contamination, was issued in January 1987. As a result of the Phase I RI, EPA identified the first operable unit, the Yak Tunnel, to address the largest single source of metallic loading. A number of additional Site-wide studies followed the Phase I RI.
EPA agreed, pursuant to a May 2, 1994 Consent Decree (1994 CD), to divide the Site into 12 operable units (OUs). The OUs are as follows: OU1, Yak Tunnel/Water Treatment Plant; OU2, Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial Tailing; OU3, D&RGW Slag Piles/Railroad Easement/Railroad Yard; OU4, Upper California Gulch; OU5, ASARCO Smelter Sites/Slag/Mill Sites; OU6, Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste Pile; OU7, Apache Tailing Impoundments; OU8, Lower California Gulch; OU9, Residential Populated Areas; OU10, Oregon Gulch; OU11, Arkansas River Valley Floodplain; and OU12, Site-wide Surface and Groundwater. With the exception of OU12, the OUs pertain to distinct geographical areas corresponding to areas of responsibility for the identified responsible parties and/or to distinct sources of contamination. To date, OU2, OU4, OU5, OU7, OU8, OU9, and OU10 have been partially deleted from the NPL.
The background and history, the Remedial Investigations and Feasibility Studies (RI/FS), Removal and Response Actions, Selected Remedies, Cleanup
Operable Unit 1 (OU1) consists of the Yak Tunnel and Water Treatment Plant. The Yak Tunnel and Yak Tunnel Water Treatment Plant are located to the southeast of the City of Leadville. A map of OU1 can be found in the docket at
The State, the EPA and certain Potentially Responsible Parties (PRPs) conducted various studies and investigations to evaluate the nature and extent of contamination generally at the Site. Remedial Investigations (RIs) began in 1986 within the Site, including mine waste rock piles, tailing disposal areas, surface water and aquatics, groundwater, smelter sites, residential/populated area soils, slag piles, and terrestrial studies. The Yak Tunnel/California Gulch Remedial Investigation (1986 RI) evaluated the human health and environmental impacts due to historic mining activities.
In May 1987, the Phase I Remedial Investigation (1987 Phase I RI) confirmed that the Yak Tunnel is a significant source of metals contamination. Results of this study indicated that 75 to 80 percent of the cadmium, manganese, and zinc detected at the confluence of California Gulch with the Arkansas River originates from the Yak Tunnel. Historical information along with data collected during the 1987 Phase I RI indicated that the Yak Tunnel discharge had a significant detrimental impact on the aquatic environment at the site. In addition, the Yak Tunnel discharge presented a potential public health risk based on exposure to affected surface and groundwater at the California Gulch Site.
The EPA released the Yak Tunnel Feasibility Study (FS) in June 1987 and a proposed plan for the Yak Tunnel in August 1987.
The EPA issued the Record of Decision (ROD) for OU1 (1988 OU1 ROD) on March 29, 1988. The remedy chosen in the 1988 OU1 ROD was modified in an Amended ROD (AROD) signed on March 23, 1989 (1989 OU1 AROD) and, further, modified in an ESD signed on October 22, 1991 (1991 OU1 ESD) and an ESD signed on July 29, 2013 (2013 OU1 ESD).
The selected remedy in the 1988 OU1 ROD was narrowly focused on the discharges from the Yak Tunnel as a major source of contamination to California Gulch and the Arkansas River. Broader issues of water quality generally in California Gulch and the Arkansas River were addressed as part of remedial actions taken at other operable units. Thus, the 1988 OU1 ROD identified a single remedial action objective (RAO) of decreasing the release and threatened release of hazardous substances, pollutants and contaminants from the Yak Tunnel into California Gulch.
The original remedy selected in the 1988 OU1 ROD consisted of the following remedial components: (1) Construction of surge ponds to capture drainage from the tunnel and to minimize the impact of surges on California Gulch and the Arkansas River; (2) Installation of an interim water treatment system to treat water from the Yak Tunnel before discharge in California Gulch; (3) Sealing of shafts, drill holes and fractured rock and diversion of surface water from tunnel recharge areas to reduce the amount of water entering the Yak Tunnel system; (4) Grouting of fractured rock, caved-in areas and drill holes to prevent seepage of contaminated water to the land surface; (5) Installation of a pumping system to control water levels behind the portal plug. The pumped water would be routed to the interim treatment system; (6) Construction of a minimum of three concrete plugs in the Yak Tunnel to seal off the major flow route for groundwater movement; (7) Establishment of a surface and groundwater monitoring system to detect leakage, seeps or migration of contaminated groundwater, which may result from installation of the tunnel plugs; (8) Development and implementation, as necessary, of a contingency plan to address any adverse effects on surface or groundwater from tunnel plugging; and (9) Operations and maintenance of the remedy.
The 1989 OU1 AROD made the following changes in the remedy: (1) Installation of a permanent water treatment system to treat contaminated groundwater from the Yak Tunnel before discharge in California Gulch, as opposed to the interim treatment facility originally proposed; (2) Construction of a surge pond or ponds to capture drainage from the tunnel and to minimize surges on California Gulch. The original remedy called for multiple surge ponds and did not consider the use of a single pond; (3) Reduction of seepage and recharge was made optional. Grouting of fractured rock, cave-ins and drill holes was removed as part of the remedy; and (4) The portal plug was modified to be a flow-through plug as opposed to a solid plug.
The 1991 OU1 ESD made the following changes in the remedy: (1) Construction of a single surge pond as a permanent part of the remedy; (2) Construction of a flow-control bulkhead within the tunnel to prevent surges. Two of three originally planned plugs were removed from the remedy; (3) Identification of groundwater flow direction and potential gradient reversal as additional element of the monitoring plan. The monitoring system was proposed to include a minimum of seven groundwater monitoring wells as opposed to a minimum of 23 wells proposed in the 1989 AROD; (4) Placement of six or more weirs, or other flow measuring devices, at key locations in the Yak Tunnel. The weir locations were selected during an initial inspection of the tunnel; (5) Periodic inspection of the Yak Tunnel. Qualified mining crews will enter the tunnel annually to inspect and maintain weirs and other structures in the tunnel. Crews will also enter the tunnel to determine the cause of unexpected increases or decreased in flow within the Yak Tunnel; and (5) Development and implementation, as necessary, of a contingency plan to address any adverse
Because the selected remedy in the 1988 OU1 ROD left wastes in place but did not include institutional controls (ICs), a second ESD was signed on July 29, 2013 to include ICs. The objectives of ICs for OU1 are as follows: (1) Reduce or control human exposure to contaminants of concern; and (2) Maintain the integrity of and prevent disturbances to engineered features or structures established as part of the current remedy or future remedies. The properties that comprise most of OU1 are owned by Resurrection/Newmont.
The OU1 remedy was the first source control remedy at the Site that addressed the Yak Tunnel discharge as the largest single source of contamination to surface water and groundwater but did not contain numeric cleanup standards for those media. Numeric cleanup standards for site-wide surface water and groundwater contamination were established in the OU12 Record of Decision.
The EPA issued a Unilateral Administrative Order (UAO) to ASARCO Incorporated, Newmont Mining Corporation, Res-ASARCO Joint Venture and Resurrection Mining Company on March 29, 1989 ordering these parties to perform the remedial design and remedial action for the Yak Tunnel. Two amendments were made to the UAO on April 30, 1993 and June 16, 1993. The UAO was replaced and terminated in a 2008 Consent Decree settlement (2008 CD) by and among the United States, State of Colorado, Newmont USA Limited and Resurrection Mining Company. Under the 2008 CD, Newmont USA Limited and Resurrection Mining Company assumed responsibility for the OU1 remedy. Construction of a surge pond and permanent water treatment plant began in September 1988 and was completed in June 1991. The construction efforts included four main elements: (1) A surface water conveyance system, (2) the surge pond itself, (3) a barge transfer system and (4) installation of gravity filters. The water treatment facility to treat waters emanating from the Yak Tunnel was constructed over a two-year period and the Yak Tunnel Water Treatment Plant has been in operation since construction was completed in February 1992. The Yak Tunnel Bulkhead was constructed in 1994 to control surges of water coming from the Yak Tunnel, particularly during spring melt. The bulkhead is located approximately 1,680 feet into the tunnel from the portal. Additional efforts were made in 1995 and 1996 to reduce metals loading into the Arkansas River from ephemeral tributaries. As part of a Consent Decree settlement with Resurrection/Newmont, Resurrection/Newmont placed environmental covenants on its properties in OU1 on July 31, 2012 and October 1, 2012 that meets the IC objectives above. All remedial components described in the 1988 OU1 ROD and subsequent 1989 OU1 AROD, 1991 OU1 ESD, and the 2013 OU1 ESD have been implemented.
The potentially responsible parties' (PRPs) operations and maintenance (O&M) responsibilities were first defined under the UAO and then updated in the 2008 CD. In accordance with the terms of the 2008 CD, the Routine Monitoring Plan (RMP), Contingency Plan (CP) and the OU1 Work Plan (Work Plan) govern the long-term implementation of the selected remedy for the OU1. The OU1 Work Plan, CP and the RMP are appendices to the 2008 CD.
Routine O&M includes repairing grouted areas of structures due to corrosion, settlement or other factors; occasional repair or replacement of monitor well pumps and surface water monitoring equipment; repair of access roads; routine repair or replacement of pumps, motors, mixers, piping and tankage; and inspections. The treatment plant operates under requirements established in the OU1 Work Plan, and submits monthly and annual reports to EPA. Resurrection/Newmont summarizes monitoring data and data evaluation required by the OU1 Routine Monitoring Plan in the Annual Monitoring Reports, Yak Tunnel System for the Yak Tunnel Operable Unit, Leadville, CO. Current reports and associated data are available by contacting EPA Region 8.
In regards to ICs, environmental covenants for Resurrection/Newmont's properties within OU1 were recorded with the Lake County Clerk and Recorder on July 31, 2012 and October 10, 2012. The environmental covenants provide the following Use Restrictions: (1) No Residential Use, Day Care Centers or Schools, Parks or Open Space that are designed or intended to provide play or recreation areas for children, (2) Restrictions on using untreated groundwater from wells, and (3) Restrictions on uses or activities that would disturb/interfere or have the potential to disturb/interfere with the protectiveness of the remedy and remedial components. All of OU1 is zoned Industrial Mining by Lake County, which serves to limit future changes of land use without County approval and Lake County has established a protocol to notify the EPA and the CDPHE of any proposed changes.
D&RGW Slag Piles/Railroad Easement/Railroad Yard (OU3) included three slag piles (Arkansas Valley (AV), La Plata, and Harrison Street), approximately 12 acres at Harrison Avenue and Monroe Street which contained the Harrison Street slag pile, an easement that runs diagonally through the City of Leadville, and a portion of the rail yard known as Poverty Flats. The Denver & Rio Grande Western Railroad Company (D&RGW) owned theses slag piles, property, easement and rail yard when OU3 was designated in 1994. A map of OU3 can be found in the docket at
In 1961, D&RGW purchased the AV Slag Pile from ASARCO Incorporated for use as railroad ballast. D&RGW purchased the La Plata Slag Pile from the Leadville Sanitation District in 1970. Additionally, D&RGW purchased the Harrison Street Slag Pile and Harrison Avenue property from NL Industries in 1983.
The AV Slag Pile covers approximately 40 acres just west of Stringtown. The pile generally consists of slag produced by the AV smelter that operated from 1882 to 1960. Based on aerial photography, the pile volume in the late 1950s was approximately 1.2 million cubic yards, whereas in 1998 approximately 422,000 cubic yards of slag remained, of which, approximately 190,000 cubic yards is stockpiled fine slag.
The La Plata Slag Pile, located west of the City limits of Leadville on Elm Street, has a volume estimated at 105,000 cubic yards. Bimetallic Smelting Company leased the La Plata Smelter Works in OU3 from 1892 to 1900 for pyritic smelting of low-grade ores.
The Harrison Reduction Works was located near the northeast corner of Harrison Avenue and Elm Street, in a residential area. The Harrison Street Slag Pile ranged from 20 to 50 feet in
Once a hotbed of transportation activities mostly related to mining, the Poverty Flats rail yard, located between 12th Street, Highway 24, 17th Street and County Road 8, is now vacant. The portion of the Poverty Flats rail yard formerly owned by D&RGW is located near the north end of the City of Leadville, encompasses an area of roughly 43 acres, and is crossed by abandoned rail lines and access roads. Slag, which was used in the rail yard as ballast and as a road base to provide support for heavy vehicle traffic, was also deposited around the loading dock due to spillage during transportation activities.
The rail easement includes the portion of railroad track that runs diagonally through Leadville and consists of approximately 25 feet on either side of the track centerline. Slag was used as a road base to provide support for heavy vehicle traffic. Slag was also deposited as spillage from passing rail cars.
D&RGW identified a small volume of fine slag in the Poverty Flats rail yard. D&RGW prepared a plan, which addressed removal of the fine slag from this area to the AV Smelter Slag Pile. As a result of the Union Pacific Railroad Company (UPRR) purchase of the Southern Pacific Transportation Company (surviving corporation from an earlier merger of D&RGW and Southern Pacific Railroad), UPRR took ownership of all D&RGW property at the Site in 1996 and assumed D&RGW's responsibilities under the 1993 D&RGW CD.
During the summer and fall of 1997, UPRR removed 1,264 cubic yards of slag, including fine slag, from the rail yard and placed it onto the AV Slag Pile. As a result, soils were exposed containing elevated concentrations of lead. Soils samples, taken before and after removal of the slag, showed levels of lead in soil that exceed the Site-wide residential action level of 3500 mg/kg lead, thus lead in the soils on this property may create the potential for unacceptable human health risks should the property be developed for residential use. This vacant property is zoned Business by Lake County. However, institutional controls are in place to protect human health in the event of future residential development.
As part of their ballast operations, UPRR relocated approximately 104,000 cubic yards of slag to the AV Slag Pile in March 1998, which brought the Harrison Street Slag Pile to grade. Soils samples taken after removal of the slag showed levels of lead in soils, both under where the slag pile was located and otherwise on the Harrison Avenue property, that exceed the residential action level for lead in soils of 3500 mg/kg. Thus, the lead in the soils on the Harrison Avenue property may create the potential for unacceptable human health risks should the property be developed for residential use. To date, the land remains vacant. Sections along the highway are zoned Commercial, and the remaining sections are zoned Transitional Commercial by the City of Leadville. However, institutional controls are in place to protect human health in the event of future residential development.
In July 1998, UPRR submitted a Work Plan for the Consolidation of Fine Slag at the Railroad Easement Near McWethy Drive to 12th Street, Leadville, Colorado. The work plan provided for the easement to be converted into a segment of the Mineral Belt Trail. Consistent with the plan, fine slag from the rail easement was used as base material on the Mineral Belt Trail. More specifically, the fine slag was consolidated and covered with a compacted gravel sub-base of six inches and then two one-inch layers of asphalt to encapsulate it. This resource utilization was consistent with the contingency under the 1998 OU3 ROD. The completion of the consolidation work was approved in September 1998. The conversion of the railroad easement to the Mineral Belt Trail was completed with the installation of a sub-base, culverts, asphalt, signs, centerline striping, and re-vegetation. In accordance with a 1998 Memorandum of Understanding between EPA, UPRR, and Lake County, Lake County completed these projects, and UPRR provided funding for the sub-base, culverts, and asphalt in 2000. Ownership of the easement has been transferred to Lake County via quitclaim deed.
The State, the EPA and certain Potentially Responsible Parties (PRPs) have conducted various studies and investigations to evaluate the nature and extent of contamination generally at the Site, and specifically within OU3. Remedial Investigations (RIs) began in 1986 within the Site, including mine waste rock piles, tailing disposal areas, surface water and aquatics, groundwater, smelter sites, residential/populated area soils, slag piles, and terrestrial studies.
Concurrent with the various investigations and studies, risk assessments were conducted at the California Gulch Superfund Site. Some included the Preliminary Baseline Risk Assessment (Preliminary BRA), and the Final Baseline Human Health Risk Assessments (Final BRA): Part A, Part B, and Part C. For human health risk issues at OU3, the Preliminary BRA and the Final BRA Part C, Evaluation of Worker Scenario and Evaluation of Recreational Scenarios, were most pertinent. The Preliminary BRA indicated that lead and arsenic are responsible for the majority of human health risks at the Site. Therefore, arsenic and lead were used as indicator contaminants for risk in the Final BRA.
EPA and D&RGW entered into an Administrative Order on Consent (1991 D&RGW AOC) on December 3, 1991. The 1991 D&RGW AOC required D&RGW to perform remedial investigations of major lead slag piles and one zinc slag pile within the Site. In 1992, D&RGW completed a remedial investigation (1992 OU3 Slag RI) of the major lead slag piles and the zinc slag pile within the Site. Slag was found to have elevated levels of zinc, lead, arsenic and cadmium along with a low acid-generating potential, and a neutral to basic pH. Fine slag, which is less than
EPA and D&RGW entered into a Consent Decree on September 15, 1993 (1993 D&RGW CD) for the completion of investigation, feasibility studies, and remediation activities to be performed for OU3. The 1993 D&RGW CD stated EPA's concerns regarding the fine fraction of the stockpiled slag at the AV Smelter site and the potential for particulate release during ballast operations as a potential human health exposure pathway. The 1993 D&RGW CD required D&RGW to perform a feasibility study for stockpiled fine slag and to submit an operations plan before initiating any ballast operations.
In 1993, the EPA conducted a Screening Feasibility Study (1993 SFS) to initiate the overall CERCLA FS process at the California Gulch Site. The purpose of the SFS was to develop general response actions and identify an appropriate range of alternatives applicable to the various contaminant sources to be considered during feasibility studies for the California Gulch Site. The 1993 SFS for Remedial Alternatives examined several remediation alternatives for slag located
In July of 1995, D&RGW submitted a ballast operations plan to EPA. Following EPA's approval of the plan, ballast operations commenced in August 1995 but ceased soon thereafter for lack of a profitable market for the slag. Ballast operations involve the sorting of larger slag so that the size fraction of greater than
D&RGW's 1996 Final Stockpiled Fine Slag Feasibility Study (1996 OU3 FS) focused on the AV Smelter Slag Pile's existing fine slag subpile and fine slag potentially generated from future ballast production. Based upon the 1993 SFS and 1993 D&RGW CD, the remedial action objective for the stockpiled fine slag was to: prevent leaching of metals of concern in concentrations that would have an adverse impact on soils, surface or ground water near the slag piles. The 1996 OU3 FS provided a detailed analysis of the three retained remediation alternatives (no action, institutional controls, and resource utilization) from the 1993 SFS as applied to the stockpiled fine slag. The result of the 1996 OU3 FS for the stockpiled fine slag was a Proposed Plan with a No Action Alternative for the stockpiled fine slag subpile of the AV Smelter Slag Pile. In September 1996, the Proposed Plan was issued with a preferred alternative of “No Action,” with a contingency for future utilization of the slag.
The EPA issued the Stockpiled Fine Slag—Arkansas Valley Smelter Slag Pile ROD for OU3 on May 6, 1998 (1998 OU3 ROD). Based on consideration of CERCLA requirements, detailed analyses of alternatives, and public comments, the EPA determined that a No Action alternative was the appropriate remedy. The No Action alternative leaves the stockpiled fine slag in its existing condition with no control or cleanup planned. The No Action alternative includes a provision, denoted as a contingency, for future utilization of the slag, if it is encapsulated prior to its use or reuse. The 1998 OU3 ROD also provides a provision to use the slag in the future if regional market demand exists for the material as a component in construction materials.
The 1998 OU3 ROD did not require maintenance of the fine slag piles. Any future use of the slag would require encapsulation prior to reuse. Encapsulation can include the use of fine slag in concrete or asphalt aggregate, as a road base, or as backfill (so long as the slag is chemically bound or physically separated from an exposure by a barrier consisting of a different material).
Sampling in the Poverty Flats rail yard property and the Harrison Avenue property shows levels of lead in soils above levels that would allow for unlimited use and unrestricted exposure,
As the final determination in the 1998 OU3 ROD was No Action ROD, no cleanup standards were identified for fine slag in the record of decision. The OU12 remedy addresses site-wide surface water and groundwater contamination.
No response actions were taken pursuant to the No Action ROD. The ICs established by the City and County ordinances were response actions that were incorporated into the OU3 remedy by the ESD. Lake County, on March 3, 2009, and the City of Leadville, on May 7, 2013, implemented ICs in the form of local ordinances, amending the Land Development Codes and adopting regulations that protect both engineered and non-engineered remedies at OU3. A best management practice handout is provided to all applicants applying for a building permit within OU3. In addition, any disruptions of engineered or non-engineered remedies, and/or excavation of more than 10 cubic yards of soil off-site within OU3 require written approval from the CDPHE.
Because the 1998 OU3 ROD was a No Action ROD, no maintenance was required.
The remedies at the entire Site, including OU1 and OU3 require ongoing five-year reviews in accordance with CERCLA Section 121(c) and Section 300.430(f)(4)(ii) of the NCP. The next five-year review for the California Gulch Site is planned for 2017.
In the 2012 five-year review dated September 27, 2012 for the Site, the OU1 remedy was determined to be protective in the short-term. There were concerns regarding continued long-term protectiveness because the requirement of ICs was not documented in a decision document even though ICs had already been implemented by the PRP and Lake County. Environmental covenants for Resurrection/Newmont's properties within OU1 were recorded with the Lake County Clerk and Recorder on July 31, 2012 and October 10, 2012. An ESD dated July 29, 2013 (2013 OU1 ESD) resolved this concern.
In the 2012 five-year review for the Site, the OU3 remedies were determined to be protective in the short-term. The five-year review, recommended a review to determine whether additional response actions were needed at OU3 to insure long-term protectiveness. The review determined that ICs were needed to insure long-term protectiveness. The 2013 OU3 ESD addresses the need for ICs because some soils and residual slag remained above the residential action level, and documents the decision to require ICs. Ordinances adopted by the City and County met the IC objectives set out in the ESD
Pursuant to CERCLA section 121(c) and the NCP, EPA will conduct the next five-year review by September 27, 2017 to ensure the continued protectiveness of remedial actions where hazardous substances, pollutants, or contaminants remain at the Site above levels that allow for unlimited use and unrestricted exposure.
Public participation activities have been satisfied as required in CERCLA Section 113(k), 42 U.S.C. 9613(k) and CERCLA Section 117, 42 U.S.C. 9617. During the development and implementation of the remedies for these operable units, comment periods were offered for proposed plans, five-year reviews, and other public meetings.
The State, the Lake County Commissioners, the City of Leadville are supportive of the partial deletion of OU1 and OU3. The State signed a letter of concurrence on October 7, 2015.
EPA has consulted with the State, Lake County Commissioners, and the City of Leadville on the proposed partial deletion of OU1 and OU3 of the California Gulch Site from the NPL prior to developing this Notice of Partial Deletion. Through the five-year reviews, EPA has also determined that the response actions taken are protective of public health or the environment and, therefore, taking of additional remedial measures is not appropriate.
The implemented remedies achieve the degree of cleanup or protection specified in: for OU1, the 1988 OU1 ROD, 1989 OU1 AROD, the 1991 OU1 ESD and 2013 OU1 ESD; and for OU3, the 1998 OU3 ROD and the 2014 OU3 ESD.
All selected removal and remedial action objectives and associated cleanup goals for OU1 and OU3 are consistent with agency policy and guidance. This partial deletion meets the completion requirements as specified in OSWER Directive 9320.2-22, Close Out Procedures for National Priority List Sites. All response activities at OU1 and OU3 of the Site are complete and the two operable units pose no unacceptable risk to human health or the environment. Therefore, EPA and CDPHE have determined that no further response is necessary at OU1 and OU3 of the Site.
The EPA, with concurrence of the State through the CDPHE has determined that all appropriate response actions under CERCLA, other than operation, maintenance, monitoring and five-year reviews, have been completed. Therefore, EPA is deleting all of OU1, Yak Tunnel/Water Treatment Plant; and OU3, D&RGW Slag Easement/Railroad Yard, of the Site.
Because EPA considers this action to be non-controversial and routine, EPA is taking it without prior publication. This action will be effective
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
Federal Railroad Administration (FRA), Department of Transportation (DOT).
Final rule.
In this final rule, FRA is revising and clarifying existing regulations related to the use of glazing materials in the windows of locomotives, passenger cars, and cabooses. This final rule reduces paperwork and other economic burdens on the rail industry by removing a stenciling requirement for locomotives, passenger cars, and cabooses that are required to be equipped with glazing. This final rule also clarifies the application of the regulations to older equipment and to the end locations of all equipment to provide more certainty to the rail industry and more narrowly address FRA's safety concerns. In addition, this final rule clarifies the definition of passenger car, updates the rule by removing certain compliance dates that are no longer necessary, and, in response to comments on the proposed rule, modifies the application of the regulations to passenger cars and cabooses in a railroad's fleet that are used only for private transportation purposes and to older locomotives used in incidental freight service.
This final rule is effective April 11, 2016. Petitions for reconsideration must be received on or before April 11, 2016. Comments in response to petitions for reconsideration must be received on or before May 24, 2016.
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Steve Zuiderveen, Railroad Safety Specialist, Motive Power & Equipment Division, Office of Safety Assurance and Compliance, Mail Stop 25, Federal
Beginning on January 18, 2011, the President issued a set of Executive Orders which require Federal agencies to review existing regulations and reduce the regulatory burden on industry, when appropriate. (
Specifically, this final rule eliminates as unnecessary the requirement to stencil inside walls of locomotive cabs, passenger cars, and cabooses to indicate that the equipment contains window glazing certified in compliance with the Safety Glazing Standards. Further, this final rule uses a rolling, 50-year calculation to determine whether equipment is “antiquated” based on its build date—rather than a fixed date of 1945 or earlier—thereby eliminating the cost of fitting equipment more than 50 years old and used only for certain purposes with compliant glazing. To maintain safety in connection with the change to the application of the term “antiquated equipment,” FRA is clarifying requirements for emergency windows in occupied passenger cars operated in intercity passenger or commuter trains, and clarifying requirements for locomotives, passengers, and cabooses currently equipped with compliant glazing.
Separately, this final rule makes changes based on a Railroad Safety Advisory Committee (RSAC) recommendation. In 2013, FRA's RSAC recommended that FRA clarify the application of the glazing requirements in part 223 to address requirements for the next generation of high-speed trainsets. FRA agrees that aspects of the RSAC recommendation are appropriate to adopt generally for all equipment, and is therefore doing so in this final rule. Specifically, FRA believes that amending application of the phrase “end facing glazing location” in part 223 reduces the economic burden on the rail industry without adversely impacting safety.
In addition, FRA is clarifying the application of requirements for private cars, and eliminating compliance phase-in dates that are no longer necessary. Also, in response to comments on the NPRM, this final rule modifies application of the safety glazing requirements to passenger cars and cabooses in a railroad's fleet used only for private transportation purposes and to older locomotives used in incidental freight service.
FRA believes this final rule is consistent with current industry practices and reduces the regulatory burden on the rail industry.
The estimated quantified benefits or cost savings of this rule total $1,088,489. The present value (PV), discounted at 7 percent, of the estimated quantified benefits is approximately $819,479. FRA concludes that the industry incurs only a minimal cost of approximately $6,000 to take advantage of the flexibilities in this rule. Therefore, FRA estimates the net benefit (cost savings) of this rule is approximately $813,479 (PV, 7 percent).
Under its general statutory rulemaking authority, FRA promulgates and enforces rules as part of a comprehensive regulatory program to address all areas of railroad safety.
On January 18, 2011, the President issued
Further, on May 10, 2012, the President issued Executive Order 13610 (Identifying and Reducing Regulatory Burdens). Executive Order 13610 requires agencies to take continuing steps to reassess regulatory requirements, and where appropriate, to streamline, improve, or eliminate those requirements. Executive Order 13610 emphasizes that agencies should prioritize “initiatives that will produce significant quantifiable monetary savings or significant quantifiable reductions in paperwork burdens.” In response to these instructions, DOT carried out a Paperwork Reduction Act initiative that focused on identifying and eliminating paperwork burdens on the rail industry as appropriate. FRA conducted a comprehensive review of its regulations based on the guidance provided in Executive Order 13610 and determined that eliminating the stenciling requirement in § 223.17 was an opportunity to reduce the paperwork burden on the rail industry without adversely impacting safety. (FRA's Executive Order 13563 review also identified § 223.17 as a candidate for elimination.) This final rule eliminates this stenciling requirement.
In addition to the changes FRA proposed in response to these Executive Orders, FRA's proposal was also based on an RSAC recommendation addressing the application of the regulations for the next generation of high-speed trainsets. RSAC is a forum for collaborative rulemaking and program development that FRA established in March 1996. RSAC includes representation from all of the agency's major stakeholder groups, including railroads, labor organizations, suppliers and manufacturers, and other interested parties.
* Indicates associate, non-voting membership.
In March 2013, after RSAC's Passenger Safety Working Group
The NPRM solicited written comments from the public under the Administrative Procedure Act (APA) (5 U.S.C. 553). FRA also invited comment on a number of specific issues related to the proposed rule to develop the final
AAR requested two changes in the final rule: (1) Confirm and clarify the glazing requirements do not apply to business cars; and (2) remove the noise emissions testing decal requirement in part 210. In response to AAR's first comment, this final rule excludes certain cars in a railroad's fleet that are used only for private transportation purposes from the glazing requirements. After reviewing favorable safety data, FRA believes the glazing requirements should not apply to these cars used only for private transportation. A fuller discussion of this issue is provided in section IV.E. of this final rule.
AAR's request to remove the noise decal required in part 210 is outside the scope of this rulemaking. Therefore FRA cannot properly adopt it in this final rule. Under the APA, a final rule must be based on the subjects and issues identified in the NPRM.
ATRRM expressed support for FRA's proposal and requested two modifications in the final rule: (1) Exclude historic or antiquated locomotives that are used primarily in excursion, educational, recreational, or private passenger service and also used in other limited types of service from the glazing requirements; and (2) confirm and clarify that § 223.3(c)(1) would not require an “open window” passenger car with windows that open wide enough to permit egress to also be equipped with a tool or implement to use to break or remove a window during an emergency.
In response to ATRRM's first comment, this final rule excludes from the glazing requirements a small number of primarily excursion locomotives that are used in incidental freight service when no other power is available. Based on its thorough review of the issue, FRA believes it can provide this relief without having an adverse impact on rail safety. A fuller discussion of this issue is provided in section IV.C. of this final rule.
In response to ATRRM's second comment, FRA confirms that § 223.3(c)(1) does not require a passenger car with windows that open wide enough to permit egress to be equipped with a tool or implement to use to break or remove a window during an emergency. FRA believes the plain language of § 223.3(c)(1) is clear, and read in conjunction with §§ 223.9(c) and 223.15(c), communicates that no tool or implement is required in such a case. Therefore, FRA believes that no change is necessary and is adopting § 223.3(c)(1) as proposed. Nevertheless, FRA takes this opportunity to clarify the language and intent of this paragraph to avoid any confusion. The purpose for requiring an emergency window exit is to help ensure passengers are not sealed inside the car during an emergency when they need to exit rapidly. If the window is open or can be opened wide enough to permit egress, passengers should be able to exit the car through that window as rapidly as they would if the window were removed by a tool or other implement. Specifically, if a window frame does not contain glass, as in an “open air car,” there is no need for a tool or implement to clear the space inside the window frame where the glass would otherwise be. Therefore, no tool or implement is required.
FRA carefully considered both sets of comments on the NPRM while developing this final rule. To further clarify written comments, FRA discussed the comments with the RSAC Tourist and Historic Railroads and Private Passenger Car Working Group
As noted above, FRA's review of its regulations under Executive Order 13563 and Executive Order 13610 identified as a candidate for elimination § 223.17, which provided that locomotive cabs, passenger cars, and cabooses be stenciled inside on an interior wall with the type of glazing present in the equipment. In particular, Executive Order 13610 requires agencies to take continuing steps to reassess regulatory requirements and, where appropriate, to streamline, improve, or eliminate those requirements. Executive Order 13610 emphasizes that agencies should prioritize “initiatives that will produce significant quantifiable monetary savings or significant quantifiable reductions in paperwork burdens.” In 2012, FRA conducted a comprehensive review of its regulations based on the guidance in Executive Order 13610 and determined removal of the certified glazing stenciling requirement inside of locomotive cabs, passenger cars, and cabooses is an opportunity to reduce the paperwork burden on the rail industry without adversely impacting safety. The certified glazing stencil was originally intended as an easily identifiable method for railroads to demonstrate compliance with the safety glazing requirements contained in part 223 when large numbers of affected equipment were not equipped with part 223 glazing. However, the need for this requirement has diminished since compliance was phased in for equipment existing at the time part 223 was promulgated. (See the discussion below on removing compliance phase-in dates from part 223.) Moreover, in practice, FRA has found the stencil is not always accurate, and that each window needs to be examined to determine whether proper glazing has been applied. An easy and reliable way to determine the compliance of each window individually is to read the permanent marking on each window panel required by part 223, appendix A. Each window that is equipped with certified glazing must be permanently marked by the manufacturer to indicate the type of glazing applied, which remains unchanged for each glazing panel's service life. Appendix A requires
FRA believes the markings on the windows are more reliable than the stenciling located inside the equipment in which they are installed, and that the markings provide sufficient information to determine compliance. Therefore, FRA concludes that the § 223.17 stenciling requirement is no longer necessary, and this rule eliminates the requirement for a certified glazing stencil located inside locomotive cabs, passenger cars, and cabooses.
Part 223 uses the term “antiquated equipment” to identify equipment excluded from the application of part 223, if the equipment is operated in only specified types of service (excursion, educational, recreational or private transportation). However, part 223 did not define the term “antiquated equipment” and the context in which the term was used in the regulation did not clearly indicate its meaning. During implementation of part 223, FRA identified the need to clarify the term “antiquated equipment” to ensure its consistent application. FRA developed guidance interpreting the term in 1989, and FRA's Associate Administrator for Safety provided it to the agency's regional safety management. Subsequently, FRA made the interpretation part of a 1990 FRA technical bulletin. For purposes of this final rule, FRA references the 1990 FRA technical bulletin (1990 Technical Bulletin) and has included it in the public docket for this rulemaking.
The 1990 Technical Bulletin stated “antiquated equipment,” as used in part 223, meant equipment built in 1945 or earlier. However, FRA did not explain why it distinguished between equipment built in 1945 or earlier from equipment built after 1945. FRA believes it chose 1945 as the cut-off date because it was the end of World War II, the date was approaching approximately 50 years before the date the guidance was issued, and the approaching 50-year difference in time was consistent with FRA's treatment of other older equipment. Based on FRA's experience, after 50 years certain equipment becomes antiquated and justifies distinct treatment due to significant changes in technology, including design standards and the materials used for construction. For example, FRA uses this distinction in the Freight Car Safety Standards in 49 CFR part 215. Part 215 restricts the operation of freight cars that are more than 50 years old, measured by the date of original construction, unless the operating railroad successfully petitions FRA for continued use. This requirement reflects FRA's general belief that after 50 years, freight equipment is typically outdated and often not in the best condition given its years of service. Accordingly, for purposes of safety, FRA believes that after 50 years of age, it should not treat freight equipment the same as newer equipment when used in certain types of service. As an industry practice, cars more than 50 years old are generally used only in limited freight service. However, passenger cars more than 50 years old have been successfully used for commuter service, which, to be clear, is not the type of service identified in part 223 as service for an educational, excursion, recreational, or private transportation purpose.
FRA has applied the term “antiquated equipment” in the enforcement of part 223 consistent with FRA's 1990 Technical Bulletin without significant opposition until industry's response to FRA's implementation of section 415 of the Rail Safety Improvement Act of 2008 (section 415), Public Law 110-432, Division A. Section 415 required the Secretary of Transportation
Following the section 415 study, FRA initiated several enforcement actions against owners of equipment in service that was more than 50 years old, but built after 1945. Many in the rail industry expressed surprise at these enforcement actions and, as a result, filed approximately 175 petitions for waiver from the relevant requirements contained in part 223 with FRA for equipment built after 1945. In addition to requesting relief from part 223, many petitioners argued that based on their understanding of the term “antiquated equipment” as used in part 223 and FRA's enforcement history (
Subsequently, Executive Order 13563 was issued requiring agencies to conduct a retrospective analysis of their existing rules. As noted above, that analysis was intended to identify requirements that may be outmoded, ineffective, insufficient, or excessively burdensome, and lead agencies to modify, streamline, expand, or repeal such rules based on that analysis. During FRA's retrospective analysis of the Safety Glazing Standards, FRA identified the application of its existing interpretation of “antiquated equipment” as potentially creating an unnecessary burden on the industry. The cost of retrofitting all non-compliant equipment built more than 50 years before the current date but after 1945 with compliant glazing would result in a considerable expense to the rail industry, would likely be too costly for some small businesses to continue operating, and would provide a nominal safety benefit. Based on this information, FRA is modifying the term “antiquated equipment” to reduce the burden on the rail industry. FRA believes the use of a rolling 50-year period to determine whether equipment is antiquated significantly reduces the burden on the rail industry by eliminating the cost of fitting equipment that is more than 50 years old and used only for certain purposes with compliant glazing. In other words, FRA believes that the term “antiquated equipment,” for purposes of part 223, should mean equipment that is more than 50 years old, not equipment that was more than 50 years old as of a certain, fixed date.
This clarification also better aligns FRA's Safety Glazing Standards with other Federal rail safety requirements that address older equipment. For example, because of its age and
In addition to clarifying the term “antiquated equipment,” in its comments, ATTRM also states FRA should clarify that the service historic or antiquated equipment operates in may exclude that equipment from the glazing requirements. Specifically, rather than exclude historic or antiquated locomotives used only for excursion, educational, recreational, or private transportation purposes, ATTRM requested that FRA exclude historic or antiquated locomotives that are used primarily in excursion, educational, recreational, or private passenger service and also in other limited types of service. For example, ATTRM stated that a steam locomotive normally used exclusively in mainline excursion service will sometimes be “broken in” in freight service after major mechanical work, to allow problems to be identified and corrected before the locomotive is used for a passenger train. According to ATTRM, a general system tourist railroad might also occasionally use a passenger locomotive on a non-excursion freight train if the railroad's normal freight power is temporarily out of service or unavailable. ATTRM made clear it is not seeking exclusion for locomotives used regularly in freight service but rather for “occasional and irregular” use.
FRA understands that all locomotives (except for a handful of newly built steam locomotives, less than ten total) currently used in excursion service would be considered antiquated based on the revised definition because they are more than 50 years old. However, many locomotives more than 50 years old used in excursion service are also used in other limited types of service but would not be excluded under the proposed rule. As a result, to comply with the proposed rule, affected railroads would need to either equip these locomotives with compliant certified glazing at a significant cost, or forgo using the locomotives for certain types of service and risk losing revenue.
FRA believes the Safety Glazing Standards should not apply to these small number of excursion locomotives that are used for limited non-excursion service when no other power is available. This is a current industry practice for approximately 120 locomotives. FRA's review of its enforcement data confirms that FRA has used its enforcement discretion consistently to permit limited use of such excursion locomotives in non-excursion service without compliant certified glazing. It also reveals that no accidents or incidents have been reported to FRA for the lack of compliant certified glazing materials in these locomotives. Based on a thorough review of this issue, FRA believes the rule can allow this current industry practice without having an adverse impact on rail safety. Therefore, this final rule provides the relief needed to permit these excursion locomotives to operate in incidental freight service, which includes the two specific scenarios ATRRM's comments identified for “antiquated” locomotives otherwise used only for excursion, educational, recreational, or private transportation purposes.
In this final rule, FRA makes clear that incidental freight service would include when an excursion locomotive that is more than 50 years old has finished hauling an excursion train for the day, a couple of freight cars need to be switched on the railroad's property, and no other locomotive is ready to switch the cars. Current industry practice is for the excursion locomotive to switch the freight cars. The alternative would be to start a freight locomotive not in use, conduct the required safety inspection to run it in service, and then use it to switch the freight cars. FRA believes this alternative is too burdensome for industry compared to the low safety risk incurred by using such an excursion locomotive to switch the freight cars—typically short moves conducted at fairly low speeds. This final rule allows the flexibility to use these small number of excursion locomotives as additional power in freight service under such limited circumstances. However, FRA emphasizes that these circumstances are limited. If a freight locomotive is in use and available for service on the property, the exception would not apply. Moreover, FRA expects railroads to have a sufficient number of locomotives available to satisfy their operational needs under ordinary circumstances.
FRA also makes clear that another example of incidental freight service would be breaking-in a steam locomotive more than 50 years old in freight service after major repairs are completed as described by ATRRM. This conditioning service is an opportunity to stress the steam locomotive to ensure the repairs are effective. Excursion operations provide few opportunities for conditioning such locomotives in higher tonnage trains. Moreover, these operations typically have fairly regimented schedules due to seasonal considerations and customer demands. Using these excursion locomotives in freight service for conditioning in this limited manner is also advantageous because freight service is more frequently available. Consequently, FRA is excluding this conditioning service for these older locomotives from the glazing requirements in this final rule. However, FRA intends for the period to be limited to only the time necessary to condition the locomotive for excursion service.
Previous amendments to part 223, which revised the definition of “passenger car” to clarify contemporaneous revisions to the regulation, may have caused some unintentional confusion regarding application of the glazing requirements to “private cars.” In 1998 and 1999, FRA issued comprehensive regulations for intercity passenger and commuter train safety, amending part 223 among other things to add requirements for emergency windows in intercity passenger and commuter trains, which part 223 has long required for passenger cars with certified glazing to facilitate occupant egress.
However, as evidenced by the “Application” section of part 223 (particularly § 223.3(b)(3)), FRA's intent was to continue to apply the glazing requirements of part 223 to private cars as previously specified, as no general exclusion was suggested or made.
As discussed above, AAR's comments request FRA to confirm the glazing requirements in part 223 do not apply to railroad private business cars. Part 223 has not specifically used the term “railroad private business cars,” and AAR's comment does not provide a definition for the term. Based on FRA's experience and discussions with AAR during the Working Group meeting on December 3, 2014, FRA understands that a railroad private business car is a specially modified passenger car or caboose a railroad uses to conduct business and entertain colleagues and guests during transport. Further, FRA understands all but a small handful of railroad private business cars are more than 50 years old. Therefore, based on their age and use, almost all these cars will be excluded from the glazing requirements because of this final rule's clarification of the term “antiquated equipment” discussed in section IV.B, above. Nonetheless, FRA understands AAR's comment to also request that the remaining small handful of cars be excluded from the glazing requirements.
FRA agrees that the remaining railroad private business cars should be excluded from the glazing requirements due to the limited safety risk. Only a small number of invited guests and employees ride these cars and FRA has no record of any accidents or incidents (including injuries) due to the lack of certified glazing materials in these cars. FRA has exercised its discretion to allow railroad private business cars that are not antiquated to operate without certified glazing. Its use of discretion has not had an adverse impact on safety.
Based on a thorough review of this issue, FRA agrees with AAR's comment and in this final rule is excluding from the glazing requirements the remaining small handful of private business cars currently held by railroads that are not equipped with certified glazing. However, railroad private business cars that are currently equipped with certified glazing are required to continue to be equipped with certified glazing to maintain the current level of safety. In addition, all new railroad private business cars must be equipped with certified glazing. Furthermore, if a railroad's private car is used in public service, the exclusion does not apply and the car must be equipped with certified glazing. FRA continues to believe the cost of equipping a new car with certified glazing is worth the safety benefit, including new railroad private business cars.
This rule clarifies application of the emergency window requirements in part 223 to passenger cars more than 50 years old, but built after 1945, by incorporating provisions in waivers FRA's Railroad Safety Board grated (
Specifically, in connection with the change to the application of the term “antiquated equipment,” FRA is revising the language in § 223.3(b) to expressly state the exclusion provided in § 223.3(b)(3) for “antiquated equipment,” for purposes of emergency windows, does not apply to occupied passenger cars built after 1945 when they operate in intercity passenger or commuter train service covered by part 238 (part 238 train).
FRA notes that passenger cars that are not covered by the requirements of part 238 but are occupied for an excursion, educational, recreational, or private purpose, and operate in a passenger train covered by the requirements of part 238, are subject to the same conditions as the train to which they are
Consequently, in clarifying the application of part 223 to “antiquated equipment” by using a rolling 50-year date, rather than a fixed date, FRA believes it must continue requiring passenger cars built after 1945 and more than 50 years old to comply with the emergency window requirements in § 223.9(c) or § 223.15(c) if they are occupied and operate in an intercity or commuter passenger train subject to part 238. FRA does not believe it is appropriate to remove the current requirement that such cars be equipped with these emergency windows, especially as the number of such cars considered “antiquated” will increase due to this rulemaking. However, consistent with the conditions of the waivers FRA has granted, a tool or other instrument may be used to remove or break the window if the tool or other instrument is clearly marked, and legible and understandable instructions are provided for its use. Nonetheless, as discussed in section III.B in response to ATRRM's comment, this final rule does not require a passenger car with windows that open wide enough to permit egress to also be equipped with a tool or implement to use to break or remove a window during an emergency.
In connection with the changes to application of the term “antiquated equipment,” all locomotives, passenger cars, and cabooses more than 50 years old, but built after 1945 and equipped with glazing that complies with the glazing test standards in appendix A to part 223, must continue to comply with those standards. Broadening the definition of the term “antiquated equipment” in this rule does not diminish the level of safety currently required. Accordingly, FRA does not intend for windows currently complying with the impact test standards in appendix A to part 223 to be replaced with windows that are not. Moreover, given that such equipment would already have the necessary framing arrangements in place to support part 223-compliant glazing, FRA expects the window panels to be replaced with like window glazing. Of course, if equipment built after 1945 that is more than 50 years old is not already fitted with compliant window glazing, then such window panels (along with their supporting, framing arrangements) do not have to be installed.
Consistent with the RSAC Task Group's recommendation and to ensure consistent application of the relevant requirements, this rule revises the definition of “end facing glazing location” to clarify that the location means an “exterior” location. It also expressly identifies locations not considered to be “end facing glazing location[s]”—namely, the coupled ends of multiple-unit (MU) locomotives or other equipment that is semi-permanently connected to each other in a train consist; and end doors at locations other than the cab end of a cab car of MU locomotive.
The former definition of “end facing glazing location” in § 223.5 does not specify that “end facing” means only a location at the exterior of a piece of equipment. As a result, the final rule clarifies that FRA does not consider windows facing an open end of a car, but located in the interior of the car, to be end facing. Thus, they do not require Type I glazing. For example, a vestibule door set back from the end frame and corner structure of a passenger car that contains a window does not require Type I glazing for the window. In this example, even if the vestibule window is exposed to the outside of the car, Type I glazing is not required. Type I glazing is not needed because the angle of incidence of a projectile to that window is significantly reduced by the presence of the structures at the end of the car located ahead of the plane of the glazing material, compared to a window aligned with the end frame of the car. Therefore, the likelihood of projectile contact is minimized.
Further, the former definition of “end facing glazing location” contains no qualification on the forward or rear end or the direction of travel of the equipment. In other words, all forward and all rearward facing windows could be considered end facing. This application of the term may have resulted in some confusion about FRA's enforcement of relevant glazing requirements, which FRA intends to clarify in this final rule. Accordingly, this rule revises the definition to clarify the term “end facing glazing location” does not apply to the coupled ends of MU locomotives or other equipment that is semi-permanently connected to each other in a train consist, nor does it apply to end doors at locations other than the cab end of a cab car or MU locomotive. The most notable example of an end door at a location other than the cab end of a cab car or MU locomotive is an end frame door on an Amfleet passenger car. The rule makes clear that windows in such doors do not require Type I glazing.
At the same time, this rule also revises the existing definition of “side facing glazing location” to clarify those locations are excluded from the definition of “end facing glazing location” and require Type II glazing. The former Safety Glazing Standards require that all side facing glazing locations be equipped with Type II glazing.
This final rule also clarifies that any location which, due to curvature of the glazing material, can meet the criteria for either an end facing location or a side facing location shall be considered an end facing location. This is a
This final rule removes outdated, compliance phase-in dates and related language to make the regulation clearer. When the Safety Glazing Standards were published on December 31, 1979, the regulation included compliance dates to phase-in requirements for equipment in existence at the time, in addition to requirements for new equipment.
This section-by-section analysis of this final rule explains the rationale for each section of the rule, together with the above discussion. The regulatory changes are organized by section number.
As discussed in section IV.B of this final rule, FRA is revising paragraph (b)(3) to clarify the meaning of the term “antiquated equipment.” Paragraph (b)(3)(i) clarifies the meaning of “antiquated equipment” by replacing the term “antiquated” with the phrase “more than 50 years old.” This change clarifies that the exclusion from the application of the rule for “antiquated equipment” in this section applies to equipment more than 50 years old measured from the time of original construction. This is a rolling, 50-year calculation, and no longer the fixed date of 1945 or earlier. As such, some of the equipment that was subject to the full requirements of part 223 before this final rule takes effect (because it is not yet more than 50 years old) is excluded from certain requirements when the equipment becomes more than 50 years old. To qualify for the exclusion under paragraph (b)(3)(i), when the equipment becomes more than 50 years old, the rule continues to require that the equipment be used only for excursion, educational, recreational, or private transportation purposes.
As discussed in section IV.C of this final rule, FRA is also revising paragraph (b)(3) to provide some flexibility in application of the glazing requirements to older locomotives used primarily in excursion service. Paragraph (b)(3)(i) also excludes from the glazing requirements locomotives that are historical or more than 50 years old and are used in incidental freight service. Incidental freight service includes operating a steam locomotive for conditioning purposes following major mechanical work and limited use of a passenger locomotive in freight service only when no other locomotive is available. Please note that paragraph (c), discussed below, qualifies the exclusion available under this paragraph (b)(3); both paragraphs must be read together.
As discussed in section IV.E of this final rule, FRA is also revising paragraph (b)(3) to allow existing “business cars” to continue to operate without certified glazing. Paragraph (b)(3)(ii) is added to exclude existing cabooses and passenger cars in a railroad's fleet on April 11, 2016 that are used only for private transportation purposes and are not currently equipped with certified glazing. This change effectively makes the exclusion in paragraph (b)(3)(i) for cabooses and passenger cars that are historic or more than 50 years old and used only for the railroad's private transportation purposes available to all of the railroad's existing cabooses and passenger cars used only for private transportation purposes.
In addition, as FRA proposed in the NPRM, FRA is revising paragraph (b)(4) to correct the reference to § 223.5. Paragraph (b)(4) formerly contained an exclusion for “[l]ocomotives that are used exclusively in designated service as defined in § 223.5(m).” The reference to § 223.5(m) is outdated, as paragraph lettering was removed from § 223.5, Definitions, when that section was reorganized and revised by the May 4, 1998 Passenger Train Emergency Preparedness final rule.
FRA is adding paragraph (c) to clarify the requirements applicable to equipment subject to the exclusion in paragraph (b)(3) of this section for “antiquated equipment,” to maintain safety in connection with the change to the application of this term for equipment built after 1945 but more than 50 years old. As discussed in sections IV.F and IV.H of this final rule, FRA is clarifying requirements for emergency windows in occupied passenger cars operated in intercity passenger or commuter trains, as well as clarifying requirements for locomotives, passenger cars, and cabooses currently equipped with compliant glazing. Paragraph (c) applies, as specified, to each locomotive, passenger car, and caboose built after 1945 more than 50 years old and used only for excursion, educational, recreational, or private transportation purposes. Specifically, paragraph (c)(1) requires each such passenger car to comply with the emergency window requirements contained in § 223.9(c) or § 223.15(c), as appropriate, when it is occupied and operates in an intercity passenger or commuter train subject to part 238 of this chapter. A tool or other instrument may be used to remove or break an emergency window if the tool or other instrument is clearly marked and legible and understandable instructions are provided for its use. Paragraph (c)(2) requires each such locomotive, passenger car, and caboose that is equipped with glazing that complies with the glazing requirements contained in appendix A to this part as of February 9, 2016, to remain in compliance with those requirements. Accordingly, the final rule will not diminish the level of safety the regulation currently provides.
FRA is revising three terms in this section: “end facing glazing location,” “passenger car,” and “side facing glazing location.” FRA is also defining “incidental freight service.”
Specifically, FRA is revising the definition of “end facing glazing location” by making clear the location means an “exterior” location and that dome and observation cars are included in the category of cars subject to the application of this definition, and by expressly identifying locations not considered “end facing glazing location[s].” The definition clearly excludes the coupled ends of MU locomotives or other equipment that is semi-permanently connected to each other in a train consist, and end doors
FRA is adopting the changes to this definition as proposed in the NPRM but also makes clear the definition continues to provide that any location which, due to curvature of the glazing material, can meet the criteria for either an end facing location or a side facing location is considered an end facing location. This provision applies unless the location is otherwise excluded from this definition. FRA also notes that in the final rule this provision uses the more general term “end facing” location rather than “front facing” location consistent with the use of “end facing” glazing location in this final rule.
In addition, this rule revises the definition of “side facing glazing location.” The definition now includes the coupled ends of MU locomotives or other equipment that is semi-permanently connected to each other in a train consist, and end doors at locations other than the cab end of a cab car or MU locomotive. Instead of considering such locations to be end facing glazing locations requiring Type I glazing, these locations are considered side facing glazing locations requiring only Type II glazing due to the generally lower risk of an exterior projectile impacting the window surface.
In addition, this rule revises the definition of “passenger car” by removing the statement that “[t]his term does not include a private car.” The revision clarifies that a private car can be considered a passenger car. Please see section IV.D of this final rule for a full discussion of this change.
Finally, FRA is adding the term “incidental freight service” to mean the occasional and irregular use of a locomotive in freight service that is more than 50 years old and used primarily for excursion, educational, recreational, or private transportation purposes. Please see the discussion in section III.B and IV.C of this final rule, above.
As discussed in section IV.I of this final rule, the amendments to this section remove the compliance phase-in dates and related language from the glazing requirements for existing locomotives. As noted above, part 223 phased in requirements for glazing standards by generally allowing the rail industry until June 30, 1984, to fit their existing locomotives with compliant glazing. The rule included an exception for locomotives that had their windows damaged by vandalism. Windows damaged due to vandalism were required to be replaced with compliant glazing sooner than the 1984 compliance phase-in date.
Paragraph (c) removes the compliance phase-in date, June 30, 1984. This date is no longer needed now that it has long passed. Paragraph (d) removes the language that required windows damaged by vandalism to be replaced with compliant glazing sooner than the 1984 compliance phase-in date. This requirement is no longer needed because the compliance phase-in period has long passed and all existing locomotives, other than yard locomotives excluded by this section or locomotives that satisfy the limited exclusions provided in § 223.3, are required to be equipped with compliant glazing.
No comments were received on this section and FRA accordingly adopts the changes to this section as proposed but further clarifies that existing yard locomotives continue to be excluded from the section's requirements. FRA's proposal may have inadvertently created an ambiguity whether this section's longstanding exception for existing yard locomotives continues to apply.
As discussed in section IV.I of this final rule, the amendments to this section remove the compliance phase-in dates and related language from the glazing requirements related to existing cabooses. As noted above, part 223 phased in requirements for glazing standards by generally allowing the rail industry until June 30, 1984, to fit their existing cabooses with compliant glazing. The rule included an exception for cabooses that had their windows damaged by vandalism. Windows damaged by vandalism were required to be replaced with compliant glazing sooner than the 1984 compliance phase-in date.
Paragraph (c) removes the compliance phase-in date, June 30, 1984. This date is no longer needed now that it has long passed. Paragraph (d) removes the language that required windows damaged by vandalism to be replaced with compliant glazing sooner than the 1984 compliance phase-in date. This requirement is no longer needed because the compliance phase-in period has long passed and all cabooses, other than yard cabooses excluded by this section or those that satisfy the limited exclusions provided in § 223.3, are required to be equipped with compliant glazing.
FRA expressly invited comment on the NPRM on whether it needed to retain this section in the final rule and specifically whether its requirements could be consolidated with those for new cabooses in § 223.9(b) in a revised or new section. No comments were received on this issue and this final rule makes no change to § 223.9(b). No comments were received on § 223.13 and FRA accordingly adopts the changes to § 223.13 as proposed but clarifies that existing yard cabooses continue to be excluded from § 223.13's requirements. FRA's proposal may have inadvertently created an ambiguity whether § 223.13's longstanding exception for existing yard cabooses continues to apply.
As discussed in section IV.I of this final rule, the amendments to this section remove the compliance phase-in dates and related language from the glazing requirements for existing passenger cars. As noted above, before these changes the rule generally allowed the rail industry until June 30, 1984, to fit their existing passenger cars with compliant glazing. Windows damaged by vandalism were required to be replaced with compliant glazing sooner than the 1984 compliance phase-in date.
Paragraph (c) removes the compliance phase-in date, June 30, 1984. This date is no longer needed now that it has long passed. Paragraph (d) removes the language that required windows damaged by vandalism to be replaced with compliant glazing sooner than the 1984 compliance phase-in date. This requirement is no longer needed because the compliance phase-in period has long passed and all passenger cars, other than those that satisfy the limited exclusions provided in § 223.3, are required to be equipped with compliant glazing.
FRA expressly invited comment on the NPRM on whether it needed to retain this section needed in the final rule and specifically whether its requirements could be consolidated with those for new passenger cars in § 223.9(c) in a revised or new section. No comments were received on this issue and this final rule makes no change to § 223.9(c). No comments were received on § 223.15 and FRA
Section § 223.17 required stenciling on the interior wall of each locomotive cab, passenger car, and caboose to identify that the equipment is fully equipped with glazing material that complies with part 223. This requirement is no longer necessary, and the final rule removes this entire section. As a result, this type of stenciling is no longer required. For a full discussion of this change, please see section IV.A of this final rule.
Appendix B to part 223 contains a schedule of civil penalties for FRA to use to enforce this part. FRA is revising the schedule of civil penalties in this final rule to reflect revisions made to part 223. Because such penalty schedules are statements of agency policy, notice and comment are not required before they are issued.
This final rule has been evaluated consistent with Executive Order 12866 (Regulatory Planning and Review), Executive Order 13563 (Improving Regulation and Regulatory Review), and DOT policies and procedures. FRA has prepared and placed in the docket a regulatory analysis addressing the economic impact of this final rule. FRA believes this final rule is consistent with current industry practices and reduces the regulatory burden on the rail industry.
The analysis includes a quantitative evaluation of the benefits of this final rule. For entities choosing to take advantage of the new flexibilities and cost savings provided in this final rule, FRA estimates there may be a minimal cost burden associated with this rule. Specifically, railroads or car owners or operators may need to purchase small hammers or other tools for occupants to use to break windows for emergency egress in passenger cars now considered “antiquated equipment,” because they were built after 1945 and are more than 50 years old, when these passenger cars are operated in intercity passenger or commuter trains. Additionally, railroads will probably modify existing specifications for new equipment orders to remove the requirement to stencil interior walls of the equipment as containing window glazing in full compliance with part 223. The present value of total voluntary costs affected entities may incur is estimated to be approximately $6,000 over a 10-year period.
Overall, the benefits of this rule greatly outweigh any costs that may be incurred. The revisions specified in this final rule eliminate the cost of stenciling, reduce the cost of certain new passenger cars, and reduce the number of waivers requested by the railroad industry. Over a 10-year period, this analysis finds that $1,088,489 in cost savings will accrue due to the changes. The present value of this amount is $819,479 (discounted at 7 percent). Therefore, accounting for the $6,000 in voluntarily-incurred costs to take advantage of the flexibilities provided in this final rule, the net savings of this rule is approximately $813,479.
FRA is eliminating the requirement to stencil the inside walls of locomotives, passenger cars, and cabooses as fully equipped with compliant glazing. This requirement was necessary during the implementation phase-in period of part 223 (in the 1980s), when large numbers of affected equipment were not equipped with glazing required by part 223. The stencil was a clear and easy way to determine whether compliant glazing was installed. Because the phase-in period for fitting equipment with certified glazing under part 223 has long passed, the required certification markings on the window panels have become more useful and reliable for FRA to determine compliance with part 223. The total annual cost for all affected entities to comply with the stenciling requirement is from $74,170 (Year 1) to $80,820 (Year 10) (non-discounted). This variability is due to the increase in real wages discussed in section 6 of the accompanying analysis in the docket for this rulemaking. Consequently, over a 10-year period, the analysis finds that a total of $773,841 in cost savings will accrue through the elimination of this requirement. The present value of this amount is $578,494 (discounted at 7 percent).
This rule revises definitions to help provide clarity to the rail industry and also greater consistency with other FRA regulations. Antiquated equipment will now be defined as equipment that is more than 50 years old. This significantly reduces the number of waiver petitions submitted to exclude from the glazing requirements equipment that is more than 50 years old but built after 1945 and operated in a train for an excursion, educational, recreational, or private transportation purpose. Based on past practice, FRA estimates it would have received approximately 140 initial waiver requests over the next five years (28 per year) if this rule were not issued. FRA is estimating the potential waivers that will no longer be needed over a five-year period because renewal waivers would have been needed every five years to avoid installing certified glazing. Therefore, no additional waiver applications would be expected after the fifth year. In years when the initial waiver petitions would have been submitted if this rule were not issued, the total annual cost for all affected entities would have been from $16,507 (Year 1) to $16,921 (Year 10) (non-discounted). This variability is due to the increase in real wages as discussed in section 6 of the accompanying analysis in the docket for this rulemaking. Accordingly, a total of $83,563 in cost savings will accrue over 10 years due to the reduction of initial waiver requests. The present value of this amount is $73,260 (discounted at 7 percent).
FRA has approved approximately 310 waivers of glazing requirements for equipment more than 50 years old but manufactured after 1945 and operated in a train for an excursion, educational, recreational, or private transportation purpose. If the final rule was not issued, renewal waivers would be required to be submitted every five years to continue operations. Under this final rule, these waivers are no longer necessary, saving the labor cost of preparing and submitting each waiver renewal request. The total annual cost for all affected entities to submit renewal waiver petitions would have increased from $18,275 (Year 1) to $28,066 (Year 10) (non-discounted) if this rule were not issued. This variability is due to the rise in real wages discussed in section 6 of the accompanying analysis this rulemaking's docket. Over a 10-year period, a total of $231,084 in cost savings will therefore accrue due to the reduction of renewal waivers. The present value of this amount is $167,725 (discounted at 7 percent).
FRA notes it is revising the definition of the term “end facing glazing location” to clarify the location means
FRA expressly requested comments on all aspects of the regulatory evaluation and its conclusions. No comments were received in response to FRA's request.
The Regulatory Flexibility Act of 1980 (RFA), Public Law 96-354, as amended, and codified as amended at 5 U.S.C. 601-612, and Executive Order 13272 (Proper Consideration of Small Entities in Agency Rulemaking), 67 FR 53461, Aug. 16, 2002, require agency review of proposed and final rules to assess their impact on “small entities” for purposes of the RFA. An agency must prepare a regulatory flexibility analysis unless it determines and certifies that a rule is not expected to have a significant economic impact on a substantial number of small entities. Pursuant to the RFA, 5 U.S.C. 605(b), the Administrator of FRA certifies that this final rule will not have a significant economic impact on a substantial number of small entities. This rule will affect small entities. However, the effect on these entities will be purely beneficial other than for a nominal cost savings offset, as it will reduce their costs and labor burden particularly by narrowing the class of equipment subject to the full requirements of the Safety Glazing Standards regulation.
The term “small entity” is defined in 5 U.S.C. 601 (section 601). Section 601(6) defines “small entity” as having the same meaning as “the terms `small business', `small organization' and `small governmental jurisdiction' defined in paragraphs (3), (4), and (5) of this section.” In turn, section 601(3) defines a “small business” as generally having the same meaning as “small business concern” under section 3 of the Small Business Act. This includes any small business concern that is independently owned and operated, and is not dominant in its field of operation. Next, section 601(4) defines “small organization” as generally meaning any not-for-profit enterprise that is independently owned and operated, and not dominant in its field of operations. Additionally, section 601(5) defines “small governmental jurisdiction” in general to include governments of cities, counties, towns, townships, villages, school districts, or special districts with populations less than 50,000.
The U.S. Small Business Administration (SBA) stipulates “size standards” for small entities. A for-profit railroad business firm may be considered a small entity if it has less than 1,500 employees for “Line-Haul Operating” railroads, and 500 employees for “Short-Line Operating” railroads.
Under exceptions provided in section 601, Federal agencies may adopt their own size standards for small entities in consultation with SBA, and in conjunction with public comment. Under the authority provided to it by SBA, FRA has published a “Final Policy Statement Concerning Small Entities Subject to the Railroad Safety Laws,” which formally establishes small entities as including, among others, the following: (1) The railroads classified by the Surface Transportation Board as Class III; and (2) commuter railroads “that serve populations of 50,000 or less.”
FRA defined `small entity,' for the purpose of communication and enforcement policies, the Regulatory Flexibility Act, 5 U.S.C. 601
68 FR 24892, May 9, 2003. “The Final Policy Statement issued today is substantially the same as the Interim Policy Statement.” 68 FR 24894.
Class I—$250 million or more;
Class II—more than $20 million, but less than $250 million; and
Class III—$20 million or less.
49 CFR 1201.1-1(a), (b)(1). STB's General Instructions at 1-1 state that carriers are grouped into three classes for purposes of accounting and reporting. The three classes are as follows:
Class I: These carriers have annual carrier operating revenues of $250 million or more after applying STB's railroad revenue deflator formula.
Class II: These carriers have annual carrier operating revenues of less than $250 million but in excess of $20 million after applying STB's railroad revenue deflator formula.
Class III: These carriers have annual carrier operating revenues of $20 million or less after applying STB's railroad revenue deflator formula.
FRA estimates that there are 726 railroads that operate on standard gage track that is part of the general railroad system of transportation and are, therefore, subject to part 223, see 49 CFR 223.3. Of these railroads, 44 are Class I freight railroads, Class II freight railroads, commuter railroads serving populations of 50,000 or more, or intercity passenger railroads (
Small railroads and private car owners will likely be affected by the clarification that certain equipment more than 50 years old is considered antiquated and thereby excluded from part 223's requirements when operated in specified service. As a result of this change, the economic burden of preparing and submitting waiver petitions will be reduced for railroads and private car owners for equipment that is more than 50 years old but built after 1945 and operated in a train for an excursion, educational, recreational, or private transportation purpose. As noted above, FRA estimates that it would
Further, for entities choosing to take advantage of the regulatory relief permitted by this change to the definition of “antiquated equipment,” FRA estimates that there may be a minimal cost burden associated with operation of such passenger cars in intercity passenger or commuter service, because they will continue to be required to have emergency windows. Some affected entities may choose to install small hammers or other small tools or implements to allow for emergency egress from passenger car windows when operated in an intercity passenger or commuter train. Hammers may be used to break these windows in case of an emergency. The population of private cars that operate in Amtrak trains is approximately 125 cars. FRA estimates that 80 percent of these cars will not have hammers or other tools already on board to facilitate emergency egress through windows. Therefore, for 100 of those private cars, car owners will have to purchase four hammers or other tools per car. That total cost will be approximately $5,000. Additionally, a minimal cost to copy and laminate instructions to use the hammers or other tools will also be incurred. FRA estimates this total cost to be $1,000 (approximately $10 per car). All these costs will be incurred during the first year. Therefore, the present value of all total costs is approximately $6,000. This $6,000 cost will easily be offset by the total cost savings of $240,985 from changing the definition of “antiquated equipment,” which is shared among all small entities. Consequently, FRA concludes this final rule will not have a significant economic impact on a substantial number of small entities.
FRA certifies that this final rule is not expected to have a significant economic impact on a substantial number of small entities under the RFA or Executive Order 13272. Although a substantial number of small entities will be affected by this rule, none of these entities will be significantly impacted. In order to determine the significance of the economic impact for the final rule's RFA requirements, FRA expressly invited comments on the NPRM from all interested parties concerning the potential economic impact on small entities resulting from the rule. FRA did not receive comments on this issue.
FRA is submitting the information collection requirements in this final rule for review and approval to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
All estimates include the time for reviewing instructions; searching existing data sources; gathering or maintaining the needed data; and reviewing the information. For information or a copy of the paperwork package submitted to OMB, contact Mr. Robert Brogan, Information Clearance Officer, Office of Railroad Safety, FRA, at 202-493-6292, or Ms. Kimberly Toone, FRA Records Management Officer, Office of Information Technology, FRA, at 202-493-6132, or via email at the following addresses:
Organizations and individuals desiring to submit comments on the collection of information requirements should send them directly to the Office of Management and Budget, Office of Information and Regulatory Affairs, Washington, DC 20503, Attention: FRA Desk Officer. Comments may also be sent via email to the Office of Management and Budget at the following address:
OMB is required to make a decision concerning the collection of information requirements contained in this final rule between 30 and 60 days after publication of this document in the
FRA cannot impose a penalty on persons for violating information collection requirements which do not display a current OMB control number, if required. FRA intends to obtain current OMB control numbers for new information collection requirements resulting from this rulemaking action prior to the effective date of this final rule. The OMB control number, when assigned, will be announced by separate notice in the
Executive Order 13132, “Federalism” (64 FR 43255, Aug. 10, 1999), requires FRA to develop an accountable process to ensure “meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.” “Policies that have federalism implications” are defined in the Executive Order to include regulations that have “substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.” Under Executive Order 13132, an agency may not issue a regulation with federalism implications that imposes substantial direct compliance costs and that is not required by statute, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by State and local governments, or the agency consults with State and local government officials early in the process of developing the regulation. Where a regulation has federalism implications and preempts State law, the agency seeks to consult with State and local officials in the process of developing the regulation.
FRA has analyzed this rule under the principles and criteria in Executive Order 13132. This rule will not have a substantial effect on the States or their political subdivisions, and it will not affect the relationships between the Federal government and the States or their political subdivisions, or the distribution of power and responsibilities among the various levels of government. In addition, FRA determined this regulatory action will not impose substantial direct compliance costs on States or their political subdivisions. Therefore, the consultation and funding requirements of Executive Order 13132 do not apply. Nevertheless, State and local officials were involved in developing recommendations that are addressed in this rule through the RSAC, which has as permanent members two organizations directly representing State and local interests, AASHTO and ASRSM.
However, this rule could have preemptive effect by operation of law under certain provisions of the Federal railroad safety statutes, specifically the former Federal Railroad Safety Act of 1970, repealed and re-codified at 49 U.S.C 20106, and the former Locomotive Boiler Inspection Act (LIA) at 45 U.S.C. 22-34, repealed and re-codified at 49 U.S.C. 20701-20703. Section 20106 provides that States may not adopt or continue in effect any law, regulation, or order related to railroad safety or security that covers the subject matter of a regulation prescribed or order issued by the Secretary of Transportation (with respect to railroad safety matters) or the Secretary of Homeland Security (with respect to railroad security matters), except when the State law, regulation, or order qualifies under the “essentially local safety or security hazard” exception to section 20106. Moreover, the Supreme Court has interpreted the former LIA to preempt the field of locomotive safety.
FRA has evaluated this final rule under the National Environmental Policy Act (NEPA; 42 U.S.C. 4321
In analyzing the applicability of a CE, the agency must also consider whether extraordinary circumstances are present that would warrant a more detailed environmental review through the preparation of an EA or EIS.
Executive Order 12898, Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations, and DOT Order 5610.2(a) (91 FR 27534, May 10, 2012) require DOT agencies to achieve environmental justice as part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects, including interrelated social and economic effects, of their programs, policies, and activities on minority populations and low-income populations. The DOT Order instructs DOT agencies to address compliance with Executive Order 12898 and requirements within the DOT Order in rulemaking activities, as appropriate. FRA has evaluated this final rule under Executive Order 12898 and the DOT Order and determined it will not cause disproportionately high and adverse human health and environmental effects on minority populations or low-income populations.
FRA has evaluated this final rule under the principles and criteria contained in Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, dated November 6, 2000. This final rule will not have a substantial direct effect on one or more Indian tribes, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal laws. Therefore, the funding and consultation requirements of Executive Order 13175 do not apply, and a tribal summary impact statement is not required.
Under Section 201 of the Unfunded Mandates Reform Act of 1995 (Public Law 104-4, 2 U.S.C. 1531), each Federal agency “shall, unless otherwise prohibited by law, assess the effects of Federal regulatory actions on State, local, and tribal governments, and the private sector (other than to the extent that such regulations incorporate requirements specifically set forth in law).” Section 202 of the Act (2 U.S.C. 1532) further requires that “before promulgating any general notice of proposed rulemaking that is likely to result in the promulgation of any rule that includes any Federal mandate that may result in expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any 1 year, and before promulgating any final rule for which a general notice of proposed rulemaking was published, the agency shall prepare a written statement” detailing the effect on State, local, and tribal governments and the private sector. When adjusted for inflation using the Consumer Price Index for All Urban Consumers as published by the Bureau of Labor Statistics, the equivalent value of $100,000,000 in year 2014 dollars is $155,000,000.
FRA wishes to inform all interested parties that anyone is able to search the electronic form of any written communications and comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). See
Glazing standards, Penalties, Railroad safety, Reporting and recordkeeping requirements.
For the reasons discussed in the preamble, FRA amends part 223 of chapter II, subtitle B of title 49, Code of Federal Regulations, as follows:
49 U.S.C. 20102-20103, 20133, 20701-20702, 21301-21302, 21304; 28 U.S.C. 2461, note; and 49 CFR 1.89.
(b) * * *
(3) Except as provided in paragraph (c) of this section:
(i) Locomotives, cabooses, and passenger cars that are historic or more than 50 years old and, except for incidental freight service, are used only for excursion, educational, recreational, or private transportation purposes; and
(ii) Cabooses and passenger cars in a railroad's fleet on April 11, 2016 that are used only for the railroad's private transportation purposes. Each such railroad caboose or car that is equipped with glazing that complies with the glazing requirements contained in appendix A to this part as of February 9, 2016, must remain in compliance with those requirements.
(4) Locomotives that are used exclusively in designated service as defined in § 223.5.
(c) Except as provided in paragraph (b)(3) of this section, this paragraph (c) applies, as specified, to each locomotive, passenger car, and caboose built after 1945 that is more than 50 years old and is used only for excursion, educational, recreational, or private transportation purposes.
(1) Each such passenger car must comply with the emergency window requirements contained in § 223.9(c) or § 223.15(c), as appropriate, when it is occupied and operates in an intercity passenger or commuter train subject to part 238 of this chapter. A tool or other instrument may be used to remove or break an emergency window if the tool or other instrument is clearly marked and legible and understandable instructions are provided for its use.
(2) Each such locomotive, passenger car, and caboose that is equipped with glazing that complies with the glazing requirements contained in appendix A to this part as of February 9, 2016, must remain in compliance with those requirements.
(c) Except for yard locomotives and locomotives equipped as described in paragraphs (a) and (b) of this section, locomotives built or rebuilt prior to July 1, 1980, shall be equipped with certified glazing in all locomotive cab windows.
(d) Except for yard locomotives, each locomotive that has a locomotive cab window that is broken or damaged so that the window fails to permit good visibility shall be—
(1) Placed in Designated Service within 48 hours of the time of breakage or damage; or
(2) Removed from service until the broken or damaged window is replaced with certified glazing.
(c) Except for yard cabooses and cabooses equipped as described in paragraphs (a) and (b) of this section, cabooses built or rebuilt prior to July 1, 1980, shall be equipped with certified glazing in all windows.
(d) Except for yard cabooses, each caboose that has a window that is broken or damaged so that the window fails to permit good visibility shall be removed from service until the broken or damaged window is replaced with certified glazing.
(c) Except for passenger cars described in paragraphs (a) and (b) of this section, passenger cars built or rebuilt prior to July 1, 1980, shall be equipped with certified glazing in all windows and a minimum of four emergency windows.
(d) Each passenger car that has a window that is broken or damaged so that the window fails to permit good visibility shall be removed from service until the broken or damaged window is replaced with certified glazing.
Bureau of Industry and Security, Department of Commerce.
Proposed rule.
This proposed rule would modify the Commerce Control List (CCL) entries for two types of items: Military aircraft and related items, and military gas turbine engines and related items. The rule would add clarifying text to the descriptions of the types of military aircraft controlled on the CCL. The lists of items that are subject only to the anti-terrorism reason for control would be clarified and expanded. This proposed rule is based on a review of the military aircraft and gas turbine engine related entries that were added to the CCL on October 15, 2013. That review was intended to ensure that the regulatory changes made by the October 15, 2013 rule are clear, do not inadvertently control items in normal commercial use, account for technological developments, and properly implement the national security and foreign policy objectives of the export control reform effort. This proposed rule is being published simultaneously with a proposed rule by the Department of State, which is based on a review of Categories VIII and XIX of the United States Munitions List (USML). This document also furthers the retrospective regulatory review directed by the President in Executive Order 13563.
Comments must be received by March 25, 2016.
You may submit comments by any of the following methods:
•
• By email directly to
• By mail or delivery to Regulatory Policy Division, Bureau of Industry and Security, U.S. Department of Commerce, Room 2099B, 14th Street and Pennsylvania Avenue NW., Washington, DC 20230. Refer to RIN 0694-AG76.
Thomas DeFee or Jeffrey Leitz in the Office of Strategic Industries and Economic Security, Munitions Control Division by telephone at (202) 482-4506 or by email at
The Bureau of Industry and Security (BIS), Department of Commerce maintains the Export Administration Regulations (EAR), including the Commerce Control List (CCL). The Export Control Reform (ECR) Initiative, a fundamental reform of the U.S. export control system announced by the President in 2010, has resulted in transfer to the CCL of items that the President has determined do not warrant control on the United States Munitions List (USML), including certain military aircraft, military gas turbine engines, and related items. The USML is part of the International Traffic in Arms Regulations (ITAR) maintained by the Department of State.
All references to the USML in this rule are to the list of defense articles that are controlled for the purpose of export or temporary import pursuant to the ITAR, and not to the defense articles on the USML that are controlled by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for the purpose of permanent import under its regulations (see 27 CFR part 447). Pursuant to § 38(a)(1) of the Arms Export Control Act (AECA), all defense articles controlled for export or import are part of the USML under the AECA. For the sake of clarity, the list of defense articles controlled by ATF for the purpose of permanent import is the United States Munitions Import List (USMIL). The transfer of defense articles from the ITAR's USML to the EAR's CCL for the purpose of export control does not affect the list of defense articles controlled on the USMIL under the AECA for the purpose of permanent import.
A core element of the ECR Initiative has been the streamlining of categories on the USML and the control on the CCL of items that the President determines do not warrant USML control. On December 10, 2010, the Department of State provided notice to the public of its intent, pursuant to the ECR Initiative, to revise the USML to create a more “positive list” that describes controlled items using, to the extent possible, objective criteria rather than broad, open-ended, subjective, or design intent-based criteria (
The advantage of revising the USML into a more positive list is that its controls can be tailored to satisfy the national security and foreign policy objectives of the ITAR by maintaining control over those defense articles that provide a critical military or intelligence advantage, or otherwise warrant control under the ITAR, without inadvertently controlling items in normal commercial use. This approach, however, requires that both the USML and the CCL be regularly revised and updated to account for technological developments, practical application issues identified
As part of the ECR Initiative, certain military aircraft and gas turbine engines along with related parts, components, accessories and attachments, materials, software and technology were added to the CCL on October 15, 2013 (
In 2015, the Departments of Defense, State and Commerce reviewed the implementation of these changes to ascertain the effectiveness and utility of the 2013 amendments. That review included soliciting public comments by the Department of Commerce (
This notice also furthers the retrospective regulatory review directed by the President in Executive Order 13563.
A note stating that forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacturing where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by the ECCN in which the note appears (or by specified paragraphs in that ECCN) are controlled by that ECCN. BIS intends that the policy set forth in these notes apply to all commodities that are controlled in all 600 series Product Group A ECCNs. Accordingly this rule would add the following text as a new interpretation in § 770.2:
Forgings, castings, and other unfinished products, such as extrusions and machined bodies, that have reached a stage in manufacturing where they are clearly identifiable by mechanical properties, material composition, geometry, or function as commodities controlled by any Product Group A (“End Items,” “Equipment,” “Accessories,” “Attachments,” “Parts,” “Components” and “Systems”) “600 series” ECCN are controlled in that “600 series” ECCN.
As a conforming change, the individual notes would be removed from ECCNs 0A604, 0A614, 3A611, 9A604 and 9A619. This change, which would merely eliminate the potential for redundancies in the EAR, is not a substantive change.
This proposed rule would remove text currently in the “Control(s)” table that excludes paragraphs .t, .u, .v and .w from national security controls. Although the text of those paragraphs is taken from the Missile Technology Control Regime Annex, the commodities that they control are unmanned aerial vehicle parts, components or associated equipment that also are subject to category ML10 on the Munitions List of the Wassenaar Arrangement on Export Controls for Conventional Arms and Dual-Use Goods and Technologies. The addition of the national security controls would not increase the number of destinations to which a license is required for the commodities controlled by these paragraphs as those paragraphs already have missile technology and regional stability controls.
This proposed rule also would revise the text of the “Controls” table so that the national security and regional stability reasons for control would not apply to L100 aircraft manufactured prior to 2013 or to specially designed parts and components for L100 aircraft controlled in paragraph .x. This change is to make the reasons for control that apply to pre 2013 L100 aircraft and parts consistent with the reasons for control that applied to them historically under ECCN 9A991.
The “Related Controls” paragraph of ECCN 9A610 would be expanded to refer to USML Category XIX and ECCN 9A619 for controls on military aircraft engines and related items.
The “Items” paragraph of ECCN 9A610 would be revised to clarify that the aircraft listed in Note 1 to paragraph .a are examples of aircraft types controlled in that paragraph whereas the substantive criteria for control in paragraph .a is that the aircraft be “specially designed” for a military use and not enumerated in USML Category VIII(a).
A new paragraph .b would be added to control L100 aircraft manufactured prior to 2013 to implement the limited applicability of national security and regional stability controls to these aircraft as described above.
A new paragraph .e would be added to control mobile aircraft arresting and engagement systems for aircraft controlled in either USML Category VIII(a) or ECCN 9A610.a.
Existing paragraph .f, which controls ground equipment specially designed for military aircraft, would be revised to incorporate into the paragraph text, the illustrative list currently in the technical note.
BIS is not proposing any changes to paragraphs .g through .s.
Paragraphs .t, .u, .v and .w would continue to control certain unmanned aerial vehicle parts, components and associated equipment. The text of these paragraphs is drawn from the Missile Technology Regime Annex and specifies range capability (paragraphs .t and .u) or range and payload capability (paragraphs .v and .w). This proposed rule would leave the control text of those paragraphs unchanged, but would add a note to each paragraph to make clear that commodities that do not meet the range or range and payload parameters specified are controlled in the “catch all” paragraph .x, which applies to parts, components, accessories and attachments specially designed for commodities in ECCN 9A610 or USML Category VIII that are not elsewhere specified. The addition of these notes would not be a substantive change.
This rule would make several changes to paragraph .y of ECCN 9A610. Paragraph .y.2, which currently applies to cockpit analog gauges and indicators, would apply to such gauges and indicators wherever they are located on the aircraft. Paragraph .y.8 would apply to all types of fluid filters and filter assemblies—not just hydraulic, oil and fuel system filters and filter assemblies. Paragraph .y.10 would be expanded to apply to fluid hoses, straight and unbent lines, fittings, couplings, clamps and brackets. Paragraph .y.15 would be expanded to cover mirrors whether located in the cockpit or cabin instead of just the cockpit as is now the case. Paragraph .y.20 would be made more precise to cover underwater locator beacons instead of underwater beacons as the text reads now. There are many types of underwater beacons. However, the underwater beacons installed on aircraft generally are designed to facilitate locating the aircraft if it crashes in the water. BIS's intent is to cover only the latter types of beacons. The word “cockpit” would be removed from paragraph .y.23, making filtered and unfiltered panel knobs, indicators, switches, buttons, and dials controlled by paragraph .y.23 wherever on the aircraft they are located.
Paragraphs .y.31 and .y.32 would be added to cover identification plates and fluid manifolds, respectively.
This rule would make three additions to the “Related Controls” paragraph.
Paragraph .y.3 would be expanded to apply to fluid hoses, straight and unbent lines, fittings, couplings, clamps and brackets, instead of only fuel lines and hoses, as is now the case.
Paragraph .y.4 would be expanded to cover fluid filters and filter assemblies, instead of only fuel and oil filters, as is now the case.
Paragraph .y.5 would be revised to remove “V-band, cushion, broomstick, hinged, and loop clamps” from paragraph .y.5, because they would be subsumed in the reference to “clamps” in paragraph .y.3, and add check valves for hydraulic and pneumatic systems in its place. Such valves for aircraft are covered in ECCN 9A610.y.4. Controlling them under a .y paragraph when used in gas turbine engines adds consistency, particularly with respect to check valves used in aircraft gas turbine engines.
The existing text of paragraph .y.8—air, fuel and oil manifolds—would be changed to “fluid manifolds.”
ECCN 9C610 would be revised by adding references to USML Category VIII in both the heading and in paragraph .a, to make clear that materials specially designed for commodities enumerated or otherwise described in that category are controlled in ECCN 9C610.
ECCN 9C619 would be revised by adding references to USML Category XIX in both the heading and in paragraph .a, to make clear that materials specially designed for commodities enumerated or otherwise described in that category are controlled in ECCN 9C619.
The related controls paragraph in ECCN 9E619 would be amended by removing the sentence that reads “Technology described in ECCN 9E003 is controlled by that ECCN.” Although true, the placement of the sentence in a 600 series ECCN could mislead readers into thinking that the order of review does not apply in this instance.
Since August 21, 2001, the Export Administration Act of 1979, as amended, has been in lapse. However, the President, through Executive Order 13222 of August 17, 2001, 3 CFR, 2001 Comp., p. 783 (2002), as amended by Executive Order 13637 of March 8, 2013, 78 FR 16129 (March 13, 2013), and as extended by the Notice of August 7, 2015, 80 FR 48233 (August 11, 2015) has continued the EAR in effect under the International Emergency Economic Powers Act. BIS continues to carry out the provisions of the Export Administration Act, as appropriate and to the extent permitted by law, pursuant to Executive Order 13222 as amended by Executive Order 13637.
1. Executive Orders 13563 and 12866 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distribute impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget (OMB).
2. Notwithstanding any other provision of law, no person is required to respond to, nor is subject to a penalty for failure to comply with, a collection of information, subject to the requirements of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
3. This rule does not contain policies with Federalism implications as that term is defined under E.O. 13132.
4. The Regulatory Flexibility Act (RFA), as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (SBREFA), 5 U.S.C. 601
The Bureau of Industry and Security (BIS) does not collect data on the size of entities that apply for and are issued export licenses. Although BIS is unable to estimate the exact number of small entities that would be affected by this
This proposed rule is part of a review of rules promulgated as part of the Export Control Reform Initiative to assess whether rules for transferring items from the United States are clear, workable and do not inadvertently control on the USML or in 600 series ECCNs items in normal commercial use. Consistent with the goals of that review, this proposed rule would reduce the level of control on some items and clarify the control status of other items. It does not impose any new export or reexport license requirements.
Several proposed changes would reduce the level of control on some minor parts and components such as check valves, fluid manifolds, identification plates, analog gauges and mirrors used on aircraft so that they will require a license only to eight countries rather than all destinations other than Canada as they do currently.
Other proposed changes would clarify that certain aircraft and parts, components, accessories and attachments that historically have been subject to the EAR, but that, under rules published by BIS and the Department of State as part of the Export Control Reform Initiative, were added to the International Traffic in Arms Regulations would again be subject to the EAR.
The remaining changes would provide clarifying text or additional cross references that would not change any requirements that apply to any person under the regulations.
Changing the jurisdictional status of an item from the USML to the CCL would reduce the burden on small entities (and other entities as well) through simpler license application procedures, and reduced (or eliminated) registration fees. In addition, small entities would be able to take advantage of
Under the USML licensing procedure, an applicant must include a purchase order or contract with its application. There is no such requirement under the CCL licensing procedure. This difference gives the CCL applicant at least two advantages. First, the applicant has a way of determining whether the U.S. Government will authorize the transaction before it enters into potentially lengthy, complex and expensive sales presentations or contract negotiations. Under the USML licensing procedure, the applicant will need to caveat all sales presentations with a reference to the need for government approval and will more likely have to engage in substantial effort and expense with the risk that the government might reject the application. Second, a CCL license applicant need not limit its application to the quantity or value of one purchase order or contract. It may apply for a license to cover all of its expected exports or reexports to a particular consignee over the life of a license, reducing the total number of licenses for which the applicant must apply.
In addition, many applicants exporting or reexporting items that this rule would transfer from the USML to the CCL would realize cost savings through the elimination of some or all registration fees currently assessed under the ITAR. Registration fees for manufacturers and exporters of articles on the USML start at $2,250 per year, increase to $2,750 for organizations applying for one to ten licenses per year and further increase to $2,750 plus $250 per license application (subject to a maximum of three percent of total application value) for those who need to apply for more than ten licenses per year. There are no registration or application processing fees for applications to export items currently listed on the CCL. Once the items that are the subject to this rulemaking are removed from the USML and added to the CCL, entities currently applying for licenses from the Department of State would find their registration fees reduced if the number of USML licenses those entities need declines. If an entity's entire product line is moved to the CCL, then its ITAR registration and registration fee requirement would be eliminated.
Finally,
BIS is unable to determine the precise number of small entities that would be affected by this rule. Based on the facts and conclusions set forth above, BIS believes that any burdens imposed by this rule would be offset by the reduction in the number of transactions that would require a license, simpler export license applications, reduced or eliminated registration fees, and application of a
For these reasons, the Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule, if adopted in final form, would not have a significant economic impact on a substantial number of small entities.
Exports.
Exports, Reporting and recordkeeping requirements.
Accordingly, the Export Administration Regulations, 15 CFR parts 730—774 are proposed to be amended as follows:
50 U.S.C. app. 2401
(n)
50 U.S.C. app. 2401
For purposes of paragraph .a the term `military aircraft' means any aircraft “specially designed” for a military use that are not enumerated in USML paragraph VIII(a). The term includes: trainer aircraft; cargo aircraft; utility fixed wing aircraft; military helicopters; observation aircraft; military non-expansive balloons and other lighter than air aircraft; and unarmed military aircraft, regardless of origin or designation. Aircraft with modifications made to incorporate safety of flight features or other FAA or NTSB modifications such as transponders and air data recorders are “unmodified” for the purposes of this paragraph .a.
9A610.a does not control ‘military aircraft’ that:
a. Were first manufactured before 1946;
b. Do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State; and
c. Do not incorporate weapons enumerated or otherwise described on the U.S. Munitions List, unless inoperable and incapable of being returned to operation.
b. L100 aircraft manufactured prior to 2013.
c.-d. [Reserved]
e. Mobile aircraft arresting and engagement systems for aircraft controlled by either USML Category VIII(a) or ECCN 9A610.a
f. Pressure refueling equipment and other ground equipment designed to facilitate operations in confined areas, where such equipment is “specially designed” for aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a.
g. Aircrew life support equipment, aircrew safety equipment and other devices for emergency escape from aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a.
h. Parachutes, paragliders, complete parachute canopies, harnesses, platforms, electronic release mechanisms “specially designed” for use with aircraft controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and “equipment” “specially designed” for military high altitude parachutists, such as suits, special helmets, breathing systems, and navigation equipment.
i. Controlled opening equipment or automatic piloting systems, designed for parachuted loads.
j. Ground effect machines (GEMS), including surface effect machines and air cushion vehicles, “specially designed” for use by a military.
k. through s. [Reserved]
t. Composite structures, laminates and manufactures thereof “specially designed” for unmanned aerial vehicles controlled under USML Category VIII(a) with a range equal to or greater than 300 km.
Composite structures, laminates and manufactures thereof “specially designed” for unmanned aerial vehicles controlled under USML Category VIII(a) with a maximum range less than 300 km are controlled in paragraph .x of this entry.
u. Apparatus and devices “specially designed” for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a, and capable of a range equal to or greater than 300 km.
Apparatus and devices “specially designed” for the handling, control, activation and non-ship-based launching of UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a with a maximum range less than 300 km are controlled in paragraph .x of this entry.
v. Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.
Radar altimeters designed or modified for use in UAVs or drones controlled by either USML paragraph
w. Hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., and capable of delivering at least 500 kilograms payload to a range of at least 300 km.
Hydraulic, mechanical, electro-optical, or electromechanical flight control systems (including fly-by-wire systems) and attitude control equipment designed or modified for UAVs or drones controlled by either USML paragraph VIII(a) or ECCN 9A610.a., not capable of delivering at least 500 kilograms payload to a range of at least 300 km are controlled in paragraph .x of this entry.
x. “Parts,” “components,” “accessories,” and “attachments” that are “specially designed” for a commodity enumerated or otherwise described in ECCN 9A610 (except for 9A610.y) or a defense article enumerated or otherwise described in USML Category VIII and not elsewhere specified on the USML, in 9A610.y, or 3A611.y.
y. Specific “parts,” “components,” “accessories,” and “attachments” “specially designed” for a commodity subject to control in this entry, ECCN 9A619, or for a defense article in USML Category VIII and not elsewhere specified in the USML or the CCL, and other aircraft commodities “specially designed” for a military use, as follows, and “parts,” “components,” “accessories,” and “attachments” “specially designed” therefor:
y.1. Aircraft tires;
y.2. Analog gauges and indicators;
y.3. Audio selector panels;
y.4. Check valves for hydraulic and pneumatic systems;
y.5. Crew rest equipment;
y.6. Ejection seat mounted survival aids;
y.7. Energy dissipating pads for cargo (for pads made from paper or cardboard);
y.8. Fluid filters and filter assemblies;
y.9. Galleys;
y.10. Fluid hoses, straight and unbent lines, fittings, couplings, clamps and brackets;
y.11. Lavatories;
y.12. Life rafts;
y.13. Magnetic compass, magnetic azimuth detector;
y.14. Medical litter provisions;
y.15. Cockpit or cabin mirrors;
y.16. Passenger seats including palletized seats;
y.17. Potable water storage systems;
y.18. Public address (PA) systems;
y.19. Steel brake wear pads (does not include sintered mix or carbon/carbon materials);
y.20. Underwater locator beacons;
y.21. Urine collection bags/pads/cups/pumps;
y.22. Windshield washer and wiper systems;
y.23. Filtered and unfiltered panel knobs, indicators, switches, buttons, and dials;
y.24. Lead-acid and Nickel-Cadmium batteries;
y.25. Propellers, propeller systems, and propeller blades used with reciprocating engines;
y.26. Fire extinguishers;
y.27. Flame and smoke/CO
y.28. Map cases;
y.29. `Military Aircraft' that were first manufactured from 1946 to 1955 that do not incorporate defense articles enumerated or otherwise described on the U.S. Munitions List, unless the items are required to meet safety or airworthiness standards of a Wassenaar Arrangement Participating State;
y.30. “Parts,” “components,” “accessories,” and “attachments,” other than electronic items or navigation equipment, for use in or with a commodity controlled by ECCN 9A610.h;
y.31. Identification plates; and
y.32. Fluid manifolds.
y. Specific “parts,” “components,” “accessories,” and “attachments” “specially designed” for a commodity subject to control in this entry, ECCN 9A610, or for a defense article in USML Category XIX and not elsewhere specified on the USML or in the CCL, and other commodities, as follows, and “parts,” “components,” “accessories,” and “attachments” “specially designed” therefor:
y.1. Oil tank and reservoirs;
y.2. Oil lines and tubes;
y.3. Fluid hoses, straight and unbent lines, fittings, couplings, clamps and brackets;
y.4. Fluid filters and filter assemblies;
y.5. Check valves for hydraulic and pneumatic systems;
y.6. Shims;
y.7. Identification plates;
y.8. Fluid manifolds.
Materials enumerated elsewhere in the CCL, such as in a CCL Category 1 ECCN, are controlled pursuant to controls of the applicable ECCN.
Materials “specially designed” for both aircraft enumerated in USML Category VIII and aircraft enumerated in ECCN 9A610 are subject to the controls of this ECCN.
b. [RESERVED]
a. Materials not elsewhere specified in the CCL or on the USML and “specially designed” for commodities enumerated or otherwise described in USML Category XIX or ECCN 9A619 (except 9A619.y).
Materials enumerated elsewhere in the CCL, such as in a CCL Category 1 ECCN, are controlled pursuant to the controls of the applicable ECCN.
Materials “specially designed” for both an engine enumerated in USML Category XIX and an engine enumerated in ECCN 9A619 are subject to the controls of this ECCN 9C619.
b. [Reserved]
Department of State.
Proposed rule.
As part of the President's Export Control Reform (ECR) effort, the Department of State proposes to amend the International Traffic in Arms Regulations (ITAR) to revise Categories VIII (aircraft and related articles) and XIX (gas turbine engines and associated equipment) of the U.S. Munitions List (USML) to describe more precisely the articles warranting control on the USML. The revisions contained in this rule are part of the Department of State's retrospective plan under E.O. 13563.
The Department of State will accept comments on this proposed rule until March 25, 2016.
Interested parties may submit comments within 45 days of the date of publication by one of the following methods:
•
• Internet: At
Comments received after that date will be considered if feasible, but consideration cannot be assured. Those submitting comments should not include any personally identifying information they do not wish to be made public or information for which a claim of confidentiality is asserted, because those comments and/or transmittal emails will be made available for public inspection and copying after the close of the comment period via the Directorate of Defense Trade Controls Web site at
Mr. C. Edward Peartree, Director, Office of Defense Trade Controls Policy, Department of State, telephone (202) 663-2792; email
The Directorate of Defense Trade Controls (DDTC), U.S. Department of State, administers the International Traffic in Arms Regulations (ITAR) (22 CFR parts 120-130). The items subject to the jurisdiction of the ITAR,
On March 2, 2015, the Department published a Notice of Inquiry requesting public comment on USML Categories VIII and XIX (
In response to this Notice of Inquiry, the Department received 25 comments from the public. These comments offered proposals for modifications to the phrasing of regulatory text in USML Category VIII and Category XIX. The public comments were reviewed and considered by the Department and other agencies. Where the recommended changes added to the clarity of the regulation and were consistent with ECR objectives, the Department accepted them.
All references to the USML in this rule are to the list of defense articles that are controlled for the purpose of export or temporary import pursuant to the ITAR, and not to the defense articles on the USML that are controlled by the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) for the purpose of permanent import under its regulations (see 27 CFR part 447). Pursuant to § 38(a)(1) of the Arms Export Control Act (AECA), all defense articles controlled for export or import are part of the USML under the AECA. For the sake of clarity, the list of defense articles controlled by ATF for the purpose of permanent import is the United States Munitions Import List (USMIL). The transfer of defense articles from the ITAR's USML to the EAR's CCL for the purpose of export control does not affect the list of defense articles controlled on the USMIL under the AECA for the purpose of permanent import.
This proposed rule revises USML Category VIII, covering aircraft and related articles, to describe more precisely the articles warranting control on the USML.
Paragraph (a) is revised to clarify that the controls for all paragraphs are applicable “whether manned, unmanned, remotely piloted, or optionally piloted,” by modifying paragraph (a)(5) to clarify the features meriting USML control, and by deleting paragraph (a)(6) and placing it into reserve, because the relevant control would be subsumed by paragraph (a)(5). Paragraphs (a)(7) and (a)(8) are modified to clarify the features meriting USML control. Paragraphs (a)(11) and (a)(13) are deleted and placed into reserve. Paragraph (a)(14) is modified to exclude L-100 aircraft manufactured prior to 2013 from the scope of control. The Note to paragraph (a) is revised to incorporate technical corrections.
Paragraph (d) is modified to delete the “ship-based” control parameter and to clarify the intent and scope of the control.
Notes 1 and 3 to paragraph (f) are modified to incorporate clarifying language.
Several changes are proposed within paragraph (h). Paragraph (h)(1) is modified to delete the references to “equipment” in order to resolve any doubt that all production and test equipment specially designed for USML Category VIII articles presently is subject to the EAR under Export Control Classification Number (ECCN) 9B610. This rule proposes to move specific types of production and test equipment for specific aircraft identified in (h)(1) to the control of the USML because they are of a nature that inherently reveals technical data directly related to the defense article. The Department requests public comment on whether the production and test equipment identified in revised paragraph (h)(30) of the proposed revisions to USML Category VIII
In addition, paragraph (h)(1) is revised to update the list of subject platforms. The Note to paragraph (h)(1) is modified to incorporate technical corrections and to enhance the clarity of the note. Paragraph (h)(2) is revised to focus the scope of control on certain rotorcraft gearboxes meeting specific technical parameters, and a note to paragraph (h)(2) is added to clarify certain terminology used therein. Paragraph (h)(4)(ii) is modified to clarify the scope of control. Paragraph (h)(5) is updated to add the words “On-aircraft” in order to clarify the scope of control. Paragraph (h)(7) is modified to clarify the scope of control and to include control over specially designed parts and components of the subject flight control systems. Paragraph (h)(8) is modified to clarify the meaning of “threat-adaptive autonomous flight control systems.” Paragraph (h)(10) is modified to enhance the clarity of the control text. Paragraph (h)(13) is deleted and placed into reserve. Paragraph (h)(16) is modified to incorporate a technical correction. Paragraph (h)(18) is modified to control specially designed parts and components of the subject systems. Paragraph (h)(19) is modified to remove reference to ECCN 9A610.
Current paragraphs (h)(23) through (h)(26) are placed into reserve, with new controls added as paragraphs (h)(27) through (h)(30). Finally, the note to Category VIII is modified to update the paragraphs of paragraph (h) that are affected.
A number of commenting parties submitted observations or recommendations that pertained to sections of the ITAR other than USML Categories VIII and XIX. Additional commenting parties offered general observations or requests regarding the ECR initiative or defense trade generally. The Department is not addressing such comments in this proposed rule because they are outside the scope of the pending inquiry. The Department welcomes input from the public on these matters under separate cover and through standard means of communication, and offers guidance to industry through the efforts of the DDTC Response Team or the Advisory Opinion process. As outlined in the Notice of Inquiry referenced above, this rulemaking addresses only the USML Categories identified specifically in the Notice of Inquiry.
One commenter recommended that paragraph (a)(5) and paragraph (a)(13) be removed, and another commenter similarly recommended that paragraph (a)(6) be deleted, with paragraphs added to each entry in paragraph (a) for which the Department sought to control unmanned or optionally-piloted variants. The Department has revised these paragraphs, as described below, and modified paragraph (a) to confirm that the subject aircraft are ITAR-controlled if manned, unmanned, remotely piloted, or optionally piloted.
A commenting party stated that the term “attack helicopters” in paragraph (a)(4) is ambiguous, and proposed a clarifying note. The Department did not accept this recommendation, because it has received little evidence to date to indicate that ITAR users have struggled with the meaning of this language and no other commenting party expressed a similar concern.
Several commenting parties suggested that the use of the term “military” in Category VIII, when used in the control text as a feature that would distinguish ITAR-controlled aircraft from other aircraft (
Additional commenting parties recommended that paragraph (a)(7) be revised to specifically describe the technical parameters or capabilities that merit ITAR control in the context of intelligence, surveillance, and reconnaissance missions. The Department has elected to limit revisions to paragraph (a)(7) to those referenced above, in order to capture an appropriate range of capabilities of concern.
One commenting party recommended that paragraph (a)(8) be revised to specifically describe the technical parameters or capabilities that merit ITAR control in this context, asserting that commercial aircraft may be captured by the existing control. The Department did not accept the recommendation to add technical parameters, but has proposed revisions to the control text in order to better clarify the classes of aircraft subject to this control.
Five commenting parties observed that the control set forth in paragraph (a)(11) created a significant burden for industry, by capturing any aircraft incorporating a mission system already controlled elsewhere in the USML, and thus recommended deletion of the control. Since the mission systems at issue in this paragraph are already subject to ITAR control and there is no other described feature that causes the aircraft at issue in this paragraph to merit ITAR control, the Department accepted these recommendations and deleted the paragraph and the notes to the paragraph.
The Department did not receive public comment on paragraph (a)(12). However, public comment is requested on whether any commercial unmanned aerial vehicles have the capability described in this paragraph. In any public comment submitted in reply to this request, please provide specific
Four commenting parties recommend revision to or deletion of paragraph (a)(13), arguing that the control is overly broad and captures all optionally piloted aircraft, including aircraft that would otherwise be controlled by the EAR. The Department accepted these comments and deleted the paragraph, while revising paragraph VIII(a) to capture all optionally piloted variants of the aircraft listed in that paragraph.
Two commenting parties recommended revision of paragraph (a)(14) to narrow the scope to capture only those aircraft platforms that provide critical military or intelligence capabilities, as well as to avoid inadvertent capture of commercial aircraft such as the L-100. The Department partially accepted the latter recommendation and excluded L-100 aircraft manufactured prior to 2013 from control under paragraph (a)(14). The Department requests public comment on the scope and effect of this control and exclusion.
Three commenting parties suggested that paragraph (a)(15)(ii) is not sufficiently clear to foreign readers, given its reliance on the military designations in paragraph (a)(15)(i) rather than specific performance criteria. While the Department believes the military designations set forth in paragraph (a)(15)(i) can be researched and understood satisfactorily using publicly available information and the relevant performance criteria can be determined based on this information, public comment is requested on whether paragraph (a)(15) captures articles that are not already controlled by paragraphs (a)(1)-(a)(14). Similar to its request for comments on paragraph (a)(15), the Department requests public comment regarding whether the scope of controls described in paragraph (a)(16) is redundant given the controls in paragraphs (a)(1)-(a)(14), and whether it effectively precludes any less sensitive aircraft from being controlled in ECCN 9A610.a that, for example, may have been once manufactured with hard points that could be used to deliver munitions.
One commenting party recommended revised control text for paragraph (a)(16), arguing that the word “armed” is ambiguous in its meaning. The Department did not accept this recommendation and believes that this term is sufficiently clear and understood by the public.
Two commenting parties requested clarification on the scope of paragraph (d), with respect to the relationship between this paragraph and paragraph (h)(6), as well as the use of “specially designed” in this paragraph. The Department observes that the reference to “launching systems” in paragraph (h)(6) is limited in scope to launching equipment for unmanned aerial vehicles. Additionally, the Department has revised paragraph (d) to remove the “ship-based” modifiers, as well as to clarify the performance characteristic for which the equipment at issue must be “specially designed.”
One commenting party recommended no change to paragraph (e), while three commenting parties recommended deletion of the paragraph or removal of its Significant Military Equipment designation. The Department did not accept any recommendation to modify this paragraph in this rulemaking. Since it is anticipated that the concurrent Category XII revision effort may impact controls over related technologies, the Department has elected to refrain from modifying the paragraph (e) control in Category VIII pending the outcome of the Category XII review and revision process.
Three commenting parties suggested revisions to paragraph (f) or the Notes to that paragraph. Where commenting parties recommended technical clarifications or changes of terminology that did not materially alter the control, the Department did not accept these recommendations in order to maintain conformity between this paragraph and the analogous paragraphs that appear in other categories of the USML. The Department also did not accept a recommendation to limit the scope of paragraph (f) to developmental aircraft “of the type described in VIII(a)(1)-(16)” in favor of the existing scope of the paragraph. The Department accepted a recommendation to limit the class of modified contract affected by Note 3 to paragraph (f) to those that initiate the development of a new defense article and are dated April 16, 2014 or later.
One commenting party remarked in numerous instances on the use of “specially designed” with respect to components of components. The Department received no other indication in the context of this review effort that the referenced control parameter is unclear and did not agree with these comments. Similarly, two commenting parties recommended the addition of technical parameters to remove “specially designed” wherever possible. The Department accepts this edit to the fullest extent possible, but notes that “specially designed” exists in recognition of the fact that an enumeration of specific technical parameters may prove too complex or unwieldy to produce a useful regulation in some cases.
Several commenters offered recommendations to revise paragraph (h)(1), arguing that the control is overly broad or offering specific examples of technologies that are controlled by the paragraph but may be more appropriately controlled by the EAR. The Department did not accept any recommendation to remove a single technology or product from the paragraph, because such a change would be inconsistent with the national security, foreign policy, and regulatory drafting objectives of the paragraph to control as defense articles all parts and components, regardless of sophistication or similarity to items subject to the EAR, that are specially designed for the stealth and low-observable aircraft platforms of greatest concern referenced in paragraph (h)(1). However, the Department modernized the list of aircraft platforms, and removed the reference to equipment. A new paragraph (h)(30) is added to capture the limited range of equipment relevant to a defense article described in paragraph (h)(1) and meriting ITAR control. Additionally, the Department notes that not all products designed for a referenced aircraft platform are “specially designed” for that platform. Please refer to ITAR § 120.41 for more information.
One commenting party requested confirmation that paragraph (h)(1) does not control articles controlled elsewhere on the USML, such as an F-35 radar that would otherwise be controlled as significant military equipment (SME) under USML Category XI(a)(3). The Department confirms that the higher-level SME control is appropriate in such a scenario. The essence of the Order of Review concept is that when determining whether an item is subject to the ITAR, one must first review the enumerated and other entries on the USML that do not use a “specially designed” catch-all reference to unspecified “parts” and “components.” If no such references apply to the product at issue, then one must then review the “specially designed” catch-all provisions in the USML. If none of the USML catch-all provisions apply to the product at issue, then one must perform the same exercise within the 600 series controls of the CCL (or with the 515 controls for satellite-related items). If none of those entries apply, then one reviews the rest of the CCL as described in the EAR.
A commenting party recommended clarification with respect to the Note to paragraph (h)(1), to confirm that the paragraph's description of specially
Three commenting parties recommended revision to paragraph (h)(2) to remove the reference to interconnecting drive shafts and to clarify the scope of gearboxes that merit control under this provision. The Department accepted these edits and proposes a rewritten paragraph (h)(2) that controls only certain rotorcraft gearboxes that meet specific technical criteria.
Two commenters recommended deletion of paragraph (h)(2) and an expansion of paragraph (h)(18) to control ballistic resistant gearbox parts and components. The Department partially accepted these comments. The revised control clarifies the narrowed scope of articles that merit control and is intended to address the commenters' objective of avoiding capture of items in normal commercial use.
One commenting party recommended removal of the “specially designed parts and components therefor” language from paragraph (h)(2). The Department rejected this comment because the revised control now sets forth specific technical criteria.
A commenter recommended revision of paragraph VIII(h)(3) to control only quick-fold systems designed for maritime operations and the specially designed parts and components thereof. In the interest of retaining the existing scope of control, the Department did not accept this recommendation.
Similarly, the Department did not accept a recommendation to remove paragraph VIII(h)(4)'s control over certain wing folding systems. This paragraph was revised as recently as July 1, 2014 to ensure that wing folding systems for commercial aircraft are not controlled as defense articles, while retaining those systems that warrant ITAR controls for foreign policy and national security reasons. The range of public comments received did not indicate that the paragraph, as revised in July 2014, required further revision at this time.
One commenting party requested clarification regarding the relationship between paragraph (h)(6) and paragraph (d) of the same category. As described above, the Department has revised paragraph (d) to provide more specific performance criteria, and further notes that the “airborne launching systems” referenced in paragraph (h)(6) pertain only to unmanned aerial vehicles.
A commenting party recommended addition of a Note to paragraph (h)(6) to explain the meaning of “external stores support systems for ordnance or weapons.” In drafting control text the Department intends to avoid the overuse of clarifying notes to the extent possible, and did not believe that the recommended Note added sufficient clarity to merit its addition.
One commenting party requested the addition of technical parameters to allow for the removal of “specially designed” language from paragraph (h)(7). The Department did not accept this comment but added a clarifying revision to the text of the paragraph, in order to better identify the intended scope of control, and added a control for parts and components of the systems described in this paragraph.
Similarly, the Department did not accept a recommendation to add a Note to paragraph (a)(10) to indicate that the paragraph does not control radar or radio altimeter equipment conforming to Federal Aviation Administration Technical Standard Order C87. The Department made a minor clarifying revision to the paragraph, but the balance of comments received did not indicate a degree of confusion that would require the addition of the recommended Note.
Two commenting parties recommended deletion of paragraph (h)(13), arguing that it does not control a uniquely military capability. The Department accepted these recommendations, deleted the control text of paragraph (h)(13), and placed the paragraph into reserve.
One commenter recommended the removal of text in paragraph (h)(15) relating to “specially designed parts, components, accessories, and attachments therefor” and moving certain connectors, cables, and cable assemblies to ECCN 9A610. The commenter argued that the only differences between the EAR and apparent ITAR variants of the subject cables are the number of connectors on the cable and the wire length between connectors. The Department did not accept this recommendation because the cables as described would not be captured by the definition of specially designed in ITAR § 120.41. The Department did not accept a similar recommended refinement of the same text to control only those specially designed parts, components, and accessories for the optical sights or slewing device of the integrated helmet. The relevant control extends to those parts, components, or accessories that meet the definition of specially designed with respect to the components described in the paragraph.
A commenting party requested clarification with respect to the words “and computers” in paragraph (h)(16). The Department accepted this recommendation and made a minor revision to clarify that the words “aircraft-weapon interface units and computers” should be read together as one concept.
One commenting party remarked that paragraphs (h)(17), (h)(19), and (h)(23) described general purpose items and thus should be deleted. As noted above, paragraph (h)(23) is placed into reserve in this rule. With respect to paragraphs (h)(17) and (h)(19), the Department did not accept these recommendations because the commenter did not provide sufficient justification or explanation for these assertions.
A commenter asked whether paragraph (h)(20) controlled all relevant classified parts, components, accessories, attachments, equipment, or systems, or if the paragraph only controlled those classified items not enumerated elsewhere in the subject category. This paragraph functions as a catch-all for classified defense articles not described elsewhere in the USML. Articles described elsewhere on the USML that are classified are controlled as specifically enumerated elsewhere in the subchapter, if applicable, or by USML Category XVII.
One commenter recommended minor revisions to paragraph (h)(20) to match the analogous entries in USML Categories IV, V, IX, X, XI, and XV. The Department accepted this comment.
Four commenting parties requested clarification of the terms “thermal engine” and “thermal batteries” as they appear in paragraphs (h)(24) and (h)(25), respectively. The Department notes that those paragraphs are deleted in this proposed rule.
A commenting party observed that paragraph VIII(k) is reserved, but in § 121.16 of this subchapter, Item 10—Category II of the Missile Technology Control Regime (MTCR) Annex references the paragraph. The MTCR Annex is beyond the scope of this review effort but the Department acknowledges the observation of an error. Once all revised USML categories are published as final rules, ITAR § 121.16 will be placed in reserve, and the parenthetical “(MT)” will be used at the end of each USML section containing such articles.
One commenter suggested that the reference to ECCN 9A610 in the Note to Category VIII is not helpful, because most EAR-controlled aircraft that
A commenting party suggested that it is logically inconsistent to subject to ITAR control any spare or replacement parts for aircraft covered by the Note to Category VIII, where the spare or replacement parts are controlled by any of the USML paragraphs referenced in that Note. The Department does not agree with this comment because it continues to value the control of exports of unincorporated parts and components that would independently merit ITAR control under normal circumstances.
This proposed rule revises USML Category XIX, covering gas turbine engines and associated equipment, to describe more precisely the articles warranting control on the USML.
Paragraph (a) is modified to clarify the scope of controlled engines and to incorporate technical corrections. Paragraph (b) is revised to provide additional technical parameters to clarify the scope of controlled engines. With respect to paragraph (b)(1), public comment is requested on whether any commercial models exceed the capability described in this paragraph. In any public comment submitted in reply to this request, please provide specific examples of the commercial models at issue.
Paragraph (c) is modified to incorporate conforming changes and to make clear that the paragraph applies only to gas turbine engines, while paragraph (d) is modified to update the list of subject engines. The Note to paragraph (e) is modified to incorporate a conforming change.
Several changes are proposed within paragraph (f). Paragraph (f)(1) is modified to incorporate technical corrections and to update the list of subject engines. Paragraph (f)(2) introduces additional text to clarify the scope of controlled hot section components. New controls are proposed for paragraphs (f)(7) through (f)(16).
A commenting party observed that Category XIX does not currently capture developmental engines that do not meet the performance criteria of paragraphs (a) through (e), and that paragraph (g) only covers technical data directly related to defense articles. A second commenter recommended the addition of a paragraph to specifically control developmental gas turbine engines, in a manner similar to development-related paragraphs in other USML categories. The Department has revised paragraphs (a) through (c) to specifically control developmental engines that meet the technical criteria specified in those paragraphs that merit ITAR control.
Two commenting parties recommended the addition of a Note to Category XIX that would allow the Department of Commerce to license the export of certain ITAR-controlled gas turbine engines when incorporated in a military aircraft subject to the EAR and classified under a “600 series” ECCN. The Department accepted this recommendation. If examples exist of non-600 series production aircraft that are subject to the EAR and incorporate, in the ordinary course of civil applications, engines subject to the ITAR, please identify them in a public comment.
A commenting party recommended the deletion of “specially designed” in various instances throughout the category. The Department has not received information indicating that the employment of the term has frustrated the application of the controls in this category, but will closely review any relevant comments received in reply to this proposed rule.
One commenting party stated that the control text of paragraph (b), in concert with Category VIII(h)(2), frustrated commercial tilt rotor aircraft development. The Department has revised both categories to more specifically describe the parameters or characteristics that merit ITAR control. One commenter requested the removal of the T700 engine from control under paragraph (d). The Department did not accept this recommendation but has revised the list of engines subject to ITAR control under this paragraph.
Several commenters offered recommendations to revise paragraph (f)(1), arguing that the control is overly broad or offering specific examples of technologies that are controlled by the paragraph but may be more appropriately controlled by the EAR. The Department did not accept any recommendation to remove the catch-all structure of the paragraph because such a revision would be inconsistent with the national security, foreign policy, and regulatory draft objectives of the paragraph to control as defense articles all parts and components specially designed for gas turbine engines of greatest concern and as identified in paragraph (f)(1). However, the Department modernized the list of gas turbine engines, and removed the reference to equipment. Several new paragraphs are added to capture the limited range of equipment relevant to a defense article described in paragraph (f)(1) and meriting ITAR control. Additionally, the Department notes that not all products designed for a referenced gas turbine engine are “specially designed” for that engine. Please refer to ITAR § 120.41 for more information.
A commenting party remarked that paragraph (f)(2) does not control augmenter parts and components. The Department confirms this observation and notes that parts and components specially designed for hot section components not controlled by paragraph (f)(2) are controlled by ECCN 9A619.x.
A commenter asked whether paragraph (f)(6) controlled all relevant classified parts, components, accessories, attachments, equipment, or systems, or if the paragraph only controlled those classified items not enumerated elsewhere in the subject category. The Department observes that the paragraph functions as a catch-all for classified defense articles not described elsewhere in the USML. Articles described elsewhere on the USML that are classified are controlled as specifically enumerated elsewhere in the subchapter, if applicable, or by USML Category XVII.
The Department of State is of the opinion that controlling the import and export of defense articles and services is a foreign affairs function of the United States Government and that rules implementing this function are exempt from sections 553 (Rulemaking) and 554 (Adjudications) of the Administrative Procedure Act. Although the Department is of the opinion that this rule is exempt from the rulemaking provisions of the APA, the Department is publishing this rule with a 45-day provision for public comment and without prejudice to its determination that controlling the import and export of defense services is a foreign affairs function. As noted above, and also without prejudice to the Department position that this rulemaking is not subject to the APA, the Department previously published a related Notice of Inquiry on March 2, 2015 (80 FR 11314), and accepted comments for 60 days.
Since the Department is of the opinion that this rule is exempt from the provisions of 5 U.S.C. 553, there is no requirement for an analysis under the Regulatory Flexibility Act.
This rulemaking does not involve a mandate that will result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more in any year and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
For purposes of the Small Business Regulatory Enforcement Fairness Act of 1996 (the “Act”), a “major” rule is a rule that the Administrator of the OMB Office of Information and Regulatory Affairs finds has resulted or is likely to result in (1) an annual effect on the economy of $100,000,000 or more; (2) a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions; or (3) significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and foreign markets.
The Department does not believe this rulemaking will have an annual effect on the economy of $100,000,000 or more. Articles that are being removed from coverage in the U.S. Munitions List categories contained in this rule will still require licensing for export, but from the Department of Commerce. While the licensing regime of the Department of Commerce is more flexible than that of the Department of State, it is not expected that the change in jurisdiction of these articles will result in an export difference of $100,000,000 or more.
The Department also does not believe that this rulemaking will result in a major increase in costs or prices for consumers, individual industries, federal, state, or local government agencies, or geographic regions, or have significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based enterprises to compete with foreign-based enterprises in domestic and foreign markets.
This rulemaking will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government. Therefore, in accordance with Executive Order 13132, it is determined that this rulemaking does not have sufficient federalism implications to require consultations or warrant the preparation of a federalism summary impact statement. The regulations implementing Executive Order 12372 regarding intergovernmental consultation on Federal programs and activities do not apply to this rulemaking.
Executive Orders 12866 and 13563 direct agencies to assess costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributed impacts, and equity). These executive orders stress the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rulemaking has been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, this rule has been reviewed by the Office of Management and Budget (OMB).
The Department of State has reviewed this rulemaking in light of sections 3(a) and 3(b)(2) of Executive Order 12988 to eliminate ambiguity, minimize litigation, establish clear legal standards, and reduce burden.
The Department of State has determined that this rulemaking will not have tribal implications, will not impose substantial direct compliance costs on Indian tribal governments, and will not preempt tribal law. Accordingly, the requirements of Executive Order 13175 do not apply to this rulemaking.
This rule does not impose any new reporting or recordkeeping requirements subject to the Paperwork Reduction Act, 44 U.S.C. Chapter 35; however, the Department of State seeks public comment on any unforeseen potential for increased burden.
Arms and munitions, Classified information, Exports.
Secs. 2, 38, and 71, Pub. L. 90-629, 90 Stat. 744 (22 U.S.C. 2752, 2778, 2797); 22 U.S.C. 2651a; Pub. L. 105-261, 112 Stat. 1920; Section 1261, Pub. L. 112-239; E.O. 13637, 78 FR 16129.
(a) Aircraft, whether manned, unmanned, remotely piloted, or optionally piloted, as follows (MT if the aircraft, excluding manned aircraft, has a range equal to or greater than 300 km):
*(1) Bombers;
*(2) Fighters, fighter bombers, and fixed-wing attack aircraft;
*(3) Turbofan- or turbojet-powered trainers used to train pilots for fighter, attack, or bomber aircraft;
*(4) Attack helicopters;
*(5) Unmanned aerial vehicles (UAVs) incorporating or specially designed to incorporate a defense article;
*(6) [Reserved]
*(7) Intelligence, surveillance, and reconnaissance aircraft incorporating or specially designed to incorporate a defense article;
*(8) Electronic warfare aircraft, or airborne warning and control aircraft; or command, control, and communications aircraft incorporating or specially designed to incorporate a defense article;
(9) Air refueling aircraft;
(10) Target drones;
(11) [Reserved]
(12) Aircraft capable of being refueled in-flight including hover-in-flight refueling (HIFR);
(13) [Reserved]
(14) Aircraft with a roll-on/roll-off ramp, capable of airlifting payloads over 35,000 lbs. to ranges over 2,000 nm without being refueled in-flight, and landing onto short or unimproved airfields, other than L-100 aircraft manufactured prior to 2013;
*(15) Aircraft not enumerated in paragraphs (a)(1) through (a)(14) as follows:
(i) U.S.-origin aircraft that bear an original military designation of A, B, E, F, K, M, P, R, or S; or
(ii) Foreign-origin aircraft specially designed to provide functions equivalent to those of the aircraft listed in paragraph (a)(15)(i) of this category; or
(16) Aircraft that are armed or are specially designed to be used as a platform to deliver munitions or otherwise destroy targets (
Note 1 to paragraph (a): Aircraft specially designed for military applications that are not identified in paragraph (a) of this section are subject to the EAR and classified as ECCN 9A610, including any model of unarmed military aircraft manufactured prior to 1956, regardless of origin or designation, and unmodified since manufacture. Aircraft with modifications made to incorporate safety of flight features or other FAA or NTSB modifications such as transponders and air data recorders are considered “unmodified” for the purposes of this paragraph.
Note 2 to paragraph (a): “Range” is the maximum distance that the specified aircraft system is capable of traveling in the mode of stable flight as measured by the projection of its trajectory over the surface of the Earth. The maximum capability based on the design characteristics of the system, when fully loaded with fuel or propellant, will be taken into consideration in determining range. The range for aircraft systems will be determined independently of any external factors such as operational restrictions, limitations imposed by telemetry, data links, or other external constraints. For aircraft systems, the range will be determined for a one-way distance using the most fuel-efficient flight profile (
(b)-(c) [Reserved]
(d) Launching and recovery equipment specially designed to allow an aircraft described in paragraph (a) of this category to take off or land on a vessel described in Category VI paragraphs (a) through (c) (MT if the launching and recovery equipment is for an aircraft, excluding manned aircraft, that has a range equal to or greater than 300 km).
*(e) Inertial navigation systems (INS), aided or hybrid inertial navigation systems, Inertial Measurement Units (IMUs), and Attitude and Heading Reference Systems (AHRS) specially designed for aircraft controlled in this category or controlled in ECCN 9A610 and all specially designed components, parts, and accessories therefor (MT if the INS, IMU, or AHRS is for an aircraft, excluding manned aircraft, or missile that has a “range” equal to or greater than 300 km). For other inertial reference systems and related components refer to USML Category XII(d).
(f) Developmental aircraft funded by the Department of Defense via contract or other funding authorization, and specially designed parts, components, accessories, and attachments therefor.
Note 1 to paragraph (f): This paragraph does not control aircraft and specially designed parts, components, accessories, and attachments therefor (a) in production; (b) determined to be subject to the EAR via a commodity jurisdiction determination (see § 120.4 of this subchapter), or (c) identified in the relevant Department of Defense contract or other funding authorization as being developed for both civil and military applications.
Note 2 to paragraph (f): Note 1 does not apply to defense articles enumerated on the U.S. Munitions List, whether in production or development.
Note 3 to paragraph (f): This paragraph is applicable only to those contracts, other funding authorizations, or modifications initiating development of a new defense article that are dated April 16, 2014, or later.
(g) [Reserved]
(h) Parts, components, accessories, attachments, associated equipment and systems, as follows:
(1) Parts, components, accessories, and attachments specially designed for the following U.S.-origin aircraft: the B-1B, B-2, F-15SE, F/A-18 E/F, EA-18G, F-22, F-35, and future variants thereof; or the F-117 or U.S. Government technology demonstrators. Parts, components, accessories, and attachments of the F-15SE and F/A-18 E/F that are common to earlier models of these aircraft, unless listed in paragraph (h) of this category, are subject to the EAR;
(2) Rotorcraft gearboxes with internal pitch line velocities exceeding 20,000 feet per minute and able to operate 30 minutes with loss of lubrication without an emergency or auxiliary lubrication system, and specially designed parts and components therefor;
(3) Tail boom folding systems, stabilator folding systems or automatic rotor blade folding systems, and specially designed parts and components therefor;
(4) Wing folding systems, and specially designed parts and components therefor, for:
(i) Aircraft powered by power plants controlled under USML Category IV(d); or
(ii) Aircraft with any of the following characteristics and powered by gas turbine engines:
(A) The portion of the wing outboard of the wing fold is required for sustained flight;
(B) Fuel can be stored outboard of the wing fold;
(C) Control surfaces are outboard of the wing fold;
(D) Hard points are outboard of the wing fold;
(E) Hard points inboard of the wing fold are capable of in-flight ejection; or
(F) The aircraft is designed to withstand maximum vertical maneuvering accelerations greater than +3.5g/−1.5g.
(5) On-aircraft arresting gear (
(6) Bomb racks, missile launchers, missile rails, weapon pylons, pylon-to-launcher adapters, unmanned aerial vehicle (UAV) airborne launching systems, external stores support systems for ordnance or weapons, and specially designed parts and components therefor (MT if the bomb rack, missile launcher, missile rail, weapon pylon, pylon-to-launcher adapter, UAV airborne launching system, or external stores support system is for an aircraft, excluding manned aircraft, or missile that has a “range” equal to or greater than 300 km);
(7) Damage or failure-adaptive flight control systems, that do not consist
(8) Threat-adaptive autonomous flight control systems, where a “threat-adaptive autonomous flight control system” is a flight control system that, without input from the operator or pilot, adjusts the aircraft control or flight path to minimize risk caused by hostile threats;
(9) Non-surface-based flight control systems and effectors (
(10) Radar altimeters with output power management LPI (low probability of intercept) or signal modulation (
(11) Air-to-air refueling systems and hover-in-flight refueling (HIFR) systems, and specially designed parts and components therefor;
(12) Unmanned aerial vehicle (UAV) flight control systems and vehicle management systems with swarming capability (
(13) [Reserved]
(14) Lift fans, clutches, and roll posts for short take-off, vertical landing (STOVL) aircraft and specially designed parts and components for such lift fans and roll posts;
(15) Integrated helmets incorporating optical sights or slewing devices, which include the ability to aim, launch, track, or manage munitions (
(16) Fire control computers, stores management systems, armaments control processors, and aircraft-weapon interface units and computers (
(17) Mission computers, vehicle management computers, and integrated core processers specially designed for aircraft controlled in this category;
(18) Drive systems and flight control systems specially designed to function after impact of a 7.62mm or larger projectile, and specially designed parts and components therefor;
(19) Thrust reversers specially designed to be deployed in flight for aircraft controlled in this category;
*(20) Any part, component, accessory, attachment, equipment, or system that:
(i) Is classified;
(ii) Contains classified software directly related to defense articles in this subchapter or 600 series items subject to the EAR; or
(iii) Is being developed using classified information.
(21)-(26) [Reserved]
(27) Variable speed gearboxes capable of varying output speed by 50% or greater and providing power to rotors, proprotors, propellers, propfans, or liftfans; and specially designed parts and components therefor;
(28) Electrical power or thermal management systems integrated with an engine controlled in Category XIX having any of the following:
(i) Electrical power generators that provide greater than 300kW of electrical power (per generator) with gravimetric power densities exceeding 2kW/pound;
(ii) Heat exchangers that exchange 200 kW of heat or greater into the gas turbine engine flow path;
(iii) Logic controls that maintain gas turbine engine operability during pneumatic and shaft power extraction of 2kW/pound; or
(iv) Direct-cooling thermal electronic package heat exchangers that transfers 20kW of heat or greater at 100W/cm
(29) Flight control algorithms or software that aid in landing a fixed-wing aircraft on any vessel controlled in Category VI(a)-(c); or
(30) The following, if specially designed for a defense article described in paragraph (h)(1):
(i) Wind tunnel and other scale test models;
(ii) Full scale iron bird ground rigs used to test major aircraft systems;
(iii) Autonomic logistics information system (ALIS); or
(iv) Jigs, locating fixtures, templates, gauges, molds, dies, and caul plates, for production of airframe parts and components.
(i) Technical data (see § 120.10 of this subchapter) and defense services (see § 120.9 of this subchapter) directly related to the defense articles described in paragraphs (a) through (h) of this category and classified technical data directly related to items controlled in ECCNs 9A610, 9B610, 9C610, and 9D610 and defense services using classified technical data. (See § 125.4 of this subchapter for exemptions.) (MT for technical data and defense services related to articles designated as such.)
(j)-(w) [Reserved]
(x) Commodities, software, and technical data subject to the EAR (see § 120.42 of this subchapter) used in or with defense articles controlled in this category.
*(a) Turbofan and Turbojet engines (including those that are technology demonstrators, developmental engines, or variable cycle engines) capable of 15,000 lbf (66.7 kN) of thrust or greater that have any of the following:
(1) With or specially designed for thrust augmentation (afterburner);
(2) Thrust or exhaust nozzle vectoring;
(3) Parts or components controlled in paragraph (f)(6) of this category;
(4) Specially designed for sustained 30 second inverted flight or negative g maneuver; or
(5) Specially designed for high power extraction (greater than 50 percent of
*(b) Turboshaft and Turboprop engines (including those that are technology demonstrators or developmental engines) that have any of the following:
(1) Capable of 1500 mechanical shp (1119 kW) or greater and specially designed with oil sump sealing when the engine is in the vertical position; or
(2) Capable of 225 specific power or greater and specially designed for armament gas ingestion and transient maneuvers, where specific power is defined as maximum takeoff shaft horsepower divided by compressor inlet flow (lbm/sec).
*(c) Gas turbine engines (including technology demonstrators, developmental engines, and variable cycle engines) specially designed for unmanned aerial vehicle systems controlled in this category, cruise missiles, or target drones (MT if for an engine used in an aircraft, excluding manned aircraft, or missile that has a “range” equal to or greater than 300 km).
*(d) GE38, AGT1500, CTS800, MT7, T55, TF60, HPW3000, GE3000, T408, and T700 engines.
*(e) Digital engine control systems (
Note to paragraph (e): Digital electronic control systems autonomously control the engine throughout its whole operating range from demanded engine start until demanded engine shut-down, in both normal and fault conditions.
(f) Parts, components, accessories, attachments, associated equipment, and systems as follows:
(1) Parts, components, accessories, and attachments specially designed for the following U.S.-origin engines (and military variants thereof): F101, F107, F112, F118, F119, F120, F135, F136, F414, F415, and J402; Note to paragraph (f)(1): This paragraph does not control parts, components, accessories, and attachments that are common to engines enumerated in paragraph (a) through (d) of this category but not identified in paragraph (f)(1), and those identified in paragraph (f)(1). For example, a part common to only the F110 and F136 is not specially designed for purposes of this paragraph. A part common to only the F119 and F135—two engine models identified in paragraph (f)(1)—is specially designed for purposes of this paragraph, unless one of the other paragraphs is applicable under § 120.41(b).
*(2) Hot section components (
(3) Uncooled turbine blades, vanes, disks, and tip shrouds specially designed for gas turbine engines controlled in this category;
(4) Combustor cowls, diffusers, domes, and shells specially designed for gas turbine engines controlled in this category;
(5) Engine monitoring systems (
*(6) Any part, component, accessory, attachment, equipment, or system that:
(i) Is classified;
(ii) Contains classified software directly related to defense articles in this subchapter or 600 series items subject to the EAR; or
(iii) Is being developed using classified information.
Note to paragraph (f)(6): “Classified” means classified pursuant to Executive Order 13526, or predecessor order, and a security classification guide developed pursuant thereto or equivalent, or to the corresponding classification rules of another government or international organization;
(7) Test cells or test stands specially designed for technology demonstrator engines, developmental engines, or variable cycle engines controlled in this category;
(8) Investment casting cores, core dies, or wax pattern dies for parts or components enumerated in paragraphs (f)(1), (f)(2), or (f)(3) of this category;
(9) Pressure gain combustors specially designed for engines controlled in this category, and specially designed parts and components therefor;
(10) Three-stream fan systems that allow the movement of airflow between the streams to control fan pressure ratio or bypass ratio (by means other than use of fan corrected speed or the primary nozzle area to change the fan pressure ratio or bypass ratio), and specially designed parts, components, accessories, and attachments therefor;
(11) High pressure compressors with core-driven bypass streams that have a pressure ratio greater than one, occurring across any section of the bypass duct, and specially designed parts, components, accessories, and attachments therefor;
(12) Intermediate compressors of a three-spool compression system with an intermediate spool-driven bypass stream that has a pressure ratio greater than one, occurring across any section of the bypass duct, and specially designed parts, components, accessories, and attachments therefor;
(13) Powders specially designed for thermal or environmental barrier coating of defense articles enumerated in paragraphs (f)(1)-(f)(4) of this category;
(14) Superalloys (
(15) Imide matrix, metal matrix, or ceramic matrix composite material (
(16) The following, if specially designed for a defense article in paragraph (f)(1):
(i) Jigs, locating fixtures, templates, gauges, molds, dies, or caul plates, for production of engine parts and components; or
(ii) Test cells or test stands.
(g) Technical data (see § 120.10 of this subchapter) and defense services (see § 120.9 of this subchapter) directly related to the defense articles described in paragraphs (a) through (f) of this category and classified technical data directly related to items controlled in ECCNs 9A619, 9B619, 9C619, and 9D619 and defense services using the classified technical data. (See § 125.4 of this subchapter for exemptions.) (MT for technical data and defense services related to articles designated as such.)
(h)-(w) [Reserved]
(x) Commodities, software, and technical data subject to the EAR (see § 120.42 of this subchapter) used in or
Office of the Assistant Secretary for Housing-Federal Housing Commissioner, HUD.
Proposed rule.
This rulemaking proposes to revise the exemption for recreational vehicles that are not self-propelled from HUD's Manufactured Housing Procedural and Enforcement Regulations. This proposed rule is based on a recommendation adopted by the Manufactured Housing Consensus Committee (MHCC) which would define a recreational vehicle as one built on a vehicular structure, not certified as a manufactured home, designed only for recreational use and not as a primary residence or for permanent occupancy, and built and certified in accordance with either the National Fire Protection Association (NFPA) 1192-15 or American National Standards Institute (ANSI) A119.5-09 consensus standards for recreational vehicles. HUD is adopting the MHCC's recommendation but modifying it to require certification with the updated ANSI standard, A119.5-15, and by including a requirement that units claiming the ANSI A119.5-15 exemption prominently display a notice stating that the unit is designed only for recreational use, and not as a primary residence or permanent dwelling.
Interested persons are invited to submit comments regarding this rule to the Regulations Division, Office of General Counsel, Department of Housing and Urban Development, 451 Seventh Street SW., Washington, DC 20410-0500. Room 10276, Washington, DC 20410-0500. Communications must refer to the above docket number and title. There are two methods for submitting public comments. All submissions must refer to the above docket number and title.
1.
2.
Pamela Beck Danner, Administrator, Office of Manufactured Housing Programs, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street SW., Washington DC 20410; telephone (202) 708-6409 (this is not a toll free number). Persons with hearing or speech impairments may access this number via TTY by calling the toll free Federal Information Relay Service at 1-800-877-8389.
The National Manufactured Housing Construction and Safety Standards Act of 1974
On May 13, 1976 (41 FR 19846), HUD issued 24 CFR part 3282, its Mobile Home Procedural and Enforcement regulations. In this regulation, HUD codified its first recreational vehicle exemption. Recognizing that recreational vehicles in excess of 256 square feet would be included in the definition of “mobile home,” HUD decided to exempt recreational vehicles from the scope of the regulation since they are not designed to be used as a permanent dwelling. HUD determined that, “[r]ecreational vehicles do not fall within the definition of mobile homes and are not subject to these regulations. A recreational vehicle is a vehicle, regardless of size, which is not designed to be used as a permanent dwelling, and in which the plumbing, heating, and electrical systems contained therein may be operated without connection to outside utilities and which are self-
In 1980, the Housing and Community Development Act of 1980 (Pub. L. 96-399, approved October 8, 1980) amended the definition of “mobile home” in the Act by striking out “eight body feet or more in width and thirty-two body feet or more in length” and substituting “in traveling mode, is eight body feet or more in width or forty body feet or more in length or, when erected on site, is three hundred twenty or more square feet.” The Housing and Community Development Act of 1980 also added a provision to the Act that exempted from the coverage, “any structure which meets all the requirements of this paragraph [42 U.S.C. 5402(6)] except the size requirements and with respect to which the manufacturer voluntarily files a certification required by the Secretary and complies with the standards established under this title.”
On August 7, 1981 (46 FR 40498), HUD proposed removing the exemption for certain recreational vehicles from its Procedural and Enforcement regulations. HUD stated that it had received numerous comments from the manufactured housing industry and from the public criticizing the exemption, and that the exemption had been difficult to apply. HUD also stated that it proposed establishing a procedure under which manufacturers of units which meet the definition of manufactured home except for the size requirements may bring their units under the jurisdiction of the Act by providing for a certification. HUD stated that the proposed certification would be easy to comply with and place a minimal burden on the manufacturer.
HUD received numerous comments, however, which were critical of the proposal to do away with the recreational vehicle exemption. As a result, relying on a conference report on the 1980 amendments that directed HUD to consider a more flexible standard for smaller manufactured homes (such as park models) whose square footage is between 320 and 400 square feet, HUD continued the exemption but expanded it to its current form. Specifically, HUD determined that recreational vehicles were exempt from HUD's Manufactured Home Construction and Safety Standards and its Procedural and Enforcement Regulations if a unit is:
(1) Built on a single chassis;
(2) 400 Square feet or less when measured at the largest horizontal projections;
(3) Self-propelled or permanently towable by a light duty truck; and
(4) Designed primarily not for use as a permanent dwelling but as temporary living quarters for recreational, camping, travel, or seasonal use.
In 1988, HUD issued guidance to clarify the method for measuring a unit to determine whether it qualified as a recreational vehicle under HUD's exemption. In interpretative bulletin A-1-88,
In the fall of 2014, HUD determined that some manufacturers were producing park model recreational vehicles (PMRVs) which were in excess of the recreational vehicle exemption's 400 square foot threshold. A PMRV (also known as a recreational park trailer) is a trailer-type recreational vehicle designed to provide temporary accommodation for recreation, camping or seasonal use. PMRVs are built on a single chassis, mounted on wheels and generally have a gross trailer area not exceeding 400 square feet in the set-up mode. Based on this determination, HUD issued a memorandum on October 1, 2014, reiterating the method through which recreational vehicles should be measured to qualify for the recreational vehicle exemption.
Subsequently, HUD also discovered that some Fifth Wheel Travel Trailers could also fall within HUD regulations. A Fifth-Wheel Travel Trailer is a towable recreational vehicle mounted on wheels and designed to be towed by a motorized vehicle by means of a towing mechanism that is mounted above or forward of the tow vehicle's rear axle. However, HUD has not exercised regulatory oversight over Fifth Wheel Travel Trailers and considered them as falling within the regulatory exemption.
On December 2, 2014, the MHCC considered HUD's October 1, 2014, memorandum and recommended that HUD adopt language that more clearly differentiated recreational vehicles and manufactured housing. Specifically, the MHCC stated that “recreational vehicles, in their many shapes and sizes, are not manufactured homes and are outside of the manufactured home standards and regulations.” It also stated there is no need for a complicated definition of recreational vehicles and recommended that HUD revise its recreational vehicle exception to provide as follows:
Recreational vehicles are not subject to this part, part 3280. A recreational vehicle is a factory built vehicular structure designed only for recreational use and not as a primary residence or for permanent occupancy, built and certified in accordance with NFPA 1192-15 or ANSI A119.5-09 consensus standards for recreational vehicles and not certified as a manufactured home.
After reviewing the MHCC's recommendation, HUD is accepting the recommendation with revision. Initially, HUD proposes to restructure the exemption by removing it from § 3282.8 and codifying it at § 3282.15. HUD is also proposing to incorporate ANSI's updated 2015 Recreational Park Trailer Standard, A119.5-15, which after review, HUD believes best reflects the current state of recreational vehicle construction. Finally, to ensure consumer awareness of the difference between manufactured housing and recreational vehicles and the construction standards used to build each, HUD is proposing to require that each ANSI A119.5-15 certified structure seeking an exemption include a notice to be prominently displayed in a temporary manner in the kitchen (
This rulemaking proposes to incorporate ANSI A119.5-15 and NFPA 1192-15 consensus standards for Recreational Vehicles by reference. The ANSI A119.5-15 standard covers fire and life safety criteria and plumbing for PMRVs considered necessary to provide a reasonable level of protection from loss of life from fire and explosion. The NFPA 1192-15 standard provides the minimum construction standards considered necessary to protect against loss of life from fire and explosion for non-Park Model Recreational Vehicles. Both ANSI A119.5-15 and NFPA 1192-15 are available for review and comment via read-only, electronic access. NFPA 1192-15 is available for review at
The public is invited to comment on any of the specific provisions included in this proposed rule and is also invited to comment on the following questions and on any other related matters or suggestions regarding this proposed rule:
1. What if any costs beyond the notice requirements for recreational vehicle manufacturers seeking an ANSI A119.5 exception would be imposed on recreational vehicle manufacturers as a result of the implementation of this proposed rule? Are PMRVs that meet HUD's statutory and regulatory definitions of “manufactured homes” currently being constructed outside the scope of ANSI A119.5? If so, how many units are being built? What would be the costs of requiring these manufacturers to build to ANSI A119.5 in order to take advantage of the exemption? Would it be more efficient and advantageous for HUD to exercise direct regulatory oversight over this portion of the industry? What would be the costs and benefits of doing so?
2. In what manner, if any, should HUD ensure that recreational vehicles conforming to NFPA 1192-2015 be certified to be exempt from the provisions of HUD's Manufactured Home Procedural and Enforcement Regulations? For example, should HUD require that a Notice of certification be provided in each such recreational vehicle built to NFPA 1192-15 similar to the notice being proposed for PMRVs or should other methods be considered such as a label to be exempt from HUD's regulations?
3. As described in the preamble to this proposed rule, HUD has not exercised regulatory oversight over Fifth Wheel Recreational Vehicles that might meet the statutory and regulatory definitions of “manufactured home,” This proposed rule proposes to except Fifth Wheel Recreational Vehicles from regulatory oversight. Should HUD take a different approach and begin exercising regulatory oversight of these units that meet the statutory and regulatory definitions of “manufactured home?” What are the costs and benefits of bringing these units within HUD oversight? Should HUD exercise any regulatory authority over Fifth Wheelers or other forms of recreational vehicles?
Under Executive Order 12866 (Regulatory Planning and Review), a determination must be made whether a regulatory action is significant and, therefore, subject to review by the Office of Management and Budget (OMB) in accordance with the requirements of the order. Executive Order 13563 (Improving Regulations and Regulatory Review) directs executive agencies to analyze regulations that are “outmoded, ineffective, insufficient, or excessively burdensome, and to modify, streamline, expand, or repeal them in accordance with what has been learned. Executive Order 13563 also directs that, where relevant, feasible, and consistent with regulatory objectives, and to the extent permitted by law, agencies are to identify and consider regulatory approaches that reduce burdens and maintain flexibility and freedom of choice for the public. This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, and it was not reviewed by the Office of Management and Budget (OMB). This proposed rule revises the definition of recreational vehicle to clarify the types of recreational vehicles excepted by 24 CFR parts 3280 and 3282. In the past, both consumers and manufacturers of recreational vehicles have questioned whether certain recreational vehicles are subject to HUD's Construction and Safety Standards, codified in 24 CFR part 3280, and HUD's Manufactured Home Procedural and Enforcement Regulations, codified in 24 CFR part 3282. This proposed rule would provide that recreational vehicles are excepted from HUD regulation if the unit is built in conformance with either NFPA 1192-15, Standard for Recreational Vehicles, or ANSI A119.5-15, Recreational Park Trailer Standard. This rulemaking is not significant because it proposes to clarify rather than change or add substance to the existing regulation.
The Regulatory Flexibility Act (RFA) (5 U.S.C. 601
The information collection requirements contained in this proposed rule have been submitted to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). In
In accordance with 5 CFR 1320.8(d)(1), HUD is soliciting comments from members of the public and affected agencies concerning the information collection requirements in the proposed rule regarding:
(1) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) The accuracy of the agency's estimate of the burden of the proposed collection of information;
(3) Whether the proposed collection of information enhances the quality, utility, and clarity of the information to be collected; and
(4) Whether the proposed information collection minimizes the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology (
Interested persons are invited to submit comments regarding the information collection requirements in this rule. Under the provisions of 5 CFR part 1320, OMB is required to make a decision concerning this collection of information between 30 and 60 days after the publication date. Therefore, a comment on the information collection requirements is best assured of having its full effect if OMB receives the comment within 30 days of the publication date. This time frame does not affect the deadline for comments to the agency on the proposed rule, however. Comments must refer to the proposal by name and docket number (FR-5776-P-01) and must be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503, Fax number: (202) 395-6947; and Colette Pollard, HUD Reports Liaison Officer, Department of Housing and Urban Development, 451 7th Street SW., Room 2204, Washington, DC 20410.
Interested persons may submit comments regarding the information collection requirements electronically through the Federal eRulemaking Portal at
A Finding of No Significant Impact with respect to the environment has been made in accordance with HUD regulations at 24 CFR part 50, which implement section 102(2)(C) of the National Environmental Policy Act of 1969 (42 U.S.C. 4332(2)(C)). The Finding of No Significant Impact is available for public inspection online at
Executive Order 13132 (entitled “Federalism”) prohibits an agency from publishing any rule that has federalism implications if the rule either imposes substantial direct compliance costs on State and local governments or is not required by statute, or the rule preempts State law, unless the agency meets the consultation and funding requirements of section 6 of the Executive Order. This proposed rule will not have federalism implications and would not impose substantial direct compliance costs on State and local governments or preempt State law within the meaning of the Executive Order.
Title II of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538) (UMRA) establishes requirements for federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments, and on the private sector. This proposed rule does not impose any federal mandates on any State, local, or tribal governments, or on the private sector, within the meaning of UMRA.
The Catalog of Federal Domestic Assistance number for the Manufactured Housing Program is 14.171.
Housing standards, Incorporation by reference, Manufactured homes.
Administrative practice and procedure, Consumer protection, Intergovernmental relations, Investigations, Manufactured homes, Reporting and recordkeeping requirements.
Accordingly, for the reasons stated in the preamble, HUD proposes to amend parts 3280 and 3282 of title 24 of the Code of Federal Regulations, as follows:
42 U.S.C. 3535(d), 5403, and 5424.
28 U.S.C. 2461, 42 U.S.C. 3535(d), 5403, and 5424.
(a)
(b)
(1) A factory built vehicular structure, not certified as a manufactured home;
(2) Designed only for recreational use and not as a primary residence or for permanent occupancy; and is either:
(3) Built and certified in accordance with either the NFPA 1192-15, Standard for Recreational Vehicles or ANSI A119.5-15, Recreational Park Trailer Standard as provided by paragraph (c) of this section; or
(4) Any vehicle which is self-propelled.
(c)
(1)
(2)
The Manufacturer of this unit certifies that it is a Park Model Recreational Vehicle designed only for recreational use, and not for use as a primary residence or for permanent occupancy. The manufacturer of this unit further certifies that this unit has been built in accordance with the ANSI A119.5-15 consensus standard for Park Model Recreational Vehicles.
(3)
(4)
Saint Lawrence Seaway Development Corporation, DOT.
Notice of proposed rulemaking.
The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Tariff of Tolls in their respective jurisdictions. The Tariff sets forth the level of tolls assessed on all commodities and vessels transiting the facilities operated by the SLSDC and the SLSMC. The SLSDC is revising its regulations to reflect the fees and charges levied by the SLSMC in Canada starting in the 2016 navigation season, which are effective only in Canada. An amendment to increase the minimum charge per lock for those vessels that are not pleasure craft or subject in Canada to tolls under items 1 and 2 of the Tariff for full or partial transit of the Seaway will apply in the U.S. (See
Comments are due March 10, 2016.
Carrie Mann Lavigne, Chief Counsel, Saint Lawrence Seaway Development Corporation, 180 Andrews Street, Massena, New York 13662; 315/764-3200.
The Saint Lawrence Seaway Development Corporation (SLSDC) and the St. Lawrence Seaway Management Corporation (SLSMC) of Canada, under international agreement, jointly publish and presently administer the St. Lawrence Seaway Tariff of Tolls (Schedule of Fees and Charges in Canada) in their respective jurisdictions.
The Tariff sets forth the level of tolls assessed on all commodities and vessels transiting the facilities operated by the SLSDC and the SLSMC. The SLSDC is proposing to revise 33 CFR 402.12, “Schedule of tolls”, to reflect the fees and charges levied by the SLSMC in Canada beginning in the 2016 navigation season. With one exception, the changes affect the tolls for commercial vessels and are applicable only in Canada. The collection of tolls by the SLSDC on commercial vessels transiting the U.S. locks is waived by law (33 U.S.C. 988a(a)). Accordingly, no notice or comment is necessary on these amendments.
The SLSDC is proposing to amend 33 CFR 402.12, “Schedule of tolls”, to increase the minimum charge per vessel per lock for full or partial transit of the Seaway from $26.92 to $27.46. This charge is for vessels that are not pleasure craft or subject in Canada to the tolls under items 1 and 2 of the Tariff. This increase is due to higher operating costs at the locks.
This proposed regulation involves a foreign affairs function of the United States and therefore Executive Order 12866 does not apply and evaluation under the Department of Transportation's Regulatory Policies and Procedures is not required.
I certify this proposed regulation will not have a significant economic impact on a substantial number of small entities. The St. Lawrence Seaway Tariff of Tolls primarily relate to commercial users of the Seaway, the vast majority of whom are foreign vessel operators. Therefore, any resulting costs will be borne mostly by foreign vessels.
This proposed regulation does not require an environmental impact statement under the National Environmental Policy Act (49 U.S.C. 4321, et reg.) because it is not a major federal action significantly affecting the quality of the human environment.
The Corporation has analyzed this proposed rule under the principles and criteria in Executive Order 13132, dated August 4, 1999, and has determined that this proposal does not have sufficient federalism implications to warrant a Federalism Assessment.
The Corporation has analyzed this proposed rule under Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4, 109 Stat. 48) and determined that it does not impose unfunded mandates on State, local, and tribal governments and the private sector requiring a written statement of economic and regulatory alternatives.
This proposed regulation has been analyzed under the Paperwork Reduction Act of 1995 and does not contain new or modified information collection requirements subject to the Office of Management and Budget review.
Vessels, Waterways.
Accordingly, the Saint Lawrence Seaway Development Corporation proposes to amend 33 CFR part 402, Tariff of Tolls, as follows:
33 U.S.C. 983(a), 984(a)(4) and 988, as amended; 49 CFR 1.52.
(a) Every vessel entering, passing through or leaving the Seaway shall pay a toll that is the sum of each applicable charge in § 402.12. Each charge is calculated on the description set out in column 1 of § 402.12 and the rate set out in column 2 or 3.
(a) To be eligible for the Gateway Incentive, cargoes, must presently be moving between a specific origin and destination via other competing gateways.
(b) To be eligible for the refund applicable under the Gateway Incentive program, a shipper, or its representative, must:
(1) Submit an application to the Manager for the proposed movement (cargo/origin/destination) to be approved under the rules of the Gateway Incentive program;
(2) Supply to the Manager the information proving that the proposed movement is currently done via a competing gateway;
(3) Negotiate with the Manager the terms of the proposal, that is an applicable toll reduction, a volume commitment, and the duration of the proposal.
(c) The shipper, or its representative, will qualify annually for the negotiated toll reduction upon completion of the annual volume commitment during the agreed upon duration period.
(d) The Gateway Incentive applies only to movements of qualified cargoes done after the commencement date of the qualified Gateway Incentive. Movements done prior to the date of commencement of the Gateway Incentive will be ineligible for the rebate.
(e) The shipper, or its representative, will provide the Manager with a request for the Gateway Incentive refund, together with copies of any documents required to support the request, within sixty (60 days) of the close of the navigation season. Requests for refunds should be submitted to the Manager, Revenue and Forecast, who will be responsible for reviewing all documents
(f) The negotiated Gateway Incentive percentage of tolls reduction paid in respect of qualifying cargo shipped will be refunded by the Manager after the close of the navigation season, once the Manager has confirmed through the review of submitted support documents that the shipper has met the volume commitment. The SLSMC reserves the right to require the ultimate origin and destination of cargoes to validate the commitment.
(a) Subject to paragraph (b) of this section, a vessel that reports for its final transit of the Seaway from a place set out in column 1 of § 402.12 within a period after the clearance date established by the Manager and the Corporation set out in column 2 of § 402.12 shall pay operational surcharges in the amount set out in column 3 of § 402.12, prorated on a per-lock basis.
Environmental Protection Agency (EPA).
Proposed rule; extension of comment period.
The Environmental Protection Agency (EPA) is extending the comment period for the proposed rule titled “Nondiscrimination in Programs or Activities Receiving Federal Assistance from the Environmental Protection Agency” that was published in the
Comments, identified by docket identification (ID) number EPA-HQ-OA-2013-0031, must be received on or before March 12, 2016.
Written comments may be submitted online through Docket ID No. EPA-HQ-OA-2013-0031, to the Federal eRulemaking Portal:
Jeryl Covington or Lilian Dorka, U.S. Environmental Protection Agency, Office of Civil Rights, (Mail Code 1201A), 1200 Pennsylvania Ave. NW., Washington, DC. 20460, telephone (202) 564-7272 or (202) 564-7713.
This document extends the public comment period for the proposed Nondiscrimination in Programs or Activities Receiving Federal Assistance from the EPA (80 FR 77284, December 14, 2015) in order to ensure that the public has sufficient time to review and comment on the proposal. That proposal provided for a public comment period ending February 12, 2016.
The EPA received several requests from the public to extend this comment period and this notice is the Agency's response to those persons who requested an extension of the comment period. In addition, EPA is providing notice that additional support documents are available for public inspection in the rulemaking docket. Finally, in response to significant public interest in the proposed rule, the Agency will conduct one additional public session in Washington, DC. Additional information on this announcement is located at
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Yolo-Solano Air Quality Management District (YSAQMD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) and oxides of nitrogen (NOx) emissions from gasoline dispensing facilities and stationary gas turbines. We are proposing to approve local rules to regulate these emission sources under the Clean Air Act (CAA or the Act).
Any comments on this proposal must arrive by March 10, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0756 at
Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses local rules 2.22 and 2.34. In the Rules and Regulations section of this
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Santa Barbara County Air Pollution Control District (SBCAPCD or District) portion of the California State Implementation Plan (SIP). These revisions concern administrative and procedural requirements to obtain preconstruction permits which regulate emission sources under the Clean Air Act as amended in 1990 (CAA or the Act).
Any comments on this proposal must arrive by March 10, 2016.
Submit comments, identified by docket number [EPA-R09-OAR-2015-0784, by one of the following methods:
1.
2.
3.
Ya-Ting (Sheila) Tsai, EPA Region IX, (415) 972-3328,
Throughout this document, “we,” “us” and “our” refer to the EPA. This proposal addresses the following local rules: 201, 203, 204, and 206. In the Rules and Regulations section of this
We do not plan to open a second comment period, so anyone interested in commenting should do so at this time. If we do not receive adverse comments, no further activity is planned. For further information, please see the direct final action.
Environmental Protection Agency (EPA).
Proposed rule.
This action proposes amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) Refinery MACT 1 and Refinery MACT 2 regulations and the New Source Performance Standards (NSPS) for petroleum refineries, which were published on December 1, 2015. In that action, as a result of a risk and technology review, the Environmental Protection Agency (EPA) finalized amendments to Refinery MACT 1 and Refinery MACT 2. In this action, the EPA is proposing to amend the compliance date in Refinery MACT 1 for maintenance vent standards that apply during periods of startup, shutdown, maintenance or inspection for sources constructed or reconstructed on or before June 30, 2014. In this action, the EPA is also proposing to revise the compliance dates in Refinery MACT 2 for the standards that apply during startup, shutdown, or hot standby for fluid catalytic cracking units (FCCU) and startup and shutdown for sulfur recovery units (SRU) constructed or reconstructed on or before June 30, 2014. These proposed revisions do not affect requirements that apply during normal operations. Finally, the EPA is proposing technical corrections and clarifications to the NESHAP and the NSPS for petroleum refineries. This action will have an insignificant effect on emissions reductions and costs.
Comments must be received on or before March 25, 2016.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2010-0682, at
The
Please note that any updates made to any aspect of the hearing, including whether or not a hearing will be held, will be posted online at
Ms. Brenda Shine, Sector Policies and Programs Division, Refining and Chemicals Group (E143-01), Office of Air Quality Planning and Standards, U.S. Environmental Protection Agency, Research Triangle Park, North Carolina, 27711; telephone number: (919) 541-3608; facsimile number: (919) 541-0246; and email address:
Table 1 of this preamble is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by the final action for the source categories listed. To determine whether your facility is affected, you should examine the applicability criteria in the appropriate NESHAP or NSPS. If you have any questions regarding the applicability of any aspect of these NESHAP or NSPS, please contact the appropriate person listed in the preceding
In addition to being available in the docket, an electronic copy of this proposal will also be available on the Internet through the Technology Transfer Network (TTN) Web site, a forum for information and technology exchange in various areas of air pollution control. Following signature by the EPA Administrator, the EPA will post a copy of this proposed action at:
On December 1, 2015 (80 FR 75178), the EPA finalized amendments to the Petroleum Refinery NESHAP in 40 CFR part 63, subparts CC and UUU, referred to as Refinery MACT 1 and 2, respectively. The final amendments to Refinery MACT 1 and 2 include a number of provisions establishing emissions limitations during startup and shutdown for emissions sources at petroleum refineries, including specific provisions for maintenance vents, FCCU, and SRU, which are the focus of this proposed action.
The Refinery MACT 1 standards regulate emissions of hazardous air pollutants (HAP) from miscellaneous process vents. Prior to the December 2015 amendments, the definition of miscellaneous process vents excluded episodic or non-routine releases such as those associated with startup, shutdown, and maintenance. The December 2015 Refinery MACT 1 rule eliminates this exclusion from the definition of miscellaneous process vent and establishes standards for these “maintenance vents” in 40 CFR 63.643(c). Maintenance vents are only used as a result of startup, shutdown, maintenance or inspection of equipment when such equipment is emptied, depressurized, degassed, or placed into service. The rule specifies that refinery owners or operators may only release HAP from these maintenance vents in order to open process equipment provided that the equipment is drained and purged to a closed system until the hydrocarbon content is less than or equal to a lower explosive limit (LEL) of 10 percent prior to venting to the atmosphere. As a secondary limit, if the LEL cannot be measured due to design constraints of the equipment, the rule requires that the pressure in the equipment be reduced to 5 pounds (lbs) per square inch gauge or less prior to venting to the atmosphere. The rule also contains additional limits such as a low emission threshold (less than 72 lbs/day), and requirements for catalyst changeout activities where hydrotreater pyrophoric catalyst must be purged.
The Refinery MACT 2 standards regulate HAP emissions from the FCCU by specifying carbon monoxide (CO) limits as a surrogate for organic HAP and by specifying particulate matter (PM) limits (or nickel limits) as a surrogate for metal HAP. In the rule, compliance with the organic HAP emissions limit is demonstrated using a continuous CO monitor; compliance with the metal HAP emissions limit is demonstrated either using continuous opacity monitoring system (COMS) or continuous parameter monitoring system (CPMS). Owners or operators of FCCU are provided two options for demonstrating compliance with the PM limit during periods of startup, shutdown, or hot standby in 40 CFR 63.1564(a)(5): Meeting the emission limit that applies during times other than startup, shutdown, or hot standby, or meeting a minimum cyclone face velocity limit. Similarly, the rule provides two options for demonstrating compliance with the CO limit during periods of startup and shutdown in 40 CFR 63.1565(a)(5): Meeting the emission limit that applies during times other than startup, shutdown, or hot standby, or meeting an excess oxygen limit in the exhaust from the catalyst regenerator.
The Refinery MACT 2 standards also regulate HAP emissions from SRU vents by specifying sulfur dioxide (SO
For owners or operators complying with any of the limits for startup, shutdown, or hot standby for FCCU and for startup or shutdown for SRU, the compliance date is the effective date of the rule (February 1, 2016, 60 days after the publication date of the rule). The compliance date for the maintenance vent provisions is also the effective date of the rule. In the next section of this preamble, we discuss some additional clarifications and technical corrections we are proposing to Table 11 of subpart CC to 40 CFR part 63, which is where the maintenance vent compliance times and other subpart CC compliance times are delineated.
The EPA has received new information that the compliance dates for standards for maintenance vents and startup, shutdown, or hot standby for FCCU and for startup or shutdown for SRU do not allow sufficient time to install additional control equipment, if needed, and to complete the management of change process, which includes addressing safety concerns associated with potential operational or procedural changes. The management of change process, which is discussed in further detail in the next section of this preamble, includes the following: Evaluating the change, forming an internal team to accomplish the change, engineering the change, which could include developing new set points, installing new controls or alarms, assessing risk of chemical accidents and catastrophic events, updating associated plans and procedures, providing training, performing pre-startup safety reviews, and implementing the change as required by other regulatory programs. In order to accommodate these steps, we are proposing to amend the compliance dates for these provisions to 18 months after the effective date of the standards (
The EPA has received additional information (see Docket ID No. EPA-HQ-OAR-2010-0682) that indicates that the compliance dates for standards for maintenance vents and periods of startup, shutdown, and hot standby for FCCU and for startup or shutdown for SRU do not provide facilities sufficient time to go through their management of change process, which includes addressing safety concerns associated with potential operational or procedural changes and coordinating any changes with other applicable regulatory requirements. The process equipment associated with maintenance vents, FCCU, and SRU are subject to requirements under the Risk Management Program regulation in 40 CFR part 68 and the Occupational Safety and Health Administration (OSHA) Process Safety Management (PSM) standard in 29 CFR part 1910. Thus, any operational or procedural changes resulting from complying with the applicable standards must follow the management of change procedures in these respective regulatory programs.
The Risk Management Program and OSHA PSM regulations provide that owners or operators follow a management of change process, as codified in 40 CFR 68.75, 29 CFR 1910.119(l) and appendix C of 29 CFR 1910.119, to ensure that the following are considered prior to making a change:
• The technical basis for the proposed change;
• Impact of change on safety and health;
• Modifications to operating procedures;
• Necessary time period for the change; and
• Authorization requirements for the proposed change.
As part of the management of change process, the EPA expects that facilities will have to perform an upfront assessment to determine what changes are required to meet the new maintenance vent requirements and standards for FCCU and SRU. Based on our review of information brought forward by industry representatives, refinery owners or operators may have to adjust or install new instrumentation, including alarms, closed drain headers, equipment blowdown drums, and other new or revised processes and controls in order to comply with these new provisions. Facilities may also have to hire a vendor to assist with the project and complete the procurement process. Additionally, we anticipate that facilities will have to assess risk of chemical accidents and catastrophic events and review and revise standard operating procedures, as necessary.
Further, the management of change provisions also require that employees who are involved in operating a process and maintenance and contract employees whose job tasks are affected by the change must be trained prior to startup of the affected process.
Finally, facilities are required to conduct pre-startup safety reviews and obtain authorization for use to fully implement and startup the modified process and/or equipment.
Therefore, to account for the applicable requirements in the Risk Management Program regulation and OSHA PSM standard, the EPA is proposing to require owners and operators of sources that were constructed or reconstructed on or before June 30, 2014, to comply with the maintenance vent provisions and limits for startup, shutdown, or hot standby for FCCU and for startup or shutdown for SRU no later than 18 months after the effective date of the December 2015 rule. We believe that this additional time is both appropriate and sufficient to accomplish the necessary compliance-related tasks discussed above.
Although not common, the possibility exists that some facilities may have to install new controls or otherwise invest in capital projects in order to comply with these new regulatory provisions. As provided in the General Provisions to part 63, owners or operators of these facilities can request an additional 12 months to comply with the standards using the provisions in 40 CFR 63.6(i).
Owners and operators must comply with the general duty requirements in 40 CFR 63.642(n) for maintenance vents and 40 CFR 63.1570 for FCCU or SRU during periods of startup, shutdown and, for FCCU only, hot standby from the effective date of the December 2015 final rule until they comply with the new requirements on or before the applicable compliance dates. Records of compliance with the general duty requirements must be maintained as specified in 40 CFR 63.643(d), 63.642(n) and 63.1570(c).
We are proposing to make clarifying revisions to Table 11 in 40 CFR part 63, subpart CC. We received numerous questions regarding the compliance date for maintenance vents and some owners or operators are interpreting Table 11 to
The EPA is also proposing to make several clarifications and technical corrections as described here and summarized in the table below. The first sentence in § 60.102a(f)(1)(i) is being changed to incorporate the pollutant of concern, SO
The EPA is also proposing to add language to clarify the effective dates of two specific provisions in 40 CFR part 63, subpart UUU. First, we are proposing to revise the catalytic reforming unit (CRU) pressure limit exclusion provision in 40 CFR 63.1566(a)(4) to specify that refiners have 3 years to comply with the requirements to meet emission limitations in Tables 15 and 16 if they actively purge or depressurize at vessel pressures of 5 psig or less. Although both the proposal and the final preambles (at 79 FR 36950 and 80 FR 75185) indicated that we intended to provide a 3-year compliance period, language in § 63.1566(a)(4) did not specifically provide 3 years. This was an inadvertent omission and in this action we are proposing to add rule language to reflect our intent.
Similarly, we are proposing to revise the entry for item 1 in Table 2 of subpart UUU to clarify that refineries have 18 months to comply with the 20 percent opacity operating limit for units subject to Refinery NSPS subpart J or electing to comply with Refinery NSPS subpart J provisions for PM. Although both the proposal and the final preambles (at 79 FR 36950 and 80 FR 75185) indicated that we intended to provide an 18-month compliance period for new or revised operating limits for FCCU, the language in Table 2 of subpart UUU did not specifically provide this 18 month compliance period. Again, this was an inadvertent omission and in this action we are proposing to add rule language to reflect our intent.
Additionally, the reference to § 60.102a(b)(1) in § 63.1564(a)(1)(iv) is being removed as this provision should only reference Option 2 in Table 1 (Item 7 in Table 1 of part 63, subpart UUU), providing owners or operators with the option to comply with the Refinery MACT 2 p.m. option when they choose not to comply with one of the NSPS options. A typographical correction is being made to the reference to § 63.1566(a)(5)(iii) in 40 CFR part 63, subpart UUU, Table 3, Item 12 to correctly reference § 63.1564(a)(5)(ii). Finally, an editorial correction is being made to add the word “and” in place of a semicolon in 40 CFR part 63, subpart UUU, Table 5, Item 2.
We expect the additional compliance time will have an insignificant effect on emission reductions and costs, as many refiners already have measures in place due to state and other federal requirements to minimize emissions during these periods. Further, these periods are relatively infrequent (some only occur on a 5-year cycle) and are usually of short duration.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was, therefore, not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA. OMB has previously approved the information collection activities contained in the existing regulations at 40 CFR part 63, subparts CC and UUU under the provisions of the
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden, or otherwise has a positive economic effect on the small entities subject to the rule. The action consists of revisions to compliance dates, clarifications, and technical corrections which do not change the expected economic impact analysis performed for the existing rule. We have, therefore, concluded that this action will have no net regulatory burden for all directly regulated small entities.
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local, or tribal governments or the private sector.
This action does not have federalism implications. It will not have substantial direct effects on the states, on the relationship between the national government and the states, or on the distribution of power and responsibilities among the various levels of government.
This action does not have tribal implications as specified in Executive Order 13175. It will not have substantial direct effect on tribal governments, on the relationship between the federal government and Indian tribes, or on the distribution of power and responsibilities between the federal government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this action.
This action is not subject to Executive Order 13045 because it is not economically significant as defined in Executive Order 12866, and because the EPA does not believe the environmental health or safety risks addressed by this action present a disproportionate risk to children. The proposed amendments serve to revise compliance dates and make technical clarifications and corrections. We expect the additional compliance time will have an insignificant effect on emission reductions as many refiners already have measures in place due to state and other federal requirements to minimize emissions during these periods. Further, these periods are relatively infrequent and are usually of short duration. Therefore, the proposed amendments should not appreciably increase risk for any populations. Further, this action will allow more time for refiners to implement procedures to safely start up and shut down equipment which should minimize safety risks for all populations.
This action is not subject to Executive Order 13211 because it is not a significant regulatory action under Executive Order 12866.
This rulemaking does not involve technical standards.
The EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations. The proposed amendments serve to revise compliance dates and make technical clarifications and corrections. We expect the additional compliance time will have an insignificant effect on emission reductions as many refiners already have measures in place due to state and other federal requirements to minimize emissions during these periods. Further, these periods are relatively infrequent and are usually of short duration. Therefore, the proposed amendments should not appreciably increase risk for any populations. Further, this action will allow more time for refiners to implement procedures to safely start up and shut down equipment which should minimize safety risks for all populations.
Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
Environmental protection, Administrative practice and procedures, Air pollution control, Hazardous substances, Incorporation by reference, Intergovernmental relations, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, title 40, chapter I, of the Code
42 U.S.C. 7401
(f) * * *
(1) * * *
(i) For a sulfur recovery plant with an oxidation control system or a reduction control system followed by incineration, the owner or operator shall not discharge or cause the discharge of any gases containing SO
42 U.S.C. 7401
(c) An owner or operator may designate a process vent as a maintenance vent if the vent is only used as a result of startup, shutdown, maintenance, or inspection of equipment where equipment is emptied, depressurized, degassed or placed into service. The owner or operator does not need to designate a maintenance vent as a Group 1 or Group 2 miscellaneous process vent. The owner of operator must comply with the applicable requirements in paragraphs (c)(1) through (3) of this section for each maintenance vent according to the compliance dates specified in table 11 of this subpart, unless an extension is requested in accordance with the provisions in § 63.6(i).
(d) After February 1, 2016 and prior to the date of compliance with the maintenance vent provisions in paragraph (c) of this section, the owner or operator must comply with the requirements in § 63.642(n) for each maintenance venting event and maintain records necessary to demonstrate compliance with the requirements in § 63.642(n) including, if appropriate, records of existing standard site procedures used to deinventory equipment for safety purposes.
(a) Each owner or operator of an existing source subject to the provisions of this subpart shall comply with the provisions of 40 CFR part 60, subpart VV, and paragraph (b) of this section except as provided in paragraphs (a)(1) and (2), (c) through (i), and (j)(1) and (2) of this section. Each owner or operator of a new source subject to the provisions of this subpart shall comply with subpart H of this part except as provided in paragraphs (c) through (i) and (j)(1) and (2) of this section.
(h) * * *
(8) For fenceline monitoring systems subject to § 63.658, within 45 calendar days after the end of each reporting period, each owner or operator shall submit the following information to the EPA's Compliance and Emissions Data Reporting Interface (CEDRI). (CEDRI can be accessed through the EPA's Central Data Exchange (CDX) (
(c) * * *
(1) As it pertains to this subpart, known sources of VOCs, as used in Section 8.2.1.3 in Method 325A of appendix A of this part for siting passive monitors, means a wastewater treatment unit, process unit, or any emission source requiring control according to the requirements of this subpart, including marine vessel loading operations. For marine vessel loading operations, one passive monitor should be sited on the shoreline adjacent to the dock.
(o) * * *
(1) * * *
(ii) * * *
(B) Implementation of prevention measures listed for pressure relief devices in § 63.648(j)(5) for each pressure relief device that can discharge to the flare.
The revisions and additions to read as follows:
(a) * * *
(1) If you startup your affected source before April 11, 2002, then you must comply with the emission limitations and work practice standards for new and reconstructed sources in this subpart no later than April 11, 2002 except as provided in paragraph (d) of this section.
(2) If you startup your affected source after April 11, 2002, you must comply with the emission limitations and work practice standards for new and reconstructed sources in this subpart upon startup of your affected source except as provided in paragraph (d) of this section.
(b) If you have an existing affected source, you must comply with the emission limitations and work practice standards for existing affected sources in this subpart by no later than April 11, 2005 except as specified in paragraphs (c) and (d) of this section.
(d) You must comply with the applicable requirements in §§ 63.1564(a)(5), 63.1565(a)(5) and 63.1568(a)(4) as specified in paragraph (d)(1) or (2), as applicable.
(1) For sources which commenced construction or reconstruction before June 30, 2014, you must comply with the applicable requirements in §§ 63.1564(a)(5), 63.1565(a)(5) and 63.1568(a)(4) on or before August 1, 2017 unless an extension is requested and approved in accordance with the provisions in § 63.6(i). After February 1, 2016 and prior to the date of compliance with the provisions in §§ 63.1564(a)(5), 63.1565(a)(5) and 63.1568(a)(4), you must comply with the requirements in § 63.1570(c) and (d).
(2) For sources which commenced construction or reconstruction on or after June 30, 2014, you must comply with the applicable requirements in §§ 63.1564(a)(5), 63.1565(a)(5) and 63.1568(a)(4) on or before February 1, 2016 or upon startup, whichever is later.
(e) If you have an area source that increases its emissions or its potential to emit such that it becomes a major source of HAP, the requirements in paragraphs (e)(1) and (2) of this section apply.
(a) * * *
(1) * * *
(iv) You can elect to comply with the PM per coke burn-off emission limit of this chapter (Option 2);
(5) On or before the date specified in § 63.1563(d), you must comply with one of the two options in paragraphs (a)(5)(i) and (ii) of this section during periods of startup, shutdown and hot standby:
(c) * * *
(5) If you elect to comply with the alternative limit in paragraph (a)(5)(ii) of this section during periods of startup, shutdown and hot standby, demonstrate continuous compliance on or before the date specified in § 63.1563(d) by:
(a) * * *
(5) On or before the date specified in § 63.1563(d), you must comply with one of the two options in paragraphs (a)(5)(i) and (ii) of this section during periods of startup, shutdown and hot standby:
(a) * * *
(4) The emission limitations in Tables 15 and 16 of this subpart do not apply to emissions from process vents during passive depressuring when the reactor vent pressure is 5 pounds per square inch gauge (psig) or less or during active depressuring or purging prior to January 30, 2019, when the reactor vent pressure is 5 psig or less. On and after January 30, 2019, the emission limitations in Tables 15 and 16 of this subpart do apply to emissions from process vents during active purging operations (when nitrogen or other purge gas is actively introduced to the reactor vessel) or active depressuring (using a vacuum pump, ejector system, or similar device) regardless of the reactor vent pressure.
(a) * * *
(4) On or before the date specified in § 63.1563(d), you must comply with one of the three options in paragraphs (a)(4)(i) through (iii) of this section during periods of startup and shutdown.
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to make minor conforming edits to the stratospheric protection regulations to implement the International Trade Data System. In the “Rules and Regulations” section of this
Written comments must be received by March 10, 2016.
Submit your comments, identified by Docket ID No. EPA-HQ-OAR-2015-0309, at
Jeremy Arling by regular mail: U.S. Environmental Protection Agency, Stratospheric Protection Division (6205T), 1200 Pennsylvania Avenue NW., Washington, DC 20460; by telephone: (202) 343-9055; or by email:
This document proposes to make minor conforming edits to the stratospheric protection regulations to implement the International Trade Data System primarily by removing references to specific Customs forms that will become obsolete under the new system. EPA has published a direct final rule making these edits in the “Rules and Regulations” section of this
If we receive no adverse comment, we will not take further action on this proposed rule. If we receive adverse comment, we will withdraw the direct final rule and it will not take effect. We would address all public comments in any subsequent final rule based on this proposed rule.
We do not intend to institute a second comment period on this action. Any parties interested in commenting must do so at this time. For further information, please see the information provided in the
This rulemaking may affect the following categories: Industrial Gas Manufacturing entities (NAICS code 325120), including fluorinated hydrocarbon gas manufacturers, importers, and exporters; Other Chemical and Allied Products Merchant Wholesalers (NAICS code 424690), including chemical gases and compressed gases merchant importers and exporters; and refrigerant reclaimers or other such entities that might import virgin, recovered, or reclaimed refrigerant gas.
This list is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be regulated by this action. To determine whether your facility, company, business, or organization could be regulated by this action, you should carefully examine the regulations promulgated at 40 CFR part 82, subpart A. If you have questions regarding the applicability of this action to a particular entity, consult the person listed in the preceding section.
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose any new information collection burden under the PRA because the requirements to maintain entry numbers and EINs are a subset of the previous requirements to maintain forms containing this information. OMB has previously approved the information collection activities contained in the existing regulations and has assigned OMB control number 2060-0170 and 2060-0438.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. In making this determination, the impact of concern is any significant adverse economic impact on small entities. An agency may certify that a rule will not have a significant economic impact on a substantial number of small entities if the rule relieves regulatory burden, has no net burden or otherwise has a positive economic effect on the small
This action does not contain any unfunded mandate as described in UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect small governments. The action imposes no enforceable duty on any state, local or tribal governments or the private sector. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
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 Executive Order 13175. This rulemaking does not significantly or uniquely affect the communities of Indian tribal governments, nor does it impose any enforceable duties on communities of Indian tribal governments. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not concern an environmental health risk or safety risk.
This action is not a “significant energy action” because it is not likely to have a significant adverse effect on the supply, distribution or use of energy. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
This rulemaking does not involve technical standards.
EPA believes the human health or environmental risk addressed by this action will not have potential disproportionately high and adverse human health or environmental effects on minority, low-income, or indigenous populations because it does not affect the level of protection provided to human health or the environment. This action makes minor changes to recordkeeping and reporting requirements to remove references to U.S. Customs forms and other small edits.
Environmental protection, Administrative practice and procedure, Air pollution control, Chemicals, Imports, Ozone, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, 40 CFR part 82 is proposed to be amended as follows:
42 U.S.C. 7414, 7601, 7671-7671q.
(1) The consignee;
(2) The importer of record;
(3) The actual owner; or
(4) The transferee, if the right to draw merchandise in a bonded warehouse has been transferred.
(g) * * *
(1) * * *
(xii) The U.S. Customs entry number;
(3) * * *
(v) To pass the approved used class I controlled substances through U.S. Customs, the non-objection notice issued by EPA must accompany the shipment through U.S. Customs.
(viii) * * *
(D) The U.S. Customs entry number.
(c) * * *
(2) * * *
(xiii) The U.S. Customs entry number;
(4) * * *
(v) To pass the approved used class II controlled substances through U.S. Customs, the non-objection notice issued by EPA must accompany the shipment through U.S. Customs.
(viii) * * *
(D) The U.S. Customs entry number.
(d) * * *
(2) * * *
(i) The Employer Identification Number of the shipper or their agent;
(3) * * *
(i) The Employer Identification Number of the shipper or their agent; and
(m) * * *
(2) The importer of record;
Environmental Protection Agency (EPA).
Notice of filing of petition and request for comment.
This document announces EPA's receipt of an initial filing of a pesticide petition requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Comments must be received on or before March 10, 2016.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2015-0742, by one of the following methods:
•
•
•
Robert McNally, Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone number: (703) 305-7090; email address:
You may be potentially affected by this action if you are 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.
3.
EPA is announcing receipt of a pesticide petition filed under section 408 of the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, requesting the establishment or modification of regulations in 40 CFR part 180 for residues of pesticide chemicals in or on various food commodities. EPA is taking public comment on the request before responding to the petitioner. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petition described in this document contains data or information prescribed in FFDCA section 408(d)(2), 21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data supports granting of the pesticide petition. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on this pesticide petition.
Pursuant to 40 CFR 180.7(f), a summary of the petition that is the subject of this document, prepared by the petitioner, is included in a docket EPA has created for this rulemaking. The docket for this petition is available at
As specified in FFDCA section 408(d)(3), 21 U.S.C. 346a(d)(3), EPA is publishing notice of the petition so that the public has an opportunity to comment on this request for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petition may be obtained through the petition summary referenced in this unit.
21 U.S.C. 346a.
Environmental Protection Agency (EPA).
Proposed rule; notice of intent.
The Environmental Protection Agency (EPA) Region 8 is issuing a Notice of Intent to Delete the Operable Unit 1 (OU1) Yak Tunnel/Water Treatment Plant; and Operable Unit 3 (OU3), Denver & Rio Grande Western Railroad Company (D&RGW) Slag Piles/Railroad Easement/Railroad Yard, of the California Gulch Superfund Site (Site), located in Lake County, Colorado, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). The EPA and the State of Colorado, through the Colorado Department of Public Health and the Environment, have determined that all appropriate response actions at OU1 and OU3 under CERCLA, other than operation, maintenance, and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.
Comments must be received by
Submit your comments, identified by Docket ID no. EPA-HQ-SFUND-1983-0002, by mail to Linda Kiefer, Remedial Project Manager, Environmental Protection Agency, Region 8, Mail Code 8EPR-SR, 1595 Wynkoop Street, Denver, CO 80202-1129. Comments may also be submitted electronically or through hand delivery/courier by following the detailed instructions in the
Linda Kiefer, Remedial Project Manager, Environmental Protection Agency, Region 8, Mail Code 8EPR-SR, 1595 Wynkoop Street, Denver, CO 80202-1129, (303) 312-6689, email:
In the “Rules and Regulations” Section of today's
For additional information, see the direct final Notice of Partial Deletion which is located in the Rules section of this
This partial deletion pertains to all of OU1 and OU3. Operable Unit 2 (OU2), Malta Gulch Tailing Impoundments and Lower Malta Gulch Fluvial Tailing; Operable Unit 4 (OU4) Upper California Gulch; Operable Unit 5 (OU5), ASARCO Smelters/Slag/Mill Sites; Operable Unit 7 (OU7), Apache Tailing Impoundment; Operable Unit 8 (OU8), Lower California Gulch; Operable Unit 9 (OU9), Residential Populated Areas; and Operable Unit 10 (OU10), Oregon Gulch, were previously deleted from the NPL. Operable Unit 6 (OU6), Starr Ditch/Stray Horse Gulch/Lower Evans Gulch/Penrose Mine Waste Pile; Operable Unit 11 (OU11), Arkansas River Floodplain; and Operable Unit 12 (OU12), Site-wide Surface and Groundwater Quality, are not being considered for deletion as part of this action and will remain on the NPL.
Environmental protection, Air pollution control, Chemicals, Hazardous waste, Hazardous substances, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements, Superfund, Water pollution control, Water supply.
33 U.S.C. 1321(c)(2); 42 U.S.C. 9601-9657; E.O. 13626, 77 FR 56749, 3 CFR, 2013 Comp., p.306; E.O. 12777, 56 FR 54757, 3 CFR, 1991 Comp., p.351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., p.193.
Animal and Plant Health Inspection Service, USDA.
Notice of availability.
We are advising the public that the Animal and Plant Health Inspection Service has prepared a final environmental assessment and finding of no significant impact relative to a national approach for the control of highly pathogenic avian influenza outbreaks within the United States. Based on the environmental assessment and our review of all public comments received, we have concluded that such an approach will not have a significant impact on the quality of the human environment.
Ms. Lori Miller, PE, Senior Staff Officer and Environmental Engineer, APHIS Veterinary Services, 4700 River Road Unit 41, Riverdale, MD 20737; (301) 851-3512. Copies of the final EA and FONSI may be obtained by contacting Ms. Michelle Gray, Environmental Protection Specialist, ERAS/PPD/APHIS, 4700 River Road Unit 149, Riverdale, MD 20737; (301) 851-3146.
Highly pathogenic avian influenza (HPAI) is a significant and often fatal zoonotic disease of poultry. In December 2014, two H5 viruses of HPAI were discovered in the United States. These viruses were subsequently detected in both migratory waterfowl and domestic poultry and significantly affected domestic poultry production within the United States. Two poultry production sectors, commercial meat turkeys and laying chickens, were heavily impacted by the disease, resulting in the loss or destruction of over 48 million birds between December 2014 and June 2015.
Disease eradication efforts, northern migration of wild waterfowl, and the natural disinfecting effect of summer heat have largely halted the spread of the disease within the United States. However, subsequent migrations of potentially infected wild waterfowl could precipitate a new round of outbreaks requiring additional actions by the Animal and Plant Health Inspection Service (APHIS) to control them.
On September 4, 2015, we published in the
The EA recommends an approach in which APHIS uses its centralized management of carcass disposal activities to ensure consistency in responses to HPAI outbreaks throughout the United States. Under this approach, APHIS provides information and other support to State and local authorities to help them determine which depopulation, disposal, and cleaning and disinfection methods are most appropriate for the situation.
We solicited comments for 30 days ending October 5, 2015. We received 3 comments by that date, from national animal welfare organizations and a member of the public. We carefully considered the comments we received on the EA and determined that none raise issues that APHIS had not already considered. Accordingly, APHIS has decided to implement this approach and concluded that it will not have a significant impact on the quality of the human environment. The comments we received are addressed in an appendix to the final EA.
The final EA and FONSI may be viewed on the Regulations.gov Web site (see footnote 1). Copies are also available for public inspection at USDA, Room 1141, South Building, 14th Street and Independence Avenue SW., Washington, DC, between 8 a.m. and 4:30 p.m. Monday through Friday, except holidays. Persons wishing to inspect copies are requested to call ahead to (202) 799-7039 to facilitate entry into the reading room. In addition, copies may be obtained by calling or writing to the appropriate person listed under
The EA and FONSI have been prepared in accordance with: (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
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 Rural Utilities Service (RUS) invites comments on this information collection for which approval from the Office of Management and Budget (OMB) will be requested.
Comments on this notice must be received by April 11, 2016.
Thomas P. Dickson, Acting Director, Program Development and Regulatory Analysis, USDA Rural Utilities Service, 1400 Independence Avenue SW., STOP
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 an information collection that RUS is submitting to OMB for extension.
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 will have practical utility; (b) the accuracy of the Agency's estimate of the burden of the proposed collection of information including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments may be sent to: Thomas P. Dickson, Director, Program Development and Regulatory Analysis, Rural Utilities Service, U.S. Department of Agriculture, STOP 1522, 1400 Independence Avenue SW., Washington, DC 20250-1522, FAX: (202) 720-8435.
The RUS Form 793, Request for Release of Lien and/or Approval of Sale, allows telecommunications program borrowers to seek agency permission to sell some of its assets. The form collects detailed information regarding the proposed sale of a portion of the borrower's system. RUS telecommunications borrowers fill out the form to request RUS approval in order to sell capital assets.
Copies of this information collection can be obtained from Rebecca Hunt, Program Development and Regulatory Analysis, at (202) 205-3660, 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.
Commission on Civil Rights.
Announcement of meetings.
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission), and the Federal Advisory Committee Act (FACA), that a planning meeting of the South Dakota Advisory Committee to the Commission will convene at 12:00 p.m. (MST) on Friday, February 26, 2016, via teleconference. The purpose of the meeting is to review and discuss current civil rights issues in the state, and potential next topics of study by the committee.
Members of the public may listen to the discussion by dialing the following Conference Call Toll-Free Number: 1-888-417-8465; Conference ID: 6984210. Please be advised that before being placed into the conference call, the operator will ask callers to provide their names, their organizational affiliations (if any), and an email address (if available) prior to placing callers into the conference room. Callers can expect to incur charges for calls they initiate over wireless lines, and the Commission will not refund any incurred charges. Callers will incur no charge for calls they initiate over land-line connections to the toll-free phone number.
Persons with hearing impairments may also follow the discussion by first calling the Federal Relay Service (FRS) at 1-800-977-8339 and provide the FRS operator with the Conference Call Toll-Free Number: 1-888-417-8465, Conference ID: 6984210. Members of the public are invited to submit written comments; the comments must be received in the regional office by Monday, March 28, 2016. Written comments may be mailed to the Rocky Mountain Regional Office, U.S. Commission on Civil Rights, 1961 Stout Street, Suite 13-201, Denver, CO 80294, faxed to (303) 866-1050, or emailed to Evelyn Bohor at
Records and documents discussed during the meeting will be available for public viewing as they become available at
• Welcome and Introductions
Richard Braunstein, Chair, South Dakota Advisory Committee
Malee V. Craft, Regional Director, Rocky Mountain Regional Office (RMRO)
• Discussion of civil rights issues in the state to select topic for future study
• Next Steps
Friday, February 26, 2016, at 12:00 p.m. (MST)
To be held via teleconference: Conference Call Toll-Free Number: 1 -888-417-8465, Conference ID: 6984210. TDD: Dial Federal Relay Service 1 -800-977-8339 and give the operator the above conference call number and conference ID.
Malee V. Craft, DFO,
Bureau of the Census, Department of Commerce.
Notice of public event.
The Bureau of the Census (U.S. Census Bureau) is announcing the following event, “Celebrating Openness,” in recognition of National Sunshine Week. In recognizing the 50th Anniversary of the Freedom of Information Act (FOIA) and as part of its efforts to promote the goals of open government, the Census Bureau will hold public workshops describing the components of our Open Government Plan.
The public workshops will be held on Wednesday, March 16 and Thursday, March 17, 2016, from 9:30 a.m. to 3:30 p.m. The Census Bureau also will co-host a kick-off event with the Department of Commerce (DOC) on March 15, 2016, in the DOC Auditorium. Additional information will follow on the DOC event.
The public workshops will be held at the U.S. Census Bureau Training Rooms, T-4 and T-5, 4600 Silver Hill Road, Suitland, MD 20746.
William Savino or Karen Bronson at the Freedom of Information Act and Open Government Office, by telephone (301) 763-2127, by email at
For TTY callers, please call the Federal Relay Service (FRS) at 1-800-877-8339 and give them the above-listed number you would like to call. This service is free and confidential.
The workshops will begin promptly at 9:30 a.m. and end at 3:30 p.m. The agenda will be available a week before the event on the Census Bureau Web site,
The workshops will translate the tenants of open government by detailing how those tenants are operationalized and advanced in our Open Government Plan. Members of the public who are unable to attend in person but wish to participate in the workshops will be provided call-in instructions upon registration. There will be an opportunity for questions and answers following each presentation. The workshops will include topics such as FOIA, Privacy, Open Data, Web site, and Records Management.
The event will be physically accessible to people with disabilities. Individuals requiring accommodations such as sign language interpretation or other auxiliary aids should call Iris Boon at (301) 763-2127 to request accommodations at least five business days in advance.
All registrants will be placed on a visitor's list. All visitors for the event must provide government-issued photo identification in order to enter the building and receive a visitor's badge. For logistical questions, call Nicole Alexander at (301) 763-2127.
Media interested in attending should call the Census Bureau's Public Information Office at (301) 763-3030.
Economic Development Administration, Commerce.
Notice of an open meeting.
The National Advisory Council on Innovation and Entrepreneurship (NACIE) will hold a teleconference meeting on Thursday, February 18, 2016, 2:00-2:45 p.m. Eastern Standard Time (EST) and will be open to the public. During this time, members will discuss and vote on the Capital Continuum Exchange proposal. If approved, the recommendation will be presented to the Secretary in March. The meeting will take place via teleconference.
Thursday, February 18, 2016. Time: 2:00-2:45 p.m. Eastern Standard Time.
N/A. Teleconference: Dial-In: 1-800-593-8978, Passcode: 5807298.
Julie Lenzer, Office of Innovation and Entrepreneurship, Room 78018, 1401 Constitution Avenue NW., Washington, DC 20230; email:
The Council was chartered on November 10, 2009 to advise the Secretary of Commerce on matters related to innovation and entrepreneurship in the United States. NACIE's overarching focus is recommending transformational policies to the Secretary that will help U.S. communities, businesses, and the workforce become more globally competitive. The Council operates as an independent entity within the Office of Innovation and Entrepreneurship (OIE), which is housed within the U.S. Commerce Department's Economic Development Administration. NACIE members are a diverse and dynamic group of successful entrepreneurs, innovators, and investors, as well as leaders from nonprofit organizations and academia.
The purpose of this meeting is to discuss the Council's planned work initiatives in three focus areas: workforce/talent, entrepreneurship, and innovation. The final agenda will be posted on the NACIE Web site at
This is a decision pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 a.m. and 5:00 p.m. in Room 3720, U.S. Department of Commerce, 14th and Constitution Ave. NW., Washington, DC.
This is a decision consolidated pursuant to Section 6(c) of the Educational, Scientific, and Cultural Materials Importation Act of 1966 (Pub. L. 89-651, as amended by Pub. L. 106-36; 80 Stat. 897; 15 CFR part 301). Related records can be viewed between 8:30 a.m. and 5:00 p.m. in Room 3720, U.S. Department of Commerce, 14th and Constitution Avenue NW., Washington, DC.
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (“the Department”) has received requests to conduct administrative reviews of various antidumping and countervailing duty orders and findings with December anniversary dates. In accordance with the Department's regulations, we are initiating those administrative reviews.
Effective date: February 9, 2016.
Brenda E. Waters, Office of AD/CVD Operations, Customs Liaison Unit, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW, Washington, DC 20230, telephone: (202) 482-4735.
The Department has received timely requests, in accordance with 19 CFR 351.213(b), for administrative reviews of various antidumping and countervailing duty orders and findings with December anniversary dates.
All deadlines for the submission of various types of information, certifications, or comments or actions by the Department discussed below refer to the number of calendar days from the applicable starting time.
If a producer or exporter named in this notice of initiation had no exports, sales, or entries during the period of review (“POR”), it must notify the Department within 30 days of publication of this notice in the
In the event the Department limits the number of respondents for individual examination for administrative reviews initiated pursuant to requests made for the orders identified below, the Department intends to select respondents based on U.S. Customs and Border Protection (“CBP”) data for U.S. imports during the period of review. We intend to place the CBP data on the record within five days of publication of the initiation notice and to make our decision regarding respondent selection within 30 days of publication of the initiation
In the event the Department decides it is necessary to limit individual examination of respondents and conduct respondent selection under section 777A(c)(2) of the Act:
In general, the Department has found that determinations concerning whether
In the event the Department limits the number of respondents for individual examination in the administrative review of the antidumping duty order on solar cells and modules from the PRC, the Department intends to select respondents based on volume data contained in responses to Q&V Questionnaires. Further, the Department intends to limit the number of Q&V Questionnaires issued in the review based on CBP data for U.S. imports of solar cells and solar modules from the PRC. The units used to measure the imported quantities of solar cells and solar modules are “number”; however, it would not be meaningful to sum the number of imported solar cells and the number of imported solar modules in attempting to determine the largest PRC exporters of subject merchandise by volume. Therefore, the Department will limit the number of Q&V Questionnaires issued based on the import values in CBP data which will serve as a proxy for imported quantities. Parties subject to the review to which the Department does not send a Q&V Questionnaire may file a response to the Q&V Questionnaire by the applicable deadline if they desire to be included in the pool of companies from which the Department will select mandatory respondents. The Q&V Questionnaire will be available on the Department's Web site at
In the event that the Department limits the number of respondents for individual examination in the administrative review of the antidumping duty order on multilayered wood flooring from the PRC, the Department intends to select respondents based on volume data contained in responses to Q&V Questionnaires. Further, the Department intends to limit the number of Q&V Questionnaires issued in the review based on CBP data for U.S. imports of multilayered wood flooring from the PRC. Since the units used to measure import quantities are not consistent across the Harmonized Tariff Schedule of the United States headings identified in the scope of the order on multilayered wood flooring from the PRC, it would not be meaningful to sum inconsistent units in attempting to determine the largest PRC exporters of subject merchandise by volume. Therefore, the Department will limit the number of Q&V Questionnaires issued based on the import values in CBP data which will serve as a proxy for import quantities. Parties subject to the review to which the Department does not send a Q&V Questionnaire may file a response to the Q&V Questionnaire by the applicable deadline if they desire to be included in the pool of companies from which the Department will select mandatory respondents. The Q&V Questionnaire will be available on the Department's Web site at
Pursuant to 19 CFR 351.213(d)(1), a party that has requested a review may withdraw that request within 90 days of the date of publication of the notice of initiation of the requested review. The regulation provides that the Department may extend this time if it is reasonable to do so. In order to provide parties additional certainty with respect to when the Department will exercise its discretion to extend this 90-day deadline, interested parties are advised that the Department does not intend to extend the 90-day deadline unless the requestor demonstrates that an extraordinary circumstance has prevented it from submitting a timely withdrawal request. Determinations by the Department to extend the 90-day deadline will be made on a case-by-case basis.
In proceedings involving non-market economy (“NME”) countries, the Department begins with a rebuttable presumption that all companies within the country are subject to government control and, thus, should be assigned a single antidumping duty deposit rate. It is the Department's policy to assign all exporters of merchandise subject to an administrative review in an NME country this single rate unless an exporter can demonstrate that it is sufficiently independent so as to be entitled to a separate rate.
To establish whether a firm is sufficiently independent from government control of its export activities to be entitled to a separate rate, the Department analyzes each entity exporting the subject merchandise under a test arising from the
All firms listed below that wish to qualify for separate rate status in the administrative reviews involving NME countries must complete, as appropriate, either a separate rate application or certification, as described below. For these administrative reviews, in order to demonstrate separate rate eligibility, the Department requires entities for whom a review was requested, that were assigned a separate rate in the most recent segment of this proceeding in which they participated, to certify that they continue to meet the criteria for obtaining a separate rate. The Separate Rate Certification form will be available on the Department's Web site at
Entities that currently do not have a separate rate from a completed segment of the proceeding
For exporters and producers who submit a separate-rate status application or certification and subsequently are selected as mandatory respondents, these exporters and producers will no longer be eligible for separate rate status unless they respond to all parts of the questionnaire as mandatory respondents.
In accordance with 19 CFR 351.221(c)(1)(i), we are initiating administrative reviews of the following antidumping and countervailing duty orders and findings. We intend to issue the final results of these reviews not later than December 31, 2016.
During
For the first administrative review of any order, there will be no assessment of antidumping or countervailing duties on entries of subject merchandise entered, or withdrawn from warehouse, for consumption during the relevant provisional-measures “gap” period, of the order, if such a gap period is applicable to the POR.
Interested parties must submit applications for disclosure under administrative protective orders in accordance with 19 CFR 351.305. On January 22, 2008, the Department published
On April 10, 2013, the Department published
Any party submitting factual information in an antidumping duty or countervailing duty proceeding must certify to the accuracy and completeness of that information.
On September 20, 2013, the Department modified its regulation concerning the extension of time limits for submissions in antidumping and countervailing duty proceedings:
These initiations and this notice are in accordance with section 751(a) of the Act (19 U.S.C. 1675(a)) and 19 CFR 351.221(c)(1)(i).
Enforcement and Compliance, International Trade Administration, Department of Commerce.
The Department of Commerce (the Department) is rescinding its administrative review of the antidumping duty order on certain magnesia carbon bricks from Mexico for the period of review September 1, 2014, through August 31, 2015 (POR).
Terre Keaton Stefanova, AD/CVD Operations, Office II, Enforcement and Compliance, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue NW., Washington, DC 20230; telephone: (202) 482-1280.
On September 1, 2015, the Department published in the
On September 30, 2015, in accordance with section 751(a) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(b), the Department received a timely request from the Magnesia Carbon Bricks Fair Trade Committee (the Committee)
Pursuant to 19 CFR 351.213(d)(1), the Department will rescind an administrative review, in whole or in part, if the parties that requested a review withdraw the request within 90 days of the date of publication of the notice of initiation of the requested review. The Committee withdrew its request for review before the 90-day deadline, and no other party requested an administrative review of the antidumping duty order on certain magnesia carbon bricks from Mexico for the POR. Therefore, in response to the timely withdrawal of the request for review and pursuant to 19 CFR 351.213(d)(1), the Department is rescinding this review in its entirety.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 41 days after the date of publication of this notice in the
This notice serves as the only reminder to importers of their responsibility, under 19 CFR 351.402(f)(2), to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice serves as the only reminder to parties subject to administrative protective order (APO) of their responsibility concerning the disposition of proprietary information disclosed under APO in accordance with 19 CFR 351.305(a)(3). Timely written notification of the return or destruction of APO materials, or conversion to judicial protective order, is hereby requested. Failure to comply with the regulations and the terms of an APO is a sanctionable violation.
This notice is published in accordance with section 777(i)(1) of the Act, and 19 CFR 351.213(d)(4).
National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice.
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Written comments must be submitted on or before April 11, 2016.
Direct all written comments to Jennifer Jessup, Departmental Paperwork Clearance Officer, Department of Commerce, Room 6616, 14th and Constitution Avenue NW., Washington, DC 20230 (or via the Internet at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Karma Norman, Northwest Fisheries Science Center, (206) 302-2418 or
This request is for a new information collection.
Fishing livelihoods are both centrally dependent on marine ecosystems and part of the set of forces acting on other components of these ecosystems, including the ecosystem's resident fish and marine species. Alongside social factors like economics and management actions, biophysical dynamics within the ecosystems, including fisheries
For this reason, the Northwest Fisheries Science Center (NWFSC) seeks to conduct fisheries participation analyses which involve a survey of United States (U.S.) West Coast commercial fishing participants. A U.S. mail survey will be conducted. The survey will be voluntary, and contacted individuals may decline to participate. Respondents will be asked to answer questions about their motivations for fishing and other factors that affect participation in the suite of West Coast commercial fisheries. Demographic and employment information will be collected so that responses can be organized based on a respondent typology. This survey is essential because data on smaller scale fishing practices, values, participation decisions and beliefs about fishing livelihoods are sparse; yet, they are critical to the development of usable fishery ecosystem models that account for non-pecuniary benefits of fishing, as well as the ways in which fishing practices shape individual and community well-being.
Respondents will be contacted via mail for administration of the survey.
Comments are invited on: (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Principal DOD Space Advisor Staff, Department of Defense (DOD).
Publicize Consent Order, Notify Public of New DOD Compliance Officer and Provide Points of Contact for Information and/or Comment Submittal.
This is not a notice of solicitation issuance. The Director, Principal DOD Space Advisor Staff, as the Compliance Officer under the Federal Trade Commission (FTC) Decision and Order (hereinafter referred to as the “Consent Order”), in the Matter of Lockheed Martin Corporation (LMC), the Boeing Company (Boeing), and United Launch Alliance, L.L.C. (ULA) (hereinafter referred to as the “Respondents”), Docket No. C-4188, dated May 1, 2007, is posting this notice to publicize the Consent Order, notify the Public of a change in DOD Compliance Officer personnel and to provide points of contact for further information or for comment submittal.
The Consent Order: The Consent Order requires that with regard to covered Government programs, (1) ULA afford all space vehicle manufacturers non-discriminatory treatment for launch services that ULA may provide, and that (2) LMC and Boeing, as space vehicle manufacturers, consider all qualified launch service providers on a non-discriminatory basis. Covered programs are Government programs which are delivered in orbit and utilize medium-to-heavy launch services. The Consent Order also requires firewalls to prevent information from a space vehicle provider being shared by ULA with its Boeing or LMC parent company. Similarly, Boeing and LMC must have firewalls to ensure that other launch service information is not shared with ULA. The Consent Order also requires that the Department of Defense appoint a Compliance Officer to oversee compliance with the Consent Order by all three Respondents. The Consent Order remains in full effect through 30 April 2017. The complete text of the ULA Consent Order and supplementary information is located on the following FTC Web site:
DOD Compliance Officer: The DOD Compliance Officer is the Director, Principal DOD Space Advisor Staff. The duties of this position are now conducted by Mr. Winston A. Beauchamp.
Points of Contact for Further Information or Inquiries: For further information and inquires, or to request a meeting with the DOD Compliance Officer or her Government Compliance Team, interested parties should contact either Mrs. Sarah Beth Cliatt (Compliance Division Chief), Tel: 719-556-2268; or Colonel Marc Berkstresser (Deputy Compliance Division Chief), Tel: 703-693-3634.
Office of the Under Secretary (Personnel and Readiness), DoD.
Notice.
The Servicemembers Civil Relief Act, as codified at 50 U.S.C. App. § 3951, prohibits a landlord from evicting a Service member (or the Service member's family) from a residence during a period of military service except by court order. The law as originally passed by Congress applied to dwellings with monthly rents of $2,400 or less. The law requires the Department of Defense to adjust this amount annually to reflect inflation and to publish the new amount in the
Lt Col Reggie D. Yager, Office of the Under Secretary of Defense for Personnel and Readiness, (703) 571-9301.
Department of the Navy, DoD.
Notice of partially closed meeting.
The U.S. Naval Academy Board of Visitors will meet to make such inquiry, as the Board shall deem necessary, into the state of morale and discipline, the curriculum, instruction, physical equipment, fiscal affairs, and academic methods of the Naval Academy. The executive session of this meeting from 11:00 a.m. to 12:00 p.m. on March 21, 2016, will include discussions of new and pending administrative/minor disciplinary infractions and non-judicial punishment proceedings involving midshipmen attending the Naval Academy to include but not limited to individual honor/conduct violations within the Brigade; the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. For this reason, the executive session of this meeting will be closed to the public.
The open session of the meeting will be held on March 21, 2016, from 9:00 a.m. to 11:00 a.m. The executive session held from 11:00 a.m. to 12:00 p.m. will be the closed portion of the meeting.
The meeting will be held at the U.S. Naval Academy, Annapolis, MD. The meeting will be handicap accessible.
Lieutenant Commander Eric Madonia, USN, Executive Secretary to the Board of Visitors, Office of the Superintendent, U.S. Naval Academy, Annapolis, MD 21402-5000, 410 293-1503.
This notice of meeting is provided per the Federal Advisory Committee Act, as amended (5 U.S.C. App.). The executive session of the meeting from 11:00 a.m. to 12:00 p.m. on March 21, 2016, will consist of discussions of new and pending administrative/minor disciplinary infractions and non-judicial punishments involving midshipmen attending the Naval Academy to include but not limited to, individual honor/conduct violations within the Brigade. The discussion of such information cannot be adequately segregated from other topics, which precludes opening the executive session of this meeting to the public. Accordingly, the Department of the Navy/Assistant for Administration has determined in writing that the meeting shall be partially closed to the public because the discussions during the executive session from 11:00 a.m. to 12:00 p.m. will be concerned with matters protected under sections 552b(c)(5), (6), and (7) of title 5, United States Code.
5 U.S.C. 552b)
Department of the Navy, DoD.
Notice; correction.
The Department of the Navy published a document in the
Rita Manak, Head, Technology Transfer Office, NRL Code 1004, 4555 Overlook Avenue SW., Washington, DC 20375-5320, telephone 202 767-3083. Due to U.S. Postal delays, please fax 202 404-7920, email:
In the
1. In the first and second column, on page 44428, revise the
“
Anyone wishing to object to the grant of this license must file written objections along with supporting evidence, if any, not later than February 24, 2016.
Department of the Navy, DoD.
Notice.
The Department of the Navy (DoN), after carefully weighing the strategic, operational, and environmental consequences of the proposed action, announces its decision to both accommodate future military operational increases and implement
The complete text of the Record of Decision is available at
On December 14, 2015, the Commission published a “60-day Public Notice” in the above-captioned proceeding,
This errata notice serves to correct the section and associated table for the FERC-542 (Gas Pipeline Rates: Rate Tracking, OMB Control No. 1902-0070).
The Abstract should indicate that the FERC-542 also includes the reporting requirements in 18 CFR 154.401 (research, development, and demonstration [RD&D] expenditures) and 18 CFR 154.403 (Periodic rate adjustments). In the table for FERC-542, the correct number of respondents is 87, with an average of 2.13 responses per respondent and a total of 185 responses.
With the updates stated above, the correct total annual burden hours is 370, and the correct total annual cost is $26,640.
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
eFiling is encouraged. More detailed information relating to filing requirements, interventions, protests, service, and qualifying facilities filings can be found at:
The Federal Energy Regulatory Commission hereby gives notice that members of the Commission's staff may attend the following meetings related to the transmission planning activities of the PJM Interconnection, L.L.C. (PJM):
The above-referenced meetings will be held at:
PJM Conference and Training Center, PJM Interconnection, 2750 Monroe Boulevard, Audubon, PA 19403.
The above-referenced meetings are open to stakeholders. Further information may be found at
The discussions at the meetings described above may address matters at issue in the following proceedings:
Docket No. ER16-429,
Docket No. ER16-736,
Docket No. ER14-972,
Docket No. ER14-1485,
Docket Nos. ER13-1944,
Docket No. ER15-1344,
Docket No. ER15-1387,
Docket No. ER15-2562,
Docket No. ER15-2563,
Docket No. EL15-18,
Docket No. EL15-41,
Docket Nos. ER13-1927,
Docket No. ER15-2114,
Docket No. EL15-79,
Docket No. EL15-95,
Docket No. EL15-67,
Docket No. EL05-121,
For more information, contact the following: Jonathan Fernandez; Office of Energy Market Regulation, Federal Energy Regulatory Commission, (202) 502-6604,
On January 27, 2016, James W. Park filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Park Farm Hydro Project would have an installed capacity of 15 kilowatts (kW), and would be located along the Lower Latham Ditch at an existing 400-foot-long concrete drop structure. The project would be located near the Town of Kersey, in Weld County, Colorado.
The proposed project would have a total installed capacity of 15 kW.
A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.
Deadline for filing motions to intervene is 30 days from the issuance date of this notice.
Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.
The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at
Take notice that the Federal Energy Regulatory Commission (Commission) will hold a Technical Conference on Wednesday, June 1, 2016, from 10:00 a.m. to 4:00 p.m. This Commissioner-led conference will be held in the Commission Meeting Room at the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426. The conference will be open for the public to attend. Advance registration is not required, but is encouraged. Attendees may register at
The purpose of the conference is to discuss policy issues related to the reliability of the Bulk-Power System. The Commission will issue an agenda at a later date.
Information on this event will be posted on the Calendar of Events on the Commission's Web site,
Commission conferences are accessible under section 508 of the Rehabilitation Act of 1973. For accessibility accommodations, please send an email to
For more information about this conference, please contact: Sarah McKinley, Office of External Affairs, Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, (202) 502-8368,
This is a supplemental notice in the above-referenced proceeding of Iron Springs Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing comments, motions to intervene, protests, and recommendations is 30 days from the date of issuance of this notice by the Commission. The Commission strongly encourages electronic filing. Please file motions to intervene, protests, comments, or recommendations using the Commission's eFiling system at
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
This is a supplemental notice in the above-referenced proceeding of Granite Mountain Solar West, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Escalante Solar III, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Escalante Solar I, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Take notice that on February 1, 2016, pursuant to Sections 206 and 306 of the Federal Power Act, 16 U.S.C. 824e, 825e (2012), and Rule 206 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.206 and 385.212 (2015), Southern Maryland Electric Cooperative, Inc. (Complainant) filed a formal complaint against J.P. Morgan Ventures Energy Corporation (Respondent) alleging that Respondent has the right to Capacity Performance (CP) credit under a bilateral capacity purchase agreement that it entered into with Complainant. Complainant believes that Respondent does not intend to transfer CP credit to Complainant, starting with the 2016-2017 Delivery Year that begins June 1, 2016, all as more fully explained in the complaint.
Complainant certifies that copies of the complaint were served on the designated corporate officials for 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 and 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 on January 20, 2016, ANR Pipeline Company (ANR), having its principal place of business at 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700, filed in the above referenced docket an application pursuant to sections 7(c) of the Natural Gas Act (NGA), and Part 157 of the Commission's regulations requesting authorization to install, own and operate its Collierville Expansion Project (Project) located in Shelby Counties, Tennessee, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Any questions concerning this application may be directed to Robert Jackson, Manager, Certificates and Regulatory Administration, ANR Pipeline Company, 700 Louisiana Street, Suite 700, Houston, Texas 77002-2700; by calling (832) 320-5487; by faxing (832) 320-6487; or by emailing
Specifically, the applicant proposes the Project will consist of modifications to upgrade ANR's existing Collierville Meter Station, and install one (1) new compressor station consisting of one (1) new, approximately 4,700 horsepower turbine compressor unit and appurtenant facilities. Upon completion, ANR avers that the Project will expand the delivery capability of ANR's existing Collierville Meter Station by an additional 200 million cubic feet per day (MMcf/d), while maintaining ANR's current certificated capacity levels. ANR estimates the total cost of the Project to be $36.7 million.
Pursuant to section 157.9 of the Commission's rules (18 CFR 157.9), within 90 days of this Notice, the Commission staff will either: complete its environmental assessment (EA) and place it into the Commission's public record (eLibrary) for this proceeding; or issue a Notice of Schedule for Environmental Review. If a Notice of Schedule for Environmental Review is issued, it will indicate, among other milestones, the anticipated date for the Commission staff's issuance of the final environmental impact statement (FEIS) or EA for this proposal. The filing of the EA in the Commission's public record for this proceeding or the issuance of a Notice of Schedule for Environmental Review will serve to notify federal and state agencies of the timing for the completion of all necessary reviews, and the subsequent need to complete all federal authorizations within 90 days of the date of issuance of the Commission staff's FEIS or EA.
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit seven copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Persons who wish to comment only on the environmental review of this project should submit an original and two copies of their comments to the Secretary of the Commission. Environmental commentors will be placed on the Commission's environmental mailing list, will receive copies of the environmental documents, and will be notified of meetings associated with the Commission's environmental review process. Environmental commentors will not be required to serve copies of filed documents on all other parties. However, the non-party commentors will not receive copies of all documents filed by other parties or issued by the Commission (except for the mailing of environmental documents issued by the Commission) and will not have the right to seek court review of the Commission's final order.
The Commission strongly encourages electronic filings of comments, protests and interventions in lieu of paper using the “eFiling” link at
Comment Date: 5:00 p.m. Eastern Time on February 24, 2016.
On January 27, 2016, the Castle Valley Special Service District filed a notice of intent to construct a qualifying conduit hydropower facility, pursuant to section 30 of the Federal Power Act (FPA), as amended by section 4 of the Hydropower Regulatory Efficiency Act of 2013 (HREA). The proposed Ferron Water Treatment Plant Project would have an installed capacity of 6 kilowatts (kW) and would be located at a vault on an 8-inch-diameter water supply pipe entering the water treatment plant The project would be located near the town of Ferron in Emery County, Utah.
A qualifying conduit hydropower facility is one that is determined or deemed to meet all of the criteria shown in the table below.
Deadline for filing motions to intervene is 30 days from the issuance date of this notice.
Anyone may submit comments or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210 and 385.214. Any motions to intervene must be received on or before the specified deadline date for the particular proceeding.
The Commission strongly encourages electronic filing. Please file motions to intervene and comments using the Commission's eFiling system at
This is a supplemental notice in the above-referenced proceeding of Innovative Solar 43, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Enterprise Solar, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Escalante Solar II, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
In accordance with the National Environmental Policy Act of 1969 and the Federal Energy Regulatory Commission's (Commission) regulations, 18 CFR part 380 (Order No. 486, 52 FR 47897), the Office of Energy Projects has reviewed the application for an original license to construct the Coleman Hydroelectric Project, located
The final EA includes staff's analysis of the potential environmental impacts of the project and concludes that licensing the project, with appropriate environmental protective measures, would not constitute a major federal action that would significantly affect the quality of the human environment.
A copy of the final EA is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
You may also register online at
For further information, contact Jim Hastreiter at (503) 552-2760.
Take notice that the Commission received the following electric rate filings:
Description: § 205(d) Rate Filing: Rate Schedule No. 55 SPPC & Liberty 2nd Amndmt Service Agr. to be effective 1/1/2016.
Description: § 205(d) Rate Filing: NEP Cost Sharing Agreement—Greater Boston Area Transmission Solution Plan to be effective 4/4/2016.
Take notice that the Commission received the following open access transmission tariff 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 exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
The filings are accessible in the Commission's eLibrary system by clicking on the links or querying the docket number.
Any person desiring to intervene or protest in any of the above proceedings must file in accordance with Rules 211 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:
This is a supplemental notice in the above-referenced proceeding of LQA, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 22, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's
Rule 2010 of the Federal Energy Regulatory Commission's (Commission) Rules of Practice and Procedure, 18 CFR 385.2010, provides that, to eliminate unnecessary expense or improve administrative efficiency, the Secretary may establish a restricted service list for a particular phase or issue in a proceeding. The restricted service list should contain the names of persons on the service list who, in the judgment of the decisional authority establishing the list, are active participants with respect to the phase or issue in the proceeding for which the list is established.
The Commission staff is consulting with the Kentucky State Historic Preservation Officer and the Advisory Council on Historic Preservation (Advisory Council) pursuant to the Advisory Council's regulations, 36 CFR part 800, implementing section 106 of the National Historic Preservation Act,
On September 30, 2015, Commission staff established a restricted service list for the Kentucky River Lock and Dam No. 11 Hydroelectric Project. Since that time, changes have occurred and therefore, the restricted service list is revised as follows:
Replace “Lisa C. Baker, Acting THPO, United Keetoowah Band of Cherokee Indians in Oklahoma” with “Assistant Chief Joe Bunch, or Representative, United Keetoowah Band of Cherokee Indians in Oklahoma.”
This is a supplemental notice in the above-referenced proceeding of Nassau Energy, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of Granite Mountain Solar East, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is February 23, 2016.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 5 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for electronic review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the Web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
Environmental Protection Agency (EPA).
Notice; public teleconference.
Pursuant to the Federal Advisory Committee Act (FACA), Public Law 92-463, the U.S. Environmental Protection Agency (EPA) hereby provides notice that the National Environmental Justice Advisory Council (NEJAC) will meet on the dates and times described below. All meetings are open to the public. Members of the public are encouraged to provide comments relevant to the specific issues being considered by the NEJAC. For additional information about registering to attend the meeting or to provide public comment, please see Registration under
The NEJAC will host a public teleconference meeting on Thursday, February 25, 2016, at 3:00 p.m. Eastern Time. The discussion will focus on EPA's Draft Environmental Justice Primer Framework. This action-oriented educational and training tool is being designed as a resource for port facilities of the perspectives, priorities, and challenges often unique to overburdened, vulnerable communities. The resource materials and process steps are designed to promote successful engagement with nearby communities in decision-making about environmental health and related concerns associated with port-related activities.
Public comment period relevant to the specific issues being considered by the NEJAC (see
Questions or correspondence concerning the teleconference meeting should be directed to Karen L. Martin, U.S. Environmental Protection Agency, by mail at 1200 Pennsylvania Avenue NW., (MC2201A), Washington, DC 20460; by telephone at 202-564-0203; via email at
The Charter of the NEJAC states that the advisory committee “will provide independent advice and recommendations to the Administrator about broad, crosscutting issues related to environmental justice. The NEJAC's efforts will include evaluation of a broad range of strategic, scientific, technological, regulatory, community engagement and economic issues related to environmental justice.”
Registrations for the February 25, 2016, pubic teleconference will be processed
Individuals or groups making remarks during the public comment period will be limited to seven (7) minutes. To accommodate the number of people who want to address the NEJAC, only one representative of a particular community, organization, or group will be allowed to speak. Written comments can also be submitted for the record. The suggested format for individuals providing public comments is as follows: Name of speaker; name of organization/community; city and state; and email address; brief description of the concern, and what you want the NEJAC to advise EPA to do. Written comments received by registration deadline, will be included in the materials distributed to the NEJAC prior to the teleconference. Written comments received after that time will be provided to the NEJAC as time allows. All written comments should be sent to Karen L. Martin, EPA, via email at
For information about access or services for individuals requiring assistance, please contact Karen L. Martin, at (202) 564-0203 or via email at
Environmental Protection Agency (EPA).
Notice.
This document announces the Office of Management and Budget (OMB) responses to Agency Clearance requests, in compliance with the Paperwork Reduction Act (44 U.S.C. 3501
Courtney Kerwin (202) 566-1669, or email at
EPA ICR Number 1550.10; Conflict of Interest Rule #1 (Renewal); 40 CFR 1552 and 486(c); was approved with change 06/03/2015; OMB Number 2030-0023; expires on 6/30/2018.
EPA ICR Number 2103.05; Title IV of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002: Drinking Water Security and Safety (Renewal); was approved without change on 06/16/2015; OMB Control Number 2040-0253; expires on 6/30/2018.
EPA ICR Number 2234.04; 2015 Drinking Water Infrastructure Needs Survey and Assessment (Reinstatement); approved without change 06/08/2015; OMB Control Number 2040-0274; expires 6/30/2018.
EPA ICR Number 1189.25; Disposal of Coal Combustion Residuals from Electric Utilities (Final Rule); 40 CFR 40 CFR 257, subpart D, 260, 261; approved with change 06/29/2015; OMB Control Number 2050-0053; expires 6/30/2018.
EPA ICR Number 1425.10; Application for Reimbursement to Local Governments for Emergency Response to Hazardous Substance Releases under CERCLA section 123 (Renewal); 40 CFR part 40 CFR 310.2-310.12 and 310, appendix II; approved without change 06/01/2015; OMB Control Number 2050-0077; expires 6/30/2018.
EPA ICR Number 1767.07; NESHAP for Primary Aluminum Reduction Plants (40 CFR part 63, subpart LL)(Renewal); 40 CFR 63, subparts A and LL, approved with change 06/01/2015; OMB Control Number 2060-0360; expires 06/30/2018.
EPA ICR Number 2277.04; NESHAP for Area Sources: Electric Arc Furnace Steelmaking Facilities (Renewal); 40 CFR part 63, subparts A and YYYYY; approved with change 06/03/2015; OMB Control Number 2060-0608; expires 06/30/2018.
EPA ICR Number 1198.10; Chemical-Specific Rules, TSCA section 8(a); 40 CFR 40 CFR 704; approved without change on 06/01/2015; OMB Control Number 2070-0067; expires 06/30/2018.
EPA ICR Number 1741.07; Correction of Misreported Chemical Substances on the Toxic Substances Control Act (TSCA) Chemical Substances Inventory; approved with change on 06/02/2015; OMB Control Number 2070-0145; expires 06/30/2018.
EPA ICR Number 2002.06; Cross-Media Electronic Reporting (Renewal); 40 CFR 3; approved without change on 07/09/2015; OMB Control Number 2025-0003; expires 07/31/2018.
EPA ICR Number 1391.10; Clean Water Act State Revolving Fund Program (Renewal); 40 CFR 35; approved without change on 07/02/2015; OMB Control Number 2040-0118; expires 07/31/2016.
EPA ICR Number 1959.09; National Listing of Fish Advisories (Renewal); approved with change on 07/08/2015; OMB Control Number 2040-0226; expires 07/30/2018.
EPA ICR Number 1774.06; Mobile Air Conditioner Retrofitting Program (Renewal); 40 CFR 82; approved with change 07/15/2015; OMB Control Number 2060-0350; expires 07/30/2018.
EPA ICR Number 1800.07; Information Requirements for Locomotives and Locomotive Engines (Renewal); 40 CFR 92 and 1033; approved with change on 07/20/2015; OMB Control Number 2060-0392; expires 07/30/2018.
EPA ICR Number 2258.03; PM 2.5 NAAQS Implementation Rule (Proposed Rule); 40 CFR 51; comment filed 06/03/2015.
Federal Communications Commission.
Notice of public meeting.
In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting on Wednesday, March 9th, 2016 in the Commission Meeting Room, from 12:30 p.m. to 4 p.m. at the Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Wednesday, March 9th, 2016.
Federal Communications Commission, 445 12th Street SW., Washington, DC 20554.
Walter Johnston, Chief, Electromagnetic Compatibility Division, 202-418-0807;
This is the first meeting of the Technological Advisory Council for 2016. At its prior meeting on December 9th, 2015, the Council had discussed possible work initiatives for 2016. These initiatives have been discussed in the interim within the FCC, with the TAC chairman, as well as with individual TAC members. At the March meeting, the FCC Technological Advisory Council will discuss its proposed work program for 2016. The FCC will attempt to accommodate as many people as possible. However, admittance will be limited to seating availability. Meetings are also broadcast live with open captioning over the Internet from the FCC Live Web page at
Federal Communications Commission.
Notice and request for comments.
As part of its continuing effort to reduce paperwork burdens, and as required by the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520), the Federal Communications Commission (FCC or Commission) invites the general public and other Federal agencies to take this opportunity to comment on the following information collections. Comments are requested concerning: Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; the accuracy of the Commission's burden estimate; ways to enhance the quality, utility, and clarity of the information collected; ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology; and ways to further reduce the information collection burden on small business concerns with fewer than 25 employees. The FCC may not conduct or sponsor a collection of information unless it displays a currently valid OMB control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Written PRA comments should be submitted on or before April 11, 2016. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Cathy Williams, FCC, via email
For additional information about the information collection, contact Cathy Williams at (202) 418-2918.
Federal Election Commission.
Thursday, February 11, 2016 At 10:00 a.m.
999 E Street NW., Washington, DC (Ninth Floor).
This meeting will be open to the public.
Correction and Approval of Minutes for December 17, 2015 and January 14, 2016
Draft Advisory Opinion 2015-14: Hillary for America
Draft Advisory Opinion 2015-16: Niger Innis for Congress
Audit Division Recommendation Memorandum on the Oklahoma Democratic Party (ODP) (A12-06)
Management and Administrative Matters
Individuals who plan to attend and require special assistance, such as sign language interpretation or other reasonable accommodations, should contact Shawn Woodhead Werth, Secretary and Clerk, at (202) 694-1040, at least 72 hours prior to the meeting date.
Judith Ingram, Press Officer. Telephone: (202) 694-1220.
Notice is given that a complaint has been filed with the Federal Maritime Commission (Commission) by D.F. Young, Inc., hereinafter “Complainant,” against NYK Line (North America) Inc., hereinafter “Respondent.” Complainant states that it is an ocean transportation intermediary licensed by the Commission and a Pennsylvania corporation. Complainant alleges that Respondent is a New York corporation and a common carrier of goods by water.
Complainant alleges that Respondent has violated the Shipping Act, 46 U.S.C. 41102, and the Commission's regulations at 46 CFR 515.42 “by refusing to compensate Complainant for the freight forwarding services performed on Ford [Motor Company] shipments placed on vessels owned/and or operated by Respondent and/or its agents or affiliates, for which Respondent received freight charges, according to the terms of the Respondent's applicable tariffs . . . .”
Complainant seeks an award of reparations in the amount of $252,776.89, plus interest and attorneys fees, “a payment of additional amounts, not exceeding twice the amount of any award for injuries” if violation of 46 U.S.C. 41103(3) be shown, and “other such relief or award as the FMC shall determine.”
The full text of the complaint can be found in the Commission's Electronic Reading Room at
This proceeding has been assigned to the Office of Administrative Law Judges. The initial decision of the presiding officer in this proceeding shall be issued by February 3, 2017, and the final decision of the Commission shall be issued by August 17, 2017.
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 Regulatory Secretariat Division will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a previously approved information collection requirement concerning use of the Data Universal Numbering System (DUNS) as primary contractor identification. The DUNS number is the nine-digit identification number assigned by Dun and Bradstreet Information Services to an establishment.
Submit comments on or before April 11, 2016.
Submit comments identified by Information Collection 9000-0145, Use of Data Universal Numbering System (DUNS) as Primary Contractor Identification, by any of the following methods:
• Regulations.gov:
• Mail: General Services Administration, Regulatory Secretariat Division (MVCB), 1800 F Street NW., Washington, DC 20405. ATTN: Ms. Flowers/IC 9000-0145, Use of Data Universal Numbering System (DUNS) as Primary Contractor Identification.
Mr. Curtis E. Glover, Sr., Procurement Analyst, Office of Governmentwide Acquisition Policy, GSA 202-501-1448 or via email at
The Data Universal Numbering System (DUNS) number is the nine-digit identification number assigned by Dun and Bradstreet Information Services to an establishment. The Government uses the DUNS number to identify contractors in reporting to the Federal Procurement Data System (FPDS). The FPDS provides a comprehensive mechanism for assembling, organizing, and presenting contract placement data for the Federal Government. Federal agencies report data on all contracts in excess of the micro-purchase threshold to the Federal Procurement Data Center which collects, processes, and disseminates official statistical data on Federal contracting. Contracting officers insert the Federal Acquisition Regulation (FAR) provision at 52.204-6, Data Universal Numbering System (DUNS) Number, in solicitations they expect will result in contracts in excess of the micro-purchase threshold and do not contain FAR 52.204-7, Central Contractor Registration. The majority of offerors submit their DUNS through CCR as required by FAR 52.204-7, and not under the FAR provision at 52.204-6.
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
Office of Government-wide Policy, General Services Administration (GSA).
Meeting Notice.
Notice of this meeting and these conference calls is being provided according to the requirements of the Federal Advisory Committee Act, 5 U.S.C. App. 10(a)(2). This notice provides the agenda and schedule for the April 28, 2016 meeting of the Green Building Advisory Committee (the Committee) and schedule for a series of conference calls, supplemented by Web meetings, for a new task group of the Committee. The meeting is open to the public and the site is accessible to individuals with disabilities. The conference calls are open for the public to listen in. Interested individuals must register to attend as instructed below under
Mr. Ken Sandler, Designated Federal Officer, Office of Federal High-Performance Green Buildings, Office of Government-wide Policy, General Services Administration, 1800 F Street NW., Washington, DC 20405, telephone 202-219-1121 (
Contact Ken Sandler at
The
The conference calls will allow the task group to coordinate the development of consensus recommendations to the full Committee, which will in turn decide whether to proceed with formal advice to GSA based upon these recommendations. The task group will provide recommendations in support of GSA's development of model commercial leasing provisions, a requirement of the Energy Efficiency Improvement Act of 2015 (42 U.S.C. 17062).
• Welcome, Introductions, Updates & Plans for Today
• Portfolio Prioritization: Task Group Report & Discussion
• Green Leasing: Task Group Report & Discussion
• Working Lunch (with Presentation)
• Energy Use Index: Task Group Report & Discussion
• Discussion of the Committee's Overall Direction
• Topics Proposed by Committee Members
• Public Comment Period
• Closing comments
• Adjourn
Detailed agendas, background information, and updates for the meeting and conference calls will be posted on GSA's Web site at
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), the CDC, National Center for Environmental Health/Agency for Toxic Substances and Disease Registry (NCEH/ATSDR) announces the following meeting of the aforementioned subcommittee:
This
Agenda items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office has been delegated the authority to sign
The Centers for Disease Control and Prevention (CDC) has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The notice for the proposed information collection is published to obtain comments from the public and affected agencies.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address any of the following: (a) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) Evaluate the accuracy of the agencies estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) Enhance the quality, utility, and clarity of the information to be collected; (d) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
To request additional information on the proposed project or to obtain a copy of the information collection plan and instruments, call (404) 639-7570 or send an email to
CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing (OMB Control No. 0920-0600, Expires 5/31/2016)—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
As part of the continuing effort to support domestic public health objectives for treatment of tuberculosis (TB), prevention of multi-drug resistance, and surveillance programs, CDC is requesting approval for an extension of three years from the Office of Management and Budget to continue information collection from participants in the Model Performance Evaluation Program for Mycobacterium Tuberculosis Susceptibility Testing. Extension of this information collection will not require changes in the scope of the study, methodology, information collection instruments, or burden on the respondents.
While the overall number of cases of TB in the U.S. has decreased, rates still remain high among foreign-born persons, prisoners, homeless populations, and individuals infected with HIV in major metropolitan areas. To reach the goal of eliminating TB, the Model Performance Evaluation Program for Mycobacterium Tuberculosis Drug Susceptibility Testing is used to monitor and evaluate performance and practices among national laboratories performing M. tuberculosis susceptibility testing. Participation in this program is one way laboratories can ensure high-quality laboratory testing, resulting in accurate and reliable testing results.
Extension of this information collection provides CDC with an
Participants in this program include domestic clinical and public health laboratories. Data collection from laboratory participants occurs twice per year. The data collected in this program will include the susceptibility test results of primary and secondary drugs, drug concentrations, and test methods performed by laboratories on a set of performance evaluation (PE) samples. The PE samples are sent to participants twice a year. Participants also report demographic data such as laboratory type and the number of tests performed annually.
There is no cost to respondents to participate other than their time.
This gives notice under the Federal Advisory Committee Act (Pub. L. 92-463) of October 6, 1972, that the Advisory Committee to the Director, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS), has been renewed for a 2-year period extending through February 1, 2018.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS).
Notice of Computer Matching Program (CMP).
In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the re-establishment of a CMP that CMS plans to conduct with the Social Security Administration (SSA).
The public should send comments to: CMS Privacy Officer, Division of Security, Privacy Policy & Governance, Information Security & Privacy Group, Office of Enterprise Information, CMS, Room N1-24-08, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9:00 a.m.-3:00 p.m., Eastern Time zone.
Elizabeth Kane, Acting Director, Verifications Policy & Operations Division, Eligibility and Enrollment Policy and Operations Group, Center for Consumer Information and Insurance Oversight, CMS, 7501 Wisconsin Avenue, Bethesda, MD 20814, Office Phone: (301) 492-4418, Facsimile: (443) 380-5531, E-Mail:
The Computer Matching and Privacy Protection Act of 1988 (Public Law (Pub. L.) 100-503), amended the Privacy Act (5 U.S.C. 552a) by describing the manner in which computer matching involving Federal agencies could be performed and adding certain protections for individuals applying for and receiving Federal benefits. Section 7201 of the Omnibus Budget Reconciliation Act of 1990 (Pub. L. 101-508) further amended the Privacy Act regarding protections for such individuals. The Privacy Act, as amended, regulates the use of computer matching by Federal agencies when records in a system of records (SOR) are matched with other Federal, state, or local government records. It requires Federal agencies involved in computer matching programs to:
1. Negotiate written agreements with the other agencies participating in the matching programs;
2. Obtain the Data Integrity Board approval of the match agreements;
3. Furnish detailed reports about matching programs to Congress and OMB;
4. Notify applicants and beneficiaries that the records are subject to matching; and,
5. Verify match findings before reducing, suspending, terminating, or denying an individual's benefits or payments.
This matching program meets the requirements of the Privacy Act of 1974, as amended.
“Computer Matching Agreement between the Department of Health and Human Services, Centers for Medicare & Medicaid Services and the Social Security Administration for Determining Enrollment or Eligibility for Insurance Affordability Programs under the Patient Protection and Affordable Care Act”
Unclassified
Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and the Social Security Administration (SSA)
Sections 1411 and 1413 of the Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148), as amended by the Health Care and Education Reconciliation Act of 2010 (Pub. L. 111-152) (collectively, the ACA) require the Secretary of HHS to establish a program for determining eligibility for certain state health subsidy programs, and certifications of Exemption; and authorize use of secure, electronic interfaces and an on-line system for the verification of eligibility.
The purpose of the Computer Matching Agreement (CMA) is to re-establish the terms, conditions, safeguards, and procedures under which SSA will disclose information to CMS in connection with the administration of state health subside programs under the ACA and its implementing regulations. SSA will provide data to CMS, and CMS will use SSA data needed to make initial eligibility determinations, eligibility redeterminations and renewal decisions, including appeal determinations, for state health subsidy programs and certifications of exemption. State health subsidy programs include:
1. Qualified Health Plan through an Exchange established under the ACA,
2. Advance payments of the premium tax credit and cost sharing reductions,
3. Medicaid,
4. Children's Health Insurance Program, and
5. Basic Health Program.
As set forth in the CMA, SSA will provide CMS the following information when relevant: (1) Social Security number (SSN) verifications, (2) a death indicator, (3) an indicator of a finding of disability by SSA under title II of the Social Security Act, (4) prisoner data, (5) monthly and annual Social Security benefit information under title II of the Social Security Act, (6) quarters of coverage, and (7) confirmation that an allegation of citizenship is consistent with SSA records.
The matching program will be conducted with data maintained by CMS in the Health Insurance Exchanges System (HIX), CMS System No. 09-70-0560, as amended, published at 78 FR 8538 (Feb. 6, 2013), 78 FR 32256 (May 29, 2013) and 78 FR 63211 (October 23, 2013).
The matching program will also be conducted with data maintained by SSA in the following SORs:
• Master Files of SSN Holders and SSN Applications, SSA/OEEAS, 60-0058, 75 FR 82121 (December 29, 2010), as amended 78 FR 40542 (July 5, 2013);
• Prisoner Update Processing System (PUPS), SSA/OPB, 60-0269, 64 FR 11076 (March 8, 1999), as amended 72 FR 69723 (December 10, 2007) and 78 FR 40542 (July 5, 2013);
• Master Beneficiary Record, SSA/ORSIS, 60-0090, 71 FR 1826 (January 11, 2006), as amended 72 FR 69723 (December 10, 2007) and 78 FR 40542 (July 5, 2013);
• Earnings Recording and Self-Employment Income System, SSA/OEEAS, 60-0059, 71 FR 1819(January 11, 2006), as amended 78 FR 40542 (July 5, 2013).
The CMP will become effective no sooner than 40 days after the report of the matching program is sent to OMB and Congress, or 30 days after publication in the
Office of Head Start (OHS), Administration for Children and Families, HHS.
Notice of meetings.
Pursuant to the Improving Head Start for School Readiness Act of 2007, Public Law 110-134, notice is hereby given of three 1-day Tribal Consultation Sessions to be held between the Department of Health and Human Services (HHS), Administration for Children and Families, OHS leadership and the leadership of Tribal Governments operating Head Start (including Early Head Start) programs. The purpose of these Consultation Sessions is to discuss ways to better meet the needs of American Indian and Alaska Native children and their families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations [42 U.S.C. 9835, section 640(l)(4)].
Locations:
Angie Godfrey, Regional Program Manager, Region XI/AIAN, Office of Head Start, email
HHS announces OHS Tribal Consultations for leaders of Tribal Governments operating Head Start and Early Head Start programs. The agenda for the scheduled OHS Tribal Consultations in Albuquerque, New Mexico, Arlington, Virginia, and Spokane, Washington, will be organized around the statutory purposes of Head Start Tribal Consultations related to meeting the needs of American Indian and Alaska Native children and families, taking into consideration funding allocations, distribution formulas, and other issues affecting the delivery of Head Start services in their geographic locations. In addition, OHS will share actions taken and in progress to address the issues and concerns raised in the 2015 OHS Tribal Consultations.
The Consultation Sessions will be conducted with elected or appointed leaders of Tribal Governments and their designated representatives [42 U.S.C. 9835, section 640(l)(4)(A)]. Designees must have a letter from the Tribal Government authorizing them to represent the tribe. Tribal Governments must submit the designee letter at least 3 days in advance of the Consultation Session to Angie Godfrey at
A detailed report of each Consultation Session will be prepared and made available within 45 days of the Consultation Sessions to all Tribal Governments receiving funds for Head Start and Early Head Start programs. Tribes wishing to submit written testimony for the report should send testimony to Angie Godfrey at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
Joshua Nipper, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, Silver Spring, MD 20993-0002, 301-796-6524.
In accordance with sections 515(d)(4) and (e)(2) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360e(d)(4) and (e)(2)), notification of an order approving, denying, or withdrawing approval of a PMA will continue to include a notice of opportunity to request review of the order under section 515(g) of the FD&C Act. The 30-day period for requesting reconsideration of an FDA action under § 10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a PMA begins on the day the notice is placed on the Internet. Section 10.33(b) provides that FDA may, for good cause, extend this 30-day period. Reconsideration of a denial or withdrawal of approval of a PMA may be sought only by the applicant; in these cases, the 30-day period will begin when the applicant is notified by FDA in writing of its decision.
The regulations provide that FDA publish a quarterly list of available safety and effectiveness summaries of PMA approvals and denials that were announced during that quarter. The following is a list of approved PMAs for which summaries of safety and effectiveness were placed on the Internet from October 1, 2015, through December 31, 2015. There were no denial actions during this period. The list provides the manufacturer's name, the product's generic name or the trade name, and the approval date.
Persons with access to the Internet may obtain the documents at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration's (FDA's) Center for Drug Evaluation and Research (CDER) is announcing the continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program (the Site Tours Program). The purpose of this document is to invite pharmaceutical companies interested in participating in this program to contact CDER.
Pharmaceutical companies may submit proposed agendas to the Agency by April 11, 2016.
Dan Brum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5480, Silver Spring, MD 20993-0002, 301-796-0578,
An important part of CDER's commitment to make safe and effective drugs available to all Americans is optimizing the efficiency and quality of the drug review process. To support this primary goal, CDER has initiated various training and development programs to promote high performance in its regulatory project management staff. CDER seeks to significantly enhance review efficiency and review quality by providing the staff with a better understanding of the pharmaceutical industry and its operations. To this end, CDER is continuing its training program to give regulatory project managers the opportunity to tour pharmaceutical facilities. The goals are to provide firsthand exposure to industry's drug development processes, and a venue for sharing information about project management procedures (but not drug-specific information) with industry representatives.
In this program, over a 2- to 3-day period, small groups (five or less) of regulatory project managers, including a senior level regulatory project manager, can observe operations of pharmaceutical manufacturing and/or packaging facilities, pathology/toxicology laboratories, and regulatory affairs operations. Neither this tour nor any part of the program is intended as a mechanism to inspect, assess, judge, or perform a regulatory function, but is meant rather to improve mutual understanding and to provide an avenue for open dialogue. During the Site Tours Program, regulatory project managers will also participate in daily workshops with their industry counterparts, focusing on selective regulatory issues important to both CDER staff and industry. The primary objective of the daily workshops is to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms, and regulatory submission operations. The overall benefit to regulatory project managers will be exposure to project management, team techniques, and processes employed by the pharmaceutical industry. By participating in this program, the regulatory project manager will grow professionally by gaining a better understanding of industry processes and procedures.
All travel expenses associated with the Site Tours Program will be the responsibility of CDER; therefore, selection will be based on the availability of funds and resources for each fiscal year. Selection will also be based on firms having a favorable facility status as determined by FDA's Office of Regulatory Affairs District Offices in the firms' respective regions. Firms interested in offering a site tour or learning more about this training opportunity should respond by submitting a proposed agenda to Dan Brum directly (see
Food and Drug Administration, HHS.
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled “Recommendations for Premarket Notifications for Lamotrigine and Zonisamide Assays.” This guidance document discusses information to be included in premarket notifications for zonisamide or lamotrigine assays.
Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time.
You may submit comments as follows:
Submit electronic comments in the following way:
• Federal eRulemaking Portal:
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of the guidance document is available for download from the Internet. See the
Courtney Lias, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 66, Rm. 4626, Silver Spring, MD 20993-0002, 301-796-5458.
FDA is issuing this guidance document to describe its current thinking concerning issues that should be addressed in premarket notifications for assays intended to quantitate the anti-seizure drugs lamotrigine and zonisamide in serum. Some of the general concepts in this guidance may also be helpful in preparing 510(k) submissions for other therapeutic drug assays previously cleared by FDA, and classified within 21 CFR 862, subpart D. The draft guidance was available for comment on August 6, 2010. The comment period closed on November 4, 2010. No comments relating to the specific recommendation in the guidance were received. Minor revisions to the guidance have been made for clarifications and updates.
This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the Agency's current thinking on Premarket Notifications for Lamotrigine and Zonisamide Assays. 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 statute and regulations.
Persons interested in obtaining a copy of the guidance may do so by downloading an electronic copy from the Internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information addressed in the guidance document have been approved by OMB in accordance with the PRA under the regulations governing premarket notification submissions (21 CFR part 807, subpart E, OMB Control No. 0910-0120). The labeling provisions addressed in the guidance have been approved by OMB Control No. 0910-0485.
Interested persons may submit either electronic comments regarding this document to
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing Booz Allen Hamilton's final evaluation report submitted as part of their independent assessment of the process for the review of medical device submissions. The evaluation is part of the FDA performance commitments relating to the Medical Device User Fee Amendments of 2012 (MDUFA III), which reauthorized device user fees for fiscal years 2013 through 2017. The assessment is described in section V, Independent Assessment of Review Process Management, of the commitment letter entitled “MDUFA Performance Goals and Procedures” (MDUFA III Commitment Letter). The evaluation has been conducted as the second phase (Phase 2) and is the last of a series of deliverables, as outlined in the contract statement of work.
Raphaela Simon, Office of Planning, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 3379, Silver Spring, MD 20993-0002, 301-796-9169,
On July 9, 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (Pub. L. 112-144) (FDASIA).
Device user fees were first established by Congress in 2002. Medical device companies pay fees to FDA when they register their establishment and list their devices with the Agency, whenever they submit an application or a notification to market a new medical device in the United States, and for certain other types of submissions. Under MDUFA III, FDA is authorized to collect user fees that will total approximately $595 million (plus adjustments for inflation) over 5 years. With this additional funding, FDA will be able to hire more than 200 full-time-equivalent workers over the course of MDUFA III. In exchange, FDA has committed to meet certain performance goals outlined in the MDUFA III Commitment Letter.
Section V of the MDUFA III Commitment Letter states that FDA and the device industry will participate in a comprehensive assessment of the process for the review of device applications. The assessment will include consultation with both FDA and industry. The assessment will be conducted in two phases by a private, independent consulting firm, under contract with FDA, that is capable of performing the technical analysis, management assessment, and program evaluation tasks required to address the assessment as described in the MDUFA III Commitment Letter.
FDA awarded the contract in June 2013 to the consulting firm Booz Allen Hamilton. Findings on high-priority recommendations (
For Phase 2 of the independent assessment, the contractor evaluated the implementation of recommendations, described under Stage 1 in the “Plan of Action,” and is publishing its written assessment
FDA has implemented all Stage 1 actions outlined in the Plan of Action, and incorporated the resulting enhancements into the management of the premarket review program. Resources permitting, the Center for Devices and Radiological Health will continue to implement Stage 2 actions. FDA will monitor implemented improvements for accomplishment of intended results and the process for the review of device submissions for additional improvement opportunities.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Display Devices for Diagnostic Radiology”. This draft guidance document provides recommendations for the types of information you should provide in your premarket notification submission (510(k)) for display devices intended for diagnostic radiology with the assigned product code PGY. This guidance, when finalized, will replace a previously issued final guidance entitled “Display Accessories for Full-Field Digital
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of 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 May 9, 2016.
You may submit comments as follows:
Submit electronic comments in the following way:
•
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).
Submit written/paper submissions as follows:
•
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”
• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION”. The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on
An electronic copy of the guidance document is available for download from the Internet. See the
Mary Pastel, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4312, Silver Spring, MD 20993-0002, 301-796-6887.
This guidance, when finalized, will apply to display devices intended for diagnostic radiology as identified in section III “Scope” of the guidance, and currently classified under 21 CFR 892.2050 as class II devices according to section 513(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C 360c(a)(1)) with the assigned product code PGY. This draft guidance is intended to assist industry in preparing a 510(k) for display devices intended for use in diagnostic radiology. This draft guidance provides recommendations for the types of information to provide in 510(k) submissions for display devices intended for diagnostic radiology. This information supplements the requirements for a 510(k) submission found in 21 CFR part 807, subpart E, as well as recommendations provided in other FDA guidance documents concerning the specific content of a 510(k) submission.
This guidance, when finalized, will apply to workstation medical image displays for diagnostic radiology. These devices are classified as class II devices that are intended to be used in controlled viewing conditions to display and view digital images for primary image interpretation. Display devices for diagnostic radiology may also be referred to as soft-copy displays or medical grade monitors.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on display devices for diagnostic radiology. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.
Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from
The draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 have been approved under OMB control number 0910-0120 and the collections of information in 21 CFR part 801 have been approved under OMB control number 0910-0485.
Office of the Secretary, HHS.
Notice.
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Comments on the ICR must be received on or before March 10, 2016.
Submit your comments to
Information Collection Clearance staff,
When submitting comments or requesting information, please include the Information Collection Request Title and document identifier HHS-OS-4040-New-30D for reference.
Abstract: Public Law 113-101, The Digital Accountability and Transparency Act of 2014 (DATA Act) expands the Federal Funding Accountability and Transparency Act of 2006 by increasing accountability and transparency in Federal spending. Section 5 of the DATA Act (“Sec. 5. Simplifying Federal Award Reporting”) tasks the Director of the Office of Management and Budget (OMB) to establish a pilot program (Sec. 5 (b)).
OMB has designated the Department of Health and Human Services (HHS) as the executing agent of the pilot program. Within HHS, the DATA Act Program Management Office (PMO) (DAP) has been established under the Office of the Assistant Secretary for Financial Resources (ASFR) in order to implement this pilot program. ASFR/DAP, in coordination with Grants.gov, is requesting a generic clearance for the purpose of conducting tests under the pilot program to obtain qualitative and quantitative data and gain an understanding of the burden imposed on Federal recipients.
The DAP has designed several test models to evaluate recipient burden and assess quality of data. The goal of these test models is to determine whether new technology, data standards, processes, and forms aid in reducing recipient burden and increase the accuracy and quality of the data submitted. Under this clearance, a variety of methods (surveys, focus groups, etc.) could be used to collect data, with the exact nature of the questions currently undetermined. DAP expects these questions to include, but not be limited to, topics pertaining to the Standard Form (SF) 424, the Consolidated Federal Financial Reports, and the expanded Single Audit form (SF-SAC). If this data is not collected, the requirements of the DATA Act Section 5 pilot will not be met. The types of collections that this generic clearance covers include, but are not limited to:
• Surveys,
• Focus Groups,
• Other qualitative methods such as interviews, small discussion groups, and case studies.
Likely Respondents: Recipients of Federal contracts, grants, and sub-awards.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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 meetings of the Board of Scientific Counselors for Basic Sciences, National Cancer Institute and the Board of Scientific Counselors for Clinical Sciences and Epidemiology, National Cancer Institute.
The meetings will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Cancer Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice provides information on the National Institutes of Health's (NIH) reassessment of the need to maintain a colony of 50 chimpanzees for future research and decision to no longer maintain a chimpanzee colony for research. This notice also provides information on conforming updates and procedures related to this action.
The Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, National Institutes of Health at
On November 18, 2015, the NIH announced it will no longer maintain a colony of 50 chimpanzees for future research and that all NIH-owned chimpanzees that reside outside the federal sanctuary system operated by Chimp Haven, Keithville, Louisiana, are eligible for retirement. Relocation of the chimpanzees to the federal sanctuary system will be conducted as space is available and on a timescale that will allow for optimal transition of each individual chimpanzee with careful consideration of their welfare, including their health and social grouping. See the NIH Director's statement at
Specifically, permissible research, as described in the “Standards of Care for Chimpanzees Held in the Federally Supported Chimpanzee Sanctuary System” at 42 CFR part 9, includes:
• Visual observation;
• Behavioral studies designed to improve the establishment and maintenance of social groups. These activities may cause stress as a result of novel interactions between chimpanzees and caregivers, but they are not considered invasive as long as they are intended to maximize the well-being of the chimpanzees;
• Medical examinations as deemed necessary to oversee the health of the chimpanzees, in the least invasive manner possible. Collection of samples routinely obtained during a physical examination for processing during this time is also considered noninvasive since a separate event is not required;
• Administration and evaluation of environmental enrichment used to promote the psychological well-being of the chimpanzees; and
• Actions taken to provide essential medical treatment to an individual chimpanzee exhibiting symptoms of illness. This applies only to serious illness that cannot be treated while the chimpanzee remains within the colony.
• Observational studies and collection of biomaterial in the wild without interfering with the chimpanzee is also permitted.
These decisions apply to all new or competing renewals of grant applications, contract proposals, intramural protocols, and 3rd party projects. The NIH may issue future guidance about the permissible noninvasive research involving chimpanzees. Researchers are encouraged to contact their program officers for additional information or the Division of Program Coordination, Planning, and Strategic Initiatives at
The NIH's decision to allow the support of noninvasive research involving the use of chimpanzees, as described in this notice, does not affect requirements for investigators and/or their institutions to obtain permits from the U.S. Fish and Wildlife Service, if applicable, nor does it affect the responsibility to meet all applicable veterinary, colony, and husbandry obligations.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
Direct Comments to Omb: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs,
Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 30 days of the date of this publication.
To obtain a copy of the data collection plans and instruments, or request more information on the proposed program, contact: Albert Avila, Ph.D., Director, Office of Diversity and Health Disparities, NIDA, NIH, 6001 Executive Blvd., Room 3106, Rockville, MD 20852, or call non-toll-free number (301)-443-0441 or Email your request, including your address to:
Proposed Collection: NIDA Summer Research Internship Program 0925-Existing Collection in Use Without an OMB Control Number, National Institute on Drug Abuse (NIDA), National Institutes of Health (NIH).
This program fills a significant unmet need to encourage and support individuals from underrepresented groups to pursue careers in substance abuse research. The NIDA Summer Research Internship program offers a unique opportunity to increase the diversity and creativity of the biomedical research workforce by fostering the development of young talent through the creation of mentorship and training opportunities with premier substance abuse research laboratories around the country.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 350.
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 sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The contract proposals and grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals
Notice is hereby given of a change in the meeting of the Neurogenesis and Cell Fate Study Section, February 18, 2016, 08:00 a.m. to February 19, 2016, 02:00 p.m., Hotel Kabuki, 1625 Post Street, San Francisco, CA, 94115 which was published in the
The meeting will be held on February 18, 2016 from 8:00 a.m.-8:00 p.m. The meeting location remains the same. The meeting is closed to the public.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Cancer Institute, the National Institutes of Health, has submitted to the Office of Management and Budget (OMB) a request for review and approval of the information collection listed below. This proposed information collection was previously published in the
To obtain a copy of the data collection plans and instruments, or request more information on the proposed project, contact: Charles Hall, RPh, M.S., Chief, Pharmaceutical Management Branch, Cancer Therapy Evaluation Program, National Cancer Institute, 9609 Medical Center Drive, RM 5W240, MSC 9725, Bethesda, Maryland 20892. Or call non-toll-free number (240) 276-6575, or email your request, include your address to:
Formal requests for additional plans and instruments must be requested in writing.
OMB approval is requested for 3 years. There are no costs to respondents other than their time. The total estimated annualized burden hours are 14,649 hours.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
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 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.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Coast Guard, DHS.
Notice of establishment of dispersant preauthorization plan.
On behalf of the Alaska Regional Response Team (ARRT), the U.S. Coast Guard (USCG) announces establishment of a more inclusive, comprehensive, and conservative dispersant use policy that includes a preauthorization area and an enhanced protocol for use of chemical dispersant during responses to spills of crude oil in certain waters offshore of Alaska. Federal regulations covering certain vessel response plans require development of defined dispersant response capabilities when such vessels are operating in waters where dispersant use preauthorization agreements exist.
Plan holders for affected vessel response plans have 24 months from the date of publication of this notice to achieve compliance.
For information about this document: From USCG: call or email Mark Everett, Incident Management & Preparedness Advisor, Seventeenth Coast Guard District, Juneau, AK; telephone (907) 463-2804; email
From Environmental Protection Agency (EPA): call or email Chris Field, Program Manager, Emergency Management Program (EPA Region 10); telephone (206) 553-1674; email
For the State of Alaska: call or email Gary Folley, Program Manager, Prevention, Preparedness & Response Program, Division of Spill Prevention & Response, Alaska Department of Environmental Conservation; telephone (907) 262-3411; email
Because this notice is non-rulemaking, no public participation or comments are being taken. Questions can be directed to any person named in the
The Alaska Regional Response Team (ARRT) is one of 13 interagency, intergovernmental groups responsible under the National Oil and Hazardous Substances Pollution Contingency Plan (a.k.a. National Contingency Plan or NCP) at 40 CFR part 300 for regional planning, including policy development, and coordination of preparedness and response actions related to discharges of oil and releases of hazardous materials and other pollutants and contaminants into the environment. The ARRT's responsibilities include development of policies regarding the preauthorization of certain alternative (non-mechanical) countermeasures, including chemical dispersants, used in oil spill response operations.
Preauthorization for use of dispersants has not existed in the Alaska region since September 2008. This new policy change will allow for industry to develop a reliable, regulated dispersant use capability to be available to mitigate—if directed by the Federal On Scene Coordinator—large crude oil spills more readily. However, extensive government, tribal, and other stakeholder notifications would be required before use.
Following a multi-year collaborative effort among governmental agencies as described in the NCP at 40 CFR 300.910, the ARRT signed a new
U.S. Coast Guard enforcement of the requirements of 33 CFR 154.1035 and 1045 and 33 CFR 155.1035, and 1050 depends upon existence of a dispersant preauthorization plan (including a preauthorization area) which complies with the requirements of the NCP, specifically at 40 CFR 300.910. Enforcement of the preauthorization area compliance requirements will take effect 24 months after publication of this notice to allow plan holders time to achieve compliance.
Development of the
This notice is issued under authority of the Oil Pollution Act of 1990 and Executive Order 12777.
U.S. Customs and Border Protection, Department of Homeland Security.
Notice; solicitation of comments.
U.S. Customs and Border Protection (CBP) has received a petition submitted on behalf of a domestic interested party requesting the reclassification under the Harmonized Tariff Schedule of the United States (HTSUS) of a steel tube fitting from Taiwan. CBP classified the steel tube fitting under subheading 7307.99.50, HTSUS, which provides for: “Tube or pipe fittings (for example, couplings, elbows, sleeves), of iron or steel: Other: Other: Other.” The 2015 column one, general rate of duty is 4.3 percent
Comments must be received on or before April 11, 2016.
You may submit comments, identified by docket number, by one of the following methods:
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Dwayne Rawlings, Tariff Classification and Marking Branch, Regulations and Rulings, Office of International Trade, Customs and Border Protection, at (202) 325-0092.
A petition has been filed under section 516 of the Tariff Act of 1930, as amended (19 U.S.C. 1516), on behalf of Brennan Industries, Inc. (“Petitioner”), which manufactures various hydraulic connectors, fittings and adapters in Solon, Ohio. Brennan meets all of the requirements of a domestic interested party set forth in 19 U.S.C. 1516(a)(2) and section 175.3(a) in Title 19 of the Code of Federal Regulations (CFR).
In New York Ruling (NY) E83408, dated July 8, 1999, a steel tube fitting from Taiwan is described as a “cold forged nonalloy steel male threaded connector body having a center hex nut, one flare tube end and one male pipe end. These tube fittings connect a piece of rigid tubing to a valve, manifold or another piece of rigid tubing in a hydraulic system.” CBP classified the steel tube fitting in subheading 7307.99.50, Harmonized Tariff Schedule of the United States (HTSUS), as a tube or pipe fitting of iron or steel, other, other, other. Petitioner contends that the proper classification for the fitting is subheading 8412.90.90, HTSUS, which covers “Other engines and motors, and parts thereof: Parts: Other.” In 1999, the column one, general rate of duty for subheading 7307.99.50, HTSUS, was 4.3 percent
Classification under the HTSUS is made in accordance with the General Rules of Interpretation (“GRIs”). GRI 1 provides that the classification of goods shall be determined according to the terms of the headings of the tariff schedule and any relative section or chapter notes. In the event that the goods cannot be classified solely on the basis of GRI 1, and if the headings and legal notes do not otherwise require, the remaining GRIs 2 through 6 may be applied, in numerical order.
The Harmonized Commodity Description and Coding System Explanatory Notes (ENs) constitute the official interpretation of the Harmonized System at the international level. While not legally binding on the contracting parties and, therefore, not dispositive, the ENs provide a commentary on the scope of each heading of the Harmonized System and are thus useful in ascertaining the classification of merchandise under the system. CBP's position is that the ENs should always be consulted.
Petitioner contends that the proper classification for the fitting is subheading 8412.90.90, HTSUS, which covers “Other engines and motors, and parts thereof: Parts: Other.” Petitioner notes that the ENs for Section XV, HTSUS, (which covers heading 7307, HTSUS), make clear that Section XV, HTSUS, does not cover “[a]rticles of Section XVI (machinery, mechanical appliances and electrical goods, which include hydraulic system parts).”
Petitioner maintains the fitting of NY E83408 is “solely imported, sold and specifically designed according to hydraulic system industry specifications for use in assembly of particular hydraulic engine or motor systems,” and is essential to the effective and safe operation of the subassemblies and components to which they are parts. As such, according to Petitioner, it is classifiable in subheading 8412.90.90, HTSUS, which specifically covers “other hydraulic engine and motor parts.” Petitioner also contends that CBP's classification is incorrect because the fitting consists of more than one material or substance, thus implicating GRI 2(b) and GRI 3. Petitioner proceeds to reason that the fitting is
In the ruling that is the subject of this petition, CBP held that a cold-forged, non-alloy, steel tube fitting that connects rigid tubing to valves, manifolds or other pieces of rigid tubing in a hydraulic system is classified in
The text of heading 7307, HTSUS, provides for “tube or pipe fittings,” which is similar to the TSUS text in the cases discussed above (“pipe and tube fittings,” heading 613, TSUS). Thus, with regard to the competing HTSUS provisions at issue, CBP's position is that if an iron or steel fitting is a part of general use and is designed in such a manner where it can be used in conjunction with tubes or pipes, or tubes, pipes and hoses, that fitting is classified in heading 7307.
However, and again with regard to the competing headings at issue, if such fittings meet the terms of Note 2 to Section XVI and are considered to be parts of hydraulic systems, such as hose fittings (as opposed to “parts of general use” of heading 7307, HTSUS), they are classified in heading 8412, HTSUS.
CBP concludes that the subject fittings are parts of general use that can connect tubes and pipes, and are thus classified under heading 7307, HTSUS, by application of GRI 1 and the exclusionary effect of Legal Note 1(g) to Section XVI. Finally, with regard to Petitioner's argument that GRI 3 is applicable, in order for classification by application of GRI 3 to be appropriate, a good must be unable to be classified by application of GRIs 1 or 2, and the good must be
Pursuant to section 175.21, CBP Regulations (19 CFR 175.21), before making a determination on this matter, CBP invites written comments on the petition from interested parties.
The domestic interested party petition concerning the tariff classification of hydraulic system fittings, as well as all comments received in response to this notice, will be available for public inspection on the docket at
This notice is published in accordance with 19 U.S.C. 1516 and section 175.21 of the CBP Regulations (19 CFR 175.21).
U.S. Citizenship and Immigration Services, Department of Homeland Security.
60-Day Notice.
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the
Comments are encouraged and will be accepted for 60 days until April 11, 2016.
All submissions received must include the OMB Control Number 1615-0054 in the subject box, the agency name and Docket ID USCIS-2006-0055. To avoid duplicate submissions, please use only
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USCIS, Office of Policy and Strategy, Regulatory Coordination Division, Samantha Deshommes, Acting Chief, 20 Massachusetts Avenue NW., Washington, DC 20529-2140, telephone number 202-272-8377 (This is not a toll-free number. Comments are not accepted via telephone message). Please note contact information provided here is solely for questions regarding this notice. It is not for individual case status inquiries. Applicants seeking information about the status of their individual cases can check Case Status Online, available at the USCIS Web site at
You may access the information collection instrument with instructions, or additional information by visiting the Federal eRulemaking Portal site at:
Written comments and suggestions from the public and affected agencies should address one or more of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
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National Park Service, Interior.
Notice of annual meeting.
This notice announces the annual meeting of the Boston Harbor Islands National Recreation Area Advisory Council (Council). The agenda includes a talk about the history and contemporary nature of the Boston Harbor Islands as “islands on the edge.” Since their ancient formation by rising sea level, the Boston Harbor Islands have literally been on the edge of the continent, places where land meets sea, and now at the edge of a major metropolitan area. The islands have often been on the “edge of society,” used to isolate people, institutions, and activities. After the talk, a business meeting will follow. The Council will introduce candidates interested in membership, hold elections for officers, and nominate Council representatives to the Partnership. Superintendent Giles Parker will also give updates about park operations and planning efforts.
March 9, 2016, from 6:00 p.m. to 8:00 p.m. (Eastern).
Museum of African American History, 14 Beacon Street, Suite 401, Boston, MA 02108.
Giles Parker, Superintendent and Designated Federal Official (DFO), Boston Harbor Islands National Recreation Area, 15 State Street, Suite 1100, Boston, MA 02109, telephone (617) 223-8669, or email
This meeting is open to the public. Those wishing to submit written comments may contact the DFO for the Council, Giles Parker, by mail at National Park Service, Boston Harbor Islands, 15 State Street, Suite 1100, Boston, MA 02109. Before including your address, telephone 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 may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The Council was appointed by the Director of the National Park Service pursuant to 16 U.S.C. 460kkk(g). The purpose of the Council is to advise and make recommendations to the Boston Harbor Islands Partnership with respect to the implementation of a management plan and park operations. Efforts have been made locally to ensure that the interested public is aware of the meeting dates.
National Park Service, Interior.
Notice.
The National Park Service is soliciting comments on the significance of properties nominated before January 9, 2016, for listing or related actions in the National Register of Historic Places.
Comments should be submitted by February 24, 2016.
Comments may be sent via U.S. Postal Service to the National Register of Historic Places, National Park Service, 1849 C St. NW., MS 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202-371-6447.
The properties listed in this notice are being considered for listing or related actions in the National Register of Historic Places. Nominations for their consideration were received by the National Park Service before January 9, 2016. Pursuant to section 60.13 of 36 CFR part 60, written comments are being accepted concerning the significance of the nominated properties under the National Register criteria for evaluation.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment—including your personal identifying information—may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
60.13 of 36 CFR part 60
National Park Service, Interior.
Meeting notice.
This notice sets forth the date of the 302nd Meeting of the Cape Cod National Seashore Advisory Commission.
The public meeting of the Cape Cod National Seashore Advisory Commission will be held on Monday, March 14, 2016, at 1:00 p.m. (Eastern).
The 302nd meeting of the Cape Cod National Seashore Advisory Commission will take place on Monday, March 14, 2016, at 1:00 p.m., in the conference room at park headquarters, 99 Marconi Site Road, Wellfleet, Massachusetts 02667 to discuss the following:
Further information concerning the meeting may be obtained from George E. Price, Jr., Superintendent, Cape Cod National Seashore, 99 Marconi Site, Wellfleet, Massachusetts 02667, or via telephone at (508) 771-2144.
The Commission was reestablished pursuant to Public Law 87-126, as amended by Public Law 105-280. The purpose of the Commission is to consult with the Secretary of the Interior, or her designee, with respect to matters relating to the development of Cape Cod National Seashore, and with respect to carrying out the provisions of sections 4 and 5 of the Act establishing the Seashore.
The meeting is open to the public. It is expected that 15 persons will be able to attend the meeting in addition to Commission members. Interested persons may make oral/written presentations to the Commission during the business meeting or file written statements. Such requests should be made to the park superintendent prior to the meeting. Before including your address, telephone 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 may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
National Park Service, Interior.
Notice of meeting.
As required by the Federal Advisory Committee Act (5 U.S.C. Appendix 1-16), the National Park Service is hereby giving notice of the March 3, 2016, meeting for the Paterson Great Falls National Historical Park Advisory Commission. The Commission is authorized by the Omnibus Public Land Management Act, (16 U.S.C. 410lll), “to advise the Secretary in the development and implementation of the management plan.” Agendas for these meetings will be provided on the Commission Web site at
The Commission will meet on Thursday, March 3, 2016, 2:00 p.m.-5:00 p.m. (Eastern).
The meeting will be held at the Rogers Meeting Center, 32 Spruce Street, Paterson, NJ 07501.
Darren Boch, Superintendent and Designated Federal Officer, Paterson Great Falls National Historical Park, 72 McBride Avenue, Paterson, NJ 07501, (973) 523-2630.
The purpose of the meeting is to formalize the Commission's comments on the Paterson Great Falls National Historical Park draft general management plan and environmental assessment.
This meeting is open to the public and time will be reserved during each meeting for public comment. Oral comments will be summarized for the record. If individuals wish to have their comments recorded verbatim, they must submit them in writing. Written comments and requests for agenda items may be sent to: Federal Advisory Commission, Paterson Great Falls National Historical Park, 72 McBride Avenue, Paterson, NJ 07501.
Before including your address, telephone 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 may ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so. All comments will be made part of the public record and will be electronically distributed to all Commission members.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (“ALJ”) initial determination (“ID”) (Order No. 1) terminating the investigation in its entirety based on a settlement agreement.
Robert Needham, Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-5468. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
The Commission instituted this investigation on January 12, 2016, based on a complaint filed by Server Technology, Inc. (“STI”), of Reno, Nevada. 81 FR 1441-42. The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain rack mountable power distribution units through the infringement of certain claims of U.S. Patent Nos. 7,162,521; 7,400,493; 7,414,329; 7,447,002; 7,567,430; 7,706,134; 8,541,907; 8,601,291; and 8,694,272.
On January 8, 2016, STI filed an unopposed motion to terminate the investigation based on a settlement agreement. No party responded to the motion.
On January 12, 2016, the ALJ issued the subject ID, granting the motion. The ALJ found that STI attached the settlement agreement, and stated that there were no other agreements between STI and Respondents concerning the subject matter of the investigation. The ALJ also found that there is no indication that terminating the investigation based on settlement would harm the public interest. No party petitioned for review of the subject ID.
The Commission has determined not to review the subject ID.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and in Part 210 of the Commission's Rules of Practice and Procedure (19 CFR part 210).
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined to review-in-part a final initial determination (“ID”) of the presiding administrative law judge (“ALJ”) finding a violation of section 337 in the above-captioned investigation. The Commission is also requesting written submissions regarding the issues under review and remedy, bonding, and the public interest.
Clint Gerdine, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 708-2310. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436, telephone (202) 205-2000. General information concerning the Commission may also be obtained by accessing its Internet server at
The Commission instituted this investigation on November 17, 2014, based on a complaint filed on behalf of Converse Inc. of North Andover, Massachusetts. 79 FR 68482-83. The complaint alleges violations of section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, by reason of infringement of certain U.S. Trademark Registration Nos.: 4,398,753 (“the '753 trademark”); 3,258,103 (“the '103 trademark”); and 1,588,960 (“the '960 trademark”). The complaint further alleges violations of section 337 based upon unfair competition/false designation of origin, common law trademark infringement and unfair competition, and trademark dilution, the threat or effect of which is to destroy or substantially injure an industry in the United States. The Commission's notice of investigation named numerous respondents including Wal-Mart Stores, Inc. of Bentonville, Arkansas; Skechers U.S.A., Inc. of Manhattan Beach, California; and Highline United LLC d/b/a Ash Footwear USA of New York City, New York. The Office of Unfair Import Investigations (“OUII”) is also a party to the investigation.
On February 10, 2015, the Commission determined not to review an ID (Order No. 32) granting a joint motion of complainant and Skeanie Shoes, Inc. (“Skeanie”) of New South Wales, Australia terminating the investigation as to Skeanie Shoes based on settlement and consent order stipulation. On the same date, the Commission determined not to review an ID (Order No. 33) granting a joint motion of complainant and PW Shoes, Inc. (“PW Shoes”) of Maspeth, New York terminating the investigation as to PW Shoes based on settlement and consent order stipulation. Also on the same date, the Commission determined not to review an ID (Order No. 34) granting a joint motion of complainant and Ositos Shoes, Inc. (“Ositos Shoes”) of South El Monte, California terminating the investigation as to Ositos Shoes based on settlement agreement and consent order stipulation. On March 4, 2015, the Commission determined not to review an ID (Order No. 52) granting a joint motion of complainant and Ralph Lauren Corporation (“Ralph Lauren”) of New York City, New York terminating the investigation as to Ralph Lauren based on settlement agreement and consent order stipulation. On March 12, 2015, the Commission determined not to review an ID (Order No. 55) granting a joint motion of complainant and OPPO Original Corp. (“OPPO”) of City of Industry, California terminating the investigation as to OPPO based on settlement agreement and consent order stipulation. On the same date, the Commission determined not to review an ID (Order No. 57) granting a joint motion of complainant and H & M Hennes & Mauritz LP (“H & M”) of New York City, New York terminating the investigation as to H & M based on settlement agreement and consent order stipulation. On March 24, 2015, the Commission determined not to review an ID (Order No. 59) granting a joint motion of complainant and Zulily, Inc. (“Zulily”) of Seattle, Washington terminating the investigation as to Zulily based on settlement agreement and consent order stipulation. On March 30, 2015, the Commission determined not to review an ID (Order No. 65) granting a joint motion of complainant and Nowhere Co. Ltd. d/b/a Bape (“Nowhere”) of Tokyo, Japan terminating the investigation as to Nowhere based on settlement agreement and consent order stipulation. On the same date, the Commission determined not to review an ID (Order No. 67) granting a joint motion of complainant and The Aldo Group (“Aldo”) of Montreal, Canada terminating the investigation as to Aldo based on settlement agreement and consent order stipulation.
On April 1, 2015, the Commission determined not to review an ID (Order No. 69) granting a joint motion of complainant and Gina Group, LLC (“Gina Group”) of New York City, New York terminating the investigation as to Gina Group based on settlement agreement and consent order stipulation. On the same date, the Commission determined not to review an ID (Order No. 70) granting a joint motion of complainant and Tory Burch LLC (“Tory Burch”) of New York City, New York terminating the investigation as to Tory Burch based on settlement agreement and consent order stipulation. On April 24, 2015, the Commission determined not to review an ID (Order No. 73) granting a joint motion of complainant and Brian Lichtenberg, LLC (“Brian Lichtenberg”) of Los Angeles, California terminating the investigation as to Brian Lichtenberg based on settlement agreement and consent order stipulation. On the same date, the Commission determined not to review an ID (Order No. 80) granting a joint motion of complainant and Fila U.S.A., Inc. (“Fila”) of Sparks, Maryland terminating the investigation as to Fila based on settlement agreement and consent order stipulation. On May 4, 2015, the Commission determined not to review an ID (Order No. 86) granting a joint motion of complainant and Mamiye Imports LLC d/b/a Lilly of New York located in Brooklyn, New York and Shoe Shox of Seattle, Washington (collectively, “Mamiye Imports”) terminating the investigation as to Mamiye Imports based on settlement agreement and consent order stipulation.
On May 6, 2015, the Commission determined not to review an ID (Order No. 83) granting New Balance's motion to terminate the investigation as to New Balance's accused CPT Hi and CPT Lo model sneakers based on a consent order stipulation. On May 13, 2015, the Commission determined not to review an ID (Order No. 93) granting a joint motion of complainant and Iconix Brand Group, Inc. (“Iconix”) of New York City, New York terminating the investigation as to Iconix based on settlement agreement and consent order stipulation. On June 4, 2015, the Commission determined not to review an ID (Order No. 108) granting a joint motion of complainant and A-List, Inc. d/b/a Kitson (“Kitson”) of Los Angeles, California terminating the investigation as to Kitson based on settlement agreement and consent order stipulation. On June 12, 2015, the Commission determined not to review an ID (Order No. 114) granting a joint motion of complainant and Esquire Footwear LLC (“Esquire”) of New York City, New York terminating the investigation as to Esquire based on settlement agreement, consent order stipulation, and consent order. On July 15, 2015, the Commission determined not to review an ID (Order No. 128) granting a joint motion of complainant and Fortune Dynamic, Inc. (“Fortune Dynamic”) of City of Industry, California terminating the investigation as to Fortune Dynamic based on settlement agreement and consent order stipulation. On August 12, 2015, the Commission determined not to review an ID (Order No. 154) granting a joint motion of complainant and CMerit USA, Inc. (“CMerit”) of Chino, California terminating the investigation as to CMerit based on settlement agreement and consent order stipulation. On August 14, 2015, the Commission determined not to review an ID (Order No. 155) granting a joint motion of complainant and Kmart Corporation (“Kmart”) of Hoffman Estates, Illinois terminating the investigation as to Kmart based on settlement agreement and consent order stipulation.
Also, on March 12, 2015, the Commission determined not to review an ID (Order No. 58) finding Dioniso SRL of Perugia, Italy; Shenzhen Foreversun Industrial Co., Ltd. (a/k/a Shenzhen Foreversun Shoes Co., Ltd.) (“Foreversun”) of Shenzhen, China; and Fujian Xinya I&E Trading Co. Ltd. of Jinjiang, China in default. Similarly, on June 2, 2015, the Commission determined not to review an ID (Order No. 106) finding Zhejiang Ouhai International Trade Co. Ltd. and Wenzhou Cereals Oils & Foodstuffs Foreign Trade Co. Ltd., both of Wenzhou, China, in default. Further, on March 25, 2015, the Commission determined not to review an ID (Order No. 68) granting the motion of Orange Clubwear, Inc. of Westminster, California to terminate the investigation as to itself based on a consent order stipulation. On May 12, 2015, the Commission determined not to review an ID terminating the investigation as to Edamame Kids, Inc. of Alberta, Canada for good cause and without prejudice.
The ALJ issued his final ID on November 17, 2015, finding a violation of section 337 as to certain accused products of each active respondent and as to all accused products of each defaulting respondent. Specifically, the
Having examined the record of this investigation including the ID, the parties' petitions for review, and the responses thereto, the Commission has determined to review-in-part the final ID. Specifically, the Commission has determined to review: (1) The ID's finding of no invalidity of the '753 trademark; (2) the ID's findings regarding infringement of the '753 trademark; (3) the ID's finding of invalidity of the common law rights asserted in the design depicted in the '753 trademark; and (4) the ID's finding of no violation of section 337 with respect to the common law rights asserted in the designs depicted in the '103 and '960 trademarks. The Commission has also determined not to review the remainder of the final ID.
On review, with respect to violation, the parties are requested to submit briefing limited to the following issues:
(1) Please explain whether and to what extent the statutory presumption of validity for a registered trademark,
(2) After secondary meaning factor (7) (evidence that actual purchasers associate the trademark with a particular source), please provide an analysis of the relative importance of each factor that courts consider regarding whether or not a trademark has acquired secondary meaning.
(3) Does secondary meaning factor (2) (exclusivity of use) require actual evidence of relative volume of sales, market penetration, and/or consumer association with the third-party's use of the relevant trademark for this factor to be meaningfully considered? Please provide an analysis of the evidence of record in your discussion of relevant authorities pertaining to this issue.
(4) What is the appropriate time frame for considering evidence pertaining to secondary meaning factor (2) (exclusivity of use)? Does the time frame used for secondary meaning factor (3) (length of use) inform the appropriate time frame for factor (2)? Please discuss applicable case law. Please include in your discussion cases analyzing historic third-party use relating to the relevant consumer group.
(5) With regard to secondary meaning factor (7) (evidence that actual purchasers associate the trademark with a particular source), please discuss how courts assess survey results with respect to the minimum acceptable percentage of survey participants who associate the relevant trademark with one source.
(6) Regarding secondary meaning factor (4) (the degree and manner of sales, advertising, and promotional activities), the ALJ found that Converse's failure to highlight the CMT in its advertisements did not lessen the support of this factor weighing in favor of secondary meaning. ID at 53-54. Is this the correct conclusion? Can other attributes of the product also identify it with the Complainant (
(7) Did the ID appropriately consider the strength of the '753 trademark in analyzing infringement?
In addressing these issues, the parties are: (1) Requested to make specific reference to the evidentiary record and to cite relevant authority, especially authority relevant to trade dress (
In connection with the final disposition of this investigation, the Commission may (1) issue an order that results in the exclusion of the subject articles from entry into the United States, and/or (2) issue one or more cease and desist orders that could result in the respective respondent being required to cease and desist from engaging in unfair acts in the importation and sale of such articles. Accordingly, the Commission is interested in receiving written submissions that address the form of remedy, if any, that should be ordered. If a party seeks exclusion of an article from entry into the United States for purposes other than entry for consumption, the party should so indicate and provide information establishing that activities involving other types of entry either are adversely affecting it or likely to do so. For background,
When the Commission contemplates some form of remedy, it must consider the effects of that remedy upon the public interest. The factors the Commission will consider include the effect that an exclusion order and/or cease and desist orders would have on (1) the public health and welfare, (2) competitive conditions in the U.S. economy, (3) U.S. production of articles that are like or directly competitive with those that are subject to investigation, and (4) U.S. consumers. The Commission is therefore interested in receiving written submissions that address the aforementioned public interest factors in the context of this investigation.
When the Commission orders some form of remedy, the U.S. Trade Representative, as delegated by the President, has 60 days to approve or disapprove the Commission's action.
Persons filing written submissions must file the original document electronically on or before the deadlines stated above and submit eight true paper copies to the Office of the Secretary by noon the next day pursuant to section 210.4(f) of the Commission's Rules of Practice and Procedure (19 CFR 210.4(f)). Submissions should refer to the investigation number (“Inv. No. 337-TA-936”) in a prominent place on the cover page and/or the first page. (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary of the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, and in Part 210 of the Commission's Rules of Practice and Procedure, 19 CFR part 210.
By order of the Commission.
On February 2, 2016, the Department of Justice lodged a proposed consent decree with the United States District Court for the District of Utah in the lawsuit entitled
The United States filed this lawsuit under the Clean Water Act. The complaint seeks injunctive relief and civil penalties. The complaint alleges that the defendant violated the Clean Water Act by failing to comply with the terms and conditions of a National Pollutant Discharge Elimination System (“NPDES”) permit, issued to the County for discharges of storm water from the County's municipal separate storm sewer system (“MS4”). The consent decree requires the defendant to perform injunctive relief to bring it into compliance with its NPDES permit and to pay a $280,000 civil penalty.
The publication of this notice opens a period for public comment on the consent decree. Comments should be addressed to the Assistant Attorney General, Environment and Natural Resources Division, and should refer to
During the public comment period, the consent decree may be examined and downloaded at this Justice Department Web site:
Please enclose a check or money order for $11.50 (25 cents per page reproduction cost) payable to the United States Treasury.
Drug Enforcement Administration, Department of Justice.
60-Day Notice.
The Department of Justice (DOJ), Drug Enforcement Administration (DEA), will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until April 11, 2016
If you have comments on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Barbara J. Boockholdt, Office of Diversion Control, Drug Enforcement Administration; Mailing Address: 8701 Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-6812.
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
1.
2.
3.
4.
Affected public (Primary): Business or other for-profit.
Affected public (Other): None.
Abstract: The Drug Enforcement Administration (DEA) collects information regarding mail order transactions conducted between a person regulated by the agency and a nonregulated person (that is, someone who does not further distribute the product) involving the chemicals ephedrine, pseudoephedrine, and phenylpropanolamine. Transactions must use, or attempt to use, the United States Postal Service or any private or commercial carrier.
5.
6.
If additional information is required please contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., Suite 3E.405B, Washington, DC 20530.
Federal Bureau of Investigation, Department of Justice.
60-Day Notice.
The Department of Justice (DOJ), Federal Bureau of Investigation (FBI), Criminal Justice Information Services (CJIS) Division, will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995.
Comments are encouraged and will be accepted for 60 days until April 11, 2016.
If you have additional comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Gerry Lynn Brovey, Supervisory Information Liaison Specialist, FBI, CJIS, Resources Management Section, Administrative Unit, Module C-2, 1000 Custer Hollow Road, Clarksburg, West Virginia 26306 (facsimile: 304-625-5093).
Written comments and suggestions from the public and affected agencies concerning the proposed collection of information are encouraged. Your comments should address one or more of the following four points:
(1)
(2)
(3)
(4)
(5)
(6)
If additional information is required contact: Jerri Murray, Department Clearance Officer, United States Department of Justice, Justice Management Division, Policy and Planning Staff, Two Constitution Square, 145 N Street NE., 3E.405B, Washington, DC 20530.
Employment and Training Administration (ETA), Labor.
Notice.
The Department of Labor (Department), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. 3506(c)(2)(A)]. This program helps ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed.
Currently, ETA is soliciting comments concerning the revisions to the WIA Management Information and Reporting System data collection supporting statement to update the burden estimate to account for annual changes in hourly rates for respondents and remove any outdated language referencing updates made to the WIA reporting system prior to its 2013 renewal. No other revisions were made to the package.
On July 22, 2015, the Department issued an information collection request (ICR) for implementing WIOA performance requirements in accordance with section 116. Section 136 of WIA will remain in place until the performance requirements under WIOA have been fully implemented. Because we are using WIA performance measures, we are referring to the reports collected under this collection as “WIA Reports.” Generally, WIOA took effect on July 1, 2015 (See WIOA sec. 506(a.)). Sec. 116 of WIOA, which outlines the performance accountability requirements, including the indicators of performance, does not take effect until July 1, 2016 (See WIOA sec. 506(b)(1)). Under the Department's transition authority, in order to provide for an orderly transition from WIA to WIOA, we will require the states to use the WIA performance metrics in WIA sec. 136 to report on WIOA participants for one program year. This means that WIOA participants who became WIOA participants after July 1, 2015, are being measured according to the WIA section 136 performance measures. Once the Department has fully implemented WIOA's performance system, and all reporting requirements under WIA are met, the WIA reporting system will be discontinued. ETA seeks extension and approval of WIA reporting requirements during this transition period. Provisions will cover both individuals who were participants under WIA and new participants who enter the workforce system prior to full implementation of WIOA. For convenience we have included references to both the WIA statute and their corresponding updated sections within WIOA.
Written comments must be submitted to the office listed in the addresses section below on or before April 11, 2016.
Submit written comments to Karen Staha, Office of Policy Development and Research, Room N-5641, Employment and Training Administration, U.S. Department of Labor, 200 Constitution Avenue NW., Washington, DC 20210. Telephone number: 202-693-2917 (this is not a toll-free number). Fax: 202-693-2766. Email:
Luke Murren at 202-693-3733 or
The accuracy, reliability, and comparability of program reports submitted by States using Federal funds are fundamental elements of good public administration, and are necessary tools for maintaining and demonstrating system integrity. The use of a standard set of data elements, definitions, and specifications at all levels of the workforce system helps improve the quality of performance information that is received by the Department of Labor. The common performance measures are an integral part of ETA's performance accountability system, and ETA will continue to collect from grantees the data on program activities, participants, and outcomes that are necessary for program management and to convey full and accurate information on the performance of workforce programs to policymakers and stakeholders.
This WIA reporting structure includes quarterly (ETA 9090) and annual (ETA 9091) reports as well as a standardized individual record file for program participants, called the Workforce Investment Act Standardized Record Data (WIASRD). The WIASRD is submitted by the States to ETA and includes participant level information on customer demographics, type of services received, and statutorily defined measures of outcomes. This reporting structure will remain in place until the Department of Labor transitions to performance reporting under section 116 of the Workforce Innovation and Opportunity Act (WIOA).
High quality program performance requires the submission of timely, accurate, and high quality data on the characteristics, services received, and outcomes of program participants. Together, the 9091, 9090, and WIASRD comprise the data collected on WIA participants. As such, these data are necessary for tracking and reporting to stakeholders, information on the usage, services provided, and performance of these programs. These data are used to monitor the core purpose of the programs—mainly, tracking how many people found jobs; did people stay employed; and what were their earnings.
This information collection has been classified as a revision with only minor edits made to the supporting statement to account for adjustment in burden estimates based on annual changes in hourly rates for respondents and to
Information is collected under the authority of WIA sections 136
WIA section 136 establishes a comprehensive performance accountability system, comprised of the activities described in this section, to assess the effectiveness of States and local areas in achieving continuous improvement of workforce investment activities funded under this subtitle, in order to optimize the return on investment of Federal funds in statewide and local workforce investment activities (WIA section 136(a)).
Further, WIA section 136(d) outlines the minimum requirements for the WIA annual reports that States must submit to DOL. The annual reports must reflect:
• The progress of the State in achieving State performance measures, including information on the levels of performance achieved by the State with respect to the core indicators of performance and the customer satisfaction indicator;
• The progress of local areas in the State in achieving local performance measures, including information on the levels of performance achieved by the areas with respect to the core indicators of performance and the customer satisfaction indicator;
• Information on the entry by participants who have completed training services provided under WIA section 134(d)(4) (superseded by WIOA section134(c)(3)) into unsubsidized employment related to the training received;
• Data on the wages at entry into employment for participants in workforce investment activities who entered unsubsidized employment, including the rate of wage replacement for such participants who are dislocated workers;
• Information on the retention and earnings received in unsubsidized employment 12 months after entry into employment;
• A description of performance with respect to the indicators of performance specified in WIA section 136(b)(2)(A) (core indicators of performance) of participants in workforce investment activities who received the training services compared with the performance of participants in workforce investment activities who received only services other than the training services (excluding participants who received only self-service and informational activities); and
• A summary of performance with respect to the indicators of performance specified in WIA section 136(b)(2)(A) (core indicators of performance) of recipients of public assistance, out-of-school youth, veterans, individuals with disabilities, displaced homemakers, and older individuals.
WIOA section 169 (WIA section 172) directs the Secretary to provide for the continuing evaluation of programs and activities authorized under WIA/WIOA title I, including demonstration grants. WIOA section 169(a) (WIA section 172(a)) specifies that the evaluations must address:
• General effectiveness of such programs and activities in relation to their cost, including the extent to which the programs and activities improve the employment competencies of participants in comparison to comparably-situated individuals who did not participate in such programs and activities and, to the extent feasible, increase the level of total employment over the level that would have existed in the absence of such programs and activities;
• Effectiveness of the performance measures relating to such programs and activities;
• Effectiveness of the structure and mechanisms for delivery of services through such programs and activities;
• Impact of the programs and activities on the community and participants involved;
• Impact of such programs and activities on related programs and activities;
• Extent to which such programs and activities meet the needs of various demographic groups; and
• Such other factors as may be appropriate.
WIA/WIOA section 185 broadly addresses reports, recordkeeping, and investigations across programs authorized under title I of the Act. The provisions of section 185:
• Require the Secretary to ensure that all elements of the information required for reports be defined and reported uniformly (WIA/WIOA section 185(d)(2));
• Direct each State, each local board, and each recipient (other than a sub-recipient, sub-grantee, or contractor of a recipient) to prescribe and maintain comparable management information systems, in accordance with the guidelines that shall be prescribed by the Secretary designed to facilitate the uniform compilation, cross tabulation, and analysis of programmatic, participant, and financial data, on statewide, local area, and other appropriate bases necessary for reporting, monitoring, and evaluating purposes, including data necessary to comply with WIA/WIOA section 188 (WIA/WIOA section 185(c)(2));
• Require that recipients of funds under title I of WIA/WIOA shall maintain such records and submit such reports in such form and containing such information as the Secretary may require regarding the performance of programs and activities carried out under title I of WIA/WIOA (section 185(a)(2));
• Compel States to submit to the Secretary on a quarterly basis, a summary of the reports submitted to the Governor under WIA/WIOA sections 185(e)(1) and 185(e)(2);
• Specify that the reports shall include information about programs and activities carried out under title I of WIA/WIOA pertaining to:
WIA/WIOA section 189 requires the Secretary to prepare and submit to Congress an annual report regarding the programs and activities carried out under title I of WIA/WIOA. The report must include:
• A summary of the achievements, failures, and problems of the programs and activities in meeting the objectives of WIA/WIOA title I;
• A summary of major findings from research, evaluations, pilot projects, and experiments conducted under WIA/WIOA title I in the fiscal year prior to the submission of the report;
• Recommendations for modifications in the programs and activities based on analysis of such findings; and
• Such other recommendations for legislative or administrative action as the Secretary determines to be appropriate.
The Department is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Comments submitted in response to this comment request will be summarized and/or included in the request for OMB approval of the ICR; they will also become a matter of public record.
National Aeronautics and Space Administration.
Notice of meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-462, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Research Subcommittee of the Human Exploration and Operations Committee of the NASA Advisory Council (NAC). This Subcommittee reports to the Human Exploration and Operations Committee.
Monday March 7, 2016, 9:00 a.m.-4:30 p.m., Local Time.
NASA Headquarters, Room 7H41, 300 E Street SW., Washington, DC 20546.
Dr. Bradley Carpenter, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-0826, or
The meeting will be open to the public up to the capacity of the room. This meeting is also available telephonically and by WebEx. Any interested person may call the USA toll free conference call number 844-467-6272 or toll number 720-259-6462, passcode: 535959, to participate in this meeting by telephone. The WebEx link is
Attendees will be requested to sign a register and to comply with NASA security requirements, including the presentation of a valid picture ID to Security before access to NASA Headquarters. Due to the Real ID Act, Public Law 109-13, any attendees with drivers licenses issued from non-compliant states/territories must present a second form of ID. [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Illinois, Minnesota, Missouri, New Mexico and Washington. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 working days prior to the meeting: full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position of attendee; and home address to Dr. Bradley Carpenter via email at
National Aeronautics and Space Administration.
Notice of Meeting.
In accordance with the Federal Advisory Committee Act, Public Law 92-463, as amended, the National Aeronautics and Space Administration (NASA) announces a meeting of the Human Exploration and Operations Committee of the NASA Advisory Council (NAC). This Committee reports to the NAC.
Wednesday, March 2, 2016, 9:30 a.m.-6:00 p.m.; and Thursday, March 3, 2016, 8:30 a.m.-12:30 p.m., Local Time.
NASA Headquarters, Glennan Conference Room, 1Q39, 300 E Street SW., Washington, DC 20546
Dr. Bette Siegel, Human Exploration and Operations Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358-2245, or
The meeting will be open to the public up to the seating capacity of the room. This meeting is also available telephonically and by WebEx. You must use a touch tone phone to participate in this meeting. Any interested person may dial the toll free access number 1-888-455-6733 or toll access number 1-210-839-8935, and then the participant passcode: NAC HEOC, to participate in this meeting by telephone. The WebEx link is
The agenda for the meeting includes the following topics:
• Human Exploration Progress and Plans
• Budget Status
• NASA Program Management Process Update
Attendees will be required to sign a register and comply with NASA security requirements, including the presentation of a valid picture ID before receiving access to NASA Headquarters. Due to the Real ID Act, Public Law 109-13, any attendees with drivers licenses issued from non-compliant states/territories must present a second form of ID. [Federal employee badge; passport; active military identification card; enhanced driver's license; U.S. Coast Guard Merchant Mariner card; Native American tribal document; school identification accompanied by an item from LIST C (documents that establish employment authorization) from the “List of the Acceptable Documents” on Form I-9]. Non-compliant states/territories are: American Samoa, Illinois, Minnesota, Missouri, New Mexico and Washington. Foreign nationals attending this meeting will be required to provide a copy of their passport and visa in addition to providing the following information no less than 10 days prior to the meeting: full name; gender; date/place of birth; citizenship; visa information (number, type, expiration date); passport information (number, country, expiration date); employer/affiliation information (name of institution, address, country, telephone); title/position; and home address to Dr. Bette Siegel via email at
National Science Foundation.
Notice.
Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation invites the general public and other Federal agencies to take this opportunity to comment on this information collection. This is the
Comments regarding these information collections are best assured of having their full effect if received by OMB within 30 days of publication in the
Written comments regarding the information collection and requests for copies of the proposed information collection request should be addressed to Suzanne Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Blvd., Rm. 295, Arlington, VA 22230, or by email to
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 the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
The Directorate for Education and Human Resources (EHR), a unit within NSF, promotes rigor and vitality within the Nation's STEM education enterprise to further the development of the 21st century's STEM workforce and public scientific literacy. EHR does this through diverse projects and programs that support research, extension, outreach, and hands-on activities that service STEM learning and research at all institutional (
The scope of this information collection request will primarily cover descriptive information gathered from education and training (E&T) projects that are funded by NSF. NSF will primarily use the data from this collection for program planning, management, and audit purposes to respond to queries from the Congress, the public, NSF's external merit reviewers who serve as advisors, including Committees of Visitors (COVs), the NSF's Office of the Inspector General, and as a basis for either internal or third-party evaluations of individual programs.
The collections will generally include three categories of descriptive data: (1) Staff and project participants (data that are also necessary to determine individual-level treatment and control groups for future third-party study or for internal evaluation); (2) project implementation characteristics (also necessary for future use to identify well-matched comparison groups); and (3) project outputs (necessary to measure baseline for pre- and post-NSF-funding-level impacts).
Since this collection will primarily be used for accountability and evaluation purposes, including responding to queries from COVs and other scientific experts, a census rather than sampling design typically is necessary. At the individual project level funding can be adjusted based on individual project's responses to some of the surveys. Some data collected under this collection will serve as baseline data for separate research and evaluation studies.
NSF-funded contract or grantee researchers and internal or external evaluators in part may identify control, comparison, or treatment groups for NSF's E&T portfolio using some of the descriptive data gathered through this collection to conduct well-designed, rigorous research and portfolio evaluation studies.
The total estimate for this collection is 58,449 annual burden hours. The average annual reporting burden is between 1.7 and 114 hours per “respondent,” depending on whether a respondent is a direct participant who is self-reporting or representing a project and reporting on behalf of many project participants.
Nuclear Regulatory Commission.
Standard review plan-final section revision; issuance
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final revision to several sections in Chapter 11, “Radioactive Waste Management,” of NUREG-0800, “Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition.” On September 17, 2014, the NRC published for public comment the proposed revisions to Chapter 11 of the SRP. The NRC made changes to the proposed revisions after the consideration of comments received. Among other changes, the revisions include (1) revision of the title of SRP Section 11.1 to “Coolant Source Terms,” (2) implementation of Interim Staff Guidance (ISG), COL/DC-ISG-013, and (3) the revision also harmonizes SRP Section 11.2 with Branch Technical Position (BTP) 11.6 regarding the guidance of COL/DC-ISG-013 for calculating doses to members of the public and identifying acceptable criteria in assessing the radiological consequences of accidental releases due to tank failures.
The effective date of this Standard Review Plan update is March 10, 2016.
Please refer to Docket ID NRC-2014-0198 when contacting the NRC about the availability of information regarding this document. You may obtain publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
Mark Notich, telephone: 301-415-3053; email:
A summary of the comments and the NRC staff's disposition of the comments are available in a separate document, “Response to Public Comments on Draft SRP Sections in Chapter 11” (ADAMS Accession No. ML15033A417).
The Office of New Reactors and the Office of Nuclear Reactor Regulation are revising these sections from their current revisions. Details of specific changes in the proposed revisions are included at the end of each of the proposed sections.
The changes to this SRP chapter reflect current NRC staff's review methods and practices based on lessons learned from the NRC's reviews of design certification and combined license applications completed since the last revision of this chapter.
Issuance of these revised SRP sections does not constitute backfitting as defined in § 50.109 of title 10 of the
The SRP provides guidance to the staff on how to review an application for the NRC's regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which either nuclear power plant applicants or licensees are protected under either the Backfit Rule or the issue finality provisions of 10 CFR part 52.
The staff does not intend to impose or apply the positions described in the SRP to existing (already issued) licenses and regulatory approvals. Therefore, the issuance of a final SRP—even if considered guidance that is within the purview of the issue finality provisions in 10 CFR part 52—need not be evaluated as if it were a backfit or as being inconsistent with issue finality provisions. If, in the future, the staff seeks to impose a position in the SRP on holders of already issued licenses in a manner which does not provide issue finality as described in the applicable issue finality provision, then the staff must make the showing as set forth in the Backfit Rule or address the criteria for avoiding issue finality as described in the applicable issue finality provision.
Applicants and potential applicants are not, with certain exceptions, protected by either the Backfit Rule or any issue finality provisions under 10 CFR part 52. This is because neither the Backfit Rule nor the issue finality provisions under 10 CFR part 52—with certain exclusions discussed in the next paragraph—were intended to apply to every NRC action which substantially changes the expectations of current and future applicants.
The exceptions to the general principle are applicable whenever an applicant references a 10 CFR part 52 license (
In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget.
The documents identified in the following table are available to interested persons through one or more of the following methods, as indicated.
For the Nuclear Regulatory Commission.
Nuclear Regulatory Commission.
Standard review plan—final section revision; issuance.
The U.S. Nuclear Regulatory Commission (NRC) is issuing a final revision to the following section in Chapter 19 of NUREG-0800, “Standard Review Plan (SRP) for the Review of Safety Analysis Reports for Nuclear Power Plants: LWR Edition,” Section 19.0, “Probabilistic Risk Assessment and Severe Accident Evaluation for New Reactors.”
The effective date of this Standard Review Plan update is March 10, 2016.
Please refer to Docket ID NRC-2012-0232 when contacting the NRC about the availability of information regarding this document. You may access publicly-available information related to this document using any of the following methods:
• Federal Rulemaking Web site: Go to
• NRC's Agencywide Documents Access and Management System (ADAMS): You may obtain publicly-available documents online in the ADAMS Public Documents collection at
• NRC's PDR: You may examine and purchase copies of public documents at the NRC's PDR, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852.
• The NRC posts its issued staff guidance on the NRC's external Web page:
Mark Notich, telephone: 301-415-3053, email:
On December 8, 2014 (79 FR 72709), the NRC published for public comment a proposed revision to this section of the SRP. The staff made changes to the proposed revision after consideration of comments received. A summary of the comments and the staff's disposition of the comments are available in a separate document, “Response to Public Comments on Draft SRP Section 19.0” (ADAMS Accession No. ML15086A472).
The changes to this SRP section reflect current staff review methods and practices based on lessons learned from NRC reviews of design certification (DC) and combined license (COL) applications completed since the last revision of this chapter. Changes include: (1) Incorporation of guidance previously published in Interim Staff Guidance (ISG) DC/COL-ISG-003 (ADAMS Accession No. ML081430087) concerning the review of probabilistic risk assessment (PRA) information and severe accident assessments submitted to support DC and COL applications, (2) incorporation of guidance for DC and COL applicants previously published in ISG DC/COL-ISG-020 (ADAMS Accession No. ML100491233) concerning review of information from PRA-based seismic margin analyses submitted in support of DC and COL applications, (3) incorporation of guidance previously published in ISG Digital Instrumentation and Controls (DI&C)/COL-ISG-003 (ADAMS Accession No. ML080570048) concerning review of DI&C system PRAs, including treatment of common cause failure (CCFs) in PRAs and uncertainty analysis associated with new reactor digital systems, (4) incorporation of additional procedures for review of PRA information and severe accident assessments developed during NRC reviews of DC and COL applications completed after Revision 2 of SRP Section 19.0 was issued, (5) additional proposed acceptance criteria and review procedures for the staff's review of an applicant's assessment of
Issuance of this final SRP does not constitute backfitting as defined in 10 CFR 50.109 (the Backfit Rule) or otherwise be inconsistent with the issue finality provisions in 10 CFR part 52. The NRC's position is based upon the following considerations:
1.
The SRP provides internal guidance to the NRC staff on how to review an application for NRC regulatory approval in the form of licensing. Changes in internal staff guidance are not matters for which either nuclear power plant applicants or licensees are protected under either the Backfit Rule or the issue finality provisions of 10 CFR part 52.
2.
The NRC staff does not intend to impose or apply the positions described in the draft SRP to existing licenses and regulatory approvals. Hence, the issuance of a final SRP—even if considered guidance within the purview of the issue finality provisions in 10 CFR part 52—need not be evaluated as if it were a backfit or inconsistent with issue finality provisions. If, in the future, the NRC staff seeks to impose a position in the SRP on holders of already issued licenses in a manner that does not provide issue finality as described in the applicable issue finality provision, then the staff must make the showing as set forth in the Backfit Rule or address the criteria for avoiding issue finality as described in the applicable issue finality provision.
3.
Applicants and potential applicants are not, with certain exceptions, protected by either the Backfit Rule or any issue finality provisions under 10 CFR part 52. Neither the Backfit Rule nor the issue finality provisions under 10 CFR part 52, with certain exclusions, were intended to apply to every NRC action that substantially changes the expectations of current and future applicants. The exceptions to the general principle are applicable whenever an applicant references a 10 CFR part 52 license (
The exceptions to the general principle are applicable whenever an applicant references a 10 CFR part 52 license (
In accordance with the Congressional Review Act, the NRC has determined that this action is not a major rule and has verified this determination with the Office of Information and Regulatory Affairs of the Office of Management and Budget.
For the Nuclear Regulatory Commission.
U.S. Office of Personnel Management (OPM).
Notice.
This notice identifies Schedule A, B, and C appointing authorities applicable to a single agency that were established or revoked from November 1, 2015, to November 30, 2015.
Senior Executive Resources Services, Senior Executive Services and Performance Management, Employee Services, 202-606-2246.
In accordance with 5 CFR 213.103, Schedule A, B, and C appointing authorities available for use by all agencies are codified in the Code of Federal Regulations (CFR). Schedule A, B, and C appointing authorities applicable to a single agency are not codified in the CFR, but the Office of Personnel Management (OPM) publishes a notice of agency-specific authorities established or revoked each month in the
(d) General—
(1) Not to exceed 1,000 positions to perform cyber risk and strategic analysis, incident handling and malware/vulnerability analysis, program management, distributed control systems security, cyber incident response, cyber exercise facilitation and management, cyber vulnerability detection and assessment, network and systems engineering, enterprise architecture, intelligence analysis, investigation, investigative analysis and cyber-related infrastructure interdependency analysis requiring unique qualifications currently not established by OPM. Positions will be at the General Schedule (GS) grade levels 09-15. Appointments may be made under this authority until March 31, 2017.
No Schedule B Authorities to report during November 2015.
The following Schedule C appointing authorities were approved during November 2015.
The following Schedule C appointing authorities were revoked during November 2015.
5 U.S.C. 3301 and 3302; E.O. 10577, 3 CFR, 1954-1958 Comp., p. 218.
U.S. Office of Personnel Management.
Notice of amendments to the project plan for the Department of Defense (DoD) Civilian Acquisition Workforce Personnel Demonstration Project (AcqDemo); Correction.
The U.S. Office of Personnel Management published a document in the
Zelma Moore, U.S. Office of Personnel Management; 1900 E Street NW., Room 7456; Washington, DC 20415; (202) 606-1157.
In FR Doc. 2015-07314, published on Tuesday, March 31, 2015, in Volume 80, Number 61, page 17114, make the following corrections:
1. On page 17114 in Table 1A, first line in the section titled “Navy,” third column, delete the location of “Arlington, VA” and replace with “All locations”.
2. On the same page in Table 1A, second line in the section titled “Navy,” third column, delete the location of “Patuxent River, MD” and replace with “All locations”.
3. On the same page in Table 1A, third line in the section titled “Navy,” third column, delete the location of “San Diego, CA” and replace with “All locations”.
U.S. Office of Personnel Management.
30-Day notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension without change, of a currently approved information collection request (ICR) 3206-0099, Initial Certification of Full-Time School Attendance. As required by the Paperwork Reduction Act of 1995, (Pub. Law 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. The information collection was previously published in the
Comments are encouraged and will be accepted until March 10, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
RI 25-41, Initial Certification of Full-Time School Attendance, is used to determine whether a child is unmarried and a full-time student in a recognized school. OPM must determine this in order to pay survivor annuity benefits to children who are age 18 or older.
U.S. Office of Personnel Management.
30-Day notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0138, Reinstatement of Disability Annuity Previously Terminated Because of Restoration to Earning Capacity, RI 30-9. As required by the Paperwork Reduction Act of 1995, (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. This information collection was previously published in the
Comments are encouraged and will be accepted until March 10, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
RI 30-9 informs former disability annuitants of their right to request restoration under title 5, U.S.C. Sections 8337 and 8455. It also specifies the conditions to be met and the documentation required for a person to request reinstatement.
U.S. Office of Personnel Management.
60-Day notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on a revised information collection (ICR) 3206-0034, Annuitant's Report of Earned Income. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection.
Comments are encouraged and will be accepted until April 11, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to Retirement Services, U.S. Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, Attention: Alberta Butler, Room 2347E, or sent via electronic mail to
A copy of this ICR with applicable supporting documentation, may be obtained by contacting the Retirement Services Publications Team, Office of Personnel Management, 1900 E Street NW., Room 3316-L, Washington, DC 20415, Attention: Cyrus S. Benson, or sent via electronic mail to
The Office of Management and Budget is particularly interested in comments that:
1. Evaluate whether the proposed collection of information is necessary for the proper performance of functions of the agency, including whether the information will have practical utility;
2. Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
3. Enhance the quality, utility, and clarity of the information to be collected; and
4. Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
RI 30-2, Annuitant's Report of Earned Income is used annually to determine if disability retirees under age 60 have earned income which will result in the termination of their annuity benefits under title 5, U.S.C Sections 8337 and 8455. It also specifies the conditions to
U.S. Office of Personnel Management.
30-Day notice and request for comments.
The Retirement Services, Office of Personnel Management (OPM) offers the general public and other Federal agencies the opportunity to comment on an extension, without change, of a currently approved information collection request (ICR) 3206-0228, CSRS/FERS Documentation in Support of Disability Retirement Application, SF 3112. As required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35) as amended by the Clinger-Cohen Act (Pub. L. 104-106), OPM is soliciting comments for this collection. This information collection was previously published in the
Comments are encouraged and will be accepted until March 10, 2016. This process is conducted in accordance with 5 CFR 1320.1.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
A copy of this ICR, with applicable supporting documentation, may be obtained by contacting the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street NW., Washington, DC 20503, Attention: Desk Officer for the Office of Personnel Management or sent via electronic mail to
SF 3112 collects information from applicants for disability retirement so that OPM can determine whether to approve a disability retirement. The applicant will only complete Standard Forms 3112A and 3112C. Standard Forms 3112B, 3112D and 3112E will be completed by the immediate supervisor and the employing agency of the applicant.
Securities and Exchange Commission (“Commission”).
Notice of an application under section 6(c) of the Investment Company Act of 1940 (“Act”) for an exemption from section 15(a) of the Act and rule 18f-2 under the Act, as well as from certain disclosure requirements in rule 20a-1 under the Act, Item 19(a)(3) of Form N-1A, Items 22(c)(1)(ii), 22(c)(1)(iii), 22(c)(8) and 22(c)(9) of Schedule 14A under the Securities Exchange Act of 1934, and Sections 6-07(2)(a), (b), and (c) of Regulation S-X (“Disclosure Requirements”). The requested exemption would permit an investment adviser to hire and replace certain sub-advisers without shareholder approval and grant relief from the Disclosure Requirements as they relate to fees paid to the sub-advisers. The order would also supersede a prior order.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicants: 14376, M243, Enfield, CT 06082.
Bruce MacNeil, Senior Counsel, at (202) 551-6817, or James M. Curtis, Branch Chief, at (202) 551-6712 (Division of Investment Management, Chief Counsel's Office).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or an applicant using the Company name box, at
1. The Manager will serve as the investment adviser to each Subadvised Series pursuant to an investment advisory agreement with each Trust (each, an “Investment Management Agreement,” and collectively, the “Investment Management Agreements”).
2. Applicants request an exemption to permit the Manager, subject to Board approval, to hire a Non-Affiliated Sub-Adviser or a Wholly-Owned Sub-Adviser, pursuant to Sub-Advisory Agreements and materially amend Sub-Advisory Agreements with Non-Affiliated Sub-Advisers and Wholly-Owned Sub-Advisers without obtaining the shareholder approval required under section 15(a) of the Act and rule 18f-2 under the Act.
3. Applicants agree that any order granting the requested relief will be subject to the terms and conditions stated in the Application. Such terms and conditions provide for, among other safeguards, appropriate disclosure to Subadvised Series' shareholders and notification about sub-advisory changes and enhanced Board oversight to protect the interests of the Subadvised Series' shareholders.
4. Section 6(c) of the Act provides that the Commission may exempt any person, security, or transaction or any class or classes of persons, securities, or transactions from any provisions of the Act, or any rule thereunder, if such relief is necessary or appropriate in the public interest and consistent with the protection of investors and purposes fairly intended by the policy and provisions of the Act. Applicants believe that the requested relief meets this standard because, as further explained in the Application, the Investment Management Agreements will remain subject to shareholder approval, while the role of the Sub-Advisers is substantially equivalent to that of individual portfolio managers, so that requiring shareholder approval of Sub-Advisory Agreements would impose unnecessary delays and expenses on the Subadvised Series. Applicants believe that the requested relief from the Disclosure Requirements meets this standard because it will improve the Manager's ability to negotiate fees paid to the Sub-Advisers that are more advantageous for the Subadvised Series.
For the Commission, by the Division of Investment Management, under delegated authority.
Securities and Exchange Commission (“Commission”).
Notice of an application for an order under section 6(c) of the Investment Company Act of 1940 (the “Act”) for an exemption from sections 23(a), 23(b) and 63 of the Act, and under sections 57(a)(4) and 57(i) of the Act and rule 17d-1 under the Act permitting certain joint transactions otherwise prohibited by section 57(a)(4) of the Act.
Secretary, U.S. Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090. Applicant, Marisa T. Silverman, General Counsel, Medallion Financial Corp., 437 Madison Avenue, 38th Floor, New York, NY 10022.
Laura L. Solomon, Senior Counsel, at (202) 551-6915, or Daniele Marchesani, Branch Chief, at (202) 551-6821, (Chief Counsel's Office, Division of Investment Management).
The following is a summary of the application. The complete application may be obtained via the Commission's Web site by searching for the file number, or for an applicant using the Company name box, at
1. The Company, a Delaware corporation, is an internally managed, non-diversified, closed-end investment company that has elected to be regulated as a business development company (“BDC”) under the Act.
2. The Company currently has a eight-member board of directors (the “Board”) of whom three are “interested persons” of the Company within the meaning of section 2(a)(19) of the Act and five are not interested persons (the “Non-interested Directors”). The Company has six directors who are neither officers nor employees of the Company.
3. The Company believes that its successful performance depends on its ability to offer fair compensation packages to its professionals that are competitive with those offered by other investment management businesses. The Company believes that the ability to offer equity-based compensation to its professionals is vital to the Company's future growth and success. The Company wishes to adopt the 2015 Employee Restricted Stock Plan (the “Plan”) providing for the periodic issuance of shares of restricted stock (
4. The Plan will authorize the issuance of shares of Restricted Stock subject to certain forfeiture restrictions. These restrictions may relate to continued employment or service on the Board, achievement of specified performance objectives, or other restrictions deemed by the Committee (as defined below) to be appropriate.
5. The maximum amount of Restricted Stock that may be issued under the Plan will be 10% of the outstanding shares of common stock of the Company on the effective date of the Plan plus 10% of the number of shares of the Company's common stock issued or delivered by the Company (other than pursuant to compensation plans) during the term of the Plan.
6. Each issuance of Restricted Stock under the Plan will be approved by the required majority, as defined in section 57(o) of the Act, of the Company's directors on the basis that the issuance
7. The Plan has been approved by the Committee, as well as the Board, including the required majority as defined in section 57(o) of the Act. The Plan will be submitted for approval to the Company's stockholders, and will become effective upon such approval, subject to and following receipt of the order.
1. Under section 63 of the Act, the provisions of section 23(a) of the Act generally prohibiting a registered closed-end investment company from issuing securities for services or for property other than cash or securities are made applicable to BDCs. This provision would prohibit the issuance of Restricted Stock as a part of the Plan.
2. Section 23(b) generally prohibits a closed-end management investment company from selling its common stock at a price below its current net asset value (“NAV”). Section 63(2) makes section 23(b) applicable to BDCs unless certain conditions are met. Because Restricted Stock that would be granted under the Plan would not meet the terms of section 63(2), sections 23(b) and 63 prohibit the issuance of the Restricted Stock.
3. Section 6(c) provides that the Commission may, by order upon application, conditionally or unconditionally exempt any person, security, or transaction, or any class or classes of persons, securities or transactions, from any provision of the Act, if and to the extent that 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 Act.
4. The Company requests an order pursuant to section 6(c) of the Act granting an exemption from the provisions of sections 23(a) and (b) and section 63 of the Act.
5. The Company further states that the Plan will not unduly complicate the Company's structure because equity-based compensation arrangements are widely used among corporations and commonly known to investors. The Company notes that the Plan will be submitted to its stockholders for their approval. The Company represents that a concise, “plain English” description of the Plan, including its potential dilutive effect, will be provided in the proxy materials that will be submitted to the Company's stockholders. The Company also states that it will comply with the proxy disclosure requirements in Item 10 of Schedule 14A under the Securities Exchange Act of 1934 (the “Exchange Act”). The Company further notes that the Plan will be disclosed to investors in accordance with the requirements of the Form N-2 registration statement for closed-end investment companies, and pursuant to the standards and guidelines adopted by the Financial Accounting Standards Board for operating companies. In addition, the Company will comply with the disclosure requirements for executive compensation plans applicable to operating companies under the Exchange Act.
6. The Company acknowledges that, while awards granted under the Plan would have a dilutive effect on the stockholders' equity in the Company, that effect would be outweighed by the anticipated benefits of the Plan to the Company and its stockholders. The Company asserts that it needs the flexibility to provide the requested equity-based employee compensation in order to be able to compete effectively with other financial services firms for talented professionals. These professionals, the Company suggests, in turn are likely to increase the Company's performance and stockholder value. The Company also asserts that equity-based compensation would more closely align the interests of the Company's employees with those of its stockholders. In addition, the Company states that its stockholders will be further protected by the conditions to the requested order that assure continuing oversight of the operation of the Plan by the Company's Board.
7. Section 57(a) proscribes certain transactions between a BDC and persons related to the BDC in the manner described in section 57(b) (“57(b) persons”), absent a Commission order. Section 57(a)(4) generally prohibits a 57(b) person from effecting a transaction in which the BDC is a joint participant absent such an order. Rule 17d-1, made applicable to BDCs by section 57(i), proscribes participation in a “joint enterprise or other joint arrangement or profit-sharing plan,” which includes a stock option or purchase plan. Employees and directors of a BDC are
8. The Company requests an order pursuant to section 57(a)(4) and rule 17d-1 to permit the Company to grant shares of Restricted Stock pursuant to the Plan. The Company states that the Plan, although benefiting the Participants and the Company in different ways, is in the interests of the Company's stockholders because the Plan will help align the interests of the Company's employees and officers with those of its stockholders, which will encourage conduct on the part of those employees and officers designed to produce a better return for the Company's stockholders.
Applicant agrees that the order granting the requested relief will be subject to the following conditions:
1. The Plan will be authorized by the Company's stockholders.
2. Each issuance of Restricted Stock to a Participant will be approved by the required majority, as defined in section 57(o) of the Act, of the Company's directors on the basis that such issuance is in the best interest of the Company and its stockholders.
3. The amount of voting securities that would result from the exercise of all of the Company's outstanding warrants, options, and rights, together with any Restricted Stock issued pursuant to the Plan, at the time of issuance shall not exceed 25% of the outstanding voting securities of the Company, except that if the amount of voting securities that would result from the exercise of all of the Company's outstanding warrants, options, and rights issued to the Company's directors, officers, and employees, together with any Restricted Stock issued pursuant to the Plan, would exceed 15% of the outstanding voting securities of the Company, then the total amount of voting securities that would result from the exercise of all outstanding warrants, options, and rights, together with any Restricted Stock issued pursuant to the Plan, at the time of issuance shall not exceed 20% of the outstanding voting securities of the Company.
4. The maximum amount of shares of Restricted Stock that may be issued under the Plan will be 10% of the outstanding shares of common stock of the Company on the effective date of the Plan plus 10% of the number of shares of the Company's common stock issued or delivered by the Company (other than pursuant to compensation plans) during the term of the Plan.
5. The Board will review the Plan at least annually. In addition, the Board will review periodically the potential impact that the issuance of Restricted Stock under the Plan could have on the Company's earnings and NAV per share, such review to take place prior to any decisions to grant Restricted Stock under the Plan, but in no event less frequently than annually. Adequate procedures and records will be maintained to permit such review. The Board will be authorized to take appropriate steps to ensure that the grant of Restricted Stock under the Plan would not have an effect contrary to the interests of the Company's stockholders. This authority will include the authority to prevent or limit the granting of additional Restricted Stock under the Plan. All records maintained pursuant to this condition will be subject to examination by the Commission and its staff.
For the Commission, by the Division of Investment Management, under delegated authority.
Pursuant to Section 19(b)(1)
The Exchange proposes to list and trade Binary Return Derivatives (“ByRDs”). 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 list and trade ByRDs. The Exchange proposes to model its ByRDs rules after the approved rules of another options exchange—namely NYSE MKT LLC (“NYSE MKT”).
ByRDs are European-style option contracts on individual stocks, exchange-traded funds (“ETFs”) and Index-Linked Securities that have a fixed return in cash based on a set strike price; satisfy specified listing criteria; and may only be exercised at expiration pursuant to the Rules of the Options Clearing Corporation (the “OCC”).
The Exchange proposes to specify which series of ByRDs options contracts may open for trading and the permissible strike price intervals.
The initial listing criteria for ByRDs require that an individual stock underlying a ByRDs contract meet the criteria for underlying securities in Rule 5.3, “Criteria for Underlying Securities,” and, in addition, have: (1) Minimum market capitalization of at least $40 billion; (2) minimum trading volume, in all markets in which the security trades, of at least one billion shares in the preceding 12 months; (3) minimum average daily trading volume of four million shares; (4) minimum average daily trading value of at least $200 million during the previous six months; and (5) a minimum market price per share of at least $10, as measured by the closing price reported in the primary listed market in which the security is traded, over the previous five consecutive business days preceding the date on which the Exchange submits a certificate to the OCC for listing and trading.
The continued listing criteria for ByRDs require that an individual stock underlying a ByRDs contract satisfy the requirements of Rule 5.4, “Withdrawal of Approval of Underlying Securities,” and, in addition, have: (1) Minimum market capitalization of at least $30 billion; (2) minimum trading volume, in all markets trading the security, of at least one billion shares in the preceding 12 months; (3) minimum average daily trading volume of four million shares; (4) minimum average daily trading value of at least $125 million during the last six months; and (5) an underlying market price per share of at least $5 at the time additional series are listed for trading.
To reduce concerns regarding potential price manipulation at expiration due to the “all-or-nothing” return provided by a ByRDs contract, the Exchange proposes to settle ByRDs using an all-day volume weighted average price (“VWAP”) based on trading in the underlying security on the last trading day prior to expiration.
The Exchange also proposes to provide that the settlement price will be calculated such that it will always round up $.01 in those instances when the settlement price exactly equals an expiring strike price.
The position limits for ByRDs will be 25,000 contracts on the same side of the market, and positions in ByRDs will not be aggregated with positions in other options on the same underlying security for purposes of determining compliance with the position limits.
A customer account with a long position in a ByRDs contract must initially deposit and maintain margin equal to at least 100% of the purchase price of the ByRD.
A Market Maker is expected to quote with no more than $0.25 between the bid and the offer for each ByRD contract, except during the last trading day prior to expiration, when the maximum width may be $0.50.
Rule 6.72, “Trading Differentials,” generally provides that MPV for an option is: (i) $0.05 for options quoted under $3 a contract; and (ii) $0.10 for options quoted at $3 a contract or greater.
Related to the adoption of ByRDs, the Exchange also proposes to revise Rule 6.87, Nullification and Adjustment of Options Transactions including Obvious Errors, to include a new subsection (c)(6) that addresses the handling of transactions in ByRDs option contracts that are subject to the Obvious Error provisions of Rule 6.87. Proposed Rule 6.87(c)(6) provides that any transaction in a ByRDs contract that is higher or lower than the Theoretical Price by $0.25 or more shall be deemed an obvious error, subject to the adjustment procedures of Rule 6.87(c)(4), unless such adjustment would result in a price higher than $1.02, in which case the adjustment price shall be $1.02.
The Exchange also proposes to adopt Rule 5.95 to make clear that the Exchange would halt or suspend trading for a ByRDs contract to the same extent that it halts or suspends trading under Rule 6.65 in an option contract on the same underlying security. In other words, trading in ByRDs contracts would be treated the same as other options contracts in the event that trading in options contracts is halted or suspended on the same underlying security.
The Exchange proposes to announce the implementation of the proposed rule change via Trader Update.
The Exchange believes that its proposal is consistent with Section 6(b) of the Act
As noted above, this proposal is designed to mirror the approved ByRDs rules that are in place on NYSE MKT, a competing options exchange.
The Exchange believes that the proposed changes to the obvious and catastrophic error rule (
The Exchange also believes that the proposed rule to make clear that ByRDs would be treated the same as other options contracts, in the event of a trading halt or suspension, would remove impediments to, and perfect the mechanisms of, a free and open market because it would add clarity and transparency to Exchange rules. Moreover, this proposed change would ensure consistent treatment of ByRDs contracts in the event of a halt or suspension of trading in options contracts on the same underlying security.
Finally, the Exchange has in place an adequate surveillance program to monitor trading in ByRDs and intends to largely apply its existing surveillance program for options to the trading of ByRDs. The Exchange also has the necessary systems capacity to support the new options series that would result from the introduction of ByRDs. In addition, (ii) the Exchange and the Options Price Reporting Authority (“OPRA”) have the necessary systems capacity to handle additional traffic associated with the listing and trading of ByRDs. The OCC has represented that it is able to accommodate the clearing and settlement of ByRDs contracts. Finally, the Exchange will monitor any increased trading volume associated with the listing of new series of ByRDs and will analyze the effect, if any, that the additional volume has on the capacity of the Exchange's, OPRA's, and the OCC's automated systems.
In accordance with Section 6(b)(8) of the Act,
No written comments were solicited or received with respect to the proposed rule change.
Because the proposed rule change does not (i) significantly affect the protection of investors or the public interest; (ii) impose any significant burden on competition; and (iii) become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, it has become effective pursuant to Section
At any time within 60 days of the filing of the proposed rule change, the Commission summarily may temporarily suspend such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act. If the Commission takes such action, the Commission shall institute proceedings to determine whether the proposed rule change should be approved or disapproved.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
Notice is hereby given, pursuant to the provisions of the Government in the Sunshine Act, Public Law 94-409, that the Securities and Exchange Commission will hold a Closed Meeting on Thursday, February 11, 2016 at 2:00 p.m.
Commissioners, Counsel to the Commissioners, the Secretary to the Commission, and recording secretaries will attend the Closed Meeting. Certain staff members who have an interest in the matters also may be present.
The General Counsel of the Commission, or her designee, has certified that, in her opinion, one or more of the exemptions set forth in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR 200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the scheduled matter at the Closed Meeting.
Chair White, as duty officer, voted to consider the items listed for the Closed Meeting in closed session.
The subject matter of the Closed Meeting will be:
At times, changes in Commission priorities require alterations in the scheduling of meeting items.
For further information and to ascertain what, if any, matters have been added, deleted or postponed, please contact the Office of the Secretary at (202) 551-5400.
On July 16, 2015, New York Stock Exchange LLC (“NYSE”) and, on July 24, 2015, NYSE MKT LLC (“NYSE MKT”) (together with NYSE, the “Exchanges”) each filed with the Securities and Exchange Commission (“Commission”) pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The proposed rule change by DTC would discontinue the options for Users (as defined below) to receive facsimile or hardcopy delivery of Security Position Reports (“SPRs”), as more fully described below.
In its filing with the Commission, DTC 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. DTC has prepared summaries, set forth in sections A, B, and C below, of the most significant aspects of such statements.
DTC may provide to Issuers, Trustees, and third party Agents authorized by the Issuer (collectively, “Users”), listings of Participants' holdings of Issuer Securities on a specific date for specific Securities, by CUSIP number. These listings are known as SPRs or Security Position Listings.
All Users must be registered for the SPR Site and all requests for subscriptions or individual copies of SPRs must be made through the SPR Site. A User may request that the delivery of an SPR be made directly through the SPR Site in either Browser or Spreadsheet formats, by CCF,
DTC is proposing to eliminate the facsimile and hardcopy methods of SPR delivery for a number of reasons. First, doing so would improve efficiencies in terms of streamlining SPR processing away from more manually intensive delivery methods and thus lower costs to DTC. Second, eliminating physical delivery methods in favor of access to SPRs through electronic interface or transmission methods provides a higher level of security.
Although Users that have SPR subscriptions would no longer have the option to receive SPRs by facsimile or hardcopy, the cost savings to DTC of eliminating these delivery methods is ultimately cost savings to the Users. The elimination of the facsimile and hardcopy methods would balance the costs to DTC and obviate the need for DTC to raise its SPR subscription fees.
In connection with this proposal to no longer offer facsimile and hard copy [sic] delivery methods, DTC would update its Pricing Schedule to remove the $25.00 additional charge per report when facsimile service is specifically
The OA would also be amended in the section relating to SPRs to:
(i) update references to the link to the DTC public Web page that provides information on SPR service options, pricing, and guidance on use of the SPR service,
(ii) remove text stating that SPRs may reflect Participant holdings in Securities of Trustees or third party Agents because an SPR reflects Participant holdings in the Security of an Issuer.
The effective date of the proposed rule change would be February 4, 2016.
Section 17A(b)(3)(F)
DTC does not believe that the proposed rule change would have any impact or impose any burden on competition because it would not have a material effect on User access to SPRs. All Users would continue to be required to register for the SPR Site in order to gain access to SPRs, as described above, and each User would have the same ability as other Users to obtain SPRs that it is authorized to access.
DTC has not solicited and does not intend to solicit comments regarding the proposed rule change. DTC has not received any unsolicited written comments from interested parties. To the extent DTC receives written comments on the proposed rule change, DTC will forward such comments to the Commission. DTC has discussed the proposed discontinuance of facsimile and hardcopy delivery of SPRs with Users that have used those methods of delivery to receive SPRs.
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)
A proposed rule change filed under Rule 19b-4(f)(6)
DTC has asked the Commission to waive the 30-day operative delay so that the proposal may become operative immediately upon filing. According to DTC, the proposed rule change does not present any novel or controversial issues. Rather, DTC is merely enhancing its process for delivery of SPRs to Users to facilitate efficiency and security in DTC's processing of SPR requests in a way that would not have a material effect on User access to SPRs. Accordingly, the Commission believes that waiving the 30-day operative delay is consistent with the protection of investors and the public interest as it will allow DTC to facilitate efficiency and security in processing SPRs. Therefore, the Commission designates the proposed rule change to be operative upon filing.
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.
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.
On December 8, 2015, The Options Clearing Corporation (“OCC”) filed with the Securities and Exchange Commission (“Commission”) the proposed rule change SR-OCC-2015-018 pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
OCC is adopting a Charter for a new committee of OCC's Board of Directors (“Board”), the Technology Committee (“TC”). Additionally, OCC is adding a description of the TC into Article III, Section 9 of OCC's By-Laws. The Board formed the TC in order to enhance the Board's understanding and oversight of key technology, information security, and cyber-security risk issues at OCC. Consistent with OCC's other Board-level committee charters, the TC Charter sets forth: (i) The purpose, functions, and responsibilities of the TC; and (ii) the composition and organization of the TC.
As set forth in the TC Charter, the TC will be responsible for: (i) Overseeing major information technology (“IT”) related strategies, projects, and technology architecture decisions; (ii) monitoring whether OCC's IT programs effectively support OCC's business objectives and strategies; (iii) monitoring OCC's IT risk management efforts as well as the security of OCC's information systems and physical security of information system assets; and (iv) conferring with OCC's senior IT management team and informing the Board on IT-related matters.
Further, and with respect to the TC Charter's role in the oversight of OCC's IT strategy and projects, the TC Charter provides that the TC will be specifically tasked with: (i) Evaluating OCC's IT strategy, including the financial, tactical, and strategic benefits of IT projects and technology architecture initiatives; (ii) critically reviewing IT projects and technology architecture decisions, including review of the process related to approval of capital expenditures as they relate to IT projects; and (iii) making recommendations to the Board with respect to IT-related projects and investments that require Board approval. In addition, the TC Charter will require that the TC: (i) Monitor the quality and effectiveness of OCC's IT and physical security, including periodically reviewing and appraising OCC's disaster recovery capabilities and crisis management plans; (ii) in coordination and cooperation with the Audit Committee of the Board, monitor the quality and effectiveness of OCC's IT systems and processes that relate to or affect OCC's internal controls and assess OCC's management of IT-related compliance risks; (iii) report to the Board and the Audit Committee about IT risks and controls; and (iv) serve in an advisory role with respect to IT decisions at OCC. In connection with carrying out its responsibilities, the TC will also, in general, inform and make recommendations to the Board and other Board-level committees with respect to IT-related matters.
The TC Charter will provide that the TC be comprised of three or more directors, and meet at least four times per year.
Section 19(b)(2)(C) of the Act
The Commission finds that the proposed rule change is consistent with Section 17A(b)(3)(F) of the Act. This section requires, among other things, that the rules of a clearing agency promote the prompt and accurate clearance and settlement of securities transactions.
Additionally, the Commission finds that the proposed rule change is consistent with Rule 17Ad-22(d)(8). This rule requires a clearing agency's the written policies and procedures to: (i) Have governance arrangements that are clear and transparent to fulfill the public interest requirements in Section 17A of the Act; (ii) support the objectives of OCC's owners and participants; and (iii) promote the effectiveness of OCC's risk management procedures.
On the basis of the foregoing, the Commission finds that the proposal is consistent with the requirements of the Act, and in particular, with the requirements of Section 17A of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On December 2, 2015, NYSE Arca, Inc. (“Exchange” or “NYSE Arca”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Commission approved the listing and trading on the Exchange of shares (“Shares”) of the WisdomTree Put Write Strategy Fund (“Fund”) under NYSE Arca Equities Rule 5.2(j)(3), which governs the listing and trading of Investment Company Units.
The Exchange has not listed or commenced trading in the Shares.
The Exchange submitted this proposal to correct two representations made in support of its prior proposal to list and trade the Shares. Specifically, the Exchange seeks to strike its representations that the Index will (1) include a minimum of 20 components; and (2) meet the numerical requirements of NYSE Arca Equities Rule 5.2(j)(3), Commentary .01(a)(A)(4). At any given time, the Index consists of one component, an “SPX Put.”
The Exchange asserts that the deletion of its prior representations would not adversely affect investors or the public interest, because the Index is based on CBOE-traded puts on the S&P 500, which are highly liquid.
The Exchange represents that trading in the Shares will be subject to the existing trading surveillances and that these procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and federal securities laws. Furthermore, the Financial Industry
After careful review, the Commission finds that the exchange's proposal is consistent with the requirements of Section 6 of the Act
The Commission believes that it would be difficult to manipulate the price of the Shares by manipulating the prices of its underlying assets. The Fund's portfolio will comprise cash, short-term U.S. Treasury bills, and SPX Puts.
For these reasons, the Commission believes that it would be difficult to manipulate the price of the Shares by manipulating the prices of its underlying assets. The Commission also notes that, except as discussed above, all other representations made in support of the Prior Release remain unchanged.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),
The purpose of this proposed rule change by The Options Clearing Corporation (“OCC”) is to revise OCC's Schedule of Fees effective March 1, 2016, to implement a reduction of clearing fees in accordance with OCC's Fee Policy, which was recently adopted as part of OCC's Capital Plan.
In its filing with the Commission, OCC included statements concerning the purpose of and basis for the proposed rule change and discussed any comments it received on the proposed rule change. The text of these statements may be examined at the places specified in Item IV below. OCC has prepared summaries, set forth in sections (A), (B), and (C) below, of the most significant aspects of these statements.
The purpose of this proposed rule change is to revise OCC's Schedule of Fees in accordance with its new Fee Policy. The revised fee schedule would become effective on March 1, 2016.
By way of background, in 2015, the Commission approved OCC's Capital Plan,
OCC analyzed its current Schedule of Fees
As a result of the aforementioned analysis, OCC proposes to revise its Schedule of Fees as set forth below.
OCC anticipates that the proposed changes to OCC's Schedule of Fees would result in an average decrease in clearing fees of 19%. Moreover, and in accordance with its Fee Policy, OCC will continue to monitor cleared contract volume and operating expenses in order to determine if further revisions to OCC's Schedule of Fees are required so that monies received from clearing fees cover OCC's operating expenses plus a Business Risk Buffer of 25%.
OCC believes that the proposed rule change concerning a reduction to OCC's clearing fees is consistent with Section 17A(b)(3)(D)
OCC does not believe that the proposed rule change would have an impact or impose a burden on competition.
Written comments on the proposed rule change were not and are not intended to be solicited with respect to the proposed rule change and none have been received.
The foregoing rule change has become effective upon filing
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an email to
• Send paper comments in triplicate to Brent J. Fields, Secretary, Securities and Exchange Commission, 100 F Street NE., Washington, DC 20549-1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
U.S. Small Business Administration.
Amendment 2.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Mississippi (FEMA-4248-DR), dated 01/04/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of Mississippi, dated 01/04/2016, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a notice of an Economic Injury Disaster Loan (EIDL) declaration for the State of California, dated 02/02/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the Administrator's EIDL declaration, applications for economic injury disaster loans may be filed at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for economic injury is 146090.
The States which received an EIDL Declaration # are California, Nevada, Oregon.
U.S. Small Business Administration
Amendment 1.
This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of Texas (FEMA-4245-DR), dated 12/24/2015.
Submit completed loan applications to: U.S. Small Business Administration, Processing And Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
The notice of the President's major disaster declaration for Private Non-Profit organizations in the State of TEXAS, dated 12/24/2015, is hereby amended to include the following areas as adversely affected by the disaster.
All other information in the original declaration remains unchanged.
U.S. Small Business Administration.
Notice.
This is a Notice of the Presidential declaration of a major disaster for Public Assistance Only for the State of Idaho (FEMA-4252-DR), dated 02/01/2016.
02/01/2016.
Submit completed loan applications to: U.S. Small Business Administration, Processing and Disbursement Center, 14925 Kingsport Road, Fort Worth, TX 76155.
A. Escobar, Office of Disaster Assistance, U.S. Small Business Administration, 409 3rd Street SW., Suite 6050, Washington, DC 20416.
Notice is hereby given that as a result of the President's major disaster declaration on 02/01/2016, Private Non-Profit organizations that provide essential services of governmental nature may file disaster loan applications at the address listed above or other locally announced locations.
The following areas have been determined to be adversely affected by the disaster:
The Interest Rates are:
The number assigned to this disaster for physical damage is 14610B and for economic injury is 14611B.
Small Business Administration.
30-Day notice.
The Small Business Administration (SBA) is publishing this notice to comply with requirements of the Paperwork Reduction Act (PRA) (44 U.S.C. chapter 35), which requires agencies to submit proposed reporting and recordkeeping requirements to OMB for review and approval, and to publish a notice in the
Submit comments on or before March 10, 2016
Comments should refer to the information collection by name and/or OMB Control Number and should be sent to:
Curtis Rich, Agency Clearance Officer, (202) 205-7030
In October 2014, a new cohort of sites was added to the Regional Innovation Clusters (RIC) initiative, which was originally started in October 1, 2010 by the Small Business Administration (SBA)'s Office of Entrepreneurial Development. Through this initiative, organizations in 11 communities across the U.S. have been selected to provide industry-specific assistance to small businesses, and to develop industry relationships and supply chains within their regions. Clusters—geographically concentrated groups of interconnected businesses, suppliers, service providers, and associated institutions in a particular industry or field—act as a networking hub to convene a number of resources to help navigate the funding, procurement, and supply-chain opportunities in a specific industry.
SBA is conducting an evaluation of the Regional Innovation Clusters initiative to determine how the clusters have developed, the type and volume of services they provided to small businesses, client perceptions of the program, and the various outcomes related to their existence, including collaboration among firms, innovation, and small business growth. Small business growth will be compared to the overall growth of firms in those same regions and industries. This evaluation will also include lessons learned and success stories. SBA proposes the use of three instruments for data collection and analysis of three distinct populations. These instruments are: (1). Small Business Survey, (2.) Large Organization Survey and (3.) Cluster Administrator Survey. In addition, SBA plans to interview each of the 11 cluster administrators several times a year regarding program impact and successes or challenges, and to obtain clarifications on information provided in quarterly reports. Each of the proposed surveys will be administered electronically and will contain both open- and close-ended questions. The information collected and analyzed from these instruments will contribute to monitoring performance metrics and program goals, as well as recommendations on improving program practices.
The Department of State announces a meeting of the U.S. State Department—Overseas Security Advisory Council on February 23 and 24, 2016. Pursuant to Section 10(d) of the Federal Advisory Committee Act (5 U.S.C. Appendix), 5 U.S.C. 552b(c)(4), and 5 U.S.C. 552b(c)(7)(E), it has been determined that the meeting will be closed to the public. The meeting will focus on an examination of corporate security policies and procedures and will involve extensive discussion of trade secrets and proprietary commercial information that is privileged and confidential, and will discuss law enforcement investigative techniques and procedures. The agenda will include updated committee reports, a global threat overview, and other matters relating to private sector security policies and protective programs and the protection of U.S. business information overseas.
For more information, contact Marsha Thurman, Overseas Security Advisory Council, U.S. Department of State, Washington, DC 20522-2008, phone: 571-345-2214.
Notice of request for public comment and submission to OMB of proposed collection of information.
The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.
Submit comments directly to the Office of Management and Budget (OMB) up to March 10, 2016.
Direct comments to the Department of State Desk Officer in the Office of Information and Regulatory Affairs at the Office of Management and Budget (OMB). You may submit comments by the following methods:
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Direct requests for additional information regarding the collection listed in this notice, including requests for copies of the proposed collection instrument and supporting documents, to PPT Forms Officer, U.S. Department of State, Bureau of Consular Affairs, Passport Services, Office of Legal Affairs and Law Enforcement Liaison, 44132 Mercure Cir, P.O. Box 1227, Sterling, Virginia 20166-1227, who may be reached on (202) 485-6538 or at
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We are soliciting public comments to permit the Department to:
• Evaluate whether the proposed information collection is necessary for the proper functions of the Department.
• Evaluate the accuracy of our estimate of the time and cost burden for this proposed collection, including the
• Enhance the quality, utility, and clarity of the information to be collected.
• Minimize the reporting burden on those who are to respond, including the use of automated collection techniques or other forms of information technology.
Please note that comments submitted in response to this Notice are public record. Before including any detailed personal information, you should be aware that your comments as submitted, including your personal information, will be available for public review.
The TVA Board of Directors will hold a public meeting on February 11, 2016, in the Missionary Ridge Auditorium of the Chattanooga Office Complex, 1101 Market Street, Chattanooga, Tennessee. The public may comment on any agenda item or subject at a
Status: Open.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of Seventh RTCA Special Committee 229 Meeting.
The FAA is issuing this notice to advise the public of the Seventh RTCA Special Committee 229 meeting.
The meeting will be held March 16-18, 2016 from 9:00 a.m.-5:00 p.m.
The meeting will be held at RTCA, Inc., 1150 18th Street NW., Suite 910, Washington, DC, 20036, Tel: (202) 330-0662.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA Special Committee 229. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Plenary information will be provided upon request. Persons who wish to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice of request to release airport property.
The FAA proposes to rule and invite public comment on the release of land at the Monroe Regional Airport at Monroe, Louisiana under the provisions of Section 125 of the Wendell H. Ford Aviation Investment Reform Act for the 21st Century (AIR 21).
Comments must be received on or before (from 30 days of the posting of this
Comments on this application may be mailed or delivered to the FAA at the following address: Mr. Lacey Spriggs, Manager, Federal Aviation Administration, Louisiana/New Mexico Airports District Office, ASW-640, 10101 Hillwood Parkway, Fort Worth, Texas 76177.
In addition, one copy of any comments submitted to the FAA must be mailed or delivered to Mr. Ron Phillips, Airport Manager, at the following address: Monroe Regional Airport, 5400 Operations Drive, Room 200, Monroe, Louisiana 71203.
Mr. Bill Bell, Lead Engineer, Federal Aviation Administration, Louisiana/New Mexico Airports District Office, ASW-640, 10101 Hillwood Parkway, Fort Worth, Texas 76177, telephone: (817) 222-5664, email:
The request to release property may be reviewed in person at this same location.
The FAA invites public comment on the request to release property at the Monroe Regional Airport at Monroe, Louisiana under the provisions of the AIR 21.
The following is a brief overview of the request:
The City of Monroe requests the release of 1.105 acres of aeronautical airport property. The property is located in the Airport Industrial Park area. The property to be released will be sold and revenues shall be used to fund the Bermuda Release Program and purchase a tractor for the operation and maintenance at the airport.
Any person may inspect the request in person at the FAA office listed above under
In addition, any person may, upon request, inspect the application, notice and other documents relevant to the application in person at the Monroe Regional Airport at Monroe, Louisiana, telephone number (318) 329-2460.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before February 29, 2016.
Send comments identified by docket number FAA-2014-0916 using any of the following methods:
• Federal eRulemaking Portal: Go to
• Mail: Send comments to Docket Operations, M-30; U.S. Department of Transportation (DOT), 1200 New Jersey Avenue SE., Room W12-140, West Building Ground Floor, Washington, DC 20590-0001.
• Hand Delivery or Courier: Take comments to Docket Operations in Room W12-140 of the West Building Ground Floor at 1200 New Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.
• Fax: Fax comments to Docket Operations at 202-493-2251.
Dan Ngo, 202-267-4264, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Federal Aviation Administration (FAA), DOT.
Notice.
This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
Comments on this petition must identify the petition docket number and must be received on or before February 29, 2016.
Send comments identified by docket number FAA-2014-0641 using any of the following methods:
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Dan Ngo, (202) 267-4264, 800 Independence Avenue SW., Washington, DC 20591.
This notice is published pursuant to 14 CFR 11.85.
Docket No.: FAA-2014-0641.
Petitioner: Sky-Futures USA, Inc.
Section(s) of 14 CFR Affected: 45.27 (a), 61.113(a) and (b), 91.7(a), 91.105, 91.119(c), 91.121, 91.151(b), 91.405(a), 91.407(a)(1), 91.409(a)(1) and (a)(2), and 91.417(a) and (b).
Description of Relief Sought: The petitioner is requesting relief to launch its small unmanned aircraft systems (sUAS) from a moving vessel such as a boat for the commercial purpose of aerial data collection of motor vessels and sailing vessels over open waters.
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of Sixty-Seventh RTCA Special Committee 135 Meeting.
The FAA is issuing this notice to advise the public of the Sixty-Seventh RTCA Special Committee 135 meeting.
The meeting will be held March 29-31, 2016 from 9:00 a.m.-5:00 p.m.
The meeting will be held at Honeywell, PRN A Conference Rooms, 21111 N. 19th Avenue, Phoenix, AZ, 85027, Tel: (202) 330-0680.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC, 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a) (2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA Special Committee 135. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Plenary information will be provided upon request. Persons who wish to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), U.S. Department of Transportation (DOT).
Notice of Twelfth RTCA Tactical Operations Committee Meeting.
The FAA is issuing this notice to advise the public of the Twelfth RTCA Tactical Operations Committee meeting.
The meeting will be held March 3, 2016 from 9:00 a.m.-4:00 p.m.
The meeting will be held at RTCA, Inc., 1150 18th Street NW., Suite 910, Washington, DC 20036, Tel: (202) 330-0655.
The RTCA Secretariat, 1150 18th Street NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-9339, fax at (202) 833-9434, or Web site at
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is hereby given for a meeting of RTCA Tactical Operations Committee. The agenda will include the following:
Attendance is open to the interested public but limited to space availability. With the approval of the chairman, members of the public may present oral statements at the meeting. Plenary information will be provided upon request. Persons who wish to present statements or obtain information should contact the person listed in the
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of information and request for comments.
This request for comments is related to the implementation of a specific provision in section 32707 of the Moving Ahead for Progress in the 21st Century Act (MAP-21) that requires an annual safety fitness assessment of certain motor carriers of passengers that serve primarily urban areas with high passenger loads. FMCSA requests comments about an appropriate definition of a “curbside bus operator” that will be subject to this annual safety fitness assessment and will be consistent with Congressional intent.
You must submit comments by April 11, 2016.
You may submit comments bearing the Federal Docket Management System (FDMS) Docket ID FMCSA-2015-0481 using any of the following methods:
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Each submission must include the Agency name and the docket number for this notice. Note that DOT posts all comments received without change to
Ms. Loretta Bitner, (202) 385-2428,
Motorcoach safety received increased public attention after several serious crashes during 2011, some of which involved “curbside” bus operators, passenger carrier operations often characterized by high passenger loads with service between urban areas. As a result, the National Transportation Safety Board (NTSB) conducted an investigation of motorcoach safety with an emphasis on curbside operations. One objective of the investigation was to describe the characteristics of the curbside business model among interstate motorcoach carriers. The NTSB examined a population of 4,172 active interstate motorcoach carriers operating in the United States and identified 71 of them as scheduled motorcoach carriers providing curbside service.
In its “Executive Report on Curbside Motorcoach Safety” that was published on October 12, 2011, the NTSB stated
The term “curbside operations” refers to a business model (that is, the means by which motorcoach service is provided) rather than a type of motorcoach carrier. In fact, no formal definition of curbside carriers exists, and federal and state oversight authorities have no unique categorization or tracking mechanism for these carriers. For the purpose of this report, curbside motorcoach operations are those in which interstate motorcoach carriers conduct scheduled trips from one city to another city or a destination and originate or terminate at a location other than a traditional bus terminal; most of these operations discharge passengers at one or more curbside locations.
Although curbside motorcoach carriers apply a similar business model, they vary greatly in other characteristics. Some carriers operate large fleets of motorcoaches throughout the United States, whereas others have a fleet of only a few buses that operate in local regions.
MAP-21 was signed into law on July 6, 2012. Section 32707, codified at 49 U.S.C. 31144(i)(4)(B), addresses improved oversight of motorcoach service providers. A ”motorcoach” is defined in section 32707(b) of MAP-21 as an “over-the-road bus;” one with an elevated passenger deck over a baggage compartment. A motorcoach does not include a bus used in public transportation provided by a State or local government, or a school bus. The statute requires an annual assessment of the safety fitness of certain motor carriers of passengers that serve primarily urban areas with high passenger loads.
Section 31144(i)(4) requires that the Secretary:
• Reassess the safety fitness rating of each motor carrier of passengers at no less than once every 3 years; and
• Annually assess the safety fitness of certain motor carriers of passengers that serve primarily urban areas with high passenger loads.
The language indicates Congress' intent to have two levels of oversight for motor carrier of passengers, a safety fitness rating every 3 years for each passenger carrier and, a safety fitness assessment annually for passenger carriers that serve primarily urban areas with high passenger loads. To effectively implement 49 U.S.C. 31144(i)(4)(B), FMCSA must define which passenger carriers will be subject to the annual safety fitness assessment requirement. While Congress directed that carriers of passengers that serve primarily urban areas with high passenger loads be subject to this requirement, FMCSA does not collect urban area service or passenger volume information from motor carriers of passengers that are subject to the Agency's safety oversight.
FMCSA believes Congress intends for the Agency to have increased safety oversight of the bus operators that generally provide low-cost, regularly scheduled passenger transportation service between major cities with curbside boarding and/or disembarking. Although some carriers purport to have a bus terminal/facility/station, the location used for passengers is a waiting area only outside of an office building and the passenger pickups and drop-offs occur at the curbside or in a parking lot.
Because FMCSA does not include in its regulations or regulatory guidance a definition of the term “curbside bus operator,” the Agency believes it is imperative that one be adopted in order to effectively implement 49 U.S.C. 31144(i)(4)(B). Therefore, the Agency proposes the following definition for identifying motor carriers of passengers that must undergo an annual assessment:
“Curbside Bus Operator” means a motor carrier of passengers that serves primarily urban areas with high passenger loads, and uses 25% or more of its motorcoaches for operations with passenger pickups and drop-offs occuring at the curbside or in a parking lot.
FMCSA would use this definition in identifying, tracking, and conducting the annual safety fitness assessments of every identified curbside bus operators. This definition would not have any impact on the enforcement of the applicable safety regulations. It would only be used to identify those carriers that Congress intends the Agency conduct annual safety assessments.
FMCSA is considering the use of the following questions during the motor carrier registration process to identify curbside bus operators that transport high passenger loads:
The operation of a motorcoach to transport passengers is the FMCSA's interpretation of a high passenger load with implementation of 49 U.S.C. 31144(i)(4)(B). Motorcoaches are large capacity passenger vehicles that are frequently operated by curbside bus operators.
FMCSA requests public comments whether the proposed definition and questions are appropriate for idenitying curbside operators for implementation of the statutorily mandated annual safety fitness assessments.
In addition to motor carriers of passengers that identify themselves as curbside bus operators through the motor carrier registration process, FMCSA will direct its enforcement personnel to designate passenger carriers as a curbside bus operators in the Agency's database when there is evidence that the carriers are conducting curbside bus operations, but fail to report it to the Agency or began curbside bus operations subsequent to registration. With this in mind, FMCSA is seeking input to the following questions.
1. Should FMCSA identify all motor carriers of passengers that have both curbside operations and operations that originate/terminate at a traditional bus terminal as curbside bus operators requiring an annual safety assessment?
2. Should a motor carrier of passengers that uses 25% or more of its motorcoaches for curbside operations be identified by FMCSA as a curbside bus operator requiring an annual safety assessment?
3. Should FMCSA base the percentage of curbside operations on the number of motorcoaches used in that type of service? If not, then what measure should be used?
4. Should FMCSA include passenger carrier operations that pick up passengers at the curbside in vehicles smaller than motorcoaches with the intent of transferring the passengers to a larger passenger vehicle such as a motorcoach as curbside bus operators requiring an annual safety assessment?
5. Should a motor carrier of passengers applicant be required to self-identify as a curbside operator during registration with FMCSA?
6. Should a motor carrier of passengers previously registered with FMCSA be required to self-identify as a curbside operator when updating its registration information as required by 49 CFR 390.201?
7. Should FMCSA base the definition of an urban area on population, incorporated land area, defined commercial zones, urbanized area as defined by the U. S. Census Bureau, or some other criteria?
8. Should a motor carrier of passengers with 25% or more of its motorcoach operation taking place in primarily urban areas be identified by
9. Is there any additional criteria we should consider to identify which motor carrier of passenger should be defined as a curbside bus operator requiring an annual safety assessment?
Federal Motor Carrier Safety Administration (FMCSA), DOT.
Notice of final disposition.
The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant TowMate, LLC's (TowMate) application for a limited two-year exemption to allow motor carriers to operate rechargeable wireless temporary stop, turn, and tail lighting systems during temporary towing operations. Under the Federal Motor Carrier Safety Regulations (FMCSRs), all required lamps, with the exception of battery-powered lamps used on projecting loads, must be powered by the electrical system of the motor vehicle. The Agency has determined that use of rechargeable wireless temporary stop, turn, and tail lighting systems during temporary towing operations would not have an adverse impact on safety, and use of these systems under the terms and conditions of the exemption would achieve a level of safety equivalent to or greater than the level of safety provided by the regulation. This decision is consistent with an August 2005 amendment to the FMCSRs to allow battery powered lamps on the rear of projecting loads.
This exemption is effective February 9, 2016 and ending February 9, 2018.
Mr. Luke Loy, Vehicle and Roadside Operations Division, Office of Carrier, Driver, and Vehicle Safety, MC-PSV, (202) 366-0676, Federal Motor Carrier Safety Administration, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant exemptions from certain parts of the Federal Motor Carrier Safety Regulations. FMCSA must publish a notice of each exemption request in the
The Agency reviews safety analyses and public comments submitted, and determines whether granting the exemption would likely achieve a level of safety equivalent to, or greater than, the level that would be achieved by the current regulation (49 CFR 381.305). The decision of the Agency must be published in the
TowMate applied for an exemption from 49 CFR 393.23 to allow motor carriers to operate rechargeable wireless temporary stop, turn, and tail lighting systems during temporary towing operations. A copy of the application is included in the docket referenced at the beginning of this notice.
Section 393.23, “Power Supply for Lamps,” provides that “All required lamps must be powered by the electrical system of the motor vehicle with the exception of battery powered lamps used on projecting loads.”
The application stated:
TowMate is making this request because the use of conventional hard wired temporary stop, turn, and tail lights has many drawbacks that wireless tow lights solve. These include broken connections, frayed wires, burnt out incandescent bulbs, and the potential to be snagged or pulled from the tow light receptacle due to improper running of wires, and road hazards, along with the safety hazard of increasing the amount of time spent on the roadside or the scene of an accident by stringing wired lighting systems between vehicles and securing the wires. With the advent of LED technology coupled with advancements in battery technologies, wireless tow lights are more reliable and better equipped for the rigors of daily temporary use.
Temporary wireless stop, turn, tail lighting systems can operate for 10+ hours of continuous use on a full charge, and in-cab wire-less monitoring systems give the driver constant information on the functioning of the system, displaying state of charge of the battery inside the unit, displaying the functioning of the system during operation, and warning the driver if the unit is no longer functioning. In this sense, wireless tow lights provide a level of safety and redundancy that is not currently required on wired temporary lighting systems. In an emergency situation with a drained battery, power can be directly connected to the temporary wireless stop, turn, and tail lighting system from a standard 4 pin or 7 pin electrical connection.
Without the proposed temporary exemption, tow and haul away operators will be forced to continue to use cumbersome wired temporary towing light systems, placing an unnecessary burden on their daily operations. The current temporary lighting requirements for stop, tail, and turn lamps require that the lamps receive their power from a direct wired connection to the towing vehicle with no ascertainable benefit from doing such. Wireless tow lights afford benefits that wired systems are unable to, such as redundancies like monitoring the status of the unit in real time, thus assuring their proper operation at all times.
On August 6, 2015, FMCSA published notice of the TowMate application and requested public comment (80 FR 47031). The Agency received thirteen comments, all in support of TowMate's application.
The Towing and Recovery Association of America, Inc., and the Wisconsin Towing Association commented that hard-wired temporary stop, tail and turn signal lighting systems take additional time to install on the side of the road or highway as compared to wireless systems, leaving tow operators vulnerable and at greater risk of being struck and injured by passing motorists These commenters stated that use of rechargeable wireless temporary stop, turn, and tail lighting
Seven commenters identified themselves as owners of small towing companies that use rechargeable wireless temporary stop, turn, and tail lighting systems when conducting temporary emergency tows. These commenters echoed the comments above, noting that use of the wireless systems allows operators to clear accident scenes from roadways faster and thereby increases tow operator safety.
Four additional commenters supported TowMate's application, noting the same benefits as the other commenters.
Prior to August 2005, section 393.23 of the FMCSRs was titled “Lighting devices to be electric,” and stated “Lighting devices shall be electric, except that red liquid-burning lanterns may be used on the end of loads in the nature of poles, pipes, and ladders projecting to the rear of the motor vehicle.” In a final rule published on August 15, 2005, FMCSA amended section 393.23 of the FMCSRs to incorporate terminology which is more consistent with current industry standards and practices (70 FR 48008). Specifically, the title of section 393.23 was revised to read “Power supply for lamps,” the reference to red liquid-burning lanterns was removed as obsolete, and—as it relates to the subject exemption application—the rule was amended to permit the use of battery powered lamps on projecting loads. With respect to the use of battery powered lamps, the August 2005 rule states “With the exception of
Motor vehicles transporting loads which extend more than 4 feet beyond the rear of the motor vehicle, or which have tailboards or tailgates extending more than 4 feet beyond the body, are required to mark those projections when the vehicle is operated during the hours when headlamps are required. Specifically, each side of the projecting load is required to be marked with one red side marker lamp, visible from the side, located to indicate the maximum overhang, and the rear of the projecting load is required to be marked with two red lamps, visible from the rear, one at each side, and two red reflectors visible from the rear, one at each side, located so as to indicate the maximum width of the projection. By expressly permitting battery powered lamps on projecting loads via the August 2005 final rule, the Agency has directly acknowledged the viability of lighting systems powered by sources other than the vehicle's electrical system in limited applications where the lamps required by the regulations are temporary in nature due to the specific vehicle operation.
Section 393.17 of the FMCSRs prescribes the lighting requirements for vehicles engaged in driveaway-towaway operations. A vehicle combination consisting of a tow vehicle pulling a wrecked or disabled vehicle is considered a driveaway-towaway operation, and the combination needs to be equipped with the lighting devices specified in section 393.17. Specifically with respect to the rear of the rearmost towed vehicle in such a combination, section 393.17(b)(2) requires at least two tail lamps, two stop lamps, two turn signals, two clearance lamps, and two reflectors, one of each type at each side. In addition, if any vehicle in the combination is 80 inches or more in overall width, there must be three identification lamps on the rear. Similar to the temporary lamps required on the rear of projecting loads, the required lamps on the rear of a wrecked or disabled vehicle being transported to a motor carrier's terminal or facility for repairs are temporary in nature.
FMCSA has evaluated the comments received in support of TowMate's application. The Agency agrees that permitting the use of rechargeable wireless temporary stop, turn, and tail lighting systems during temporary towing operations will reduce the time tow operators spend at the side of the road connecting wired lighting systems between vehicles, thereby reducing their risk of injury and increasing safety. The Agency believes that use of the rechargeable wireless lighting systems will maintain a level of safety that is equivalent to, or greater than, the level of safety achieved without the exemption. This decision is consistent with the amendment made in the August 2005 final rule to allow battery powered lamps on the rear of projecting loads.
The Agency hereby grants the exemption for a two-year period, beginning February 9, 2016 and ending February 9, 2018. During the temporary exemption period, motor carriers will be allowed to use rechargeable wireless temporary stop, turn, and tail lighting systems that do not meet the lighting power supply requirements of 49 CFR 393.23 during temporary towing operations, provided the requirements of 49 CFR 393.17(b)(2) are met. The exemption will be valid for two years unless rescinded earlier by FMCSA. The exemption will be rescinded if: (1) Motor carriers and/or commercial motor vehicles fail to comply with the terms and conditions of the exemption; (2) the exemption has resulted in a lower level of safety than was maintained before it was granted; or (3) continuation of the exemption would not be consistent with the goals and objectives of 49 U.S.C. 31136(e) and 31315(b).
Interested parties possessing information that would demonstrate that motor carriers using rechargeable wireless temporary stop, turn, and tail lighting systems during temporary towing operations are not achieving the requisite statutory level of safety should immediately notify FMCSA. The Agency will evaluate any such information and, if safety is being compromised or if the continuation of the exemption is not consistent with 49 U.S.C. 31136(e) and 31315(b), will take immediate steps to revoke the exemption.
In accordance with 49 U.S.C. 31313(d), as implemented by 49 CFR 381.600, during the period this exemption is in effect, no State shall enforce any law or regulation applicable to interstate commerce that conflicts with or is inconsistent with this exemption with respect to a firm or person operating under the exemption. States may, but are not required to, adopt the same exemption with respect to operations in intrastate commerce.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
General Motors LLC, (GM) has determined that certain model year 2014
For further information on this decision contact Amina Fisher, Office of Vehicle Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-5307, facsimile (202) 366-5930.
Notice of receipt of the petition was published, with a 30-day public comment period, on February 24, 2014, in the
S5.3.1 Timing of illumination
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(e) A telltale must not emit light except when identifying the malfunction or vehicle condition it is designed to indicate, or during a bulb check.
Paragraph S3.1.4. of FMVSS No. 102 states specifically:
S3.1.4 Identification of shift positions and of shift position sequence.
S3.1.4.1 Except as specified in S3.1.4.3, if the transmission shift position sequence includes a park position, identification of shift positions, including the positions in relation to each other and the position selected, shall be displayed in view of the driver whenever any of the following conditions exist:
(a) The ignition is in a position where the transmission can be shifted; or
(b) The transmission is not in park. . . .
GM believes that the condition is short-lived as disruption of the PRNDM is said to persist for one and one half seconds, and the telltale bulb check is said to persist for approximately five seconds. GM cited a 1979 interpretation to Ford in which NHTSA acknowledged that a short-lived inability to view telltales does not necessarily warrant manufacturers correcting the condition.
GM states that the noncompliance that is the subject of the petition has little effect on the normal operation of the vehicle. GM states that when the operation of the instrument panel is briefly affected by the noncompliance, none of the other vehicle operations are affected; any underlying messages remain in place and will continue to be displayed after the instrument panel resets; other operations, like cruise control, are unaffected by the noncompliance (only the displays on the instrument panel are briefly affected by the condition); and if the noncompliance were to occur, it is unlikely the brief disruption of the PRNDM will affect the driver.
Lastly, GM states that NHTSA has previously granted petitions for a determination of inconsequential noncompliance, finding no risk to motor vehicle safety, where the sequence of events causing the noncompliant condition is exceptionally rare. GM states that these granted petitions allow specific telltales to extinguish for a limited period of time while the vehicle is being operated.
In summation, GM believes that the described noncompliance of the subject vehicles is inconsequential to motor vehicle safety, and that its petition, to be exempt from providing recall notification of the noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120, should be granted.
GM states its belief that the subject condition is unlikely to occur due to the series of events that must take place before the instrument cluster resets. GM explains that the driver must operate a USB media device by using the steering wheel controls to search for a song, select “audio”, select “browse”, and select another song to play while the total information in titles of the buffered songs exceeds 2000 bytes for the condition to occur.
GM states that the condition is short-lived with the disruption of the PRNDM illumination lasting approximately one and one half seconds and the telltale
After receipt of GM's petition, NHTSA requested more information regarding the subject noncompliance. GM submitted videos showing that when the condition occurs any existing warning lights extinguish, the indicators (gauges) drop to zero, and operation of the entire instrument panel is interrupted. Specifically, any illuminated telltales extinguish for approximately one and one half seconds before a bulb check that lasts approximately five seconds is initiated. At the conclusion of the bulb check, any previously illuminated telltales will illuminate and remain illuminated.
NHTSA agrees with GM that if the instrument panel reset were to happen it would only be a momentary condition, the instrument panel telltales and indicators would extinguish and return to normal very quickly, with little, if any, impact to the driver.
GM mentioned two previous petitions that the agency granted due to the loss or failure of telltale indications. In the first petition,
In the second petition, submitted by Nissan,
Five commenters (four individuals and the Advocates for Highway and Auto Safety) provided comments about GM's petition when NHTSA issued the notice of receipt in the
One individual stated that “there is no such potential product recall as `inconsequential' ” and that “all product recalls must be effectively enforced against the vehicle manufacturer.” We note that the Motor Vehicle Safety Act requires the Secretary of Transportation to provide the vehicle manufacturers an opportunity to submit information, views, and arguments showing that a noncompliance does not impact motor vehicle safety. NHTSA is then required to consider information and arguments submitted and make a determination whether the noncompliance is, or is not, inconsequential to motor vehicle safety. If NHTSA determines that the subject noncompliance has no consequence to motor vehicle safety, the manufacturer is exempted from notification and remedy requirements of 49 U.S.C. 30118 and 30120.
The second individual commenter believes that GM should conduct a recall because the touch screen is not covered by the vehicle's warranty. The agency feels that this comment is not relevant because the steering wheel controls (rather than the touch screen on the center console) are the controls that must be used for the subject noncompliance to occur.
The two remaining individuals that provided comments believe that anything causing a distraction to the occupants of a motor vehicle under operation should be recalled. One of the commenters expressed that using a USB music device would be distracting and the other believes that the cluster becoming inoperable, even for a second, is enough time to distract the driver and cause an accident.
After reviewing the video provided by GM, the agency believes that a reset of the instrument panel would be corrected quickly within seconds, before the driver would be distracted, or realize what was happening.
The Advocates for Highway and Auto Safety does not specifically support the granting or denial of GM's petition, but believes that the existence of such a malfunction raises serious questions regarding vehicle design which can lead to this kind of situation.
Finally, GM stated that a Service Update Bulletin was issued to update the software of all IP clusters whenever any service to the affected vehicles is done at the dealership. The agency understands that GM's action to update the IP cluster software on these vehicles as they are brought in for regular service should reduce considerably the number of affected vehicles.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject noncompliant vehicles that GM no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after GM notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8.
National Highway Traffic Safety Administration (NHTSA), Department of Transportation (DOT).
Grant of petition.
McLaren has determined that certain model year (MY) 2012-2015 MP4 12-C Spider and Coupe passenger cars do not fully comply with paragraph S4.4(c)(2), of Federal Motor Vehicle Safety Standard (FMVSS) No. 138,
For further information on this decision contact Kerrin Bressant, Office of Vehicles Safety Compliance, the National Highway Traffic Safety Administration (NHTSA), telephone (202) 366-1110, facsimile (202) 366-3081.
This notice of receipt of McLaren's petition is published under 49 U.S.C. 30118 and 30120 and does not represent any agency decision or other exercise of judgment concerning the merits of the petition.
S4.4 TPMS Malfunction.
. . .
(c)
(2) Flashes for a period of at least 60 seconds but no longer than 90 seconds upon detection of any condition specified in S4.4(a) after the ignition locking system is activated to the “On” (“Run”) position. After each period of prescribed flashing, the telltale must remain continuously illuminated as long as a malfunction exists and the ignition locking system is in the “On” (“Run”) position. This flashing and illumination sequence must be repeated each time the ignition locking system is placed in the “On” (“Run”) position until the situation causing the malfunction has been corrected. . . .
(A) McLaren stated that although the TPMS malfunction indicator telltale will not illuminate immediately after the vehicle is restarted, it generally will illuminate shortly thereafter and in any event it will illuminate in no more than 40 seconds after the vehicle accelerates at or above 23 mph. McLaren submits that this brief pause before the malfunction indicator illuminates is inconsequential to motor vehicle safety.
(B) McLaren explained that if the TPMS fails to detect a signal from a compatible sensor, the TPMS indicator on the instrument cluster will display no value for the tire pressure at the affected wheel(s). A display of no value will therefore also alert the driver to the fact that something is not functioning properly.
(C) McLaren further states that with the exception of the subject noncompliance, all other aspects of the Malfunction Indicator and the TPMS in general are compliant with FMVSS No. 138.
(D) McLaren noted that it is not aware of any customer complaints related to this condition.
(E) McLaren has additionally informed NHTSA that it has corrected this noncompliance in all vehicles manufactured after February 18, 2014.
In summation, McLaren believes that the described noncompliance of the subject vehicles is inconsequential to motor vehicle safety, and that its petition, to exempt McLaren from providing recall notification of noncompliance as required by 49 U.S.C. 30118 and remedying the recall noncompliance as required by 49 U.S.C. 30120 should be granted.
NHTSA agrees with McLaren that the malfunction indicator telltale will not illuminate as required only during very short periods of time when the vehicle is traveling at low speeds and thus poses little risk to motor vehicle safety. Under normal driving conditions, a driver will begin a trip by accelerating moderately beyond 23 mph, and as explained by McLaren, once the vehicle accelerates to or above 23 mph, the malfunction indicator telltale re-illuminates and then remains illuminated for the entire ignition cycle, regardless of vehicle speed. The telltale fails to re-illuminate only in the very rare case when the driver begins a trip and never exceeds 23 mph (the threshold speed necessary to re-activate the malfunction indicator telltale). No real safety risk exists because at such low speeds there is little risk of the driver losing control of the vehicle due to underinflated tires. Furthermore, the possibility that the vehicle will experience both a low inflation pressure condition and a malfunction simultaneously is highly unlikely.
McLaren stated that if the TPMS fails to detect a compatible wheel sensor, the TPMS indicator on the instrument cluster will display no value for the tire pressure at the affected wheel(s). McLaren explained that this information will help to alert the driver that some kind of system malfunction is occurring.
The agency evaluated the displays McLaren uses in the noncompliant vehicles. In addition to the combination telltale indicator lamp, the subject vehicles are equipped with a “plan view” icon which displays the pressures for all four wheels individually. If any wheel has a malfunctioning pressure sensor the indicator for that wheel displays several dashes “---” indicating the there is a problem with that respective wheel. The additional information is not required by the safety standard, but can be used as an aid to the driver to determine the status of a vehicle's tires.
McLaren discussed that with the exception of the subject noncompliance, all other aspects of the TPMS functionality are compliant with the FMVSS 138 requirements. The primary functions of the TPMS, the identification of all other required malfunctions as well as the identification of low tire inflation pressure scenarios, is not affected.
The agency agrees with McLaren's reasoning with regards to the subject noncompliance involving only one aspect of the system's malfunction functionality. The primary function of the TPMS is to identify low inflation pressure conditions which McLaren's system appears to do as required by FMVSS No. 138. Also, there are a
McLaren also mentioned that they have not received or are aware of any consumer complaints, field communications, incidences or injuries related to this noncompliance. In addition to the analysis done by McLaren that looked at customer complaints, field communications, incidents or injuries related to this condition, the agency conducted additional checks of its Office of Defects Investigations consumer complaint database and found no related complaints.
McLaren stated that they have corrected the noncompliance in all unsold vehicles manufactured after February 18, 2014, as required by NHTSA.
NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and 30120(h)) that permit manufacturers to file petitions for a determination of inconsequentiality allow NHTSA to exempt manufacturers only from the duties found in sections 30118 and 30120, respectively, to notify owners, purchasers, and dealers of a defect or noncompliance and to remedy the defect or noncompliance. Therefore, this decision only applies to the subject noncompliant vehicles that McLaren no longer controlled at the time it determined that the noncompliance existed. However, the granting of this petition does not relieve vehicle distributors and dealers of the prohibitions on the sale, offer for sale, or introduction or delivery for introduction into interstate commerce of the noncompliant vehicles under their control after McLaren notified them that the subject noncompliance existed.
49 U.S.C. 30118, 30120: Delegations of authority at 49 CFR 1.95 and 501.8.
Office of the Secretary (OST), Department of Transportation (Department) or (DOT).
Notice and request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Department of Transportation's (DOT) Office of the Secretary (OST) announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for its review and approval and invites public comment. Executive Order 12862 directs Federal agencies to provide service to the public that matches or exceeds the best service available in the private sector. In order to work continuously to ensure that our programs are effective and meet our customers' needs, the Department of Transportation (DOT) seeks to obtain OMB approval of a generic clearance to collect feedback on our service delivery. A
Comments on this notice must be received by March 10, 2016.
Your comments should be identified by Docket No. DOT-OST-2015-0194 and may be submitted through one of the following methods:
•
•
•
Habib Azarsina, Office of the Chief Information Officer, Office of the Secretary, U.S. Department of Transportation, 1200 New Jersey Avenue SE., Washington, DC, 20590, 202-366-1965 (Voice), 202-366-7870 (Fax), or
The Department will only submit a collection for approval under this generic clearance if it meets the following conditions:
• The collections are voluntary.
• The collections are low-burden for respondents (based on considerations of total burden hours, total number of respondents, or burden-hours per respondent) and are low-cost for both the respondents and the Federal Government.
• The collections are noncontroversial and do not raise issues of concern to other Federal agencies.
• Any collection is targeted to the solicitation of opinions from respondents who have experience with the program or may have experience with the program in the near future.
• Personally identifiable information (PII) is collected only to the extent necessary and is not retained.
Information gathered is intended to be used only internally for general service improvement and program management
This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: The target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential nonresponse bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior to fielding the study. Depending on the degree of influence the results are likely to have, such collections may still be eligible for submission for other generic mechanisms that are designed to yield quantitative results.
Office of Foreign Assets Control, Treasury.
Notice.
The Treasury Department's Office of Foreign Assets Control (“OFAC”) is publishing the names of five individuals whose property and interests in property are blocked pursuant to the Sergei Magnitsky Rule of Law Accountability Act of 2012 (Pub. L. 112-208, December 14, 2012) (the “Magnitsky Act”).
OFAC's actions described in this notice were effective on February 1, 2016.
The Department of the Treasury's Office of Foreign Assets Control: Assistant Director for Licensing, tel.: 202-622-2480, Assistant Director for Policy, tel.: 202-622-2746, Assistant Director for Regulatory Affairs, tel.: 202-622-4855, Assistant Director for Sanctions Compliance & Evaluation, tel.: 202-622-2490; or the Department of the Treasury's Chief Counsel (Foreign Assets Control), Office of the General Counsel, tel.: 202-622-2410.
This document and additional information concerning OFAC are available from OFAC's Web site (
On February 1, 2016, OFAC blocked the property and interests in property of the following five individuals pursuant to the Magnitsky Act:
Aleksey Vasilyevich Anichin participated in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
Yevgeni Yuvenalievich Antonov is responsible for extrajudicial killings, torture, or other gross violations of internationally recognized human rights committed against an individual seeking to obtain, exercise, defend, or promote internationally recognized human rights and freedoms, such as the freedoms of religion, expression, association, and assembly, and the rights to a fair trial and democratic elections, in Russia.
Boris Borisovich Kibis participated in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
Pavel Vladimirovich Lapshov participated in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
Oleg Vyacheslavovich Urzhumtsev participated in efforts to conceal the legal liability for the detention, abuse, or death of Sergei Magnitsky.
U.S. Environmental Protection Agency (EPA).
Proposed rule.
The Environmental Protection Agency (EPA) is proposing to approve, conditionally approve, and disapprove state implementation plan (SIP) revisions submitted by California to address Clean Air Act (CAA or Act) requirements for the 1997 24-hour and annual fine particulate matter (PM
Any comments must arrive by March 10, 2016.
Submit your comments, identified by Docket ID No. EPA-R09-OAR-2015-0432 at
Rory Mays, Air Planning Office (AIR-2), EPA Region 9, (415) 972-3227,
Throughout this document, “we,” “us” and “our” refer to the EPA.
On July 18, 1997, the EPA established new national ambient air quality standards (NAAQS) for particles less than or equal to 2.5 micrometers (μm) in diameter (PM
Epidemiological studies have shown statistically significant correlations between elevated PM
PM
Following promulgation of a new or revised NAAQS, the EPA is required under Clean Air Act (CAA) section 107(d) to designate areas throughout the nation as attaining or not attaining the NAAQS. On January 5, 2005, the EPA published initial air quality designations for the 1997 annual and 24-hour PM
The SJV PM
Between 2007 and 2011, California made six SIP submissions to address nonattainment area planning requirements for the 1997 PM
On January 4, 2013, the U.S. Court of Appeals for the D.C. Circuit (“D.C. Circuit”) issued its decision in a challenge by the Natural Resources Defense Council (NRDC) to the EPA's 2007 PM
Consistent with the
As a consequence of its reclassification as a Serious PM
Given the December 31, 2015 outermost attainment deadline for the SJV area under section 188(c)(2), the EPA noted its expectation that the State would adopt and submit a Serious area plan for the SJV well before the statutory SIP submission deadlines in CAA section 189(b)(2).
We are proposing action on two California SIP submissions that address the 1997 annual and 24-hour PM
The first submission includes two sets of documents: The “2015 Plan for the PM
The 2015 PM
Chapter 5, Appendix C (“BACM and MSM for Stationary and Area Sources”), and Appendix D (“BACM and MSM for Mobile Sources (Provided by ARB)”) provide analyses of District and State rules to address the statutory requirements for Best Available Control Measures (BACM) and Most Stringent Measures (MSM) and the District's calculation of de minimis thresholds for directly emitted PM
Chapters 6 and 7 present the District's summary analysis to address the planning requirements for PM
The additional documents adopted by CARB on May 21, 2015 supplement the analysis and demonstrations of those adopted by SJVUAPCD. In particular, the CARB Staff Report presents estimated emission reductions by 2018 and 2020 from specific District control measures; an accounting of how the State has complied with its control measure and emission reduction commitments in the 2008 PM
We present our evaluation of the 2015 PM
CAA sections 110(a)(1) and (2) and 110(l) require each state to provide reasonable public notice and opportunity for public hearing prior to the adoption and submission of a SIP or SIP revision to the EPA. To meet this requirement, every SIP submission should include evidence that adequate public notice was given and an opportunity for a public hearing was provided consistent with the EPA's implementing regulations in 40 CFR 51.102.
Both the District and CARB satisfied applicable statutory and regulatory requirements for reasonable public notice and hearing prior to adoption and submission of the 2015 PM
CAA section 110(k)(1)(B) requires the EPA to determine whether a SIP submission is complete within 60 days of receipt. This section also provides that any plan that the EPA has not affirmatively determined to be complete or incomplete will become complete by operation of law six months after the date of submission. The EPA's SIP completeness criteria are found in 40 CFR part 51, Appendix V. The initial SIP submission, dated June 25, 2015, became complete by operation of law on December 25, 2015 and we find that the SIP submission pertaining to 2018 transportation conformity motor vehicle emission budgets, dated August 13, 2015, satisfies the completeness criteria in 40 CFR part 51, appendix V.
Upon reclassification of a Moderate nonattainment area as a Serious nonattainment area under subpart 4, the CAA requires the State to submit the following Serious area SIP elements:
1. A comprehensive, accurate, current inventory of actual emissions from all sources of PM
2. Provisions to assure that the best available control measures (BACM), including best available control technology (BACT), for the control of direct PM
3. A demonstration (including air quality modeling) that the plan provides for attainment as expeditiously as practicable but no later than December 31, 2015, or where the State is seeking an extension of the attainment date under section 188(e), a demonstration that attainment by December 31, 2015 is impracticable and that the plan provides for attainment by the most expeditious alternative date practicable (CAA sections 188(c)(2) and 189(b)(1)(A));
4. Plan provisions that require reasonable further progress (RFP) (CAA section 172(c)(2));
5. Quantitative milestones which are to be achieved every 3 years until the area is redesignated attainment and which demonstrate RFP toward attainment by the applicable date (CAA section 189(c));
6. Provisions to assure that control requirements applicable to major stationary sources of PM
7. Contingency measures to be implemented if the area fails to meet RFP or to attain by the applicable attainment date (CAA section 172(c)(9)); and
8. A revision to the nonattainment new source review (NSR) program to lower the applicable “major stationary source”
Serious area PM
The EPA provided its preliminary views on the CAA's requirements for particulate matter plans under part D, title I of the Act in the following guidance documents: (1) “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990, 57 FR 13498 (April 16, 1992) (hereafter “General Preamble”); (2) “State Implementation Plans; General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990; Supplemental,” 57 FR 18070 (April 28, 1992) (hereafter “Supplement”); and (3) “State Implementation Plans for Serious PM-10 Nonattainment Areas, and Attainment Date Waivers for PM-10 Nonattainment Areas Generally; Addendum to the General Preamble for the Implementation of Title I of the Clean Air Act Amendments of 1990,” 59 FR 41998 (August 16, 1994) (hereafter “Addendum”). Additionally, in a proposed rule published March 23, 2015 (80 FR 15340), the EPA provided further interpretive guidance on the statutory SIP requirements that apply to areas designated nonattainment for the PM
Section 189(b)(1)(B) of the Act requires for any serious PM
The EPA has historically provided an exemption from BACM and BACT for source categories that contribute only
1. Develop a detailed emission inventory of the sources of PM
2. Evaluate source category impacts;
3. Evaluate alternative control techniques and their technological feasibility; and
4. Evaluate the costs of control (
Once these analyses are complete, the State must use this information to develop enforceable control measures and submit them to the EPA for evaluation under CAA section 110. We use these steps as guidelines in our evaluation of the BACM measures and related analyses in the 2015 PM
When the EPA reclassifies a Moderate area to Serious under subpart 4, the requirement to implement reasonably available control measures (RACM) in section 189(a)(1)(C) remains. Thus, a Serious area PM
However, the EPA does not normally conduct a separate evaluation to determine whether a Serious area plan's measures also meet the RACM requirements. As explained in the Addendum, we interpret the BACM requirement as generally subsuming the RACM requirement—
Under section 188(e) of the Act, a state may apply to the EPA for a single extension of the Serious area attainment date by up to 5 years, which the EPA may grant if the State satisfies certain conditions. Before the EPA may extend the attainment date for a Serious area under section 188(e), the State must: (1) Apply for an extension of the attainment date beyond the statutory attainment date; (2) demonstrate that attainment by the statutory attainment date is impracticable; (3) have complied with all requirements and commitments pertaining to the area in the implementation plan; (4) demonstrate to the satisfaction of the Administrator that the plan for the area includes the “most stringent measures” that are included in the implementation plan of any State or are achieved in practice in any State, and can feasibly be implemented in the area; and (5) submit a demonstration of attainment by the most expeditious alternative date practicable.
In addition to establishing these preconditions for an extension of the Serious area attainment date, section 188(e) provides that the EPA may consider a number of factors in determining whether to grant an extension and the appropriate length of time for any such extension. These factors are: (1) The nature and extent of nonattainment in the area, (2) the types and numbers of sources or other emitting activities in the area (including the influence of uncontrollable natural sources and trans-boundary emissions from foreign countries), (3) the population exposed to concentrations in excess of the standard in the area, (4) the presence and concentrations of potentially toxic substances in the mix of particulate emissions in the area, and (5) the technological and economic feasibility of various control measures.
The EPA has previously interpreted section 188(e) in approving an extension of the PM
Section 188(e) authorizes the EPA to grant a state request for an extension of the Serious area attainment date if,
This interpretation parallels our interpretation of the impracticability option for Moderate PM
A second precondition for an extension of the Serious area attainment under section 188(e) is a showing that the State has complied with all requirements and commitments pertaining to that area in the implementation plan. We interpret this criterion to mean that the State has implemented the control measures and commitments in the SIP revisions it has submitted to address the applicable requirements in CAA sections 172 and 189 for PM
A third precondition for an extension of the Serious area attainment under section 188(e) is for the State to demonstrate to the satisfaction of the Administrator that the plan for the area includes the most stringent measures that are included in the implementation plan of any state, or are achieved in practice in any state, and can feasibly be implemented in the area. The EPA has interpreted the term “most stringent measure” (MSM) to mean the maximum degree of emission reduction that has been required or achieved from a source or source category in any other attainment plan or in practice in any other state and that can feasibly be implemented in the area seeking the extension.
An MSM demonstration should follow a process similar to a BACM demonstration, but with one additional step, as follows:
1. Develop a detailed emission inventory of the sources of PM
2. Evaluate source category impacts;
3. Identify the potentially most stringent measures in other implementation plans or used in practice in other states for each relevant source category and, for each measure, determine their technological and economic feasibility in the nonattainment area;
4. Compare the potential MSM for each relevant source category to the measures, if any, already adopted for that source category in the Serious nonattainment area to determine whether such potential MSM would further reduce emissions; and
5. Provide for the adoption and expeditious implementation of any MSM that is more stringent than existing measures or, in lieu of adoption, provide a reasoned justification for rejecting the potential MSM (
The level of control required under the MSM standard may depend on how well other areas have chosen to control their sources. If a source category has not been well controlled in other areas then MSM could theoretically result in a low level of control. This contrasts with BACM which is determined independently of what other areas have done and depends only on what is the best level of control feasible for an area.
Notably, the “to the satisfaction of the Administrator” qualifier on the MSM requirement indicates that Congress granted the EPA considerable discretion in determining whether a plan in fact includes MSM, recognizing that the overall intent of section 188(e) is that we grant as short an extension as practicable. For this reason, the EPA will apply greater scrutiny to the evaluation of MSM for source categories that contribute the most to the PM
Section 189(b)(1)(A) requires that the Serious area plan for the SJV area
Evaluation of a modeled attainment demonstration consists of two parts: Evaluation of the technical adequacy of the modeling itself and evaluation of the control measures that are relied on to demonstrate attainment. The EPA's determination of whether the plan provides for attainment by the most expeditious date practicable depends on whether the plan provides for implementation of BACM and BACT no later than the statutory implementation deadline, MSM as expeditiously as practicable, and any other technologically and economically feasible measures that will result in attainment as expeditiously as practicable.
Finally, the State must apply in writing to the EPA for an extension of a Serious area attainment date, and this request must accompany the modeled attainment demonstration showing attainment by the most expeditious alternative date practicable. Additionally, the State must provide the public reasonable notice and opportunity for a public hearing on the attainment date extension request before submitting it to the EPA, in accordance with the requirements for SIP revisions in CAA section 110.
CAA section 172(c)(3) requires that each SIP include a “comprehensive, accurate, current inventory of actual emissions from all sources of the relevant pollutant or pollutants in [the] area . . . .” By requiring an accounting of actual emissions from all sources of the relevant pollutants in the area, this section provides for the base year inventory to include all emissions that contribute to the formation of a particular NAAQS pollutant. For the 1997 PM
A state must include in its SIP submission documentation explaining how the emissions data were calculated. In estimating mobile source emissions, a state should use the latest emissions models and planning assumptions available at the time the SIP is developed. States are also required to use the EPA's
In addition to the base year inventory submitted to meet the requirements of CAA section 172(c)(3), the State must also submit future “baseline inventories” for the projected attainment year and each reasonable further progress (RFP) milestone year, and any other year of significance for meeting applicable CAA requirements.
The planning inventories for direct PM
Each inventory includes emissions from point, area, on-road, and non-road sources. The inventories use EMFAC2014 for estimating on-road motor vehicle emissions.
Tables 1 and 2 provide a summary of the annual average and winter daily average inventories of direct PM
The inventories in the 2015 PM
We discuss the adequacy of the monitoring network in this preamble to support our finding that the plan appropriately evaluates the PM
Section 110(a)(2)(B)(i) of the CAA requires states to establish and operate air monitoring networks to compile data on ambient air quality for all criteria pollutants. Our regulations in 40 CFR part 58 establish specific requirements for operating air quality surveillance networks to measure ambient concentrations of PM
Under 40 CFR part 58, states are required to submit Annual Network Plans (ANPs) for ambient air monitoring networks for approval by the EPA. The most recent ANP, entitled “2014 Air Monitoring Network Plan,” summarizes the state of the ambient air monitoring network in the San Joaquin Valley as it operated from January 2013 through May 2014.
Similarly, the District's previous ANP, entitled “Annual Air Monitoring Network Plan, June 25, 2013,” summarizes the state of the ambient air monitoring network in the San Joaquin Valley as it operated from January 2012 through March 2013.
In sum, the PM
The composition of PM
The 2007 PM
In
The provisions of subpart 4 do not define the term “precursor” for purposes of PM
Section 189(e) of the Act requires that the control requirements for major stationary sources of direct PM
We are evaluating the 2015 PM
In the 2015 PM
CARB and the SJVUAPCD base these conclusions on various air quality monitoring and modeling studies, modeling done by CARB for the 2008 PM
The 2015 PM
Ambient PM
Based on the technical analyses provided in the Plan, the EPA agrees with the State's and District's conclusion that SO
The 2015 PM
The 2015 PM
Similarly, using the 2011-2013 24-hour PM
In addition to this evidence concerning the contribution of NO
The 2015 PM
The 2015 PM
The WOEA analysis includes plots
The WOEA also considers emissions inventories to support the argument that NO
Based on the range of technical analyses provided in the Plan and other information available to the EPA, we agree with the State's and District's conclusion that NO
The 2015 PM
The Plan indicates that ammonia contributes to ambient concentrations of PM
Using the highest 2011-2013 annual average PM
Similarly, using the 2011-2013 24-hour PM
Ammonia emissions are essential to the formation of both of these components of the ambient particulate matter, and the EPA finds that these levels of contribution are a substantial fraction of the SJV's 2011-2013 annual average design value of 17.3 µg/m
Next we examined information in the 2015 PM
CARB and the SJVUAPCD 's evidence discussed above to support the argument that NO
CARB and the SJVUAPCD also considered air quality modeling analyses to evaluate the effectiveness of reducing ammonia as compared to other precursors, and to PM
The State and District assume in the 2015 PM
The EPA finds the modeling and other analyses presented and referred to in the 2015 PM
The percentages for ammonia benefits are generally smaller than those for NO
Taking into consideration a number of factors, the EPA does not agree with the conclusion in the Plan that the more than 100,000 annual tons of ammonia emissions from sources in the SJV area do not contribute significantly to PM
Second, modeled evidence submitted by the State and studies available to the EPA indicate that although ammonia control is less effective at reducing PM
Finally, despite the fact that a broad range of emission reduction measures have been implemented to reduce emissions of direct PM
Given the severity of the PM
Although the Plan states that ammonia is not a significant precursor to ambient PM
The 2015 PM
There are two routes by which VOC can contribute to ambient PM
For the direct contribution of VOC to PM
Applying this roughly 5% SOA proportion to the organic carbon portion of the measured 2011-2013 peak day 24-hour average PM
For the indirect contribution of VOC to PM
The findings from those reviews remain the same for the current Plan: Past modeling studies vary on whether controlling VOC reduces PM
The overall conclusion is that the effect of reducing VOC emissions is somewhat uncertain, but in general produces little benefit or even a disbenefit in PM
The modeling for the prior 2012 PM
The 2015 PM
In sum, the information provided by the State and District in the Plan indicates that: (a) Wintertime levels of secondary organic aerosol measured in the SJV are low and therefore the
The EPA believes that several precursor issues warrant further explanation and exploration in future PM
For VOC, the apparent conflict between different past modeling studies on whether VOC emission reductions are beneficial or not also should be more fully explained. As mentioned above, and discussed further in the EPA's TSD for the 2012 PM
A related issue is why a VOC disbenefit occurs. One explanation is that VOC can remove nitrate via a “sink” reaction to organic nitrates, so reducing VOC frees nitrate to form PM
Evaluation of the available research and its implications for the effectiveness of various precursor emissions controls would also be useful as part of the next plan. This research includes projects funded by the San Joaquin Valley-wide Air Pollution Study Agency, including “Improve emission estimates for urban ammonia sources,” “Update of CRPAQS conceptual model and synthesis of results,” and “Develop Improvements to the PM
Some results from the CalNex study are already available in a Synthesis document.
Based on a review of the information provided in the 2015 PM
As discussed in section IV.B of this proposed rule, section 189(b)(1)(B) of the Act requires for any serious PM
In addition, before the EPA may extend the attainment date for a Serious nonattainment area under CAA section 188(e), the State must, among other things, demonstrate to the satisfaction of the Administrator that the plan for the area includes the most stringent measures that are included in the implementation plan of any State or are achieved in practice in any State, and can feasibly be implemented in the area (MSM). As discussed above, we have established a process for evaluating BACM in serious area plans and a similar process for evaluating MSM. Because of the substantial overlap in the source categories and controls evaluated for BACM and those evaluated for MSM, we present our evaluation of the 2015 PM
The first step in determining BACM and MSM is to develop a detailed emissions inventory of the sources of direct PM
As discussed in section V.A of this proposed rule, Appendix B of the 2015 PM
1. Open Burning;
2. Glass Melting Furnaces;
3. Agricultural Conservation Management Practices;
4. Commercial Charbroiling;
5. Wood Burning Fireplaces and Wood Burning Heaters; and
6. Paved and Unpaved Roads.
CARB identified most mobile source categories as “significant” and identified only several (
Separately in Appendix C and Appendix D of the Plan, however, both CARB and the District identified all of the sources of direct PM
With respect to ammonia, the District states in Appendix C of the 2015 PM
Because the State and District have evaluated a much larger set of emission sources than those identified as “significant” sources in the Plan, and because the District's evaluation of
As part of its process for identifying candidate BACM and MSM and considering the technical and economic feasibility of additional control measures, CARB and the District reviewed the EPA's guidance documents on BACM, guidance documents on control measures for direct PM
Based on our evaluation of these State and District demonstrations, we propose to determine that the 2015 PM
The District's BACM and MSM process is described in the 2015 PM
For each identified source category, the District first identified potential control measures included in SIPs for other areas, addressed in federal regulations or guidance (
SJVUAPCD Rule 4103 (“Open Burning”), as amended April 15, 2010, is designed to minimize impacts of smoke and other air pollutants from open burning of agricultural waste and other materials.
The District compared Rule 4103 to several other open burning rules implemented in other parts of California and found no other rules more stringent as a whole than those in Rule 4103. According to the District, although the South Coast Air Quality Management District (SCAQMD) implements a rule that restricts burning on residential wood combustion (RWC) curtailment days (Rule 444) and District Rule 4103 does not contain the same restriction, in practice the District currently bans all burning on RWC curtailment days through implementation of its Smoke Management Program, which specifically allocates allowable burn acreage for 103 geographic zones based on local meteorology.
Sections 41855.5 and 41855.6 of the California Health and Safety Code require the District to prohibit open burning of specific crop categories unless the District determines either that there is no economically feasible alternative means of eliminating the waste or that there is no long-term federal or state funding commitment for the continued operation of biomass facilities in the SJV or for the development of alternatives to burning.
SJVUAPCD Rule 4306 (“Boilers, Steam Generators, and Process Heaters—Phase 3”), as amended October 16, 2008, establishes NO
The District compared both Rule 4306 and Rule 4320 to several other analogous rules implemented in other parts of California, including the Sacramento metropolitan area, the South Coast, and the Bay Area.
SCAQMD Rule 1146 establishes a 5 ppm NO
The District also considered the technical and economic feasibility of alternative NO
Although the NO
SJVUAPCD Rule 4311 (“Flares”), as amended June 18, 2009, establishes specific operational and administrative requirements to limit emissions of NO
The District compared Rule 4311 with several other analogous rules implemented in other parts of California, including the South Coast, Bay Area, Ventura County, and Santa Barbara, all of which require regulated sources to submit FMPs to the local districts.
The District also considered the technical and economic feasibility of alternative control techniques for flares, such as maximum monthly flared gas targets and requirements to capture gas before it is flared.
Chapter 8 of the 2015 PM
SJVUAPCD Rule 4352 (“Solid Fuel-Fired Boilers, Steam Generators, and Process Heaters”), as amended December 15, 2011, establishes NO
According to the District, the NO
The District also considered the technical and economic feasibility of alternative control techniques for this source category, such as selective catalytic reduction (SCR) for NO
We note that biomass- and MSW-fired units provide an environmental benefit by diverting these wastes from landfills and reducing open burning.
SJVUAPCD Rule 4354 (“Glass Melting Furnaces”), as amended May 19, 2011, establishes NO
According to the District, the NO
We are not aware of prohibitory rules for glass melting furnaces in other areas that are more stringent than Rule 4354. We note that the SCAQMD has found a 1.2 lb./ton NO
SJVUAPCD Rule 4550 (“Conservation Management Practices”), as adopted August 19, 2004, establishes requirements for owners and operators of agricultural sites to implement conservation management practices (CMPs) to control PM
According to the District, Rule 4550 is the most stringent rule of its kind.
The District also considered the technical and economic feasibility of additional control options for this source category, such as misting to reduce PM
Chapter 8 of the 2015 PM
SJVUAPCD Rule 4692 (“Commercial Charbroiling”), as amended September 17, 2009, establishes control
The District compared the requirements in Rule 4692 to analogous requirements for chain-driven charbroilers implemented by the SCAQMD, Ventura County Air Pollution Control District (VCAPCD), and BAAQMD and found no requirements in these rules more stringent than those contained in Rule 4692, with one exception in the BAAQMD rule.
The District also considered the technical and economic feasibility of alternative control techniques for UFCs, such as catalytic oxidizers, high efficiency particulate-arresting filtration system, ESPs, and wet scrubbers.
As part of the 2015 PM
SJVUAPCD Rule 4702 (“Internal Combustion Engines”), as amended November 14, 2013, establishes NO
For SI non-AO engines, Rule 4702 establishes NO
Some of the emission limits for SI non-AO engines in Rule 4702 are, however, less stringent than those implemented in the South Coast, El Dorado, and Antelope Valley areas for similar engines. Specifically, the SCAQMD has adopted an 11 ppmv limit for all IC engines;
For SI AO engines, Rule 4702 establishes NO
The District considered the technical and economic feasibility of alternative control techniques for SI AO engines that would lower their emission levels and found that for reasons of both technical and economic feasibility, NO
Finally, for compression-ignited IC engines (both those used in agricultural operations and those used in non-agricultural operations), Rule 4702 requires that all certified engines meet the EPA's Tier 3 and Tier 4 emission standards for nonroad diesel engines and that non-certified engines meet the same standards or a numerical NO
SJVUAPCD Rule 4703 (“Stationary Gas Turbines”), as amended September 20, 2007, establishes NO
According to the District, the NO
SJVUAPCD Rule 4901 (“Wood Burning Fireplaces and Wood Burning Heaters”), as amended September 18, 2014, is designed to limit emissions of PM, including PM
Rule 4901 includes a mandatory two-tiered curtailment program. During a Level One Episodic Wood Burning Curtailment, which is declared when the PM
According to SJVAPCD, Rule 4901 is at least as stringent as analogous rules in other areas, including the South Coast, Bay Area, Sacramento Metro area, Washoe County, Nevada, and Washington State.
Rule 4901 incorporates all elements outlined in the EPA's
SJVUAPCD Rule 8061 (“Paved and Unpaved Roads”), as amended August 19, 2004, is designed to limit fugitive dust emissions generated from paved and unpaved roads. The rule establishes control measures and design criteria for existing public and private paved or unpaved roads, road construction projects, and road modification projects, such as requirements to stabilize unpaved roads by applying water, a uniform layer of washed gravel, chemical/organic dust stabilizers/suppressants, paving, or any other method demonstrated to effectively limit visible dust to 20% opacity.
The District compared Rule 8061 to SCAQMD Rule 1156 (“Further Reductions of Particulate Emissions from Cement Manufacturing Facilities”); SCAQMD Rule 1157 (“PM-10 Emission Reductions from Aggregate and Related Operations”); SMAQMD Rule 403 (“Fugitive Dust”); VCAPCD Rule 55 (“Fugitive Dust”); Clark County
The District also considered the feasibility of requiring control measures on paved and unpaved roads with less than 26 annual average daily trips (AADT). Such a measure would require more road owners/operators to implement control measures to reduce fugitive emissions from paved and unpaved roads. SJVUAPCD's analysis of the emission inventory indicates that the majority of the particulate emissions attributable to unpaved roads are from roads with more than 26 AADT. Because these roads are already subject to the mitigation requirements of Rule 8061, the District concluded that the remaining emissions from unpaved roads with less than 26 AADT provide very little opportunity for additional emissions reductions. Additionally, the District noted that emissions from unpaved roads are lowest in the winter months, when exceedances of the 24-hour PM
SJVUAPCD Rule 4101 (“Visible Emissions”), as amended February 17, 2005, establishes limits on opacity, which is often used as an indicator of PM emissions. SJVUAPCD Rule 4309 (“Dryers, Dehydrators, and Ovens”), as amended December 15, 2005, establishes NO
According to the District, there are no state regulations that apply to this source category and no analogous rules in the Bay Area, Sacramento Metro, or Ventura County areas.
The District also considered the technical and economic feasibility of using warm mix asphalt (WMA), a newer substance which is produced at temperatures 25 to 90 degrees (Fahrenheit) lower than hot mix asphalt (HMA) and which results in lower emissions because it requires less fuel to heat the asphalt. Although the use of WMA has grown steadily in the U.S., the District concluded that use of WMA at asphalt production facilities in the SJV is not technically and economically feasible at this time given the high costs of, and technical difficulties associated with, converting equipment.
Chapter 8 of the 2015 PM
SJVUAPCD Rule 4570 (“Confined Animal Facilities”), as amended October 21, 2010, applies to large dairy, poultry, beef cattle feeding and swine CAFs and requires operators of such facilities to implement measures to control VOC emissions for each major stage of operation,
The District compared the requirements of Rule 4570 with those in analogous prohibitory rules implemented in other areas, including the South Coast, Bay Area, Sacramento Metro, Ventura County, Imperial County, and the State of Idaho, and concluded that Rule 4570 is more stringent than all of these rules.
The District also considered the technical and economic feasibility of alternative control techniques for CAFs, including episodic application of sodium bisulfate (SBS) on manure at dairies, which converts a greater fraction of ammonia to non-volatile ammonium.
SJVUAPCD Rule 4565 (“Biosolids, Animal Manure, and Poultry Litter Operations”), as adopted March 15, 2007, establishes requirements for facilities that landfill, land apply, compost, or co-compost biosolids, animal manure, or poultry litter.
The District compared the requirements of Rule 4565 and Rule 4566 with those in an analogous prohibitory rule implemented in the South Coast area (Rule 1133.2) and found that the SCAQMD rule requires in-vessel composting with 70% to 80% control efficiency for existing and new facilities, respectively, while SJVUAPCD Rule 4565 requires 10% to 80% control efficiency based on annual throughput.
The District also considered the technical and economic feasibility of alternative control techniques for compost operations, including finished compost covers and water systems, but found that these control techniques are not technically and economically feasible for compost operations in the SJV at this time.
CARB's BACM and MSM demonstration for mobile sources is in Appendix D of the 2015 PM
Under the Clean Air Act, the EPA is charged with establishing national emission limits for mobile sources. States are generally preempted from establishing such limits except for California, which can establish these limits subject to EPA waiver or authorization under CAA section 209 (referred to herein as “waiver measures”). Over the years, the EPA has issued waivers (for on-road vehicles and engines measures) or authorizations (for non-road vehicle and engine measures)
CAA section 209(b)(1) and (e)(2) give California unique authority under the CAA to regulate emissions from new motor vehicles and nonroad engines, except for locomotives and engines used in farm and construction equipment less than 175 horsepower. To exercise its authority, California must obtain a waiver from EPA demonstrating that the standards, in the aggregate, are at least as protective of public health and welfare as applicable federal standards. Additionally, EPA must grant a waiver unless California's “protectiveness determination” is arbitrary and capricious; California does not need the standards to meet compelling and extraordinary conditions; or California's standards and accompanying enforcement procedures are not consistent with CAA § 202(a). EPA has previously stated that consistency with section 202(a) requires that California's standards must be technologically feasible within the lead time provided, giving due consideration of costs.
Historically, California has not submitted, and the EPA has not required that California submit, its mobile source rules that have been granted a waiver or authorization by the EPA for inclusion in the California SIP. However, a recent decision by the Ninth Circuit Court of Appeals held that the EPA's longstanding practice in this regard was at odds with the CAA requirement that state and local emissions limits relied upon to meet the NAAQS be enforceable by the EPA or private citizens through
In response to the Court's ruling, CARB has submitted its mobile source control rules that have been granted waivers or authorizations but have not been included in the SIP, and, in a separate rulemaking, the EPA has proposed to approve these rules into the SIP.
In addition to waiver measures, CARB has adopted operational requirements for in-use vehicles, rules that limit the amounts of pollutants allowed in transportation fuels, and incentive programs that provide funding to replace or retrofit older, dirtier vehicles and equipment with cleaner technologies.
The EPA previously determined that California's mobile source control programs constituted BACM for PM
CARB's BACM and MSM analysis provides a discussion of the measures adopted and implemented for each of the identified source categories. We discuss each of these mobile source categories below.
This category includes light-duty passenger cars, light-duty trucks, and medium-duty trucks. The source category's emissions are 32.2 tpd NO
CARB has a long history of adopting programs for reducing emissions from this source category. Light-duty and medium-duty motor vehicles are currently subject to California's “Low-Emission Vehicle III” (LEV III) standards as well as a “Zero Emission Vehicle” (ZEV) requirement. The LEV III standards are consistent, or harmonized, with the subsequently adopted national Tier 3 standards for the same vehicles. California's ZEV program, however, does not have a national counterpart and results in additional emissions reductions as it phases in a requirement that 15% of new light-duty vehicle sales consist of ZEV or partial ZEV.
California has also adopted regulations for gasoline fuel (California Reformulated Gasoline or CaRFG) which reduce emissions from light-duty and medium-duty vehicles. On July 10, 2009, the EPA approved the CaRFG regulations into the California SIP.
This category includes heavy-duty gas and diesel trucks, heavy-duty gas and diesel urban buses, school buses and motor homes. The emissions from this category are 130.6 tpd NO
California has the most stringent heavy-duty vehicle emissions control measures in the nation, including engine standards for diesel and gasoline vehicles, idling requirements, certification procedures, on-board diagnostic requirements, and verification measures for emissions control devices. Many of these control measures are subject to the CAA waiver process and have also been submitted for inclusion in the SIP.
California has also adopted many in-use requirements to help reduce emissions from the vehicles already on the road, which may remain in use for many years. The most recently adopted in-use requirement is the Cleaner In-Use Heavy-Duty Trucks measure (“Truck and Bus Regulation and Drayage Truck Regulation”), which became effective in 2011 and the EPA approved into the SIP in 2012.
Finally, California has adopted regulations for diesel fuel that further reduce emissions from heavy-duty trucks. The EPA approved these diesel fuel regulations into the California SIP on July 10, 2009.
This category includes off-road compression ignition (diesel) engines and equipment, small spark ignition (gasoline) off-road engines and equipment less than 25 horsepower (hp) (
As it has done for the on-road categories discussed above, CARB has adopted stringent new emissions standards subject to EPA authorization under CAA section 209(e) and in-use measures or requirements for this source category (
The farm equipment category includes agricultural equipment such as tractors, harvesting equipment and sprayers. The category's emissions are 50.4 tpd NO
Other mobile source categories identified by CARB in the Plan include cargo handling equipment, motorcycles, recreational boats, off-road recreational vehicles and commercial harbor craft. The emissions from all of these
TCMs are, in general, measures designed to reduce emissions from on-road motor vehicles through reductions in vehicle miles traveled or traffic congestion. TCMs can reduce PM
The current efforts by the SJV's eight local jurisdiction metropolitan planning organizations (MPO)
Each Valley MPO is required to update its Regional Transportation Plan (RTP) at least once every four years.
The SJV has a long history of adopting and then enhancing programs to reduce emissions from on-road motor vehicles by reducing vehicle miles traveled, vehicle trips, and/or congestion. For example, Rule 9410 (“Employer Based Trip Reduction” or “eTRIP”), requires larger employers to establish an Employer Trip Reduction Implementation Plan to encourage employees to reduce single-occupancy vehicle trips, thus reducing emissions, including PM
In our approval of California's Serious area plan for the 1987 PM
In their implementation of the Congestion Mitigation and Air Quality (CMAQ) Improvement Program, the SJV MPOs evaluate and prioritize the
Based on all of these evaluations, we propose to find that the 2015 PM
Section 188(e) of the Act allows the EPA to extend the attainment date for a serious area for up to five years if attainment by the applicable date is impracticable. However, before we may grant an extension of the attainment date, the State must first:
(1) Apply to the EPA for an extension of the PM
(2) demonstrate that attainment by 2015 is impracticable,
(3) have complied with all requirements and commitments applying to the area in its implementation plan,
(4) demonstrate to our satisfaction that its serious area plan includes the most stringent measures that are achieved in practice in any state and are feasible for the area, and
(5) submit SIP revisions containing a demonstration of attainment by the most expeditious alternative date practicable.
We evaluate the 2015 PM
As discussed in section IV.D of this proposed rule, for the SJV, the Serious area attainment date for the 1997 PM
Despite the implementation of BACM as expeditiously as practicable, as discussed in section V.D. above, the 2015 PM
Chapter 4, Section 4.1 of the 2015 PM
The annual average value for a given year is calculated using the quarterly average concentrations for that year, while the 24-hour value for a given year is calculated using the 98th percentile of 24-hour average concentrations for that year.
According to the District, the maximum 2015 annual average concentration at the Bakersfield-Planz site (which recorded the area's highest annual average in 2013, and is estimated to have the highest annual average in 2014) that will enable the site to show a design value at or below 15.0 µg/m
The EPA independently evaluated 2013 and 2014 PM
The EPA found that four monitoring sites located in the three southern-most counties of the SJV would have to have 2015 annual mean concentrations 35% or more below their corresponding historical lows in order to attain by the end of 2015.
In sum, air quality data for the 2013-2014 period indicate that it is not practicable for the Hanford, Visalia-Church, Bakersfield-California, and Bakersfield-Planz monitoring sites to show an annual PM
According to the District, the maximum 2015 24-hour average PM
As with the annual standard, the EPA independently evaluated 2013 and 2014 PM
The EPA found that the Bakersfield-Planz monitoring site would have to have a 2015 annual mean concentration recorded at 44% below its
For these three sites, the EPA's analysis largely confirms the analysis presented in the 2015 PM
In sum, air quality data for the 2013-2014 period indicate that it is not practicable for the Bakersfield-Planz monitoring site to show an annual PM
We interpret this criterion to mean that the State has implemented the control measures and commitments in the plan revisions it has submitted to address the applicable requirements in CAA sections 172 and 189 for PM
Between 2007 and 2011, California made six SIP submissions to address nonattainment area planning requirements for the 1997 PM
On May 20, 2015, the Ninth Circuit Court of Appeals issued its decision in a challenge to the EPA's November 9, 2011 action on the 2008 PM
The specific State and District commitments that the EPA approved into the California SIP as part of the 2008 PM
(1) A commitment by the District to “adopt and implement the rules and measures in the 2008 PM
(2) A commitment by CARB to propose specific measures identified in Appendix B of the “Progress Report on Implementation of PM
(3) A commitment by the District to achieve a total of 8.97 tpd of NO
(4) A commitment by CARB to achieve a total of 17.1 tons per day (tpd) of NO
As of November 9, 2011, the date of the EPA's final action on the 2008 PM
The CARB Staff Report for the 2015 PM
With respect to the outstanding emission reduction commitments (also called “aggregate commitments”), Tables 9 and 10 of the CARB Staff Report, as amended by CARB's Technical Clarifications, identify nine specific State and District control measures that, according to CARB, achieved emission reductions beyond those already credited toward the 2008 PM
We have reviewed the State's demonstration with respect to each of these nine measures and, for the reasons provided below, we propose to find that all but one may be credited toward the State's outstanding 2014 emission reduction obligations.
First, with respect to SJVUAPCD's Rule 4320 (“Advanced Emission Reduction Options for Boilers, Steam Generators, and Process Heaters Greater than 5.0 MMBtu/hr”), also called the “AERO Rule,” the EPA approved this rule as adopted October 2008 into the
In the CARB Staff Report, the State explained that it now has documentation showing that operators of 472 of the units subject to Rule 4320 chose to pay fees and that operators of the remaining 692 units subject to the rule chose to retrofit their equipment to comply with the NO
Second, with respect to SJVUAPCD's Rule 9510 (“Indirect Source Review”), the EPA approved this rule as adopted December 2005 into the California SIP on May 9, 2011
In the CARB Staff Report, the State explained that it now has documentation of the number of projects that have complied with the rule through on-site mitigation (instead of payment of a fee) and the associated reductions in on-site emissions of NO
Third, with respect to wood stove replacements, the CARB Staff Report explains that the District implements a voluntary wood stove replacement program that provides funding for residents to replace less efficient wood stoves with more efficient gas-burning devices.
Fourth, with respect to District-funded incentive programs, CARB provided a list of stationary and portable agricultural engines and off-road agricultural equipment that were repowered, retrofitted with controls, or replaced with newer equipment through incentive funds disbursed by the District pursuant to the Carl Moyer Memorial Air Quality Standards Attainment Program (Carl Moyer Program). Specifically, the CARB Staff Report documents the State's bases for concluding that a total of 824 incentive projects implemented in the SJV between January 2009 and December 2013 in accordance with specified portions of the Carl Moyer Program Guidelines have achieved a total of 1.8 tons per day (tpd) of NO
Fifth, with respect to SJVUAPCD's Rule 9410 (“Employer Based Trip Reduction”), CARB submitted this rule as adopted December 2009 to the EPA as a revision to the California SIP on May 17, 2010, and on December 11, 2015, the EPA fully approved the rule into the SIP.
Sixth, with respect to SJVUAPCD's Rule 4901 (“Wood Burning Fireplaces and Wood Burning Heaters”), the EPA approved this rule as adopted October 2008 into the California SIP on November 10, 2009
Seventh, with respect to State Funded Incentive-Based Emission Reduction Measures, CARB submitted the “Report on Reductions Achieved from Incentive-based Emission Reduction Measures in the San Joaquin Valley” (Emission Reduction Report) to the EPA as a revision to the California SIP on November 17, 2014,
Eighth, with respect to CARB's Cleaner In-Use Heavy Duty Trucks measure (also called the Truck and Bus Regulation and Drayage Truck Regulation), the EPA approved these rules as adopted September 2011 into the California SIP on April 4, 2012
Finally, with respect to CARB's Portable Equipment Registration Program (PERP) and Portable Engine Airborne Toxic Control Measure (Portable Engine ATCM), CARB adopted these programs in 1997 and 2004, respectively, to reduce pollution by requiring the removal of uncertified engines from the registered fleet of nonroad engines operating in California.
According to the CARB Staff Report, implementation of these control measures resulted in NO
Table 7 identifies the State and District measures that the EPA is proposing to credit toward the State's outstanding 2014 emission reduction obligations, the amount of SIP-creditable emission reductions for each measure, and the 9:1 NO
In sum, the CARB Staff Report demonstrates that implementation of State and District measures achieved a total of 16.4 tpd of NO
Based on these evaluations, we propose to determine that California has complied with all requirements and commitments pertaining to the SJV area in the implementation plan.
We interpret this criterion to mean that the State must demonstrate to the EPA's satisfaction that its serious area plan includes the most stringent measures that are included in the implementation plan of any state, or achieved in practice in any state, and can feasibly be implemented in the area.
As discussed above in section V.D, because of the substantial overlap in the source categories and controls evaluated for BACM and those evaluated for MSM, we present our evaluation of the 2015 PM
Section 189(b)(1)(A) of the CAA requires that each Serious area plan include a demonstration (including air quality modeling) that the plan provides for attainment of the PM
The EPA's PM
The attainment demonstration in the 2015 PM
The formula in the 2015 PM
CARB's procedure for using emissions from the two plans in the RRF scaling formula differed to some extent between the two plans due to data availability, even though ideally they would be treated in the same way. The reason the scaling is being done rather than new modeling is that modeling inventories were not available for the base and future years of the 2015 PM
CARB's modeling domain is somewhat larger than the SJV nonattainment area, so emission totals differ between the modeling inventory and the planning inventory. But we expect that percent changes are comparable because both the modeling inventories and planning inventories reflect emissions from the same types of sources and in similar proportions. The inventories also reflect similar controls, for example statewide motor vehicle emissions controls, where motor vehicles are the main source of NO
The 2015 PM
These observations indicate that the 2013 PM
CARB calculated an RRF from the scaling formula using the concentration of each PM
This is in line with information in the Plan indicating that ammonium nitrate formation responds far more to NO
As discussed in section V.C of this notice, modeling for the 2012 PM
Aside from the RRFs themselves, the procedure that CARB followed in the 2015 PM
Two aspects of the Plan's approach to modeling differ from the Modeling Guidance recommendations. First, for the 24-hour PM
Second, the Modeling Guidance recommends that RRFs be applied to the average of three three-year design values
Although the Plan's procedure is not entirely consistent with EPA guidance, we find it acceptable in this context given the time constraints imposed by EPA's April 2015 reclassification of the SJV area
Three other considerations give some reassurance of the acceptability of a scaling approach. First, EPA's 2014 draft modeling guidance explicitly recognizes that “there may be plausible alternative means of calculating the relative response factors [RRFs] that can differ from the approaches recommended.”
Finally, while scaling itself is relatively crude, the scaling of RRFs is less so. The procedure is not a simple scaling of an emission total, but reflects the geographic and temporal distribution of the emissions sources and the emission changes, since it is based on modeling. The pattern of emission changes during the span of the 2015 PM
Late in EPA's review process, EPA and CARB found that the scaling factor for EC had been applied to the RRF for OC and the product used as the RRF for EC, and vice versa.
However, CARB presents compelling reasons for discounting this high Madera projected 2020 annual design value. The starting point for the scaled modeling projection is the 2013 design value—the average of annual means during 2011-2013. The 2011 monitoring data included within that 2013 design value appears anomalous, as documented in the WOEA at Appendix A2 (“Assessment of the Representativeness of 2011 PM
EPA's regulations require that monitoring data for comparison to the NAAQS be collected using specific equipment and procedures to ensure accuracy and reliability.
As described in the S.R. App. A2, 2011 was the first full year of data collected by the Madera BAM, and the concentrations were unexpectedly high in comparison with other monitoring sites, including both BAMs and FRM monitor sites. During 2011-2013, annual concentrations at Madera were some 30% higher than at Fresno, and as much as 100% higher during the summer, historically the season with the lowest PM
Various checks on the monitor and its operation were made over time without affecting the high readings, but in April 2014, adjustments were made as a result of checking the zero point of the instrument using outdoor air, rather than indoor air (both are permissible; outdoor air could be more representative of the conditions the instrument normally operates under).
The 2015 PM
The fact that 2011-2013 Madera BAM concentrations are higher than values at the Fresno FRM and other sites does not in itself prove they are incorrect; it is conceivable that unknown sources were contributing there. Also, the later agreement between the lower Madera BAM and FRM concentrations could be explained as sources that are now emitting less, or that are contributing less at the monitor due to different wind patterns. Nevertheless, the mismatch with the historical gradient pattern, the unexpectedly but only temporarily high readings that declined after an adjustment in operation, and the current lower FRM readings do suggest that the 2011 Madera concentrations were anomalous. EPA believes that the 2011-2013 readings at the Madera site are not known to be representative of air quality for Madera and not sufficiently certain to drive the SJV control strategy, or to invalidate the conclusion of the attainment demonstration that the SJV will attain the 1997 annual NAAQS in 2020.
CARB explored two alternative scenarios to estimate annual average, ambient PM
EPA accepts the scaled modeling approach of the attainment demonstration in the 2015 PM
As described in the 2015 PM
The Plan provides an assessment of the representativeness of this data for purposes of inclusion in the attainment demonstration analyses
“In summary, comparison of the 167.3 µg/m
The assessment provided in the Plan
Information provided regarding the representativeness of Bakersfield-Planz data included analyses of San Joaquin Valley seasonal PM
The State and District's assessment of potential fugitive dust sources affecting the Bakersfield-Planz site was based on an evaluation of aerial photos to identify sources and field investigation by District enforcement staff.
The third part of the assessment evaluated meteorology at the Bakersfield-Planz Monitoring Site.
Overall, EPA agrees with the evidence provided that the Bakersfield-Planz monitor was affected by an unusual high wind dust event on May 5, 2013 that resulted in anomalous PM
“An air agency incorporating the event-related concentration in a design value used for a prospective attainment demonstration might seem to need more emission reductions to attain the NAAQS by its attainment deadline than is actually the case. The EPA plans to more formally address this topic on a pollutant/NAAQS basis, the first of which will be ozone guidance in the preamble of a soon-to-be-proposed rulemaking on SIP requirements for areas designated nonattainment for the 2008 ozone NAAQS. Until the planned guidance for a pollutant and NAAQS of interest is issued, air agencies should consult with their EPA regional office if they face this situation.”
EPA reviewed PM
In addition to EPA's 2013 guidance on exceptional events, EPA also considered the monitoring requirements for PM
“The required monitoring stations or sites must be sited to represent area-wide air quality. These sites can include sites collocated at PAMS. These monitoring stations will typically be at neighborhood or urban-scale; however, micro-or middle-scale PM
Based on the information provided in the Plan, EPA agrees that the Bakersfield-Planz concentrations on May 5, 2013 appear to have been affected by a localized event; therefore, it was neither representative of neighborhood scale concentrations, nor occurring at many locations. EPA agrees with the State and District that the May 5, 2013 concentrations at Bakersfield-Planz were not representative of area-wide, typical PM
Based on the technical analyses provided in the Plan and EPA guidance and requirements as cited in this section, EPA agrees with the State and District that the May 5, 2013 Bakersfield-Planz 24-hour PM
The attainment control strategy in the 2015 PM
With respect to mobile sources, the State identified the source categories and described the EMFAC2014 emission factor model used to project their future emission levels in Appendix B, sections B.2.2.4 through B.2.2.7 of the Plan.
Table 8 below summarizes the emission reductions needed in the SJV to attain the 1997 24-hour and annual PM
The Plan identifies four District measures that will achieve additional emission reductions beyond baseline measures and contribute to expeditious attainment of the 1997 PM
Second, the District has committed to amend Rule 4692 (“Commercial Charbroiling”) in 2016 to add requirements for under-fired charbroilers, with an anticipated compliance date in 2017.
Emission reductions of 0.4 tpd of direct PM
Third, the District projects that Rule 4901 (“Wood Burning Fireplaces and Wood Burning Heaters”), as amended September 18, 2014, will achieve 2.9 tpd of direct PM
Finally, the District projects that Rule 4905 (“Natural Gas-Fired, Fan-Type Residential Central Furnaces”), as amended January 22, 2015, will achieve 0.2 tpd of NO
The EPA recently proposed to approve Rule 4905 into the California SIP.
In sum, the attainment demonstration in the 2015 PM
As discussed above, the 2015 PM
CAA section 172(c)(2) requires nonattainment area plans to provide for reasonable further progress (RFP). In addition, CAA section 189(c) requires PM
RFP has historically been met by showing annual incremental emission reductions sufficient generally to maintain at least linear progress toward attainment by the applicable deadline.
• the pollutant is emitted by a large number and range of sources,
• the relationship between any individual source or source category and overall air quality is not well known,
• a chemical transformation is involved (
• the emission reductions necessary to attain the PM
The Addendum states that requiring linear progress may be less appropriate in other situations, such as:
• where there are a limited number of sources of direct PM
• where the relationships between individual sources and air quality are relatively well defined, and/or
• where the emission control systems utilized (
In nonattainment areas characterized by any of these latter conditions, RFP may be better represented as step-wise progress as controls are implemented and achieve significant reductions soon thereafter. For example, if an area's nonattainment problem can be attributed to a few major sources, EPA guidance indicates that “RFP should be met by `adherence to an ambitious compliance schedule' which is likely to periodically yield significant emission reductions of direct PM
Plans for PM
Section 189(c) requires that attainment plans include quantitative milestones in order to demonstrate RFP. The purpose of the quantitative milestones is to allow periodic evaluation of the area's progress towards attainment of the NAAQS through the RFP requirements. Thus, the EPA determines an area's compliance with RFP in conjunction with determining its compliance with the quantitative milestone requirement. Because RFP is an annual emission reduction requirement and the quantitative milestones are to be achieved every three years, when a state demonstrates compliance with the quantitative milestone requirement, it will demonstrate that RFP has been achieved during each of the relevant three years. Quantitative milestones should provide an objective means to evaluate progress toward attainment meaningfully,
The CAA does not specify the starting point for counting the three-year periods for quantitative milestones under CAA section 189(c). In the General Preamble and Addendum, EPA interpreted the CAA to require that the starting point for the first three-year period be the due date for the Moderate area plan submission.
The RFP demonstration and quantitative milestones appear in Chapter 6, section 6.3 (pp. 6-6 to 6-8) of the 2015 PM
The Plan estimates that emissions of direct PM
The BACM control strategy that provides the basis for these emissions projections is described in Chapters 5 and 7 and Appendices C and D of the Plan. For stationary and area sources, the Plan highlights several rules that are projected to contribute to attainment of the PM
With respect to ammonia, the 2015 PM
The NO
Control measures for ammonia sources are described in Appendix C of the Plan. For example, ammonia controls resulting from Rule 4570 (“Confined Animal Facilities”), Rule 4565 (“Biosolids, Animal Manure, and Poultry Litter Operations”), and Rule 4566 (“Organic Material Composting”) are discussed at length in section C.41 of Appendix C and their emission projections are presented collectively under farming operations in the Plan's emissions inventory.
With respect to quantitative milestones, the CARB Staff Report states that the Plan identifies RFP emissions levels for direct PM
Additionally, the QM Letter contains the State's commitment to submit, by December 31, 2016, a SIP revision that supplements the quantitative milestone portion of the 2015 PM
With respect to direct PM
The 2015 PM
The Truck and Bus Regulation and Drayage Truck Regulation became effective in 2011 and have rolling compliance deadlines based on truck engine model year. These and other regulations applicable to heavy duty diesel trucks will continue to reduce emissions of diesel particulate matter and NO
Additionally, the method used to calculate RFP target (or “benchmark”) emission levels for direct PM
With respect to ammonia, the 2015 PM
Several District measures already in the SIP for the SJV area control ammonia emissions from two of these source categories. District Rule 4570 (“Confined Animal Facilities”) required implementation of control measures to reduce VOCs in 2008 and required full compliance by affected sources by mid-2012.
The statement in the Plan that ammonia is an insignificant precursor in the SJV area is based on the State's analysis of the relative sensitivity of ambient PM
The 2015 PM
The Bakersfield-California site is projected to be the design value site for the 1997 24-hour PM
Taking the ammonia emissions increases into account, the NO
As discussed in section V.C of this proposed rule, we are proposing to determine that VOCs do not contribute significantly to ambient PM
In sum, the 2015 PM
Although the RFP emission levels identified in the Plan for the 2017 and 2020 milestone years represent generally linear progress toward attainment by 2018 and 2020, the Plan as originally submitted in June 2015 does not identify an objective means for evaluating the area's compliance with these emission targets or progress toward attainment, other than through 2017 and 2020 emissions levels and CARB's commitment to report on the “status of any emission reduction commitments” in the Plan. We note that the Plan contains only one emission reduction commitment: To adopt amendments to District Rule 4692 (“Commercial Charbroiling”) in 2016 and to achieve 0.4 tpd of direct PM
In the QM Letter, however, CARB committed to adopt and submit, no later than December 31, 2016, a revision to the 2015 PM
Under section 110(k)(4) of the Act, EPA may conditionally approve a plan revision based on a commitment by the State to adopt specific enforceable measures by a date certain but not later than 1 year after the date of the plan approval. Based on CARB's commitments to submit the specific SIP revisions identified in the QM Letter by December 31, 2016, as discussed above, we propose to conditionally approve the quantitative milestone component of the 2015 PM
We note that, consistent with the requirements of CAA section 189(c)(2) as interpreted in longstanding EPA policy, each of the milestone reports due March 31, 2018 (for the December 31, 2017 milestone date) and March 31, 2021 (for the December 31, 2020 milestone date) should include technical support sufficient to document completion statistics for appropriate milestones,
Under CAA section 172(c)(9), PM
The purpose of contingency measures is to continue progress in reducing emissions while a state revises its SIP to meet the missed RFP requirement or to correct continuing nonattainment. The principle requirements for contingency measures are:
• Contingency measures must be fully adopted rules or control measures that are ready to be implemented quickly upon failure to meet RFP or failure of the area to meet the relevant NAAQS by the applicable attainment date.
• The SIP should contain trigger mechanisms for the contingency measures, specify a schedule for implementation, and indicate that the measures will be implemented without further action by the State or by the EPA. In general, we expect all actions needed to affect full implementation of the measures to occur within 60 days after EPA notifies the State of a failure.
• The contingency measures should consist of other control measures for the area that are not already relied upon to
• The measures should provide for emissions reductions equivalent to approximately one year of reductions needed for RFP calculated as the overall level of reductions needed to demonstrate attainment divided by the number of years from the base year to the attainment year.
Finally, we note that contingency measures can include federal, state, and local measures that are already scheduled for implementation or already implemented that provide for additional emissions reductions that are not relied on to demonstrate RFP or attainment. In other words, contingency measures are intended to achieve reductions over and beyond those relied on in the RFP and attainment demonstrations. Nothing in the CAA precludes a state from implementing such measures before they are triggered by a failure to meet RFP or a failure to attain by the applicable attainment date. EPA has approved numerous SIPs under this interpretation.
The 2015 PM
Chapter 6 of the Plan identifies emission reductions to be achieved by the control strategy in the Plan in 2014 and 2017 that the District considers “surplus” to those reductions necessary to demonstrate RFP. The District states that these emission reductions are thus available to meet the contingency measure requirement.
For the 2020 attainment year, the Plan provides estimates of emission reductions projected in 2021 from a combination of adopted state and local measures, including District Rules 4901, 4306, 4308, and 4905 for direct PM
Finally, for the 2018 attainment year for the 24-hour PM
The contingency measures portion of the 2015 PM
First, the Plan incorrectly calculates one year's worth of RFP emission
Thus, according to EPA's calculation, one year's worth of RFP is 0.65 tpd of direct PM
Second, the 2015 PM
Third, two of the control measures identified in the CARB Staff Report as contingency measures—SJVUAPCD Rule 4320 (AERO Rule) and SJVUAPCD Rule 9510 (ISR On-Site Mitigation)—are not creditable for SIP purposes at this time. Rule 4320 (AERO Rule) is not SIP-creditable because it contains provisions that allow owners and operators to pay a fee in lieu of complying with the rule's emission limits and which render the NO
Fourth, the contingency measure portion of the 2015 PM
In sum, the 2015 PM
Section 189(e) of the Act specifically requires that the control requirements applicable to major stationary sources of direct PM
California has not yet submitted the NNSR SIP revisions required to satisfy the subpart 4 requirements for Serious nonattainment areas because they are not yet due. Accordingly, we are not proposing any action with respect to these requirements at this time. CARB submitted amendments to the SJVUAPCD's NNSR rules in 2011 to address the 1997 PM
Section 176(c) of the CAA requires federal actions in nonattainment and maintenance areas to conform to the SIP's goals of eliminating or reducing the severity and number of violations of the NAAQS and achieving expeditious attainment of the standards. Conformity to the SIP's goals means that such actions will not: (1) Cause or contribute to violations of a NAAQS, (2) worsen the severity of an existing violation, or (3) delay timely attainment of any NAAQS or any interim milestone.
Actions involving Federal Highway Administration (FHWA) or Federal Transit Administration (FTA) funding or approval are subject to the EPA's transportation conformity rule, codified at 40 CFR part 93, subpart A. Under this rule, metropolitan planning organizations (MPOs) in nonattainment and maintenance areas coordinate with state and local air quality and transportation agencies, EPA, FHWA, and FTA to demonstrate that an area's regional transportation plans (RTP) and transportation improvement programs (TIP) conform to the applicable SIP. This demonstration is typically done by showing that estimated emissions from existing and planned highway and transit systems are less than or equal to the motor vehicle emissions budgets (budgets) contained in all control strategy SIPs. An attainment, maintenance, or RFP SIP should include budgets for the attainment year, each required RFP milestone year, or the last year of the maintenance plan, as appropriate. Budgets are generally established for specific years and specific pollutants or precursors and must reflect all of the motor vehicle control measures contained in the attainment and RFP demonstrations.
PM
Transportation conformity trading mechanisms are allowed under 40 CFR 93.124 where a SIP establishes appropriate mechanisms for such trades. The basis for the trading mechanism is the SIP attainment modeling which established the relative contribution of each PM
In general, only budgets in approved SIPs can be used for transportation conformity purposes. However, section 93.118(e) of the transportation conformity rule allows budgets in a SIP submission to apply for conformity purposes before the SIP submission is approved under certain circumstances. First, there must not be any other approved SIP budgets that have been established for the same time frame, pollutant, and CAA requirement. Second, the EPA must find that the submitted SIP budgets are adequate for transportation conformity purposes. To be found adequate, the submission must meet the conformity adequacy requirements of 40 CFR 93.118(e)(4) and (5). The transportation conformity rule does, however, allow for replacement of previously approved budgets by submitted motor vehicle emissions budgets that the EPA has found adequate, if the EPA has limited the duration of its prior approval to the period before it finds replacement budgets adequate.
The 2015 PM
The direct PM
The 2015 PM
Using the same Community Multiscale Air Quality modeling application
To ensure that the trading mechanism does not affect the ability of the SJV to meet the NO
We have evaluated the budgets against our adequacy criteria in 40 CFR 93.118(e)(4) and (5) as part of our review of the budgets' approvability (
Based on the information about re-entrained road dust in the Plan and in accordance with 40 CFR 93.102(b)(3), we propose to concur with the District's finding that re-entrained road dust emissions from paved roads, unpaved roads, and road construction are not significant contributors to the PM
For the reasons discussed in section V.E.2 of this proposed rule, we are proposing to approve the State's demonstration that it is impracticable to attain the 1997 PM
For the reasons discussed in sections V.E.v and V.F of this proposed rule, we are proposing to approve the RFP and attainment demonstrations in the 2015 PM
CARB has requested that we limit the duration our approval of the budgets only until the effective date of the EPA's adequacy finding for any subsequently submitted budgets.
• An acknowledgement and explanation as to why the budgets under consideration have become outdated or deficient;
• A commitment to update the budgets as part of a comprehensive SIP update; and
• A request that the EPA limit the duration of its approval to the time when new budgets have been found to be adequate for transportation conformity purposes.
Because CARB's request does not include all of these elements, we cannot at this time propose to limit the duration of our approval of the submitted budgets until new budgets have been found adequate. In order to limit the approval, we would need the information described above in order to determine whether such limitation is reasonable and appropriate in this case. Once CARB has adequately addressed that information, we intend to review it and take appropriate action. If we propose to limit the duration of our approval of the MVEB in the 2015 PM
We have previously approved motor vehicle emissions budgets for the 1997 annual and 24-hour PM
As noted above, the State included a trading mechanism to be used in transportation conformity analyses that would use the proposed budgets in the 2015 PM
The EPA has reviewed the trading mechanism as described on page 6-17 in section 6.5.5 of Chapter 6 the 2015 PM
Under CAA sections 110(k)(3) and 110(k)(4), the EPA is proposing to approve, conditionally approve, and disapprove SIP revisions submitted by California to address the Act's Serious area planning requirements for the 1997 PM
1. The 2012 base year emissions inventories as meeting the requirements of CAA section 172(c)(3);
2. the best available control measures/best available control technology demonstration as meeting the requirements for RACM/RACT and BACM/BACT in CAA sections 172(c)(1), 189(a)(1)(C), and 189(b)(1)(B);
3. the attainment demonstration as meeting the requirements of CAA sections 172(c)(1) and 189(b)(1)(A);
4. the reasonable further progress demonstration as meeting the requirements of CAA section 172(c)(2);
5. the State's application for an extension of the Serious area attainment date to December 31, 2018 for the 1997 24-hour PM
6. the District's commitment to amend and implement revisions to Rule 4692 (“Commercial Charbroiling”) for under-fired charbroilers in accordance with the schedule provided on page 7-6 of the 2015 PM
7. the 2014, 2017, 2018, and 2020 motor vehicle emissions budgets, as shown in Table 13 of this proposed rule, because they are derived from approvable attainment and RFP demonstrations and meet the requirements of CAA section 176(c) and 40 CFR part 93, subpart A.
EPA is also proposing to approve the interpollutant trading mechanism provided in the 2015 PM
Under CAA section 110(k)(4), the EPA is proposing to conditionally approve the quantitative milestones identified in the 2015 PM
Finally, under CAA section 110(k)(3), the EPA is proposing to disapprove the contingency measure portion of the 2015 PM
We will accept comments from the public on these proposals for the next 30 days. The deadline and instructions for submission of comments are provided in the “Date” and “Addresses” sections at the beginning of this preamble.
Additional information about these statutes and Executive Orders can be found at
This action is not a significant regulatory action and was therefore not submitted to the Office of Management and Budget (OMB) for review.
This action does not impose an information collection burden under the PRA because this action does not impose additional requirements beyond those imposed by state law.
I certify that this action will not have a significant economic impact on a substantial number of small entities under the RFA. This action will not impose any requirements on small entities beyond those imposed by state law.
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 does not impose additional requirements beyond those imposed by state law. Accordingly, no additional costs to State, local, or tribal governments, or to the private sector, will result from this action.
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 Executive Order 13175, because 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, and will not impose substantial direct costs on tribal governments or preempt tribal law. Thus, Executive Order 13175 does not apply to this action.
The EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern environmental health or safety risks that the EPA has reason to believe may disproportionately affect children, per the definition of “covered regulatory action” in section 2-202 of the Executive Order. This action is not subject to Executive Order 13045 because it does not impose additional requirements beyond those imposed by state law.
This action is not subject to Executive Order 13211, because it is not a significant regulatory action under Executive Order 12866.
Section 12(d) of the NTTAA directs the EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. The EPA believes that this action is not subject to the requirements of section 12(d) of the NTTAA because application of those requirements would be inconsistent with the CAA.
The EPA lacks the discretionary authority to address environmental justice in this rulemaking.
Environmental protection, Air pollution control, Ammonia, Incorporation by reference, Intergovernmental relations, Nitrogen dioxide, Particulate matter, Reporting and recordkeeping requirements, Sulfur dioxide, Volatile organic compounds.
42 U.S.C. 7401
Substance Abuse and Mental Health Services Administration (SAMHSA), HHS.
Proposed rule.
This proposed rule addresses changes to the Confidentiality of Alcohol and Drug Abuse Patient Records regulations. This proposal was prompted by the need to update and modernize the regulations. These laws and regulations governing the confidentiality of substance abuse records were written out of great concern about the potential use of substance abuse information against an individual, preventing those individuals with substance use disorders from seeking needed treatment. The last substantive update to these regulations was in 1987. Over the last 25 years, significant changes have occurred within the U.S. health care system that were not envisioned by the current regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient information, and a new focus on performance measurement within the health care system. SAMHSA wants to ensure that patients with substance use disorders have the ability to participate in, and benefit from new integrated health care models without fear of putting themselves at risk of adverse consequences. These new integrated models are foundational to HHS's triple aim of improving health care quality, improving population health, and reducing unnecessary health care costs. SAMHSA strives to facilitate information exchange within new health care models while addressing the legitimate privacy concerns of patients seeking treatment for a substance use disorder. These concerns include: The potential for loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. This proposal is also an effort to make the regulations more understandable and less burdensome. We welcome public comment on this proposed rule.
To be assured consideration, comments must be received at one of the
In commenting, please refer to file code SAMHSA 4162-20.
Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission.
You may submit comments in one of four ways (to avoid duplication, please submit your comments in only one of the ways listed):
1.
2.
3.
4.
For information on viewing public comments, see the beginning of the
Kate Tipping, 240-276-1652, Email address:
Comments received before the close of the comment period will also be available for public inspection, generally beginning approximately 3 weeks after publication of a document, at the headquarters of the Substance Abuse and Mental Health Services Administration, 5600 Fishers Lane, Rockville, Maryland 20857, Monday through Friday of each week from 8:30 a.m. to 4 p.m. To schedule an appointment to view public comments, phone 240-276-1660.
We will consider all comments we receive by the date and time specified in the
To assist readers in referencing sections contained in this preamble, we are providing a table of contents.
This proposed rule would revise title 42 of the Code of Federal Regulations part 2 (42 CFR part 2), Confidentiality of Alcohol and Drug Abuse Patient Records regulations. The authorizing statute (Title 42, United States Code, Section 290dd-2) protects the confidentiality of the identity, diagnosis, prognosis, or treatment of any patient records which are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research. Title 42 of the CFR part 2 was first promulgated in 1975 (40 FR 27802) and last substantively updated in 1987 (52 FR 21796).
The laws and regulations governing the confidentiality of substance abuse records were written out of great concern about the potential use of substance abuse information against individuals, causing individuals with substance use disorders to not seek needed treatment. The disclosure of records of individuals with substance use disorders has the potential to lead to a host of negative consequences including: Loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration. The purpose of the regulations at 42 CFR part 2 is to ensure that a patient receiving treatment for a substance use disorder in a part 2 program is not made more vulnerable by reason of the availability of their patient record than an individual with a substance use disorder who does not seek treatment. Under the current regulations, a federally assisted substance use disorder program generally may only release identifiable information related to substance use disorder diagnosis, treatment, or referral for treatment with the individual's express consent. Now over 25 years later, this proposed rule would make policy changes to the regulations to better align them with advances in the U.S. health care delivery system while retaining important privacy protections.
Unless otherwise noted, these changes would be applicable beginning 180 days after the publication of the final rule. If programs that were required to comply with 42 CFR part 2 prior to the effective date of the final rule continue to fall within the scope of 42 CFR part 2 as outlined in the final rule, they would be required to come into compliance with any revised regulations by the effective date of the final rule. However, signed consent forms in place prior to the effective date of the final rule would be valid until they expire. Nonetheless, part 2 programs may update signed consent forms consistent with the final rule, prior to the effective date of the final rule if they so choose. Consents obtained after the effective date would need to comply with the final rule, regardless of whether the consents involve patient identifying information obtained prior to or after the effective date of the final rule.
This proposed rule is intended to modernize the 42 CFR part 2 (part 2) rules by facilitating the electronic exchange of substance use disorder information for treatment and other legitimate health care purposes while ensuring appropriate confidentiality protections for records that might identify an individual, directly or indirectly, as having or having had a substance use disorder. To achieve this goal, we propose the following modifications.
We propose, in Section III.A., Reports of Violations (§ 2.4), to revise the requirement for reporting violations of these regulations by methadone programs (now referred to as opioid treatment programs) to the Food and Drug Administration (FDA) because the authority over these programs was transferred from the FDA to Substance Abuse and Mental Health Services Administration (SAMHSA) in 2001.
In Section III.B., Definitions (§ 2.11), we propose to revise some existing definitions, add new definitions of key terms that apply to 42 CFR part 2, and consolidate all but one of the definitions that are currently in other sections in § 2.11. We propose to revise the definitions of “Central registry,” “Disclose or disclosure,” “Maintenance treatment,” “Member program,” “Patient,” “Patient identifying information,” “Person,” “Program,” “Qualified service organization (QSO),” “Records,” and “Treatment.” We also propose to add definitions of “Part 2 program,” “Part 2 program director,” “Substance use disorder,” “Treating provider relationship,” and “Withdrawal management.” Some of these new definitions replace existing definitions. In addition, we propose to revise the regulatory text to use terminology in a consistent manner.
In Section III.C., Applicability (§ 2.12), SAMHSA proposes to continue to apply the 42 CFR part 2 regulations to a program that is federally assisted and holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment, but, where currently paragraph (1) of the definition of “Program” does not apply to general medical facilities, SAMHSA now proposes that paragraph (1) would not apply to either general medical facilities or general medical practices. The proposed language goes on to clarify that paragraph (2) and (3) of the definition of Program would apply to “general medical facilities” and “general medical practices” under certain conditions. For example, an identified unit within a general medical facility or general medical practice will be subject to part 2 if it holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment, or if the primary function of medical personnel or other staff in the general medical facility or general medical practice is the provision of such services and they are identified as providing such services.
In Section III.D., Confidentiality Restrictions and Safeguards (§ 2.13), SAMHSA proposes to add a requirement that, upon request, patients who have included a general designation in the “To Whom” section of their consent form (see § 2.31) must be provided a list of entities to which their information has been disclosed pursuant to the general designation.
In Section III.E., Security for Records (§ 2.16), SAMHSA proposes to clarify that this section requires both part 2 programs and other lawful holders of patient identifying information to have in place formal policies and procedures addressing security, including sanitization of associated media, for both paper and electronic records.
In Section III.F., Disposition of Records by Discontinued Programs (§ 2.19), we propose to address both paper and electronic records. SAMHSA also is proposing to add requirements for sanitizing associated media.
In Section III.G., Notice to Patients of Federal Confidentiality Requirements (§ 2.22), we propose to clarify that the written summary of federal law and regulations may be provided to patients in either paper or electronic format. SAMHSA also proposes to require the statement regarding the reporting of violations include contact information for the appropriate authorities.
In Section III.H., Consent Requirements (§ 2.31), SAMHSA is proposing to allow, in certain circumstances, a patient to include a general designation in the “To Whom” section of the consent form, in conjunction with requirements that: (1) The consent form include an explicit description of the amount and kind of substance use disorder treatment information that may be disclosed; and (2) the “From Whom” section of the consent form specifically name the part 2 program or other lawful holder of the patient identifying information permitted to make the disclosure. SAMHSA also is proposing to require the part 2 program or other lawful holder of patient identifying information to include a statement on the consent form that the patient understands the terms of their consent and, when using a general designation in the “To Whom” section of the consent form, that they have a right to obtain, upon request, a list of entities to which their information has been disclosed pursuant to the general designation (see § 2.13). In addition, SAMHSA is proposing to permit electronic signatures to the extent that they are not prohibited by any applicable law.
In Section III.I., Prohibition on Re-disclosure (§ 2.32), we propose to clarify that the prohibition on re-disclosure only applies to information that would identify, directly or indirectly, an individual as having been diagnosed, treated, or referred for treatment for a substance use disorder, such as indicated through standard medical codes, descriptive language, or both, and allows other health-related information shared by the part 2 program to be re-disclosed, if permissible under other applicable laws.
In Section III.J., Disclosures to Prevent Multiple Enrollments (§ 2.34), we propose to modernize the terminology and definitions and move the definitions to § 2.11, Definitions.
In Section III.K., Medical Emergencies (§ 2.51), we propose to revise the medical emergency exception to make it consistent with the statutory language and to give providers more discretion to determine when a “bona fide medical emergency” exists.
In Section III.L., Research (§ 2.52), SAMHSA proposes to revise the research exception to permit data protected by 42 CFR part 2 to be disclosed to qualified personnel for the purpose of conducting scientific research by a part 2 program or any other individual or entity that is in lawful possession of part 2 data if the researcher provides documentation of meeting certain requirements related to other existing protections for human research. SAMHSA also is proposing to address data linkages to enable researchers holding part 2 data to link to data sets from federal data repositories, and is seeking comment on expanding this provision to non-federal data repositories.
We propose, in Section III.M., Audit and Evaluation (§ 2.53), to modernize the requirements to include provisions for governing both paper and electronic patient records. SAMHSA also proposes to permit an audit or evaluation necessary to meet the requirements of a Centers for Medicare & Medicaid Services (CMS)-regulated accountable care organization (CMS-regulated ACO) or similar CMS-regulated organization (including a CMS-regulated Qualified Entity (QE)), under certain conditions.
Our goal in modernizing the part 2 regulations is to increase opportunities for individuals with substance use disorders to participate in new and emerging health and health care models and health information technology (IT). Our intent is to facilitate the sharing of information within the health care system to support new models of integrated health care which, among other things, improve patient safety while maintaining or strengthening privacy protections for individuals seeking treatment for substance use disorders. We expect the proposed changes to 42 CFR part 2 to result in a decrease in the burdens associated with several aspects of this rule, including consent requirements. Moreover, as patients are allowed, in certain circumstances, to include a general designation in the “To Whom” section of the consent form, we anticipate there
When estimating the total costs associated with changes to the 42 CFR part 2 regulations, we assumed five sets of costs: Updates to health IT system costs, costs for staff training and updates to training curricula, costs to update patient consent forms, costs associated with providing patients a list of entities to which their information has been disclosed pursuant to a general designation on the consent form (
We estimate, therefore, that in the first year that the final rule is in effect, the costs associated with updates to 42 CFR part 2 would be $74,217,979. In year two, we estimate that costs would be $47,021,182. In years 3 through 10, we estimate the annual costs would be $14,835,444. Over the 10-year period 2015-2024, the total undiscounted cost of the proposed changes would be $239,922,716 in 2015 dollars. When future costs are discounted at 3 percent or 7 percent per year, the total costs become approximately $220.9 million or $200.9 million, respectively.
Based on data from the 2013 National Survey of Substance Abuse Treatment Services (N-SSATS), we estimate that 12,034 hospitals, outpatient treatment centers, and residential treatment facilities are covered by part 2. N-SSATS is an annual survey of U.S. substance abuse treatment facilities. Data is collected on facility location, characteristics, and service utilization. Not all treatment providers included in N-SSATs are believed to be under the jurisdiction of the part 2 regulations. The 12,034 number is a subset of the 14,148 substance abuse treatment facilities that responded to the 2013 N-SSATS, and includes all federally operated facilities, facilities that reported receiving public funding other than Medicare and Medicaid, facilities that reported accepting Medicare, Medicaid, TRICARE, and/or Access to Recovery (ATR) voucher payments, or were SAMHSA-certified Opioid Treatment Programs.
If an independently practicing clinician does not meet the requirements of paragraph (1) of the definition of Program (an individual or entity (other than a general medical facility or general medical practice) who holds itself out as providing and provides substance use disorder diagnosis, treatment or referral for treatment), they may be subject to 42 CFR part 2 if they constitute an identified unit within a general medical facility or general medical practice which holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment, or if their primary function in the facility or practice is the provision of such services and they are identified by the facility or practice as providing such services. Due to data limitations, it was not possible to estimate the costs for independently practicing providers covered by part 2 that did not participate in the 2013 N-SSATS. For example, data from the American Board of Addiction Medicine (ABAM) provides the number of physicians since 2000, who have active ABAM certification. However, there is no source for the number of physicians who have not participated in the ABAM certification process. In addition, it is not possible to determine which ABAM-certified physicians practice in a general medical setting rather than in a specialty treatment facility that was already counted in the N-SSATS data.
Several provisions in the Notice of Proposed Rulemaking (NPRM) reference other lawful holders of patient identifying information in combination with part 2 programs. These other lawful holders must comply with part 2 requirements with respect to information they maintain that is covered by part 2 regulations. However, because this group is not clearly defined with respect to the range of organizations it may include, we are unable to include estimates regarding the number and type of these organizations and are only including part 2 programs in this analysis.
In addition to the part 2 programs described above, entities named on a consent form that disclose patient identifying information to their participants under the general designation must provide patients, upon request, a list of entities to which their information has been disclosed pursuant to a general designation. These entities primarily would include organizations that facilitate the exchange of health information (
Since the promulgation of 42 CFR part 2, significant technology changes have impacted the delivery of health care. The Office of the National Coordinator for Health Information Technology (ONC) was established as an office within the Department of Health and Human Services (HHS) under Executive Order 13335 on April 27, 2004. Subsequently, on February 17, 2009, the Health Information Technology for Economic and Clinical Health Act (HITECH Act) of the American Recovery and Reinvestment Act of 2009 (ARRA) (Pub. L. 111-5) expanded the Department's health IT work, including the expansion of ONC's authority and the provision of federal funds for ONC's activities consistent with the
SAMHSA has played a role in encouraging the use of health IT by behavioral health (substance use disorders and mental health) providers. SAMHSA's efforts included collaborating with ONC to develop two sets of Frequently Asked Questions and convening a number of stakeholder meetings to provide guidance on the application of 42 CFR part 2 within HIE models. In addition, SAMHSA funded a one-year pilot project in 2012 with five state HIEs to support the exchange of health information among behavioral health and physical health providers. SAMHSA also worked with ONC and other federal agencies on several projects to support behavioral health and health information exchange.
The Data Segmentation for Privacy (DS4P) initiative within ONC's Standards and Interoperability (S&I) Framework facilitated the development of standards to improve the interoperability of EHRs containing sensitive information that must be protected to a greater degree than other health information due to 42 CFR part 2 and similar state laws. The DS4P initiative met its two goals, which were to: Demonstrate how standards can be used to support current privacy policies for sharing sensitive health information across organizational boundaries; and develop standards that will enable sensitive electronic health information to flow more freely to authorized users while improving the ability of health IT systems to implement current privacy protection requirements for certain types of health care data, such as substance use disorder patient records. The S&I Framework is a collaborative community of contributors from the public and private sectors who are focused on providing the tools, services, and guidance to facilitate the electronic exchange of health information. The DS4P initiative involved 344 volunteers, including, but not limited to, federal and state government agencies, behavioral health providers, EHR and other IT companies, health information exchanges, patient advocacy groups, professional societies/associations, consultants, health systems, health insurers, and universities.
Through the DS4P initiative, federal and community stakeholders developed standards and guidelines for enabling data segmentation and managing patient consent preferences. The technical approach outlined in the DS4P Implementation Guide (IG) is based on the experience of the six pilot projects and the solutions they developed to meet the DS4P project requirements. The DS4P IG is an American National Standards Institute (ANSI) approved standard. It was also voted on and approved at the highest level to become what Health Level 7 (HL7) calls a normative standard (a foundational part of the technology needed to meet the global challenge of integrating health care information). The HL7 balloting process included 155 stakeholders, including HL7 affiliates, vendors, consultants, payers, providers, non-profit organizations, and federal government representatives. The HL7 standard is the currently acceptable standard for data segmentation and consent management. In addition, it is in compliance with 42 CFR part 2.
The six DS4P IG use case pilot projects that were conducted in accordance with ONC's S&I Framework included the Department of Veterans Affairs (VA)/Substance Abuse and Mental Health Services Administration (SAMHSA) Pilot. The VA/SAMHSA Pilot implemented all the DS4P use cases and passed all conformance tests. The VA/SAMHSA Pilot was also the first application to show that managing consents and patient directives, as well as segmenting structured data in a patient record, can be done. SAMHSA used these DS4P standards to develop the application branded Consent2Share, an open-source health IT solution which assists in consent management and data segmentation. Consent2Share validates that the DS4P IG can be used to build a production-based application to manage the patient consent lifecycle electronically. The Consent2Share software is currently being used by the Prince Georges County (Maryland) Health Department to manage patient consent directives while sharing substance use disorder information with an HIE. While this technology is not perfect, it provides a foundational standard and shows promise for sharing substance use disorder information while complying with 42 CFR part 2.
Notwithstanding these efforts, SAMHSA is aware that technology adoption is an ongoing process and the majority of current EHR and HIE applications may not have the capability to support the DS4P initiative. In addition, paper records are still used today in some part 2 programs and shared through facsimile (FAX). Despite SAMHSA's efforts to clarify the part 2 regulations through guidance and to demonstrate that exchange of sensitive health information can be accomplished through pilot projects that adhere to the regulations, some stakeholders continued to request modernization of 42 CFR part 2. These stakeholders are concerned that part 2, as currently written, continues to be a barrier to the integration of substance use disorder treatment and physical health care. For example, some substance use disorder treatment centers cannot participate in integrated care models because they have not implemented data segmentation and consent management functionalities necessary to comply with the part 2 rules. Further, under the current regulations, the part 2 program director is the only individual authorized to release of information for scientific research purposes. In addition, under the current regulatory framework, absent consent, organizations that store patient health data, including data that are subject to part 2, do not have the authority to disclose part 2 data for scientific research purposes to qualified researchers or research organizations. This could hinder a full understanding of impacts of treatment for addiction and other health issues. Finally, some stakeholders continue to request modernization of the part 2 rules, in media and other public and private forums.
The Confidentiality of Alcohol and Drug Abuse Patient Records regulations, 42 CFR part 2, implement section 543 of the Public Health Service Act, 42 United States Code (U.S.C.) § 290dd-2, as amended by section 131 of the Alcohol, Drug Abuse and Mental Health Administration Reorganization Act (ADAMHA Reorganization Act), Pub. L. 102-321 (July 10, 1992). The regulations were promulgated as a final rule on July 1, 1975 (40 FR 27802). In 1980, the Department invited public comment on 15 substantive issues arising out of its experience interpreting and implementing the regulations (45 FR 53). More than 450 public responses to that invitation were received and taken into consideration in the preparation of a 1983 NPRM (48 FR 38758). Approximately 150 comments were received in response to the NPRM and were taken into consideration in the preparation of the final rule released on June 9, 1987 (52 FR 21798).
The Department published a NPRM again in the
SAMHSA posted a document in the
In the
SAMHSA decided not to address issues pertaining to e-prescribing and PDMPs in this NPRM. SAMHSA concluded that the part 2 program e-prescribing and PDMPs are not ripe for rulemaking at this time due to the state of technology and because the majority of part 2 programs are not prescribing controlled substances electronically. SAMHSA intends to monitor developments in this area to see whether further action may be warranted in the future.
The intent of this NPRM is to propose revisions to key provisions of 42 CFR part 2 to modernize the regulations adopted in the June 1987 final rule and amended by the May 1995 final rule. This modernization is necessary because behavioral health, including substance use disorder treatment, is essential to overall health; the costs of untreated substance use disorders, both personal and societal, are substantial; and there continues to be a need for confidentiality protections that encourage patients to seek treatment without fear of compromising their privacy.
Individuals seeking treatment for substance use disorders often are met with a host of negative reactions including discrimination and harm to their reputations and relationships. In addition, there is a potential for serious civil and criminal consequences for the disclosure of patient identifying information associated with substance use disorders beyond the health care context. We are mindful of the intent of the governing statute (42 U.S.C. 290dd-2) and regulations at 42 CFR part 2, which is to protect the confidentiality of substance abuse patient records so as not to make an individual receiving treatment for a substance use disorder in a part 2 program more vulnerable by virtue of seeking treatment than an individual with a substance use disorder who does not seek treatment. SAMHSA strives to facilitate information exchange within new and emerging health and health care models, which promote integrated care and patient safety, while respecting the legitimate privacy concerns of patients seeking treatment for a substance use disorder due to the potential for discrimination, harm to their reputations and relationships, and serious civil and criminal consequences. SAMHSA also is mindful that any regulatory changes contemplated must be consistent with the authorizing legislation (42 U.S.C. 290dd-2) and its statutory intent.
This proposed rule also proposes editorial changes. SAMHSA deleted references to 42 U.S.C. 290ee-3 and 42 U.S.C. 290dd-3 in § 2.1, Statutory authority for confidentiality of drug abuse patient records, and § 2.2, Statutory authority for confidentiality of alcohol abuse patient records. Sections 290dd-3 and 290ee-3 were omitted by Public Law 102-321 and combined and renamed into Sections 290dd-2, Confidentiality of records. We also combined §§ 2.1 and 2.2 and propose to rename the new § 2.1 (Statutory authority for confidentiality of substance abuse patient records) and re-designate §§ 2.2-2.5. In addition, we deleted references to laws and regulations that have been repealed in § 2.21. Finally, we made editorial changes throughout the regulations to increase clarity and consistency.
Along with proposing substantive revisions to various sections of 42 CFR part 2, SAMHSA has proposed a number of technical, non-substantive changes for clarity and consistency that are reflected throughout the regulations. For the convenience of the public, SAMHSA is reprinting the text of 42 CFR part 2 in its entirety, which includes the proposed modifications incorporated into the existing provisions. SAMHSA, however, is only seeking comment on the proposed changes to the regulations that are discussed in the preamble of this NPRM. Sections of 42 CFR part 2 that have not been proposed for revision are not subject to review or comment under this NPRM.
In the current regulations, methadone programs are required to report violations of these regulations to the FDA.
We propose to revise the requirement (§ 2.5(b)) of reporting violations of these regulations by a methadone program to the FDA. The authority over methadone programs (now referred to as opioid treatment programs) was transferred from the FDA to SAMHSA in 2001 (66 FR 4076). Suspected violations of 42 CFR part 2 by opioid treatment programs may be reported to the U.S. Attorney's Office for the judicial district in which the violation occurred, as well as the SAMHSA office responsible for opioid treatment program oversight.
Certain defined terms in the current regulations are used inconsistently. SAMHSA also received inquiries regarding certain terms and how they apply to new health care models. In addition, the current regulations include definitions in four different sections (§§ 2.11, 2.12, 2.14 and 2.34).
SAMHSA proposes to consolidate all of the definitions, with the exception the definition of the term “Federally assisted,” in a single section at § 2.11. SAMHSA proposes to retain the definition of the term “Federally assisted” in the Applicability provision at § 2.12 for the purpose of clarity because it is key to understanding the applicability of 42 CFR part 2. We encourage readers to review all of the definitions, since a clear understanding of the regulations builds on an understanding of the definitions and their inter-relationships.
The current regulations define “Federally assisted” separately from the term “Program” but do not define the term “Part 2 program.” In addition, the terms “Program” and “federally assisted alcohol or drug abuse program” are used interchangeably. Therefore, SAMHSA proposes to define a “Part 2 program” as a federally assisted program (federally assisted as defined in § 2.12(b) and program as defined in § 2.11). See § 2.12(e)(1) for examples.
We proposed to retain the examples provided in § 2.12(e)(1) of the current regulations, with a clarification, because they explain the part 2 applicability and coverage.
SAMHSA proposes to replace the term “Program” with “Part 2 program,” where appropriate. For example, we propose to revise the definition of QSO, including replacing “Program” with “Part 2 program,” which is discussed in depth below (see Section III.B.2.b., Existing Definitions). We also propose to replace “Program” with “Part 2 program” in several other definitions, while making no additional changes.
Because of the addition of the “Part 2 program” definition, we also are proposing to define a “Part 2 program director” as:
• In the case of a part 2 program which is an individual, that individual, and
• In the case of a part 2 program which is an entity, the individual designated as director or managing director, or individual otherwise vested with authority to act as chief executive officer of the part 2 program.
We propose to delete the definition of “Program director.”
SAMHSA proposes to refer to alcohol abuse and drug abuse collectively as “Substance use disorder” and, when referring to the authorizing statute, use “substance abuse” since that is the term used in Title 42, United States Code, Section 290dd-2. SAMHSA also uses the term “substance abuse” when referencing information from other publications that use that term. SAMHSA proposes to use the term “Substance use disorder” to be consistent with recognized classification manuals, current diagnostic lexicon, and commonly used descriptive terminology, and, for consistency, proposes to revise the title of 42 CFR part 2 from “Confidentiality of Alcohol and Drug Abuse Patient Records” to “Confidentiality of Substance Use Disorder Patient Records.”
While SAMHSA proposes to delete the definitions of “Alcohol abuse” and “Drug abuse,” we continue to use the terms “Alcohol abuse” and “Drug abuse” when referring to 42 U.S.C. 290dd-3 and 42 U.S.C. 290ee-3 (omitted by Pub. L. 102-321 and combined and renamed into Section 290dd-2), respectively, because they are the terms used in the outdated statutes. See § 2.11 of the current regulations for definitions of the terms “Alcohol abuse” and “Drug abuse”.
SAMHSA proposes to define the term “Substance use disorder” in such a manner as to cover substance use disorders that can be associated with altered mental status that has the potential to lead to risky and/or socially prohibited behaviors, including, but not limited to, substances such as, alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives, hypnotics, anxiolytics, and stimulants. In addition, SAMHSA proposes to clarify that, for the purposes of these regulations, the definition excludes both tobacco and caffeine.
As noted in more detail in Section III.H., Consent Requirements, SAMHSA has heard a number of concerns from stakeholders regarding the current consent requirements in § 2.31 of the regulations. SAMHSA is proposing to revise the consent requirements to permit, in certain circumstances, a more general description of the individuals or entities to which a disclosure is made, but only if the individuals or entities have a treating provider relationship with the patient whose information is being disclosed. This change, therefore, creates a need to define a treating provider relationship.
A treating provider relationship begins when an individual seeks health-related assistance from an individual or entity who may provide assistance. However, the relationship is clearly established when the individual or entity agrees to undertake diagnosis, evaluation and/or treatment of the patient, or consultation with the patient, and the patient agrees to be treated, whether or not there has been an actual in-person encounter between the individual or entity and patient. A treating provider relationship with a patient may be established by a health care provider or another member of a health care team as long as the relationship meets the definition of “Treating provider relationship.”
A treating provider relationship means that, regardless of whether there has been an actual in-person encounter:
• A patient agrees to be diagnosed, evaluated and/or treated for any condition by an individual or entity, and
• The individual or entity agrees to undertake diagnosis, evaluation and/or treatment of the patient, or consultation with the patient, for any condition.
The term “agrees” as used in the definition does not necessarily imply a formal written agreement. An agreement might be evidenced, among other things, by making an appointment or by a telephone consultation.
SAMHSA proposes to update the terminology in § 2.34. We propose to delete the definition of “Detoxification treatment” and replace it with the definition of the currently acceptable term, “Withdrawal management.” We also propose to move this definition from § 2.34 to § 2.11 to consolidate definitions in one section of the regulations.
SAMHSA proposes to update terminology in existing definitions to accurately convey the meaning of terms and increase the understandability of the proposed rule. In addition, SAMHSA proposes to consolidate all but one of the defined terms in § 2.11.
SAMHSA proposes to update the terminology in § 2.34 and move this
We are proposing to revise the definition to incorporate currently accepted terminology.
We propose to define only one word, “Disclose,” since it is implied that the same definition applies to other forms of the word. We also propose to update terminology and make the definition clearer.
SAMHSA proposes to update the terminology in § 2.34 and move this definition from § 2.34 to § 2.11 to consolidate definitions.
SAMHSA proposes to update the terminology in § 2.34 and move this definition from § 2.34 to § 2.11 to consolidate definitions.
To emphasize that the term “Patient” refers to both current and former patients, SAMHSA proposes to revise the definition to provide that a patient is any individual who has applied for or been given diagnosis, treatment, or referral for treatment for a substance use disorder at a part 2 program. Patient includes any individual who, after arrest on a criminal charge, is identified as an individual with a substance use disorder in order to determine that individual's eligibility to participate in a part 2 program. This definition includes both current and former patients.
SAMHSA proposes to clarify that “Patient,” as used in this definition, is a defined term in § 2.11. In addition, SAMHSA deleted the words “and speed.” If the information could identify the patient, the speed with which it identifies the patient is not relevant.
The current definition of “Person” includes both individuals and entities. For the purpose of this proposed regulation, SAMHSA considers an “individual” to be a human being. SAMHSA proposes to revise the definition of “Person” to clearly indicate that “Person” is also referred to as individual and/or entity.
SAMHSA is proposing to make the following changes to the “Program” definition. First, because the current definition of “Program” includes both the terms “general medical care facility” and “general medical facility,” and because these terms are used interchangeably, we are proposing to consistently use the term “general medical facility.”
Second, more substance use disorder treatment services are occurring in general health care and integrated care settings, which are typically not covered under the current regulations. Providers who in the past offered only general or specialized health care services (other than substance use disorder services) now, on occasion, provide substance use disorder treatment services, but only as incident to the provision of general health care. Therefore, SAMHSA proposes to make clear that paragraph (1) of the definition of “Program” would
The inclusion of general medical practices with general medical facilities is consistent with SAMHSA's intention to ensure confidentiality protections and access to treatment for individuals whose identity as substance use disorder patients would be compromised if records of the specialized programs from which they seek treatment were not covered by these regulations while not unnecessarily imposing requirements on general medical facilities or practices in an overly broad manner.
Consistent with the definition of “Program”:
1. If a provider is
2. If the provider is an identified unit within a general medical facility or general medical practice, it is a “Program” if it holds itself out as providing,
3. If the provider consists of medical personnel or other staff in a general medical facility or general medical practice, it is a “Program” if its primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment
While the term “general medical facility” is not defined at 42 CFR 2.11 (Definitions), hospitals, trauma centers, or federally qualified health centers would generally be considered “general medical facilities.” Therefore, primary care providers who work in such facilities would only be covered by the part 2 definition of a “Program” if: (1) They work in an identified unit within such general medical facility that holds itself out as providing,
In addition, a practice comprised of primary care providers could be considered a “general medical practice.” As such, an identified unit within that general medical practice that holds itself out as providing
Finally, “Holds itself out” is currently not defined in § 2.11, Definitions. SAMHSA has previously published guidance relative to the term and proposes to add an explanation of “Holds itself out” to the Preamble discussion in § 2.12, Applicability. Consistent with that guidance, “Holds itself out” means any activity that would lead one to reasonably conclude that the individual or entity provides substance use disorder diagnosis, treatment, or referral for treatment including but not limited to:
• Authorization by the state or federal government (
• Advertisements, notices, or statements relative to such services, or
• Consultation activities relative to such services.
As is the case throughout these regulations, understanding all defined terms is important. In the case of the definition of “Program” and how it
A qualified service organization (QSO) is an individual or entity (see definition of “Person,” above) that provides a service to a part 2 program consistent with a qualified service organization agreement (QSOA). A QSOA is a two-way agreement between a part 2 program and the individual or entity providing the desired service. Under the current statutory authority, patient records pertaining to substance abuse may be shared only with the prior written consent of the patient or under a few limited exceptions that are specifically enumerated in 42 U.S.C. 290dd-2. However, § 2.12(c)(4) indicates that these restrictions on disclosure do not apply to communications between a part 2 program and a QSO regarding information needed by the QSO to provide services to the part 2 program consistent with the QSOA. Accordingly, SAMHSA has consistently articulated in applicable guidance that a QSO would be permitted to disclose the part 2 information to a contract agent if it needs to do so in order to provide the services described in the QSOA, and as long as the agent only discloses the information back to the QSO or the part 2 program from which the information originated. If a disclosure is made by the QSO to an agent acting on its behalf to perform the service, both the QSO and the agent are bound by the part 2 regulations, and neither organization can disclose the information except as permitted by part 2 and SAMHSA's interpretive guidance.
Recognizing the importance of population health management, SAMHSA proposes to revise the definition of QSO to include population health management in the list of examples of services a QSO may provide. Population health management refers to increasing desired health outcomes and conditions through monitoring and identifying individual patients within a group. To achieve the best outcomes, providers must supply proactive, preventive, and chronic care to all of their patients, both during and between encounters with the health care system. For patients with substance use disorders, who often have comorbid conditions, proactive, preventive, and chronic care is important to achieving desired outcomes.
Any QSOA executed between a part 2 program and an organization providing population health management services would be limited to the office or unit responsible for population health management in the organization (
SAMHSA's proposal to add population health management to the list of examples of the services that may be offered by a QSO is consistent with the Affordable Care Act (Patient Protection and Affordable Care Act of 2010 (Pub. L. 111-148)) and the HHS Strategic Plan FY 2014-2018 which includes the goals of improving health care and population health through meaningful use of health IT. We believe this revision would benefit patients' health, safety, and quality of life while maintaining the confidentiality protections that attach to the part 2 program's patient records.
SAMHSA also proposes to revise the term “medical services” as listed in the examples of permissible services offered by a QSO to clarify that it is limited to “medical staffing services.” SAMHSA proposes to make this revision to emphasize that QSOAs should not be used to avoid obtaining patient consent. Accordingly, a QSOA could be used by a part 2 program to contract with a provider of on-call coverage services (previously clarified in guidance) or other medical staffing services but could not be used to disclose John Doe's patient identifying information to his primary care doctor for the purpose of treatment (other than that provided under a QSOA for medical staffing services). However, an individual or entity who is prohibited from providing treatment to an individual patient under a QSOA, may still meet the requirements of having a treating provider relationship (based on the definition in § 2.11) with respect to the Consent Requirements in § 2.31. Likewise, care coordination was not added to the list of examples of permissible services offered by a QSO because care coordination has a patient treatment component.
Consistent with the goal of modernizing the regulations, SAMHSA proposes to revise the definition of “
As part of its effort to modernize these regulations, SAMHSA is proposing to delete the term, “management,” from the “Treatment” definition. In today's health care environment, “management” has a much broader meaning than it did when the regulations were last revised.
In addition to proposing changes to several definitions, we propose the following terminology changes. These changes are intended to ensure consistency in the use of terms throughout the regulations, and to increase the understandability of the proposed rule.
The current regulations use a variety of terms to refer to law enforcement (
For the purposes of this regulation, we also propose that the term “written” include both paper and electronic documentation. In addition, we propose to use the phrase “part 2 program or other lawful holder of patient identifying information” to refer to a part 2 program or other individual or entity that is in lawful possession of patient identifying information. A
A patient who has obtained a copy of their records or a family member who has received such information from a patient would not be considered a “lawful holder of patient identifying information” in this context. As stated in § 2.23(a), the regulations do not prohibit a part 2 program from giving a patient access to their own records, including the opportunity to inspect and copy any records that the part 2 program maintains about the patient. The part 2 program is not required to obtain a patient's written consent or other authorization under these regulations in order to provide such access to the patient or their legal representative.
The 1987 regulations (52 FR 21798) limited the applicability of 42 CFR part 2 to specialized programs, (
SAMHSA considered options for defining what information is covered by 42 CFR part 2, including the option of defining covered information based on the type of substance use disorder treatment services provided instead of the type of facility providing the services. SAMHSA, however, rejected that approach because more substance use disorder treatment services are occurring in general health care and integrated care settings, which typically are not covered under the current regulations. Providers who in the past offered only general or specialized health care services (other than substance use disorder services) now, on occasion, provide substance use disorder treatment services, but only as incident to the provision of general health care.
As discussed in Section III.B.2.b., Existing Definitions, we propose to revise the definition of “Program” to align it more closely with current health care delivery models. SAMHSA proposes to make clear that paragraph (1) of the definition of “Program” would not apply to “general medical facilities” and “general medical practices.” However, paragraphs (2) and (3) of the definition of “Program” would apply to “general medical facilities” and “general medical practices.”
SAMHSA also proposes to include the term “Part 2 program,” as discussed in Section III.B.2.a.i. The definition of “Program” in § 2.11 did not explicitly include “Federally assisted as defined in § 2.12(b)”. As a result, we are proposing to add a definition of “Part 2 program.” We propose to define the term and to use the term “Part 2 program,” where appropriate, throughout the proposed regulations.
This approach is consistent with the approach taken in 1987 because it essentially limits the applicability of 42 CFR part 2 to specialized programs, which simplifies the administration of the regulations without significantly affecting the incentive to seek treatment provided by the confidentiality protections. We do not foresee that the exclusion from part 2 coverage of health care providers who work in general medical practices and provide substance use disorder treatment services as incident to the provision of general health care would act as a deterrent to individuals seeking assistance for substance use disorders.
In addition, in the current regulation, § 2.12(d)(2)(iii), restrictions on disclosures apply to individuals or entities who have received patient records directly from part 2 programs. SAMHSA proposes to revise § 2.12(d)(2)(iii) so that restrictions on disclosures also apply to individuals or entities who receive patient records directly from other lawful holders of patient identifying information. This change is consistent with the discussion of “other lawful holder of patient identifying information” in the preamble discussion in Terminology Changes in Section III.B.2.c. and the proposed inclusion of this term in other sections of this NPRM. Patient records subject to these regulations include patient records maintained by part 2 programs as well as those records in the possession of “other lawful holders of patient identifying information.”
Currently, 42 CFR part 2 does not include a way for patients to determine to whom their records have been disclosed.
As discussed in Section G., Consent Requirements (§ 2.31), SAMHSA proposes to permit, in certain circumstances, the inclusion of a general designation in the “To Whom” section of the consent form. Specifically, in the case of an entity that does not have a treating provider relationship with the patient whose information is being disclosed, SAMHSA proposes to permit the designation of the name(s) of theentity(-ies) and a general designation of an individual or entity participant(s) or a class of participants that must be limited to those participants who have a treating provider relationship with the patient whose information is being disclosed. An entity without a treating provider relationship includes, for example, an entity that facilitates the exchange of health information (
SAMHSA is proposing to require that the list of disclosures include a list of the entities to which the information was disclosed pursuant a general designation. However, if entities that are required to comply with the List of Disclosures requirement wish to include individuals on the list of disclosures, in addition to the required data elements which are outlined in § 2.13(d)(2)(ii), nothing in this proposed rule prohibits it.
SAMHSA considered requiring both individuals and entities to be included on the list of disclosures but, after reviewing the Health Information Technology Privacy Committee's recommendations, decided to require, at a minimum, a list of entities. These recommendations addressed the HITECH requirement that HIPAA covered entities and business associates account for disclosures for treatment, payment, and health care operations made through an EHR. The Committee recommended, “that the content of the disclosure report be required to include only an entity name rather than a specific individual as proposed in the NPRM.” In addition, the report noted that the Organization for Economic Cooperation and Development (OECD) principles, the Fair Credit Reporting Act, and the Privacy Act of 1974 do not require that the names of individuals be provided.
SAMHSA proposes that individuals who received patient identifying information pursuant to the general designation on a consent form should be included on the List of Disclosures based on an entity affiliation, such as the name of their practice or place of employment. Patients who wish to know the name of the individual to whom their information was disclosed may ask the entity on the List of Disclosures to provide that information, however, 42 CFR part 2 would not require the entity to comply with a patient's request.
In order to allow time to develop, test, and implement advanced technology to more efficiently comply with this requirement, SAMHSA is proposing that the List of Disclosures requirement become effective two years after the effective date of the final rule. Some entities may be able to comply with this requirement without developing and implementing new technologies. In addition, entities that use and disclose primarily paper records could easily implement a system, if one does not already exist, such as a sign-out/sign-in log, that could be used to generate such a list. SAMHSA anticipates that there will be few requests based on the relatively small number of accounting requests that most covered entities have received to date under the HIPAA Accounting for Disclosures rule, according to some anecdotal reports.
SAMHSA is proposing that patient requests for a list of entities to which their information has been disclosed must be in writing and limited to disclosures made within the past two years. Consistent with the preamble discussion of terminology (§ 2.11, Definitions), “written” includes both paper and electronic documentation. A request letter addressed to the entity that disclosed the information might include language such as: “I am writing to request a list of the entities to which my information has been disclosed within the past two years. This request is consistent with 42 CFR 2.13, which also includes the requirements for your response. Thank you for your assistance.”
In addition, SAMHSA is proposing that entities named on the consent form that disclose information to their participants under the general designation (entities without a treating provider relationship that serve as intermediaries) must respond to requests for a list of disclosures in 30 or fewer calendar days of receipt of the request. Responses sent to the patient electronically may be sent by encrypted transmission (
Before using an unsecured method to respond to a request for a list of disclosures, an entity should take certain precautions, such as checking an email address for accuracy before sending it or sending an email alert to the patient for address confirmation to avoid unintended disclosures. Patients may also request that the entity communicate with them by an alternative means or at an alternative location. Responses sent by mail may be sent by United States Postal Service first class mail, an equivalent service, or a service with additional security features (
This proposed revision would facilitate patients' participation in advances in the health care delivery system by increasing their confidence that they could be informed, upon request, of who received their information pursuant to a general designation on the consent form.
In addition, confirming the identity of an individual who is not and has never been a patient while remaining silent on the identity of an actual patient could, by inference, compromise patient privacy. For example, if a reporter is inquiring about five individuals and only Mr. Smith is not and never has been a patient, by confirming that Mr. Smith is not and never has been a patient and remaining silent on the other four individuals, the part 2 program could enable the reporter to conclude that the other four individuals either are patients or have been patients. Therefore, SAMHSA is proposing to remove the concept from § 2.13(c)(2) that the regulations do not restrict a disclosure that an identified individual is not and never has been a patient. If confirming the identity of an individual who is not and never has been a patient, caution should be used so as not to make an inadvertent disclosure with respect to one or more other individuals. This proposed rule does not prohibit entities that receive a request for information about an individual from refusing to disclose any information regardless of whether the individual is or ever has been a patient(s).
Currently, the Security for Written Records section in § 2.16 addresses the maintenance, disclosure, access to, and
SAMHSA is proposing to modernize this section to address both paper and, in light of the steady increase in the adoption of health IT, electronic records. Specifically, SAMHSA proposes to revise the heading by deleting the word “written” so that it now reads: Security for Records. SAMHSA also proposes to clarify that this section requires both part 2 programs and other lawful holders of patient identifying information to have in place formal policies and procedures for the security of both paper and electronic records. These formal policies and procedures are intended to ensure protection of patient identifying information when records are exchanged electronically using health IT as well as when they are exchanged using paper records. The formal policies and procedures must reasonably protect against unauthorized uses and disclosures of patient identifying information and protect against reasonably anticipated threats or hazards to the security of patient identifying information. The formal policies and procedures must address, among other things, the sanitization of hard copy and electronic media, which is addressed in the preamble discussion of Disposition of Records by Discontinued Programs (§ 2.19). Suggested resources for part 2 programs and other lawful holders developing formal policies and procedures include materials from the HHS Office for Civil Rights (
The proposed regulations provide further guidance for these policies and procedures. Finally, we are proposing to replace language in other sections of the proposed rule with a reference to the policies and procedures established under § 2.16, where applicable.
As with § 2.16, the Disposition of Records by Discontinued Programs section in the current regulations do not address electronic records.
SAMHSA proposes to modernize this section to address both paper and electronic records. Specifically, we propose to address the disposition of both paper and electronic records by discontinued programs, and add requirements for sanitizing paper and electronic media. By sanitizing paper or electronic media, we mean to render the data stored on the media non-retrievable. Sanitizing electronic media is distinctly different from deleting electronic records and may involve clearing (using software or hardware products to overwrite media with non-sensitive data) or purging (degaussing or exposing the media to a strong magnetic field in order to disrupt the recorded magnetic domains) the information from the electronic media. If circumstances warrant the destruction of the electronic media prior to disposal, destruction methods may include disintegrating, pulverizing, melting, incinerating, or shredding the media. Because failure to ensure total destruction of patient identifying information may lead to the unauthorized disclosure of sensitive information regarding a patient's substance use disorder history, SAMHSA expects the process of sanitizing paper (including printer and FAX ribbons, drums, etc.) or electronic media to be permanent and irreversible, so that there is no reasonable risk that the information may be recovered. This result is best achieved by sanitizing the paper or electronic media in a manner consistent with the most current version of the NIST Special Publication 800-88,
Currently, § 2.22 lists the requirements of a notice to patients of the federal confidentiality requirements, including giving the patient a summary in writing of the federal law and regulations. As with other sections in the current regulations, this section requires that the notice to patients be in writing, but does not address electronic formats.
SAMHSA proposes to continue to require that patients be given a summary in writing of the federal law and regulations. Consistent with the Preamble discussion in Terminology Changes in Section III.B.2.c., the term “written” includes both paper and electronic documentation. We, therefore, propose to permit the notice to patients to be either on paper or in an electronic format. SAMHSA also proposes to require the statement regarding the reporting of violations to include contact information for the appropriate authorities. The reporting of any violation of these regulations may be directed to the U.S. Attorney for the judicial district in which the violation occurs and the report of any violation of these regulations by an opioid treatment program may also be directed to the SAMHSA office responsible for opioid treatment program oversight (see § 2.4 of the proposed rule). SAMHSA is considering whether to issue guidance at a later date that includes a sample notice.
Although it is not a proposed requirement, SAMHSA encourages the part 2 program to be sensitive to the cultural composition of its patient population when considering whether the notice should also be provided in a language(s) other than English (
SAMHSA has heard a number of concerns from individuals regarding the current consent requirements of 42 CFR part 2. In particular, stakeholders expressed concern that the current requirements for sharing patient records covered by part 2 deter patients from participating in HIEs, ACOs, CCOs, and similar organizations. While technical solutions for managing consent collection, such as data segmentation, are possible, they are not widely incorporated into existing systems.
SAMHSA examined the consent requirements in § 2.31 to explore options for facilitating the sharing of information within the health care context while ensuring the patient is fully informed and the necessary protections are in place. As a result, we propose several changes to this section. First, we propose to revise the section heading from “Form of written consent” to “Consent requirements.” SAMHSA also proposes to make revisions in three sections of the consent form requirements: The “To Whom” section, the “Amount and Kind” section, and the “From Whom” section. SAMHSA also is proposing to require a part 2 program or other lawful holder of patient identifying information to obtain written confirmation from the patient
As mentioned in Section III.C.2.a., New Definitions, SAMHSA is proposing to include a new definition of “Treating provider relationship” in § 2.11. Finally, as a result of these proposed revisions, we renumbered the subsections accordingly.
Section 2.31(a)(2) of the current regulations requires that a consent form include the name or title of the individual or the name of the organization to which disclosure is to be made as part of the patient's written consent to the disclosure of their records regulated by 42 CFR part 2. The intent of the specificity required in the “To Whom” section was for the patient to be able to identify, at the point of consent, exactly who they are authorizing to receive their information.
Some stakeholders have reported that the requirement in 42 CFR 2.31(a)(2) for the name of the individual or organization that will be the recipient of the patient identifying information makes it difficult to include programs covered by the regulations in organizations that facilitate the exchange of health information or coordinate care (
SAMHSA is proposing to move the current § 2.31(a)(2), “To Whom,” to § 2.31(a)(4). In the following discussion of the “To Whom” section of the consent form and in the regulatory text, SAMHSA makes a distinction between individuals and entities who have a treating provider relationship with the patient and those who do not. As discussed in § 2.11, SAMHSA proposes to define the term “Treating provider relationship” to provide that regardless of whether there has been an actual in-person encounter, (a) a patient agrees to be diagnosed, evaluated and/or treated for any condition by an individual or entity and (b) the individual or entity agrees to undertake diagnosis, evaluation and/or treatment of the patient, or consultation with the patient, for any condition.
Based on this definition, SAMHSA considers an entity to have a treating provider relationship with a patient if the entity employs or privileges one or more individuals who have a treating provider relationship with the patient.
SAMHSA is continuing to permit the name(s) of the individual(s) to whom a disclosure is to be made to be designated in the “To Whom” section of the consent form (
In the case of an entity that has a treating provider relationship with the patient whose information is being disclosed, SAMHSA is proposing to permit the designation of the name of the entity without requiring any further designations (as is required for an entity that does not have a treating provider relationship with the patient whose information is being disclosed, see below). For example, the consent form could specify any of the following names of entities: Lakeview County Hospital, ABC Health Care Clinic, or Jane Doe & Associates Medical Practice.
In the case of an entity that does not have a treating provider relationship with the patient whose information is being disclosed and is a third-party payer that requires patient identifying information for the purpose of reimbursement for services rendered to the patient by the part 2 program, SAMHSA proposes to permit the designation of the name of the entity (
In the case of an entity that does not have a treating provider relationship with the patient whose information is being disclosed and is not covered by § 2.31(a)(4)(iii) (
In the case of a research institution, a “participant” could be a clinical researcher with a treating provider relationship with the patient whose information is being disclosed, or a general researcher who does not have a treating provider relationship with the patient whose information is being disclosed. The clinical researcher could be included as “my treating provider” in a general designation on the consent form, whereas the general researcher would have to be named on the consent form. Alternatively, a research institution could obtain patient identifying information without consent if it meets the requirements in § 2.52.
If a general designation is used, the entity must have a mechanism in place to determine whether a treating provider relationship exists with the patient whose information is being disclosed.
Improving the quality of substance use disorder care depends on effective collaboration of mental health, substance use disorder, general health care, and other service providers in coordinating patient care. However, the composition of a health care team varies widely among entities. Because SAMHSA wants to ensure that patient identifying information is only disclosed to those individuals and entities on the health care team with a need to know this sensitive information, we are limiting a general designation to those individuals or entities with a treating provider relationship. Patients may further designate their treating providers as “past,” “current,” and/or “future” treating providers. In addition, a patient may designate, by name, one or more individuals on their health care team with whom they do not have a treating provider relationship.
SAMHSA proposes to balance the flexibility afforded by the general designation in the “To Whom” section by adding a new confidentiality safeguard: List of Disclosures (§ 2.13(d)). The List of Disclosures provision allows patients who have included a general designation in the “To Whom” section of their consent form to request and be provided a list of entities to which their information has been disclosed pursuant to the general designation. In addition, when using a general designation, a statement must be included on the consent form noting that, by signing the consent form, the patient confirms their understanding of the List of Disclosures provision.
Many new integrated care models rely on interoperable health IT and these proposed changes are expected to support the integration of substance use disorder treatment into primary and other specialty care, improving the patient experience, clinical outcomes, and patient safety while at the same time ensuring patient choice, confidentiality, and privacy.
The following table provides an overview of the options permitted when completing the designation in the “To Whom” section of the proposed consent form.
SAMHSA is seeking public comment on an alternative approach to the proposed required elements for the “To Whom” section of the consent form. The current part 2 required elements for the “To Whom” section of written consent are the name or title of the individual or the name of the organization to which the disclosure is to be made. The term “organization” is not defined in the current regulations, but SAMHSA has interpreted the term narrowly in guidance to mean that information can be sent to a lead organization but the information cannot flow from the lead organization to organization members or participants. Historically, that meant that all members or participants of an organization would need to be listed on the consent form and a new consent form would need to be obtained each time a new provider joined the organization.
SAMHSA's alternative approach reflects the same policy goal as the proposed regulation text (
Under this alternative approach, SAMHSA would add a definition of “organization” to § 2.11. Organization would mean, for purposes of § 2.31, (a) an organization that is a treating provider of the patient whose
Paragraph (a) of this definition relies on the definition of “Treating provider relationship” as defined in § 2.11. SAMHSA considers an organization to be a treating provider of a patient if the organization employs or privileges one or more individuals who have a treating provider relationship(s) with the “patient.”
Paragraph (b) of this definition refers to an organization that is not a treating provider of the patient whose information is being disclosed but that requires patient identifying information in connection with its role as a third-party payer for the purpose of reimbursement for services rendered to the patient (
Paragraph (c) of this definition refers to an organization that is not a treating provider of the patient whose information is being disclosed but that serves as an intermediary in implementing the patient consent. It permits these organizations to further disclose patient identifying information to its members or participants that have a treating provider relationship with the patient. It also allows the patient to specify further instructions for re-disclosure to the organization's members or participants.
In all instances, patient identifying information should only be disclosed to those individuals and organizations in accordance with the purpose stated by the patient on the signed consent form and only to those individuals with a need to know this sensitive information.
SAMHSA is seeking public comment on the advantages and disadvantages of this alternative approach as compared to SAMHSA's proposed approach. If commenters believe the definition of “organization” in the alternative approach should be broader, please include proposals for alternate or additional required elements for the consent form that facilitate the sharing of information within the health care context while ensuring the patient is fully informed of the individuals and organizations that potentially could receive their patient identifying information and that the necessary protections are in place.
To consider this alternative approach, SAMHSA would require resolution of several issues. Therefore, SAMHSA is also seeking public comment on the following questions:
(1) To allow patients to determine which specific members or participants are authorized to receive their information from an organization that serves an intermediary in paragraph (c) of the proposed organization definition in SAMSHA's alternative approach, what additional elements would need to be required on the consent form?
(2) How would the List of Disclosures requirement be applied under a broad definition of organization? Should the requirement be applied only to paragraph (c) of the proposed organization definition in SAMHSA's alternative approach or should different safeguards replace or supplement the List of Disclosures requirement?
Section 2.31(a)(5) currently requires the consent to include how much and what kind of information is to be disclosed. Because we are proposing to allow the “To Whom” section of the consent form to include a general designation under certain circumstances, we want patients to be aware of the information they are authorizing to disclose when they sign the consent form.
SAMHSA is proposing to move the current § 2.31(a)(5), “Amount and Kind,” to § 2.31(a)(3) and revise the provision to require the consent form to explicitly describe the substance use disorder-related information to be disclosed. The types of information that might be requested include diagnostic information, medications and dosages, lab tests, allergies, substance use history summaries, trauma history summary, employment information, living situation and social supports, and claims/encounter data. The designation of the “Amount and Kind” of information to be disclosed must have sufficient specificity to allow the disclosing program or other entity to comply with the request. For example, the description may include: “medications and dosages, including substance use disorder-related medications,” or “all of my substance use disorder-related claims/encounter data.” Examples of unacceptable descriptions would be “all of my records” (does not address the substance use disorder-related information to be disclosed) and “only my substance use disorder records my family knows about” (lacks specificity).
Section 2.31 currently requires the specific name or general designation of the program or person permitted to make the disclosure. In 1987, the requirement for the “From Whom” section of the consent form was broadened to the current requirement to permit a patient to consent to either a disclosure from a category of facilities or from a single specified program.
SAMHSA is proposing to move the current § 2.31(a)(1), “From Whom,” to § 2.31(a)(2). Because SAMHSA is now allowing, in certain instances, a general designation in the “To Whom” section of the consent form, we propose to require the “From Whom” section of the consent form to specifically name the part 2 program(s) or other lawful holder(s) of the patient identifying information permitted to make the disclosure. This revision would avoid any unintended consequences of including general designations in both the “From Whom” and “To Whom” sections. For example, the patient may be unaware of possible permutations of combining the two broad designations to which they are consenting, especially if these designations include future unnamed treating providers.
Currently, the consent requirements do not include any requirement that the patient confirms their understanding of the information on the consent form.
As discussed in the proposed revisions to the “To Whom” section, SAMHSA proposes to add two new requirements related to the patient's signing of the consent form. The first would require the part 2 program or other lawful holder of patient identifying information to include a statement on the consent form that the patient understands the terms of their consent. The second would require the part 2 program or other lawful holder of patient identifying information to include a statement on the consent form that the patient understands their right, pursuant to § 2.13(d), to request and be provided a list of entities to which their
There is confusion on the part of some providers as to how much of a patient's record is subject to 42 CFR part 2, which often leads to a decision to protect the entire record.
SAMHSA proposes to clarify that the prohibition on re-disclosure provision (§ 2.32) only applies to information that would identify, directly or indirectly, an individual as having been diagnosed, treated, or referred for treatment for a substance use disorder, such as indicated through standard medical codes, descriptive language, or both, and allows other health-related information shared by the part 2 program to be re-disclosed, if permissible under the applicable law. For example, if an individual receives substance use disorder treatment from a part 2 program and also receives treatment for a health condition such as high blood pressure, the individual's record would include information unrelated to their substance use disorder (i.e., high blood pressure). Part 2 does not prohibit re-disclosure of the information related to the high blood pressure as long as it does not include information that would identify the individual as having or having had a substance use disorder.
However, illnesses that are brought about by drug or alcohol abuse may reveal that a patient has a substance use disorder. For example, cirrhosis of the liver or pancreatitis could reveal a substance use disorder. Also, if a prescription for a medication used for substance use disorder treatment is revealed without further clarification of a non-substance disorder use (e.g., methadone used for the treatment of cancer), it would suggest that the individual has a substance use disorder and also would be prohibited.
If data provenance (the historical record of the data and its origins) reveals information that would identify, directly or indirectly, and individual as having or having had a substance use disorder, the information would be prohibited from being re-disclosed. For example, if the treatment location is a substance use disorder treatment clinic, this information would identify an individual as having had a substance use disorder and is therefore prohibited.
SAMHSA also proposed to clarify that the federal rules restrict any use of the information to criminally investigate or prosecute any patient with a substance use disorder, except as provided in § 2.12(c)(5).
In the current regulations, special rules are included for disclosures to prevent multiple enrollments in detoxification and maintenance treatment programs because these types of disclosure necessitate some adjustment of the basic written consent procedures in order to ensure maximum protection for patients. Under § 2.34, the timing, content, and use of the patient information is strictly limited in accordance with the purpose of the disclosure.
SAMHSA proposes to modernize section § 2.34 by updating terminology and revising corresponding definitions. SAMHSA also proposes to consolidate definitions by moving definitions from this section to Definitions in § 2.11, as discussed in Section III.B., Definitions.
SAMHSA is considering aligning the regulatory language with the statutory language regarding the medical emergency exception of 42 CFR part 2 (§ 2.51). The current regulations state that information may be disclosed without consent for the purpose of treating a condition which poses an immediate threat to the health of any individual and which requires immediate medical intervention. The statute, however, states that records may be disclosed “to medical personnel to the extent necessary to meet a bona fide medical emergency.”
SAMHSA proposes to adapt the medical emergency exception to give providers more discretion to determine when a “bona fide medical emergency” (42 U.S.C. 290dd-2(b)(2)(A)) exists. The proposed language states that patient identifying information may be disclosed to medical personnel to the extent necessary to meet a bona fide medical emergency, in which the patient's prior informed consent cannot be obtained.
SAMHSA proposes to continue to require the part 2 program to immediately document, in writing, specific information related to the medical emergency. Before a part 2 program enters into an affiliation with an HIE, it should consider whether the HIE has the capability to comply with all part 2 requirements, including the capacity to immediately notify the part 2 program when its records have been disclosed pursuant to a medical emergency. To promote compliance, SAMHSA recommends that the notification include all the information that the part 2 program is required to document in the patient's records (
Under the current regulations at § 2.52, only the program director (part 2 program director) may authorize the disclosure of patient identifying information for scientific research purposes to qualified personnel. Part 2 data may be derived from a variety of sources, including federal or state agencies that administer Medicare, Medicaid, or Children's Health Insurance Program (CHIP), part 2 programs, or other individuals or entities that have lawfully obtained the information and may wish to facilitate a sharing of the information for purposes of scientific research that would ultimately benefit substance use disorder patients/beneficiaries.
Along with fifteen other federal departments and agencies, HHS has announced proposed revisions to the regulations for protection of human subjects in research (Common Rule). An NPRM was published in the
First, we propose to revise the section heading by deleting the word “activities” (§ 2.52, Research). SAMHSA also proposes to revise the research exception to permit data protected by 42 CFR part 2 to be disclosed to qualified personnel for the purpose of conducting scientific research by a part 2 program or any other individual or entity that is in lawful possession of part 2 data (lawful holder of part 2 data). For example, these lawful holders of part 2 data could include third-party payers, HIEs, ACOs, and CCOs. Qualified personnel are those individuals who meet the requirements specified in the Research provision to receive part 2 data for the purpose of conducting scientific research. SAMHSA examined the existing regulations that protect human subjects in research and concluded that, if those requirements were fulfilled, 42 CFR part 2 would ensure confidentiality protections consistent with the Congressional intent, while providing the expanded authority for disclosing patient identifying information.
Under 42 CFR part 2, part 2 programs or other lawful holders of part 2 data are permitted to disclose patient identifying information for research with patient consent, or without patient consent under limited circumstances. SAMHSA is proposing to allow patient identifying information to be disclosed for purposes of scientific research: (1) If the researcher is a HIPAA covered entity or business associate and provides documentation that the researcher obtained research participants' authorization, or a waiver of research participants' authorization by an Institutional Review Board (IRB) or privacy board, for use or disclosure of information about them for research purposes consistent with the HIPAA Privacy Rule, (45 CFR 164.512(i)); or (2) if the researcher is subject to just the HHS Common Rule (45 CFR part 46, subpart A) and provides documentation that the researcher is in compliance with the requirements of the HHS Common Rule, including requirements relating to informed consent or a waiver of consent (45 CFR 46.111 and 46.116); or (3) if the researcher is both a HIPAA covered entity or business associate and subject to the HHS Common Rule, the researcher has met the requirements of both (1) and (2).
IRBs that are designated by an institution under an assurance of compliance approved for Federalwide use (referred to as Federalwide Assurance, or FWA) by HHS Office for Human Research Protections (OHRP) under § 46.103(a) and that review research involving human subjects conducted or supported by HHS must be registered with HHS. The FWA is the assurance from an institution engaging in HHS-conducted or -supported human subjects research regarding compliance with 45 CFR part 46. An institution must have an FWA to receive HHS support for research involving human subjects, and the FWA has to designate an IRB registered with OHRP, whether it is an internal or external IRB.
A privacy board is a review body that may be established to act upon requests for a waiver or an alteration of the requirement under the HIPAA Privacy Rule to obtain an individual's authorization for uses and disclosures of protected health information for a particular research study. Like an IRB, a privacy board may waive or alter all or part of the HIPAA authorization requirements for a specified research project or protocol, provided certain conditions are met as provided in 45 CFR 164.512(i).
Currently, much research involving human subjects operates under the HHS Common Rule (45 CFR part 46, subpart A). These regulations, which apply to HHS-conducted or -supported research or to institutions that have voluntarily extended their FWA to apply to all research regardless of funding, include protections to help ensure confidentiality. Under this rule, IRBs determine that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data before approving the research (45 CFR 46.111(a)(7)). IRBs can therefore address the requirements under the HIPAA Privacy Rule and the HHS Common Rule, which contain somewhat similar, but different sets of requirements. The proposed part 2 rules set out the requirements for a researcher conducting research with patient identifying information. Compliance with the HIPAA Privacy Rule and/or federal human subjects research protections, as set forth in the HHS Common Rule, where they apply, as well as the specific additional requirements in § 2.52(b) discussed below, is sufficient to meet the requirements for research disclosures under part 2.
SAMHSA also is proposing to address data linkages because the process of linking two or more streams of data opens up new research opportunities. For example, the practice of requesting data linkages from other data sources to study the longitudinal effects of treatment on patients is becoming widespread. SAMHSA is interested in affording patients protected by 42 CFR part 2 the same opportunity to benefit from these advanced research protocols while continuing to safeguard their privacy.
We propose to permit researchers to request to link data sets that include patient identifying information if: (1) The data linkage uses data from a federal data repository; and (2) the project, including a data protection plan, is reviewed and approved by an IRB registered with OHRP in accordance with 45 CFR part 46. This permissible disclosure would allow a researcher to disclose patient identifying information to a federal data repository and permit the federal data repository to link the patient identifying information to data held by that repository and return the linked data file back to the researcher. It would also ensure that patient privacy is considered, that the disclosure and use of identifiable data is justified, and that the research protocol includes an appropriate data protection plan. SAMHSA is proposing to limit the data repositories from which a researcher may request data for data linkages purposes to federal data repositories because federal agencies that maintain data repositories have policies and procedures in place to protect the security and confidentiality of the patient identifying information that must be submitted by a researcher in order to link the data sets. For example, in addition to meeting requirements under the HIPAA Rules and/or the HHS Common Rule, as applicable, requests for “research identifiable files” data from CMS require a Data Use Agreement and are reviewed by CMS's Privacy Board. CMS also has internal policies to protect the privacy and security of data received from the researcher, including the retention and destruction of that data. In addition, all federal agencies must comply with directives that protect sensitive data such as Office of Management and Budget Circular No. A-130, Appendix III—
SAMHSA is soliciting public input regarding whether to expand the data linkages provision beyond federal data repositories, what confidentiality, privacy, and security safeguards are in place for those non-federal data repositories, and whether those safeguards are sufficient to protect the security and confidentiality of the patient identifying information.
We invite stakeholders to provide input and recommendations on the specific policies, procedures, and other safeguards that non-federal data
1. Data use agreements (
2. A review by a privacy board or other regulatory body(-ies);
3. Internal security and privacy protections (both physical and electronic) for the confidentiality and security of data, including the retention and destruction of data received for data linkage purposes (
4. Security and privacy protections (both physical and electronic) for receiving and linking data (
5. Internal confidentiality agreements for staff members who have access to patient identifying information and other confidential data;
6. Laws and regulations governing functions and operations, including those that address security and privacy;
7. Capability to perform data linkages according to recognized standards; and
8. Other relevant safeguards.
SAMHSA also is requesting public comment on the following three sets of questions:
First, should state government, local government, private, and/or other non-federal data repositories (please address separately) that meet the criteria above be permitted to conduct data linkages?
Second, are there additional or alternative criteria that should be included in the list above? Are there specific categories of data repositories that are already required to provide similar safeguards? When providing categories of data repositories, please describe the safeguards that are already in place for those entities.
Third, how could it be ensured that data repositories providing data linkages are in compliance with criteria or standards concerning confidentiality, privacy, and security safeguards? Are there any regulatory or oversight bodies (including non-governmental and governmental) that currently oversee compliance with criteria or standards concerning confidentiality, privacy, and security safeguards of data in non-federal repositories?
A researcher may report findings in aggregate form from patient information that has been rendered non-identifiable as long as there are assurances in place that the information cannot be re-identified and possibly serve as an unauthorized means to identify a patient, directly or indirectly, as having or having had a substance use disorder.
SAMHSA is proposing to require any individual or entity conducting scientific research using patient identifying information to meet additional requirements to ensure compliance with confidentiality provisions under part 2. Among these are a provision (§ 2.52(b)(1)) that requires researchers to be fully bound by these regulations and, if necessary, to resist in judicial proceedings any efforts to obtain access to patient records except as permitted by these regulations. This requirement means that researchers involved in a judicial proceeding are only required to disclose patient identifying information pursuant to a subpoena that is accompanied by a court order. In addition, we have included a provision (§ 2.52(b)(2)) prohibiting researchers from re-disclosing patient identifying information except back to the individual or entity from whom that patient identifying information was obtained or as permitted under § 2.52(b)(4), the data linkages provision. With respect to this re-disclosure provision, an individual or entity from whom the patient identifying information was obtained does not refer to patients.
Finally, SAMHSA is proposing to address, in addition to the maintenance of part 2 data, the retention and disposal of such information used in research. SAMHSA is proposing to do so by expanding the provisions in § 2.16, Security for Records and referencing the policies and procedures established under § 2.16 in this section.
These proposed revisions would allow additional scientific research to be conducted that would facilitate continual quality improvement of part 2 programs and the important services they offer. In doing so, SAMHSA proposes to incorporate existing protections for human subjects research that are widely accepted.
Under the current Medicare or Medicaid audit or evaluation section at § 2.53, an audit or evaluation is limited to a civil investigation or administrative remedy by any federal, state, or local agency responsible for oversight of the Medicare or Medicaid program. It also includes administrative enforcement, against the program by the agency, or any remedy authorized by law to be imposed as a result of the findings of the investigation.
First, we propose to revise the section heading by deleting the word “activities” (§ 2.53, Audit and Evaluation). SAMHSA also proposes to modernize this section to include provisions for governing both paper and electronic patient records. In addition, we propose to revise the requirements for destroying patient identifying information by citing the expanded Security for Records section (§ 2.16). Furthermore, we propose to update the Medicare or Medicaid audit or evaluation subsection title to include CHIP and, in subsequent language, refer to Medicare, Medicaid and CHIP (SAMHSA has always applied this section to CHIP and is proposing to explicitly refer to it in the proposed regulation text).
SAMHSA proposes to permit the part 2 program, not just the part 2 program director, to determine who is qualified to conduct an audit or evaluation of the part 2 program in paragraph (a)(2). SAMHSA also proposes to permit an audit or evaluation necessary to meet the requirements of a CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE), under certain conditions. To ensure that patient identifying information is protected, the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) that is the subject of, or is conducting, the audit or evaluation must have a signed Participation Agreement with CMS which provides that the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must comply with all applicable provisions of 42 U.S.C 290dd-2 and 42 CFR part 2.
Under the Paperwork Reduction Act of 1995 (PRA), agencies are required to provide a 60-day notice in the
Under the PRA, the time, effort, and financial resources necessary to meet the information collection requirements referenced in this section are to be considered in rule making. We explicitly seek, and will consider, public comment on our assumptions as they relate to the PRA requirements summarized in this section.
This proposed rule includes changes to information collection requirements, that is, reporting, recordkeeping or third-party disclosure requirements, as defined under the PRA (5 CFR part 1320). Some of the provisions involve changes from the information collections set out in the previous regulations. Information collection requirements are: (1)
As described in greater detail in Section VI., Regulatory Impact Analysis, the respondents for the collection of information under 42 CFR 2.22 and 2.51 are publicly (federal, state, or local) funded, assisted, or regulated substance use disorder treatment programs. The estimate of the number of such programs (respondents) is based on the results of the 2013 N-SSATS, and the average number of annual total responses is based on 2010-2012 information on patient admissions reported to the Treatment Episode Data Set (TEDS), approved under OMB Control No. 0930-0106 and OMB Control No. 0930-0335.
The respondents for the collection of information under 42 CFR 2.13(d) are entities named on the consent form that disclose information to their participants pursuant to the general designation. These entities primarily would be organizations that facilitate the exchange of health information (
Because of the large number of public comments, we anticipate receiving on this
This proposed rule is necessary to modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations at 42 CFR part 2. The last substantive update to 42 CFR part 2 was in 1987. The part 2 laws were written out of great concern about the potential use of substance use disorder treatment information causing individuals with substance use disorders from seeking needed treatment. Over the last 25 years, significant changes have occurred within the U.S. health care system that were not envisioned by the current regulations, including new models of integrated care that are built on a foundation of information sharing to support coordination of patient care, the development of an electronic infrastructure for managing and exchanging patient data, and a new focus on performance measurement within the health care system. The goal of this proposed rule is to update 42 CFR part 2, and clarify the requirements associated with information exchange in these new health care models.
We have examined the impacts of this rule as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (March 22, 1995; Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999) and the Congressional Review Act (5 U.S.C. 804(2)). Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action that is likely to result in a rule: (1) Having an annual effect on the economy of $100 million or more in any 1 year, or adversely and materially affecting a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or state, local or tribal governments or communities (also referred to as “economically significant”); (2) creating a serious inconsistency or otherwise interfering with an action taken or planned by another agency; (3) materially altering the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raising novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order.
A regulatory impact analysis must be prepared for major rules with economically significant effects ($100 million or more in any 1 year). This rule does not reach the economic threshold and thus is not considered a major rule.
When estimating the total costs associated with changes to the 42 CFR part 2 regulations, we assumed five sets of costs: updates to health IT systems costs, costs for staff training and updates to training curriculum, costs to update patient consent forms, costs associated with providing patients a list of entities to which their information has been disclosed pursuant to a general designation on the consent form (
We estimate, therefore, that in the first year that the final rule is in effect, the costs associated with updates to 42 CFR part 2 would be $74,217,979. In year two, we estimate that costs would be $47,021,182. In years 3 through 10, we estimate the annual costs would be $14,835,444. Over the 10-year period of 2015-2024, the total undiscounted cost of the proposed changes would be $239,922,716 in 2015 dollars. When future costs are discounted at 3 percent or 7 percent per year, the total costs become approximately $220.9 million or $200.9 million, respectively. These costs are presented in the tables below.
The costs associated with the proposed revisions stem from staff training and updates to training curriculum, updates to patient consent forms, compliance with the List of Disclosures requirement (including implementation costs), and updates to health IT infrastructure for information exchange. Based on data from the 2013 N-SSATS, we estimate that 12,034 hospitals, outpatient treatment centers, and residential treatment facilities are covered by part 2. N-SSATS is an annual survey of U.S. substance abuse treatment facilities. Data is collected on facility location, characteristics, and service utilization. Not all treatment providers included in N-SSATs are believed to be under the jurisdiction of the part 2 regulations. The 12,034 number is a subset of the 14,148 substance abuse treatment facilities that responded to the 2013 N-SSATS, and includes all federally operated facilities, facilities that reported receiving public funding other than Medicare and Medicaid, facilities that reported accepting Medicare, Medicaid, TRICARE, and/or ATR voucher payments, or were SAMHSA-certified Opioid Treatment Programs. If a facility did not have at least one of these conditions, it was interpreted not to have received any federal funding and, therefore, not included in the estimate.
If an independently practicing clinician does not meet the requirements of paragraph (1) of the definition of Program (an individual or entity (other than a general medical facility or general medical practice) who holds itself out as providing and provides substance use disorder diagnosis, treatment or referral for treatment), they may be subject to 42 CFR part 2 if they constitute an identified unit within a general medical facility or general medical practice which holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment or if their primary function in the facility or practice is the provision of such services and they are identified as providing such services. Due to data limitations, it was not possible to estimate the costs for independently practicing providers covered by part 2 that did not participate in the 2013 N-SSATS. For example, data from ABAM provides the number of physicians since 2000 who have active ABAM certification. However, there is no source for the number of physicians who have not participated in the ABAM certification process. In addition, it is not possible to determine which ABAM-certified physicians practice in a general medical setting rather than in a specialty treatment facility that was already counted in the N-SSATS data.
Several provisions in the draft NPRM reference “other lawful holders of patient identifying information” in combination with part 2 programs. These other lawful holders must comply with part 2 requirements with respect to information they maintain that is covered by part 2 regulations. However, because this group could encompass a wide range of organizations, depending on whether they received part 2 data via patient consent or as a result of one of the limited exceptions to the consent requirement specified in the regulations, we are unable to include estimates regarding the number and type of these organizations and are only including part 2 programs in this analysis.
In addition to the part 2 programs described above, entities named on a consent form that disclose patient identifying information to their participants under the general designation must provide patients, upon request, a list of entities to which their information has been disclosed pursuant to a general designation. These entities primarily would include organizations that facilitate the exchange of health information (
There is no known baseline estimate of the current costs associated with 42 CFR part 2 compliance. Instead, SAMHSA estimated these cost based on a range of published costs associated with HIPAA implementation and compliance.
A Standard HIPAA training that meets or exceeds the federal training requirements is, on average, one hour long.
With regard to training materials, most part 2 programs are assumed to already have training curricula in place that covers current 42 CFR part 2 regulations, and, therefore, these facilities would only need to update existing training materials rather than develop new materials. The American Hospital Association estimated that the costs for the development of Privacy and Confidentiality training, which would include the development of training materials and instructor labor costs, was $16 per employee training hour in 2000.
Using SAMHSA's 2010-2012 TEDS average annual number of treatment admissions (n=1,861,693) as an estimate of the annual number of patients at part 2 programs and calculated staffing numbers based on a range of counseling staff-to-client ratios (
Updates to the 42 CFR part 2 regulations will need to be reflected in patient consent forms. Results from a 2008 study from the Mayo Clinic Health Care Systems
The updated part 2 regulations allow patients who have consented to disclose their identifying information using a general designation to request a list of entities to which their information has been disclosed pursuant to the general designation. Under this proposed rule, entities named on a consent form that disclose patient identifying information to their participants under the general designation would be required to provide a list of disclosures after receiving a patient request. Under the List of Disclosure requirements, a patient could make a request, for example, to an organization that facilitates the exchange of health information (
For purposes of this analysis, we assumed that entities disclosing patient identifying information to their participants pursuant to a patient's general designation on a consent form are already collecting the information necessary to comply with the List of Disclosure requirement, in some form, either electronically or using paper records. We also assumed that these entities could comply with the List of Disclosures requirement by either collecting this information electronically by using audit logs to obtain the required information or by keeping a paper record. However, to address possible concerns about technical feasibility and other implementation issues, SAMHSA is proposing that the List of Disclosures requirement become effective two years after the effective date of the final rule to allow entities collecting this information time to review their operations and business processes and to decide whether technological solutions are needed to enable them to more efficiently comply with the requirement.
In order to make preliminary estimates of the implementation costs, we first estimated the number of potentially impacted entities based on the anticipated number of patient requests for a disclosure report in a calendar year. We used the average number of substance abuse treatment admissions from SAMHSA's 2010-2012 TEDS (n = 1,861,693) as the number of patients treated annually by part 2 programs. We then used the average of a 0.1 and 2 percent patient request rate as our estimate of the number of impacted entities (n = 19,548).
From there, we assumed ten percent of the impacted entities would use paper records to comply with the disclosure reporting requirements (n = 1,995) and would have minimal implementation costs in years 1 and 2. Among the remaining entities, many may be able to comply with the disclosure reporting requirements without developing or implementing new technologies. For entities that do choose to either update their existing capabilities or develop and implement new technologies to facilitate compliance, we assumed two sets of costs: (1) Planning and policy development costs in year 1 and (2) system update costs in year 2.
Absent any data on the number of facilities that would require new technology or the type of technology to be implemented, we assumed that twenty-five percent (n = 4,398) of the remaining entities would choose to upgrade their existing health IT systems. The actual system upgrade costs will vary considerably based on the type of upgrades that are required. Some entities may only require minor system updates to streamline the reporting requirements, while others may choose to implement an entirely new system. Given these data limitations, we assumed an average, per-entity cost, of $2,500 for planning development costs in year 1 and an average, per-entity cost, of $8,000 for system upgrades in year 2. The implementation costs for List of Disclosure reporting compliance across are estimated to be $10,995,750 in year 1 (4,398 * $2,500) and $35,186,400 (4,398 * $8,000) in year 2.
Once the disclosure reporting requirements go into effect, we assumed that the majority of the costs associated with the List of Disclosures requirement would primarily come from staff time needed to prepare a list of disclosures upon a patient's request. We also assumed that the information would need to be converted to a format that is accessible to patients.
For those entities with a health IT system, we expected that disclosure information would be available in the system's audit log. We also assumed that, unless the audit log has some sort of electronic filtering system, it would contain information above and beyond the requirements for complying with a request for a list of disclosures. We have also assumed that the staff accessing and filtering an audit log to compile the information for lists of disclosures would be health information technicians. The average hourly rate for health information technicians is $18.68 an hour.
For entities using paper records to track disclosures, we expected that a staff member would need to gather and aggregate the requested list of disclosures from paper records. We assumed medical record technicians would be the staff with the primary responsibility for compiling the information for a list of disclosures. The average hourly rate for medical record technicians is $18.68 an hour.
The number of requests for a list of disclosures will determine the overall burden associated with the List of Disclosures reporting requirements. However, because this is a new requirement, there were no data on which to base an estimated number of requests per year. We expect that the rate of requests will be relatively low. We therefore calculated the total costs for two rates, 0.1 percent and 2 percent of patients per year.
We used the average number of substance abuse treatment admissions from SAMHSA's 2010-2012 TEDS as the number of patients treated annually by part 2 programs. Assuming that 10 percent of patients making requests (n = 186.17 to n = 3,723.39) would request a list of disclosures from entities that track disclosures through paper records and 90 percent of patients making requests (n = 1,675.52 to n = 33,510.47) would make such a request of entities that track disclosures through health IT audit logs, the estimated costs to develop lists of disclosures range from $20,865.86 to $417,317.10 for entities using paper records, and $250,390.26 to $5,007,805.23 for entities using audit logs. (These ranges reflect the costs based on the two estimated patient rates of request referenced above (
Once a list of disclosures has been produced, it can be returned to the patient either by email or mail. Since the method of sending the list of disclosures depends on patient preference, we assumed that 50 percent of the lists of disclosures would be sent by email and 50 percent by first-class mail. We assumed that mailing and supply costs related to list of disclosures notifications were $0.10 supply cost per notification and $0.49 postage cost per mailing. We also estimated that it would take an administrative staff member 15 minutes to prepare each list of disclosures for mailing and/or transmitting, and that staff preparing the letters earn $15.01
To produce the final overall cost estimate, we took the average of the minimum and maximum estimated costs to develop lists of disclosures by entities collecting the information electronically by using an audit log, and the average of the minimum and maximum estimated costs to develop lists of disclosures by entities using paper records. We then added the averages together to produce our estimate of the total cost to entities to develop lists of disclosures. Next we took the average of the minimum and maximum estimated costs for list of disclosures notifications sent via email and the minimum and maximum estimated costs for such notifications sent via first-class mail. We then added these two averages together to produce our estimate of the total cost to entities for list of disclosures notifications. Finally, the development and notification costs for these lists of disclosures were added together for the final estimate of costs associated with complying with List of Disclosure reporting requirements. The total cost for List of Disclosure reporting compliance across all entities was $3,000,661.88 in 2015 dollars. Complying with List of Disclosure requirements is assumed to be an ongoing, annual activity. Across the ten-year period, the total costs associated with the List of Disclosure reporting includes $10,995,750 in year 1, $35,186,400 in year 2, and $3,000,662 annually in years 3-10 for a total cost of $70,187,445 across the ten-year period.
SAMHSA, in collaboration with ONC and Federal and community stakeholders, has developed Consent2Share which is an open source tool for consent management and data segmentation that is designed to integrate with existing EHR and HIE systems. The Consent2Share architecture has a front-end, patient facing system known as Patient Consent Management and a backend control system known as Access Control Services. Communications with EHR vendors indicate that the cost to facilities of purchasing and installing additional functionality to existing electronic medical records applications, such as Consent2Share, typically range from $2,500 to $5,000. Because the add-on systems for part 2 programs may be more complex than standard patient monitoring systems, we estimate that the cost of adding the new functionality would be approximately $8,000 per facility. We also assumed that this
Furthermore, national estimates indicated that no more than 50 percent of substance use disorder treatment facilities have an operational “computerized administrative information system.”
The RFA requires agencies to analyze options for regulatory relief of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small governmental jurisdictions. Most hospitals and most other providers are small entities, either by nonprofit status or by having revenues of less than $7.5 million to $38.5 million in any 1 year. Individuals and states are not included in the definition of a small entity. We are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities. While the changes in the regulations would apply to all part 2 programs, the impact on these entities would be quite small. Specifically, as described in the Overall Impact section, the cost to part 2 programs associated with updates to 42 CFR part 2 in the first year that the final rule is in effect would be $74,217,979, a figure that, due to a number of one-time updates, is the highest for any of the 10 years estimated. The per-entity economic impact in the first year would be approximately $6,167 ($74,217,979 ÷ 12,034), a figure that is unlikely to represent 3% of revenues for 5% of impacted small entities. Consequently, it has been determined that the proposed regulations would not have a significant economic impact on small entities.
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 603 of the RFA. For purposes of section 1102(b) of the Act, we define a small rural hospital as a hospital that is located outside of a Metropolitan Statistical Area for Medicare payment regulations and has fewer than 100 beds. We are not preparing an analysis for section 1102(b) of the Act because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2014, that threshold is approximately $141 million. This rule would have no consequential effect on state, local, or tribal governments or on the private sector.
Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 are not applicable.
SAMHSA is proposing to modernize 42 CFR part 2. With respect to our proposal to revise the regulations, we do not believe that this proposal would have a significant impact as it gives more flexibility to individuals and entities covered by 42 CFR part 2 but also adds privacy protections within the consent requirements for the patient. We are making this proposal in response to concerns that 42 CFR part 2 is outdated and burdensome.
Executive Order 13132 on Federalism (August 4, 1999) establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on state and local governments, preempts state law, or otherwise has Federalism implications. We have reviewed this proposed rule under the threshold criteria of Executive Order 13132, Federalism, and have determined that it would not have substantial direct effects on the rights, roles, and responsibilities of states, local or tribal governments.
SAMHSA is proposing to modernize 42 CFR part 2. With respect to our proposal to revise the regulations, we do not believe that this proposal would have a significant impact as it gives more flexibility to individuals and entities covered by 42 CFR part 2 but also increases privacy protections within the consent requirements and adds an additional confidentiality safeguard for patients. This proposed rule does not reach the economic threshold for requiring a regulatory impact by Executive Orders 12866 and 13563 and thus is not considered a major rule. Likewise, we are not preparing an analysis for the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant economic impact on a substantial number of small entities. We are not preparing an analysis for section 1102(b) of the RFA because we have determined, and the Secretary certifies, that this proposed rule would not have a significant impact on the operations of a substantial number of small rural hospitals. This proposed rule would have no consequential effect on state, local, or tribal governments or on the private sector. Since this rule does not impose any costs on state or local governments, the requirements of Executive Order 13132 on federalism are not applicable.
We invite public comments on this section and request any additional data that would help us determine more accurately the impact on individuals and entities by the proposed rule. In accordance with the provisions of Executive Order 12866, this rule was reviewed by the OMB.
Alcohol abuse, Alcoholism, Drug abuse, Grant programs-health, Health records, Privacy, Reporting, and Recordkeeping requirements.
For the reasons stated in the preamble of this proposed rule, 42 CFR part 2 is proposed to be revised as follows:
42 U.S.C. 290dd-2.
Title 42, United States Code, Section 290dd-2(g) authorizes the Secretary to prescribe regulations. Such regulations may contain such definitions, and may provide for such safeguards and procedures, including procedures and criteria for the issuance and scope of orders, as in the judgment of the Secretary are necessary or proper to effectuate the purposes of this statute, to prevent circumvention or evasion thereof, or to facilitate compliance therewith.
(a)
(1) Subpart B of this part: General Provisions, including definitions, applicability, and general restrictions;
(2) Subpart C of this part: Disclosures with Patient Consent, including disclosures which require patient consent and the consent form requirements;
(3) Subpart D of this part: Disclosures without Patient Consent, including disclosures which do not require patient consent or an authorizing court order; and
(4) Subpart E of this part: Court Orders Authorizing Disclosure and Use, including disclosures and uses of patient records which may be made with an authorizing court order and the procedures and criteria for the entry and scope of those orders.
(b)
(2) These regulations are not intended to direct the manner in which substantive functions such as research, treatment, and evaluation are carried out. They are intended to ensure that a patient receiving treatment for a substance use disorder in a part 2 program is not made more vulnerable by reason of the availability of their patient record than an individual with a substance use disorder who does not seek treatment.
(3) Because there is a criminal penalty (a fine—see 42 U.S.C. 290dd-2(f) and § 2.3) for violating the regulations, they are to be construed strictly in favor of the potential violator in the same manner as a criminal statute (see
Under 42 U.S.C. 290dd-2(f), any person who violates any provision of that statute or these regulations shall be fined not more than $500 in the case of a first offense, and not more than $5,000 in the case of each subsequent offense.
(a) The report of any violation of these regulations may be directed to the United States Attorney for the judicial district in which the violation occurs.
(b) The report of any violation of these regulations by an opioid treatment program may be directed to the United States Attorney for the judicial district in which the violation occurs as well as to the Substance Abuse and Mental Health Services Administration (SAMHSA) office responsible for opioid treatment program oversight.
For purposes of these regulations:
(1) Who is a patient or employee of a part 2 program or who becomes a patient or employee of a part 2 program at the request of a law enforcement agency or official; and
(2) Who at the request of a law enforcement agency or official observes
(1) In the case of a part 2 program which is an individual, that individual.
(2) In the case of a part 2 program which is an entity, the individual designated as director or managing director, or individual otherwise vested with authority to act as chief executive officer of the part 2 program.
(1) An individual or entity (other than a general medical facility or general medical practice) who holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
(2) An identified unit within a general medical facility or general medical practice that holds itself out as providing, and provides, substance use disorder diagnosis, treatment, or referral for treatment; or
(3) Medical personnel or other staff in a general medical facility or general medical practice whose primary function is the provision of substance use disorder diagnosis, treatment, or referral for treatment and who are identified as such providers.
(1) Provides services to a part 2 program, such as data processing, bill collecting, dosage preparation, laboratory analyses, or legal, accounting, population health management, medical staffing, or other professional services, or services to prevent or treat child abuse or neglect, including training on nutrition and child care and individual and group therapy, and
(2) Has entered into a written agreement with a part 2 program under which that individual or entity:
(i) Acknowledges that in receiving, storing, processing, or otherwise dealing with any patient records from the part 2 program, it is fully bound by these regulations; and
(ii) If necessary, will resist in judicial proceedings any efforts to obtain access to patient identifying information related to substance use disorder diagnosis, treatment, or referral for treatment except as permitted by these regulations.
(1) A patient agrees to be diagnosed, evaluated and/or treated for any condition by an individual or entity; and
(2) The individual or entity agrees to undertake diagnosis, evaluation and/or treatment of the patient, or consultation with the patient, for any condition.
(a)
(i) Would identify a patient as having or having had a substance use disorder either directly, by reference to publicly available information, or through verification of such identification by another person; and
(ii) Is drug abuse information obtained by a federally assisted drug abuse program after March 20, 1972 (part 2 program), or is alcohol abuse information obtained by a federally assisted alcohol abuse program after May 13, 1974 (part 2 program); or if obtained before the pertinent date, is maintained by a part 2 program after that date as part of an ongoing treatment episode which extends past that date; for the purpose of treating a substance use disorder, making a diagnosis for that
(2)
(b)
(1) It is conducted in whole or in part, whether directly or by contract or otherwise by any department or agency of the United States (but see paragraphs (c)(1) and (2) of this section relating to the Department of Veterans Affairs and the Armed Forces);
(2) It is being carried out under a license, certification, registration, or other authorization granted by any department or agency of the United States including but not limited to:
(i) Participating provider in the Medicare program;
(ii) Authorization to conduct maintenance treatment or withdrawal management; or
(iii) Registration to dispense a substance under the Controlled Substances Act to the extent the controlled substance is used in the treatment of substance use disorders;
(3) It is supported by funds provided by any department or agency of the United States by being:
(i) A recipient of federal financial assistance in any form, including financial assistance which does not directly pay for the substance use disorder diagnosis, treatment, or referral for treatment; or
(ii) Conducted by a state or local government unit which, through general or special revenue sharing or other forms of assistance, receives federal funds which could be (but are not necessarily) spent for the substance use disorder program; or
(4) It is assisted by the Internal Revenue Service of the Department of the Treasury through the allowance of income tax deductions for contributions to the program or through the granting of tax exempt status to the program.
(c)
(2)
(i) Any interchange of that information within the Armed Forces; and
(ii) Any interchange of that information between the Armed Forces and those components of the Department of Veterans Affairs furnishing health care to veterans.
(3)
(i) Within a part 2 program; or
(ii) Between a part 2 program and an entity that has direct administrative control over the program.
(4)
(5)
(i) Are directly related to a patient's commission of a crime on the premises of the part 2 program or against part 2 program personnel or to a threat to commit such a crime; and
(ii) Are limited to the circumstances of the incident, including the patient status of the individual committing or threatening to commit the crime, that individual's name and address, and that individual's last known whereabouts.
(6)
(d)
(2)
(A) Third-party payers with regard to records disclosed to them by part 2 programs;
(B) Entities having direct administrative control over part 2 programs with regard to information that is subject to these regulations communicated to them by the part 2 program under paragraph (c)(3) of this section; and
(C) Individuals or entities who receive patient records directly from a part 2 program or other lawful holder of patient identifying information and who are notified of the prohibition on re-disclosure in accordance with § 2.32.
(ii) [Reserved]
(e)
(2)
(3)
(4)
(i) Diagnosis which is made solely for the purpose of providing evidence for use by law enforcement agencies or officials; or
(ii) A diagnosis of drug overdose or alcohol intoxication which clearly shows that the individual involved does not have a substance use disorder (
(a)
(b)
(c)
(2) Any answer to a request for a disclosure of patient records which is not permissible under these regulations must be made in a way that will not affirmatively reveal that an identified individual has been, or is being, diagnosed or treated for a substance use disorder. An inquiring party may be provided a copy of these regulations and advised that they restrict the disclosure of substance use disorder patient records, but may not be told affirmatively that the regulations restrict the disclosure of the records of an identified patient.
(d)
(1) Under this paragraph (d), patient requests:
(i) Must be made in writing; and
(ii) Are limited to disclosures made within the past two years;
(2) Under this paragraph (d), the entity named on the consent form that discloses information pursuant to a patient's general designation (the entity without a treating provider relationship that serves as an intermediary, as described in § 2.31(a)(4)(iv)) must:
(i) Respond in 30 or fewer days of receipt of the written request; and
(ii) Provide, for each disclosure, the name(s) of the entity(-ies) to which the disclosure was made, the date of the disclosure, and a brief description of the patient identifying information disclosed.
(a)
(b)
(2) Where state law requires parental consent to treatment, the fact of a minor's application for treatment may be communicated to the minor's parent, guardian, or other individual authorized under state law to act in the minor's behalf only if:
(i) The minor has given written consent to the disclosure in accordance with subpart C of this part; or
(ii) The minor lacks the capacity to make a rational choice regarding such consent as judged by the part 2 program director under paragraph (c) of this section.
(c)
(1) A minor applicant for services lacks capacity because of extreme youth or mental or physical condition to make a rational decision on whether to consent to a disclosure under subpart C of this part to their parent, guardian, or other individual authorized under state law to act in the minor's behalf; and
(2) The applicant's situation poses a substantial threat to the life or physical well-being of the applicant or any other individual which may be reduced by communicating relevant facts to the minor's parent, guardian, or other individual authorized under state law to act in the minor's behalf.
(a)
(2)
(b)
(2)
(a) The part 2 program or other lawful holder of patient identifying information must have in place formal policies and procedures to reasonably protect against unauthorized uses and disclosures of patient identifying information and to protect against reasonably anticipated threats or hazards to the security of patient identifying information. These formal policies and procedures must address:
(1) Paper records, including:
(i) Transferring and removing such records; and
(ii) Destroying such records, including sanitizing the hard copy media associated with the paper printouts, to render the patient identifying information non-retrievable; and
(iii) Maintaining such records in a secure room, locked file cabinet, safe, or other similar container, or storage facility when not in use; and
(iv) Using and accessing workstations, secure rooms, locked file cabinets, safes, or other similar containers, and storage facilities that use or store such information; and
(v) Rendering patient identifying information non-identifiable in a manner that creates a very low risk of re-identification (
(2) Electronic records, including:
(i) Copying, downloading, forwarding, transferring, and removing such records; and
(ii) Destroying such records, including sanitizing the electronic media on which it was stored, to render the patient identifying information non-retrievable; and
(iii) Maintaining such records; and
(iv) Using and accessing electronic records or other electronic media containing patient identifying information; and
(v) Rendering the patient identifying information non-identifiable in a manner that creates a very low risk of re-identification (
(b) [Reserved]
(a)
(b)
No person may require any patient to carry in their immediate possession while away from the part 2 program premises any card or other object which would identify the patient as having a substance use disorder. This section does not prohibit a person from requiring patients to use or carry cards or other identification objects on the premises of a part 2 program.
(a)
(1) The patient who is the subject of the records gives written consent (meeting the requirements of § 2.31) to a transfer of the records to the acquiring program or to any other program designated in the consent (the manner of obtaining this consent must minimize the likelihood of a disclosure of patient identifying information to a third party); or
(2) There is a legal requirement that the records be kept for a period specified by law which does not expire until after the discontinuation or acquisition of the part 2 program.
(b)
(1) Records, which are paper, must be:
(i) Sealed in envelopes or other containers labeled as follows: “Records of [insert name of program] required to be maintained under [insert citation to statute, regulation, court order or other legal authority requiring that records be kept] until a date not later than [insert appropriate date]”; and
(A) All hard copy media from which the paper records were produced, such as printer and facsimile ribbons, drums, etc., must be sanitized to render the data non-retrievable; and
(B) [Reserved]
(ii) Held under the restrictions of these regulations by a responsible person who must, as soon as practicable after the end of the retention period specified on the label, destroy the records and sanitize any associated hard copy media to render the patient identifying information non-retrievable in a manner consistent with the discontinued program's or acquiring program's policies and procedures established under § 2.16.
(2) Records, which are electronic, must be:
(i) Transferred to a portable electronic device with implemented encryption to encrypt the data at rest so that there is a low probability of assigning meaning without the use of a confidential process or key and implemented access controls for the confidential process or key; and
(A) All electronic media on which the patient records or patient identifying information resided prior to being transferred to the device, including email and other electronic communications, must be sanitized to render the patient identifying information non-retrievable in a manner consistent with the discontinued program's or acquiring program's policies and procedures established under § 2.16; and
(B) The device must be:
(
(
(C) The responsible person must be included on the access control list and be provided a means for decrypting the data. The responsible person must store the decryption tools on a device or at a location separate from the data they are used to encrypt or decrypt; and
(D) As soon as practicable after the end of the retention period specified on the label, the portable electronic device must be sanitized to render the patient identifying information non-retrievable consistent with the policies established under § 2.16.
(ii) [Reserved]
The statute authorizing these regulations (42 U.S.C. 290dd-2) does not preempt the field of law which they cover to the exclusion of all state laws in that field. If a disclosure permitted under these regulations is prohibited under state law, neither these regulations nor the authorizing statute may be construed to authorize any violation of that state law. However, no state law may either authorize or compel any disclosure prohibited by these regulations.
(a)
(b)
(a)
(1) Communicate to the patient that federal law and regulations protect the confidentiality of substance use disorder patient records; and
(2) Give to the patient a summary in writing of the federal law and regulations.
(b)
(1) A general description of the limited circumstances under which a part 2 program may acknowledge that an individual is present or disclose outside the part 2 program information identifying a patient as having or having had a substance use disorder.
(2) A statement that violation of the federal law and regulations by a part 2 program is a crime and that suspected violations may be reported to appropriate authorities consistent with § 2.4, along with contact information.
(3) A statement that information related to a patient's commission of a crime on the premises of the part 2 program or against personnel of the part 2 program is not protected.
(4) A statement that reports of suspected child abuse and neglect made under state law to appropriate state or local authorities are not protected.
(5) A citation to the federal law and regulations.
(c)
(a)
(b)
(a)
(1) The name of the patient.
(2) The name of the part 2 program(s) or other lawful holder(s) of the patient identifying information permitted to make the disclosure.
(3) How much and what kind of information is to be disclosed, including an explicit description of the substance use disorder information that may be disclosed.
(4)(i) The name(s) of the individual(s) to whom a disclosure is to be made; or
(ii) If the entity has a treating provider relationship with the patient whose information is being disclosed, such as a hospital, a health care clinic, or a private practice, the name of that entity; or
(iii) If the entity does not have a treating provider relationship with the patient whose information is being disclosed and is a third-party payer that requires patient identifying information for the purpose of reimbursement for services rendered to the patient by the part 2 program, the name of the entity; or
(iv) If the entity does not have a treating provider relationship with the patient whose information is being disclosed and is not covered by paragraph (a)(4)(iii) of this section, such as an entity that facilitates the exchange of health information or a research institution, the name(s) of the entity(-ies); and
(A) The name(s) of an individual participant(s); or
(B) The name(s) of an entity participant(s) that has a treating provider relationship with the patient whose information is being disclosed; or
(C) A general designation of an individual or entity participant(s) or class of participants that must be limited to a participant(s) who has a treating provider relationship with the patient whose information is being disclosed.
(
(
(5) The purpose of the disclosure.
(6) A statement that the patient (or other individual authorized to sign in lieu of the patient) confirms their understanding of the terms of their consent.
(7) A statement that the consent is subject to revocation at any time except to the extent that the part 2 program or other lawful holder of patient identifying information that is permitted to make the disclosure has already acted in reliance on it. Acting in reliance includes the provision of treatment services in reliance on a valid consent to disclose information to a third-party payer.
(8) The date, event, or condition upon which the consent will expire if not revoked before. This date, event, or condition must ensure that the consent will last no longer than reasonably necessary to serve the purpose for which it is provided.
(9) The signature of the patient and, when required for a patient who is a minor, the signature of an individual authorized to give consent under § 2.14; or, when required for a patient who is incompetent or deceased, the signature of an individual authorized to sign under § 2.15. Electronic signatures are permitted to the extent that they are not prohibited by any applicable law.
(10) The date on which the consent is signed.
(b)
(1) Has expired;
(2) On its face substantially fails to conform to any of the requirements set forth in paragraph (a) of this section;
(3) Is known to have been revoked; or
(4) Is known, or through reasonable diligence could be known, by the individual or entity holding the records to be materially false.
(a)
(b) [Reserved]
If a patient consents to a disclosure of their records under § 2.31, a program may disclose those records in accordance with that consent to any person identified in the consent, except that disclosures to central registries and in connection with criminal justice referrals must meet the requirements of §§ 2.34 and 2.35, respectively.
(a)
(1) The disclosure is made when:
(i) The patient is accepted for treatment;
(ii) The type or dosage of the drug is changed; or
(iii) The treatment is interrupted, resumed or terminated.
(2) The disclosure is limited to:
(i) Patient identifying information;
(ii) Type and dosage of the drug; and
(iii) Relevant dates.
(3) The disclosure is made with the patient's written consent meeting the requirements of § 2.31, except that:
(i) The consent must list the name and address of each central registry and each known withdrawal management or maintenance treatment program to which a disclosure will be made; and
(ii) The consent may authorize a disclosure to any withdrawal management or maintenance treatment
(b)
(c)
(1) The name, address, and telephone number of the member program(s) in which the patient is already enrolled to the inquiring member program; and
(2) The name, address, and telephone number of the inquiring member program to the member program(s) in which the patient is already enrolled. The member programs may communicate as necessary to verify that no error has been made and to prevent or eliminate any multiple enrollments.
(d)
(a) A part 2 program may disclose information about a patient to those individuals within the criminal justice system who have made participation in the part 2 program a condition of the disposition of any criminal proceedings against the patient or of the patient's parole or other release from custody if:
(1) The disclosure is made only to those individuals within the criminal justice system who have a need for the information in connection with their duty to monitor the patient's progress (
(2) The patient has signed a written consent meeting the requirements of § 2.31 (except paragraph (a)(8) which is inconsistent with the revocation provisions of paragraph (c) of this section) and the requirements of paragraphs (b) and (c) of this section.
(b)
(1) The anticipated length of the treatment;
(2) The type of criminal proceeding involved, the need for the information in connection with the final disposition of that proceeding, and when the final disposition will occur; and
(3) Such other factors as the part 2 program, the patient, and the individual(s) within the criminal justice system who will receive the disclosure consider pertinent.
(c)
(d)
(a)
(b)
(c)
(1) The name of the medical personnel to whom disclosure was made and their affiliation with any health care facility;
(2) The name of the individual making the disclosure;
(3) The date and time of the disclosure; and
(4) The nature of the emergency (or error, if the report was to FDA).
(a) Patient identifying information may be disclosed by the part 2 program or other lawful holder of part 2 data for the purpose of conducting scientific research if the individual designated as director or managing director, or individual otherwise vested with authority to act as chief executive officer or their designee makes a determination that the recipient of the patient identifying information:
(1) If a Health Insurance Portability and Accountability Act (HIPAA) covered entity or business associate, has obtained and documented authorization, or a waiver or alteration of authorization, consistent with the HIPAA privacy rule at 45 CFR 164.512(i); or
(2) If subject to the HHS regulations regarding the protection of human subjects (45 CFR part 46), provides documentation that the researcher is in compliance with the requirements of the HHS regulations, including the requirements related to informed consent or a waiver of consent (45 CFR 46.111 and 46.116); or
(3) If both a HIPAA covered entity or business associate and subject to the HHS regulations regarding the protection of human subjects, has met the requirements of paragraphs (a)(1) and (2) of this section; and
(b) Any individual or entity conducting scientific research using patient identifying information obtained under paragraph (a) of this section:
(1) Is fully bound by these regulations and, if necessary, will resist in judicial proceedings any efforts to obtain access to patient records except as permitted by these regulations.
(2) Must not re-disclose patient identifying information except back to the individual or entity from whom that patient identifying information was obtained or as permitted under paragraph (b)(4) of this section.
(3) May include part 2 data in reports only in aggregate form to limit the
(4) That requests linkages to data sets from a federal data repository(-ies) holding patient identifying information must have the request reviewed and approved by an Institutional Review Board (IRB) registered with the Department of Health and Human Services, Office for Human Research Protections in accordance with 45 CFR part 46 to ensure that patient privacy is considered and the need for identifiable data is justified.
(i) Upon request, the researcher may be required to provide evidence of the IRB approval of the research project that contains the data linkage component.
(ii) Except as provided in paragraph (b) of this section, a researcher may not use patient identifying information for data linkages purposes.
(5) Must maintain and destroy patient identifying information in accordance with the security policies and procedures established under § 2.16.
(6) Must retain records in compliance with applicable federal, state, and local record retention laws.
(a)
(1) Performs the audit or evaluation on behalf of:
(i) Any federal, state, or local government agency which provides financial assistance to the part 2 program or is authorized by law to regulate its activities; or
(ii) Any individual or entity who provides financial assistance to the part 2 program, which is a third-party payer covering patients in the part 2 program, or which is a quality improvement organization performing a utilization or quality control review; or
(2) Is determined by the part 2 program to be qualified to conduct an audit or evaluation of the part 2 program.
(b)
(1) Agrees in writing to:
(i) Maintain and destroy the patient identifying information in a manner consistent with the policies and procedures established under § 2.16;
(ii) Retain records in compliance with applicable federal, state, and local record retention laws; and
(iii) Comply with the limitations on disclosure and use in paragraph (d) of this section; and
(2) Performs the audit or evaluation on behalf of:
(i) Any federal, state, or local government agency which provides financial assistance to the part 2 program or is authorized by law to regulate its activities; or
(ii) Any individual or entity who provides financial assistance to the part 2 program, which is a third-party payer covering patients in the part 2 program, or which is a quality improvement organization performing a utilization or quality control review.
(c)
(i) Maintain and destroy the patient identifying information in a manner consistent with the policies and procedures established under § 2.16;
(ii) Retain records in compliance with applicable federal, state, and local record retention laws; and
(iii) Comply with the limitations on disclosure and use in paragraph (d) of this section.
(2) A Medicare, Medicaid, or CHIP audit or evaluation under this section includes a civil or administrative investigation of a part 2 program by any federal, state, or local government agency with oversight responsibilities for Medicare, Medicaid, or CHIP and includes administrative enforcement, against the part 2 program by the government agency, of any remedy authorized by law to be imposed as a result of the findings of the investigation.
(3) An audit or evaluation necessary to meet the requirements for a CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must be conducted in accordance with the following:
(i) A CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must:
(A) Have in place administrative and clinical systems; and
(B) Have in place a leadership and management structure, including a governing body and chief executive officer with responsibility for oversight of the organization's management and for ensuring compliance with and adherence to the terms and conditions of the Participation Agreement with CMS; and
(ii) A CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) must have a signed Participation Agreement with CMS, which provides that the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE):
(A) Is subject to periodic evaluations by CMS, or is required by CMS to evaluate participants in the CMS-regulated ACO or similar CMS-regulated organization (including a CMS-regulated QE) relative to CMS-defined or approved quality and/or cost measures;
(B) Must designate an executive who has the authority to legally bind the organization to ensure compliance with 42 U.S.C. 290dd-2 and this part and the terms and conditions of the Participation Agreement in order to receive patient identifying information from CMS;
(C) Agrees to comply with all applicable provisions of 42 U.S.C. 290dd-2 and this part;
(D) Must ensure that any audit or evaluation involving patient identifying information occurs in a confidential and controlled setting approved by the designated executive;
(E) Must ensure that any communications or reports or other documents resulting from an audit or evaluation under this section do not allow for the direct or indirect identification of a patient as having or having had a substance use disorder; and
(F) Must establish policies and procedures to protect the confidentiality of the patient identifying information consistent with this part, the terms and conditions of the Participation Agreement, and the requirements set forth in paragraph (c)(1) of this section.
(4) Program, as defined in § 2.11, includes an employee of, or provider of medical services under the program
(5) If a disclosure to an individual or entity is authorized under this section for a Medicare, Medicaid, or CHIP audit or evaluation, including a civil investigation or administrative remedy, as those terms are used in paragraph (c)(2) of this section, then a quality improvement organization which obtains the information under paragraph (a) or (b) of this section may disclose the information to that individual or entity but only for the purpose of conducting a Medicare, Medicaid, or CHIP audit or evaluation.
(6) The provisions of this paragraph do not authorize the part 2 program, the federal, state, or local government agency, or any other individual or entity to disclose or use patient identifying information obtained during the audit or evaluation for any purposes other than those necessary to complete the audit or evaluation as specified in paragraph (c) of this section.
(d)
(a)
(b)
(2) An authorizing court order is entered under these regulations, but the person authorized does not want to make the disclosure. If there is no subpoena or other compulsory process or a subpoena for the records has expired or been quashed, that person may refuse to make the disclosure. Upon the entry of a valid subpoena or other compulsory process the person authorized to disclose must disclose, unless there is a valid legal defense to the process other than the confidentiality restrictions of these regulations.
A court order under these regulations may not authorize qualified personnel, who have received patient identifying information without consent for the purpose of conducting research, audit or evaluation, to disclose that information or use it to conduct any criminal investigation or prosecution of a patient. However, a court order under § 2.66 may authorize disclosure and use of records to investigate or prosecute qualified personnel holding the records.
(a) A court order under these regulations may authorize disclosure of confidential communications made by a patient to a part 2 program in the course of diagnosis, treatment, or referral for treatment only if:
(1) The disclosure is necessary to protect against an existing threat to life or of serious bodily injury, including circumstances which constitute suspected child abuse and neglect and verbal threats against third parties;
(2) The disclosure is necessary in connection with investigation or prosecution of an extremely serious crime, such as one which directly threatens loss of life or serious bodily injury, including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, or child abuse and neglect; or
(3) The disclosure is in connection with litigation or an administrative proceeding in which the patient offers testimony or other evidence pertaining to the content of the confidential communications.
(b) [Reserved]
(a)
(b)
(1) Adequate notice in a manner which will not disclose patient identifying information to other persons; and
(2) An opportunity to file a written response to the application, or to appear in person, for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order.
(c)
(d)
(1) Other ways of obtaining the information are not available or would not be effective; and
(2) The public interest and need for the disclosure outweigh the potential injury to the patient, the physician-patient relationship and the treatment services.
(e)
(1) Limit disclosure to those parts of the patient's record which are essential to fulfill the objective of the order;
(2) Limit disclosure to those persons whose need for information is the basis for the order; and
(3) Include such other measures as are necessary to limit disclosure for the protection of the patient, the physician-
(a)
(b)
(1) Adequate notice (in a manner which will not disclose patient identifying information to other persons) of an application by a law enforcement agency or official;
(2) An opportunity to appear and be heard for the limited purpose of providing evidence on the statutory and regulatory criteria for the issuance of the court order; and
(3) An opportunity to be represented by counsel independent of counsel for an applicant who is a law enforcement agency or official.
(c)
(d)
(1) The crime involved is extremely serious, such as one which causes or directly threatens loss of life or serious bodily injury including homicide, rape, kidnapping, armed robbery, assault with a deadly weapon, and child abuse and neglect.
(2) There is a reasonable likelihood that the records will disclose information of substantial value in the investigation or prosecution.
(3) Other ways of obtaining the information are not available or would not be effective.
(4) The potential injury to the patient, to the physician-patient relationship and to the ability of the part 2 program to provide services to other patients is outweighed by the public interest and the need for the disclosure.
(5) If the applicant is a law enforcement agency or official that:
(i) The person holding the records has been afforded the opportunity to be represented by independent counsel; and
(ii) Any person holding the records which is an entity within federal, state, or local government has in fact been represented by counsel independent of the applicant.
(e)
(1) Limit disclosure and use to those parts of the patient's record which are essential to fulfill the objective of the order;
(2) Limit disclosure to those law enforcement and prosecutorial officials who are responsible for, or are conducting, the investigation or prosecution, and limit their use of the records to investigation and prosecution of extremely serious crime or suspected crime specified in the application; and
(3) Include such other measures as are necessary to limit disclosure and use to the fulfillment of only that public interest and need found by the court.
(a)
(2) The application may be filed separately or as part of a pending civil or criminal action against a part 2 program or the person holding the records (or agents or employees of the part 2 program or person holding the records) in which it appears that the patient records are needed to provide material evidence. The application must use a fictitious name, such as John Doe, to refer to any patient and may not contain or otherwise disclose any patient identifying information unless the court has ordered the record of the proceeding sealed from public scrutiny or the patient has provided a written consent (meeting the requirements of § 2.31) to that disclosure.
(b)
(c)
(d)
(2) No information obtained under this section may be used to conduct any investigation or prosecution of a patient, or be used as the basis for an application for an order under § 2.65.
(a)
(b)
(1) The part 2 program director is involved in the criminal activities to be investigated by the undercover agent or informant; or
(2) The part 2 program director will intentionally or unintentionally disclose the proposed placement of an undercover agent or informant to the employees or agents who are suspected of criminal activities.
(c)
(1) There is reason to believe that an employee or agent of the part 2 program is engaged in criminal activity;
(2) Other ways of obtaining evidence of this criminal activity are not available or would not be effective; and
(3) The public interest and need for the placement of an undercover agent or informant in the part 2 program outweigh the potential injury to patients of the part 2 program, physician-patient relationships and the treatment services.
(d)
(1) Specifically authorize the placement of an undercover agent or an informant;
(2) Limit the total period of the placement to six months;
(3) Prohibit the undercover agent or informant from disclosing any patient identifying information obtained from the placement except as necessary to criminally investigate or prosecute employees or agents of the part 2 program; and
(4) Include any other measures which are appropriate to limit any potential disruption of the part 2 program by the placement and any potential for a real or apparent breach of patient confidentiality; for example, sealing from public scrutiny the record of any proceeding for which disclosure of a patient's record has been ordered.
(e)
| 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 |